临床试验和系统评价中疼痛报告的最佳策略：OMERACT 12研讨会的建议

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

作者信息

Busse Jason W, Bartlett Susan J, Dougados Maxime, Johnston Bradley C, Guyatt Gordon H, Kirwan John R, Kwoh Kent, Maxwell Lara J, Moore Andrew, Singh Jasvinder A, Stevens Randall, Strand Vibeke, Suarez-Almazor Maria E, Tugwell Peter, Wells George A

机构信息

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.

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.

出版信息

J Rheumatol. 2015 Oct;42(10):1962-1970. doi: 10.3899/jrheum.141440. Epub 2015 May 15.

DOI:10.3899/jrheum.141440

PMID:25979719

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.

摘要

目的

疼痛是患者重要的结局指标，但目前随机对照试验和系统评价中的报告往往不尽人意，阻碍了临床解读和决策。

方法

2014年风湿病疗效评估（OMERACT 12）工作组召开会议，为个体研究和系统评价中疼痛治疗效果的报告提供指导。

结果

对于个体试验，作者除了应报告平均变化外，还应报告从基线疼痛改善达到1个或更多阈值的患者比例（例如，≥20%、≥30%、≥50%）、达到理想疼痛状态（例如，不比轻度疼痛更严重），和/或变化与状态的组合。对疼痛的影响应伴有其他患者重要的结局指标，以促进解读。在汇总数据进行荟萃分析时，作者应考虑将所有疼痛的连续测量指标转换为100毫米视觉模拟量表（VAS），并使用既定的最小重要差异（MID）10毫米，以及常规使用的明显重要差异20毫米、30毫米和50毫米，以促进解读。效应≤0.5个单位表明效应小或非常小。为了进一步提高可解释性，VAS上的汇总估计值也应转换为二分类结局，并表示为相对风险和风险差异。这种转换可以通过计算对照组和干预组中经历大于MID的治疗效果的概率以及疼痛减轻明显重要差异的阈值来实现。