Adherence to direct or vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: a long-term observational study.

Our objectives were to measure long-term adherence to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) and to identify patient factors associated with adherence. Using linked, population-based administrative data from British Columbia, Canada, an incident cohort of adults prescribed OACs for AF was identified. We calculated the proportion of days covered (PDC) as a time-dependent covariate for each 90-day window from OAC initiation until the end of follow-up. Associations between patient attributes and adherence were assessed using generalized mixed effect linear regression models. 30,264 patients were included. Mean PDC was 0.69 (SD 0.28) over a median follow-up of 6.7 years. 54% of patients were non-adherent (PDC < 0.8). After controlling for confounders, factors positively associated with adherence were number of drug class switches, history of stroke or transient ischemic attack, history of vascular disease, time since initiation, and age. Age > 75 years at initiation, polypharmacy (among VKA users only), and receiving DOAC (vs. VKA) were negatively associated with adherence. PDC decreased over time for VKA users and increased for DOAC users. Over half of AF patients studied were, on average, nonadherent to OAC therapy and missed 32% of their doses. Several patient factors were associated with higher or lower adherence, and adherence to VKA declined during therapy while DOAC adherence increased slightly over time. To min im ize the risk stroke, adherence-supporting interventions are needed for all patients with AF, particularly those aged > 75 years, those with prior stroke or vascular disease, VKA users with polypharmacy, and DOAC recipients.

Patients' Beliefs About Their Cardiovascular Medications After Acute Coronary Syndrome: A Prospective Observational Study.

Background: Adherence to secondary preventive pharmacotherapy after an acute coronary syndrome (ACS) is generally poor and is associated with recurrent cardiovascular events. Patients' beliefs about their medications are a strong predictor of intentional nonadherence. Methods: This prospective, observational study assessed adult patients' beliefs about their post-ACS medications, using the Beliefs About Medicines Questionnaire (BMQ), and adherence, using the Medication Adherence Report Scale (MARS-5) at St. Paul's Hospital in Vancouver, Canada during May-December, 2022. The BMQ and MARS-5 were administered in-hospital and at 4 weeks after discharge. Outcomes included difference in BMQ necessity-concerns differential (BMQ-NCD) from hospitalization to 4-week follow-up and factors associated with the BMQ-NCD. Results: Forty-seven participants completed the 4-week follow-up. The mean age was 64 years, and 83% were male. Most presented with a non-ST-segment-elevation ACS. No difference occurred in BMQ-NCD (7.3 vs 6.6, P = 0.29) or MARS-5 scores from discharge to 4 weeks (22.8 vs 23.7, P = 0.06); however, the BMQ specific-necessity subscale score decreased significantly (20.3 vs 18.8, P = 0.002). South Asian and Middle Eastern ethnic origins, compared to European, were associated with a higher BMQ-NCD. Part-time employment and male sex were associated with a lower BMQ-NCD. Conclusions: Participants held favourable beliefs about their post-ACS medications, which were largely unchanged from hospitalization to 4 weeks postdischarge, except for beliefs about the necessity of taking their medications. Those of European descent, those with part-time employment, and males had the lowest BMQ-NCD. Self-reported adherence was high. Ongoing reassessment of patients' beliefs about the necessity of taking their post-ACS medications may be warranted to mitigate further decline in BMQ-NCD.

Contexte: L'adhésion à une pharmacothérapie préventive secondaire après la survenue d'un syndrome coronarien aigu (SCA) est généralement faible et associée à des manifestations cardiovasculaires récurrentes. Les croyances du patient au sujet de ses médicaments représentent un facteur prédictif majeur de la non-adhésion intentionnelle. Méthodologie: Cette étude observationnelle prospective avait pour objectif d'évaluer les croyances des patients au sujet des médicaments à prendre après la survenue d'un SCA, au moyen du questionnaire BMQ (Beliefs About Medicines), ainsi que l'adhésion thérapeutique, à l'aide de l'échelle de rapport sur l'adhésion aux médicaments MARS-5 (Medication Adherence Report Scale), à l'hôpital St. Paul de Vancouver, au Canada, de mai à décembre 2022. Les questionnaires BMQ et MARS-5 ont été administrés pendant l'hospitalisation, puis 4 semaines après le congé de l'hôpital. Les résultats comprenaient la différence du score BMQ-NCD (necessity-concerns differential ­ écart nécessité-inquiétudes), entre l'hospitalisation et le suivi à 4 semaines, et les facteurs associés au score BMQ-NCD. Résultats: Au total, 47 participants ont terminé l'étude, jusqu'au suivi à 4 semaines. L'âge moyen était de 64 ans, et 83 % des sujets étaient de sexe masculin. La plupart des sujets présentaient un SCA sans élévation du segment ST. Aucune variation du score BMQ-NCD (7,3 vs 6,6; p = 0,29) ou MARS-5 (22,8 vs 23,7; p = 0,06) n'a été observée entre le congé de l'hôpital et le suivi à 4 semaines; cependant, le score BMQ spécifique à la nécessité avait significativement diminué (20,3 vs 18.8; p = 0,002). Les origines ethniques sud-asiatiques et moyen-orientales étaient associées à des scores BMQ-NCD plus élevés que les origines européennes. L'occupation d'un emploi à temps partiel et le sexe masculin étaient associés à des scores BMQ-NCD inférieurs. Conclusions: Les participants entretenaient des croyances favorables envers leurs médicaments à prendre après la survenue d'un SCA, qui sont demeurées largement les mêmes entre l'hospitalisation et le suivi, 4 semaines après le congé de l'hôpital, à l'exception des croyances au sujet de la nécessité de prendre les médicaments. Les sujets d'origine européenne, ceux occupant un emploi à temps partiel et les sujets masculins ont eu les scores BMQ-NCD les plus faibles. L'adhésion thérapeutique autosignalée était élevée. Des réévaluations constantes des croyances des patients au sujet de la nécessité de prendre leurs médicaments après la survenue d'un SCA pourraient être justifiées afin d'éviter que les scores BMQ-NCD diminuent davantage.

