Evidence map›Paper›PMID 29201388›Full record

ArticlePilot and feasibility studies2017

Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial.

Sandra L Carroll, Dawn Stacey, Michael McGillion, Jeff S Healey, Gary Foster, Sarah Hutchings, Heather M Arthur, Gina Browne, Lehana Thabane

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01876173 (Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 9% 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.

NCT01876173 nacompletednot on this map

Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator

TypeinterventionalSponsorMcMaster UniversityRan2012 to 2014Enrolled82ConditionsCardiovascular Disease, Sudden Cardiac DeathArmsPatient Decision Aid for an ICD (primary prevention, non-CRT)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Article
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  7. Review
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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

9 authors at 4 institutions in 2 countries.

Sandra L CarrollFaculty of Health Sciences, School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
Dawn StaceySchool of Nursing, University of Ottawa, Ottawa, Canada.
Michael McGillionFaculty of Health Sciences, School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
Jeff S HealeyPopulation Health Research Institute, Hamilton Health Sciences, Hamilton, ON Canada.
Gary FosterDepartment of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON Canada.
Sarah HutchingsNational University of Ireland, Galway, Ireland.
Heather M ArthurFaculty of Health Sciences, School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
Gina BrowneFaculty of Health Sciences, School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
Lehana ThabanePopulation Health Research Institute, Hamilton Health Sciences, Hamilton, ON Canada.
McMaster University · CAImpact · CAOllscoil na Gaillimhe – University of Galway · IEOttawa Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes.

methodsPrior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group.

resultsWe identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care (

conclusionOur results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes.

trial registrationNCT01876173.

Indexed as

Decision aidImplantable cardio-defibrillatorKnowledge translationShared decision-making

Identifiers

PMID29201388
PMCPMC5697082
OpenAlexW2765649883

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.