Patient-reported outcomes for menopause management interventions study: PROMMIS
Introduction: Greater confidence in hormone replacement therapy (HRT) in clinical practice means that many women with complex comorbidities are now being offered HRT for menopause symptoms.Modern HRT formulations are generally considered safer than older regimens, and accumulating evidence allows be...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-06-01
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| Series: | Future Healthcare Journal |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2514664525002012 |
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| Summary: | Introduction: Greater confidence in hormone replacement therapy (HRT) in clinical practice means that many women with complex comorbidities are now being offered HRT for menopause symptoms.Modern HRT formulations are generally considered safer than older regimens, and accumulating evidence allows better risk stratification. However, there is a lack of outcome data for under-represented groups with complex health issues, particularly concerning cardiometabolic and gynaecological risks, oestrogen-related cancers and testosterone use. The clinical outcomes associated with HRT regimens outside regulator-approved dosing are also unknown. Furthermore, there is a lack of data to guide management for HRT-unsuitable women.The Society for Endocrinology (SfE) has recognised that large-scale randomised trials using modern, novel or unconventional menopause treatments are unlikely to receive the necessary funding. There is an unmet need in menopause management and clinical outcome data, and the case for menopause research and real-world data collection is now widely recognised.1–3 Therefore, there is a novel research opportunity to develop an innovative, secure online, real-world data collection platform (PROMMIS) to collect data on menopause management outcomes. Materials and methods: The SfE will host this real-world data registry, with unrestricted educational grant funding support. A steering group of leaders from endocrinology, gynaecology, oncology, other allied specialities, affiliated charities and patient groups, underpin the PROMMIS registry's operational details.The data collection process is Information Commissioner’s Office (ICO) and Organisation for the Review of Care and Health Apps (ORCHA) approved and utilises a novel, secure, general data protection regulation (GDPR) compliant online platform accessed via site-specific QR codes. Following patient consent, self-reported data will be inputted and relevant data from primary care records will be obtained through automation, with options for additional data input from secondary care.Patient reported outcomes are at the centre of data collection. The primary outcome measure is to assess the impact of menopause and management approaches on self-reported quality of life, as measured by EQ5D and SF-36 questionnaires. There is intentional focus on specific comorbidities and treatment interventions in clinical areas where evidence is lacking.Four specific areas will be studied: 1. Treatment outcomes in women with metabolic diseases, including diabetes, non-diabetic hyperglycaemia and Turner syndrome; 2. HRT doses and regimens with a focus on breast and gynaecological oncology and surgical outcomes; 3. Hormone implants and transdermal testosterone; 4. Long-term GnRH agonist and antagonist use for chronic gynaecological conditions. Results: The registry has received full ethics approval and is applying for research delivery network (RDN) adoption. The steering group chairs will share future developments and encourage stakeholders to engage with this pivotal and innovative registry through research questions and data access requests. Discussion: The SfE has founded the first UK women's health real-world data registry, aiming to capture critical outcomes across key areas of menopause and women's healthcare. Conclusions: The SfE women's health registry, PROMMIS, is an ambitious long-term initiative aiming to support stakeholders in menopause and women’s healthcare to help to shape the future research and practice. |
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| ISSN: | 2514-6645 |