The financial burden of accessing care for people with scleroderma in Canada: a patient-oriented, cross-sectional survey.

BACKGROUND: Patients with scleroderma require a lifetime of treatment and frequent contacts with rheumatologists and other health care professionals. Although publicly funded health care systems in Canada cover many costs, patients may still face a substantial financial burden in accessing care. The purpose of this study was to quantify out-of-pocket costs borne by people with scleroderma in Canada and compare this burden for those living in large communities and smaller communities. METHODS: We analyzed responses to a Web-based survey of people living in Canada with scleroderma. Respondents reported annual out-of-pocket medical, travel and accommodation and other nonmedical costs (2019 Canadian dollars). We used descriptive statistics to describe travel distance and out-of-pocket costs. We used a 2-part model to estimate the impact on out-of-pocket costs of living in a large urban centre (≥ 100 000 population), compared with smaller urban centres or rural areas (< 100 000 population). We generated combined mean estimates from the 2-part models using predictive margins. RESULTS: The survey included 120 people in Canada with scleroderma. The mean, annual, total out-of-pocket costs were $3357 (standard deviation $5580). Respondents living in smaller urban centres and rural areas reported higher mean total costs ($4148, 95% confidence interval [CI] $3618-$4680) and travel or accommodation costs ($1084, 95% CI $804-$1364) than those in larger urban centres (total costs $2678, 95% CI $2252-$3104; travel or accommodation costs $332, 95% CI $207-$458). INTERPRETATION: Many patients with scleroderma incur considerable out-of-pocket costs, and this burden is exacerbated for those living in smaller urban centres and rural areas. Health care systems and providers should consider ways to alleviate this burden and support equitable access to care.

Fabrication of Cell-Laden AME-Loaded Collagen-Based Hydrogel Promotes Fibroblast Proliferation and Wound Healing In Vitro.

OBJECTIVE: The biological factors secreted from cells and cell-based products stimulate growth, proliferation, and migration of the cells in their microenvironment, and play vital roles in promoting wound healing. The amniotic membrane extract (AME), which is rich in growth factors (GFs), can be loaded into a cell-laden hydrogel and released to a wound site to promote the healing of the wound. The present study was conducted to optimize the concentration of the loaded AME that induces secretion of GFs and structural collagen protein from cell-laden AME-loaded collagen-based hydrogels, to promote wound healing in vitro. MATERIALS AND METHODS: In this experimental study, fibroblast-laden collagen-based hydrogel loaded with different concentrations of AME (0.1, 0.5, 1, and 1.5 mg/mL, as test groups) and without AME (as control group), were incubated for 7 days. The total proteins secreted by the cells from the cell-laden hydrogel loaded with different concentrations of AME were collected and the levels of GFs and type I collagen were assessed using ELISA method. Cell proliferation and scratch assay were done to evaluate the function of the construct. RESULTS: The results of ELISA showed that the concentrations of GFs in the conditioned medium (CM) secreted from the cell-laden AME-loaded hydrogel were significantly higher than those secreted by only the fibroblast group. Interestingly, the metabolic activity of fibroblasts and the ability of the cells to migrate in scratch assay significantly increased in the CM3-treated fibroblast culture compared to other groups. The concentrations of the cells and the AME for preparation of CM3 group were 106 cell/mL and 1 mg/mL, respectively. CONCLUSION: We showed that 1 mg/ml of AME loaded in fibroblast-laden collagen hydrogel significantly enhanced the secretion of EGF, KGF, VEGF, HGF, and type I collagen. The CM3 secreted from the cell-laden AME-loaded hydrogel promoted proliferation and scratch area reduction in vitro.

IMplementing Predictive Analytics towards efficient COPD Treatments (IMPACT): protocol for a stepped-wedge cluster randomized impact study.

