TY - JOUR
T1 - Redesigning a Web-Based Stakeholder Consensus Meeting About Core Outcomes for Clinical Trials
T2 - Formative Feedback Study
AU - Katiri, Roulla
AU - Hall, Deborah A.
AU - Hoare, Derek J.
AU - Fackrell, Kathryn
AU - Horobin, Adele
AU - Buggy, Nóra
AU - Hogan, Nicholas
AU - Kitterick, Pádraig T.
AU - Core Rehabilitation Outcome Set For Single-Sided Deafness (CROSSSD) Initiative
N1 - 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.
PY - 2021/8/19
Y1 - 2021/8/19
N2 - 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.
AB - 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.
KW - COVID-19
KW - Formative research
KW - Mobile phone
KW - Nominal group technique
KW - Patient participation
KW - Persons with hearing impairments
UR - http://www.scopus.com/inward/record.url?scp=85113328113&partnerID=8YFLogxK
U2 - 10.2196/28878
DO - 10.2196/28878
M3 - Article
C2 - 34420915
SN - 2561-326X
VL - 5
JO - JMIR Formative Research
JF - JMIR Formative Research
IS - 8
M1 - e28878
ER -