Publications by authors named "Louise Pilote"

292 Publications

Adaptive web-based stress management programs among adults with a cardiovascular disease: A pilot Sequential Multiple Assignment Randomized Trial (SMART).

Patient Educ Couns 2021 Oct 23. Epub 2021 Oct 23.

St. Mary's Research Centre, 3830 Lacombe Ave., Hayes Pavilion, Suite 4720, Montreal, Quebec, Canada H3T 1M5; Montreal West Island Integrated University Health and Social Services Centre (CIUSSS-ODIM), 3830 Lacombe Ave., Montreal, Quebec, Canada H3T 1M5.

Objective: To assess the feasibility and acceptability of using a Sequential Multiple Assignment Randomized Trial (SMART) to optimize the delivery of a web-based, stress management intervention for patients with a cardiovascular disease (CVD).

Methods: 59 patients with a CVD and moderate stress were randomized to a self-directed web-based stress management program (n = 30) or the same intervention plus lay telephone coaching (n = 29). After 6 weeks, non-responders were re-randomized to continue with their initial intervention or switched to motivational interviewing (MI). Feasibility, acceptability, and clinical significance were assessed.

Results: SMART procedures were feasible. Attrition rates were almost twice as high in the web-only group than the lay coach group. This might be because of the low satisfaction (47%) in the web-only group. On average, 1.7/5 modules were completed. Effect sizes for stress and quality of life generally exceeded 0.2 (clinical benchmark), except for the group that initially received lay coaching and then switched to MI.

Conclusions: Results suggest that a larger trial would be feasible. Issues pertaining to attrition and satisfaction for non-responders need to be addressed.

Practice Implications: Findings contribute to the evidence on how best to develop and deliver e-Health interventions to maximize their efficacy while remaining cost-effective.
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http://dx.doi.org/10.1016/j.pec.2021.10.020DOI Listing
October 2021

Variations in Quality of Care by Sex and Social Determinants of Health Among Younger Adults With Acute Myocardial Infarction in the US and Canada.

JAMA Netw Open 2021 Oct 1;4(10):e2128182. Epub 2021 Oct 1.

Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut.

Importance: Quality of care of young adults with acute myocardial infarction (AMI) may depend on health care systems in addition to individual-level factors such as biological sex and social determinants of health (SDOH).

Objective: To examine whether the quality of in-hospital and postacute care among young adults with AMI differs between the US and Canada and whether female sex and adverse SDOH are associated with a low quality of care.

Design, Setting, And Participants: This retrospective cohort analysis used data from 2 large cohorts of young adults (aged ≤55 years) receiving in-hospital and outpatient care for AMI at 127 centers in the US and Canada. Data were collected from August 21, 2008, to April 30, 2013, and analyzed from July 12, 2019, to March 10, 2021.

Exposures: Sex, SDOH, and health care system.

Main Outcomes And Measures: Opportunity-based quality-of-care score (QCS), determined by dividing the total number of quality indicators of care received by the total number for which the patient was eligible, with low quality of care defined as the lowest tertile of the QCS.

Results: A total of 4048 adults with AMI (2345 women [57.9%]; median age, 49 [interquartile range, 44-52] years; 3004 [74.2%] in the US) were included in the analysis. Of 3416 patients with in-hospital QCS available, 1061 (31.1%) received a low QCS, including more women compared with men (725 of 2007 [36.1%] vs 336 of 1409 [23.8%]; P < .001) and more patients treated in the US vs Canada (962 of 2646 [36.4%] vs 99 of 770 [12.9%]; P < .001). Conversely, low quality of post-AMI care (748 of 2938 [25.5%]) was similarly observed for both sexes, with a higher prevalence in the US (678 of 2346 [28.9%] vs 70 of 592 [11.8%]). In adjusted analyses, female sex was not associated with low QCS for in-hospital (odds ratio [OR], 1.05; 95% CI, 0.87-1.28) and post-AMI (OR, 1.07; 95% CI, 0.88-1.30) care. Conversely, being treated in the US was associated with low in-hospital (OR, 2.93; 95% CI, 2.16-3.99) and post-AMI (OR, 2.67; 95% CI, 1.97-3.63) QCS, regardless of sex. Of all SDOH, only employment was associated with higher quality of in-hospital care (OR, 0.72; 95% CI, 0.59-0.88). Finally, only in the US, low quality of in-hospital care was associated with a higher 1-year cardiac readmissions rate (234 of 962 [24.3%]).

Conclusions And Relevance: These findings suggest that beyond sex, health care systems and SDOH that depict social vulnerability are associated with quality of AMI care. Taking into account SDOH among young adults with AMI may improve quality of care and reduce readmissions, especially in the US.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.28182DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8529414PMC
October 2021

Sex, rurality and socioeconomical status in Spanish centennial population (2017).

Aging (Albany NY) 2021 09 26;13(18):22059-22077. Epub 2021 Sep 26.

Clinical and Experimental Neuroscience (NiCE), Institute for Aging Research, Biomedical Institute for Bio-Health Research of Murcia (IMIB-Arrixaca), School of Medicine, University of Murcia, Campus Mare Nostrum, Murcia, Spain.

World's population is exponentially aging as people reaching 100 years old has increased. The number of areas with the highest centennial population rates (Blue Zones), are significantly higher. Are there any determinant factors that favor this situation in Spain? The goal of this study was to determine the possible influence of sex, rurality and socioeconomic factors (Gross Domestic Product (GDP)) on the prevalence of the centennial population of the Spanish society. The Spanish register of inhabitants was published in 2017 by the National Statistics Institute. The analysis was carried out both by Autonomous Communities and by provinces in phases: a first descriptive analysis, followed by an inferential analysis, based on statistical tests (independent T- Student test, Pearson correlation and ANOVA). There were significant interactions between: i) sex and longevity (in favor of the female population); ii) female and rural housing and iii) female, GDP and urban areas. Feminization was proven in the longevity revolution, but, in general, GDP per Capita was not a significant survival factor on its own. This study was the first step of further analysis related to extreme longevity in Spain, which will include other dependent variables such as state of health and well-being as well as social factors.
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http://dx.doi.org/10.18632/aging.203563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8507300PMC
September 2021

Vaccine hesitancy: evidence from an adverse events following immunization database, and the role of cognitive biases.

