Evidence map›Paper›PMID 28923013›Full record

ArticleBMC medical research methodology2017

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

Kevin P Weinfurt, Adrian F Hernandez, Gloria D Coronado, Lynn L DeBar, Laura M Dember, Beverly B Green, Patrick J Heagerty, Susan S Huang, Kathryn T James, Jeffrey G Jarvik and 11 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC medical research methodology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03713333 (Implementation of High Definition Screening Using Handheld Imaging and Digital Health Technologies Within a Learning Health System to Identify Cardiovascular Disease at the Point-of-care), which is not on this map. Cited by 115 papers.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed
83.2field-weighted citation impact, top 1% 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.

NCT03713333 nacompletednot on this mapstarted 2018, after this paper: background citation

Implementation of High Definition Screening Using Handheld Imaging and Digital Health Technologies Within a Learning Health System to Identify Cardiovascular Disease at the Point-of-care: The ASE-INNOVATE Program

TypeinterventionalSponsorScripps HealthRan2018 to 2020Enrolled374ConditionsCardiovascular Diseases, Hypertension, Heart Failure, Atrial FibrillationArmsDigital Health Device Diagnostics
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 183 citations in OpenAlex.

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  14. A Framework of Institutional Obligations for Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2026
    Article
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55 more citing papers are in PubMed but not listed here.

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

21 authors at 12 institutions in 1 country.

Kevin P WeinfurtDepartment of Population Health Sciences, Duke University School of Medicine, 220 W Main St., Suite 720A, Durham, NC, 27705, USA. kevin.weinfurt@duke.edu.
Adrian F HernandezDuke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
Gloria D CoronadoKaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
Lynn L DeBarKaiser Permanente Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
Laura M DemberPerelman School of MedicineBlockley Hall, Office 920, 423 Guardian Drive, Philadelphia, PA, 19104, USA.
Beverly B GreenKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
Patrick J HeagertyUniversity of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
Susan S HuangUniversity of California Irvine School of Medicine, 101 The City Drive South, City Tower, Suite 400, Mail Code: 4081, Orange, CA, 92868, USA.
Kathryn T JamesUniversity of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
Jeffrey G JarvikUniversity of Washington, 325 Ninth Ave, Box 359728, Seattle, WA, 98104-2499, USA.
Eric B LarsonGroup Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
Vincent MorDepartment of Community Health, Brown University, Box G-S121-2, Providence, RI, 02912, USA.
Richard PlattDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA.
Gary E RosenthalDepartment of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Edward J SeptimusHospital Corporation of America Nashville TN, AND Texas A&M College of Medicine, One Park Plaza, Nashville, TN, 37203, USA.
Gregory E SimonKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA, 98101-1466, USA.
Karen L StamanCHB Wordsmith, Inc., 22 Bagwell Ave, Raleigh, NC, 27607, USA.
Jeremy SugarmanJohns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Room 203, Baltimore, MD, 21205, USA.
Miguel VazquezUniversity of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390-8856, USA.
Douglas ZatzickUniversity of Washington School of Medicine, 325 9th Ave, Seattle, WA, 98104, USA.
Lesley H CurtisDuke Clinical Research Institute, 2400 Pratt St., Durham, NC, 27710, USA.
University of Washington · USKaiser Permanente Washington Health Research Institute · USDuke University · USKaiser Permanente Center for Health Research · USAshland (United States) · USBrown University · USClinical Research Institute · USHarvard Pilgrim Health Care · USHCA Healthcare · USThe University of Texas Southwestern Medical Center · USUniversity of California, Irvine · USWake Forest University · US

