Donald J. Willison

For decades, researchers have used linkable administrative health data for evaluating the health care system, subject to local privacy legislation. In Ontario, Canada, the relevant privacy legislation permits some organizations (prescribed entities) to conduct this kind of research but is silent on their ability to identify and contact individuals in those datasets. Following consultation with the Office of the Information and Privacy Commissioner of Ontario, we developed a pilot study to identify and contact by mail a sample of people at high risk for kidney failure within the next 2 years, based on laboratory and administrative data from provincial datasets held by ICES, to ensure they receive needed kidney care. Before proceeding, we conducted six focus groups to understand the acceptability to the public and people living with chronic kidney disease of direct mail outreach to people at high risk of developing kidney failure. While virtually all participants indicated they would likely participate in the study, most felt strongly that the message should come directly from their primary care provider or whoever ordered the laboratory tests, rather than from an unknown organization. If this is not possible, they felt the health care provider should be made aware of the concern related to their kidney health. Most agreed that, if health authorities could identify people at high risk of a treatable life-threatening illness if caught early enough, there is a social responsibility to notify people. While privacy laws allow for free flow of health information among health care providers who provide direct clinical care, the proposed case-finding and outreach falls outside that model. Enabling this kind of information flow will require greater clarity in existing laws or revisions to these laws. This also requires adequate notification and culture change for health care providers and the public around information uses and flows.

Background: Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) levels ≤7% (≤53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. Objective: As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. Methods: In this patient-led retrospective cross-sectional study with multiple time points of measurement, we used generalized estimating equations to analyze the associations of age, sex, and socioeconomic status with 947,543 HbA1c results collected from 2010 to 2019 among 90,770 people living with type 1 or type 2 diabetes in Canada and housed in the Canadian National Diabetes Repository. People living with diabetes reviewed and interpreted the results. Results: HbA1c results ≤7.0% represented 30.5% (male people living with type 1 diabetes), 21% (female people living with type 1 diabetes), 55% (male people living with type 2 diabetes) and 59% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence, and for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c levels than male people during childbearing years but higher HbA1c levels than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested that these results be communicated to health professionals and other stakeholders to improve the treatment for people living with diabetes. Conclusions: A substantial proportion of people with diabetes in Canada may need additional support to reach or maintain the guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people going through adolescence or menopause or those living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management, and policy makers in Canada should provide more support for people with diabetes to live healthy lives.

BACKGROUND Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) levels ≤7% (≤53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. OBJECTIVE As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. METHODS In this patient-led retrospective cross-sectional study with multiple time points of measurement, we used generalized estimating equations to analyze the associations of age, sex, and socioeconomic status with 947,543 HbA1c results collected from 2010 to 2019 among 90,770 people living with type 1 or type 2 diabetes in Canada and housed in the Canadian National Diabetes Repository. People living with diabetes reviewed and interpreted the results. RESULTS HbA1c results ≤7.0% represented 30.5% (male people living with type 1 diabetes), 21% (female people living with type 1 diabetes), 55% (male people living with type 2 diabetes) and 59% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence, and for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c levels than male people during childbearing years but higher HbA1c levels than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested that these results be communicated to health professionals and other stakeholders to improve the treatment for people living with diabetes. CONCLUSIONS A substantial proportion of people with diabetes in Canada may need additional support to reach or maintain the guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people going through adolescence or menopause or those living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management, and policy makers in Canada should provide more support for people with diabetes to live healthy lives.

Background: Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) ≤7.0% (<53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. Methods: We used generalized estimating equations to analyze the effects of age, sex and socioeconomic status in 947,543 HbA1c results measured from 2010 to 2019 among 90,770 people living with type 1 or 2 diabetes in Canada. People living with diabetes reviewed and interpreted the results. Results: HbA1c results at or below 7.0% represented 30.5% (male people living with type 1 diabetes), 21.0% (female people living with type 1 diabetes), 55.0% (male people living with type 2 diabetes) and 59.0% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence and, for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c than male people during childbearing years but higher HbA1c than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested these results be communicated to health professionals and other stakeholders to improve treatment for people living with diabetes. Interpretation: A substantial proportion of people with diabetes in Canada are insufficiently supported to maintain guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people who are going through adolescence, menopause, or living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management and policymakers in Canada should provide more support for people with diabetes to live healthy lives.

Little is known about the Canadian public’s perspective regarding clinical trials. We surveyed 1602 Ontario and British Columbia residents to ascerta

Digital data generated in the course of clinical care are increasingly being leveraged for a wide range of secondary purposes. Researchers need to develop governance policies that can assure the public that their information is being used responsibly. Our aim was to develop a generalisable model for governance of research emanating from health data repositories that will invoke the trust of the patients and the healthcare professionals whose data are being accessed for health research. We developed our governance principles and processes through literature review and iterative consultation with key actors in the research network including: a data governance working group, the lead investigators and patient advisors. We then recruited persons to participate in the governing and advisory bodies. Our governance process is informed by eight principles: (1) transparency; (2) accountability; (3) follow rule of law; (4) integrity; (5) participation and inclusiveness; (6) impartiality and independence; (7) effectiveness, efficiency and responsiveness and (8) reflexivity and continuous quality improvement. We describe the rationale for these principles, as well as their connections to the subsequent policies and procedures we developed. We then describe the function of the Research Governing Committee, the majority of whom are either persons living with diabetes or physicians whose data are being used, and the patient and data provider advisory groups with whom they consult and communicate. In conclusion, we have developed a values-based information governance framework and process for Diabetes Action Canada that adds value over-and-above existing scientific and ethics review processes by adding a strong patient perspective and contextual integrity. This model is adaptable to other secure data repositories.

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. 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. 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. 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.

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. 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. 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.

Stigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research.