Search

Background Immense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: (a) broad versus specific consent; (b) opt-in versus opt-out approaches; (c) comfort level sharing with different recipients; (d) attitudes towards commercialization; and (e) options to track PHI use and study results. Results 222 participants were included in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients (≤ 49 years) were more uncomfortable than older patients (50 + years; 13% versus 2% uncomfortable, p Conclusions While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research.

Objective To engage with patients, caregivers and care providers to co‐design components of an intervention that aims to improve delayed hospital discharge experiences. Design This is a qualitative study, which entailed working groups and co‐design sessions utilizing World Café and deliberative dialogue techniques to continually refine the intervention. Setting and Participants Our team engaged with 61 participants (patients, caregivers and care providers) in urban and rural communities across Ontario, Canada. A 7‐member Patient and Caregiver Advisory Council participated in all stages of the research. Results Key challenges experienced during a delayed discharge by patients, caregivers and care providers were poor communication and a lack of care services. Participants recommended a communication guide to support on‐going conversation between care providers, patients and caregivers. The guide included key topics to cover and questions to ask during initial and on‐going conversations to manage expectations and better understand the priorities and goals of patients and caregivers. Service recommendations included getting out of bed and dressed each day, addressing the psycho‐social needs of patients through tailored activities and having a storyboard at the bedside to facilitate on‐going engagement. Discussion and Conclusions Our findings outline ways to meaningfully engage patients and caregivers during a delayed hospital discharge. Combining this with a minimal basket of services can potentially facilitate a better care experience and outcomes for patients, their care providers and families.

BackgroundClinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) ≤7.0% (MethodsWe 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.ResultsHbA1c 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.InterpretationA 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.

Background: Little is known about the Canadian public’s perspective regarding clinical trials. Methods: We surveyed 1602 Ontario and British Columbia residents to ascertain their understanding of and willingness to participate in clinical trials. Results: Clinical trials are regarded positively with overall perceptions that they provide societal and personal benefits. Most respondents were somewhat (49%) or very willing (19%) to participate in a clinical trial. This increased with age and level of education. It was also greater among those with poor or very poor health, those with multiple chronic conditions, and those who had previously been invited into a clinical trial, all of which were correlated with age. Still, there was room for improvement in awareness and understanding of clinical trials. Forty-three percent of those surveyed felt not very informed or not at all informed and 37% had no opinion regarding clinical trials. Respondents would most often turn to their treating physician if considering participating in a clinical trial and least often to social media. Conclusion: While Canadians’ views about clinical trials are generally positive, they are somewhat muted and a significant minority feels poorly or not at all informed. They are less willing to participate in clinical research than Americans and are roughly equivalent to Europeans. While clinicians are the top choice for learning about clinical trials, they have little or no training and little time for this role. As we move toward integrating clinical trials into the practice setting, these issues of time, training, and resources must be addressed.

Background Artificial intelligence (AI) has been described as the “fourth industrial revolution” with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: What ethical issues have been identified in relation to AI in the field of health, including from a global health perspective? Methods Eight electronic databases were searched for peer reviewed and grey literature published before April 2018 using the concepts of health, ethics, and AI, and their related terms. Records were independently screened by two reviewers and were included if they reported on AI in relation to health and ethics and were written in the English language. Data was charted on a piloted data charting form, and a descriptive and thematic analysis was performed. Results Upon reviewing 12,722 articles, 103 met the predetermined inclusion criteria. The literature was primarily focused on the ethics of AI in health care, particularly on carer robots, diagnostics, and precision medicine, but was largely silent on ethics of AI in public and population health. The literature highlighted a number of common ethical concerns related to privacy, trust, accountability and responsibility, and bias. Largely missing from the literature was the ethics of AI in global health, particularly in the context of low- and middle-income countries (LMICs). Conclusions The ethical issues surrounding AI in the field of health are both vast and complex. While AI holds the potential to improve health and health systems, our analysis suggests that its introduction should be approached with cautious optimism. The dearth of literature on the ethics of AI within LMICs, as well as in public health, also points to a critical need for further research into the ethical implications of AI within both global and public health, to ensure that its development and implementation is ethical for everyone, everywhere.

