TY - JOUR
T1 - Optimal strategies for reporting pain in clinical trials and systematic reviews
T2 - Recommendations from an OMERACT 12 workshop
AU - Busse, Jason W.
AU - Bartlett, Susan J.
AU - Dougados, Maxime
AU - Johnston, Bradley C.
AU - Guyatt, Gordon H.
AU - Kirwan, John R.
AU - Kwoh, Kent
AU - Maxwell, Lara J.
AU - Moore, Andrew
AU - Singh, Jasvinder A.
AU - Stevens, Randall
AU - Strand, Vibeke
AU - Suarez-Almazor, Maria E.
AU - Tugwell, Peter
AU - Wells, George A.
N1 - Publisher Copyright:
Copyright © 2015. All rights reserved.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - 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.
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.
KW - Clinical trials
KW - OMERACT
KW - Outcomes
KW - Pain
KW - Systematic reviews
KW - Visual analog scale
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U2 - 10.3899/jrheum.141440
DO - 10.3899/jrheum.141440
M3 - Article
AN - SCOPUS:84943230116
SN - 0315-162X
VL - 42
SP - 1962
EP - 1970
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 10
ER -