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Sepsis is a global health threat with significant morbidity and mortality. Despite clinical practice guidelines and developed health systems, sepsis is often unrecognized or misdiagnosed, leading to preventable harm. In Canada, sepsis is responsible for 1 in 20 deaths and is a significant driver of health system costs. Despite being a signatory to the World Health Organization's Resolution WHA 70.7, adopted in 2017, Canada has not lived up to its commitment. Many existing sepsis policies were developed in response to a specific tragedy, and there is no national sepsis action plan. In this article, we describe the burden of sepsis, provide examples of existing, context-specific, reactionary sepsis policies, and urge a coordinated, proactive Canadian sepsis action plan to reduce the burden of sepsis., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: GG is an employee of the Canadian Medical Protective Association. NK is the president of the Global Sepsis Alliance. LS is funded by the Arnold L. Johnson Chair in Health Care Ethics, an endowed Chair at McMaster University. AFR is the Scientific Director of Sepsis Canada, a CIHR-funded network, and holds the Hamilton Health Sciences Chair in Sepsis Research. KB has consulted for Fresenius Medical Care. The other authors have no conflicts of interest to declare.

Background: The pandemic has upended much clinical care, irrevocably changing our health systems and thrusting emergency physicians into a time of great uncertainty and change. This study is a follow-up to a survey that examined the early pandemic experience among Canadian emergency physicians and aimed to qualitatively describe the experiences of these physicians during the global pandemic. The study was conducted at a time when Canadian COVID-19 case numbers were low., Methods: The investigators engaged in an interview-based study that used an interpretive description analytic technique, sensitised by the principles of phenomenology. One-to-one interviews were conducted, transcribed and then analysed to establish a codebook, which was subsequently grouped into key themes. Results underwent source triangulation (with survey data from a similar period) and investigator-driven audit trail analysis., Results: A total of 16 interviews (11 female, 5 male) were conducted between May and September 2020. The isolated themes on emergency physicians' experiences during the early pandemic included: (1) disruption and loss of emergency department shift work; (2) stress of COVID-19 uncertainty and information bombardment; (3) increased team bonding; (4) greater personal life stress; (5) concern for patients' isolation, miscommunication and disconnection from care; (6) emotional distress., Conclusions: Canadian emergency physicians experienced emotional and psychological distress during the early COVID-19 pandemic, at a time when COVID-19 prevalence was low. This study's findings could guide future interventions to protect emergency physicians against pandemic-related distress., Competing Interests: Competing interests: CG-L reports employment with the Canadian Medical Association and notes that the opinions and conclusions expressed are the writers’ own and are not those of the Canadian Medical Association., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

There exists considerable research which reports that mental health disparities persist among visible minority immigrants and refugees within Canada. Accessing mental health care services becomes a concern which contributes to this, as visible minority migrants are regarded as an at-risk group that are clinically underserved. Thus, the purpose of this review is to explore the following research question: "what are the barriers and facilitators for accessing mental health care services among visible immigrants and refugees in Canada?". A scoping review following guidelines proposed by Arksey and O'Malley (International Journal of Social Research Methodology 8(1): 19-32, 2005) was conducted. A total of 45 articles published from 2000 to 2020 were selected through the review process, and data from the retrieved articles was thematically analyzed. Wide range of barriers and facilitators were identified at both the systemic and individual levels. Unique differences rooted within landing and legal statuses were also highlighted within the findings to provide nuance amongst immigrants and refugees. With the main layered identity of being a considered a visible minority, this yielded unique challenges patterned by other identities and statuses. The interplay of structural issues rooted in Canadian health policies and immigration laws coupled with individual factors produce complex barriers and facilitators when seeking mental health services. Through employing a combined and multifaceted approach which address the identified factors, the findings also provide suggestions for mental health care providers, resettlement agencies, policy recommendations, and future directions for research are discussed as actionable points of departure., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: A previous survey of Canadian emergency medicine (EM) physicians during the first wave of the COVID-19 pandemic documented less than 20% experienced high levels of burnout. This study examined the experience of a similar group of physicians during the second pandemic wave. We reported the associations between burnout and physician age, gender, having children at home and training route., Methods: This study utilized a national survey of Canadian emergency physicians. We collected data on demographics and measured burnout using the Maslach Burnout Inventory (MBI). Multiple logistic regression models identified associations between the emotional exhaustion and depersonalization domains of the MBI and EM physician demographics (age, gender, children living at home, and training route)., Results: Between November 25, 2020, and February 4, 2021, 416 emergency physicians completed the survey, representing all Provinces or Territories in Canada (except Nunavut). The mean participant age was 44, 53% were male, 64% had children living at home and 41% were FRCPC and 41% CCFP-EM trained. Sixty percent reported high burnout (either high emotional exhaustion and/or high depersonalization). Increasing age was associated with lower emotional exhaustion and depersonalization; female or nonbinary gender was associated with an increase in emotional exhaustion; and having children living at home was associated with lower depersonalization., Conclusions: Most Canadian emergency physicians participating in our study during the COVID-19 pandemic reported high burnout levels. Younger physicians and female physicians were more likely than their coworkers to report high burnout levels. Hospitals should address emergency physician burnout during the pandemic because it is a threat to quality of patient care and retention of the workforce for the future., (© 2021. The Author(s), under exclusive licence to Canadian Association of Emergency Physicians (CAEP)/ Association Canadienne de Médecine d'Urgence (ACMU).)

