临床试验中药物无线电子监测的可取性与可行性。
Desirability and feasibility of wireless electronic monitoring of medications in clinical trials.
作者信息
Robiner William N, Flaherty Nancy, Fossum Thyra A, Nevins Thomas E
机构信息
Health Psychology, Department of Medicine, University of Minnesota Medical School, Mayo Mail Code 741, 420 Delaware Street, S.E., Minneapolis, MN 55455 USA ; Department of Pediatrics, University of Minnesota Medical School, 420 Delaware Street, S.E., 13-152 Phillips-Wangensteen Building, Minneapolis, MN 55455 USA.
Department of Pediatrics, University of Minnesota Medical School, 420 Delaware Street, S.E., 13-152 Phillips-Wangensteen Building, Minneapolis, MN 55455 USA.
出版信息
Transl Behav Med. 2015 Sep;5(3):285-93. doi: 10.1007/s13142-015-0316-1.
Medication nonadherence is a vexing problem in health care necessitating patients and health professionals' efforts to prevent, minimize, or reverse it. Research participants' inconsistent medication taking obscures treatment efficacy and adds costs to biomedical research. Electronic monitoring devices (EMDs), like the Medication Event Monitoring System (MEMS), have grown in sophistication, providing precise, timely insights into individuals' medication-taking patterns across clinical populations. This article reports on the desirability and feasibility study of using a wireless EMD in clinical research to promote adherence to clinical regimens and research protocols. Nonadherence in transplant patients has been linked to late acute rejection and graft loss. High levels of adherence (97.7 %) were documented for six renal transplant recipients for a mean of 6 months (M = 196.1 ± 71.2 days) who indicated acceptance of the technology. MEMS data confirmed the feasibility of using wireless EMDs to monitor medication use. Monitoring provides greater assurance that research studies reflect the biological impact of medications and provide a basis for targeting adherence enhancement efforts within research investigations.
药物治疗依从性不佳是医疗保健领域一个棘手的问题，需要患者和医疗专业人员努力预防、尽量减少或扭转这种情况。研究参与者服药不规律会掩盖治疗效果，并增加生物医学研究的成本。诸如药物事件监测系统（MEMS）之类的电子监测设备（EMD）已经越来越精密，能够针对临床人群中个体的服药模式提供精确、及时的洞察。本文报告了在临床研究中使用无线EMD以促进对临床治疗方案和研究方案依从性的可行性和可取性研究。移植患者的依从性不佳与晚期急性排斥反应和移植物丢失有关。记录显示，6名肾移植受者在平均6个月（M = 196.1±71.2天）的时间里依从性较高（97.7%），他们表示接受该技术。MEMS数据证实了使用无线EMD监测药物使用情况的可行性。监测能更有力地确保研究反映药物的生物学影响，并为在研究调查中针对性地加强依从性努力提供依据。
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