Funding

Health Care Systems Research Collaboratory SupplementU54AT007748 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2012 to 2017
$15.1M
PPACT Administrative Supplement for Research on Sleep Disturbances and Impact on Chronic PainUH3NS088731 · NINDS · KAISER FOUNDATION RESEARCH INSTITUTE · PI DEBAR, LYNN L. · 2014 to 2017
$7.7M
Decreasing Bioburden to Reduce Healthcare-Associated Infections and ReadmissionsUH3AI113337 · NIAID · UNIVERSITY OF CALIFORNIA-IRVINE · PI HUANG, SUSAN S. · 2014 to 2017
$6.2M
PROVEN: PRagmatic trial Of Video Education in Nursing homesUH3AG049619 · NIA · BROWN UNIVERSITY · PI MITCHELL, SUSAN L, MOR, VINCENT · 2015 to 2018
$6.2M
Strategies and Opportunities to Stop Colon Cancer in Priority PopulationsUH3CA188640 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI CORONADO, GLORIA D · 2014 to 2017
$6.1M
A Pragmatic Trial of Lumbar Image Reporting with Epidemiology (LIRE)UH3AR066795 · NIAMS · UNIVERSITY OF WASHINGTON · PI JARVIK, JEFFREY G · 2014 to 2017
$6.0M
Pragmatic Trials in Maintenance HemodialysisUH3DK102384 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI DEMBER, LAURA M · 2013 to 2016
$5.8M
Improving Chronic Disease Management with Pieces (ICD-Pieces)UH3DK104655 · NIDDK · UT SOUTHWESTERN MEDICAL CENTER · PI VAZQUEZ, MIGUEL A · 2015 to 2019
$5.6M
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and ComorbidityUH3MH106338 · NIMH · UNIVERSITY OF WASHINGTON · PI ZATZICK, DOUGLAS F · 2015 to 2018
$5.5M
DECREASING BIOBURDEN TO REDUCE HEALTHCARE-ASSOCIATED INFECTIONS AND READMISSIONSUH2AT007769 · NCCIH · UNIVERSITY OF CALIFORNIA-IRVINE · PI HUANG, SUSAN S. · 2012 to 2013
$1.0M
PROVEN: PRagmatic trial Of Video Education in Nursing homesUH2AG049619 · NIA · BROWN UNIVERSITY · PI MITCHELL, SUSAN L, MOR, VINCENT · 2014 to 2014
$860k
Strategies and Opportunities to Stop Colon Cancer in Priority PopulationsUH2AT007782 · NCCIH · KAISER FOUNDATION RESEARCH INSTITUTE · PI CORONADO, GLORIA D, DEVOE, JENNIFER E · 2012 to 2013
$859k
NCCIH NIH HHS U54 AT007748NCCIH NIH HHS UH2 AT007755NCCIH NIH HHS UH2 AT007766NCCIH NIH HHS UH2 AT007769NCCIH NIH HHS UH2 AT007782NCCIH NIH HHS UH2 AT007784NCCIH NIH HHS UH2 AT007788NCCIH NIH HHS UH2 AT007797NCI NIH HHS UH3 CA188640NIAID NIH HHS UH3 AI113337NIAMS NIH HHS UH3 AR066795NIA NIH HHS UH2 AG049619NIA NIH HHS UH3 AG049619NIDDK NIH HHS UH2 DK104655NIDDK NIH HHS UH3 DK102384NIDDK NIH HHS UH3 DK104655NIMH NIH HHS UH2 MH106338NIMH NIH HHS UH3 MH106338NINDS NIH HHS UH3 NS088731
6 · The paper itself

Abstract

backgroundThe clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.

methodsTo strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.

resultsIn this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.

conclusionA planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Indexed as

Cost-Benefit AnalysisDecision MakingDelivery of Health CareElectronic Health RecordsHumansNational Institutes of Health (U.S.)Pragmatic Clinical Trials as TopicResearch DesignResearch ReportUnited StatesCluster randomized trialsEmbedded clinical trialsPragmatic clinical researchPragmatic researchStakeholder engagement

Identifiers

PMID28923013
PMCPMC5604499
OpenAlexW2754542146

What OpenQuestion holds

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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.