Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design. METHODS: This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs. RESULTS: We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio, 0.78 [95% CI, 0.61 to 1.00]; P=0.047). No significant between-group changes in quality of life over time were observed (mean difference, 0.0001 [95% CI, -0.018 to 0.018]; P=0.99). The proportion of participants who were adherent to medications was not different between the 2 groups (P=0.199 for statins and P=0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; P=0.320). CONCLUSIONS: For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes. METHODS: This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs. RESULTS: A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P=0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P=0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P=0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P=0.098). CONCLUSIONS: In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Health system structure and its influence on outcomes: The Canadian experience.

Healthcare delivery systems in Canada are structured using three models: individual institutions, health regions, and single provincial systems, usually with smaller geographic zones. The comparative ability of these models to improve care, outcomes, and the Quadruple Aim is largely unstudied. We reviewed Canadian studies examining outcomes of provincial healthcare delivery system restructuring. Across models, results were inconsistent, and quality of evidence was low. For all provinces, primary care sits outside healthcare delivery systems, with limited governance and integration. The single provincial model can reduce costs of non-clinical support functions like finance, human resources, and analytics. This model may also be best at reducing variations in care, improving electronic information integration that enables clinical decision support and reporting, and supporting the provincial spread and scale of innovations, but further refinements are required and existing studies have major limitations, limiting definitive conclusions.

Association of Kidney Function With Major Postoperative Events After Noncardiac Ambulatory Surgeries: A Population-Based Cohort Study.

OBJECTIVE: The aim of this study was to estimate the association between estimated glomerular filtration rate (eGFR) and acute myocardial infarction (AMI) or death after ambulatory noncardiac surgery. SUMMARY BACKGROUND DATA: People with chronic kidney disease (CKD) commonly undergo surgical procedures. Although most are performed in an ambulatory setting, the risk of major perioperative outcomes after ambulatory surgery for people with CKD is unknown. METHODS: In this retrospective population-based cohort study using administrative health data from Alberta, Canada, we included adults with measured preoperative kidney function undergoing ambulatory noncardiac surgery between April 1, 2005 and February 28, 2017. Participants were categorized into 6 eGFR categories (in mL/min/1.73m 2 )of ≥60 (G1-2), 45 to 59 (G3a), 30 to 44 (G3b), 15 to 29 (G4), <15 not receiving dialysis (G5ND), and those receiving chronic dialysis (G5D). The odds of AMI or death within 30 days of surgery were estimated using multivariable generalized estimating equation models. RESULTS: We identified 543,160 procedures in 323,521 people with a median age of 66 years (IQR 56-76); 52% were female. Overall, 2338 people (0.7%) died or had an AMI within 30 days of surgery. Compared with the G1-2 category, the adjusted odds ratio of death or AMI increased from 1.1 (95% confidence interval: 1.0-1.3) for G3a to 3.1 (2.6-3.6) for G5D. Emergency Department and Urgent Care Center visits within 30 days were frequent (17%), though similar across eGFR categories. CONCLUSIONS: Ambulatory surgery was associated with a low risk of major postoperative events. This risk was higher for people with CKD, which may inform their perioperative shared decision-making and management.

Quality improvement strategies for diabetes care: Effects on outcomes for adults living with diabetes.

