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Sexually inactive (n=64)
Rescaling the overall score in the Cervantes short-form scale for measuring health-related quality of life in menopausal women sexually inactive Pluvio J. Coronado1, Rafael Sánchez-Borrego2, Miguel A. Ruiz3, Javier Rejas4 and the Cervantes Health-related-Quality-of-Life 16-items Short Form scale collaborative group. 1Department of Obstetrics and Gynecology, Hospital Universitario San Carlos, Madrid, Spain; 2Clínica DIATROS, Barcelona, Spain; 3School of Psychology, Universidad Autónoma de Madrid, Spain; 4HEOR Department, Pfizer SLU, Alcobendas, Spain. OBJECTIVE: The Cervantes short-form (Cervantes-SF) scale is a psychometrically valid tool assessing the impact of menopausal symptomatology on patient quality-of-life. The objective was testing the need for rescaling the overall score of the scale in subjects sexually inactive. INTRODUCTION The Cervantes scale is a specific health-related-quality-of-life (HRQoL) questionnaire developed in Spanish women through and beyond menopause. The original 31-item scale was reduced to a less time consuming 16-item sort form (the Cervantes-SF) maintaining the original four main dimensions: Menopause and health, Mental health, Sexuality, and Couple Relationship, being the first dimension composed by 3 sub-dimensions: Vasomotor Symptoms, Health, and Aging. MATERIALS AND METHODS Patients A sample of peri and postmenopause adult women were recruited at random by demand of attention at outpatient clinics of Gynecology all over Spain. All patients gave is consent in written and had to understand questionnaires written in Spanish and have no major diseases which could interfere with patient´s responses to questionnaires. Method This was a post-hoc analysis of a study carried-out to test the psychometric properties of the Cervantes-SF in menopausal women. For this analysis, we used the subsample of outpatients women years with menstrual problems associated with the climacteric syndrome who informed to be sexually inactive. The Cervantes-SF scale was used. Overall score was calculated using the original correction instructions which calculates the overall score adding the four primary domains of the scale (menopause and health, psychological, couple relations and sexuality) and dividing by four, and alternative method excluding the sexuality domain in the total punctuation and dividing by three. Agreement was tested using the paired t-test and the intraclass correlation coefficient (ICC). RESULTS Sixty-four out of 317 women [58.5±4.2 years (mean ± standard deviation)] sexually inactive were included in the analysis: 90.6% were post- and 9.4% were peri-menopausal. Overall score with four domains was 39.4 (13.1) and 38.4 (13.0) excluding sexuality domain; difference; 1.0 (95% bootstrap confidence interval: -3.2; 1.2, p=0.376). ICC was (0.789; 0.922, p<0.001) and Pearson correlation coefficient was (0.691; 0.845, p<0.001). Excluding the sexuality domain only modified Cronbach’s alpha from to Table 1. Demographic data of women sexually inactive relative to the whole sample in the Cervantes-short form psychometric attributes testing study. Overall sample (n=317) Sexually inactive (n=64) Age (years): Mean (SD) 55.7 (5.4) 58.5 (4.2) BMI (kg/m2): Mean (SD) 25.3 (4.3) 26.2 (4.2) Educational Level (%) Primary 54 (18%) 14 (22%) Secondary 105 (35%) 23 (36%) Labor training 1 (1%) 1 (2%) Undergraduate or university 137 (46%) 26 (41%) Working status (%) Active 209 (70%) 37 (58%) Disabled 4 (1%) 2 (3%) Unemployed 15 (5%) Retired 11 (4%) 6 (9%) Homemaker 55 (19%) 16 (25%) Unknown Civil status (%) Single 25 (8%) 13 (20%) Married 212 (71%) 19 (30%) Divorced 42 (14%) 20 (31%) Widowed 17 (6%) 12 (19%) Other 2 (1%) - Smokers 79 (25%) Daily alcohol intake 10 (16%) Table 2. Reliability estimates (Cronbach’s alpha and ICC) for the Cervantes short form in the overall sample and women sexually inactive. Dimension Overall sample Sexually inactive Scoring ICC (95% CI) ICC (95% CI) Menopause & Health (9) 28.1 (18.6) .774 27.7 (17.0) .704 Vasomotor Symptoms (2) 36.0 (31.1) .778 33.8 (29.6) .862 Health (3) 24.3 (20.2) .918 22.9 (18.1) .450 Aging (4) 23.9 (17.9) .596 26.5 (17.3) .342 Psychological (3) 23.7 (23.0) .731 24.5 (22.0) .673 Sexuality (2) 44.1 (29.0) .745 79.6 (21.5) .404 Couple Relations (2) 25.5 (30.2) .898 63.0 (31.8) .787 Total (16) 29.5 (15.9) 39.4 (13.0) .802 # items in parenthesis, α=Cronbach´s alpha, ICC=Intra-class Correlation Coefficient, CI=Confidence interval. SD: standard deviation. BMI: body mass index. CONCLUSION According with these findings, rescaling of the overall score of the Cervantes-SF scale in menopausal women sexually inactive does not require excluding the sexuality domain from the overall scale scoring, while allowing clinicians to explore this domain when pertinent. ISPOR 17th Annual European Congress, 29 October-2 November 2016 Vienna, Austria Conflict of interest:This project was endorsed and promoted by the SEM (Spanish Society of Menopause). No funding was received from any part or institution to carry out this research. The Cervantes Health-related-Quality-of-Life 16-items Short Form scale collaborative group is formed by: P Coronado, R Sánchez-Borrego, A Duque, M Fernández-Abellán, S Sánchez, E Iglesias, L Baquedano, S González, B Otero, J Presa, F Ruiz, J Calleja, C Argudo, M Ruiz and J Rejas from the, respectively, Departments of Obstetrics and Gynecology of Hospital Universitario San Carlos, Madrid, Spain; Clínica DIATROS, Barcelona, Spain; Hospital Universitario Miguel Servet, Zaragoza, Spain; Hospital Sagrado Corazón, Barcelona, Spain; Clínica Begoña, Gijón (Asturias), Spain; Clínica Quirón, Málaga, Spain; Gabinete Médico Velázquez, Madrid, Spain; Hospital de Valme, Sevilla, Spain; Clínica Quirón, Madrid, Spain; Hospital Clínico de Jaén, Spain; Clínica Ruber, Madrid, Spain; Hospital Clínico Universitario, Valencia, Spain; Hospital Universitario de Cruces, Baracaldo (Vizcaya), Spain; School of Psychology, Universidad Autónoma de Madrid, Spain; Health Economics and Outcomes Research Department, Pfizer SLU, Alcobendas, Spain. Javier Rejas is an employ of Pfizer, S.L.U. All other authors declare no conflicts of interest.
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