Supplement 9
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Proceedings of the Royal College of Physicians of Edinburgh Supplement No. 9 Clinical effectiveness, clinical guidelines and clinical standards ‘from history to the future’ Papers from a symposium held on 11 May 2000 2001 Volume 31 and a conference held on 3 November 2000 CONTENTS ...................................... 1 Preface N. Finlayson 2 Clinical effectiveness 2000: an overview A. Walker 9 The scientific basis of clinical effectiveness: setting the scene C. Warlow 13 Sharp end experience J.A. Grant 16 Economics-based medicine: an evolving paradigm A. Maynard 18 The relationship of the Health Technology Board to the science of clinical effectiveness A.V.P. Mackay 21 Industrial experience and case studies of intelligent decision support systems J.R. McDonald, S.D.J. McArthur 26 Reducing errors in medical practice: barriers to monitoring clinical performance G.D. Murray 28 The public, the physician and the patient I. Watt 31 Scientific basis of clinical effectiveness – professionalism in practice P.W. Brunt 34 Quality of hospital care: measuring patients’ experiences A. Coulter 39 Evidence-based medicine: a historical and international overview S. Woolf 42 The history of clinical effectiveness U. Tröhler 46 Tackling bias in assessing the effects of health care interventions: early contributions from James Lind, Alexander Lessassier Hamilton and T. Graham Balfour I. Milne, I. Chalmers 49 The Scottish Intercollegiate Guidelines network (SIGN): developing national guidelines to an international methodology J. Miller 52 The establishment of the National Institute for Clinical Excellence (NICE) P. Littlejohns 57 Council of Europe – guideline development in Europe M. Mäkelä 59 The German Guidelines Clearing house (GGC) – rationale, aims and results G. Ollenschläger, H. Kirchner, U. Oesingmann, F.W. Kolkmann, R. Kunz 65 Advances in systematic review methods A. Grant 68 Economic analysis within national guidelines J. Mason, M. Eccles 72 Evidence-based implementation of evidence-based guidelines J. Grimshaw, A. Walker 74 From evidence-based medicine to clinical standards D.R. Steel Supplement number 9 Publication number 71 ISSN 0953-0932 Clinical effectiveness, clinical guidelines and clinical standards ‘from history to the future’ Papers from a symposium held on 11 May 2000 and a conference held on 3 November 2000 at the Royal College of Physicians of Edinburgh Editorial and Production Team: G. McAlister Head of Publications A. Borthwick Publications Officer A. Wood Assistant Publications Officer E. Clifford Publications Assistant © Royal College of Physicians of Edinburgh 2001. All rights reserved. No part of this publication may be produced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photo- copying or otherwise, without the prior permission of the Editor, Royal College of Physicians of Edinburgh, 9 Queen Street, Edinburgh EH2 1JQ. Papers from the symposium on the scientific basis of clinical effectiveness held on 11 May 2000 at the Royal College of Physicians of Edinburgh Organised by the Royal Society of Edinburgh and the Royal College of Physicians of Edinburgh with support from the Clinical Resource and Audit Group (CRAG) Papers from the conference on clinical effectiveness, clinical guidelines and clinical standards ‘from history to the future’ held on 3 November 2000 at the Royal College of Physicians of Edinburgh Organised by the Royal College of Physicians of Edinburgh in collaboration with the Scottish Intercollegiate Guidelines Network (SIGN) with support from the Clinical Resource and Audit Group (CRAG) Acknowledgements The Royal College of Physicians of Edinburgh would like to thank: Sheikh Al Hammadi CRAG Merck Novo Nordisk Organon Laboratories Solvay 3M Healthcare for their contribution as sponsors of the conference held on 3 November 2000 and also: CRAG The Royal Society of Edinburgh for their support of the symposium held on 11 May 2000 ORGANISING COMMITTEE FOR SYMPOSIUM HELD ON 11 MAY 2000 Professor Gordon Lowe Assessor, the Royal College of Physicians of Edinburgh Professor John Beck Programme Convener, the Royal Society of Edinburgh Dr Jill Pell Consultant in Public Health Medicine, Greater Glasgow Health Board Professor Jeremy Grimshaw Dean of the Faculty of Medicine, University of Sheffield Professor Iain Bouchier Formerly Chief Scientist, Scotland ORGANISING COMMITTEE FOR CONFERENCE HELD ON 3 NOVEMBER 2000 Professor Gordon Lowe Assessor, the Royal College of Physicians of Edinburgh Professor Jeremy Grimshaw Programme Director, Health Services Research Unit, University of Aberdeen Professor James Petrie President, the Royal College of Physicians of Edinburgh Ms Juliet Miller Director of SIGN PREFACE PREFACE Biomedical information