BACKGROUND: There is a large body of evidence evaluating quality improvement (QI) programmes to improve care for adults living with diabetes. These programmes are often comprised of multiple QI strategies, which may be implemented in various combinations. Decision-makers planning to implement or evaluate a new QI programme, or both, need reliable evidence on the relative effectiveness of different QI strategies (individually and in combination) for different patient populations. OBJECTIVES: To update existing systematic reviews of diabetes QI programmes and apply novel meta-analytical techniques to estimate the effectiveness of QI strategies (individually and in combination) on diabetes quality of care. SEARCH METHODS: We searched databases (CENTRAL, MEDLINE, Embase and CINAHL) and trials registers (ClinicalTrials.gov and WHO ICTRP) to 4 June 2019. We conducted a top-up search to 23 September 2021; we screened these search results and 42 studies meeting our eligibility criteria are available in the awaiting classification section. SELECTION CRITERIA: We included randomised trials that assessed a QI programme to improve care in outpatient settings for people living with diabetes. QI programmes needed to evaluate at least one system- or provider-targeted QI strategy alone or in combination with a patient-targeted strategy. - System-targeted: case management (CM); team changes (TC); electronic patient registry (EPR); facilitated relay of clinical information (FR); continuous quality improvement (CQI). - Provider-targeted: audit and feedback (AF); clinician education (CE); clinician reminders (CR); financial incentives (FI). - Patient-targeted: patient education (PE); promotion of self-management (PSM); patient reminders (PR). Patient-targeted QI strategies needed to occur with a minimum of one provider or system-targeted strategy. DATA COLLECTION AND ANALYSIS: We dual-screened search results and abstracted data on study design, study population and QI strategies. We assessed the impact of the programmes on 13 measures of diabetes care, including: glycaemic control (e.g. mean glycated haemoglobin (HbA1c)); cardiovascular risk factor management (e.g. mean systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), proportion of people living with diabetes that quit smoking or receiving cardiovascular medications); and screening/prevention of microvascular complications (e.g. proportion of patients receiving retinopathy or foot screening); and harms (e.g. proportion of patients experiencing adverse hypoglycaemia or hyperglycaemia). We modelled the association of each QI strategy with outcomes using a series of hierarchical multivariable meta-regression models in a Bayesian framework. The previous version of this review identified that different strategies were more or less effective depending on baseline levels of outcomes. To explore this further, we extended the main additive model for continuous outcomes (HbA1c, SBP and LDL-C) to include an interaction term between each strategy and average baseline risk for each study (baseline thresholds were based on a data-driven approach; we used the median of all baseline values reported in the trials). Based on model diagnostics, the baseline interaction models for HbA1c, SBP and LDL-C performed better than the main model and are therefore presented as the primary analyses for these outcomes. Based on the model results, we qualitatively ordered each QI strategy within three tiers (Top, Middle, Bottom) based on its magnitude of effect relative to the other QI strategies, where 'Top' indicates that the QI strategy was likely one of the most effective strategies for that specific outcome. Secondary analyses explored the sensitivity of results to choices in model specification and priors.  Additional information about the methods and results of the review are available as Appendices in an online repository. This review will be maintained as a living systematic review; we will update our syntheses as more data become available. MAIN RESULTS: We identified 553 trials (428 patient-randomised and 125 cluster-randomised trials), including a total of 412,161 participants. Of the included studies, 66% involved people living with type 2 diabetes only. Participants were 50% female and the median age of participants was 58.4 years. The mean duration of follow-up was 12.5 months. HbA1c was the commonest reported outcome; screening outcomes and outcomes related to cardiovascular medications, smoking and harms were reported infrequently. The most frequently evaluated QI strategies across all study arms were PE, PSM and CM, while the least frequently evaluated QI strategies included AF, FI and CQI. Our confidence in the evidence is limited due to a lack of information on how studies were conducted.  Four QI strategies (CM, TC, PE, PSM) were consistently identified as 'Top' across the majority of outcomes. All QI strategies were ranked as 'Top' for at least one key outcome. The majority of effects of individual QI strategies were modest, but when used in combination could result in meaningful population-level improvements across the majority of outcomes. The median number of QI strategies in multicomponent QI programmes was three.  Combinations of the three most effective QI strategies were estimated to lead to the below effects:  - PR + PSM + CE: decrease in HbA1c by 0.41% (credibility interval (CrI) -0.61 to -0.22) when baseline HbA1c < 8.3%; - CM + PE + EPR: decrease in HbA1c by 0.62% (CrI -0.84 to -0.39) when baseline HbA1c > 8.3%;  - PE + TC + PSM: reduction in SBP by 2.14 mmHg (CrI -3.80 to -0.52) when baseline SBP < 136 mmHg; - CM + TC + PSM: reduction in SBP by 4.39 mmHg (CrI -6.20 to -2.56) when baseline SBP > 136 mmHg;  - TC + PE + CM: LDL-C lowering of 5.73 mg/dL (CrI -7.93 to -3.61) when baseline LDL < 107 mg/dL; - TC + CM + CR: LDL-C lowering by 5.52 mg/dL (CrI -9.24 to -1.89) when baseline LDL > 107 mg/dL. Assuming a baseline screening rate of 50%, the three most effective QI strategies were estimated to lead to an absolute improvement of 33% in retinopathy screening (PE + PR + TC) and 38% absolute increase in foot screening (PE + TC + Other). AUTHORS' CONCLUSIONS: There is a significant body of evidence about QI programmes to improve the management of diabetes. Multicomponent QI programmes for diabetes care (comprised of effective QI strategies) may achieve meaningful population-level improvements across the majority of outcomes. For health system decision-makers, the evidence summarised in this review can be used to identify strategies to include in QI programmes. For researchers, this synthesis identifies higher-priority QI strategies to examine in further research regarding how to optimise their evaluation and effects. We will maintain this as a living systematic review.

