Jana Karam

Objectives: Psychological health changes are known to occur during perimenopause, but the extent to which these differ from premenopause remains unclear. This study aimed to assess psychological symptoms during perimenopause compared with premenopause and evaluate differences by country. Methods: Flo app users aged 35 years or above not taking hormonal contraception or hormone therapy were included. The psychological domain of the Menopause Rating Scale (range 0-16) and symptoms within this domain of depressive mood, irritability, anxiety, and exhaustion (range 0-4 each) were evaluated. Participants in perimenopause were compared with those in premenopause (self-reported not in perimenopause or postmenopause). Results: A total of 7,975 women were included, with 2,353 in perimenopause (mean age 45 years [SD±4.5]) and 5,622 in premenopause (39 y [SD±4.0]). Psychological Menopause Rating Scale scores in the perimenopause group were significantly higher (7.3 [SD±3.56]) than in the premenopause group (4.8 [SD±3.56]; P P <0.001, for all respectively), with the largest difference being exhaustion. These findings remained after adjusting for known confounders, including an existing diagnosis of anxiety or depression. Geographic analysis included 20 countries across 6 continents, with significant differences identified between countries for the overall psychological symptom domain score and all individual symptoms. Conclusion: Significantly greater psychological symptom burden was identified in the perimenopause group compared with the premenopause group, with the greatest difference noted for the individual symptom of exhaustion. Differences in symptom burden were also identified by country.

Perimenopause is the time leading up to and including the first 12 months after the final menstrual period. This study examined how social determinants of health (SDOH) including race/ethnicity, income, education and healthcare access influence perimenopause symptom burden. A cross-sectional survey was distributed to English, Spanish, Portuguese and French-speaking Flo app users aged 35 years and above. Participants completed the validated Menopause Rating Scale (MRS) and provided data on key SDOH. Associations between SDOH and total MRS and domain scores (psychological, somatic, urogenital) were evaluated using multivariable linear regression. A total of 12,382 women completed the survey. All examined SDOH were significantly associated with total and domain MRS scores (p < 0.001). Healthcare access had the strongest association, followed by income sufficiency and education level. Asian, Black and Hispanic/Latino race/ethnicities were significantly associated with MRS scores (p < 0.001) compared with White race/ethnicity. In a subset of 2618 women who reported being in perimenopause, SDOH remained significantly associated with MRS scores, with income sufficiency showing the strongest association (p < 0.001). SDOH, particularly healthcare access and income, are strongly associated with perimenopause symptom burden. Addressing health inequities is essential to improve perimenopause care and reduce symptom burden.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Menopause symptoms are common but often inadequately addressed by primary care clinicians due to limited time for discussions and resources. Mobile health apps can play a crucial role in symptom identification and management; yet, many existing menopause-focused apps lack evidence-based content and medical expertise. Objective: The aim of this study is to describe the protocol study design and methodology of a randomized controlled trial to evaluate the effectiveness of the emmii mobile app for improving menopause-related knowledge and shared decision-making compared to a traditional menopause education pamphlet. Methods: This randomized controlled trial will recruit women aged 45-55 years with upcoming primary care appointments at Mayo Clinic within 3 weeks of the date of initial outreach. Eligible patients must be English-speaking, able to provide informed consent, and report a Menopause Rating Scale score ≥5, which indicates that they are experiencing significant menopause-related symptoms. Patients will be randomized to have access to either the emmii app (intervention, n=200) or an evidence-based menopause education pamphlet (control, n=200). The emmii app is developed with direct input from primary care clinicians certified by The Menopause Society and offers symptom tracking, personalized treatment recommendations based on a protocol, and a discussion guide to support communication between patients and their primary care clinicians. Outcomes will include a postappointment survey sent to the patients and their primary care clinicians within 1-3 weeks of the appointment, and assessment of patient knowledge, clinical treatment plans, and both the patient and clinician experience. The study will also compare prescribing rates of hormonal and nonhormonal therapies for menopause symptoms between the emmii intervention and control groups to assess for influence on treatment patterns. Data will be analyzed using descriptive statistics, including chi-square tests, Wilcoxon rank sum tests, and multivariable modeling. Results: Data collection is scheduled to begin in April 2025. Conclusions: This protocol outlines the design and methodology of a randomized controlled trial that aims to assess the impact of the emmii app in facilitating menopause care through primary care clinician–patient communication and shared decision-making. Trial Registration: ClinicalTrials.gov NCT06919887; https://clinicaltrials.gov/ct2/show/NCT06919887

BACKGROUND Menopause symptoms are common but often inadequately addressed by primary care clinicians due to limited time for discussions and resources. Mobile health apps can play a crucial role in symptom identification and management; yet, many existing menopause-focused apps lack evidence-based content and medical expertise. OBJECTIVE The aim of this study is to describe the protocol study design and methodology of a randomized controlled trial to evaluate the effectiveness of the emmii mobile app for improving menopause-related knowledge and shared decision-making compared to a traditional menopause education pamphlet. METHODS This randomized controlled trial will recruit women aged 45-55 years with upcoming primary care appointments at Mayo Clinic within 3 weeks of the date of initial outreach. Eligible patients must be English-speaking, able to provide informed consent, and report a Menopause Rating Scale score ≥5, which indicates that they are experiencing significant menopause-related symptoms. Patients will be randomized to have access to either the emmii app (intervention, n=200) or an evidence-based menopause education pamphlet (control, n=200). The emmii app is developed with direct input from primary care clinicians certified by The Menopause Society and offers symptom tracking, personalized treatment recommendations based on a protocol, and a discussion guide to support communication between patients and their primary care clinicians. Outcomes will include a postappointment survey sent to the patients and their primary care clinicians within 1-3 weeks of the appointment, and assessment of patient knowledge, clinical treatment plans, and both the patient and clinician experience. The study will also compare prescribing rates of hormonal and nonhormonal therapies for menopause symptoms between the emmii intervention and control groups to assess for influence on treatment patterns. Data will be analyzed using descriptive statistics, including chi-square tests, Wilcoxon rank sum tests, and multivariable modeling. RESULTS Data collection is scheduled to begin in April 2025. CONCLUSIONS This protocol outlines the design and methodology of a randomized controlled trial that aims to assess the impact of the emmii app in facilitating menopause care through primary care clinician–patient communication and shared decision-making. CLINICALTRIAL ClinicalTrials.gov NCT06919887; https://clinicaltrials.gov/ct2/show/NCT06919887 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/76536