The Advanced Handbook of Methods in Evidence Based Healthcare

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Edited by: Andrew Stevens, Keith Abrams, John Brazier, Ray Fitzpatrick & Richard Lilford

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  • Part I: Clinical Trials

    Part II: Observational and Qualitative Methods

    Part III: Measurement of Benefit and Cost

    Part IV: Analytical Methods

    Part V: Consensus, Reviews and Meta-Analysis

    Part VI: Identifying and Filling Gaps in the Evidence

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    Contributors

    Keith Abrams (editor) is Reader in Medical Statistics, in the Department of Epidemiology and Public Health, at the University of Leicester, having previously held posts at King's College School of Medicine and Dentistry and the London School of Hygiene and Tropical Medicine. He has gained degrees from the Universities of Warwick, Leicester and Liverpool. His research interests include: the development and application of Bayesian methods in Health Services Research (HSR)/Health Technology Assessment (HTA), systematic reviews and meta-analysis, and analysis of time to event data. He is a fellow of the Royal Statistical Society and a Chartered Statistician.

    Richard Ashcroft is Lecturer in Medical Ethics at Imperial College School of Medicine. He trained as an undergraduate in mathematics and philosophy at Cambridge University, before completing a PhD in ethics and philosophy of science, also at Cambridge. The chapter in this volume is based on work carried out as a postdoctoral research fellow in the Philosophy Department at Liverpool University, funded by the NHS Health Technology Assessment programme, grant 93/41/4, held by Dr Jane Hutton with Prof. David Chadwick, Prof. Stephen Clark, Prof. Richard Edwards, and Ms. Lucy Frith. He is currently working on ethical issues in medical research and technology assessment.

    Janet Askham is Professor of Gerontology and Director of the Age Concern Institute of Gerontology at King's College London. She is a sociologist whose research career has covered topics spanning the life course: fertility behaviour, marriage and family relationships, chronic illness and disability, care in old age. She has particular interests in family life and care for people with dementia, late-life marriage and inter-generational relationships.

    Chris Bain is Reader in Social and Preventive Medicine at the University of Queensland. Whilst much of his research is in cancer epidemiology, he has maintained an interest in health services research which was happily fanned into life during a sabbatical spent with his co-authors.

    Claire Bamford graduated in Psychology from the University of London and also has an MSc in social research methods from the University of Surrey. Her research interests include provision of services and informal care to older people with dementia, and the measurement of outcomes of community care. She is currently a research fellow at the Social Policy Research Unit at the University of York working on a Department of Health-funded programme of research into ways of collecting and using information on the outcomes of community care in routine practice.

    Cindy Billingham currently works at the Cancer Research Campaign Trials Unit at the University of Birmingham as a Senior Biostatistician. Her area of special interest is the analysis of quality of life data, and she is registered for a part-time PhD at Leicester University researching into joint modelling of quality of life and survival data.

    Andrew Black was educated in Pakistan, Scotland and Oxford. He did his Postgraduate clinical training in Oxford, Gloucester, Sydney and Auckland. He was a Lecturer in Anaesthesia at the University of Oxford from 1977–1982. Since then he has been a Consultant Senior Lecturer in Anaesthesia at the University of Bristol. His academic interests are in pulmonary gas exchange, control of breathing, postoperative analgesia, clinical applications of classification approaches including statistical multi-variable and multi-variate modelling and neural networks, applications of medical simulation and role play in medical undergraduate education.

    Nick Black is Professor of Health Services Research (since 1995) and Head of the Department of Public Health and Policy at the London School of Hygiene and Tropical Medicine (since May 1998). After qualifying in medicine from Birmingham University in 1974, he worked in NHS hospitals for two-and-a-half years before joining Save the Children Fund and running a child health programme in Nepal for 18 months. He then underwent postgraduate training in public health at Oxford including a doctorate on reasons for the epidemic in surgery for glue ear in the UK. The next three years were spent half time as a lecturer at the Open University writing a new distance-learning course ‘Health and Disease’ with a biologist, sociologist and economist, and half time as a Consultant in Public Health for Oxfordshire Health Authority. In 1985 he moved to a Senior Lectureship at the LSHTM. His main research interests are the evaluation and audit of health services (particularly in the field of surgery), non-randomised methods of evaluation, R&D policy, and organisational research. He is involved in several aspects of the NHS R&D programme at national and regional levels. In 1996, together with Nick Mays (a Visiting Professor in PHP), he founded the Journal of Health Services Research & Policy. He was promoted to a Readership in 1993 and to his current Chair in 1995.

    Andrew Boddy is an Honorary Senior Research Fellow in the Department of Public Health, University of Glasgow and was formerly Director of the University's Public Health Research Unit. He has a long-standing interest in the uses of routinely assembled data for health services planning and evaluation, including methods of their analysis and interpretation.

    John Bond is a Sociologist with a special interest in social gerontology and health services research. He is currently Professor of Health Services Research at the Centre for Health Services Research at the University of Newcastle upon Tyne and Associate Director at the Institute for the Health of the Elderly, University of Newcastle upon Tyne. His research interests are health policy and older people, in particular looking at social protection policy for dependency in old age; health services research and older people with dementia; health services research and older people who fall; disability and older people; and Health Technology Assessment with particular reference to older people. He is a Member of the Health Technology Assessment, Primary and Community Care Panel and the Health Technology Assessment Commissioning Board.

    D. Jane Bower currently holds a Chair in the Department of Economics and Enterprise at Glasgow Caledonian University. She graduated with a PhD in Molecular Genetics from Edinburgh University and worked initially for 15 years as a biomedical scientist at Stanford Medical School, Edinburgh University and the MRC Human Genetics Unit. Since 1989 her research has focused on issues surrounding the development of new technologies into useful application. In the course of this research she has worked with public and private sector organisations in Europe, the USA and Japan.

    David Braunholtz is currently Senior Research Fellow in Medical Statistics in the Department of Public Health and Epidemiology at the University of Birmingham, having worked previously in medical schools in Leeds and Managua, at the Greater London Council, and in the Scottish Office. He graduated in Maths and Physics. Interests include research ethics, clinical trials and Bayesian methods.

