Background:
Outcome measurement is essential to progress clinical practice and improve patient care.
Aim:
To develop a Core Outcome Set for best care for the dying person.
Design:
We followed the Core Outcome Measures in Effectiveness Trials (COMET) Initiative guidelines, which involved identifying potential outcomes via a systematic literature review (n?=?619 papers) and from participants in the “iLIVE” project (10 countries: 101 patients, 37 family members, 63 clinicians), followed by a two-round Delphi study, and a consensus meeting.
Setting/participants:
Clinicians, researchers, family members, and patient representatives from 20 countries participated in the Delphi Rounds 1 (n?=?462) and 2 (n?=?355). Thirty-two participants attended the consensus meeting.
Results:
From the systematic review and the cohort study we identified 256 and 238 outcomes respectively, from which we extracted a 52-outcome list covering areas related to the patients’ physical, psychosocial, and spiritual dimensions, family support, place of care and care delivery, relational aspects of care, and general concepts. A preliminary 13-outcome list reached consensus during the Delphi. At the consensus meeting, a 14-item Core Outcome Set was ratified by the participants.
Conclusions:
This study involved a large and diverse sample of key stakeholders in defining the core outcome set for best care for the dying person, focusing on the last days of life. By actively integrating the perspectives of family carers and patient representatives from various cultural backgrounds this Core Outcome Set enriches our understanding of essential elements of care for the dying and provides a solid foundation for advancing quality of end-of-life care.
Sofia C Zambrano, Martina Egloff, Valentina Gonzalez-Jaramillo, Andri Christen-Cevallos Rosero, Simon Allan, Pilar Barnestein-Fonseca, John Ellershaw, Claudia Fischer, Dagny Faksvåg Haugen, Urška Lunder, Marisa Martin-Rosello, Stephen Mason, Birgit Rasmussen, Valgerdur Sigurðardóttir, Judt Simon, Vilma A Tripodoro, Agnes van der Heide, Lia van Zuylen, Raymond Voltz, Carl Johan Fürst, Paula R Williamson, and Steffen Eychmüller on behalf of iLIVE
Disease Category: Other
Disease Name: Advanced cancer and advanced non-malignant illnesses, Palliative care
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Palliative
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review
Q-sort interviews
The study will involve four stages for the development of a core outcome set.
Initially, a systematic review of the literature will identify the outcomes measured in existing peer reviewed literature, including interventional studies, observational studies, and qualitative studies. Grey literature and relevant national guidelines from different countries will be searched for.
A second stage will determine patient and proxy defined outcomes of care at the end of life through quantitative and qualitative methodologies (e.g. in-depth interviews, focus groups, q-sort interviews, questionnaires) with participants from these stakeholder groups. This step will be duplicated in several countries lead by members of the International Collaborative for Best Care for the Dying Person. Results from existing studies from the Collaborative will also be collated into the list of outcomes.
Thirdly, from a list of salient outcomes identified through stages 1 and 2, international experts, researchers, bereaved family members, and patients will be asked to rank the importance of the preselected outcomes in order to prioritise outcomes through a Delphi process.
Lastly, a face-to-face consensus meeting of international experts, researchers, family members, and patient/family representatives will take place in order to define, propose and endorse the core outcome set.