BMC Public Health 2021 09 16;21(1):1686. Epub 2021 Sep 16.

Centre for Outcomes Research and Evaluation, McGill University, 5252 De Maisonneuve Blvd, Montreal, Quebec, H4A 3S5, Canada.

Background: Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process.

Methods: First, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM).

Results: Our results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people's vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy.

Conclusions: This paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases.
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http://dx.doi.org/10.1186/s12889-021-11745-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444164PMC
September 2021

Role of GDF-15, YKL-40 and MMP 9 in patients with end-stage kidney disease: focus on sex-specific associations with vascular outcomes and all-cause mortality.

Biol Sex Differ 2021 09 15;12(1):50. Epub 2021 Sep 15.

Division of Renal Medicine, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.

Background: Sex differences are underappreciated in the current understanding of cardiovascular disease (CVD) in association with chronic kidney disease (CKD). A hallmark of CKD is vascular aging that is characterised, amongst others, by; systemic inflammation, microbiota disbalance, oxidative stress, and vascular calcification-features linked to atherosclerosis/arteriosclerosis development. Thus, it is the necessary to introduce novel biomarkers related to athero-/arteriosclerotic damage for better assessment of vascular ageing in patients CKD. However, little is known about the relationship between uraemia and novel CVD biomarkers, such as growth differentiation factor-15 (GDF-15), cartilage glycoprotein-39 (YKL-40) and matrix metalloproteinase-9 (MMP-9). Therefore, we hypothesise that there are sex-specific relationships between GDF-15, YKL-40, MMP-9 levels in end-stage kidney disease (ESKD) patients in relation to gut microbiota, vascular calcification, inflammation, comorbidities, and all-cause mortality.

Methods: ESKD patients, males (n = 151) and females (n = 79), not receiving renal replacement therapy were selected from two ongoing prospective ESKD cohorts. GDF-15, YKL-40 and MMP9 were analysed using enzyme-linked immunosorbent assay kits. Biomarker levels were analysed in the context of gut microbiota-derived trimethylamine N-oxide (TMAO), vascular calcification, inflammatory response, oxidative stress, comorbidities, and all-cause mortality.

Results: Increased GDF-15 correlated with higher TMAO in females only, and with higher coronary artery calcification and IL-6. In females, diabetes was associated with elevated GDF-15 and MMP-9, whilst males with diabetes only had elevated GDF-15. No associations were found between biomarkers and CVD comorbidity. Deceased males and females had higher GDF-15 concentrations (p = 0.01 and p < 0.001, respectively), meanwhile only YKL-40 was increased in deceased males (p = 0.02).

Conclusions: In conclusion, in males GDF-15 and YKL-40 were related to vascular calcification, inflammation, and oxidative stress, whilst in females GDF-15 was related to TMAO. Increased levels of YKL-40 and GDF-15 in males, and only GDF-15 in females, were associated with all-cause mortality. Our findings suggest that sex-specific associations of novel CVD biomarkers have a potential to affect development of cardiovascular complications in patients with ESKD.
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http://dx.doi.org/10.1186/s13293-021-00393-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444580PMC
September 2021

Development and Validation of a Risk Prediction Model for 1-Year Readmission Among Young Adults Hospitalized for Acute Myocardial Infarction.

J Am Heart Assoc 2021 09 13;10(18):e021047. Epub 2021 Sep 13.

Program on Aging Department of Internal Medicine Yale School of Medicine New Haven CT.

Background Readmission over the first year following hospitalization for acute myocardial infarction (AMI) is common among younger adults (≤55 years). Our aim was to develop/validate a risk prediction model that considered a broad range of factors for readmission within 1 year. Methods and Results We used data from the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study, which enrolled young adults aged 18 to 55 years hospitalized with AMI across 103 US hospitals (N=2979). The primary outcome was ≥1 all-cause readmissions within 1 year of hospital discharge. Bayesian model averaging was used to select the risk model. The mean age of participants was 47.1 years, 67.4% were women, and 23.2% were Black. Within 1 year of discharge for AMI, 905 (30.4%) of participants were readmitted and were more likely to be female, Black, and nonmarried. The final risk model consisted of 10 predictors: depressive symptoms (odds ratio [OR], 1.03; 95% CI, 1.01-1.05), better physical health (OR, 0.98; 95% CI, 0.97-0.99), in-hospital complication of heart failure (OR, 1.44; 95% CI, 0.99-2.08), chronic obstructive pulmomary disease (OR, 1.29; 95% CI, 0.96-1.74), diabetes mellitus (OR, 1.23; 95% CI, 1.00-1.52), female sex (OR, 1.31; 95% CI, 1.05-1.65), low income (OR, 1.13; 95% CI, 0.89-1.42), prior AMI (OR, 1.47; 95% CI, 1.15-1.87), in-hospital length of stay (OR, 1.13; 95% CI, 1.04-1.23), and being employed (OR, 0.88; 95% CI, 0.69-1.12). The model had excellent calibration and modest discrimination (C statistic=0.67 in development/validation cohorts). Conclusions Women and those with a prior AMI, increased depressive symptoms, longer inpatient length of stay and diabetes may be more likely to be readmitted. Notably, several predictors of readmission were psychosocial characteristics rather than markers of AMI severity. This finding may inform the development of interventions to reduce readmissions in young patients with AMI.
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http://dx.doi.org/10.1161/JAHA.121.021047DOI Listing
September 2021

Impact of Race on the In-Hospital Quality of Care Among Young Adults With Acute Myocardial Infarction.

J Am Heart Assoc 2021 09 25;10(17):e021408. Epub 2021 Aug 25.

Department of Emergency Medicine University School of Medicine New Haven CT.

