Evidence map›Paper›PMID 31007049›Full record

Trial reportClinical trials (London, England)2019

Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience.

Vanita R Aroda, Patricia R Sheehan, Ellen M Vickery, Myrlene A Staten, Erin S LeBlanc, Lawrence S Phillips, Irwin G Brodsky, Chhavi Chadha, Ranee Chatterjee, Miranda G Ouellette and 3 more

Abstract readMulticenter StudyObservational StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical trials (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
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  4. Effects of Vitamin D Supplementation on Insulin Sensitivity and Secretion in Prediabetes.The Journal of clinical endocrinology and metabolism · 2022
    Trial
  5. Vitamin D Supplementation and Prevention of Type 2 Diabetes.The New England journal of medicine · 2019
    Trial
  6. Article
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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

13 authors.

Vanita R Aroda1 MedStar Health Research Institute, Hyattsville, MD, USA.
Patricia R Sheehan3 Tufts Medical Center, Boston, MA, USA.
Ellen M Vickery3 Tufts Medical Center, Boston, MA, USA.
Myrlene A Staten4 KGS for The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.ORCID 0000-0001-8610-8917
Erin S LeBlanc5 Kaiser Permanente Center for Health Research NW, Portland, OR, USA.
Lawrence S Phillips6 Atlanta VA Medical Center, Decatur, GA, USA.
Irwin G Brodsky8 Maine Medical Center, Scarborough, ME, USA.
Chhavi Chadha9 HealthPartners, Minneapolis, MN, USA.
Ranee Chatterjee10 Duke University School of Medicine, Durham, NC, USA.
Miranda G Ouellette11 University of Kansas Medical Center, Kansas City, KS, USA.
Cyrus Desouza13 University of Nebraska Medical Center, Omaha, NE, USA.
Anastassios G Pittas3 Tufts Medical Center, Boston, MA, USA.
D2d Research Group

Funding

Vitamin D and Type 2 Diabetes (D2d)U01DK098245 · NIDDK · TUFTS MEDICAL CENTER · PI PITTAS, ANASTASSIOS G · 2013 to 2020
$45.6M
Vitamin D for Type 2 Diabetes (D2D trial)U34DK091958 · NIDDK · TUFTS MEDICAL CENTER · PI PITTAS, ANASTASSIOS G · 2011 to 2012
$792k
NIDDK NIH HHS U01 DK098245NIDDK NIH HHS U34 DK091958
6 · The paper itself

Abstract

aimsTo establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods.

methodsObservational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods.

resultsIn total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level.

conclusionEstablishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.

Indexed as

CholecalciferolDiabetes Mellitus, Type 2Electronic Health RecordsPatient SelectionPrediabetic StateAgedBlood GlucoseComorbidityDietary SupplementsDouble-Blind MethodFeasibility StudiesGlycated HemoglobinHumansMiddle AgedResearch DesignBlood GlucoseCholecalciferolGlycated Hemoglobindiabeteshealth recordsPrediabetesrecruitmenttrial

Identifiers

PMID31007049
PMCPMC6764596

What OpenQuestion holds

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LicenceTDM
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Registered trials

None linked

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.