INTRODUCTION: Personalized disease management informed by quantitative risk prediction has the potential to improve patient care and outcomes. The integration of risk prediction into clinical workflow should be informed by the experiences and preferences of stakeholders, and the impact of such integration should be evaluated in prospective comparative studies. The objectives of the IMplementing Predictive Analytics towards efficient chronic obstructive pulmonary disease (COPD) treatments (IMPACT) study are to integrate an exacerbation risk prediction tool into routine care and to determine its impact on prescription appropriateness (primary outcome), medication adherence, quality of life, exacerbation rates, and sex and gender disparities in COPD care (secondary outcomes). METHODS: IMPACT will be conducted in two phases. Phase 1 will include the systematic and user-centered development of two decision support tools: (1) a decision tool for pulmonologists called the ACCEPT decision intervention (ADI), which combines risk prediction from the previously developed Acute COPD Exacerbation Prediction Tool with treatment algorithms recommended by the Canadian Thoracic Society's COPD pharmacotherapy guidelines, and (2) an information pamphlet for COPD patients (patient tool), tailored to their prescribed medication, clinical needs, and lung function. In phase 2, we will conduct a stepped-wedge cluster randomized controlled trial in two outpatient respiratory clinics to evaluate the impact of the decision support tools on quality of care and patient outcomes. Clusters will be practicing pulmonologists (n ≥ 24), who will progressively switch to the intervention over 18 months. At the end of the study, a qualitative process evaluation will be carried out to determine the barriers and enablers of uptake of the tools. DISCUSSION: The IMPACT study coincides with a planned harmonization of electronic health record systems across tertiary care centers in British Columbia, Canada. The harmonization of these systems combined with IMPACT's implementation-oriented design and partnership with stakeholders will facilitate integration of the tools into routine care, if the results of the proposed study reveal positive association with improvement in the process and outcomes of clinical care. The process evaluation at the end of the trial will inform subsequent design iterations before largescale implementation. TRIAL REGISTRATION: NCT05309356.

A parametric model to jointly characterize rate, duration, and severity of exacerbations in episodic diseases.

BACKGROUND: The natural history of many chronic diseases is characterized by periods of increased disease activity, commonly referred to as flare-ups or exacerbations. Accurate characterization of the burden of these exacerbations is an important research objective. METHODS: The purpose of this work was to develop a statistical framework for nuanced characterization of the three main features of exacerbations: their rate, duration, and severity, with interrelationships among these features being a particular focus. We jointly specified a zero-inflated accelerated failure time regression model for the rate, an accelerated failure time regression model for the duration, and a logistic regression model for the severity of exacerbations. Random effects were incorporated into each component to capture heterogeneity beyond the variability attributable to observed characteristics, and to describe the interrelationships among these components. RESULTS: We used pooled data from two clinical trials in asthma as an exemplary application to illustrate the utility of the joint modeling approach. The model fit clearly indicated the presence of heterogeneity in all three components. A novel finding was that the new therapy reduced not just the rate but also the duration of exacerbations, but did not have a significant impact on their severity. After controlling for covariates, exacerbations among more frequent exacerbators tended to be shorter and less likely to be severe. CONCLUSIONS: We conclude that a joint modeling framework, programmable in available software, can provide novel insights about how the rate, duration, and severity of episodic events interrelate, and enables consistent inference on the effect of treatments on different disease outcomes. Trial registration Ethics approval was obtained from the University of British Columbia Human Ethics Board (H17-00938).

Generalizability of Risk Stratification Algorithms for Exacerbations in COPD.

BACKGROUND: Contemporary management of COPD relies on exacerbation history to risk-stratify patients for future exacerbations. Multivariable prediction models can improve the performance of risk stratification. However, the clinical utility of risk stratification can vary from one population to another. RESEARCH QUESTION: How do two validated exacerbation risk prediction models (Acute COPD Exacerbation Prediction Tool [ACCEPT] and the Bertens model) compared with exacerbation history alone perform in different patient populations? STUDY DESIGN AND METHODS: We used data from three clinical studies representing populations at different levels of moderate to severe exacerbation risk: the Study to Understand Mortality and Morbidity in COPD (SUMMIT; N = 2,421; annual risk, 0.22), the Long-term Oxygen Treatment Trial (LOTT; N = 595; annual risk, 0.38), and Towards a Revolution in COPD Health (TORCH; N = 1,091; annual risk, 0.52). We compared the area under the receiver operating characteristic curve (AUC) and net benefit (measure of clinical utility) among three risk stratification algorithms for predicting exacerbations in the next 12 months. We also evaluated the effect of model recalibration on clinical utility. RESULTS: Compared with exacerbation history, ACCEPT showed better performance in all three samples (change in AUC, 0.08, 0.07, and 0.10, in SUMMIT, LOTT, and TORCH, respectively; P ≤ .001 for all). The Bertens model showed better performance compared with exacerbation history in SUMMIT and TORCH (change in AUC, 0.10 and 0.05, respectively; P < .001 for both), but not in LOTT. No algorithm was superior in clinical utility across all samples. Before recalibration, the Bertens model generally outperformed the other algorithms in low-risk settings, whereas ACCEPT outperformed others in high-risk settings. All three algorithms showed the risk of harm (providing lower net benefit than not using any risk stratification). After recalibration, risk of harm was mitigated substantially for both prediction models. INTERPRETATION: Exacerbation history alone is unlikely to provide clinical utility for predicting COPD exacerbations in all settings and could be associated with a risk of harm. Prediction models have superior predictive performance, but require setting-specific recalibration to confer higher clinical utility.

ACCEPT 2·0: Recalibrating and externally validating the Acute COPD exacerbation prediction tool (ACCEPT).

