Methodische Implikationen zur minimalen klinisch relevanten Differenz von Fragebögen als Patient-Reported Outcome Measures im Bereich der CI-Versorgung

Research output: Contribution to journal › Research article › Contributed › peer-review

Contributors

  • Martin Scharpenberg - , University of Bremen (Author)
  • Lasse Fischer - , University of Bremen (Author)
  • Heidi Olze - , Charité – Universitätsmedizin Berlin (Author)
  • Ulrich Hoppe - , University Hospital at the Friedrich-Alexander University Erlangen-Nürnberg (Author)
  • Susen Lailach - , Department of Otorhinolaryngology, Head and Neck Surgery, Saxonian Cochlear Implant Centre (Author)
  • Markus Meis - , Jade University of Applied Sciences (Author)

Abstract

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.

Translated title of the contribution
Methodological implications of the minimal clinically important difference in patient-reported outcome measures in the field of cochlear implant provision. German version

Details

Original languageGerman
JournalHNO
Publication statusE-pub ahead of print - 7 Oct 2026
Peer-reviewedYes

External IDs

PubMed 42841941

Keywords

ASJC Scopus subject areas

  • Otorhinolaryngology - Anchor based, CI upgrade, Cochlear implant, MCID, Patient-reported outcome measure

Keywords

  • Anchor based, CI upgrade, Cochlear implant, MCID, Patient-reported outcome measure