慢性疼痛临床试验的核心结局领域：IMMPACT 建议。

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

作者信息

Turk Dennis C, Dworkin Robert H, Allen Robert R, Bellamy Nicholas, Brandenburg Nancy, Carr Daniel B, Cleeland Charles, Dionne Raymond, Farrar John T, Galer Bradley S, Hewitt David J, Jadad Alejandro R, Katz Nathaniel P, Kramer Lynn D, Manning Donald C, McCormick Cynthia G, McDermott Michael P, McGrath Patrick, Quessy Steve, Rappaport Bob A, Robinson James P, Royal Mike A, Simon Lee, Stauffer Joseph W, Stein Wendy, Tollett Jane, Witter James

机构信息

Department of Anesthesiology, University of Washington, Seattle, WA 98195, USA University of Rochester, Rochester, NY, USA AstraZeneca, Wilmington, DE, USA University of Queensland, Australia Pfizer Pharmaceutical Group New York, NY, USA Department of Anesthesiology, Tufts University, Medford, MA, USA MD Anderson Cancer Center, Houston, TX, USA National Institute of Dental and Craniofacial Research, Bethesda, MA, USA Center for Clinical Epidemiology & Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA Ortho-McNeil Pharmaceutical Inc., Raritan, NJ, USA University Health Network and University of Toronto, Toronto, ON, Canada Harvard University, Cambridge, MA, USA Purdue Pharma, Stamford, CT, USA Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA National Institutes of Health, Bethesda, MD, USA Department of Psychology, Dalhousie University, Halifax, Nova Scotia, Canada GlaxoSmithKline, Research Triangle Park, NC, USA Food and Drug Administration, Rockville, MD, USA Department of Physical Medicine and Rehabilitation, University of Washington, Seattle, WA, USA Elan Pharmaceuticals, San Diego, CA, USA Abbott Laboratories, Lake Forrest, IL, USA University of California San Diego, La Jolla, CA, USA US Department of Veterans Affairs, Washington, DC, USA.

出版信息

Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001.

DOI:10.1016/j.pain.2003.08.001

PMID:14659516

Abstract

OBJECTIVE

To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment.

METHODS

Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain.

CONCLUSIONS

There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.

摘要

目的

为开展慢性疼痛治疗疗效和有效性临床试验的研究人员应考虑的核心结局领域提供建议。制定一套核心结局领域将有助于数据的比较和汇总，鼓励更全面地报告结局，简化研究方案和稿件的准备与评审，并使临床医生能够就治疗的风险和益处做出明智的决策。

方法

在临床试验方法、测量与疼痛评估倡议（IMMPACT）的主持下，来自学术界、政府机构和制药行业的27位专家参加了一次共识会议，确定了慢性疼痛治疗临床试验中应考虑的核心结局领域。

结论

达成的共识是，慢性疼痛临床试验应评估代表六个核心领域的结局：（1）疼痛，（2）身体功能，（3）情绪功能，（4）参与者对治疗改善和满意度的评分，（5）症状和不良事件，（6）参与者情况（如对治疗方案的依从性以及提前退出试验的原因）。尽管应考虑对每个领域进行评估，但在慢性疼痛试验中纳入所有这些领域的一般建议可能存在例外情况。当出现这种情况时，应提供不纳入某些领域的理由。这些建议并非旨在表明对核心领域的评估应被视为监管机构批准产品申请的要求，也不是说一种治疗方法必须在所有相关核心领域都显示出统计学上的显著效果才能确立其疗效证据。