Background
Implementing a prognostic model in clinical practice requires assessing not just its accuracy but also how it may impact patient and healthcare outcomes. Evaluating these impacts requires clinical trials that are carefully designed to select, collect, and report key outcomes. However, there is currently no consensus on which outcomes are key to evaluating the impact of prognostication. Core Outcome Sets can standardise outcome selection, collection, and reporting, and thereby improve the comparability of studies. Our study aimed to develop a preliminary Core Outcome Set for evaluating the impact of prognostication on people living with advanced cancer.
Methods
Following the Core Outcome Measures in Effectiveness Trials initiative’s recommended methodology, we first conducted a systematic review of prognostic studies and in-depth interviews with patients, informal caregivers, and clinicians. Drawing on these findings, we produced a comprehensive list of potential outcomes, which we refined and prioritised through a two-round modified Delphi survey with an international expert panel. An online consensus meeting finalised the preliminary Core Outcome Set.
Results
The systematic review identified 70 outcomes, and the interviews contributed another 16. Consolidation produced 67 outcomes for review in the Delphi survey. A total of 49 experts from 14 countries; participated in the Delphi survey, with 31 (63%) completing both rounds. After two rounds, 34 outcomes were rated as critically important. These were discussed further in the consensus meeting, attended by 12 participants, who reached agreement on 9 core outcomes spanning five domains: physiological/clinical outcomes, global quality of life, care delivery, perceived health status, and personal circumstances.
Conclusions
This preliminary Core Outcome Set offers a standardised approach for selecting, collecting, and reporting outcomes in prognostic impact studies in advanced cancer, which could enhance the comparability of future prognostic impact studies, and thereby potentially improve clinical practice and patient care outcomes.
This study aims to create a COS for measuring the outcomes of prognostication methods in palliative cancer care. Studies exploring the impact on patients and their informal carers of receiving end-of-life prognoses use a variety of different measures to evaluate the outcomes, and thus report often conflicting findings. The development of a core outcome set for end-of-life prognosis in palliative care could enable uniform assessment and reporting, as well as inter-trial comparisons.
This is a multiphase, mixed-methods study involving systematic literature reviews, semi-structured interviews, and a Delphi survey. This study will involve patients with advanced cancer who are receiving palliative care, informal caregivers, clinicians, and academics/researchers. This study will follow the COMET guidelines to support the development, implementation, and evaluation of the COS for end-of-life prognostication.
The development of this COS will consist of three phases: (1) a systematic literature review will be conducted, and retrieve papers analysed in two subsets to identify relevant outcomes: one to identify outcome measures previously used to assess the outcomes of prognostication in palliative care, the second to explore patients’ and informal caregivers' experiences of prognostication; (2) semi-structured, qualitative interviews to explore the views and experiences of patients, informal caregivers and health professionals; (3) a Delphi study to prioritise outcomes derived from Phases I and II.
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 prognostication in palliative care which are acceptable to key stakeholders.
Caitlin Medlock, Bella Vivat, Nicola White, Jannicke Rabben, Patrick Stone
Disease Category: Cancer
Disease Name: Advanced cancer
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Palliative
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
This project will adopt a mixed method approach and consist of three phases, using methodology recommended by the Core Outcome Measure in Effectiveness Trials (COMET) initiative.
In Phase I, a systematic review will be performed to identify the existing outcomes to inform COS items and/or domains. Retrieved papers were analysed in two subsets; 1) quantitative studies seeking to identify the outcomes used in previous research to measure the impact of prognostication in end-of-life palliative cancer care; 2) qualitative studies exploring patients’ and informal caregivers’ experiences of prognostication in palliative cancer care.
In Phase II, semi-structured interviews with patients with advanced cancer who are receiving palliative care, informal caregivers, and clinicians will be conducted, to explore their perceptions and experiences of prognostication. Outcomes identified in the interviews will be combined with those found in existing literature and taken forward to Phase III, a Delphi survey, where patients, informal caregivers, clinicians, and relevant researchers will be asked to rate these outcomes until consensus is achieved as to which are considered to be the most important for inclusion in future palliative care studies. The resulting, prioritised outcomes will be discussed in a consensus meeting to agree and endorse the final core outcome set.