Patient Registry Data for Research: A Basic Practical Guide

MOHAMAD ADAM BUJANG

Patient Registry Data for Research: A Basic Practical Guide

With

ANG SWEE HUNG, TG MOHD IKHWAN TG ABU BAKAR SIDIK, TASSHA HILDA ADNAN, NADIAH SA’AT, HON YOON KHEE & ALAN FONG YEAN YIP

Editors

PROF. DR. JAMALLUDIN AB RAHMAN

&

PROF. DR. SHAMSUL AZHAR SHAH

May 2021

Institute for Clinical Research (ICR),

National Institutes of Health, Blok B4, Aras 1, Jalan Setia Murni U13/52, Seksyen U13, Setia Alam, 40170 Shah Alam, Selangor, Malaysia

www.crc.gov.my | Phone: 603-3362 7700

© INSTITUTE FOR CLINICAL RESEARCH (ICR), Mohamad Adam Bujang, 2021.

Cover and interior design by Chew Cheng Hoon.

All rights reserved.

The authors retain the sole copyright ownership of this book. Therefore, it is necessary to obtain prior permission from either the author or the Director of Institute for Clinical Research, Ministry of Health, Malaysia, in order to reuse the content(s) of this book and/or to reproduce the content(s) of this book in any form. However, the author wishes for this book to serve as a useful and not-for-sale reference for managing and conducting medical research consultations.

PATIENT REGISTRY DATA FOR RESEARCH: A BASIC PRACTICAL GUIDE

First Edition, 2021.

Cite as: Mohamad Adam B., Swee Hung A., Tassha Hilda A., Tg Mohd Ikhwan T.A.B.S., Nadiah S., Yoon Khee H., Alan Fong Y.Y. (2021) PATIENT REGISTRY DATA FOR RESEARCH: A BASIC PRACTICAL GUIDE. Kuala Lumpur, Malaysia: Institute for Clinical Research, NIH MY.

ISBN: 9781005767600

DOI: doi.org/10.5281/zenodo.4722674

Authors

Dr. Mohamad Adam Bujang, PhD (Information Technology & Quantitative Sciences)

Clinical Research Centre, Sarawak General Hospital

Institute for Clinical Research

Ministry of Health Malaysia

––––––––

Dr. Ang Swee Hung, Msc (Public Health)

Institute for Clinical Research

Ministry of Health Malaysia

––––––––

Mr. Tg. Mohd Ikhwan Tg Abu Bakar Sidik, Msc (Statistics)

UKM Medical Molecular Biology Institute

Universiti Kebangsaan Malaysia

––––––––

Mrs. Tassha Hilda Adnan, Bsc (Statistics)

Sector for Biostatistics & Data Repository,

National Institutes of Health

Ministry of Health Malaysia

––––––––

Ms Nadiah Sa'at, Bsc (Mathematics)

Institute for Clinical Research

Ministry of Health Malaysia

––––––––

Mr. Hon Yoon Khee, BPharm (Pharmacy)

Institute for Clinical Research

Ministry of Health Malaysia

––––––––

Dr Alan Fong Yean Yip, MRCP (UK), FRCP (Edin)

Clinical Research Centre, Sarawak General Hospital

Institute for Clinical Research

Ministry of Health Malaysia

––––––––

Editors

Prof. Dr. Jamalludin Ab Rahman

Deputy Dean (Postgraduate & Research)

Department of Community Medicine

Kulliyyah (Faculty) of Medicine

International Islamic University Malaysia

––––––––

Prof. Dr Shamsul Azhar Shah

Community Health Department

Faculty of Medicine,

University Kebangsaan Malaysia

Acknowledgements

The authors would like to thank the Director-General of Health Malaysia for his permission to publish this e-book/book. The appreciation also goes to Dr. Lim Teck Onn, Dato' Dr. Goh Pik Pin, the former Directors of Institute for Clinical Research, and Dr Kalai Peariasamy, the Director of Institute for Clinical Research, for their support and guidance. A special appreciation also goes to Dr Chew Cheng Hoon for helping in the design of the book’s cover and also in the process to publish this e-book/book. Last but not least, the author would like to express his sincere appreciation to our colleagues, Mr. Abd Muneer Abd Hamid, Mdm. Premaa Supramaniam, Mdm. Evi Diana Omar, Mr. Shahrul Aiman Soelar, Mdm. Nor Aizura Zulkifli, Mdm. Mariana Mohamad Ali, Mdm. Nur Amirah Zolkepali and Mdm. Nurakmal Baharum for their involvement in conducting the statistical analysis service for producing reports and scientific articles from patient registry databases for Institute for Clinical Research's research clients.

Table of Content

Preface

Abbreviations

Tables

Figures

Chapter 1 - Background

1.1 Purpose and Scope

Chapter 2 - Data Acquisition

2.1 Obtain Prior Consent and Study Approval

2.2 Understand the Scope of a Registry

2.3 Estimate the Minimum Sample Size Required for a Registry Study

2.4 Prepare a Dummy Table for Statistical Analysis

Chapter 3 - Data Preparation

3.1  Proper Handling of Duplicates Found in a Dataset

3.2  Match and Combine Data from Different Datasets

3.3  Set up Conditions and Requirements for Analysis

3.4  Establish Data Cleaning Procedures

3.5  Proper Handling of Missing Data in a Registry Database

3.6 A Summary of Data Preparation Procedures

Chapter 4 - Approach for Statistical Analysis

4.1 A Proposed Guide for Statistical Analysis of Patient Registry Data

Before statistical analysis

During statistical analysis

After statistical analysis

4.2  Presentation of the Final Results

4.3  Development of the Statistical Analysis Plan

Chapter 5 - Summary

References

Appendix 1

Examples list of scientific articles published based on data from patient registries by the authors

Appendix 2

Example part of a Case Report Form (CRF) from