It is important to recognize the studies that yield the most reliable evidence upon which to base treatment decisions. Randomized trials have a particular place in providing high-quality unbiased comparisons of different treatments, when carried out to a high methodological standard. Empirical evidence shows that such trials are not always done well, and also that poor methodology is associated with biased findings. Consumers of the published literature need to be able to recognize which trials can be trusted. Systematic reviews and meta-analyses offer an organized approach to assessing all the relevant literature on a topic, particularly when several randomized trials address the same treatment comparison. Like trials, systematic reviews and meta-analyses need to be carried out to a high standard. They offer particular potential for providing the most useful information for clinical decision making. Critical aspects of these types of study are considered in this paper.

1.
Sackett DL, Richardson WS, Rosenberg W, Haynes RB: Evidence-Based Medicine. How to Practice and Teach EBM. London: Churchill-Livingstone, 1997.
2.
Miao LL: Gastric freezing: An example of the evaluation of medical therapy by randomized clinical trials. In: Bunker JP, Barnes BA, Mosteller F (eds.). Costs, risks, and benefits of surgery. New York, Oxford University Press, 1977, pp 198–211.
3.
Medical Research Council: Streptomycin treatment of pulmonary tuberculosis. BMJ 1948;ii:769–782.
4.
Chalmers I: Unbiased, relevant, and reliable assessments in health care. BMJ 1998;317:1167–1168.
5.
Chalmers I: Assembling comparison groups to assess the effects of health care. J R Soc Med 1997;90:379–386.
6.
Jadad AR: Randomised controlled trials. London, BMJ Books, 1998.
7.
Altman DG: Randomisation. BMJ 1991;302:1481–1482.
8.
Ellenberg JH: Selection bias in observational and experimental studies. Stat Med 1994;13:557–567.
9.
Thornley B, Adams C: Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ 1998;317:1181–1184.
10.
Oxman AD, Guyatt GH: A consumer’s guide to subgroup analyses. Ann Intern Med 1992;116:78–84.
11.
Sackett DL, Haynes RB, Guyatt GH, Tugwell P: Clinical epidemiology: A basic science for clinical medicine, 2nd ed. Boston, Little Brown, 1991, pp 296.
12.
Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S: Assessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists. Controlled Clin Trials 1995;16:62–73.
13.
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds JM, Gavaghan DJ, McQuay H: Assessing the quality of reports on randomized clinical trials: Is blinding necessary? Controlled Clin Trials 1996;17:1–12.
14.
Downs SH, Black N: The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health 1998;52:377–384.
15.
Kunz R, Oxman AD: The unpredictability paradox: Review of empirical comparisons of randomised and non-randomised clinical trials. BMJ 1998;317:1185–1190.
16.
Hall JC, Mills B, Nguyen H, Hall JL: Methodologic standards in surgical trials. Surgery 1996;119:466–472.
17.
Schulz KF, Chalmers I, Grimes DA, Altman DG: Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynaecology journals. JAMA 1994;272:125–128.
18.
Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408–412.
19.
Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP: Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet 1998;352:609–613.
20.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I et al: Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637–639.
21.
Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC: A comparison of the results of meta-analyses and randomized controlled trials and recommendations of clinical experts. JAMA 1992;268:240–248.
22.
Deeks JJ: Systematic reviews of published evidence: Miracles or minefields? Ann Oncol 1998;9:703–709.
23.
D’Agostino RB, Weintraub M: Meta-analysis: A method for synthesizing research. Clin Pharmacol Ther 1995;58:605–616.
24.
Stern JM, Simes RJ: Publication bias: Evidence of delayed publication in a cohort study of clinical research projects. BMJ 1997;315:640–645.
25.
Jadad AR, Haynes RB: The Cochrane Collaboration – advances and challenges in improving evidence-based decision making. Med Decis Making 1998;18:2–9.
26.
Cochrane AL: 1931–1971: A critical review, with particular reference to the medical profession. In: Medicines for the year 2000. London, Office of Health Economics, 1979, pp 1–11.
27.
Cochrane AL. Foreword. In: Chalmers I, Enkin M, Keirse MJNC (eds). Effective care in pregnancy and childbirth. Oxford, Oxford University Press, 1989.
28.
The Cochrane Collaboration: The Cochrane Library. Issue 1. Oxford: Update Software; 1999. [Database on disk and CD-ROM Updated quarterly.]
29.
Cook DJ, Mulrow CD, Haynes RB: Systematic reviews: Synthesis of best evidence for clinical decisions. Ann Intern Med 1997;126:376–380.
30.
Bero LA, Jadad AR: How consumers and policymakers can use systematic reviews for decision making. Ann Intern Med 1997;127:37–42.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.