This work was supported by Diabetes Action Canada, which is funded, in part, through a Canadian Institutes of Health Research chronic disease network grant under the Strategy for Patient-Oriented Research (Funding Reference number: SCA 145101). 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. Publisher PDF

e14122 Background: Massive volumes of patient health information (PHI) are required to realize the anticipated benefits of artificial intelligence in future clinical medicine. To maintain public trust in medical research however, consent policies must evolve to reflect contemporary patient preferences. Methods: From January-December 2019, patients attending clinics at a large academic cancer centre were invited to complete a 27-item iPad survey on consent preferences. Survey items focused on: (a) broad vs. specific consent; (b) opt-in vs. opt-out approaches for research contact; (c) comfort sharing with different recipients; (d) perceptions on commercialization; and (e) options to track information use and study results. Demographic questions addressed cancer type, treatment stage, age, gender, ethnicity, education level, and household income. Results: A total of 222 participants were included in the analysis (112 males, 108 females; 2 rather not say); 83% were comfortable sharing PHI with researchers at their own hospital. While 56% of patients preferred broad consent, 38% preferred to be contacted with study details and asked to consent every time (specific consent); 6% prefer not to share at all. Younger patients ( < 49 years) most often chose specific consent (50%); significantly more than those 75+ years (24%; p < .05). Younger patients ( < 49 years) were also significantly more uncomfortable than older patients (50+ years) sharing even within their own hospital (13% uncomfortable vs. 1% uncomfortable; p < .05). A significant majority of patients (63%, p = .0001) preferred to be asked for permission before being entered into a contact pool vs. automatic entry with opportunity to opt-out. The majority of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). A significant majority expressed the desire to track who is using their PHI (61%, p < .0001), and be notified regarding study results (70%, p < .0001). Conclusions: While most patients were willing to share their PHI with researchers at their own hospital, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more informed consent options. Modernizing consent policies to reflect increased patient interest in the exercise of their autonomy is crucial in fostering sustained public engagement in medical research.

Introduction Diabetes Action Canada is developing a data repository and registry of potential research participants to support research, QI, and service to improve diabetes care. Central to the repository are pseudonymised linkable electronic medical records (EMRs) from family practices that are participating in the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Objectives and Approach We sought to develop an information governance process that would engender the trust of patients and the health care professionals (HCPs) that their EMR data were being managed responsibly in the best interests of patients living with diabetes. Following an extensive literature review, we developed a principles-based governance framework and operational model, with a strong focus on patient participation in the governance process. We recruited patients through our pre-existing patient advisory circles and physicians through our partners in CPCSSN. In January 2018, we held a training workshop for Research Governing Committee (RGC) members. Results We identified eight values-based principles to guide our governance process: transparency; accountability; following the rule of law; integrity of purpose, science and ethics; participation and inclusiveness; impartiality and independence; effectiveness; efficiency and responsiveness; and reflexivity and continuous quality improvement of process. Patients represent 50% of RGC members and HCPs 20%. Patient members provide their perspectives on: goals and outcomes of the research; the benefits and burdens among people living with diabetes; and the communication preferences of patients around recruitment. HCPs provide a deep understanding of the settings and systems in which care is provided to ensure contextual integrity of the research. Two researchers and one person with bioethics expertise provide technical and ethics perspectives on data requests. Conclusion/Implications Governance must go beyond legal compliance to ensure a ’social licence’ for the use of the data. In part, we address this through our guiding principles, our emphasis on patient and healthcare provider perspectives, and focus on research that is scientifically sound, ethically robust and in the public interest.