Background The extent to which race influences in-hospital quality of care for young adults (≤55 years) with acute myocardial infarction (AMI) is largely unknown. We examined racial disparities in in-hospital quality of AMI care and their impact on 1-year cardiac readmission. Methods and Results We used data from the VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) study enrolling young Black and White US adults with AMI (2008-2012). An in-hospital quality of care score (QCS) was computed (standard AMI quality indicators divided by the total a patient is eligible for). Multivariable logistic regression was performed to identify factors associated with the lowest QCS tertile, including interactions between race and social determinants of health. Among 2846 young adults with AMI (median 48 years [interquartile range 44-52], 67.4% women, 18.8% Black race), Black individuals, especially women, exhibited a higher prevalence of cardiac risk factors and social determinants of health and were more likely to experience a non-ST-segment-elevation myocardial infarction than White individuals. Black individuals were more likely in the lowest QCS tertile than White individuals (40.8% versus 34.7%; =0.003). The association between Black race and low QCS (odds ratio [OR], 1.25; 95% CI, 1.02-1.54) was attenuated by adjustment for confounders. Employment was independently associated with better QCS, especially among Black participants (OR, 0.76; 95% CI, 0.62-0.92; P-=0.02). Black individuals experienced a higher rate of 1-year cardiac readmission (29.9% versus 20.0%; <0.0001). Conclusions Black individuals with AMI received lower in-hospital quality of care and exhibited a higher rate of cardiac readmissions than White individuals. Black individuals had a lower quality of care if unemployed, highlighting the intersection of race and social determinants of health.
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http://dx.doi.org/10.1161/JAHA.121.021408DOI Listing
September 2021

Relative effectiveness of influenza vaccines in elderly persons in the United States, 2012/2013-2017/2018 seasons.

NPJ Vaccines 2021 Aug 24;6(1):108. Epub 2021 Aug 24.

Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, QC, H4A 3S5, Canada.

Influenza immunization protects seniors against influenza and its potentially serious complications. It is uncertain whether standard-dose (SD) quadrivalent vaccine offers better protection over other formulations in the elderly. In this study, we compared the effectiveness of SD-trivalent, high-dose (HD) trivalent, SD-quadrivalent, and adjuvanted trivalent vaccines in seniors (≥65 years) in a real-world setting. We selected over 200,000 individuals in each of 6 influenza seasons from 2012 to 2018 using MarketScan® databases. The two outcomes were hospitalization or emergency room (ER) visit due to (1) influenza or (2) pneumonia. Here, SD-quadrivalent was associated with higher risk of influenza-related hospitalization/ER visit (adjusted hazard ratio (aHR) 1.14 and 95% confidence interval (95% CI) 1.05-1.24) and of pneumonia-related hospitalization/ER visit (aHR 1.04 and 95% CI 1.01-1.07) vs. HD-trivalent. SD-trivalent followed similar trends compared to HD-trivalent (aHR 1.16 and 95% CI 1.06-1.27 for hospitalized/ER visit influenza; aHR 1.07 and 95% CI 1.05-1.10 for hospitalized/ER visit pneumonia). We could not demonstrate risk differences between SD vaccine formulations and between adjuvanted trivalent and one of the other three vaccines. Risk estimates slightly varied across seasons. These findings suggest that SD vaccine formulations vs. HD-trivalent were associated with higher risk of hospitalization/ER visit for influenza and pneumonia in seniors.
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http://dx.doi.org/10.1038/s41541-021-00373-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385076PMC
August 2021

Determinants of perceived health and unmet healthcare needs in universal healthcare systems with high gender equality.

BMC Public Health 2021 07 31;21(1):1488. Epub 2021 Jul 31.

Research Institute of McGill University Health Centre, Division of Clinical Epidemiology McGill University, Montreal, Canada.

Background: Patient attitudes about health and healthcare have emerged as important outcomes to assess in clinical studies. Gender is increasingly recognized as an intersectional social construct that may influence health. Our objective was to determine potential sex differences in self-reported overall health and access to healthcare and whether those differences are influenced by individual social factors in two relatively similar countries.

Methods: Two public health surveys from countries with high gender equality (measured by UN GII) and universal healthcare systems, Canada (CCHS2014, n = 57,041) and Austria (AT-HIS2014, n = 15,212), were analysed. Perceived health was assessed on a scale of 1 (very bad) to 4 (very good) and perceived unmet healthcare needs was reported as a dichotomous variable (yes/no). Interactions between sex and social determinants (i.e. employment, education level, immigration and marital status) on outcomes were analysed.

Results: Individuals in both countries reported high perceived health (Scoring > 2, 85.0% in Canada, 79.9% in Austria) and a low percentage reported unmet healthcare needs (4.6% in Canada, 10.7% in Austria). In both countries, sex and several social factors were associated with high perceived health, and a sex-by-marital status interaction was observed, with a greater negative impact of divorce for men. Female sex was positively associated with unmet care needs in both countries, and sex-by-social factors interactions were only detected in Canada.

Conclusions: The intersection of sex and social factors in influencing patient-relevant outcomes varies even among countries with similar healthcare and high gender equality.
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http://dx.doi.org/10.1186/s12889-021-11531-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325202PMC
July 2021

Clinical Trials of Heart Failure: Is There a Question of Sex?

Can J Cardiol 2021 Sep 14;37(9):1303-1309. Epub 2021 Jul 14.

Department of Medicine, McGill University, Montréal, Québec, Canada; Department of Epidemiology, Occupational Health, and Biostatistics, McGill University, Montréal, Québec, Canada; Division of General Internal Medicine, Department of Medicine, McGill University, Montréal, Québec, Canada. Electronic address:

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http://dx.doi.org/10.1016/j.cjca.2021.07.003DOI Listing
September 2021

Prevalence and perinatal outcomes of non-communicable diseases in pregnancy in a regional hospital in Haiti: A prospective cohort study.

J Glob Health 2021 Apr 17;11:04020. Epub 2021 Apr 17.

Department of Medicine, Saint-Nicolas Hospital, Saint-Marc, Haiti.

Background: The prevalence of non-communicable diseases (NCDs) is rising in low and middle-income countries (LMIC). We aimed to report on the prevalence of NCDs in pregnancy and their associated perinatal outcomes in a regional hospital in Haiti.

Methods: We conducted the "Diabète et hYpertension Artéerielle et leurs issues MAternelles et Néonatales" (DYAMAN) prospective cohort study in a regional hospital in Haiti. Pregnant women presenting to care at 24-28 weeks were screened and treated for diabetes (DM) and hypertensive disorders of pregnancy (HDP) using setting-adapted protocols. Prevalence of NCDs and associated maternal-neonatal outcomes were described.

