Journal of Clinical Epidemiology
Volume 54, Issue 7 , Pages 651-654 , July 2001

The art of quality assessment of RCTs included in systematic reviews

  • Arianne P Verhagen

      Affiliations

    • Department of Epidemiology, Maastricht University, Maastricht, The Netherlands
    • Department of General Practice, Erasmus University Rotterdam, Rotterdam, The Netherlands
    • Corresponding Author InformationCorresponding author. Department of General Practice, Erasmus University Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, the Netherlands. Tel.: +31 10 408 8109; fax: +31 10 408.9491.(A.P. Verhagen)
    • ,
  • Henrica C.W de Vet

      Affiliations

    • Department of Epidemiology, Maastricht University, Maastricht, The Netherlands
    • Institute of Extramural Medicine, Vrije Universiteit, Amsterdam, The Netherlands
    • ,
  • Robert A de Bie

      Affiliations

    • Department of Epidemiology, Maastricht University, Maastricht, The Netherlands
    • ,
  • Maarten Boers

      Affiliations

    • Department of Clinical Epidemiology, Vrije Universiteit, University Hospital, Amsterdam, The Netherlands
    • ,
  • Piet A van den Brandt

      Affiliations

    • Department of Epidemiology, Maastricht University, Maastricht, The Netherlands

Received 4 January 2000 ,Revised 3 October 2000 ,Accepted 23 October 2000.

References 

  1. Cook DJ, Sackett DL, Spitzer WO. Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam consultation on meta-analysis. J Clin Epidemiol. 1995;48:167–171
  2. Oxman AD, Guyatt GH. Validation of an index of the quality of review articles. J Clin Epidemiol. 1991;44:1271–1278
  3. 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). Control Clin Trials. 1995;16:62–73
  4. The SoRTG . A proposal for structured reporting of randomized controlled trials. JAMA. 1994;272:1926–1931
  5. Chalmers TC, Smith H, Blackburn B, Silverman B, Schoeder B, Reitman D. A method for assessing the quality of a randomized control trial. Control Clin Trials. 1980;2:31–49
  6. Colditz GA, Miller JN, Mosteller F. How study design affects outcomes in comparisons of therapy (I). Medical Stat Med. 1989;8:441–454
  7. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Cavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials (is blinding necessary?). Control Clin Trials. 1996;17:1–12
  8. Verhagen AP, de-Vet HCW, de-Bie RA, Kessels AGH, Boers M, Bouter LM, et al. The Delphi list (a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by delphi consensus). J Clin Epidemiol. 1998;51:1235–1241
  9. Begg C, Cho M, Eastwood S, Harton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–639
  10. Moher D, Jadad AR, Tugwell P. Assessing the quality of randomized controlled trials. Current issues and future directions. Intern J Tech Asses Health Care. 1996;12:195–208
  11. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimesions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273:408–412
  12. Assendelft WJ, Koes BW, van der Heijden GJ, Bouter LM. The efficacy of chiropractic manipulation for back pain (blinded review of relevant randomized clinical trials). J Manipulative Physiol Ther. 1992;15:487–494
  13. de Bie RA. Methodology of systematic reviews (an introduction). Phys Ther Rev. 1996;1:47–51
  14. Jüni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282:1054–1060
  15. Riet G ter, Kleijnen J, Knipschild P. Acupuncture and chronic pain (a criteria-based meta-analysis). J Clin Epidemiol. 1990;43:1191–1199
  16. Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homoeopathy [published erratum appears in BMJ 1991;302(6780):818. BMJ. 1991;302:316–323
  17. Emerson JD, Burdick E, Hoaglin DC, Mosteller R, Chalmers TC. An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Control Clin Trials. 1990;11:339–352
  18. Bender JS, Halpern SH, Thangaroopan M, Jadad AR, Ohlsson A. Quality and retrieval of obstetrical anaesthesia randomized controlled trials. Can J Anaesth. 1997;44:14–18
  19. Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy and quality assessment (interobserver reliability of the Maastricht criteria list and the need for blinded quality assessment). J Clin Epidemiol. 1998;51:335–341
  20. Clark HD, Wells GA, Huet C, McAlister FA, Salmi LR, Fergusson D, et al. Assessing the quality of randomized trials (reliability of the Jadad scale). Control Clin Trials. 1999;20:448–452
  21. Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials (survey of published parallel group trials in obstetrics and gynaecology). BMJ. 1996;312:742–744
  22. Grimes DA, Schulz KF. Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology. Am J Obstet Gynecol. 1996;174:1312–1315
  23. Evans M, Pollock AV. Trials on trial (a review of trials of antibiotic prophylaxis). Arch Surg. 1984;119:109–113
  24. Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990;335:149–153
  25. Horton R, Smith R. Time to register randomised trials. The case is now unanswerable. BMJ. 1999;319:865–866
  26. Horton R, Smith R. Time to register randomised trials. Lancet. 1999;354:1138–1139
  27. Gerbarg ZB, Horwitz RI. Resolving conflicting clinical trials (guidelines for meta analysis). J Clin Epidemiol. 1988;41:503–509
  28. Sacks HS, Berrier J, Reitman D, Ancona BVA, Chalmers TC. Special article (meta-analysis of randomized controlled trials). N Engl J Med. 1987;316:450–455
  29. Jadad AR, Moher D, Klassen TP. Guides for reading and interpreting systematic reviews (II. How did the authors find the studies and assess their quality?). Arch Pediatr Adolesc Med. 1998;152:812–817
  30. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet. 1998;352:609–613
  31. Greenland S. Invited commentatory (a critical look at some popular meta-analytic methods). Am J Epidemiol. 1994;140:290–296
  32. Detsky AS, Naylor CD, Rourke K, McGeer AJ, L'Abbe KA. Incorporating variations in the quality of individual randomized trials into meta-analysis. J Clin Epidemiol. 1992;45:255–265
  33. Koes BW, van Tulder MW, van der Windt WM, Bouter LM. The efficacy of back schools (a review of randomized clinical trials). J Clin Epidemiol. 1994;47:851–862
  34. Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine. 1996;21:2860–2871
  35. Jenicek M. Meta-analysis in medicine (where we are and where we want to go). J Clin Epidemiol. 1989;42:35–44
  36. Linde K, Scholz M, Ramirez G, Clausius N, Melchart D, Jonas WB. Impact of study quality on outcome in placebo-controlled trials of homeopathy. J Clin Epidemiol. 1999;52:631–636
  37. Kunz R, Oxman AD. The unpredictability paradox (review of empirical comparisons of randomised and non-randomised clinical trials). BMJ. 1998;317:1185–1190

PII: S0895-4356(00)00360-7

Journal of Clinical Epidemiology
Volume 54, Issue 7 , Pages 651-654 , July 2001

Article Tools