    John Brazier (editor) is Professor of Health Economics and Director of the Sheffield Health Economics Group (which includes 14 health economists) in the School of Health and Related Research at the University of Sheffield. His main interests have been in the measurement and valuation of health services outcomes and economic evaluation, including the development of a preference-based measure from the SF-36 for use in economic evaluation. He continues to be actively involved in the design, analysis and interpretation of economic evaluations conducted alongside clinical trials and modelling.

    John Brebner is a Senior Lecturer in the Department of General Practice and Primary Care at the University of Aberdeen; Director of the Remote Health Care Unit/Telemedicine Laboratory and Visiting Professor at the United Arab Emirates University. His main research interests and projects are the human resource implications for the nursing profession in developing telemedicine within the NHS; when and how to assess fast-changing technology; an evaluation of the feasibility and diagnostic acceptability of tele-ultrasonography for rural areas and telemedicine in Primary Care.

    Andrew Briggs is a Joint MRC/South East Region Training Fellow in Health Services Research at the Health Economics Research Centre, University of Oxford. Andrew joined the Health Economics Research Centre in 1996. He is particularly interested in statistical issues associated with economic evaluation alongside clinical trials, and currently holds a joint MRC/South East Region Training Fellowship to study statistical methods in cost-effectiveness analysis. He also has a general interest in decision analysis and modelling techniques applied to the economic evaluation of healthcare interventions, and has been involved with economic evaluations of interferon treatment for hepatitis, total hip replacement, and various screening programmes.

    Annie Britton is a lecturer at the London School of Hygiene and Tropical Medicine. She has worked in public health research for several years, and her study interests include trial methodology, health promotion evaluation, and most recently an epidemiological assessment of alcohol consumption in Europe. She has published over 20 articles in peer-reviewed journals.

    Peter Burney is Professor of Public Health Medicine and Chairman of the Division of Primary Care and Public Health Sciences at King's College London. He is the Honorary Director of the Department of Health's Social Medicine and Health Services Research Unit. His current work is focused on the aetiology and management of allergic and respiratory conditions.

    Martin Buxton is Director of the Health Economics Research Group (HERG) at Brunel University. He has been concerned with the economics of healthcare and with health service policy for over 20 years. Martin has been responsible for a number of major projects for the UK Department of Health, including the early evaluation of the costs and benefits of the UK heart transplant programmes. HERG's recent work for the Department includes research on liver transplantation, an evaluation of picture archiving and communication systems, on screening programmes, and a project devising a methodology to assess the payback on Health Services Research. He is involved in many clinical trials, particularly of cardiac interventions. Professor Buxton currently sits on a number of advisory groups: he is a member of the NHS Standing Group on Health Technology, Chair of the NHS R&D Methodology Group and a member of the HEFCE RAE 2001 Panel for Community-Based Clinical Subjects.

    John Cairns is an economist who has specialised in the area of health economics for the past ten years. He is currently acting director of the Health Economics Research Unit at the University of Aberdeen.

    Michael Campbell is Professor of Medical Statistics with an interest in Primary Care at the University of Sheffield. He is interested in the design and analysis of trials, particularly in primary care. He is interested in sample size calculations and analysis of quality of life data. He is a co-author with David Machin of Statistical Tables for the Design of Clinical Trials (Blackwells) and Medical Statistics: A Common Sense Approach (Wiley).

    Susan Chinn is a Reader in Medical Statistics at the Department of Public Health Sciences, King's College, London. Her current work is mainly in respiratory epidemiology, especially asthma, and she has been involved in child growth surveillance for many years. She is interested in all applications of statistics that further excellence in medical research, of which the design of cluster randomised trials is a good example.

    Iain Colthart is currently employed as a research and information officer at the British Medical Association in Edinburgh. He contributed to the chapter in this volume when he was employed as a research associate in the Medical Statistics Unit at the Department of Public Health, University of Edinburgh. His qualifications are B.Com. (Hons) and M.A.

    Deborah Cook is an Associate Professor at McMaster University, and a general internist, intensivist and epidemiologist. She is Director of the Academic General Internal Medicine Fellowship at McMaster, Chair of the Canadian Critical Care Trials Group and Consulting Editor for Journal of the American Medical Association. Her research interests are in pneumonia, gastrointestinal bleeding, end-of-life decisions and evidence based medicine.

    Carl Counsell is a Specialist Registrar in neurology at the Western General Hospital in Edinburgh with research interests in stroke, movement disorders and epidemiology, particularly clinical trials and systematic reviews. He has an MSc in epidemiology, and was involved in setting up the Cochrane Stroke Group.

    Rosemary Crow is Professor of Nursing Science in the European Institute of Health and Medical Sciences at the University of Surrey. She trained as a nurse before reading psychology at the University of Edinburgh. Her research interests lie in clinical judgement within the field of medical and surgical nursing.

    Claire Davey obtained her Bachelor of Applied Science at the University of Victoria, Australia. She worked in health promotion for three years before moving to the University of Oxford, England in 1992 to work on research into measurement of patient-assessed outcomes and methods of providing information for cancer screening programmes. She is the co-author with Ray Fitzpatrick, Martin Buxton and David Jones of a monograph published by the Health Technology Assessment (HTA) Programme, Evaluating patient-basedoutcome measures for use in clinical trials, HTA Programme, University of Southampton, 1998.

    Mark Deverill is a research fellow in the Sheffield Health Economics Group at the University of Sheffield. His main research interest lies in the use of quality of life instruments in the economic evaluation of health technologies. With colleagues he has worked on the SF-6D, the generation of utility values

    from the SF-36.

    Robert Dingwall is Professor of Sociology and Director of the Genetics and Society Unit at the University of Nottingham. His career has spanned both medical sociology, the field of his PhD from the University of Aberdeen, and law and society studies, through work at the University of Oxford. These are united by the application of qualitative research methods to questions about professions, work, organisations and social interaction. He is currently developing a new research and graduate programme for the study of social, legal and ethical aspects of new genetic science and technologies as applied to humans, plants and animals.

    Allan Donner is Professor and Chair in the Department of Epidemiology and Biostatistics at the University of Western Ontario. His methodologic research has contributed to the design and analysis of clinical trials, with publications over the past ten years appearing in Biometrics, Statistics in Medicine and the Journal of Clinical Epidemiology. Dr Donner served on the Editorial Board of the American Journal of Epidemiology from 1991–1999, and is a Fellow of the American Statistical Association.

