Evidence map›Paper›PMID 16401631›Full record

ArticleBMJ (Clinical research ed.)2006

Receiving a summary of the results of a trial: qualitative study of participants' views.

Mary Dixon-Woods, Clare Jackson, Kate C Windridge, Sara Kenyon

Abstract read
In one paragraph

Article in BMJ (Clinical research ed.), 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 1 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

52 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery.Health expectations : an international journal of public participation in health care and health policy · 2018
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  13. Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.Health expectations : an international journal of public participation in health care and health policy · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Mary Dixon-WoodsSocial Science Group, Department of Health Sciences, University of Leicester, Leicester LE1 6TP. md11@le.ac.uk
Clare Jackson
Kate C Windridge
Sara Kenyon

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore trial participants' responses to receiving a summary of the results of a trial in pregnancy.

designQualitative study with semistructured interviews.

participants20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results.

resultsLess than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings.

conclusionsRecommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

Indexed as

Attitude to HealthDisclosureFeedbackAnti-Bacterial AgentsFemaleHumansObstetric Labor, PrematurePamphletsPatient SatisfactionPregnancyPremature Rupture of Fetal MembranesRandomized Controlled Trials as TopicResearch SubjectsAnti-Bacterial AgentsBiomedical and Behavioral ResearchEmpirical Approach

Identifiers

PMID16401631
PMCPMC1352050

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.