Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop
Related Experiment Video
Updated: Apr 12, 2026
Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery
Published on: April 14, 2016
Jason W Busse1,2, Susan J Bartlett3,4, Maxime Dougados3,4
1From the Michael G. DeGroote Institute for Pain Research and Care, McMaster University; Department of Anesthesia, McMaster University; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario; Department of Medicine, McGill University, Divisions of Rheumatology and Clinical Epidemiology, Royal Victoria Hospital, Montreal, Quebec, Canada; Paris Descartes University, APHP Cochin Hospital, Rheumatology Department, Cochin Hospital, INSERM (U1153) Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité, Paris, France; The Hospital for Sick Children Research Institute, Toronto; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto; Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; University of Pittsburgh and Veterans Affairs (VA) Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, USA; Institute of Population Health, University of Ottawa, Ottawa, Ontario, Canada; Pain Research, University of Oxford, Nuffield Division of Anaesthetics, The Churchill, Oxford, UK; Birmingham VA Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; Inflammation and Immunology Clinical Research, Celgene Corporation, Summit, New Jersey; Department of Medicine, Division of Rheumatology, the State University of New Jersey, New Brunswick, New Jersey; Division of Immunology/Rheumatology, Stanford University, Palo Alto, California; University of Texas MD Anderson Cancer Center, Houston, Texas, USA; Department of Medicine, Faculty of Medicine, Institute of Population Health, University of Ottawa; Ottawa Hospital Research Institute, Clinical Epidemiology Program; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada. bussejw@mcmaster.ca.
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.
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