JOURNAL TRANSCRIPT

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Official Journal of the Malaysian Medical Association

The Medical Journal of Malaysia Patient Registry Supplement

Volume: 63 Supplement C September 2008

ISSN 0300-5283 PP 2121/12/08 (020757) MITA(P) 124/1/91

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MJM

Official Journal of the Malaysian Medical Association Volume 63

Supplement C September 2008

EDITORIAL BOARD Editor-in-Chief Azhar Md Zain Editorial Advisor John T Arokiasamy

Editor Lim Kean Ghee

Members Abdul Hamid Abdul Kadir

Members Sim Kui Hian

Members H Krishna Kumar

Sivalingam Nalliah

Lim Thiam Aun

Zabidi Azhar Mohd Hussin

S Fadilah Abdul Wahid

Siva Achanna

Harvinder Singh

Gurdeep Singh Mann

Tan Si Yen

Kelvin Lim L ye Hock

Ex-officio Teoh Siang Chin PP 2121/12/2008 (020757)

Administrative Officer (Publications) Matilda Cruz MCI (P) 124/1/91

ISSN 0300-5283

The Medical Journal of Malaysia is published five times a year i.e. March, June, August, October and December. All articles which are published, including editorials, letters and book reviews represent the opinion of the authors and are not necessarily those of the Malaysian Medical Association unless otherwise expressed.

Copyright reserved © 1998 Malaysian Medical Association

Adver tisement Rates: Enquiries to be directed to the Secretariat.

Subscription Rates: Price per copy is RM70.00 or RM300.00 per annum, for all subscribers.

Secretariat Address: Malaysian Medical Association 4th Floor, MMA House, 124, Jalan Pahang, 53000 Kuala Lumpur. P.O. Box S-20, 51700 Kuala Lumpur. Tel: (03) 4042 0617, 4041 8972, 4041 1375 Fax: (03) 4041 8187 E-mail: [email protected] / [email protected] Website: www.mma.org.my Printed by: New Voyager Corporation Sdn. Bhd. (514424 U) 37 Jalan Gangsa SD 5/3D, Bandar Sri Damansara, 52200 Kuala Lumpur. Tel: 03–6272 2097, 6273 2900 Fax: 03–6272 2380

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The Medical Journal of Malaysia

MJM NOTICE TO CONTRIBUTORS The Medical Journal of Malaysia welcomes articles of interest on all aspects of medicine in the form of original papers, research notes, communications and correspondence. The MJM also welcomes brief abstracts, of not more than 50 words, of original papers published elsewhere, concerning medicine in Malaysia. Articles are accepted for publication on condition that they are contributed solely to The Medical Journal of Malaysia. Neither the Editorial Board nor the Publishers accept responsibility for the views and statements of authors expressed in their contributions. The Editorial Board further reserves the right to reject papers read before a society. To avoid delays in publication, authors are advised to adhere closely to the instructions given below. Manuscripts: All manuscripts should be submitted in triplicate to: Hon Editor Medical Journal of Malaysia Malaysian Medical Association 4th Floor, MMA House,124, Jalan Pahang 53000 Kuala Lumpur Manuscripts should be typed on one side of A4 paper and doublespaced throughout (including tables, legends and references), with wide margins. An electric typewriter, letter quality or laser printer should be used. Do not use dot-matrix printer. ‘San Serif’ typefaces/fonts such as Helvetica are preferred. The title page should state the title of the paper, initials and name(s) of the author(s), degrees (limited to one degree or diploma) and address(es). The name and address of the author for correspondence should be clearly indicated. Names of authors should be written in style of initials followed by the surname or preferred name e.g., K G Lim for Lim Kean Ghee or B S Gendeh for Balwant Singh Gendeh. For those without surnames, the MJM would like to suggest that authors use their given name in place of their surname e.g. M Z Azhar for Azhar bin Md Zain, K Suresh for Suresh Kumarasamy or S Harwant for Harwant Singh. Authors however, who have previously published should try as much as possible to keep the abbreviation of their name consistent. Summary, Introduction, Materials and Methods, Results, Discussion, Acknowledgment and References should follow each section beginning on a fresh page. Papers may be submitted in Bahasa Malaysia but must be accompanied by a short summary in English. Scientific names, foreign words and Greek symbols should be clearly indicated and underlined. Reviewers: Authors may submit the names of two possible reviewers whom they feel are qualified and suitable to review their paper, who are not involved in the work presented, and from another institution. This may hasten the process of peer review. Authors need not obtain the permission of these possible reviewers’ as it is both the responsibility and perogative of the MJM to approach them. Case Reports: Papers on case reports (one to five cases) must follow these rules: maximum of 1,000 words; only one table is allowed; maximum of two photographs; only up to five references quoted. Having a unique lesson in the diagnosis, pathology or management of the case is more valuable than mere finding a rare entity. Being

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able to report the outcome and length of survival of a rare problem is more valuable than merely describing what treatment was rendered at the time of diagnosis. Photographs of Patients: Proof of permission and/or consent from the patient must be submitted with the manuscript. A statement on this must be included as a footnote to the relevant photograph. Short Communications: Short communications should not exceed 1,000 words and shall consist of a Summary and the Main Text. The number of figures and tables should be limited to three and the number of references to five. Letters to Editor: Such correspondence must not exceed 450 words. Summary and Key Words: A summary of not more than 100 words should be provided immediately after the title page. Below the summary, provide and identify 3 to 10 key words or short phrases that will assist indexers in cross-indexing your article. Use terms from the medical subject headings list from Index Medicus where possible. Introduction: Clearly state the purpose of the article. Summarise the rationale for the study or observation. Give only strictly pertinent references, and do not review the subject extensively. Materials and Methods: Describe your selection of the observational or experimental subjects (patients or experimental animals, including controls) clearly, identify the methods, apparatus (manufacturer’s name and address in parenthesis), and procedures in sufficient detail to allow other workers to reproduce the results. Give references to established methods, including statistical methods; provide references and brief descriptions of methods that have been published but are not wellknown; describe new or substantially modified methods, give reasons for using them and evaluate their limitations. Identify precisely all drugs and chemicals used, including generic name(s), dosage(s) and route(s) of administration. Do not use patients’ names, initials or hospital numbers. Include numbers of observation and the statistical significance of the findings when appropriate. When appropriate, particularly in the case of clinical trials, state clearly that the experimental design has received the approval of the relevant ethical committee. Results: Present your results in logical sequence in the text, tables and illustrations. Do not repeat in the text all the data in the tables or illustrations, or both: emphasise or summarise only important observations. Discussion: Emphasise the new and important aspects of the study and conclusions that follow from them. Do no repeat in detail data given in the Results section. Include in the Discussion the implications of the findings and their limitations and relate the observations to other relevant studies.

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The Medical Journal of Malaysia Conclusion: Link the conclusions with the goals of the study but avoid unqualified statements and conclusions not completely supported by your data. Avoid claiming priority and alluding to work that has not been completed. State new hypotheses when warranted, but clearly label them as such. Recommendations, when appropriate, may be included. Acknowledgements: Acknowledge grants awarded in aid of the study (state the number of the grant, name and location of the institution or organisation), as well as persons who have contributed significantly to the study. Authors are responsible for obtaining written permission from everyone acknowledged by name, as readers may infer their endorsement of the data. References: Number references consecutively in the order in which they are first mentioned in the text. Identify references in text, tables and legends by Arabic numerals (in parenthesis). References cited only in tables or legends to figures should be numbered in accordance with a sequence established by the first identification in the text of the particular table or illustration. Use the form of references adopted by the US National Library of Medicine and used in the Index Medicus. Use the style of the examples cited at the end of this section, which have been approved by the National Library of Medicine. The titles of journals should be abbreviated according to the style used in the Index Medicus. Try to avoid using abstracts as references; "unpublished observations" and "personal communications" may not be used as references, although references to written, not verbal, communication may be inserted (in parenthesis) in the text. Include among the references manuscripts accepted but not yet published; designate the journal followed by "in press" (in parenthesis). Information from manuscripts should be cited in the text as "unpublished observations" (in parenthesis). The references must be verified by the author(s) against the original documents. List all authors when six or less; when seven or more list only first three and add et al. Examples of correct forms of references are given below: Journals: 1. Standard Journal Article Soter NA, Wasserman SI, Austen KF et al. Cold uticaria: release into the circulation of histamine and eosinophil chemotaxic factor of anaphylaxis during cold challenge. New Engl J Med 1976; 294 : 687 - 90. 2. Corporate Author The Committee on Enzymes of the Scandinavian Society of Clinical Chemistry and Clinical Physiology. Recommended method for the determination of gammaglutamyltransferase in blood. Scand J Clin Lab Invest 1976; 36: 119 -25. Books and Other Monographs: 3. Personal Author(s) Osler AG. Complement: mechanisms and functions. Englewood Cliffs: Prentice-Hall, 1976. 4. Corporate Author American Medical Association Department of Drugs. AMA drug evaluation (3rd ed.) Littleton: Publishing Sciences Group, 1977. 5. Editor, Compiler, Chairman as Author Rhodes AJ, Van Rooyen CE (comps). Textbook of virology: For students and practitioners of medicine and the other health sciences (5th ed). Baltimore: Williams & Wilkins, 1968. Med J Malaysia Vol 63 Supplement C September 2008

6. Chapter in Book Weinstein L, Swartz MN. Pathogenic properties of invading microorganisms. In: Sodeman WAJr, Sodeman WA (eds). Pathologic physiology: mechanisms of disease. Philadelphia: WB Saunders, 1974; 457 - 72. 7. Agency Publication National Care for Health Statistics. Acute conditions: incidence and associated disability, United States, July1968 - June 1969. Rockville, Me: National Centre for Health Statistics, 1972. (Vital and health statistics). Series 10: data from the National Health Survey, No 69). (DHEW Publication No (HSM) 72 - 1036). Other Articles: 8. Newspaper Article Shaffer RA. Advances in chemistry are starting to unlock mysteries of the brain: discoveries could help cure alcoholism and insomnia, explain mental illness. However, the messengers work. Wall Street Journal 1977; Aug 12: 1(col 1), 10 (col 1). 9. Magazine Article Roucehe B. Annals of medicine: the Santa Claus culture. The New Yorker 1971; Sep 4: 66 - 81). Tables and illustrations: Roman numerals should be used for numbering tables. Arabic numerals should be used when numbering illustrations and diagrams. Illustrations and tables should be kept to a minimum. All tables, illustrations and diagrams should be fully labelled so that each is comprehensible without reference to the text. All measurements should be reported using the metric system. Each table should be typed on a separate sheet of paper, doublespaced and numbered consecutively. Omit internal horizontal and vertical rules. The contents of all tables should be carefully checked to ensure that all totals and subtotals tally. All illustrations and diagrams should be in Indian ink on separate sheets of thick, smooth, white paper of Bristol board or in the form of photographs printed on glossy paper and should be 12.7cm x 17.3cm but not larger than 20.3cm x 25.4cm. They should bear, on the reverse side, the author’s name, short title of the paper, the figure number and an arrow indicating the top of each illustration. All illustrations and diagrams should be referred to as "Figures" and numbered consecutively. Their approximate position in the text should be indicated. Legends and captions should be typed on separate sheets and numbered correspondingly. Whenever possible, please include all data used for construction of graphs in order to ensure clarity or reproduction. Colour reproduction: Illustrations and diagrams are normally reproduced in black and white only. Colour reproductions can be included if so required and upon request. However, a nominal charge must be paid by the authors for this additional service; the charges to be determined as and when on a per article basis. Colour illustrations and diagrams should be supplied in the form of colour positive photographic prints or slides. All other specifications should be as for normal illustrations and diagrams, as noted above. Abbreviations: Use only standard abbreviations. The full term for which an abbreviation stands should precede its first use in the text, unless it is a standard unit of measurement. Reprints: 25 copies of the article will be supplied free of charge to the leading author. Requests for additional reprints should be made to the MMA Secretariat. A nominal charge will be levied for each additional reprint.

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CONTENTS

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• Patient Registries in Malaysia and the Role of the Clinical Research Centre of the Ministry of Health

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M S Pillay, A Noor Hisham, M Z Zaki Morad, T O Lim, H Jamaiyah, S P Jaya Purany

• A Report of the Malaysian Dialysis Registry of the National Renal Registry, Malaysia

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Y N Lim, T O Lim, D G Lee, H S Wong, L M Ong, W Shaariah, G Rozina, Z Morad

• National Transplant Registry

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L S Hooi, M Lela Yasmin

• The Malaysian Liver Registry: A Database of the Common Liver Diseases

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S S Tan, I Merican

• The National Mental Health Registry (NMHR)

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A A Aziz, A A Salina, A B Abdul Kadir, Y Badiah, Y C Cheah, A Nor Hayati, Z Z Ruzanna, S M Sharifah Suziah, K Y Chee

• Report of the Malaysian Registry of Renal Biopsy (MRRB)

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R Yahya, S Bavanandan, Y C Yap, W Jazilah, W Shaariah, H S Wong, D G Lee

• National Eye Database – A Web Based Surveillance System

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P P Goh, H Elias, N NorFariza, I Mariam, on behalf of the National Eye Database Steering Committee

• Status of Diabetic Retinopathy Among Diabetics Registered to the Diabetic Eye Registry, National Eye Database, 2007

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P P Goh, for the National Eye Database Study Group

• Acute Coronary Syndrome (ACS) Registry - Leading the Charge for National Cardiovascular Disease (NCVD) Database

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S P Chin, S Jeyaindran, R Azhari, W A Wan Azman, I Omar, Z Robaayah, K H Sim

• A National Database on Children and Adolescent with Diabetes (e-DiCARE): Results from April 2006 to June 2007

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M Z Fuziah, Janet Y H Hong, H Zanariah, F Harun, S P Chan, P Rokiah, L L Wu, R Rahmah, H Jamaiyah, A Geeta, W S Chen, B Adam

• The Foundation of NCVD PCI Registry: The Malaysia’s First Multi-Centre Interventional Cardiology Project

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H B Liew, M A Rosli, W A Wan Azman, Z Robaayah, K H Sim, on behalf of the NCVD PCI investigators

• National Trauma Database (NTrD) – Improving Trauma Care: First Year Report

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F J Sabariah, N Ramesh, A W Mahathar

• National Suicide Registry Malaysia (NSRM)

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A N Hayati, A K Kamarul

• National Cancer Patient Registry - A Patient Registry/ Clinical Database to Evaluate the Health Outcomes of Patients Undergoing Treatment for Cancers in Malaysia

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G C C Lim, D Azura

• New Registry: National Cancer Patient Registry - Colorectal Cancer

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L Wendy, M Radzi

• Nasopharyngeal Carcinoma Database

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K C Pua, A S B Khoo, Y Y Yap, S K Subramaniam, C A Ong, G Gopala Krishnan, H Shahid, The Malaysian, Nasopharyngeal Carcinoma Study Group

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CONTENTS • Preliminary Results from the Pilot Study on the National Cancer Patient Registry - Cervical Cancer

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C R Devi Beena, T S Tang, L C C Gerard

• National Cancer Patient Registry- Haematology Malignancy (NCPR-HM)

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K M Chang, T C Ong

• Malaysian Psoriasis Registry – Preliminary Report of a Pilot Study Using a Newly Revised Registry Form

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C C Chang, H B Gangaram, S H Hussein

• National Cancer Patient Registry-Breast Cancer (NCPR-Breast Cancer)

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E Nor Aina

• National Orthopedic Registry in Malaysia - National Orthopedic Hip Fracture Database (NOHFD)

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A Muhammad Anwar Hau

• National Orthopedic Registry in Malaysia – National Orthopedics Diabetic Hand and Foot Database (NODFD)

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A Muhammad Anwar Hau

• An Audit of Diabetes Control and Management (ADCM)

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I Mastura, H Zanariah, I Fatanah, M Feisul Idzwan, M Y Wan Shaariah, H Jamaiyah, A Geeta

• Malaysian Cardiothoracic Surgery Registry - A Patient Registry to Evaluate the Health Outcomes of Patients Undergoing Surgery for Cardiothoracic Diseases in Malaysia

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R Anas, I Rahman, H Jahizah, A Hassan, T Ezani, Y H Jong, E Norzalina, G Ziyadi, S Balan, J Ramdzan, T O Lim, H Jamaiyah, H Hidayah

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FOREWORD

Epidemiological data derived from patient registries is the basis for clinical research as the information compiled is vital for clinicians and investigators to structure and develop trials to suit local demographics. A well-established patient registry would provide a clear depiction of the incidence, prevalence and progression of a particular disease. This is especially imperative for critical illnesses and diseases with high morbidity and mortality rates such as renal disease, cardiovascular conditions and cancer. As such, I am proud to note, that in addition to state-of-the-art medical technology and an advanced healthcare system, we have progressively developed and are managing numerous patient registries. These registries are comprehensively covered in this supplement which can easily be utilised to promote clinical research in Malaysia. We should bear in mind that despite modern medical infrastructure, efficient logistics for trial supplies and ready access to GCP-certified and English-literate medical professionals in various therapeutic areas, Malaysia still offers a low cost and competitive alternative for multinational corporations such as contract research organisations and pharmaceutical companies to conduct their trials. These companies are constantly on the look out for favourable spots, and as such, it is our duty to try to maximise efforts to make Malaysia the chosen destination for clinical trials in Asia and the production of publications such as this is essential. I am aware that the successful completion of this project is as a result of the dedication and hard work of all those involved. As such, I extend my appreciation to the personnel of each registry, the editorial team and the reviewers, all of whom brought us this publication. I thank the offices of my previous Deputy Director-General of Health (Research and Technical Support); Datuk Dr Ir MS Pillay, and the Secretariat of the National Institute of Health; Dr Asmaliza Binti Ismail whose support and encouragement were instrumental in bringing this endeavour to this stage. My gratitude also goes to the Clinical Research Centre (CRC), for their excellent organisation of this major collaborative effort. We, in the Ministry of Health, always strive to improve patients’ outcome, which is also the mission statement of CRC. Ultimately, our aim is to ensure and safeguard the health of our nation and patient registries provide the foundation for clinical and healthcare policies, for the implementation of treatment guidelines and for the evaluation of drug safety profiles.

…………………………………….……………………………… Tan Sri Dato’ Seri Dr Hj. Mohd Ismail Merican Director-General of Health Malaysia

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FOREWORD

This supplement on Patient Registries is indeed a timely and necessary step in promoting Malaysia as a clinical research hub in Asia. The publication showcases some of our very own home-grown Patient Registries. While it may not be well known, some of the registries have been around for some time; indeed the National Renal Registry (NRR) has been running for 15 years. There are also newer registries like the Diabetes in Children and Adolescents Registry (DiCARE) which has just launched its first report. Evidence derived from Randomised Control Trial (RCT) is said to be the gold standard. However there are instances where it is nearly impossible to conduct a RCT, either due to ethical and/or logistical reasons. Here is where Patient Registries provide the solution; using ‘real world’ evidence on effectiveness or cost effectiveness of intervention. For diseases requiring in-hospital care, like Myocardial Infarction, the National Cardiovascular Disease (NCVD) Registry (which incorporates all the main heart care centres in the country) would be able to give a fair estimate of the nation’s disease burden. This is true only if all institutions agree to share their data. In this manner, Malaysia, and Malaysian doctors, will be self reliant in terms of our own data and our own evidence. The many patient registries that are available are well designed and cover multi-centre data, encouraging uniformity and collaboration between public and private healthcare providers. These registries would be able to provide useful and robust data of clinical practice; giving snapshots of disease demographics, its management, the patients’ outcome and resource utilisation for the nation. The effort put forth by the Clinical Research Centre in facilitating clinical groups with their various Patients Registries is commendable. I am happy to note that the good office of the previous Deputy Director-General of Health (Research and Technical support), Datuk Dr Ir MS Pillay, has provided generous support in this endeavour. Thanks also to the Secretariat of the National Institute of Health; Dr Asmaliza Binti Ismail and her team. I take this opportunity to congratulate all registries who have contributed to this publication and to express special thanks to all the reviewers for their wonderful work. Lastly, I must express my gratitude to the editorial committee for successfully putting everything together to make this supplement as comprehensive as possible. I believe that patient registries have established their role in our health care system, and I am sure that the publication of this supplement will stimulate further research and bring about munificent benefits.

……………………………………. Dr Maimunah Abdul Hamid Acting Deputy Director General of Health (Research and Technical support) Date : 12 September 2008

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MMA House, 2nd Floor, 124, Jalan Pahang, 53000 Kuala Lumpur. Tel/Fax: 03 4042 8924 Email: [email protected]

(749349-T)

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Patient Registries in Malaysia and the Role of the Clinical Research Centre of the Ministry of Health M S Pillay*, A Noor Hisham**, M Z Zaki Morad***, T O Lim****, H Jamaiyah****, S P Jaya Purany**** *Pejabat Timbalan Ketua Pengarah (Sokongan Teknikal), Kementerian Kesihatan Malaysia, Aras 12, Blok E7, Parcel E, Pusat Pentadbiran Kerajaan Persekutuan, 62590 Putrajaya, **Pejabat Timbalan Ketua Pengarah (Perubatan), Kementerian Kesihatan Malaysia, Aras 7, Blok E7, Parcel E, Pusat Pentadbiran Kerajaan Persekutuan, 62590 Putrajaya,***International Medical University, No 126, Jalan 19/155B, Bukit Jalil, 57000 Kuala Lumpur,****Clinical Research Centre, Tingkat 3, Blok Dermatologi, Hospital Kuala Lumpur, 50586 Kuala Lumpur, Malaysia

INTRODUCTION A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and others) to evaluate specified outcomes for a population defined by a particular disease or therapy (target disease or therapy), and that serves one or more predetermined scientific, clinical, or policy purposes 1. The resulting clinical database describes a file (or files) derived from the registry. Patient registries have four common objectives. These are to: 1. Describe the natural history of the target disease. 2. Determine clinical and cost effectiveness of treatments for the target disease. 3. Monitor safety and harm of therapeutic products and services for target disease. 4. Evaluate access to and quality of healthcare for the target disease.

Natural history of the target disease Patient registry data from real-world clinical setting is ideally suited to describe the characteristics of patients, the healthcare they had received, and the resulting long term patient survival and quality of life outcomes. The data are also useful for describing the variation in patient care and outcomes across different patient groups, clinical practices, healthcare sectors or geographic regions, and the secular trend over time of such variations in Malaysia. Clinical and cost effectiveness of treatments for the target disease Patient registry data from real-world clinical practices in Malaysia is also useful for determining the clinical and cost effectiveness of treatments provided. Multiple studies 2,3 have demonstrated disparities between the results of clinical trials and results in actual clinical practice. Furthermore, efficacy in a clinical trial for a well-defined population may not be generalizable to the Malaysian population. The registry is also particularly useful for tracking effectiveness outcomes for a longer time period than is typically feasible with clinical trials. Beyond clinical effectiveness, registry may also be designed to collect resource use and cost data for the same patients to be used in modeling cost effectiveness. Cost effectiveness refers to a means to describe the comparative value of a health care

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product or service in terms of its ability to achieve a desired outcome for a given unit of resources 4.

Monitoring the safety and harm of therapeutic products and services for the target disease. Patient registry can serve as an active surveillance system for the occurrence of unexpected or harmful events for products and services. Patient registries offer several advantages for active surveillance. First, the current practice of spontaneous reporting of adverse events relies on a nonsystematic recognition of an adverse event by a clinician and the active effort by the clinician to make a report to manufacturers and health authorities. Second, these events are generally reported without a denominator (i.e., the exposed population), and therefore an incidence level is difficult to determine. Because patient registries can provide systematic data on adverse events and the incidence of these events, they are being used with increasing frequency in the areas of health care products and services 5. Evaluating access to and quality of healthcare for the target disease. Patient registry data can be used to assess differences between providers or patient populations based on performance measures that compare treatments provided or outcomes achieved with “gold standards” (e.g., evidence-based guidelines) or comparative benchmarks for specific health outcomes (e.g., risk-adjusted survival rates). Such programs may be used to identify disparities in access to care, demonstrate opportunities for improvement, establish differentials for payment by third parties, or provide transparency through public reporting. Patient registry is clearly a powerful tool to observe the course of disease; to understand variations in treatment and outcomes; to examine factors that influence prognosis and quality of life; to describe care patterns, including appropriateness of care, access to treatments and disparities in delivery of care; to assess effectiveness; to monitor safety; and to change behavior through feedback of data. Its benefits are evident from several perspectives: • For clinicians, registries can collect data about disease presentation and outcomes on large numbers of patients

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rapidly, thereby producing a real-world picture of disease. This establishes the evidence base to underpin clinicians’ demand for more resources to better treat their patients. For academic organization or medical association, a registry might assess the degree to which clinicians are managing a disease in accordance with evidence-based guidelines, focus attention on specific aspects of a particular disease that might otherwise be overlooked, or provide data for clinicians to compare themselves with their peers. From policy-makers and payers’ perspective, registries can provide detailed information from large numbers of patients on how procedures, devices, or pharmaceuticals are actually used and on their effectiveness in different populations. This information may be useful to drive resource allocation for under served therapeutic groups and for determining coverage or reimbursement policies. For a drug or device manufacturer, a registry might demonstrate the performance of a product in the real world, meet a post-marketing study commitment, develop hypotheses, or identify patient populations that will be useful for product development, clinical trials design, and patient recruitment. The U.S. Food and Drug Administration (FDA) has noted that “through the creation of registries, a sponsor can evaluate safety signals identified from spontaneous case reports, literature reports, or other sources, and evaluate the factors that affect the risk of adverse outcomes such as dose, timing of exposure, or patient characteristics.” 5

Setting up a patient registr y in Malaysia It takes much to set up and operate a patient registry. Key success factors are: 1. An able leadership, typically the well respected keyopinion leaders in the relevant clinical discipline, to galvanize the commitment of all stakeholders. 2. Source Data Providers (SDP) buy-in are obviously crucial. SDPs are the individual clinicians or clinical departments who report the required data to the registry. Patient registries however also receive data from other sources such as other clinical databases and, particularly important, data from the National Registration Department (Jabatan Pendaftaran Negara) to ascertain or verify mortality outcomes of registered patients. 3. Skilled organization, which will typically include the sponsors to provide funding, a Governance Board with broad oversight responsibility, a Steering Committee to direct the registry operations, and a Registry Coordinating centre for day-today operations. 4. Skilled human resource in a multi-disciplinary team, including the all important dedicated and obsessive administrative personnel and other supporting staff to operate the registry day-to-day. 5. Competent clinical epidemiological, biostatistical and data processing capability, and a sophisticated IT infrastructure to underpin that. And of course the financial resources to pay for much of the above

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Ethical and legal considerations Several ethical and legal issues require critical considerations in the design and operations of any patient registry. Participation in patient registry in Malaysia is entirely voluntary; there is no legal provision to compel any individual or institution to report data to a registry. Hence, to secure and maintain SDP buy-in, any registry must conduct itself in accordance with the highest ethical standards and applicable regulations in the country. In particular, we expect registries in Malaysia to comply with the ethical principles as stated in the Declaration of Helsinki, CIOMS’s International Guidelines for Ethical Review of Epidemiological Studies6, Good Pharmaco-epidemiological Practice7 as well as applicable local research guideline such as those of our National Institute of Health (NIH)8. Patient registry resembles observational research that involves the participation of human subjects. In compliance with current NIH research guideline 8, the registry protocol must be reviewed and approved by a properly constituted Independent Ethics Committee (IEC). Moreover, patient registry typically also operates under a waiver from the requirement to obtain individual informed consent from the patients whose data are reported to the registry by participating clinical sites. This requires explicit justifications and approval by IEC. Usual justifications of such waiver, in accordance with current ethical guidelines 7,9 are: 1. Registry is an observational research and involves no physical risk to the subjects. 2. The waiver will not adversely affect the rights and welfare of the subjects. 3. The requirement of individual informed consent would make the conduct of the registry impracticable and unscientific. In particular, observational research (unlike randomized trial) needs to avoid selection bias that the requirement for informed consent would inevitably introduce. A waiver permits the registry to include all patients who are eligible, rather than those who consent. 4. The registry cannot be practically be conducted without access to patients’ health information. 5. An adequate policies and procedures will be implemented by the registry to protect patients’ data and prevent improper use or disclosure. No individual information will ever be disclosed; only aggregate statistical results will be published by the registry. 6. Patients will not actually be enrolled since the registry is based entirely on review of medical record. The registry does not collect data that is not already routinely available. 7. The registry is carried out under the public health authority residing with the Ministry of Health, the primary sponsor of most registries in Malaysia. In addition, in view of the confidential medical information, often identifiable, that are collected and stored by registry, a registry must institute stringent information security policies and procedures, supported by state of the art data protection technology, which will be in accord with the requirements regarding personal data protection in applicable local guideline 10, and for us in Malaysia, often with applicable US and European standards too 11,12,13, until such time the much anticipated Malaysian Data Protection regulation are enforced.

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Table I: Patient registers currently supported by CRC

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4 5 6

7 8 9

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11 12 13 14 15 16 17 18 19 20 21 22

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Clinical Database or Disease Registry National Renal Registry (NRR) http://www.msn.org.my/nrr National Neonatal Registry (MNNR) http://www.acrm.org.my/mnnr National Transplant Registry (NTR)- Kidney, Bone Marrow, Heart and Lung, Liver, Corneal, Bone, Tissue and Heart valve http://www.mst.org.my/ntrSite/index.htm Malaysian Liver Registry Website not ready National Medicines Use Survey (NMUS) http://www.crc.gov.my/nmus National Mental Health Registry (NMHR): Schizophrenia Registry http://www.nmhr.gov.my Malaysian Registry of Renal Biopsy (MRRB) https://www.macr.org.my/emrrb National Eye Database (NED) http://www.acrm.org.my/ned National Cardiovascular Disease Database (NCVD)Acute Coronary Syndrome (ACS) & Percutaneous Coronary Intervention (PCI) http://www.acrm.org.my/ncvd National Trauma Database (NTrD)- Major Trauma Outcome & Traumatic Brain Injury database http://www.acrm.org.my/ntrd Diabetes in Children and Adolescent Registry (DiCARE) http://www.acrm.org.my/dicare National Suicide Registry (NSRM) http://www.nsrm.gov.my National Cancer Patient Registry (NCPR) https://app.acrm.org.my/ncpr NCPR: Colorectal Cancer https://app.acrm.org.my/CCD/ NCPR: Nasopharyngeal Carcinoma Cancer (NPC) https://app.acrm.org.my/npc/ NCPR: Cervical Cancer Website not ready NCPR: Hematology Malignancy https://app.acrm.org.my/hema/ Malaysian Psoriasis Registry (MPR) https://www.macr.org.my/empr National Endoscopy Registry (NER) https://www.macr.org.my/ener/ NCPR: Breast Cancer https://app.acrm.org.my/breast National Inflammatory Arthritis Registry (NIAR) Website not ready National Orthopaedic Registry: Hip Fracture Register (NOHFD) https://www.macr.org.my/enorm National Orthopaedic Registry: Diabetic Hand & Foot Disorder Register (NODFD) https://www.macr.org.my/enorm An Audit of Diabetes Control & Management (ADCM) https://app.acrm.org.my/ADCM Malaysian Cardiothoracic Registry (MyCaRe) Website not ready

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Since 1993

Owners MOH Nephrology & Malaysian Society of Nephrology (MSN)

2003

MOH Pediatric Dept & Perinatal Society of Malaysia

2004

MOH Transplant & Malaysian Society of Transplantation (MST)

2004

MOH Hepatology

2004

MOH Pharmaceutical Services & CRC, HKL

2004

MOH Psychiatry Services

2005

MOH Nephrology & Malaysian Society Nephrology (MSN)

2006

MOH Ophthalmology

2006

MOH Cardiac & Medical Services, UM, HUKM & IJN

2006

MOH Trauma & MOH Neurology

2006

CRC, MOH Pediatric Dept, HUKM & UMMC

2007 2007

Psychiatry and Mental Health Services, Forensic Medicine Services, Mental Health Registry Unit, MOH & CRC HKL CRC MOH

2007

MOH Gastro, Surgery, Pathology

2007 2007

MOH ENT, Pathology, Radiotherapy & Oncology, UMMC, CARIF, IMR & CRC MOH Oncology

2007

MOH Hematology & CRC

2007

MOH Dermatology

2007

MOH Gastro

2008

MOH Surgery

2008

MOH Rheumatology & Arthritis Foundation

2008

MOH Orthopaedic

2008

MOH Orthopaedic

2008

CRC HKL, MOH Medical Dept, Disease Control Dept & Medical Development Dept

2008

CRC HKL

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Since most registries in Malaysia are funded largely by public funds disbursed through the CRC MOH, it is desirable that the operations of patient registries be transparent. That means, making information about the registry operations public and readily accessible to anyone who is interested. Transparency in registry operations is desirable because it helps to realize the potential benefits of the registry; educates the public and other stakeholders about the scientific process; contributes to public and professional confidence in the scientific integrity and validity of the registry processes, and thus its findings; and finally transparency increases scientific utility of the registry data by promoting inquiries from interested scientists. To this end, a registry is expected to achieve transparency by publishing a regular report on its findings at least annually and disseminating the report free of charge to anyone who is interested through its official website; and by providing information on the registry’s objectives; governance, policy and organization; methods, operations and data sources available to anyone who is interested through its official website Finally, concerning registry data ownership, in theory, it is likely that the health information compiled by the registry will satisfy the statutory definition of a compilation, and thus copyright law may provide a legal basis for claims of ownership and legal restrictions on access to and use of the registry data by other parties. In practice, however, given the large number of parties involved in the creation of a registry, from funders, participating clinical sites and individual specialists involved in its design, it is uncertain how any claims of property rights in the registry data may be distributed and legally constituted. Further, the health information in the registry are information concerning individual patients, it is also uncertain how patients would respond, favorably or adversely, to any such claims of data ownership. As a practical matter, since “ownership” implies operational control of the registry data and publication rights, a funding agency such CRC, should agree to cede control of the registry operations and publication rights to the Steering Committee, the membership of which shall be appointed after due consultation with participating SDPs and individual subject matter experts involved in the creation of the registry. Role of CRC and cur r ently suppor ted registries in Malaysia In working towards accomplishing our stated mission, which is “To improve patients’ outcomes through quality clinical research”, the CRC has an important role in promoting and supporting the establishment and operations of patient registries in Malaysia. Table I below show all the patient registers currently supported by the CRC.

2. Technical resources for the registers; in particular the requisite expertise in registry sciences (clinical epidemiology, clinical economics, biostatistics, medical informatics etc). 3. Oversight to ensure that all registries produce the promised results and operationally comply with applicable regulations, ethical guidelines and best practices concerning operational transparency, information security, access to data for research and so on. In other words, we assist medical professionals to establish patient registries in their therapeutic areas. However, we expect each clinical group to be committed to owning and operating its own registries to ensure continuing funding and support by CRC.

CONCLUSION Any serious effort to advance healthcare in Malaysia requires hard information on its availability and distribution, and its effect on our population health outcomes. The availability of such information is currently very limited for most diseases in our country. There is a cogent need to establish more high quality patient registers in Malaysia to bridge the information gap. We urge all stakeholders in healthcare, whether as policy-makers, funders or providers to support this mission critical national endeavor.

ACKNOWLEDGEMENT We would like to acknowledge all the staff at CRC especially Ms Harnani Tamat, Editor of MJM and the staff of MMA especially Ms Matilda and Ms Norazlin for all their effort in making this supplement possible.

REFERENCES 1.

2.

3.

4.

5. 6.

7. 8.

