Core Outcome Measures in Effectiveness Trials

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains

General Information

Abstract:
Background
Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology (‘Delphi’ survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains.

Methods
Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains
over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an
additional lay review by 14 patients and 5 clinical experts, via an online survey platform.

Results
Insights gained from the workshops and survey feedback pr ompted substantial, unforeseen modifications to the
long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment ex ceeded the target by 171%, there were equivalent numbers of patient and professional participants (n= 358 and n= 312, respectively), feedback was mostly positive, and retentionwas high (87%).

Conclusions
Patient involvement was an integral and transformative step of the study design process. Patient involvement
was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were
many comments about a positive participatory experience. Se ven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers.

Authors:
Harriet Smith
Adele Horobin
Kathryn Fackrell
Veronica Colley
Brian Thacker
Deborah A. Hall
and for the Core Outcome Measures in Tinnitus (COMiT) initiative

Publication

Journal:
Research Involvement and Engagement
Volume:
4
Issue:
8
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
Not stated
Funding source(s):
The main source of funding was from the NIHR Nottingham Hearing Biomedical Research Unit and NIHR Nottingham Biomedical Research Centre. An additional grant of £4803 was awarded to AH, VC and KF from the British Tinnitus Association to support the public involvement work described in this article. TINNET is supported by a European Cooperation in Science and Technology (COST) Action (BM1306).

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Tinnitus

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Drug
Other
Psychological & behavioural

Method(s)

Semi structured discussion
Survey

Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform.


Stakeholders Involved

Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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