Mc Cord Kimberly A, Ewald Hannah, Ladanie Aviv, Briel Matthias, Speich Benjamin, Bucher Heiner C, Hemkens Lars G
Basel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
CMAJ Open. 2019 Feb 3;7(1):E23-E32. doi: 10.9778/cmajo.20180096. Print 2019 Jan-Mar.
Electronic health records (EHRs) may support randomized controlled trials (RCTs). We aimed to describe the current use and costs of EHRs in RCTs, with a focus on recruitment and outcome assessment.
This descriptive study was based on a PubMed search of RCTs published since 2000 that evaluated any medical intervention with the use of EHRs. Cost information was obtained from RCT investigators who used EHR infrastructures for recruitment or outcome measurement but did not explore EHR technology itself.
We identified 189 RCTs, most of which (153 [81.0%]) were carried out in North America and were published recently (median year 2012 [interquartile range 2009-2014]). Seventeen RCTs (9.0%) involving a median of 732 (interquartile range 73-2513) patients explored interventions not related to EHRs, including quality improvement, screening programs, and collaborative care and disease management interventions. In these trials, EHRs were used for recruitment (14 [82%]) and outcome measurement (15 [88%]). Overall, in most of the trials (158 [83.6%]), the outcome (including many of the most patient-relevant clinical outcomes, from unscheduled hospital admission to death) was measured with the use of EHRs. The per-patient cost in the 17 EHR-supported trials varied from US$44 to US$2000, and total RCT costs from US$67 750 to US$5 026 000. In the remaining 172 RCTs (91.0%), EHRs were used as a modality of intervention.
Randomized controlled trials are frequently and increasingly conducted with the use of EHRs, but mainly as part of the intervention. In some trials, EHRs were used successfully to support recruitment and outcome assessment. Costs may be reduced once the data infrastructure is established.
电子健康记录（EHRs）可能有助于支持随机对照试验（RCTs）。我们旨在描述RCTs中EHRs的当前使用情况和成本，重点关注招募和结局评估。
这项描述性研究基于对2000年以来发表的使用EHRs评估任何医学干预措施的RCTs进行的PubMed检索。成本信息来自使用EHR基础设施进行招募或结局测量但未探索EHR技术本身的RCT研究人员。
我们识别出189项RCTs，其中大部分（153项[81.0%]）在北美开展且近期发表（中位年份为2012年[四分位间距为2009 - 2014年]）。17项RCTs（9.0%）涉及中位数量为732名（四分位间距为73 - 2513名）患者，探索了与EHRs无关的干预措施，包括质量改进、筛查项目以及协作护理和疾病管理干预措施。在这些试验中，EHRs被用于招募（14项[82%]）和结局测量（15项[88%]）。总体而言，在大多数试验（158项[83.6%]）中，结局（包括许多与患者最相关的临床结局，从未计划的住院到死亡）是使用EHRs进行测量的。17项由EHR支持的试验中每位患者的成本从44美元到2000美元不等，RCT的总成本从67750美元到5026000美元不等。在其余172项RCTs（91.0%）中，EHRs被用作一种干预方式。
随机对照试验越来越频繁地使用EHRs进行，但主要作为干预的一部分。在一些试验中，EHRs成功用于支持招募和结局评估。一旦建立数据基础设施，成本可能会降低。
