Enhancing Clinical Guideline Development via Patient and Stakeholder Engagement

 描述(由申请者提供)：AHRQ指导的临床科学家研究职业发展奖(K08)旨在为首席研究员Melissa Armstrong博士提供独立的医疗服务研究职业生涯所需的培训和技能，重点是通过患者参与来改进临床实践指南(CPG)的开发过程。这项拟议的研究调查了患者、家庭和倡导者的参与对发展CPG问题的影响。将患者和利益相关者纳入指南制定现在是推荐的做法。尽管如此，患者和利益相关者的参与对指南的影响仍不清楚。本研究的目的是：(1)通过比较有无参与的指南制定小组(GDGs)的结果，调查患者、家人和倡导者参与对指南问题形成的影响；(2)比较患者、家属、倡导者和内容专家对建议指南问题的每个要素的重要性评分；(3)确定患者/家属/倡导者(目标1)和重要性评分(目标2)对最终共识指南问题的影响。这项拟议的研究是基于PI的神经学专业知识，并将利用即将到来的美国神经病学学会关于在痴呆症患者或有痴呆风险的患者中使用β-淀粉样蛋白成像的指南项目。将召集两个GDG来制定指导问题：一个单独由卫生保健专业人员(HCP)组成的“对照”(常规做法)GDG，以及一个包括HCP和患者、家属和倡导者在内的“试验性”GDG。指导性问题和分析框架的差异将被定性分析。对于目标2，患者、家属、倡导者和HCP/内容专家将对指南问题的每个组成部分(例如相关结果)的重要性进行9分顺序评分。将调查患者/家庭/倡导者和HCP的三个级别：GDG上的评级，参与在线公众评论的评级，以及通过对更大人群的调查。重要性评级的差异将使用Wilcoxon Rank Sum测试进行比较。对于目标#3，定性分析将比较最终达成共识的CPG问题与目标#1中提出的问题。为了实现这些目标，阿姆斯特朗博士将使用指导技能，包括患者参与培训、以患者为中心的结果研究、定性方法和传播/实施策略。调查患者、家人和倡导者的参与对CPG的影响对于解决重要的医疗保健问题至关重要，例如指南开发者是否通过排除这些利益相关者而错过了关键问题，指南是否解决了对患者重要的健康结果，以及可变的利益相关者参与是否解释了CPG的不一致。从这项研究中获得的知识将进一步推动最终目标，即了解患者参与是否促进最终用户对CPG的接受和实施，以加强为数百万患有慢性病的美国人提供循证和个性化的医疗保健。

 DESCRIPTION (provided by applicant): This AHRQ Mentored Clinical Scientist Research Career Development Award (K08) is designed to provide the Principal Investigator, Dr. Melissa Armstrong, with the training and skills needed for an independent career in health services research focusing on improving the clinical practice guideline (CPG) development process through patient engagement. The proposed research investigates the impact of patient, family, and advocate involvement on developing CPG questions. The inclusion of patients and stakeholders in guideline development is now recommended practice. Despite this, the effect of patient and stakeholder involvement on guidelines remains unknown. The study aims are to: (1) investigate the effect of patient, family, and advocate involvement on guideline question formation by comparing results of guideline development groups (GDGs) with and without their involvement, (2) compare importance ratings between patients, families, advocates, and content experts for each element of the proposed guideline questions, and (3) identify the effect of patients/families/advocates (Aim #1) and importance scores (Aim #2) on final consensus guideline questions. The proposed research is based on the PI's neurological expertise and will make use of an upcoming American Academy of Neurology guideline project regarding the use of beta-amyloid imaging in patients with - or at risk for - dementia. Two GDGs will be convened to develop the guideline questions: a "control" (routine practice) GDG of health care professionals (HCPs) alone and an "experimental" GDG including HCPs and patients, family, and advocates. Differences in guideline questions and analytic frameworks will be analyzed qualitatively. For Aim #2, patients, family, advocates, and HCPs/content experts will rate the importance of each component of the guideline questions (e.g. relevant outcomes) on a 9-point ordinal scale. Three levels of patient/family/advocate and HCP ratings will be surveyed: those on the GDGs, those participating in online public comment, and via survey of the larger population. Differences in importance ratings will be compared using Wilcoxon Rank Sum Tests. For Aim #3, a qualitative analysis will compare the final consensus CPG questions to the questions posed in Aim #1. To achieve these aims, Dr. Armstrong will use mentored skills including training in patient engagement, patient-centered outcomes research, qualitative methods, and dissemination/implementation strategies. Investigating the effect of patient, family, and advocate involvement on CPGs is critical in order to address important healthcare questions such as whether guideline developers miss key questions by excluding these stakeholders, whether guidelines are addressing health outcomes of importance to patients, and whether variable stakeholder engagement explains CPG inconsistencies. The knowledge gained from this study will further the ultimate goal of understanding whether patient engagement facilitates CPG acceptance and implementation by end-users in order to enhance provision of evidence-based and personalized healthcare for millions of Americans with chronic disease.