Recommended measurement instruments for genitourinary symptoms associated with menopause: the COMMA (Core outcomes in menopause) consortium.

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.

Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

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.

Interventions to improve oncofertility knowledge and decision-making in patients with low health literacy: A systematic review.

OBJECTIVE: To conduct a systematic review of interventions that improve knowledge, health and decision-related outcomes in cancer, fertility or the intersection of both among low health literacy (LHL) patients. METHODS: Articles published from 2000 to March 2022 in English were identified through searching MEDLINE, PsycInfo, and Embase databases on 29/03/2022. Studies were independently screened against eligibility criteria and appraised for quality. A narrative synthesis of data was presented. RESULTS: Of 235 citations, 11 studies (2585 participants) investigating three categories were included: decision-support tools (n = 8), mobile health applications (n = 2) and communication tools (n = 1). No eligible study was identified for fertility or oncofertility. All interventions integrated multimedia or interactivity to supplement plain-language text. Decision aids and mobile health applications improved knowledge, reduced decisional conflict and increased clarity around cancer-related choices. Overall, findings favoured the use of online interventions tailored for LHL patients. CONCLUSION: There is a lack of data on LHL interventions in fertility and oncofertility. In cancer, LHL interventions improved knowledge and decision-making outcomes. The ideal intervention remains inconclusive. PRACTICE IMPLICATIONS: Lack of engagement with LHL needs in oncofertility and fertility settings have implications for informed treatment decision-making. In cancer, further research is required to ascertain most effective intervention format.

Mania Following Traumatic Brain Injury: A Systematic Review.

OBJECTIVE: Traumatic brain injury (TBI) is a leading cause of mortality and morbidity worldwide. Mania is an uncommon, but debilitating, psychiatric occurrence following TBI. The literature on mania following TBI is largely limited to case reports and case series. In the present review, the investigators describe the clinical, diagnostic, and treatment characteristics of mania following TBI. METHODS: A systematic search of MEDLINE, EMBASE, and PsycINFO was conducted for English-language studies published from 1980 to July 15, 2021. The included studies provided the required individual primary data and sufficient information on clinical presentation or treatment of manic symptoms. Studies with patients who reported a history of mania or bipolar disorder prior to TBI and studies with patients who sustained TBI before adulthood were excluded. RESULTS: Forty-one studies were included, which reported information for 50 patients (the mean±SD age at mania onset was 39.1±14.3 years). Patients were more frequently male, aged <50 years, and without a personal or family history of psychiatric disorders. Although 74% of patients reported mania developing within 1 year following TBI, latencies of up to 31 years were observed. Illness trajectory varied from a single manic episode to recurrent mood episodes. Rapid cycling was reported in six patients. Mood stabilizers and antipsychotics were most frequently used to improve symptoms. CONCLUSIONS: Heterogeneity of lesion locations and coexisting vulnerabilities make causality difficult to establish. Valproate or a second-generation antipsychotic, such as olanzapine or quetiapine, may be considered first-line therapy in the absence of high-level evidence for a more preferred treatment. Early escalation to combined therapy (mood stabilizer and second-generation antipsychotic) is recommended to control symptoms and prevent recurrence. Larger prospective studies and randomized controlled trials are needed to refine diagnostic criteria and provide definitive treatment recommendations.

Unmet Needs and Experiences of Adolescent Girls with Heavy Menstrual Bleeding and Dysmenorrhea: A Qualitative Study.

STUDY OBJECTIVE: To identify and examine the key areas of need and explore the experiences of adolescent girls with heavy menstrual bleeding and/or dysmenorrhea. DESIGN AND SETTING: Qualitative interview study using semi-structured interviews. Gynaecology outpatient clinic at The Royal Children's Hospital, Melbourne, Australia. PARTICIPANTS: Adolescent girls (12-18 years; mean age, 14.8 ± 1.5 years) presenting with heavy menstrual bleeding and/or dysmenorrhea at the clinic (N = 30). INTERVENTIONS AND MAIN OUTCOME MEASURES: In-depth semi-structured interviews were conducted between May and August 2018. Interview data were thematically analyzed using a grounded theory approach. Themes covered experiences and unmet needs of adolescent girls with heavy menstrual bleeding and/or dysmenorrhea. RESULTS: A total of 12 themes were identified, and covered the impact of symptoms, experiences, and/or unmet needs of these adolescents. Key themes highlighting experiences and unmet needs related to (1) coordination of healthcare, (2) day-to-day coping, (3) school, and (4) information surrounding menstrual issues. From these themes, 7 unmet needs emerged and were organized under 3 key areas of need: (1) treatment, management, and care, (2) improvements in the school environment, and (3) menstrual health as a gendered issue. CONCLUSION: Menstrual concerns can have a profound physical and psychosocial impact on adolescents. Effective school-based menstrual education programs may be key in reducing stigma, fear, and shame surrounding menstruation, in teaching positive management strategies and in encouraging adolescents to seek help for their menstrual concerns.

Exploring the Unmet Needs of Parents of Adolescent Girls with Heavy Menstrual Bleeding and Dysmenorrhea: A Qualitative Study.

STUDY OBJECTIVE: To provide insight into the unmet needs of parents of adolescents with heavy menstrual bleeding or dysmenorrhea, in the context of their daughters' menstrual concerns. DESIGN: Qualitative interview study using semi-structured interviews. SETTING: Gynecology outpatient clinic at The Royal Children's Hospital, Melbourne, Australia. PARTICIPANTS: Parents of adolescent girls with heavy menstrual bleeding or dysmenorrhea recruited from an adolescent gynecology clinic between May and August 2018. INTERVENTIONS: In depth, semi-structured interviews with 24 parents whose daughters had heavy menstrual bleeding or dysmenorrhea. Data were analyzed using a grounded theory approach. MAIN OUTCOME MEASURES: Themes derived from interview transcripts about the supportive care needs of parents. RESULTS: Thirteen themes emerged in the interviews across 4 areas of need: (1) experiences with healthcare, (2) informational needs, (3) support and acceptance, and (4) financial impacts. Across the interviews, parents identified a need for greater awareness and education among parents and daughters, health professionals, and the broader community. CONCLUSION: This research confirmed that parents play a significant role in daughters' menstrual health care and have a series of unmet needs. Strategies and interventions specifically targeting these parents may be warranted.