The Advanced Handbook of Methods in Evidence Based Healthcare

'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.

Table of Contents:
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 McKee, Annie Britton, Nicholas Black, Klim McPherson 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 MacLehose, Ian Harvey, Trevor Sheldon, Ian Russell and Andrew McLaren 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 McColl, 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 McKee, 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 McKee Preliminary Economic Evaluation of Health Technologies - Gareth Harper, Joy Townsend and Martin Buxton