Deficiencies in reporting of statistical methodology in recent randomized trials of nonpharmacologic pain treatments: ACTTION systematic review

Journal of Clinical Epidemiology

Volumn 72, Issue , 2016, Pages 56-65

  Dworkin, Jordan D ^a   McKeown, Andrew ^b   Farrar, John T ^a   Gilron, Ian ^c   Hunsinger, Matthew ^d   Kerns, Robert D ^e   McDermott, Michael P ^f   Rappaport, Bob A ^g   Turk, Dennis C ^h   Dworkin, Robert H ^f   Gewandter, Jennifer S ^f  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b CITY UNIVERSITY OF NEW YORK   (United States)

^c QUEEN S UNIVERSITY   (Canada)

^d PACIFIC UNIVERSITY   (United States)

^e VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^f UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^g University of Washington ^*  (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Clinical trials; Missing data; Multiplicity; Nonpharmacologic trials; Prespecification; Reporting

Indexed keywords

ANALGESIC AGENT;

ACUPUNCTURE; ARTICLE; COGNITIVE THERAPY; HEALTH CARE QUALITY; HUMAN; MASSAGE; OUTCOME VARIABLE; PAIN; PHYSIOTHERAPY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL ANALYSIS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; ANALGESIA; FEMALE; MALE; NEEDS ASSESSMENT; PAIN MEASUREMENT; PROCEDURES; RESEARCH; SEVERITY OF ILLNESS INDEX; STATISTICS;

FEMALE; HUMANS; MALE; NEEDS ASSESSMENT; PAIN; PAIN MANAGEMENT; PAIN MEASUREMENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH REPORT; SEVERITY OF ILLNESS INDEX; STATISTICS AS TOPIC;

EID: 84961052436     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2015.10.019     Document Type: Article

References (33)

1. T.R. Fleming Clinical trials: discerning hype from substance Ann Intern Med 153 2010 400 406
2. J.P. Ioannidis Why most published research findings are false PLos Med 2 2005 e124
3. R.J. Little, R. D'Agostino, M.L. Cohen, K. Dickersin, S.S. Emerson, J.T. Farrar, and et al. The prevention and treatment of missing data in clinical trials N Engl J Med 367 2012 1355 1360
4. National Research Council The prevention and treatment of missing data in clinical trials 2010 Available at http://www.nap.edu/catalog/12955.html. Accessed November 30, 2015
5. R.T. O'Neill Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance Control Clin Trials 18 1997 550 556
6. S.J. Pocock, M.D. Hughes, and R.J. Lee Statistical problems in the reporting of clinical trials. A survey of three medical journals N Engl J Med 317 1987 426 432
7. D.C. Turk, R.H. Dworkin, M.P. Mcdermott, N. Bellamy, L.B. Burke, J.M. Chandler, and et al. Analyzing multiple endpoints in clinical trials of pain treatments: IMMPACT recommendations Pain 139 2008 485 493
8. A.J. Sankoh, M.F. Huque, and S.D. Dubey Some comments on frequently used multiple endpoint adjustment methods in clinical trials Stat Med 16 1997 2529 2542
9. S. Holm A simple sequentially rejective multiple test procedure Scand J Stat 6 1979 65 70
10. Y. Hochberg A sharper Bonferroni procedure for multiple tests of significance Biometrika 75 1998 800 802
11. G. Hommel A stepwise rejective multiple test procedure based on a modified Bonferroni test Biometrika 75 1988 383 386
12. J.W. Tukey Exploratory data anlysis 1977 Addison-Wesley Reading, MA
13. C.W. Dunnett A multiple comparison procedure for comparing several treatments with a control J Am Stat Assoc 50 1955 1096 1121
14. A. Dmitrienko, B.L. Wiens, A.C. Tamhane, and X. Wang Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives Stat Med 26 2007 2465 2478
15. P. Westfall, and A. Krishen Optimal, weighted, fixed sequence, and gatekeeping multiple testing procedures J Stat Plan Infer 99 2001 25 40
16. J.S. Gewandter, M.P. McDermott, A. McKeown, S.M. Smith, J. Farrar, M. Hunsinger, and et al. Methods used to address missing data in recent analgesic clinical trials: ACTTION systematic review and recommendations Pain 155 2014 1871 1877
17. T.R. Fleming Addressing missing data in clinical trials Ann Intern Med 154 2011 113 117
18. R.J. Little, and D. Rubin Statistical analysis with missing data 2nd ed. 2002 John Wiley & Sons New York
19. G. Molenberghs, and M.G. Kenward Missing data in clincal studies 2007 John Wiley & Sons Chichester, UK
20. R.T. O'Neill, and R. Temple The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it Clin Pharmacol Ther 91 2012 550 554
21. European Medicines Agency. Guideline on Missing Data in Confirmatory Clinical Trials: Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/09/WC500096793.pdf. Accessed November 30, 2015
22. J.S. Gewandter, S.M. Smith, A. McKeown, L.B. Burke, S.H. Hertz, M. Hunsinger, and et al. Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations Pain 155 2014 461 466
23. R. Chou, A. Qaseem, V. Snow, D. Casey, T. Cross Jr., P. Shekelle, et al. For the Clinical Efficacy Assessment Subcommittee of the American College of Physicians and the American College of Physicians/American Pain Society Low Back Pain Guidance Panel Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society Ann Intern Med 147 2007 478 491
24. W. Hauser, K. Thieme, and D.C. Turk Guidelines on the management of fibromyalgia syndrome - a systematic review Eur J Pain 14 2010 5 10
25. Institute of Medicine Relieving pain in America: a blueprint for transforming prevention, care, education, and research 2011 The National Academies Press Washington, DC
26. M.I. Bonnett, and S.J. Closs Methodological issues in nonpharmacological trials for chronic pain Anaesth Pain Intensive Care 14 2010 49 55
27. M. Hunsinger, S.M. Smith, D. Rothstein, A. McKeown, M. Parkhurst, S. Hertz, and et al. Adverse event reporting in non-pharmacologic, non-interventional pain clinical trials: ACTTION systematic review Pain 155 2014 2252 2262
28. R.A. Moore, C. Eccleston, S. Derry, P. Wiffen, R. Bell, S. Straube, et al. for the ACTINPAIN writing group of the IASP Special Interest Group on Systematic Reviews in Pain Relief and the Cochrane Pain, Palliative and Supportive Care Systematic Review Group editors "Evidence" in chronic pain - establishing best practice in the reporting of systematic reviews Pain 150 2010 386 389
29. R.A. Moore, S. Derry, and P.J. Wiffen Challenges in design and interpretation of chronic pain trials Br J Anaesth 111 2013 38 45
30. R.A. Moore, D. Gavaghan, M.R. Tramer, S.L. Collins, and H.J. McQuay Size is everything - large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects Pain 78 1998 209 216
31. S. Morley, A. Williams, and C. Eccleston Examining the evidence about psychological treatments for chronic pain: time for a paradigm shift? Pain 154 2013 1929 1931
32. S.M. Smith, R.D. Chang, A. Pereira, N. Shah, I. Gilron, N.P. Katz, and et al. Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review Pain 153 2012 2415 2421
33. J.P. Higgins, and S. Green Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series 2008 MRC Biostatistics Unit Cambridge, UK