Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.
Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.
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DOI：
10.1177/1740774513493149
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Dew MA
中科院分区：
文献类型：
--
作者：
DeVito Dabbs A;Song MK;Myers B;Hawkins RP;Aubrecht J;Begey A;Connolly M;Li R;Pilewski JM;Bermudez CA;Dew MA
尽管卫生信息技术（IT）干预措施的扩散，但缺乏对针对患者使用的卫生信息技术干预措施进行随机试验的独特考虑因素的描述。我们的目的是评估Pocket PATH®（健康追踪个人助理），这是一种新型的健康IT干预措施，作为如何解决随机对照试验中可能存在的问题的范例，以评估患者使用的健康IT。介绍了研究方案的概述。本文描述了医疗信息技术干预试验的独特考虑因素和策略，以保持平衡、监测数据安全和干预保真度，并在此类试验期间与不断变化的技术保持同步。赋予技术的主权、技术变化的快速步伐、医疗保健中的普遍使用以及维护研究参与者安全的义务，都向研究人员提出了挑战，要求他们在解决这些问题的同时，保持旨在评估供患者使用的医疗信息技术干预措施影响的干预试验的完整性。我们评估Pocket PATH疗效的经验可以为研究人员提供实用指导，指导他们如何遵守进行随机对照试验的既定程序，并包括解决与评估患者使用健康IT相关的独特问题的策略。
Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. Our purpose is to evaluate Pocket PATH® (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial to evaluate health IT intended for patient use. An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies to maintain equipoise, monitor data safety and intervention fidelity, and keep pace with changing technology during such trials are described. The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting randomized controlled trials and include strategies to address the unique issues associated with the evaluation of health IT for patient use.
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影响因子：
7
作者：
Collins, Linda M.;Dziak, John J.;Li, Runze
通讯作者：
Li, Runze
影响因子：
7.3
作者：
DAVIS, FD
通讯作者：
DAVIS, FD
影响因子：
2.1
作者：
DeVito Dabbs A;Dew MA;Myers B;Begey A;Hawkins R;Ren D;Dunbar-Jacob J;Oconnell E;McCurry KR
通讯作者：
McCurry KR
影响因子：
4.2
作者：
Carroll, KM;Nich, C;Rounsaville, BJ
通讯作者：
Rounsaville, BJ
影响因子：
3.5
作者：
Cayton, Harry
通讯作者：
Cayton, Harry