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Purpose: Unsupervised item-response theory (IRT) models such as polytomous IRT based on recursive partitioning (IRTrees) and mixture IRT (MixIRT) models can be used to assess differential item functioning (DIF) in patient-reported outcome measures (PROMs) when the covariates associated with DIF are unknown a priori. This study examines the consistency of results for IRTrees and MixIRT models. Methods: Data were from 4478 individuals in the Alberta Provincial Project on Outcome Assessment in Coronary Heart Disease registry who received cardiac angiography in Alberta, Canada, and completed the Hospital Anxiety and Depression Scale (HADS) depression subscale items. The partial credit model (PCM) based on recursive partitioning (PCTree) and mixture PCM (MixPCM) were used to identify covariates associated with differential response patterns to HADS depression subscale items. Model covariates included demographic and clinical characteristics. Results: The median (interquartile range) age was 64.5(15.7) years, and 3522(78.5%) patients were male. The PCTree identified 4 terminal nodes (subgroups) defined by smoking status, age, and body mass index. A 3-class PCM fits the data well. The MixPCM latent classes were defined by age, disease indication, smoking status, comorbid diabetes, congestive heart failure, and chronic obstructive pulmonary disease. Conclusion: PCTree and MixPCM were not consistent in detecting covariates associated with differential interpretations of PROM items. Future research will use computer simulations to assess these models' Type I error and statistical power for identifying covariates associated with DIF. [ABSTRACT FROM AUTHOR]

PURPOSE: To develop a tool that can be used to predict early discontinuation of adjuvant chemotherapy among patients with stage III colon cancer. PATIENTS AND METHODS: Through record linkage of Alberta administrative and tumor registry databases, we identified a cohort of individuals age ≥ 18 years who were diagnosed with stage III colon cancer and who received adjuvant chemotherapy in Alberta between 2004 and 2015. Early discontinuation was defined as receipt of < 5 months of a planned 6-month course of chemotherapy. By a systematic review of the literature and a survey of medical oncologists, the following candidate variables were identified: age (years), number of comorbidities (0, 1, ≥ 2), cancer stage (IIIC v IIIA-B), type of chemotherapy (fluorouracil, leucovorin, and oxaliplatin; capecitabine and oxaliplatin; or monotherapy), time from surgery to chemotherapy initiation (weeks), type of treatment facility (academic or community), and distance from home to treatment center (kilometers). Models developed using penalized logistic regression and the random forest algorithm were compared. Model performance was assessed using the C-statistic, Brier score, and a calibration plot. Internal validation was performed using the bootstrap method. RESULTS: From an initial 3,115 patients identified, 1,378 were deemed eligible for inclusion. Of these patients, 474 patients (34.4%) failed to complete at least 5 months of chemotherapy. Although well calibrated, the penalized logistic regression model had poor discrimination (optimism-adjusted C-statistic, 0.63; 95% CI, 0.60 to 0.67). In contrast, the random forest model achieved adequate discrimination (optimism-adjusted C-statistic, 0.80; 95% CI, 0.79 to 0.82). Although the degree of calibration of the random forest was acceptable, it was slightly worse than that of the penalized logistic regression model. CONCLUSION: Internal validation of our random forest model suggests that it may have clinical utility. Additional research regarding its external validation and clinical impact is needed. [ABSTRACT FROM AUTHOR]

Background: Factors that are prognostic of early discontinuation of adjuvant chemotherapy among stage III colon cancer patients have yet to be described. To address this gap, a survey of medical oncologists and a systematic review and meta‐analysis were conducted. Methods: A survey was distributed in March 2019 to medical oncologists who treat colon cancer within Alberta, Canada. Clinicians were asked to rank the prognostic importance of a set of variables using a Likert scale and agreement was quantified using a weighted Cohen's kappa. In addition, we systematically searched four databases up to July 2019. Meta‐analyses were conducted using a random‐effects model. Results: Of the 25 clinicians who were sent the survey, 14 responded. Overall, there was no agreement regarding which variables were prognostic of early discontinuation (weighted Cohen's kappa = 0.12; 95% CI = 0.05‐0.18). From an initial 3927 articles, 18 investigations were identified for inclusion in our review. Based upon evidence from both the survey and the systematic review, the following four variables were identified as being prognostic of early discontinuation: (a) comorbidity (OR2+ vs 0 = 1.53; 95% CI = 1.30‐1.79); (b) performance status (ORECOG 2+ vs 0‐1 = 1.33; 95%CI = 1.07‐1.65); (c) T stage (ORT4 vs T1‐2 = 1.57; 95% CI = 0.99‐2.50); and (d) chemotherapy regimen (estimates not pooled due to heterogeneity). In addition to these factors, there was some suggestion that age, marital status/social support, muscle mass, N stage, and tumor grade had prognostic value. Conclusions: Current evidence is heterogeneous and limited. Additional research is needed to confirm our findings and to explore additional prognostic factors. [ABSTRACT FROM AUTHOR]

