′This handbook is an excellent reflection of the growing maturity and methodological sophistication of the field of Health Technology Assessment. The
Handbook covers a spectrum of issues, from primary evidence (clinical trials) through reviews and meta-analysis, to identifying and filling gaps in the evidence. Up-to-date, clearly written, and well-edited, the handbook is a needed addition to any personal or professional library dealing with Health Technology Assessment.′
Professor David Banta, TNO Prevention and Health, The Netherlands
′This text presents the most advanced knowledge on methodology in health care research, and will form the backbone of many future studies′ – Paula Roberts, Nurse Researcher
The `effectiveness revolution′ both in research and clinical practice, has tested available methods for health services research to the extreme. How far can observational methods, routine data and qualitative methods be used in health care evaluation? What cost and outcome measures are appropriate, and how should data be gathered?
With the support of over two million pounds from the British Health Technology Assessment Research Programme, the research project for this Handbook has led to both a synthesis of all of the existing knowledge in these areas and an agenda for future debate and research.
The chapters and their authors have been selected through a careful process of peer review and provide a coherent and complete approach to the field. The handbook has been a unique collaboration between internationally regarded clinicians, statisticians, epidemiologists, social scientists, health economists and ethicists. It provides the most advanced thinking and the most authoritative resource for a state of the art review of methods of evaluating health care and will be required reading for anyone involved in health services research and management.
Inhoudsopgave
Introduction
Methods in Evidence Based Healthcare and Health Technology Assessment – An Overview
PART ONE: CLINICAL TRIALS
Introduction – Richard J Lilford and Andrew Stevens
Ethical Issues in the Design and Conduct of Randomized Controlled Trials – Richard J Lilford, Sarah Edwards, David Braunholtz, Jennifer Jackson, Jim Thornton and Jenny Hewison
Ethics of Clinical Trials – Richard E Ashcroft
Social, Cultural and Economic Factors
Factors That Limit the Number, Progress and Quality of Randomized Controlled Trials – Sue Ross, Carl Counsell, William J Gillespie, Adrian Grant, Robin Prescrott, Ian Russell, Iain Colthart, Sandra Kiauka, Daphne Russell and Sue Shepard
A Systematic Review
Results of Clinical Trials and Systematic Reviews – Dianne O′Connell, Paul P Glasziou, Suzanne Hill, Jasminka Sarunac, Julia Lowe and David Henry
To Whom Do They Apply?
The Placebo Effect – Rosemary Crow, Heather Gage, Sarah E Hampson, Jo Hart, Alan C Kimber and Hilary Thomas
Methodological Process and Implications of a Structured Review
PART TWO: OBSERVATIONAL AND QUALITATIVE METHODS
Introduction – Ray Fitzpatrick
Randomized and Non-Randomized Studies – Colin Sanderson, Martin Mc Kee, Annie Britton, Nicholas Black, Klim Mc Pherson and Chris Bain
Threats to Internal and External Validity
A Review of Observational, Quasi-Experimental and Randomized Study Designs for the Evaluation of the Effectiveness of Healthcare Interventions – Barnaby Reeves, Rachel Mac Lehose, Ian Harvey, Trevor Sheldon, Ian Russell and Andrew Mc Laren Spiers Black
The Potential Use of Routine Data Sets in Health Technology Assessment – James Raftery, Andrew Stevens and Paul Roderick
Using Routine Data to Complement and Enhance the Results of Randomized Controlled Trials – James Lewsey, Gordon Murray, Alastair H Leyland and Andrew Boddy
Qualitative Methods in Health Technology Assessment – Elizabeth Murphy and Robert Dingwall
PART THREE: MEASUREMENT OF BENEFIT AND COST
Introduction – John Brazier
