Breast cancer screening programmes are widely implemented worldwide and play a key role in reducing mortality through early detection of cancers. Whilst such programmes are broadly used, there is currently no agreed Core Outcome Set (COS) or core outcome measures for breast cancer screening. This leads to inconsistent outcome reporting and measurement across studies, limits comparability, and may contribute to research waste and reduced relevance to screening clients and other stakeholders.
Stakeholders for this COS are defined as individuals or groups with an interest in, or affected by, breast screening outcomes, including those who deliver care, participate in screening, conduct research, or influence policy and practice globally.
This study aims to develop a COS and associated core outcome measures for breast cancer screening using established COMET methodology. The study will include:
1. A systematic literature review to identify outcomes and how they are currently measured in international breast screening research
2. Brief interviews with stakeholders to explore outcomes and measurement approaches important to individuals
3. A Delphi survey to prioritise outcomes, followed by a consensus process to agree the final COS and corresponding core outcome measures.
The study will follow COS-STAD standards. An international steering group will be established to support the study, drawing on expertise and networks in breast screening experience, research, and practice. The resulting COS and core outcome measures will support more consistent, transparent, and patient-centred outcome selection and measurement in breast cancer screening research and practice.
Lead investigators:
Sadie Mckeown-Keegan
Dr Lyn Jones
Professor Shelley Potter
Co-applicants:
Clinical leads representing key stakeholder groups (e.g radiology, radiography, breast screening)
Patient representative(s)
Trialist
Steering/working group:
International experts in breast screening and COS development
Charities
Clinical experts
Screening age women and women with experience of breast screening
Patient/ support group / charity representatives
Disease Category: Cancer
Disease Name: Breast cancer
Age Range: 50 - 70
Sex: Female
Nature of Intervention: Screening
- Charities
- Clinical experts
- Conference participants
- Consumers (patients)
- Economists
- Epidemiologists
- Ethicists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Survey
- Systematic review
This study will develop a Core Outcome Set (COS) and associated core outcome measures for breast cancer screening using established COMET methodology, addressing the current lack of standardisation and resulting inconsistencies in outcomes and measures.
Methods will include a systematic literature review to identify outcomes and measures reported internationally, alongside stakeholder engagement with individuals involved in delivering, participating in, researching, and influencing breast screening to explore outcomes of importance. A Delphi survey and subsequent consensus process will be conducted to prioritise outcomes and agree both the final COS and core outcome measures, guided by COS-STAD standards and supported by an international steering group with expertise in breast screening research and practice.