Tpq3: European Guidance Document for the Improvement of the Integration of Health-Related Quality of Life (Hrql) Assessment in the Drug Regulatory Process

Health-Related Quality of Life and Utility in Patients With Age-Related Macular Degeneration

“…46 Analyses of variance were performed on all QoL and utility scores to estimate their sensitivity to BEVA and WEVA severity levels. Least squares means adjusted on age, sex, and country were estimated from the model for each QoL and utility instrument, as were P values estimating the effect of VA severity on QoL scores, for each eye independently.…”

“…The capability of the chosen instruments to discriminate between groups of patients with known differences, such as severity or health status, was assessed by comparing patients grouped according to the level of visual impairment. 46 Analyses of variance were performed on all QoL and utility scores to estimate their sensitivity to BEVA and WEVA severity levels. Least squares means adjusted on age, sex, and country were estimated from the model for each QoL and utility instrument, as were P values estimating the effect of VA severity on QoL scores, for each eye independently.…”

Predictive and criterion validity of the Cervantes-SF menopause quality of life questionnaire

“…The Cervantes-SF scale has been shown to have good psychometric properties for measuring HRQoL in women with menopausal symptoms, 9 and, under conditions of routine medical practice it has been shown that women who choose menopausal hormone therapy for the treatment of menopausal symptoms have a poorer quality of life according to this scale. 30 However, until now, no tests have been conducted to confirm whether this instrument has the necessary properties for interpreting the health status of the population, 10,11 that is, criterion and predictive validity. Therefore-and as a complement to the validation of its main psychometric properties-the chief objective of this work was to confirm the 1.2 (0.5) Some patients did not respond to all questions on the case record form.…”

“…Criterion validity was checked by establishing the a priori hypothesis that the Cervantes-SF scale shows a significant relationship with the main clinical criteria used to evaluate the characteristic symptomatology of menopause. [10][11][12][13] These criteria are the presence of vasomotor (vasomotor syndrome) and genital symptoms (genital syndrome), 16 along with receiving treatment for this symptomatology, and the type of treatment applied. The Menopause Symptom Severity Scale (see Supplemental Digital Content, 17,18 http://links.…”

“…In addition, the Cervantes-SF preserves the structure of the original scale with the following four first-order dimensions and three second-order dimensions 8 : Menopause and Health (Vasomotor Symptoms, Health and Aging), Psychology, Sexuality, and Partner Relationship. 9,10 This version has been shown to measure a health concept equivalent to that measured by the original Cervantes scale, 8 while being more feasible to administer and score. Although the short version of the Cervantes scale has previously been shown to have good psychometric properties, rather less is known about its other attributes such as criterion or predictive validity.…”