When responding to a novel infectious disease outbreak, policies are set under time constraints and uncertainty which can limit the ability to control the outbreak and result in unintended consequences including lack of public confidence. The H1N1 pandemic highlighted challenges in public health decision-making during a public health emergency. Understanding this process to identify barriers and modifiable influences is important to improve the response to future emergencies. The purpose of this study is to examine the H1N1 pandemic decision-making process in Canada with an emphasis on the use of evidence for public health decisions. Using semi-structured key informant interviews conducted after the pandemic (July–November 2010) and a document analysis, we examined four highly debated pandemic policies: use of adjuvanted vaccine by pregnant women, vaccine priority groups and sequencing, school closures and personal protective equipment. Data were analysed for thematic content guided by Lomas' policy decision-making framework as well as indicative coding using iterative methods. We interviewed 40 public health officials and scientific advisors across Canada and reviewed 76 pandemic policy documents. Our analysis revealed that pandemic pre-planning resulted in strong beliefs, which defined the decision-making process. Existing ideological perspectives of evidence strongly influenced how information was used such that the same evidentiary sources were interpreted differently according to the ideological perspective. Participants recognized that current models for public health decision-making failed to make explicit the roles of scientific evidence in relation to contextual factors. Conflict avoidance theory explained policy decisions that went against the prevailing evidence. Clarification of roles and responsibilities within the public health system would reduce duplication and maintain credibility. A more transparent and iterative approach to incorporating evidence into public health decision-making that reflects the realities of the external pressures present during a public health emergency is needed., Highlights ► Canadian public health officials revealed challenges in considering scientific evidence for decision-making. ► Pandemic pre-planning helped deal with uncertainty but resulted in strong beliefs that isolated policy entrepreneurs. ► Ideologies of evidence affected the interpretation of information and their application to Canadian pandemic policies. ► Conflict avoidance theory explained Canadian pandemic policy decisions that went against the prevailing evidence. ► Clarification of roles within Canada's public health system is needed to avoid duplication and maintain credibility.

Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.

Please cite this paper as: Laurie et al. (2013) Influenza serological studies to inform public health action: best practices to optimise timing, quality and reporting. Influenza and Other Respiratory Viruses 7(2) 211–224. Background Serological studies can detect infection with a novel influenza virus in the absence of symptoms or positive virology, providing useful information on infection that goes beyond the estimates from epidemiological, clinical and virological data. During the 2009 A(H1N1) pandemic, an impressive number of detailed serological studies were performed, yet the majority of serological data were available only after the first wave of infection. This limited the ability to estimate the transmissibility and severity of this novel infection, and the variability in methodology and reporting limited the ability to compare and combine the serological data. Objectives To identify best practices for conduct and standardisation of serological studies on outbreak and pandemic influenza to inform public policy. Methods/Setting An international meeting was held in February 2011 in Ottawa, Canada, to foster the consensus for greater standardisation of influenza serological studies. Results Best practices for serological investigations of influenza epidemiology include the following: classification of studies as pre-pandemic, outbreak, pandemic or inter-pandemic with a clearly identified objective; use of international serum standards for laboratory assays; cohort and cross-sectional study designs with common standards for data collection; use of serum banks to improve sampling capacity; and potential for linkage of serological, clinical and epidemiological data. Advance planning for outbreak studies would enable a rapid and coordinated response; inclusion of serological studies in pandemic plans should be considered. Conclusions Optimising the quality, comparability and combinability of influenza serological studies will provide important data upon emergence of a novel or variant influenza virus to inform public health action.

To determine how patients and physicians balance the perceived benefits and harms of sharing electronic health data for patient care and for secondary purposes.Before-after survey of patients and providers in practices using electronic medical records (EMRs) enrolled in a clinical trial in Ontario, Canada.Outcomes were measured using the Health Information Privacy Questionnaire (HIPQ) at baseline and end of study. Thirteen questions in 4 general domains investigated attitudes towards the privacy of EMRs, outsider's use of patient's health information, the sharing of patient's information within the health care system, and the overall perception of benefits versus harms of computerization in health care.511 patients (mean age 60.3 years, 49.6% female) and 46 physicians (mean age 47.2 years, 37.0% female) participated. Most (90%) supported the computerized sharing of the patient's health records among their health care professionals and to provide clinical advice. Fewer agreed that the patient's de-identified information should be shared outside of the health care circle (70%). Only a minority of either group supported the notion that computerized records can be keep more private than paper records (38-50%). Overall, a majority (58% patients, 70% physicians) believed that the benefits of computerization were greater than the risks of confidentiality loss. This was especially true for patients who were frequent computer users.While these primary care physicians and their patients valued the clinical features of EMRs, a substantial minority have concerns about the secondary use of de-identified information.

