A framework for critical care triage during a major surge in critical illness.

During the COVID-19 pandemic, many jurisdictions experienced surges in demand for critical care that strained or overwhelmed their healthcare system's ability to respond. A major surge necessitates a deviation from usual practices, including difficult decisions about how to allocate critical care resources. We present a framework to guide these decisions in the hope of saving the most lives as ethically as possible, while concurrently respecting, protecting, and fulfilling legal and human rights obligations. It was developed in Ontario in 2020-2021 through an iterative consultation process with diverse participants, but was adopted in other jurisdictions with some modifications. The framework features three levels of triage depending on the degree of the surge, and a system for prioritizing patients based on their short-term mortality risk following the onset of critical illness. It also includes processes aimed at promoting consistency and fairness across a region where many hospitals are expected to apply the same framework. No triage framework should ever be considered "final," and there is a need for further research to examine ethical issues related to critical care triage and to increase the extent and quality of evidence to inform critical care triage.

RéSUMé: Pendant la pandémie de COVID-19, de nombreuses régions ont connu une augmentation de la demande de soins intensifs qui a mis à rude épreuve ou dépassé la capacité de réponse du système de santé existant. Lors de toute augmentation importante de cette demande, un écart par rapport aux pratiques habituelles est nécessaire, y compris la prise de décisions difficiles sur la façon d'allouer les ressources en soins intensifs. Nous présentons un algorithme pour guider ces décisions dans l'espoir de sauver le plus de vies possibles et ce, de la manière la plus éthique possible, tout en respectant, en protégeant et en remplissant les obligations légales et en matière de droits de l'homme. Cet algorithme a été élaboré en Ontario en 2020-2021 dans le cadre d'un processus de consultation itératif avec divers participants, mais a été adopté dans d'autres juridictions avec quelques modifications. L'algorithme comprend trois niveaux de triage en fonction du degré d'augmentation de la demande, ainsi qu'un système permettant de prioriser les patients en fonction de leur risque de mortalité à court terme après l'apparition d'une maladie grave. Il comporte également des processus visant à promouvoir l'uniformité et l'équité dans une région où de nombreux hôpitaux vont appliquer le même algorithme. Aucun algorithme de triage ne devrait jamais être considéré comme « définitif ¼, et il est nécessaire d'approfondir les recherches pour examiner les questions éthiques liées au triage aux soins intensifs et accroître l'étendue et la qualité des données probantes afin d'éclairer le triage aux soins intensifs.

Beyond Research Ethics: Novel Approaches of 3 Major Public Health Institutions to Provide Ethics Input on Public Health Practice Activities.

Public health institutions increasingly realize the importance of creating a culture in their organizations that values ethics. When developing strategies to strengthen ethics, institutions will have to take into account that while public health research projects typically undergo thorough ethics review, activities considered public health practice may not be subjected to similar oversight. This approach, based on a research-practice dichotomy, is increasingly being criticized as it does not adequately identify and manage ethically relevant risks to those affected by nonresearch activities. As a reaction, 3 major public health institutions (the World Health Organization, US Centers for Disease Control and Prevention, and Public Health Ontario) have implemented mechanisms for ethics review of public health practice activities. In this article, we describe and critically discuss the different modalities of the 3 approaches. We argue that although further evaluation is necessary to determine the effectiveness of the different approaches, public health institutions should strive to implement procedures to ensure that public health practice adheres to the highest ethical standards.

A risk screening tool for ethical appraisal of evidence-generating initiatives.

BACKGROUND: The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as "non-research" are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and determination of risk level across a broad range of projects (e.g., clinical research, laboratory-based projects, population-based surveillance, and program evaluation) and health-related contexts. This paper describes the development of the Public Health Ontario (PHO) Risk Screening Tool. METHOD: Development of the PHO Risk Screening Tool included: (1) preparation of a draft risk tool (n = 47 items); (2) expert appraisal; (3) internal stakeholder validation; (4) external validation; (5) pilot testing and evalution of the draft tool; and (6) revision after 1 year of testing. RESULTS: A risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score (0-3) associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool. CONCLUSIONS: The PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions.

What makes public health studies ethical? Dissolving the boundary between research and practice.

BACKGROUND: The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. DISCUSSION: The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. SUMMARY: Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

Pilot study of an information aid for women with a family history of breast cancer.

OBJECTIVE: To develop and pilot study an information aid for women with a family history of breast cancer. DESIGN, SETTING AND PARTICIPANTS: The information aid, consisting of a booklet and audiotape, was developed by a multi-disciplinary team of health care professionals, breast cancer survivors and their relatives. Women with no personal history of breast cancer, on the waiting list for a familial breast cancer clinic at either of two centres, who could read English, were eligible for the pilot study which consisted of three sets of mailed questionnaires. MAIN OUTCOME MEASURES: The baseline questionnaires included: demographic information: the Breast Cancer and Heredity Knowledge Scale (BCHK); psychological measures (the State-Trait Anxiety Inventory [STAI], Centre for Epidemiologic Studies Depression Scale [CES-D] and an item about breast cancer worry), and an item about breast cancer risk perception. Immediately after reviewing the information aid, participants completed a satisfaction survey, the risk perception and cancer worry items and a checklist about their personal family history. The third set of questionnaires, completed 2-4 weeks after reviewing the aid, was identical to the first. Patients then attended their scheduled clinic visit and an objective hereditary breast cancer risk assessment was made by the genetic counselling team. RESULTS AND CONCLUSIONS: Of 97 eligible women who were contacted, 67 completed all three sets of questionnaires. Overall, women were very satisfied with the aid and 96% would recommend it to other women. There was a highly significant improvement in their knowledge scores after they reviewed the aid. Anxiety and depression did not change and there was a decline in breast cancer worry. Risk perception did not change significantly. Ninety per cent of women completed their personal family history checklist accurately. Several important improvements have been made in the information aid and it will now be evaluated in the community.