Evidence map›Paper›PMID 35508349›Full record

Trial reportBMJ open2022

Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in the

Lorna Sweeney, Doris Lanz, Jahnavi Daru, Annika M P Rasijeff, Farzana Khanom, Amy Thomas, Angela Harden, Laura Green

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
1.7field-weighted citation impact, top 17% 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

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. 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

8 authors at 5 institutions in 2 countries.

Lorna SweeneyCentre for Effective Services, Dublin 2, Ireland lorna.christine@gmail.com.ORCID 0000-0002-1630-467X
Doris LanzBarts Research Centre for Women's Health, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Jahnavi DaruBarts Research Centre for Women's Health, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.ORCID 0000-0001-5816-2609
Annika M P RasijeffBlizard Institute, Queen Mary University of London, London, UK.
Farzana KhanomKatie's Team Patient and Public Advisory Group, Barts Research Centre for Women's Health, Queen Mary University of London, London, UK.
Amy ThomasBarts Health NHS Trust, London, UK.
Angela HardenSchool of Health Sciences, City University of London, London, UK.
Laura GreenBlizard Institute, Queen Mary University of London, London, UK.ORCID 0000-0003-4063-9768
Queen Mary University of London · GBBarts Health NHS Trust · GBCity, University of London · GBNHS Blood and Transplant · GBPublicPolicy.ie (Ireland) · IE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe ACROBAT pilot trial of early cryoprecipitate for severe postpartum haemorrhage used deferred consent procedures. Pretrial discussions with a patient and public involvement group found mixed views towards deferred consent. This study aimed to build an understanding of how the deferred consent procedures worked in practice, to inform plans for a full-scale trial.

settingQualitative interview study within a cluster-randomised pilot trial, involving four London maternity services.

participantsIndividual interviews were conducted postnatally with 10 women who had received blood transfusion for severe postpartum haemorrhage and had consented to the trial. We also interviewed four 'recruiters'-two research midwives and two clinical trials practitioners who conducted trial recruitment.

resultsConsent procedures in the ACROBAT pilot trial were generally acceptable and the intervention was viewed as low risk, but most women did not remember much about the consent conversation. As per trial protocol, recruiters sought to consent women before hospital discharge, but this time pressure had to be balanced against the need to ensure women were not approached when distressed or very unwell. Extra efforts had to be made to communicate trial information to women due to the exhaustion of their recovery and competing demands for their attention. Participant information was further complicated by explanations about the cluster design and change in transfusion process, even though the consent sought was for access to medical data.

conclusionOur findings indicate that deferred consent procedures raise similar concerns as taking consent when emergency obstetric research is occurring-that is, the risk that participants may conflate research with clinical care, and that their ability to process trial information may be impacted by the stressful nature of recovery and newborn care. A future trial may support more meaningful informed consent by extending the window of consent discussion and ensuring trial information is minimal and easy to understand. TRIAL REGISTRATION NUMBER: ISRCTN12146519.

Indexed as

Postpartum HemorrhageFemaleHumansInfant, NewbornInformed ConsentPilot ProjectsPostpartum PeriodPregnancyQualitative ResearchETHICS (see Medical Ethics)HAEMATOLOGYOBSTETRICSQUALITATIVE RESEARCH

Identifiers

PMID35508349
PMCPMC9073399
OpenAlexW4225429098

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.