    Lelia Duley is an Obstetric Epidemiologist and MRC Senior Clinical Research Fellow in the Resource Centre for Randomised Trials at the Institute of Health Sciences, Oxford. Her areas of work interest include the design and conduct of randomised trials, systematic reviews, perinatal epidemiology and maternal mortality.

    Alison Eastwood is currently a senior research fellow at the NHS Centre for Reviews and Dissemination. Her background is in statistics and economics, and throughout her career she has been involved in health services research. Prior to joining the Centre over five years ago, she was a biostatistician on the myocardial infarction Patient Outcomes Research Team at Harvard Medical School in the US.

    Sarah Edwards is Lecturer in Ethics in Medicine at the Centre for Ethics in Medicine, Bristol. Her research interests major on ethics and medical research, but include other methods and types of research besides Randomised Controlled Trials (RCTs). In particular, she is interested in the use of patient records for epidemiologial studies that don't ‘use’ the patients personally or directly at all. In her previous post in the Department of Public Health and Epidemiology she completed a review of ethics and RCTs for the NCCHTA.

    Ray Fitzpatrick (editor) is Professor of Public Health and Primary Care, Institute of Health Sciences, University of Oxford and Fellow and Dean, Nuffield College, Oxford. He is currently chair of the MRC Health Services and Public Health Research Board. His research interests focus on measurement of outcomes of healthcare, such as health status, quality of life and patient satisfaction and their use in clinical trials and evaluative research. With Gary Albrecht he edited Quality of Life in Health Care (JAI Press, Greenwich, Connecticut, 1994). With Stan Newman and other colleagues he wrote Understanding Rheumatoid Arthritis (Routledge, London 1995). He co-edited with Nick Black, John Brazier and Barnaby Reeves Health Service Research Methods: A Guide to Best Practice (BMJ Books, London 1988). With Gary Albrecht and Susan Scrimshaw he co-edited The Handbook of Social Studies in Health and Medicine (Sage, London 2000).

    John Gabbay qualified in medicine at Manchester in 1974. After seven years at the University of Cambridge working on the social origins of medical knowledge, he trained in public health. His early research included working on the Templeton Study of NHS managers, and the development and critical evaluation of audit methods. Since 1992, he has directed the Wessex Institute of Health R&D, which now houses the National Co-ordinating Centre for Health Technology Assessment, which runs the HTA programme for the NHS. His recent research includes evaluations of several national pilot schemes to implement clinical effectiveness in the NHS.

    Heather Gage is a Senior Lecturer in Economics at the University of Surrey. Her research interests focus on various aspects of health service delivery, including the development of patient-centred outcome measures, international comparisons of healthcare systems, and evaluations of new healthcare technologies. Recent publications have appeared in The European Journal of Cancer Prevention, The Journal of Medical Screening, Archives of Neurology and Health Technology Assessment.

    Andrew Garratt is co-director of the National Centre for Health Outcomes Development at the Institute of Health Sciences in Oxford. His research interest is in patient-assessed health outcome measures.

    Steve George is Senior Lecturer in Public Health Medicine at the University of Southampton. In 1997 he formed and became the first Director of the University of Southampton Health Care Research Unit (HCRU). He has published widely in health services research, and his research grants total over £4,000,000. He is an epidemiologist, and his interests include both the application of epidemiological methods to the evaluation of medical care, and the development and use of outcome measures. A particular interest is the rising demand for healthcare, and the evaluation of attempts to meet it. In 1998 he published the SWOOP study, the first ever randomised controlled trial of a nurse telephone consultation system in primary care, which formed the evidence base for the new NHS Direct telephone service. He was also one of the developers of the EORTC PAN-26, a questionnaire for measuring outcomes in people with carcinoma of the pancreas and, with Professor Mike Campbell, has published on sample size calculations and analysis of quality of life data.

    Simon Gilbody has first degrees in medicine and psychology and is a member of the Royal College of Psychiatrists. He currently holds an MRC Special Training Fellowship in Health Services Research at the University of York and is an editor of the Cochrane Schizophrenia Group.

    William J. Gillespie is Dean of the Dunedin School of Medicine of the University of Otago in New Zealand. His recent work interests have been in systematic reviews, and in clinical trials in orthopaedic surgery.

    Paul P. Glasziou is a general practitioner and Associate Professor in Clinical Epidemiology at the Department of Social and Preventive Medicine, University of Queensland. He is co-editor of the Journal of Evidence-Based Medicine, a member of the editorial board of the British Medical Journal, and co-chair of the Cochrane Collaboration Methods Group on Applicability and Recommendations.

    Adrian Grant is Director of the Health Services Research Unit, a 50-strong Scottish Executive core funded research group within the University of Aberdeen, UK. He leads the Unit's programme on ‘Health Care Evaluation’. His work has centred around the place and conduct of pragmatic trials in health technology assessment, and he has a special interest in the evaluation of non-drug technologies, particularly those, such as minimal access surgery, whose evaluation is complicated by learning, skill and preference issues.

    Alastair Gray is Reader in Health Economics at the University of Oxford and Director of the Health Economics Research Centre, Institute of Health Sciences, Oxford. He has previously held posts in health economics at Aberdeen University, the Open University and the London School of Hygiene and Tropical Medicine. His main research interests are the methodology and application of economic evaluation in healthcare, priority setting methods, the economics of ageing and the economics of medical negligence.

    Colin Green is a Research Fellow in Health Economics at the School of Health and Related Research at the University of Sheffield. His research interests include the measurement and valuation of health outcomes, the application of economic theory to NHS decision-making, and the societal valuation of health and healthcare.

    Martin Gulliford is Senior Lecturer in Public Health Medicine at GKT School of Medicine, King's College London. His research interests are in epidemiology as applied to health services research, and Caribbean health.

    Sarah E. Hampson is Professor of Psychology and Health at the University of Surrey, Guildford. Her research examines personality and beliefs as determinants of health behaviours.