Background: The Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Prediction Tool (ACCEPT) was developed for individualised prediction of COPD exacerbations. ACCEPT was well calibrated overall and had a high discriminatory power, but overestimated risk among individuals without recent exacerbations. The objectives of this study were to 1) fine-tune ACCEPT to make better predictions for individuals with a negative exacerbation history, 2) develop more parsimonious models, and 3) externally validate the models in a new dataset. Methods: We recalibrated ACCEPT using data from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE, a three-year observational study, 1,803 patients, 2,117 exacerbations) study by applying non-parametric regression splines to the predicted rates. We developed three reduced versions of ACCEPT by removing symptom score and/or baseline medications as predictors. We examined the discrimination, calibration, and net benefit of ACCEPT 2·0 in the placebo arm of the Towards a Revolution in COPD Health (TORCH, a three-year randomised clinical trial of inhaled therapies in COPD, 1,091 patients, 1,064 exacerbations) study. The primary outcome for prediction was the occurrence of ≥2 moderate or ≥1 severe exacerbation in the next 12 months; the secondary outcomes were prediction of the occurrence of any moderate/severe exacerbation or any severe exacerbation. Findings: ACCEPT 2·0 had an area-under-the-curve (AUC) of 0·76 for predicting the primary outcome. Exacerbation history alone (current standard of care) had an AUC of 0·68. The model was well calibrated in patients with positive or negative exacerbation histories. Changes in AUC in reduced versions were minimal for the primary outcome as well as for predicting the occurrence of any moderate/severe exacerbations (ΔAUC<0·011), but more substantial for predicting the occurrence of any severe exacerbations (ΔAUC<0·020). All versions of ACCEPT 2·0 provided positive net benefit over the use of exacerbation history alone for some range of thresholds. Interpretation: ACCEPT 2·0 showed good calibration regardless of exacerbation history, and predicts exacerbation risk better than current standard of care for a range of thresholds. Future studies need to investigate the utility of exacerbation prediction in various subgroups of patients. Funding: This study was funded by a team grant from the Canadian Institutes of Health Research (PHT 178432).

16-year trends in asthma hospital admissions in Canada.

BACKGROUND: Asthma hospitalizations declined rapidly in many parts of the world, including Canada, in the 1990s and early 2000s. OBJECTIVE: To examine whether the declining trend of asthma hospitalizations persisted in recent years in Canada. METHODS: Using the Canadian comprehensive nationwide hospitalization data (2002-2017), we identified hospital admissions with the main International Classification of Diseases codes for asthma. We analyzed sex-specific age-standardized trends in annual hospitalization rates among pediatric (&lt; 19 years) and adult (19+ years) patients. We used change-point analysis to evaluate any substantial changes in the trends in the sex-age groups. RESULTS: There were 254,672 asthma-related hospital admissions (59% pediatric, 50% female) during the study period. Among children, age-adjusted annual rates per 100,000 decreased by 55% in females (152-69) and by 60% in males (270-108) from 2002 to 2017. Among adults, the rates decreased by 59% in both sexes (females: 61-25; males: 27-11). Change-point analysis indicated a substantial plateauing of the annual rate in both pediatric (from -15.3 [females] and -25.8 [males] before 2010 to -0.6 [females] and -0.8 [males] after 2010) and adult (from -5.4 [females] and -2.6 [males] before 2008 to -0.6 [females] and -0.2 [males] after 2008) groups. CONCLUSION: After a substantial decline in hospital admissions for acute asthma, there has been minimal further decline since 2010 for children and 2008 for adults. In addition to adhering to the contemporary standards of asthma care, novel, disruptive strategies are likely needed to further reduce the burden of asthma.

Oral anticoagulant adherence and switching in patients with atrial fibrillation: A prospective observational study.

BACKGROUND: Adherence to oral anticoagulants (OACs) in patients with atrial fibrillation (AF) is important in preventing stroke. The dominance of retrospective studies using administrative data has led to a lack of data on psychosocial determinants of adherence and prevented comparison of adherence between OAC drug classes. OAC switching is another aspect of adherence that is unexplored. METHODS: A prospective design was utilized to measure AF patients' self-reported adherence and OAC switching, and to identify their clinical, demographic, and psychosocial determinants. Participants were recruited from specialized AF clinics in Canada and followed for up to 2 years. Data were collected via telephone every 3-4 months using a structured survey. Adherence was measured using the Morisky Medication Adherence scale (©MMAS-8). RESULTS: The included participants (N = 306) were followed for a median follow up time of 14.1 months and had an average of 3.2(SD 1.4) study visits. The mean self-reported adherence on the ©MMAS-8 was 7.28(SD 0.71) for patients receiving care at specialized AF clinics. Older age, experiencing a bleed, and higher satisfaction with the burden of medications were significantly associated with higher adherence. Drug class did not have any significant impact on adherence. 7.8% of the cohort experienced a switch with most of them being from warfarin to DOAC. Taking warfarin as the index medication, experiencing a bleed and older age were significantly associated with higher odds of switching. CONCLUSION: Patients with AF reported high adherence to their OAC therapy however being on DOAC may not translate to better adherence compared to VKA. Improving satisfaction with the burden of therapy is important in improving adherence.

Clinician preferences for neurotechnologies in pediatric drug-resistant epilepsy: A discrete choice experiment.

