Uterine fibroids are one of the most common benign gynecological conditions and can substantially impact women's quality of life and daily functioning. Despite the availability of several patient-reported outcome measures (PROMs), outcome assessment in fibroid research remains heterogeneous, limiting comparability between studies and hindering evidence synthesis and clinical decision-making. In addition, existing instruments often focus on overall symptom burden or health-related quality of life, with limited ability to capture domain-specific treatment effects relevant to contemporary care.
To address these challenges, this project aims to develop a comprehensive, patient-centered PROM set for uterine fibroids by identifying relevant patient-reported outcomes (PROs) and selecting the most appropriate measurement instruments, in line with COMET and COSMIN guidance. The project follows a multi-stage, mixed-methods approach. First, an existing systematic review of PROMs for uterine fibroids will be used to identify relevant outcome domains and available instruments. These findings will be complemented by focus groups including patients and healthcare professionals to explore additional outcomes and refine domain definitions. Second, a multi-round online Delphi process involving key stakeholders (including patients, clinicians, and researchers), followed by a consensus meeting, will be conducted to achieve agreement on the final PROM set. This project aims to (re-)use existing validated PROMs, including generic instruments such as PROMIS and disease-specific measures. They will be evaluated and selected based on their measurement properties and relevance. Where necessary, additional items will be developed and pilot-tested.
The resulting PROM set will enable standardized, domain-specific outcome assessment in uterine fibroid research and clinical practice. By improving comparability across studies and aligning outcome measurement with patient priorities, this project aims to support high-quality research, facilitate shared decision-making, and contribute to more effective and patient-centered care for women with uterine fibroids.
The development of a core outcome set (COS) for uterine fibroids has been registered in COMET before by Amoah et al. Two members of our research team (ML and WH) take place in the steering committee of this COS. Since, Amoah and her research group are not proceeding with a core outcome measurement set after finishing the core outcome set. We proceed with this PROM-set in advance. Amoah and her research group will/may use information derived from our focus groups for the development of the COS.
- N.S. de Smit
- M.E. de Lange
- J. van 't Hooft
- W.J.K. Hehenkamp (PI)
- J.A.F. Huirne (PI)
All abovementioned contributors are affiliated to Amsterdam Reproduction & Development Research Institute, Amsterdam, Netherlands.
N.S. de Smit and W.J.K. Hehenkamp are affiliated to Amsterdam UMC location University of Amsterdam, Department of Obstetrics and Gynecology, Amsterdam, Netherlands
J.A.F. Huirne, M.E. de Lange and J. van 't Hooft are affiliated to Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Obstetrics and Gynecology, Amsterdam, Netherlands
Disease Category: Gynaecology
Disease Name: Uterine fibroids
Age Range: 16 - 60
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Patient/ support group representatives
- Researchers
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
This is a mixed method study that follows a consensus-building approach. For the development of the PROM-set for uterine fibroids, we will follow a multi-stage approach similar to that described by Pelouto et al. in their protocol for developing a PROM set in patients with Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy (Pelouto et al., 2025). Our protocol will built on an existing systematic review of PROMs for uterine fibroids (Yang et al., 2025). This review serves as basis for domain selection and is used as identification of disease specific PROMs. Focus group meetings with uterine fibroid patients and experts in the field will be organized to discuss important PROs and PROMs. Subsequently, when focus groups reach data saturation a stakeholder panel meeting is organized to develop a disease-specific symptom checklist with PROs and PROMS. A Delphi study, using this disease-specific symptom checklist, will then be undertaken to achieve consensus on the final PROM-set, followed by a validation analyses of the selected PROMs. Finally, a stakeholder consensus meeting will address implementation and valorization strategies.