COVID-19 Pandemic on COPD Healthcare Utilization, Exacerbations and Mortality: A Population Study.

RATIONALE: Existing work suggests that patients with COPD (pwCOPD) presented less frequently to the emergency department (ED) and were less likely to be hospitalized during the COVID-19 pandemic but it is unclear if this was due to improved health and disease management or to increased barriers/avoidance of healthcare. The objective of this study is to determine the impact of the pandemic on inpatient and outpatient healthcare utilization, disease incidence, and mortality rates in pwCOPD. METHODS: A retrospective population-based analysis using linked administrative datasets from Alberta, Canada18 months before and after March 12, 2020 was conducted to measure hospitalization, ED and outpatient visits, and COPD outpatient exacerbations during these time periods. Mortality data was also analyzed pre- versus post-pandemic, taking confirmed COVID-19 infection within 30 days into account. Subgroup analysis based on COPD exacerbation risk stratification was undertaken to determine if healthcare utilization differed based on exacerbation risk. Finally, sex-based analysis of healthcare utilization during the pandemic was also completed. RESULTS: Hospitalization/ED visits and outpatient treatment for acute exacerbations of COPD dropped while total outpatient COPD visits, including both virtual and in-person, increased during the pandemic for pwCOPD. Mortality rate increased even after adjusting for COVID-19-associated deaths. Sex-based subgroup analysis showed a greater drop in acute care utilization for females but the rise in mortality was seen for both sexes with men experiencing greater rate of mortality than women. CONCLUSIONS: Overall pwCOPD accessed acute care resources less during the pandemic which may have contributed to a rise in non-COVID all-cause mortality.

Excess Deaths in Assisted Living and Nursing Homes during the COVID-19 Pandemic in Alberta, Canada.

OBJECTIVES: Assisted living (AL) is a significant and growing congregate care option for vulnerable older adults designed to reduce the use of nursing homes (NHs). However, work on excess mortality in congregate care during the COVID-19 pandemic has primarily focused on NHs with only a few US studies examining AL. The objective of this study was to assess excess mortality among AL and NH residents with and without dementia or significant cognitive impairment in Alberta, Canada, during the first 2 years of the COVID-19 pandemic, relative to the 3 years before. DESIGN: Population-based, retrospective cohort study. SETTING AND PARTICIPANTS: Residents who lived in an AL or NH facility operated or contracted by the Provincial health care system to provide publicly funded care in Alberta between January 1, 2017, and December 31, 2021. METHODS: We used administrative health care data, including Resident Assessment Instrument - Home Care (RAI-HC, AL) and Minimum Data Set 2.0 (RAI-MDS 2.0, NHs) records, linked with data on residents' vital statistics, COVID-19 testing, emergency room registrations, and hospital stays. The outcome was excess deaths during COVID-19 (ie, the number of deaths beyond that expected based on pre-pandemic data), estimated, using overdispersed Poisson generalized linear models. RESULTS: Overall, the risk of excess mortality [adjusted incidence rate ratio (95% confidence interval)] was higher in ALs than in NHs [1.20 (1.14-1.26) vs 1.10 (1.07-1.13)]. Weekly peaks in excess deaths coincided with COVID-19 pandemic waves and were higher among those with diagnosed dementia or significant cognitive impairment in both, AL and NHs. CONCLUSIONS AND IMPLICATIONS: Finding excess mortality within both AL and NH facilities should lead to greater focus on infection prevention and control measures across all forms of congregate housing for vulnerable older adults. The specific needs of residents with dementia in particular will have to be addressed.

Increased frequency and mortality in persons with neurological disorders during COVID-19.

Determining the frequency and outcomes of neurological disorders associated with COVID-19 is imperative for understanding risks as well as recognition of emerging neurological disorders. We investigated the susceptibility and impact of SARS-CoV-2 infection among persons with premorbid neurological disorder rs, as well as the post-infection incidence of neurological sequelae in a case-control population-based cohort. Using health service data collected from March 1, 2020, to June 30, 2021, we constructed a cohort of SARS-CoV-2 RNA-positive (n=177,892) and -negative (n=177,800) adults who were age-, sex-, and comorbidity-matched and underwent RT- PCR testing at similar times. COVID-19 associated mortality rates were examined within the cohort. Neurological sequelae were analysed during the acute (less than three months) and the post-acute (three to nine months) phases post-infection. The risk of death was significantly greater in the SARS-CoV-2 RNA-positive (2,140 per 100,000 person years) compared to RNA-negative (922 per 100,000 person years) over a follow-up of 9 months, particularly amongst those with premorbid neurological disorders: adjusted odds ratios (aOR, 95% CI) in persons with a prior history of parkinsonism (1·65, 1·15-2·37), dementia (1·30, 1·11-1·52), seizures (1·91, 1·26-2·87), encephalopathy (1·82, 1·02-3·23), and stroke (1·74, 1·05-2·86). There was also a significantly increased risk for diagnosis of new neurological sequelae during the acute time phase after COVID-19 including encephalopathy (2·0, 1·10-3·64), dementia (1·36, 1·07-1·73), seizure (1·77, 1·22-2·56), and brain fog (1·96, 1·20-3·20). These risks persisted into the post-acute phase after COVID-19 during which inflammatory myopathy (2·57, 1·07-6·15) and coma (1·87, 1·22-2·87) also became significantly increased. Thus, persons with SARS-CoV-2 infection and premorbid neurological disorders are at greater risk of death while SARS-CoV-2 infection was complicated by increased risk of new onset neurological disorders in both the acute and post-acute phases of COVID-19.

