Outcome measures in rheumatoid arthritis randomised trials over the last 50 years

Trials

Volumn 14, Issue 1, 2013, Pages

  Kirkham, Jamie J ^a   Boers, Maarten ^b   Tugwell, Peter ^c   Clarke, Mike ^d   Williamson, Paula R ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^c UNIVERSITY OF OTTAWA   (Canada)

^d QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

COMET; Core outcome set; OMERACT; Outcome reporting bias; Rheumatoid arthritis

Indexed keywords

ACUTE PHASE PROTEIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; GLUCOCORTICOID;

ALTERNATIVE MEDICINE; ARTICLE; ASSISTIVE TECHNOLOGY; COCHRANE LIBRARY; DIET; DISEASE ACTIVITY SCORE; DRUG SCREENING; EXERCISE; HUMAN; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; WORLD HEALTH ORGANIZATION;

ARTHRITIS, RHEUMATOID; ENDPOINT DETERMINATION; EVIDENCE-BASED MEDICINE; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PREDICTIVE VALUE OF TESTS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84885027350     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-324     Document Type: Article

References (16)

1. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, von Elm E, Gamble C, Ghersi D, Ioannidis JPA, Simes J, Williamson PR. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008, 3(8):e3081. 10.1371/journal.pone.0003081, 2518111, 18769481.
2. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, Williamson PR. The impact of outcome reporting bias on systematic reviews. BMJ 2010, 340:c365. 10.1136/bmj.c365, 20156912.
3. Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials 2007, 8:39. 10.1186/1745-6215-8-39, 2169261, 18039365.
4. Williamson PR, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy 2012, 17(1):1-2.
5. Felson DT, Anderson JJ, Meenan RF. Time for changes in the design, analysis, and reprint of rheumatoid arthritis clinical trials. Arthritis Rheum 1990, 33:140-149. 10.1002/art.1780330119, 2405863.
6. Tugwell P, Boers M, Brooks P, Simon L, Strande V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007, 8:38. 10.1186/1745-6215-8-38, 2169260, 18039364.
7. Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, Smolen JS, Khaltaev N, Muirden KD. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol 1994, 21(suppl 41):86-89.
8. http://ctrc.liv.ac.uk/orbit/ (accessed 6 October 2013).
9. Van der Heijde DM, Van 't Hof MA, Van Riel PL, van de Putte LB. Development of a disease activity score based on judgement in clinical practice by rheumatologists. J Rheumatol 1993, 20:579-581.
10. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, Furst D, Goldsmith C, Kieszak S, Lightfoot R, Paulus H, Tugwell P, Weinblatt M, Widmark R, James Williams H, Wolfe F. The American college of rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The committee on outcome measures in rheumatoid arthritis clinical trials. Arthritis Rheum 1993, 36(6):729-740. 10.1002/art.1780360601, 8507213.
11. US Department of Health and Human Services, Food and Drug Administration Guidance for Industry Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) 1999, [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071579.pdf], US Department of Health and Human Services, Food and Drug Administration.
12. The European Agency for the Evaluation of Medicinal Products, Unit for the Evaluation of Medicinal Products for Human Use Guideline on Clinical Investigation of Medicinal Products other than NSAIDs for Treatment of Rheumatoid Arthritis 2003, [http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003439.pdf], The European Agency for the Evaluation of Medicinal Products, Unit for the Evaluation of Medicinal Products for Human Use.
13. Kirwan JR, Minnock P, Adebajo A, Bresnihan B, Choy E, de Wit M, Hazes M, Richard P, Saag K, Suarez-Almazor M, Wells G, Hewlett S. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol 2007, 34(5):1174-1177.
14. Schmitt J, Langan S, Stamm T, Williams HC. Core outcome domains for controlled trials and clinical recordkeeping in eczema: international multiperspective Delphi consensus process. J Invest Dermatol 2011, 131(3):623-630. 10.1038/jid.2010.303, 20944653.
15. Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials 2012, 13:103. 10.1186/1745-6215-13-103, 3433381, 22747787.
16. COMET initiative Core Outcome Measures in Effectiveness Trials [http://www.comet-initiative.org/], COMET initiative.