Ballengee Lindsay A, Horn Maggie E, Lentz Trevor A, Check Devon, Zullig Leah L, George Steven Z
Duke University School of Medicine, Department of Population Health Sciences, 215 Morris Street, Durham, NC, 27701, USA.
Duke University School of Medicine, Department of Orthopaedic Surgery, 300 W. Morgan Street, Durham, NC, 27701, USA.
Contemp Clin Trials Commun. 2025 Feb 15;44:101453. doi: 10.1016/j.conctc.2025.101453. eCollection 2025 Apr.
Delivering evidence-based interventions remains challenging, particularly for complex conditions like chronic musculoskeletal pain. Non-pharmacologic treatments are recommended for many pain conditions, but implementing these can be difficult due to their complexity and resource demands. Pragmatic trials, especially embedded designs, provide a method to see how interventions are being implemented and adapted in real-world settings throughout the trial process. This study explored how intervention delivery complexity and adaptations differ between non-pharmacologic pain trials and non-pain trials to provide guidance on future treatment delivery and implementation.
From July to October 2023, an online survey was distributed to members of three NIH Trial Collaboratories to assess intervention delivery complexity and adaptations during their pragmatic trials. Participants rated their trial's intervention delivery complexity using a 7-item tool and reported any adaptations to intervention delivery throughout the trial process. Data analysis compared complexity and adaptations between the two trial types to explore differences and relationships between intervention delivery complexity and adaptations.
We analyzed 12 pain and 12 non-pain trials and found that intervention delivery complexity was not discernibly different between the two trial types, however, pain trials did have a slightly higher average intervention delivery complexity, overall. Pain trials also had more adaptations in the workflow domain compared to non-pain trials, while adaptations across other domains were similar between the two types. Workflow emerged as the most challenging domain for adaptation among all trials.
Intervention delivery complexity may be higher for pragmatic trials that are investigating non-pharmacologic pain interventions versus non-pain trials, but only in very specific areas.
提供循证干预措施仍然具有挑战性，尤其是对于慢性肌肉骨骼疼痛等复杂病症。许多疼痛病症推荐使用非药物治疗方法，但由于其复杂性和资源需求，实施起来可能会很困难。实用试验，特别是嵌入式设计，提供了一种方法来观察干预措施在整个试验过程中是如何在现实环境中实施和调整的。本研究探讨了非药物疼痛试验和非疼痛试验之间干预措施实施的复杂性和调整情况有何不同，以为未来的治疗实施和执行提供指导。
2023年7月至10月，向三个美国国立卫生研究院试验合作组织的成员开展了一项在线调查，以评估其实用试验期间干预措施实施的复杂性和调整情况。参与者使用一个包含7个条目的工具对其试验的干预措施实施复杂性进行评分，并报告在整个试验过程中对干预措施实施所做的任何调整。数据分析比较了两种试验类型之间的复杂性和调整情况，以探讨干预措施实施复杂性与调整之间的差异和关系。
我们分析了12项疼痛试验和12项非疼痛试验，发现两种试验类型之间干预措施实施的复杂性没有明显差异，不过总体而言，疼痛试验的平均干预措施实施复杂性略高。与非疼痛试验相比，疼痛试验在工作流程领域的调整也更多，而两种类型在其他领域的调整相似。在所有试验中，工作流程成为最难进行调整的领域。
与非疼痛试验相比，研究非药物疼痛干预措施的实用试验的干预措施实施复杂性可能更高，但仅在非常特定的领域如此。