Increased Prevalence of Adverse Health Outcomes Across the Lifespan in Those Affected by Polycystic Ovary Syndrome: A Canadian Population Cohort.

Background: Polycystic ovary syndrome (PCOS) is the most common metabolic-endocrine disorder impacting the health and quality of life of women over the lifespan. Evidence-based data on the scope of adverse health outcomes in those affected by PCOS is critical to improve healthcare and quality of life in this population. The aim of this study was to determine the prevalence of adverse health outcomes in those with PCOS compared to age-matched controls. Methods: We conducted a retrospective observational case-control study in those diagnosed with PCOS and age-matched controls using the Alberta Health Services Health Analytics database and the International Classification of Diseases, for the period from 2002-2018 in Alberta, Canada. Results: The cohort consisted of n = 16,531 exposed PCOS cases and n = 49,335 age-matched un-exposed controls. The prevalences of hypertension, renal disease, gastrointestinal disease, eating disorders, mental illness, depression-anxiety, rheumatoid arthritis, respiratory infections, and all malignancies were 20%-40% (P < 0.0001) higher in those with PCOS, compared to controls. The prevalence of obesity, dyslipidemia, nonalcoholic fatty liver disease, and type 2 diabetes was 2-3 fold higher in those with PCOS (P < 0.001). Cardiovascular, cerebrovascular, and peripheral vascular disease were 30%-50% higher, and they occurred 3-4 years earlier in those with PCOS (P < 0.0001); a 2-fold higher prevalence of dementia occurred in those with PCOS, compared to controls. Conclusion: These findings provide evidence that PCOS is associated with a higher prevalence of morbidities over the lifespan, and the potential scope of the healthcare burden in women affected by PCOS.

Contexte: Le syndrome des ovaires polykystiques (SOPK) est le trouble métabolique et endocrinien le plus courant à toucher la santé et la qualité de vie des femmes de tout âge. Il est essentiel de disposer de données probantes sur l'ampleur des effets néfastes sur la santé des personnes qui en sont atteintes afin d'améliorer les soins de santé offerts à cette population et sa qualité de vie. Le but de la présente étude était de déterminer la prévalence des effets néfastes sur la santé des personnes atteintes du SOPK et de les comparer aux effets chez des témoins appariés selon l'âge. Méthodologie: Nous avons mené une étude cas-témoin observationnelle rétrospective chez des personnes diagnostiquées avec un SOPK et des témoins appariés selon l'âge en utilisant la base des données analytiques de santé de l'Alberta Health Services et la classification internationale des maladies pour l'Alberta (Canada) de 2002 à 2018. Résultats: La cohorte à l'étude était composée de cas de SOPK (n = 16 531) et de témoins appariés selon l'âge qui n'y étaient pas exposés (n = 49 335). L'hypertension, les maladies rénales, les maladies gastro-intestinales, les troubles alimentaires, les troubles de santé mentale, la dépression et l'anxiété, la polyarthrite rhumatoïde, les infections respiratoires, et les cancers de tout type étaient de 20 % à 40 % plus fréquents (p < 0,0001) chez les personnes atteintes de SOPK que chez les témoins. La prévalence de l'obésité, de la dyslipidémie, de la stéatose hépatique non alcoolique et du diabète de type 2 était 2 à 3 fois plus élevée chez les personnes atteintes de SOPK (p < 0,001). L'incidence des maladies cardiovasculaires, vasculaires cérébrales et vasculaires périphériques était 30 % à 50 % plus élevée et ces maladies survenaient 3 à 4 ans plus tôt chez les personnes atteintes de SOPK (p < 0,0001), et la prévalence de démence était 2 fois plus élevée chez les personnes atteintes de SOPK que chez les témoins. Conclusions: Ces résultats démontrent que le SOPK est associé à une prévalence plus élevée de morbidité tout au long de la vie et démontrent l'ampleur possible du fardeau en soins de santé chez les femmes touchées par le SOPK.

