Adam P. McGuire , Alexander Riera , Xrystyan Lascano
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引用次数: 0
Abstract
Background
Alternative, easily accessible treatment options are needed to aid efforts to address the negative effects of PTSD among veterans. One approach that has shown promise in a pilot trial is a moral elevation-based intervention titled, MOVED. Qualitative feedback from veterans in the pilot trial identified several strengths, but also highlighted opportunities to improve the intervention. In this adaptation phase, we incorporated feedback from pilot participants with input from subject matter experts (SMEs) to inform adaptation decisions using the Model for Adaptation Design and Impact (MADI) framework. In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED on targeted outcomes for veterans with PTSD.
Method
We identified 10 SMEs that included veterans, clinicians, and researchers who participated in workgroup meetings to review 17 identified issues from the pilot and potential adaptations to address those concerns. We used the MADI framework to guide workgroup meeting discussions to determine what changes should be incorporated, including identifying potential negative outcomes for any adaptations and if they can be mitigated with other actions.
Results
SMEs agreed with proposed adaptations for 15 of 17 issues and proposed mitigating measures for four of those adaptations to avoid anticipated negative outcomes. Two proposed solutions were refuted and not selected for adaptation.
Conclusions
Using the MADI framework with input from SMEs allowed us to make informed decisions about adaptations for MOVED, thus contributing to further treatment development in preparation for a future efficacy trial.
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.