Development and validation of the SEC-QOL questionnaire in women using contraceptive methods.

OBJECTIVES: Develop and validate a Spanish society of contraception quality-of-life (SEC-QOL) questionnaire to assess the impact of contraceptive methods on the health-related quality of life (HRQOL) of women. METHODS: SEC-QOL was developed following a standardized procedure including review of the literature, interviews with contraception users, and the administration of a pilot questionnaire to 187 women. SEC-QOL consists of 19 items and includes five dimensions. To validate the questionnaire, a multicenter, observational, prospective study was conducted in Spain. The following three study groups were defined: group A (n = 129) comprised women using effective contraceptive methods; group B (n = 251), comprised women about to start using an effective method; and group C (n = 73) comprised women using no or poorly effective contraception. All women attended baseline and final visits (4 ± 1 months). Participants completed the SEC-QOL, psychological well-being index, EuroQol five-dimensional questionnaire, and perceived health state questionnaires. RESULTS: At baseline, women from group A had a better HRQOL in all SEC-QOL dimensions, except for breast symptoms. Heavier menstrual bleeding, more androgenic and breast symptoms, menstrual pain, and not using hormonal contraceptive methods were associated with lower HRQOL. SEC-QOL scores showed moderate correlations to psychological well-being index and slightly lower correlation to EuroQol five-dimensional questionnaire scores. At follow-up, HRQOL had improved in all groups; most markedly in group B, which obtained an average effect size of 0.59. The minimum important difference was established as a 3.4-point change in the global SEC-QOL score. SEC-QOL obtained a Cronbach's α of 0.88 and an intraclass correlation coefficient of 0.82. CONCLUSIONS: SEC-QOL is a valid, reliable, and sensitive to change questionnaire for use in daily clinical practice and future research projects on contraception.