9.

In such collaborative efforts, the CRC’s role is to provide: 1. Funding through a Special Registry Grant generously set aside by the office of the Deputy Director General (Research & Technical Support) Ministry of Health Malaysia.

10. 11.

12. 13.

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Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. April 2007. Wennberg DE, Lucas FL, Birkmeyer JD et al. Variation in carotid endarterectomy mortality in the Medicare population. JAMA 1998; 279: 1278-81. MacIntyre K, Capewell S, Stewart S et al. Evidence of improving prognosis in heart failure: trends in case fatality in 66 547 patients hospitalized between 1986 and 1995. Circulation 2000; 102: 1126–31. Eichler HG, Kong SX, Gerth WC et al. Use of cost-effectiveness analysis in health-care resource allocation decision-making: how are cost-effectiveness thresholds expected to emerge? Value in Health 2004; 7: 518-28. U.S. Food and Drug Administration. FDA Guidance for Industry. Good pharmacovigilance and pharmacoepidemiologic assessment. March 2005. Council for International Organizations of Medical Sciences: 1991 International Guidelines for Ethical Review of Epidemiological Studies. Available at: http://www.cioms.ch/ Epstein M. Guidelines for Good Pharmacoepidemiology practice. ISPE commentary. Pharmacoepidemiol Drug Safety 2005; 14: 589-95. National Institute of Health Ministry of Health Malaysia. NIH Guidelines for conducting research at MOH Institutes and facilities. Available at: http://www.nmrr.gov.my Code of Federal Regulations. Title 45-Department of Health and Human Services; Part 46-Protection of Human subjects. Updated 1 Oct 1997. Available at: www4.law.cornell.edu/cfr Malaysian Public sector management of ICT Security handbook. MAMPU 2001. Directive 94/ /EC and 95/EC Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 1995. Implementation 2000. European Network of Cancer Registries. Guidelines on Confidentiality in population-based Cancer Registration in the EU. Feb 2002. US Health Insurance Portability and Accountability Act 1996 (HIPAA).

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A Report of the Malaysian Dialysis Registry of the National Renal Registry, Malaysia Y N Lim, T O Lim, D G Lee, H S Wong, L M Ong, W Shaariah, G Rozina, Z Morad National Renal Registry Malaysia, 2nd Floor, MMA House, 124, Jalan Pahang, 50286 Kuala Lumpur, Malaysia

SUMMARY The Malaysian National Renal Registry was set up in 1992 to collect data for patients on renal replacement therapy (RRT). We present here the report of the Malaysian dialysis registry. The objectives of this papar are: (1) To examine the overall provision of dialysis treatment in Malaysia and its trend from 1980 to 2006 . (2) To assess the treatment rate according to the states in the country. (3) To describe the method, location and funding of dialysis. (4) To characterise the patients accepted for dialysis treatment. (5) To analyze the outcomes of the dialysis treatment. Data on patients receiving dialysis treatment were collected at initiation of dialysis, at the time of any significant outcome, as well as yearly. The number of dialysis patients increased from 59 in 1980 to almost 15000 in 2006. The dialysis acceptance rate increased from 3 per million population in 1980 to 116 per million population in 2006, and the prevalence rate from 4 to 550 per million population over the same period. The economically advantaged states of Malaysia had much higher dialysis treatment rates compared to the less economically advanced states. Eighty to 90% of new dialysis patients were accepted into centre haemodialysis (HD), and the rest into the chronic ambulatory peritoneal dialysis (CAPD) programme. The government provided about half of the funding for dialysis treatment. Patients older than 55 years accounted for the largest proportion of new patients on dialysis since the 1990s. Diabetes mellitus has been the main cause of ESRD and accounted for more than 50% of new ESRD since 2002. Annual death rate averaged about 10% on HD and 15% on CAPD. The unadjusted 5-year patient survival on both HD and CAPD was about 80%. Fifty percent of dialysis patients reported very good median QoL index score. About 70% of dialysis patients were about to work full or part time. There has been a very rapid growth of dialysis provision in Malaysia particularly in the older age groups. ESRD caused by diabetes mellitus, despite being a preventable and treatable cause of ESRD - has increased and accounted for more than 50% of incident dialysis patients. Death and survival rates on dialysis are comparable to those from other countries. KEY WORDS: End-stage renal disease, Renal replacement therapy, Renal, Dialysis, Database, Registry

INTRODUCTION The Malaysian National Renal Registry (NRR) collects information on patients with end stage renal disease (ESRD) on renal replacement therapy (RRT) and patients with other

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types of kidney diseases in Malaysia. This report presents data on patients on chronic dialysis therapy. The NRR has its origin in the Dialysis and Transplant Registry established by the Department of Nephrology, Kuala Lumpur Hospital (HKL) in 1992 to collect data from patients on renal replacement therapy within the Ministry of Health (MOH). In order to expand coverage to include non-MOH patients so that the registry may truly claim to be a national one, the running of the NRR was transferred to the Malaysian Society of Nephrology. The objectives of this paper are: 1. To examine the overall provision of dialysis treatment in Malaysia and its trend from 1980 to 2006. 2. To assess the treatment rate according to the states in the country. 3. To describe the method, location and funding of dialysis. 4. To characterise the patients accepted for dialysis treatment. 5. To analyze the outcomes of the dialysis treatment.

MATERIALS AND METHODS Patients with ESRD from participating clinical sites who were on dialysis or received renal transplantation were enrolled into the registry. This registry is open to all clinical sites that provide healthcare services for patients with ESRD in Malaysia. The data collected consists of initial patient notification including - demography, medical history, current treatment modality, source of funding; patient outcome including death, change of RRT modality, moved to another clinical centre; and annual data collection on individual patients on RRT, including medications, dialysis prescription, management of uraemic complications; and annual quality of life (QoL) assessment using the Spitzer’s index. In addition, dialysis centre surveys were conducted in December of each year since 1999. This annual cross-sectional survey was carried out to describe the most current level and distribution of dialysis provision at the end of each year, and to determine the completeness of data submission of patients on RRT to the NRR. Treatment rate was calculated by the ratio of the number of new patients or prevalent patients in a given year to the midyear population of Malaysia in that year, and expressed in per million-population. Annual death rates were calculated by

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Fig. 1: Number of new Dialysis patients and per capita GDP3, Malaysia 1980 – 2006

Fig. 2: Incident and prevalent rates of Dialysis patients. in Malaysia 1980-2006

Fig. 3: Primary renal disease in Malaysia, 1980-2006

Fig. 4: Death rates on Dialysis in Malaysia, 1980 – 2006

RESULTS AND DISCUSSION P rovision of dialysis treatment in Malaysia Overall and trends Dialysis therapy in Malaysia was introduced on a rudimentary basis in 1964 mainly to support patients with acute renal failure. Chronic haemodialysis (HD) was introduced in 1969 and the first renal transplantation was performed in Malaysia in 1975. Chronic ambulatory peritoneal dialysis (CAPD) was first introduced into Malaysia in 1981 2.

Fig. 5: Unadjusted patient survival by dialysis modality in Malaysia, 1993- 2006

dividing the number of deaths in a year by the estimated midyear patient population. The unadjusted survival probabilities were calculated using the Kaplan-Meier method, in which the probability of surviving more than a given time can be estimated for members of a cohort of patients without accounting for the characteristics of the members of that cohort. The dialysis patient survival by modality was calculated based on the duration of the patients up to the moment when they switched modality. The duration and modality after switching dialysis modality were censored.

6

Since those early days, the RRT scene in this country has changed dramatically. In 1980 there were only 59 patients on dialysis. Since then the number of patients has increased exponentially to almost 15,000 in 2006 as shown in Figure 1. The dialysis acceptance rate increased from 3 per million population in 1980 to 116 per million-population in 2006 and the prevalence rate from 4 per million to 550 per millionpopulation respectively (Figure 2). The reason for the rapid increase in the RRT population in this country is no doubt due to the rapid economic growth Malaysia has experienced in the last two decades, as shown in Figure 1 coupled with the increasing awareness among the Malaysian public and politicians of this lethal disease 3. This has resulted in more funds being channeled for dialysis therapy both through public donations as well as subsidies from the government.

Geographic distribution The economically advantaged states of Malaysia i.e. Pulau Pinang, Melaka, Johor, Perak, Selangor, Wilayah Persekutuan

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of Kuala Lumpur, and Negeri Sembilan had much higher dialysis treatment rates compared to the less economically advanced states and this trend persisted throughout the study period. Pulau Pinang had the highest treatment rate at 181 and Sabah the lowest at 56 per million in 2006.

Method, location and funding of dialysis In the 1980’s so-called home- or office-HD (HD carried out at home or in the work-place) made up a third to half of new dialysis treatment. Since the mid 1990’s the proportion of new patients started on home HD has been almost negligible and 80-90% of new patients were accepted into centre HD. The proportion of patients accepted into the CAPD programme increased in the early 1990’s to about 22-24%, plateau in the mid 1990’s; and decreased in the late 1990’s to a low of 10 to 11% since 2000. This trend reflected the prevailing conditions and funding of the ESRD programme. Almost all CAPD patients were found in government centres. Before 1990, the majority of patients received HD therapy in government centres. Since the mid 1990’s, the three main providers of dialysis namely government, non-governmental organisations and the private sector each provided a third of all HD therapy. Hence, in the 1980’s the government provided three-quarters of the funding for dialysis. This amount has decreased to about half since the mid 1990’s. Characteristics of patients accepted for dialysis treatment Demographics In the 1980s new dialysis patients were disproportionately male. Since then, as treatment provision increased markedly, the proportion of female patients steadily improved. This initial convergence in male and female treatment rates implied that there had been a gender bias in dialysis provision in the early years of chronic dialysis treatment in Malaysia when dialysis provision was scarce and males were preferentially treated. We believe this reflects a cultural bias which placed greater value on male life, rather than a conscious decision on the part of nephrologists or policy makers. The consistent treatment gap noted in the last ten years between men and women accepted for dialysis suggests that this is a true reflection of the difference in ESRD incidence between the two sexes rather than any conscious or unconscious bias in treatment allocation In the 1980s, patients aged 25 to 45 years comprised more than 50% of all new patients accepted for chronic dialysis therapy. Since the 1990s, older patients more than 55 years accounted for the largest proportion of new dialysis patients. Dialysis treatment rates were static for those less than 55 years of age but continued to increase for those over 55. In 2006, the dialysis incident rate for age < 15 years was 5 per million age related population, 26 for those 15 to 24 years, 595 in age group 55-64 years and 710 per million age related population in those >65 years old. Hence with increasing availability of dialysis therapy, the older age group with the highest incidence of ESRD has benefited the most.

Causes of ESRD As shown in Figure 3, in the initial years of dialysis therapy, when younger patients without diabetes mellitus were selected for dialysis, the largest known cause of ESRD was chronic glomerulonephritis and diabetes mellitus accounted for less then 10%. Since the1990’s diabetic nephropathy has been the main known cause of ESRD and accounted for more than 50% of new ESRD from 2002. Outcomes of dialysis treatment Death and Patient survival on dialysis Figure 4 shows that the annual death rates in patients on HD had been below 10% prior to 2000 but have increased to 11% for the last five years. Patients on CAPD have consistently higher death rates compared to patients on HD but these rates have now averaged about 15%. In contrast, the death rate in the USA was 20 per 100 patient-years for HD and 17 for CAPD, and the UK where death rate was 18 per 100 patientyears 3,4. The increase in annual death rate that is similar to the higher death rate in the USA may reflect a greater intake of older patients onto dialysis rather than suboptimal care of these patients. As shown in Figure 5, the unadjusted 5-year patient survival on both CAPD and HD was about 80%. After five years, patient survival on HD was better than on CAPD. This difference remains even with adjustment for age and diabetes mellitus. This contrasts with data from the USA, Canadian, Australian and the UK registries which show that CAPD appeared to have a better survival compared to haemodialysis3,4. The fact that more CAPD patients switched to haemodialysis and not vice versa may explain the difference between the two modalities.

Quality of life (QOL) and work related rehabilitation on dialysis. Fifty percent of dialysis patients reported median QoL index score of 9 or 10, (10 being the highest Spitzer QoL score). Older patients and diabetics reported lower median QoL index score but there was no difference between QoL scores by gender. Patients on CAPD reported higher median QoL index score compared to those on haemodialysis. About 70% of dialysis patients were able to work full or part time, 30% were not employed for health related reasons.

CONCLUSION The Malaysian dialysis registry has demonstrated the rapid growth of dialysis provision in this country. This has been particularly dramatic in the older age groups. It has noted the unequal distribution of dialysis provision in the various states of this country. It has also shown that diabetic nephropathy leading to ESRD is on the rise and worryingly accounts for more than 50% of all incident dialysis patients. Hence prevention of ESRD is eminently achievable with better management of diabetes mellitus. Deaths and survival on dialysis is comparable to data from other countries. The time has come to take a closer look at the quality of dialysis provision.

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ACKNOWLEDGEMENT We gratefully acknowledge all the dialysis centres for their participation in the National Renal Registry, and the staff of Clinical Research Centre in particular Ms Lim Jie Ying, Mr Tan Wei Hao and Dr Hoo Ling Ping for IT and statistical support.

REFERENCES 1. 2. 3.

4.

5.

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Malaysian Organ Sharing System (MOSS). Letter to editor. Med J Malaysia,1999; 54: 537-38. Morad Z. Nephrology in Malaysia: Then and now. In Eleventh report of the Malaysian Dialysis and Transplant Registry 2003. Kuala Lumpur 2004 Economic Research Unit, USA and United Nations Statistics Division http://unstats.un.org/unsd/cdb/cdb_country_prof_results.asp?crID=458&c pID=11. U.S. Renal Data System, USRDS 2005 Annual Data Report: Atlas of EndStage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases Bethesda, MD, 2007. Ansell D, Feest TG, Tomson C, Williams AJ, Warwick G. UK Renal Registry Report 2007. UK Renal Registry, Bristol, UK.

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National Transplant Registry L S Hooi*, M Lela Yasmin** *Haemodialysis Unit, Hospital Sultanah Aminah, 80100 Johore Bahru, Johore, **Department of Anaesthesia, Hospital Ampang, Jalan Mewah Utara, Pandan Mewah, 68000 Ampang, Selangor, Malaysia

INTRODUCTION The National Transplant Registry (NTR) was started in 2003. Although transplant activities have been carried out in the country for the last 30 years and include several organs and tissues, there was no centralised register to monitor the outcome and practice prior to this. Whatever registries that existed then were limited to individual centres and there was no sharing of data. There was a need for a centralised register and to compare results with the rest of the world. The sponsors of NTR are the Ministry of Health (MOH), Clinical Research Centre (CRC) and Malaysian Society of Transplantation (MST). The Clinical Registry Unit of CRC, Kuala Lumpur Hospital convened a governance board; Tan Sri Dato’ Dr Yahya Awang was appointed as the Chairman while Dato’ Dr Zaki Morad and Dr Fadhilah Zowyah Lela Yasmin Mansor became co–chairs. The board included parties interested in organ and tissue transplants e.g. representatives from CRC, MOH, MST, Malaysian Urological Association, Malaysian Society of Nephrology, Malaysian Society of Thoracic and Cardiovascular Surgeons, National Heart Association, National Tissue Bank, Ophthalmological Society of Malaysian Medical Association (MMA), Malaysian Liver Foundation, Malaysian Thoracic Society, Malaysian Orthopaedic Association, National Kidney Foundation, Malaysian Society of Haematology, Malaysian Association of Oral and Maxillofacial Surgeons, Malaysian Dental Association and the chairmen of the seven expert panels (see below). NTR became part of the Malaysian Society of Transplantation in 2006 but continued to receive technical support from CRC. National Transplant Registry •

Dr. Alan Teh Kee Hean NTR Expert Panel Co-chair of Blood and Marrow Transplant (Adult)

•

Prof. Dr. Chan Lee Lee NTR Expert Panel Co-chair of Blood and Marrow Transplant (Pediatric)

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Dato’ Dr. Zakaria Zahari NTR Expert Panel Chairman of Liver Transplant

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Dr. Shamala Retnasabapathy NTR Expert Panel Chairperson of Cornea Transplant

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•

Dr. Goh Bak Leong NTR Expert Panel Co-chair of Renal Transplant

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Mr. Mohammed Ezani Hj Md. Taib NTR Expert Panel Co-chair of Heart/Lung/Heart Valve Transplant

•

Prof. Zulmi Wan NTR Expert Panel Chairman of Bone and Tissue Transplant

The objectives of the NTR are to determine the frequency and distribution of all types of transplantation activity in Malaysia, outcomes and factors influencing outcomes of transplantation, evaluate transplantation services in the country, stimulate and facilitate research on transplantation and its management. Two reports have since been published for the year 2004 and 2005. These reports provide data from seven types of transplantation, i.e. blood and marrow, cornea, heart and lung, liver, renal, heart valve, bone and tissue. Each section has its own editor(s) and expert panel comprising of experts in the field. A section on cadaveric organ and tissue donation was introduced in 2005 contributed by the National Transplant Resource Centre and there is also a directory of transplant centres. Source Data Providers (SDPs) comprise of centres for various transplanted organs throughout Malaysia. Bone and tissue transplant, cornea transplant, kidney transplant and liver transplant SDPs submit case report forms to NTR. Blood and marrow transplant and heart and lung transplant SDPs submit data via web applications. The webpage is password protected with confirmation of new password by mobile phone text message for each entry session. There is a transplant registry manager and coordinator to collect and manage the data. The support staff from CRC included an epidemiologist, information and communication technology manager, network administrator, database administrator, webmaster, programmer, desktop publisher and biostatistician. The expert panels undertake quality control of the clinical registry forms and the data dictionary, quality control of the reported data, literature review in the relevant area and interpret the results generated by the report relevant to the

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panel expertise and specify the data reporting procedure. They facilitate access to source documents for NTR staff to do data verification.

Blood and Marrow Transplants For the blood and marrow transplant chapter, it had been reported that there were a total of 1048 haematopoietic stem cell transplantations performed by nine centres between 1987 and 2005. Of these, 699 were functioning at the end of 2005 (Table I). The majority (72%) were for malignant disorders e.g. leukaemia and lymphoma. Non-malignant disorders transplanted were thalasaemia and aplastic anaemia. There were 145 new transplants done in 2005 (rate of 6 per million population) which was an increase over the previous year’s total of 139 (5 pmp). Mean age of new transplant patients in 2005 was 26 + 16 years; 48% were male. Autologous transplants accounted for 39%. Seventy-nine percent of the transplant source was from peripheral blood stem cells and 94% were from HLA identical donors. In 2005, 36 patients died. Underlying disease, infection and graft versus host disease were commonest causes of death, 39%, 25% and 17% respectively. Cornea Transplants Cornea transplantations have been performed in Malaysia since the 1970’s. Forty-six centres provided data. There were a total of 1332 cornea transplantations between 1998 and 2005 (Table II). One hundred and ninety-two transplants were reported in 2005 (rate of 7 pmp). Mean age of new recipients in 2005 was 46 + 21 years. Fifty-nine percent were male. Majority were Chinese (39%) followed by Malays (32%) and Indians (22%). Seventy-six percent were legally blind before transplant. The primary diagnoses were cornea perforation (19%), keratoconus (18%), pseudophakic bullous keratopathy (18%), microbial keratitis (17%), cornea scars (10%). In 2005, 71% of donated corneas were from the USA, 17% from Sri Lanka and 12% from local sources. The mean age of the donors was 57 + 14 years. Commonest surgery on the whole was penetrating keratoplasty (94%). Overall graft survival was 80% at one year for the 2004 cohort, with 92% of one year graft survival being for the optical group (transplant done to restore vision) and 57% in the nonoptical group. Heart and Lung Transplants There were a total of 16 heart transplantations done between 1997 and 2005; 14 of which were by orthoptic biatrial procedure. Seven grafts were functioning at the end of 2005 and all were followed up in National Heart Institute (Table III). Two thirds of recipients were male and over half were Ischaemic Indians. Mean age was 36 + 16 years. cardiomyopathy was the commonest diagnosis (8/16) followed by dilated cardiomyopathy (6/16). Four recipients were transplanted before being put formally on waiting list due to severe heart failure. Average waiting time on the waiting list was nine months. All recipients received methylprednisolone followed by prednisolone as well as cyclosporine and azathioprine. Azathioprine was replaced by mycophenolate mofetil in three patients. Five patients died in hospital following transplantation; four succumbed to late deaths after heart transplant. The transplant patient survival rate was 60% and 40% at one year and three years respectively.

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Only one heart transplant was done in 2005. It was for a boy who had a Thoratec implantable Ventricular Assist Device (VAD) placed as a bridge to transplant. He was on the VAD for 4.5 months before finally receiving his heart transplant. The first lung transplant was performed in December 2005 and this was a single lung transplant.

Liver Transplants There were a total of 80 liver transplantations reported between 1993 and 2005; 66 of which were performed locally. Forty-five grafts were functioning at the end of 2005 (Table IV). There were five new liver transplantations done in 2005. There were four centres of follow-up for liver transplant recipients in 2005. Mean age of all transplant patients was 7 + 13 years (range three months to 74 years); 55% were male. 51% were Chinese followed by Malays (40%). 76% of transplants were for biliary atresia; (84%) were living donor liver transplantations. At the time of transplant the main immunosuppressive drugs used were tacrolimus (76%) and steroids (55%). Transplant patient survival rate for the cohort 1993 to 1998 was 71% at one year; while for the cohort 1999 to 2005 it was 66%. Overall one year patient survival was better for age group greater than 10 years (88%) compared to the younger age group (66%). Renal Transplants The renal transplant report was the most comprehensive as it was a part of the National Renal Registry which has been in existence for many years. It was reported that there were a total of 2650 patients who had undergone renal transplantations between 1975 and 2004. There were 67 centres of follow-up for renal transplant recipients in 2005. The kidney transplant program was initiated in Malaysia after the first successful living related renal transplantation was carried out in Hospital Kuala Lumpur on 15th December 1975. The transplant program in Malaysia was almost exclusively a living related program until 1987 when many patients sought commercial living unrelated/cadaveric transplantation overseas. In the early years, the local transplant program used an immunosuppressive protocol combining azathioprine and corticosteroids until 1992 when cyclosporine based triple therapy was introduced. New renal transplants showed a modest increase from about 30 new transplants per year in 1980 to 155 per year in 2005. The number of functioning renal transplants had increased from 1023 in 1996 to 1681 in 2005 (Table V). Incident rates for renal transplantation showed modest increase from about 2-3 per million population in the early 80’s to between 5-7 per million since 1990. The transplant prevalence rates had also increased from 4 per million population in 1980 to 69 per million in 2005. The mean age for new transplant recipients had increased from 31± 6 years in 1980 to 38 ± 14 years in 2005. Since 1975, men were in the majority among recipients. However, the percentage had reduced from 7080% in the early 1980’s to 55-65% for the last 10 years. The proportion of diabetic transplant recipients had increased, from hardly any in the early 1980’s to 10-20% in the last decade. In 2005, 70% of incident renal transplants were male, 19% were diabetic. Ninety-nine percent of prevalent recipients were on prednisolone, 78% cyclosporine, 14% tacrolimus, 44% mycophenolate mofetil and 39% azathioprine. In 2005,

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38 (2%) of prevalent recipients died and 15 (1%) lost their grafts. Infection and cardiovascular disease were the commonest causes of death accounting for 42% and 11% respectively. Death at home was the third commonest cause at 11%. Renal allograft rejection accounted for 78% of graft loss. The overall transplant patient survival rate from 1993 to 2005 was 95%, 92%, 89% and 81% at 1 year, 3 years, 5 years and 10 years respectively, while the overall graft survival rate was 92%, 85%, 79% and 63% respectively.

Heart valve transplants For heart valve transplants there were a total of 163 heart valve homografts between 1996 and 2005; 144 grafts were functioning at the end of 2005 (Table VI). Eighty-two were aortic and 81 were pulmonary valves. Mean age of all heart valve transplant patients was 11 + 11 years (range three months to 70 years); 50% were male.

Bone and Tissue Transplants The brief bone and tissue report is that in 2005, 131 bone allografts and 64 amniotic membranes were supplied by National Tissue Bank, Universiti Sains Malaysia (Table VII). Twenty-one hospitals used the bone grafts and 16 centres used the amniotic membranes. Cadaveric Organ and Tissue Donors There were 13 cadaveric donors in 2005 of which five were brain dead multi-organ and tissue donors and eight were post cardiac death tissue donors. This corresponded to a rate of 0.53 donations per million population (Table VIII). Mean age of the donors was 46.4 + 24.8 years, 62% were male. More than half were Indians, followed by Chinese and one Malay child aged three years. Three donors carried the donor pledge card. Nine of the donors died from medical causes, three from road accidents and one homicide. Seven procurements took place in government hospitals, five from private hospitals and one from a University Hospital.

Table I: Stock and Flow of Blood and Marrow Transplantation, 1987-2005 Year New transplant patients Deaths Lost to follow up Alive at 31st December

1987 8 1 0 7

1988 6 1 0 12

1989 22 6 0 28

1990 5 6 0 27

1991 12 1 0 38

1992 21 2 0 57

1993 19 9 0 67

1994 25 5 0 87

1995 30 16 0 101

Ye a r New transplant patients Deaths Lost to follow up Alive at 31st December

1996 28 11 0 118

1997 33 15 0 136

1998 49 17 0 168

1999 62 15 0 215

2000 94 31 0 278

2001 108 47 0 338

2002 114 30 0 422

2003 128 50 0 500

2004 139 43 0 596

2005 145 39 0 699

Table II: Types of Cornea Transplant, 1998-2005 Year

Penetrating Keratoplasty Lamellar Keratoplasty Patch Graft for Cornea Patch Graft for Sclera Cornea Scleral Keratoplasty No data Year

Penetrating Keratoplasty Lamellar Keratoplasty Patch Graft for Cornea Patch Graft for Sclera Cornea Scleral Keratoplasty No data

1998 (N = 119) No. % 114 96 1 1 0 0 0 0 0 0 4 3 2003 (N = 165) No. % 156 95 8 5 0 0 0 0 1 0 0 0

1999 (N = 122) No. % 116 95 5 4 0 0 0 0 1 1 0 0 2004 (N = 184) No. % 165 90 10 5 2 1 0 0 7 4 0 0

2000 (N = 126) No. % 120 95 5 4 0 0 0 0 0 0 1 1 2005 (N = 192) No. % 173 90 13 7 3 2 1 0 2 1 0 0

2001 (N = 221) No. % 207 94 14 6 0 0 0 0 0 0 0 0 TOTAL (N = 1332) No. % 1247 94 61 5 5 0 1 0 11 1 7 0

2002 (N = 203) No. % 196 97 5 2 0 0 0 0 0 0 2 1

Table III: Stock and Flow of Heart Transplantation, 1997-2005 Year New transplant patients Deaths Alive at 31st December

1997 1 0 1

1998 3 1 3

1999 2 0 5

2000 3 3 5

2001 4 1 8

2002 0 3 5

2003 2 1 6

2004 0 0 6

2005 1 0 7

Table IV: Stock and Flow of Liver Transplantation, 1993-2005 Year New transplant patients Deaths Re-transplant Lost to follow up Functioning graft at 31st December

1993 1 0 0 0 1

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1994 1 0 0 0 2

1995 8 3 0 0 7

1996 13 4 0 0 16

1997 3 1 0 0 17

1998 2 0 0 0 19

1999 8 4 0 0 23

2000 3 1 0 1 24

2001 5 2 0 0 27

2002 2003 10 5 5 1 0 0 1 0 31 34

2004 16 4 0 1 45

2005 5 4 0 1 45

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Table V: Stock and Flow of Renal Transplantation, 1996-2005 Year New transplant patients Died Graft failure Lost to follow up Functioning graft at 31st December

1996 151 31 28 1 1023

Year New transplant Deaths Alive with functioning graft at 31st December

1996 4 1 3

1997 126 29 38 0 1082

1998 104 23 48 2 1113

1999 127 25 36 4 1175

2000 143 27 32 9 1250

2001 161 35 40 2 1334

2002 168 31 38 7 1426

2003 160 36 41 9 1500

2004 187 37 44 21 1585

2005 155 38 15 6 1681

2003 21 2 135

2004 9 3 141

2005 3 0 144

Table VI: Stock and Flow of Heart Valve Transplantation, 1996-2005 1997 32 0 35

1998 22 4 53

1999 17 3 67

2000 13 0 80

2001 20 3 97

2002 22 3 116

Table VII: The types of tissue/bone allografts supplied by National Tissue Bank, Universiti Sains Malaysia in 2005 Tissue/Bone Bank Ty p e s o f Ti s s u e / B o n e A l l o g r a f t

N a t i o n a l Ti s s u e B a n k , U S M No. (pieces) 0 7 88 3 6 2 3 1 19 0 2 64 195

DF Knee slices DF Femur DF Femoral head DF Humerus DF Tibia DF Radius DF Ulna DF Patella FD Cancellous FD Cortical FD Cortico-cancellous Amniotic membranes TOTAL DF – Deep-frozen FD – Freeze-dried

Table VIII: Number of cadaveric organ/tissue procurement by year, 1997-2005

Year Number of donors Rate of procurement (per million population) Organs procured Cornea Heart Liver Kidney Heart valve Bone Skin Lung

1997 5 0.25

1998 7 0.34

4 1

10 3

8

10 1 1

Number of procurement by year Total=137 1999 2000 2001 2002 4 13 24 30 0.19 0.59 1.07 1.31

6 2 2 6 2

CONCLUSION The third report is being edited and will be published by mid – 2008. The success and sustainability of the NTR shows that diverse specialties may cooperate to produce a complete and coherent report. The National Organ, Tissue and Cell Transplantation Policy of the MOH was introduced in June 2007. One of its provisions is that all centres performing transplantations shall report to the NTR. The registry shall include appropriate details on the centre, the surgery and short and long term outcomes. The NTR shall report annually on all transplantations in the country.

12

18 3 1 22 8 3 2

34 4 1 38 11 2 2

48 2 25 11 6 3

2003 25 1.07

2004 16 0.67

2005 13 0.53

40 2 1 16 10 5

20

22 1 3 8 6 2

3 18 20 5 1

1

REFERENCES 1.

2.

3.

Hooi L S, Lela Yasmin Mansor (Eds). First Report of the National Transplant Registry Malaysia 2004. Kuala Lumpur 2005. ISSN 1823-5719, www.mst.org.my Hooi L S, Lela Yasmin Mansor (Eds). Second Report of the National Transplant Registry Malaysia 2005. Kuala Lumpur 2006. ISSN 1823-5719, www.mst.org.my Ministry of Health Malaysia. National Organ, Tissue and Cell Transplantation Policy. Putrajaya 2007. MOH/P/PAK/131.07 (BP). www.moh.gov.my

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The Malaysian Liver Registry: A Database of the Common Liver Diseases S S Tan, I Merican Department of Hepatology, Selayang Hospital, 68100 Batu Caves, Selangor, Malaysia

INTRODUCTION The pattern of liver diseases varies regionally and geographically. The Liver Registry is a database of common diseases of the liver in Malaysia. Digestive disorders was responsible for 3.2% of the total burden of disease in Malaysia in the year 2000. And cirrhosis of the liver was the most important cause of burden of illness among digestive disorders contributing to 60% of the total burden in this category 1. This registry is a joint venture between the Ministry of Health Malaysia and the Malaysian Liver Foundation. This database will be invaluable in the planning, operation, evaluation of health services and other policy management development for the Ministry of Health and other health care providers. Clinicians and other interested health care providers will also find this information useful for patient and public education.

MATERIALS AND METHODS This is a retrospective and prospective observational study of the cases seen in a national tertiary referral liver unit (the Department Hepatology of Selayang Hospital). The registry is being developed in stages from 2003 and we have been collecting data on chronic hepatitis B, chronic hepatitis C and acute liver failure. Its activities, development and progress are directed by a steering committee consisting of the President and Council members of the Malaysian Liver Foundation. The registry is based in the foundation office and data are collected and entered from Selayang Hospital. All patients with the above three liver diseases presenting to our outpatient and inpatient facilities are eligible. The initial reporting is done on a voluntary basis from attending clinicians. This is then followed up by a research assistant who collects detailed data from blood tests or other investigations from the patient’s electronic medical records. The subsequent follow-up visit to this hospital is also captured for tracking of disease progression or treatment outcomes. Data is entered into a software application with in-built patient analysis and tracking systems. The data is cleaned and reviewed at regular intervals by the data manager or clinician.

RESULTS There are 746 chronic hepatitis B(CHB), 164 chronic hepatitis C (CHC) and 71 acute liver failure cases registered. Here we are reporting the initial data at presentation on chronic hepatitis B (n=746) and C (n=164) cases. The demographic data for both CHB and CHC are reported in Table I. On presentation 33.1% (n=247) of the CHB patients are asymptomatic. However 0.02% (n=18) patients already had hepatocellular carcinoma. Many of the patients also had features of liver decompensation at initial presentation, with 117 reports of jaundice, ascites (59), encephalopathy (6) and upper gastrointestinal bleed (22). A positive family history was found in 239 CHB cases but an equally high number of patients (n=238) did not have family screening. The alanine aminotransaminase (ALT) levels on presentation in chronic hepatitis B patients are reported in Figure I. For the CHC patients, 60.4% were asymptomatic on presentation. The presentation was for abnormal liver function test in 14.6% of cases and/or anti-HCV positive in 36%. The commonly reported possible risk factors include: previous blood or blood product transfusion in 46.3%; intravenous drug use in 22%; and high risk sexual behaviour in 17.1% while 17.7% of our CHC also were on hemodialysis. The ALT levels on presentation in chronic hepatitis C patients are reported in Figure II.

CONCLUSIONS In this tertiary liver unit, our CHB and CHC patients are young and affect more males than females. We see both ends of the spectrum of severity of liver disease. More of the CHC patients were at the early asymptomatic stage compared to CHB patients. This could be due to greater awareness of risk factors for hepatitis C transmission and having screening performed. On the other hand a significant number of CHB patients presented with severe disease while there is an apparent lack of family screening measures despite this being the most common route of transmission in our region. It is clear that public education about viral hepatitis, especially hepatitis B, is very much needed. The main

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Table I : The demographic characteristics Demographic Characteristics Gender Male : Female (ratio) Mean age (range) in years Ethnic Origin, n (%) Malay Chinese Indian Others State of origin, n (%) From within WPKL, WPP, Selangor From other states Source of referral, n (%) From public sector From private Sector Not available

CHB (n=746)

CHC (n=164)

515: 231 (2.2:1) 42.4 (11-84)

99:65 (1.5:1) 45.2 (15-74)

285 425 23 13

(38) (57) (3) (2)

57 76 27 4

(35) (46) (16) (2)

565 (76) 91 (55)

181 (24) 73 (45)

557 (75) 178 (24) 11 (1)

134 (82) 26 (16) 4 (2)

ALT=Alanine Aminotransaminase ULN=upper limit of normal (normal ALT=40 u/l)

ALT=Alanine Aminotransaminase ULN=upper limit of normal (normal ALT=40 u/l)

Fig. 1: Number of patients by ALT level at presentation (chronic hepatitis B).

Fig. 2: Number of patients by ALT level at presentation (chronic hepatitis C).

challenges being the low rate and frequency of reporting from source data provider, limited funding and lack of dedicated staff. These factors had hampered efforts in the second and third year of registry work. However, with the support and commitment of the Ministry of Health, Malaysia and the Clinical Research Center, this registry has progressed and achieved some of its original objectives.

REFERENCE 1.