Mamdani and Laupacis describe multiple sources of health care data that are increasingly available for observational studies, including those involving advanced analytics to facilitate point-of-care decision- making.[1][1] We add primary care electronic medical record (EMR) data to the sources of

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Objectives: This study sought to determine public opinion on alternatives to project-specific consent for use of their personal information for health research. Design: The authors conducted a fixed-response random-digit dialed telephone survey of 1,230 adults across Canada. Measurements: We measured attitudes toward privacy and health research; trust in different institutions to keep information confidential; and consent choice for research use of one's own health information involving medical record review, automated abstraction of information from the electronic medical record, and linking education or income with health data. Results: Support was strong for both health research and privacy protection. Studying communicable diseases and quality of health care had greatest support (85% to 89%). Trust was highest for data institutes, university researchers, hospitals, and disease foundations (78% to 80%). Four percent of respondents thought information from their paper medical record should not be used at all for research, 32% thought permission should be obtained for each use, 29% supported broad consent, 24% supported notification and opt out, and 11% felt no need for notification or consent. Opinions were more polarized for automated abstraction of data from the electronic medical record. Respondents were more willing to link education with health data than income. Conclusions: Most of the public supported alternatives to study-specific consent, but few supported use without any notification or consent. Consent choices for research use of one's health information should be documented in the medical record. The challenge remains how best to elicit those choices and ensure that they are up-to-date.

Data protection laws offer such broad exemptions for research that research ethics boards and data custodians lack sufficient guidance as to when it may be acceptable to release data to researchers without consent. The result: idiosyncratic institutional policies that create major challenges for researchers conducting multi-centred studies. The 2005 CIHR Best Practices for Protecting Privacy in Health Research provide an important first step towards greater clarity. However, there is still a need to translate these Best Practices into harmonized policies. This should be seen as an opportunity rather than a threat. Clear rules for data protection will reinforce public trust, which is essential for continued access to personal information for research.

Objective: To explore the consent preferences of patients whose health data are currently being used for research purposes. Methods: Semi-structured interviews were conducted with 17 patients whose primary physicians were taking part in a study that utilized de-identified individual-level health information from their electronic medical record. All physicians practised in southwestern Ontario. All interviews were taped, transcribed verbatim and analysed using a constant comparative method. All transcripts and debriefing notes were read and reread to elicit general themes. Results: Three main themes emerged from the data: patients recognized the need to balance their consent preferences with time pressures in the clinical encounter when deciding the nature of consent for a study; patients generally regarded the seeking of consent as being an issue of respect for them as individuals; and patients were also weighing their perceived benefits and concerns related to the research. For these patients, seeking their consent was an important step in research participation. For some patients, the sponsor and the research topic were factors that would influence their decision to provide consent. Conclusion: Patients want their consent to be sought when their data are used for research purposes. This will involve explicitly informing patients that a study is taking place, providing written consent and offering regular updates about the study.

This paper has three parts. The first part describes developments in the use of personal information for health research in Canada, challenges in responding to new data protection legislation and the work of the Canadian Institutes of Health Research in assisting the research community to adapt to these developments. The second part critiques two aspects of the stakeholder analysis posited in William Lowrance's report: the lack of an analysis of researchers' interests as distinct from those of society at large, and the framing of privacy as an individual interest. I argue for recasting the privacy and research tension as a values conflict between two societal goods and not an individual versus a societal interest, and for explicitly acknowledging researchers' interests as data users. In so doing, there is no clear trump of privacy or research, and greater importance is placed upon the weighing of benefits and risks of individual studies to determine whether the waiving of consent for a particular study or programme of research is justified. The third part makes specific suggestions as to future ways in which data use practices may evolve. I argue the need to engage the public in deliberating the broad parameters under which personal information will be used, as the public collectively has a major stake in this issue and their input provides legitimacy for these uses of information. In addition, given the proliferation of prospectively-developed databases for research purposes, a 'systems' approach for obtaining consent for participation to replace the current study-by-study recruitment of individuals is appropriate.

