Clinical investigation protocol for tinnitus (CIP-t): development and validation of an instrument

The objective of this study was the development and validation of a clinical investigation protocol for tinnitus and the analysis of its applicability.

The research was conducted in eight stages: Stage 1: Literature review and development of the pilot protocol; Stage 2: Expert judges I - first analysis/evaluation; Stage 3: Elaboration of the unified investigation protocol and the application guide; Stage 4: Expert judges II - second analysis/evaluation of the instruments from the previous stage; Stage 5: Refinement of materials; Stage 6: Application of the protocol by expert and non-expert clinicians; Stage 7: Final construction; Stage 8: Pilot study - convenience sample. The results of each stage were compiled into an Excel spreadsheet for specific analyses (content validity ratio calculation and suggestions).

The structure of the protocol was successfully developed, resulting in a unified instrument subdivided into: tinnitus-focused anamnesis, audiological, emotional, metabolic, somatosensory, and vascular history, assessment results, a framework for subgroup classification, clinical decision tree, and complementary evaluations. The protocol was applied to a sample of 83 adults and older individuals.

The clinical investigation protocol for tinnitus was finalized and its content validated, demonstrating applicability for adult and elderly individuals with tinnitus.