Predicting inpatient rehabilitation length of stay for adults with traumatic spinal cord injury.

INTRODUCTION: Most post-injury traumatic spinal cord injury (TSCI) care occurs in the inpatient rehabilitation setting. The inpatient rehabilitation length of stay (R-LOS) has been shown to be a significant predictor of motor function restoration in persons with TSCI. Due to the complexity, and heterogeneity of individuals with TSCI, the R-LOS is challenging to predict at admission. PURPOSE: To identify the main predictors of R-LOS and derive an equation to estimate R-LOS in persons with TSCI. METHODS: This is a retrospective analysis of data from adults with TSCI from The Rick Hansen Spinal Cord Injury Registry in Alberta, Canada, who received rehabilitation care between May 10, 2005, and January 28, 2020. Multiple linear regression analysis was used to determine significant relationships between R-LOS and measures of participant demographics, length of stay, impairment and injury classification, and comorbidities. RESULTS: The analysis included 736 adults with TSCI from an eligible cohort of 1365. The median R-LOS was 65 days (IQR 39-99 days), ranging from 1 to 469 days. Multivariate linear regression analysis identified two significant predictors of R-LOS, total FIM score and the injury classification. This model was used to derive a R-LOS prediction equation, which explained 34% of the variance in R-LOS. CONCLUSION: We developed a simple equation to predict R-LOS based on the level of impairment and total FIM scores in persons with TSCI. These data have implications for health system planning, improvement, and innovation, and provide insights to support further research into the predictors of R-LOS, identification of higher-risk individuals.

Symptomology following COVID-19 among adults in Alberta, Canada: an observational survey study.

OBJECTIVE: Fatigue, headache, problems sleeping and numerous other symptoms have been reported to be associated with long COVID. However, many of these symptoms coincide with symptoms reported by the general population, possibly exacerbated by restrictions/precautions experienced during the COVID-19 pandemic. This study examines the symptoms reported by individuals who tested positive for COVID-19 compared with those who tested negative. DESIGN: Observational study. SETTING: The study was conducted on adult residents in Alberta, Canada, from October 2021 to February 2023. PARTICIPANTS: We evaluated self-reported symptoms in 7623 adults with positive COVID-19 tests and 1520 adults who tested negative, using surveys adapted from the internationally standardised International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)-developed COVID-19 long-term follow-up tools. These individuals had an index COVID-19 test date between 1 March 2020 and 31 December 2022 and were over 28 days post-COVID-19 testing. PRIMARY OUTCOME MEASURES: The primary outcomes were to identify the symptoms associated with COVID-19 positivity and risk factors for reporting symptoms. RESULTS: Fatigue was the top reported symptom (42%) among COVID-19-positive respondents, while headache was the top reported symptom (32%) in respondents who tested negative. Compared with those who tested negative, COVID-19-positive individuals reported 1.5 times more symptoms and had higher odds of experiencing 31 out of the 40 listed symptoms during the postinfectious period. These symptoms included olfactory dysfunction, menstruation changes, cardiopulmonary and neurological symptoms. Female sex, middle age (41-55 years), Indigeneity, unemployment, hospital/intensive care unit (ICU) admission at the time of testing and pre-existing health conditions independently predicted a greater number and variety of symptoms. CONCLUSIONS: Our results provide evidence that COVID-19 survivors continue to experience a significant number and variety of symptoms. These findings can help inform targeted strategies for the unequally affected population. It is important to offer appropriate management for symptom relief to those who have survived the acute COVID-19 illness.

Publicly funded healthcare costs associated with orofacial clefts for children born in Alberta, Canada between 2002 and 2018.

