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Office of Research on Women's Health (ORWH)

Purpose

Purpose 

The National Institutes of Health (NIH) has issued a Request for Information (RFI) to gather input from the scientific community, health professionals, professional societies, patient advocates, data standards experts and the public to inform the development of Common Data Elements (CDEs) for menopause-related data collection across research, clinical care, and health-system settings. Menopause CDEs will standardize questions and defined response options to support the robust collection of data on issues related to women's midlife health.

Background
Menopause is a normal, universal life stage marked by the permanent cessation of menstrual cycles following an aging-related decline in female reproductive hormones.  More than one million women in the United States enter menopause each year, typically between ages 50 and 51. However, menopause can occur earlier, including among women who undergo certain medical procedures, such as hysterectomy, with approximately 12% entering menopause before the typical age range. The menopausal transition is associated with changes in menstrual patterns, hormone profiles and significant physiologic, biological, psychosocial changes affecting quality-of-life.  Women experience substantial variability in the type, severity, and duration of symptoms, which are closely linked to the increasing burden of chronic disease after menopause. This heterogeneity underscores the importance of evidence-based treatment for symptoms and access to high-quality care tailored for women with different needs and within varying contexts. Thus, more research and systematically collected real-world information is necessary to best understand how to treat menopausal symptoms. This information is essential for understanding the short and long-term impact of those treatments on women's health and wellbeing. However, differences in data collection, outcome definitions, and reporting standards limit the ability to compare, combine, and reuse data across studies, clinical care, and health-system settings. Developing standardized Menopause CDEs would improve rigor, reproducibility, interoperability, and data sharing across clinical, epidemiologic, and translational research.

CDEs are standardized, precisely defined questions paired with a set of specific allowable responses, used systematically across different sites, studies, demographics, or clinical trials and applicable within clinical, healthcare, and public-health settings to ensure consistent data collection (https://cde.nlm.nih.gov/home). Implementation of CDEs promotes data interoperability, quality, reproducibility, efficiency of collection and efficiency of use across research platforms (e.g. different sites, studies or clinical trials) and within health-system workflows. 

Biomedical data are collected in different ways and formats across studies and routine clinical practice, making them difficult to share and combine; the use of CDEs standardizes how data are organized and defined so they can be more easily shared and used together. CDEs can be connected across shared data models and standard healthcare vocabularies, such as SNOMED CT, LOINC, UMLS, and others catalogued in public repositories, such as the National Library of Medicine's Value Set Authority Center. This connection helps research data align with real-world information from electronic health records, health insurance claims, wearable devices, and patient-reported outcomes, supporting research, clinical documentation, and clinical decision-making. This is especially important for menopause research because symptoms, treatments, and related health conditions are often recorded in different ways across clinical care, surveys, and research studies which make it difficult to compare findings or combine data. Using CDEs helps ensure these data can be compared and combined accurately to better understand women's midlife health. Menopause affects quality of life, daily functioning, emotional well-being, social relationships, and work productivity. Menopause CDEs should therefore incorporate patient-reported outcomes and other measures that reflect women's lived experiences across research, clinical care, and public health settings. Broader use of Menopause CDEs across HHS, including in population-based surveys such as CDC's National Health Interview Survey (NHIS), can promote more consistent data collection and improve coordination and data sharing across agencies.

NIH recognizes the continued need to develop common data CDEs related to women's health that will help researchers, clinicians, healthcare professionals, patients and communities share and combine datasets, promote interoperability, and improve the accuracy of datasets when it comes to women's health. Although a number of validated menopause-related surveys, instruments, and measures already exist, including but not limited to Menopause Quality of Life (MENQOL) questionnaire, the Greene Climacteric Scale (GCS), Menopause Rating Scale (MRS), Hot Flash Related Daily Interference Scale (HFRDIS/HFI), Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS/FSDS-R), and the DIVA sexual health subscale, their use remains fragmented across research studies, clinical care, and population-based surveys. The lack of consistent standardization, harmonization, and mapping to common data frameworks limits interoperability and the ability to compare, combine, and reuse data across settings. NIH has successfully implemented CDE frameworks in other research domains, including maternal health, and seeks to build on these efforts by developing, with community input, a menopause-specific CDE structure that is patient and community informed, flexible, and aligned with existing standards where appropriate. These CDEs will support NIH's development of a data resource that better coordinates and integrates investments in women's health research across NIH. This RFI seeks feedback on the development and implementation of Menopause CDEs including a set of minimal core CDEs, supplementary CDEs and exploratory CDEs. This RFI also seeks feedback to develop guidance and tools that make Menopause CDEs easier to use and improve the ability to combine and integrate data collected with Menopause CDEs. 

