title: Development and validation of the SEC-QOL questionnaire in women using contraceptive methods.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Hospital General de Requena, Requena, Valencia, Spain.
authors.forename: Ezequiel
authors.initials: E
authors.lastname: Pérez-Campos
authors.forename: Jose Luís
authors.initials: JL
authors.lastname: Dueñas
authors.forename: Esther
authors.initials: E
authors.lastname: de la Viuda
authors.forename: María Ángeles
authors.initials: MÁ
authors.lastname: Gómez
authors.forename: Roberto
authors.initials: R
authors.lastname: Lertxundi
authors.forename: Rafael
authors.initials: R
authors.lastname: Sánchez-Borrego
authors.forename: Ignaci
authors.initials: I
authors.lastname: Canals
authors.forename: Rafael
authors.initials: R
authors.lastname: Bermejo
authors.forename: Agnès
authors.initials: A
authors.lastname: Arbat
authors.forename: Xavier
authors.initials: X
authors.lastname: Badia
authors.forename: Núria
authors.initials: N
authors.lastname: Perulero
authors.forename: Luis Ignacio
authors.initials: LI
authors.lastname: Lete
mesh_terms: D000328:Adult; D003267:Contraception / Q000379:methods*; D005260:Female; D006801:Humans; D011446:Prospective Studies; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012959:Socioeconomic Factors; D013030:Spain; D011795:Surveys and Questionnaires