Malaysian Burden of Disease and Injury Study, Health Prioritization: Burden of Disease Approach by Division of Burden of Disease Institute for Public Health, National Institutes of Health, Ministry of Health, Malaysia 2004.

ACKNOWLEDGEMENT The Ministry of Health, Malaysia for funding and other support. The doctors who contributed cases: Dr Asmarani Abdullah, Dr Sharmila Sachithanandan, Dr Chan Yee Ming, Dr Tan Ooi Keat, Dr Haniza Omar, Dr Dennise Khoo. The staff of the Hepatology Department, Selayang Hospital and the staff of the Malaysian Liver Foundation.

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The National Mental Health Registry (NMHR) A A Aziz*, A A Salina**, A B Abdul Kadir**, Y Badiah***, Y C Cheah****, A Nor Hayati*, Z Z Ruzanna*****, S M Sharifah Suziah*, K Y Chee* *Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, **Hospital Sultanah Aminah, 80100 Johor Bahru, Johor, ***Hospital Permai, Jalan Tampoi, 81200 Johor Bahru, Johor, ****Hospital Bahagia, Tanjung Rambutan, 31250 Ulu Kinta, Perak, *****Hospital Universiti Kebangsaan Malaysia, Jalan Ya'acob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia

SUMMARY The National Mental Health Registry (NMHR) collects information about patients with mental disorder in Malaysia. This information allows us to estimate the incidence of selected mental disorders, and to evaluate risk factors and treatment in the country. The National Mental Health Registry (NMHR) presented its first report in 2004, a year after its establishment. The report focused on schizophrenia as a pioneer project for the National Mental Health Registry. The development of the registry has progressed with data collected from government-based facilities, the academia and the private sector. The 2003-2005 report was recently published and distributed. Since then the registry has progressed to include suicides and other mental illnesses such as depression. The NMHR Report 2003-2005 provides detailed information about the profile of persons with Schizophrenia who presented for the first time to various psychiatry and mental health providers throughout Malaysia. More detailed description regarding pharmacotherapy is reported and few cross tabulations done in an effort to provide better understanding and more clinically meaningful reports. KEY WORDS: Schizophrenia, Mental Health, Registry

Research capacity and culture are both greatly influenced by an efficient health information system. The National Mental Health Registry (NMHR) would be addressing the first component of health information with regard to current services and clients and provide input regarding criteria for access in relation to needs of population served, intervention provided, minimum data set for individual patients and outcome data (Raphael, 2004). The National Mental Health Registry (NMHR) collects information about patients with mental disorders in Malaysia. This information allows us to estimate the incidence of selected mental disorders, and to evaluate risk factors and treatments in the country. Such information is useful in assisting the MOH, Non - Governmental Organizations, private providers and industry in the planning and evaluation of mental health services, leading to its prevention and control. The NMHR is co-sponsored by the following organizations of the Ministry of Health Malaysia: • Medical Development Division, Ministry of Health; • Public Health Department; • Psychiatry services (Department of Psychiatry and Mental Health).

INTRODUCTION The decision to develop this registry is to ensure that accurate information is readily available and accessible in a timely manner within the mental health sector. With this information, a clear and coherent strategy can be implemented to improve mental health services and reduce the burden of mental health disorders in this country.

An Advisory Committee has been established to oversee the operations of the NMHR. The MOH, Universities, professional bodies, Non-Governmental Organization and private healthcare providers are represented on this committee to ensure that the NMHR stays focussed on its objectives, and to assure its continuing relevance and justification.

Based on the World Health Organization’s recommendations (WHO, 2002) there is need to narrow the gap between what is urgently needed and what is currently available. The four strategies recommended by WHO are: 1. Information for better decisions; 2. Integrate policy and service development; 3. Advocacy against stigma and discrimination; 4. Enhanced research capacity.

The objectives of the National Mental Health Registry are to: i. Determine the disease burden attributable to mental disorders by quantifying its morbidity, and its geographic and temporal trends in Malaysia. ii. Identify subgroups in the population at high risk of mental disorders to whom prevention effort should be targeted. iii. Identify potential risk factors involved in mental disorders. iv. Evaluate the treatment, control and prevention of mental disorders. v. Stimulate and facilitate epidemiological research on mental disorder, e.g. generating hypotheses on etiology.

These strategies are fundamentally inter-related, the development and existence of a registry is a prerequisite for translating policies into service needs.

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MATERIALS AND METHODS Disease Registration Methods The National Mental Health Registry (NMHR) has established a dynamic unit named the Mental Health Registry Unit (MHRU) to systematically collect data from the registered Source Data Providers. Based in the Department of Psychiatry and Mental Health, Hospital Kuala Lumpur, MHRU manages the data collection, data entry, data analysis and data reporting. The source data providers are the Ministry of Health hospitals and health facilities, the hospitals under Ministry of Education and Private Hospitals where mental disorders are seen and treated. The data standards were established based on usefulness for the mental health registry, ease of data collection and compatibility with other data sets (e.g. DSM IV). Two types of case record forms (CRF) are employed in data collection. The schizophrenia notification forms gather information on patient’s demography, clinical history and process of care. The outcome form collects data on medical outcome, side effects, social functioning and quality of life. The CRFs are used as part of the clinical records. Regardless of age, all patients diagnosed as Schizophrenia are included in the registry. The completed forms are sent to the MHRU where data are analysed, interpreted and presented in regular reports to be disseminated to users. Participation of source data producers is entirely voluntary. The data transferred to MHRU are kept strictly confidential with access limited only to authorized individuals working in the MHRU.

RESULTS Coverage In 2003 there were 29 Departments of Psychiatry under the Ministry of Health (MOH) and four from the universities. Of the public service departments, 29 were registered as source data producers from January 2003 and gave a coverage of 90.6% in the initial phase. If only the Ministry of Health Hospitals were taken into account, the coverage was 87.5%. In 2004, the number of participating source data producers increased to 73, consisting of 20 health facilities and 21 Ministry of Health Hospitals. In 2005, an one health facility was further added.

Progress The National Mental Health Registry (NMHR) presented its first report in 2004, a year after its development. The report focused on schizophrenia as a pioneer project for the National Mental Healt Registry. Since then, development of the registry has progressed, collecting data from governmentbased facilities, the academia and the private sector. The 2003-2005 report has recently been published and distributed. Now the registry has progressed to include suicides and other mental illness such as depression.

Incidence Rate The incidence rate from this report is about five cases per 100,000 population/year. Comparing the incidence rates from other countries, rates of Schizophrenia fell within a range of 7.7 to 43.0 per 100,00014. This wide variation in incidence rate could be attributed to the diagnostic criteria used in diagnosing Schizophrenia. Other reasons that could contribute to this differences includes social cultural reason and under reporting especially in East Malaysia. Demographic Profile shows that the majority of patients with schizophrenia in Malaysia are in the productive age of 20-40 years. Eighty percent of the patients were either single, divorced, widowed or separated. The majority of the cases had some form of education, at least have completed middle secondary level.

Unemployment Employment data of the registered case revealed that almost 70% were never employed or unemployed at the time of registration. Weight Mean weight of the patients were 58-59kg with about 60% within normal BMI, with one fifth of them either overweight or obese. Based on data available from registered cases on BMI, prescribers of antipsychotics need to consider the possible associated weight gain. Family History of Schizophrenia Twenty three percent of cases had a positive family history of schizophrenia. DUP The duration of untreated illness is long; with a mean of 28.7 months (median of 12 months); the mean being longer among females. Comorbidities Approximately 20% suffered from some form of co-morbidity with substance abuse being the commonest (about 80%). Cannabis was found to be the most common substance abused followed by amphetamine / methamphetamine. Care setting More than a quarter of patients were brought into contact for treatment by their families. However more than 40% were first seen as inpatients. Pharmacotherapy About 75% of the registered cases registered over the three years had been given monotherapy antipsychotic treatment (Haloperidol being the most common typical agent and Risperidone the most common atypical). About 20% of cases were given atypical oral antipsychotic. Twelve percent of the new cases had been treated with more than one antipsychotic at their first contact.

From the three year (2003-2005) National Mental Health Registry for Schizophrenia, the following can be concluded: DISCUSSION/CONCLUSIONS The NMHR had provided vital information in the development of mental health services in Malaysia. Programs

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on awareness and early detection of cases of schizophrenia have to be strengthened and there is a need for concerted effort from all sectors including the community. There should be a multi disciplinary team approach in managing comorbidities and medical related conditions amongst people with schizophrenia. The data from this registry had been used as a platform for further research on schizophrenia in Malaysia by postgraduate students and others.

4. 5.

6. 7. 8. 9. 10.

REFERENCES 1.

Addington DD, A J, Falloon IR, Gerlach J, Hirsch SR, Siris SG. Clinical issues related to depression in schizophrenia: an international survey of psychiatrists. Acta Psychiatr Scand 2002; 105: 189-95. 2. Arseneault L, CM, Witton J, et al. Causal association between cannabis andpsychosis: Examination of the evidence. Br J Psychiatry. 2004; 184: 110-17. 3 . Davies LM, DM. Economics and schizophrenia: the real cost. British JPsychiatry 1994; 165 (Suppl.25): 18-21.

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11. 12.

13. 14.

Dencker SJ, AR. Optimising the use of depot antipcychotics. CNS Drugs1996; 6: 367-81. Dixon L, Welden P, Delahanty J,et al. Prevalence and collerates ofdiabetes in national schizophrenia samples. Schizophrenia Bulletin 2003;26: 90312. Fenton WS. Comorbid conditions in schizophrenia. Current Opinion Psychiatry 2001; 14: 17-23. Hall W. Cannabis use and psychosis. Drug Alcohol Rev 1998; 433-44. Hall W, DL. Cannabis use and psychosis: A review of clinical and epidemiological evidence. Aus NZ J Psychiatry 2000; 24: 217-26. Henderson DC. Atypical antipsychotic - induced diabetes mellitus: how strong is the evidence? CNS Drugs 2002; 16: 77-89. Lindenmayer JP, Czobor P, Volavka J. et al. Changes in glucose and cholestrol levels in patients with schizophrenia treated with typical or atypical antipsychotics. American Journal of Psychiatry 2003; 160: 290-96. Mckay DR, TC. Is the grass greener? The link between cannabis and psychosis. Med J Aust 2000; 172: 284-6. Subramaniam M, Chong SA. and Pek E. Diabetes mellitus and impaired glucose tolerance in patients with schizophrenia. Canadian Journal of Psychiatry 2003; 48: 345-48. WH. Cannabis use and psychosis. Drug Alcohol Rev 1998; 17: 433-44. Mc. Grath John J. Variations in the Incidence of Schizophrenia: Data Versus Dogma. Schizophrenia Bulletin 2006; 195-7.

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Report of the Malaysian Registry of Renal Biopsy (MRRB) R Yahya, S Bavanandan, Y C Yap, W Jazilah, W Shaariah, H S Wong, D G Lee Malaysian Registry of Renal Biopsy, 2nd Floor, MMA House, 124, Jalan Pahang, 50286 Kuala Lumpur, Malaysia

INTRODUCTION Renal biopsy remains the main investigation in the diagnosis of renal diseases. In addition, it plays a major role in determining the management and prognosis of parenchymal renal disease. The collection of demographic, clinical and laboratory data at the time of biopsy and the set up of a database are useful tools for studying renal parenchymal diseases. The development of a renal biopsy registry in each country promotes many advantages and these include comparison in incidence of renal diseases, identification of different policies and practices in renal biopsy in different areas, linkage with other registries such as dialysis or transplant registry and identification of rare renal diseases. Thus, the registry is a source of epidemiological data and would provide useful information in the planning of health care and in organizing prospective clinical studies. The incidence of glomerular disease varies according to population, demographic characteristics, environmental factors, socio-economic status and the prevalence of infectious diseases. At present, there is limited information on the prevalence and incidence of glomerular disease, its potential disease burden and the temporal trend in Malaysia. Hence, the Malaysian Registry of Renal Biopsy (MRRB) was set up in 2005 to address this deficiency. The MRRB collects information about patients who undergo renal biopsy in Malaysia. The MRRB is a new component of National Renal Registry (NRR), which has been operating the Malaysian Dialysis and Transplant Registry (MDTR) since 1993.

OBJECTIVE The objectives of the MRRB registry are to: 1. Determine the disease burden attributable to glomerular disease (GD) by quantifying its incidence and prevalence, and its geographic and temporal trends in Malaysia. 2. Identify subgroups in the population at high risk of GD to whom preventive efforts should be targeted. 3. Identify potential causal and risk factors involved in GD. 4. Describe the clinical presentation and spectrum of GD. 5. Stimulate and facilitate basic, clinical and epidemiological research on GD. 6. Identify causes of allograft failure in our renal transplant population. 7. To audit the renal biopsy procedure, monitoring both complications and quality of specimens in addition to identifying risk factors associated with complications.

18

ORGANIZATION The NRR organization is as follows:

Owner The Malaysian Society of Nephrology (MSN) is the owner of this registry. Sponsors The MRRB is sponsored by the Malaysian Society of Nephrology (MSN) and the Ministry of Health, Malaysia. NRR Advisory Committee This is the committee established by the sponsors. The NRR Advisory Committee to ensure that the MRRB stay focused on its objectives and to assure its continuing relevance and justification. MRRB Working Committee The MRRB Working Committee supervises its operations. National Renal Registry Office The NRR coordinating office is the designated coordinating center. It coordinates the data collection among the Source Data Providers (SDPs). It collaborates with Clinical Research Centre of Hospital Kuala Lumpur which provides epidemiological and statistical support for MRRB. Source Data Providers (SDP) These are centres that contribute the required data for MRRB. The SDP collects and enters data directly through the on-line web-base system. The pilot phase of the registry consists of SDPs from Ministry of Health. Throughout this initial phase, we have refined and improved the database. This year (2008), the registry is expanding to a national level to include participation from all nephrologists and renal physicians in Malaysia who perform renal biopsies.

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We hope the nephrology community will support us by submitting information, which is crucial to eventually improve the management of patients with Chronic Kidney Disease (CKD).

To Participate in MRRB Centres interested to participate in this registry can register on-line at https://www.macr.org.my/emrrb/ or write in to NRR officially. The following documents need to be completed and returned to facilitate participation. • Centre Participation Self Reply Form • Authorization Form • Information Security Policy/User Agreement (One form per nominee listed in the Authorization form) Upon receiving these documents, the centre shall be registered and each of the users of the MRRB shall be notified via their e-mail address.

MATERIALS AND METHODS All patients from participating centres who undergo any kidney biopsy (native or graft) are to be enrolled into the registry.

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The data variables collected include demography, clinical presentation, and indication of biopsy, renal function, and laboratory data at presentation and at the time of biopsy, serological markers, virology status and histopathological result. In addition, an update on outcomes in terms of significant end-points such as end stage renal disease or death will be recorded annually.

RESULTS Pending publication which is expected in June 2008.

ACKNOWLEDGEMENT We gratefully acknowledge all participating centres for their data submission to the Malaysian Registry of Renal Biopsy. We are grateful to the Malaysian Society of Nephrology and the Ministry of Health, Malaysia for financial support and the Director General of Health for granting us permission to publish this article.

REFERENCES 1. 2. 3.

Satellite Symposium: Renal Biopsy Registries. Kidney International 2004; 66: 889-923. A Renal Biopsy Registry in Scotland .www.srr.scot.nhs.uk/ Vendemia F, Gesualdo L, Schena FP, et al. Epidemiology of primary glomerulonephritis in the elderly. Report from the Italian Registry of Renal Biopsy. Journal of Nephrology 2001; 14: 340-352.

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National Eye Database – A Web Based Surveillance System P P Goh, H Elias, N NorFariza, I Mariam, on behalf of the National Eye Database Steering Committee Ophthalmology Department, Hospital Selayang, 61800 Batu Caves, Selayang, Selangor, Malaysia

SUMMARY National Eye Database (www.acrm.org.my/ned) is a web based surveillance system which collects data on eye diseases and clinical performance in ophthalmology service. It is a prospective study with online data collection, concurrent descriptive data analysis and real time report. It includes cataract surgery registry, diabetic eye registry, glaucoma registry, contact lens related corneal ulcer surveillance and monthly ophthalmology service census. This article presents the methodology and some registries reports. The web based surveillance system has made dissemination of report prompt, easy and without barrier. KEY WORDS: Database, Surveillance, Census, Web based, Cataract surgery registry, Diabetic eye registry, Glaucoma registry, Contact lens related corneal ulcer surveillance

INTRODUCTION Systematic, prospective collection of data on disease distributions, natural history and treatment outcomes in the form of register is valuable in disease surveillance, monitoring clinical performance and healthcare planning. With the advancement in information technology, this effort can be optimized through web application. The Swedish National Cataract Register (NCR) has been collecting data on cataract extractions since 1992 and has good coverage of all cataract operations performed in Sweden1. It has evolved into a web-based European Cataract Outcome Study Group with participation from 15 countries Data from these cataract surgery (www.eurocat.org) 2. registers have been instrumental in setting the basis for quality assurance and enabling further clinical studies. The European Cataract Outcome Study Group has evaluated the database and published articles on cataract surgery outcome3, Cost effectiveness4, and quality of life 5, 6. Due to the large number of cataract surgery registered, the data enable study on rare events such as post-operative infectious In the United Sates of America, the endophthalmitis 7. annual National Health and Nutrition Examination Survey (hosted at (http://www.cdc.gov/nchc/nhanes.htm) utilizes web site to disseminate results to public and allows data download for those interested. In United Kingdom, the British Ophthalmological Surveillance (http://www.inopsu.com) reports rare but important eye diseases which led to a better understanding and improvement in management 8, 9.

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In 2002, the Ophthalmology service of Ministry of Health (MOH) established the National Cataract Surgery Registry (NCSR). It is a paper-based registry participated by 33 Ophthalmology departments. It contains data on 60,077 patients who have had cataract surgery from 2002 to 2004. Annual reports 10,11,12, and data on various aspects of NCSR has been published 13,14,15,16,17,18,19,20,21. As a paper-based registry is effort intensive, it was withheld in 2005 while effort was put into developing a web based registry. National Eye Database (NED) was established on 1st January 2007. It is a web-based patient registry consisting of Cataract Surgery Registry (CSR), Diabetic Eye Registry, Glaucoma Registry, Contact Lens Related Corneal Ulcer Surveillance, and Monthly Ophthalmology Service Census, MOH. It is supported by the MOH and hosted by the Association of Clinical Research Malaysia (ACRM) at www.acrm.org.my/ned. The main objectives of NED are to determine the magnitude and trend of eye diseases, to facilitate quality initiatives at individual ophthalmology departments through monitoring of key performance indicators (KPIs), and to stimulate research. The long term goals are to promote quality improvement and provide a benchmarking for comparing and demonstrating good practice. We present the method and some reports of NED in this article.

MATERIALS AND METHODS NED is a prospective, multi-center cohort study designed to have on-line data entry at study site. Participating centers or source data producers (SDP) are any clinical sites, both public and private, that provide eye care services in Malaysia. Eligible study populations are those fulfilling the criteria for each specific registry. Currently all 35 MOH ophthalmology departments participate in it. NED is sponsored by the Ophthalmology Service and Clinical Research Centre, MOH. It has a steering committee which establishes policy, directs its activities and is governed by an advisory board. It is managed by a clinical registry manager who coordinates with site coordinators at each SDP. NED has high level security in protecting its data. Data protection is being ensured at all time through strict compliance with regulatory requirements such as authentication of users and web application owners, access control, encryption, audit trail, control of external

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Table I: Data from National Cataract Surgery Registry 2002 to 2004 and NED 2007 2002

2003

2004

25 12,798 12512 (97.7%)

32 16,815 14,683 (87.3%)

33 18,392 6228 (33.9%)

Patients’ Demographic Mean age (years) % Women % Second eye surgery % Ocular co-morbidity in operated eye

64.0 51.0% 30.0% 28.8%

63.7 50.0% 29.5% 36.0%

63.5 51.0% 29.8% 38.0%

64.0 51.5% 29.8% 41.3%

C a t a r a c t S u rg e ry P r a c t i c e % Performed by specialists % Phacoemulsification (phaco) % Extracapsular cataract extraction (ECCE) % Phaco convert to ECCE % Local anaesthesia % IOL implanted % Implanted with foldable IOL

69.0% 39.7% 54.0% 2.4% 93.6% 97.3% 26.5%

71.8% 45.6% 47.6% 2.9% 93.2% 97.5% 37.8%

71.6% 50.7% 42.5% 2.5% 92.5% 97.6% 45.6%

77.2% 65.8% 29.2% 1.7% 93.6% 98.2% 68.5%

6.0%

4.6%

4.1%

4.4%

80.7% 86.9% 77.5%

88.6% 93.2% 84.5%

89.5% 93.8% 85.0%

84.4% 87.6% 79.9%

0.20%

0.24%

0.16%

0.26%

Number of participating centre Total number of surgeries reported Number of cases with post-operative vision (%)

S u rg i c a l O u t c o m e Rate of posterior capsular rupture (KPI standard- 5%) % of patients with post-operative refracted vision of 6/12 or better for : All Patients (KPI standard- 85%) Phacoemulsification ECCE Annual incidence of post- operative infectious endophthalmitis

2007 ( January to September) 30 12,072 5273 (43.7%)

Table II: Characteristics of diabetic patients registered to Diabetic Eye Registry, NED, January to September 2007

Age Mean (SD) years % Female Type of diabetes mellitus (DM) - % NIDDM - % IDDM Mean Duration of DM, years (SD) % with systemic co-morbidity % with hypertension % with hypercholesterolemia % with ischaemic heart disease % with renal impairment % Smoking No. of patient without DR (%)

All pts reported N=7797 57.0 (11.4) 54.2

Pt without DR N=4335 56.9 (12.3) 55.0

Pt with DR N=2838 56.6 (9.8) 46.4

91.5 5.8 7.7 (7.0) 77.8 64.5 17.7 11.7 6.2 9.68 4335 (55.6%)

92.6 4.8 6.3 (6.1) 75.9 63.2 17.5 12.0 3.5 8.54

90.9 6.7 9.9 (7.4) 80.0 67.0 18.3 11.9 10.3 10.99

Table III: Status of diabetic retinopathy on diabetic patients registered to Diabetic Eye Registry, NED, January-September 2007 With diabetic retinopathy (DR) only With maculopathy Ty p e s o f D R % Mild non proliferative DR % Moderate non proliferative DR % Severe non proliferative DR % Proliferative DR % Advance diabetic eye disease

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Right eye 2559 (32.8%) 703 (9.0%)

Left eye 2580 (33.1%) 663 (8.5%)

44.4% 25.9% 9.3% 14.8% 7.2%

44.8% 25.7% 8.6% 14.9% 6.3%

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Fig. 1: National Eye Database home page at www.acrm.org.my/ned

published, both on the web and hard copy. By having reports on the web, timely dissemination is especially effective.

RESULTS NED home page is shown in Figure 1. The icon ‘eNED web application’ will bring registered users to the protected web page for data entry and to view reports.

Fig. 2: Epidemiologic curve of contact lens related corneal ulcer, by week, 2007

communication links and access, as well as system backup and disaster recovery. Head of departments and site sub-investigators, usually ophthalmologists at each SDP, are given the right to manage data entered by their own centres, including data edit, data download and view centre reports. They ensure complete data ascertainment and up to date data entry. Site coordinators, usually optometrists or paramedical staffs are responsible to enter data and supervise other staff to enter data. Descriptive analysis is performed concurrently as the data are being received and are displayed as tables and graphs in reports. Reports are of two types, SDP report based on data entered by individual SDP, and overall report based on aggregated data entered by all SDPs. Individual patients’ identification is never displayed in the report. Reports are accessible in real time on the website. Annual reports are

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Table I displays CSR data entered from 1st January to 30th September 2007 and for comparison, data from the NCSR for the year 2002, 2003, and 2004 were shown. Over the years, patients who have had cataract surgery had similar mean age at surgery, i.e. 64 years, had equal gender distributions and about one third of them had second eye cataract surgery. The proportion of cataract surgery performed using phacoemulsification technique has increased from 54.0% in 2002 to 65.8% in 2007. This trend is reflected in the increasing proportion of foldable intraocular lens (IOL) being implanted, from 26.5% in 2002 to 68.5% in 2007. Results for KPI based on cataract surgery shown reduction in the rate of posterior capsular rupture, from 6.0% in 2002 to 4.4% in 2007, with the standard sets at 5%. While percentage of patients with post-operative refracted vision of 6/12 or better over the years was above target set, i.e. 85%. From January to September 2007, 7797 diabetic patients, who were seen for the first time at Ophthalmology clinics, were registered at Diabetic Eye Registry (Table II). More than half (55.6%) did not have diabetic retinopathy. Among those who have diabetic retinopathy, 70% of the eyes have mild or moderate non-proliferative diabetic retinopathy, while 30% has severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy or advanced diabetic eye disease. The later group of patients will need laser photocoagulation or vitrectomy. (Table III)

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Figure 2 shows the epidemiologic curve of the incidence of contact lens related contact lens ulcer reported to NED in 2007. A total of 103 cases were reported. Most of them related to monthly disposable lens and caused by bacteria.

DISCUSSION The findings from cataract surgery and diabetic eye registry demonstrate their usefulness in evaluating patients’ characteristics and status of diseases, in monitoring the trend of cataract surgery practice and surgery outcomes. The database has made tracking of KPI and clinical practice trend easy and efficient. NED provides useful information in epidemiology of eye diseases with data on visually threatening eye diseases such as cataract, diabetic retinopathy, glaucoma and contact lens related corneal ulcer. The clinical outcome data in NED is useful in assisting MOH, Non-Governmental Organizations, private healthcare providers and industry in program planning and service evaluation. This effort will lead to better management of eye disease, thus continuous improvement of ophthalmic service. There is a plan to incorporate audit tools such as cumulative sum (CUSUM) 22 into NED web application to effectively monitor doctors’ clinical competency. This will be implemented once the pilot study on CUSUM in monitoring surgeons’ cataract surgery complication, i.e. posterior capsular rupture and post-operative visual outcome has been completed. NED will actively promote participation by university hospitals and private eye care providers so that its’ database will truly be national.

national aggregated data on important eye diseases and eye services by a click of the mouse.

ACKNOWLEDGEMENT The NED is supported by special registry grant from Clinical Research Centre, MOH. We wish to thank heads, site subinvestigators, site coordinators and all the staff of Ophthalmology Departments, MOH for their support.

REFERENCES 1. 2.

3. 4.

5.

6.

7.

8. 9.

10. 11.

The main challenge faced by NED is incomplete caseascertainment, especially when the registry collects outcome data in a prospective manner. For example, in cataract surgery registry, only 43.7% of patients operated in 2007 have records on post-operative refracted vision. Measures to increase active case ascertainment include awareness through road shows, newsletters, NED specific scientific meetings, journal publications and presentation at national and international scientific meetings, as well as active reminders by NED clinical registry manager. The other challenge is to ensure continuous funding to support NED web application.

12. 13.

14. 15.

16.

17.

18.

CONCLUSION The attempt in applying information technology in clinical performance monitoring is timely, especially with the government’s effort to improve public service accountability and MOH’s commitment in ensuring high standards of healthcare. The NED web application will overcome conventional constraints in paper –based surveillance, i.e. short of human resources, delay in timely dissemination and storage place for data collection forms. With electronic-NED, ophthalmologists will have access to individual centre and

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19.

20.

21. 22.

Lundström M, Stenevi U, Thorburn W. The Swedish National Cataract Register: A 9-year review. Acta Ophthalmol Scand. 2002; 80: 248-57. Lundström M, Barry P, Leite E, Seward H, Stenevi U. 1998 European Catatact Outcome Study. Report from the European Cataract Outcome Study Group. J Cataract Refract Surg 2001; 27: 1176-84. Lundström M. Measuring surgical outcomes. Ed. J Cataract Refract Surg. 2004; 10: 2025-26. Kobelt G, Lundström M, Stenevi U. Cost-effectiveness of cataract surgery: Method to assess cost-effectiveness using registry data. J Cataract & Refract Surg 2002; 28: 1742-49. Lundström M, Stenevi U, Thorburn W. Quality of life after first- and second-eye cataract surgery. Five-year data collected by the Swedish National Cataract Register. J Cataract & Refract Surg. 2001; 27: 1553-59. Lundström M, Brege KG, Florén I, Lundh B, Stenevi U, Thorburn W. Cataract surgery and quality of life in patients with age-related macular degeneration (AMD). Brit J Ophthalmol 2002; 86: 1330-35. Lundström M, Wejde G, Stenevi U, Thorburn W, Montan P. Endophthalmitis following cataract surgery. A nation-wide prospective study evaluating incidence in relation to incision type and location. Ophthalmology. 2007; 114: 866-70. Stanford MR. A British ophthalmological surveillance unit. Br J Ophthalmol 1997; 81: 932-33. MR Stanford on behalf of the British Ophthalmological Surveillance Unit Steering Committee. Five years of surveillance. The British ophthalmological surveillance unit. Br J Ophthalmol 2002; 86: 838-39. Goh PP, R Sharmala, G Rajalakshmi, Ronald AD. The First Report of National Cataract Surgery Registry 2002. Goh PP, R Sharmala, G Rajalakshmi, Ronald AD. The Second Report of National Cataract Surgery Registry 2003. Goh PP, R Sharmala, G Rajalakshmi, Ronald AD. The Third Report of National Cataract Surgery Registry 2004. Rajalakshmi G, Goh PP, Mariam I. National Cataract Surgery Registry 2002-2003– Profile of Patients Presenting for Cataract Surgery. Am J Ophthal 2005; 139: S1 (supplement). Yen SS, Goh PP, Mariam I. National Cataract Surgery Registry 2002-2003 – A Report of Clinical Outcome. Am J Ophthal 2005; 139: S2 (supplement). Tara MG, Rampal SL, Choong YF, Goh PP. National Cataract Surgery Registry: Cataract Surgery in Diabetes Mellitus. Am J Ophthal 2005; 139: S2 (supplement). Li Chang, Choong YF, Goh PP. National Cataract Surgery Registry (NCSR) - Types of Anaesthesia And Intra-Operative Complications. Am J Ophthal. 2005; 139: S3 (supplement). Goh PP, Rampal SL, Choong YF. National Cataract Surgery Registry 20022003 – The Risk of Acute Endophthalmitis Following Cataract Surgery. Am J Ophthal 2005; 139: S4 (supplement). Goh PP, Rampal SL, Choong YF. National Cataract Surgery Registry 20022003 - Predictors for Poor Visual Outcome. Am J Ophthal 2005; 139: S4 (supplement). Shamala R, Goh PP, Mariam I. National Cataract Surgery Registry –Cataract Surgery Practice Pattern and Its Trend in Malaysia. Am J Ophthal 2005; 139: S4 (supplement). Poh EP, Choong YF, Goh PP. National Cataract Surgery Registry: Postoperative Clinically Significant Cystoid Macular Oedema. Am J Ophthal 2005; 139: S8( supplement). Lee PP, Goh PP, Lim TO. National Cataract Surgery Registry –Methods Am J Ophthal 2005; 139: S67 (supplement). Aziz S, Choong YF, Goh P, Ismail M, Lim TO. Cusum – A Statistical Process Control Charting to Monitor Surgeon Performance in Cataract Surgery. Am J Ophthal 2005; 139: S1 (supplement).

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Status of Diabetic Retinopathy Among Diabetics Registered to the Diabetic Eye Registry, National Eye Database, 2007 P P Goh, for the National Eye Database Study Group Department of Ophthalmology, Hospital Selayang, 68100 Batu Caves, Selayang, Selangor, Malaysia

SUMMARY Diabetic Eye Registry, a web based registry hosted at the National Eye Database (www.acrm.org.my/end) collects data in a systematic and prospective nature on status of diabetic retinopathy (DR) among diabetics seen for the first time at Ministry of Health ophthalmology clinics. The 2007 report on 10, 586 diabetics revealed that 63.3% of eyes examined had no DR, 36.8% had any form of DR, of which 7.1% had proliferative diabetic retinopathy. Up to 15.0% of eyes had vision threatening DR requiring laser or surgery at their first visit. Data on diabetic eye registry is useful in monitoring the quality of diabetic management, particularly in eye screening as reflected by the proportion of patients with severe DR needing intervention at the first visit to Ophthalmology clinics. KEY WORDS: Diabetes mellitus, Diabetic retinopathy, Diabetic complication, Diabetic eye screening

INTRODUCTION Diabetic retinopathy (DR) is not only a common complication of diabetes mellitus (DM) 1 but it leads to disability. It is the main contributor to blindness among working age group1,2,3. Every year, 10,000 American diabetics become blind 4 and globally 2% diabetics become blind and 10% visually impaired after 15 years of diabetes2 . The prevalence of DR differs by regions and it is best estimated from population based survey. The recent Singapore Malay Eye Study on 3280 Malay adults 40 to 80 years with diabetes revealed 35.0% prevalence of any form of DR, 4.9% with proliferative DR (PDR) and 35.0% with macular edema. Among those known DM, 35.3% have any DR, 6.8% has PDR and 10.8% has vision threatening DR5. However, population based survey is labour intensive and costly. Thus, hospital based multi centre studies have been conducted to assess the magnitude of DR among diabetics. Results from these studies may serve as proxy indicator to prevalence of DR 6,7,8,9,10,11,12,13. Table I shows results from studies done on DR in Malaysia and other countries. The prevalence of DR varies with type of DM. Among Malaysian diagnosed to have DM before the age of 40 years, the prevalence of DR was 12.3% in type I and 22.3% in type II DM, and prevalence of proliferative DR was 4.0% in type I and 9.3% in type II DM 14. In advanced country like the

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United State prevalence of DR for all diabetics was 86.4% for type I and 40.3% for type II DM, and vision threatening DR was 42.1% for type I and 8.2% for Type II DM 15,16. The prevalence of DR increases with duration of DM. In Malaysia, prevalence of DR among type I DM was 9.9% after 5 years, increased to 35.8% after 10 years of diagnosis, and for type II DM, it was 10.0% and 42.9% respectively 14 In the United State, the prevalence was 5% after 5 years, increased to 60% after 10 years for type I DM, and for type II DM taking insulin, it was 40% and 84% respectively, for type II DM not taking insulin, it was 24% and 53% respectively 17,18. Data on diabetic patients seen at hospitals provide essential information on severity of DR and the proportion of patients who need treatment. The Diabetic Eye Registry was established in 2007. It is a web based registry hosted by the National Eye Database. It collects data on diabetic patients seen at the first time at ophthalmology clinics. We present here some descriptive findings of the first year data.

MATERIALS AND METHODS Details of the NED methods is presented in this same issue. Data on diabetic patients who were seen for the first time at ophthalmology clinics were recorded on data collection forms. This was done by trained paramedical staff or medical doctors who saw the patients. The forms were later entered into the web based registry. Thirty three MOH ophthalmology departments took part in the registry. Participation is voluntary and thus the completeness of data ascertainment on diabetics seen at each centre is difficult to determine. Though features such as range check and compulsory fields to reduce error and missing data are in place in the web based application, there remained a small percentage of variables with missing data. Grading of DR is based on the International Clinical Diabetic Retinopathy Disease Severity Scale 19 (Table II). Maculopathy is presence if there is evidence of hard exudates or retinal thickening at the posterior pole. Clinical significant macular edema (CSME) is presence when retinal thickening or hard exudates is one disc size in an area ≤ one disc diameter from the centre of fovea. Vision threatening retinopathy (VTR) includes severe NPDR, PDR and maculopathy. The data were analysed using Stata software20.

