Validation of a Spanish chronic obstructive sialadenitis quality of life questionnaire (CSOC).

BACKGROUND AND

OBJECTIVES

Interest in chronic obstructive sialadenitis is increasing with the introduction of sialendoscopy. A self-administered instrument to assess quality of life in patients with chronic obstructive sialadenitis is needed to improve clinical management and support research. The objectives of this study are to design a Spanish questionnaire to assess quality of life in chronic obstructive sialadenitis, named CSOC and assess its reliability, validity and feasibility.

MATERIAL AND

METHODS

A prospective, multicentre, observational study was conducted. Patients with diagnosis of chronic obstructive sialadenitis were included in the study. The item generation process included a review of published data as well as interviews with patients. An expert panel then tested the content validity of the instrument, and the construct validity was tested in 120 patients and 100 controls. Patients completed a self-administered CSOC questionnaire, a Short Form-36 and a Visual Analogue Scale. Feasibility, reliability, internal consistency, construct validity and responsiveness were assessed.

RESULTS

All the patients found the instrument understandable. Cronbach α coefficient was high (0.85). The time required to fill out was 5.7 and 4.5min for pre and postsialendoscopy CSOC respectively. Cronbach α coefficient was very high for both pre and postsialendoscopy CSOC (0.90 and 0.94 respectively). The correlation with the SF-36 dimensions was negative and positive with the VAS. The mean score of CSOC was 28.63 and 8.33 for pre and postsialendoscopy. In the control group the mean score of CSOC was 1.31.

CONCLUSIONS

The CSOC questionnaire is understandable, feasible, reliable and representative of quality of life in chronic obstructive sialadenitis.