Stille Christopher J, Lockhart Steven A, Maertens Julie A, Madden Christi A, Darden Paul M
University of Colorado School of Medicine.
University of Oklahoma Health Sciences Center.
EGEMS (Wash DC). 2015 Feb 10;3(1):1111. doi: 10.13063/2327-9214.1111. eCollection 2015.
Primary care practice-based research has become more complex with increased use of electronic health records (EHRs). Little has been reported about changes in study planning and execution that are required as practices change from paper-based to electronic-based environments. We describe the evolution of a pediatric practice-based intervention study as it was adapted for use in the electronic environment, to enable other practice-based researchers to plan efficient, effective studies.
We adapted a paper-based pediatric office-level intervention to enhance parent-provider communication about subspecialty referrals for use in two practice-based research networks (PBRNs) with partially and fully electronic environments. We documented the process of adaptation and its effect on study feasibility and efficiency, resource use, and administrative and regulatory complexities, as the study was implemented in the two networks.
Considerable time and money was required to adapt the paper-based study to the electronic environment, requiring extra meetings with institutional EHR-, regulatory-, and administrative teams, and increased practice training. Institutional unfamiliarity with using EHRs in practice-based research, and the consequent need to develop new policies, were major contributors to delays. Adapting intervention tools to the EHR and minimizing practice disruptions was challenging, but resulted in several efficiencies as compared with a paper-based project. In particular, recruitment and tracking of subjects and data collection were easier and more efficient.
Practice-based intervention research in an electronic environment adds considerable cost and time at the outset of a study, especially for centers unfamiliar with such research. Efficiencies generated have the potential of easing the work of study enrollment, subject tracking, and data collection.
随着电子健康记录（EHRs）使用的增加，基于初级保健实践的研究变得更加复杂。关于从纸质环境转变为电子环境时研究规划和执行所需的变化，鲜有报道。我们描述了一项基于儿科实践的干预研究在适应电子环境时的演变过程，以使其他基于实践的研究人员能够规划高效、有效的研究。
我们对一项基于纸质的儿科办公室层面的干预措施进行了调整，以加强关于专科转诊的医患沟通，用于两个部分或完全电子化环境的基于实践的研究网络（PBRN）。在两个网络中实施该研究时，我们记录了调整过程及其对研究可行性和效率、资源使用以及行政和监管复杂性的影响。
将基于纸质的研究适应电子环境需要大量的时间和资金，需要与机构的电子健康记录、监管和行政团队额外开会，并增加实践培训。机构在基于实践的研究中对使用电子健康记录不熟悉，以及因此需要制定新政策，是导致延迟的主要因素。使干预工具适应电子健康记录并尽量减少对实践的干扰具有挑战性，但与基于纸质的项目相比，带来了一些效率提升。特别是，受试者的招募、跟踪和数据收集变得更加容易和高效。
在电子环境中进行基于实践的干预研究在研究开始时会增加相当多的成本和时间，尤其是对于不熟悉此类研究的中心。所产生的效率有可能减轻研究入组、受试者跟踪和数据收集的工作负担。