BACKGROUND: Orofacial clefts (OFCs) include cleft palate (CP), cleft lip (CL), and cleft lip with cleft palate (CLP) and require multidisciplinary healthcare services. Alberta, Canada has a publicly funded, universal access healthcare system. This study determined publicly funded healthcare costs for children with an OFC and compared these costs to children without congenital anomalies. METHODS: This retrospective population-based cohort analysis used the Alberta Congenital Anomalies Surveillance System to identify children born between 2002 and 2018 with an isolated OFC. They were matched 1:1 to a reference cohort based on sex and year of birth. The study population included 1614 children, from birth to 17 years of age linked to administrative databases to estimate annual inpatient and outpatient costs. Average annual all-cause costs were compared using two-sample independent t tests. RESULTS: The mean total cleft-related costs per patient were highest for children with CLP ($74,138 CAD, standard deviation (SD) $43,447 CAD), followed by CP ($53,062 CAD, SD $74,366 CAD), and CL ($35,288 CAD, SD $49,720 CAD). The mean total all-cause costs per child were statistically significantly higher (p < .001) in children with an OFC ($56,305 CAD, SD $57,744 CAD) compared to children without a congenital anomaly ($18,600 CAD, SD $61,300 CAD). CONCLUSIONS: Despite public health strategies to mitigate risk factors, the trend for OFCs has remained stable in Alberta, Canada for over 20 years. The costs reported are useful to other jurisdictions for comparison, and to families, healthcare professionals, service planners, and policy makers.

The Impact of Integrated Palliative Care on Survival in Idiopathic Pulmonary Fibrosis: A Retrospective Multicenter Comparison.

Background: Early and integrated palliative care is recommended for patients with idiopathic pulmonary fibrosis. Unfortunately, palliative care delivery remains poor due to various barriers in practice. This study describes various palliative care delivery models in a real-world cohort of patients with idiopathic pulmonary fibrosis, examines the predictors of survival in this cohort of patients, and explores the impact of palliative care on survival. Design: Charts were reviewed retrospectively and analyzed. The primary outcome was survival during a 4-year follow-up period. Two multivariable models were created to examine the impact of therapeutic strategies including palliative intervention on survival. Results: 298 patients with idiopathic pulmonary fibrosis were enrolled from 3 interstitial lung disease clinics with different palliative care models in Edmonton, Canada; Bristol, UK; and Kingston, Canada. 200 (67%) patients received palliative care and 119 (40%) died during follow up. Primary palliative care models (Edmonton and Bristol) delivered palliative care to 96% and 100% respectively compared 21% in the referral model (Queens). Palliative care [adjusted hazard ratio (aHR) .28 (.12-.65)] along with the use of antifibrotics [aHR .56 (.37-.84)], and body mass index >30 [aHR .47 (.37-.85)] reduced the risk of death in our idiopathic pulmonary fibrosis cohort. Opioid use was associated with worse survival [aHR 2.11 (1.30-23.43)]. Conclusions: Both palliative care and antifibrotic use were associated with survival benefit in this cohort of patients with idiopathic pulmonary fibrosis after adjusting for covariates. The benefit was seen despite differences in disease severity and different palliative care delivery models.

Validation of a Novel Clinical Dyspnea Scale - A Retrospective Pilot Study.

Objective: to examine the validity of a novel dyspnea scale, Edmonton Dyspnea Inventory in idiopathic pulmonary fibrosis (IPF). Methods: Edmonton Dyspnea Inventory (EDI), is a clinical instrument to measure dyspnea severity with activities of daily living, exercise and rest using a numeric rating scale (0 -10). Consecutive IPF patients (2012-2018) with baseline MRC and EDI were included. To validate EDI, psychometric analysis was conducted. Correlations between EDI, MRC and lung function were examined. Group-based trajectory modeling was used to group patients based on dyspnea severity. Net Reclassification Improvement (NRI) was calculated to assess the improvement in 1-year mortality prediction by adding trajectory groups to MRC grade. Results: 100 consecutive IPF patients were identified; mean age 73 years (SD = 9) and 65% males; 73% were in MRC grades ≥3. Item analysis showed all 8 EDI components have excellent discrimination power with ability to differentiate patients with varying dyspnea severity. EDI has good internal consistency (Cronbach α = .92). Exploratory factor analysis showed a one-factor solution with loadings from .66 to .89 suggesting 8 EDI components measured essentially one dimension of dyspnea. All EDI components were correlated with MRC and some with lung function. Modeling data identified three EDI dyspnea severity groups with differing mortality (P = .009). The addition of EDI dyspnea severity groups to the MRC score improved 1-year mortality prediction (NRI = .66; 95% CI, .18-1.14). Conclusions: EDI is a valid dyspnea instrument, correlated with MRC and lung function. It can categorize IPF patients into 3 dyspnea severity groups associated with increased mortality. Key Message: We describe the development of a novel scale, Edmonton Dyspnea Inventory, that facilitates measurement of dyspnea severity in the context of daily activities in patients with IPF. The results indicate that the new instrument is valid and correlated to MRC. It identifies 3 categories of severity not recognized by MRC with impact on mortality. Knowledge of dyspnea severity can help triage patients and assign appropriate therapies.

Prognostic Utility of Cardiovascular Magnetic Resonance-Based Phenotyping in Patients With Muscular Dystrophy.

