RT Journal Article
SR Electronic
T1 Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1962
OP 1970
DO 10.3899/jrheum.141440
VO 42
IS 10
A1 Jason W. Busse
A1 Susan J. Bartlett
A1 Maxime Dougados
A1 Bradley C. Johnston
A1 Gordon H. Guyatt
A1 John R. Kirwan
A1 Kent Kwoh
A1 Lara J. Maxwell
A1 Andrew Moore
A1 Jasvinder A. Singh
A1 Randall Stevens
A1 Vibeke Strand
A1 Maria E. Suarez-Almazor
A1 Peter Tugwell
A1 George A. Wells
YR 2015
UL http://www.jrheum.org/content/42/10/1962.abstract
AB Objective. Pain is a patient-important outcome, but current reporting in randomized controlled trials and systematic reviews is often suboptimal, impeding clinical interpretation and decision making.Methods. A working group at the 2014 Outcome Measures in Rheumatology (OMERACT 12) was convened to provide guidance for reporting treatment effects regarding pain for individual studies and systematic reviews.Results For individual trials, authors should report, in addition to mean change, the proportion of patients achieving 1 or more thresholds of improvement from baseline pain (e.g., ≥ 20%, ≥ 30%, ≥ 50%), achievement of a desirable pain state (e.g., no worse than mild pain), and/or a combination of change and state. Effects on pain should be accompanied by other patient-important outcomes to facilitate interpretation. When pooling data for metaanalysis, authors should consider converting all continuous measures for pain to a 100 mm visual analog scale (VAS) for pain and use the established, minimally important difference (MID) of 10 mm, and the conventionally used, appreciably important differences of 20 mm, 30 mm, and 50 mm, to facilitate interpretation. Effects ≤ 0.5 units suggest a small or very small effect. To further increase interpretability, the pooled estimate on the VAS should also be transformed to a binary outcome and expressed as a relative risk and risk difference. This transformation can be achieved by calculating the probability of experiencing a treatment effect greater than the MID and the thresholds for appreciably important differences in pain reduction in the control and intervention groups.Conclusion. Presentation of relative effects regarding pain will facilitate interpretation of treatment effects.