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Gewandter JS, Eisenach JC, Gross RA, et al. Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT. Pain Rep. 2017;4(3):e621doi: 10.1097/PR9.0000000000000621.
Gewandter, J. S., Eisenach, J. C., Gross, R. A., Jensen, M. P., Keefe, F. J., Lee, D. A., & Turk, D. C. (2019). Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT. Pain reports, 4(3), e621. https://doi.org/10.1097/PR9.0000000000000621
Gewandter, Jennifer S, et al. "Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT." Pain reports vol. 4,3 (2019): e621. doi: https://doi.org/10.1097/PR9.0000000000000621
Gewandter JS, Eisenach JC, Gross RA, Jensen MP, Keefe FJ, Lee DA, Turk DC. Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT. Pain Rep. 2019 May-Jun;4(3):e621. doi: 10.1097/PR9.0000000000000621. Epub 2017 Sep 13. PMID: 28989992; PMCID: PMC5625298.
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Pain Rep. 2019 May-Jun;4(3):e621. doi: 10.1097/PR9.0000000000000621. Epub 2017 Sep 13.

Checklist for the preparation and review of pain clinical trial publications: a pain-specific supplement to CONSORT.

Pain reports

Jennifer S Gewandter, James C Eisenach, Robert A Gross, Mark P Jensen, Francis J Keefe, David A Lee, Dennis C Turk

Affiliations

  1. Department of Anesthesiology, University of Rochester, Rochester, NY.
  2. Departments of Anesthesiology and Physiology & Pharmacology, Wake Forest, Winston-Salem, NC.
  3. Departments of Neurology and Pharmacology & Physiology, University of Rochester, Rochester, NY.
  4. Department of Rehabilitation Medicine, University of Washington, Seattle, WA.
  5. Department of Psychiatry and Behavioral Science and Department Psychology and Neuroscience, Duke University, Durham NC.
  6. Seattle, WA.
  7. Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA.

PMID: 28989992 PMCID: PMC5625298 DOI: 10.1097/PR9.0000000000000621

Abstract

INTRODUCTION: Randomized clinical trials (RCTs) are considered the gold standard when assessing the efficacy of interventions because randomization of treatment assignment minimizes bias in treatment effect estimates. However, if RCTs are not performed with methodological rigor, many opportunities for bias in treatment effect estimates remain. Clear and transparent reporting of RCTs is essential to allow the reader to consider the opportunities for bias when critically evaluating the results. To promote such transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) group has published a series of recommendations starting in 1996. However, a decade after the publication of the first CONSORT guidelines, systematic reviews of clinical trials in the pain field identified a number of common deficiencies in reporting (e.g., failure to identify primary outcome measures and analyses, indicate clearly the numbers of participants who completed the trial and were included in the analyses, or report harms adequately).

METHODS: Qualitative review of a diverse set of published recommendations and systematic reviews that addressed the reporting of clinical trials, including those related to all therapeutic indications (e.g., CONSORT) and those specific to pain clinical trials.

RESULTS: A checklist designed to supplement the content covered in the CONSORT checklist with added details relating to challenges specific to pain trials or found to be poorly reported in recent pain trials was developed.

CONCLUSIONS: Authors and reviewers of analgesic RCTs should consult the CONSORT guidelines and this checklist to ensure that the issues most pertinent to pain RCTs are reported with transparency.

Conflict of interest statement

Conflict of interest statement The views expressed in this article are those of the authors and no official endorsement by the Food and Drug Administration (FDA) or the pharmaceutical and device compa

References

  1. Pain. 2015 Dec;156(12):2616-26 - PubMed
  2. J Am Dent Assoc. 2015 Apr;146(4):246-54.e6 - PubMed
  3. Pain. 2005 Jan;113(1-2):9-19 - PubMed
  4. Pain. 2015 Aug;156(8):1382-95 - PubMed
  5. Pain. 2012 Jun;153(6):1148-58 - PubMed
  6. BMJ. 2010 Mar 23;340:c869 - PubMed
  7. J Public Health Dent. 2011 Winter;71(s1):S52-S63 - PubMed
  8. Ann Intern Med. 2001 Apr 17;134(8):657-62 - PubMed
  9. Pain. 2013 Jul;154(7):997-1008 - PubMed
  10. Pain. 2014 Sep;155(9):1871-7 - PubMed
  11. JAMA. 2010 May 26;303(20):2058-64 - PubMed
  12. J Biopharm Stat. 2006 May;16(3):275-83; discussion 285-91, 293-8, 311-2 - PubMed
  13. Ann Intern Med. 1986 Sep;105(3):429-35 - PubMed
  14. Pain. 2012 Dec;153(12):2415-21 - PubMed
  15. Clin J Pain. 2009 Nov-Dec;25(9):797-807 - PubMed
  16. J Rheumatol. 1991 May;18(5):728-33 - PubMed
  17. J Pain. 2015 Jan;16(1):3-10 - PubMed
  18. PLoS Med. 2005 Aug;2(8):e124 - PubMed
  19. BMJ. 2004 May 8;328(7448):1135-6; author reply 1136 - PubMed
  20. Ann Intern Med. 1994 Aug 1;121(3):200-6 - PubMed
  21. J Rheumatol. 1988 Dec;15(12):1833-40 - PubMed
  22. Pain. 2008 Oct 31;139(3):485-93 - PubMed
  23. Ann Intern Med. 2004 Nov 16;141(10):781-8 - PubMed
  24. Clin J Pain. 2015 Jul;31(7):599-602 - PubMed
  25. BMJ. 2001 Jul 7;323(7303):42-6 - PubMed
  26. Neurology. 2005 Dec 29;65(12 Suppl 4):S32-49 - PubMed
  27. Pain. 2014 Mar;155(3):461-6 - PubMed
  28. JAMA. 1995 Feb 1;273(5):408-12 - PubMed
  29. BMJ. 1995 Aug 19;311(7003):485 - PubMed
  30. Arch Intern Med. 1985 Apr;145(4):709-12 - PubMed
  31. Stat Med. 2006 May 30;25(10):1628-38 - PubMed
  32. J Pain. 2015 Apr;16(4):299-305 - PubMed
  33. J Clin Epidemiol. 2016 Apr;72:56-65 - PubMed
  34. Pain. 2014 Sep;155(9):1683-95 - PubMed
  35. Pain. 2008 Apr;135(3):217-20 - PubMed
  36. JAMA. 2012 Dec 26;308(24):2594-604 - PubMed
  37. Pain. 2014 Nov;155(11):2253-62 - PubMed
  38. Pain. 2014 Dec;155(12):2714-9 - PubMed
  39. Pain. 2016 May;157(5):1056-64 - PubMed

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