Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations

Pain

Volumn 157, Issue 11, 2016, Pages 2544-2551

  Gewandter, Jennifer S ^a   McDermott, Michael P ^a   McKeown, Andrew ^b   Hoang, Kim ^a   Iwan, Katarzyna ^a   Kralovic, Sarah ^a   Rothstein, Daniel ^c   Gilron, Ian ^d   Katz, Nathaniel P ^e,f   Raja, Srinivasa N ^g   Senn, Stephen ^h   Smith, Shannon M ^a   Turk, Dennis C ⁱ   Dworkin, Robert H ^a  

^a UNIVERSITY OF ROCHESTER   (United States)

^b CITY UNIVERSITY OF NEW YORK   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d QUEEN S UNIVERSITY   (Canada)

^e Analgesic Solutions   (United States)

^f TUFTS UNIVERSITY   (United States)

^g JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h LUXEMBOURG INSTITUTE OF HEALTH   (Luxembourg)

ⁱ UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Chronic pain; Clinical trial reporting; Cross over trials

Indexed keywords

ANALGESIC AGENT;

ARTICLE; CHRONIC PAIN; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); CROSSOVER PROCEDURE; DIABETIC NEUROPATHY; EXPERIMENTAL PAIN; HUMAN; META ANALYSIS (TOPIC); MUSCULOSKELETAL PAIN; NEUROPATHIC PAIN; OSTEOARTHRITIS; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; PRACTICE GUIDELINE; PRIORITY JOURNAL; SELF REPORT; STUDY DESIGN; SYSTEMATIC REVIEW; ANIMAL; FACTUAL DATABASE; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA;

ANALGESICS; ANIMALS; CHRONIC PAIN; CROSS-OVER STUDIES; DATABASES, FACTUAL; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TRANSLATIONS;

EID: 84992656222     PISSN: 03043959     EISSN: 18726623     Source Type: Journal    
DOI: 10.1097/j.pain.0000000000000673     Document Type: Article

References (21)

1. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988;15:1833-40.
2. Breivik H, Eisenberg E, O'Brien T. The individual and societal burden of chronic pain in Europe: the case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health 2013;13:1229.
3. Consort. Extensions of the CONSORT statement. Available at: http:// www. consort-statement. org/extensions. Accessed November 24, 2015.
4. Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Farrar JT, Katz NP, Lin AH, Rappaport BA, Rowbotham MC. Assay sensitivity and study features in neuropathic pain trials: An ACTTION meta-analysis. Neurology 2013;81:67-75.
5. Dworkin RH, Turk DC, Peirce-Sandner S, He H, McDermott MP, Hochberg MC, Jordan JM, Katz NP, Lin AH, Neogi T, Rappaport BA, Simon LS, Strand V. Meta-analysis of assay sensitivity and study features in clinical trials of pharmacologic treatments for osteoarthritis pain. Arthritis Rheumatol 2014;66:3327-36.
6. Elbourne DR, Altman DG, Higgins JP, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol 2002;31:140-9.
7. Elzahaf RA, Tashani OA, Unsworth BA, Johnson MI. The prevalence of chronic pain with an analysis of countries with a Human Development Index less than 0. 9: A systematic review without meta-analysis. Curr Med Res Opin 2012;28:1221-9.
8. Freeman PR. The performance of the two-stage analysis of twotreatment, two-period crossover trials. Stat Med 1989;8:1421-32.
9. Gewandter JS, Dworkin RH, Turk DC, McDermott MP, Baron R, Gastonguay MR, Gilron I, Katz NP, Mehta C, Raja SN, Senn S, Taylor C, CowanP, Desjardins P, Dimitrova R, Dionne R, Farrar JT, HewittDJ, Iyengar S, Jay GW, Kalso E, Kerns RD, Leff R, Leong M, Petersen KL, Ravina BM, RauschkolbC, Rice AS, RowbothamMC, Sampaio C, Sindrup SH, Stauffer JW, Steigerwald I, Stewart J, Tobias J, Treede RD, Wallace M, White RE. Research designs for proof-of-concept chronic pain clinical trials: IMMPACT recommendations. PAIN 2014;155:1683-95.
10. Gewandter JS, McDermott MP, McKeown A, Smith SM, Williams MR, Hunsinger M, Farrar J, Turk DC, Dworkin RH. Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations. PAIN 2014; 155:1871-7.
11. Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health 2011;11:770.
12. Jones B, Kenward MG. Design and analysis of cross-over trials. Boca Raton, London, New York, Washington: Chapman & Hall/CRC, 2003.
13. Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, FrangakisC, Hogan JW, MolenberghsG, Murphy SA, Neaton JD, Rotnitzky A, ScharfsteinD, ShihWJ, Siegel JP, SternH. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012;367:1355-60.
14. Mills EJ, Chan AW, Wu P, Vail A, Guyatt GH, Altman DG. Design, analysis, and presentation of crossover trials. Trials 2009;10:27.
15. Molenberghs G, Kenward MG. Missing data in clincal studies. Chichester: John Wiley and Sons, 2007.
16. Rosenkranz GK. Analysis of cross-over studies with missing data. Stat Methods Med Res 2015;24:420-33.
17. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152:726-32.
18. Senn S. Cross-over trials in clinical research. 2nd ed. Chichester: John Wiley & Sons, Ltd, 2002.
19. Senn SJ. Problems with the two stage analysis of crossover trials. Br J Clin Pharmacol 1991;32:133.
20. Senn SJ. Turning a blind eye: Authors have blinkered view of blinding. BMJ 2004;328:1135-6; author reply 1136.
21. Straube S, Werny B, Friede T. A systematic review identifies shortcomings in the reporting of crossover trials in chronic painful conditions. J Clin Epidemiol 2015;68:1496-503.