Provincial government drug plans are the primary source of insurance for drugs taken by seniors in outpatient settings. The adequacy of this coverage has been called into question, given the increased clinical importance of pharma-ceuticals, shifts in the provision of health care from inpatient to outpatient settings, increased use of restrictive formularies, and reductions in provincial drug subsidies. To assess the adequacy of provincial coverage, we estimated what a typical single senior beneficiary of a provincial drug plan paid out-of-pocket in 1998 on prescription drugs covered by the public program, depending on his/her province of residence, level of drug consumption, and income. We compared provincial coverage for seniors with large drug costs. We also assessed provincial coverage of drugs that were introduced into the Canadian market between 1991 and 1998. The cost of drugs consumed by a senior in a given province and year was estimated by multiplying the average number of prescription drugs consumed by senior drug users by the average per-prescription costs. High drug consumption was defined as twice the average. We used the provincial drug cost sharing rules to estimate the senior's share of the total cost of drugs consumed. Mean out-of-pocket costs range from $42 to $1,302 per year, are lower for lower-income seniors, and increase with drug use, although the charge per drug decreases with the number used. There was up to a 12-fold variation among the provinces in the charges faced by seniors with similar incomes and drug use. All but one province limits costs to seniors with catastrophic drug costs, but there was 21-fold variation in the expenditure limits. The substantial variation in seniors' out-of-pocket drug costs raises questions about the distributive equity of drug subsidies in Canada. Recent evidence on the deleterious health effects of drug charges faced by seniors in Quebec and the fact that seniors in some other provinces face direct charges similar to those faced in Quebec raise the possibility of adverse consequences of drug charges in other provinces.

Growth in pharmaceutical expenditures in Canada is approximately double the rate of growth in other healthcare expenditures. Conventional approaches to controlling expenditures are not working. The policy options proposed by Laupacis, Anderson and O'Brien for managing pharmaceutical budgets--better evidence, better dissemination, additional regulation and increased dialogue--are necessary but not sufficient to bring about more cost-effective prescribing. This paper suggests three additional strategies that will complement existing policies: restructuring consumer co-payments such that consumer cost-sharing varies inversely with therapeutic necessity; introducing physician budgets for those pharmaceuticals for which there is reasonable suspicion of overuse; and price-volume contracting with pharmaceutical firms, consistent with evidence from pharmaco-economic evaluation. The first strategy will send better signals to the consumer as to the value of the pharmaceuticals they are consuming. The latter two strategies will provide incentives for physicians to prescribe and industry to market their pharmaceuticals in a fashion more consistent with cost-effective use of these drugs. Better evidence and better dissemination are simply not enough.

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.

OBJECTIVE: To determine demographic and clinical factors associated with delayed thrombolysis in patients with acute myocardial infarction. DESIGN: A retrospective cohort. SETTING: 37 Minnesota hospitals during the time periods October 1992-July 1993 and July 1995-April 1996. PATIENTS: We reviewed the medical records of 776 older patients aged 65 or older hospitalized with an admission diagnosis of acute myocardial infarction, suspected acute myocardial infarction, or rule-out acute myocardial infarction, who were treated with a thrombolytic agent. MEASUREMENT: We used multivariate logistic regression models to examine the association between selected study characteristics and time between hospital presentation and administration of thrombolytic treatment. Early thrombolysis was defined as less than 60 minutes after hospital presentation and late thrombolysis as 60+ minutes. RESULTS: Of 776 study patients, 57.5% (n = 446) received early thrombolysis. Of the remaining 330 patients receiving late treatment, 12.1% (n = 94) were thrombolyzed more than 2 hours after hospital presentation. After controlling for other factors, the odds of delayed thrombolysis among patients aged 75 or older were 1.48 compared with younger individuals (95% CI, 1.17-1.88). The odds of delayed thrombolysis among patients with severe comorbidity were 1.46 (95% CI, 1.10— 1.94) compared with individuals without severe comorbidity. Predictors of early thrombolytic treatment included hospital arrival via emergency transport (ORdelay = 0.46; 95% CI, 0.34–0.63) and chest discomfort at admission (ORdelay = 0.40; 95% CI, 0.18–0.86). CONCLUSIONS: The present study indicates that patients of advanced age and with severe comorbidity are more likely to experience delayed thrombolytic treatment after hospital presentation. These are the patients who suffer the highest morbidity from acute myocardial infarction and for whom expeditious treatment may enhance therapeutic benefit.

