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Development and validation of a disease specific quality of life questionnaire for potentially curable patients with carcinoma of the esophagus

University of British Columbia

Objectives: To develop, pre-test and validate a disease specific quality of life (QOL) questionnaire (EQOL) for potentially curable patients with esophageal carcinoma, for use with the EORTC QLQ-C30 questionnaire, assessing treatment associated quality of life. Methods: Questionnaire development Patients enrolled in three centres. Literature reviews, patients, family members, and health care professionals generated 195 items - symptoms (55); emotions (53); physical functioning (17); activities of daily living (ADL) (48); leisure/social (22). 38 patients identified items of importance and assigned importance ratings on a five point Likert scale. Impact scores were calculated as frequency times mean item importance. Item impact scores less than 20/100 were excluded. Pearson's Correlation Co-efficients compared domains with the MOS SF-20. Fifteen items remained in the EQOL. Questionnaire validation Sixty-five patients enrolled in four centres. EORTC QLQ-C30, EQOL, MOS SF-36 and a Global Rating of Change Questionnaire were completed at baseline, one week, one month, three months, and six months after treatment began. Reliability was assessed comparing mean baseline and one week scores. Responsiveness was assessed between mean scores of changed and unchanged patients, and a responsiveness index was calculated. The MOS SF-36 was used for criterion validity. Construct validity included four a priori predictions. Results: Mean scores between baseline and one week for unchanged patients were not significant (p>0.05), except in the physical function domain (p=0.025). Symptom, physical function and social domains were responsive to change at all time intervals (p<0.05). Emotional function was responsive at one and three months, ADL's at one and six months. Magnitude of change was significant when direction of change was stated. Between better and worse, magnitude of change was significant in all domains except at six months in symptoms, emotional and physical domains. The minimal clinically important difference was consistently around 0.5 for all domains. Minimal, moderate and large effect ranges were established. Only two out of 16 time intervals had poor correlations with the MOS SF-36, establishing criterion validity. Of the four a priori predications for construct validity, only the second part of one prediction, in the emotional function domain, was not confirmed. Conclusions: Quality of life can be assessed using the EQOL. Future studies can further test the EQOL where validation was not confirmed.

Thesis/Dissertation

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2009-10-29

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http://hdl.handle.net/2429/14406

Health Care and Epidemiology

University of British Columbia

UBCV

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