Redesigning a web-based stakeholder consensus meeting about core outcomes for clinical trials: formative feedback study
Redesigning a web-based stakeholder consensus meeting about core outcomes for clinical trials: formative feedback study
Background: Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. Objective: This study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. Methods: The study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome. Results: Overall, 98% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day. Conclusions: Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs.
COVID-19, Formative research, Mobile phone, Nominal group technique, Patient participation, Persons with hearing impairments
Katiri, Roulla
e80b4405-4ef3-4379-a801-c92ad6561ef2
Hall, Deborah A.
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Hoare, Derek J.
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Fackrell, Kathryn
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Horobin, Adele
e708ec81-cf21-4870-9d1d-6794aa77ad42
Buggy, Nóra
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Hogan, Nicholas
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Kitterick, Pádraig T.
8b0f195a-7f4b-41e2-8d5f-2f296ad5005f
Core Rehabilitation Outcome Set For Single-Sided Deafness (CROSSSD) Initiative
19 August 2021
Katiri, Roulla
e80b4405-4ef3-4379-a801-c92ad6561ef2
Hall, Deborah A.
917cd3f4-0242-4dc4-9473-4a2097c1ba06
Hoare, Derek J.
69d0a4d9-8bd2-4b5e-ac32-605b13de8980
Fackrell, Kathryn
47992aeb-c6a0-44a2-b59c-8b53d7a70520
Horobin, Adele
e708ec81-cf21-4870-9d1d-6794aa77ad42
Buggy, Nóra
5a85f1a7-4dd0-4f51-8498-8819e96d081f
Hogan, Nicholas
4e542260-0080-48fa-9004-fe1a575f3c95
Kitterick, Pádraig T.
8b0f195a-7f4b-41e2-8d5f-2f296ad5005f
Katiri, Roulla, Hall, Deborah A. and Hoare, Derek J.
,
Core Rehabilitation Outcome Set For Single-Sided Deafness (CROSSSD) Initiative
(2021)
Redesigning a web-based stakeholder consensus meeting about core outcomes for clinical trials: formative feedback study.
JMIR Formative Research, 5 (8), [e28878].
(doi:10.2196/28878).
Abstract
Background: Clinical trials that assess the benefits and harms of an intervention do so by measuring and reporting outcomes. Inconsistent selection and diversity in the choice of outcomes make it challenging to directly compare interventions. To achieve an agreed core set of outcomes, a consensus methodology is recommended, comprising a web-based Delphi survey and a face-to-face consensus meeting. However, UK government regulations to control the pandemic prohibited plans for a face-to-face consensus meeting as part of the Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study. Objective: This study aims to evaluate the modifications made by the CROSSSD study team to achieve consensus using web-based methods, but with minimal deviation from the original study protocol. Methods: The study team worked with health care users and professionals to translate the planned face-to-face consensus meeting in a web-based format, preserving the key elements of the nominal group technique. A follow-up survey gathered evaluation feedback on the experiences of the 22 participating members. Feedback covered premeeting preparation, the process of facilitated discussions and voting, ability to contribute, and perceived fairness of the outcome. Results: Overall, 98% (53/54) of feedback responses agreed or strongly agreed with the statements given, indicating that the web-based meeting achieved its original goals of open discussion, debate, and voting to agree with a core outcome set for single-sided deafness. Hearing-impaired participants were fully engaged, but there were some methodological challenges. For the participants, challenges included building rapport, understanding, and delivering the tasks in hand. For the study team, challenges included the need for thorough preparation and management of the unpredictability of tasks on the day. Conclusions: Sharing our experiences and lessons learned can benefit future core outcome set developers. Overcoming the challenges of delivering a web-based consensus exercise in the face of the pandemic can be applied more generally to maximize inclusiveness, enhance geographical access, and reduce research costs.
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Accepted/In Press date: 29 May 2021
Published date: 19 August 2021
Additional Information:
Funding Information:
PTK declares receiving grants and other support from Cochlear Europe Ltd and Cochlear Ltd (Australia) outside the submitted work. The rest of the authors declare no conflict of interest.
Funding Information:
The study sponsor was the University of Nottingham. The CROSSSD study group would like to acknowledge the generous contributions of all health care users, health care professionals, manufacturers’ representatives, and observers who attended and participated during the consensus meeting: Ad Snik, Carly Sygrove, Cherith Campbell-Bell, Christopher Parker, Daniel M Zeitler, Lewis Williams, Maxine Oxford, Patrick Boyle, Paul K James, Penelope R Hill-Feltham, Peter Toth, Richard Bowles, Richard Nicholson, Roger Bayston, and Tove Rosenbom. The authors would also like to thank Paul Van de Heyning (Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium), Jill B Firszt (School of Medicine, Washington University in St Louis, St Louis, Missouri, USA), and Iain A Bruce (Manchester University Hospitals National Health Service Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom) for their input as members of the CROSSSD study international experts steering group. The CROSSSD initiative also acknowledges the support of the NIHR Clinical Research Network in recruitment. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. NIHR Nottingham Biomedical Research Centre, funding reference number BRC-1215-20003, provided funding. DAH is an NIHR senior investigator. KF was funded by the NIHR and Postdoctoral Fellowship PDF-2018-11-ST2-003. Additional grants obtained for the CROSSSD study are as follows: Graham Fraser Foundation Travel Grant to attend the 15th International Conference on Cochlear Implants and other Implantable Auditory Technology, where the study was first launched. Oticon Medical provided funding to purchase DelphiManager software from the COMET Initiative, University of Liverpool. The funding bodies had no role in the study design and implementation, writing the report, or decision to submit the report for publication.
Publisher Copyright:
© Roulla Katiri, Deborah A Hall, Derek J Hoare, Kathryn Fackrell, Adele Horobin, Nóra Buggy, Nicholas Hogan, Pádraig T Kitterick, Core Rehabilitation Outcome Set For Single-Sided Deafness (CROSSSD) Initiative. Originally published in JMIR Formative Research (https://formative.jmir.org), 19.08.2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on https://formative.jmir.org, as well as this copyright and license information must be included.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
Keywords:
COVID-19, Formative research, Mobile phone, Nominal group technique, Patient participation, Persons with hearing impairments
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Local EPrints ID: 453253
URI: http://eprints.soton.ac.uk/id/eprint/453253
PURE UUID: 8f027363-0b1f-43be-bfa9-5ec5b8533a2e
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Date deposited: 11 Jan 2022 17:48
Last modified: 17 Mar 2024 12:52
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Author:
Roulla Katiri
Author:
Deborah A. Hall
Author:
Derek J. Hoare
Author:
Adele Horobin
Author:
Nóra Buggy
Author:
Nicholas Hogan
Author:
Pádraig T. Kitterick
Corporate Author: Core Rehabilitation Outcome Set For Single-Sided Deafness (CROSSSD) Initiative
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