Department of Physical Therapy & Athletic Training, University of Utah, 383 Colorow Drive, Room 391, Salt Lake City, UT, 84108, USA.
Department of Population Health Sciences, University of Utah, Salt Lake City, UT, USA.
Trials. 2023 Feb 23;24(1):137. doi: 10.1186/s13063-023-07150-1.
The OPTIMIZE trial is a multi-site, comparative effectiveness research (CER) study that uses a Sequential Multiple Assessment Randomized Trial (SMART) designed to examine the effectiveness of complex health interventions (cognitive behavioral therapy, physical therapy, and mindfulness) for adults with chronic low back pain. Modifications are anticipated when implementing complex interventions in CER. Disruptions due to COVID have created unanticipated challenges also requiring modifications. Recent methodologic standards for CER studies emphasize that fully characterizing modifications made is necessary to interpret and implement trial results. The purpose of this paper is to outline the modifications made to the OPTIMIZE trial using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) to characterize modifications to the OPTIMIZE trial in response to the COVID pandemic and other challenges encountered.
The FRAME outlines a strategy to identify and report modifications to evidence-based interventions or implementation strategies, whether planned or unplanned. We use the FRAME to characterize the process used to modify the aspects of the OPTIMIZE trial. Modifications were made to improve lower-than-anticipated rates of treatment initiation and COVID-related restrictions. Contextual modifications were made to permit telehealth delivery of treatments originally designed for in-person delivery. Training modifications were made with study personnel to provide more detailed information to potential participants, use motivational interviewing communication techniques to clarify potential participants' motivation and possible barriers to initiating treatment, and provide greater assistance with scheduling of assigned treatments.
Modifications were developed with input from the trial's patient and stakeholder advisory panels. The goals of the modifications were to improve trial feasibility without compromising the interventions' core functions. Modifications were approved by the study funder and the trial steering committee.
Full and transparent reporting of modifications to clinical trials, whether planned or unplanned, is critical for interpreting the trial's eventual results and considering future implementation efforts.
ClinicalTrials.gov NCT03859713. Registered on March 1, 2019.
OPTIMIZE 试验是一项多地点、比较有效性研究（CER），采用序贯多项评估随机试验（SMART）设计，旨在检验针对慢性下腰痛成年人的复杂健康干预（认知行为疗法、物理疗法和正念）的有效性。在 CER 中实施复杂干预措施时预计会进行修改。由于 COVID 的出现，造成了意想不到的挑战，这也需要进行修改。最近 CER 研究的方法标准强调，充分描述所做的修改对于解释和实施试验结果是必要的。本文的目的是使用循证干预措施改编和修改框架（FRAME）概述对 OPTIMIZE 试验所做的修改，以描述 OPTIMIZE 试验因 COVID 大流行和其他遇到的挑战而进行的修改。
FRAME 概述了一种识别和报告对基于证据的干预措施或实施策略的修改的策略，无论是计划内还是计划外的修改。我们使用 FRAME 来描述修改 OPTIMIZE 试验的过程。进行了修改以提高治疗开始率和 COVID 相关限制的预期较低率。对环境进行了修改，允许最初为面对面交付而设计的治疗进行远程医疗交付。对研究人员进行了培训修改，为潜在参与者提供更详细的信息，使用动机性访谈沟通技巧来澄清潜在参与者的动机和开始治疗的可能障碍，并提供更大的帮助来安排分配的治疗。
修改是在试验的患者和利益相关者咨询小组的参与下制定的。修改的目标是在不损害干预措施核心功能的情况下提高试验的可行性。修改获得了研究资助者和试验指导委员会的批准。
对临床试验进行全面和透明的修改报告，无论是计划内还是计划外的修改，对于解释试验的最终结果和考虑未来的实施工作都至关重要。
ClinicalTrials.gov NCT03859713。注册于 2019 年 3 月 1 日。
