{"title":"Clinical investigation protocol for tinnitus (CIP-t): development and validation of an instrument.","authors":"Hélinton Goulart Moreira, Michele Vargas Garcia","doi":"10.1590/2317-1782/e20250125pt","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The objective of this study was the development and validation of a clinical investigation protocol for tinnitus and the analysis of its applicability.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The clinical investigation protocol for tinnitus was finalized and its content validated, demonstrating applicability for adult and elderly individuals with tinnitus.</p>","PeriodicalId":46547,"journal":{"name":"CoDAS","volume":"38 3","pages":"e20250125"},"PeriodicalIF":0.8000,"publicationDate":"2026-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"CoDAS","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1590/2317-1782/e20250125pt","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: The objective of this study was the development and validation of a clinical investigation protocol for tinnitus and the analysis of its applicability.
Methods: 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).
Results: 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.
Conclusion: The clinical investigation protocol for tinnitus was finalized and its content validated, demonstrating applicability for adult and elderly individuals with tinnitus.