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RESULTS Coverage From 1st January to 31st December 2007, 15,564 new diabetics patients were seen at MOH Ophthalmology clinics and these data were registered to the Monthly Ophthalmology Service Census at National Eye Database website21. Of these, 10,856 (69.8%) patients were registered to diabetic eye registry.

Characteristic of Diabetic Patients The mean age of patients registered was 57.2 years; About half were at working age group; between 30 to 60 years (52.8%). There were slightly more female (54.6%) and Malay (54.0%) patients formed the majority. (Table III) Medical and Ocular History Most of the patients (92.0%) have type II DM, 64.1% with less than 10 years of DM and 82.0% was treated with oral medication. About 2/3 has hypertension and 9% was current smokers. (Table IV). Majority of the patients seen were referred from government healthcare facility (91.7%). (Table V) One hundred and sixty patients seen were pregnant. Although the current protocol for pregnant diabetics states that these women should have their eye examined at the time of conception or at least during the first trimester, only in 41.2% had eye examination. Majority of the patients seen were referred from government health care facility (91.7%). (Table V)

Status of Eye More than two third of the patients has never had any prior eye examination. Among those who have had eye examination, 71.9% had it done about one year ago. (Table VI) More than one third of eyes had unaided vision of 6/12 and better, one third had vision between 6/18 to 3/60 and about 10% was blind with worse than 3/60 vision. Among those examined, 40.9% did not have other ocular disease, 44.2% patients had evidence of cataract, 3.1% had glaucoma and 0.5% had rubeosis irides, a sign which signifies retinal ischemia. (Table IV) More than half of the eyes (63.3%) examined did not have diabetic retinopathy and 36.8% had any form of DR, 16.5% had mild non-proliferative DR (NPDR), 9.8% had moderate NPDR, 3.4% has severe NPDR, 7.1% has proliferative DR. About 9.5% of eyes have maculopathy, of which, 4.2% had clinical significant macular edema (CSME). As such, 14.7% of eyes had vision threatening retinopathy (VTR). (Table VII)

Treatment plan Of the 10,856 patients registered majority (83.3%) were given an appointment for routine follow up eye examination, 10.2% required laser photocoagulation, 3.1% needed diabetic vitrectomy and 0.5% needed fundal fluorecence angiogram to assess extend of retinal ischaemia or maculopathy. (Table VIII)

Table I: Literature Review of Recent Studies by Types of DR and in Comparison with Present Study Study, year Universiti Sains Malaysia Hospital, 1996 6 DiabCare Asia in 29 public hospitals,19977

Sample Size 140

No DR

DiabCare Asia Project in 10 public hospitals, 1998 8, DiabCare Asia Project in 49 private clinics in Malaysia, 20019 DiabCare Asia Project at 19 public hospitals in Malaysia, 2003 10 University Malaya Medical Centre, Malaysia, 2005 11 Veterans Affairs Medical Center in USA, 2005 12 An inner-city primary care clinic in Australia, 200713 Singapore Malay Eye Study 2008 5 2006, Present study, 2007

438 1244 217 1219 495 3280 10,856

63.0% 51.7% 65.0% 63.3%

Any DR 48.6% 23.5%, (background DR) 37% (background DR) 23.5% (background DR) 11.1% 51.6% 23.4% 37.3% 35.3% 36.8%

PDR* 6.2%

VTR**

5.4%

(0.8%legal blindness)

28.1% 0.9% 6.8% 7.1%

3.8% 11.0% 10.8% 14.7%

*PDR - Proliferative diabetic retinopathy *VTR - Vision threatening retinopathy

Table II: International Clinical Diabetic Retinopathy Disease Severity Scale (adapted from ref?) Proposed disease severity level No apparent retinopathy Mild NPDR*** Moderate NPDR Severe NPDR

PDR

Findings observable upon dilated ophthalmoscopy No abnormalities Microaneurysms only More than just microaneurysms but less than severe NPDR Any of the following: >20 intraretinal hemorrhages in each of 4 quadrants Definite venous beading in 2+ quadrants Prominent intraretinal microvascular abnormalities in 1+ quadrant And no signs of proliferative retinopathy One or more of the following: Neovascularization Vitreous/ preretinal hemorrhage

***NPDR = Non proliferative diabetic retinopathy,

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Table III: Demographics of Diabetic Patients by Status of DR, National Eye Database, 2007

Mean Age, years A g e g ro u p , y e a r s 20 Missing Ty p e s o f t r e a t m e n t Oral medication Insulin Other Systematic co-morbidity None HPT Hypercholesterolemia IHD Renal Impairment CVA Amputation Others Smoking Pregnant Ocular co-morbidity None Cataract Glaucoma Rubeosis irides Others

No. 9995 571 290

% 92.0 5.3 2.7

3612 3355 1625 333 1931

33.3 30.8 15.0 3.1 17.8

8958 1393 727

82.0 11.8 6.2

2463 6935 1981 1203 632 260 70 1064 991 160

22.7 63.9 18.2 11.1 5.8 2.4 0.6 9.7 9.1 3.3% among female

4435 4799 337 58 445

40.9 44.2 3.1 0.5 4.1

Table V: Number and percentages of diabetic patients by sources of referral to Ophthalmology clinics, National Eye Database, 2007 Sources of referral Government OPD clinic/Klinik Kesihatan/Klinik Desa Government hospital-MO or specialist General Practitioner (GP) Private Hospital-MO or specialists Optometrists Others Missing

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N=10856 No. 6576 3378 133 82 14 38 635

% 60.6 31.1 1.2 0.8 0.1 0.4 5.8

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Table VI : Number and percentages of diabetic patients by past history of eye examination, National Eye Database, 2007 Eye examination

N=10856 No. 7701 1871 1354 79 1 450 1284

Never had eye examination before Had eye examination before • Last 1 year • Last 1-2 years • > 2 years • Missing Missing

% 70.9 17.2 71.9 4.2 0.1 23.9 11.8

Table VII: Number and percentages of diabetic patients by severity of diabetic retinopathy and maculopathy, National Eye Database, 2007 Right Eye n=9575

Severity of Diabetic Retinopathy

No apparent diabetic retinopathy Mild non proliferative diabetic retinopathy Moderate non proliferative diabetic retinopathy Severe non proliferative diabetic retinopathy Proliferative diabetic retinopathy

No. 6058 1578 931 337 671

Maculopathy Clinical significant macular edema Vision threatening retinopathy

1002 432 1440

Left Eye n=9556 % 63.3 16.5 9.7 3.5 7.0

n=10381 9.7 4.2 14.7

All eyes N=19131 No. % 12109 63.3 3151 16.5 1875 9.8 644 3.4 1352 7.1 n=20809 1981 9.5 866 4.2 2862 14.7

No. 6051 1573 944 307 681

% 63.3 16.5 9.9 3.2 7.1 n=10428 979 9.4 434 4.2 1422 14.5

Table VIII: Number and percentages of diabetic patients by treatment plans, National Eye Database, 2007 Treatment plans Follow up only Need laser Need vitrectomy Need further assessment such as FFA Missing

DISCUSSION With 69.8% coverage, data collected on 10,856 at diabetic eye registry is relatively representative of all new diabetic patients seen at MOH Ophthalmology clinics. NHMS III estimated the prevalence of known diabetics among population 18 years and older as 7.0% 22 . This gives an estimate of 1,492,665 people who needed regular eye examinations in Malaysia. Through NHMS indicated as prevalence of known DM is highest among Indians (14.7%) as compared to Malays (7.4%) and Chinese (6.2%)22, and Indians has the highest rate of lower limb amputation (Indian, 4.6%, Malay, 4.1%, Chinese 4.5%), strokes (Indian, 3.1%, Malay, 2.9%, Chinese 5.5%), and kidney transplant or dialysis (Indian, 2.4%, Malay, 1.2%, Chinese 2.3%). They are also most likely to have higher rate of DR, only 18.4% of those seen at eye clinics are Indians. Barriers for asccessing health care, especially in terms of affordability and equity, as well as compliance to medical advice among Indian patients warrants a special study. The diabetic eye registry also showed very few Type I DM (572, 5.3%) patients. This needs further assessement as patients with Type I DM have a higher proportion of DR when compare to Type II DM 15,17.

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N=10856 No. 9038 1103 332 49 631

% 83.3 10.2 3.1 0.5 5.8

Majority of patients seen were referred from government health care facilities (91.7%) with only 2.0% from private clinics or hospitals. This low rate of referral is compounded by a disturbing fact from the NHMS III that indicated a significant lower proportion of diabetic patients treated at private healthcare facilities ever having fundal examination as compared to patients in the government healthcare facilities (40.3% vs. 50.6%)22 . Although only 22.3% diabetics gets treatment from private clinics22, unless their eyes are examined by treating doctors or private ophthalmologists, those with severe DR who would need to be referred would be denied interventions which can actually retard the disease progression and prevent blindness. Private health care providers need to take a holistic approach in managing diabetic patients and ensure comprehensive medical examination to detect complications which should include annual vision and fundal check as recommended in clinical practice guideline published by MOH/Academy of Medicine 23 and preferred practice pattern by the America Academy of Ophtahlmology 19. As DM complications escalate during pregnancy, clinical practice guideline 19,23 recommended that diabetics must have their baseline eye examination at the time of conception and at every trimaster. The fact revealed a worrisome finding; where less than half of pregnant diabetic had a first eye examination at first trimester or earlier. The knowledge that

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diabetics who become pregnant require eye examination at a shorter interval needs to be made known to all doctors and antinatal nurses. Only one third of the patients who were seen for the first time at ophthalmology clincis has ever had a prior eye examiantion. This figure is worst than the population based survey at NHMS III where 45% reported ever having their eye(s) checked 22. The distribution of types of DR seen in the patients registered to this registry is comparable to findings from the population based study in Singapore5, and DiabCare Asia project at 19 hospitals in Malaysia10, an inner-city primary care clinic in Australia12 and Veterans Affairs Medical Center in USA13 as shown in Table I. However, patients seen at MOH clinics had a higher rate of VTR. For every 10 diabetic patients seen for the first time at ophthalmology clinic, 1.5 of them may become irreversibly blind. Diabetic eye screening should be done where patients receive his/her medical treatment. Detection of severe DR indicates poor blood sugar or blood pressure control. Immediate action in terms of advice to patient to modify their lifestyle and diet, and adjustment of medication for good DM control is necessary to regress or retard DR progression. Patients with more severe DR or those with maculopathy should be referred early to ophthalmology clinics for closer monitoring and laser photocoagulation when indicated. Management of diabetics need a coordinated team approach from all parties who come into contact with the patients. Nurses and dietician who provide counseling, pharmacists who dispense and counsel on medicine, doctors who provide diabetic medical treatment and opticians or optometrists who prescribe glasses, should remind diabetics patients of the necessary scheduled eye examination. Patients need to be constantly motivated for best possible metabolic control. Warning of potential disability such as blindness, loss of limbs, renal failure requiring dialysis or kidney transplant may be the best motivation to achieve that.

CONCLUSION Diabetic eye registry provides reliable and useful information for health care policy makers in evaluating the national diabetic program and for participating ophthalmology departments in assessing magnitude of diabetic retinopathy and the eye status among patients referred. Eye care providers who conduct diabetic eye screening, either public or private, are welcome to participate in this web-based registry.

ACKNOWLEDGEMENT The National Eye Database study group namely Dr Mariam Ismail, Dr Elias Hussein, Dr Radzlian Othman, Dr Zuraidah Mustari, Dr Ong Poh Yen, Dr Nor Fariza Ngah, Dr Shamala Retnasabapathy. The clinical research center, Dr Lim Teck Onn, Dr Jamaiyah Haniff and others from the Clinical Epidemiology Unit, CRC HKL. We also wish to thank heads, site sub-investigators, site coordinators and all the staff of Ophthalmology Departments, MOH for their support in registering diabetic patients to the Diabetic Eye Registry.

REFERENCES 1. 2.

3. 4. 5.

6.

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8.

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19.

Findings from the 2007 diabetic eye registry clearly revealed the suboptimal eye screening among diabetics, especially among Indians, Type I DM, diabetics who are pregnant and overall infrequent eye examination which cuts across all diabetics. If remedial actions are not taken, many diabetics who are at their prime, productive age group, will be visually impaired or irreversibly blind from DR.

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20. 21. 22.

23.

R Klein, BEK Klein, SE Moss. Visual impairment in Diabetes. Ophthalmology. 1984; 91: 1-9. World Health Organization. Prevention of blindness and visual impairment. [webpage]. Available from http://www.who.int/blindness/causes/priority/en/index6.html. Accessed 6 July 2008. American Diabetes Association: All about diabetes [webpage]. Available from http://www.diabetes.org/about-diabetes.jsp. Accessed 16 January 2004. Fong DS, Llyod P A, Frederick LF, Ronald Klein. Diabetic retinopathy. Diabetes Care. 2004; 27: 2540-553 . Tien Y, Wong, MD, PhD,1,2,3 Ning Cheung, MBBS,1 Wan Ting Tay, Prevalence and Risk Factors for Diabetic Retinopathy. The Singapore Malay Eye Study. Ophthalmology 2008 ( in press). Shirwas SR, Rhaman Isa AB, Reddy SC, et. al. Risk factors for diabetic retinopathy in Diabetes mellitus in Kelantan, Malaysia. Med. J Malaysia 1996; 51: 447-52. Mustaffa BE, Wan Mohamad WB, Chan SP, et. al. The current status of diabetes management in Malaysia. The Journal of the ASEAN Federation of Endocrine Societies 1998; 16(2): 1-13. DiabCare-Asia: A survey study on diabetes management and diabetes complication status in Asian Countries. Final country report on outcome data and analysis (1998) Malaysia. Novo Nodisk Healthcare. Asia Pacific Centre, Singapore. Mafauzy M. Diabetes control and complications in private primary healthcare in Malaysia. Med J Malaysia 2005; 60: 212-7. Mafauzy M for the DiabCare-Malaysia Study Group. Diabetes control and complications in public hospitals in Malaysia. Med J Malaysia 2006; 61: 477-48. I Tajunisah, H Nabilah, SC Reddy. Prevalence and risk factors for diabetic retinopathy-A study of 217 patients from University of Malaya Medical Centre. Med. J Malaysia 2006; 61: 451-6. Taylor CR, Merin LM, Salunga AM, Improving diabetic retinopathy screening ratios using telemedicine-based digital retinal imaging technology: the Vine Hill study. Diabetes Care. 2007; 30(3): 574-8. Cavallerano AA, Cavallerano JD, Katalinic P, et. al. A telemedicine program for diabetic retinopathy in a Veterans Affairs Medical Center--the Joslin Vision Network Eye Health Care Model. Am J Ophthalmol. 2005; 139(4): 597-604. WM Wan Nazaimoon a,*, R Letchuman B, N Noraini, et al. Systolic hypertension and duration of diabetes mellitus are important determinants of retinopathy and microalbuminuria in young diabetics. Diabetes Research and Clinical Practice 1999; 46: 213-21. The Eye Disease Prevalence Research Group. The Prevalence Of Diabetic Retinopathy Among Adult Type 1 Diabetic Person In The Untied State. Arch Ophthalmol 2004; 122; 246-551. The Eye Disease Prevalence Research Group. The Prevalence of Diabetic Retinopathy among Adults in the Untied State. Arch Ophthalmol 2004; 122: 252-563. Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol 1984; 102: 520-6. Klein R, Klein BE, Moss SE, et al. The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. Arch Ophthalmol 1984; 102: 527-32. American Academy of Ophthalmology. Preferred Practice Pattern: Diabetic retinopathy 2003. San Francisco, Calif: American Academy of Ophthalmology. Stata Statistical Software [computer program]. Release 8.0.College Station, TX: Stata Corp.; 2003. 2007 Report on Monthly Ophthalmology Service, MOH. Available from http://www.acrm.org.my/ned Accessed 10 July 2008. Topic 12 Diabetes Mellitus. Volume II. The Third National Health and Morbidity Survey 2006. Institute of Public Health (IPH)2008. Ministry of Health, Malaysia. Clinical Practice Guidelines in the Management of diabetic retinopathy, MOH Publication, 1996.

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Acute Coronary Syndrome (ACS) Registry - Leading the Charge for National Cardiovascular Disease (NCVD) Database S P Chin*, S Jeyaindran**, R Azhari***, W A Wan Azman****, I Omar*****, Z Robaayah ***, K H Sim****** *International Medical University, No 126, Jalan 19/155B, Bukit Jalil, 57000 Kuala Lumpur, **Kuala Lumpur Hospital, Jalan Pahang, 50586 Kuala Lumpur, ***National Heart Institute, 145, Jalan Tun Razak, 50400 Kuala Lumpur, ****University Malaya Medical Centre, 50603 Kuala Lumpur, *****Penang Hospital, Jalan Residensi, 10990 Georgetown, Penang, ******Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, 93586 Kuching, Sarawak, Malaysia

SUMMARY Coronary artery disease is one of the most rampant noncommunicable diseases in the world. It begins indolently as a fatty streak in the lining of the artery that soon progresses to narrow the coronary arteries and impair myocardial perfusion. Often the atherosclerotic plaque ruptures and causes sudden thrombotic occlusion and acute ST-elevation myocardial infarction (STEMI), non-ST-elevation MI (NSTEMI) or unstable angina (UA). This phenomenon is called acute coronary syndrome (ACS) and is the leading cause of death not only in Malaysia but also globally. In order for us to tackle this threat to the health of our nation we must arm ourselves with reliable and accurate information to assess current burden of disease resources available and success of current strategies. The acute coronary syndrome (ACS) registry is the flagship of the National Cardiovascular Disease Database (NCVD) and is the result of the dedicated and untiring efforts of doctors and nurses in both public and private medical institutions and hospitals around the country, ably guided and supported by the National Heart Association, the National Heart Foundation, the Clinical Research Centre and the Ministry of Health of Malaysia. Analyses of data collected throughout 2006 from 3422 patients with ACS admitted to the 12 tertiary cardiac centres and general hospitals spanning nine states in Malaysia in this first report has already revealed surprising results. Mean age of patients was 59 years while the most consistent risk factor for STEMI was active smoking. Utilization of medications was high generally. Thirty-day mortality for STEMI was 11%, for NSTEMI 8% and UA 4%. Thrombolysis (for STEMI only) reduced in-hospital and 30-day mortality by nearly 50%. Percutaneous coronary intervention or PCI also reduced 30day mortality for patients with non-ST elevation MI and unstable angina. The strongest determinants of mortality appears to be Killip Class and age of the patient. Fewer women received thrombolysis or underwent PCI on same admission although women make up 25% of the cohort. KEY WORDS: Acute coronary syndrome, Registry, ST-elevation MI

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INTRODUCTION Coronary artery disease (CAD) is officially the world’s number one killer disease. It is characterized pathophysiologically by progressive occlusive atherosclerosis, acute plaque rupture and atherothrombosis1. Atherothrombosis manifests clinically as acute coronary syndrome (ACS). ACS encompasses a broad spectrum of clinical conditions from unstable angina (UA) to non-ST-segment elevation infarct (NSTEMI) with micro-necrosis and through to transmural STelevation myocardialinfarction (STEMI). Formerly associated with more wealthy and developed countries, it has now cut across socio- economic and geographical lines locally and universally. In order to reduce the global burden of CAD, many strategies have been put in place. These strategies have been implemented over a decade ago in countries like the U.S., Sweden and Norway and are only starting to bear fruit now, reflective of the indolent silently progressive nature of CAD. The strategies were also formulated after extensive clinical and epidemiological research 2-4. The three target areas for treatment and prevention of CAD are 1) the identification of persons at risk of developing CVD and predisposing factors, 2) the development and clinical evidence of drugs and other interventional procedures that halt or modulate atherosclerosis, and 3) the implementation of clear strategies based on sound clinical evidence at all stages of the disease and clinical manifestation. Therefore, if we want to have a fighting chance at reducing the risk and burden of CAD in Malaysia before 2020, when we hope to have achieved first world status, we should start now! When we began searching for epidemiological databases of cardiovascular disease in Malaysia, there was none to be found. None at least that met our standards nor that we could conclusively verify as true and more so, one that encompasses the whole nation. Furthermore, despite the paucity of real useful data, the records of government hospital admissions and deaths collected by the Ministry of Health clearly indicate that CAD is the leading cause of admission and non-accidental death for the last 10 years. Even then, as is true now, cardiovascular disease accounted for 25% of all deaths in Malaysia 5. In 2001, ACS apparently accounted for nearly 35,000 acute admissions into Government hospitals in

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Malaysia 6. The epidemic of the deadly cardiovascular disease was not only destined to arrive in Malaysia, it apparently reached our shores more than a decade ago. The government already spends about 10% of its health budget providing resources to fight CAD and the private sector as well has played its role to fill the gaps not covered by government facilities. But why are we still losing the battle? The answer could lie in the approach used by clinicians and administrators alike, because we have been fighting the consequences of CAD rather than attacking its cause. Until this fire-fighting strategy changes, until we adopt a pro-active strategy based upon intelligence, information and evidence, we may never triumph. Why not adopt the statistics and guidelines issued by key opinion leaders from countries that have expended Considerable budget for understanding and fighting cardiovascular disease? Indeed, much of what we understand about risk and likelihood of CVD, its incidence and prevalence are derived from ‘western’ data. However, there is now an increasing awareness of ethnic variations and risk, socio-cultural and socio-economic influences as well as geographical variations 7-11. The risk prediction of ACS is also unclear and may be different from patients with chronic stable angina. Therefore, against this bleak backdrop, blind and without hindsight, armed only with lessons from other countries but, fortunately, and with a new canvas to plot our strategy, we spread across the land to improve the cardiovascular health landscape of our nation. This registry for Acute Coronary Syndrome (ACS), is the first of the National Cardiovascular Database (NCVD) to report its results since it was established in 2006. Yet the report has already revealed some startling facts about the health of the nation. We are confident the registry will be able to successfully meet its objectives that ultimately will lead to reducing the burden of heart disease in Malaysia. (See Table I as a milestone of development) Objectives of the NCVD • Determine the number and the time trend of ACS in Malaysia. • Determine the socio demographic profiles of patients to better identify the high-risk group in Malaysian population. • Determine the efficiency of, and adherence to current guidelines treatment guidelines. • Determine cost to the nation by cardiovascular disease and the cost-effectiveness of treatment and prevention programs. • Stimulate and facilitate cardiovascular disease research using this database. The objectives listed above, are clearly rather ambitious and will certainly not be met right away, especially for a first effort. Realistically, it has to be implemented in phases with the later phases building upon the foundation laid by the earlier phases while expanding the scope and coverage of the database. Beyond that, the database also provides a less tangible but no less important input in the form of expertise and experience gained by staff in the course of operating the database. In the long term, this will be an extremely useful asset to support cardiology research in Malaysia.

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MATERIALS AND METHODS The ACS registry was drawn up by content experts in the discipline led by representatives from the departments of cardiology the Ministry of Health, universities and the National Heart Institute and the department of medicine at Kuala Lumpur Hospital. The dataset amalgamates existing individual registries that existed separately in each hospital. It was designed to be compatible with international registries and to comply with guidelines issued by Australia’s National Data Elements for ACS, the European’s Cardiology Audit and Registration Data Standards (CARDS), and the American College of Cardiology Clinical Data Standards. The full version was designed to collect detailed demographic, past medical history, clinical and procedural information and pharmacotherapy. This was later abridged to make it more user-friendly, to encourage completion without compromising the objectives of registry and to ensure international compatibility. Thirty-days and 12-months follow-up forms have been attached to document the progress of patients, in particular the occurrence of any major adverse cardiovascular events (MACE) following discharge from hospital. The first meeting of the NCVD Steering Committee was convened in October 2005. (See https://www.macr.org.my/encrd/zAu-datastandard.jsp for the case report form)

Participating Sites The ACS database was piloted in six coronary care units (CCU) on January 1st, 2006. The CCUs were based at the National Heart Institute, Kuala Lumpur Hospital, University Malaya Medical Centre, Penang Hospital, Sultanah Aminah Hospital, Johore and Sarawak General Hospital. One month later, following minor adjustments and review of the work flow process; the CRF was approved for nationwide use. An additional five MOH general hospitals joined the six pilot centres. They are Tuanku Fauziah Hospital Kangar, Perlis; Tuanku Ja’afar Hospital Seremban, Negeri Sembilan; Sultanah Bahiyah Hospital Alor Setar, Kedah; Raja Perempuan Zainab II Hospital Kota Bahru, Kelantan; and Tengku Ampuan Afzan Hospital Kuantan, Pahang. In addition the medical department of Sarawak General Hospital also participated. More hospitals have joined NCVD since 2006. They are Ipoh Hospital, Perak; Queen Elizabeth Hospital, Sabah; Seberang Jaya Hospital, Penang; Sultanah Nur Zahirah Hospital, Terengganu; Tengku Ampuan Rahimah Hospital Klang, Selangor; and Malacca General Hospital. Patient Enrolment The registry records any patient age 18 and above who is diagnosed with ACS including ST-elevation myocardial infarction (STEMI), non-STEMI and unstable angina (UA) and admitted to the participating centres. ACS is defined as the presence of at least two of the following a) clinical presentation, b) electrocardiography and c) cardiac enzyme elevation. [See Table II] After discharge, the patient will be contacted by telephone or seen in the clinic for follow-ups after 30 days and 12 months. For the purpose of the registry, any new episodes of chest pain or diagnosis of ACS within 30 days of discharge are considered recurrent episodes or complications of the index event. Symptoms that occur more than 30 days later are considered as new episodes in which new event notification forms are submitted. The Medical Research and Ethics Committee (MREC) waived informed consent for this national registry. Med J Malaysia Vol 63 Supplement C September 2008

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Notification and Web Application Notification is served electronically to provide real-time updates. For centres without broadband internet connection, CRC has allowed centres to submit data in hardcopy forms to be delivered via the postal service and entered into the computer database by CRC. This temporary measure has ensured that more centres participate right from the inception of the registry while awaiting Internet connection. The application applies two-tiers of security whereby users will access the web application by using their username and password given by the registry manager. Once the details have been submitted, an authentication code will be sent to the particular user to log in into the system. The encryption system further enhances security. Although the participating centre shares the same pool of patients, they are not given access to patient database of other centres. Used correctly, these measures should ensure security of database and confidentiality of patient details.

number of co-morbidities and risk factors. Dyslipidaemia was present in 19% of STEMI patients but in 41 to 46% of NSTEMI/UA patients. Hypertension was present in 47% of STEMI patients but 70 to 73% of NSTEMI/UA patients. Diabetes was present in 36% of STEMI patients and 47 to 51% of NSTEMI/UA patients. Coronary disease was present in 54% of STEMI patients but 70-75% of NSTEMI/UA patients. Heart failure was present in 3% of STEMI patients and 10 to 14% of NSTEMI/UA patients.

RESULTS Baseline Characteristics There were 3422 patients with confirmed ACS admitted to the 11 participating sites in 2006. Out of these, there were 1445 patients or 42% of ACS patients with STEMI, 1132 patients or 32% with NSTEMI, and 845 patients or 25% with UA. [Figure 1] Ratio of men to women was 3:1 while mean age was 59 years. The highest incidence of ACS for men was in the 5060 year age group. The highest incidence of ACS for women was in the 70-80 year age group with a clear linear increasing trend. [Figures 2a and 2b] The ethnic composition of the patients were 49% Malay, 23% Chinese, 23% Indian and 1% each of Iban, Bidayuh, other races.

ACS Management Patients with ACS stayed an average of six days in hospital including about three days on CCU. [Table III] Younger patients (age 20 to 40 years) stayed for an average of five days while older patients (age 60 years and above) stayed for an average of seven days. For the STEMI patients, 70% received thrombolysis, 13% missed thrombolysis, 8% proceeded directly to primary angioplasty and 8% were not given thrombolysis because of contraindication or other reasons. Seventy-eight percent of younger age group received thrombolysis and from this only 12% missed thrombolysis because of delay or contraindications. In contrast for the older age group, 62% received thrombolysis while 24% missed thrombolysis because of delay or contraindications. Twenty-one percent of STEMI patients underwent PCI during the same admission including primary and rescue angioplasty. PCI was also performed on the same admission in 14% and 9% of NSTEMI and UA patients respectively. Besides PCI, 1% of STEMI patients underwent CABG as compared to 4% and 2% of NSTEMI and UA patients respectively. There was no difference between rates of PCI and CABG for STEMI patients among different age groups. For NSTEMI and UA patients however, younger patients more often underwent PCI (19% versus 13% of middle and older age groups).

Mean Body Mass Index or BMI was 25.8 kg/m2 and Waist Hip Ratio or WHR was 0.97. Seventy-five percent of all patients had BMI greater than 23 (the cut-off point for overweight for Asian population) Dyslipidaemia was present in 33% of patients and unknown in 41%. Hypertension was present in 23% and unknown in 16%. Diabetes was present in 36% and unknown in 20%. Thirty-three percent were active smokers while 24% quit smoking over one month previously. Coronary disease (including previous myocardial infarction for documentation of significant coronary disease) was present in 64% and unknown in 20%. Other co-morbidities were heart failure (8%), chronic renal disease or failure (7%), cerebrovascular disease (4%), chronic lung disease (4%) and peripheral vascular disease (1%). Only 2% of patients did NOT have any of the co-morbidities or risk factors mentioned above. [Figures 3 and 4]

Baseline Characteristics and co-morbidities according to ACS stratum The mean age of patients with STEMI was 56 years, which is younger than the NSTEMI group (62 years) and UA group (60 years). Males comprised 85% in the STEMI group that is much more than the NSTEMI group (69%) and UA group (66%). There were also more Malays that make up the STEMI group (54%) compared to NSTEMI and UA groups (both 45%). Active smoking was significantly higher in the STEMI group (50%) compared to NSTEMI and UA groups (23% and 18% respectively). However, STEMI patients have lower

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Clinical Examination and Investigation Most of the patients were in Killip Class I or II. Five percent of STEMI patients were in Killip Class IV (signs consistent with cardiogenic shock) compared to 3% in NSTEMI group and none in UA. There was no difference in baseline blood pressure, heart rate, cholesterol or blood sugar levels. Left ventricular ejection fraction by bedside echocardiography was also similar (47% in STEMI and NSTEMI groups and 50% in UA group).

More men underwent PCI than women. For the STEMI group, 22% of men in all underwent PCI on the same admission compared to 16% of women. For the NSTEMI and UA groups, 14% of men underwent PCI compared to 9% of women. Also 71% of men received thrombolysis compared to 67% of women. It is interesting to note also that use of thrombolysis in STEMI was highest in the Malay ethnic group (73% compared to 67% for other ethnic groups) while sameadmission PCI in STEMI was highest for Indians (29% compared to 20% for other ethnic groups). Prescription and utilization of adjunctive proven pharmacological therapy were high in all groups. Aspirin and cholesterol-lowering “statins” were given during admission in over 90% of patients in all groups. ADP antagonists (clopidogrel or ticlopidine) was used in 60% of STEMI

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patients, 64% of NSTEMI patients and 50% of UA patients. Unfractionated heparin or low molecular weight heparin (all enoxaparine) were used in 86% of NSTEMI and UA patients. Fourty-four percent of STEMI patients also received enxaparine including those that received thrombolysis. Betablockers and Angiotensin Converting Enzyme (ACE) inhibitiors were used in over 60% of patients in all groups. There was no difference in rates of prescription of these admission drugs among different age groups and gender.

cumulative 30-day mortality was 9%. Significantly those who missed thrombolysis due to delay or contraindications had nearly double the mortality rate, that is 13% for in-hospital and 16% cumulative 30-day. [Table VI] In contrast, there was no difference in outcome between those who underwent PCI on the same admission or not (both groups 8% in-hospital mortality and 11% 30-day mortality). [Table VII]

For the NSTEMI group, in-hospital mortality was 7% and cumulative 30-day mortality was 8%. For the UA group, inhospital mortality was 3% and cumulative 30-day mortality was 4%. For both NSTEMI and UA patients, those who underwent PCI on the same admission had lower 30-day cumulative mortality rate (5%) compared to those who did not undergo PCI (7%). [Table V ]

DISCUSSION The results of this inaugural report of ACS in Malaysia were collected from 11 hospitals around the country in 2006. The 3422 patients represented only a fraction of the true number of new ACS cases each year. We are satisfied with the accuracy of the results in this pilot NCVD survey. The 11 hospitals and departments taking part have allocated valuable resources and time to ensure the correctness of entry. Staff were sent for regular training and updates and specialists representing all participating centres were invited to review the results and provide feedback. A Governance Board for NCVD was established to oversee the operations. The Board has provided leadership and direction for the NCVD and ensured the continuing relevance to the database. Furthermore we were able to verify the results by comparing it with published reports on the prevalence of co-morbidities. In addition, the 11 pilot centres were among the largest and busiest receiving hospitals for ACS in Malaysia as these included government-funded facilities for tertiary cardiology services and intervention. Through the participation of these hospitals, most of the states in Malaysia were thereby represented.

For the STEMI group, in-hospital mortality was 9% and cumulative 30-day mortality was 11%. For patients who received thrombolysis, the in-hospital mortality was 7% and

It is still too early to draw definitive conclusions. Nevertheless these preliminary results have revealed several important and surprising points. ACS remains a disease that affects all races.

Outcome We report the results of ACS patient outcomes during admission (in-hospital) and 30 days after discharge (including in-hospital deaths). Total in-hospital mortality was 7% (229 deaths) while 30-day total mortality was 8% (288 deaths). [Table IV] In-hospital death was highest for the elderly age group (10%) compared to the younger (2%) and middle (4%) age groups. Thirty-day cumulative mortality was highest for the elderly age group (13%) compared to the younger (4%) and middle (5%) age groups. There was no difference between gender or presence of dyslipidaemia, diabetes and hypertension.