Background: Hospital- and physician-level variation for selection of percutaneous coronary intervention versus coronary artery bypass grafting (CABG) for patients with coronary artery disease has been associated with outcome differences. However, most studies excluded patients treated medically., Methods and Results: From 2010 to 2019, adults with 3-vessel or left main coronary artery disease at 3 hospitals (A, B, C) in Alberta, Canada, were categorized by treatment with medical therapy, percutaneous coronary intervention, or CABG. Multilevel regression models determined the proportion of variation in treatment attributable to patient, physician, and hospital factors, and survival models assessed outcomes including death and major adverse cardiovascular events over 5 years. Of 22 580 patients (mean age, 67 years; 80% men): 6677 (29%) received medical management, 9171 (41%) percutaneous coronary intervention, and 6732 (30%) CABG. Hospital factors accounted for 10.8% of treatment variation. In adjusted models (site A as reference), patients at sites B and C had 49% (95% CI, 44%-53%) and 43% (95% CI, 37%-49%) lower rates of medical therapy, respectively, and 31% (95% CI, 24%-38%) and 32% (95% CI, 24%-40%) lower rates of CABG. During 5.0 years median follow-up, 3287 (14.6%) patients died, with no intersite mortality differences. There were no between-site differences in acute coronary syndromes or stroke; patients at sites B and C had 24% lower risk (95% CI, 13%-34% and 11%-35%, respectively) of heart failure hospitalization., Conclusions: Hospital-level variation in selection of percutaneous coronary intervention, CABG, or medical therapy for patients with complex coronary artery disease was not associated with differences in 5-year mortality rates. Research and quality improvement initiatives comparing revascularization practices should include medically managed patients.

Background: Coronary artery disease (CAD) confers increased risks of premature mortality, non-fatal morbidity, and significant impairment in functional status and health-related quality of life. Routine administration of electronic patient-reported outcome measures (PROMs) and its real time delivery to care providers is known to have the potential to inform routine cardiac care and to improve quality of care and patient outcomes. This study describes a user-centered development and evaluation of the Alberta Provincial Project for Outcomes Assessment (APPROACH) electronic Patient Reported Outcomes Measurement (e-PROM) system. This e-PROM system is an electronic system for the administration of PROMs to patients with CAD and the delivery of the summarized information to their care providers to facilitate patient-physician communication and shared decision-making. This electronic platform was designed to be accessible via web-based and hand-held devices. Heuristic and user acceptance evaluation were conducted with patients and attending care providers., Results: The APPROACH e-PROM system was co-developed with patients and care providers, research investigators, informaticians and information technology experts. Five PROMs were selected for inclusion in the online platform after consultations with patient partners, care providers, and PROMs experts: the Seattle Angina Questionnaire, Patient Health Questionnaire, EuroQOL, and Medical Outcomes Study Social Support Survey, and Self-Care of Coronary Heart Disease Inventory. The heuristic evaluation was completed by four design experts who examined the usability of the prototype interfaces. User acceptance testing was completed with 13 patients and 10 cardiologists who evaluated prototype user interfaces of the e-PROM system., Conclusion: Both patients and physicians found the APPROACH e-PROM system to be easy to use, understandable, and acceptable. The APPROACH e-PROM system provides a user-informed electronic platform designed to incorporate PROMs into the delivery of individualized cardiac care for persons with CAD., (© 2024. The Author(s).)

