María Fasero1, Javier Rejas-Gutiérrez2, Pluvio J Coronado3. 1. Clínica Corofas. Corofas Menopause, Universidad Francisco de Vitoria., Madrid, Spain. mfaserol@gmail.com. 2. EACCOS Research Group, Universidad Autónoma de Madrid, Madrid, Spain. 3. Women's Health Institute, Hospital Clínico San Carlos, IdISSC, Universidad Complutense, Madrid, Spain.
Abstract
OBJECTIVES: To explore, for the first time, the ability of the Cervantes Short-Form (C-SF) questionnaire to detect and to predict meaningful changes (sensitivity-to-change and predictive validity) in women with menopausal symptoms receiving any therapeutic management under routine medical care. METHODS: Postmenopausal women included in a registry study were the source of data. Sensitivity-to-change was explored by assessing the responses of C-SF to different type of treatment management: no treatment, natural therapies or systemic hormonal therapy (SHT). Predictive validity assessed the ability of baseline score to predict the reduction in the impact of menopausal symptoms in C-SF scoring equal or higher than one time its minimally important difference (MID) of improvement (response rate). RESULTS: A total of 245 women were enrolled. C-SF score was significantly reduced (better QoL) with SHT by 10.62 points versus no change or 2.32 point by natural therapies or no treatment, respectively (p < 0.001 in both cases). Women declaring better improvement after treatment showed higher significant reduction in C-SF score versus those with no self-perceived improvement or impairment: -12.49 point versus +1.06 and +12.71, respectively (p < 0,01 in both cases). Responder rate showed a significant lineal growing trend with higher C-SF scoring at baseline in women who received SHT: higher scoring showed higher response rates (lineal Chi2 = 15.9, p < 0.001), but not in the case of receiving natural therapies or no treatment. CONCLUSIONS: C-SF was shown to be sensitive-to-change when postmenopausal QOL status changes due to mainly systemic hormonal treatment, therefore, supporting the utilization of this instrument to monitor response to treatment. Likewise, pre-treatment scoring in C-SF was able to predict woman's QOL meaningful response with hormonal treatment.
OBJECTIVES: To explore, for the first time, the ability of the Cervantes Short-Form (C-SF) questionnaire to detect and to predict meaningful changes (sensitivity-to-change and predictive validity) in women with menopausal symptoms receiving any therapeutic management under routine medical care. METHODS: Postmenopausal women included in a registry study were the source of data. Sensitivity-to-change was explored by assessing the responses of C-SF to different type of treatment management: no treatment, natural therapies or systemic hormonal therapy (SHT). Predictive validity assessed the ability of baseline score to predict the reduction in the impact of menopausal symptoms in C-SF scoring equal or higher than one time its minimally important difference (MID) of improvement (response rate). RESULTS: A total of 245 women were enrolled. C-SF score was significantly reduced (better QoL) with SHT by 10.62 points versus no change or 2.32 point by natural therapies or no treatment, respectively (p < 0.001 in both cases). Women declaring better improvement after treatment showed higher significant reduction in C-SF score versus those with no self-perceived improvement or impairment: -12.49 point versus +1.06 and +12.71, respectively (p < 0,01 in both cases). Responder rate showed a significant lineal growing trend with higher C-SF scoring at baseline in women who received SHT: higher scoring showed higher response rates (lineal Chi2 = 15.9, p < 0.001), but not in the case of receiving natural therapies or no treatment. CONCLUSIONS: C-SF was shown to be sensitive-to-change when postmenopausal QOL status changes due to mainly systemic hormonal treatment, therefore, supporting the utilization of this instrument to monitor response to treatment. Likewise, pre-treatment scoring in C-SF was able to predict woman's QOL meaningful response with hormonal treatment.
Authors: Pluvio J Coronado; Rafael Sánchez-Borrego; Miguel A Ruiz; Laura Baquedano; Sonia Sánchez; Cristina Argudo; Mariela Fernández-Abellán; Silvia González; Eva Iglesias; Jackie Calleja; Jesus Presa; Alfonso Duque; Fernando Ruiz; Borja Otero; Javier Rejas Journal: Maturitas Date: 2015-10-31 Impact factor: 4.342
Authors: Pluvio J Coronado; Manuel Monroy; María Fasero; Rafael Sánchez-Borrego; Santiago Palacios; Javier Rejas; Miguel A Ruiz Journal: Maturitas Date: 2021-01-30 Impact factor: 4.342
Authors: Juan E Blümel; Camil Castelo-Branco; Nicolas Kerrigan; María J Cancelo; Bernardita Blümel; Javier Haya; Mariana Flores; Maria Carolina Carvajal; Salvador Sarrá Journal: Menopause Date: 2003 May-Jun Impact factor: 2.953
Authors: N Mendoza; R Sánchez-Borrego; M J Cancelo; A Calvo; M A Checa; J Cortés; M A Elorriaga; T Díaz; J V González; I Lete; P Lobo; T Martínez-Astorquiza; A Nieto; M A Olalla; E Pérez-Campos; R Porqueras; F Quereda; A Salamanca; E De La Viuda Journal: Maturitas Date: 2013-01-14 Impact factor: 4.342
Authors: Samar R El Khoudary; Gail Greendale; Sybil L Crawford; Nancy E Avis; Maria M Brooks; Rebecca C Thurston; Carrie Karvonen-Gutierrez; L Elaine Waetjen; Karen Matthews Journal: Menopause Date: 2019-10 Impact factor: 2.953