Purpose
For patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue.
Methods
An international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n?=?17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n?=?141: patients/patient advocates (n?=?45), health care professionals/researchers (n?=?64), pharmaceutical industry representatives (n?=?28), and health authority representatives (n?=?4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting.
Results
The final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n?=?26) and adverse events (n?=?24); (2) baseline patient characteristics (n?=?9); and (3) clinical variables (n?=?42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team.
Conclusion
The COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).
Project coordinator H2O: Tanja Stamm, Medical University of Vienna
Project leader H2O: Meni Styliadou, Takeda Pharmaceuticals
Project leader breast cancer and lung cancer: Lonneke van de Poll-Franse, IKNL
Sub-team lead breast cancer: Kelly de Ligt, NKI
Sub-team lead lung cancer: Corina van den Hurk, IKNL
Disease Category: Cancer
Disease Name: Breast cancer, Lung cancer
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Epidemiologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
Review on existing outcome sets/outcome measures, Delphi rounds for each cancer type separately, consensus meetings with stakeholders involved.