The Library

Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials : a consensus study

Tools

Pincus, Tamar, Miles, Clare, Froud, Robert J., Underwood, M. (Martin) M.D., Carnes, Dawn and Taylor, Stephanie J. C.. (2011) Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials : a consensus study. BMC Medical Research Methodology, Vol.11 . Article:14. ISSN 1471-2288

Preview

PDF
WRAP_Underwood_methodological_criteria.pdf - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Download (434Kb)

Official URL: http://dx.doi.org/10.1186/1471-2288-11-14

Abstract

Background: Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. Method: We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers’ Handbook, and the process was repeated. Results: The recommendations are that meta-analysts report both confirmatory and exploratory findings for subgroups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based apriori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. Conclusions: There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Clinical trials, Systematic reviews (Medical research) -- Methodology
Journal or Publication Title:	BMC Medical Research Methodology
Publisher:	BioMed Central Ltd.
ISSN:	1471-2288
Date:	31 January 2011
Volume:	Vol.11
Page Range:	Article:14
Identification Number:	10.1186/1471-2288-11-14
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	National Institute for Health Research (Great Britain) (NIHR), Advantage West Midlands (AWM), Birmingham Science City
Grant number:	RP-PG-0707-10189 (NIHR)
References:	1. Kraemer HC, Wilson GT, Fairburn CG, Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry 2002, 59(10):877-883. 2. Higgins JPT, Green S: Cochrane Handbook for Systematic Reviews of Interventions. Version 502 [updated September 2009] 2009, The Cochrane Collaboration, 2009. 3. Bender R, Bunce C, Clarke M, Gates S, Lange S, Pace NL, Thorlund K: Attention should be given to multiplicity issues in systematic reviews. J Clin Epidemiol 2008, 61(9):857-865. 4. Baron RM, Kenny DA: The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol 1986, 51(6):1173-1182. 5. Laurenceau JP, Hayes AM, Feldman GC: Some methodological and statistical issues in the study of change processes in psychotherapy. Clin Psychol Rev 2007, 27(6):682-695. 6. McClelland GH, Judd CM: Statistical difficulties of detecting interactions and moderator effects. Psychol Bull 1993, 114(2):376-390. 7. MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V: A comparison of methods to test mediation and other intervening variable effects. Psychol Methods 2002, 7(1):83-104. 8. Viswesvaran C, Sanchez JI: Moderator search in meta-analysis: A review and cautionary note on existing approaches. Educational and Psychological Measurement 1998, 58(1):77-87. 9. Cole DA, Maxwell SE: Testing mediational models with longitudinal data: questions and tips in the use of structural equation modeling. J Abnorm Psychol 2003, 112(4):558-577. 10. Gelfand LA, Mensinger JL, Tenhave T: Mediation analysis: a retrospective snapshot of practice and more recent directions. J Gen Psychol 2009, 136(2):153-176. 11. Kraemer HC: Toward non-parametric and clinically meaningful moderators and mediators. Stat Med 2008, 27(10):1679-1692. 12. Champoux J, Peters W: Form, effect size, and power in moderated regression analysis. Journal of Occupational and Organizational Psychology 1987, 60:243-255. 13. Aguinis H, Beaty JC, Boik RJ, Pierce CA: Effect size and power in assessing moderating effects of categorical variables using multiple regression: a 30-year review. J Appl Psychol 2005, 90(1):94-107. 14. Hedges LV, Pigott TD: The power of statistical tests for moderators in meta-analysis. Psychol Methods 2004, 9(4):426-445. 15. Edwards JR, Lambert LS: Methods for integrating moderation and mediation: a general analytical framework using moderated path analysis. Psychol Methods 2007, 12(1):1-22. 16. Nicholson RA, Hursey KG, Nash JM: Moderators and mediators of behavioral treatment for headache. Headache 2005, 45(5):513-519. 17. Hancock M, Herbert RD, Maher CG: A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther 2009, 89(7):698-704. 18. Furlan AD, Pennick V, Bombardier C, van Tulder M: 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 2009, 34(18):1929-1941. 19. Fitch K: The Rand/UCLA appropriateness method user’s manual. Santa Monica: Rand, c2001 1991. 20. Park RE, Fink A, Brook RH, Chassin MR, Kahn KL, Merrick NJ, Kosecoff J, Solomon DH: Physician ratings of appropriate indications for six medical and surgical procedures. Am J Public Health 1986, 76(7):766-772. 21. Fitch K, Bernstein SJ, Aguilar MD, Burnand B, La-Calle J, Lazaro P, van het Loo M, McDonnell J, Vader J, Kahan JP: The RAND/UCLA Appropriateness Method User’s Manual. RAND, Santa Monica. 2001. 22. Taylor WJ, Schumacher HR Jr, Baraf HS, Chapman P, Stamp L, Doherty M, McQueen F, Dalbeth N, Schlesinger N, Furst DE, et al: A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout. Ann Rheum Dis 2008, 67(6):888-891. 23. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey-Smith G: Subgroup analyses in randomised controlledd trials: Quantifying the risks of false-positives and false-negatives. Health Technol Assess 2001, 5(33). 24. Centre for Reviews and Dissemination: Systematic reviews: CRD’s guidance for undertaking reviews in health care. [Internet] York: University of York 2009 [http://www.york.ac.uk/inst/crd/pdf/Systematic_Reviews.pdf], accessed 20/04/10. 25. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010. 26. Assmann SF, Pocock SJ, Enos LE, Kasten LE: Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000, 25(355 (9209)):1064-1069. 27. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM: Statistics in medicine – reporting of subgroup analyses in clinical trials. N Engl J Med 2007, 357:2189-2194. 28. Rothwell PM: Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005, 365(9454):176-186.
URI:	http://wrap.warwick.ac.uk/id/eprint/34575