Purpose: Patients with coronary artery disease (CAD) experience significant angina symptoms and lifestyle changes. Revascularization procedures can result in better patient-reported outcomes (PROs) than optimal medical therapy (OMT) alone. This study evaluates the impact of response shift (RS) on changes in PROs of patients with CAD across treatment strategies., Methods: Data were from patients with CAD in the Alberta Provincial Project on Outcome Assessment in Coronary Heart Disease (APPROACH) registry who completed the 16-item Canadian version of the Seattle Angina Questionnaire at 2 weeks and 1 year following a coronary angiogram. Multi-group confirmatory factor analysis (MG-CFA) was used to assess measurement invariance across treatment groups at week 2. Longitudinal MG-CFA was used to test for RS according to receipt of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimal medical therapy (OMT) alone., Results: Of the 3116 patients included in the analysis, 443 (14.2%) received CABG, 2049(65.8%) PCI, and the remainder OMT alone. The MG-CFA revealed a partial-strong invariance across the treatment groups at 2 weeks (CFI = 0.98, RMSEA [90% CI] = 0.05 [0.03, 0.06]). Recalibration RS was detected on the Angina Symptoms and Burden subscale and its magnitude in the OMT, PCI, and CABG groups were 0.32, 0.28, and 0.53, respectively. After adjusting for RS effects, the estimated target changes were largest in the CABG group and negligible in the OMT group., Conclusion: Adjusting for RS is recommended in studies that use SAQ-CAN to assess changes in patients with CAD who have received revascularization versus OMT alone., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: The Seattle Angina Questionnaire (SAQ) is a widely used patient-reported measure of health status in patients with coronary artery disease. Comparisons of SAQ scores amongst population groups and over time rely on the assumption that its factorial structure is invariant. This study evaluates the measurement invariance of the SAQ across different demographic and clinical groups and over time., Methods: Data were obtained from the Alberta Provincial Project on Outcome Assessment in Coronary Heart Disease registry, a registry of patients who received coronary angiogram in Alberta, Canada. The study cohort consists of adult patients who completed the paper-based version of the 16-item Canadian version of the SAQ (SAQ-CAN) 2 weeks and 1-year post-coronary angiogram between 2009 and 2016. Multi-group confirmatory factor analysis was used to assess configural, weak, strong, and strict measurement invariance across age groups, sex, angina type, treatment, and over time. Model fit was assessed using the comparative fit index and root mean square error of approximation., Results: Of the 8101 patients included in these analysis, 1300 (16.1%) were at least 75 years old, while 1755 (21.7%) were female, 5154 (63.6%) were diagnosed with acute coronary syndrome, 1177 (14.5%) received coronary artery bypass graft treatment, and 3279 had complete data on the SAQ-CAN at both occasions. There was evidence of strict invariance across age, sex, and angina type, and treatment groups, but partial strict invariance was established over time., Conclusion: SAQ-CAN can be used to compare the health status of coronary artery disease patients across population groups and over time., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: The relationship between antiseizure medications (ASMs), which improve health outcomes by controlling seizures, and health-related quality of life (HRQOL) is poorly understood and may involve intermediate variables. We evaluated the potential mediators of the association between ASMs and HRQOL., Methods: Data are from an outpatient registry of adult patients with epilepsy seen at the Foothills Medical Center, Calgary, Alberta, Canada. Quality of life was measured using the 10-item Quality of Life in Epilepsy, and depression was measured using the Neurological Disorders Depression Inventory for Epilepsy. Propensity score matching was used to adjust for covariate imbalance between patients who received a single ASM (monotherapy) and those who received two or more ASMs (polytherapy) due to confounding. Mediation analysis was used to estimate the mediating effects of depression and ASM side effects on the association between patients' ASM polytherapy and HRQOL., Results: Of 778 patients included in this analysis, 274 (35.2%) were on two or more ASMs. Patient-reported depression and ASM side effects jointly mediated the association between ASMs and HRQOL; these mediators accounted for 42% of the total average effect of ASM polytherapy ( β  = -13.6, 95% confidence interval = -18.2 to -8.6) on HRQOL., Significance: These findings highlight the importance of managing depression and ASM side effects for improving health outcomes of patients requiring treatment with ASMs. Intervention programs aimed at improving HRQOL of patients with epilepsy need to target these potential mediators., (© 2021 International League Against Epilepsy.)

