Canada has an opportunity to address antimicrobial resistance through COVID-19 recovery spending.

Antimicrobial Resistance (AMR) causes more than a million deaths globally per year due to infections incurable with currently available antibiotics. Failing to effectively address AMR will have significant negative consequences for Canadians and the Canadian economy. Canada is behind on allocation of required funding and nationally coordinated AMR mitigation strategies relative to other high-income countries. A Pan-Canadian AMR action plan and development of a new governance model is pending. Recent AMR-specific funding commitments are significant but fall short while distribution of funds indicate a siloed approach. Canada could initiate progress towards AMR mitigation through incorporation within the scope of budget allocations intended for COVID-19 recovery and mitigation efforts. We discuss the following components for inclusion: development of infectious disease diagnostics and therapeutics; antimicrobial stewardship interventions in long-term care and Indigenous communities; environmental monitoring of AMR; comprehensive antimicrobial use, and AMR surveillance; and support for capacity-building in low and middle-income countries.

Knowledge, perspectives and health outcome expectations of antibiotic therapy in hospitalized patients.

Background: The World Health Organization (WHO) has recognized antimicrobial resistance (AMR) as a top threat to global health. However, the public has an incomplete understanding of AMR and its consequences. Aim: The aim of this study was to explore patients' understanding, perspective and health outcome expectations for antibiotic therapy within an inpatient internal medicine population. Methods: A mixed methods study, combining a cross-sectional survey with qualitative methods. Fourteen questions (10 paper survey and four open ended interview questions) were used, and were completed by the participant in one sitting. Participants were recruited from General Internal Medicine units at two academic hospitals in Canada (convenience sample). Findings: Thirty participants were included. Out of a scale of 1-100%, participants indicated moderate concern (mean of 40%) about getting an infection that could not be cured by antibiotics. The majority agreed that they trusted their healthcare team to decide on appropriate antibiotic therapy (mean of 81%). The participants strongly agreed (mean of 90%) that it was important to understand the rationale for their antibiotic therapy. Three themes emerged from the qualitative analysis: 1) varying levels of knowledge; 2) viewing antibiotics as beneficial while emphasizing effectiveness; and 3) trusting the healthcare team with expectations for inclusion in decision making. Conclusion: The study results showed varying levels of patients' antibiotic knowledge and large gaps in awareness related to AMR. Exploring the role and workflow of interdisciplinary healthcare professionals may be a potential strategy to minimize patients' knowledge gap related to antimicrobial therapy and AMR.

Inclusion of pregnant and breastfeeding women in nonobstetrical randomized controlled trials.

