The COMiT’ID Study: Developing Core Outcome Domains Sets for Clinical Trials of Sound-, Psychology-, and Pharmacology-Based Interventions for Chronic Subjective Tinnitus in Adults

Abstract

Subjective tinnitus is a chronic heterogeneous condition that is typically managed using intervention approaches based on sound devices, psychologically informed therapies, or pharmaceutical products. For clinical trials, there are currently no common standards for assessing or reporting intervention efficacy. This article reports on the first of two steps to establish a common standard, which identifies what specific tinnitus-related complaints (“outcome domains”) are critical and important to assess in all clinical trials to determine whether an intervention has worked. Using purposive sampling, 719 international health-care users with tinnitus, health-care professionals, clinical researchers, commercial representatives, and funders were recruited. Eligibility was primarily determined by experience of one of the three interventions of interest. Following recommended procedures for gaining consensus, three intervention-specific, three-round, Delphi surveys were delivered online. Each Delphi survey was followed by an in-person consensus meeting. Viewpoints and votes involved all stakeholder groups, with approximately a 1:1 ratio of health-care users to professionals. “Tinnitus intrusiveness” was voted in for all three interventions. For sound-based interventions, the minimum set included “ability to ignore,” “concentration,” “quality of sleep,” and “sense of control.” For psychology-based interventions, the minimum set included “acceptance of tinnitus,” “mood,” “negative thoughts and beliefs,” and “sense of control.” For pharmacology-based interventions, “tinnitus loudness” was the only additional core outcome domain. The second step will next identify how those outcome domains should best be measured. The uptake of these intervention-specific standards in clinical trials will improve research quality, enhance clinical decision-making, and facilitate meta-analysis in systematic reviews.

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey

“…Attrition, referring to the percentage of participants who withdraw or drop out between rounds, will be analysed and reported using methods similar to those employed by the mOMEnt team [106] and the COMiT'ID team [84]. For example, attrition bias which might occur if participants who do not respond in round 2 have different views from their stakeholder group peers who participate in both rounds [23] will be considered and analysed.…”

“…Round 2 score distributions for each outcome domain will be considered at the final consensus meeting using a nominal group technique to evaluate individual perspectives. For example, like the methods adopted by Harman et al [106], the results of the stakeholder group responses will be compared with the whole group's response, and percentage agreement will be considered to plan the focus of the consensus meeting [84]. The data derived from the Delphi feedback questionnaire and consensus meeting evaluation form will comprise opentext responses, and these will be analysed using a thematic analytic approach.…”

“…Some of the outcome domains were the same as had been defined in our previous work on tinnitus [84] and hearing loss [97], so we used the same plain-language descriptors when appropriate. Others required plainlanguage descriptors to be developed through interactive discussion during the workshop.…”

“…Consensus recommendations will be guided by round 2 results. The '70/15%' consensus approach as described by Williamson et al [71], and Williamson et al [23] and successfully used by Harman et al [104] and Hall et al [84] will be employed, as follows:…”

“…One of the earliest examples of an attempt to standardise outcomes is an initiative by the World Health Organisation in the 1970s relating to cancer trials [79]. More recent projects are the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) study for chronic pain [80], the OMERACT (Outcome Measures in Rheumatoid Arthritis Clinical Trials) consensus initiative for many rheumatologic conditions [81], the HOME (Harmonizing Outcome Measures for Eczema) framework in dermatology [82], the GASTROS (Standardising Outcome Reporting in Gastric Cancer Surgery Research) study for reporting outcomes in gastric cancer surgery [83], and the COMi-T'ID (Core Outcome Measures in Tinnitus International Delphi) initiative for chronic subjective tinnitus [84]. It is vital that all stakeholders, such as healthcare users, with lived experience of the condition, as well as healthcare professionals, commercial representatives or budget holders, are involved in the development of relevant COS [23,85].…”