Defining Symptom Concepts in Chronic Subjective Tinnitus: Web-Based Discussion Forum Study

Abstract

Background A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) that should be assessed and reported in all clinical trials as this enables comparisons to be made across studies as well as data pooling for meta-analysis. Objective This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified. Methods A series of 5 focus group–style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders. Results The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case. Conclusions The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.

Multidisciplinary Tinnitus Research: Challenges and Future Directions From the Perspective of Early Stage Researchers

“…The Core Outcome Measures in Tinnitus (COMiT) initiative aimed to establish an international standard for outcome measures in clinical trials of tinnitus. This was achieved by using a Delphi approach for three intervention types (sound-based, psychology-based and drug-based), leading to separate recommendations for each intervention type (Hall et al, 2018c(Hall et al, , 2019aHibbert et al, 2020). This provided a critical starting point for the standardization of tinnitus research.…”

Consensus Statements on the Definition, Classification, and Diagnostic Tests for Tinnitus: A Delphi Study Conducted by the Korean Tinnitus Study Group

“…Similar statements were combined and duplicative questions were removed, leaving a total of 38 statements for assessment ( Table 1 ). 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 …”

Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study

“…Initially, the long list will be inspected and reviewed by members of the Study Management Team (MS, DH and BL). Domains that have numerous different conceptualisations, or reflect complex composite complaints, may be combined based on the COMiT’D forum study results [ 21 ] or may be removed if deemed irrelevant to electrical stimulation interventions. Exclusions will be based on discussions of the Study Management Team and Advisory Group.…”