Results: 715 women were included, of which 51 (7.1%) had DM, 90 (12.6%) had HDP, and 30 (4.2%) had both DM and HDP (DM/HDP). Of 422 (59%) women delivered in hospital, 58 (13.7%) had preeclampsia, including 5 (8.6%) with eclampsia. Preterm birth <32 weeks was more common in the HDP than the control, DM, and DM/HDP groups. More low birth weight babies (n = 20, 25.6%) were born to the HDP group than to the control (n = 20, 7.1%), DM (n = 1, 2.7%), and DM/HDP (n = 3, 12%) groups ( < 0.001). Macrosomia and hypoglycemia affected 5 (8%) neonates of women with DM. Perinatal mortality, affecting 36/1000 births, was mainly driven by maternal NCDs.

Conclusions: NCDs in pregnancy led to adverse maternal and perinatal outcomes. This study will help to prepare future refinements aimed at optimizing the management of NCDs in pregnancy in LMIC. Research is required to understand barriers to patient attendance at antenatal follow-up, treatment escalation for hyperglycemia, and in-hospital delivery.
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http://dx.doi.org/10.7189/jogh.11.04020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053393PMC
April 2021

Can synthetic data be a proxy for real clinical trial data? A validation study.

BMJ Open 2021 04 16;11(4):e043497. Epub 2021 Apr 16.

Electronic Health Information Laboratory, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada

Objectives: There are increasing requirements to make research data, especially clinical trial data, more broadly available for secondary analyses. However, data availability remains a challenge due to complex privacy requirements. This challenge can potentially be addressed using synthetic data.

Setting: Replication of a published stage III colon cancer trial secondary analysis using synthetic data generated by a machine learning method.

Participants: There were 1543 patients in the control arm that were included in our analysis.

Primary And Secondary Outcome Measures: Analyses from a study published on the real dataset were replicated on synthetic data to investigate the relationship between bowel obstruction and event-free survival. Information theoretic metrics were used to compare the univariate distributions between real and synthetic data. Percentage CI overlap was used to assess the similarity in the size of the bivariate relationships, and similarly for the multivariate Cox models derived from the two datasets.

Results: Analysis results were similar between the real and synthetic datasets. The univariate distributions were within 1% of difference on an information theoretic metric. All of the bivariate relationships had CI overlap on the tau statistic above 50%. The main conclusion from the published study, that lack of bowel obstruction has a strong impact on survival, was replicated directionally and the HR CI overlap between the real and synthetic data was 61% for overall survival (real data: HR 1.56, 95% CI 1.11 to 2.2; synthetic data: HR 2.03, 95% CI 1.44 to 2.87) and 86% for disease-free survival (real data: HR 1.51, 95% CI 1.18 to 1.95; synthetic data: HR 1.63, 95% CI 1.26 to 2.1).

Conclusions: The high concordance between the analytical results and conclusions from synthetic and real data suggests that synthetic data can be used as a reasonable proxy for real clinical trial datasets.

Trial Registration Number: NCT00079274.
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http://dx.doi.org/10.1136/bmjopen-2020-043497DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8055130PMC
April 2021

Identification and inclusion of gender factors in retrospective cohort studies: the GOING-FWD framework.

BMJ Glob Health 2021 04;6(4)

Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada

Gender refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men and gender diverse people. Gender-related factors are seldom assessed as determinants of health outcomes, despite their powerful contribution. The Gender Outcomes INternational Group: to Further Well-being Development (GOING-FWD) project developed a standard five-step methodology applicable to retrospectively identify gender-related factors and assess their relationship to outcomes across selected cohorts of non-communicable chronic diseases from Austria, Canada, Spain, Sweden. Step 1 (identification of gender-related variables): Based on the gender framework of the Women Health Research Network (ie, identity, role, relations and institutionalised gender), and available literature for a certain disease, an optimal 'wish-list' of gender-related variables was created and discussed by experts. Step 2 (definition of outcomes): Data dictionaries were screened for clinical and patient-relevant outcomes, using the International Consortium for Health Outcome Measurement framework. Step 3 (building of feasible final list): a cross-validation between variables per database and the 'wish-list' was performed. Step 4 (retrospective data harmonisation): The harmonisation potential of variables was evaluated. Step 5 (definition of data structure and analysis): The following analytic strategies were identified: (1) local analysis of data not transferable followed by a meta-analysis combining study-level estimates; (2) centrally performed federated analysis of data, with the individual-level participant data remaining on local servers; (3) synthesising the data locally and performing a pooled analysis on the synthetic data and (4) central analysis of pooled transferable data. The application of the GOING-FWD multistep approach can help guide investigators to analyse gender and its impact on outcomes in previously collected data.
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http://dx.doi.org/10.1136/bmjgh-2021-005413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043043PMC
April 2021

Sex, Gender, and Cardiovascular Health in Canadian and Austrian Populations.

Can J Cardiol 2021 Aug 27;37(8):1240-1247. Epub 2021 Mar 27.

Centre for Outcomes Research and Evaluation, McGill University Health Centre Research Institute, Montréal, Québec, Canada; Divisions of Clinical Epidemiology and General Internal Medicine, McGill University Health Centre Research Institute, Montréal, Québec, Canada. Electronic address:

Background: Evidence differentiating the effect of biological sex from psychosociocultural factors (gender) in different societies and its relation to cardiovascular diseases is scarce. We explored the association between sex, gender, and cardiovascular health (CVH) among Canadian (CAN) and Austrian (AT) populations.

Methods: The Canadian Community Health Survey (CCHS) (n = 63,522; 55% female) and Austrian Health Interview Survey (AT-HIS) (n = 15,771; 56% female) were analyzed in a cross-sectional survey design. The CANHEART/ATHEART index, a measure of ideal CVH composed of 6 cardiometabolic risk factors (smoking, physical activity, fruit and vegetable consumption, overweight/obesity, diabetes, and hypertension; range 0-6; higher scores reflecting better CVH) was calculated for both databases. A composite measure of psychosociocultural gender was computed for each country (range 0-1, higher score identifying characteristics traditionally ascribed to women).

