ABSTRACT
Female sexual dysfunction commonly occurs during the menopause transition and post-menopause due to hormonal, physiologic, and psychosocial factors. Sexuality is important to aging women; however, many are reluctant to seek treatment for their sexual concerns. Clinicians should be adept at managing and treating sexual dysfunction in this population. A multi-dimensional treatment approach that addresses modifiable mental, physical, and psychosocial factors is warranted to improve sexual function and quality of life.
Subject(s)
Quality of Life , Sexual Dysfunction, Physiological , Sexual Dysfunctions, Psychological , Humans , Female , Sexual Dysfunction, Physiological/therapy , Sexual Dysfunction, Physiological/etiology , Sexual Dysfunction, Physiological/diagnosis , Sexual Dysfunctions, Psychological/therapy , Sexual Dysfunctions, Psychological/diagnosis , Postmenopause/physiology , Menopause/physiology , Practice Guidelines as Topic , Middle AgedABSTRACT
OBJECTIVE: The aim of the study is to identify appropriate definitions and patient-reported outcome measures (PROMs) for each of the eight core outcomes previously selected for genitourinary symptoms associated with menopause: pain with sex, vulvovaginal dryness, vulvovaginal discomfort or irritation, discomfort or pain when urinating, change in most bothersome symptom, distress, bother or interference of genitourinary symptoms, satisfaction with treatment, and side effects. METHODS: We conducted a systematic review to identify possible definitions and PROMs, including their measurement properties. Identified definitions and relevant PROMs with acceptable measurement properties were entered into an international consensus process involving 28 participants from 10 countries to achieve final recommendations for each core outcome. RESULTS: A total of 87 publications reporting on 34 PROMs were identified from 21,207 publications screened. Of these 34 PROMs, 29 were not considered to sufficiently map onto the core outcomes, and 26 of these also had insufficient measurement properties. Therefore, only five PROMs corresponding to two core outcomes were considered for recommendation. We recommend the PROMIS Scale v2.0 - Sexual Function and Satisfaction: Vaginal Discomfort with Sexual Activity to measure the outcome of "pain with sexual activity" and the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire to measure "distress, bother or interference" from genitourinary symptoms. Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events in study participants, which is a requirement of Good Clinical Practice. CONCLUSIONS: Suitable PROMs and definitions were identified to measure three of eight core outcomes. Because of the lack of existing measures, which align with the core outcomes and have evidence of high-quality measurement properties, future work will focus on developing or validating PROMs for the remaining five core outcomes.
Subject(s)
Menopause , Patient Reported Outcome Measures , Humans , Female , Menopause/physiology , Female Urogenital Diseases/therapy , Quality of Life , Sexual Dysfunction, Physiological , Surveys and Questionnaires/standards , Middle AgedABSTRACT
BACKGROUND: Congenital toxoplasmosis is a treatable, preventable disease, but untreated causes death, prematurity, loss of sight, cognition and motor function, and substantial costs worldwide. OBJECTIVES: We asked whether high performance of an Immunochromatographic-test (ICT) could enable accurate, rapid diagnosis/treatment, establishing new, improved care-paradigms at point-of-care and clinical laboratory. METHODS: Data were obtained in 12 studies/analyses addressing: 1-feasibility/efficacy; 2-false-positives; 3-acceptability; 4-pink/black-line/all studies; 5-time/cost; 6-Quick-Information/Limit-of-detection; 7, 8-acute;-chronic; 9-epidemiology; 10-ADBio; 11,12-Commentary/Cases/Chronology. FINDINGS: ICT was compared with gold-standard or predicate-tests. Overall, ICT performance for 1093 blood/4967 sera was 99.2%/97.5% sensitive and 99.0%/99.7% specific. However, in clinical trial, FDA-cleared-predicate tests initially caused practical, costly problems due to false-positive-IgM results. For 58 persons, 3/43 seronegative and 2/15 chronically infected persons had false positive IgM predicate tests. This caused substantial anxiety, concerns, and required costly, delayed confirmation in reference centers. Absence of false positive ICT results contributes to solutions: Lyon and Paris France and USA Reference laboratories frequently receive sera with erroneously positive local laboratory IgM results impeding patient care. Therefore, thirty-two such sera referred to Lyon's Reference laboratory were ICT-tested. We collated these with other earlier/ongoing results: 132 of 137 USA or French persons had false-positive local laboratory IgM results identified correctly as negative by ICT. Five false positive ICT results in Tunisia and Marseille, France, emphasize need to confirm positive ICT results with Sabin-Feldman-Dye-test or western blot. Separate studies demonstrated high performance in detecting acute infections, meeting FDA, CLIA, WHO REASSURED, CEMark criteria and patient and physician satisfaction with monthly-gestational-ICT-screening. CONCLUSIONS/SIGNIFICANCE: This novel paradigm using ICT identifies likely false positives or raises suspicion that a result is truly positive, rapidly needing prompt follow up and treatment. Thus, ICT enables well-accepted gestational screening programs that facilitate rapid treatment saving lives, sight, cognition and motor function. This reduces anxiety, delays, work, and cost at point-of-care and clinical laboratories. TRIAL REGISTRATION: NCT04474132, https://clinicaltrials.gov/study/NCT04474132 ClinicalTrials.gov.
Subject(s)
Toxoplasmosis, Congenital , Female , Humans , Infant, Newborn , Pregnancy , Antibodies, Protozoan/blood , False Positive Reactions , Immunoglobulin M/blood , Prenatal Diagnosis/methods , Sensitivity and Specificity , Toxoplasma/immunology , Toxoplasmosis, Congenital/diagnosis , Toxoplasmosis, Congenital/prevention & controlABSTRACT
OBJECTIVE: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects. METHODS: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome. RESULTS: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice. CONCLUSIONS: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.
Subject(s)
Hot Flashes , Menopause , Patient Reported Outcome Measures , Humans , Female , Menopause/physiology , Consensus , Patient Satisfaction , Vasomotor System/physiopathology , Quality of LifeABSTRACT
Genitourinary syndrome of menopause encompasses the group of urogenital signs and symptoms resultant from hypoestrogenism, including genital dryness, burning or irritation, sexual discomfort, pain or dysfunction, and urinary urgency, dysuria, and recurrent urinary tract infections. Genitourinary syndrome of menopause can have a profound impact on well-being, functioning, and quality of life in postmenopausal women. Treatment includes vaginal moisturizers and lubricants geared towards providing symptomatic relief; hormonal treatments which promote epithelial thickening and production of vaginal secretions; and pelvic floor physical therapy along with behavioral therapies that address pelvic floor hypertonicity and psychosocial factors.
Subject(s)
Menopause , Quality of Life , Female , Humans , Atrophy , Vagina/pathologyABSTRACT
Una mujer de 35 años se presenta a su clíni- ca. Estado: posoperatorio de histerectomía ab- dominal; salpingooforectomía bilateral y pélvica; radiación hace 2 años para la etapa 1, grado 2, de adenocarcinoma endometrial. Ella no tiene evidencia actual de la enfermedad. Tiene un índice de masa corporal de 28, y su historia es significativa para el síndrome de ovario poliquístico.
A 35-year-old woman comes to her clinic. Condition: postoperative abdominal hysterectomy; bilateral and pelvic salpingo-oophorectomy; radiation 2 years ago for stage 1, grade 2, of endometrial adenocarcinoma. She does not have current evidence of the disease. It has a body mass index of 28, and its history is significant for polycystic ovarian syndrome.