Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

中文翻译：

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疼痛治疗的实用随机临床试验方法：IMMPACT 声明。

务实、随机、对照试验有可能直接为有关疼痛患者治疗的临床决策和健康政策提供信息。实用试验旨在复制或嵌入常规临床护理中，并且越来越重视弥合试验研究和临床实践之间的差距，特别是在多维条件下，例如疼痛和非药物干预研究。为了最大限度地发挥疼痛研究中实用试验的潜力，需要仔细考虑每个方法学决定。与常规实践相一致的试验提出了一些挑战，例如确定和招募适当的研究参与者、决定治疗实施的适当灵活性水平、整合有关伴随治疗和依从性的信息，以及选择比较条件和结果测量。确保现实临床环境中的数据质量是另一个具有挑战性的目标。此外，当前该领域的试验将受益于分析方法，这些方法可以对不同患者亚组的影响有不同的理解，并改进方法和背景的报告，这是评估研究结果的普遍性所必需的。与此同时，一系列新颖的方法为提高利益相关者和临床决策的实用性试验的效率和相关性提供了机会。在这项研究中，针对疼痛治疗的实用试验中的这些问题和其他问题提供了最佳实践考虑因素，并讨论了许多有希望的解决方案。这些建议的基础是由镇痛、麻醉和成瘾临床试验翻译、创新、机会和网络组织的临床试验方法、测量和疼痛评估倡议 (IMMPACT) 会议。