    Gareth Harper is currently a Senior Research Officer in the Policing and Reducing Crime Unit (PRCU), which is part of the Research, Development and Statistics (RDS) Directorate of the Home Office. Prior to this, he was a Research Health Economist at the University of Hertfordshire, where he worked for Professor Joy Townsend in the Centre for Research in Primary and Community Care (CRIPACC). His work was primarily on the methods of Preliminary Economic Evaluation of Health Technologies. Prior to this, Gareth had undertaken postgraduate research on modelling the costs of acute care hospitals, and the efficiency measurement of hospitals.

    Jo Hart is currently conducting doctoral research in health psychology at the University of St Andrews. She has considerable experience working on systematic literature reviews.

    Emma Harvey graduated with a degree in Psychology in 1991, and spent several years working in the NHS evaluating the provision of local services. In 1995 she moved to the University of York, where she works in the field of evidence based healthcare. She has developed interests in systematic reviewing, multi-centre trials, the implementation of healthcare research findings and effective professional practice. She is currently working on a national trial of physical treatments for back pain, and has recently completed a PhD on health professionals’ views and practice in relation to obesity.

    Ian Harvey is Professor of Epidemiology and Public Health at the University of East Anglia, Norwich. His research interests include pragmatic randomised trials of non-pharmaceutical interventions in primary and secondary healthcare and social care; and the use of observational studies in the assessment of health technologies.

    David Henry is Professor of Clinical Pharmacology at the University of Newcastle, Waratah, Australia. His interests span pharmaco-epidemiology, pharmaco-economics, evidence based practice and health technology assessment. He is a member of the Pharmaceutical Benefits Advisory Committee, and the Health Advisory Committee of NHMRC, and chairs the Economics Sub-Committee of PBAC. Invitations to make presentations on topics listed above include US Congressional advisors, the shadow Ministry of Health in the UK, the Cochrane Colloquium, The American Society of Clinical Pharmacology and Therapeutics, International Society of Technology Assessment in Health Care, the International Society of Pharmaco-Epidemiology, and the International Society for Outcomes Research.

    Jenny Hewison is a Senior Lecturer in the School of Psychology at the University of Leeds, specialising in the psychology of health and healthcare. She has particular research interests in mother and child health and in genetics, and more general methodological interests in the evaluation and assessment of health technologies.

    Suzanne Hill is Senior Lecturer in Clinical Pharmacology at the University of Newcastle. Her research interests are in pharmaco-economics, the use of evidence in public policy and decision-making, and in applying the results of clinical trials in these settings as well as in clinical practice.

    Jennifer Jackson is Senior Lecturer in Philosophy and Director of the Centre for Business and Professional Ethics at the University of Leeds. She has published in academic journals articles on abortion, euthanasia, competence, surrogacy and consent. She has a book forthcoming on Truth, Trust and Medicine (Routledge). She runs a postgraduate MA course on Health Care Ethics.

    Ann Jacoby is Professor of Medical Sociology in the Department of Primary Care at the University of Liverpool. Prior to this she was a Reader in Health Services Research at the Centre for Health Services Research at the University of Newcastle. Her areas of work interest include assessment of quality of life in chronic illness, particularly neurological (epilepsy, stroke); patient based outcomes in the context of clinical trials; patient satisfaction and research methods.

    Alejandro Jadad is Chief at the Health Information Research Unit; Director, McMaster Evidence-based Practice Center (designated by the US Agency for Health Care Policy and Research); Co-Director, Canadian Cochrane Network and Centre Investigator, Supportive Cancer Care Research Unit; Professor, Departments of Clinical Epidemiology & Biostatistics, McMaster University, Canada; and Associate Medical Director, Program in Evidence-based Care, Cancer Care, Ontario. His current research interests focus on pain and palliative care; the study of the information needs of different decision-makers and their barriers to the use of best available research evidence; the development of strategies to promote interaction and communication amongst decision makers operating at different levels in the healthcare system; the role of the Internet as a source of information for providers and consumers during healthcare decisions; the design and execution of empirical methodological studies to improve the design, conduct, reporting and dissemination of individual studies and systematic reviews; the use of systematic reviews and randomised trials as tools to gather new knowledge in healthcare; and the development of strategies (with members of the public as co-investigators) to transfer health research information to clinicians, patients, managers, policymakers, journalists and other lay decision-makers, and its use in conjunction with their values and circumstances. He is Chair, Consumers and Health

    Informatics Working Group, American Medical Informatics Association; Editor, Cochrane Consumers and Communication Review Group; Associate Editor, Health Expectations, a new peer-reviewed journal that focuses on patient participation in healthcare decisions. In 1997, Dr Jadad received the ‘National Health Research Scholars Award’, by Health Canada, to support his program ‘Knowledge synthesis and transfer, consumers and evidence-based health care’. In 1999, he received one of ‘Canada's Top 40 Under 40’ awards and one of the ‘Premier's Research Excellence Awards’ in recognition for the achievements and leadership in his multiple areas of interest, and his contributions to society.

    Katharine Johnston is a Research Fellow at the Health Economics Research Centre, University of Oxford. She has previously held appointments at Brunel University, the NHS Executive in Edinburgh and the University of Aberdeen. Her research interests include methodological issues in economic evaluation; the economics of screening (particularly breast screening); and the innovation and diffusion of health technologies.

    Alison Jones is based at the Thomas C. Chalmers Centre for Systematic Reviews in Ontario. She co-ordinates a series of studies pertaining to the effects of language publication of included randomised controlled trials on the benefits of treatment interventions. She is also involved with the evaluation of the CONSORT statement which was designed to improve the quality of reports of randomised trials.

    David Jones completed an MSc and PhD in mathematics before taking up a series of posts in medical statistics and epidemiology in the NHS and several universities. In 1991, he was appointed to the new Chair in Medical Statistics at the University of Leicester. His research interests in the methodology of health services research and clinical trials include meta-analysis, quality of life assessment, and applications of Bayesian methods.

    Steven Julious graduated in 1991 from the University of Reading with an MSc in Biometry and took up a post as a medical statistician in the medical school of the University of Southampton. Here he developed an interest in the methodology of clinical trial design, in particular the aspect of sample size estimation, and the statistical methodologies underpinning quality of life assessment. In 1996, Steven left academia to take up a post at Glaxo-Wellcome, and now works in the department of Clinical Pharmacology Statistics, SmithKline Beecham.