continues to accumulate rapidly, group data, are translated into the best clinical standards and it is not surprising that there is now a demand that for an individual patient. This may be the most difficult the fruits of this research should be reflected in improved step of all, requiring that we produce doctors with the clinical care for patients. The notion that medical practice necessary knowledge of guidelines and the wisdom and should be based on evidence of the clinical effectiveness compassion to apply them to individuals. We hope readers of different treatment options can be seen as a response will benefit from the wealth of information in this to this demand, and Evidence Based Medicine (EBM) is supplement, and we are grateful to Anne Walker for now challenging medical practice based on patho- producing a masterly overview2 which we recommend to physiological theory and personal clinical experience. The readers as their starting point. development of EBM is not, however, either simple or straightforward; there are problems of patchy availability NF of reliable information, even for common diseases; differences of opinion regarding the methodology for bringing information together into evidence-based recommendations; the place of clinical effectiveness, REFERENCES irrespective of cost; the necessity for cost-effectiveness in 1 Tröhler U. “To Improve the Evidence of Medicine”. The 18th a world of limited resources; the place of equity in century British origins of a critical approach. Edinburgh: Royal determining care; and the mechanisms for producing valid College of Physicians of Edinburgh; 2000. 2 guidelines and standards for clinical practice. Furthermore, Walker A. Clinical effectiveness 2000: an overview. This supplement, pp. 2-6. the problems do not cease with the production of high quality guidelines or the definition of clinical standards. It is necessary for guidelines to be easily implemented; evidence of implementation (Evidence Based Implementation) should be demonstrated and resources for education and audit to underpin this needs to be allocated. The RCPE was founded to promote the highest standards of clinical practice and, given the importance of promoting and implementing clinical effectiveness in achieving this end, the College hardly needs to explain two meetings on this subject in one year. Indeed, Fellows of the College such as Charles Lind, Alexander Hamilton and Thomas Balfour were important in producing reliable evidence for medical practice based on sound methods in the eighteenth and nineteenth centuries, long before our current notions of EBM. The College and our then President, Jim Petrie, recognised that EBM had reached a stage where progress could best be facilitated by bringing acknowledged experts in this field together. The College therefore welcomed an approach from the Royal Society of Edinburgh proposing a joint conference on the scientific basis of clinical effectiveness. Our second conference, on the clinical application of EBM, coincided with publication by the College of the book “To Improve the Evidence of Medicine”. The 18th century origins of a critical approach.1 This allowed us to set the conference’s deliberations in the context of an historical continuum whilst highlighting current (and future) developments in clinical effectiveness, clinical guidelines and clinical standards which concern all health care professionals. The College’s ultimate interest in standards of medical practice focuses on the care given to individual patients by individual doctors. ‘Progress’ with EBM needs to take this into account and requires that guidelines, based on 1 CLINICAL EFFECTIVENESS CLINICAL EFFECTIVENESS 2000: AN OVERVIEW* A. Walker, Senior Research Fellow, Health Services Research Unit, University of Aberdeen SCIENTIFIC BASIS OF CLINICAL EFFECTIVENESS biopsychosocial models that take a holistic view of the Clinical effectiveness at the sharp end patient are more appropriate. The challenge here is to Evidence-based practice implies that decisions about create a science base (and implementation strategy) that treatment options will depend largely on evidence of their supports decision-making without losing the ‘whole person clinical effectiveness. Developing and using this evidence approach’ that is the cornerstone of high quality general practice. is not always straightforward, however. Professor Charles Warlow from the Department of Clinical Neurosciences From clinical effectiveness to evidence-based prioritisation at the Western General Hospital in Edinburgh argued that Concern about rising health care costs has been a major while scientific evidence of clinical effectiveness is growing, impetus behind the rise of evidence-based practice. there are numerous gaps. For some health