Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.
Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.
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DOI：
10.1097/j.pain.0000000000002475
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发表时间：
2022-06-01
期刊：
影响因子：
7.4
通讯作者：
Wilson HD
中科院分区：
文献类型：
--
作者：
Kleykamp BA;Dworkin RH;Turk DC;Bhagwagar Z;Cowan P;Eccleston C;Ellenberg SS;Evans SR;Farrar JT;Freeman RL;Garrison LP;Gewandter JS;Goli V;Iyengar S;Jadad AR;Jensen MP;Junor R;Katz NP;Kesslak JP;Kopecky EA;Lissin D;Markman JD;McDermott MP;Mease PJ;O'Connor AB;Patel KV;Raja SN;Rowbotham MC;Sampaio C;Singh JA;Steigerwald I;Strand V;Tive LA;Tobias J;Wasan AD;Wilson HD
慢性疼痛临床试验历来分别评估获益和风险结果。然而，越来越多的研究表明，考虑彼此相关的获益和风险的综合指标可以为不同治疗的效果提供有价值的见解。研究人员和监管机构已经开发了各种效益-风险综合指标，尽管这些方法在慢性疼痛随机临床试验（RCT）中的适用程度尚未在已发表的文献中进行评估。本文是受临床试验方法、测量和疼痛评估共识会议倡议的启发，并基于与会者的专家意见。此外，还完成了对已发表的慢性疼痛随机对照试验中使用的或主要专业组织（即 Cochrane、欧洲药品管理局、风湿病结果测量和美国食品和药物管理局）强调的效益-风险评估工具的审查。总体而言，审查发现，尽管有已发表的方法，但效益-风险指标在慢性疼痛的随机对照试验中并不常用。主要建议是，除了治疗组层面的获益-风险评估之外，如果可能，还应在个体患者层面结合获益-风险的综合指标。两个层面的分析（个人和团体）都可以为不同患者亚群的特定治疗相关的获益和风险之间的关系提供有价值的见解。临床试验中获益-风险的系统评估有可能增强随机对照试验结果的临床意义。
Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit–risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. This article was motivated by an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting and is based on the expert opinion of those who attended. In addition, a review of the benefit–risk assessment tools used in published chronic pain RCTs or highlighted by key professional organizations (ie, Cochrane, European Medicines Agency, Outcome Measures in Rheumatology, and US Food and Drug Administration) was completed. Overall, the review found that benefit–risk metrics are not commonly used in RCTs of chronic pain despite the availability of published methods. A primary recommendation is that composite metrics of benefit–risk should be combined at the level of the individual patient, when possible, in addition to the benefit–risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit–risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results.
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影响因子：
7.4
作者：
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通讯作者：
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