    Sandra Kiauka is currently working as a staff Epidemiologist at the Institute for Health Care Systems Research in Germany. Previous to this she has worked as a research fellow at the Medical Statistics Unit at the University of Edinburgh and a clinical co-ordinator at Shared Care Informatics in Halifax, Nova Scotia, Canada. Her areas of work interest include health service research, healthcare reforms, service packages, public health, epidemiology and information technology in public health research. She has a B.Sc. in Health Information Sciences and an M.Sc. in Epidemiology.

    Alan Kimber is Head of the Department of Mathematics and Statistics at the University of Surrey. He has been a Fellow of the Royal Statistical Society since 1979 and is a Chartered Statistician. His research interests include survival analysis and reliability, statistical modelling and applications of statistics to the medical and health sciences.

    Terry Klassen is currently professor and chair of the Department of Pediatrics, University of Alberta in Edmonton, Alberta, Canada. He is the co-ordinator for the Child Health Field for the Cochrane Collaboration. His research interests are in the use of clinical trials and systematic reviews for assessing the effectiveness of interventions in child health.

    Donna Lamping is Senior Lecturer and Head of the Health Services Research Unit at the London School of Hygiene and Tropical Medicine. She trained as a research psychologist (specialisation in health psychology, psychometrics/measurement, personality) and worked at universities in Canada (McMaster, McGill) and the USA (Harvard, Fordham) before coming to LSHTM in January 1992. Her research is in two main areas: (i) methodological work on developing and validating patient-based measures of outcome in several areas of medicine and surgery (e.g. prostatectomy, gynaecological surgery, maternity services, HIV/AIDS, renal dialysis, back pain, venous diseases of the leg, multiple sclerosis, ocular disease, neuro-rehabilitation, cardiothoracic surgery, plastic surgery); and (ii) substantive work on quality of life and psychosocial aspects of chronic illness (e.g. elderly people on dialysis, HIV+ women, children at risk for hyperlipidaemia, CABG patients randomised to conventional versus community care, dialysis patients being treated in satellite units, arthritis patients).

    James Lewsey is a Research Fellow in the Biostatistics Unit of the Eastman Dental Institute, UCL. His current areas of interest include multilevel modelling and Bayesian analysis in oral health services research, meta-analysis, and generalised linear modelling.

    Alastair Leyland is a Research Scientist in the MRC Social and Public Health Sciences Unit at the University of Glasgow. He is head of a programme concerned with measuring health, variations in health and the determinants of health in Scotland, and his current areas of interest include applications of multilevel modelling to health data and the spatial modelling of disease.

    Richard Lilford (editor) was born in Cape Town in 1950, received his schooling in Johannesburg, and became a doctor in that city. He moved to Cape Town where he specialised in obstetrics and gynaecology at the Groote Schuur Hospital, before coming to work in London, first as a registrar and then a senior registrar. He was appointed as a consultant at Queen Charlotte Hospital in 1982, and was then made a professor in Leeds in 1984, where he ran a department for seven years. He then headed the Institute of Epidemiology and Health Service Research at the University of Leeds for a further four years before coming to his present job where he directs the government's programme of research in the West Midlands, directs the central programme of methodological research, and advises the government on trials. He is also a part-time Professor in the Department of Public Health and Epidemiology at the University of Birmingham.

    Julia Lowe completed her medical training in the UK and then moved to Australia. She worked part-time in private practice while her children were small, completing a masters degree in clinical epidemiology in her spare time. She moved back to the public sector in 1991 and became Director of General Medicine at John Hunter teaching hospital in 1996. She has established research programmes in diabetes and cardiac failure as well as maintaining an interest in health services research. She is criticism editor for the Cochrane Heart Group.

    David Machin is currently Professor of Clinical Trials Research at the University of Sheffield, former Director of the National Medical Research Council, Clinical Trials and Epidemiology Research Unit, Singapore (1996–9) and Chief Medical Statistician MRC Cancer Trials Office, Cambridge (1988–98). His degrees include a MSc from the University of Newcastle upon Tyne, and PhD from the University of Southampton. He is an honorary Member of the Royal College of Radiologists. He has published more than 200 articles and several books on a wide variety of topics in statistics and medicine. His earlier experience included teaching at the Universities of Wales, Leeds, Stirling and Southampton, a period with the European Organisation for Research and Treatment of Cancer, Brussels, Belgium and at the World Health Organization in Geneva, Switzerland working on contraceptive trials. He is an editor of Statistics in Medicine and member of the Editorial Board of the British Journal of Cancer.

    Rachel MacLehose is currently working as a Public Health Epidemiologist at South Essex Health Authority. Previous posts include working as an environmental epidemiologist at the Chemical Incident Response Service at Guy's and St. Thomas’ Hospital Trust and as research associate at the University of Bristol. Rachel holds an MSc in Environmental Epidemiology and Policy from the London School of Hygiene and Tropical Medicine.

    Theresa Marteau is Professor of Health Psychology and Director of the Psychology and Genetics Research Group at King's College, London. Over the past 15 years she has been conducting research on psychological aspects of health risk assessment. The work has covered genetic testing in pregnancy, adulthood and childhood, as well as population based screening programmes. The conditions studied include heart disease, cervical, breast and bowel cancer and cystic fibrosis. The aim of this research is to understand responses as a first step towards evaluating different methods of communicating information to promote understanding, reduce emotional distress and enhance health-promoting behaviours. She has published over 100 peer-reviewed articles in this and related areas and is co-editor of The Troubled Helix (1996; paperback edition: 1999), a book reviewing the psychological implications of the new human genetics.

    Elaine McColl has a first degree in Geography and Economics and an MSc in Applied Statistics. She is a native of Dublin and worked for several years in the Department of Statistics, Trinity College, Dublin, where she taught formal courses and provided informal advice on survey design and analysis. Since 1987, she has been a member of the Centre for Health Services Research, University of Newcastle upon Tyne, where she currently holds the post of Senior Research Associate. Her main research interests are in the assessment of health-related quality of life and in survey methodology. She has recently been awarded an NHS Primary Care Career Scientist award, to develop a programme of research into quality of life in chronic disease. Elaine was principal investigator for a recently completed literature review Designing and using patient and staff questionnaires which was funded by the NHS Health Technology Assessment Programme and upon which the findings reported here are based.

