[Development and validation of the Chronic Otitis Media Outcome Test 15 (COMOT-15). Measurement of health-related quality of life in patients with chronic otitis media].
BACKGROUND
Clinical experience has shown that chronic otitis media (COM) affects health-related quality of life (HR-QOL) of the patients. Nevertheless, up to now no validated measurement instrument encompassing all the relevant dimensions of HR-QOL is available.


METHODS
In phase 1 the development of the Chonic Otitis Media Outcome Test (COMOT) was conducted. A group of experts identified 31 HR-QOL concepts as being relative for COM which was reduced to 15 items (COMOT-15) by sequential statistical analysis on the basis of data from 50 consecutive COM patients. In addition to the overall score (GS), three sub-scores (ear symptoms, OS; hearing function, HF; and mental being, PB) were introduced. In phase 2 validation was performed by calculating reliability, validity, and responsiveness with the data of 121 prospectively evaluated patients.


RESULTS
COMOT-15 showed an excellent reliability with high internal consistency (Cronbach's alpha from 0.89 to 0.91) and high retest reliability coefficients (all r>0.8). Content validity was determined by a study of the literature. COMOT-15 can distinguish COM patients from healthy subjects. Global assessment of impairment of HR-QOL by COM correlated very well with the scores of COMOT-15. However, the responsiveness of the COMOT-15 questionnaire was low.


CONCLUSIONS
COMOT-15 is a reliable, valid and sensitive instrument for measurement of HR-QOL of COM patients. The results obtained with the questionnaire can be interpreted very well by the investigator. COMOT-15 should be used in otological outcomes research.
Baumann
I
I
Universitäts-HNO-Klinik, Im Neuenheimer Feld 400, 69120, Heidelberg, Deutschland. ingo.baumann@med.uni-heidelberg.de
Kurpiers
B
B
Plinkert
P K
PK
Praetorius
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010033:Otitis Media / Q000175:diagnosis / Q000523:psychology* / Q000601:surgery*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011594:Psychometrics / Q000379:methods*; D011788:Quality of Life; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult