Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop

Jason W Busse^{1

2}, Susan J Bartlett^{3

4}, Maxime Dougados^{3

4}, Bradley C Johnston^{3

4}, Gordon H Guyatt^{3

4}, John R Kirwan^{3

4}, Kent Kwoh^{3

4}, Lara J Maxwell^{3

4}, Andrew Moore^{3

4}, Jasvinder A Singh^{3

4}, Randall Stevens^{3

4}, Vibeke Strand^{3

4}, Maria E Suarez-Almazor^{3

4}, Peter Tugwell^{3

4}, George A Wells^{3

4}

Affiliations

¹ From 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.
² J.W. Busse, DC, PhD, Michael G. DeGroote Institute for Pain Research and Care; Department of Anesthesia, Department of Clinical Epidemiology and Biostatistics, McMaster University; S.J. Bartlett, PhD, Department of Medicine, McGill University, Divisions of Rheumatology and Clinical Epidemiology, Royal Victoria Hospital; M. Dougados, MD, Paris Descartes University, APHP Cochin Hospital; Rheumatology Department, Cochin Hospital, INSERM (U1153) Clinical Epidemiology and Biostatistics, PRES Sorbonne; B.C. Johnston, PhD, Department of Clinical Epidemiology and Biostatistics, McMaster University and Hospital for Sick Children Research Institute, Institute of Health Policy, Management and Evaluation, University of Toronto, and Department of Anesthesia and Pain Medicine, Hospital for Sick Children, University of Toronto; G.H. Guyatt, MD, MSc, Department of Clinical Epidemiology and Biostatistics, McMaster University; J.R. Kirwan, MD, FRCP, University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary; K. Kwoh, MD, University of Pittsburgh and VA Pittsburgh Healthcare System; L.J. Maxwell, MSc, Institute of Population Health, University of Ottawa; A. Moore, DSc, Pain Research, University of Oxford, Nuffield Division of Anaesthetics; J.A. Singh, MBBS, MPH, Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; R. Stevens, MD, Inflammation and Immunology Clinical Research, Celgene Corporation, and Department of Medicine, Division of Rheumatology, State University of New Jersey; V. Strand, MD, Division of Immunology/Rheumatology, Stanford University; M.E. Suarez-Almazor, MD, PhD, University of Texas, MD Anderson Cancer Center; P. Tugwell, MD, MSC, FRCPC, Department of Medicine, Faculty of Medicine, Institute of Population Health, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Department of Epidemiology and Community Medicine, University of Ottawa; G.A. Wells, PhD, Department of Epidemiology and Community Medicine, University of Ottawa. bussejw@mcmaster.ca.
³ From 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.
⁴ J.W. Busse, DC, PhD, Michael G. DeGroote Institute for Pain Research and Care; Department of Anesthesia, Department of Clinical Epidemiology and Biostatistics, McMaster University; S.J. Bartlett, PhD, Department of Medicine, McGill University, Divisions of Rheumatology and Clinical Epidemiology, Royal Victoria Hospital; M. Dougados, MD, Paris Descartes University, APHP Cochin Hospital; Rheumatology Department, Cochin Hospital, INSERM (U1153) Clinical Epidemiology and Biostatistics, PRES Sorbonne; B.C. Johnston, PhD, Department of Clinical Epidemiology and Biostatistics, McMaster University and Hospital for Sick Children Research Institute, Institute of Health Policy, Management and Evaluation, University of Toronto, and Department of Anesthesia and Pain Medicine, Hospital for Sick Children, University of Toronto; G.H. Guyatt, MD, MSc, Department of Clinical Epidemiology and Biostatistics, McMaster University; J.R. Kirwan, MD, FRCP, University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary; K. Kwoh, MD, University of Pittsburgh and VA Pittsburgh Healthcare System; L.J. Maxwell, MSc, Institute of Population Health, University of Ottawa; A. Moore, DSc, Pain Research, University of Oxford, Nuffield Division of Anaesthetics; J.A. Singh, MBBS, MPH, Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; R. Stevens, MD, Inflammation and Immunology Clinical Research, Celgene Corporation, and Department of Medicine, Division of Rheumatology, State University of New Jersey; V. Strand, MD, Division of Immunology/Rheumatology, Stanford University; M.E. Suarez-Almazor, MD, PhD, University of Texas, MD Anderson Cancer Center; P. Tugwell, MD, MSC, FRCPC, Department of Medicine, Faculty of Medicine, Institute of Population Health, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Department of Epidemiology and Community Medicine, University of Ottawa; G.A. Wells, PhD, Department of Epidemiology and Community Medicine, University of Ottawa.

PMID: 25979719
DOI: 10.3899/jrheum.141440

Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop

Jason W Busse et al. J Rheumatol. 2015 Oct.

