Evidence map›Paper›PMID 16585108›Full record

ArticleQuality & safety in health care2006

Participating in a trial in a critical situation: a qualitative study in pregnancy.

S Kenyon, M Dixon-Woods, C J Jackson, K Windridge, E Pitchforth

Abstract read
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Article in Quality & safety in health care, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 6 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

48 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  10. An exploration of women's experience of taking part in a randomized controlled trial of a diagnostic test during pregnancy: A qualitative study.Health expectations : an international journal of public participation in health care and health policy · 2020
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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.

S KenyonReproductive Sciences Section, Department of Cancer Studies and Molecular Medicine, University of Leicester, UK.
M Dixon-Woods
C J Jackson
K Windridge
E Pitchforth

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes. Pregnant women have been identified as a potentially vulnerable population.

objectiveTo explore women's experiences of being recruited to ORACLE, a randomised controlled trial of antibiotics in pre-term labour.

methodsTwenty qualitative interviews were conducted with women who had participated in ORACLE. Analysis was based on the constant comparative method.

resultsWomen gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation. Comments on the quality of written and spoken information were generally favourable, but women's accounts suggest that the stressful nature of the situation affected their ability to absorb the information. Women generally had poor understanding of trial design and practices. The main motivation for trial participation was the possibility of an improved outcome for the baby. The second and less prominent motivation was the opportunity to help others, but this was conditional on there being no risks associated with trial participation. In judging the risks of participation, women seemed to draw on "common sense" understandings including a perception that antibiotics were risk free. DISCUSSION: Recruitment to trials in critical situations raises important questions. Future studies should explore how rigorous governance arrangements for trials, particularly in critical situations, can protect participants rather than relying on ideals of informed consent that may be impossible to achieve. Future research should include a focus on interactions between research candidates and professionals involved in recruitment.

Indexed as

ComprehensionPatient SelectionRandomized Controlled Trials as TopicAntibiotic ProphylaxisDecision MakingFemaleHumansInformed ConsentInterviews as TopicMotivationObstetric Labor, PrematurePatient Education as TopicPlacebosPregnancyPregnant PeopleResearcher-Subject RelationsPlacebos

Identifiers

PMID16585108
PMCPMC2464828

What OpenQuestion holds

Textmetadata
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.