Abstract
BackgroundThe reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is, therefore to, develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes.MethodsThe ‘Core Outcome Measures in Tinnitus: International Delphi’ (COMIT’ID) study will use a mixed-methods approach that incorporates input from health care users at the pre-Delphi stage, a modified three-round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following Core Outcome Set publication.DiscussionThe COMIT’ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term.Trial registrationThis project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative.
Highlights
The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound to psychosocial impacts
The COMIT’ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term
This paper describes the design of a Delphi process to develop a Core Outcome Domain Set for sound, psychology, and pharmacology-based interventions for chronic subjective tinnitus in adults, to identify the strengths and limitations of the study design with respect to methods for recruiting and for reducing attrition of health care users across English-speaking and non-English-speaking countries, and to determine if participation increases adoption of the recommendations in the long term
Summary
We will use the Delphi process to achieve a consensus of opinion from broadly representative and international expert stakeholder groups [15]. In line with recommended considerations [10; 13], we used qualitative research data gathered from health care users to make informed decisions about the main content of the online Delphi surveys and to ensure that outcome domain concepts are explained in ways that patient participants can understand and generate meanings which are consistent across all Delphi stakeholder groups This goal is highly relevant for any participants whose native language is not English; a factor for consideration in our international Delphi process. Observational cohort study We aspire to conduct a prospective observational cohort study to determine if participation of clinical researchers in the Delphi process increases uptake of the recommended Core Outcome Domain Sets for trials of sound, psychology-, and pharmacology-based interventions for chronic subjective tinnitus in adults, compared with researchers who did not participate.
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