Development of an international Core Outcome Set (COS) for best care for the dying person: study protocol

Abstract

Background In contrast to typical measures employed to assess outcomes in healthcare such as mortality or recovery rates, it is difficult to define which specific outcomes of care are the most important in caring for dying individuals. Despite a variety of tools employed to assess different dimensions of palliative care, there is no consensus on a set of core outcomes to be measured in the last days of life. In order to optimise decision making in clinical practice and comparability of interventional studies, we aim to identify and propose a set of core outcomes for the care of the dying person. Methods Following the COMET initiative approach, the proposed study will proceed through four stages to develop a set of core outcomes: In stage 1, a systematic review of the literature will identify outcomes measured in existing peer reviewed literature, as well as outcomes derived through qualitative studies. Grey literature, will also be included. Stage 2 will allow for the identification and determination of patient and proxy defined outcomes of care at the end of life via quantitative and qualitative methods at an international level. In stage 3, from a list of salient outcomes identified through stages 1 and 2, international experts, family members, patients, and patient advocates will be asked to score the importance of the preselected outcomes through a Delphi process. Stage 4 consists of a face-to-face consensus meeting of international experts and patient/family representatives in order to define, endorse, and propose the final Core Outcomes Set. Discussion Core Outcome Sets aim at promoting uniform assessment of care outcomes in clinical practice as well as research. If consistently employed, a robust set of core outcomes for the end of life, and specifically for the dying phase, defined by relevant stakeholders, can ultimately be translated into best care for the dying person. Patient care will be improved by allowing clinicians to choose effective and meaningful treatments, and research impact will be improved by employing internationally agreed clinically relevant endpoints and enabling accurate comparison between studies in systematic reviews and/or in meta-analyses.

Updating international consensus on best practice in care of the dying: A Delphi study

“…In addition, it can promote quality improvement initiatives and provide outcomes for research in care for the dying. It is important to highlight that ongoing research by Zambrano et al 24 (which includes some of the authors of this paper) to develop a core outcome set (COS) for care of the dying, has the potential to complement and inform the ongoing development and use of the 10/40 model. This work aims to achieve consensus opinion on what are the most important outcomes that should be measured in research studies, to assess the quality of care that has been provided to patients and their families at the end of life, for example, after implementation of a model of care such as the 10/40 model.…”

Live well, die well – an international cohort study on experiences, concerns and preferences of patients in the last phase of life: the research protocol of the iLIVE study

“…Despite a variety of available tools to assess different dimensions of palliative care, there is no consensus yet on which outcomes need to be measured in the last days of life. Therefore, this project will establish a Core Outcome Set (COS) for care of dying patients that includes valid, reliable and precise outcomes to enable international benchmarking, quality improvement and research in the last days of life 38. In each country, patients and relatives will be invited to participate during this process.…”

“…Therefore, this project will establish a Core Outcome Set (COS) for care of dying patients that includes valid, reliable and precise outcomes to enable international benchmarking, quality improvement and research in the last days of life. 38 In each country, patients and relatives will be invited to participate during this process.…”

Effectiveness of home-based end-of-life care

“…Another avenue of focus for future research should be on effects of home-based end-of-life care on patient specific outcomes. There is currently no overall core outcome set for end-of-life care (Zambrano et al 2020). However, one is currently being developed and when published the recommendation should be followed regarding which outcomes are important for patients (Zambrano et al 2020).…”