15th October 2005 9th December 2006 1st January 2006 2nd March 2006 31st March 2006 12th July 2006 14th April 2007 13th August 2007 30th August 2007 23rd October 2007 19th December 2007 5th January 2008

a) Clinical Presentation:

b) Electrocardiography:

c) Cardiac enzymes:

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Table I: Milestones of the Registry Approval of grant 1st National Cardiovascular Disease Database (NCVD) meeting NCVD – Acute Coronary Syndrome: 1st stage of realizing the objective e-NCVD web application uploaded online Pilot Sites initiation in 6 centres Involvement of state hospitals in NCVD Officially launched by Deputy DG 1st Technical Committee meeting Milestones of NCVD database, during NHAM Annual scientific meeting at the Le Meridien Hotel First meeting for all ground-staffs, operators, lab nurses, research nurses of all initiated sites Designing the dummy tables for ACS Registry Annual Report 2006 2nd Technical Committee meeting Reviewed the first draft of Annual Report Formed the ACS Report Writing Committee First ACS Report Writing Committee meeting

Table II: Acute Coronary Syndrome Criteria (Any 2 of the 3 following): Typical anginal pain at rest lasting more than 20 minutes New-onset angina of at least CCS grade III severity Previously diagnosed angina that has become more frequent, longer in duration or more easily provoked Acute decompensated heart failure in a patient with known ischemic heart disease. ST segment depression by more than 0.05mV in 2 or more contiguous leads. Marked symmetrical T-wave inversion by more than 0.2mV in the precordial leads. New bundle branch block Sustained ventricular tachycardia Typical pattern of elevation of conventional cardiac enzymes including creatine kinase (CK), aspartate transaminase (AST) and lactate dehydrogenase (LDH). Elevated Troponin T or I Elevated isoenzyme CK-MB

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Table III: Summary of treatments for patients with ACS by ACS stratum, Malaysia 2006

Mean, SD of Total admission days Mean, SD of Number of days on CCU Fibrinolytic therapy, no. % • Given • Not given–proceeded directly to primary angioplasty • Not given-Contraindicated • Not given–Missed thrombolysis • Not given–Others Cardiac catheterization, no. % Percutaneous coronary intervention, no. % CABG, no. % Pharmacological therapy given during admission, no. % • ASA • ADP antagonist • GP receptor inhibitor • Unfrac heparin • LMWH • Beta blocker • ACE inhibitor • Angiotensin II receptor blocker • Statin • Other lipid lowering agent • Diuretics • Calcium antagonist • Oral hypoglycaemic agent • Insulin • Anti-arrhythmic agent

STEMI N=1445 6 (3) 3 (3) 1018 117 70 193 47 298 308 10

(70) (8) (5) (13) (3) (21) (21) (1)

1368 868 77 181 446 951 865 66 1333 54 393 94 373 379 135

(95) (60) (5) (13) (31) (66) (60) (5) (92) (4) (27) (7) (26) (26) (9)

NSTEMI N=1132 6 (4) 4 (3)

UA N=845 5 (4) 3 (3)

NA NA NA NA NA 251 (22) 162 (14) 42 (4) 1018 719 47 203 767 737 597 131 1022 79 464 253 364 320 72

NA NA NA NA NA 106 (13) 80 (9) 15 (2)

(90) (64) (4) (18) (68) (65) (53) (12) (90) (7) (41) (22) (32) (28) (6)

765 (91) 422 (50) 19 (2) 197 (23) 537 (64) 587 (69) 510 (60) 70 (8) 769 (91) 54 (6) 241 (29) 195 (23) 236 (28) 183 (22) 49 (6)

Table IV: Overall outcomes for patients with ACS by ACS stratum, Malaysia 2006 Outcome STEMI • • • • •

Discharged / Alive Transferred to another centre Died Lost to follow-up Missing

No. 1312 0 129 NA 4

% 91 0 9 NA 0

In-hospital NSTEMI No. % 1056 93 0 0 75 7 NA NA 1 0

UA No. 818 0 25 NA 2

% 97 0 3 NA 0

STEMI No. % 939 65 0 0 158 11 348 24 0 0

30-day* NSTEMI No. % 796 70 0 0 92 8 244 22 0 0

UA No. 567 0 38 240 0

% 67 0 4 28 0

*Including patients who died in-hospital

Table V: Overall outcomes for patients with NSTEMI/UA by percutaneous coronary intervention, Malaysia 2006 Outcome

• • • •

Discharged / Alive Transferred to another centre Died Lost to follow-up

In-hospital Percutaneous coronary intervention Yes No No. % No. % 233 96 1641 95 0 0 0 0 9 4 91 5 NA NA NA NA

30-day* Percutaneous coronary intervention Yes No No. % No. % 207 86 1156 67 0 0 0 0 12 5 118 7 23 10 461 27

*Including patients who died in-hospital.

Table VI: Overall outcomes for patients with STEMI by fibrinolytic therapy, Malaysia 2006 Outcome

• • • • •

Discharged / Alive Transferred to another centre Died Lost to follow-up Missing

No. 940 0 74 NA 4

In-hospital Fibrinolytic therapy Yes No % No. 92 372 0 0 7 55 NA NA 0 0

% 87 0 13 NA 0

No. 686 0 90 242 0

30-day* Fibrinolytic therapy Yes No % No. 67 253 0 0 9 68 24 106 0 0

% 59 0 16 25 0

*Including patients who died in-hospital

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Table VII: Overall outcomes for patients with STEMI by percutaneous coronary intervention at admission, Malaysia 2006 Outcome

• • • •

Discharged / Alive Transferred to another centre Died Lost to follow-up

In-hospital Percutaneous coronary intervention Yes No No. % No. % 283 92 1029 91 0 0 0 0 25 8 104 9 NA NA NA NA

30-day* Percutaneous coronary intervention Yes No No. % No. % 242 79 697 61 0 0 0 0 34 11 124 11 32 10 316 28

*Including patients who died in-hospital

(STEMI)

% of patients

(UA)

(NSTEMI)

Fig. 2a : Age-gender distribution for male patients with ACS by ACS stratum, Malaysia 2006

% of patients

Fig. 1: Stratum distribution for patients with ACS, Malaysia 2006 (Number and Percentage)

Fig. 2b: Age-gender distribution for female patients with ACS by ACS stratum, Malaysia 2006

1. Dyslipidaemia, 2. Hypertension, 3. Diabetes, 4. Myocardial infarction history, 5. Documented CAD > 50% stenosis, 6. Chronic angina (onset more than 2 weeks ago), 7. New onset angina (less than 2 weeks), 8. Heart failure, 9. Chronic lung disease, 10. Renal disease, 11. Cerebrovascular disease, 12. Peripheral vascular disease, 13. None of the above, 14. Any Coronary artery disease

Fig. 3: Co-morbidities for patients with ACS, Malaysia 2006

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doctors and nurses dedicated to the treatment and prevention of heart disease in our daily practice. We are based at government hospitals, private hospitals, cardiologists, physicians, and nurses. We are together in solving this problem. Are you with us? Please join us! The NCVD and its objectives can only be achieved through your participation and contribution.

143,4% 720,21% 634,19%

or more

938,27% 987,29%

* Risk factors are defined as dyslipidaemia, hypertension, diabetes, family history of premature cardiovascular disease, smoking, obesity.

Fig. 4: Distribution of the presence of cumulative risk factors (Number and Percentage)

Men were three times more likely than women to have ACS. However, the number of women in the database confirmed that more women get ACS each year than had been previously thought with a clear increasing trend from the 3rd decade of life onwards. Traditional cardiovascular risk factors such as diabetes, dyslipidaemia, smoking and hypertension were present in less than half of the ACS patients. Infact patients with STEMI had lower prevalence of diabetes, hypertension and dyslipidaemia compared to NSTEMI and UA patients. The only traditional risk factor that was highest in STEMI compared to other groups is active smoking. This could indicate that active smoking habit is probably the most important risk factor for STEMI. The mortality for ACS, in particular STEMI, remains unacceptably high. Over 75% of STEMI patients received thrombolysis or proceeded to primary angioplasty. Patients who missed thrombolysis were nearly twice as likely to die than those who received them. PCI reduced mortality in the NSTEMI and UA groups but not the STEMI groups. This is most probably because the indication for same admission PCI in Malaysia appear to be “rescue” in response to failure to revascularization by thrombolysis or otherwise when the patient is in severe heart failure. Such patients are normally at highest risk of mortality. Therefore the results in this survey, which indicates no difference in outcomes between the PCI and non-PCI groups, may actually favour PCI. Besides thrombolysis and PCI, other factors that may affect mortality include increasing age and high killip class. It is clear to us now that Malaysia has a high incidence of ACS and a resultant high mortality rate. Nevertheless, although medical therapy and utilization are appropriate and have made significant impact in improving survival, interventional therapies such as PCI and CABG remained under-utilized. We are confident that even more results with be revealed to us in the coming years by way of the NCVD. Who are we? We are the National Heart Association of Malaysia (NHAM), the National Heart Foundation (NHF), and the Clinical Research Centre for Malaysia (CRC). We are

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ACKNOWLEDGEMENT We would like to thank the governance board of NCVD, steering committee of ACS registry, doctors in charge of participating sites and their study coordinators involved; and the Clinical Research Centre, Ministry of Health for their support in epidemiological advice, statistics, project management and IT infrastructure especially to Dr Jamaiyah Haniff, Ms. Gunavathy Selvaraj and Ms Noor Amirah Muhamad. We also wish to thank the Ministry of Health, Malaysia and National Heart Association of Malaysia for their continued support and generous funding towards this project. NCVD ACS Investigators: AA Abd Rahim, AA Nuruddin, A F Musa, AH Jaafar, A Hiew, A Hussin, AK Abd Rahman, AK Abdullah, A Khairuddin, A Rapaee, A Rosman, ASM Shah, AYY Fong, B Badusha, BSK Ching, BT Khor, CG Khor, CH Ngeyu, CH Tee, CK Ang, CK Cheah, CK Liew, CK Liew, CL Loh, CL Mooi, CT Liew, CY Lee, DSP Chew, EKY Chan, ELK Tan, EMJ Mah, ER Neoh, F Ilyas, HA Ang, H Abd Manap, HB Liew, HC Tan, H Haron Kamar, H Kamaruddin, HM Chong, HN Abdullah, H Noor Hasni, HT Lu, I Yaakob, I Zainal Abidin, J Sinnadurai, K Chandran, K Balachandran, KH Chee, KH Lam, KH Ling, KH Ng, KH Sim, K Joseph, KK Chan, KK Sia, KL Yew, KM Helmy, KS Khaira, KT Ong, LSS Sujana, MAS Abd Kader, M Mohamed, M Mustafa, MN Muda, MR Yusoff, M Yahya, NHM Amin, NH Nik Zainal Abidin, NM Jamid, N Mazwan, N Yahaya, O Ismail, PM Abdul Malik, P Mahadasa, RM Ali, R Omar, RS Veriah, R Salleh, R Zambahari, SA Yahaya, S Elis, SF Wong, SK Lim, SK Lim, S Krishnan, SM Noohu, SNH Adznan, S Omar, SP Chin, S Satwi, S Sharma, S Syed Tamin, SW Tiang, S Vijayasingham, Santha Kumari, Siti Khairani, Sree Raman, Sudarshan, Surinder Kaur, TC Wong, TH Goh, TZ Yew, WA Wan Ahmad, VH Tan, WL Chan, WMR Wan Hassan, WP Chong, Vijiya Mala, YK Foong, YL Cham, YS Chong, Y Sanjiv, Y Yusof, Z Yaacob.

REFERENCES 1. 2.

3.

4.

5.

Libby P. Current concepts of the pathogenesis of the acute coronary syndromes. Circulation 2001; 104: 365-72. Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction 2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). Circulation 2002; 106: 1893-900. Clinical Practice Guidelines on Acute Myocardial Infarction 2001. Z Robaayah (Chair) for the expert committee of the National Heart Association Malaysia/ Academy of Medicine Malaysia/ Ministry of Health Malaysia. Clinical Practice Guidelines on Unstable Angina and Non-ST-elevation Myocardial Infarction 2003. Quek D (Chair) for the expert committee of the National Heart Association Malaysia/ Academy of Medicine Malaysia/ Ministry of Health, Malaysia. AMI death in the government hospital Malaysia 1990-1998. Management Information System Annual Report for Medical Care. Ministry of Health, Malaysia.

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6. 7.

8.

9.

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Management Information System Annual Report for Medical Care Year 2001. Ministry of Health, Malaysia. Chew DPB, Allan RM, Aroney CN, Sheerin NJ. National data elements for the clinical management of acute coronary syndromes. Med J Austr 2005; 182: S1-S16. Rathore SS, Weinfurt KP, Gross CP, Krumholz HM. Validiaty of a simple STelevation acute myocardial infarction risk index: are randomized trial prognostic estimates gneralizable to elderly patients? Circulation 2003; 107: 811-16. Spertus JA, Radford MJ, Every NR, et al. Challenges and opportunities in quantiying the quality of care for acute myocardial infarction: summary from the Acute Myocardial Infarction Working Group of the American Heart Association/ American College of Cardiology First Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke. Circulation 2003; 107: 1681-91.

10. Cannon CP, Battler A, Brindis RG, et al. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol 2001; 38: 2114-130. 11. Mak KH, Chia KS, Kark JD, Chua T, Tan C, Foong BH, Lim YL, Chew SK. Ethnic differences in acute myocardial infarction in Singapore. European Heart J 2003; 24: 151-60.

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A National Database on Children and Adolescent with Diabetes (e-DiCARE): Results from April 2006 to June 2007 M Z Fuziah*, Janet Y H Hong*, H Zanariah**, F Harun***, S P Chan****, P Rokiah****, L L Wu*****, R Rahmah*****, H Jamaiyah******, A Geeta******, W S Chen******, B Adam****** *Paediatric Department, Hospital Putrajaya, Precint 7, 62250 Putrajaya, **Medical Department, Hospital Putrajaya, Precint 7,62250 Putrajaya, ***Pediatric Department, University Malaya Medical Centre, Jalan Universiti, 59100 Kuala Lumpur,****Medical Department, University Malaya Medical Centre, Jalan Universiti, 59100 Kuala Lumpur, *****Paediatric Department, Hospital Universiti Kebangsaan Malaysia (HUKM), Jalan Yaakob Latiff, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, ******Clinical Research Centre, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY In Malaysia, Diabetes in Children and Adolescents Registry (DiCARE) was launched nationwide in August 2006 to determine and monitor the number, the time trend of diabetes mellitus (DM) patients, their socio-demographic profiles, outcome of intervention and facilitate research using this registry. This is an on going real time register of diabetic patients 7.0 mmol/L (FBS) OGTT (2 hours) > 11.1 mmol/L Insulin auto-antibodies C-peptide/ insulin level Ketonuria Ketoaemia (>0.5 mmol/L) HCO3 < 15mmol/L Incomplete data

N 2 89 3 3 2 1 78 98 98 2 122 27 3 4 17 94 14 54 0

T2DM N=41 % 1.2 57.1 1.9 1.9 1.3 0.6 50.0 62.8

N 1 2 20 16 5 0 8 23

% 2.4 5.6 55.6 44.4 13.9 0 22.2 63.9

1.3 89.1 19.7 2.2 2.9 12.4 68.6 10.2 39.4 0

1 23 16 8 0 5 4 1 1 1

2.9 69.7 48.5 24.2 0 15.2 12.1 3 3 3

Table II: Number, Mean and Median of HbA1c by Type of Diabetes Mellitus amongst those with known HbA1c study, DiCARE April 2006- June 2007 Type T1DM T2DM Others

N 50 20 7

in Malaysia. The mean age was 12.51 years ranging from 1.08 – 19.75 years old and 46.4% were boys. The mean age at diagnosis was 8.31 ± 4.13 years old with an estimated duration of diabetes of 4.32 ± 3.55 years. Among the three major ethnic groups in Malaysia, the Malays constituted 45.4%, Chinese 32.5% and Indians 19.2%. Our national data from National Health Morbidity Survey (NHMS) showed that Malays constitute 65.1%, Chinese 26.0% and Indians 7.7% of the population4. Positive family history of diabetes is present in 22/166 (13.3%) of T1DM patients and 27/42 (64.3%) of T2DM patients. A total of 166/240 (69.2%) have T1DM, 42/240 (17.5%) have T2DM and 18/240 (7.5%) have other types of DM that included secondary causes such as thalassaemia.

Clinical characteristics and basis of diagnosis of T1DM: Out of 166 patients with T1DM reported in this registry, basis of diagnosis is known in 162 patients. The clinical presentations of these patients at diagnosis included hyperosmolar symptoms (62.8%), DKA (57.1%) and weight loss (50%). The biochemical characteristics at the time of diagnosis included RBS >11.1 mmol/L (89.1%), ketonuria (68.6%) and HCO3 < 15mmol/L (39.4%). Of these patients only 2.9% had insulin auto-antibodies measured and 12.4% had C-peptide/insulin level tested. This may reflect the unavailability of these tests in most centres. Two patients had the diagnosis made incidentally based only on biochemical findings (Refer Table I).

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Mean (SD) 9.9 (2.0) 9.7 (2.3) 10.8 (3.7)

Median (min. max) 9.5 (6.8, 17.0) 9.8 (5.2, 13.4) 10.2 (6.8, 16.3)

Of all T1DM patients (N=166) reported in the registry, only 67% had their BMI reported. Of the 64 girls with BMI reported, only 2 (3.0%) were obese and 2 (3.0%) were overweight. One girl was noted to be underweight. Majority (92.2%) of the girls with T1DM fall in the normal weight category. Of the 47 boys with BMI reported, 4 (8.5%) were obese and 5 (10.6%) were overweight while 6 (12.8%) were underweight. Thirty-two boys (68.1%) with T1DM fall in the normal weight category. It appears that more boys seem with T1DM in this registry had weight problems as compared to girls (refer Figure 1 and Figure 2).

Clinical characteristics and basis of diagnosis of T2DM: Out of 42 T2DM patients in this registry, the basis of diagnosis was reported for 41 patients. The common clinical manifestations were hyperosmolar symptoms (63.9%), obesity (55.6%) and acanthosis nigricans (44.4%). Only 5.6% of these patients presented with DKA, while 2.4% had the diagnosis made incidentally. DKA is an uncommon presentation in this group of patients with T2DM. The observed discrepancy between the number of patients with DKA and those with bicarbonate 11.1 mmol/L (69.7%), FBS >7 mmol/L (48.5%) and OGTT (2 hours) >11.1 mmol/L (24.2%). Only 15.2% of patients had their C-peptide / insulin levels measured (Refer Table I). Of all T2DM patients (N=42) reported in the registry, only 64.3% had their BMI reported. Of the 15 girls with BMI reported, 6 (40.0%) were obese and 4 (26.7%) were

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Fig. 1: BMI chart for T1DM and T2DM girls amongst type with known BMI study, DiCARE April 2006 to June 2007

Fig. 2: BMI chart for T1DM and T2DM boys amongst type with known BMI study, DiCARE April 2006 to June 2007

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overweight. Five (33.3%) girls were of normal weight. None were underweight. Of the 12 boys with BMI reported, 7 (58.3%) were obese and 4 (33.3%) were overweight while 1 (8.3%) had normal weight. None were found to be underweight. (As expected, our data shows that overweight and obesity is more common in T2DM). It appeared that more boys seem with T2DM in this registry have overweight and obesity in comparison to the girls. (Refer Figure 1 and Figure 2) 67.7% of T2DM girls who have their BMI reported in this registry are overweight / obese as compared to only 6.3% in T1DM girls. Majority (91.7%) of T2DM boys who have their BMI reported in this registry are overweight / obese as compared to only 19.1% in T1DM boys.

Diabetes management and self care practice of: Most patients (80.4%) practiced home blood glucose monitoring while only a few did blood ketone testing (2.5%) and urine ketone testing (1.3%). As to the management of patients by the diabetes team, patients were seen by dietitian in 66.7%, by diabetes educator in 50.0%, and by optometrist or ophthalmologist in 45.0%. However, only 10.8% reported to have attended diabetic camps. Other self-care practices included patients carrying medic alert (10.0%), carrying simple carbohydrates (36.7%) and keeping glucagon at home (2.1%). At the time of diagnosis, there were 78.0% patients who were on insulin, 14.7% who were on oral hypoglycaemics only, and 2.8% were on combination of both insulin and oral hypoglycaemics. Outcome The annual census on the 117 patients reported did not show good glycaemic control with a mean HbA1c level of 10.0% + 2.2 (median 9.7, minimum 5.2, maximum 17.0). The mean HbA1c results of all types of DM were also noted to be above that of the target (Table II).

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report of 240 would not reflect true national estimate encouraged to register new sites (SDP) and more cases. Tracking of outcome on an annual basis would provide a richer insight into the crux of the matter. Hence, better validity of the condition can lead to better ways to care for this subgroup health of the population. More work is needed on e-DiCARE. Further improvement in reporting to DiCARE must be emphasized to more doctors so as to obtain more accurate and complete information. The early results of DiCARE however, serve to be a good starting point to improve the standard of care for young people with diabetes. National benchmarking and also perhaps later on international comparisons would spell standards of care in the future. It is timely that this study is undertaken in Malaysia so that further research on diabetes can stem out of this national registry. From the registry, we can evaluate the efficiency and effectiveness of health care among the young diabetics and the health economics of diabetes. It is hope that if we tackle the issues related to diabetes care when the patients are still young, they will become knowledgeable adults who can reasonably handle their diabetes well and decrease the long term complications.

ACKNOWLEDGEMENT All the hospital, which have provided invaluable data for this study.

REFERENCES 1.

2.

CONCLUSION This study found that there are more T1 than T2 children and adolescent diabetic in this sample. Boys appeared to suffer from weight problem more than girls. However, the first year

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3. 4.

Maria E, Craig A, Hattersley K Donaghue. ISPAD Clinical Practice Consensus Guidelines 2006-2007. Definition, epidemiology and classification. Pediatric Diabetes 2006; 7: 343-51. Worldwide childhood type 1 diabetes incidence – what can we learn from epidemiology? Soltesz G, Patterson CC, Dahlquist G. Pediatric Diabetes 2007; 8 (Suppl 6): 6-14. Epidemiology of childhood type 2 diabetes and obesity. Shaw J. Pediatric Diabetes 2007; 8 (Suppl. 9): 7-15. Vital Statistics Malaysia Special Edition 2001-2006.

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The Foundation of NCVD PCI Registry: The Malaysia’s First Multi-Centre Interventional Cardiology Project H B Liew*, M A Rosli **, W A Wan Azman ***, Z Robaayah **, K H Sim*; on behalf of the NCVD PCI investigators *Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, 93586 Kuching, Sarawak, **National Heart Institute, 145, Jalan Tun Razak, 50400 Kuala Lumpur, ***University Malaya Medical Centre, 50603 Kuala Lumpur, Malaysia

SUMMARY The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database. KEY WORDS: Cardiovascular, Percutaneous coronary intervention, Registry

INTRODUCTION Cardiovascular disease is the leading cause of death in Malaysia and accounts for 15-16% of all Ministry of Health (MOH) Hospitals’ deaths annually for the 1995 – 2003 period. Ischemic heart disease (IHD) was the commonest cause of cardiovascular mortality; accounting for 2556 deaths in 2002 and a further 896 deaths due to heart failure of ischemic origin. Despite improvement in health services, mortality has been rising steadily since 1990. Nationally, IHD probably account for 20-30% of all-cause mortality annually. Multi-centre registries play an important role in the era of evidence-based medical practice by addressing the gap between clinical trials’ findings and ‘real-life’ practice. Large databases have been used to develop risk-adjusted multivariate predictive models; and these “practice-based evidence” also provide new insights to future directions in research and development. Registries are also a form of postmarketing surveillance for PCI devices, and form the foundation for evaluation of patient outcomes, effectiveness and satisfaction.

established under the National Cardiovascular Disease Database (NCVD). Henceforth, the registry was named NCVD PCI Registry. (See Table I as a milestone of development)

The National Cardiovascular Disease database (NCVD) The NCVD is an initiative under the Malaysian Ministry of Health (MOH) that collects information about cardiovascular disease. The information can be used to estimate the incidence of cardiovascular disease according to type, and evaluate risk factors and treatments in the country. Such information is useful in assisting the MOH, nongovernmental organizations, private providers and industry in planning and evaluation strategies for cardiovascular disease prevention and control. Malaysia already had several cardiovascular disease databases in public and private healthcare providers located in Kuala Lumpur, Sarawak, Penang, Johore and at the National Heart Institute (Institut Jantung Negara, IJN). The NCVD Database was established to integrate these various databases and other data sources to achieve a nation-wide database. The NCVD is sponsored and coordinated, by the Clinical Research Centre (CRC), a research body within the MOH, and the National Heart Association of Malaysia (NHAM), the main professional body representing cardiologists and allied professionals in the field of cardiovascular medicine. The Governance Board was established in year 2006 to oversee operations of the NCVD. The MOH, universities, professional bodies, NGOs and private healthcare providers are represented in this committee to ensure that the NCVD stays focused on its objectives, its continuing relevance and justification.

In Malaysia, percutaneous coronary intervention (PCI) was introduced in the year 1983, and has grown over the last two decades. Today, at least 35 public, private and teaching institutions performed approximately 9000 PCI procedures annually. However, there is no national registry to record clinical data. Minority of hospitals collect information for local use only, with variable data elements.

Aims of NCVD PCI Registry The eventual goal of NCVD PCI is to provide a contemporary appraisal of Malaysian interventional cardiology practice, and to improve short-term and long-term outcomes of coronary artery disease. Ultimately, we hope the registry will engage all interventionalists to commit to this nationwide effort towards continuous quality improvement, and facilitate the introduction of international, multi-centre, randomized clinical trials in interventional cardiology.

It is against this background, the PCI registry is established to fulfil the need, for a large scale national level, multi-centre, collaborative group; to ensure uniform data collection and clinical follow-up. The PCI registry was the second registry

The objectives of NCVD PCI are: • To determine the number, and evaluate and monitor the outcomes of PCI based on selected performance indicators.

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To determine the cost of cardiovascular disease to the nation, and evaluate the cost-effectiveness of treatment and prevention programs. To determine the level of adherence to current practice guidelines. To stimulate and facilitate research. To facilitate quality improvement activities of participants (e.g. door-balloon-time in primary infarct PCI). To act as a reference for future studies (e.g. volume, pattern of practice, temporal trend, etc.) To facilitate future research and development. To benchmark with other national PCI registries.

It is hoped that this voluntary collaborative group will act as a catalyst for individual research ideas and projects. All participants share ‘ownership’ with access and utilization of the NCVD PCI database. This provides the platform to facilitate local audits and other quality-assurance activities at participating sites. It is also expected that this registry shall inculcate a culture of quality assurance, amongst interventional cardiology trainees; with plans for regular presentations at annual scientific meetings of the NHAM, and other national, regional, and international meetings. Interaction and collaboration with other collaborative groups and professional bodies, is anticipated in the near future.

MATERIALS AND METHODS Design The NCVD PCI registry is a voluntary, multi-centre collaboration amongst the main PCI centres in Malaysia. Consecutive patients undergoing PCI are included in the database.

Establishment of dataset The standardized data abstraction form and dataset definitions were adopted from those of the Melbourne Interventional Group (MIG) PCI Registry. The MIG collaborative group has consented to the adoption as a

goodwill gesture and in anticipation of future collaboration. The MIG abstraction form was developed with reference to current international databases including the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), and interventional databases at Cleveland Clinic and Washington Hospital Centre, USA. The case report forms (CRF) were designed to collect detail demographic, past medical history, clinical and procedural information and pharmacotherapy. The PCI registry shares the same demographic component of the NCVD ACS registry. There are three notifications: Initial notification form for the PCI procedure, patient follow-up at 30-day, six-month and 12-month. We recognized from the out-set; the importance of comprehensive data fields that are sufficient to address the important clinical questions in PCI, and yet ensure that it is not too large and cumbersome to manage. After several meetings and much deliberation, consensus was made on a dataset to reflect the contemporary PCI practice in Malaysia. With the introduction of electronic web-based CRF (eCRF), certain data fields were deemed compulsory so as not to compromise the objectives of the registry. It was felt that these compulsory data fields were important to record, in particular lesion characteristic, procedural details, in-hospital outcomes and 30-day outcomes. The initial notification is in four-page format comprising nine sections that include: demographics, clinical status, clinical examination and baseline investigations, previous revascularization, cardiac status at time of PCI, cathlab visit (including adjunctive pharmacotherapy), PCI procedural details, procedural outcome, clinical status at discharge. (See http://www.macr.org.my/encrd/zAu-data-standard.jsp for the case report form)

Data collection Consecutive patients undergoing PCI, both elective and urgent cases, were enrolled by participating sites. Commencement of data recordings started from 1st January

Table I : Milestones of the Registry

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2007, and were initiated in 12 centres. The cases were initially notified using data abstraction form, completed at each site by interventional cardiologist, fellows, or nurses. The CRF were compiled and maintained at each site. Subsequently, with the launch of the web-based registry, the data were transcribed to the electronic CRF (eCRF). All participating sites also submit a monthly notification, enlisting the PCI cases by the seventh of each month. Patients’ contact telephone number were recorded to facilitate phone call follow-ups at 30 days and then six months, after the index procedure; and at 12 months preferably by clinic visit. Longer term follow-ups shall be considered depending on future funding status. The registry is coordinated by a data manager at the Clinical Research Centre (CRC). Monthly census of each participating centre will be collected at the coordinating centre to keep track on the number of PCI performed. Data queries are referred to the participating sites, for clarification of possible errors and omissions. At present, individual sites may generate simple reports of their own centre to facilitate local audit activities. In future, regular audit program will be considered to ensure data quality. Thirty-day, six-month, 12-month follow-up was performed by cathlab nurses, or dedicated research coordinators by respective centres. The follow-up data was then centralised at CRC. Since January 2007, approximately 2500 PCI patients have been enrolled in the registry, and 30-day follow-up completed for 90% of these cases.

Web Application The data will be entered online. Individual sites submit names of interventionalists and coordinating nurses to the Registry data manager, to apply for individual username and password. The website address is at www.acrm.org.my/ncvd. The electronic CRF is launched online on 6th February 2007. The application applies a 2-tier security system where users will access the web application by using their username and password assigned by the registry manager. Once details are submitted, an authentication code will be sent to the particular user via short-messaging-system (sms), allowing access into the system. The participating centre has access to their own database but they are not given access to view the database of other centres.

to facilitate harmonious working of the group. The following centres are actively contributing to the Registry: National Heart Institute (IJN); Penang Hospital; Sultanah Aminah Hospital, Johore; Sarawak General Hospital; Serdang Hospital; University Malaya Medical Centre (UMMC); Hospital Universiti Kebangsaan Malaysia (HUKM); Selangor Medical Centre.

Ethics approval All centres practice the standard institutional procedure for obtaining informed consent from patients preceding their PCI procedure. Separate informed consent for participation of the NCVD PCI Registry was waived. The collection of patient data and follow-up was considered “observational” and non-interference to the patient care process. Confidentiality is secured via restricted access to the database as already described earlier.

RESULTS Presentation of first six-months database An introductory presentation of the Registry was made during the Annual Scientific Meeting of the National Heart Association of Malaysia (NHAM) in April 2007. Six months after the launch, an interim analysis of the registry was presented during the annual meeting (My LIVE) of the Malaysian Society of Interventional Cardiology (MSIC) in July 2007. A total of 2349 PCI cases was enrolled in the first six month of 2007. Amongst the 1249 patients that have been reported and analyzed, the mean age was 56 years (min of 23, max of 86). Eighty two percent were males. Hypertension and dyslipidaemia are the most prevalent risk factors at 70.5% and 70.3% respectively. Diabetes affected 42.8%, of the cohort, and 6.7% has chronic renal failure.

Twenty four percent of these cases presented as acute coronary syndrome, of which 48% was STEMI, 22.7% NSTEMI, and unstable angina 26.3%. Majority of PCI was on elective basis (87.4%). Transfemoral approach comprised 59% of cases, with 34% transradial. Fifty percent of cases involved multi-vessel disease. Drug eluting stents were used in 46.5% of PCI, with mean stent length of 22.4mm, and diameter of 3.0mm.

Participating centre PCI registry involves cardiac centres of the Ministry of Health Malaysia, National Heart Institute, universities and private centres that provide the majority of PCI service in the country. PCI registry has completed one year of data collection by 1st January 2008. Eight centres out of 12 contributed data in the first year.

Procedural complications include peri-procedural myocardial infarction 0.8%, emergency reintervention 0.88% (11 cases of stent thrombosis). There was no bailout CABG. Overall, bleeding complications occurred in 1.5% of procedures. For 544 patients in the first six months, the 30-day mortality was 0.37%.

Participation of individual centres is voluntary, and spearheaded by heads of respective centres. This collaborative venture has been successfully implemented into the workflow of the participating centres. By targeting institutions rather than individual cardiologists, the group felt this will ensure continuity and sustainability of the registry. Collaborators from participating centres together form the Working Committee, which has a democratic management structure

DISCUSSION Future direction There is ongoing effort to encourage the participation from other hospitals. The need for data quality is recognized by the Working Committee and in future, audit shall be carried out. At present, the responsibility for accurate data rests with the respective centres having to perform data verification,

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and local audit. It is anticipated that with the growth of the database volume, subgroup analysis will be performed. It is hoped the analysis of the database shall provide the contemporary pattern of practices in Malaysia, as well as provide a platform for local research in health economics that will contribute useful information for public health policy, and assist in formulation of clinical practice guidelines.

CONCLUSION The NCVD PCI Registry is the first Registry comprising the main hospitals and centres that provide PCI services in Malaysia. This Registry represents the voluntary collaboration of interventional cardiologists to provide a contemporary appraisal of Malaysian interventional cardiology practices. The Registry documents demographic, clinical and procedural details of consecutive patients undergoing PCI. Follow-up is planned up to 12 months. This venture shall facilitate continuous quality improvement in PCI, and facilitate the introduction of international clinical trials in interventional cardiology.

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ACKNOWLEDGMENT We wish to thank Melbourne Interventional Group (MIG), Australia for their goodwill in allowing the adoption of their concept, abstraction form and data field’s definition. We wish to also thank the Ministry of Health, the Clinical Research Centre, and the National Heart Association of Malaysia for their guidance and financial support of the Registry.

REFERENCES 1.

2.

KH Sim et al; Recommendations of the Expert Committee for the Identification of Research Priority Areas for Ischaemic Heart Disease; 9TH National Health Plan 2006-2010; Ministry of Health Malaysia. AE Ajani et al; The Foundation and Launch of the Melbourne Interventional Group: A Collaborative Interventional Cardiology Project; Heart Lung and Circulation 2006; 15: 44-7.

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National Trauma Database (NTrD) – Improving Trauma Care: First Year Report F J Sabariah*, N Ramesh**, A W Mahathar*** *Emergency Department, Sungai Buloh Hospital, 47000 Sungai Buloh, Selangor, **Department of Neurosurgery, Kuala Lumpur Hospital, Jalan Pahang, 50586 Kuala Lumpur ***Emergency Department, Kuala Lumpur Hospital, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY The first Malaysian National Trauma Database was launched in May 2006 with five tertiary referral centres to determine the fundamental data on major trauma, subsequently to evaluate the major trauma management and to come up with guidelines for improved trauma care. A prospective study, using standardized and validated questionnaires, was carried out from May 2006 till April 2007 for all cases admitted and referred to the participating hospitals. During the one year period, 123,916 trauma patients were registered, of which 933 (0.75%) were classified as major trauma. Patients with blunt injury made up for 83.9% of cases and RTA accounted for 72.6% of injuries with 64.9% involving motorcyclist and pillion rider. 42.8% had severe head injury with an admission Glasgow Coma Scale (GCS) of 3-8 and the Revised Trauma Score (RTS) of 5-6 were recorded in 28.8% of patients. The distribution of Injury Severity Score (ISS) showed that 42.9% of cases were in the range of 16-24. Only 1.9% and 6.3% of the patients were reviewed by the Emergency Physician and Surgeon respectively. Patients with admission systolic blood pressure of less than 90mmHg had a death rate of 54.6%. Patients with severe head injury (GCS 15, C)Patients admitted to Intensive Care Unit (ICU) or high dependency ward (HDW) for > 24 hours and mechanically ventilated, D)Urgent surgery within 24 hours for intracranial, intrathoracic, intra-abdominal, or fixation for pelvic or spinal injuries, E)All severe head injury patients with Glasgow Coma Scale (GCS) of 3-8, F) All moderate head injury patients with GCS of 9-12. Data is entered directly into the National Trauma Database web application at www.acrm.org/ntrd or entered into a form and later into the web application.

