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We were tasked by Canada's COVID-19 Immunity Task Force to describe severe adverse events (SAEs) associated with emergency department (ED) visits and/or hospitalizations in individuals with immune-mediated inflammatory diseases (IMIDs). At eight Canadian centres, data were collected from adults with rheumatoid arthritis (RA), axial spondyloarthritis (AxS), systemic lupus (SLE), psoriatic arthritis (PsA), and inflammatory bowel disease (IBD). We administered questionnaires, analyzing SAEs experienced within 31 days following SARS-CoV-2 vaccination. About two-thirds (63%) of 1556 participants were female; the mean age was 52.5 years. The BNT162b2 (Pfizer) vaccine was the most common, with mRNA-1273 (Moderna) being second. A total of 49% of participants had IBD, 27.4% had RA, 14.3% had PsA, 5.3% had SpA, and 4% had SLE. Twelve (0.77% of 1556 participants) SAEs leading to an ED visit or hospitalization were self-reported, occurring in 11 participants. SAEs included six (0.39% of 1556 participants) ED visits (including one due to Bell's Palsy 31 days after first vaccination) and six (0.39% of 1556 participants) hospitalizations (including one due to Guillain-Barré syndrome 15 days after the first vaccination). Two SAEs included pericarditis, one involved SLE (considered a serious disease flare), and one involved RA. Thus, in the 31 days after SARS-CoV-2 vaccination in our IMID sample, very few serious adverse events occurred. As SARS-CoV2 continues to be a common cause of death, our findings may help optimize vaccination acceptance. [ABSTRACT FROM AUTHOR]

Background: Given the limited access to invasive vasospastic reactivity testing in Western Countries, there is a need to further develop alternative non‐invasive diagnostic methods for vasospastic angina (VSA). Hyperventilation testing (HVT) is defined as a class IIa recommendation to diagnose VSA by the Japanese Society of Cardiology. Methods: In this systematic review and meta‐analysis reported according to the PRISMA statement, we review the mechanisms, methods, modalities and diagnostic accuracy of non‐invasive HVT for the diagnostic of VSA. Results: A total of 106 articles published between 1980 and 2022 about VSA and HVT were included in the systematic review, among which 16 were included in the meta‐analysis for diagnostic accuracy. Twelve electrocardiogram‐HVT studies including 804 patients showed a pooled sensitivity of 54% (95% confidence intervals [CI]; 30%–76%) and a pooled specificity of 99% (95% CI; 88%–100%). Four transthoracic echocardiography‐HVT studies including 197 patients revealed a pooled sensitivity of 90% (95% CI; 82%–94%) and a pooled specificity of 98% (95% CI; 86%–100%). Six myocardial perfusion imaging‐HVT studies including 112 patients yielded a pooled sensitivity of 95% (95% CI; 63%–100%) and a pooled specificity of 78% (95% CI; 19%–98%). Non‐invasive HVT resulted in a low rate of adverse events, ventricular arrhythmias being the most frequently reported, and were resolved with the administration of nitroglycerin. Conclusions: Non‐invasive HVT offers a safe alternative with high diagnostic accuracy to diagnose VSA in patients with otherwise undiagnosed causes of chest pain. [ABSTRACT FROM AUTHOR]