OBJECTIVE: Novel and minimally invasive neurotechnologies offer the potential to reduce the burden of epilepsy while avoiding the risks of conventional resective surgery. Few neurotechnologies have been tested in randomized controlled trials with pediatric populations, leaving clinicians to face decisions about whether to recommend these treatments with insufficient evidence about the relevant risks and benefits. This study specifically explores the preferences of clinicians for treating pediatric drug-resistant epilepsy (DRE) with novel neurotechnologies. METHODS: A discrete-choice experiment (DCE) was designed to elicit the preferences of clinicians with experience in treating children with DRE using novel neurotechnological interventions. The preferences for six key attributes used when making treatment decisions (chances of clinically significant improvement in seizures, major and minor risks from intervention, availability of evidence, financial burden for the family, and access to the intervention) were estimated using a conditional logit model. The estimates from this model were then used to predict the adoption of existing novel neurotechnological interventions. RESULTS: Sixty-eight clinicians completed the survey: 33 neurosurgeons, 28 neurologists, and 7 other clinicians. Most clinicians were working in the United States (74%), and the remainder (26%) in Canada. All attributes, apart from the nearest location with access to the intervention, influenced preferences significantly. The chance of clinically significant improvement in seizures was the most positive influence on clinician preferences, but low-quality evidence and a higher risk of major complications could offset these preferences. Of the existing neurotechnological interventions, vagus nerve stimulation was predicted to have the highest likelihood of adoption; deep brain stimulation had the lowest likelihood of adoption. SIGNIFICANCE: The preferences of clinicians are drive primarily by the likelihood of achieving seizure freedom for their patients, but preferences for an intervention are largely eradicated if only low quality of evidence supporting the intervention is available. Until better evidence supporting the use of potentially effective, novel neurotechnologies becomes available, clinicians are likely to prefer more established treatments.

Marginal Versus Conditional Odds Ratios When Updating Risk Prediction Models.

Risk prediction models often need to be updated when applied to new settings. A simple updating method involves fixed odds ratio transformation of predicted risks to adjust the model for outcome prevalence in the new setting. When a sample from the target population is available, the gold standard is to use a logistic regression model to estimate this odds ratio. A simpler method has been proposed that calculates this odds ratio from the prevalence estimates in the original and new samples. We show that the marginal odds ratio estimated in this way is generally closer to one than the correct (conditional) odds ratio; thus, the simpler method should be avoided when individual-level data are available. When such data are not available, we suggest an approximate method for recovering the conditional odds ratio from the variance of predicted risks in the development sample. Brief simulations and examples show that this approach reduces undercorrection, often substantially.

The Random Effects Warfarin Days' Supply (REWarDS) Model: Development and Validation of a Novel Method for Estimating Exposure to Warfarin Using Administrative Data.

Warfarin's complex dosing is a significant barrier to measurement of its exposure in observational studies using population databases. Using population-based administrative data (1996-2019) from British Columbia, Canada, we developed a method based on statistical modeling (Random Effects Warfarin Days' Supply (REWarDS)) that involves fitting a random-effects linear regression model to patients' cumulative dosage over time for estimation of warfarin exposure. Model parameters included a minimal universally available set of variables from prescription records for estimation of patients' individualized average daily doses of warfarin. REWarDS estimates were validated against a reference standard (manual calculation of the daily dose using the free-text administration instructions entered by the dispensing pharmacist) and compared with alternative methods (fixed window, fixed tablet, defined daily dose, and reverse wait time distribution) using Pearson's correlation coefficient (r), the intraclass correlation coefficient, and the root mean squared error. REWarDS-estimated days' supply showed strong correlation and agreement with the reference standard (r = 0.90 (95% confidence interval (CI): 0.90, 0.90); intraclass correlation coefficient = 0.95 (95% CI: 0.94, 0.95); root mean squared error = 8.24 days) and performed better than all of the alternative methods. REWarDS-estimated days' supply was valid and more accurate than estimates from all other available methods. REWarDS is expected to confer optimal precision in studies measuring warfarin exposure using administrative data.

Satisfaction With Oral Anticoagulants Among Patients With Atrial Fibrillation: A Prospective Observational Study.

BACKGROUND: Satisfaction with treatment has been identified as an important contributing factor to adherence with oral anticoagulant (OAC) therapy in patients with atrial fibrillation (AF). We aimed to evaluate the satisfaction level of patients with AF regarding OAC use over time, using validated patient-reported outcome instruments, and to identify associated patient characteristics. METHODS: Participants were recruited from specialized AF clinics in Canada. Eligible AF patients who were prescribed OACs were followed for up to 2 years. Participants were interviewed via telephone every 3-4 months using a structured survey. The Treatment Satisfaction Questionnaire for Medication (TSQM II) and the Anti-Clot Treatment Scale (ACTS) were used to measure satisfaction over time. RESULTS: Among the 306 participants, satisfaction scores on the TSQM II and ACTS instruments were high. Unadjusted analyses showed significantly greater satisfaction with the burden of therapy with direct OACs (DOACs) compared to that with warfarin (small-magnitude effect) and greater satisfaction with the convenience of rivaroxaban, compared with that of all other OACs (moderate-magnitude effect). After adjustment for all other variables, vitamin K antagonist therapy was associated with greater global satisfaction than was DOAC treatment. Satisfaction with benefit and burden as measured by the ACTS scale, and global satisfaction on the TSQM II scale, tended to increase over time. Patient factors that were somewhat consistently associated with greater satisfaction were female sex and younger age. CONCLUSIONS: Patients with AF were highly satisfied with their therapy, with few differences among OAC classes and individual OACs. Individual patients may or may not be more satisfied with DOAC than VKA therapy, and regardless of the OAC prescribed, the may require significant support to maintain therapy adherence.

