The objective of this Working Group is to establish standards for outcome measurements in clinical trials to enable data collection of treatment results in the central database. Participants of this Action have recently proposed a standard for the performance of clinical trials in tinnitus (32). The WG will also be responsible for expanding the common central database to longitudinal data in order to collect information about treatment response of individual patients to defined treatments. Such longitudinal data will provide the possibility to test tinnitus subtyping criteria for their clinical relevance and to identify response predictors for specific treatments. This WG will bring together clinicians, experts for clinical research methodology, statisticians, and representatives of the health industry. Patient organisations will be involved for specification of outcome measurements relevant for patients.
Main goals of this WG will include the following tasks:
- Establishing and further developing standards for clinical trials in tinnitus
- Establishing standards for outcome measurement both in clinical trials and in clinical routine
- Developing standards for describing and defining specific therapeutic interventions
- Extending the database to accommodate longitudinal data
- Developing statistical methods for analysing longitudinal data
- Developing statistical methods to identify clinical, neuroimaging or genetic treatment predictors
- Developing strategies to advance the database in a self-learning expert system to assist clinicians in treatment decisions
- Dissemination of the guidelines and standards
- Organization of Short Term Scientific Missions, allowing medical professionals to benefit from clinical training in the setting of established clinics dedicated to the assessment and management of tinnitus and related disorder
- Implementation of guidelines and recommendations on the COST Action website