    Lorna McKee is Director of Research at the Department of Management Studies, University of Aberdeen and was previously principal researcher at the Centre for Corporate Strategy and Change, University of Warwick. She is joint author of Shaping Strategic Change (1992) with Andrew Pettigrew and Ewan Ferlie, and has published in an extensive range of academic and professional journals. She has recently investigated medical leadership, primary care management and biomedical innovation transfer processes in research projects funded by the ESRC, CSO and NHS. She regularly acts as a consultant to healthcare organisations across the United Kingdom, and jointly co-ordinates the Multi-Disciplinary Primary Care Leadership Programme leading the module on Developing and Leading Effective Teams.

    Martin McKee is Professor of European Public Health at the London School of Hygiene and Tropical Medicine and co-director of the School's European Centre on Health of Societies in Transition. His main research interest is health and healthcare in central and eastern Europe and the former Soviet Union, but he also has a more general interest in the interpretation and use of evidence in policy-making.

    Klim McPherson is Professor of Public Health Epidemiology in the Cancer and Public Health Unit at the London School of Hygiene and Tropical Medicine. He has written over 300 refereed papers during his 30-year career in epidemiology. His particular interests include the relationship between breast cancer and hormone supplements such as HRT and oral contraceptives, the incidence of coronary heart disease, the effects of tobacco and alcohol and the widening of public health training to include those who do not come from a conventional and traditional medical background. He is a member of the editorial board of various refereed journals, including the Journal of Epidemiology and Community Health, and his membership of different organisations includes the Board of the Faculty of Public Health Medicine and the Council of the UK Public Health Association. He has been the author and co-author of many books and book chapters such as Hormones and Cancer, ed. by O'Brien and MacLean, published by the RCOG Press (Chapter 16), a chapter in Health issues related to consumption, ed. by Ian MacDonald, published by Blackwell Science, and with Prakash Shetty, he edited Diet Nutrition and Chronic Disease, Lessons from Contrasting Worlds, published by John Wiley & Sons.

    David Moher is an Assistant Professor in the Departments of Pediatrics, Epidemiology and Community Medicine and Medicine, Faculty of Medicine, University of Ottawa, and Director, Thomas C. Chalmers Centre for Systematic Reviews at the Children's Hospital of Eastern Ontario Research Institute. During the past ten years his interests have focused on how randomised trials and meta-analyses of these studies are conducted and reported. He has been particularly interested in how biases individually and collectively influence estimates of treatment efficacy.

    Michael Moher is currently a GP and Research Fellow at the Department of Primary Health Care at the University of Oxford. He is currently involved as medical co-ordinator, in research on the evidence based secondary prevention of coronary heart disease in primary care. This research is comparing, in a randomised controlled trial, three methods of promoting secondary prevention of heart disease in primary care: audit and feedback, the introduction of structure of records, registers and recall, and the introduction of nurse-run clinics.

    Graham Mowatt has, since April 1997, been Review Group Co-ordinator for the Cochrane Effective Practice and Organisation of Care Group (EPOC). The focus of EPOC is on producing systematic reviews of interventions designed to improve health professional practice and the delivery of effective health services. This includes various forms of continuing education, quality assurance, informatics, financial, organisational and regulatory interventions that can affect the ability of health professionals to deliver services more effectively and efficiently. Prior to working on the NHS Health Technology Assessment Programme project on assessing fast-changing technologies he was employed by Grampian Health Board for four years on a health service project which was concerned with primary care technological innovation. He also possesses a Master of Business Administration (MBA) degree.

    Elizabeth Murphy is a senior lecturer in Sociology and Social Policy at the University of Nottingham. Before moving to Nottingham, she was a research fellow in the Department of Primary Medical Care at the University of Southampton. Her major research interests lie in the medical sociology and the sociology of food. Her doctoral work was concerned with the lay health concepts held by people with non-insulin-dependent diabetes and their implications for their response to medical advice about lifestyle. This interest in responses to behavioural advice has been extended in more recent studies of patients with other chronic disorders and, most recently, a study of the decisions mothers make in relation to infant feeding. While she has used both qualitative and quantitative methods in her research, she has a particular interest in the rigorous application of qualitative methods to policy and practice-related issues.

    Maggie Murphy is a lecturer in Social Psychology in the School of Humanities and Social Sciences, University of Glamorgan. Her research interests include social psychological aspects of healthcare provision and social psychological determinants of health behaviours.

    Gordon Murray is Professor of Medical Statistics at the University of Edinburgh, having previously worked at the University of Glasgow where he was Director of the Robertson Centre for Biostatistics. A mathematician by training, Professor Murray was recently elected to Fellowship of the Royal College of Physicians of Edinburgh. His main interest is in multicentre clinical trials, particularly in the cardiovascular and cerebrovascular areas. He has also worked extensively in prognostic modelling, and in the application of such methodology to permit casemix adjustment in clinical audit.

    Jonathan Myles is a statistician at the MRC Biostatistics Unit. His interests include the application of Bayesian statistics to medicine including the use of Markov Chain Monte Carlo for complex models in epidemiology and population genetics, the assessment of breast cancer screening effectiveness, and problems in AIDS epidemiology.

    Dianne O'Connell is a biostatistician with a strong interest in evidence based medicine. She was a Senior Brawn Research Fellow for two years (1997–99), and is now a Senior Research Academic in the Discipline of Clinical Pharmacology, Faculty of Medicine and Health Sciences, University of Newcastle, Australia. Her research interests are in methods for conducting systematic reviews and methods for translating the results of medical research (in particular randomised controlled trials and systematic reviews) into information that can readily be used in clinical decision-making and policy formulation. This work includes developing methods for identifying in which individuals an intervention is more likely to do good than harm (the topic of Chapter 4) and the effects of information framing (how the data about an intervention's effectiveness are presented) on clinical decision-making.

    Ba’ Pham is a biostatistician with the Thomas C. Chalmers Centre for Systematic Reviews and an associate member of the Children's Hospital of Eastern Ontario Research Institute. His main research interest is to perform empirical studies evaluating statistical methods used to estimate the risks and benefits of healthcare interventions.

