Evidence map›Paper›PMID 34632824›Full record

ArticleClinical trials (London, England)2022

Clinical studies sponsored by digital health companies participating in the FDA's Precertification Pilot Program: A cross-sectional analysis.

Victoria L Bartlett, Sanket S Dhruva, Nilay D Shah, Joseph S Ross

Abstract readLetter
In one paragraph

Article in Clinical trials (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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

4 authors.

Victoria L BartlettYale School of Medicine, New Haven, CT, USA.ORCID 0000-0001-8422-1510
Sanket S DhruvaSection of Cardiology, San Francisco Veterans Affairs Health Care System, Department of Medicine, School of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Nilay D ShahDivision of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
Joseph S RossSection of General Internal Medicine and National Clinician Scholars Program, Center for Outcomes Research & Evaluation, Department of Health Policy and Management, Yale-New Haven Hospital, Yale School of Public Health, Yale School of Medicine, Yale University, New Haven, CT, USA.ORCID 0000-0002-9218-3320

Funding

PA-20-072: Accelerating the Use of Evidence-based Innovation in Healthcare SystemsU19HS024075 · AHRQ · DARTMOUTH COLLEGE · PI MEARA, ELLEN R. · 2015 to 2021
$19.8M
Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)R01HL131535 · NHLBI · MAYO CLINIC ROCHESTER · PI MONTORI, VICTOR MANUEL · 2016 to 2020
$3.2M
UCSF Career Development Program in Implementation Research in Heart and Lung DiseasesK12HL138046 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BIBBINS-DOMINGO, KIRSTEN, CATTAMANCHI, ADITHYA · 2017 to 2021
$2.9M
Understanding hospital value: provider, hospital and community effectsR01HS022882 · AHRQ · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HORWITZ, LEORA · 2014 to 2023
$2.9M
Gastrointestinal Safety of Antithrombotic Drug RegimensR01HS025402 · AHRQ · MAYO CLINIC ARIZONA · PI ABRAHAM, NEENA S · 2017 to 2020
$1.6M
Medical reversals: De-implementing ineffective and unsafe treatmentsR01HS025164 · AHRQ · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2017 to 2020
$1.4M
Impact of Publicity Reporting Hospital Outcome Measures for Older AdultsK08AG032886 · NIA · YALE UNIVERSITY · PI ROSS, JOSEPH SOLOMON · 2008 to 2012
$738k
Diffusion of Clinical Evidence into Practice: Physician Networks, Delivery Organizations, and MarketsR56HL130496 · NHLBI · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2016 to 2016
$634k
Optimizing Medical Device Post-Market Surveillance for Public ValueU01FD004585 · FDA · YALE UNIVERSITY · PI KRUMHOLZ, HARLAN MARC · 2012 to 2016
$592k
The ICAN Discussion Aid to Optimize Treatment for People Living with Multiple Chronic ConditionsR03HS025517 · AHRQ · MAYO CLINIC ROCHESTER · PI SHAH, NILAY D · 2017 to 2018
$100k
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164AHRQ HHS R01 HS025402AHRQ HHS R03 HS025517AHRQ HHS U19 HS024075FDA HHS U01 FD004585NHLBI NIH HHS K12 HL138046NHLBI NIH HHS R01 HL131535NHLBI NIH HHS R56 HL130496NIA NIH HHS K08 AG032886
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Drug ApprovalCross-Sectional StudiesHumansUnited StatesUnited States Food and Drug Administration

Identifiers

PMID34632824
PMCPMC9888320

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.