Center for Translational Science, Children's National Health System, Washington, DC.
Division of Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins Medical Center, Baltimore, Md.
J Allergy Clin Immunol. 2016 Dec;138(6):1512-1517. doi: 10.1016/j.jaci.2016.10.001. Epub 2016 Oct 12.
Stakeholder engagement has the potential to develop research interventions that are responsive to patient and provider preferences. This approach contrasts with traditional models of clinical research in which researchers determine the study's design. This article describes the effect of stakeholder engagement on the design of a randomized trial of an intervention designed to improve child asthma outcomes by reducing parental stress. The study team developed and implemented a stakeholder engagement process that provided iterative feedback regarding the study design, patient-centered outcomes, and intervention. Stakeholder engagement incorporated the perspectives of parents of children with asthma; local providers of community-based medical, legal, and social services; and national experts in asthma research methodology and implementation. Through a year-long process of multidimensional stakeholder engagement, the research team successfully refined and implemented a patient-centered study protocol. Key stakeholder contributions included selection of patient-centered outcome measures, refinement of intervention content and format, and language framing the study in a culturally appropriate manner. Stakeholder engagement was a useful framework for developing an intervention that was acceptable and relevant to our target population. This approach might have unique benefits in underserved populations, leading to sustainable improvement in health outcomes and reduced disparities.
利益相关者的参与有可能开发出能够响应患者和提供者偏好的研究干预措施。这种方法与传统的临床研究模式形成对比，在传统模式中，研究人员确定研究的设计。本文描述了利益相关者的参与对一项随机试验设计的影响，该试验旨在通过减轻父母压力来改善儿童哮喘结局。研究小组制定并实施了利益相关者参与的过程，就研究设计、以患者为中心的结果和干预措施提供了迭代反馈。利益相关者的参与纳入了哮喘儿童的父母、社区医疗、法律和社会服务的当地提供者以及哮喘研究方法学和实施方面的国家专家的观点。通过长达一年的多维度利益相关者参与过程，研究小组成功地改进并实施了以患者为中心的研究方案。主要利益相关者的贡献包括选择以患者为中心的结果衡量标准、改进干预内容和形式，以及用文化上合适的方式为研究提供语言框架。利益相关者的参与是开发对我们目标人群可接受且相关的干预措施的有用框架。这种方法在服务不足的人群中可能具有独特的优势，可导致健康结果的可持续改善和减少差距。