RESULTS During the 12 month period, there were 123,916 trauma patients of which 933 (0.75%) were classified as major trauma. There were 84% men and 16% women. Malaysians made up 88.2% of the cases with Malays 58%, Chinese 22.5% and Indians 15.6%. The majority of patients were within 1524 years old (30.2%) (Fig.1). Most of the patients were admitted between 6pm – 12 midnight representing 25.6% and most commonly on Wednesday with 16.7%. Cases referred from other hospital accounted for 53.5% of cases. Patients with blunt injury made up for 83.9% of cases. RTA accounted for 72.6% of injuries with 64.9% involving motorcyclist and pillion rider. Trauma at home recorded 9.3%. As expected, the majority of patients 42.8% had severe head injury with an admission Glasgow Coma Scale (GCS) of 3-8 and the Revised Trauma Score (RTS) of 5-6 were recorded in 28.8% of patients. (Table I). Traumatic subdural haematoma accounted for most of the intracranial injury with 20.7%. The distribution of Injury Severity Score (ISS) showed that 42.9% of cases were in the range of 16-24 (Fig. 2). However, there were numerous missing data (>50%) but the ISS trend here is comparable as most trauma database and registries. Only 1.9% and 6.3% of the patients were reviewed by the emergency physician and surgeon respectively. 35.5% of patients were sent immediately to ICU from the Emergency Department while 32.6% were admitted to the general wards. Only 3.2% of patients were transferred to other hospitals. 28.7% of cases were operated upon with 89.2% for intracranial surgery of which 55.6% were for intracranial haematoma. (Table II).

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More than half (57.7%) of patients survived to hospital discharge and 63.4% of these patients were discharged home while 17.3% patients were discharged back to the referring hospital. Despite RTA being the most common cause of injury, injuries at trade/service areas and industrial/construction sites recorded the highest mortality with 33.3% and 30.6% of patients respectively versus 18.3% for RTA. Patients with admission systolic blood pressure of less than 90mmHg had a death rate of 54.6%. Patients with severe head injury (GCS 15 with the highest in the >40 range. The average LOS of trauma patient is seven days. Despite receiving ICU management, 48.5% patients died. Patients with higher ISS and who were operated upon might be the choice of ICU candidate and therefore are more severely ill, thus the higher mortality. In one series of Injury Severity Score of ICU patients, FJ Sabariah and colleagues (unpublished report) found that the mean ISS for nonsurvivors was 27(± 9.1) and for survivors 20.1(± 10.8)14.

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CONCLUSION Trauma registries are at an early stage of development relative to other disease registries13. Experience from other established registries in Malaysia such as the National Renal Registry as well as the support of the Clinical Research Centre has helped in the development of the NTrD.

REFERENCES

The first year of the NTrD has successfully given us insights to the pattern of major trauma in the country. However, persistent concerns about the completeness of data and incomplete geographical coverage will be addressed. In 2008, there will be an additional seven centres that, with further funding from the Ministry of Health, will definitely give us a more accurate picture allowing a more detailed analysis including the probability of survival and other statistics used in the analysis of trauma databases and registries.

5.

1. 2. 3. 4.

6.

7.

8.

9.

ACKNOWLEDGMENTS The database is supported by the Ministry of Health grant MRG - 2006-1. The authors would like to thank the DirectorGeneral of Health, the Deputy Director-General of Health (Technical Support and Research), Clinical Research Centre of Hospital Kuala Lumpur, the National Institute of Health and all staff involved with data collection and data entry.

10. 11.

12.

13. 14.

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Ministry of Health Malaysia. Annual Report 2006. Kuala Lumpur, Malaysia: Ministry of Health Malaysia; 2007. Yates DW. Scoring Systems for Trauma. BMJ 1990; 301: 1090-94. World Health Organisation: Global Burden of Disease 2002. World Health Organisation, Department of Measurement and Health Information; 2004. Cameron P, Dzukias L, Hadj A, Clark P, Hooper S. The Victorian Major Trauma Study 1993. Victorian Government Department of Health Services, Melbourne, Victoria, Australia 1994. Champion HR, Sacco WJ, Copes WS et al. The Major Trauma Outcome Study: establishing national norms for trauma care. J Trauma 1990; 30: 1356-65. Sethi D, Aljunid S, Saperi SB et al. Comparison of the Effectiveness of Major Trauma Services Provided by Tertiary and Secondary Hospitals in Malaysia. J Trauma 2002; 53: 508-16. Sethi D, Aljunid S, Saperi SB et al. Comparison of the Effectiveness of Major Trauma Services Provided by Secondary and Tertiary Hospitals in Malaysia. Ann Emerg Med 2007; 49: 52-61. Victorian State Trauma Registry. 1 July 2005 to 30 June 2006 Summary Report: Victorian Government Department of Health Services, Melbourne, Victoria, Australia; 2007. Clark DE, Fantus R (eds). American College of Surgeons National Trauma Databank 2006 version 6.0: American College of Surgeons; 2006. Peden M, Scurfield R, Sleet D, et al. World Report on Road Traffic Injury Prevention. Geneva, Switzerland: World Health Organisation; 2004. Emergency Admissions: A journey in the right direction? Executive Summary: A report of the National Confidentiality Enquiry into Patient Outcome and Death; 2007. Ali J, Adam. R, Butler AK et al. Trauma outcome improves following the advance life support program in a developing country. J Trauma. 1993; 34: 890-99. Pollock DA, McClain DW. Trauma Registries: Current status and current prospects. JAMA. 1989; 262: 2280-83. Sabariah FJ, Arbayah R, Norhayati H, Ahmad S M, Huwaida A H. Injury Severity Score of Trauma in the ICU. Selayang Hospital. 2003.

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National Suicide Registry Malaysia (NSRM) A N Hayati, A K Kamarul NSRM, c/o Department of Psychiatry and Mental Health, Kuala Lumpur Hospital, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY To create a nationwide system to capture data on completed suicide in Malaysia i.e. the morbidity, geographic and temporal trends and the population at high risk of suicide. Data from this registry can later be used to stimulate and facilitate further research on suicide. This paper describes the rationale and processes involved in developing a national suicide registry in 2007. The diagnosis of suicide is based on the ICD-10 codes for fatal intentional self-harm (X60-X84). A case report form with an accompanying instruction manual had been prepared to ensure systematic and uniform data collection. State Forensic Pathologist’s offices are responsible for data collection in their respective states, and in turn will submit the data to a central data management unit. Data collection began in July 2007 and currently in data cleaning process. Training for source data producers is ongoing. In 2008, the NSRM plans to involve university hospitals into its network as currently only Ministry of Health hospitals are involved. The NSRM will be launching its online application for case registration this year while an overview of results will be available via its public domain at www.nsrm.gov.my beginning 20 April 2008. To efficiently capture the data on suicide, a concerted effort between various agencies is needed. A lot of conceptual work and data base development remains to be done in order to position preventive efforts on a more solid foundation.

suicidal deaths that occur in Malaysia via its network of forensic services. This initiative is sponsored by the Psychiatric and Mental Health Services and the Forensic Medicine Services of the Ministry of Health Malaysia (MOH); while the Clinical Research Centre CRC) provides the technical expertise. It is managed by a Joint Technical Committee comprising these three agencies. The NSRM is affiliated with the Clinical Research Centre (CRC) Network of Registries.

KEY WORDS: Suicide, Suicidal, Para suicide, Registry database, Fatal intentional, self-harm

Demographics In industrialised nations there has been an increase in male suicide rates within all age groups, but most worryingly is the trend in younger cohorts2. It is generally rare to encounter suicides in children under 10, but young children are capable of deliberate self-harm and suicidal acts. Almost all children have a basic understanding of what suicide is by age 113. There have been sporadic newspaper reports on school children who commit suicide – and this registry aims to capture systematic data on this. Another age group at high risk of suicide is the elderly population.

INTRODUCTION Nationwide epidemiological data on suicides will not only be useful in identifying high-risk groups and changes in suicidal behaviour over time, it will also provide baseline for testing the outcomes associated with specific intervention and prevention programs. Although the National Registration Department (NRD) reports annual causes of mortality, it would seem that rates of death by suicide appear rather low. For example in 1999, the NRD reported only 79 suicidal deaths, whereas a cross sectional study done in Kuala Lumpur Hospital during the same period only identified 76 cases1. It is postulated that among the difficulties that could have caused these discrepancies include: the degree of subjectivity of identifying a death by suicide, lack of structured data describing the ‘manner of death’ for cases of traumatic or non-natural deaths, and inconsistencies in the way terms are defined, data collected and coded. In response to this, the National Suicide Registry Malaysia was officially initiated in 2007 to compile the census of

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The ground work for the implementation of this registry had taken place since 2005 including: preparation of a module for data collection; discussions with stakeholders, namely relevant departments within the Ministry of Health and the Royal Malaysian Police; training of officers dealing with death certification which include processes for queries and feedbacks; developing a system for data collection and analysis; and preparing for data dissemination. The NSRM is governed by an advisory committee which consists of policy-makers and senior clinicians to ensure that the NSRM stay focused on its objectives and to assure its continuing relevance and justification. Literature Review A. Epidemiology of Suicide

Urban life has often been blamed for creating isolating anomic environments with high suicide rates. This may be a cause for concern because 62% of Malaysians are staying in urbanized areas 4. However, there has not been empirical research support for this. A more systematic nationwide suicide database would be able to show whether there are actual differences between urban and rural areas. Other factors of interest are the influence of marital status, ethnicity or religious beliefs.

Methods of Suicide In 1965-1970, the most common methods of suicide in Kuala Lumpur were by hanging (50%), caustic soda ingestion

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(12.8%), jumping from height (11.4%) and swallowing insecticides (7.9%). Within two decades, the pattern changed: hanging had gone down to 34%, poisoning predominates with 39% and jumping from height had doubled to 22%1. Thus, methods of suicide appear to reflect on availability of means. Other special conditions related to suicide e.g. homicidesuicide and suicide pact will also be investigated. B. Factors Contributing to Suicide and Suicidal Behaviours Suicide is a process in which neurobiological, psychological, cultural and social variables contribute to produce the end result. Different contributing factors lend unequal weights with no single one having been proven to be necessary or sufficient to cause suicide. Healthcare service providers, however, need to recognize populations which may be especially vulnerable to suicide when faced with a stressor or combination of stressors that may hold dark or intolerable personal implications.

Sociological, Economic and Cultural Factors Although available literature supports the hypothesis of a link between unemployment and increased rates of suicide and parasuicide, it is a controversial link. One possible contributor to unemployment is large increases in the sizes of successive birth cohorts5. Meanwhile, there does not appear to be a straightforward and predictable link between income and suicide risk. In many developed countries where gross national product has been increasing over the past decades, suicide rates have also been increasing. By contrast, Wilkins, Adams and Brancker 6, found that people in the poorest quintile had a suicide mortality rate 1.5 times that of the wealthiest quintile in 1971, and more than twice as high in 1986. Psychiatric Conditions Among a wide variety of causes, mental disorder features consistently in the matrix of causation. Retrospective studies based on psychological autopsies (reconstruction of events leading up to a suicide) and/or record linkages (review of medical, psychological and social records of persons who have completed suicide) have been conducted in various countries. The majority of these report the presence of a mental disorder or a recent history of mental disorder in a high proportion of persons who die by suicide (ranging from 11% to 92%)7. Many studies identify mood disorders (particularly depression) as the most frequent disorder in persons who complete suicide, affecting from 30% to 70%8. Other disorders found more commonly among suicide completers than in the general population include substance abuse disorders and schizophrenia. Genetic and Family Background There is some evidence that suicide tends to run in families. However, it is difficult to differentiate between possible genetic factors involved in suicide such as the presence of a family member as a role model, and effect of psychiatric disturbance in families9. Kety10 pointed out that neither environmental nor genetic influence alone may be sufficient to cause suicide, but suggested that a major inherited factor is an inability to control impulsive behaviour.

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Life Events Rich, Richard, Fogarty and Young 11 found that between 27% and 39% of people who completed suicide had experienced a stressful life event within the six weeks preceding their suicide attempt. The majority of these precipitating events were losses or interpersonal conflicts. Those who were diagnosed as suffering from drug or alcohol abuse were more likely to have an identifiable precipitating event before their suicide than those with other psychiatric diagnoses. Paykel, Prusoff and Myers12 found that, in a clinical sample, among events that best differentiated suicidal from non- suicidal persons were severe conflict with the partner or spouse, serious illness in the family and serious illness(hospitalization or absence from work over one month) in the suicidal person. Tousignant and Hanigan13 described that students who attempted suicide or had serious suicidal ideation could be differentiated from non-suicidal groups using the following variables: running away from home, dropping out of school, “bad trips,” rejection from social groups and being physically attacked. In addition, break-up of a relationship featured prominently in several studies. However, failure in interpersonal relationships and school problems did not result in suicide unless they occurred in a chaotic or disturbed family context 7. AIDS/Terminal Illness American studies found astonishingly high rates of completed suicide in terminally ill patients, equivalent to 463 per 100,000 per year in California; 681 per 100,000 per year in New York City; and 222 per 100,000 per year in Texas 7. The fact that a person is terminally ill is not, in itself, sufficient cause for suicide. As with other suicidal acts, there is generally considerable ambivalence on the part of the suicidal person, despite the terminal illness. Depression caused by social isolation and the strain of being terminally ill may be diminished by appropriate psychotherapeutic interventions, and by the support of family, friends, and the community 7. C. High-Risk Groups Adolescents and Young Adults Suicide is a leading cause of death for young adults - it is among the top three causes of death in the population aged 15–34 years. This represents a massive loss to societies of young persons in their productive years of life14. Suicidal thinking or parasuicide among adolescents was usually linked to the presence of conduct or emotional disorder and somatization. Family dysfunction and parental arrests were two variables independently related to suicidality7. An important subgroup of suicidal youth consists of wellbehaved, anxious, perfectionist youngsters who cope poorly with change. However, the majority of suicides occur in depressed and/or substance abusing youngsters, often with a seemingly trivial humiliation as a precipitating factor 7. For young adult males, relevant factors might include a range of stressors associated with the transition to adult roles and relationships (higher education, work, marriage, etc.), the timing of the onset of mental disorders(notably schizophrenia), and adults’ easier access to alcohol and drugs. The publicizing suicides of well-known persons may also create clusters of suicide amongst the youth 7.

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Fig. 1: Pathways to Suicidal Behaviour1

Late Middle-aged and Elderly Persons Late middle-aged and elderly persons have consistently had high suicide rates. Medical advances have extended the lifespan of the very old, but their quality of life has yet to catch up with this increased longevity. Suggested risk factors for suicide among seniors are generally similar to those for other groups, and include unemployment, isolation, poor health, pain, depression, alcoholism, low self-esteem, feeling rejected, a history of mental illness, and previous suicide attempts7. Loss is the major theme in suicide among the elderly - loss of companions, of health, of mobility, of usefulness to others, and of independence 7. However, preventive measures have shown results in developed countries. These measures include ensuring that seniors have continued social support, valued social roles, and an adequate quality of life (for example, appropriate housing) 7.

Persons in Custody Persons in custody constitute another high-risk group, which is about 47 to 10 times15 higher than the general populace. Inmate suicide was more common among males and showed; that being single, separated, divorced or widowed appeared to be a risk factor; that hanging was the most common method; that a previous history of psychiatric hospitalization or outpatient psychiatric treatment was common; and that a high proportion of persons who committed suicide had made

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an attempt within the previous year. In the majority of cases the suicide occurred in the prisoner’s own cell. History of alcohol abuse or drug abuse featured in half to two third of cases. The remand period or the first six months after sentencing represent a high-risk period. There was a moderate association between violent or weapons-related offences and suicide. However, the most studies do not report any comparisons between the suicides and the general prison population, making it difficult to judge the predictive value of the characteristics being highlighted 7.

Parasuicide as a Risk Factor Parasuicide (non-lethal suicidal behaviour, commonly referred to as “attempted suicide”) occurs most frequently in young persons, particularly females. Long-term follow-up studies by Sakinofsky et al. 16 found that 10 to 13% of parasuicides ultimately take their lives. Beautrais had summarized the factors that led to suicidal behaviour based on studies done in New Zealand, as shown in Figure 1. OBJECTIVE The National Suicide Registry Malaysia (NSRM) aims to: 1. Determine the prevalence of suicide in Malaysia. 2. Determine the factors that are associated with suicide i.e. demographics, social factors and risk factors (psychiatric illness, physical illness, and life events) as outlined above.

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3. Identify methods of suicide and special circumstances of suicidal acts i.e. homicide-suicide and suicide pacts. 4. Outline the strategy for intervention, promotion and prevention based on the above findings. Data from this project will provide more accurate statistics on suicide in Malaysia. This is important for health prioritizing and identifying of areas which health providers should focus on.

MATERIALS AND METHODS • Study Design: Data collection will be done in a prospective manner. • Subjects and sampling: All cases of sudden or ‘nonnatural’ deaths handled by all public-based hospitals in Malaysia. • Inclusion criteria: The registry defines suicide as a death resulting from intentional use of physical force or power against oneself with a preponderance of evidence indicating that the use of force was intentional. This will be based on a post-mortem examination of the dead body and other supporting features and will be coded according to the International Statistical Classification of Diseases and Related Health Problems version 10 (ICD-10). Codes for fatal intentional self-harm are covered in Chapter XX – External Causes of Mortality and Morbidity (X60-X84)17. • Instrument: Mixed mode; an online- and paper-based Case Report Forms (CRF). The technical committee reviewed the literature and collected views of prospective participants before determining the final design of the CRF. The committee also prepared an instruction manual (hard and soft copies) alongside the CRF to ensure systematic and efficient data collection. With due regard to the sensitive nature of data acquisition, a specific chapter was specifically dedicated to techniques for interviewing grieving family members18. Regional and national-level training will also be carried out to enhance the competence and capability of officers involved in this project. For more detailed information on the variables, kindly visit our website at www.nsrm.gov.my (will be available from 20 April 2008 onwards).

Data Flow Process The registry will be coordinated at the central data management centre i.e. the Suicide Registry Unit (SRU). However, this will depend on separate data collection efforts in each state coordinated by the State Forensic Pathologists’ office. All hospitals that are identified as Source Data Providers (SDPs) will develop an alert system to identify cases. Data will be collected via interviews with the family members or significant others or police; and review of medical records or other official documents. The relevant variables will be recorded in the paper-based CRF with carbon copy. These CRFs will be sent to the State Forensic Pathologist’s office and subsequently submitted via a web-based CRF by the State Coordinator to the Suicide Registry Unit. The web application will allow the respective SDP to securely upload data as well as to download confidential communication when required. A verification process by the State Forensic

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Pathologist have been put in place to ensure that the diagnosis of intentional self-harm/ poisoning has been justified. The Registry Manager based in the SRU will track data returns and prompt State Coordinators to submit data whenever they fall behind schedule in reporting. The original paper- based CRF will be collected by the SRU later for archiving and data cleaning purposes; while carbon copies will be retained and archived by the State Forensic Pathologist office. Strict data protection procedures will be put in place, following standard disease registration practices, and in compliance with applicable regulatory guidelines.

Progress In 2007, efforts were mostly focused on finalizing instruments, training of SDPs, and developing a viable webbased system. Training was carried out regionally from April – June 2007. Data collection had been done manually beginning July 2007 and is still in the data cleaning process. Some of the difficulties in data collection identified were rapid staff turnovers (some of those already trained had been promoted and transferred elsewhere), lack of interview area, no informant available (in some cases) and limited resources in the forensics unit. For 2008, a national-level meeting has been scheduled to give feedback to the SDP and to expose them to the online registration system. The NSRM have also invited the universities to participate in this registry beginning this year. Data will be reported in collapsed figures or trends, and will not give details of the individual. Real-time brief reports will be made available via the NSRM’s official website www.nsrm.gov.my, while more detailed queries will have to go through the advisory committee. Meanwhile, annual reports will be produced to give a clearer picture of national trends.

CONCLUSION Suicide rates are a recognized health outcome indicator internationally14. This project will provide information on the natural history and causation of suicide; the contributing factors most amenable to preventive efforts; and the most appropriate target population(s). This information will aid in planning and place preventive efforts on a more solid foundation19. This registry will be able to provide both stateand national-level data. Suicidal acts will incur medical costs which include emergency transport, medical, hospital, rehabilitation, pharmaceutical, ancillary, and related treatment costs, as well as funeral or coroner expenses for fatalities and administrative costs 20. Better and evidence-based efforts at suicide prevention may be able to reduce suicide rates in Malaysia and allow the government or families to offset these costs. Apart from that, a structured investigation into the process of identification and reporting of non-natural deaths (specifically suicide) will assist in streamlining the management of dead bodies and ascertaining the manner of death. Indirectly it will also provide a training exercise for medical officers in reporting deaths by suicide.

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The uniqueness of NSRM lies in its multidisciplinary platform. Although this presents some communication problems, it also offers advantages in the form of pooling of resources and expertise. After all, suicide is a very complex phenomenon. Being a registry, the NSRM might not be able to provide in-depth details about the causation of suicide. However, it would certainly identify trends and form the baseline for further research in this area.

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REFERENCES

13.

1.

2.

3. 4. 5.

6. 7.

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Hayati AN. The pattern of completed suicides seen in Kuala Lumpur General Hospital 1999. Medical Journal of Malaysia 2004; 59(No.2): 19098. Masterton C. Suicide and deliberate self-harm, in Companion to Psychiatric Studies, J. EC, F. CPL, and Z. AK, Editors. 1998, Churchill Livingstone: Edinburgh. 1998; 751-65. Normand CL, Mishara BL. The development of the concept of suicide in children. OMEGA Journal of Death and Dying. 1992; 25(3): 183-203. Department of Statistics Malaysia, Yearbook of Statistics 2003. Kuala Lumpur: Percetakan Nasional Berhad. 2003; 8 -11. Ahlburg DA, Schapiro MO. Socioeconomic ramifications of changing cohort size: an analysis of U.S. postwar suicide rates by age and sex. Demography. 1984; 21: 97-108. Wilkins R, Adams O, Brancker A. Changes in mortality by income in urban Canada from 1971-1986. Health Reports, 1989; 1(2): 137-74. National Task Force on Suicide in Canada, Suicide in Canada: update of the report of the task force on suicide in Canada, M.o.N.H.a. Welfare, Editor. 1994.

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10. 11. 12.

14.

15. 16. 17. 18. 19.

20.

Tanney BL, Mental disorders, psychiatric patients and suicide, in Assessment and prediction of suicide, R. Maris, et al., Editors. 1992, The Guilford Press: New York. Roy A, Genetics, biology and suicide in the family., in Assessment and Prediction of Suicide, R. Maris, et al., Editors. 1992, The Guilford Press: New York. Kety S, Genetic factors in suicide, in Suicide, A. Roy, Editor. 1990, Williams & Wilkins: Baltimore. 1990; 127-33. Rich CL, et al., San Diego Suicide Study: III. Relationships between diagnoses and stressors. Archives of General Psychiatry, 1988; 45: 589-92. Paykel ES, Prusoff B, Myers JK, Suicide attempts and recent life events: a controlled comparison. Archives of General Psychiatry. 1975; 32(3): 32733. Tousignant M, D Hanigan. Suicidal behaviour and depression in youth, in Depression and the social environment, P. Cappaliez and R.S. Flynn, Editors. McGill-Queen's University Press: Montreal and Kingston. p. 1993; 93-120. World Health Organization, Burden of mental and behavioural disorders, in The world health report: 2001: mental health: new understanding, new hope. World Health Organization: Geneva. p. 2001; 19-44. Dalton V. Suicide in prison 1980 to 1998: national overview. Trends and Issues in Crime and Criminal Justice. 1999; 126. I Sakinofsky. Problem of resolution and repetition of parasuicide: a prospective study. British Journal of Psychiatry 1990; 156: 395-99. World Health Organization. International Classification of Diseases and Related Health Problems. 10th Revision 2007 [cited]. Reiget MS. Saying the Right Thing: Death in the Field and Grief Support Guidelines Curriculum Workbook. 2001 15 Jan 2007 [cited]. World Health Organization, Self-directed violence, in World Report on Violence and Health, E. Krug and et al. Editors. World Health Organization: Geneva. 2002; 185-212. National Center for Injury Prevention and Control, Preventing Suicidal Behaviour, in CDC Injury Research Agenda. Centers for Disease Control and Prevention: Atlanta (GA). 2002; 61-72.

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National Cancer Patient Registry A Patient Registry/ Clinical Database to Evaluate the Health Outcomes of Patients Undergoing Treatment for Cancers in Malaysia G C C Lim, D Azura Department of Radiotherapy and Oncology, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY Cancer burden in Malaysia is increasing. Although there have been improvements in cancer treatment, these new therapies may potentially cause an exponential increase in the cost of cancer treatment. Therefore, justification for the use of these treatments is mandated. Availability of local data will enable us to evaluate and compare the outcome of our patients. This will help to support our clinical decision making and local policy, improve access to treatment and improve the provision and delivery of oncology services in Malaysia. The National Cancer Patient Registry was proposed as a database for cancer patients who seek treatment in Malaysia. It will be a valuable tool to provide timely and robust data on the actual setting in oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients. KEY WORDS: Patient registry, Cancer

INTRODUCTION Cancer burden in Malaysia is increasing. The latest National Cancer Registry Report in 2003 estimated a 1:4 risk of developing cancer for the Malaysian population 1. However as data in our local setting is scarce, the actual incidence and outcome of treatment for these patients is still largely unknown. Given the increasing cancer burden in Malaysia, one would expect anti-neoplastic medicines to be widely used for cancer treatment in Malaysia. However, the most recent data from the Malaysian Statistics on Medicines 2005 report 2 shows that the utilization of anti-neoplastic drugs in the Malaysian population do not even rank among the top 30 by utilization level or by cost. In contrast, in Australia, a country with comparable population and cancer burden (although it is a wealthier nation), anti-neoplastic drugs ranked seventh by cost in its top ten therapeutic groups 3. Anti-neoplastic drugs alone cost the Australian taxpayer RM600 million in 2004-5, while in Malaysia the total expenditure on all prescription drugs was only about RM2 billion in 2005.

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This relative under treatment of cancer is of course not unique to Malaysia. A recent report 4 shows that even among developed countries, the use of modern cancer drugs can vary by a factor of 10, demonstrating huge inequalities in access to cancer medicine around the world, which ultimately results in significant differences in patient survival. The biggest differences were seen in four innovator cancer drugs bevacizumab (Avastin); cetuximab (Erbitux); erlotinib (Tarceva); and pemetrexed (Alimta). For example, the use of Avastin for colorectal cancer in the United States was 10-times the European average, as was the use of Tarceva for lung cancer. In the recent years there have been significant improvements in cancer treatment, including new chemotherapy regimes, targeted therapies and advanced radiotherapy techniques. However, these new treatments may potentially cause an exponential increase in the cost of cancer treatment. Therefore, justification for the usage of these treatments is mandated. Availability of local data will enable us to evaluate and compare the outcome of our patients. This will help to support our clinical decision making and local policy, improve access to treatment and improve the provision and delivery of oncology services in Malaysia. The National Cancer Patient Registry was proposed as a database for cancer patients who seek treatment in Malaysia. It will be a valuable tool to provide timely and robust data on the actual setting in oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients.

OBJECTIVE 1. Describe the natural history of cancers in Malaysia. 2. Determine effectiveness of treatment for cancer. 3. Monitor safety of products and services used in the treatment of cancers. 4. Evaluate access to and quality of treatment services for cancer.

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MATERIALS AND METHODS Study Design A multicentre observational cohort study Patient Selection All patients with a confirmed diagnosis of cancer at participating sites will be enrolled into the registry.

Duration of Study The study is expected to start in early 2008. Patients will be followed up according to the standard of care of each participating site. The duration of follow up is anticipated to be about 10 years. Location of Study Participating sites include centers in the government and private centers. The government centers are Hospital Kuala Lumpur, Hospital Umum Sarawak and Hospital Sultan Ismail. Private centers consist of Nilai Cancer Institute, Hospital Mutiara Penang, Sabah Medical Centre, Damansara Specialist Hospital and Pantai Medical Centre. Participation from more centres is expected in the future.

Data collection will be done electronically. Stringent information security policies will be implemented to maintain confidentiality.

Data Analysis Data analysis will be done by a third party biostatistical consulting vendor company. This will be done at least annually.

CONCLUSION The National Cancer Patient Registry is the first database to record detailed information on cancer patients in Malaysia. Currently it is at the final planning stage and is expected to start data collection soon. Its first report is anticipated a year after data collection is started.

REFERENCES 1.

2.

Data Collection All new cancer patients will be registered on attendance at participating sites. Existing patients on follow-up may also be included in the registry. Two datasets are defined, core dataset which is essential for data analysis and non core dataset which is additional data for further analysis.

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3. 4.

Gerard Lim CC, Yahya H. Second Report of the National Cancer Registry, Cancer Incidence in Malaysia. National Cancer Registry, Ministry of Health, Kuala Lumpur, 2003. Sameerah SAR, Sarojini S. (Eds). Malaysian Statistics on Medicine 2005. Kuala Lumpur 2007. Available at http://www.crc.gov.my/nmus Australian Bengt Jonsson, Nils Wilking. The burden and cost of Cancer. Annals of Oncology 2007; 18 (Supplement 3): iii8–iii22, 2007.

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New Registry: National Cancer Patient Registry - Colorectal Cancer L Wendy*, M Radzi** *Department of Medicine, Clinical Campus of UPM, Aras 9&10B, Grand Seasons Avenue, 72, Jalan Pahang, 53000 Kuala Lumpur, **Department of Medicine, Hospital Sultanah Bahiyah, KM 6, Jalan Langgar, 05460 Alor Star, Kedah, Malaysia

SUMMARY Colorectal cancer is emerging as one of the commonest cancers in Malaysia. Data on colorectal cancer from the National Cancer Registry is very limited. Comprehensive information on all aspects of colorectal cancer, including demographic details, pathology and treatment outcome are needed as the management of colorectal cancer has evolved rapidly over the years involving several disciplines including gastroenterology, surgery, radiology, pathology and oncology. This registry will be an important source of information that can help the development of guidelines to improve colorectal cancer care relevant to this country. The database will initially recruit all colorectal cancer cases from eight hospitals. The data will be stored on a customized webbased case report form. The database has begun collecting data from 1 October 2007 and will report on its first year findings at the end of 2008. KEY WORDS: Colorectal, Cancer, Registry

INTRODUCTION Recent studies have shown an increasing incidence of colorectal cancer (CRC) in Asian populations 1. According to the Second Report of the National Cancer Registry 2, colorectal cancers accounted for 14.2% of male cancers and 10.1% of female cancers in Malaysia, making it the commonest cancers among men and the third most common cancer among women respectively. CRC is the third commonest cause of cancer-related mortality in Malaysia. Management of colorectal cancer has evolved rapidly over the past decade with advances in endoscopic techniques, surgery, oncology, radiology and molecular genetics. The wealth of clinical and epidemiological evidence has allowed formulation of clear practice guidelines on the management of colorectal cancer in average risk and high risk groups by international gastroenterological, surgical and oncology societies. Management of CRC is multidisciplinary and should include selection of appropriate therapy, surveillance strategies post surgical resection, identification of high risk groups e.g. inherited colon cancer syndromes and screening of CRC in high risk groups. At present, no such registry that dedicates itself to comprehensive reporting on all aspects of colorectal cancer

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exists in Malaysia. Currently, data that is available on colorectal cancer from the National Cancer Registry in Malaysia is limited 2.

MATERIALS AND METHODS Patient population This is a multi-center project involving eight hospitals scattered throughout Malaysia. All confirmed cases of colorectal cancer from these hospitals will be recruited into the database from October 2007 to December 2010. The colorectal cancer cases are identified through the gastroenterologists, colorectal surgeons, pathologists and oncologists working in these eight centers. The eight initial pilot sites are based at Hospital Sultanah Bahiyah (Alor Star), Hospital Sultanah Aminah (Johor Bahru), Hospital Kuala Lumpur, Hospital Serdang , Hospital Selayang, Hospital Queen Elizabeth (Kota Kinabalu), Hospital Raja Perempuan Zainab II, (Kota Bharu), Hospital Universiti Sains Malaysia (Kubang Kerian). There are plans to include one new site which is Hospital Umum Sarawak. These are large hospital centers with heavy case workloads dealing with colorectal cancer. The sources of patients are from the local population and referrals from the local surrounding hospitals.

Inclusion criteria All histologically verified colorectal cancer cases from these eight hospitals will be reported to the colorectal cancer database (irrespective of the staging, histopathology, duration of the disease) within the study period. Exclusion criteria Any patient who received their treatment at participating study sites not within the study period. Anal cancers are also excluded. Case report form (CRF) All data on demographics, clinical history, family history, pathology and treatment details (including, surgical, oncology and palliation treatment) will be extracted from patients’ medical records by research assistants under supervision by site investigators. The data is stored on a customized web-based electronic case report form readily accessible to the source data providers from the eight initial pilot sites.

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Database monitoring and data management Database monitoring and data management will be carried out by the research assistants who are under the supervision of the principal investigators and the Clinical Research Centre, Hospital Kuala Lumpur in compliance with patient data protection.

RESULTS One hundred and ninety seven cases of colorectal cancers have been reported to the database from the eight participating hospitals between 1st October 2007 and 29 February 2008. Data collected are as follows: • demographic details • family history • concomitant medical problems • presenting symptoms • investigation details • pathology staging • therapy offered • details of surgical and oncology therapy, including complications • follow-up details The registry will report on its findings at the end of 2008.

DISCUSSION All the cancer statistics in Malaysia is derived from the National Cancer Registry. The data derived from the National Cancer Registry on colorectal cancer is rather limited. As management of colorectal cancer care advances, we need not just detailed and comprehensive demographic data, but treatment outcome data is also essential. The key areas benefiting from establishing a colorectal cancer registry are as follows: i. Patient care and education • Identification of high risk patients for colorectal cancer by virtue of their family history. • Risk assessment and person contact is easier using a customized computer database. ii. Education of healthcare professionals • Fostering collaboration with other colorectal cancer registries throughout the world. • Audit and review cancer treatment outcomes (surgery and oncology outcomes) in terms of disease-free survival, mortality, complications and side-effects.

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iii. Research • Provide a more accurate and refined prevalence estimates of colorectal cancer in Malaysia e.g. ethnic variations and risk, geographical variations as well as socio-cultural and socio-economic influences. • Facilitate clinically important research on colorectal cancer from data collected in the registry. e.g. is the population of hereditary colon cancer in Malaysia similar to the Western population? • Generate data for publication of original scientific papers. iv. Health Policy Makers • Help decision making on the resource allocation, need on improvement of quality control on equipments, training personnel and strengthening areas which require improvement and provide optimal care to patients. • Provide evidence to help formulate screening and surveillance strategies that are relevant and cost-effective in the Malaysian setting.

CONCLUSION It is hoped that the establishment of the database will further our knowledge on colorectal cancer in the Malaysian population. This database will serve as an invaluable repository of data for quality assessment of colorectal cancer management in Malaysia.

FINANCIAL SUPPORT AND ETHICS APPROVAL The NCPR - Colorectal Cancer is supported by grants administered via the Clinical Research Centre, Kuala Lumpur. The project has been approved by the Medical Research and Ethics Committee of the Ministry of Health, Malaysia.

ACKNOWLEDGEMENT We would like to thank the Ministry of Health and the Clinical Research Centre for the support in this project. In addition, we are grateful to the various hospitals, the source data providers and the registry manager and research assistants for their assistance in providing the data on the patients.

REFERENCES 1. 2.

