Background
With the Chronic Ear Survey (CES), a validated measurement instrument for the assessment of disease-specific health-related quality of life (HRQoL) has been available internationally since ...2000. The aim of this study was to provide a validated German version of this international instrument and to compare it with the German Chronic Otitis Media Outcome Test 15 (COMOT-15).
Methodology
The CES was translated into German via a forward-backward translation process. For validation, 79 patients with COM undergoing middle ear surgery were prospectively included. HRQoL was determined preoperatively and 6 months postoperatively using the CES and the COMOT-15. Pure tone audiometry was also performed at both measurement time points. In the control examination, an additional retrospective assessment of the preoperative situation was additionally performed using the CES and the COMOT-15 to assess the response shift. The determined psychometric characteristics were internal consistency, test–retest reliability, discrimination validity, agreement validity, responsiveness, and response shift for both measurement instruments. Convergent validity of both measurement instruments was assessed using linear regression.
Results
On the basis of the CES, patients with COM could be reliably distinguished from patients with healthy ears. The CES showed satisfactory reliability with high internal consistency (Cronbach α 0.65–0.85) and high retest reliability (r > 0.8). The global assessment of HRQoL impairment correlated very well with the scores of the CES (r = 0.51). In addition, it showed a high sensitivity to change (standardized response mean −0.86). Compared to the COMOT-15, it showed a lower response shift (effect size −0.17 vs. 0.44). Both measurement instruments correlated only slightly with air conduction hearing threshold (r = 0.29 and r = 0.24, respectively). The concordant validity of both measurement instruments was high (r = 0.68).
Conclusion
The German version of the CES shows satisfactory psychometric characteristics, so that its use can be recommended. The CES focuses on the influence of ear symptoms on HRQoL, whereas the COMOT-15 also includes functional and psychological aspects. Due to only minor response shift effects, the CES is particularly suitable for studies with multiple repeat measurements.
Zusammenfassung
Hintergrund
Mit dem Chronic Ear Survey (CES) steht seit 2000 ein validiertes Messinstrument zur Erfassung der krankheitsspezifischen bzw. gesundheitsbezogenen Lebensqualität (HRQoL) ...international zur Verfügung. Ziel der Studie war es, für dieses internationale Messinstrument eine validierte deutschsprachige Fassung zur Verfügung zu stellen und diese mit dem deutschen Chronic Otitis Media Outcome Test 15 (COMOT-15) zu vergleichen.
Methodik
Der CES wurde über einen Vorwärts-rückwärts-Übersetzungsprozess in die deutsche Sprache transferiert. Zur Validierung wurden 79 Patient:innen mit einer COM, bei denen eine Mittelohroperation durchgeführt wurde, prospektiv in die Studie eingeschlossen. Die HRQoL wurde präoperativ und 6 Monate postoperativ mit dem CES und dem COMOT-15 bestimmt. Zu beiden Messzeitpunkten erfolgte auch eine Reintonaudiometrie. In der Kontrolluntersuchung wurde zusätzlich eine rückwirkende Beurteilung der präoperativen Situation anhand des CES und des COMOT-15 zur Bestimmung des Response-Shifts durchgeführt. Als psychometrische Kenndaten wurden die interne Konsistenz, die Test-Retest-Reliabilität, die Diskriminationsvalidität, die Übereinstimmungsvalidität, die Responsivität für beide Messinstrumente bestimmt. Die konvergente Validität beider Messinstrumente wurde anhand einer linearen Regression bewertet.
Ergebnisse
Anhand des CES konnten Patient:innen mit COM von Ohrgesunden sicher unterschieden werden. Der CES zeigte eine sehr gute Reliabilität mit hoher interner Konsistenz (Cronbach‑α 0,65–0,85) und hoher Retest-Reliabilität (r > 0,8). Die globale Einschätzung der Beeinträchtigung der HRQoL korrelierte sehr gut mit den Scores des CES (r = 0,51). Zudem zeigte er eine hohe Änderungssensitivität („standardized response mean“ −0,86). Im Vergleich zum COMOT-15 zeigte sich ein geringerer Response-Shift (Effektstärke −0,17 vs. 0,44). Beide Messinstrumente korrelierten nur gering mit der Luftleitungshörschwelle (r = 0,29 bzw. r = 0,24). Die konkordante Validität beider Messinstrumente war hoch (r = 0,68).
Schlussfolgerung
Die deutsche Version des CES weist zufriedenstellende psychometrische Kenndaten auf, sodass das Einsatz empfohlen werden kann. Der CES legt hierbei den Fokus auf den Einfluss der Ohrsymptomatik auf die HRQoL, wohingegen der COMOT-15 auch funktionelle und psychologische Aspekte miteinschließt. Aufgrund nur geringer Response-Shift-Effekte eignet sich der CES insbesondere für Untersuchungen mit mehreren Wiederholungsmessungen.
With the Chronic Ear Survey (CES), a validated measurement instrument for the assessment of disease-specific health-related quality of life (HRQoL) has been available internationally since 2000. The ...aim of this study was to provide a validated German version of this international instrument and to compare it with the German Chronic Otitis Media Outcome Test 15 (COMOT-15).
The CES was translated into German via a forward-backward translation process. For validation, 79 patients with COM undergoing middle ear surgery were prospectively included. HRQoL was determined preoperatively and 6 months postoperatively using the CES and the COMOT-15. Pure tone audiometry was also performed at both measurement time points. In the control examination, an additional retrospective assessment of the preoperative situation was additionally performed using the CES and the COMOT-15 to assess the response shift. The determined psychometric characteristics were internal consistency, test-retest reliability, discrimination validity, agreement validity, responsiveness, and response shift for both measurement instruments. Convergent validity of both measurement instruments was assessed using linear regression.
On the basis of the CES, patients with COM could be reliably distinguished from patients with healthy ears. The CES showed satisfactory reliability with high internal consistency (Cronbach α 0.65-0.85) and high retest reliability (r > 0.8). The global assessment of HRQoL impairment correlated very well with the scores of the CES (r = 0.51). In addition, it showed a high sensitivity to change (standardized response mean -0.86). Compared to the COMOT-15, it showed a lower response shift (effect size -0.17 vs. 0.44). Both measurement instruments correlated only slightly with air conduction hearing threshold (r = 0.29 and r = 0.24, respectively). The concordant validity of both measurement instruments was high (r = 0.68).
The German version of the CES shows satisfactory psychometric characteristics, so that its use can be recommended. The CES focuses on the influence of ear symptoms on HRQoL, whereas the COMOT-15 also includes functional and psychological aspects. Due to only minor response shift effects, the CES is particularly suitable for studies with multiple repeat measurements.
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