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使用康复治疗规范系统描述乳腺癌幸存者临床试验的试验组和对照组。

Using the Rehabilitation Treatment Specification System to Describe Experimental and Control Arms of a Clinical Trial for Breast Cancer Survivors.

作者信息

Lyons Kathleen D, Hart Tessa, Singh Sheel, Wolfberg Jeremy, Whyte John, Wechsler Stephen, Lin Susan H, Fasoli Susan E, Van Stan Jarrad H

机构信息

Professor, Department of Occupational Therapy, MGH Institute of Health Professions, Boston, MA.

Scientist Emerita, Moss Rehabilitation Research Institute, Elkins Park, PA.

出版信息

Rehabil Oncol. 2024 Oct;42(4):181-197. doi: 10.1097/01.reo.0000000000000373. Epub 2024 Oct 9.

DOI:10.1097/01.reo.0000000000000373
PMID:40837008
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12362348/
Abstract

The Rehabilitation Treatment Specification System (RTSS) provides a framework to decompose complex interventions into components, each defined by its known or hypothesized active ingredients. In addition to its value in planning new interventions and understanding existing ones, we suggest it can be used to help interpret findings of clinical trials and plan next steps in a research program. This paper presents an analysis in which we used the RTSS to retrospectively delineate targets and ingredients of an experimental treatment, Behavioral Activation and Problem-Solving (BA/PS), and then examined the attention control condition for overlapping ingredients that could clarify the control condition's unanticipated effects. Our BA/PS intervention had seven treatment components; three were unique to the BA/PS condition, but the attention control condition contained ingredients that mirrored those found in four of the BA/PS components. Our results illuminate the challenges of designing an adequate control condition for behavioral rehabilitation trials among survivors of cancer. This RTSS application was instrumental in refining our conceptual model and preparing for future research. It serves as a model for other cancer rehabilitation researchers, emphasizing the importance of intentional and transparent intervention specification to advance the field.

摘要

康复治疗规范系统(RTSS)提供了一个框架,用于将复杂的干预措施分解为各个组成部分,每个组成部分都由其已知或假设的活性成分来定义。除了在规划新干预措施和理解现有干预措施方面具有价值外,我们认为它还可用于帮助解释临床试验的结果并规划研究项目的后续步骤。本文介绍了一项分析,我们使用RTSS回顾性地描绘了一种实验性治疗方法——行为激活与问题解决(BA/PS)的目标和成分,然后检查了注意力控制条件中是否存在可能解释该控制条件意外效果的重叠成分。我们的BA/PS干预有七个治疗成分;其中三个是BA/PS条件所独有的,但注意力控制条件包含的成分与BA/PS四个成分中的成分相似。我们的结果揭示了为癌症幸存者的行为康复试验设计适当对照条件的挑战。这种RTSS应用有助于完善我们的概念模型并为未来研究做好准备。它为其他癌症康复研究人员树立了一个榜样,强调了有意且透明的干预规范对推动该领域发展的重要性。

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本文引用的文献

1
Rehabilitation Treatment Specification System: Content and Criterion Validity Across Evidence-Based Voice Therapies for Muscle Tension Dysphonia.康复治疗规范系统:基于证据的肌肉紧张性发声障碍语音治疗的内容和标准有效性。
Am J Speech Lang Pathol. 2024 Jul 3;33(4):1774-1791. doi: 10.1044/2024_AJSLP-23-00362. Epub 2024 Apr 12.
2
Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial.基于电话的康复干预以优化乳腺癌后的活动参与:一项随机临床试验。
JAMA Netw Open. 2024 Mar 4;7(3):e242478. doi: 10.1001/jamanetworkopen.2024.2478.
3
A Systematic Review of Speech-Language Pathology Interventions for Presbyphonia Using the Rehabilitation Treatment Specification System.使用康复治疗规范系统对老年聋进行言语语言病理学干预的系统评价。
J Voice. 2024 Jan 8. doi: 10.1016/j.jvoice.2023.12.010.
4
Rehabilitation Treatment Specification System for Voice Therapy: Application to Everyday Clinical Care.嗓音治疗康复治疗规范系统:在日常临床护理中的应用。
Am J Speech Lang Pathol. 2024 Mar 7;33(2):814-830. doi: 10.1044/2023_AJSLP-23-00283. Epub 2023 Dec 19.
5
A Process Evaluation of Intervention Delivery for a Cancer Survivorship Rehabilitation Clinical Trial Conducted during the COVID-19 Pandemic.一项针对在 COVID-19 大流行期间开展的癌症康复临床试验中干预措施实施情况的过程评估。
Curr Oncol. 2023 Oct 16;30(10):9141-9155. doi: 10.3390/curroncol30100660.
6
Considerations of Control Conditions Designs in Randomized Controlled Trials of Exercise Interventions for Cancer Survivors.考虑在针对癌症幸存者的运动干预随机对照试验中控制条件设计。
Can J Nurs Res. 2022 Dec;54(4):377-391. doi: 10.1177/08445621211062467. Epub 2022 Feb 4.
7
Demystifying the Complexity of Aphasia Treatment: Application of the Rehabilitation Treatment Specification Systemx.揭开失语症治疗复杂性的面纱:康复治疗规范系统x的应用
Arch Phys Med Rehabil. 2022 Mar;103(3):574-580. doi: 10.1016/j.apmr.2021.08.025. Epub 2021 Nov 5.
8
Cancer health self-efficacy improvement in a randomized controlled trial.癌症健康自我效能提升的随机对照试验。
Cancer. 2022 Feb 1;128(3):597-605. doi: 10.1002/cncr.33947. Epub 2021 Oct 20.
9
Psychoeducation as Precision Health in Military-Related Mild Traumatic Brain Injury.军人相关轻度创伤性脑损伤的精准健康中的心理教育。
Arch Phys Med Rehabil. 2022 Jun;103(6):1222-1232. doi: 10.1016/j.apmr.2021.08.012. Epub 2021 Sep 10.
10
Voice Therapy According to the Rehabilitation Treatment Specification System: Expert Consensus Ingredients and Targets.嗓音治疗根据康复治疗规范系统:专家共识成分和目标。
Am J Speech Lang Pathol. 2021 Sep 23;30(5):2169-2201. doi: 10.1044/2021_AJSLP-21-00076. Epub 2021 Aug 31.