Cancer incidence in five continents vol IX. http://www.iarc. Second Report of the National Cancer Registry. http://www.makna.org.my/NCR/

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Nasopharyngeal Carcinoma Database K C Pua*, A S B Khoo**, Y Y Yap***, S K Subramaniam****, C A Ong*****, G Gopala Krishnan******, H Shahid*******, The Malaysian Nasopharyngeal Carcinoma Study Group# *Department of Otorhinolaryngology, Hospital Pulau Pinang, Jalan Residensi, 10990 Penang, **Molecular Pathology Unit, Cancer Research Centre, Institute for Medical Research, Jalan Pahang, 50588 Kuala Lumpur, ***Department of Surgery, Clinical Campus Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, ****Department of Otorhinolaryngology, Head and Neck Surgery, Sarawak General Hospital, Jalan Hospital, 53586 Kuching, Sarawak, *****ENT Department, Queen Elizabeth Hospital, Kota Kinabalu, Sabah, ******Department of Otorhinolaryngology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur , ******* Department of ORL-Head and Neck Surgery, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia

SUMMARY Nasopharyngeal carcinoma (NPC) is a cancer which is common in Asia. We report the establishment and early results of a multi-institutional prospective study of nasopharyngeal carcinoma, which seeks to systematically collect data as well as blood and tumour tissue samples from patients diagnosed with nasopharyngeal cancer at six centres in Malaysia. A total of 484 confirmed NPC cases were reported from the six participating centres between 1st July 2007 and 29th February 2008. Of these, 225 were newly diagnosed cases, 53 were recurrent cases and 206 were in remission at the time of reporting. Amongst the newly diagnosed cases, the most common presenting symptom was the presence of neck lumps (42%). Ophthalmo-neurologic symptoms were the presenting symptoms of 11% of the new cases. The majority of cases (75%) presented at stage III/IV. KEY WORDS: Nasopharyngeal carcinoma, Database, Symptom, Diagnosis, Multi-center

INTRODUCTION Although Nasopharyngeal Carcinoma (NPC) is rare in most populations, it is a leading form of cancer in a few welldefined populations, including natives of southern China, Southeast Asia, the Arctic, and the Middle East/North Africa. The distinctive racial/ethnic and geographic distribution of NPC worldwide suggests that both environmental factors and genetic traits contribute to its development. Nasopharyngeal carcinoma (NPC) is a prevalent cancer in Malaysia. According to the National Cancer Registry, there were 1,125 incident cases of NPC in Peninsular Malaysia in 2003, where it was the second most common cancer among males1. The age-standardized incidence was 10.2 and 3.6 per 100,000 of the population for males and females, respectively, in Peninsular Malaysia1. The incidence is particularly high in some native groups in Sarawak 2. While there have been several hospital studies on NPC in Malaysia 3,4,5,6, there is a lack of multi-centre studies on the disease. In addition, there is a paucity of information of the clinical outcome of NPC patients in Malaysia. In order to

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collect and analyse the pattern of presentation and clinical outcome of NPC patients in Malaysia and to collect samples for research, we have established a multi-institutional study of NPC in Malaysia. The linkage of high quality clinical information to the bio-specimens will open up new avenues of research that could help prevent, treat and control this disease. The study involves six major tertiary referral centres representing parts of Peninsular Malaysia (one centre each in Penang and Kelantan and two centres in Kuala Lumpur) and East Malaysia (one centre each in Sabah and Sarawak). In this preliminary report, we present the demographic and clinical information of the patients in the first eight months of the establishment of the Malaysian NPC Clinical Outcome database.

MATERIALS AND METHODS Centres The NPC clinical outcome study is a multi-centre, prospective study which recruited all patients with confirmed NPC regardless of the stage, histopathology and duration of disease, who were seen at the participating sites: Penang Hospital, Kuala Lumpur Hospital/Universiti Putra Malaysia (UPM), Sarawak General Hospital (Hospital Umum Sarawak)/Universiti Malaysia Sarawak (UNIMAS), Queen Elizabeth Hospital, Sabah, University of Malaya Medical Centre (UMMC) and Universiti Sains Malaysia (USM) Hospital, Kubang Kerian, Kelantan. The study was monitored and data was managed by the Department of Otorhinolaryngology and the Clinical Research Centre, Penang Hospital in compliance with patient data protection. This study is approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia and the institutional ethics committees of UMMC and the USM Hospital.

Inclusion criteria and data collection All cases reported between 1st July 2007 and 29th February 2008, were included in this preliminary analysis. We established a secure clinical database (https://app.acrm.org.my/npc/) to enable secure real-time collection of data. All centres were responsible for entering

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data through a web-based interface into the database. All confirmed cases of nasopharyngeal cancer patients were recruited to the study and clinical data was collected by a research assistant or doctor responsible for the care of the patient. The histopathology was classified according to the World Health Organization Classification of Nasopharyngeal Carcinoma (WHO I, WHO II and WHO III) 7. The disease was staged according to the AJCC Staging for Nasopharyngeal Carcinoma 20028. The data was cleaned by the database manager and reviewed. The cases were analysed separately for newly diagnosed cases (New), recurrent cases (Recurrent), and cases which were already in remission at the time of diagnosis (Remission).

RESULTS Cases reported by Centres (Table I) Between July 2007 and February 2008, a total of 484 confirmed NPC cases were reported from the six participating centres. Of these, 225 were newly diagnosed cases, 53 were recurrent cases and 206 were in remission at the time of reporting.

Socio-demographic Distribution of Cases (Table II and III) As has been described previously in other populations 9,10, we found a higher incidence of NPC in men compared to women: the male: female ratio was ~3:1 for both newly diagnosed and recurrent cases. Seventy-one percent of the new cases were in the productive working age group of 21 to 60 years. Among the new cases, 49% were Chinese, 22% Malays, 1% Indians and 28% were of other ethnic groups (primarily, the natives of Sabah and Sarawak). The majority were non-professionals (96%) without tertiary education

(98%). This reflects the group of patients commonly treated in public hospitals throughout the country.

First Presenting symptoms, histopathology types & Staging (Table IV) The most common presenting symptom was neck lumps (42%), followed by nasal symptoms (30%). Notably, 11% of the new patients had ophthalmo-neurologic symptoms i.e. headache and cranial nerves palsy. Ninety-seven percent of the new cases were non-keratinising carcinomas (WHO type II and III). Seventy-five percent of the newly diagnosed patients presented at late stages (Stages III/IV).

DISCUSSION AND CONCLUSION Our preliminary findings show that the spectrum of first presenting symptoms from our cases were similar to those reported elsewhere (Table V)6,9,10, in which neck lumps were the most common presentation and about a tenth of cases presented with ophthalmo-neurologic symptoms. Despite advances in diagnosis of NPC, the percentage of cases presenting at late stages remains high (Table VI) 6. Since the database became operational only eight months ago it is still too early to analyse treatment and clinical outcome. Collectively, the fact that nearly 80% of patients present at late stages as evidenced by our data suggests that the development and effective implementation of screening methods could help in early detection of NPC thereby improving the survival outcome of NPC patients in Malaysia. Further work is on-going to recruit more patients and to collect patient data during subsequent follow up visits. This might throw more light on survival outcome and prognostic factors.

Table I: Total NPC cases reported from six selected centers in Malaysia Centre Hospital Pulau Pinang Hospital Kuala Lumpur / UPM Kuching General Hospital / UNIMAS Queen Elizabeth Hospital, Sabah University of Malaya Medical Centre (UMMC) Hospital USM, Kubang Kerian Total

New 90 52 11 62 7 3 225

Recurrent 33 16 0 1 3 0 53

Remission 45 54 62 0 44 1 206

Total 168 122 73 63 54 4 484

Table II: Age and Sex Distribution of Patients Reported with Nasopharyngeal Carcinoma Cases Gender Male Female Age distribution 11-20 yrs 21-30 yrs 31-40 yrs 41-50 yrs 51-60 yrs 61-70 yrs 71-80 yrs 81-90 yrs

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New N (%)

Recurrent N (%)

Remission N (%)

173 52

(77) (23)

40 13

(75) (25)

138 68

(67) (33)

5 19 23 57 61 46 14 0

(2) (8) (10) (25) (28) (20) (7) (0)

1 2 7 5 23 13 2 0

(2) (4) (13) (9) (43) (25) (4) (0)

4 7 33 43 62 45 11 1

(2) (3) (16) (21) (30) (22) (5) (1)

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Table III: Ethnicity, Education Status, Occupation and Social Risk Factors of Patients Reported with Nasopharyngeal Carcinoma Cases

New N (%)

Ethnicity Malay Chinese Indians Others Education Primary Secondary Tertiary No formal education Occupation Service Labourer Unemployed Agriculture Professional Others Social Risk Factors Tobacco consumption Alcohol consumption

Recurrent N (%)

Remission N (%)

50 110 3 62

(22) (49) (1) (28)

4 48 0 1

(7) (89) (0) (4)

49 122 2 33

(24) (60) (1) (15)

82 96 5 38

(38) (43) (2) (17)

16 25 2 7

(32) (50) (4) (14)

66 79 14 30

(35) (42) (7) (16)

57 30 52 12 8 66

(25) (13) (23) (5) (4) (30)

13 7 21 0 1 11

(25) (13) (40) (0) (2) (20)

48 15 90 4 6 42

(23) (8) (44) (2) (3) (20)

124 83

(55) (37)

23 13

(43) (25)

72 43

(35) (21)

Table IV: First presenting symptoms, Histological types and Stage at Initial diagnosis of patients Cases

New N (%)

First Presenting Symptoms Neck lumps Nasal obstruction Ear Headache Cranial nerve Others Histological Types WHO Type I WHO Type II/III Staging at initial diagnosis* Stage I Stage II Stage III Stage IV

Recurrent N (%)

Remission N (%)

95 67 25 11 13 14

(42) (30) (11) (5) (6) (6)

16 15 5 3 7 7

(31) (27) (10) (6) (13) (13)

82 72 23 5 8 16

(40) (35) (11) (2) (4) (8)

6 211

(3) (97)

4 44

(8) (92)

4 180

(2) (98)

7 35 47 78

(4) (21) (28) (47)

2 10 13 13

(5) (27) (34) (34)

6 37 52 43

(4) (27) (38) (31)

* The stage at presentation when diagnosed to have NPC for the first time, prior to the appearance of the recurrence (if applicable)

Table V: Comparison of First Presenting Symptoms of NPC Symptoms

Neck Mass Nasal Ear Ophtalmo-neurologic Others Total

NPC Database Malaysia 2007/2008 N (%) 95 (42) 67(30) 25(11) 24(11) 14(6) 225(100)

University Hospital, Kuala Lumpur (6) 1994/1997 N (%) 50(50) 26(26) 12(12) 11(11) 1(1) 100(100)

North American Series (9) N (%) 54(36) 32(21) 44(29) 12(8) 9(6) 151(100)

Prince of Wales Hospital, Hong Kong (10) 1991 N (%) 188(43) 131(30) 75(17) 39(9) 4(1) 437(100)

Table VI: Comparison of Stage of Disease at Diagnosis of NPC Staging Stage Stage Stage Stage Total

NPC Database 2007/2008 (%)

I II III IV

7(4) 35(21) 47(28) 78(47) 167(100)

University Hospital, Kuala Lumpur (6) 1994/1997 (%) 3(3) 3(3) 14(14) 80(80) 100(100)

# Note: NPC Database used AJCC Staging (2002) while University Hospital series used UICC Staging 1987

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ACKNOWLEDGEMENT The authors would like to sincerely thank the Director General of Health, Malaysia for his permission to publish this paper. We wish to thank the Director of the Institute for Medical Research, the Director of the Network of Clinical Research Centres as well as the Directors of the participating centres for their support. We wish to acknowledge the contributions by otorhinolaryngologists, oncologists, radiotherapists, and pathologists of the participating centres as well as the staff of the Clinical Research Centres of Kuala Lumpur Hospital and Penang Hospital as well as the Cancer Research Initiatives Foundation and the Institute for Medical Research for their contribution and support. This project was funded by the Ministry of Health, Malaysia (Project code: JPPIMR 06-060). Note: #Malaysian Nasopharyngeal Carcinoma Study Group • Hospital Pulau Pinang: K C Pua (Project Leader), S Subathra, Y S Ee, M Goh, A H Rahmah, C H Fong, N Punithavathi, L M Ong • Hospital Kuala Lumpur/UPM: Y Y Yap, B D Dipak, R Deepak, F N Lau, P Shalini, M A Atiliyana • University of Malaya: G Gopala Krishnan, S Shamshinder, M Anura, A Z Bustam, M Saad, M Dahalil, L M Looi, P Shahfinaz, O Hashim, C C Ng, O Rahmat, J Amin • Institute for Medical Research: A S B Khoo, (Programme Leader), N M Kumaran • Cancer Research Initiatives Foundation: S H Teo, L F Yap • Sarawak General Hospital/UNIMAS: S K Subramaniam, T S Tiong, U H Sim, T W Tharumalingam, D Norlida, M Zulkarnaen, W H Lai • Queen Elizabeth Hospital: C A Ong, S Bokari, C L Lum, A Vivekananda, A Othman, D Jayendran, A Kam • Hospital USM Kubang Kerian: S Hassan, B Biswal, H Nik Fariza, H A Mubassir, A H Suzina Sheikh

REFERENCES 1.

Lim GCC, Halimah YY (Eds). Second Report of the National Cancer Registry. Cancer Incidence in Malaysia 2003. National Cancer Registry. Kuala Lumpur 2004. 2. Devi BCR, Pisani P, Tang TS, Parkin DM. High incidence of nasopharyngeal carcinoma in native people of Sarawak, Borneo Island. Cancer Epi Bio Prev 2004; 13: 482-85. 3. Tiong TS, Selva KS. Clinical Presentation of NPC in Sarawak, Malaysia. Med J Malaysia 2005; 60: 624-28. 4. Indudharan R, Valuyeetham KA, Kankan T, Sidek DS 1997, Nasopharyngeal carcinoma: clinical trends. J Laryngol Otol 1997; 111: 724-29. 5. Suzina SA, Hamzah M. Clinical presentation of patients with nasopharyngeal carcinoma. Med J Malaysia 2003; 58: 539-45. 6. Prasad U, Pua KC. Nasopharyngeal Carcinoma: A Delay in Diagnosis Med J Malaysia 2000; 55: 230-35. 7. Shanmugaratnam K (1978) Histological Typing of Upper Respiratory Tract Tumours. International Histological Typing of Tumours No. 19 World Health Organization, 1978: 19-21. 8. Greene FL, Page DL, Fleming ID, Fritz A, Balch CM, Haller DG, Morrow M (eds). AJCC Cancer Staging Manual (6th. Edition) Chicago: Springer 2002. 9. Neel III HB, Taylor WF. Clinical presentation and diagnosis of nasopharyngeal carcinoma: Current Status presented at International Symposium on Nasopharyngeal Carcinoma, Kuala Lumpur, 1982. 10. Skinne DW, van Hasselt CA, Tsao SY. Nasopharyngeal carcinoma: a study of the modes of presentation. Annals of Otology, Rhinology and Laryngology 1991; 100: 544.

For further enquiries regarding the NPC Database, please contact: Manager Nasopharyngeal Carcinoma Treatment Outcome Database Clinical Research Centre Penang General Hospital Residensi Road 10990 Penang, Malaysia Tel: 604- 228 9246/ 227 4982 Fax: 604- 226 1579 Email: [email protected] Website: https://app.acrm.org.my/NPC

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Preliminary Results from the Pilot Study on the National Cancer Patient Registry - Cervical Cancer C R Devi Beena, T S Tang, L C C Gerard Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, 93586 Kuching, Sarawak and Hospital Kuala Lumpur Hospital, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY Carcinoma of the cervix is the most common malignancy in many developing countries. The purpose of this pilot study on cervical cancer patients treated at selected sites in Malaysia is to examine the achievability of collecting information on patients. The data was collected from the medical records of the patients using case report form. The results reveal that more than 90% of the forms had completed data from all sites. The pilot study has demonstrated that it is feasible to register and collect information on cervical cancer patients using the case report forms. Treatment outcome obtained from this data will form the baseline to establish existing clinical practice and will be useful for treating physicians to monitor the treatment outcome and the late complications and with longer followup to measure the disease free and overall survival. In addition, it is an useful tool as the national indicator.

in long term survivors. In order to achieve this target, a system of long-term surveillance needs to be developed in all hospitals which treat cancer patients. The information gathered from these reports can then be utilized to interpret treatment outcome and thereby provide baseline audit. Clinical audit forms a vital part of any quality assurance program. These indicators may be challenging to record systematically over a large population of patients, and by a large number of institutions treating such patients. However, the outcome of the clinical audit can be used to establish a national indicator based on consensus reached by the treating physicians in Malaysia. Cancer of the cervix was selected as we are interested in establishing a national indicator for radiotherapy as this common disease is treated with radiotherapy, and information that is gained from this project will be likely to have a significant impact on the treatment policies in future.

KEY WORDS: Patient registry, Cervical cancer

INTRODUCTION In many developing countries, carcinoma of the cervix is the most common malignancy 1. In Malaysia, cancer of the cervix is the second most common cancer among women. It constituted 12.9% of total female cancers. There were a total of 1,557 cases of cancer cervix, with an ASR of 19.7 per 100,000 populations 2. In developing countries women present in more advanced stage, whereby radiotherapy plays an important modality of treatment. The mode of treatment for cervical cancer would be based on stage of disease. In early stage where surgery is feasible, Whertheim’s hysterectomy would be the first choice of treatment. In most instances in Malaysia, most patients would be treated using a combination of external beam radiotherapy (EBRT) with intra-cavity radiotherapy (ICRT). The outcome of treatment and late toxicity has been well documented in other countries3,4. The five year disease-free survival (DFS) and overall survival have usually been reported as 50-70% for stage II, 30-50% for stage III and 5-15% for stage IV 3,4. Treatment outcome of cancer of the cervix has not been prospectively carried out in Malaysia. The purpose of this study on follow up of treated patients will be to measure not only the treatment outcome and the late complications observed in our population but also the disease free survival and overall survival and the occurrence of second malignancy

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OBJECTIVE The main objective of the National Cancer Patient Registry (NCPR) for cervical cancer is to evaluate the clinical treatment outcome of patients diagnosed with invasive cervical cancer that are seen and treated at participating hospitals. The main objective the pilot study is to ascertain if the information from the clinical case notes of the patients can be captured consistently in the case report form (CRF). Then the specific objectives of the registry are: 1. To describe the pattern of cervical cancer in Malaysia. 2. To determine the effectiveness of treatment for cervical cancer. 3. To monitor side effects i.e. acute and chronic used in the treatment of cervical cancer. 4. To utilize the outcome of the cancer cervix treatment to establish a national indicator.

MATERIALS AND METHODS NCPR-cervical cancer is a multi-centre study. In this pilot study, the participating sites include government hospitals; Hospital Umum Sarawak, Hospital Kuala Lumpur, Hospital Penang and Hospital Sultanah Bahiyah, with Hospital USM being the only university hospital. All new cervical cancer patients seen from 1st of January, 2007 are to be registered at participating sites. Prior to the start of the study, all personnel from the participating sites

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Fig. 1: Contribution of patients from participating sites in Malaysia.

were trained on the need for registration and use of the care report form (CRF). Case Report Form (CRF) was used to collect all the information from the patient record at the end of treatment and at six months from last date of treatment. The CRF is divided into various sections: first part collects demographic information, the next section collects information on clinical history, histopathology, followed by treatment details, including surgical treatment. The final part collects information on acute morbidity as well as chronic morbidity on follow-up. In this study, the source data providers are the individuals or institutions that collect the required data. They are trained and motivated to ensure high data quality. The key data sources identified for this registry are: all clinical oncologists, gynecologic oncologists and therapy radiographers in Malaysia and Jabatan Pendaftaran Negara (JPN) for data on all cause mortality in the country. The data collected from each site will then be sent to the team at the Clinical Research Center at Kuala Lumpur who would then digitize and ensure the completeness and accuracy of the data. Any query raised will then be resolved with the site concerned. Being a pilot study, the CRF will be revised or maintained based on the analysed data to ensure that a user friendly CRF can then be made available for all hospitals that treat cervical cancer patients. For future data collection, a web based system will be used. The STATA statistical software was used for the analysis.

RESULTS Demography From the data analysis, 90% of the CRFs had complete information. There were 252 cases with cervical cancer registered at the participating sites (Figure 1). Malays were the largest group in this sample. Thirty one percent (n=79) of women presented at 41-50 age group and the age distribution is shown in Figure 2.

Stage and Histology Fifty-six percent (n=141) present at stages I and II, with 30% (n=77) at stage III and 4% (n=28) at stage IV. Seventy percent (n=178) of the cases had squamous cell carcinoma.

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Fig. 2: Age distribution of patients

Treatment For treatment, cases which were operable, 36% (n=13/36) had radical surgery and 94% (n = 204/216) had radical radiotherapy and 4% (n=9/252) had combination of surgery followed by radiotherapy due to recurrence or residual disease. Fifty-seven percent (n=123) were able to have concurrent chemotherapy with a mean of 4 cycles. For radiotherapy fields, 68% (n=147), were treated using the fourfiled box technique. Eighty percent (n=173) received HDR brachytherapy with 20% (n=44) receiving no brachytherapy treatment. Acute side effects The acute side effects from surgery were 6% (n=2) had bladder dysfunction and 3% (N=1) had vesicovaginal fistula. The acute effects form radiotherapy were; 27% (n=12) had > RTOG grade II diarrhea, 14% (n=4) had >RTOG grade II vomiting, 7% (n=8) RTOG grade II loss of weight, 14% (n=8) had RTOG grade II fall in white blood cell count and 37% (n=22) had >RTOG grade II anemia.

DISCUSSION A vast majority of the forms had complete data indicating that the clinical notes were able to provide the information required in the CRF thereby demonstrating the ease of using these forms for data capture. Our results are preliminary and should not be interpreted as being conclusive. However, this is the first attempt to register cervical cancer patients and present information on the treatment outcome. All sites except for USM and HKL were able to complete the registration of all cases seen in the respective departments. Hence, information on race and stage of disease is inconclusive. Our results reveal that the treatment was well tolerated with acceptable side effects for both surgery and radiotherapy as indicated by the low morbidity. Though, these results are encouraging, it is not possible to compare our results with other international centers as all treating centers in the country were not included. Nevertheless, we are able

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to demonstrate with this pilot study that it is feasible to register and collect treatment outcome information. This study should be regarded by all physicians who treat cancer patients that it is possible to collect data for clinical audit that is vital for improvement and understanding of the type of care that we provide our patients. In addition, this will enable any changes that need to be carried without delay regarding treatment policies. NCPR-cervical cancer is intended to serve not only as an audit but also to assist clinicians and healthcare providers in reviewing the treatment for cervical cancer. The information from such a study will provide clinicians a tool to further improve their skills, provide areas for further research and overall contribute to improvement on the care that can be provided in Malaysian hospitals. These results can provide insight for policy makers with regards to decision making on resource allocation, the need to improve on quality control on equipments, training of personnel, strengthen areas which require improvement and provide optimal care to patients.

We hope that the feasibility of registering patients with cervical cancer will encourage all treating centers in Malaysia to participate in this study. A larger sample size would provide data that would enable comparisons with other international centers.

ACKNOWLEDGEMENT This study was done using grant from MOH. We would like to thank Dr Jamaiyah, Dr Jeyashree, Ms Tee Chin Kim, Miss Norazlinda Bt Md Nordin and Sr Julie Lee Pek Keow from CRC for their valuable assistance towards to successful completion of this pilot study. We thank all radiographers and nurses who assisted to complete the CRFs.

REFERENCES 1. 2.

3. 4.

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Stewart BW, Kleihues P eds. World cancer report. Lyon: IARC Press 2003; 215-22. Gerard Lim CC, Yahya H. Second Report of the National Cancer Registry, Cancer Incidence in Malaysia. National Cancer Registry, Ministry of Health, Kuala Lumpur, 2003. Waggoner SE. Cervical cancer. Lancet Jun 2003; 361(9376): 2217-25. Nakano T, Kato S et al. Long-term results of high dose intracavitary brachytherapy for squamous cell carcinoma of the uterine cervix. American Cancer Society 2004; 92-101.

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National Cancer Patient Registry- Haematology Malignancy (NCPR-HM) K M Chang, T C Ong Department of Haematology, Ampang Hospital, Kuala Lumpur, Malaysia

SUMMARY Treatment option of Haematological malignancies has expanded over the last decade. The outcome of treatment is expected to be better compare to previously. However, study of treatment outcome for haematological malignancies has not been carried out in Malaysia. The goal of this study is to measure the treatment outcome in patients with haematological malignancy. KEY WORDS: Patient registry, Haematology malignancy

INTRODUCTION Malignancy of Blood and Lymphatic system includes leukaemia, myelodysplasia and lymphomas. Based on Malaysian National Cancer Registry data, Leukaemia is the fourth most common cancers among peninsular Malaysia males in 2003 and seventh commonest among the females; 7.1% of all cancers in males compared to 4.0% of all cancers in females. Lymphoma accounts for 4.3% of all cancers in males living in peninsular Malaysia in the 2003 NCR report. Treatment option of Haematological malignancies has expanded over the last decade, with better understanding of disease biology and development of novel treatment modalities e.g. monoclonal antibody and refinement of transplantation besides improvement on chemotherapeutic drugs and supportive care, the outcome of treatment is expected to be better compare to previously. However, study of treatment outcome for haematological malignancies has not been carried out in Malaysia. A system of long term follow-up and surveillance is instituted in centres treating haematological malignancy. Information on treatment and long term outcome are collected to generate meaningful data for future planning and reference. Aims of NCPR-HM The primary goal of NCPR-HM is to evaluate the treatment outcome of patients diagnosed with haematological malignancy. The objectives for this patient registry are: 1. Describe the natural history of haematological malignancy in Malaysia. 2. Determine effectiveness of treatment for haematological malignancy. 3. Monitor safety of products and services used in the treatment of haematological malignancy. 4. Evaluate access to and quality of treatment services for haematological malignancy.

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MATERIALS AND METHODS This is a multi-centre, prospective study which will register all patients with haematological malignancy i.e. Acute lymphoblastic leukaemia (ALL), acute myeloid leukaemia (AML), chronic lymphocytic leukaemia (CLL), chronic myeloid leukaemia (CML), myelodysplasia, plasma cell dysplasia, Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, aplastic anaemia and multiple myeloma, who also fit other inclusion criteria. These cases are taken from cases referred to the participating centres from 2008 – 2010. All cases will be followed up for every 3 months, 6 months and 12 months. This database shall cover all patients with confirmed diagnosis of haematological malignancy, who are being treated in centres with clinical haematologists in MOH and private medical centre. However participation in this database is completely voluntary. All sites that satisfy the following selection criteria are invited to participate: • Hospitals that provide care for haematological malignancy treatment in the MOH with specialised care. • Each site has appointed a Site Coordinator (SC) who is responsible for database-related administration and data collection, and who is liaise with the registry manager. • Accept responsibilities for data collection as well as for ensuring proper record keeping and document filing. • Agree to comply with the registry procedures and are willing to be subjected to ongoing review of data by medical monitor or other representative of NCPR-HM office. NCPR-HM has started to collect data using CRF in hard copy for pilot stage in March 2008 until end of July 2008. It involves MOH hospital at this moment. The government centers are Ampang Hospital, Sultanah Aminah Hospital, Ipoh Hospital, Queen Elizabeth Hospital, Tengku Ampuan Rahimah Hospital, HUKM, General Hospital Sarawak and Penang Hospital. In future more centres are expected to participate. It will eventually expand to more MOH and private medical centers. The data will then capture electronically via a web application. Stringent information security policies are implemented to maintain confidentiality. All new cancer patients are registered on attendance at participating sites and existing patients on follow up may also be included in the registry. The patients are followed up every 3 months, 6 months and 12 months. A report will be generated for that. There are two datasets used in this registry: 1) core dataset which is essential for data analysis, 2) non core dataset which

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Table I: Milestone of the Registry February 2008 March 2008 – July 2008 April 2008 May 2008 July 2008 August 2008

NCPR-HM steering committee meeting Pilot study started in eight participating sites Revised Case Report Form (CRF) to rectified the problems after one month data collection CRF is finalized and ready for web application development e-NCPR web application is ready for trial Official launch of e-NCPR web application

is additional data for further analysis. It is expected that a report for the haematological malignancy patients will be produced by end of this year. Milestone of the registry is shown in Table I.

to understand more about the treatment outcome of haematology malignancy. We also hope to get more participation from other sites to in the future.

Futur e dir ection At present, cooperation of existing participating sites is fully needed to get quality data. It is hope that the data would provide useful information for the public and local research

REFERENCE

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1.

Gerard Lim CC, Yahya H. Second Report of the National Cancer Registry, Cancer Incidence in Malaysia. National Cancer Registry, Ministry of Health, Kuala Lumpur, 2003.

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Malaysian Psoriasis Registry – Preliminary Report of a Pilot Study Using a Newly Revised Registry Form C C Chang, H B Gangaram, S H Hussein Department of Dermatology, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY The Malaysian Psoriasis Registry, established in 1998, is the first skin disease clinical registry in Malaysia. It aims to provide useful data on various aspects of psoriasis. Following an extensive revision of the registry form in 2007, a total of 509 psoriasis patients from 10 government dermatologic centres were reviewed in a three month pilot study. The onset of psoriasis was during the second to fourth decade of life in the majority of patients. There was no sexual and ethnic predilection. A positive family history was present in 21.2%, and more common in patients with younger disease onset. The main aggravating factors of psoriasis were stress, sunlight and infection. Plaque psoriasis was the commonest clinical type (80.9%). Joint disease was present in 17.3% of patients, among which mono/oligoarticular type being the commonest. Nail changes occurred in 68%. More psoriasis patients were overweight and obese compared to the normal population. The mean Dermatologic Life Quality Index (DLQI) score was 8.08 ± 6.29, and changes during subsequent follow-up may reflect therapeutic effectiveness. This study enabled evaluation of the revised registry form and helped in identifying shortcomings in the implementation of the registry.

With strong financial and technical support from the Ministry of Health and Clinical Research Centre, MPR was given a new lease of life in 2007. A permanent Steering Committee based in the Department of Dermatology Hospital Kuala Lumpur (HKL), and an Advisory Committee represented by senior consultant dermatologists from government, private and university hospitals were formed. The registry case report form was extensively revised.

OBJECTIVE The primary objective the MPR is to obtain more accurate data on various aspects of psoriasis in Malaysia. Secondary objectives are : 1. To determine the socio-demographic profiles of patients with psoriasis. 2. To determine the disease burden attributed to psoriasis. 3. To provide information for planning of medical services, facilities, manpower and training related to the management of psoriasis. 4. To stimulate and facilitate research on psoriasis and its management. These objectives are planned to be achieved in two phases.

KEY WORDS: Psoriasis, Clinical Registry

INTRODUCTION Psoriasis is a common chronic inflammatory disease affecting the skin, nails and joints with significant physical, psychosocial and economic impact. There has been a worldwide effort to obtain comprehensive epidemiological and clinical data on psoriasis in different populations1,2,3,4. However, published reports of successful clinical registries on psoriasis are few 6,7. The Malaysian Psoriasis Registry (MPR) is the first skin disease clinical registry in Malaysia. Pioneer efforts towards establishing a clinical registry for psoriasis was started in 1998 by a group of dermatologists under the umbrella body of the Dermatological Society of Malaysia. Following nationwide data collection from public and private dermatologic centres from March 2000 to July 2005, a preliminary report was published in August 20055. However, the continuity of this registry was challenged by the limitations in budget and resources, as well as the lack of a stable secretariat and steering committee.

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The first phase begins with a pilot study limited only to a number of government hospitals with dermatologic services. The second phase expands the coverage to include university hospitals, private hospitals and private dermatologists throughout the country. This paper reports the finding of the pilot study.

MATERIALS AND METHODS The MPR is an ongoing systematic collection of data pertaining to patients who have psoriasis. All patients clinically diagnosed to have psoriasis by a registered dermatologist or by a medical practitioner under the supervision of a dermatologist are included. Confirmation of mdiagnosis by histopathologic examination is optional. Patients whose diagnosis is in doubt are excluded. The study involves collection of data on the patient’s first visit to the participating centre and thereafter every six monthly on follow-up visits. The Case Report Form (CRF) consists of a clinical data form and multilingual Dermatology Life Quality Index (DLQI) forms separately for adult and children. The DLQI is a widely used and validated

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Fig. 1: Aggravating factor of Psoriasis reported by patient

Fig. 3: Extent of skin involvement in Psoriasis patient

dermatology-specific questionnaire consisting of 10 questions concerning health-related quality of life (QOL) relating to the previous one week. The total DLQI score ranges between 0 (no impairment of QOL) and 30 (maximum impairment of QOL)11,12. The clinical data form in the CRF is to be completed by the doctor in-charge while the DLQI form is to be completed by the patient (parent or guardian for young patient) with guidance from trained staff if necessary.

Fig. 2: Clinical types of Psoriasis

Fig. 4: Joint involvement in Psoriasis patient

RESULTS AND DISCUSSION This preliminary report contains the results and analysis of data over collected over a three-month period from 1st October to 31st December 2007. Data was collected from new and follow-up patients of psoriasis from ten participating centres on a voluntary basis. However, all completed CRFs received by the PRU upto 31st January 2008 were also included. Hence the number of cases might not reflect the true burden of psoriasis in each centre.

One set of CRF is to be completed for each new patient during consultation at the participating centre. A new set of CRF is to be completed for the same patient every six months to record the progress of the patient. Data collected is analysed, interpreted and presented in regular reports to be disseminated to the users.

A total of 509 patients with psoriasis (80 new cases and 429 follow-up cases) were reported. Male-to-female ratio was 1.26:1. Ethnic distribution was similar to that of government clinic attendance: Malays 51.1%, Chinese 26.3%, Indians 17.3% and other ethnic groups 5.3%. Previous registry reported a higher male-to-female ratio of 3:2 and a similar ethnic distribution5. There is no sexual or ethnic predilection reported worldwide.

During this current pilot phase of the registry, all CRFs were sent to the Psoriasis Registry Unit (PRU) based in HKL for data entry. A centralized computer database with web application has been set up and a research assistant employed to perform data entry for all centres. With the availability of additional resources, future plans include data entry performed directly using online electronic CRF at individual centres.

In the majority of patients (59.7%), the disease onset was during the second to fourth decade of life. Overall mean age of onset was 32.9 years with a wide range from two to 80 years. Females had slightly earlier onset compared to males (mean age of onset 30.2 years vs. 35 years, t=3.255, p=0.001). Most patients (70.4%) knew about the diagnosis within a year from the onset of the disease.

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About one-fifth (21.2%) of patients had at least one family member suffering from psoriasis. Of those patients with a positive family history, about half (48.9%) had either of their parents affected. Siblings were affected in 26.9%, and children in 15.7%. In four patients, family members of both preceding and succeeding generations were affected by psoriasis. Positive family history seemed to be more common in patients with younger onset of disease (aged 40 and below), 24.8% vs. 13.9% (OR=2.05, 95%CI=1.24-3.39, p90% BSA involved), while the remaining 21.4% was unknown. (Figure 3) The commonest body region involved was the lower limbs (81.1%), followed by the scalp (78.8%), upper limbs (74.1), the trunk (72.7%), and the face and neck (49.7%). Psoriatic arthropathy occurred in 17.3% of patients. The commonest clinical pattern of arthropathy was oligo/monoarticular type (46.6%), followed by symmetrical polyarthropathy involving proximal hand joints orRheumatoid-like type (33%), distal hand joints arthropathy (30.7%), spondylitic type (12.5%), and arthritis mutilans (3.4%). (Figure 4) Two patients had only morning stiffness of > 30 minutes duration, and one patient developed enthesopathy alone. Only 15.9% patients with joint disease had rheumatoid factor tested, and all of them were negative. More than one-third (36.8%) of patients with arthropathy had joint deformities. About two-third of patients (68%) had nail changes related to psoriasis. The majority of these patients had nail pitting (50.9%), followed by onycholysis (38.5%), nail discolouration (28.7%), subungual hyperkeratosis (13.4%), and total nail dystrophy (4.3%).

