Evidence map›Paper›PMID 32605679›Full record

ArticleCardiology in the young2020

Registry-based trials: a potential model for cost savings?

Brett R Anderson, Evelyn G Gotlieb, Kevin Hill, Kimberly E McHugh, Mark A Scheurer, Carlos M Mery, Glenn J Pelletier, Jonathan R Kaltman, Owen J White, Felicia L Trachtenberg and 14 more

Open access · greenAbstract read
In one paragraph

Article in Cardiology in the young, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% 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.

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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. ENDOCOR: a nationwide consortium of endocarditis teams-initiating a registry for infective endocarditis within the Netherlands Heart Registration.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2025
    Article
  4. Article
  5. Review
  6. Observational
  7. Article
  8. Review
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

24 authors at 18 institutions in 2 countries.

Brett R AndersonDivision of Pediatric Cardiology, NewYork-Presbyterian/Morgan Stanley Children's Hospital, Columbia University Irving Medical Center, New York, NY, USA.
Evelyn G GotliebThe Wharton School, University of Pennsylvania, Philadelphia, PA, USA.ORCID https://orcid.org/0000-0002-9809-4046
Kevin HillDepartment of Pediatrics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Kimberly E McHughDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
Mark A ScheurerDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC, USA.
Carlos M MeryTexas Center for Pediatric and Congenital Heart Disease, Dell Children's Medical Center, University of Texas Dell Medical School, Austin, TX, USA.
Glenn J PelletierDivision of Cardiac Surgery, Nemours Cardiac Center, Alfred I duPont Hospital for Children, Wilmington, DE, USA.
Jonathan R KaltmanNational Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
Owen J WhiteCardioAccess, Fort Lauderdale, FL, USA.
Felicia L TrachtenbergNew England Research Institutes, Watertown, MA, USA.
Danielle Hollenbeck-PringleNew England Research Institutes, Watertown, MA, USA.
Brian W McCrindleDepartment of Cardiology at SickKids, Labatt Family Heart Centre, University of Toronto, The Hospital for Sick Children, Toronto, Canada.
Donna M SylvesterDepartment of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Aaron W EckhauserSection of Pediatric Cardiothoracic Surgery, Division of Cardiothoracic Surgery, Department of Surgery, University of Utah, Salt Lake City, UT, USA.ORCID https://orcid.org/0000-0001-6436-7504
Sara K PasqualiDivision of Pediatric Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Jeffery B AndersonDivision of Pediatric Cardiology, Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
Marcus S SchambergerDivision of Pediatric Cardiology, Riley Children's Hospital, Indianapolis, IN, USA.
Subhadra ShashidharanDivision of Cardiovascular Surgery, Children's Healthcare of Atlanta, Atlanta, GA, USA.
Jeffrey P JacobsDivision of Cardiovascular Surgery, Department of Surgery, Johns Hopkins All Children's Heart Institute, St. Petersburg, FL, USA.
Marshall L JacobsDivision of Cardiac Surgery, Department of Surgery, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Marko BoskovskiDivision of Cardiac Surgery, Harvard Medical School, The Brigham and Women's Hospital, Boston, MA, USA.
Jane W NewburgerDepartment of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Meena NathanDepartment of Pediatrics, Harvard Medical School, Boston, MA, USA.
Pediatric Heart Network
Boston Children's Hospital · USJohns Hopkins University · USMedical University of South Carolina · USNew England Research Institutes · USAlfred I. duPont Hospital for Children · USBrigham and Women's Hospital · USChildren's Healthcare of Atlanta · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USClinical Research Institute · USC. S. Mott Children's Hospital · USDell Children's Medical Center of Central Texas · USMorgan Stanley Children's Hospital · USNational Institutes of Health · USRiley Hospital for Children · USUniversity of Pennsylvania · USUniversity of Toronto · CAUniversity of Utah · US

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
Ventricular Volumes and Varability (VVV)U01HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI SLEEPER, LYNN A · 2001 to 2010
$40.3M
MIS-C Program: Data Coordinating Center for the Pediatric Heart Network MIS-C ProgramU24HL135691 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2017 to 2024
$37.9M
RESEARCH METHODS IN PEDIATRICS HEART DISEASET32HL007572 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI Sarah D DE FERRANTI, Jane W. Newburger · 1985 to 2026
$13.0M
Sidenafil Impacts Exercise Performance in Adolescent Survivors of the FontanU10HL109818 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI GAYNOR, JAMES WILLIAM, PARIDON, STEPHEN · 2011 to 2015
$2.7M
Randomized Trial of Nonflouroscopic Technologies in Pediatric SVT AblationU10HL109816 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI NEWBURGER, JANE W., TRIEDMAN, JOHN K · 2011 to 2015
$2.6M
Pediatric Heart Network Regents of the University of MichiganUG1HL135665 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GOLDBERG, CAREN S, OHYE, RICHARD G · 2017 to 2023
$2.4M
Pediatric Heart Network Prairieland ConsortiumU10HL109673 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI CNOTA, JAMES, PAYNE, RONALD MARK · 2011 to 2015
$2.3M
Pediatric Heart Network University of UtahU10HL109743 · NHLBI · UNIVERSITY OF UTAH · PI MINICH, L. LUANN, WILLIAMS, RICHARD VINCENT · 2011 to 2015
$2.2M
Pediatric Heart Network Medical University of South CarolinaU10HL109778 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ATZ, ANDREW M, GRAHAM, ERIC M. · 2011 to 2015
$2.2M
Baylor/Texas Children's Hospital Pediatric Heart NetworkU10HL109741 · NHLBI · BAYLOR COLLEGE OF MEDICINE · PI ANDROPOULOS, DEAN B., FRASER, CHARLES D. · 2011 to 2015
$2.1M
Pediatric Heart Network Emory UniversityU10HL109781 · NHLBI · EMORY UNIVERSITY · PI BORDER, WILLIAM, MAHLE, WILLIAM T · 2011 to 2015
$1.7M
NHLBI NIH HHS K23 HL119600NHLBI NIH HHS K23 HL133454NHLBI NIH HHS T32 HL007572NHLBI NIH HHS U01 HL068270NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109673NHLBI NIH HHS U10 HL109741NHLBI NIH HHS U10 HL109743NHLBI NIH HHS U10 HL109778NHLBI NIH HHS U10 HL109781NHLBI NIH HHS U10 HL109816NHLBI NIH HHS U10 HL109818NHLBI NIH HHS U24 HL135691NHLBI NIH HHS UG1 HL135665NHLBI NIH HHS UG1 HL135680
6 · The paper itself

Abstract

BACKGROUND/

aimsRegistry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.

methodsWe built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.

resultsRegistry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.

conclusionsRegistries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.

Indexed as

RegistriesResearch DesignCost SavingsHumansMarkov ChainsModels, EconomicPragmatic Clinical Trials as Topiccost savingspragmatic trialRegistry-based trialtrial design

Identifiers

PMID32605679
PMCPMC7682727
OpenAlexW3023682628

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.