Pharmacogenetic Testing: Challenges of Clinical Integration

描述（由申请人提供）：将药物遗传学（PGx）测试整合到初级保健中正在迅速发展。据估计，有四分之一的门诊病人正在服用产品标签上含有PGx信息的药物，其中大多数是由初级保健医生开出的。我们之前从母体R01 （R01 GM081416, Haga， PI）的工作表明，公众对PGx测试非常感兴趣。然而，由于缺乏对现有检测方法的认识、缺乏对遗传学和药物反应的知识、缺乏确凿的临床证据、关于何时订购检测以及针对哪种药物或患者的问题、以及对覆盖范围和报销的担忧，医生对将PGx检测纳入临床实践的热情较低。因此，为了提高医生的知识，解决如何以及何时将PGx检测整合到临床护理中的问题，并促进PGx检测与治疗决策的整合，本更新建议将重点放在评估PGx检测的交付模式上。我们将在初级保健实践中实施和评估两种提供PGx测试的模式：医生发起的测试和药剂师发起的测试。每个实践将提供一个教育干预（研讨会，内部网模块，药物口袋指南适用的PGx测试）。在由医生发起的小组中，医生也会有随叫随到的药剂师支持。在药剂师发起的小组中，基于实践的药剂师将通过图表审查确定处方药物和可用的PGx测试，并向订购医生提供关于PGx测试的具体信息和建议。该研究旨在从医生、患者和实践环境三个角度评估PGx检测的交付。交付模式的有效性将通过6个月干预期间与干预前6个月和干预后6个月相比的新处方和最近处方（少于1个月）的剂量调整次数和不良反应以及每次诊所的就诊次数来评估，以评估任何变化的变化和持久性（目标1）。在研究的开始和结束时，将对每个实践的提供者进行调查，以评估对PGx检测的知识和态度的变化以及检测的感知价值和障碍（目标2）。同样，我们将对接受PGx检测的患者进行随访，以探讨检测的感知价值和风险，影响其检测决策的因素，以及基于检测结果的治疗满意度（目的3）。我们还将进行经济分析，以评估和比较与每种递送模式相关的成本，以及与靶向药物、相关监测成本和药物不良事件相关的成本（目标4）。这些结果将提供关于在初级保健实践中整合PGx检测的两种交付模式的吸收、影响、障碍和成本的基本信息。

DESCRIPTION (provided by applicant): The integration of pharmacogenetic (PGx) testing into primary care is rapidly evolving. It has been estimated that one-fourth of outpatients are taking medications containing PGx information in their product labels, the majority of which are prescribed by primary care physicians. Our previous work from the parent R01 (R01 GM081416, Haga, PI) indicated that the general public is very interested in PGx testing. However, physicians are less enthusiastic about integrating PGx testing into clinical practice, due lack of awareness of available tests, lack of knowledge about genetics and drug response, lack of conclusive clinical evidence, questions about when to order testing and for which drugs or patients, and concerns regarding coverage and reimbursement. Thus, to improve physician knowledge, address issues about how and when to integrate PGx testing into clinical care, and to facilitate integration of PGx testing into therapeutic decision-making this renewal proposal will focus on assessing delivery models of PGx testing. We will implement and evaluate two delivery models of PGx testing into primary care practices: physician-initiated testing and pharmacist-initiated testing. Each practice will be provided an educational intervention (seminars, Intranet module, and pocket guide of drugs with applicable PGx testing). In the physician-initiated group, physicians will also have on-call pharmacist support. In the pharmacist-initiated group, a pharmacist based within the practice will identify prescribed drugs with available PGx testing through chart review and provide specific information and recommendations about PGx testing to the ordering physician. The proposed study aims to evaluate the delivery of PGx testing from three perspectives: physician, patient, and practice setting. Effectiveness of the delivery models will be evaluated by the number of dosage adjustments and adverse responses for new and recent prescriptions (less than 1month) of target drugs and number of office visits in each practice during the 6- month intervention period compared to the 6 months prior to the intervention and the 6 months following the intervention in order to assess change and durability of any changes (Aim 1). Providers in each practice will be surveyed at the start and conclusion of the study to assess changes in knowledge and attitudes of PGx testing and perceived value of and barriers to testing (Aim 2). Similarly, we will follow-up with patients offered PGx testing to explore the perceived value and risks of testing, factors influencing their decision about testing, , and their satisfaction with treatment based on the test result (Aim 3). We will also perform an economic analysis to evaluate and compare the costs associated with each delivery model as well as costs associated with targeted medications, associated monitoring costs, and adverse drug events (Aim 4). These results will provide essential information on the uptake, impact, barriers, and cost of two delivery models for integration of PGx testing in primary care practices.