CONTEXTE: La satisfaction à l'égard du traitement a été désignée comme un facteur important contribuant à l'adhésion au traitement par anticoagulants oraux (ACO) chez les patients atteints de fibrillation auriculaire (FA). Notre objectif était d'évaluer le degré de satisfaction des patients atteints de FA concernant l'utilisation des ACO au fil du temps, à l'aide d'instruments validés mesurant les résultats signalés par les patients, et de déterminer les caractéristiques connexes des patients. MÉTHODOLOGIE: Les participants ont été recrutés dans des cliniques spécialisées en FA au Canada. Les patients admissibles atteints de FA qui se sont fait prescrire des ACO ont été suivis pendant une période allant jusqu'à 2 ans. Les participants ont été interrogés par téléphone tous les 3 ou 4 mois à l'aide d'une enquête structurée. Le questionnaire Treatment Satisfaction Questionnaire for Medication ­ Version II (TSQM II) et l'échelle Anti-Clot Treatment Scale (ACTS) ont été utilisés pour mesurer la satisfaction au fil du temps. RÉSULTATS: Parmi les 306 participants, les taux de satisfaction indiqués par les instruments TSQM II et ACTS étaient élevés. Les analyses non corrigées ont montré une satisfaction liée au fardeau du traitement significativement plus élevée avec les ACO directs qu'avec la warfarine (effet de faible ampleur) et une plus grande satisfaction concernant la commodité du rivaroxaban par rapport à celle de tous les autres ACO (effet de moyenne ampleur). Après ajustement pour tenir compte de toutes les autres variables, le traitement par antivitamines K (AVK) était associé à une plus grande satisfaction globale que le traitement par ACO direct. La satisfaction à l'égard des avantages et du fardeau, mesurée par l'échelle ACTS, et la satisfaction globale sur l'échelle TSQM II, ont eu tendance à augmenter avec le temps. Les facteurs liés aux patients qui ont été associés de manière assez constante à une plus grande satisfaction étaient le sexe féminin et un âge plus jeune. CONCLUSIONS: Les patients atteints de FA étaient très satisfaits de leur traitement, et peu de différences existaient entre les classes d'ACO et les ACO individuels. Chaque patient peut être ou non plus satisfait du traitement par ACO direct que par AVK et, quel que soit l'ACO prescrit, il peut avoir besoin d'un soutien important pour maintenir l'adhésion au traitement.

Longitudinal Oral Anticoagulant Adherence Trajectories in Patients With Atrial Fibrillation.

BACKGROUND: Conventional adherence summary measures do not capture the dynamic nature of adherence. OBJECTIVES: This study aims to characterize distinct long-term oral anticoagulant adherence trajectories and the factors associated with them in patients with atrial fibrillation. METHODS: Adults with incident atrial fibrillation were identified using linked population-based administrative health data in British Columbia, Canada (1996-2019). Group-based trajectory modeling was used to model patients' 90-day proportions of days covered over time to identify distinct 5-year adherence trajectories. Multinomial regression analysis was used to assess the effect of various demographic and clinical factors on exhibiting each adherence trajectory. RESULTS: The study cohort included 19,749 patients with AF (mean age: 70.6 ± 10.6 years), 56% male, mean CHA2DS2-VASc stroke risk score 2.8 ± 1.4. Group-based trajectory modeling identified 4 distinct oral anticoagulants adherence trajectories: "consistent adherence" (n = 14,631, 74% of the cohort), "rapid decline and discontinuation" (n = 2,327, 12%), "rapid decline and partial recovery" (n = 1,973, 10%), and "slow decline and discontinuation" (n = 819, 4%). Very few patient variables were found to be associated with specific adherence trajectories. CONCLUSIONS: There is heterogeneity among nonadherent patients in the rate and timing of decline in their medication taking. Clinical and demographic characteristics were found to be inadequate to predict patients' adherence trajectories. Insights from this study could be used to inform the design and timing of adherence interventions, and qualitative studies may be needed to better understand the psychosocial determinants and reasons for the behaviors reflected in the identified trajectories.

Adiposity and the role of diverse social supports: an observational, gender-sensitive study using the baseline Canadian Longitudinal Study on Aging.

