Publications by authors named "Cynthia A Jackevicius"

118 Publications

Renin-angiotensin-aldosterone system inhibitors and major cardiovascular events and acute kidney injury in patients with coronary artery disease.

Pharmacotherapy 2021 Sep 8. Epub 2021 Sep 8.

Institute of Health Policy Management, and Evaluation, University of Toronto, Toronto, ON, Canada.

Background: Renin-angiotensin-aldosterone system inhibitors (RAASIs) are recommended for most patients with coronary artery disease (CAD). However, there is debate across guidelines as to which patients with CAD benefit the most from these agents. This study investigated the association between RAASIs and cardiovascular outcomes and acute kidney injury in a contemporary cohort of patients with CAD.

Methods: Patients ≥65 years of age with CAD alive on April 1, 2012 in Ontario, Canada were included. Outcomes included major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction (MI), unstable angina, stroke, or coronary revascularization), and acute kidney injury (AKI) hospitalizations at 4 years. Inverse probability of treatment-weighted Cox proportional hazards regression models was used to compare the rates of each outcome in patients treated with and without RAASIs (angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers).

Results: There were 165,058 patients with CAD identified (mean age 75 years, 65.5% male, 64.7% prescribed RAASIs). After inverse-probability weighting, treatment with RAASIs was associated with a lower rate of MACE compared with treatment without RAASIs (17.6% vs 18.2%, hazard ratio [HR]: 0.96, 95% CI: 0.93-0.99, respectively). However, treatment with RAASIs was associated with a higher rate of AKI compared with treatment without RAASIs (1.7% vs 1.5%, HR: 1.14, 95% CI: 1.02-1.29, respectively). The reduction in MACE was greater in patients with prior MI (HR: 0.87, 95% CI: 0.82-0.92) compared with patients without prior MI (HR: 1.00, 95% CI: 0.97-1.04, interaction p < 0.01). The increase in AKI was lower in patients with prior MI (HR: 0.82, 95% CI: 0.66-1.00) compared with patients without prior MI (HR: 1.37, 95% CI: 1.19-1.57, interaction p < 0.01).

Conclusions: This study supports the continued use of RAASIs in patients with CAD, although the benefit appears smaller in magnitude than observed in prior trials. High-risk patients, particularly those with prior MI, appear to benefit the most from RAASIs.
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http://dx.doi.org/10.1002/phar.2624DOI Listing
September 2021

Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction.

Circ Cardiovasc Qual Outcomes 2021 Sep 1;14(9):e007665. Epub 2021 Sep 1.

Department of Pharmacy Practice and Administration, Western University of Health Sciences, Pomona, CA (A.F.O., T.T.T., Q.T.L., M.Y., C.A.J.).

Background: Slow uptake of sacubitril/valsartan in patients with heart failure with reduced ejection fraction has been reported, which may negatively impact clinical outcomes. We characterized prior authorization (PA) burden, prescription copayment, and utilization of sacubitril/valsartan by insurance plan type to identify potential barriers to its use.

Methods: We conducted a national population-level, cross-sectional study using PA data from an insurance coverage website accessed in March 2019 and IQVIA National Prescription Audit data from August 2018 to July 2019. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan prescriptions, and copayments per insurance plan type.

Results: Overall, 48.1% (1394/2896) of insurance plans required PA for sacubitril/valsartan. Fewer Medicare (27.7%) than commercial (57.2%) plans required PA (<0.001). For both plan types, the most frequently required PA criteria were ejection fraction (71.6%, 90.9%) and New York Heart Association class (60.4%, 90.8%) for Medicare and commercial plans, respectively. Copayment amounts varied by plan type, with more sacubitril/valsartan prescriptions for commercial plans not requiring a patient copayment (32.4%) compared with Medicare plans (19.3%; <0.001). There were 814 437 sacubitril/valsartan prescriptions for Medicare and 822 292 for commercial plans dispensed from August 2018 to July 2019. Based on estimated heart failure with reduced ejection fraction populations for each plan type, 4-fold more sacubitril/valsartan prescriptions were dispensed in commercial than in Medicare plans (820 versus 215 prescriptions/1000 individuals in the heart failure with reduced ejection fraction population). The estimated proportion of heart failure with reduced ejection fraction patients prescribed sacubitril/valsartan was 3.6% (1.5%-6.8%) for Medicare and 13.7% (4.9%-31.8%) for commercial plan populations.

