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      The complexity of genitourinary syndrome of menopause: number, severity, and frequency of vulvovaginal discomfort symptoms in women enrolled in a randomized trial evaluating treatment for genitourinary syndrome of menopause

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          Abstract

          Objective

          The aim of the study is to describe the location, severity, and frequency of genitourinary symptoms in postmenopausal women enrolled in a randomized trial of treatment for vulvovaginal discomfort.

          Methods

          This is a post hoc analysis of enrollment responses for participants in the MsFLASH Vaginal Health Trial. Participants were asked about the severity (0-3), frequency (in days per week) and location (vulvar or vaginal) of itch, dryness, pain/soreness, irritation, as well as severity and frequency of pain with penetration, vaginal discharge, urinary incontinence, and urinary urgency.

          Results

          A total of 302 participants were enrolled, with a mean age of 60.9 ± 4.1 years. The mean number of moderate-severe vulvovaginal symptoms experienced by trial participants in the month before enrollment was 3.4 ± 1.5, with a range from 1 to 7. The most commonly reported symptom across all severity categories was vaginal dryness (285/302, 94%), but the one most frequently rated as severe was pain with vaginal penetration (121/302, 40%). Vaginal dryness was the symptom with highest frequency; 53% of participants with that symptom reported experiencing it ≥4 d/wk. For vaginal symptoms, 80% of participants (241/302) reported that at least one of these symptoms occurred during or after sex while only 43% (158/302) reported that at least one vulvar symptom occurred during or after sex. Urinary incontinence (202/302, 67%) and urinary frequency (128/302, 43%) were the two most commonly reported urinary issues.

          Conclusions

          Our data highlight the complexity of genitourinary syndrome of menopause symptoms in quantity, severity, and frequency, suggesting that measuring distress, bother, or interference may be the most comprehensive measure.

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          Most cited references18

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          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function.

            This article presents the development of a brief, self-report measure of female sexual function. Initial face validity testing of questionnaire items, identified by an expert panel, was followed by a study aimed at further refining the questionnaire. It was administered to 131 normal controls and 128 age-matched subjects with female sexual arousal disorder (FSAD) at five research centers. Based on clinical interpretations of a principal components analysis, a 6-domain structure was identified, which included desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Overall test-retest reliability coefficients were high for each of the individual domains (r = 0.79 to 0.86) and a high degree of internal consistency was observed (Cronbach's alpha values of 0.82 and higher) Good construct validity was demonstrated by highly significant mean difference scores between the FSAD and control groups for each of the domains (p < or = 0.001). Additionally, divergent validity with a scale of marital satisfaction was observed. These results support the reliability and psychometric (as well as clinical) validity of the Female Sexual Function Index (FSFI) in the assessment of key dimensions of female sexual function in clinical and nonclinical samples. Our findings also suggest important gender differences in the patterning of female sexual function in comparison with similar questionnaire studies in males.
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              Screening for depression in medical settings with the Patient Health Questionnaire (PHQ): a diagnostic meta-analysis.

              To summarize the psychometric properties of the PHQ2 and PHQ9 as screening instruments for depression. We identified 17 validation studies conducted in primary care; medical outpatients; and specialist medical services (cardiology, gynecology, stroke, dermatology, head injury, and otolaryngology). Electronic databases from 1994 to February 2007 (MEDLINE, PsycLIT, EMBASE, CINAHL, Cochrane registers) plus study reference lists have been used for this study. Translations included US English, Dutch, Italian, Spanish, German and Arabic). Summary sensitivity, specificity, likelihood and diagnostic odds ratios (OR) against a gold standard (DSM-IV) Major Depressive Disorder (MDD) were calculated for each study. We used random effects bivariate meta-analysis at recommended cut points to produce summary receiver-operator characteristic (sROC) curves. We explored heterogeneity with metaregression. Fourteen studies (5,026 participants) validated the PHQ9 against MDD: sensitivity = 0.80 (95% CI 0.71-0.87); specificity = 0.92 (95% CI 0.88-0.95); positive likelihood ratio = 10.12 (95% CI 6.52-15.67); negative likelihood ratio = 0.22 (0.15 to 0.32). There was substantial heterogeneity (Diagnostic Odds Ratio heterogeneity I2 = 82%), which was not explained by study setting (primary care versus general hospital); method of scoring (cutoff > or = 10 versus "diagnostic algorithm"); or study quality (blinded versus unblinded). The diagnostic validity of the PHQ2 was only validated in 3 studies and showed wide variability in sensitivity. The PHQ9 is acceptable, and as good as longer clinician-administered instruments in a range of settings, countries, and populations. More research is needed to validate the PHQ2 to see if its diagnostic properties approach those of the PHQ9.
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                Author and article information

                Journal
                Menopause
                Menopause
                Ovid Technologies (Wolters Kluwer Health)
                1072-3714
                2023
                August 2023
                July 4 2023
                : 30
                : 8
                : 791-797
                Affiliations
                [1 ]Vincent Center for Reproductive Biology, Massachusetts General Hospital, Boston, MA
                [2 ]Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA
                Article
                10.1097/GME.0000000000002212
                2cd96b6e-e0d0-456d-96a9-435cf8436c7a
                © 2023
                History

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