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

By Tamar Pincus, Clare Miles, Robert J. Froud, Martin Underwood, Dawn Carnes and Stephanie J. C. Taylor

Abstract

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

Topics: R1
Publisher: BioMed Central Ltd.
Year: 2011
OAI identifier: oai:wrap.warwick.ac.uk:34575

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  1. (2002). Agras WS: Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry doi
  2. (2008). 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 doi
  3. (2010). Altman DG: CONSORT doi
  4. (2005). CA: Effect size and power in assessing moderating effects of categorical variables using multiple regression: a 30-year review. doi
  5. (2009). CG: A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther doi
  6. (1993). CM: Statistical difficulties of detecting interactions and moderator effects. Psychol Bull doi
  7. (1986). DH: Physician ratings of appropriate indications for six medical and surgical procedures. doi
  8. (2007). Drazen JM: Statistics in medicine – reporting of subgroup analyses in clinical trials. doi
  9. (1987). effect size, and power in moderated regression analysis. doi
  10. (2007). GC: Some methodological and statistical issues in the study of change processes in psychotherapy. Clin Psychol Rev doi
  11. (1998). Moderator search in meta-analysis: A review and cautionary note on existing approaches. doi
  12. (2005). Moderators and mediators of behavioral treatment for headache. Headache doi
  13. (2009). Reviews and Dissemination: Systematic reviews: CRD’s guidance for undertaking reviews in health care. [Internet] doi
  14. (2009). S: Cochrane Handbook for Systematic Reviews of Interventions. doi
  15. (2001). Subgroup analyses in randomised controlledd trials: Quantifying the risks of false-positives and false-negatives. Health Technol Assess doi
  16. (2000). Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet doi
  17. (2004). TD: The power of statistical tests for moderators in meta-analysis. Psychol Methods doi
  18. (2009). Tenhave T: Mediation analysis: a retrospective snapshot of practice and more recent directions. doi
  19. (2003). Testing mediational models with longitudinal data: questions and tips in the use of structural equation modeling. doi
  20. (1986). The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol doi
  21. (2001). The Rand/UCLA appropriateness method user’s manual.
  22. (2008). Thorlund K: Attention should be given to multiplicity issues in systematic reviews. doi
  23. (2008). Toward non-parametric and clinically meaningful moderators and mediators. Stat Med doi
  24. (2009). updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa doi
  25. (2002). V: A comparison of methods to test mediation and other intervening variable effects. Psychol Methods doi

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