BackgroundA large proportion of surgical patient harm is preventable; yet, our ability to systematically learn from these incidents and improve clinical practice remains limited. The Operating Room Black Box was developed to address the need for comprehensive assessments of clinical performance in the operating room. It captures synchronized audio, video, patient, and environmental clinical data in real time, which are subsequently analyzed by a combination of expert raters and software-based algorithms. Despite its significant potential to facilitate research and practice improvement, there are many potential implementation challenges at the institutional, clinician, and patient level. This paper summarizes our approach to implementation of the Operating Room Black Box at a large academic Canadian center. ObjectiveWe aimed to contribute to the development of evidence-based best practices for implementing innovative technology in the operating room for direct observation of the clinical performance by using the case of the Operating Room Black Box. Specifically, we outline the systematic approach to the Operating Room Black Box implementation undertaken at our center. MethodsOur implementation approach included seeking support from hospital leadership; building frontline support and a team of champions among patients, nurses, anesthesiologists, and surgeons; accounting for stakeholder perceptions using theory-informed qualitative interviews; engaging patients; and documenting the implementation process, including barriers and facilitators, using the consolidated framework for implementation research. ResultsDuring the 12-month implementation period, we conducted 23 stakeholder engagement activities with over 200 participants. We recruited 10 clinician champions representing nursing, anesthesia, and surgery. We formally interviewed 15 patients and 17 perioperative clinicians and identified key themes to include in an information campaign run as part of the implementation process. Two patient partners were engaged and advised on communications as well as grant and protocol development. Many anticipated and unanticipated challenges were encountered at all levels. Implementation was ultimately successful, with the Operating Room Black Box installed in August 2018, and data collection beginning shortly thereafter. ConclusionsThis paper represents the first step toward evidence-guided implementation of technologies for direct observation of performance for research and quality improvement in surgery. With technology increasingly being used in health care settings, the health care community should aim to optimize implementation processes in the best interest of health care professionals and patients.

This study aims to investigate the effect of antipsychotic agents on cardiovascular and cerebrovascular diseases (CVD/CEV) and mortality risks in the older population living in a community. A cohort of 42,650 new users of antipsychotic agents was built using Quebec healthcare databases (1998–2011). The outcomes were CVD/CEV and mortality incidence in 5 years of follow-up in the total cohort, sub-cohort of patients with no schizophrenia/dementia, sub-cohort with schizophrenia, and sub-cohort with dementia. Comparisons were made between the new users who continued the treatment (adherent level ≥ 60%) vs. those ceasing treatment (adherence level < 60%) using inverse probability of treatment weighting and Cox models. Comparing high adherence vs. low levels, CVD/CEV risk was increased by 36% in the sub-cohort with schizophrenia for atypical antipsychotic users and by 25% in the sub-cohort with dementia for typical antipsychotic users. An increasing mortality risk of 2- to 3-fold was linked with the typical antipsychotic use in all cohorts except the sub-cohort with schizophrenia; in addition, mortality risk is linked with the use of high vs. low doses. Antipsychotics were not linked with CVD/CEV risk, except for atypical antipsychotics in patients with schizophrenia and typical antipsychotics in patients with dementia. The mortality risk was linked with the use of typical antipsychotics and the dose used. [ABSTRACT FROM AUTHOR]

Aim: To understand the postpartum care received by birthing people with disabilities and their newborns, from their own perspectives. Design: A qualitative study with semi‐structured interviews. Methods: Between July 2019 and February 2020, in‐person and virtual interviews were conducted with 31 people with physical, sensory, and intellectual/developmental disabilities in Ontario, Canada, about the formal inpatient and outpatient services and supports they used in the first few months after they gave birth. Thematic analysis was used identify common themes. Results: We identified three overall themes concerning participants' postpartum care experiences and the different types of formal services received in and out of hospital: (1) lack of adequate care, (2) lack of provider awareness of disability and disability accommodations, and (3) fear of judgement, discrimination, and intrusive surveillance. The identified themes were applicable across disability groups. However, most comments on disability accommodations came from participants with physical or sensory disabilities, while participants with intellectual/developmental disabilities most commonly reported concerns about lack of adequate care and fear of judgement, discrimination, and intrusive surveillance. Conclusion: Findings indicate that postpartum care often fails people with disabilities. This could contribute to negative health consequences for them and their newborns. Impact: Birthing people with disabilities need multidisciplinary, proactive, and strengths‐based postpartum care to mitigate risk for health complications. Further, disability‐related training and guidelines for health and social service providers is required. Reporting method: Consolidated criteria for reporting qualitative research (COREQ). Patient or Public contribution: Our research team included two peer researchers with physical disabilities who served as co‐interviewers and participated in data analysis, contributing their lived experience of disability and interactions with the health care system. All stages of the study were also informed by feedback from the study's Advisory Committee, which comprised women with disabilities (many of whom are parents), disability organization staff, clinicians, and policy representatives. [ABSTRACT FROM AUTHOR]