Background The prognostic utility of cardiovascular magnetic resonance imaging, including strain analysis and tissue characterization, has not been comprehensively investigated in adult patients with muscular dystrophy. Methods and Results We prospectively enrolled 148 patients with dystrophinopathies (including heterozygotes), limb-girdle muscular dystrophy, and type 1 myotonic dystrophy (median age, 36.0 [interquartile range, 23.0-50.0] years; 51 [34.5%] women) over 7.7 years in addition to an age- and sex-matched healthy control cohort (n=50). Cardiovascular magnetic resonance markers, including 3-dimensional strain and fibrosis, were assessed for their respective association with major adverse cardiac events. Our results showed that markers of contractile performance were reduced across all muscular dystrophy groups. In particular, the dystrophinopathies cohort experienced reduced left ventricular (LV) ejection fraction and high burden of replacement fibrosis. Patients with type 1 myotonic dystrophy showed a 26.8% relative reduction in LV mass with corresponding reduction in chamber volumes. Eighty-two major adverse cardiac events occurred over a median follow-up of 5.2 years. Although LV ejection fraction was significantly associated with major adverse cardiac events (adjusted hazard ratio [aHR], 3.0 [95% CI, 1.4-6.4]) after adjusting for covariates, peak 3-dimensional strain amplitude demonstrated greater predictive value (minimum principal amplitude: aHR, 5.5 [95% CI, 2.5-11.9]; maximum principal amplitude: aHR, 3.3 [95% CI, 1.6-6.8]; circumferential amplitude: aHR, 3.4 [95% CI, 1.6-7.2]; longitudinal amplitude: aHR, 3.4 [95% CI, 1.7-6.9]; and radial strain amplitude: aHR, 3.0 [95% CI, 1.4-6.1]). Minimum principal strain yielded incremental prognostic value beyond LV ejection fraction for association with major adverse cardiac events (change in χ2=13.8; P<0.001). Conclusions Cardiac dysfunction is observed across all muscular dystrophy subtypes; however, the subtypes demonstrate distinct phenotypic profiles. Myocardial deformation analysis highlights unique markers of principal strain that improve risk assessment over other strain markers, LV ejection fraction, and late gadolinium enhancement in this vulnerable patient population.

COVID-19 vaccine uptake among people with HIV: identifying characteristics associated with vaccine hesitancy.

People with HIV (PWH) are at increased risk of COVID-19 infection. Both Canadian (NACI) and US (CDC) guidelines recommend that all PWH receive at least 2 doses of COVID-19 vaccine, and a booster. We examined vaccination uptake among PWH in Southern Alberta, Canada. Among adult PWH, we evaluated COVID-19 vaccination uptake between December 2020 and August 2022. Poisson regression models with robust variance (approximating log binomial models) estimated crude and adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for receiving (1) any vs. no vaccine, and (2) primary series with booster (≥ 3 vaccines) versus primary series without booster. Among 1885 PWH, 10% received no COVID-19 vaccinations, 37% < 3 vaccines and 54% received ≥ 3 vaccines. Females (vs. males) were less likely to receive a vaccine booster. Receiving no COVID-19 vaccines was associated with White ethnicity, unsuppressed HIV viral load (> 200 copies/mL), and using illegal substances. Factors associated with decreased booster uptake included being younger, Black (vs. White) ethnicity, substance use, lower educational attainment, and having an unsuppressed HIV viral load. COVID-19 booster uptake among PWH does not meet vaccine guidelines, and receipt of vaccines is unevenly distributed. Booster uptake is lowest among young females and marginalized individuals. Focused outreach is necessary to close this gap.

Epidemiology and healthcare utilization of First Nations peoples living with spinal cord injury in Alberta: an observational study to explore health inequities.

STUDY DESIGN: Retrospective observational cohort study. OBJECTIVES: Estimate spinal cord injury (SCI) prevalence in First Nations and non-First Nations populations and compare healthcare utilization as an indirect marker of health inequities. SETTING: Alberta, Canada. METHODS: We created a prevalent adult SCI cohort by identifying cases between April 1, 2002 and December 31, 2017 who were followed for common SCI complications and location of healthcare access from January 1, 2018 to December 31, 2019 using administrative data sources housed within Alberta Health Services (AHS). First Nations and non-First Nations SCI cohorts were divided into SCI etiology: traumatic SCI (TSCI) and non-traumatic SCI (NTSCI). Statistical analyses compared prevalence, demographics, healthcare utilization, and SCI complication rates. A secondary analysis was performed using case matching for demographics, injury type, injury level, and comorbidities. RESULTS: TSCI prevalence: 248 and 117 per 100,000 in First Nations and non-First Nations cohorts, respectively. NTSCI prevalence: 74 and 50 per 100,000 in First Nations and non-First Nations cohorts, respectively. Visit rates were higher in the TSCI First Nations cohort for visits to General Practitioner (GP), Emergency Department (ED), inpatient visits, and inpatient days with higher complication rates due to pulmonary, genitourinary, skin, and 'other' causes after case matching. Visits rates were higher in the NTSCI First Nations cohort for GP and specialists without differences in complication types after case matching. CONCLUSIONS: Significant differences exist between First Nations and non-First Nations cohorts living with SCI in Alberta, suggesting healthcare inequities against First Nations Peoples in this province.

Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial.

INTRODUCTION: BedMed-Frail explores risks and benefits of switching antihypertensives from morning to bedtime in a frail population at greater risk of hypotensive adverse effects. METHODS AND ANALYSIS: Design: Prospective parallel randomised, open-label, blinded end-point trial.Participants: Hypertensive continuing care residents, in either long-term care or supportive living, who are free from glaucoma, and using ≥1 once daily antihypertensive.Setting: 16 volunteer continuing care facilities in Alberta, Canada, with eligible residents identified using electronic health claims data.Intervention: All non-opted out eligible residents are randomised centrally by the provincial health data steward to bedtime versus usual care (typically morning) administration of once daily antihypertensives. Timing changes are made (maximum one change per week) by usual care facility pharmacists.Follow-up: Via linked governmental healthcare databases tracking hospital, continuing care and community medical services.Primary outcome: Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke, or congestive heart failure.Secondary outcomes: Each primary outcome element on its own, all-cause unplanned hospitalisation or emergency department visit, non-vertebral fracture and, as assessed roughly 135 days postrandomisation, fall in the last 30 days, deteriorated cognition, urinary incontinence, decubitus skin ulceration, inappropriate or disruptive behaviour a minimum of 4 days per week, and receipt of antipsychotic medication or physical restraints in the last 7 days.Process outcome: Proportion of blood pressure medication doses taken at bedtime (broken down monthly).Primary outcome analysis: Cox-Proportional Hazards Survival Analysis.Sample size: The trial will continue until a projected 368 primary outcome events have occurred.Current status: Enrolment is ongoing with 642 randomisations to date (75% female, mean age 88 years). ETHICS AND DISSEMINATION: BedMed-Frail has ethical approval from the University of Alberta Health Ethics Review Board (Pro00086129) and will publish results in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04054648.

Tolerability of bedtime diuretics: a prospective cohort analysis.

OBJECTIVES: We sought to validate, or refute, the common belief that bedtime diuretics are poorly tolerated due to nocturia. DESIGN: Prespecified prospective cohort analysis embedded within the randomised BedMed trial, in which hypertensive participants are randomised to morning versus bedtime antihypertensive administration. SETTING: 352 community family practices across 4 Canadian provinces between March 2017 and September 2020. PARTICIPANTS: 552 hypertensive patients (65.6 years old, 57.4% female) already established on a single once-daily morning antihypertensive and randomised to switch that antihypertensive to bedtime. Of these, 203 used diuretics (27.1% thiazide alone, 70.0% thiazide/non-diuretic combinations) and 349 used non-diuretics. INTERVENTION: Switching the established antihypertensive from morning to bedtime, and comparing the experience of diuretic and non-diuretic users. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: Adherence to bedtime allocation time at 6 months (defined as the willingness to continue with bedtime use, not an assessment of missed doses). Secondary 6-month outcomes: (1) nocturia considered to be a major burden and (2) increase in overnight urinations/week. All outcomes were self-reported and additionally collected at 6 weeks. RESULTS: At 6 months: Adherence to bedtime allocation time was lower in diuretic users than non-diuretic users (77.3% vs 89.8%; difference 12.6%; 95% CI 5.8% to 19.8%; p<0.0001; NNH 8.0), and more diuretic users considered nocturia a major burden (15.6% vs 1.3%; difference 14.2%; 95% CI 8.9% to 20.6%; p<0.0001; NNH 7.0). Compared with baseline, diuretic users experienced 1.0 more overnight urinations/week (95% CI 0.0 to 1.75; p=0.01). Results did not differ between sexes. CONCLUSIONS: Switching diuretics to bedtime did promote nocturia, but only 15.6% found nocturia a major burden. At 6 months, 77.3% of diuretic users were adherent to bedtime dosing. Bedtime diuretic use is viable for many hypertensive patients, should it ever become clinically indicated. TRIAL REGISTRATION NUMBER: NCT02990663.