Background: Individuals with prior experience in international disaster response represent an essential source of expertise to support disaster response in their home countries. Our objective was to explore the experiences of personnel involved in international emergency health response regarding their perceptions of essential disaster response attributes and capacities and determine how these competencies apply to the Canadian context., Methods: For this qualitative study, we conducted semistructured interviews with key informants in person or over the telephone from May to December 2018. Participants were delegates deployed as part of the Canadian Red Cross medical response team in a clinical or technical, or administrative role within the last 5 years. Interviews were audio-recorded and transcribed. Conventional content analysis was performed on the transcripts, and themes were developed., Results: Eighteen key informants from 4 Canadian provinces provided perspectives on individual attributes acquired during international deployments, such as agility and stress management, and team capacities developed, including collaboration and conflict management. Key informants, including administrators ( n = 5), technicians ( n = 4), nurses ( n = 4), physicians ( n = 3) and psychosocial support workers ( n = 2), described these experiences as highly relevant to the Canadian domestic context., Interpretation: Canadian physicians and health care workers involved with international disaster response have already acquired essential capacities, and this experience can be vital to building efficient disaster response teams in Canada. These findings complement the Canadian Medical Education Directives for Specialists (CanMEDS) roles and can inform course design, competency and curriculum development for physician and professional training programs related to disaster response and preparedness., Competing Interests: Competing interests: Lynda Redwood-Campbell has acted as a contracted delegate with Canadian Red Cross. Lisa Schwartz declares COVID research support from the World Health Organization, consulting fees from the Ontario Regional Blood Coordinating Network (ORBCoN), payment for guest lectures from McMaster University and a salary award from the Arnold L. Johnson Chair in Health Care Ethics at McMaster University; she is a member of the Canadian Cancer Trials Group and of the Médecins Sans Frontières ethics review board. Salim Sohani is an employee of the Canadian Red Cross. No other competing interests were declared., (© 2022 CMA Impact Inc. or its licensors.)

The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset ( NCT04348656 ). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm-relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94-1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02-1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57-0.95 and OR = 0.66, 95% CI 0.50-0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14-2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care., (© 2021. The Author(s).)