Conclusions: Despite commercial plans having greater PA requirements than Medicare, population-adjusted use of sacubitril/valsartan was higher in commercial plans. Given that commercial plans had more prescriptions with low copayments than Medicare, copayment policies may be more influential on sacubitril/valsartan use than its PA policies. Low sacubitril/valsartan use in both plan types highlights the multifactorial nature of medication underutilization that includes factors beyond the drug policies that we evaluated.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007665DOI Listing
September 2021

Comparison of measures of medication adherence from pharmacy dispensing and insurer claims data.

Health Serv Res 2021 Aug 13. Epub 2021 Aug 13.

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

Objective: Medication nonadherence is linked to worsened clinical outcomes and increased costs. Existing system-level adherence interventions rely on insurer claims for patient identification and outcome measurement, yet suffer from incomplete capture and lags in data acquisition. Data from pharmacies regarding prescription filling, captured in retail dispensing, may be more efficient.

Data Sources: Pharmacy fill and insurer claims data.

Study Design: We compared adherence measured using pharmacy fill data to adherence using insurer claims data, expressed as proportion of days covered (PDC) over 12 months. Agreement was evaluated using correlation/validation metrics. We also explored the relationship between adherence in both sources and disease control using prediction modeling.

Data Extraction Methods: Large pragmatic trial of cardiometabolic disease in an integrated delivery network.

Principal Findings: Among 1113 patients, adherence was higher in pharmacy fill (mean = 50.0%) versus claims data (mean = 47.4%), although they had moderately high correlation (R = 0.57, 95% CI: 0.53-0.61) with most patients (86.9%) being similarly classified as adherent or nonadherent. Sensitivity and specificity of pharmacy fill versus claims data were high (0.89, 95% CI: 0.86-0.91 and 0.80, 95% CI: 0.75-0.85). Pharmacy fill-based PDC predicted better disease control slightly more than claims-based PDC, although the difference was nonsignificant.

Conclusions: Pharmacy fill data may be an alternative to insurer claims for adherence measurement.
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http://dx.doi.org/10.1111/1475-6773.13714DOI Listing
August 2021

Neoplasm Reports in Food and Drug Administration Adverse Event Reporting System Following Angiotensin Receptor Blocker Recalls.

Circ Cardiovasc Qual Outcomes 2021 Aug 12;14(8):e007476. Epub 2021 Aug 12.

Western University of Health Sciences, Pomona, CA (R.C.S., J.M., C.A.J.).

Background: A worldwide voluntary recall of valsartan in July 2018 due to the potential carcinogen N-nitrosodimethylamine received extensive media and public attention. This was followed by more Food and Drug Administration (FDA) recalls regarding other contaminated ARB (angiotensin receptor blocker) products. Our study investigated the association between the FDA recalls and ARB neoplasm adverse events (AEs) reported to the FDA adverse event reporting system.

Methods: In this cross-sectional study, data were retrospectively collected from the FDA adverse event reporting system database from January 2015 to December 2019. Reporting odds ratios (RORs) were estimated to detect signals of association between ARBs (valsartan, irbesartan, and losartan) and reported neoplasm AEs using negative (amoxicillin and sertraline) and positive (omeprazole and ranitidine) control exposures. The χ was used to compare categorical variables.

Results: A total of 2 181 524 AEs, including 10 461 nonmetastatic neoplasm AEs were analyzed. Monthly RORs (95% CI) of valsartan-associated neoplasms versus controls (ROR*: valsartan/negative exposures; ROR†: valsartan/omeprazole; and ROR‡: valsartan/ranitidine) showed the highest signals after the recall date in July 2018 (7.64 [4.78-12.19]*; 4.77 [3.36-6.79]†; 4.13 [2.50-6.84]‡) and August 2018 (7.87 [5.19-11.94]*; 5.65 [4.12-7.75]†; and 7.20 [4.46-11.63]‡). In contrast, the highest cancer signals for the irbesartan and losartan recalls detected in March 2019 (4.80*; 4.06†; and 3.38‡) and April 2019 (3.63*; 3.69†; and 2.52‡) respectively, were lower. One-year postrecall reported neoplasm AEs were ≈2-fold higher for valsartan than irbesartan (OR, 1.77 [95% CI, 1.47-2.13], <0.0001) and losartan (OR, 2.07 [95% CI, 1.85-2.32], <0.0001). Although all ARBs had the same nitrosamine contamination, we found 1-year postrecall versus prerecall cancer signals for valsartan were 3-fold higher versus control exposures, while the changes in RORs for irbesartan and losartan were only 20-30% higher.