Results: Median CANHEART 4 (interquartile range 3-5) and CAN gender scores 0.55 (0.49-0.60) were similar to median ATHEART 4 (3-5) and AT gender scores 0.55 (0.46-0.64). Although higher gender scores (CCHS: β = -1.33, 95% confidence interval [CI] -1.44 to -1.22; AT-HIS: β = -1.08, 95% CI -1.26 to -0.89)) were associated with worse CVH, female sex (CCHS: β = 0.35, 95% CI (0.33-0.37); AT-HIS: β = 0.60, 95% CI (0.55-0.64)) was associated with better CVH in both populations. In addition, higher gender scores were associated with increased prevalence of heart disease compared with female sex. The magnitude of this risk was higher in Austrians.

Conclusions: These results demonstrate that individuals with characteristics typically ascribed to women reported poorer cardiovascular health and higher risk of heart disease, independently from biological sex and baseline CV risk factors, in both countries. Female sex exhibited better CV health and a lower prevalence of heart disease than male in both populations. However, gender factors and magnitude of gender impact varied by country.
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http://dx.doi.org/10.1016/j.cjca.2021.03.019DOI Listing
August 2021

Gender-related variables for health research.

Biol Sex Differ 2021 Feb 22;12(1):23. Epub 2021 Feb 22.

History of Science, Stanford University, Building 200, 450 Jane Stanford Way, Stanford, CA, 94305, USA.

Background: In this paper, we argue for Gender as a Sociocultural Variable (GASV) as a complement to Sex as a Biological Variable (SABV). Sex (biology) and gender (sociocultural behaviors and attitudes) interact to influence health and disease processes across the lifespan-which is currently playing out in the COVID-19 pandemic. This study develops a gender assessment tool-the Stanford Gender-Related Variables for Health Research-for use in clinical and population research, including large-scale health surveys involving diverse Western populations. While analyzing sex as a biological variable is widely mandated, gender as a sociocultural variable is not, largely because the field lacks quantitative tools for analyzing the influence of gender on health outcomes.

Methods: We conducted a comprehensive review of English-language measures of gender from 1975 to 2015 to identify variables across three domains: gender norms, gender-related traits, and gender relations. This yielded 11 variables tested with 44 items in three US cross-sectional survey populations: two internet-based (N = 2051; N = 2135) and a patient-research registry (N = 489), conducted between May 2017 and January 2018.

Results: Exploratory and confirmatory factor analyses reduced 11 constructs to 7 gender-related variables: caregiver strain, work strain, independence, risk-taking, emotional intelligence, social support, and discrimination. Regression analyses, adjusted for age, ethnicity, income, education, sex assigned at birth, and self-reported gender identity, identified associations between these gender-related variables and self-rated general health, physical and mental health, and health-risk behaviors.

Conclusion: Our new instrument represents an important step toward developing more comprehensive and precise survey-based measures of gender in relation to health. Our questionnaire is designed to shed light on how specific gender-related behaviors and attitudes contribute to health and disease processes, irrespective of-or in addition to-biological sex and self-reported gender identity. Use of these gender-related variables in experimental studies, such as clinical trials, may also help us understand if gender factors play an important role as treatment-effect modifiers and would thus need to be further considered in treatment decision-making.
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http://dx.doi.org/10.1186/s13293-021-00366-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898259PMC
February 2021

The Importance of Gender to Understand Sex Differences in Cardiovascular Disease.

Can J Cardiol 2021 05 13;37(5):699-710. Epub 2021 Feb 13.

Department of Translational Medicine, University of Ferrara, Ferrara, Italy; University of Alberta, Faculty of Nursing, Edmonton, Alberta, Canada.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. There is robust evidence of heterogeneity in underlying mechanism, manifestation, prognosis, and response to treatment of CVD between male and female patients. Gender, which refers to the socially constructed roles, behaviours, expressions, and identities of individuals, is an important determinant of CV health, and its consideration might help in attaining a broader understanding of the observed sex differences in CVD. Established risk factors such as hypertension, dyslipidemia, diabetes mellitus, obesity, and smoking are well known to contribute to CVD. However, despite the differences in CVD risk between male and female, most studies looking into the magnitude of effect of each risk factor have traditionally focused on male subjects. While biological sex influences disease pathophysiology, the psycho-socio-cultural construct of gender can further interact with this effect. Behavioural, psychosocial, personal, cultural, and societal factors can create, repress, or strengthen underlying biological CV health differences. Although mechanisms of action are largely unclear, it is suggested that gender-related factors can further exacerbate the detrimental effect of established risk factors of CVD. In this narrative review, we explore the current literature investigating the role of gender in CV risk and its impact on established risk factors as a fundamental step toward precision medicine.
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http://dx.doi.org/10.1016/j.cjca.2021.02.005DOI Listing
May 2021

A Longitudinal Pilot Study on Cognition and Cerebral Hemodynamics in a Mouse Model of Preeclampsia Superimposed on Hypertension: Looking at Mothers and Their Offspring.

Front Physiol 2021 1;12:611984. Epub 2021 Feb 1.

Laboratory of Cerebrovascular Research, Montreal Neurological Institute, McGill University, Montréal, QC, Canada.

Preeclampsia is a common hypertensive disorder in pregnant women and whose causes and consequences have focused primarily on cardiovascular outcomes on the mother and offspring, often without taking into consideration the possible effects on the brain. One possible cause of preeclampsia has been attributed to alterations in the renin-angiotensin system, which has also been linked to cognitive decline. In this pilot study, we use a transgenic mouse model that chronically overexpresses human angiotensinogen and renin (RA mice) that displayed characteristics of preeclampsia such as proteinuria during gestation. Offspring of these mothers as well as from control mothers were also examined. We were primarily interested in detecting whether cognitive deficits were present in the mothers and offspring in the long term and used a spatial learning and memory task as well as an object recognition task at three timepoints: 3, 8, and 12 months post-partum or post-natal, while measuring blood pressure and performing urine analysis after each timepoint. While we did not find significant deficits in preeclamptic mothers at the later timepoints, we did observe negative consequences in the pups of RA mice that coincided with hemodynamic alterations whereby pups had higher whisker-evoked oxygenated hemoglobin levels and increased cerebral blood flow responses compared to control pups. Our study provides validation of this preeclampsia mouse model for future studies to decipher the underlying mechanisms of long-term cognitive deficits found in offspring.
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http://dx.doi.org/10.3389/fphys.2021.611984DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878560PMC
February 2021

Gender score development in the Berlin Aging Study II: a retrospective approach.