Canada is the only high-income country with a universal healthcare system that does not provide prescription drug coverage for all its residents. This study examines whether Canadians' prescription drug coverage status is associated with their health services use and how this association differs by gender across non-migrants and three categories of migrants: economic immigrants, family-class immigrants, and refugees. Very few studies have examined differences across these migrant groups, and there is a need to do so as they experience varying health disparities. This study contributes to the prescription drug coverage, migration and health literature by employing an intersectional lens to analyze a sample of Ontario working-aged residents (n=39,792) generated from linking the Canadian Community Health Survey (2005, 2008, 2013, 2014) and Longitudinal Immigrant Database. Predicted probabilities and average marginal effects from multivariable logistic regression models were generated, and interaction effects between prescription drug coverage and immigrant status were examined. The study reveals important differences in the use of health services across prescription drug coverage groups by immigration status. As the general debate about universal pharmacare in Canada is ongoing, this study reveals that drug insurance is positively associated with health services use of most migrants and non-migrants, however, some immigrant women may still experience barriers to access general practitioner services. If pharmacare is introduced, ongoing evaluation is needed to ensure that its implementation produces equitable outcomes for all., Competing Interests: Declaration of Competing Interest None., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: The practice of public and patient engagement (PPE) in health technology assessment (HTA) has spread worldwide, yet gaps in knowledge remain. We carried out an institutional ethnography of the Canadian Agency for Drugs and Technologies in Health (CADTH) public and patient involvement in HTA., Methods: The research took place over 15 months and included observational work in the institutional settings, text review, and interviews with individuals working for or involved with the agency., Results: We found that despite demonstrated commitment to PPE, organizational history, governance structure, and practices were impediments to a unified approach to PPE. Unclear role descriptions for committee members and differences in philosophy and priority given to PPE across the organization presented challenges to effective participation. The high degree of value given to evidence-based principles at times conflicted with meaningful integration of patient input. A lack of clear goals and processes, roles, and differential treatment of evidence in PPE served to minimize the importance of patient experiences and to displace their validity. An acknowledgment of conflicts between multiple epistemic traditions at work within HTA activities may strengthen organizational approaches to PPE., Conclusion: HTA organizations can learn from this study by reflecting on the challenges described and the recommendations offered to address them. We suggest solidifying CADTH's commitment to PPE with clear agency-wide roles and direction, values, and outcomes, a comprehensive framework, and policy and procedures. An acknowledgment of diverse epistemic traditions, as well as leadership and expertise in PPE, will strengthen CADTH's PPE activities and sustain its leadership position in the HTA field.

Introduction: The PIBD-classes criteria were developed to standardise the classification of children with inflammatory bowel disease [IBD], from Crohn's disease [CD], through IBD-unclassified [IBD-U], to typical ulcerative colitis [UC]. We aimed to further validate the criteria and to explore possible modifications., Methods: This was a multicentre retrospective cohort study of children diagnosed with IBD with at least 1 year of follow-up. Clinical, radiological, endoscopic, and histological data were recorded at diagnosis and latest follow-up, as well as the 23 items of the PIBD-classes criteria. The PIBD-classes criteria were assessed for redundant items, and a simplified algorithm was proposed and validated on the original derivation cohort from which the PIBD-classes algorithm was derived., Results: Of the 184 included children [age at diagnosis 13 ± 3 years, 55% males], 122 [66%] were diagnosed by the physician with CD, 17 [9%] with IBD-U, and 45 [25%] with UC. There was high agreement between physician-assigned and PIBD-classes generated diagnosis for CD [93%; eight patients moved to IBD-U] and for UC [84%; six moved to IBD-U and one to CD]. A simplified version of the algorithm with only 19 items is suggested, with comparable performance to the original algorithm [81% sensitivity and 81% specificity vs 78% and 83% for UC; and 79% and 95% vs 80% and 95% for CD, respectively]., Conclusions: The PIBD-classes algorithm is a useful tool to facilitate standardised objective classification of IBD subtypes in children. A modified version of the PIBD-classes maintains accuracy of classification with a simplified algorithm., (Copyright © 2020 European Crohn's and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

The development of refugee health policies is significant, given the increased volume of displaced persons seeking refuge in Canada and around the world. Changes to the Canadian refugee health policy, known as the Interim Federal Health Program (IFHP), limited healthcare access for refugees and refugee claimants from 2012 to 2016. In this article, we present a policy analysis using the case of the IFHP retrenchments to examine how political actors on opposing sides of the issue defined the problem using different causal story mechanisms. This analysis reveals that organized interests dramatically changed the problem definition of the IFHP reforms. Following their use of causal stories in redefining the problem, the courts declared that the reforms to refugee healthcare were a form of cruel and unusual treatment. Understanding policy strategies used by proponents of refugee healthcare coverage expansion is important for countries responding to the current, enduring refugee crisis., (Copyright © 2020 Longwoods Publishing.)

