Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

IGNITE（在实践中实施基因组学）联盟的建立是为了加强基因组学的使用。 通过支持开发将基因组信息纳入临床护理的方法， 并探索在不同临床领域有效实施、传播和可持续发展的方法。 设置. IGNITE II赠款旨在为选定的实用临床试验奠定基础。作为 作为网络资金的一部分，印第安纳州大学临床小组正在招募参与者， ADOPT-PGx（药物遗传学中的抑郁症和阿片类药物实用性试验）和GUARDD-US（遗传学 了解和解决美国肾脏疾病差异的测试）临床试验。 GUARDD-US：该试验旨在招募患有高血压的非裔美国人，有或没有慢性肾脏疾病 疾病，随机分为立即与延迟返回APOL 1基因检测结果。在那些 APOL 1阴性，我们还将进行一项初步研究，以测试药物遗传学检测对收缩压的影响。 血压.次要结局包括慢性肾脏疾病患者6个月收缩压 患者，医嘱药物，肾脏诊断和检测，患者心理行为结局，费用 有效性，以及药物遗传学指导的高血压管理对收缩压的影响。 ADOPT-PGx：这项随机、实用的基因型指导临床试验测试了基因型指导的 在三种情况下的患者治疗：急性手术后疼痛，慢性疼痛和抑郁症。为每个 在这种情况下，参与者被随机分配到基因型指导的药物治疗组，而不是常规的药物治疗组。 治疗选择患者报告的结果变化代表使用 标准PROMIS量表定义了主要终点。次要分析包括安全性终点、变化 在整体幸福感和经济影响代表的差异，在医疗保健利用。 行政补编支持继续和结束GUARDD-US和ADOPT-PGx。

The IGNITE (Implementing Genomics in Practice) Consortium was created to enhance the use of genomic medicine by supporting the development of methods for incorporating genomic information into clinical care and exploration of the methods for effective implementation, diffusion and sustainability in diverse clinical settings. The IGNITE II grant was designed to establish the foundation for selected pragmatic clinical trials. As part of the network funding, the Indiana University Clinical Group is recruiting participants into both the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) and GUARDD-US (Genetic Testing to Understand and Address Renal Disease Disparities across the United States) clinical trials. GUARDD-US: This trial aims to recruit African Americans with hypertension, with or without chronic kidney disease, randomized to immediate versus delayed return of APOL1 genetic testing results. In those who are APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic testing on systolic blood pressure. Secondary outcomes include 6-month systolic blood pressure in chronic kidney disease patients, medications ordered, renal diagnosis and testing, patient psycho-behavioral outcomes, cost effectiveness, and the effect of pharmacogenetic-guided hypertension management on systolic blood pressure. ADOPT-PGx: This randomized pragmatic genotype-guided clinical trial tests the effect of genotype-guided therapy in three scenarios of patients: acute post-surgical pain, chronic pain, and depression. For each scenario, participants are randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection. Changes in patient reported outcomes representing pain and depression control using standard PROMIS scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization. The Administrative Supplement supports the continuation and conclusion of GUARDD-US and ADOPT-PGx.