Information Requested
The purpose of this RFI is to solicit input on priorities, scope, and considerations for the development and implementation of Menopause CDEs. Responses will help inform NIH's approach to structuring CDE domains, identifying key data elements, and engaging relevant communities. NIH seeks input, including from patients, patient advocates, and support organizations, on what information is most important to collect about menopause, and why it matters, and how to involve patients in the initial development and testing of CDEs to ensure they reflect a wide range of research needs, clinical contexts, lived experiences and health-system priorities. This RFI seeks input on standard terminologies and metadata to inform the development of menopause CDEs. It does not propose a data repository or request the submission of patient or research data.

The NIH Office of Research on Women's Health (ORWH) seeks feedback on any or all of the following topics:

1. Priority Domains and Concepts. ORWH seeks feedback on key topics and subcomponents that should be included in Menopause CDEs, including but not limited to:

• Menstrual history: Last menstrual period, cycle regularity and frequency, bleeding heaviness, duration of flow, use of hormonal suppression methods (e.g., continuous oral contraceptives or hormonal intrauterine devices (IUDs) used for cycle control).
• Menopausal Status: Stage (pre-menopausal, perimenopause, menopausal transition, postmenopausal, uncertain); age at final menstrual period, cause (e.g. natural, surgical [removal of ovaries], pharmacologic [side effect of chemotherapy]), age at natural, surgical or pharmacologic menopause, time since menopause.
• Symptoms: Hot flashes, night sweats, sleep disturbances, insomnia, genitourinary issues, (urinary incontinence, nocturia, pain w sexual activity, recurrent urinary tract infection (UTI)), heavy vaginal bleeding or irregular menstrual cycles, vaginal dryness, changes in sexual health, (low libido, pain with intercourse), depressive symptoms, anxiety, irritability, mood lability, urinary incontinence, and nocturia. joint pain, cognitive issues (brain fog, difficulty concentrating), weight gain, fatigue, not feeling like myself.
• Biomarkers: Estradiol, progesterone, testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), Anti-Müllerian hormone (AMH), inhibin-B, Antral follicle count, testosterone (total and free testosterone), measures of hormonal dysregulation and low-energy conditions, sex hormone-binding globulin (SHBG).
• Physical, Mental and Well-being Outcomes: Blood pressure, lipid profile, bone mineral density, cognitive screening [working memory, executive functioning], anemia., Depression, anxiety and post-traumatic stress disorder screening measures, measures of adjustment to life-stage transitions, abdominal circumference, HgA1C, Coronary Artery Calcium (CAC) score, Atherosclerotic Cardiovascular Disease risk score, sleep apnea
• Physiological Changes: Changes in waist diameter, bleeding pattern, bone loss, changes in weight and body composition, lipid profile and cardiovascular risk, and onset or worsening of musculoskeletal pain; functional performance metrics (e.g., endurance, recovery time).
• Patient-Reported Outcomes: Menopause-specific quality of life QoL, sexual function, physical functioning, work productivity, daily life impacts, including relationships, body image, and hot flash interference; measures included in existing instruments such as MENQOL, the Greene Climacteric Scale, FSFI, FSDS, and Hot Flash Related Daily Interference Scale
• Treatments: Hormone therapies (including route of administration: oral, transdermal, vaginal, pellet, personalized formulation), non-hormonal therapies (including but not limited to: off-label prescription therapies (e.g., serotonin-norepinephrine reuptake inhibitor, selective serotonin reuptake inhibitors, gabapentin), neurokinin-receptor therapies, or supplements), treatments targeting menstrual bleeding and menses-related conditions, behavioral/psychological therapies, lifestyle interventions, weight loss medications, complementary and integrative approaches, such as yoga, tai chi, and acupuncture.
• Reproductive Health History: Age of menarche, number of pregnancies, number of live births, number of miscarriages, health complications during or after pregnancy, (gestational diabetes, hypertensive disorders, pre-eclampsia, preterm delivery, etc.), age at pregnancy, fertility treatments, endometriosis, fibroids, polyendocrine metabolic ovarian syndrome (formerly polycystic ovary syndrome), history of hysterectomy with or without unilateral and bilateral oophorectomy, maternal reproductive history, including age at menopause; adenomyosis; and contraceptive use and duration.
• Breast cancer risk assessment: Personal history of breast cancer, history of breast biopsy (with pathology), breast density on imaging (heterogeneously or extremely dense breasts), family history of cancer (including details on age, type), history of genetic testing, lifetime risk if calculated (using Gail or Tyrer-Cusick Calculator)
• Contextual Factors: Age, race and ethnicity, educational attainment, socioeconomic status, geographic location (including rural and urban settings), occupation, disability status, current or prior military service, occupational/environmental exposures, healthcare access/use including use of Veterans Affairs healthcare 

2. Data Tiering. ORWH seeks feedback on how often data should be collected in and across research studies. Responses may highlight data elements, concepts, domains, or outcomes that are currently missing or underrepresented in menopause research.