Objectives: This study's intent was to determine if a qualitative benefit risk framework could be used or modified to further enable Health Technology Reassessment (HTR) of prescription medicine recommendations. The purpose of this research was to understand Canadian Health Technology Agency assessors past experiences and insights to inform any modifications to the Universal Methodology for Benefit-Risk Assessment (UMBRA) qualitative framework. The UMBRA framework consists of an eight-step process, used during the assessment phase, to aid in decision making and dissemination., Methods: A qualitative descriptive study was conducted and included a purposeful, criterion-based sample of eight assessors who had participated in Health Technology Assessment (HTA) or HTR for prescription medicines or in qualitative decision-making frameworks., Results: Participant interviews lead to four common themes: "adoption of a qualitative benefit risk framework," "data (either too much or not enough)," "importance of incorporating stakeholder values," and "feasibility of the UMBRA framework." Methodological challenges with HTR were highlighted including the lack of clinical outcome data and the ability to compare clinically relevant meaningful differences. The implementation of a ranking or weighing process found within the UMBRA framework was not favored by half of the participants., Conclusions: Research participants did not consider all steps of the UMBRA framework to be transferable to the assessment phase of HTR given the need for simplicity, resource efficiency, and stakeholder input throughout the process. The assessor experiences and insights and the resultant key themes can be used in future research to aid in the development of a qualitative recommendation framework for HTR.

We conducted a review of research literature related to anxiety, depression, and mood problems in Indigenous women in Canada, the United States (including Hawaii), Australia, and New Zealand. Quantitative and qualitative research studies published between 1980 and March 2010 were reviewed. The initial search revealed 396 potential documents, and after being checked for relevance by two researchers, data were extracted from 16 quantitative studies, one qualitative research article, and one dissertation. Depression is a common problem in Indigenous pregnant and postpartum women; however, the prevalence and correlates of anxiety and mood disorders are understudied. The review identified four key areas where further research is needed: (a) longitudinal, population-based studies; (b) further validation and modification of appropriate screening tools; (c) exploration of cultural diversity and meaning of the lived experiences of antenatal and postpartum depression, anxiety, and mood disorders; and (d) development of evidence-informed practices for researchers and practitioners through collaborations with Aboriginal communities to better understand and improve mental health of women of childbearing age.

Health professionals working in humanitarian relief projects encounter a range of ethical challenges. Applying professional and ethical norms may be especially challenging in crisis settings where needs are elevated, resources scarce, and socio-political structures strained. Situations when clinicians must decide whether to provide care that is near the margins of their professional competency are a source of moral uncertainty that can give rise to moral distress. The authors suggest that responding ethically to these dilemmas requires more than familiarity with ethical codes of conduct and guidelines; it requires practical wisdom, that is, the ability to relate past experience and general guidance to a current situation in order to render a morally sound action. Two sets of questions are proposed to guide reflection and deliberation for clinicians who face competency dilemmas. The first is prospective and intended to aid clinicians in evaluating an unfolding situation. The second is retrospective and designed to support debriefing about past experiences and difficult situations. The aim of this analysis is to support clinicians in evaluating competency dilemmas and provide ethical care and services.

Background: Despite the mandate to examine the medical, ethical, and economic implications of the development and use of health technology, health technology assessment (HTA) reports often emphasize the epidemiologic and economic aspects, and omit ethical considerations. This study examines both whether and how ethical issues are incorporated into HTA., Objectives: We aim to (i) review a set of Canadian HTA reports for ethics content, (ii) describe the strategies used to incorporate ethically relevant information into HTA, and (iii) determine the presence of implicit ethical issues in a sample of HTA reports., Methods: Descriptive and qualitative content analysis of 608 HTA reports produced by six Canadian HTA agencies from January 1997 to December 2006., Results: We found that (i) a minority (17 percent) of Canadian HTA reports addressed ethical issues, (ii) secondary research predominates while primary analysis is rare, (iii) implicit ethical issues are present in HTA reports that do not purport to address ethics., Conclusions: Canadian HTA reports rarely explicitly, and then only superficially, address ethics, though implicit ethical issues abound.

Background: 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., Methods: We surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices., Results: We observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education., Conclusions: The heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive.

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: 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.

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.

