Development and Psychometric Validation of a Screening Questionnaire to Detect Excessive Menstrual Blood Loss That Interferes in Quality of Life: The SAMANTA Questionnaire.

Background: Heavy menstrual bleeding (HMB) affects up to 35% of women at some point in their lives, and has an important impact on their quality of life (QoL). Current techniques to assess and quantify menstrual blood loss are inconvenient and the correlation between actual and perceived blood loss is poor. This study aimed to develop and validate a screening questionnaire in Spanish to identify HMB in women of reproductive age. Methods: The study consisted of two phases: the conceptual development of a set of items to discriminate between women with and without HMB and the assessment of the sensitivity and specificity of these items. Correlation of the screening tool with women's perception of the intensity of bleeding and the interference in their daily life activities was also assessed. Results: An initial set of 46 items were identified, from which 21 items were selected following the cognitive interviews. For the psychometric validation phase, 389 patients were enrolled, of whom 364 were assessable: 211 cases with Pictorial Blood loss Assessment Chart-confirmed excessive menstrual loss (EML) and 153 controls. Six items met entry criteria in the model and together yielded a sensitivity of 86.7% and specificity of 89.5% to identify cases and controls. These items were weighted according to their contribution to the final model to yield a tool that can be scored from 0 to 10 being 3 the cutoff point to diagnose EML that interferes in QoL. Conclusions: The 6-item SAMANTA questionnaire represents a valid screening tool to easily identify women with EML that interfere with QoL.

One year quality of life measured with SEC-QoL in levonorgestrel 52 mg IUS users.

OBJECTIVES: The present study aims to prospectively evaluate quality of life (QoL) of women using 52-mg levonorgestrel intrauterine system (LNG-IUS) for contraception determined through the Sociedad Española de Contracepción (Spanish contraception Society) (SEC)-QoL, a questionnaire specifically designed to assess the impact of contraceptive methods on QoL of fertile women. STUDY DESIGN: We conducted a prospective observational multicenter study of 201 reproductive age women who initiated the LNG-IUS for contraception. Sociodemographic and clinical data were collected at baseline and 12 months afterwards. Participants filled in the SEC-QoL questionnaire at both visits. SEQ-QoL scores range from 0 (worst QoL) to 100 (best QoL). RESULTS: Participants claimed an increased QoL 12 months after insertion in all five dimensions of SEC-QoL due to its high contraceptive efficacy and its capability to reduce other menstrual symptoms (e.g., heavy menstrual bleeding or dysmenorrhoea), overall exerting a positive impact on user's satisfaction. SEC-QoL general overall score went from a mean (S.D.) score of 46.3 (17.3) at baseline to 72.2 (14.8) 12 months afterwards (p<.001). Overall, 94.6% of women claimed having found additional benefits other than contraception. No pregnancies were reported during the 12 months of study duration, and only 14 women discontinued use of LNG-IUS (only two of them due to an adverse event), representing a continuation rate of 93%. CONCLUSIONS: Women using LNG-IUS for contraception have an increased QoL after 12 months of use, demonstrated by the increased score in all dimensions of the SEC-QoL questionnaire. IMPLICATIONS: The present study prospectively evaluated QoL of women using LNG-IUS for contraception through the SEC-QoL questionnaire. Participants claimed increased QoL 12 months afterwards, implying that women using LNG-IUS for contraception in usual clinical practise also benefit from the reduction of period-related symptoms, overall leading to very low discontinuation rates.

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.