The dynamic nature of patient engagement within a Canadian patient-oriented kidney health research network: Perspectives of researchers and patient partners.

INTRODUCTION: Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease (Can-SOLVE CKD) is a pan-Canadian health research network that engages patients as partners across 18 unique projects and core infrastructure. In this qualitative study, we explored how research teams integrated patient partners into network research activities to inform our patient engagement approach. METHODS: To capture a breadth of perspectives, this qualitative descriptive study purposively sampled researchers and patient partners across 18 network research teams. We conducted 4 focus groups (2 patients and 2 researchers; n = 26) and 28 individual telephone interviews (n = 12 patient partners; n = 16 researchers). Transcripts were coded in duplicate, and themes were developed through an inductive, thematic analysis approach. RESULTS: We included 24 patient partners and 24 researchers from 17 of the 18 projects and all core committees within the network. Overarching concepts relate participants' initial impressions and uncertainty about patient engagement to an evolving appreciation of its value, impact and sustainability. We identified four themes with subthemes that characterized the dynamic nature of patient engagement and how participants integrated patients across network initiatives: (1) Reinforcing a shared purpose (learning together, collective commitment, evolving attitudes); (2) Fostering a culture of responsive and innovative research (accessible supports, strengthened process and product); (3) Aligning priorities, goals and needs (amenability to patient involvement, mutually productive relationships, harmonizing expectations); (4) Building a path to sustainability (value creation, capacity building, sustaining knowledge use). CONCLUSIONS: Our findings demonstrate the dynamic and adaptive processes related to patient engagement within a national, patient-oriented kidney health research network. Optimization of support structures and capacity are key factors to promote sustainability of engagement processes within and beyond the network. PATIENT OR PUBLIC CONTRIBUTION: This project was conceived in collaboration with a Can-SOLVE CKD patient partner (N. F.), with lived experience of kidney failure. He also co-designed the study's protocol, led focus groups and researcher interviews, and contributed to data analysis. L. G. has lived experience as a caregiver for a person with CKD and facilitated patient partner focus groups. The patient partners, both of whom are listed authors, provided important insights that shaped our interpretation and presentation of study findings.

Prediction of major postoperative events after non-cardiac surgery for people with kidney failure: derivation and internal validation of risk models.

BACKGROUND: People with kidney failure often require surgery and experience worse postoperative outcomes compared to the general population, but existing risk prediction tools have excluded those with kidney failure during development or exhibit poor performance. Our objective was to derive, internally validate, and estimate the clinical utility of risk prediction models for people with kidney failure undergoing non-cardiac surgery. DESIGN, SETTING, PARTICIPANTS, AND MEASURES: This study involved derivation and internal validation of prognostic risk prediction models using a retrospective, population-based cohort. We identified adults from Alberta, Canada with pre-existing kidney failure (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73m2 or receipt of maintenance dialysis) undergoing non-cardiac surgery between 2005-2019. Three nested prognostic risk prediction models were assembled using clinical and logistical rationale. Model 1 included age, sex, dialysis modality, surgery type and setting. Model 2 added comorbidities, and Model 3 added preoperative hemoglobin and albumin. Death or major cardiac events (acute myocardial infarction or nonfatal ventricular arrhythmia) within 30 days after surgery were modelled using logistic regression models. RESULTS: The development cohort included 38,541 surgeries, with 1,204 outcomes (after 3.1% of surgeries); 61% were performed in males, the median age was 64 years (interquartile range [IQR]: 53, 73), and 61% were receiving hemodialysis at the time of surgery. All three internally validated models performed well, with c-statistics ranging from 0.783 (95% Confidence Interval [CI]: 0.770, 0.797) for Model 1 to 0.818 (95%CI: 0.803, 0.826) for Model 3. Calibration slopes and intercepts were excellent for all models, though Models 2 and 3 demonstrated improvement in net reclassification. Decision curve analysis estimated that use of any model to guide perioperative interventions such as cardiac monitoring would result in potential net benefit over default strategies. CONCLUSIONS: We developed and internally validated three novel models to predict major clinical events for people with kidney failure having surgery. Models including comorbidities and laboratory variables showed improved accuracy of risk stratification and provided the greatest potential net benefit for guiding perioperative decisions. Once externally validated, these models may inform perioperative shared decision making and risk-guided strategies for this population.

A Systems-Level Evaluation Framework for Virtual Care.

