Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial

Annabelle South; Julia Bailey; Barbara E Bierer; Eva Burnett; William J Cragg; Carlos Diaz-Montana; Katie Gillies; Talia Isaacs; Nalinie Joharatnam-Hogan; Claire Snowdon; Matthew R Sydes; Andrew J Copas

doi:10.1177/17407745231186088

Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial

Annabelle South^* (Corresponding Author), Julia Bailey, Barbara E Bierer, Eva Burnett, William J Cragg, Carlos Diaz-Montana, Katie Gillies, Talia Isaacs, Nalinie Joharatnam-Hogan, Claire Snowdon, Matthew R Sydes, Andrew J Copas

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND/AIMS: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches.

METHODS: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression.

RESULTS: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients.

CONCLUSIONS: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants.

Original language	English
Number of pages	12
Journal	Clinical Trials
Early online date	29 Jul 2023
DOIs	https://doi.org/10.1177/17407745231186088
Publication status	E-pub ahead of print - 29 Jul 2023

Bibliographical note

Acknowledgments
We are grateful to the patients and site staff who participated in this study. We dedicate this article to the memory of Amanda Hunn, who was part of the steering group for this study until she passed away in 2022. We thank other members of the steering group for their input into the study, especially Conor Tweed and Liz James. We acknowledge the hard work and diligence of Cara Purvis, the trial manager, and the data managers for Show RESPECT. We also thank the ICON8 trial team for their support, particularly Babasola Popoola, Francesca Schiavone, Jonathan Badrock, Andrew Clamp and Rick Kaplan.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Show RESPECT study was funded by the Medical Research Council through core grants to MRS at the MRC CTU at UCL for Trial Conduct Methodology (MC_UU12023/24 and MC_UU_00004/08) https://mrc.ukri.org/. The funder had no role in the study design, collection, analysis and interpretation of data, the writing of the report and the decision to submit the article for publication. All authors had full access to the study data, including statistical reports and tables, and take responsibility for the integrity of the data and accuracy of the data analysis.

Data Availability Statement

The individual participant data, qualitative and quantitative, that underlie the results reported in this article, after de-identification, will be available beginning 12 months after publication following the MRC CTU’s standard moderated access approach (details of which are available at https://www.mrcctu.ucl.ac.uk/our-research/other-research-policy/data-sharing/). Applicants will need to state the aims of any analyses and provide a methodologically sound proposal. Applications should be directed to mrcctu.datareleaserequest@ucl.ac.uk. Data requestors will need to sign a data access agreement at an institutional level.

Keywords

Feedback of results
communicating results
researcher perspective
researcher-participant relations
trial conduct
trial ethics
mixed methods

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1177/17407745231186088Licence: CC BY

Cite this

South, A., Bailey, J., Bierer, B. E., Burnett, E., Cragg, W. J., Diaz-Montana, C., Gillies, K., Isaacs, T., Joharatnam-Hogan, N., Snowdon, C., Sydes, M. R., & Copas, A. J. (2023). Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial. Clinical Trials. Advance online publication. https://doi.org/10.1177/17407745231186088

South, A, Bailey, J, Bierer, BE, Burnett, E, Cragg, WJ, Diaz-Montana, C, Gillies, K, Isaacs, T, Joharatnam-Hogan, N, Snowdon, C, Sydes, MR & Copas, AJ 2023, 'Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial', Clinical Trials. https://doi.org/10.1177/17407745231186088

@article{b5923ed14b644cafb98daca8cb68daac,

title = "Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial",

abstract = "BACKGROUND/AIMS: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches.METHODS: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression.RESULTS: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients.CONCLUSIONS: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants.",

keywords = "Feedback of results, communicating results, researcher perspective, researcher-participant relations, trial conduct, trial ethics, mixed methods",

author = "Annabelle South and Julia Bailey and Bierer, {Barbara E} and Eva Burnett and Cragg, {William J} and Carlos Diaz-Montana and Katie Gillies and Talia Isaacs and Nalinie Joharatnam-Hogan and Claire Snowdon and Sydes, {Matthew R} and Copas, {Andrew J}",

note = "Acknowledgments We are grateful to the patients and site staff who participated in this study. We dedicate this article to the memory of Amanda Hunn, who was part of the steering group for this study until she passed away in 2022. We thank other members of the steering group for their input into the study, especially Conor Tweed and Liz James. We acknowledge the hard work and diligence of Cara Purvis, the trial manager, and the data managers for Show RESPECT. We also thank the ICON8 trial team for their support, particularly Babasola Popoola, Francesca Schiavone, Jonathan Badrock, Andrew Clamp and Rick Kaplan. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Show RESPECT study was funded by the Medical Research Council through core grants to MRS at the MRC CTU at UCL for Trial Conduct Methodology (MC_UU12023/24 and MC_UU_00004/08) https://mrc.ukri.org/. The funder had no role in the study design, collection, analysis and interpretation of data, the writing of the report and the decision to submit the article for publication. All authors had full access to the study data, including statistical reports and tables, and take responsibility for the integrity of the data and accuracy of the data analysis.",