Biol Sex Differ 2021 01 18;12(1):15. Epub 2021 Jan 18.

Berlin Institute for Gender in Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.

In addition to biological sex, gender, defined as the sociocultural dimension of being a woman or a man, plays a central role in health. However, there are so far few approaches to quantify gender in a retrospective manner in existing study datasets. We therefore aimed to develop a methodology that can be retrospectively applied to assess gender in existing cohorts. We used baseline data from the Berlin Aging Study II (BASE-II), obtained in 2009-2014 from 1869 participants aged 60 years and older. We identified 13 gender-related variables and used them to construct a gender score by using primary component and logistic regression analyses. Of these, nine variables contributed to a gender score: chronic stress, marital status, risk-taking behaviour, personality attributes: agreeableness, neuroticism, extraversion, loneliness, conscientiousness, and level of education. Females and males differed significantly in the distribution of the gender score, but a significant overlap was also found. Thus, we were able to develop a gender score in a retrospective manner from already collected data that characterized participants in addition to biological sex. This approach will allow researchers to introduce the notion of gender retrospectively into a large number of studies.
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http://dx.doi.org/10.1186/s13293-020-00351-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7814714PMC
January 2021

Agreement in the CARTaGENE cohort between self-reported medication use and claim data.

Chronic Illn 2021 Jan 10:1742395320985913. Epub 2021 Jan 10.

Centre for Outcomes Research and Evaluation and Division of Clinical Epidemiology, McGill University Health Centre, Montreal, Canada.

Objectives: To describe the agreement of self-reported medication use with claim prescription records and to ascertain factors associated with agreement between the two data sources.

Methods: Baseline data on self-reported medication use was extracted from CARTaGENE, a cohort study in Quebec, Canada, and from the provincial health insurance records (dispensation database) of the same individuals. Kappa statistics were used to estimate concordance beyond chance between the two data sources. Logistic regression models were adjusted to estimate the association between agreement and selected individual's characteristics (sex, age, education, region, income, utilization of health care system, and comorbidities).

Results: Agreement between self-reported medication use and administrative data varied considerably across medication classes (kappa 0.54 for respiratory system and 0.91 for systemic hormonal preparations). Overall, agreement improved when a fixed time window of 90 days was used for exposure measurement. Sex, education level, frequency of health care use and the number of reported medications were associated with agreement.

Discussion: Overall, there was a reasonable agreement between the two data sources, but important variations were found for the different drug classes. These results could be used by researchers to more accurately assess drug exposures using real-world data, which are increasingly important to regulators.
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http://dx.doi.org/10.1177/1742395320985913DOI Listing
January 2021

The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation.

Can J Cardiol 2020 12 22;36(12):1847-1948. Epub 2020 Oct 22.

Institut de Cardiologie de Montréal, Université de Montréal, Montréal, Québec, Canada.

The Canadian Cardiovascular Society (CCS) atrial fibrillation (AF) guidelines program was developed to aid clinicians in the management of these complex patients, as well as to provide direction to policy makers and health care systems regarding related issues. The most recent comprehensive CCS AF guidelines update was published in 2010. Since then, periodic updates were published dealing with rapidly changing areas. However, since 2010 a large number of developments had accumulated in a wide range of areas, motivating the committee to complete a thorough guideline review. The 2020 iteration of the CCS AF guidelines represents a comprehensive renewal that integrates, updates, and replaces the past decade of guidelines, recommendations, and practical tips. It is intended to be used by practicing clinicians across all disciplines who care for patients with AF. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to evaluate recommendation strength and the quality of evidence. Areas of focus include: AF classification and definitions, epidemiology, pathophysiology, clinical evaluation, screening and opportunistic AF detection, detection and management of modifiable risk factors, integrated approach to AF management, stroke prevention, arrhythmia management, sex differences, and AF in special populations. Extensive use is made of tables and figures to synthesize important material and present key concepts. This document should be an important aid for knowledge translation and a tool to help improve clinical management of this important and challenging arrhythmia.
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http://dx.doi.org/10.1016/j.cjca.2020.09.001DOI Listing
December 2020

Blood pressure variability in normotensive perimenopausal women: Non-dipping status, maximum blood pressure and arterial stiffness.

Int J Cardiol 2021 02 16;325:149-154. Epub 2020 Oct 16.

McGill University Health Center Research Institute, Montreal, QC, Canada; Department of Medicine, McGill University, Montreal, QC, Canada.

Background: Postmenopausal women are more likely to have uncontrolled hypertension and are at higher risk of cardiovascular disease compared with age-matched men. Blood pressure variability is emerging as a predictor of adverse cardiovascular outcomes and may be implicated in the relationship between menopause and worsened vascular health in women. We conducted an observational study, BRAVE (Blood pRessure And Vascular hEalth around menopause) to study this relationship.

Method: Normotensive perimenopausal women were recruited. Blood pressure variability was measured through 24-h blood pressure monitoring. Vascular health was assessed through arterial stiffness (carotid-femoral pulse wave velocity), carotid intima-media thickness and endothelial function (reactive hyperemic index). Multivariate models were performed to identify factors associated with blood pressure variability and arterial stiffness in perimenopausal women.

Results: Forty-nine healthy women (mean age 52.9 ± 4.0, 63% postmenopausal) were recruited. There was a high prevalence (40%) of night non-dipping, a measure of an abnormal pattern of blood pressure variability. Aside from night dipping, other measures of blood pressure variability were similar between premenopausal and postmenopausal women. In the multivariate analysis, body mass index was the only factor associated independently with different measures of blood pressure variability, including the maximum overnight blood pressure (ß = 1.95, p < 0.01). The latter was also significantly associated with arterial stiffness (ß = 0.035, p = 0.048). Finally, poor sleep was independently associated with an increase in arterial stiffness.

Conclusions: Abnormal blood pressure variability, particularly night non-dipping, is common in normotensive perimenopausal women. Maximum overnight blood pressure is independently associated with arterial stiffness and may identify women at higher cardiovascular risk.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.027DOI Listing
February 2021

Sex differences in clinical phenotype and transitions of care among individuals dying of COVID-19 in Italy.

