Evidence-based medical monitoring

Transcription

1 Evidence-based medical monitoring From principles to practice Edited by Paul P. Glasziou Professor of Evidence-Based Medicine Centre for Evidence-Based Medicine Les Irwig Professor of Epidemiology Screening and Test Evaluation Program Sydney, Jeffrey K. Aronson Reader in Clinical Pharmacology

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3 Evidence-based medical monitoring From principles to practice

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5 Evidence-based medical monitoring From principles to practice Edited by Paul P. Glasziou Professor of Evidence-Based Medicine Centre for Evidence-Based Medicine Les Irwig Professor of Epidemiology Screening and Test Evaluation Program Sydney, Jeffrey K. Aronson Reader in Clinical Pharmacology

6 C 2008 by Blackwell Publishing BMJ Books is an imprint of the BMJ Publishing Group Limited, used under licence Blackwell Publishing, Inc., 350 Main Street, Malden, Massachusetts , USA Blackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK Blackwell Publishing Asia Pty Ltd, 550 Swanston Street, Carlton, Victoria 3053, The right of the Author to be identified as the Author of this Work has been asserted in accordance with the Copyright, Designs and Patents Act All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. First published Library of Congress Cataloging-in-Publication Data Evidence-based medical monitoring : from principles to practice / edited by Paul Glasziou, Jeffrey Aronson, Les Irwig. p. ; cm. ISBN (pbk. : alk. paper) 1. Patient monitoring. 2. Chronic diseases Treatment. 3. Evidence-based medicine. I. Glasziou, Paul, 1954 II. Aronson, J. K. III. Irwig, Les. [DNLM: 1. Chronic Disease therapy. 2. Aftercare methods. 3. Aftercare trends. 4. Evidence-Based Medicine methods. 5. Evidence Based Medicine trends. WT 500 E ] RT48.55.E dc ISBN: A catalogue record for this title is available from the British Library Set in 9.5/12pt Meridien by Aptara Inc., New Delhi, India Printed and bound in Singapore by COS Printers Pte Ltd Commissioning Editor: Mary Banks Editorial Assistant: Victoria Pittman Development Editor: Simone Dudziak Production Controller: Rachel Edwards For further information on Blackwell Publishing, visit our website: The publisher s policy is to use permanent paper from mills that operate a sustainable forestry policy, and which has been manufactured from pulp processed using acid-free and elementary chlorine-free practices. Furthermore, the publisher ensures that the text paper and cover board used have met acceptable environmental accreditation standards. Blackwell Publishing makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always check that any product mentioned in this publication is used in accordance with the prescribing information prepared by the manufacturers. The author and the publishers do not accept responsibility or legal liability for any errors in the text or for the misuse or misapplication of material in this book.

7 Contents Contributors, ix Part 1 The Theory of Monitoring INTRODUCTORY MATERIAL 1 An introduction to monitoring therapeutic interventions in clinical practice, 3 Paul P. Glasziou, Jeffrey K. Aronson 2 A framework for developing and evaluating a monitoring strategy, 15 David Mant THE MEASUREMENT 3 Developing monitoring tools: integrating the pathophysiology of disease and the mechanisms of action of therapeutic interventions, 31 Jeffrey K. Aronson, Susan Michie 4 Biomarkers and surrogate endpoints in monitoring therapeutic interventions, 48 Jeffrey K. Aronson 5 Choosing the best monitoring tests, 63 Les Irwig, Paul P. Glasziou THE CONTROL PHASES 6 Monitoring the initial response to treatment, 75 Katy Bell, Jonathan Craig, Les Irwig 7 Control charts and control limits in long-term monitoring, 90 Petra Macaskill 8 Developing a monitoring schedule: frequency of measurement, 103 Andrew J. Farmer v

8 vi Contents 9 How should we adjust treatment?, 114 Paul P. Glasziou THE PSYCHOLOGY OF MONITORING 10 Monitoring as a learning and motivational tool, 123 Susan Michie, Kirsten McCaffery, Carl Heneghan 11 Monitoring from the patient s perspective: the social and psychological implications, 140 Kirsten McCaffery, Susan Michie THE EVALUATION OF MONITORING TECHNIQUES 12 Evaluating the effectiveness and costs of monitoring, 158 Patrick M.M. Bossuyt 13 Good practice in delivering laboratory monitoring, 166 W. Stuart A. Smellie 14 Point-of-care testing in monitoring, 179 Christopher P. Price 15 Monitoring for the adverse effects of drugs, 194 Jamie J. Coleman, Robin E. Ferner, Jeffrey K. Aronson Part 2 The Practice of Monitoring 16 Monitoring diabetes mellitus across the lifetime of illness, 213 Andrew J. Farmer 17 Oral anticoagulation therapy (OAT), 229 Carl Heneghan, Rafael Perera 18 Monitoring cholesterol-modifying interventions, 245 Paul P. Glasziou, Les Irwig, Stephane Heritier 19 Monitoring levothyroxine replacement in primary hypothyroidism, 254 Andrea Rita Horvath 20 Monitoring in renal transplantation, 286 Nicholas B. Cross, Jonathan Craig 21 Monitoring in pre-eclampsia, 303 Pisake Lumbiganon, Malinee Laopaiboon 22 Monitoring in intensive care, 313 Jan M. Binnekade, Patrick M.M. Bossuyt