The aim was to identify sex‐specific factors linked with oral anticoagulant initiation in a cohort of patients with atrial fibrillation using administrative data from Quebec (Canada) between 2014 and 2017. Cohort entry defined as new users, that is, no claims in last 12 months, a cohort of 32 050 patients was stratified in two groups, that is, women and men. Multivariable regression models were used to identify factors of initiations for low‐ and standard‐dose direct oral anticoagulants (DOACs) versus warfarin, and low‐ versus standard‐dose DOACs. In both sexes, warfarin initiation decreased and DOAC initiation increased, with year of initiation as major factors of DOACs use. In 2017, the increase was of 2‐ to 4‐fold and 3‐ to 8‐fold for low‐ and standard‐dose DOACs (vs. warfarin), respectively. The proportion of patients starting on a low‐dose DOAC was higher in women than men. Older age for both sexes and CHADS2 score ≥2 (only women) were major factors of low‐dose dabigatran and rivaroxaban versus warfarin use. The only significant factor of standard‐dose DOAC versus warfarin use was age of 65–79 for women or men treated with apixaban by 1.8‐ and 1.4‐fold, respectively. Factors that made women and men less likely to receive a standard‐dose DOAC versus warfarin were higher CHADS2 (for dabigatran and rivaroxaban), HAS‐BLED and frailty scores, prior coronary disease, major bleeding, and chronic kidney disease (CKD) status. The choice of a low‐ versus standard‐dose DOAC was mainly driven by age and CKD, and higher CHADS2 score (for dabigatran and apixaban) for both sexes. [ABSTRACT FROM AUTHOR]

Background: Surgery is one of the most common patient experiences in the health care system. Yet, efforts to engage patients in surgical safety research have not matched those of other health care fields. This is a critical issue given the nature of surgery inhibits patients' abilities to advocate for themselves as they are typically under anesthetic when the procedure is performed. We partnered with patients throughout our research program, which uses the Operating Room Black Box® to enhance surgical patient safety through transparent and proactive analysis of human factors to detect and prevent avoidable errors. Main body: In this article, we outline the need for, and our approach to, patient engagement in surgical safety research. Our approach included a series of planned activities and skill development opportunities designed to build capacity and bring together patients, clinicians, and researchers to inform research and practice. We also conducted evaluation surveys during the first year of our program, which have indicated a positive experience by both patient partners and the research team. Conclusion: We believe our approach can serve as an important first step toward building a model for patient engagement in the surgical safety field and could significantly contribute to improved quality of care and outcomes for surgical patients. Plain English summary: Although surgery is one of the most common patient experiences, patients have not been engaged in surgical safety research. Patients were engaged as patient advisors in the use of the Operating Room Black Box® at The Ottawa Hospital. The Operating Room Black Box® is a tool that is used in the operating room (OR) which captures audio, video, patient vital signs and other information that are analyzed for research purposes. The aim of the OR Black Box® is to learn from experience and improve practice and care. Patient advisors influenced the nature of the activities undertaken, co-developed the communication materials for patients, evaluated patient engagement practices, and disseminated the research results. These patient engagement activities are an important first step in engaging patients in surgical safety research. [ABSTRACT FROM AUTHOR]

