[Methodological implications of the minimal clinically important difference in patient-reported outcome measures in...

To determine the minimal clinically important difference (MCID), patient-reported outcome measures (PROMs) are presented that cover the dimensions 1. subjective hearing ability, 2. hearing-specific quality of life, and 3. generic quality of life, which are largely mentioned in corresponding guidelines and recommendations for device provision and aural rehabilitation in Germany. In the absence of recognized MCID thresholds in the field of cochlear implant (CI) provision in Germany, a methodological framework for future clinical studies was developed based on a two-stage anchor-based retrospective survey (1. significant change and 2. extent of significant change; 6‑point Likert scale) in accordance with the three PROM dimensions. The aim is to determine MCID thresholds for three different severity groups in CI patients: single-sided deafness (SSD), asymmetric hearing loss (AHL), and symmetric hearing loss (SHL). It is proposed to first use pilot data to estimate the sample size and to consider the correlation (r) thresholds of the PROM with the anchor question at baseline (r < 0.1) and follow-up (r > 0.2). The correlation between the difference in the PROM in the pre-post comparison and the anchor question should be r > 0.5 to subsequently determine cut-off values using logistic regression/receiver operating characteristic (ROC) analysis. Minimal clinically important difference thresholds can be used in the future as a supplement for individual case decisions in the field of CI sound processor upgrade and provide guidance for optimized CI fitting and rehabilitation.