OBJECTIVE: To quantify associations between four types of social support and measured adiposity among women and men. DESIGN: The cross-sectional sample from the Canadian Longitudinal Study on Aging (CLSA, 2012-2015). Height, weight and waist circumference (WC) were clinically measured, and perceived availability of informational, tangible, emotional and belonging social supports was self-reported. SETTING: Canada. PARTICIPANTS: 28 779 adults aged 45-85 years from the CLSA. RESULTS: All social support types were associated with WC and BMI among women but not among men. Women reporting the lowest informational support had significantly higher mean BMI (28·84 kg/m2 (95 % CI 28·63, 29·05)) and WC (90·81 cm (95 % CI 90·31, 91·30)) compared with women reporting maximum support (respectively, 28·09 kg/m2 (95 % CI 27·88, 28·30) and 88·92 cm (95 % CI 88·43, 89·4)). Women's abdominal obesity was associated with low levels of informational, emotional and belonging support, and women's general obesity with informational and emotional support. Notably, informational and emotional support were associated with both obesity outcomes independent of other supports among women. Only a low level of informational support was significantly independently associated with higher odds of obesity among men. CONCLUSIONS: Our study provides novel insights into gender-specific associations between different types of social support and adiposity. Prospective studies are needed to further investigate potential causality of these associations between the specific social supports and future weight status, especially among women.

Gender Differences in the Role of Social Support for Hypertension Prevention in Canada: A Population-Based Cross-Sectional Study of the Canadian Longitudinal Study on Aging Cohort.

BACKGROUND: The relationship between social support and hypertension is poorly understood in women and men. We investigated whether multiple measures of social support are linked to blood pressure levels differentially by gender. METHODS: Cross-sectional study of 28,779 middle-age and older-age adults (45-85 years) in the baseline Canadian Longitudinal Study on Aging comprehensive cohort. Stratified multivariable regression models estimated the role and relative contribution of 4 types of support to blood pressure in women and men. RESULTS: The highest levels of perceived availability of informational, tangible, emotional, and belonging support were significantly associated with the lowest mean level of systolic blood pressure (SBP) but not diastolic blood pressure, independent of known confounders and other support types. However, associations were small, and their directions were more consistent in women. The lowest levels of informational support, relative to the highest, were associated with higher odds of hypertension in women (odds ratio [OR] = 1.20 [95% confidence interval {CI}: 1.06, 1.36]), more so than in men (OR = 1.16 [95% CI: 1.03, 1.32]). The lowest levels of emotional support were similarly associated with the odds of hypertension (OR = 1.08 [95% CI: 1.00, 1.17] in women and OR = 1.08 [95% CI: 1.00, 1.15] in men), relative to the highest. Larger differences in mean SBP in women, compared with men, were seen for informational support (2.43 and 1.18 mm Hg, respectively) and emotional support (1.60 and 0.74 mm Hg, respectively). Findings were unaltered by sensitivity analyses. CONCLUSIONS: Informational and emotional support were inversely associated with SBP, more so in women than men. Further longitudinal investigation is warranted, as results suggest that specific supports may help prevent hypertension and lower cardiovascular risk, especially in women.

CONTEXTE: La relation entre le soutien social et l'hypertension est mal comprise chez les femmes et les hommes. Nous avons tenté de déterminer si diverses mesures de soutien social sont liées aux valeurs de la pression artérielle différemment selon le sexe. MÉTHODOLOGIE: Étude transversale menée chez 28 779 adultes d'âge moyen ou plus avancé (45-85 ans) au sein de la cohorte globale initiale de l'Étude longitudinale canadienne sur le vieillissement. Des modèles stratifiés de régression à variables multiples ont servi à estimer le rôle et la contribution relative de quatre types de soutien sur la pression artérielle chez les femmes et les hommes. RÉSULTATS: Les niveaux les plus élevés de disponibilité perçue d'un soutien informationnel, tangible, émotionnel et axé sur l'appartenance étaient associés de façon significative à la plus faible valeur moyenne de la pression artérielle systolique (PAS), mais pas de la pression artérielle diastolique (PAD), indépendamment des facteurs de confusion connus et des autres types de soutien. Toutefois, les associations étaient faibles et leurs tendances étaient plus constantes chez les femmes. Les plus faibles niveaux de soutien informationnel, par rapport aux plus élevés, étaient associés à un plus grand risque d'hypertension chez les femmes (rapport de cotes [RC] = 1,20 [intervalle de confiance [IC] à 95 % : 1,06, 1,36]), et ce plus que chez les hommes (RC = 1,16 [IC à 95 % : 1,03, 1,32]). De même, les plus faibles niveaux de soutien émotionnel étaient associés au risque d'hypertension (RC = 1,08 [IC à 95 % : 1,00, 1,17] chez les femmes et RC = 1,08 [IC à 95 % : 1,00, 1,15] chez les hommes), par rapport aux plus élevés. Des différences plus importantes des valeurs moyennes de la PAS ont été observées chez les femmes comparativement aux hommes relativement au soutien informationnel (2,43 et 1,18 mm Hg, respectivement) et au soutien émotionnel (1,60 et 0,74 mm Hg, respectivement). Les résultats n'ont pas été modifiés par les analyses de sensibilité. CONCLUSIONS: Le soutien informationnel et le soutien émotionnel étaient inversement associés aux valeurs de la PAS, et ce plus chez les femmes que chez les hommes. Une investigation longitudinale est nécessaire pour approfondir le sujet, car les résultats donnent à penser que certaines formes de soutien peuvent contribuer à prévenir l'hypertension et à réduire le risque cardiovasculaire, en particulier chez les femmes.