The virtual care landscape is significantly changing, largely due to an increased demand initiated by the COVID-19 pandemic and the evolution of technology. Complex questions about how to best leverage virtual care and its impact remain unanswered. Our team developed a systems-level evaluation framework to inform virtual care service design and evaluation to take a more comprehensive approach to planning and implementing virtual care. We designed the framework for application in Alberta Health Services (AHS) by engaging virtual care users (patients, families and healthcare providers), implementation staff and decision makers across the organization. Here we report our design process and key lessons learned. The framework received endorsement by AHS senior leadership for application across the system. Our next step is to test the framework. By sharing our design process and experiences, we aim to help inform other national and international jurisdictions plan virtual care evaluations within their context.

Avoidable intensive care unit resource use and costs of unvaccinated patients with COVID-19: a historical population-based cohort study.

PURPOSE: SARS-CoV-2 vaccines have been proven effective at preventing poor outcomes from COVID-19; however, voluntary vaccination rates have been suboptimal. We assessed the potential avoidable intensive care unit (ICU) resource use and associated costs had unvaccinated or partially vaccinated patients hospitalized with COVID-19 been fully vaccinated. METHODS: We conducted a retrospective, population-based cohort study of persons aged 12 yr or greater in Alberta (2021 population ~ 4.4 million) admitted to any ICU with COVID-19 from 6 September 2021 to 4 January 2022. We used publicly available aggregate data on COVID-19 infections, vaccination status, and health services use. Intensive care unit admissions, bed-days, lengths of stay, and costs were estimated for patients with COVID-19 and stratified by vaccination status. RESULTS: In total, 1,053 patients admitted to the ICU with COVID-19 were unvaccinated, 42 were partially vaccinated, and 173 were fully vaccinated (cumulative incidence 230.6, 30.8, and 5.5 patients/100,000 population, respectively). Cumulative incidence rate ratios of ICU admission were 42.2 (95% confidence interval [CI], 39.7 to 44.9) for unvaccinated patients and 5.6 (95% CI, 4.1 to 7.6) for partially vaccinated patients when compared with fully vaccinated patients. During the study period, 1,028 avoidable ICU admissions and 13,015 bed-days were recorded for unvaccinated patients and the total avoidable costs were CAD 61.3 million. The largest opportunity to avoid ICU bed-days and costs was in unvaccinated patients aged 50 to 69 yr. CONCLUSIONS: Unvaccinated patients with COVID-19 had substantially greater rates of ICU admissions, ICU bed-days, and ICU-related costs than vaccinated patients did. This increased resource use would have been potentially avoidable had these unvaccinated patients been vaccinated against SARS-CoV-2.

RéSUMé: OBJECTIF: Les vaccins contre le SRAS-CoV-2 se sont avérés efficaces pour prévenir les devenirs défavorables associés à la COVID-19; toutefois, les taux de vaccination volontaire ont été sous-optimaux. Nous avons évalué l'utilisation potentiellement évitable des ressources des unités de soins intensifs (USI) et les coûts associés si les patients non vaccinés ou partiellement vaccinés qui ont dû être hospitalisés pour la COVID-19 avaient été complètement vaccinés. MéTHODE: Nous avons réalisé une étude de cohorte rétrospective basée sur la population de personnes âgées de 12 ans ou plus en Alberta (population de 2021 ~ 4,4 millions) admises dans une unité de soins intensifs et atteintes de COVID-19 du 6 septembre 2021 au 4 janvier 2022. Nous avons utilisé des données agrégées accessibles au public sur les infections à la COVID-19, le statut vaccinal et l'utilisation des services de santé. Les admissions aux soins intensifs, les journées-patients, les durées de séjour et les coûts ont été estimés pour les patients atteints de la COVID-19 et stratifiés selon le statut vaccinal. RéSULTATS: Au total, 1053 patients admis à l'USI souffrant de la COVID-19 n'étaient pas vaccinés, 42 étaient partiellement vaccinés et 173 étaient complètement vaccinés (incidence cumulative 230,6, 30,8 et 5,5 patients / 100 000 habitants, respectivement). Les taux d'incidence cumulés des admissions aux soins intensifs étaient de 42,2 (intervalle de confiance [IC] à 95 %, 39,7 à 44,9) pour les patients non vaccinés et de 5,6 (IC 95 %, 4,1 à 7,6) pour les patients partiellement vaccinés par rapport aux patients entièrement vaccinés. Au cours de la période à l'étude, 1028 admissions évitables aux soins intensifs et 13 015 journées-patients ont été enregistrées pour les patients non vaccinés, et les coûts totaux évitables étaient de 61,3 millions de dollars canadiens. L'économie potentielle la plus importante en matière de journées-patients et de coûts en soins intensifs touchait les patients non vaccinés âgés de 50 à 69 ans. CONCLUSION: Les patients non vaccinés atteints de COVID-19 ont affiché des taux beaucoup plus élevés d'admissions à l'USI, de journées-patients à l'USI et de coûts liés à l'USI que les patients vaccinés. Cette utilisation accrue des ressources aurait été potentiellement évitable si ces patients non vaccinés avaient été vaccinés contre le SRAS-CoV-2.

Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial.

BACKGROUND: The Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise. METHODS: To evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting. RESULTS: The analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient. CONCLUSIONS: A multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987.

Variation in Patient-Described Barriers to and Facilitators of Diabetes Management by Individual-Level Characteristics: A Cross-Sectional, Open-Ended Survey.

This study analyzed patient-described barriers and facilitators related to diabetes management, focusing on how these differ by glycemia and across individual characteristics. A cross-sectional telephone survey was conducted with adult patients with diabetes in Alberta, Canada, asking two open-ended questions to describe the most helpful and difficult components of their diabetes management. Responses were analyzed using directed content analysis using the Theoretical Domains Framework as a template. The most frequently cited facilitator was care context and information, and the most frequently cited barriers were cognitive challenges and structural barriers, with patient-perceived barriers and facilitators varying by individual-level factors.

Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial.

BACKGROUND: Adherence to medicines is low for a variety of reasons, including the cost borne by patients. Some jurisdictions publicly fund medicines for the general population, but many jurisdictions do not, and such policies are contentious. To our knowledge, no trials studying free access to a wide range of medicines have been conducted. METHODS AND FINDINGS: We randomly assigned 786 primary care patients who reported not taking medicines due to cost between June 1, 2016 and April 28, 2017 to either free distribution of essential medicines (n = 395) or to usual medicine access (n = 391). The trial was conducted in Ontario, Canada, where hospital care and physician services are publicly funded for the general population but medicines are not. The trial population was mostly female (56%), younger than 65 years (83%), white (66%), and had a low income from wages as the primary source (56%). The primary outcome was medicine adherence after 2 years. Secondary outcomes included control of diabetes, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients taking relevant treatments and healthcare costs over 2 years. Adherence to all appropriate prescribed medicines was 38.7% in the free distribution group and 28.6% in the usual access group after 2 years (absolute difference 10.1%; 95% confidence interval (CI) 3.3 to 16.9, p = 0.004). There were no statistically significant differences in control of diabetes (hemoglobin A1c 0.27; 95% CI -0.25 to 0.79, p = 0.302), systolic blood pressure (-3.9; 95% CI -9.9 to 2.2, p = 0.210), or LDL cholesterol (0.26; 95% CI -0.08 to 0.60, p = 0.130) based on available data. Total healthcare costs over 2 years were lower with free distribution (difference in median CAN$1,117; 95% CI CAN$445 to CAN$1,778, p = 0.006). In the free distribution group, 51 participants experienced a serious adverse event, while 68 participants in the usual access group experienced a serious adverse event (p = 0.091). Participants were not blinded, and some outcomes depended on participant reports. CONCLUSIONS: In this study, we observed that free distribution of essential medicines to patients with cost-related nonadherence substantially increased adherence, did not affect surrogate health outcomes, and reduced total healthcare costs over 2 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT02744963.

Estimated GFR and Incidence of Major Surgery: A Population-Based Cohort Study.

