Evidence map›Paper›PMID 38982441›Full record

ArticleTrials2024

The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff.

Annabelle South, Claire Snowdon, Eva Burnett, Barbara E Bierer, Katie Gillies, Talia Isaacs, Matthew R Sydes

Abstract read
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

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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

7 authors.

Annabelle SouthMRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. a.south@ucl.ac.uk.ORCID http://orcid.org/0000-0001-8912-2001
Claire SnowdonLondon School of Hygiene and Tropical Medicine, London, UK.
Eva BurnettPatient Representative On Studies at the MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
Barbara E BiererHarvard Medical School and Brigham and Women's Hospital, Boston, MA, 02115, USA.
Katie GilliesHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Talia IsaacsUCL Institute of Education, UCL, London, UK.
Matthew R SydesMRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.

Funding

Medical Research Council MC_UU_00004/08Medical Research Council MC_UU_12023/24
6 · The paper itself

Abstract

backgroundSharing trial results with participants is a moral imperative, but too often does not happen in appropriate ways.

methodsWe carried out semi-structured interviews with patients (n = 13) and site staff (n = 11), and surveyed 180 patients and 68 site staff who were part of the Show RESPECT study, which tested approaches to sharing results with participants in the context of the ICON8 ovarian cancer trial (ISRCTN10356387). Qualitative and free-text data were analysed thematically, and findings used to develop the SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants. This paper presents the framework, with illustrations drawn from the Show RESPECT study.

resultsOur adaptable 'SHOW RESPECT' framework covers (1) Supporting and preparing trial participants to receive results, (2) HOw will the results reach participants?, (3) Who are the trial participants?, (4) REsults-what do they show?, (5) Special considerations, (6) Provider-who will share results with participants?, (7) Expertise and resources, (8) Communication tools and (9) Timing of sharing results. While the data upon which the framework is based come from a single trial, many of our findings are corroborated by findings from other studies in this area, supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place.

conclusionsThis adaptable 'SHOW RESPECT' framework can guide researchers as they plan how to share aggregate trial results with participants. While our data are drawn from a single trial context, the findings from Show RESPECT illustrate how approaches to communication in a specific trial can influence patient and staff experiences of feedback of trial results. The framework generated from these findings can be adapted to fit different trial contexts and used by other researchers to plan the sharing of results with their own participants.

trial registrationISRCTN96189403. Registered on February 26, 2019. Show RESPECT was supported by the Medical Research Council (MC_UU_12023/24 and MC_UU_00004/08) and the NIHR CRN.

Indexed as

Ovarian NeoplasmsQualitative ResearchAttitude of Health PersonnelFemaleHealth Knowledge, Attitudes, PracticeHumansInformation DisseminationInterviews as TopicMiddle AgedResearch PersonnelResearch SubjectsTime FactorsCommunicating resultsFeedback of resultsResearcher–participant relationsResearcher perspectiveTrial conductTrial ethics

Identifiers

PMID38982441
PMCPMC11234608

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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.