BACKGROUND: There is an urgent need to prioritize and expedite the inclusion of pregnant and breastfeeding women in research. Characterizing trials that have successfully included these populations could inform the design and execution of future studies. In addition, up-to-date data on their inclusion in clinical research could assist in setting benchmarks, establishing targets, and monitoring progress toward more equitable inclusion. OBJECTIVE: This study aimed to characterize the eligibility and enrollment of pregnant and breastfeeding women in randomized controlled trials evaluating interventions for nonobstetrical conditions experienced by, but not limited to, these populations. STUDY DESIGN: We developed a literature search in collaboration with an information specialist. We included randomized controlled trials published between 2017 and 2019 in the 5 highest-impact general medicine journals and the 3 highest-impact specialty journals in cardiovascular disease, critical care, general infectious diseases, HIV, and psychiatry. We included randomized controlled trials that evaluated screening, diagnosis, prevention, or treatment of nonobstetrical medical conditions. We excluded randomized controlled trials exclusively focused on males, pediatrics, geriatrics, oncology, or postmenopausal women, and publications reporting subgroup, pooled, or follow-up analyses of previously published randomized controlled trials. We screened titles and abstracts independently and in duplicate, with discrepancies resolved by a third reviewer. We entered data into a standardized electronic case report form. We reviewed study protocols, appendices, and trial registries for additional data. RESULTS: Of the 1333 randomized controlled trials, pregnant and breastfeeding women were eligible for 13 (1.0%) and 6 (0.5%), respectively. Pregnancy and breastfeeding eligibility criteria were not addressed in 383 of 1333 (28.7%) and 710 of 1333 (53.3%) randomized controlled trials, respectively. In total, 102 of 937 (10.9%) and 33 of 617 (5.3%) randomized controlled trials that explicitly excluded pregnant and breastfeeding women documented the rationale. Most studies excluding pregnant women (542/937; 57.8%) required at least 1 method of contraception and/or pregnancy testing as part of trial participation for women with reproductive capacity. Among the 13 randomized controlled trials that allowed inclusion of pregnant women, 3 restricted eligibility to specific trimesters. Two randomized controlled trials enrolled pregnant women after the first year of the study following interim review of safety results in nonpregnant participants. Four randomized controlled trials reported the number of pregnant women enrolled, which ranged from 0.7% to 3.4% of the study population. None of the studies reported on pregnancy or perinatal outcomes. Compared with randomized controlled trials that excluded pregnant women, those including them more commonly had an infectious disease focus (12/13 [92.3%] vs 270/937 [28.8%]; p<.0001), including HIV (5/13 [38.5%] vs 96/937 [10.2%]; p=.0079), enrolled participants in sub-Saharan Africa (5/13 [38.5%] vs 111/937 [11.8%]; p=.0143), and had exclusively nonindustry sponsorship (13/13 [100%] vs 559/937 [59.7%]; p=.0025); inclusion varied by study phase, randomization level, and intervention type. CONCLUSION: This study illustrates a major inequity in research involving pregnant and breastfeeding women. As new health challenges arise, including novel pandemics, and the research community mobilizes to develop therapies and innovate in patient care, it is crucial that pregnant and breastfeeding women not be left behind. Greater regulatory support, in the form of explicit requirements and incentives, will be needed to ensure these populations are integrated into the research agenda.

Characterizing the inclusion of pregnant and breastfeeding people in infectious diseases randomized controlled trials: a targeted literature review.

OBJECTIVES: Severe complications of infectious diseases can occur during pregnancy. Evidence-based prevention and treatment strategies are critical to improve maternal and neonatal health outcomes. Despite this medical need, pregnant and breastfeeding people have been systematically excluded from biomedical research. The objective of this study was to characterize representation of pregnant and breastfeeding people in randomized controlled trials (RCTs) evaluating a broad range of interventions for infectious diseases. METHODS: Pregnancy and breastfeeding inclusion criteria were examined in infectious diseases RCTs published between 1 January 2017, and 31 December 2019, in the top five highest impact general medicine and the top three highest impact infectious diseases and HIV journals. RESULTS: Of 376 RCTs, 5.3% and 1.9% included pregnant and breastfeeding people, respectively. Justification for exclusion was documented in 36/271 (13.3%) studies that explicitly excluded pregnant people. Most studies excluding pregnant people (177/271, 65.3%) required at least one form of contraception, abstinence and/or negative pregnancy test(s) as part of participation. Only 11/271 (4.1%) studies excluding pregnant people allowed participants to continue the intervention if unintended pregnancy occurred during the study. When both pregnant and non-pregnant people were eligible, pregnant people made up <3% of participants. Only 2/48 (4.2%) vaccine studies included pregnant people; 13/234 (5.5%) drug studies included pregnant people. All studies of procedures, devices, behaviour/education and supplements/vitamins explicitly excluded or did not address pregnancy eligibility criteria. Only 2/20 (10.0%) RCTs including pregnant people collected pharmacokinetic data. DISCUSSION: This study demonstrates widespread exclusion of pregnant and breastfeeding people from infectious disease RCTs.

Quality and Variability of Cardiovascular Rehabilitation Delivery: APPLYING THE CANADIAN QUALITY INDICATORS.