    Robin Prescott is Director of the Medical Statistics Unit at the University of Edinburgh and has research interests in clinical trials stretching back for 30 years. He has particular interests in the application of mixed models in medicine and in the methodology associated with cross-over trials.

    James Raftery is Director of Health Economics Facility and Professor of Health Economics at the Health Services Management Centre (HSMC), University of Birmingham. He joined HSMC to become director of the Health Economics Facility in 1996. Before moving to HSMC, James worked at the Wessex Institute for Research and Development and for Wandsworth Health Authority. He has also worked on secondment as an economic adviser to the Department of Health and to the National Casemix Office. James’ current projects include: involvement in several health technology evaluations (anti-coagulation clinics, chondrocyte implantation, stroke services); analysis of the public expenditure impact of new health technologies; the use of routine data in health technology assessment (a national R&D project); and methods of costing diseases, interventions and programmes. He has also edited a series on economic evaluation for the British Medical Journal. Other recent publications include the three volume series: Health care needs assessment: the epidemiologically based needs assessment reviews. First and second series, which were edited by Andrew Stevens and James Raftery.

    Barnaby Reeves is Senior Lecturer in Epidemiology and Director of the Clinical Effectiveness Unit at the Royal College of Surgeons. Following a doctorate in Experimental Psychology, he worked on the development and evaluation of psychophysical tests in ophthalmology for several years. His interest in healthcare evaluation led him to study epidemiology, following which he was appointed as a senior lecturer in health services research at the University of Bristol. In this post, he designed and set up a wide range of evaluations, including surgical procedures, physiotherapy, nursing, rehabilitation and educational interventions. His main interests are: use of non-randomised or hybrid designs for evaluating interventions, especially surgery, the measurement of the quality of healthcare provision and evaluations of diagnostic accuracy.

    Glenn Robert is currently Research Fellow at the Health Services Management Centre, University of Birmingham. Previous to this he was a Research Fellow in the Health Economics Research Group at Brunel University and a researcher at the National Co-ordinating Centre for Health Technology Assessment at the University of Southampton. His recently submitted PhD thesis examines the use of different sources for identifying new healthcare technologies prior to their widespread adoption by the NHS, and makes recommendations regarding the establishment and operation of an early warning system in the United Kingdom.

    Paul Roderick trained in general medicine and then public health medicine. He has been senior lecturer in Public Health Medicine at Southampton University since 1993. His main research interests are in evaluating the equity and effectiveness of healthcare delivery, and in defining the epidemiology of chronic renal failure. He is a member of the Steering Committee of the UK Renal Registry.

    Sue Ross co-ordinated/edited Chapter 3, ‘Factors That Limit the Number, Progress and Quality of Randomized Controlled Trials: a Systematic Review’ on behalf of a large group of authors. Sue has worked as a health services researcher for 12 years. She is currently Co-ordinator of Clinical Research at Mount Sinai Hospital, Toronto. At the time the review was carried out, she was Trials Programme Co-ordinator in the Health Services Research Unit at the University of Aberdeen, managing a programme of health technology evaluation trials, mainly in surgery and orthopaedics. Prior to that she had been involved in surgical and primary care trials.

    Daphne Russell is a biostatistician based in North Yorkshire. She was educated at the Universities of Cambridge (graduating in Mathematics and Mathematical Statistics) and Aberdeen (Public Health). She has held academic appointments in the Universities of Essex, Newcastle upon Tyne, Aberdeen and Hull (as Director of the University Statistical Support Unit).

    Ian Russell has been Founding Professor of Health Sciences at the University of York since 1995. He was educated at the Universities of Cambridge (graduating in Mathematics), Birmingham (Statistics) and Essex (Health Services Research). He has held academic appointments in the Universities of Newcastle upon Tyne, North Carolina, Aberdeen (as Director of the Scottish Health Services Research Unit) and Wales (while Director of R&D for NHS Wales).

    Colin Sanderson is Reader is Health Services Research (HSR) at the London School of Hygiene and Tropical Medicine. He has a background in operational research and epidemiology, and has been involved in HSR for over 15 years. His research interests include monitoring quality of care, quantitative modelling for policy evaluation, equitable allocation of healthcare resources and needs assessment.

    Jasminka Sarunac obtained a Bachelor of Pharmacy at the University of Belgrade. He went on to be a pharmacist and subsequently Director of the Pharmacy Department at Clinical Centre Dr Lj. D. Kraljevo in Yugoslavia. He has completed a postgraduate course of Clinical Pharmacy Practice and has a Master of Medical Science in Pharmaco-epidemiology Studies from the University of Newcastle, NSW, Australia. He has published work on “GPs’ beliefs regarding benefits and risks of Hormone Replacement Therapy: Does framing of information affect enthusiasm for prescribing HRT”. He is currently employed by the Pharmacy Department at John Hunter Hospital, Newcastle, Australia in the capacity of Hospital Pharmacist. His areas of research interest include prescribing practices and evidence based medicine.

    Trevor Sheldon is Professor and Head of the Department of Health Studies at the University of York and co-director of the York Health Policy Group. He trained in medicine, economics and medical statistics. His main research interests are in resource allocation, healthcare quality, the organisation and delivery of healthcare, and the evaluation of healthcare interventions. He was director of the NHS Centre for Reviews and Dissemination at the University of York from 1993–1998 and manager of the Effective Health Care bulletins.

    Sue Shepherd is currently a Specialist Registrar in Public Health Medicine, and her special interests are Communicable Disease and Health Needs Assessments. Prior to this she was a Clinical Lecturer in Epidemiology. She has been involved with large epidemiological studies and is presently a co-grant holder in a randomised controlled trial looking at radiotherapy in older women with early breast cancer.

    Fujian Song has an MD in public health medicine (China) and a PhD in health services studies (Leeds). He is a senior research fellow at the NHS Centre for Reviews and Dissemination at the University of York. Current areas of work interests include methodology of systematic reviews and evaluation of healthcare interventions.