Assessing how health information needs of individuals with colorectal cancer are met across the care continuum: an international cross-sectional survey.

BACKGROUND: Studies evaluating health information needs in colorectal cancer (CRC) lack specificity in terms of study samples involving patients. We assessed how health information needs of individuals with CRC are met across the care continuum. METHODS: We administered an international, online based survey. Participants were eligible for the study if they: 1) were 18 years of age or older; 2) received a diagnosis of CRC; and 3) were able to complete the online health survey in English, French, Spanish, or Mandarin. We grouped participants according to treatment status. The survey comprised sections: 1) demographic and cancer characteristics; 2) health information needs; and 3) health status and quality of life. We used multivariable regression models to identify factors associated with having health information needs met and evaluated impacts on health-related outcomes. RESULTS: We analyzed survey responses from 1041 participants including 258 who were currently undergoing treatment and 783 who had completed treatment. Findings suggest that information needs regarding CRC treatments were largely met. However, we found unmet information needs regarding psychosocial impacts of CRC. This includes work/employment, mental health, sexual activity, and nutrition and diet. We did not identify significant predictors of having met health information needs, however, among participants undergoing treatment, those with colon cancer were more likely to have met health information needs regarding their treatments as compared to those with rectal cancer (0.125, 95% CI, 0.00 to 0.25, p-value = 0.051). CONCLUSIONS: Our study provides a comprehensive assessment of health information needs among individuals with CRC across the care continuum.

Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA.

Purpose: The purpose of this study was to compare perfusion parameters of the parafovea with scans outside the parafovea to find an area most susceptible to changes secondary to diabetic retinopathy (DR). Methods: Patients with different DR severity levels as well as controls were included in this cross-sectional clinical trial. Seven standardized 3 × 3 mm areas were recorded with Swept Source Optical Coherence Tomography Angiography: one centered on the fovea, three were temporal to the fovea, and three nasally to the optic disc. The capillary perfusion density (PD) of the superficial capillary complex (SCC) and deep capillary complex (DCC) as well as the fractal dimension (FD) were generated. Statistical analyses were done with R software. Results: One hundred ninety-two eyes (33 controls, 51 no-DR, 41 mild DR, 37 moderate/severe DR, and 30 proliferative DR), of which 105 patients with diabetes and 25 healthy controls were included (59 ± 15 years; 62 women). Mean PD of the DCC was significantly less in patients without DR (parafovea = 0.48 ± 0.03; temporal = 0.48 ± 0.02; and nasal = 0.48 ± 0.03) compared to controls (parafovea = 0.49 ± 0.02; temporal = 0.50 ± 0.02; and nasal = 0.50 ± 0.03). With increasing DR severity, PD and FD of the SCC and DCC further decreased. Conclusions: Capillary perfusion of the retina is affected early by diabetes. PD of the DCC was significantly reduced in patients with diabetes who did not have any clinical signs of DR. The capillary network outside the parafovea was more susceptible to capillary perfusion deficits compared to the capillaries close to the fovea. Trial Registration: clinicaltrial.gov, NCT03765112, https://clinicaltrials.gov/ct2/show/NCT03765112?term=NCT03765112&rank=1.

The Acute COPD Exacerbation Prediction Tool (ACCEPT): a modelling study.

BACKGROUND: Accurate prediction of exacerbation risk enables personalised care for patients with chronic obstructive pulmonary disease (COPD). We developed and validated a generalisable model to predict individualised rate and severity of COPD exacerbations. METHODS: In this risk modelling study, we pooled data from three COPD trials on patients with a history of exacerbations. We developed a mixed-effect model to predict exacerbations over 1 year. Severe exacerbations were those requiring inpatient care. Predictors were history of exacerbations, age, sex, body-mass index, smoking status, domiciliary oxygen therapy, lung function, symptom burden, and current medication use. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE), a multicentre cohort study, was used for external validation. RESULTS: The development dataset included 2380 patients, 1373 (58%) of whom were men. Mean age was 64·7 years (SD 8·8). Mean exacerbation rate was 1·42 events per year and 0·29 events per year were severe. When validated against all patients with COPD in ECLIPSE (mean exacerbation rate was 1·20 events per year, 0·27 events per year were severe), the area-under-curve (AUC) was 0·81 (95% CI 0·79-0·83) for at least two exacerbations and 0·77 (95% CI 0·74-0·80) for at least one severe exacerbation. Predicted exacerbation and observed exacerbation rates were similar (1·31 events per year for all exacerbations and 0·25 events per year for severe exacerbations vs 1·20 events per year and 0·27 events per year). In ECLIPSE, in patients with previous exacerbation history (mean exacerbation rate was 1·82 events per year, 0·40 events per year were severe), AUC was 0·73 (95% CI 0·70-0·76) for two or more exacerbations and 0·74 (95% CI 0·70-0·78) for at least one severe exacerbation. Calibration was accurate for severe exacerbations (predicted 0·37 events per year vs observed 0·40 events per year) and all exacerbations (predicted 1·80 events per year vs observed 1·82 events per year). INTERPRETATION: This model can be used as a decision tool to personalise COPD treatment and prevent exacerbations. FUNDING: Canadian Institutes of Health Research.