Cardiovascular Survey Methods
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Cardiovascular survey methods THIRD EDITION Russell V. Luepker Alun Evans Paul McKeigue K. Srinath Reddy World Health Organization Geneva 2004 WHO Library Cataloguing-in-Publication Data Cardiovascular survey methods / Russell V. Luepker . [et al.l-3rd ed 1.Cardiovascular diseases-epidemiology 2.Health surveys-methods 3.Epidemiologic methods ILLuepker, Russell V. ISBN 92 4 154576 3 (NLM classification: WG 100) O World Health Organization 2004 All rights reserved. Publications of the World Health Organization can be obtalned from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 121 1 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications-whether for sale or for noncommerc~aldistribution-should be addressed to Publications, at the above address (fax: +41 22 791 4806; email: [email protected]). 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TYPESET IN HONG KONG PRINTED IN MALTA 2002114796-SNPBest-setilnterpr~nt-5000 Contents Preface ix Acknowledgements xi Acronyms and abbreviations xiii lntroduction References 1. History of cardiovascular epidemiology lntroduction The modern era References 2. General principles Concepts Objectives of cardiovascular disease surveys Overview Frequency and distributions Associations Natural history of diseases Trends Trials Health services research Unique aspects of cardiovascular disease epidemiology Ethics of epidemiological research lntroduction Basic precepts Informed consent Rewards and inducements Responsibility to diseased or high-risk subjects Confidentiality Ethical review panels Special circumstances in epidemiological and public health research CONTENTS Interpretation of data: bias and confounding Overview Random error Systematic error or bias Confounding Overview Statistical associations Criteria for causal inference Design of research studies to determine causation Use and misuse of epidemiological data Misuse of survey data Regression dilution bias Generalizability References 3. Study designs Overview Ecological studies Case reports and series Cross-sectional surveys Case-controls studies Cohort studies Trials Community trials Clinical trials Genetic epidemiology Sample size and power Studies of continuous variables Other considerations Statistical analysis Risk assessment Relative risk Odds ratio Attributable risk Population attributable risk Absolute risk References 4. Principles of study design and measurement Overview Hypotheses Study design Objectives and specific aims CONTENTS Population definition Sample size Measurements Quality control Data handling 5. Data sources Overview Vital statistics Routine patient data Insurance data Interview data Observation of subjects Physical measurements Unobtrusive measurements References 6. Conducting the research Overview Hypotheses Specific aims and objectives Selecting and defining a population Available data Choosing data collection instruments Pilot studies Manual of operations Sample participation and collection Record abstraction Sampling and recruitment Staff selection, training and supervision Data handling Quality control Running the study References 7. Mortality surveillance Introduction Background Mortality issues specific to CVD Methods Evaluation of available data Specific approaches Evaluation of mortality data CONTENTS Standardized death rates References 8. Morbidity surveillance lntroduction Registries Overv~ew Uses of registries Examples of registries The WHO myocardial infarction register The WHO MONlCA Project Atherosclerosis risk in communities (ARIC) The Minnesota Heart Survey (MHS) American College of CardiologyIEuropean Society of Cardiology definition Stroke surveys Heart failure Peripheral vascular disease (PVD) Other registries Registries in developing countries Establishing and Running a Register Location and settlng of the register Funding Management Staffing Good relationships with other departments Statistical analysis Data collection "Hot" vs "cold" pursuit Quality control A "Happy" register Knowing when to stop References 9. Population surveys lntroduction Questionnaires and medical records Angina pectoris and other cardiovascular symptoms Medical history and the prevalence of diagnosed disease Measurements of health status and quality of life Demographic data Occupation and socioeconomic status CONTENTS Family history Size at birth Participant's own medical history Smoking Alcohol Psychosocial factors Physical activity and energy expenditure Activity diaries Dietary intake measurements 24-hour recall Diet history Food frequency questionnaires Household food inventory Food analysis Physical examination Anthropometry Clinical examination of the heart Examination of retina1 blood vessels Blood pressure measurement Measurement of body fat mass Measurement of cardiorespiratory fitness Electrocardiography Recording of the electrocardiogram Coding of the ECG Ultrasound of the heart M-mode echocardiography Two-dimensional echocardiography Doppler ultrasound Ultrasound of peripheral arteries Ultrasound of the carotid arteries Ultrasound of the abdominal aorta Endothelium-dependent vasodilatation Coronary calcification by electron beam computed tomography Collection and analysis of biological specimens Blood sampling Plasma lipids Glucose tolerance testing and insulin sensitivity Methods in genetic studies Other biological specimens References Glossary List of Appendices 1-37 (on CD Rom) Preface There is a continuing need for surveys to establish the frequency, distribution and risk associations of cardiovascular diseases (CVD). They define in cross-section the individual and population characteristics related to disease, and they provide base data for follow-up of defined cohorts that allow hypotheses of disease causation and prevention to be tested. Surveillance, including population-based surveys, is also needed to establish time trends of CVD mortality and morbidity, which indicate the impact of medical care, preventive strategies and cultural change in the community. Used intelligently and in conjunction with clinical and laboratory evidence, surveys provide evidence essential to causal inference. Surveillance provides information on the status of medical care, public health and cultural priorities. The two approaches are complementary and both require sound standard methods and procedures, carefully tested among real populations for reliability, validity, and feasibility. This new edition of WHO'S Cardiovascular survey methods goes beyond practical guidelines to detail different useful methods for data collection, editing, analysis and interpretation. Besides being an operational manual for surveys, it provides also the conceptual background and literature base for proposed research approaches and procedures. Above all, this edition brings both method and concept up to date; CVD epidemiology today has greater complexity, technicality and subtlety than it had in 1968 and 1982 when the first two editions of this manual were pub- lished. The international epidemiological investigators who compiled the new edition have brought to it new skills and viewpoints, and their rich and diverse experience. The original edition of Cardiovascuhr survey methods had proved a useEul guide over the last 30 years, mainly to clinicians drawn to the study of CVD in the world beyond the clinic. This new edition is a more complete source and critical reference for the many and varied health care professionals and support personnel now involved in cardiovascular research, in evaluation of health care effects and costs, in hospital and population surveillance of trends, and in treatment and prevention trials of new agents, instruments, and procedures. As such, this edition is most welcome. Henry Blackburn. Division of Epidemiology, School of Public Health, University of Minnesota, Min- neapolis, MN, USA. Zdenek Fejfar. Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. Acknowledgements The authors wish to express their appreciation to the late Professor Geoffrey Rose and Professor Henry Blackburn, authors of the initial WHO monograph on Car- diovascular Survey Methods, published in 1968, for their encouragement in updating their important monograph. They also wish to thank Ron Prineas and Richard Gillum who co-authored the second edition with Geoffrey Rose and Henry Blackburn. Ivan Gyarfas, Ingrid Martin, Shanthi Mendis and Porfirio Nordet of the World Health Organization provided consistent encouragement, editorial advice and support. Professor