Importance: Several real-world oncology studies have produced findings that contradict those from randomized clinical trials. Such disparities may be associated with methodological shortcomings., Objective: To examine the association between a shortened duration of adjuvant chemotherapy among individuals with stage III colon cancer using real-world data., Design, Setting, and Participants: This comparative effectiveness study included individuals diagnosed with stage III colon cancer between January 2004 and December 2015 who initiated adjuvant chemotherapy at oncology clinics within the province of Alberta, Canada. Patients were identified through record linkage of various administrative databases and were followed up until September 2017. Eligibility criteria were modeled after those used in the International Duration Evaluation of Adjuvant (IDEA) trial. A target trial emulation and naive observational analysis were conducted. Results from both cohorts were benchmarked against findings from the IDEA trial. Data analysis was conducted from March to December 2020., Exposure: A shortened duration of adjuvant 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX) or capecitabine plus oxaliplatin (CAPOX) chemotherapy, defined as 3 to 5 months of treatment vs 6 months., Main Outcomes and Measures: Overall survival assessed via vital statistics. The per-protocol hazard ratio (HR) was estimated using a weighted pooled logistic regression model. Subgroup analyses were conducted by treatment regimen (ie, FOLFOX vs CAPOX) and cancer stage (ie, T1-3 and N1 vs T4 or N2)., Results: From an initial cohort of 3086 patients, 485 (16%) were eligible for inclusion in the target trial analysis. The median age was 59 years (range, 19-81 years), and 230 (47%) were women. The maximum follow-up was 11.6 years. Median overall survival was not reached. A total of 90 patients (19%) died. The 5-year Kaplan Meier overall survival estimate was 0.79 (95% CI, 0.75-0.84). Estimates from the trial emulation were similar to those from the IDEA trial. For example, a shortened duration of adjuvant chemotherapy was not associated with overall survival among patients prescribed CAPOX in the IDEA trial (HR, 0.96; 95% CI, 0.85-1.08) or in the trial emulation (HR, 0.96; 95% CI, 0.43-2.14). In contrast, the naive observational analysis suggested that a shortened duration of CAPOX was significantly associated with worse survival (HR, 3.33; 95% CI, 1.04-10.65)., Conclusions and Relevance: In this study, the explicit emulation of a target trial better approximated results from an analogous well-conducted randomized clinical trial.

Background and Purpose: Patients with transient ischemic attack (TIA) show evidence of cognitive impairment but the reason is not clear. Measurement of microstructural changes in white matter (WM) using diffusion tensor imaging (DTI) may be a useful outcome measure. We report WM changes using DTI and the relationship with neuropsychological performance in a cohort of transient ischemic attack (TIA) and non-TIA subjects., Methods: Ninety-five TIA subjects and 51 non-TIA subjects were assessed using DTI and neuropsychological batteries. Fractional anisotropy (FA) and mean diffusivity (MD) maps were generated and measurements were collected from WM tracts. Adjusted mixed effects regression modelled the relationship between groups and DTI metrics., Results: Transient ischemic attack subjects had a mean age of 67.9 ± 9.4 years, and non-TIA subjects had a mean age 64.9 ± 9.9 years. The TIA group exhibited higher MD values in the fornix (0.36 units, P < 0.001) and lower FA in the superior longitudinal fasciculus (SLF) (-0.29 units, P = 0.001), genu (-0.22 units, P = 0.016), and uncinate fasciculus (UF) (-0.26 units, P = 0.004). Compared to non-TIA subjects, subjects with TIA scored lower on the Addenbrooke's Cognitive Assessment-Revised (median score 95 vs 91, P = 0.01) but showed no differences in scores on the Montreal Cognitive Assessment (median 27 vs 26) or the Mini-Mental State Examination (median 30). TIA subjects had lower scores in memory (median 44 vs 52, P < 0.01) and processing speed (median 45 vs 62, P < 0.01) but not executive function, when compared to non-TIA subjects. Lower FA and higher MD in the fornix, SLF, and UF were associated with poorer performance on tests of visual memory and executive function but not verbal memory. Lower FA in the UF and fornix were related to higher timed scores on the TMT-B (P < 0.01), and higher SLF MD was related to higher scores on TMT-B (P < 0.01), confirming worse executive performance in the TIA group., Conclusions: DTI scans may be useful for detecting microstructural disease in TIA subjects before cognitive symptoms develop. DTI parameters, white matter hyperintensities, and vascular risk factors underly some of the altered neuropsychological measures in TIA subjects., Competing Interests: The authors have declared that no competing interests exist.