RATIONALE & OBJECTIVE: Kidney disease is associated with an increased risk for postoperative morbidity and mortality. However, the incidence of major surgery on a population level is unknown. We aimed to determine the incidence of major surgery by level of kidney function. STUDY DESIGN: Retrospective cohort study with entry from January 1, 2008, through December 31, 2009, and outcome surveillance from January 1, 2010, through December 31, 2016. SETTING & PARTICIPANTS: Population-based study using administrative health data from Alberta, Canada; adults with an outpatient serum creatinine measurement or receiving maintenance dialysis formed the study cohort. EXPOSURE: Participants were categorized into 6 estimated glomerular filtration rate (eGFR) categories: ≥60 (G1-G2), 45 to 59 (G3a), 30 to 44 (G3b), 15 to 29 (G4), and<15mL/min/1.73m2 with (G5D) and without (G5) dialysis. eGFR was examined as a time-varying exposure based on means of measurements within 3-month ascertainment periods throughout the study period. OUTCOME: Major surgery defined as surgery requiring admission to the hospital for at least 24 hours. ANALYTICAL APPROACH: Incidence rates (IRs) for overall major surgery were estimated using quasi-Poisson regression and adjusted for age, sex, income, location of residence, albuminuria, and Charlson comorbid conditions. Age- and sex-stratified IRs of 13 surgery subtypes were also estimated. RESULTS: 1,455,512 cohort participants were followed up for a median of 7.0 (IQR, 5.3) years, during which time 241,989 (16.6%) underwent a major surgery. Age and sex modified the relationship between eGFR and incidence of surgery. Men younger than 65 years receiving maintenance dialysis experienced the highest rates of major surgery, with an adjusted IR of 243.8 (95% CI, 179.8-330.6) per 1,000 person-years. There was a consistent trend of increasing surgery rates at lower eGFRs for most subtypes of surgery. LIMITATIONS: Outpatient preoperative serum creatinine measurement was necessary for inclusion and outpatient surgical procedures were not included. CONCLUSIONS: People with reduced eGFR have a significantly higher incidence of major surgery compared with those with normal eGFR, and age and sex modify this increased risk. This study informs our understanding of how surgical burden changes with differing levels of kidney function.

First-line pharmacotherapy for incident type 2 diabetes: Prescription patterns, adherence and associated costs.

AIMS: To use real-world prescription data from Alberta, Canada to: (a) describe the prescribing patterns for initial pharmacotherapy for those with newly diagnosed uncomplicated type 2 diabetes; (b) describe medication-taking behaviours (adherence and persistence) in the first year after initiating pharmacotherapy; and (c) explore healthcare system costs associated with prescribing patterns. METHODS: We employed a retrospective cohort design using linked administrative datasets from 2012 to 2017 to define a cohort of those with uncomplicated incident diabetes. We summarized the initial prescription patterns, adherence and costs (healthcare and pharmaceutical) over the first year after initiation of pharmacotherapy. Using multivariable regression, we determined the association of these outcomes with various sociodemographic characteristics. RESULTS: The majority of individuals for whom metformin was indicated as first-line therapy received a prescription for metformin monotherapy (89%). Older individuals, those with higher baseline A1C and those with no comorbidities, were most likely to be started on non-metformin agents. Adherence with the initially prescribed regimen was suboptimal overall, with nearly half (48%) being non-adherent over the first year. One-third of those who started metformin discontinued it in the first 3 months. Those started on non-metformin agents had roughly twice the healthcare costs, and five to seven times higher medication costs, compared to those started on metformin, in the first year after starting therapy. CONCLUSIONS: With the addition of new classes of medications, healthcare providers who look after those with type 2 diabetes have more pharmaceutical options than ever. Most individuals continue to be prescribed metformin monotherapy. However, adherence is suboptimal, and drops off considerably within the first 3 months.

Economic evaluation of an absorbable antibiotic envelope for prevention of cardiac implantable electronic device infection.

AIMS: Recent evidence suggests that an antibiotic impregnated envelope inserted at time of cardiac implantable electronic device (CIED) implantation may reduce risk of subsequent CIED infection compared with standard of care (SoC). The objective of the current work was to perform a cost-effectiveness analysis comparing an antibiotic impregnated envelope with SoC at time of CIED insertion. METHODS AND RESULTS: Decision analytic models were used to project healthcare costs and benefits of two strategies, an antibiotic impregnated envelope plus SoC (Env+SoC) vs. SoC alone, in a cohort of patients undergoing CIED implantation over a 1-year time horizon. Evidence from published literature informed the model inputs. Probabilistic and deterministic sensitivity analyses were performed. The primary outcome was the incremental cost per infection prevented, assessed from the Canadian healthcare system perspective. Envelope plus SoC was associated with fewer CIED infection (7 CIED infections/1000 patients) at higher total costs ($29 033 000/1000 patients) compared with SoC (11 CIED infections and $27 926 000/1000 patients). The incremental cost per infection prevented over 1 year was $274 416. Use of Env+SoC was cost saving only when baseline CIED infection risk was increased to 6% (vs. base case of 1.2%). CONCLUSIONS: A strategy of Env+SoC was not economically favourable compared with SoC alone, and the opportunity cost of widescale implementation should be considered. Future work is required to develop validated risk stratification tools to identify patients at greatest risk of CIED infection. The value proposition of Env+SoC improves when applying this intervention to patients at greatest infection risk.

Mortality and cardiovascular events in adults with kidney failure after major non-cardiac surgery: a population-based cohort study.