Conclusions: Significantly more postrecall neoplasms were reported for valsartan, with higher valsartan-associated cancer signals compared with irbesartan and losartan, although they all contained the same carcinogenic contaminant. Extensive media coverage of the FDA valsartan recall may have alarmed patients and generated these abrupt, biologically infeasible cancer signals.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007476DOI Listing
August 2021

National Trends in the Use of Sacubitril/Valsartan.

J Card Fail 2021 Aug;27(8):839-847

Department of Pharmacy Practice and Administration, Western University of Health Sciences, Pomona, California; Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California; ICES, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada. Electronic address:

Background: Better understanding of recent sacubitril/valsartan prescription patterns may help identify factors that influence its use. The aim of the study was to characterize sacubitril/valsartan use and dosage patterns nationally.

Methods And Results: We conducted a population-level cohort study using IQVIA Inc. National Prescription Audit™ data in the United States from August 2016 to July 2019. Over 3 years, there was a 5.6-fold increase in the number of sacubitril/valsartan prescriptions dispensed per month, totaling 3.3 million prescriptions. For the most recent year, this extrapolates to a best-case scenario of 13.8% of patients with heart failure with reduced ejection fraction using sacubitril/valsartan, representing at most one-half of those eligible for sacubitril/valsartan use. During the most recent year, 48.7% of dispensed prescriptions were for the lowest strength (24/26 mg) and only 20.6% for the target strength (97/103 mg). A greater proportion of the target strength was used in younger patients (< 65years: 24.6%; ≥ 85: 11.1%; P<0.0001). Cardiologists prescribed 59.0% of all dispensed prescriptions, and noncardiologists showed a greater increase (7.5-fold vs 4.9-fold; P<0.0001) over time.

Conclusions: Recent use of sacubitril/valsartan has increased greatly in the United States; however, a substantial proportion of eligible patients with heart failure with reduced ejection fraction did not receive treatment, and only 1 in 5 prescriptions dispensed were for the target strength. Further exploration of barriers to the use of sacubitril/valsartan and dosing uptitration and their clinical implications warrant further evaluation.
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http://dx.doi.org/10.1016/j.cardfail.2021.05.015DOI Listing
August 2021

Evaluation of the Risk of Stroke Without Anticoagulation Therapy in Men and Women With Atrial Fibrillation Aged 66 to 74 Years Without Other CHA2DS2-VASc Factors.

JAMA Cardiol 2021 Aug;6(8):918-925

ICES (formerly known as the Institute for Clinical Evaluative Sciences), Toronto, Ontario, Canada.

Importance: There are limited clinical trial data and discrepant recommendations regarding use of anticoagulation therapy in patients with atrial fibrillation (AF) aged 65 to 74 years without other stroke risk factors.

Objectives: To evaluate the risk of stroke without anticoagulation therapy in men and women with AF aged 66 to 74 years without other CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex) risk factors and examine the association of stroke incidence with patient age.

Design, Setting, And Participants: A population-based retrospective cohort study was conducted using linked administrative databases. The population included 16 351 individuals aged 66 to 74 years who were newly diagnosed with AF in Ontario, Canada, between April 1, 2007, and March 31, 2017. Exclusion criteria included long-term care residence, prior anticoagulation therapy, valvular disease, heart failure, hypertension, diabetes, stroke, and vascular disease. The cumulative incidence function was used to estimate the 1-year incidence of stroke in patients who did not receive anticoagulation therapy. Fine-Gray regression was used to study the association of patient characteristics with stroke incidence and derive estimates of stroke risk at each age. Death was treated as a competing risk and patients were censored if they initiated anticoagulation therapy. Inverse probability of censoring weights was used to account for patient censoring. Data analysis was performed from May 26, 2019, to December 9, 2020.

Exposures: Atrial fibrillation and age.

Main Outcomes And Measures: Hospitalizations for stroke.

Results: Of the 16 351 individuals with AF (median [interquartile range] age, 70 [68-72] years), 8352 (51.1%) were men; 6314 individuals (38.6%) started anticoagulation therapy during follow-up. The overall 1-year stroke incidence among patients who did not receive anticoagulation therapy was 1.1% (95% CI, 1.0%-1.3%) and the incidence of death without stroke was 8.1% (95% CI, 7.7%-8.5%). The incidence of stroke was not significantly associated with sex. The estimated 1-year stroke risk increased with patient age from 66 years (0.7%; 95% CI, 0.5%-0.9%) to 74 years (1.7%; 95% CI, 1.3%-2.1%).