Importance: Patients with epilepsy are at an elevated risk of premature mortality. Interventions to reduce this risk are crucial., Objective: To determine if the level of care (non-neurologist, neurologist, or comprehensive epilepsy program) is negatively associated with the risk of premature mortality., Design, Setting, and Participants: In this retrospective open cohort study, all adult patients 18 years or older who met the administrative case definition for incident epilepsy in linked databases (Alberta Health Services administrative health data and the Comprehensive Calgary Epilepsy Programme Registry [CEP]) inclusive of the years 2002 to 2016 were followed up until death or loss to follow-up. The final analyses were performed on May 1, 2019., Exposures: Evaluation by a non-neurologist, neurologist, or epileptologist., Main Outcomes and Measures: The outcome was all-cause mortality. We used extended Cox models treating exposure to a neurologist or the CEP as time-varying covariates. Age, sex, socioeconomic deprivation, disease severity, and comorbid burden at index date were modeled as fixed-time coefficients., Results: A total 23 653 incident cases were identified (annual incidence of 89 per 100 000); the mean age (SD) at index date was 50.8 (19.1) years and 12 158 (50.3%) were women. A total of 14 099 (60%) were not exposed to specialist neurological care, 9554 (40%) received care by a neurologist, and 2054 (9%) received care in the CEP. In total, 4098 deaths (71%) occurred in the nonspecialist setting, 1481 (26%) for those seen by a neurologist, and 176 (3%) for those receiving CEP care. The standardized mortality rate was 7.2% for the entire cohort, 9.4% for those receiving nonspecialist care, 5.6% for those seen by a neurologist, and 2.8% for those seen in the CEP. The hazard ratio (HR) of mortality was lower in those receiving neurologist (HR, 0.85; 95% CI, 0.77-0.93) and CEP (HR, 0.49; 95% CI, 0.38-0.62) care. In multivariable modeling, specialist care, the age at index, and disease severity were retained in the final model of the association between specialist care and mortality., Conclusions and Relevance: Exposure to specialist care is associated with incremental reductions in the hazard of premature mortality. Those referred to a comprehensive epilepsy program received the greatest benefit.

