Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.
Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.
复制标题
DOI：
10.1371/journal.pone.0170905
复制
发表时间：
2017
期刊：
影响因子：
3.7
通讯作者：
Thirumaran RK
中科院分区：
文献类型：
--
作者：
Elliott LS;Henderson JC;Neradilek MB;Moyer NA;Ashcraft KC;Thirumaran RK
在家庭健康管理下的多药患者中，药物遗传学检测结合临床决策支持工具（CDST）关于降低药物、基因和累积相互作用风险的指导，可为处方药治疗提供有价值的见解，减少再次住院和急诊（艾德）就诊。我们评估了整合二元和累积药物和基因相互作用警告的药物遗传学分析对家庭健康多药患者的临床影响。这项前瞻性、开放标签、随机对照试验于2015年2月至2016年2月在一家医院的家庭健康机构进行。招募来自出院时转诊到家庭健康的患者。符合条件的患者年龄在50岁及以上，正在使用或开始使用具有潜在或显著药物-基因相互作用的药物治疗。受试者（n = 110）被随机分配至药物遗传学分析组（n = 57）。研究药剂师使用YouScript® CDST审查药物-药物、药物-基因以及累积药物和/或基因相互作用，为临床医生提供药物治疗建议。对照组（n = 53）接受常规治疗，包括使用标准药物信息资源的药剂师指导的药物管理。主要结果指标是出院后30天和60天再次住院和艾德访视的次数。30天时，试验组与未试验组每例患者的平均再住院次数分别为0.25与0.38（相对风险（RR），0.65; 95%置信区间（CI），0.32-1.28; P = 0.21）和0.33 vs. 0.70（入组后60天）（RR，0.48; 95% CI，0.27-0.82; P = 0.007）。在30天时，试验组与未试验组每例患者的平均艾德访视次数分别为0.25 vs. 0.40（RR，0.62; 95% CI，0.31-1.21; P = 0.16）和0.39 vs. 0.66（RR，0.58; 95% CI，0.34-0.99; P = 0.045）。在60天的复合结局（探索性终点）中也发现了差异。在向临床医生传达的124项药物治疗建议中，96项（77%）被遵循。这些发现应通过更多的前瞻性验证性研究进行验证，这些研究涉及更大人群中的实际应用，以扩大常规临床实践的可接受性。在适当的CDST支持下，对50岁及以上的多药患者进行药物遗传学检测，大大减少了入组后60天的再次住院和艾德访视，从而节省了潜在的卫生资源利用并改善了医疗保健。ClinicalTrials.gov www.example.com
In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at 60 days (exploratory endpoints) were also found. Of the total 124 drug therapy recommendations passed on to clinicians, 96 (77%) were followed. These findings should be verified with additional prospective confirmatory studies involving real-world applications in larger populations to broaden acceptance in routine clinical practice. Pharmacogenetic testing of polypharmacy patients aged 50 and older, supported by an appropriate CDST, considerably reduced re-hospitalizations and ED visits at 60 days following enrollment resulting in potential health resource utilization savings and improved healthcare. ClinicalTrials.gov NCT02378220