BACKGROUND: People with kidney failure have a high incidence of major surgery, though the risk of perioperative outcomes at a population-level is unknown. Our objective was to estimate the proportion of people with kidney failure that experience acute myocardial infarction (AMI) or death within 30 days of major non-cardiac surgery, based on surgery type. METHODS: In this retrospective population-based cohort study, we used administrative health data to identify adults from Alberta, Canada with major surgery between April 12,005 and February 282,017 that had preoperative estimated glomerular filtration rates (eGFRs) < 15 mL/min/1.73m2 or received chronic dialysis. The index surgical procedure for each participant was categorized within one of fourteen surgical groupings based on Canadian Classification of Health Interventions (CCI) codes applied to hospitalization administrative datasets. We estimated the proportion of people that had AMI or died within 30 days of the index surgical procedure (with 95% confidence intervals [CIs]) following logistic regression, stratified by surgery type. RESULTS: Overall, 3398 people had a major surgery (1905 hemodialysis; 590 peritoneal dialysis; 903 non-dialysis). Participants were more likely male (61.0%) with a median age of 61.5 years (IQR 50.0-72.7). Within 30 days of surgery, 272 people (8.0%) had an AMI or died. The probability was lowest following ophthalmologic surgery at 1.9% (95%CI: 0.5, 7.3) and kidney transplantation at 2.1% (95%CI: 1.3, 3.2). Several types of surgery were associated with greater than one in ten risk of AMI or death, including retroperitoneal (10.0% [95%CI: 2.5, 32.4]), intra-abdominal (11.7% [8.7, 15.5]), skin and soft tissue (12.1% [7.4, 19.1]), musculoskeletal (MSK) (12.3% [9.9, 15.5]), vascular (12.6% [10.2, 15.4]), anorectal (14.7% [6.3, 30.8]), and neurosurgical procedures (38.1% [20.3, 59.8]). Urgent or emergent procedures had the highest risk, with 12.1% experiencing AMI or death (95%CI: 10.7, 13.6) compared with 2.6% (1.9, 3.5) following elective surgery. CONCLUSIONS: After major non-cardiac surgery, the risk of death or AMI for people with kidney failure varies significantly based on surgery type. This study informs our understanding of surgery type and risk for people with kidney failure. Future research should focus on identifying high risk patients and strategies to reduce these risks.

Online clinical pathway for chronic kidney disease management in primary care: a retrospective cohort study.

BACKGROUND: Clinical pathways aim to improve patient care. We sought to determine whether an online chronic kidney disease (CKD) clinical pathway was associated with improvements in CKD management. METHODS: We conducted a retrospective pre/post population-based cohort study using linked health data from Alberta, Canada. We included adults 18 years or older with mean estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2. The primary outcome was measurement of an outpatient urine albumin creatinine ratio (ACR) in a 28-day period, among people without a test in the prior year. Secondary outcomes included use of guideline-recommended drug therapies (angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and statins). RESULTS: The study period spanned October 2010 to March 2017. There were 84 independent 28-day periods (53 pre, 31 post pathway implementation) including 345,058 adults. The population was predominantly female (56%) with median age 77 years; most had category 3A CKD (67%) and hypertension (82%). In adjusted segmented regression models, the increase in the rate of change of ACR testing was greatest in Calgary zone (adjusted OR 1.19 per year, 95% CI 1.16-1.21), where dissemination of the pathway was strongest; this increase was more pronounced in those without diabetes (adjusted OR 1.25 per year, 95% CI 1.21-1.29). Small improvements in guideline-concordant medication use were also observed. CONCLUSIONS: Following implementation of an online CKD clinical pathway, improvements in ACR testing were evident in regions where the pathway was most actively used, particularly among individuals without diabetes.

Attitudes, behaviours and barriers to public health measures for COVID-19: a survey to inform public health messaging.

