Jordan D Dworkin1, Andrew McKeown2, John T Farrar1, Ian Gilron3, Matthew Hunsinger4, Robert D Kerns5, Michael P McDermott6, Bob A Rappaport7, Dennis C Turk8, Robert H Dworkin9, Jennifer S Gewandter10. 1. Department of Biostatistics and Epidemiology, University of Pennsylvania, 423 Guardian Dr., Philadelphia, PA 19104, USA. 2. City University of New York-Hunter College, 695 Park Ave, New York City, NY 10065, USA. 3. Department of Anesthesiology, Queen's University, 99 University Ave, Kingston, Ontario K7L3N6, Canada. 4. School of Professional Psychology, Pacific University, 222 SE 8th Ave, Hillsboro, OR 97123, USA. 5. VA Connecticut Healthcare System, 950 Campbell Ave, West Haven, CT 06516, USA. 6. Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Rd, Rochester, NY 14642, USA; Department of Neurology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA. 7. Arlington, VA, USA. 8. Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific St, Seattle, WA 98195, USA. 9. Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA. 10. Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, 601 Elmwood Ave, Rochester, NY 14642, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu.
Abstract
OBJECTIVE: The goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage). STUDY DESIGN: Systematic review of 101 articles reporting RCTs of pain treatments that were published between January 2006 and June 2013 in the European Journal of Pain, the Journal of Pain, and Pain. SETTING: Systematic review. RESULTS: Sixty-two percent of studies identified a primary outcome variable, 46% identified a primary analysis, and of those with multiple primary analyses, only 21% adjusted for multiplicity. Slightly over half (55%) of studies reported using at least one method to accommodate missing data. Only four studies reported prespecifying at least one of these four study methods. CONCLUSION: This review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.
OBJECTIVE: The goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage). STUDY DESIGN: Systematic review of 101 articles reporting RCTs of pain treatments that were published between January 2006 and June 2013 in the European Journal of Pain, the Journal of Pain, and Pain. SETTING: Systematic review. RESULTS: Sixty-two percent of studies identified a primary outcome variable, 46% identified a primary analysis, and of those with multiple primary analyses, only 21% adjusted for multiplicity. Slightly over half (55%) of studies reported using at least one method to accommodate missing data. Only four studies reported prespecifying at least one of these four study methods. CONCLUSION: This review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.
Authors: Marina R Connolly; Jenna Y Chaudari; Ximeng Yang; Nam Ward; Rachel A Kitt; Rachel S Herrmann; Elliot J Krane; Alyssa A LeBel; Shannon M Smith; Gary A Walco; Steven J Weisman; Dennis C Turk; Robert H Dworkin; Jennifer S Gewandter Journal: J Pain Date: 2018-09-13 Impact factor: 5.820
Authors: Nathaniel Katz; Robert H Dworkin; Richard North; Simon Thomson; Sam Eldabe; Salim M Hayek; Brian H Kopell; John Markman; Ali Rezai; Rod S Taylor; Dennis C Turk; Eric Buchser; Howard Fields; Gregory Fiore; McKenzie Ferguson; Jennifer Gewandter; Chris Hilker; Roshini Jain; Angela Leitner; John Loeser; Ewan McNicol; Turo Nurmikko; Jane Shipley; Rahul Singh; Andrea Trescot; Robert van Dongen; Lalit Venkatesan Journal: Pain Date: 2021-07-01 Impact factor: 6.961
Authors: Charlotte Krahé; Marianne M Drabek; Yannis Paloyelis; Aikaterini Fotopoulou Journal: Philos Trans R Soc Lond B Biol Sci Date: 2016-10-10 Impact factor: 6.237
Authors: Jennifer S Gewandter; James C Eisenach; Robert A Gross; Mark P Jensen; Francis J Keefe; David A Lee; Dennis C Turk Journal: Pain Rep Date: 2017-09-13