Biol Sex Differ 2020 10 16;11(1):57. Epub 2020 Oct 16.

Department of Cardiovascular, Endocrine-metabolic Diseases and Aging, Istituto Superiore di Sanità, Via Giano della Bella, 34, 00161, Rome, Italy.

Background: Among the unknowns posed by the coronavirus disease 2019 (COVID-19) outbreak, the role of biological sex to explain disease susceptibility and progression is still a matter of debate, with limited sex-disaggregated data available.

Methods: A retrospective analysis was performed to assess if sex differences exist in the clinical manifestations and transitions of care among hospitalized individuals dying with laboratory-confirmed SARS-CoV-2 infection in Italy (February 27-June 11, 2020). Clinical characteristics and the times from symptoms' onset to admission, nasopharyngeal swab, and death were compared between sexes. Adjusted multivariate analysis was performed to identify the clinical features associated with male sex.

Results: Of the 32,938 COVID-19-related deaths that occurred in Italy, 3517 hospitalized and deceased individuals with COVID-19 (mean 78 ± 12 years, 33% women) were analyzed. At admission, men had a higher prevalence of ischemic heart disease (adj-OR = 1.76, 95% CI 1.39-2.23), chronic obstructive pulmonary disease (adj-OR = 1.7, 95% CI 1.29-2.27), and chronic kidney disease (adj-OR = 1.48, 95% CI 1.13-1.96), while women were older and more likely to have dementia (adj-OR = 0.73, 95% CI 0.55-0.95) and autoimmune diseases (adj-OR = 0.40, 95% CI 0.25-0.63), yet both sexes had a high level of multimorbidity. The times from symptoms' onset to admission and nasopharyngeal swab were slightly longer in men despite a typical acute respiratory illness with more frequent fever at the onset. Men received more often experimental therapy (adj-OR = 2.89, 95% CI 1.45-5.74) and experienced more likely acute kidney injury (adj-OR = 1.47, 95% CI 1.13-1.90).

Conclusions: Men and women dying with COVID-19 had different clinical manifestations and transitions of care. Identifying sex-specific features in individuals with COVID-19 and fatal outcome might inform preventive strategies.
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http://dx.doi.org/10.1186/s13293-020-00334-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7562690PMC
October 2020

Methods for prospectively incorporating gender into health sciences research.

J Clin Epidemiol 2021 01 24;129:191-197. Epub 2020 Sep 24.

Research Institute of McGill University Health Centre, Division of Clinical Epidemiology McGill University, Montréal, Quebec, Canada. Electronic address:

Numerous studies have demonstrated that sex (a biological variable) and gender (a psychosocial construct) impact health and have discussed the mechanisms that may explain these relationships. Funding agencies have called for all health researchers to incorporate sex and gender into their studies; however, the way forward has been unclear to many, particularly due to the varied definition of gender. We argue that just as there is no standardized definition of gender, there can be no standardized measurement thereof. However, numerous measurable gender-related variables may influence individual or population-level health through various pathways. The initial question should guide the selection of specific gender-related variables based on their relevance to the study, to prospectively incorporate gender into research. We outline various methods to provide clarification on how to incorporate gender into the design of prospective clinical and epidemiological studies as well as methods for statistical analysis.
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http://dx.doi.org/10.1016/j.jclinepi.2020.08.018DOI Listing
January 2021

High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial.

Am Heart J 2020 11 25;229:18-28. Epub 2020 Jun 25.

BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address:

Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.
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http://dx.doi.org/10.1016/j.ahj.2020.06.013DOI Listing
November 2020

The influence of sex and gender domains on COVID-19 cases and mortality.

CMAJ 2020 09;192(36):E1041-E1045

Research Institute of McGill University Health Centre (Tadiri, Pilote), Division of Clinical Epidemiology McGill University, Montréal, Que.; Division of Endocrinology and Metabolism (Gisinger, Kautzy-Willer), Department of Medicine III, Medical University of Vienna, Vienna, Austria; Department of Renal Medicine (Kublickiene), Institution for Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden; Clinical and Experimental Neuroscience (Herrero), Institutes for Aging Research and Bio-Health Research of Murcia. School of Medicine, University of Murcia, Murcia, Spain; Department of Experimental Medicine (Raparelli), Sapienza University of Rome, Rome, Italy; Faculty of Nursing (Norris), University of Alberta, Edmonton, Alta; Cardiovascular and Stroke Strategic Clinical Network (Norris), Alberta Health Services, Edmonton, Alta.

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http://dx.doi.org/10.1503/cmaj.200971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7504881PMC
September 2020

Anticoagulant Use and the Risk of Thromboembolism and Bleeding in Postoperative Atrial Fibrillation After Noncardiac Surgery.

Can J Cardiol 2021 03 4;37(3):391-399. Epub 2020 Sep 4.

Research Institute McGill University Health Centre, Montréal, Québec, Canada; Division of General Internal Medicine, Department of Medicine, McGill University, Montréal, Québec, Canada. Electronic address:

Background: An effective and safe oral anticoagulation (OAC) strategy for patients with new postoperative AF (POAF) after noncardiac surgery remains unclear. We aimed to determine the association between OAC use and 1) thromboembolic events and 2) major bleeding in patients with POAF after noncardiac surgery.

Methods: A retrospective cohort (1999-2015) was used to identify patients with new POAF after inpatient noncardiac surgery. Initiation of OAC was defined as prescription of an OAC within 30 days following hospital discharge. Times to first hospital admission or emergency department visit for a thromboembolic or major bleeding event were compared using Cox proportional hazards models.

Results: We identified 22,007 patients with new POAF after inpatient noncardiac surgery. The majority of patients had intermediate (CHADS-VASc 2-3: 45%) to high (CHADS-VASc ≥ 4: 42%) thromboembolic risk. During a mean follow-up of 4 years, a total of 1099 (5%) thromboembolic and 3250 (15%) bleeding events occurred. Compared with patients not on anticoagulation, anticoagulation did not reduce the risk for thromboembolic events (adjusted hazard ratio [aHR] 0.89, 95% CI 0.73-1.07). In patients initiated on anticoagulation, there was an association with a higher risk for major bleeding (aHR 1.14, 95% CI 1.04-1.25).