Background: Contrast-induced acute kidney injury (CI-AKI) is a common and serious complication of invasive cardiac procedures. Quality improvement programs have been associated with a lower incidence of CI-AKI over time, but there is a lack of high-quality evidence on clinical decision support for prevention of CI-AKI and its impact on processes of care and clinical outcomes., Methods: The Contrast-Reducing Injury Sustained by Kidneys (Contrast RISK) study will implement an evidence-based multifaceted intervention designed to reduce the incidence of CI-AKI, encompassing automated identification of patients at increased risk for CI-AKI, point-of-care information on safe contrast volume targets, personalized recommendations for hemodynamic optimization of intravenous fluids, and follow-up information for patients at risk. Implementation will use cardiologist academic detailing, computerized clinical decision support, and audit and feedback. All 31 physicians practicing in all 3 of Alberta's cardiac catheterization laboratories will participate using a cluster-randomized stepped-wedge design. The order in which they are introduced to this intervention will be randomized within 8 clusters. The primary outcome is CI-AKI incidence, with secondary outcomes of CI-AKI avoidance strategies and downstream adverse major kidney and cardiovascular events. An economic evaluation will accompany the main trial., Conclusions: The Contrast RISK study leverages information technology systems to identify patient risk combined with evidence-based protocols, audit, and feedback to reduce CI-AKI in cardiac catheterization laboratories across Alberta. If effective, this intervention can be broadly scaled and sustained to improve the safety of cardiac catheterization., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: Perceived social support is known to be an important predictor of health outcomes in patients with acute coronary syndrome (ACS). This study investigates patterns of longitudinal trajectories of patient-reported perceived social support in individuals with ACS., Methods: Data are from 3013 patients from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease registry who had their first cardiac catheterization between 2004 and 2011. Perceived social support was assessed using the 19-item Medical Outcomes Study Social Support Survey (MOS) 2 weeks, 1 year, and 3 years post catheterization. Group-based trajectory analysis based on longitudinal multiple imputation model was used to identify distinct subgroups of trajectories of perceived social support over a 3-year follow-up period., Results: Three distinct social support trajectory subgroups were identified, namely: "High" social support group (60%), "Intermediate" social support group (30%), and "Low" social support subgroup (10%). Being female (OR = 1.67; 95% CI = [1.18-2.36]), depression (OR = 8.10; 95% CI = [4.27-15.36]) and smoking (OR = 1.70; 95% CI = [1.23-2.35]) were predictors of the differences among these trajectory subgroups., Conclusion: Although the majority of ACS patients showed increased or fairly stable trajectories of social support, about 10% of the cohort reported declining social support. These findings can inform targeted psycho-social interventions to improve their perceived social support and health outcomes.

Objective: There is growing evidence that the well-being of childcare workers has important implications for the care provided to children attending childcare centers. To add to the growing body of research in this area and to lay the groundwork for further research, we report the results of a pilot study examining factors that are associated with the health status of childcare workers in southern Alberta, Canada. The factors examined include: health control, employer's interest in the childcare worker's wellbeing, and actions that childcare workers are taking to improve their own health., Results: A total of 260 "Workplace Health and Risks Survey 2008" questionnaires were sent to 13 licensed daycare centers in southern Alberta, Canada. Of these, a total of 110 questionnaires were completed by childcare workers at these centers and returned. Regression analysis results show that control over one's health (Standardized Beta = .504, p < .001), employers' knowledge of negative effects of stress (Standardized Beta = - .328, p = .017), employers' interest in employees' well-being (Standardized Beta = .366, p = .008), and actions that are planned to be taken to improve or maintain health in the future (Standardized Beta = .231, p = .005) are all significant predictors of health status among childcare workers.

Background: Health-related quality of life (HRQOL) assessment is an important health outcome for measuring the efficacy of treatments and interventions for coronary artery disease (CAD). HRQOL is known to improve over the first year after interventions for CAD, but there is limited knowledge of the changes in HRQOL beyond 1 year. We investigated heterogeneity in long-term trajectories of HRQOL in patients with CAD., Methods and Results: Data were obtained from 6226 patients identified from the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease with at least 1-vessel CAD who underwent their first catheterization between 2006 and 2009. HRQOL was assessed using the Seattle Angina Questionnaire, a 19-item disease-specific measure of HRQOL for patients with CAD. Group-based trajectory analysis was used to identify various subgroups of Seattle Angina Questionnaire trajectories over time while adjusting for missing data through a longitudinal multiple imputation model. Multinomial logistic regression was used to identify the predictors of differences among the identified subgroups. Our analysis revealed significant improvements in HRQOL across all the 5 domains of Seattle Angina Questionnaire overtime for the whole data. Multitrajectory analyses revealed 4 HRQOL trajectory subgroups including high (25.1%), largely increased (32.3%), largely decreased (25.0%), and low (17.6%) trajectories. Age, sex, body mass index, diabetes mellitus, previous history of myocardial infarction, smoking, depression, anxiety, type of treatment received, and perceived social support were significant predictors of differences among these trajectory subgroups., Conclusions: This study highlights variations in longitudinal trajectories of HRQOL in patients with CAD. Despite overall improvements in HRQOL, about a quarter of our cohort experienced a significant decline in their HRQOL over the 5-year period. Understanding these HRQOL trajectories may help personalize prognostic information, identify patients and HRQOL domains on which clinical interventions are most beneficial, and support treatment decisions for patients with CAD., (© 2018 American Heart Association, Inc.)