Evidence map›Paper›PMID 34281607›Full record

ArticleTrials2021

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

Emily C O'Brien, Sudha R Raman, Alicia Ellis, Bradley G Hammill, Lisa G Berdan, Tyrus Rorick, Salim Janmohamed, Zachary Lampron, Adrian F Hernandez, Lesley H Curtis

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465515 (A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02465515 phase4completednot on this map

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2018Enrolled9,463ConditionsDiabetes MellitusArmsAlbiglutide 30 mg, Albiglutide 50 mg, Albiglutide matching placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Emily C O'BrienDuke Clinical Research Institute, Durham, NC, USA. emily.obrien@duke.edu.
Sudha R RamanDepartment of Population Health Sciences, Duke University School of Medicine, 215 Morris Street, Suite 210, Durham, NC, 27701, USA.
Alicia EllisDuke Clinical Research Institute, Durham, NC, USA.
Bradley G HammillDuke Clinical Research Institute, Durham, NC, USA.
Lisa G BerdanDuke Clinical Research Institute, Durham, NC, USA.
Tyrus RorickDuke Clinical Research Institute, Durham, NC, USA.
Salim JanmohamedGlaxoSmithKline, Durham, NC, USA.
Zachary LampronDuke Clinical Research Institute, Durham, NC, USA.
Adrian F HernandezDuke Clinical Research Institute, Durham, NC, USA.
Lesley H CurtisDuke Clinical Research Institute, Durham, NC, USA.
Clinical Research Institute · USDuke University · USGlaxoSmithKline (United States) · USNorth Carolina Central University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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.

resultsNearly 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.

conclusionsWhile 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 registrationClinicalTrials.gov NCT02465515. Registered on 8 June 2015.

Indexed as

Diabetes Mellitus, Type 2Electronic Health RecordsAsiaHumansNorth AmericaSurveys and QuestionnairesClinical trialsElectronic health recordsRecruitmentScreening

Identifiers

PMID34281607
PMCPMC8287813
OpenAlexW3184888007

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.