PURPOSE: Cardiac care, including cardiovascular rehabilitation (CR), is most effective if it is high-quality. The aim of this study was to describe CR quality, using the recently developed Canadian Cardiovascular Society CR quality indicators (QIs). Difference in quality between CR sites was also assessed. METHODS: Secondary analysis was conducted on an observational, prospective, multisite CR program evaluation cohort. A convenience sample of patients from 1 of 3 CR programs was approached at their first CR visit, and consenting participants completed a survey. Clinical data were extracted from charts pre- and postprogram. Of the 30 CR QIs, 21 (70.0%) were assessable: 10 process, 9 outcome, and 2 structure QIs. RESULTS: Of 411 consenting patients, 209 (53.0%) completed CR. The greatest quality was observed for assessment of blood pressure (98.1%), communication with primary health care at CR discharge (94.2%), and patient enrollment (94.0%). The lowest quality was observed for wait time from hospital discharge (9.2%), assessments of blood glucose (42.1%), and lipid control (53.0%). Of the 7 QIs that had an established benchmark, quality for 2 (28.6%) was above the benchmark (particularly assessment of blood pressure). Significant between-site differences were observed in 11 (64.7%) QIs. The magnitude of quality differences between sites was largest for assessment of lipid control (72.6%), assessment of blood glucose control (69.0%), and wait time in median days from referral to enrollment (30.6 days). CONCLUSION: There is wide variability in CR program quality, both overall and between CR sites. Quality improvement in particular aspects of CR care is required.

The quality of cardiac rehabilitation in Canada: a report of the Canadian Cardiac Rehab Registry.

Cardiac rehabilitation (CR) significantly reduces morbidity and mortality compared with usual care. CR quality indicators (QIs) have recently been established in Canada. This article presents an assessment of real-world CR program achievement of process and outcome QIs in Canada, using the Canadian Cardiac Rehab Registry (CCRR). The CR QIs were developed through the Canadian Cardiovascular Society's Best Practice Methodology. After reconciling the QI with CCRR definitions, it was identified that 14 (46.7%) of the 30 QIs could be assessed through the CCRR. There were 5447 patient records from 11 CR programs in the CCRR. Wait times exceeded the 30-day QI target, at a median of 84 days from referral to enrollment. Assessment of QIs of blood pressure (90%) and adiposity (85%) were high, however assessment of QIs for lipids (41%), blood glucose among patients with diabetes (23%), and depression overall (13%) were low. A majority of the participants (68%) achieved the half metabolic equivalent increase in the exercise capacity QI from CR program entry to exit. Of smokers, only 61% were offered smoking cessation therapy. Thirty percent of participants were offered stress management. The CR program completion QI was met in 90% of patients. Areas for care and quality improvement have been identified for the CR community in Canada. Efforts to engage more CR programs assess a greater number of QIs, and to feed back the findings to participating programs quarterly are currently under way.

Pan-Canadian development of cardiac rehabilitation and secondary prevention quality indicators.

The Canadian Cardiovascular Society (CCS) is implementing the Canadian Heart Health Strategy and Action Plan recommendation to build knowledge infrastructure, through its Data Definitions and Quality Indicator (QI) project. The CCS selected cardiac rehabilitation (CR) and secondary prevention as a content area for QI development. In accordance with the CCS QI Best Practice Methodology, rapid reviews of the literature were conducted. A long list of 37 QIs, in the areas of structure, process, and outcome were developed. Through an online survey, 26 (42%) of all contacted external experts rated each QI on importance, scientific acceptability, and feasibility, using a 7-point scale. The overall mean rating was 5.4 ± 1.4. Through a consensus process, the working group excluded 8 QIs based on this feedback, and several others were revised. A 30-day Web consultation was then undertaken, to solicit input from the broader CCS and CR community. A "top 5" list of QIs was requested by the CCS, which were: (1) inpatients referred to CR; (2) wait times from referral to CR enrollment; (3) patient self-management education; (4) increase in exercise capacity; and (5) emergency response strategy. Knowledge translation activities are now under way to promote utilization of the QIs and ultimately improve CR care.