• Core CDEs. These are data that should always be collected. Examples can include:
  • Menstrual Cycle Characteristics: Last menstrual period, regular cycles, days of bleeding, menstrual flow (heaviness) and use of hormonal suppression methods (e.g., continuous oral contraceptives or hormonal IUDs used for cycle control).
  • Menopausal Status: Stage determined using standardized criteria, linked with symptom assessments using established instruments.
  • Menstrual Cessation: No period in the last 12 months (noting if cessation is natural, surgical, chemically induced, or secondary to ongoing hormonal suppression).
  • Current hormone treatment
  • Menopause Age: Age when menopause began (final menstrual period), Menopausal Status: Stage determined using standardized criteria, linked with symptom assessments using established instruments.
  • General Health Metrics: Age, Height, Weight, Body Mass Index (BMI), and body composition changes.
  • Behavioral Health Metrics: Anxiety, Depression, Stress, Post Traumatic Stress Disorder.
• Supplemental CDEs: These are data that are recommended based on thematic aims. Examples can include:
  • Lifestyle Factors: Nutrition, sleep duration and quality, physical activity, (type [e.g. cardio, weight bearing] , frequency, and intensity), social engagement and support, functional status (e.g. Activities of Daily Living)
  • Substance Use: Specific agents, frequency and duration of use.
  • Life Experiences/Mental Health: Trauma history, (including Military Sexual Trauma [MST] or operational stress), chronic stress.
  • Healthcare Access: Access to primary care and menopause/reproductive health services, including barriers to obtaining care.
• Exploratory CDEs: Emerging or research-use only. Examples can include:
  • Novel Technology: passive weight data, app-based symptom and menstrual tracking, wearables, light therapy devices.
  • Emerging Biomarkers: microbiome, continuous glucose monitoring,bone turnover markers (e.g., C-terminal telopeptide, N-terminal telopeptide). 

3. Alignment With Existing Standards. ORWH seeks feedback on how Menopause CDEs can connect to widely used health standards and systems. These can include: 

• Existing data standards, instruments, or CDEs that should be leveraged or harmonized with Menopause CDEs.
• Lessons learned from maternal health or other life-course CDE initiatives that could inform menopause CDE development.
• Opportunities to align or harmonize Menopause CDEs with existing symptom, quality-of-life, sexual health, and well-being instruments (e.g., MRS, MENQOL, GCS, HFRDIS/HFI, the DIVA sexual health subscale, FSFI, FSDS/FSDS-R, and Whole Health measures), and risk assessment tools (e.g., PREVENT, Tyrer-Cusick, and Gail).

4. Population Considerations. ORWH seeks feedback on best ways to engage all populations of women. These can include: 

• Strategies to ensure Menopause CDEs contain data from all women including individuals with low socioeconomic status, populations in rural or underserved geographic areas, with pre-existing mental health conditions, racial and ethnic minority populations, military and veteran populations, and people with disabilities, active-duty service members, and Veterans.
• Considerations for capturing surgical menopause, premature or early menopause, and menopause in populations with chronic conditions or who have received gonadotoxic therapies, including those that have experienced chemotherapy for cancer or autoimmune conditions; those experiencing associated emotional and social impacts, such as grief and isolation from peers.

5. Implementation and Burden. ORWH seeks feedback on how to ensure Menopause CDEs are usable in real-world settings. These can include: 

• Recommendations for minimizing participant and study burden while maintaining scientific value.
• Considerations for use across different study types (clinical trials, observational studies, electronic health record (EHR) based research, community-based research).
• Desired characteristics of a Menopause CDE repository.
• Use of validated short-form instruments and priorities for developing and validating abbreviated measures to reduce respondent burden.
• Consensus-based identification of high-priority CDEs for EHR integration, including measures not routinely captured.
• Standardized templates incorporating symptom and quality-of-life instruments and relevant calculators to track menopausal status, symptoms, and treatment response over time across health systems.
• Adaptive branching logic in patient forms to skip questions that are not applicable.

6. Engagement of Key Interested Parties. ORWH seeks feedback on which groups to engage in development and dissemination of Menopause CDEs. Examples include:

• Department of War, Department of Veterans Affairs, HRSA's Federally Qualified Health Centers
• professional societies, including The Menopause Society and ACOG
• academic institutions, including Uniformed Services University of the Health Sciences [USU]
• Medical and health-professional training programs (e.g., Family Medicine, Internal Medicine, and Obstetrics and Gynecology (OB/GYN) residency programs, midwifery programs, nursing, physician assistant programs, nurse practitioner programs, clinical psychology and clinical social work programs)
• research networks
• patient advocacy and support organizations

ORWH also seeks comments on strategies for continued engagement of key interested parties throughout the development, implementation, and ongoing refinement of Menopause CDEs. 

How Responses will be collected: Please only provide responses via: https://rfi.grants.nih.gov/?s=6a709e396a30cef7730be0c2

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any information you do not wish to be made public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitations(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for information and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

Inquiries

Please direct all inquiries to:

Office of Research on Women's Health (ORWH)
Email: [email protected]