JMIR Publications

ABSTRACT

Background:

A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) which should be assessed and reported in all clinical trials since this enables comparisons to be made across studies as well as data pooling for meta-analysis.

Objective:

To further clarify how the outcome domain concepts should be defined for five 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 vague concept to an operationalised and measurable health-related construct, so that suitable measurement instruments can then be identified.

Methods:

A series of five focus-group-style semi-structured discussions were conducted via an online discussion forum, each open for two weeks and ending with a vote. Participants were 148 tinnitus experts who completed a preceding online Delphi survey which had generated the original set of minimum standards. Participants were healthcare users living with tinnitus, healthcare professionals, clinical researchers, commercial representatives and funders.

Results:

The online discussions led to a revision of all five original plain language definitions which had been used in the preceding online Delphi survey. Each revised definition was voted by 8-53 participants and reached the pre-specified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed for tinnitus intrusiveness, a majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. Examples included tinnitus awareness, unpleasantness and impact on different aspects of everyday life. Thematic analysis of the five online discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalised and measurable health construct in each case.

Conclusions:

The qualitative data gathered during the online discussion forum provided important in-depth understanding of the health concepts which had raised debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalisation of those concepts to proceed to the second stage of Core Outcome Set development which is to identify and evaluate suitable measurement instruments. This work supports the use of online peer discussion forums in defining health concepts.