Conclusions And Relevance: The risk of stroke more than doubled in this study as men and women with AF but no other CHA2DS2-VASc risk factors aged from 66 to 74 years. These data suggest that anticoagulation therapy is more likely to benefit older individuals within this group of patients, whereas younger individuals are less likely to gain net clinical benefit from anticoagulation therapy.
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http://dx.doi.org/10.1001/jamacardio.2021.1232DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8135054PMC
August 2021

Prescribing of two potentially interacting cardiovascular medications in atrial fibrillation patients on direct oral anticoagulants.

Int J Cardiol Heart Vasc 2021 Jun 29;34:100788. Epub 2021 Apr 29.

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

Background: Amiodarone and diltiazem are commonly recommended cardiovascular medications for use in atrial fibrillation (AF) patients. They are known to have drug-drug interactions (DDIs) with direct oral anticoagulants (DOACs). We aimed to evaluate frequency of use of amiodarone or diltiazem among continuous users of DOACs in AF patients and to determine factors associated with their co-use.

Methods: The study population included all AF patients with continuous DOAC use in Ontario, Canada, ≥66 years, from April 1, 2017 to March 31, 2018. Concurrent use of amiodarone or diltiazem was determined by identifying the presence of an overlapping prescription. Multivariable logistic regression models were used to identify predictors of amiodarone or diltiazem use.

Results: In total, 5,390 AF patients, ≥66 years, with continuous DOAC use were identified. Amiodarone was co-prescribed in 6.4% patients and diltiazem was co-prescribed in 11.2% patients. Prior percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) were associated with significantly increased odds of amiodarone co-use (OR 2.51 [95% CI 1.54, 4.09], p = 0.0002 and OR 5.28 [95% CI 3.52, 7.93], p= <0.001, respectively). Patients with a heart failure (HF) history also had increased co-use of amiodarone (OR 2.05 [95% CI 1.57, 2.67], p < 0.001). The presence of chronic obstructive pulmonary disease (COPD) was associated with significantly increased odds of diltiazem co-use (OR 1.58 [95% CI 1.31, 1.9], p=<0.001).

Conclusions: Among AF patients with continuous DOAC use, amiodarone was co-prescribed in 1 in 16 patients and diltiazem was co-prescribed in 1 in 9 patients. Predictors such as history of HF, PCI, CABG or COPD help identify vulnerable populations at increased risk of DDIs.
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http://dx.doi.org/10.1016/j.ijcha.2021.100788DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8105295PMC
June 2021

Bleeding Risk of Direct Oral Anticoagulants in Patients With Heart Failure And Atrial Fibrillation.

Circ Cardiovasc Qual Outcomes 2021 02 5;14(2):e007230. Epub 2021 Feb 5.

Department of Cardiology (A.L.W., Z.G.), Veterans Affairs Greater Los Angeles Healthcare System, CA.

Background: Patients with heart failure and atrial fibrillation are an important atrial fibrillation subgroup in which direct oral anticoagulants (DOACs) have not been adequately studied in real-world settings. Since DOACs rely on renal elimination and renal dysfunction is prevalent in patients with heart failure, their use may increase bleeding risk, negating some of their advantage over warfarin.

Methods: We conducted a retrospective cohort study using linked Veterans Administration databases of patients with heart failure newly started on warfarin or DOACs for atrial fibrillation from October 2010 to August 2017 (23 635 warfarin, 25 823 DOAC). Outcomes included time to first bleeding, stroke, and death using Cox proportional hazards models with inverse probability of treatment weighting.

Results: Total bleeding (hazard ratio, 0.62 [95% CI, 0.56-0.68]), major bleeding (hazard ratio, 0.49 [95% CI, 0.40-0.61]), and death (hazard ratio, 0.74 [95% CI, 0.71-0.78]) were lower with DOAC than warfarin, and with apixaban and dabigatran, but not rivaroxaban. Moderate/severe chronic kidney disease was common (48.7%); moderate chronic kidney disease was associated with increased bleeding with DOACs but not warfarin. However, death and bleeding remained lower with DOACs than warfarin across all renal function levels and clinical subgroups. A >20% transient/persistent decline in renal function occurred in 53% of DOAC-treated patients at some point during follow-up, would have required dose reduction in 10.5% of patients, and was associated with increased bleeding. Dose adjustments were made more often, and bleeding and death were lower in patients seen by pharmacists or anticoagulation clinics. There were significant between-site variations in DOAC dosing.