Objectives To understand the perspectives of patients and rheumatologists for tapering DMARDs in RA. Methods Using semi-structured interview guides, we conducted individual interviews and focus groups with RA patients and rheumatologists, which were audiotaped and transcribed. We conducted a pragmatic thematic analysis to identify major themes, comparing and contrasting different views on DMARD tapering between patients and rheumatologists. Results We recruited 28 adult patients with RA (64% women; disease duration 1–54 y) and 23 rheumatologists (52% women). Attitudes across both groups towards tapering DMARDs were ambivalent, ranging from wary to enthusiastic. Both groups expressed concerns, particularly the inability to 'recapture' the same level of disease control, while also acknowledging potential positive outcomes such as reduced drug harms. Patient tapering perspectives (whether to and when) changed over time and commonly included non-biologic DMARDs. Patient preferences were influenced by lived experiences, side effects, previous tapering experiences, disease trajectory, remission duration and current life roles. Rheumatologists' perspectives varied on timing and patient profile to initiate tapering, and were informed by both data and clinical experience. Patients expressed interest in shared decision-making (SDM) and close monitoring during tapering, with ready access to their health-care team if problems arose. Rheumatologists were generally open to tapering (not stopping), though sometimes only when requested by their patients. Conclusion The perspectives of patients and rheumatologists on tapering DMARDs in RA vary and evolve over time. Rheumatologists should periodically discuss DMARD tapering with patients as part of SDM, and ensure monitoring and flare management plans are in place. [ABSTRACT FROM AUTHOR]

Background: Several Canadian provinces have introduced reimbursement policies mandating substitution of innovator biologics with lower-cost biosimilars. We estimated the number of patients affected and cost implications if such policy changes were to be implemented in Ontario, Canada. Methods: We conducted a cross-sectional time series analysis of Ontarians dispensed publicly funded biologics indicated for inflammatory diseases (rheumatic conditions, inflammatory bowel disease: infliximab, etanercept, adalimumab) between January 2018 and December 2019, and forecasted trends to Dec. 31, 2020. The primary source of data was pharmacy claims data for all biologics reimbursed by the public drug program. We modelled the number of patients affected and government expenditures (in nominal Canadian dollars) of several biosimilar policy options, including mandatory nonmedical biosimilar substitution, substitution in new users, introduction of a biosimilar for adalimumab, and price negotiations. In a secondary analysis, we included insulin glargine. Results: In 2018, 14 089 individuals were prescribed a publicly funded biologic for inflammatory diseases. A mandatory nonmedical biosimilar substitution would potentially have affected 7209 patients and saved $238.6 million from 2018 to 2020. A new-user substitution would have affected 757 patients and saved $34.2 million. If an adalimumab biosimilar were to become available, 12 928 patients would be affected by a mandatory nonmedical substitution and the 3-year savings would increase to $645.9 million (all biosimilars priced at 25% of innovator biologics). Finally, an expanded nonmedical substitution policy including insulin glargine would affect 115 895 patients and save $288.7 million (not including adalimumab). Interpretation: Policies designed to curb rising costs of biologics can have substantially different effects on patients and government expenditures. Such analyses warrant careful consideration of the balance between cost savings and effects on patients. [ABSTRACT FROM AUTHOR]

Objective Partners of patients with RA often take on supportive roles given the debilitating nature of RA. Our objective was to explore the perspectives, attitudes and experiences of partners of female patients with RA regarding reproductive experiences and decision-making. Methods We conducted a qualitative study involving semi-structured interviews with partners of female patients with RA. We defined a partner as an individual within a romantic relationship. Constructivist grounded theory was applied to interview transcripts to identify and conceptualize themes. Results We interviewed 10 partners of female patients with RA (10 males; mean age, 35 [23–56] years), of whom 40% had at least one child with a female patient with RA and did not desire additional children. We identified four themes representing stages of reproductive decision-making: (1) developing an understanding of RA, (2) contemplating future family decision-making, (3) initiating reproductive decision-making with partner, and (4) reflecting on past reproductive experiences. Participants contemplated their attitudes and perspectives regarding pregnancy and used available information to support their partner's medication decisions. When reflecting on their reproductive experiences, participants shared the impacts of past reproductive decisions on their romantic relationship and their mental health and wellbeing. Conclusion Our study highlights the need for comprehensive support for both female patients with RA and their partners at all stages of reproductive decision-making. Health-care providers can identify opportunities for intervention that involves female patients with RA and their partners to minimize stress and its negative impacts on the family. [ABSTRACT FROM AUTHOR]