9 Contents vii 23 Monitoring intraocular pressure in glaucoma, 325 Les Irwig, Paul R. Healey, Jefferson D Assunção, Petra Macaskill 24 Monitoring in osteoarthritis, 335 George Peat, Mark Porcheret, John Bedson, Alison M. Ward Index, 357

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11 Contributors Jeffrey K. Aronson, MA, MBChB, DPhil, FRCP, FBPharmacolS Reader in Clinical Pharmacology John Bedson, MD MRCGP GP Research Fellow Primary Care Musculoskeletal Research Centre Keele University Keele, UK Katy Bell, MBChB, MMed(Clin Epi) Screening and Test Evaluation Program Jan M. Binnekade, RN, PhD Researcher Department of Intensive Care Academic Medical Center University of Amsterdam Amsterdam, The Netherlands Patrick M.M. Bossuyt, PhD Professor of Clinical Epidemiology Department of Clinical Epidemiology Biostatistics and Bioinformatics Academic Medical Center University of Amsterdam Amsterdam, The Netherlands Jamie J. Coleman, MBChB, MRCP (UK) Lecturer in Clinical Pharmacology Department of Clinical Pharmacology Queen Elizabeth Hospital Birmingham, UK Jonathan Craig, MBChB, FRACP, MMed (Clin Epi) PhD Senior Staff Specialist Department of Nephrology Children s Hospital at Westmead Subdean, Clinical Epidemiology Screening and Test Evaluation Program Nicholas B. Cross, MBChB, FRACP Centre for Kidney Research Children s Hospital at Westmead Screening and Test Evaluation Program Jefferson D Assunção, BEc Research Officer Screening and Test Evaluation Program Andrew J. Farmer, DM, FRCGP University Lecturer in General Practice Robin E. Ferner, MSc, MD, FRCP Director West Midlands Centre for Adverse Drug Reactions City Hospital Birmingham, UK ix

12 x Contributors Paul Glasziou, MBBS, FRACGP, PhD Professor of Evidence-based Medicine Paul R. Healey, MBBS(Hons), B(Med)Sc, MMed, FRANZCO, PhD Clinical Senior Lecturer Centre for Vision Research Carl Heneghan, MA, MRCGP Senior Clinical Research Fellow Stephane Heritier Head of Statistical Methodology The George Institute, Sydney Senior Lecturer in Biostatistics Andrea Rita Horvath, MD, PhD, FRCPath, EurClinChem Head of Clinical Chemistry Albert Szent-Györgyi Medical and Pharmacological Centre University of Szeged Szeged, Hungary Les M. Irwig, MBBCh, PhD, FFPHM Professor of Epidemiology Screening and Test Evaluation Program Malinee Laopaiboon, PhD Associate Professor Department of Biostatistics and Demography Faculty of Public Health Khon Kaen University Khon Kaen, Thailand Pisake Lumbiganon, MD, MS Professor in Obstetrics and Gynaecology Department of Obstetrics and Gynaecology Faculty of Medicine Khon Kaen University Khon Kaen, Thailand Petra Macaskill, BA, MappStat, PhD Associate Professor in Biostatistics Screening and Test Evaluation Program Kirsten McCaffery, BSc, PhD, MBPsS Senior Research Fellow Screening and Test Evaluation Program David Mant, FRCP, FRCGP, FMedSci Professor of General Practice Susan Michie, BA, MPhil, DPhil, CPsychol, FBPsS Professor of Health Psychology Department of Psychology University College London London, UK George Peat, PhD, MCSP Senior Lecturer in Clinical Epidemiology Primary Care Musculoskeletal Research Centre Keele University Keele, UK Rafael Perera, DPhil Lecturer in Medical Statistics

13 Contributors xi Mark Porcheret, MBBS, FRCGP GP Research Fellow Primary Care Musculoskeletal Research Centre Keele University Keele, UK Christopher P. Price, PhD, FRSC, FRCPath, FACB Visiting Professor in Clinical Biochemistry Department of Clinical Biochemistry W. Stuart A. Smellie Consultant Chemical Pathologist Clinical Laboratory Bishop Auckland Hospital County Durham, UK Alison M. Ward, BPsych, PhD Research Support Director

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15 PART 1 The Theory of Monitoring