Novel Application of the World Health Organization Community-Based Rehabilitation Matrix to Understand Services' Contributions to Community Participation for Persons With Traumatic Spinal Cord Injury: A Mixed-Methods Study.

PURPOSE: The aim of the study is to use the World Health Organization community-based rehabilitation matrix for understanding services' contributions to foster community participation for people with traumatic spinal cord injury. METHODS: This study used a convergent mixed-methods design with a quantitative arm describing the frequency with which services contributed to 22 of the community-based rehabilitation-matrix elements and a qualitative arm involving document reviews and stakeholder interviews. Results were integrated following Onwuegbuzie and Teddlie's method (i.e., quan + QUAL). RESULTS: Twenty of the 22 (91%) of the World Health Organization community-based rehabilitation elements were addressed by traumatic spinal cord injury services. Five types of services were identified. Integrated results showed that the strengths of traumatic spinal cord injury services were as follows: (1) comprehensiveness; (2) essential medical services publicly funded; (3) numerous social protections available; and (4) highly active community-based organizations. Identified opportunities to improve these services were as follows: (1) increase specificity for traumatic spinal cord injury and (2) increase communication and integration among services. CONCLUSIONS: Services available for people with traumatic spinal cord injury in the province studied address most of the elements of the World Health Organization community-based rehabilitation matrix. However, lack of cohesion between services could create gaps that hinder community participation. Addressing these gaps could improve the quality of life and outcomes of people with traumatic spinal cord injury.

Frequency and Type of Outpatient Visits for Patients With Cardiovascular Ambulatory-Care Sensitive Conditions During the COVID-19 Pandemic and Subsequent Outcomes: A Retrospective Cohort Study.

Background Because the impact of changes in how outpatient care was delivered during the COVID-19 pandemic is uncertain, we designed this study to examine the frequency and type of outpatient visits between March 1, 2019 to February 29, 2020 (prepandemic) and from March 1, 2020 to February 28, 2021 (pandemic) and specifically compared outcomes after virtual versus in-person outpatient visits during the pandemic. Methods and Results Population-based retrospective cohort study of all 3.8 million adults in Alberta, Canada. We examined all physician visits and 30- and 90-day outcomes, with a focus on those adults with the cardiovascular ambulatory-care sensitive conditions heart failure, hypertension, and diabetes. Our primary outcome was emergency department visit or hospitalization, evaluated using survival analysis accounting for competing risk of death. Although in-person outpatient visits decreased by 38.9% in the year after March 1, 2020 (10 142 184 versus 16 592 599 in the prior year), the introduction of virtual visits (7 152 147; 41.4% of total) meant that total outpatient visits increased by 4.1% in the first year of the pandemic for Albertan adults. Outpatient visit frequency (albeit 41.4% virtual, 58.6% in-person) and prescribing patterns were stable in the first year after pandemic onset for patients with the cardiovascular ambulatory-care sensitive conditions we examined, but laboratory test frequency declined by 20% (serum creatinine) to 47% (glycosylated hemoglobin). In the first year of the pandemic, virtual outpatient visits were associated with fewer subsequent emergency department visits or hospitalizations (compared with in-person visits) for patients with heart failure (adjusted hazard ratio [aHR], 0.90 [95% CI, 0.85-0.96] at 30 days and 0.96 [95% CI, 0.92-1.00] at 90 days), hypertension (aHR, 0.88 [95% CI, 0.85-0.91] and 0.93 [95% CI, 0.91-0.95] at 30 and 90 days), or diabetes (aHR, 0.90 [95% CI, 0.87-0.93] and 0.93 [95% CI, 0.91-0.95] at 30 and 90 days). Conclusions The adoption and rapid uptake of virtual outpatient care during the COVID-19 pandemic did not negatively impact frequency of follow-up, prescribing, or short-term outcomes, and could have potentially positively impacted some of these for adults with heart failure, diabetes, or hypertension in a setting where there was an active reimbursement policy for virtual visits. Given declines in laboratory monitoring and screening activities, further research is needed to evaluate whether long-term outcomes will differ.

The empirical estimate of the survival and variance using a weighted composite endpoint.