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Body mass index (BMI) was determined in 461 (90.8%) patients. In adult patients (age above 18 years), the mean body mass index was 25.8. Using the standard World Health Organization (WHO) Classification, 33.6% adult patients were overweight (BMI 25 to 29.9), and 21.3% were obese (BMI 30 and above). These figures are high compared to the corresponding figures of 20.7% and 5.8% in normal Malaysian population according to the National Health and Morbidity Survey13. A number of psoriasis patients had one or multiple concomitant diseases such as hypertension (21%), hyperlipidaemia (16.3%), diabetes mellitus (15.3%), and ischaemic heart disease (4.9%). These findings echoed the concern on recent association of psoriasis with obesity, dyslipidaemia, and cardiovascular diseases2,4,9. In terms of treatment, almost all patients were treated with topical medications which are the first line therapy in psoriasis. The most widely used topical treatments were emollients (82.5%), followed by tar preparations (79.6%), topical corticosteroids for areas other than face and flexures (72.3%), keratolytics (67.8%), vitamin D analogues such as calcipotriol (22.4%), and dithranol (0.8%). Phototherapy was used in 6.1% of patients. Narrowband UVB was used in the majority (67.7%). Other types of phototherapy used were broadband UVB (9.7%), oral PUVA (two patients), and topical/bath PUVA (3 patients). Systemic treatment as thirdline therapy had to be given to 26.3% of patients. The most commonly used drug was methotrexate (69.4%), followed by acitretin (23.9%), systemic corticosteroids (7.5%), sulphasalazine (4.5%), cyclosporine (3.7%), and hydroxyurea (1.5%). Patients with psoriasis have been reported to have a reduction in the quality of life similar to or worse than other chronic diseases3,12. In this pilot study, the measurement of quality of life using DLQI was performed in 505 patients. The mean DLQI score was 8.08 ± 6.29 (Min 0, Max 29). As this is an ongoing registry, changes in DLQI scores can be measured during subsequent follow-up visits of these patients as part of an evaluation of therapeutic effectiveness. Quality control measures are important in ensuring data quality of a registry. In this study, an audit of data entry revealed an accuracy rate of 99.9%. Rate of missing data was less than 3% in most data fields except for weight and height (up to 9%). Periodic re-training of source data providers have been planned to further reduce the missing data. Further refinement of the CRF and guidelines have been proposed to improve reporting.

CONCLUSION This pilot study provides a great opportunity to evaluate the newly revised registry form, and provides an excellent starting point for what will be a large scale nationwide continuous data collection effort. Apart from revealing several interesting findings about psoriasis, more importantly the study helped to identify short- comings in the implementation of this registry. Our next steps should focus on resolving these issues in order to ensure greater benefit and future success of the registry.

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ACKNOWLEDGEMENT We would like to thank the Ministry of Health for financial support, the Clinical Research Centre for technical assistance and advice, as well as all doctors and staff of the participating dermatologic centres who contributed to this registry.

6. 7. 8.

9.

REFERENCES 1. 2. 3. 4. 5.

Elder JT. Psoriasis clinical registries, genetics, and genomics. Ann Rheum 2005; 64(Suppl II). Christophers E. Psoriasis – epidemiology and clinical spectrum. Clin Exp Dermatol 2001; 26: 314-20. Langley RGB, Krueger GG and Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis 2005; 64; 18-23. Neimann AL, Porter SB, Gelfand JM. The epidemiology of psoriasis. Expert Rev Dermatol 2006; 1(1): 63-75. Gangaram HB, Chang CC. Malaysian Psoriasis Registry. Malaysian J Dermatol 2005; 18: 1-5.

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11.

12. 13.

Marcus Schmitt-Egenolf. PsoReg – The Swedish Registry for Systemic Psoriasis Treatment. Dermatology 2007; 214: 112-17. Gladman DD, Ritchlin C, Helliwell PS. Psoriatic arthritis clinical registries and genomics. Ann Rheum Dis 2005; 64(Suppl II). Henseler T, Christophers E. Psoriasis of early and late onset: characterization of two types of psoriasis vulgaris. J Am Acad Dermatol 1985; 13(3): 450-56. Henseler T, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol 1995; 32(6): 982-86. Naldi L, Chatenoud L, Linder D et al. Cigarette smoking, body mass index, and stressful life events as risk factors for psoriasis: results from an Italian case-control study. J Invest Dermatol 2005; 125(1): 61-67. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI): a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 21016. Finlay AY, Kelly SE. Psoriasis—an index of disability. Clin Exp Dermatol 1987; 12: 8-11. Lim TO, Zaki M, et al. Distribution of Body Weight, Height and Body Mass Index in a National Sample of Malaysian Adults. Med J Malaysia 2000; 55: 108-28.

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National Cancer Patient Registry-Breast Cancer (NCPR-Breast Cancer) E Nor Aina Breast and Endocrine Surgical Unit, Department of Surgery, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY Breast cancer is the most common cancer in most part of the world and it is the most common cancer among Malaysian women. In order to estimate the overall survival and prognosis, it was decided that a National Cancer Patient Registry-Breast cancer be set up. It would be a tracking system form for breast cancer patients in Malaysia to help treatment outcomes. There would be useful for evaluating clinical management.

For Malaysian women, due to lack of data collection and registry we do not know the overall survival and prognosis. We always quote western figures as our reference values that may not be exactly reflect our own population. With the launching of National Cancer Patient Registry by Ministry of Health, a more accurate figure could be obtained. It will be a valuable tool to provide timely and robust data on the real worldview of oncology practice, safety and cost effectiveness of treatment and most importantly the outcome of these patients.

KEY WORDS: Patient registry, Breast cancer

INTRODUCTION Breast cancer is the most common cancer in women in most part of the world and it is the most common cancer among Malaysian women. It is also the most common cause of cancer death 1, 2. In the year 2000, it was reported that there were 1,050,346 cases of breast cancer worldwide with 372,969 deaths. The average crude incidence rate was 94.93 per 100,000 in more developed country as compared to 19.66 per 100,000 in less developed country 3. In Malaysia, there is difficulty in determining the exact incidence of breast cancer because of lack of a breast cancer registry 1. In 2000, International Agency for Research in Cancers (IARC) estimated that there were 3835 new cases of breast cancer reported, with 1707 deaths. The crude incidence rate was estimated to be 34.86 per 100,000 in the world. Management of breast cancer is usually based on multidisciplinary approach. As a good guide there is a Clinical Practice Guideline on Management of Breast Cancer prepared by a collaborative effort from Ministry of Health and Academy of Medicine issued in 2002. This evidence-based guideline provides a comprehensive outline on managing patient from confirming the diagnosis to specific treatment 4. With the advent of new research findings, more modalities of therapy are made available such as targeted therapy e.g. Herceptin 5. Another evidence-based guideline has been developed to address these newer regimes for breast as well as other type of cancers 6. However, with the addition of these new drugs the cost of treatment will escalate tremendously. The outcome of breast cancer patients in general is based on the stage of the disease at the time of diagnosis. Overall prognosis is poor in patients with stage 3 and 4 disease.

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AIM OF THE STUDY The aim of this registry is to provide a more accurate and refined prevalence estimates of breast cancer in Malaysia, help formulate screening and surveillance strategies that are relevant and facilitate clinically important research on breast cancer. All these aims can be achieve by the following objectives: 1. Describe the natural history of breast cancers in Malaysia. 2. Determine effectiveness of treatment for breast cancer. 3. Monitor safety of products and services used in the treatment of breast cancers. 4. Evaluate access to and quality of treatment services for breast cancer. The objectives listed are implemented in phases. Building on the foundation laid by the early phase, the scope and coverage of the registry can then be expanded in later phases. The objectives above are listed in order of the scope and coverage of the registry to be implemented over time in phases.

MATERIALS AND METHODS Study design and patient selection NCPR-Breast cancer is a multi-centre, prospective study, which will register all patients with breast cancer who fit the inclusion criteria. Enrolment would be done from 2008 – 2010. Subject enrolment is universal whereby all new patients who are seen at the participating centres with confirmed diagnosis of breast cancer during the study period will be included. Existing patients on follow up may also be included in the registry.

Data collection With increasing operational experience and stability over time, NCPR-Breast cancer will be going to use a front-end

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Table I: Milestone of the Registry January 2008 April 2008 June - July 2008 June 2008 August 2008

NCPR-Breast cancer steering committee meeting to discuss about development of the Case Report Form (CRF) Site visit to Hospital Kuala Lumpur to understand the work-flow and process in the breast cancer clinic CRF is finalized and ready for web application development NCPR-Breast cancer meeting to discuss on access level & authorization list for e-NCPR Breast cancer web application Plan to official launch of e-NCPR Breast cancer web application

application and installed at source data provider (SDP) sites. The front-end application will be ready in mid of August 2008. Hence, data collection is expected to start in June 2008. The application will facilitate the patient registration and documentation process in the sites. It will add value to daily operations by improving efficient and effective management of information in the sites. The data captured is then electronically transferred to CRC for back end processing. Stringent information security policies had been implemented to maintain confidentiality. A report for the registry will be produced by end of this year 2008. Milestone of the registry is shown in Table I. The principal investigator, co-investigators and the project manager will need to collaborate with individual source data provider (SDP) to identify key site coordinators (SC) responsible for the administration and management of registry data. The SC is responsible in providing timely and accurate data, and reports should be made to the centre registry office on a regular basis, detailing progress and any problem that needs to be addressed. Registry manager will be required to disseminate this information to all parties.

Hospital Kuala Lumpur, Hospital Putrajaya, Hospital Sultan Ismail, Hospital Raja Perempuan Zainab II, Hospital Pulau Pinang. In future more centres are expected to participate.

CONCLUSION The National Cancer Patient Registry is the first database to record detailed information on cancer patients in Malaysia. Currently it is at the final planning stage and is expected to start data collection soon. Its first report is anticipated a year after starting data collection. Generated data will be used for writing up scientific papers and publications.

REFERENCES 1. 2. 3.

4. 5.

Location of the study Participating sites include centres in the government and private centres. At the moment, the government centres are

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6.

AN Hisham, CH Yip. Overview of Breast Cancer in Malaysian Women: A Problem with Late Diagnosis. Asian J Surg 2004; 27(2): 130-3. AN Hisham, CH Yip. Spectrum of Breast Cancer in Malaysian Women: Overview. World J Surg 2003; 27(8): 921-3. Ferlay J, Bray F, Pisani P, Parkin DM. Globocan 2000: Cancer Incidence, Mortality and Prevalence Worlwide.Version 1.0 IARC CancerBase N0.5 Lyon: IARC Press, 2001. Clinical Practice Guidelines. Management of Breast Cancer. Ministry of Health and Academy of Medicine Malaysia. 2002. Romond EH. Trastuzumab plus adjuvant chemotherapy for operable her2positive breast cancer. N Engl Med J 2005; 353: 673-84. MOH Systemic Therapy Protocol 2008. (Under development).

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National Orthopedic Registry in Malaysia - National Orthopedic Hip Fracture Database (NOHFD) A Muhammad Anwar Hau Orthopedic Department, Hospital Raja Perempuan Zainab II, 15586 Kota Bharu, Kelantan, Malaysia

INTRODUCTION Hip fracture, an osteoporosis related fractures, is one of the leading causes of hospitalization for the elderly population. Many reports from developed countries have demonstrated that Osteoporosis related hip fractures are also associated with substantial increase in the mortality (12 to 20%), morbidly and health care cost. In Malaysia, hip fractures in the elderly is not uncommon, and as our population continues to age, the number of osteoporosis-related hip fractures will increased substantially. Yet, presently we do not have a systematic and comprehensive database on hip fracture as well as its treatment and outcome. In cognizance of this, the orthopedic surgeons in the Ministry of Health (Ortho KKM)) have taken the initiative to start a database on hip fractures called the National Orthopedics Hip Fracture Database (NOHFD). Objectives of NOHFD The objectives of this database are to: 1. Determine the prevalence and type of hip fracture amongst those aged 50 and above who are admitted to the orthopedic wards of the Ministry of Health Hospitals. 2. Determine the demographic variables associated with hip fractures including age, sex, race, socio-economic status, pre-fracture residence, pre-fracture morbidity and mechanism of injury. 3. Record factors related to the treatment of hip fractures including length of hospital stay, percentage of patients who undergo surgery and waiting time for surgery. 4. Record the prevailing practices amongst orthopedic surgeons in MOH in the treatment of hip fractures in this group of patients including timing and type of surgery, use of antibiotic prophylaxis and prophylaxis against thrombo-embolic events. 5. Study treatment outcomes including functional capacity of patients treated for hip fracture. 6. Monitor trends in treatment. 7. And facilitate improvements in care of patients with hip fracture.

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Milestones in the Development of NOHFD The steering committee was formed in August 2007. A proposal and proforma on the NOHFD was submitted at the end of November 2007 through the Clinical Research Centre MOH for a research grant. The Department of Orthopedics, Hospital Sultanah Nurzahirah, Terengganu was designated as the coordinator of the NOHFD. In December 2007 a pilot study to validate the Case Report Form (CRF) of the database was carried out. As with the development of more recent registries, the NOHFD will be web based and a meeting to organize this was held in February 2008. In compliance with current guidelines, the database will be registered with the National Medical Research Register (NMRR). It is anticipated that the database will be rolled out in June/July 2008. P a rticipating Hospitals The Department of Orthopedics in all MOH hospitals where there are also CRC units will participate in NOHFD. An exception is the Department of Orthopedics in Hospital Sultan Ismail, Johor Bahru. This is to facilitate the smooth running of the database in its initial years.

CONCLUSION Hip fracture amongst the older population in the country is not uncommon and its incidence is expected to rise with increasing proportion of the elderly. Unfortunately little is known of the various factors thatimpact on and influence outcomes in this condition including treatment variables. The Orthopedic surgeons in the Ministry of Health have taken an initiative to start a database on this clinical condition called the National Orthopedic Hip Fracture Database.

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National Orthopedic Registry in Malaysia – National Orthopedics Diabetic Hand and Foot Database (NODFD) A Muhammad Anwar Hau Orthopedic Department, Hospital Raja Perempuan Zainab II, 15586 Kota Bharu, Kelantan, Malaysia

INTRODUCTION Diabetis mellitus (DM) is a serious debilitating and deadly disease causing significant mortality and morbidity globally. The reported prevalence of DM in Malaysia was 14% in 2006 (NHMS 3). Other studies in the country similarly documented not only a high prevalence of the condition in Malaysia but also increasing prevalence over the years. Even though there are multiple reports on prevalence of diabetic complications such as neuropathy, retinopathy and albuminuria, there however has been no published reports on the prevalence of diabetic foot/hand complications in Malaysia. It is estimated that 15% to 20% of diabetic sufferer will be hospitalized with a foot complication at some point of time during the course of their disease and 12-24% of affected individuals with foot ulcers require amputation. In view of the paucity of data in this area, the orthopedic surgeons in the Ministry of Health (ORTHO KKM) have decided to have a database (registry) on diabetic foot and hand complications. It is proposed that the database be known as the National Orthopedic Diabetic Foot Database (NODFD).

OBJECTIVE The objectives of the NODFD are: 1. Determine the prevalence of Diabetic foot/hand complications in the MOH orthopedic service. 2. Document the demographic factors associated with diabetic foot/hand complications including age, gender, ethnic, geographical location as well as socio-economic and educational level. 3. Study the factors affecting outcome of patients with diabetic foot/hand complications including control of diabetes, presence of co-morbid illness, surgical treatment and mortality. 4. Study the impact of patient education program and preventive measures in patients admitted with diabetic

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foot/hand complications admitted to MOH orthopedic education, keep good records in the diabetic care booklet and maintain healthy lifestyle practices. 5. Facilitate improvements in the delivery of healthcare services and research in the area of diabetic foot care through the provision of relevant data from the database. Milestones in the development of NODFD The steering committee for NODFD was set up in August 2007 and submitted its proposal for the application of a research grant to start the registry. The application was made through the Clinical Research Centre of Hospital Kuala Lumpur. The committee decided that the coordinating centre for the NODFD will be at the Department of Orthopedics, Hospital Raja perempuan Zainab II, Kota Bahru. A pilot study was carried out in December 2007 to validate the database. In February the design of the CRF, including its web based format, was finalized. The steering committee plans to roll out the web-based reporting application in June/July 2008. The NODFD will be registered with the National Medical Research Register (NMRR) and with all other registries/database a waiver from individual consent to participate in the database will be requested. P a r t i c i p a t i n g C e n t r es As an initial step, Departments of Orthopedics in all hospitals in MOH where Clinical Research Centres are available and also the Department of Orthopedics of Hospital Sultan Ismail, Johor Bahru will participate.

CONCLUSION The increasing prevalence of Diabetes mellitus with its attendant complications has posed medical as well as resource utilization challenges for the country. A major complication that impact on economic productivity of the affected individuals is diabetic foot/hand disease. There is presently limited data on the subject. A database called the National Orthopedic Diabetic Foot Database will be set up to fill the gap in data on the subject. The database is expected to be operational in June/July 2008.

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An Audit of Diabetes Control and Management (ADCM) I Mastura*, H Zanariah**, I Fatanah***, M Feisul Idzwan***, M Y Wan Shaariah****, H Jamaiyah*****, A Geeta***** *Kuala Pilah Health Clinic, 72000 Kuala Pilah, Negeri Sembilan, **Medical Department, Hospital Putrajaya, Precint 7, 62250 Putrajaya, ***Non Communicable Department, Ministry of Health Malaysia, Parcel E, 62590 Putrajaya, ****Clinical Research Centre, Hospital Seremban, Jalan Rasah, 70300 Seremban, *****Clinical Research Centre, Hospital Kuala Lumpur, Jalan Pahang, 50586 Kuala Lumpur, Malaysia

SUMMARY Diabetes is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia. Cost in managing diabetes plus indirect cost of lost work, pain, and suffering have all increased. The optimal management of patients with diabetes require the tracking of patients over time to monitor the progression of the disease, compliance with treatment, and preventive care. Diabetes care can be improved by standardizing access to, and improving the use of, clinical information. Access to timely, accurate and wellorganized electronic data will improve the quality of care for patients with diabetes. Clinical Research Center convened an expert workshop to forecast how physicians, hospitals and clinics will employ clinical information technology (IT) applications to diabetes care over the next year. Workshop participants included experts from research organizations, government, and the IT vendor. This is a summary of the workshop organised for the purpose of the Audit of Diabetes Control and Management (ADCM) project. We hope to identify the gaps, if any, that exists in delivering diabetes care and to improve the quality of care. In future, we hope to develop an expansion of this project for the Adult Diabetes Registry that will be implemented for the whole country.

patients had not been given adequate care. Only 10% had Alc measured, 22% had blood lipids measured and 30% had urine albumin checked4. A study in 2001 amongst general practitioners in Peninsular Malaysia showed that the majority of patients were not well controlled and had a high prevalence of complications. Only 20% had Alc of < 7%, 12.3% had total cholesterol of < 4.8 mmol/L and 44.1% had systolic blood pressure of 7.0% and 82% had FPG > 6.1 mmol/L) and the majority also had poorly controlled hypertension (85% had BP > 130/80 mmHg) and dyslipidemia (68% had total cholesterol > 4.8% mmol/L). There was also a high prevalence of complications such as neuropathy (19.0%), albuminuria (15.7%) and background retinopathy (11.1%). As for lifestyle, 66.5% of the patients were either overweight or obese, and only 54.8% admitted to adhering to diabetic diet regularly and 38.9% exercised regularly. These factors could explain the poor control of diabetes in this study6.

Diabetes is a major problem in this country and is predicted to become an even bigger problem. It is a matter for concern that diabetes care is far from satisfactory with the majority of patients not achieving the clinical goals and the rate of complications being still high. Serious and urgent efforts are required to address these issues; otherwise the nation will be burdened by patients suffering from diabetes and its complications. New comprehensive approaches for chronic disease careincorporating a variety of interventions such as casemanagement, physician feedback, clinical information

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systems such as disease registries, adoption of clinical practice guidelines, and a focus on patient self-management skills were first developed many years ago. These comprehensive approaches to chronic care can be very effective in managing chronic disease including diabetes 8, 9.

OBJECTIVE (i) Determine the demographics of diabetic patients attending the MOH health clinics and hospital. (ii) Determine the diabetes sub-types and date of diagnosis. (iii) Determine diabetes control and clinical variables in the past one year. (iv) Determine diabetes management in term of pharmacological, non-pharmacological, concomitant and self monitoring. (v) Determine the diabetic complications workload in health clinics/hospitals. (vi) Determine the co-morbidities among diabetic patients. (vii) Stimulate and facilitate diabetic research activities using this database.

MATERIALS AND METHODS Study Design A multi-center observational cohort study.

Patient Selection All patients 18 years and above with a confirmed diagnosis of diabetes mellitus at participating sites will be enrolled into the registry. Duration of Study The study is expected to start in middle 2008. Patients will be followed up according to the standard of care of each participating site.

details will be abstracted from patients’ medical records by research assistants under supervision by site investigators. A copy of the case report form is attached. The data will be stored on a web-based electronic case report form readily accessible to source data providers from the sites. Stringent information security policies will be implemented to maintain confidentiality.

Data Analysis The characteristics of the study sample will be described using numbers and percentages for categorical variables or means with their standard deviations for continuous variables. The descriptive statistical pertaining to clinical practice, other clinical feature, treatment and outcome would be analyzed.

CONCLUSION There is a consensus that a database on Diabetes Mellitus in the country will be compiled and assessed with a view towards understanding the results of treatment as well as to benchmark quality of care to be on par with that of international standards. This database ought to fill the gaps in information that has long been perceived no matter challenging the actual establishment taken. Thus, we urge all parties concerned to lend their full cooperation and sincere support behind this worthwhile and undertaking.

REFERENCES 1. 2.

3.

Location of Study Participating sites are from all government hospitals and all health clinics in the state of Negeri Sembilan and will later on be extended to other states in Malaysia. In future more centers are expected to participate.

4.

Data Collection All new diabetes mellitus patients will be registered on attendance at participating sites as well as existing patients on follow up may also be included in the registry. Datasets which are essential for data analysis are mandatory to be collected. All data on demographics, clinical information, complications, concomitant co-morbidity and management

7.

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5. 6.

8. 9.

International Diabetes Federation. Facts & figures: did you know? Available at http://www.idf.org/home/index.cfm. Rugayah B. Diabetes mellitus among adults aged 30 years and above. Report of the Second National Health and Morbidity Survey (Vol. (9). Ministry of Health, Malaysia. 1990. Chandran LR, Mohamad WB, Nazaimoon WM, Letchumanan GR, Zanariah H, Jamaiyah H, et al. Diabetes mellitus: Report of the 3rd Malaysia National Health Morbidity Survey 2006, NHMS III Conference. 8 - 10th Aug 2007, J.W. Marriot Hotel, Putrajaya. Mustafa B, Mohammad WW. for the Diabetes Data Collection Project (Diabcare-Malaysia) Study Group. The current status of diabetes management in Malaysia. J ASEAN Fed Endo Soc 1998; 16(2 Suppl):1-13. J ASEAN Fed Endo Soc 1998; 16(Suppl 2): 1-13. Mafauzy M. Diabetes control and complications in private primary healthcare in Malaysia. Med J Malaysia 2005; 60(2): 212-7. Mafauzy M. Diabetes control and complication in public hospitals in Malaysia Med J Malaysia 2006; 61: 477-83. McGlynn E. The Quality of Health Care Delivered to Adults in the United States. N Eng J Med Jun 26, 2003; 348: 2635-45. Wagner E. Improving Chronic Disease Care: Translating Evidence into Action. Health Affairs (Millwood) 2001; 20: 64-78. Bodenheimer T. Improving Primary Care for Patients with Chronic Illness: The Chronic Care Model, Part 2. JAMA October 16, 2002; 288(15): 1909-14.

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Malaysian Cardiothoracic Surgery Registry - A Patient Registry to Evaluate the Health Outcomes of Patients Undergoing Surgery for Cardiothoracic Diseases in Malaysia R Anas*, I Rahman**, H Jahizah***, A Hassan****, T Ezani*****, Y H Jong******, E Norzalina*******, G Ziyadi********, S Balan*********, J Ramadan**********, T O Lim***********, H Jamaiyah***********, H Hidayah*********** Department of Cardiothoracic Surgery, *Penang Hospital, Jalan Residensi, 10990 Penang, **Hospital Sultanah Aminah, 80100 Johor Bahru, Johor, *****Institut Jantung Negara, 145 Jalan Tun Razak, 50400 Kuala Lumpur, ******Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, 93586 Kuching, Sarawak, ********Hospital Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Department of Cardiac Anaesthesia, ***Penang Hospital, Jalan Residensi, 10990 Penang, ****Institut Jantung Negara, 145 Jalan Tun Razak, 50400 Kuala Lumpur, *******Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce, 93586 Kuching, Sarawak, *********Hospital Sultanah Aminah, 80100 Johor Bahru, Johor, **********Hospital Serdang, Jalan Puchong, 43000 Kajang, ***********Clinical Research Centre, Level 3, Dermatology Block, Hospital Kuala Lumpur, 50586 Jalan Pahang, Kuala Lumpur, Malaysia

SUMMARY The formulation of the Cardiothoracic Registry. Cardiothoracic surgery is the field of medicine involved in surgical treatment of diseases affecting organs inside the thorax (the chest). It is a general treatment of conditions of the heart (heart disease) and lungs (lung disease). In Malaysia, due to lack of data collection we do not have estimates of number and outcome of such procedure in the country. Western figures are often used as our reference values and this may not accurately reflect our Malaysian population. The Malaysian Cardiothoracic Surgery Registry (MyCARE) by the Ministry of Health will be a valuable tool to provide timely and robust data of cardiology practice, its safety and cost effectiveness and most importantly the outcome of these patients in the Malaysian setting. KEY WORDS: Patient registry, Cardiothoracic surgery

INTRODUCTION Cardiovascular disease (CVD) is a modern global disease which, despite recent advances in therapeutics, continues to rise in incidence. CVD accounts for 25% of all deaths in Malaysia in 1998 1. Acute coronary syndrome (ACS) accounted for nearly 35,000 acute admissions into Government hospitals in Malaysia within year of 2001 2. Treatment and prevention of CVD include 1) the identification of persons at risk of developing CVD and predisposing factors, 2) the development and clinical evidence of drugs and other interventional procedures that halt or modulate atherosclerosis, and 3) the implementation of clear strategies based on sound clinical evidence at all stages of the disease and clinical manifestation. In addition, it is also known that death from aneurysmal rupture is one of the 15 leading causes of death in most series.

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The estimated incidence of thoracic aortic aneurysms is 6-10 cases per 100,000 person-years 3. In addition, the overall prevalence of aortic aneurysms has increased significantly in the last 30 years. This is partly due to an increase in diagnosis based on the widespread use of imaging techniques. However, the prevalence of fatal and nonfatal rupture has also increased, suggesting a true increase in prevalence. Population-based studies suggest an incidence of acute aortic dissection of 3.5 per 100,000 persons; an incidence of thoracic aortic rupture of 3.5 per 100,000 persons; and an incidence of abdominal aortic rupture of 9 per 100,000 persons. An aging population probably plays a significant role. Untreated, 75% to 80% of thoracic aortic aneurysms will eventually rupture Five-year untreated survival ranges between 10% and 20%. Rupture risk increases with age and female gender 4. The critical ascending aortic aneurysm diameter is 6cm (31% rupture risk) meanwhile the critical descending aortic aneurysm diameter is 7cm (43% rupture risk). Unfortunately all these data are “Western Data” does not reflect the local disease pattern. The wealth of clinical and epidemiological evidence has allowed for clear practice guidelines to be formulated both internationally and locally 3-5. These issues have been rightfully addressed by the cardiology group and the surgical group intends to complete the picture by providing the results through the registry. The Malaysian Cardiothoracic Surgery Registry (MyCARE) will seek to address the issues related to the specifically identified diseases namely coronary artery disease, aortic aneurysmal diseases and valvular heart diseases that were subjected to surgical referral and subsequently various surgical treatment modalities. The committee realized the lack of accurate and up-to-date data in Malaysia, which addressed the issues of prevalence, surgical treatments and the outcomes of these diseases following surgery and this registry is established to overcome these issues. The registry itself will be a useful tool to provide a timely, accurate and

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robust data that reflects the Malaysian population and it can be mined for other research as well. It is hoped that this database will gradually streamline on all data pertaining to these issues. As a kick-start, MyCARE will cover the adult cardiac surgery procedure as the primary scope which involves any cardiac surgery that is done for patient with age 12 years and above. In future, the committee is planning to include other additional 2 scopes which are paediatric cardiac surgery procedure and other thoracic surgery procedure. Thus, it is crucial for MyCARE to run the primary scope toward the expectation in order to make sure that the objectives are fulfilled and the establishment of other scopes will become reality.

OBJECTIVE 1. Determine the number of referrals, the time trend of waiting for surgery and the risk as well as surgical outcomes in Malaysia for coronary heart disease, valvular heart disease and aortic aneurysm. 2. Determine the socio demographic profiles of these patients to better identify the high-risk group in our Malaysian population. 3. Determine the number, evaluate and monitor the outcomes of each disease and surgical intervention based on selected performance indicators. 4. Determine the efficiency of, and adherence to current guidelines treatment guidelines. 5. Determine the cost to the nation by cardiothoracic disease and the cost-effectiveness of treatment and prevention programs. 6. Stimulate and facilitate research cardiothoracic disease research using this database.

MATERIALS AND METHODS Design MyCARE is a voluntary, MOH sponsored and multicentre hospital based cohort study.

Patient Selection All patients age 12 years and above who are diagnosed with Coronary, Valvular and Aortic Aneurysym Diseases where surgical management is an option are eligible to be recorded. The patients must be referred to and seen at any of the participating centres. Duration of Study Currently, this study is in piloting phase which started on July of 2008 and it is expected to be launched on September 2008. The patient records are collected during the attendance, ward admission, surgery and he/she will be followed up till 30 days after surgery. Source Data Provider Participating sites include centres in government hospitals, universities and private centres. Currently, the government centres are Hospital Pulau Pinang, Hospital Umum Sarawak, Hospital Serdang dan Hospital Sultanah Aminah Johor Bahru. The participating universities centres are Hospital Universiti

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Kebangsaan Malaysia (HUKM) and Hospital Universiti Sains Malaysia (HUSM). The only private centre that is currently involved in this registry is National Heart Institute or IJN. We are expecting and welcoming other cardiothoracic surgery centre to voluntarily participate in the registry in the future. However, under piloting period, only MOH hospitals will be collecting the data and after the registry is officially launched, the other SDPs (HUKM, HUSM and IJN) will follow the procedure.

Data Collection All patients who underwent surgery will be registered on attendance at participating sites. The case report form will be filled up with the details of the patient by surgeon and anaesthetist that are involved in the surgery. The surgery procedure details are also filled up in the same case report form (CRF) as per Appendix 1. The CRF is designed using datasets from other similar registries from our countries as our references. The datasets are taken from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database 2.61 24 August 2007; the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS) – The National Cardiac Surgery Database Version 1, 30/04/01; and SCTS The Society of Cardiothoracic Surgeons of Great Britain and Ireland National Adult Cardiac Surgical Database dataset version 3.8. The CRF design is matched to Malaysian surgery procedures and during piloting period, hardcopy CRF is used to record the patients’ details. The registry is coordinated by a registry manager at the Clinical Research Centre (CRC). Monthly census of each participating centre will be collected at the coordinating centre to keep track on the number of surgery performed. Upon the completion of the pilot study, the data collection will be done electronically using eCRF through web application. Stringent information security policies will be implemented to maintain confidentiality. The participating centres have access to their own database but they do not granted access to database of other centres.

CONCLUSION The Malaysian Cardiothoracic Surgery Registry is the first database to record detailed information of patients who undergo cardiothoracic surgery in Malaysia. Currently, it is in the piloting stage and it is expected to be launched soon. Its’ first report is anticipated a year after data collection has started.

ACKNOWLEDGEMENT The MyCARE committee would like to express gratitude to Ministry of Health, Malaysia for their experts and financial support in order to establish this registry. The committee also is glad to acknowledge the Australasian Society of Cardiac and Thoracic Surgeons (ASCTS), the Society of Thoracic Surgeons (STS) United States and the Society of Cardiothoracic Surgeons of Great Britain and Ireland since these societies have made their dataset available that can be used as our references and MyCARE is hoping to learn more from these registries. Lastly, the committee also would like to thank the

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Clinical Research Centre (CRC) which has been helping us to establish this registry from the scratch and also to any participating party that involves directly or indirectly in this registry.

3.

4.

REFERENCES 1.

2.

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AMI death in the government hospital Malaysia 1990-1998. AMI death in the government hospital Malaysia 1990-1998. Management Information System Annual Report for Medical Care. Ministry of Health, Malaysia. Management Information System Annual Report for Medical Care Year 2001. Ministry of Health, Malaysia.

5.

Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction 2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). Circulation 2002; 106: 1893-900. Clinical Practice Guidelines on Acute Myocardial Infarction 2001. Z Robaayah (Chair) for the expert committee of the National Heart Association Malaysia/ Academy of Medicine Malaysia/ Ministry of Health, Malaysia. Clinical Practice Guidelines on Unstable Angina and Non-ST-elevation Myocardial Infarction 2003. Quek D (Chair) for the expert committee of the National Heart Association Malaysia/ Academy of Medicine Malaysia/ Ministry of Health, Malaysia.

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National Renal Registry, M’sian Society of Nephrology

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eClinReg® eMOSS® - Malaysian Organ Sharing System

National Renal Registry, M’sian Society of Nephrology

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eClinReg® eDownload Own Centre Data System

National Renal Registry, M’sian Society of Nephrology

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ClinReg® Cancer Registry System

National Cancer Registry, Department of radiotherapy and Oncology HKL and MAKNA

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ClinReg® Neonatal Management System

National Neonatal Registry, Hospital Selayang

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ClinReg® HIV/AIDS Treatment Registry Management System

National HIV/AIDS Treatment Registry, Department of Medicine Hospital Kuala Lumpur

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ClinReg® Cataract Surgery Registry Management System

National Cataract Surgery Registry, Dept of Ophthalmology Hospital Selayang

8.

eClinReg® Eye Database Registry Management System

National Cataract Surgery Registry, Dept of Ophthalmology Hospital Selayang

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eClinReg® GlomeruloNephritis Registry Management System

GN Registry, Malaysian Society of Nephrology

10.

ClinReg® and eClinReg® Transplantation Registry

National Transplant Registry, M’sian Society of Transplantation

11.

National Medicine Use Survey Database Application

National Medicine Use Survey, Clinical Research Centre, HKL

12.

eABC ® Actonel Bone Care Support System

Sanofi Aventis

eNSR ® National Specialist Register Online Registration System

National Specialist Register, Academy of Medicine

14.

eNCVD ® CardioVascular disease Database

National Cardiovascular disease Database Registry, Hospital Umum Sarawak

15.

eNTrD ® Trauma Database

National Trauma Database Registry, Emergency Dept & Neurology Dept, Hospital Kuala Lumpur

16.

National Medical Research Register

NIH, Ministry of Health

17.

Malaysian Medical and Health Directory

National Medicine Use Survey, National Medical Device Survey

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IVRS ClinRandomize®

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ClinSafetyTrack®

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