PDF(Pubmed)
Abstract：
BACKGROUND: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.
OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.
METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.
RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group.
CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.
OBJECTIVE: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.
METHODS: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.
RESULTS: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P=.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA1c], lower C-reactive protein levels) than the nonresponse group.
CONCLUSIONS: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.
摘要：
背景：电子知情同意书（eIC）由于包括增加注册和提高效率在内的多种益处而越来越多地用于临床研究。在学习型医疗保健系统中，与eIC进行了试点，将电子健康记录中的数据与国家注册管理机构联系起来，全科医生,和其他医院。
目的：我们通过比较对eIC的反应与以前的传统纸质知情同意书（IC）来评估eIC试点。我们通过比较eIC的反应类别和以前的面对面IC程序之间的临床患者特征来评估eIC的使用是否导致不同的研究人群。
方法：所有心血管风险增加的患者访问乌得勒支大学医学中心，荷兰,有资格学习医疗保健系统。从2021年11月到2022年8月，eIC在心脏病学门诊进行了试点。在飞行员之前，使用传统的面对面纸质IC方法。回应(即，同意,没有同意,或无应答)在eIC和面对面IC队列之间进行评估和比较。使用多元回归分析，在eIC和面对面队列之间和内部比较了同意和无反应患者的临床特征。
结果：共有2254名患者被纳入面对面IC队列，885名患者被纳入eIC队列。与面对面队列相比，在eIC中获得完全同意的频率更高（415/885，46.9％vs876/2254，38.9％，分别)。除了eIC队列的完全同意组的平均血红蛋白较低（8.5vs8.8；P=.0021），在eIC和面对面IC队列中,完全同意患者的特征没有差异.在eIC队列中，完全同意组和无反应组之间仅年龄不同（中位数分别为60和56；P=.0002），而在面对面的IC队列中，完全同意小组似乎更健康(即，更高的血红蛋白，低糖化血红蛋白[HbA1c]，C反应蛋白水平较低）。
结论：更多患者提供了使用eIC的完全同意书。此外,研究人群大致相似.面对面的IC方法似乎导致更健康的研究人群(即，完全同意患者)比没有IC的患者，而在eIC队列中，同意组之间的特征具有可比性.因此，eIC可能会导致目标人群的更好代表性，增加结果的普遍性。
目的：我们通过比较对eIC的反应与以前的传统纸质知情同意书（IC）来评估eIC试点。我们通过比较eIC的反应类别和以前的面对面IC程序之间的临床患者特征来评估eIC的使用是否导致不同的研究人群。
方法：所有心血管风险增加的患者访问乌得勒支大学医学中心，荷兰,有资格学习医疗保健系统。从2021年11月到2022年8月，eIC在心脏病学门诊进行了试点。在飞行员之前，使用传统的面对面纸质IC方法。回应(即，同意,没有同意,或无应答)在eIC和面对面IC队列之间进行评估和比较。使用多元回归分析，在eIC和面对面队列之间和内部比较了同意和无反应患者的临床特征。
结果：共有2254名患者被纳入面对面IC队列，885名患者被纳入eIC队列。与面对面队列相比，在eIC中获得完全同意的频率更高（415/885，46.9％vs876/2254，38.9％，分别)。除了eIC队列的完全同意组的平均血红蛋白较低（8.5vs8.8；P=.0021），在eIC和面对面IC队列中,完全同意患者的特征没有差异.在eIC队列中，完全同意组和无反应组之间仅年龄不同（中位数分别为60和56；P=.0002），而在面对面的IC队列中，完全同意小组似乎更健康(即，更高的血红蛋白，低糖化血红蛋白[HbA1c]，C反应蛋白水平较低）。
结论：更多患者提供了使用eIC的完全同意书。此外,研究人群大致相似.面对面的IC方法似乎导致更健康的研究人群(即，完全同意患者)比没有IC的患者，而在eIC队列中，同意组之间的特征具有可比性.因此，eIC可能会导致目标人群的更好代表性，增加结果的普遍性。