. 2015 Oct;42(10):1962-1970.

doi: 10.3899/jrheum.141440. Epub 2015 May 15.

Authors

Affiliations

¹ From 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.
² J.W. Busse, DC, PhD, Michael G. DeGroote Institute for Pain Research and Care; Department of Anesthesia, Department of Clinical Epidemiology and Biostatistics, McMaster University; S.J. Bartlett, PhD, Department of Medicine, McGill University, Divisions of Rheumatology and Clinical Epidemiology, Royal Victoria Hospital; M. Dougados, MD, Paris Descartes University, APHP Cochin Hospital; Rheumatology Department, Cochin Hospital, INSERM (U1153) Clinical Epidemiology and Biostatistics, PRES Sorbonne; B.C. Johnston, PhD, Department of Clinical Epidemiology and Biostatistics, McMaster University and Hospital for Sick Children Research Institute, Institute of Health Policy, Management and Evaluation, University of Toronto, and Department of Anesthesia and Pain Medicine, Hospital for Sick Children, University of Toronto; G.H. Guyatt, MD, MSc, Department of Clinical Epidemiology and Biostatistics, McMaster University; J.R. Kirwan, MD, FRCP, University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary; K. Kwoh, MD, University of Pittsburgh and VA Pittsburgh Healthcare System; L.J. Maxwell, MSc, Institute of Population Health, University of Ottawa; A. Moore, DSc, Pain Research, University of Oxford, Nuffield Division of Anaesthetics; J.A. Singh, MBBS, MPH, Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; R. Stevens, MD, Inflammation and Immunology Clinical Research, Celgene Corporation, and Department of Medicine, Division of Rheumatology, State University of New Jersey; V. Strand, MD, Division of Immunology/Rheumatology, Stanford University; M.E. Suarez-Almazor, MD, PhD, University of Texas, MD Anderson Cancer Center; P. Tugwell, MD, MSC, FRCPC, Department of Medicine, Faculty of Medicine, Institute of Population Health, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Department of Epidemiology and Community Medicine, University of Ottawa; G.A. Wells, PhD, Department of Epidemiology and Community Medicine, University of Ottawa. bussejw@mcmaster.ca.
³ From 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.
⁴ J.W. Busse, DC, PhD, Michael G. DeGroote Institute for Pain Research and Care; Department of Anesthesia, Department of Clinical Epidemiology and Biostatistics, McMaster University; S.J. Bartlett, PhD, Department of Medicine, McGill University, Divisions of Rheumatology and Clinical Epidemiology, Royal Victoria Hospital; M. Dougados, MD, Paris Descartes University, APHP Cochin Hospital; Rheumatology Department, Cochin Hospital, INSERM (U1153) Clinical Epidemiology and Biostatistics, PRES Sorbonne; B.C. Johnston, PhD, Department of Clinical Epidemiology and Biostatistics, McMaster University and Hospital for Sick Children Research Institute, Institute of Health Policy, Management and Evaluation, University of Toronto, and Department of Anesthesia and Pain Medicine, Hospital for Sick Children, University of Toronto; G.H. Guyatt, MD, MSc, Department of Clinical Epidemiology and Biostatistics, McMaster University; J.R. Kirwan, MD, FRCP, University of Bristol Academic Rheumatology Unit, Bristol Royal Infirmary; K. Kwoh, MD, University of Pittsburgh and VA Pittsburgh Healthcare System; L.J. Maxwell, MSc, Institute of Population Health, University of Ottawa; A. Moore, DSc, Pain Research, University of Oxford, Nuffield Division of Anaesthetics; J.A. Singh, MBBS, MPH, Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; R. Stevens, MD, Inflammation and Immunology Clinical Research, Celgene Corporation, and Department of Medicine, Division of Rheumatology, State University of New Jersey; V. Strand, MD, Division of Immunology/Rheumatology, Stanford University; M.E. Suarez-Almazor, MD, PhD, University of Texas, MD Anderson Cancer Center; P. Tugwell, MD, MSC, FRCPC, Department of Medicine, Faculty of Medicine, Institute of Population Health, University of Ottawa, and Ottawa Hospital Research Institute, Clinical Epidemiology Program, Department of Epidemiology and Community Medicine, University of Ottawa; G.A. Wells, PhD, Department of Epidemiology and Community Medicine, University of Ottawa.

PMID: 25979719
DOI: 10.3899/jrheum.141440

Abstract

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.

Keywords: CLINICAL TRIALS; OMERACT; OUTCOMES; PAIN; SYSTEMATIC REVIEWS; VISUAL ANALOG SCALE.

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Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop

Affiliations

Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop

Authors

Affiliations

Abstract

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LinkOut - more resources

Full Text Sources

Medical