The use of research evidence in policy making at the legislative and administrative levels would appear to be very selective. Focusing on pharmaceutical policy, this paper argues that research evidence is only one ingredient leading to a policy decision and that any examination of research transfer into policy must take into account the many other factors which impact on decision making. The paper describes the policy making process, barriers to the uptake of research evidence into policy and ways of improving research uptake into policy making. Examples are given from drug licensing, remuneration policies, post-marketing surveillance and product withdrawal from the market.

Traditionally, the pharmacist has been viewed as an important source of medication-related information for the public. In the last few years, this role has been supported by a professional philosophy called "pharmaceutical care."' Because patient counselling has become a defining characteristic of the new role of the pharmacist, the quality of cognitive services offered by community pharmacists has become a subject of research for pharmacy educators. Early studies were very disappointing for advocates of the new role of the pharmacist.2-6 Recent studies suggest that there has been some improvement in frequency and quality of patient counselling,7'8 however relatively little is known concerning those factors that underlie successful counselling.

Background Immunization information systems (IISs) are electronic registries used to monitor individual vaccination status and assess vaccine coverage. IISs are currently not widely used across Canada, where health jurisdictions employ a range of approaches to capture influenza immunization information. Conducted in advance of the 2009 H1N1 vaccination campaign, the objectives of this study were to understand the perceived value of individual-level data and IISs for influenza control, identify ideal system functions, and explore barriers to implementation. Methods In July and August 2009, semi-structured interviews were conducted with key informants engaged in vaccine delivery and/or pandemic planning at regional, provincial/territorial and federal levels across Canada. Key informants were recruited using a combination of convenience and snowball sampling methodologies. Qualitative analysis was used to extract themes from interview content. Results Patient management, assessment of vaccine coverage, and evaluation of safety and effectiveness were identified as public health priorities that would be achieved in a more timely manner, and with greater accuracy, through the use of an IIS. Features described as ideal included system flexibility, rapid data entry, and universality. Financial and human resource constraints as well as coordination between immunization providers were expressed as barriers to implementation. Conclusions IISs were perceived as valuable by key informants for strengthening management capacity and improving evaluation of both seasonal and pandemic influenza vaccination campaigns. However, certain implementation restrictions may need to be overcome for these benefits to be achieved.

Data protection laws offer such broad exemptions for research that research ethics boards and data custodians lack sufficient guidance as to when it may be acceptable to release data to researchers without consent. The result: idiosyncratic institutional policies that create major challenges for researchers conducting multi-centred studies. The 2005 CIHR Best Practices for Protecting Privacy in Health Research provide an important first step towards greater clarity. However, there is still a need to translate these Best Practices into harmonized policies. This should be seen as an opportunity rather than a threat. Clear rules for data protection will reinforce public trust, which is essential for continued access to personal information for research.

Background The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.

Background Methods are needed for using confidential data to select and reach patients without compromising their health privacy. Methods (a) Sampling: we created (1) an anonymous list of encrypted personal health numbers (EPHNs) of target patients (e.g., users of the medications of interest) and (2) an anonymous list of EPHNs of people randomly sampled from the general population of non-users. The two lists were merged and randomly ordered to make a camouflaged list. People on the second list were called camouflagers. Then EPHNs were matched to names and contact information, and the EPHNs were removed from the contact list. (b) Contacting: when we contacted patients by mail or telephone, we told them their names were selected from one of two lists, and their health status was unknown to us. We invited respondents to answer (1) a short survey for the general population or (2) a longer survey concerning the target condition. Results In five studies, the percentage of camouflagers—equal to one minus the positive predictive value of the camouflaged list—has varied from 10 to over 50%. This depended on the psychosocial sensitivity of the target medications or health conditions, the natural camouflaging by the population's heterogeneity or inaccuracy of the data on the target characteristic, the degree of stratification of the sample, and the cost of contacting. Conclusion Camouflaging enables administrative data to be used for contacting target patients in selected populations while adhering to current data privacy laws and ethics principles. Copyright © 2008 John Wiley & Sons, Ltd.

