Paltin Dafna, Montoya Jessica L, Weise Celeste, Conroy Carla, Radatz Ethan E, Strange Kurt C, Moore David J, Sajatovic Martha, Levin Jennifer B
SDSU/UC San Diego Joint Doctoral Program in Clinical Psychology, San Diego, California, USA.
Department of Psychiatry, UC San Diego, San Diego, California, USA.
Int J Healthc. 2022 Nov;8(2):9-18. doi: 10.5430/ijh.v8n2p9. Epub 2022 Jul 1.
Poor adherence to antihypertensive medication occurs in 50-80% of patients. An ongoing randomized controlled trial (RCT) is evaluating a personalized mobile-health intervention in poorly adherent hypertensive persons with bipolar disorder. To enhance efficacy, the ongoing trial elicited guidance from a Stakeholder Advisory Board (SAB) comprised of patients, family members, clinicians, and health system administrators. Our goal is to describe the formation, role, decision-making process, and key contributions of the SAB as a means of demonstrating meaningful community engagement in mental health research.
Using models and measures from the field of implementation science, eleven SAB members convened across three meetings followed by quantitative surveys that assessed SAB member satisfaction and engagement during the meeting.
Significant suggestions from the SAB included 1) expanding inclusion/exclusion criteria, and 2) operationalizing remote implementation of the RCT. Primary study implementation challenges identified by the SAB were 1) participant difficulty engaging in the mHealth intervention, and 2) identification of procedures for monitoring participant adherence to the RCT protocol and contacting under-engaged participants. Quantitative surveys indicated that all SAB members believed that the objectives of the meetings were clear, perceived that they were able to participate in the discussions, and that they were heard.
Increasing evidence demonstrates the feasibility of engaging with SABs in clinical research and that this process improves intervention design, increases participant engagement, reduces mental health-related stigma, and produces more effective implementation strategies. We encourage future investigators to use an implementation science framework in partnership with SABs to refine their proposed interventions and improve clinical outcomes.
50%-80%的患者存在抗高血压药物依从性差的问题。一项正在进行的随机对照试验（RCT）正在评估针对双相情感障碍的高血压依从性差患者的个性化移动健康干预措施。为提高疗效，正在进行的试验征求了由患者、家庭成员、临床医生和卫生系统管理人员组成的利益相关者咨询委员会（SAB）的指导意见。我们的目标是描述SAB的组建、作用、决策过程和关键贡献，以此作为展示在心理健康研究中社区有意义参与的一种方式。
利用实施科学领域的模型和措施，11名SAB成员参加了三次会议，随后进行了定量调查，评估SAB成员在会议期间的满意度和参与度。
SAB提出的重要建议包括：1）扩大纳入/排除标准；2）实施RCT的远程实施。SAB确定的主要研究实施挑战是：1）参与者参与移动健康干预存在困难；2）确定监测参与者对RCT方案依从性以及联系参与度低的参与者的程序。定量调查表明，所有SAB成员都认为会议目标明确，觉得自己能够参与讨论，且意见得到了听取。
越来越多的证据表明，在临床研究中与SAB合作是可行的，这一过程可改善干预设计、提高参与者参与度、减少与心理健康相关的污名，并产生更有效的实施策略。我们鼓励未来的研究人员与SAB合作，使用实施科学框架来完善他们提出的干预措施并改善临床结果。
