Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
Estimation of Minimal Clinically Important Difference for Tinnitus Handicap Inventory and Tinnitus Functional Index.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Engelke Milena, Basso Laura, Langguth Berthold, Zeman Florian, Schlee Winfried, Schoisswohl Stefan, Cima Rilana, Kikidis Dimitris, Lopez-Escamez Jose Antonio, Brüggemann Petra, Mazurek Birgit, Simões Jorge Piano
Аннотация
OBJECTIVE: The minimal clinically important difference (MCID) represents the smallest change in treatment outcome deemed clinically meaningful. This study estimates the MCID for 2 widely used tinnitus measures: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI), using anchor-based approaches while accounting for baseline severity and time interval.
STUDY DESIGN: A multi-center randomized clinical trial.
SETTING: European tinnitus centers.
METHODS: Anchor-based approaches, including the effect size, receiver-operating characteristics, and ΔTHI/TFI methods, were employed to determine the MCID. The "minimally improved" category of the Clinical Global Impression Scale-Improvement (CGI-I) served as the anchor. The standard error of measurement was used to assess random variation.
RESULTS: For the THI, MCID estimates ranged from 7.8 to 12, with a point estimate of 11 after 12 weeks of treatment (N = 364). For the TFI, MCID estimates ranged from 7.3 to 9.4, with a point estimate of 9 points after 12 weeks (N = 359). Both measures indicated that higher baseline severity and longer time intervals required greater score reduction for clinical relevance.
CONCLUSION: This study highlights the context-specific nature of MCID values for tinnitus measures and emphasizes the need for consensus on optimal anchor-based approaches to improve comparability.
STUDY DESIGN: A multi-center randomized clinical trial.
SETTING: European tinnitus centers.
METHODS: Anchor-based approaches, including the effect size, receiver-operating characteristics, and ΔTHI/TFI methods, were employed to determine the MCID. The "minimally improved" category of the Clinical Global Impression Scale-Improvement (CGI-I) served as the anchor. The standard error of measurement was used to assess random variation.
RESULTS: For the THI, MCID estimates ranged from 7.8 to 12, with a point estimate of 11 after 12 weeks of treatment (N = 364). For the TFI, MCID estimates ranged from 7.3 to 9.4, with a point estimate of 9 points after 12 weeks (N = 359). Both measures indicated that higher baseline severity and longer time intervals required greater score reduction for clinical relevance.
CONCLUSION: This study highlights the context-specific nature of MCID values for tinnitus measures and emphasizes the need for consensus on optimal anchor-based approaches to improve comparability.