Evidence map›Paper›PMID 33622954›Full record

Trial reportBMJ open2021

Understanding parents' decision-making on participation in clinical trials in children's heart surgery: a qualitative study.

Nigel E Drury, Julie C Menzies, Clare J Taylor, Timothy J Jones, Anna C Lavis

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.3field-weighted citation impact, top 6% 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

13 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Parents' and children's experiences of participating in a randomized controlled clinical trial: AIDIT-QS.International journal of qualitative studies on health and well-being · 2024
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
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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

5 authors at 3 institutions in 1 country.

Nigel E Drury *Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, UK n.e.drury@bham.ac.uk.ORCID 0000-0001-9012-6683
Julie C Menzies *Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham, UK.ORCID 0000-0003-2080-3364
Clare J TaylorNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.ORCID 0000-0001-8926-2581
Timothy J JonesPaediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, UK.ORCID 0000-0001-8870-3496
Anna C LavisInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.ORCID 0000-0002-1080-2512
Birmingham Children's Hospital · GBUniversity of Birmingham · GBUniversity of Oxford · GB

Funding

British Heart Foundation FS/15/49/31612
6 · The paper itself

Abstract

objectivesFew children undergoing heart surgery are recruited to clinical trials and little is known about the views and attitudes of parents towards trials. This study explored parents' perspectives on decision-making about their child's participation in a clinical trial during their elective cardiac surgery.

designQualitative interview study.

settingSingle-centre substudy of a multicentre, double-blind, randomised controlled trial to investigate the effects of remote ischaemic preconditioning in children undergoing cardiac surgery.

participantsParents of children approached to participate in the trial, both consenters and decliners.

methodsSemistructured interviews were conducted face-to-face or by telephone following discharge, digitally audio-recorded, transcribed and thematically analysed.

resultsOf 46 patients approached for the trial, 24 consenting and 2 declining parents agreed to participate in an interview (21 mothers, 5 fathers). Parental decision-making about research was influenced by (1) potential risks or additional procedures; (2) personal benefit and altruism for the 'cardiac community'; (3) information, preparation, timing and approach; and (4) trust in the clinical team and collaboration with researchers. All of these were placed within the context of their understanding of the trial and knowledge of research.

conclusionsParents of children undergoing cardiac surgery attach value to clinical research and are supportive of clinical trials when there is no or minimal perceived additional risk. These findings enhance our understanding of the factors that influence parents' decision-making and should be used to inform the design and conduct of future paediatric surgical trials. TRIAL REGISTRATION NUMBER: ISRCTN12923441; Pre-results.

Indexed as

Cardiac Surgical ProceduresParentsChildComprehensionDecision MakingDouble-Blind MethodHumansQualitative ResearchTrustclinical trialspaediatric cardiac surgeryqualitative research

Identifiers

PMID33622954
PMCPMC7907877
OpenAlexW3133199699

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.