Developing a Core Outcome Set for Prognostic Research in Palliative Cancer Care: Protocol for a Mixed Methods Study

Area of Science:

• Palliative Care
• Oncology
• Clinical Trials

Background:

• Conflicting findings exist regarding the impact of end-of-life prognoses in advanced cancer patients due to varied outcome measures.
• Standardizing outcomes in palliative cancer care prognostication is crucial for consistent assessment and comparison across studies.
• A core outcome set ensures uniform selection and reporting of outcomes in prognostication research.

Purpose of the Study:

• To develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care.
• To establish a standardized approach for evaluating prognoses in advanced cancer patients.
• To facilitate consistent reporting and intertrial comparisons in prognostication studies.

Main Methods:

• A mixed-methods approach following the Core Outcome Measure in Effectiveness Trials (COMET) initiative guidelines.
• Phase I: Systematic review to identify existing outcomes used in prognostication studies.
• Phase II: Semistructured interviews with patients, caregivers, and clinicians; Phase III: Delphi survey and consensus meeting to prioritize and endorse core outcomes.

Main Results:

• Ethical approval obtained in September 2022.
• Systematic review (Phase I) completed and published; recruitment for Phase II initiated as of July 2023.
• Study completion is anticipated by October 2024.

Conclusions:

• The protocol outlines a stepwise approach to developing a core outcome set for end-of-life prognostication in palliative cancer care.
• The resulting core outcome set has the potential to enhance clinical practice by enabling consistent evaluation of prognostic algorithms and improving communication.
• This initiative will also support the design of future clinical trials that are acceptable to key stakeholders.