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Core outcome set for metastatic breast cancer (MBC)

Toolvalidated✓ Source-grounded

A standardized list of outcomes that matter most to patients with metastatic breast cancer, especially related to quality of life, symptoms, and treatment impact. It helps ensure that studies and care focus on what's important to patients.

At a glance

Use when

Conducting clinical trials or observational studies in MBC; designing patient follow-up in clinical practice; developing patient-reported outcome measures; aligning with ICHOM standards

Avoid when

Focusing only on economic evaluation or cost-effectiveness; when only tumor response or survival outcomes are needed; in settings where data collection capacity is very limited

Inputs

Patient-reported outcomes, clinician-reported measures, clinical records, baseline patient characteristics

Outputs

Standardized set of 101 outcomes covering HRQoL, adverse events, clinical data, and patient characteristics

How it works

A Core Outcome Set (COS) for metastatic breast cancer developed through a modified Delphi process involving 141 stakeholders across patient, clinical, industry, and regulatory roles. Finalized by an expert group and accredited by ICHOM, the COS includes 101 variables across health-related quality of life (n=26), adverse events (n=24), baseline patient characteristics (n=9), and clinical variables (n=42). Designed for use in clinical research and practice to standardize outcome measurement.

Project
H2O
Funding
IMI
Project status
Ongoing
HTA domains
Clinical Effectiveness, Patient and Social Aspects
Categories
PROsPROMs
Technology
Non-specific
Assumptions
Outcomes identified reflect international consensus and patient priorities; data can be feasibly collected in research and clinical settings
Strengths
Developed with broad international stakeholder involvement including patients; accredited by ICHOM; supports comparability across studies and systems; covers comprehensive domains including psychosocial and functional aspects
Limitations
May be resource-intensive to implement fully in routine care; does not include cost or economic outcomes; limited focus on organizational aspects of care
Geographic & clinical scope
Metastatic breast cancer (MBC)
Also known as
MBC COS, ICHOM Standard Set for Metastatic Breast Cancer

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Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.