Purpose: We describe issues and outcomes in the development of a specialized, central institutional review board (IRB) for multicenter oncology protocols. Numerous authoritative bodies have called for a change to the ethics review system to better manage multicenter trials in terms of quality, timeliness, and efficiency. In 2003, the American Society of Clinical Oncology proposed a network of regional IRBs for cancer. Previous experience with central IRBs has been met with mixed success., Methods: We took a bottom-up approach to organizing a province-wide IRB, which was led by an IRB chair and a clinical investigator at one cancer center. Participation on the part of institutions was voluntary., Results: Uptake in the first 2 years was modest and increased from 11 clinical trials in year 1 to 21 in year 2. In the third year, there was an apparent upsurge in the number of involved centers (14) and in the number of submitted clinical protocols (54)., Conclusion: Sponsors and investigators are loath to risk development of a novel IRB until there is a clear demonstration of quality, efficiency, and timeliness of decision. Development of a regional, specialized IRB requires considerable efforts to develop and maintain the trust of sponsors, investigators, and institutions despite prior demands for more efficient and timely ethics review. Voluntary institutional participation, clear delineation of roles and responsibilities, and effective execution promote development of this trust.

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.

Objectives: Our objective was to determine whether a strategy of intended incomplete percutaneous transluminal coronary angioplasty revascularization (IR) compromises long-term patient outcome., Background: Complete angioplasty revascularization (CR) is often not planned nor attempted in patients with multivessel coronary disease, and the extent to which this influences outcome is unclear., Methods: Before randomization, in the Bypass Angioplasty Revascularization Investigation, all angiograms were assessed for intended CR or IR via angioplasty. Outcomes were compared among patients with IR intended if assigned to angioplasty, randomized to coronary artery bypass graft surgery (CABG) versus angioplasty; and within angioplasty patients only, among patients with IR versus CR intended., Results: At 5 years, there was a trend for higher overall (88.6% vs. 84.0%) and cardiac survival (94.5% vs. 92.1%) in CABG versus angioplasty patients with IR intended. The excess mortality in angioplasty patients occurred solely in diabetic subjects; overall and cardiac survival were similar among nondiabetic CABG and angioplasty patients. Freedom from myocardial infarction (MI) at 5 years was higher in nondiabetic CABG versus angioplasty patients (92.4% vs. 85.2%, p = 0.02), vet was similar to the rate observed (85%) in nondiabetic CABG and angioplasty patients with CR intended. Five-year rates of death, cardiac death, repeat revascularization and angina were similar in all angioplasty patients with IR versus CR intended. However, a trend for greater freedom from subsequent CABG was seen in CR patients (70.3% vs. 64.0%, p = 0.08)., Conclusions: Intended incomplete angioplasty revascularization in nondiabetic patients with multivessel disease who are candidates for both angioplasty and CABG does not compromise long-term survival; however, subsequent need for CABG may be increased with this strategy. Whether the risk of long-term MI is also increased remains uncertain.

A cohort of 12,110 male workers employed 1 or more years in eight styrene-butadiene polymer (SBR) manufacturing plants in the United States and Canada has been followed for mortality over a 40-year period, 1943 to 1982. The all-cause mortality of these workers was low [standardized mortality ratio (SMR) = 0.81] compared to that of the general population. However, some specific sites of cancers had SMRs that exceeded 1.00. These sites were then examined by major work divisions. The sites of interest included leukemia and non-Hodgkin's lymphoma in whites. The SMRs for cancers of the digestive tract were higher than expected, especially esophageal cancer in whites and stomach cancer in blacks. The SMR for arteriosclerotic heart disease in black workers was significantly higher than would be expected based on general population rates. Employees were assigned to a work area based on job longest held. The SMRs for specific diseases differed by work area. Production workers showed increased SMRs for hematologic neoplasms and maintenance workers, for digestive cancers. A significant excess SMR for arteriosclerotic heart disease occurred only in black maintenance workers, although excess mortality from this disease occurred in blacks regardless of where they worked the longest. A significant excess SMR for rheumatic heart disease was associated with work in the combined, all-other work areas. For many causes of death, there were significant deficits in the SMRs.

Consecutive female admissions to the Winnipeg Remand Centre were studied and data concerning personal history, family background, psychological factors and mental health were recorded. An effort was made to determine a typical profile of female offenders and relate this to the alleged offences. Our data failed to identify what has been described by others as the "new female criminal".