Proposing Treatments: Enrolment Issues

Clearly, more high-quality clinical trials will lead to better treatment options for tinnitus. For clinicians who would like to endeavor to do so, however, it is useful to know that enrolment of tinnitus patients in studies where treatment is offered may be difficult. For instance, a recent study (Bauer et al. 2016) investigating the effectiveness of Tinnitus Retraining Therapy (a therapy combining sound therapy and counselling (Jastreboff 2007, 2015)), 21% of study participants who had responded to advertisement had subsequently declined participation because they did not want to wear hearing aids—provided for free—or to travel to obtain treatment and participate in follow-ups. Enrolment rates in this particular multicenter clinical study varied between 3.5 and 11.9% depending on sites and overall totalled 6.3% over a 17-month recruitment period. Another study (Piccirillo et al. 2007) that investigated pharmacological treatment reported that of 1028 patients recruited, 259 came to screening, and 135 eventually participated, which represents only a rate of 13%. Given the great distress and severity of symptoms reported by this population, these low rates of enrolment are surprising. Although studies do not systematically report their enrolment rates, qualitative studies may be useful to get more information about this situation.