year = "2023",

month = jul,

day = "29",

doi = "10.1177/17407745231186088",

language = "English",

journal = "Clinical Trials",

issn = "1740-7745",

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TY - JOUR

T1 - Site staff perspectives on communicating trial results to participants

T2 - Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial

AU - South, Annabelle

AU - Bailey, Julia

AU - Bierer, Barbara E

AU - Burnett, Eva

AU - Cragg, William J

AU - Diaz-Montana, Carlos

AU - Gillies, Katie

AU - Isaacs, Talia

AU - Joharatnam-Hogan, Nalinie

AU - Snowdon, Claire

AU - Sydes, Matthew R

AU - Copas, Andrew J

N1 - Acknowledgments We are grateful to the patients and site staff who participated in this study. We dedicate this article to the memory of Amanda Hunn, who was part of the steering group for this study until she passed away in 2022. We thank other members of the steering group for their input into the study, especially Conor Tweed and Liz James. We acknowledge the hard work and diligence of Cara Purvis, the trial manager, and the data managers for Show RESPECT. We also thank the ICON8 trial team for their support, particularly Babasola Popoola, Francesca Schiavone, Jonathan Badrock, Andrew Clamp and Rick Kaplan. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The Show RESPECT study was funded by the Medical Research Council through core grants to MRS at the MRC CTU at UCL for Trial Conduct Methodology (MC_UU12023/24 and MC_UU_00004/08) https://mrc.ukri.org/. The funder had no role in the study design, collection, analysis and interpretation of data, the writing of the report and the decision to submit the article for publication. All authors had full access to the study data, including statistical reports and tables, and take responsibility for the integrity of the data and accuracy of the data analysis.

PY - 2023/7/29

Y1 - 2023/7/29

N2 - BACKGROUND/AIMS: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches.METHODS: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression.RESULTS: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients.CONCLUSIONS: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants.

AB - BACKGROUND/AIMS: Sharing trial results with participants is an ethical imperative but often does not happen. Show RESPECT (ISRCTN96189403) tested ways of sharing results with participants in an ovarian cancer trial (ISRCTN10356387). Sharing results via a printed summary improved patient satisfaction. Little is known about staff experience and the costs of communicating results with participants. We report the costs of communication approaches used in Show RESPECT and the views of site staff on these approaches.METHODS: We allocated 43 hospitals (sites) to share results with trial participants through one of eight intervention combinations (2 × 2 × 2 factorial; enhanced versus basic webpage, printed summary versus no printed summary, email list invitation versus no invitation). Questionnaires elicited data from staff involved in sharing results. Open- and closed-ended questions covered resources used to share results and site staff perspectives on the approaches used. Semi-structured interviews were conducted. Interview and free-text data were analysed thematically. The mean additional site costs per participant from each intervention were estimated jointly as main effects by linear regression.RESULTS: We received questionnaires from 68 staff from 41 sites and interviewed 11 site staff. Sites allocated to the printed summary had mean total site costs of sharing results £13.71/patient higher (95% confidence interval (CI): -3.19, 30.60; p = 0.108) than sites allocated no printed summary. Sites allocated to the enhanced webpage had mean total site costs £1.91/patient higher (95% CI: -14, 18.74; p = 0.819) than sites allocated to the basic webpage. Sites allocated to the email list had costs £2.87/patient lower (95% CI: -19.70, 13.95; p = 0.731) than sites allocated to no email list. Most of these costs were staff time for mailing information and handling patients' queries. Most site staff reported no concerns about how they had shared results (88%) and no challenges (76%). Most (83%) found it easy to answer queries from patients about the results and thought the way they were allocated to share results with participants would be an acceptable standard approach (76%), with 79% saying they would follow the same approach for future trials. There were no significant effects of the randomised interventions on these outcomes. Site staff emphasised the importance of preparing patients to receive the results, including giving opt-in/opt-out options, and the need to offer further support, particularly if the results could confuse or distress some patients.CONCLUSIONS: Adding a printed summary to a webpage (which significantly improved participant satisfaction) may increase costs to sites by ~£14/patient, which is modest in relation to the cost of trials. The Show RESPECT communication interventions were feasible to implement. This information could help future trials ensure they have sufficient resources to share results with participants.

KW - Feedback of results

KW - communicating results

KW - researcher perspective

KW - researcher-participant relations

KW - trial conduct

KW - trial ethics

KW - mixed methods

U2 - 10.1177/17407745231186088

DO - 10.1177/17407745231186088

M3 - Article

C2 - 37515519

SN - 1740-7745

JO - Clinical Trials

JF - Clinical Trials

ER -

Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial

Abstract

Bibliographical note

Data Availability Statement

Keywords

UN SDGs

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