实用主义疼痛疗法试验:方法的系统评价。

Pragmatic trials of pain therapies: a systematic review of methods.

机构信息

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, United Kingdom.

Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, United States.

出版信息

Pain. 2022 Jan 1;163(1):21-46. doi: 10.1097/j.pain.0000000000002317.

Abstract

Pragmatic randomised clinical trials aim to directly inform clinical or health policy decision making. Here, we systematically review methods and design of pragmatic trials of pain therapies to examine methods, identify common challenges, and areas for improvement. Seven databases were searched for pragmatic randomised controlled clinical trials that assessed pain treatment in a clinical population of adults reporting pain. All screening steps and data extractions were performed twice. Data were synthesised descriptively, and correlation analyses between prespecified trial features and PRECIS-2 (PRagmatic-Explanatory Continuum Indicator Summary 2) ratings and attrition were performed. Protocol registration: PROSPERO-ID CRD42020178954. Of 57 included trials, only 21% assessed pharmacological interventions, the remainder physical, surgical, psychological, or self-management pain therapies. Three-quarters of the trials were comparative effectiveness designs, often conducted in multiple centres (median: 5; Q1/3: 1, 9.25) and with a median sample size of 234 patients at randomization (Q1/3: 135.5; 363.5). Although most trials recruited patients with chronic pain, reporting of pain duration was poor and not well described. Reporting was comprehensive for most general items, while often deficient for specific pragmatic aspects. Average ratings for pragmatism were highest for treatment adherence flexibility and clinical relevance of outcome measures. They were lowest for patient recruitment methods and extent of follow-up measurements and appointments. Current practice in pragmatic trials of pain treatments can be improved in areas such as patient recruitment and reporting of methods, analysis, and interpretation of data. These improvements will facilitate translatability to other real-world settings-the purpose of pragmatic trials.

摘要

实用随机临床试验旨在直接为临床或卫生政策决策提供信息。在这里,我们系统地回顾了疼痛疗法实用试验的方法和设计,以检查方法、确定常见挑战和改进领域。我们在七个数据库中搜索了评估成年疼痛患者临床人群疼痛治疗的实用随机对照临床试验。所有的筛选步骤和数据提取都进行了两次。数据以描述性方式进行综合,并且对预设试验特征与 PRECIS-2(实用-解释连续性指标总结 2)评分和失访率之间的相关性进行了分析。方案注册:PROSPERO-ID CRD42020178954。在纳入的 57 项试验中,只有 21%评估了药物干预,其余为物理、手术、心理或自我管理疼痛疗法。四分之三的试验为比较有效性设计,通常在多个中心进行(中位数:5;Q1/3:1,9.25),随机分组的中位数样本量为 234 例患者(Q1/3:135.5;363.5)。尽管大多数试验招募了慢性疼痛患者,但对疼痛持续时间的报告很差,描述也不充分。大多数一般项目的报告都很全面,而具体的实用方面的报告往往不足。治疗依从性灵活性和结果测量的临床相关性的实用主义平均评分最高。它们在患者招募方法和随访测量和预约的程度方面最低。疼痛治疗实用试验中的当前实践可以在患者招募和方法报告、数据分析和解释等方面得到改进。这些改进将促进在其他真实世界环境中的可翻译性-实用试验的目的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d92/8675058/21ae33bdc8f2/jop-163-0021-g001.jpg

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