Development of a health-related quality of life instrument for nausea and vomiting of pregnancy

OBJECTIVE: To develop a questionnaire that measures change in symptoms of nausea and vomiting of pregnancy (NVP). METHODS: Eligible and consenting callers to the NVP Healthline at the Hospital for Sick Children, Toronto, underwent telephone interview by using a structured questionnaire. Callers were asked to indicate which of 195 items had been a problem for them and the importance of that problem. For each item, the "frequency" (of women who identified the item as problematic) and "mean importance" (mean importance score of women who indicated that the item was problematic) were multiplied to give the "overall impact." Patterns of response were examined by maternal characteristics. Factor analysis was used to explore relationships between factors. RESULTS: Among 500 women enrolled, areas of quality of life impairment were frequent and similar by maternal characteristics. The questionnaire contains 30 items in 4 domains (physical symptoms/aggravating factors, fatigue, emotions, and limitations) and takes 10 minutes to administer. CONCLUSIONS: This questionnaire contains topics of quality of life impairment important to women with NVP and shows promise for use as an outcome measure in clinical trials.