دورية أكاديمية
أعرض في EDS

The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study.

التفاصيل البيبلوغرافية
العنوان: The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study.
المؤلفون: O'Brien EC; Duke Clinical Research Institute, Durham, NC, USA. emily.obrien@duke.edu.; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA. emily.obrien@duke.edu., Raman SR; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA., Ellis A; Duke Clinical Research Institute, Durham, NC, USA.; UCB, Durham, NC, USA., Hammill BG; Duke Clinical Research Institute, Durham, NC, USA.; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA., Berdan LG; Duke Clinical Research Institute, Durham, NC, USA., Rorick T; Duke Clinical Research Institute, Durham, NC, USA., Janmohamed S; GlaxoSmithKline, Durham, NC, USA., Lampron Z; Duke Clinical Research Institute, Durham, NC, USA., Hernandez AF; Duke Clinical Research Institute, Durham, NC, USA.; Department of Medicine, Duke University School of Medicine, Durham, NC, USA., Curtis LH; Duke Clinical Research Institute, Durham, NC, USA.; Department of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
المصدر: Trials [Trials] 2021 Jul 19; Vol. 22 (1), pp. 465. Date of Electronic Publication: 2021 Jul 19.
نوع المنشور: Journal Article; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Diabetes Mellitus, Type 2*/diagnosis , Diabetes Mellitus, Type 2*/drug therapy , Electronic Health Records*, Asia ; Humans ; North America ; Surveys and Questionnaires
مستخلص: Background: The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment.
Methods: We conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial.
Results: Nearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific.
Conclusions: While EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification.
Trial Registration: ClinicalTrials.gov NCT02465515. Registered on 8 June 2015.
(© 2021. The Author(s).)
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فهرسة مساهمة: Keywords: Clinical trials; Electronic health records; Recruitment; Screening
سلسلة جزيئية: ClinicalTrials.gov NCT02465515
تواريخ الأحداث: Date Created: 20210720 Date Completed: 20210721 Latest Revision: 20210723
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC8287813
DOI: 10.1186/s13063-021-05397-0
PMID: 34281607
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-021-05397-0