Johnson Adrienne L, Ecker Anthony H, Fletcher Terri L, Hundt Natalie, Kauth Michael R, Martin Lindsey A, Curran Geoffrey M, Cully Jeffrey A
Department of Psychology, University of Cincinnati, Cincinnati, OH, USA.
Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Houston, TX, USA.
Transl Behav Med. 2020 Aug 7;10(3):629-636. doi: 10.1093/tbm/iby116.
Randomized controlled trials (RCTs) are the gold standard for clinical research. However, significant delays between completion of RCTs and adoption of evidence-based practices into clinical settings remain. Engagement of stakeholders and implementation-focused outcomes to augment traditional RCTs hold the potential to increase the impact of RCT outcomes for clinical practice and more rapidly lead to the adoption of evidence-based practices in clinical settings. The purpose of this study is to discuss hybrid effectiveness-implementation designs and use a project example to highlight important methodological considerations to enhance the impact of RCTs. A hybrid effectiveness-implementation study assessed the effectiveness and implementation potential of brief cognitive behavioral therapy (bCBT) for rural Veterans. A patient-randomized trial (bCBT vs. enhanced usual care) explored the impact on depression symptoms. Implementation elements included engagement of stakeholders and a multifaceted provider training and support program to increase bCBT use by providers in Veterans Health Administration (VA) community-based outpatient clinics. Implementation outcomes included the number of providers who adopted bCBT, provider fidelity, and delivery outcomes (e.g., use of measurement-based care, treatment engagement, and completion). Hybrid designs offer opportunities to improve the alignment between research and practice, potentially improving dissemination of evidence-based interventions and reducing known delays in the translation from research to practice. Expansion of traditional RCTs through collaborative stakeholder contributions and stakeholder/consumer-informed implementation approaches is critical to improve adoption postproject. Although hybrid designs offer significant benefits related to generalizability and adoption, these approaches involve complex procedures and processes and often come at the cost of reduced internal study controls.
随机对照试验（RCTs）是临床研究的金标准。然而，随机对照试验完成后与将循证实践应用于临床环境之间仍存在显著延迟。让利益相关者参与并以实施为重点的结果来补充传统的随机对照试验，有可能增加随机对照试验结果对临床实践的影响，并更快地促使循证实践在临床环境中得到应用。本研究的目的是讨论混合有效性-实施设计，并通过一个项目实例来突出重要的方法学考量，以增强随机对照试验的影响。一项混合有效性-实施研究评估了简短认知行为疗法（bCBT）对农村退伍军人的有效性和实施潜力。一项患者随机试验（bCBT与强化常规护理对比）探讨了对抑郁症状的影响。实施要素包括利益相关者的参与以及一个多方面的提供者培训和支持项目，以增加退伍军人健康管理局（VA）社区门诊诊所的提供者对bCBT的使用。实施结果包括采用bCBT的提供者数量、提供者的保真度以及提供结果（如基于测量的护理的使用、治疗参与度和完成情况）。混合设计提供了改善研究与实践之间一致性的机会，有可能促进循证干预措施的传播，并减少从研究到实践转化过程中已知的延迟。通过利益相关者的协作贡献和基于利益相关者/消费者信息的实施方法来扩展传统的随机对照试验，对于提高项目后采纳率至关重要。尽管混合设计在普遍性和采纳方面有显著益处，但这些方法涉及复杂的程序和流程，并且往往以减少内部研究控制为代价。
