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

doi:10.1186/s13063-024-08291-7

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

Trials. 2024 Jul 10;25(1):467. doi: 10.1186/s13063-024-08291-7.

Authors

Annabelle South¹, Claire Snowdon², Eva Burnett³, Barbara E Bierer⁴, Katie Gillies⁵, Talia Isaacs⁶, Matthew R Sydes⁷

Affiliations

¹ MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK. a.south@ucl.ac.uk.
² London School of Hygiene and Tropical Medicine, London, UK.
³ Patient Representative On Studies at the MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
⁴ Harvard Medical School and Brigham and Women's Hospital, Boston, MA, 02115, USA.
⁵ Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
⁶ UCL Institute of Education, UCL, London, UK.
⁷ MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.

Abstract

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

Methods: We 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.

Results: Our 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.

Conclusions: This 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 registration: ISRCTN96189403. 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.

Keywords: Communicating results; Feedback of results; Researcher perspective; Researcher–participant relations; Trial conduct; Trial ethics.

MeSH terms

Attitude of Health Personnel
Female
Health Knowledge, Attitudes, Practice
Humans
Information Dissemination
Interviews as Topic
Middle Aged
Ovarian Neoplasms* / psychology
Qualitative Research*
Research Personnel / psychology
Research Subjects / psychology
Time Factors

Abstract

MeSH terms

Grants and funding