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

Background: Studies exploring the impact of receiving end-of-life prognoses in patients with advanced cancer use a variety of different measures to evaluate the outcomes, and thus report often conflicting findings. The standardization of outcomes reported in studies of prognostication in palliative cancer care could enable uniform assessment and reporting, as well as intertrial comparisons. A core outcome set promotes consistency in outcome selection and reporting among studies within a particular population. We aim to develop a set of core outcomes to be used to measure the impact of end-of-life prognostication in palliative cancer care.

Objective: This protocol outlines the proposed methodology to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care.

Methods: We will adopt a mixed methods approach consisting of 3 phases using methodology recommended by the Core Outcome Measure in Effectiveness Trials (COMET) initiative. In phase I, we will conduct a systematic review to identify existing outcomes that prognostic studies have previously used, so as to inform the development of items and domains for the proposed core outcome set. Phase II will consist of semistructured interviews with patients with advanced cancer who are receiving palliative care, informal caregivers, and clinicians, to explore their perceptions and experiences of end-of-life prognostication. Outcomes identified in the interviews will be combined with those found in existing literature and taken forward to phase III, a Delphi survey, in which we will ask patients, informal caregivers, clinicians, and relevant researchers to rate these outcomes until consensus is achieved as to which are considered to be the most important for inclusion in the core outcome set. The resulting, prioritized outcomes will be discussed in a consensus meeting to agree and endorse the final core outcome set.

Results: Ethical approval was received for this study in September 2022. As of July 2023, we have completed and published the systematic review (phase I) and have started recruitment for phase II. Data analysis for phase II has not yet started. We expect to complete the study by October 2024.

Conclusions: This protocol presents the stepwise approach that will be taken to develop a core outcome set for measuring the impact of end-of-life prognostication in palliative cancer care. The final core outcome set has the potential for translation into clinical practice, allowing for consistent evaluation of emerging prognostic algorithms and improving communication of end-of-life prognostication. This study will also potentially facilitate the design of future clinical trials of the impact of end-of-life prognostication in palliative care that are acceptable to key stakeholders.

Trial Registration: Core Outcome Measures in Effectiveness Trials 2136; https://www.comet-initiative.org/Studies/Details/2136.

International Registered Report Identifier (irrid): DERR1-10.2196/49774.