Evidence map›Paper›PMID 34528271›Full record

Trial reportPacing and clinical electrophysiology : PACE2021

Development and piloting of four decision aids for implantable cardioverter-defibrillators in different media formats.

Bryan C Wallace, Jacqueline Jones, Frederick A Masoudi, Carolyn T Nowels, Paul Varosy, Richard Thomson, Glyn Elwyn, Angela G Brega, Travis Vermilye, Christopher E Knoepke and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pacing and clinical electrophysiology : PACE, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
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  9. Challenging the status quo: a scoping review of value-based care models in cardiology and electrophysiology.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
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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.

Bryan C WallaceAdult and Child Consortium for Outcomes Research and Delivery Science, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0001-5326-6783
Jacqueline JonesCollege of Nursing, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Frederick A MasoudiAscension Health, St Louis MO.
Carolyn T NowelsDivision of General Internal Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Paul VarosyDivision of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
Richard ThomsonPopulation Health Sciences Institute, Newcastle University, UK.
Glyn ElwynCoproduction Laboratory, Dartmouth Institute, Lebanon, New Hampshire, USA.
Angela G BregaDepartment of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Travis VermilyeDepartment of Visual Arts, University of Colorado Denver, Denver, Colorado, USA.
Christopher E KnoepkeAdult and Child Consortium for Outcomes Research and Delivery Science, Aurora, Colorado, USA.ORCID https://orcid.org/0000-0003-3521-7157
Amneet SandhuVA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado, USA.
Larry A AllenAdult and Child Consortium for Outcomes Research and Delivery Science, Aurora, Colorado, USA.
Daniel D MatlockAdult and Child Consortium for Outcomes Research and Delivery Science, Aurora, Colorado, USA.

Funding

A Multicenter Trial of a Shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE - ICD TrialR01HL136403 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI MATLOCK, DANIEL D · 2017 to 2021
$3.8M
Decision Support for Older and Frail Patients Considering Advanced Cardiovascular Therapies: Improving Models of Personal Values ClarificationK23HL153892 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI KNOEPKE, CHRISTOPHER · 2020 to 2024
$824k
Implanted Defibrillators and Older Adults: A Model of Decisions and TechnologiesK23AG040696 · NIA · UNIVERSITY OF COLORADO DENVER · PI MATLOCK, DANIEL D · 2011 to 2015
$716k
NHLBI NIH HHS K23 HL153892NHLBI NIH HHS R01 HL136403NIA NIH HHS K23 AG040696
6 · The paper itself

Abstract

backgroundUsing DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs.

methodsDevelopment Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option Grid

resultsTwenty-one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = .06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence.

conclusionsParticipants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed.

Indexed as

Decision Support TechniquesDefibrillators, ImplantableColoradoDeath, Sudden, CardiacFemaleHeart FailureHumansInterviews as TopicMalePilot ProjectsResearch DesignSurveys and Questionnairesdefibrillation-implantable cardioverter-defibrillatorheart failurepatient decision aidqualitativeshared decision making

Identifiers

PMID34528271
PMCPMC9272704

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.