Criteria for Assessing Patient-Based Outcome Measures for Use in Clinical Trials – Ray Fitzpatrick, Claire Davey, Martin Buxton and David Jones
The Use of Health Status Measures in Economic Evaluation – John Brazier, Mark Deverill and Colin Green
Collecting Resource Use Data for Costing in Clinical Trials – Katharine Johnstone, Martin Buxton, David Jones and Ray Fitzpatrick
Eliciting Time Preferences for Health – John Cairns and Marjon van der Pol
The Conduct and Design of Questionnaire Surveys in Healthcare Research – Elaine Mc Coll, Ann Jacoby, Lois Thomas, Jennifer Soutter, Claire Bamford, Nick Steen, Roger Thomas, Emma Harvey, Andrew Garratt and John Bond
PART FOUR: ANALYTICAL METHODS
Introduction – Keith R Abrams
Bayesian Methods – David Spiegelhalter, Jonathan Myles, David Jones and Keith Abrams
Methods for Evaluating Organization or Area-Based Health Interventions – Martin Gulliford, Obioha C Ukoummunne, Susan Chinn, Jonathan Sterne, Peter Burney and Allan Donner
Handling Uncertainty in Economic Evaluation – Andrew Briggs and Alastair Gray
A Review of the Use of the Main Quality of Life Measures, and Sample Size Determination for Quality of Life Measures, Particularly in Cancer Trials – Michael Campbell, Steven A Julious, Sarah Walker, Steve George and David Machin
Simultaneous Assessment of Quality of Life and Survival Data – Lucinda Billingham, Keith Abrams and David Jones
PART FIVE: CONSENSUS, REVIEWS AND META-ANALYSIS
Introduction – Andrew Stevens and Keith R Abrams
Publication and Related Biases – Fuijan Song, Alison Eastwood, Simon Gilbody, Lelia Buley and Alex Sutton
Meta-Analysis in Health Technology Assessment – Alexander Sutton, David Jones, Keith Abrams, Trevor Sheldon and Fujian Song
Assessing the Quality of Reports of Randomized Trials Included in Meta-Analyses – David Moher, Terry Klassen, Alison Jones Ba′Pham, Deborah Cook, Alejandro Jada, Peter Tugwell and Michael Moher
Attitudes, Practice, Evidence and Guides
Consensus Development Methods, and Their Use in Creating Clinical Guidelines – Nick Black, Maggie Murphy, Donna Lamping, Martin Mc Kee, Colin Sanderson, Janet Askham and Theresa Marteau
PART SIX: IDENTIFYING AND FILLING GAPS IN THE EVIDENCE
Introduction – Andrew Stevens
Identifying New Health Care Technologies – Glenn Robert, Andrew Stevens and John Gabbay
Timing of Assessment of Fast-Changing Health Technologies – Graham Mowatt, Adrian Grant, D Jane Bower, John A Brebner, John Cairns and Lorna Mc Kee
Preliminary Economic Evaluation of Health Technologies – Gareth Harper, Joy Townsend and Martin Buxton
Over de auteur
John Brazier is Professor of Health Economics at the Health Economics and Decision Science section of the School of Health and Related Research at the University of Sheffield. He has more than 20 years’ experience of conducting economic evaluations of health care interventions for policy makers. He has also undertaken numerous economic evaluations alongside clinical trials and decision analytic models. He has a particular interest in the measurement and valuation of health for economic evaluation where he has published widely. He is perhaps best known for his work in developing a preference-based measure of health for the SF-36, but more recently has extended these methods to a number of specific condition including measures in asthma, cancer, overactive bladder, dementia and epilepsy. More recently he has been developing ways to incorporate equity concerns such as burden of disease into the weights applied to QALYs for Value Based Pricing. He is Director of an Economic Evaluation Policy Research Unit (EEPRU) that is funded by the Department of Health in England. He was a member of the National Institute for Clinical Excellence (NICE) Technology Appraisal Committee from 2000-2004 and is a member of the Working Group on revising Methods of Economic Evaluation for Technology Appraisal in 2012.
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