Table 6.

Meeting Votes and Comments in Favor and Against, Explaining the Reasons for Recommending the Two Outcome Domains for Evaluating Pharmacology-Based Interventions.

Outcome domains	Vote	Comments in favor	Comments against
Tinnitus intrusiveness	100	• The group felt that “intrusiveness” captures aspects of tinnitus that are more relevant than “loudness” alone. • “Tinnitus intrusiveness” is related to “loudness” but is distinct from it. It is a target for developing a tinnitus cure based on pharmacology. • Comment indicated that this is a relatively broad construct that could be sensitive to the impact of tinnitus in a variety of areas of life (quality of life).	• A few participants believed “intrusiveness” is a subdomain of loudness (i.e., you cannot have intrusiveness without loudness). • The concept of intrusiveness may be problematic to explain consistently across different languages and cultures.
Tinnitus loudness	100	• “Tinnitus loudness” is all about the sensation of the sound. It is the direct target for drug treatments. Fix this and you fix everything else. • The group considered this to be a “semiobjective” measure and therefore reliable and critical to include alongside the more “subjective” domains. • The group felt that “loudness” needs to be measured alongside with intrusiveness as they interrelate but are separate.	Some acknowledged that a change in loudness may not always reflect a tangible benefit on the patient’s life.

Note. Votes represent the % of the 16 participants who agreed that these outcome domains should be included in the Core Outcome Domain Set.