Research to Advance Community Health (ReACH) Center, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, Mail Code 7768, San Antonio, TX, 78229, USA.
Psychiatry & Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
J Clin Psychol Med Settings. 2022 Mar;29(1):185-194. doi: 10.1007/s10880-021-09790-4. Epub 2021 Jun 7.
Pragmatic trials testing the effectiveness of interventions under "real world" conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.
实用临床试验在“真实世界”条件下测试干预措施的有效性，有助于弥合研究与实践之间的差距。这种试验设计对于研究实施工作的影响最为理想，例如在初级保健环境中整合行为健康临床医生的效果。在整合的初级保健环境中进行正式的实用临床试验并不常见，这使得研究人员难以预测在平衡科学严谨性与常规临床实践需求方面可能出现的潜在问题。本文基于我们在使用手册化干预措施（慢性疼痛简短认知行为疗法，即 BCBT-CP）对使用慢性疼痛患者的行为健康顾问进行实施和有效性评估的大型多地点实用临床试验第一阶段的经验。本文使用 PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) 工具突出了关键选择点。我们讨论了我们面临的实用研究困境，并为有志于进行综合初级保健实用试验的人员提供了建议。