BACKGROUND: Public support of public health measures including physical distancing, masking, staying home while sick, avoiding crowded indoor spaces and contact tracing/exposure notification applications remains critical for reducing spread of COVID-19. The aim of our work was to understand current behaviours and attitudes towards public health measures as well as barriers individuals face in following public health measures. We also sought to identify attitudes persons have regarding a COVID-19 vaccine and reasons why they may not accept a vaccine. METHODS: A cross-sectional online survey was conducted in August 2020, in Alberta, Canada in persons 18 years and older. This survey evaluated current behaviours, barriers and attitudes towards public health measures and a COVID-19 vaccine. Cluster analysis was used to identify key patterns that summarize data variations among observations. RESULTS: Of the 60 total respondents, the majority of persons were always or often physically distancing (73%), masking (65%) and staying home while sick (67%). Bars/pubs/lounges or nightclubs were visited rarely or never by 63% of respondents. Persons identified staying home while sick to provide the highest benefit (83%) in reducing spread of COVID-19. There were a large proportion of persons who had not downloaded or used a contact tracing/exposure notification app (77%) and who would not receive a COVID-19 vaccine when available (20%) or were unsure (12%). Reporting health authorities as most trusted sources of health information was associated with greater percentage of potential uptake of vaccine but not related to contact tracing app download and use. Individuals with lower concern of getting and spreading COVID-19 showed the least uptake of public health measures except for avoiding public places such as bars. Lower concern regarding COVID-19 was also associated with more negative responses to taking a potential COVID-19 vaccine. CONCLUSION: These results suggest informational frames and themes focusing on individual risks, highlighting concern for COVID-19 and targeting improving trust for health authorities may be most effective in increasing public health measures. With the ultimate goal of preventing spread of COVID-19, understanding persons' attitudes towards both public health measures and a COVID-19 vaccine remains critical to addressing barriers and implementing targeted interventions and messaging to improve uptake.

Secular Changes in Mortality and Hospitalization over Time in People with Kidney Failure or Severe CKD as Compared with Other Noncommunicable Diseases.

BACKGROUND: Few new treatments have been developed for kidney failure or CKD in recent years, leading to perceptions of slower improvement in outcomes associated with CKD or kidney failure than for other major noncommunicable diseases. METHODS: Our retrospective cohort study included 548,609 people with an incident noncommunicable disease, including cardiovascular diseases, diabetes, various cancers, and severe CKD or kidney failure treated with renal replacement (KF-RRT), treated in Alberta, Canada, 2004-2015. For each disease, we assessed presence or absence of 8 comorbidities; we also compared secular trends in relative (compared to a referent year of 2004) and absolute risks of mortality and mean annual days in the hospital associated with each disease after 1 year and 5 years. RESULTS: Comorbidities increased significantly in number over time for all noncommunicable diseases except diabetes, and increased most rapidly for CKD and KF-RRT. Significant but relatively small reductions over time in the risk ratio of mortality at 1 year occurred for nearly all noncommunicable diseases. Secular trends in the absolute risk of mortality were similar; CKD and KF-RRT had a relatively favorable ranking at 1 year. Breast cancer, KF-RRT, diabetes, and colorectal cancer displayed the largest relative reductions in number of hospital days at 1 year. Significant absolute reductions in the number of hospital days were observed for both KF-RRT and CKD; the former had the highest absolute reduction among all noncommunicable diseases. Results were similar at 5 years. CONCLUSIONS: We observed secular reductions in mortality and annual hospital days at 1 year and 5 years among incident patients with KF-RRT and severe CKD, as well as several other common noncommunicable diseases.

Estimating Urine Albumin-to-Creatinine Ratio from Protein-to-Creatinine Ratio: Development of Equations using Same-Day Measurements.

BACKGROUND: Urine albumin-to-creatinine ratio (ACR) and protein-to-creatinine ratio (PCR) are used to measure urine protein. Recent guidelines endorse ACR use, and equations have been developed incorporating ACR to predict risk of kidney failure. For situations in which PCR only is available, having a method to estimate ACR from PCR as accurately as possible would be useful. METHODS: We used data from a population-based cohort of 47,714 adults in Alberta, Canada, who had simultaneous assessments of urine ACR and PCR. After log-transforming ACR and PCR, we used cubic splines and quantile regression to estimate the median ACR from a PCR, allowing for modification by specified covariates. On the basis of the cubic splines, we created models using linear splines to develop equations to estimate ACR from PCR. In a subcohort with eGFR<60 ml/min per 1.73 m2, we then used the kidney failure risk equation to compare kidney failure risk using measured ACR as well as estimated ACR that had been derived from PCR. RESULTS: We found a nonlinear association between log(ACR) and log(PCR), with the implied albumin-to-protein ratio increasing from <30% in normal to mild proteinuria to about 70% in severe proteinuria, and with wider prediction intervals at lower levels. Sex was the most important modifier of the relationship between ACR and PCR, with men generally having a higher albumin-to-protein ratio. Estimates of kidney failure risk were similar using measured ACR and ACR estimated from PCR. CONCLUSIONS: We developed equations to estimate the median ACR from a PCR, optionally including specified covariates. These equations may prove useful in certain retrospective clinical or research applications where only PCR is available.