Comparison of Clinical Characteristics Between Clinical Trial Participants and Nonparticipants Using Electronic Health Record Data.
Comparison of Clinical Characteristics Between Clinical Trial Participants and Nonparticipants Using Electronic Health Record Data.
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DOI：
10.1001/jamanetworkopen.2021.4732
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发表时间：
2021-04-01
影响因子：
13.8
通讯作者：
Weng C
中科院分区：
文献类型：
--
作者：
Rogers JR;Liu C;Hripcsak G;Cheung YK;Weng C
这项横断面研究使用电子健康记录和临床试验入组数据来评估试验参与者和非参与者临床特征的差异。临床试验参与者和非参与者之间的临床特征是否存在电子健康记录数据所捕获的差异？在这项对1645名临床试验参与者和1645名匹配的非参与者进行的横断面研究中，大多数试验参与者的基础疾病和药物使用比非参与者少。这些研究结果表明，一个更全面的方法来评估试验可能有利于解决临床试验结果的普遍性的关注。评估临床试验的可推广性对于确保干预措施的适当应用非常重要，但大多数评估提供了最小的临床特征比较粒度。通过结合使用电子健康记录和试验入组数据，评估临床试验参与者和非参与者之间潜在临床差异的程度。这项横断面研究使用了1996年9月至2019年1月期间从一个学术医学中心获得的数据，从该中心进行的202项可用试验中确定了1645名临床试验参与者。使用一个汇总的再分配程序，非参与者与参与者根据试验条件，最近访问医疗保健专业人员的次数和日历时间1：1匹配。临床试验入组与未入组。主要结果是临床试验中参与者和非参与者之间临床特征的标准化差异，这些临床试验分为4个最常见的疾病领域。这项横断面研究包括来自202项试验的1645名参与者（929名[56.5%]男性;平均[SD]年龄，54.65 [21.38]岁）和一组1645名非参与者（855名[52.0%]男性;平均[SD]年龄，57.24 [21.91]岁）。所选试验中最常见的疾病领域是肿瘤性疾病（86项试验; 737例受试者）、消化系统疾病（31项试验; 321例受试者）、炎症性疾病（28项试验; 276例受试者）和心血管系统疾病（27项试验; 319例受试者）;试验可能符合多个疾病领域的要求。在31种疾病中，根据标准化差异，参与者中患病率低于非参与者的疾病百分比为64.5%（20种疾病），肿瘤疾病试验为61.3%（19种），消化系统试验为61.3%（19种），炎症性疾病试验为58.1%（18种），心血管系统试验为38.7%（12种）。在17种药物中，根据标准化差异，参与者使用的药物比例低于非参与者，肿瘤性疾病试验为64.7%（11），消化系统试验为58.8%（10），炎症性疾病试验为88.2%（15），心血管系统试验为52.9%（9）。结合使用电子健康记录和试验入组数据，本研究发现，在各种疾病领域，临床试验参与者的合并症和药物使用比非参与者少。将试验入组数据与电子健康记录数据相结合可能有助于更好地理解试验结果的普遍性。
This cross-sectional study uses electronic health records and clinical trial enrollment data to assess differences in the clinical characteristics of trial participants and nonparticipants. Are there differences in clinical characteristics between clinical trial participants and nonparticipants as captured by electronic health record data? In this cross-sectional study of 1645 clinical trial participants and an aggregated set of 1645 matched nonparticipants, most of the trial participants had fewer underlying conditions and less medication use than nonparticipants. These findings suggest that a more comprehensive approach to evaluating trials may be beneficial for addressing concerns about the generalizability of clinical trial results. Assessing generalizability of clinical trials is important to ensure appropriate application of interventions, but most assessments provide minimal granularity on comparisons of clinical characteristics. To assess the extent of underlying clinical differences between clinical trial participants and nonparticipants by using a combination of electronic health record and trial enrollment data. This cross-sectional study used data obtained from a single academic medical center between September 1996 and January 2019 to identify 1645 clinical trial participants from a diverse set of 202 available trials conducted at the center. Using an aggregated resampling procedure, nonparticipants were matched to participants 1:1 based on trial conditions, number of recent visits to a health care professional, and calendar time. Clinical trial enrollment vs no enrollment. The primary outcome was standardized differences in clinical characteristics between participants and nonparticipants in clinical trials stratified into the 4 most common disease domains. This cross-sectional study included 1645 participants from 202 trials (929 [56.5%] male; mean [SD] age, 54.65 [21.38] years) and an aggregated set of 1645 nonparticipants (855 [52.0%] male; mean [SD] age, 57.24 [21.91] years). The most common disease domains for the selected trials were neoplastic disease (86 trials; 737 participants), disorders of the digestive system (31 trials; 321 participants), inflammatory disorders (28 trials; 276 participants), and disorders of the cardiovascular system (27 trials; 319 participants); trials could qualify for multiple disease domains. Among 31 conditions, the percentage of conditions for which the prevalence was lower among participants than among nonparticipants per standardized differences was 64.5% (20 conditions) for neoplastic disease trials, 61.3% (19) for digestive system trials, 58.1% (18) for inflammatory disorder trials, and 38.7% (12) for cardiovascular system trials. Among 17 medications, the percentage of medications for which use was less among participants than among nonparticipants per standardized differences was 64.7% (11) for neoplastic disease trials, 58.8% (10) for digestive system trials, 88.2% (15) for inflammatory disorder trials, and 52.9% (9) for cardiovascular system trials. Using a combination of electronic health record and trial enrollment data, this study found that clinical trial participants had fewer comorbidities and less use of medication than nonparticipants across a variety of disease domains. Combining trial enrollment data with electronic health record data may be useful for better understanding of the generalizability of trial results.
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