We read with interest Fletcher’s editorial on ethics approval for all studies involving human participants as a condition of publication, and the importance of having this done by ethics review boards as knowledgeable and unbiased third parties.[1][1] As noted, although this approach is now

Background Public insurance plans for pharmaceuticals in Canada differ substantially across provinces in the conditions under which pharmaceuticals are reimbursed. Coxibs provide a good example. Quebec had no restrictions on reimbursement for these drugs. Ontario required physicians to submit the clinical indications for their use on the prescription. British Columbia required physicians to seek and receive prior authorisation from the drug plan. Objective This study compares the effects of different reimbursement policies on coxib, non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs), and gastro-protective agent (GPA) use and cost. Study design Analysis of retrospective time series analysis of all NSAID and GPA administrative claims data from April 1997 through December 2002. Setting Administrative claims data from April 1997 through December 2002 for each of the publicly funded drug plans in Quebec, Ontario, and British Columbia. In addition, we obtained data from BC PharmaNet, which records all dispensed prescriptions in British Columbia. Patients or other participants Senior beneficiaries (≥ 65 years). Main outcome measure We compared the projected total NSAID utilisation in the absence of coxib reimbursement restriction with actual utilisation by province and drug category. Projected utilisation was based on ARIMA modelling and reported as the number of defined daily doses (DDDs) per 100 senior (≥65 years) beneficiaries/month. Results In Ontario, under its “limited use” policy, uptake and steady-state use of coxibs was similar to that in Quebec, where there were no restrictions. In British Columbia, publicly funded use of coxibs was 6% of that in Ontario and Quebec. Despite a shift to private reimbursement, total coxib use in BC was only 50% of use in Ontario and Quebec. The use of all NSAIDS (nsNSAIDS plus coxibs) increased for all provincial drug plans except for BC. The increase and overall rate of total NSAID use was greatest in Ontario. Neither Ontario's nor BC's policies had an impact on use of nsNSAIDs or GPAs. Conclusion Only BC's policy effectively limited publicly funded coxib use. However, there was substantial cost-shifting to out-of-pocket and third party insurance plans in BC.

Emergency contraception[1][1] is just the latest example in a long list of medications that are being shifted from prescription only to over-the-counter (OTC) status. More experience with other potent and effective prescription drugs and an increased understanding of their safety and efficacy in the

Canada's public-private mix in coverage for pharmaceuticals has long created variation across provinces in access to needed treatments and has contributed to persistent cost growth in both the private and public sectors. Among the recommendations of the 2002 Romanow Commission was a proposed national standard for "last-dollar" pharmacare that would cover any household's drug costs beyond a high annual deductible. Such a program contrasts with the "first-dollar" pharmacare programs currently available for vulnerable populations (e.g., seniors and social assistance recipients) in most provinces. While last-dollar coverage may be a valuable set toward broadening public pharmacare in Canada, there is a risk that provincial governments may interpret the coverage of catastrophic costs as the new pharmacare ideal and therefore reduce or eliminate existing programs that currently offer first-dollar benefits.

Government legislators and research ethics boards in some jurisdictions require all patients to give written informed consent before enrollment in clinical registries. However, the effect of such a requirement on the use of clinical registries and the extent to which registry data can be generalized remain uncertain.We examined the effectiveness of a comprehensive attempt to obtain informed consent between June 2001 and December 2002 on the overall participation rate and the characteristics of participating patients in the Registry of the Canadian Stroke Network, a prospective registry based at 20 major stroke centers across Canada.The overall participation rate (i.e., the consent rate among all potential participants) was 39.3 percent of 4285 eligible patients during phase 1 of the project (June 2001 through February 2002) and 50.6 percent of 2823 eligible patients during phase 2 (June 2002 through December 2002), despite the presence of neurologic research nurse coordinators at each site. Many patients died or left the hospital before they could be approached for consent. Major selection biases were found; the in-hospital mortality rate was much lower among patients who were enrolled (6.9 percent) than among those who were not enrolled (21.7 percent) (relative risk of in-hospital death, 3.13; 95 percent confidence interval, 2.65 to 3.70; P0.001). We estimate that approximately 500,000 dollars (Canadian dollars) was spent on consent-related issues during the first two years of the registry.Obtaining written informed consent for participation in a stroke registry led to important selection biases, such that registry patients were not representative of the typical patient with stroke at each center. These findings highlight the need for legislation on privacy and policies permitting waivers of informed consent for minimal-risk observational research.

