[The development of a new QOL Questionnaire on chemotherapy - induced emesis and vomiting--investigation of reliability and validity. Group for Investigation of QOL Questionnaire for Anti-Emetics Used in Cancer Chemotherapy. Joint Research Group for Tropisetron Double-Blind Comparative study].

A new questionnaire on QOL of patients with chemotherapy-induced emesis and vomiting was developed, and its reliability and validity were investigated in the present multi-center clinical trial. The questionnaire consisted of 15 items which included descriptive questions on appetite, feeling, sleep, mental fatigue, anxiety, pain, sputum, respiratory distress, nausea, vomiting, abdominal condition, daily life in a hospital and relationship with family, a linear analogue scale representing influence of nausea and vomiting on patient's life during 24 hours, and a face scale as the global scale. Data from 98 patients with cancer were analyzed by principal component analysis and correlation analysis. The results were summarized as follows: 1) Recollect rate was 78.1% and complete response rate was 86.0% in this QOL measurement. 2) A clear correlation was observed between appetite, feeling, nausea, vomiting and the physiological scale, between sleep, mental fatigue, anxiety, pain, abdominal condition and the psychological scale, between sputum, respiratory distress and the respiratory condition related scale, between daily life in hospital and the active scale, between relationship with family and the social relation scale. These results satisfied internal consistency. 3) As for test-retest reliability, the total score of 13 descriptive items between the day before and two days before the start of chemotherapy showed no significant difference. 4) The 13 items were grouped into physiological, the psychological, the respiratory condition related, the active and the social relation scales, and these scales belonged to a different dimension. 5) The linear analogue scale, the face scale and the total scores of 13 descriptive items correlated respectively with all of items except item of, relationship with family. 6) As for concurrent validity, vomiting frequency, severity of nausea and anorexia correlated with the physiological scale. Severity of nausea and anorexia also correlated with the psychological and active scales. 7) As a result of investigation of sensitivity, the total score of the 13 descriptive items, the linear analogue scale representing influence of nausea and vomiting on patient's life during 24 hours and the face scale revealed the poorest levels 2-3 days after chemotherapy but recovered thereafter. The aggravation of QOL of patients treated with chemotherapy was reduced in the anti-emetic administration group compared with the placebo administration group. These results suggested that this new questionnaire developed for chemotherapy-induced emesis and vomiting had sufficient validity and reliability to reflect the effects of anti-emetic drug.