BACKGROUND: Composite endpoints for estimating treatment efficacy are routinely used in several therapeutic areas and have become complex in the number and types of component outcomes included. It is assumed that its components are of similar asperity and chronology between both treatment arms as well as uniform in magnitude of the treatment effect. However, these assumptions are rarely satisfied. Understanding this heterogeneity is important in developing a meaningful assessment of the treatment effect. METHODS: We developed the Weighted Composite Endpoint (WCE) method which uses weights derived from stakeholder values for each event type in the composite endpoint. The derivation for the product limit estimator and the variance of the estimate are presented. The method was then tested using data simulated from parameters based on a large cardiovascular trial. Variances from the estimated and traditional approach are compared through increasing sample size. RESULTS: The WCE method used all of the events through follow-up and generated a multiple recurrent event survival. The treatment effect was measured as the difference in mean survivals between two treatment arms and corresponding 95% confidence interval, providing a less conservative estimate of survival and variance, giving a higher survival with a narrower confidence interval compared to the traditional time-to-first-event analysis. CONCLUSIONS: The WCE method embraces the clinical texture of events types by incorporating stakeholder values as well as all events during follow-up. While the effective number of events is lower in the WCE analysis, the reduction in variance enhances the ability to detect a treatment effect in clinical trials.

Assessing the impact of COVID-19 pandemic on the health of residents and the healthcare system in Alberta, Canada: an observational study-The Alberta POST-COVID Follow-up Study.

INTRODUCTION: Very little is known about how the COVID-19 pandemic has affected the health of residents and the healthcare system in Alberta, Canada. The purpose of this study is to establish an observational study to characterise the health of residents in Alberta, Canada, over time, covering a population that tested negative or positive for COVID-19 during the pandemic. The primary outcome is to characterise 'long COVID-19' and the health status of residents during the COVID-19 pandemic. Secondary outcomes include the estimation of the risk of and risk factors associated with adverse health outcomes and healthcare utilisation and burdens. METHODS AND ANALYSIS: This is a population-level provincial observational study which will follow-up with Alberta residents who underwent testing for COVID-19 and completed surveys adapted from the ISARIC COVID-19 long-term follow-up survey. The survey data will be linked with medical records. Statistical analyses will be carried out to characterise 'long COVID-19' and the health status of residents during the pandemic. The outcomes of this study will inform strategies for primary care and rehabilitation services to prevent chronic consequences; contribute to healthcare management, interventional studies, rehabilitation and health management to reduce overall morbidity and improve long-term outcomes of COVID-19 and the COVID-19 pandemic and potentially guide a self-evaluation of a remote monitoring system to manage individuals' health. ETHICS AND DISSEMINATION: This study was reviewed and approved by the University of Alberta ethics committee (Study ID: Pro00112053 & Pro00113039) on 13 August 2021 and adheres to the Alberta Health Services research information management policy. Study results will be used to manage clinical care, published in peer-reviewed journals and presented at local, national and international conferences. PROTOCOL VERSION: 6 June 2022 EUROQOL ID: 161 015.

Variation in Testing for and Incidence of Celiac Autoimmunity in Canada: A Population-Based Study.

BACKGROUND & AIMS: The incidence of biopsy-confirmed celiac disease has increased. However, few studies have explored the incidence of celiac autoimmunity based on positive serology results. METHODS: A population-based cohort study assessed testing of tissue transglutaminase antibodies (tTG-IgA) in Alberta from 2012 to 2020. After excluding prevalent cases, incident celiac autoimmunity was defined as the first positive tTG-IgA result between 2015 and 2020. Testing and incidence rates for celiac autoimmunity were calculated per 1000 and 100,000 person-years, respectively. Incidence rate ratios (IRRs) were calculated to identify differences by demographic and regional factors. Average annual percent changes (AAPCs) assessed trends over time. RESULTS: The testing rate of tTG-IgA was 20.2 per 1000 person-years and remained stable from 2012 to 2020 (AAPC, 1.2%; 95% confidence interval [CI], -0.5 to 2.9). Testing was higher in female patients (IRR, 1.66; 95% CI, 1.65-1.66), those living in metropolitan areas (IRR, 1.39; 95% CI, 1.38-1.40), and in areas of lower socioeconomic deprivation (lowest compared to highest IRR, 1.24; 95% CI, 1.23-1.25). Incidence of celiac autoimmunity was 33.8 per 100,000 person-years and increased from 2015 to 2020 (AAPC, 6.2%; 95% CI, 3.1-9.5). Among those with tTG-IgA results ≥10 times the upper limit of normal, the incidence was 12.9 per 100,000 person-years. The incidence of celiac autoimmunity was higher in metropolitan settings (IRR, 1.28; 95% CI, 1.21-1.35) and in the least socioeconomically deprived areas compared to the highest (IRR, 1.22; 95% CI, 1.14-1.32). CONCLUSIONS: Incidence of celiac autoimmunity is high and increasing, despite stable testing rates. Variation in testing patterns may lead to underreporting the incidence of celiac autoimmunity in nonmetropolitan areas and more socioeconomically deprived neighborhoods.