实施非药物性疼痛干预的干预交付复杂性和适应性

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Lindsay A. Ballengee , Maggie E. Horn , Trevor A. Lentz , Devon Check , Leah L. Zullig , Steven Z. George
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引用次数: 0

摘要

提供基于证据的干预措施仍然具有挑战性,特别是对于慢性肌肉骨骼疼痛等复杂疾病。非药物治疗被推荐用于许多疼痛状况,但由于其复杂性和资源需求,实施这些治疗可能很困难。实用试验,特别是嵌入式设计,提供了一种方法,可以在整个试验过程中了解干预措施是如何在现实环境中实施和适应的。本研究探讨了非药理学疼痛试验和非疼痛试验之间干预交付复杂性和适应性的差异,为未来的治疗交付和实施提供指导。方法从2023年7月至10月,对三个NIH试验合作实验室的成员进行在线调查,评估干预措施在实际试验中的交付复杂性和适应性。参与者使用7项工具评估他们的试验干预交付的复杂性,并报告在整个试验过程中对干预交付的任何适应。数据分析比较了两种试验类型的复杂性和适应性,以探索干预交付复杂性和适应性之间的差异和关系。结果我们分析了12个疼痛试验和12个非疼痛试验,发现两种试验类型之间的干预交付复杂性没有明显差异,然而,总体而言,疼痛试验的平均干预交付复杂性略高。与非疼痛试验相比,疼痛试验在工作流领域也有更多的适应性,而在其他领域的适应性在两种类型之间是相似的。在所有试验中,工作流成为最具挑战性的适应领域。结论:在研究非药物疼痛干预的实用试验中,干预交付的复杂性可能高于非疼痛试验,但仅在非常特定的领域。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intervention delivery complexity and adaptations for implementation of non-pharmacologic pain interventions

Background

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.

Methods

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.

Results

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.

Conclusion

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.
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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