Conclusions: In patients with new POAF after noncardiac surgery, anticoagulation was not associated with a reduction in long-term thromboembolic events; however, this was accompanied by an overall increased risk for major bleeding. Future prospective clinical studies are needed to better address the role for anticoagulation therapy in the setting of POAF after noncardiac surgery to understand the efficacy and safety of treatment.
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http://dx.doi.org/10.1016/j.cjca.2020.08.023DOI Listing
March 2021

Real-world analyses of therapy discontinuation of checkpoint inhibitors in metastatic melanoma patients.

Sci Rep 2020 09 3;10(1):14607. Epub 2020 Sep 3.

Department of Medicine, McGill University, Montreal, Canada.

The 'real-world' patient population of metastatic melanoma is not fully represented in clinical trials investigating checkpoint inhibitors. We described therapy discontinuation in an unselected population-based cohort of adults with metastatic melanoma who started therapy with pembrolizumab, nivolumab, or nivolumab/ipilimumab from January 2015 to August 2017. Therapy discontinuation was defined as a gap between doses beyond 120 days, and/or initiation of another cancer therapy. We estimated drug-specific rate ratios for therapy discontinuation adjusted for age, sex, comorbidities, health care use, and past cancer therapies. We included 876 metastatic melanoma patients initiating pembrolizumab (44.3%), nivolumab/ipilimumab (31.2%), and nivolumab (24.5%). At 12 months of follow-up, the probabilities of therapy discontinuation were 49.9% (95% confidence interval, CI 43.6-56.5) for pembrolizumab, 58.8% (95% CI 50.5-67.3) for nivolumab, and 59.2% (95% CI 51.7-66.8) for nivolumab/ipilimumab. Stratified analyses based on prior cancer therapy, brain metastases at baseline, and sex showed similar trends. In multivariable analyses, compared with pembrolizumab, patients starting nivolumab (rate ratio 1.38, 95% CI 1.08-1.77) or nivolumab/ipilimumab (rate ratio 1.30, 95% CI 1.02-1.65) were more likely to discontinue therapy. Our findings indicate frequent discontinuations of checkpoint inhibitors at one year. The lower discontinuation associated with pembrolizumab should be confirmed in further studies.
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http://dx.doi.org/10.1038/s41598-020-71788-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471311PMC
September 2020

Population-Level Sex Differences and Predictors for Treatment With Catheter Ablation in Patients With Atrial Fibrillation and Heart Failure.

CJC Open 2020 May 12;2(3):85-93. Epub 2020 Feb 12.

Division of Clinical Epidemiology, Research Institute McGill University Health Centre, Montreal, Quebec, Canada.

Background: Current guidelines are relatively general regarding the type of patient with heart failure (HF) who should be considered for catheter ablation (CA) of atrial fibrillation (AF). The aim of the present study was to identify clinical predictors and sex differences for treatment with CA in the AF-HF population.

Methods: A population-based AF-HF cohort was created using the Quebec administrative data (2000-2017). Patients were followed from the date of diagnosis of both diseases to the date of CA or death. Predictors for CA, represented by time-varying covariates, were assessed in a multivariable Cox model that accounted for the competing risk of death.

Results: Among 101,931 patients with AF-HF with medication information (median age, 80.7 years; interquartile range [IQR], 73.9-86.3; 51.4% were female, median CHADS-VASc, 4; IQR, 3-4), only 432 (0.4%) underwent CA after a median of 0.8 years (IQR, 0.1-2.7). Independent of multiple comorbidities and advanced age, which were associated with a lower likelihood of CA, women were approximately half as likely to undergo a CA (26% were women; adjusted hazard ratio, 0.6; 95% confidence interval, 0.4-0.7). Prior use of direct-acting oral anticoagulants and antiarrhythmics, and the presence of an implantable cardioverter-defibrillator were also predictors for CA treatment ( < 0.05 for all).

Conclusion: In a real-world population, CA was infrequently used to treat AF among patients with HF, and the likelihood of CA was further reduced in women. Because patients with CA had few comorbidities, future studies need to be conducted to determine whether CA can be beneficial in subjects whose clinical characteristics are more representative of the AF-HF population.
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http://dx.doi.org/10.1016/j.cjco.2020.01.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242511PMC
May 2020

COVID-SAFER: Deprescribing Guidance for Hydroxychloroquine Drug Interactions in Older Adults.

J Am Geriatr Soc 2020 Aug 30;68(8):1636-1646. Epub 2020 Jun 30.

Division of Experimental Medicine, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.

Background/objectives: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection causes high morbidity and mortality in older adults with chronic illnesses. Several trials are currently underway evaluating the antimalarial drug hydroxychloroquine as a potential treatment for acute infection. However, polypharmacy predisposes patients to increased risk of drug-drug interactions with hydroxychloroquine and may render many in this population ineligible to participate in trials. We aimed to quantify the degree of polypharmacy and burden of potentially inappropriate medications (PIMs) that older hospitalized adults are taking that would interact with hydroxychloroquine.

Methods: We reanalyzed data from the cohort of patients 65 years and older enrolled in the MedSafer pilot study. We first identified patients taking medications with potentially harmful drug-drug interactions with hydroxychloroquine that might exclude them from participation in a typical 2019 coronavirus disease (COVID-19) therapeutic trial. Next, we identified medications that were flagged by MedSafer as potentially inappropriate and crafted guidance around medication management if contemplating the use of hydroxychloroquine.

Results: The cohort contained a total of 1,001 unique patients with complete data on their home medications at admission. Of these 1,001 patients, 590 (58.9%) were receiving one or more home medications that could potentially interact with hydroxychloroquine, and of these, 255 (43.2%) were flagged as potentially inappropriate by the MedSafer tool. Common classes of PIMs observed were antipsychotics, cardiac medications, and antidiabetic agents.

Conclusion: The COVID-19 pandemic highlights the importance of medication optimization and deprescribing PIMs in older adults. By acting now to reduce polypharmacy and use of PIMs, we can better prepare this vulnerable population for inclusion in trials and, if substantiated, pharmacologic treatment or prevention of COVID-19. J Am Geriatr Soc 68:1636-1646, 2020.
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http://dx.doi.org/10.1111/jgs.16623DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7280600PMC
August 2020
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