Objective: The aim of this study was to evaluate the cost effectiveness of multitherapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis. Design: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy. Main outcome measures and results: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium → no therapy; (ii) ovarian hormone therapy (OHT) → calcium → no therapy [166 Canadian dollars ($Can)]; (iii) OHT → etidronate → calcium → no therapy ($Can2331); and (iv) OHT → alendronate → calcium → no therapy ($Can40 965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy. Conclusions: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decisionmakers may select from among these efficient strategies on the basis of incremental cost effectiveness.

Growing evidence indicates that life-sustaining therapies for the treatment of acute myocardial infarction (AMI) are underused among patients eligible for therapy, including the elderly and women. We examined the effect of a patient's comorbidity burden on use of these highly effective therapies in eligible populations of individuals with AMI. Retrospective cohort design. We reviewed the medical records of 2,409 individuals at 37 Minnesota hospitals from October 1992 through July 1993 with an admission diagnosis of AMI, suspected AMI, or rule-out AMI, who met electrocardiographic, laboratory, and clinical criteria for AMI. Using multivariate logistic regression models, we determined the association between a validated comorbidity measure and the proportion of eligible patients who received thrombolysis or aspirin. Controlling for other factors previously reported to influence rates of study treatment, the odds of receipt of thrombolysis among patients with severe comorbidity was 0.49 (95% confidence interval [CI] 0.27, 0.88) when compared with individuals without such limitation. Similarly, the odds of aspirin treatment among study patients with severe comorbidity was 0.46 (95% CI 0.30, 0.72), compared with individuals without severe comorbidity. We did not distinguish any differences in patterns of treatment with either study treatment among patients with mild or moderate comorbidity when compared with individuals without any concomitant comorbidity. This study indicates that patients with severe mental and physical comorbidities are less likely to receive standard therapies for AMI recommended in national treatment guidelines.

Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. Design Systematic review. Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161 604 eligible patients, 66.9% consented to use of data from their medical records. Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.

Context.—The effectiveness of recruiting local medical opinion leaders to improve quality of care is poorly understood.Objective.—To evaluate a guideline-implementation intervention of clinician education by local opinion leaders and performance feedback to (1) increase use of lifesaving drugs (aspirin and thrombolytics in eligible elderly patients, β-blockers in all eligible patients) for acute myocardial infarction (AMI), and (2) decrease use of a potentially harmful therapy (prophylactic lidocaine).Design.—Randomized controlled trial with hospital as the unit of randomization, intervention, and analysis.Setting.—Thirty-seven community hospitals in Minnesota.Patients.—All patients with AMI admitted to study hospitals over 10 months before (1992-1993, N=2409) or after (1995-1996, N=2938) the intervention.Intervention.—Using a validated survey, we identified opinion leaders at 20 experimental hospitals who influenced peers through small and large group discussions, informal consultations, and revisions of protocols and clinical pathways. They focused on (1) evidence (drug efficacy), (2) comparative performance, and (3) barriers to change. Control hospitals received mailed performance feedback.Main Outcome Measures.—Hospital-specific changes before and after the intervention in the proportion of eligible patients receiving each study drug.Results.—Among experimental hospitals, the median change in the proportion of eligible elderly patients receiving aspirin was +0.13 (17% increase from 0.77 at baseline), compared with a change of −0.03 at control hospitals (P=.04). For β-blockers, the respective changes were +0.31 (63% increase from 0.49 at baseline) vs +0.18 (30% increase from baseline) for controls (P=.02). Lidocaine use declined by about 50% in both groups. The intervention did not increase thrombolysis in the elderly (from 0.73 at baseline), but nearly two thirds of eligible nonrecipients were older than 85 years, had severe comorbidities, or presented after at least 6 hours.Conclusions.—Working with opinion leaders and providing performance feedback can accelerate adoption of some beneficial AMI therapies (eg, aspirin, β-blockers). Secular changes in knowledge and hospital protocols may extinguish outdated practices (eg, prophylactic lidocaine). However, it is more difficult to increase use of effective but riskier treatments (eg, thrombolysis) for frail elderly patients.