    Jennifer Soutter has a first degree in English and Psychology; her PhD is titled ‘Archetypal Elements in the Poetry of Sylvia Plath’. Returning to work after completing six years of higher education, she has worked in health services research for the past ten years, over six of these years being at the Centre for Health Services Research at the University of Newcastle upon Tyne. Her current post is as research associate at the Department of Child Health at the Royal Victoria Infirmary working on a project with children diagnosed with Duchenne muscular dystrophy. This links with work carried out with children with life-limiting illnesses some six years ago.

    David Spiegelhalter is a Senior Scientist at the MRC Biostatistics Unit in Cambridge. His current interests include the development and dissemination of Bayesian methods in biostatistics, including applications in health technology assessment and the analysis of performance indicators. He has published widely on Bayesian theory and applications, and has been instrumental in the development of the BUGS and WinBUGS software for Bayesian analysis using graphical models and Markov Chain Monte Carlo methods.

    Nick Steen is a medical statistician based at the Centre for Health Services Research at the University of Newcastle upon Tyne with special interests in the design and analysis of cluster randomised trials and the development of health outcome measures. He is currently involved with a number of trials involving the assessment of health technology.

    Jonathan Sterne is a Senior Lecturer in Medical Statistics in the Department of Social Medicine at the University of Bristol. His research interests include methods to detect bias in meta-analysis and systematic reviews, the use of statistical methods for the analysis of clustered and longitudinal data, and the epidemiology of asthma and allergic diseases.

    Andrew Stevens (editor) is Professor of Public Health and Head of Department in the Department of Public Health and Epidemiology at the University of Birmingham, England. His interests concern health technology assessment, evidence based healthcare, and needs assessment. He is (co-)director of the National Horizon Scanning Centre, providing advance notice of new medical innovations to government; and a founder member of Euro-Scan, a collaborative healthcare horizon scanning group across Europe and Canada. He edits a series of publications on Health Care Needs Assessment and has established a Health Care Evaluation Service which reviews, models cost-utility and appraises the evidence on new and existing health technologies. He was formerly the first Director of the National Co-ordinating Centre for Health Technology Assessment at Southampton University.

    Alex Sutton is a Lecturer in Medical Statistics at the University of Leicester. His research interests encompass several aspects of systematic review methodology, including the use of Bayesian methods; methods for addressing publication bias; and methods for the synthesis of results from studies with different designs. He is an active member of the Cochrane Collaboration, contributing to both the statistical and non-randomised studies methods groups.

    Hilary Thomas is a Lecturer in the Department of Sociology, University of Surrey. She is President of the European Society of Health and Medical Sociology (1999–2003). Her research interests include the sociology of health and illness, reproduction and women's health, and the sociology of time.

    Lois Thomas is a Senior Research Associate at the Centre for Health Services Research and the Department of Epidemiology and Public Health at the University of Newcastle upon Tyne. A nurse by background, her research interests are in stroke, user satisfaction and evidence based practice.

    Roger Thomas is a Research Director in the Survey Methods Centre of the National Centre for Social Research (formerly SCPR) and also Director of the ESRC-funded Centre for Applied Social Surveys (CASS). He has more than 30 years’ experience as a quantitative social survey project designer and manager in many different topic areas. Much of this was in Social Survey and Census Divisions of the Office for National Statistics, where he was assistant director responsible for survey methodology and also for the design and conduct of major government suveys. In the Survey Methods Centre he acts as consultant on survey design problems, works on methodological research projects and writes on survey methods. As Director of CASS he teaches survey methods courses at postgraduate level and heads a team which develops and disseminates a Social Survey Question Bank, containing examples and commentary on questionnaire design, on the World Wide Web.

    Jim Thornton is Reader in Obstetrics and Gynaecology at Leeds University, and honorary consultant at Leeds General Infirmary. He qualified in medicine in Leeds in 1977, and worked for four years in Africa before training as a specialist. He has organised and participated in trials of many pregnancy interventions, and is currently principal investigator of the MRC Growth Restriction Intervention Trial (GRIT). Since 1997 he has been Chairman of Northern and Yorkshire Multicentre Research Ethics Committee. He is an advocate of free-market solutions to healthcare problems, and was in the news in 1999 for suggesting that much NHS health screening would be better done privately!

    Joy Townsend is a health economist and statistician, director of the Centre for Research in Primary and Community Care and Professor of Primary Healthcare. For many years she was senior scientist with the Medical Research Council. Her major interests are in prioritisation of research using ex ante modelling of health benefits and costs, randomised controlled trials of new health services and economics of tobacco control.

    Peter Tugwell joined the University of Ottawa as Chairman of the Department of Medicine and as Physician-in-Chief at the Ottawa General Hospital (now the Ottawa Hospital) in July 1991. He is the author/co-author of over 170 published articles, which focus principally on technology assessment and the clinical epidemiology of the rheumatic diseases. He is actively involved in several international organisations. He is the editor of the Musculoskeletal review group within the International Cochrane Collaboration Centre. His research interests are in the areas of clinical epidemiology, quality of life, economic evaluation, and technology assessment both within the context of industrialised countries as well as developing countries.

    Obioha C. Ukoumunne obtained an MSc in Social Research Methods and Statistics from City University in 1994. He has worked as a Research Statistician at the Department of Medical Statistics and Evaluation, within Imperial College School of Medicine since 1997. His chief research interest is in methods appropriate for the design and analysis of cluster randomised trials. His experience of applied medical statistics is mainly in the fields of psychiatry and general practice. His previous research posts were at the Department of General Practice and the Department of Public Health Sciences, both within GKT School of Medicine. Work on Chapter 17 was completed whilst based at the Department of Public Health Sciences.

    Marjon van der Pol is an economist who works for the Health Economics Research Unit at the University of Aberdeen.

    Sarah Walker is currently a Research Officer at the Office for National Statistics where she is working with others on improving the coverage of the next UK Population Census. She was a Research Assistant in the Medical Statistics and Computing Department at the University of Southampton and undertook a years’ research into ‘Sample size determination for quality of life measures’. She investigated QoL measures commonly used with cancer patients which generated categorical responses. She also worked on a variety of clinical trials and survival analyses. Her research interests are still in medical analysis, particularly in the field of disability and housing which, at present, she undertakes on a consultancy or voluntary basis.


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