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J Clin Epidemiol. 2017 Apr;84:85-94. doi: 10.1016/j.jclinepi.2017.02.005. Epub 2017 Feb 27.

Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.

Journal of clinical epidemiology

Ian J Saldanha, Tianjing Li, Cui Yang, Jill Owczarzak, Paula R Williamson, Kay Dickersin

Affiliations

  1. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room W6507-B, Baltimore, MD 21205, USA. Electronic address: [email protected].
  2. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6011, Baltimore, MD 21205, USA.
  3. Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, 2213 McElderry Street, 2nd floor, Baltimore, MD 21205, USA.
  4. Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Room 739, Baltimore, MD 21205, USA.
  5. MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Shelley's Cottage, Brownlow Street, Liverpool L69 3GS, UK.
  6. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6152, Baltimore, MD 21205, USA.

PMID: 28249722 PMCID: PMC5441957 DOI: 10.1016/j.jclinepi.2017.02.005

Abstract

BACKGROUND: The usefulness of clinical trials and systematic reviews is compromised when they report different outcomes. We compared outcomes in reviews of HIV/AIDS and the trials included in the reviews.

STUDY DESIGN AND SETTING: We examined all Cochrane reviews of HIV/AIDS (as of June 2013) that included ≥1 trial and the trials that the reviews included. We compared outcomes within subgroups defined by type of intervention: clinical management, biomedical prevention, behavioral prevention, and health services.

RESULTS: We included 84 reviews that encompassed 524 trials. Although the median number of outcomes per trial (8) and per review (7.5) was similar, the trials reported a considerably greater number of unique outcomes than the reviews (779 vs. 218), ranging from 2.3 times greater (clinical management) to 5.4 times greater (behavioral prevention). High proportions of trial outcomes were not in any review: 68% (clinical management) to 83% (behavioral prevention). Lower proportions of review outcomes were not in any trial: 11% (clinical management) to 39% (health services).

CONCLUSION: Outcomes in trials and reviews are not well aligned for appropriate inclusion of trial results in reviews and meta-analyses. Differences in perspectives, goals, and constraints between trialists and reviewers may explain differences in outcomes they consider important.

Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Keywords: Clinical trials; Core outcome sets; HIV/AIDS; Outcome selection; Outcomes; Systematic reviews

References

  1. PLoS One. 2010 Mar 22;5(3):e9810 - PubMed
  2. Am Heart J. 2011 Sep;162(3):412-24 - PubMed
  3. JAMA. 2004 May 26;291(20):2457-65 - PubMed
  4. Trials. 2012 Aug 06;13:132 - PubMed
  5. BMJ. 2015 Jan 26;350:h72 - PubMed
  6. Mayo Clin Proc. 2011 Apr;86(4):304-14 - PubMed
  7. JAMA. 2007 Feb 7;297(5):468-70 - PubMed
  8. Clin Trials. 2010 Feb;7(1):19-35 - PubMed
  9. Ann Intern Med. 2015 Feb 17;162(4):287-94 - PubMed
  10. PLoS One. 2013 Jul 05;8(7):e66844 - PubMed
  11. BMJ. 2010 Feb 15;340:c365 - PubMed
  12. PLoS One. 2014 Jun 16;9(6):e99111 - PubMed
  13. Stat Med. 2001 Dec 15;20(23):3539-56 - PubMed
  14. Clin Trials. 2016 Aug;13(4):379-81 - PubMed
  15. Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000005 - PubMed
  16. J Clin Epidemiol. 2015 Mar;68(3):237-45 - PubMed
  17. J Clin Epidemiol. 2016 Feb;70:164-75 - PubMed
  18. Trials. 2013 Jan 22;14:21 - PubMed
  19. PLoS One. 2014 Oct 16;9(10):e109400 - PubMed
  20. Clin Trials. 2016 Aug;13(4):372-8 - PubMed
  21. Trials. 2016 Apr 26;17 (1):213 - PubMed
  22. J Comp Eff Res. 2016 Mar;5(2):193-205 - PubMed
  23. Syst Rev. 2016 Jan 20;5:11 - PubMed
  24. Syst Rev. 2012 Feb 21;1:15 - PubMed

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