Conclusions: DOACs overall, apixaban, and dabigatran, but not rivaroxaban, were associated with less total bleeding and death than warfarin in patients with heart failure and atrial fibrillation at all levels of renal function. Renal function decline resulted in increased bleeding in patients with DOACs. DOAC dose adjustment was often indicated, associated with increased bleeding when not adjusted, emphasizing the need for closer monitoring in these patients.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007230DOI Listing
February 2021

Une médecine fondée sur les données probantes à l’époque de la COVID-19.

Can J Hosp Pharm 2021 1;74(1):5-6. Epub 2021 Jan 1.

, BScPhm, PharmD, MSc, est professeure au département de pratique de la pharmacie, Western University of Health Sciences, Pomona, California, et scientifique auxiliaire principale à ICES, Toronto, Ontario. Elle est également rédactrice adjointe au Journal canadien de la pharmacie hospitalière.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801328PMC
January 2021

Evidence-Based Medicine in the COVID-19 Era.

Can J Hosp Pharm 2021 1;74(1):3-4. Epub 2021 Jan 1.

, BScPhm, PharmD, MSc, is Professor with the Department of Pharmacy Practice, Western University of Health Sciences, Pomona, California, and Senior Adjunct Scientist with ICES, Toronto, Ontario. She is also an Associate Editor with the Canadian Journal of Hospital Pharmacy.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801342PMC
January 2021

Examining the Nocebo Effect of Statins Through Statin Adverse Events Reported in the Food and Drug Administration Adverse Event Reporting System.

Circ Cardiovasc Qual Outcomes 2021 01 9;14(1):e007480. Epub 2020 Nov 9.

Western University of Health Sciences, Pomona, CA (J.M., R.C., C.A.J.).

Background: This study aimed to evaluate whether the high frequency of reported statin adverse effects (AEs) may be associated with the nocebo effect. We compared nocebo-related subjective AEs with objective AEs and investigated factors potentially associated with the nocebo effect.

Methods: A retrospective cohort study was conducted using the Food and Drug Administration Adverse Event Reporting System between January 2010 and December 2019 for statins, including, atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. Subjective AEs included fatigue, subjective muscular, and nervous system AEs. Objective AEs were defined as hepatic and objective muscular AEs. We compared the number of subjective and objective AEs using the Mann-Whitney test and examined trends in the frequency of subjective versus objective reports over time using linear regression with interaction terms. We evaluated the association between AEs and gender and country using linear regression. Quantitative detection of signals was estimated using proportional reporting ratio and reporting odds ratio for simvastatin.

Results: Of 2 994 487 overall AE reports, more subjective than objective AEs were reported per quarter (mean±SD: 4777±1375.45 versus 999±276.95; <0.0001), and over time during the study period (<0.001). Women reported more subjective AEs than men per quarter (fatigue: 86.98 more per quarter, =0.035; subjective muscular AE: 417.95, <0.0001; nervous system AE: 273.60, <0.0001), but fewer objective muscular AEs (-125.23 per quarter, <0.0001). More subjective AEs and fewer objective AEs were reported per quarter in the United States relative to other countries. Simvastatin-associated reports showed signals for higher objective muscular AEs relative to all other statins (reporting odds ratio, 1.53 [95% CI, 1.49-1.58]).

Conclusions: This study found that significantly more subjective than objective AEs are reported for statins. Subjective statin AEs, potentially related to the nocebo effect are reported more often by women than by men, and in the United States than in other countries.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007480DOI Listing
January 2021

Fixed-Dose Combination Medications for Treating Hypertension: A Review of Effectiveness, Safety, and Challenges.

Curr Hypertens Rep 2020 10 14;22(11):95. Epub 2020 Oct 14.

Department of Pharmacy Practice and Administration, Western University of Health Sciences, Pomona, CA, USA.

Purpose Of Review: To summarize the recent evidence on the effectiveness and safety of antihypertensive fixed-dose combination (FDC) medications, and to describe the facilitators and barriers to implementing FDCs in US clinical practice.

Recent Findings: Recent clinical practice guidelines include FDC use for treating high BP. Clinical trials in recent years support the use of antihypertensive FDCs including low-dose triple- and quadruple-therapy FDCs. Initiating a low-to-standard dose dual-therapy FDCs showed better BP control than initiating treatment with a standard-dose monotherapy, and triple-therapy FDCs produced better BP control rates than dual-therapy FDCs. Retrospective cohort studies showed that FDCs are associated with increased medication adherence, reduced clinical inertia, decreased time to BP control, and improved cardiovascular outcomes. We further discussed barriers and facilitators of wider implementation of antihypertensive FDCs in clinical practice. FDC treatment for hypertension is not commonly used despite historical and recent data which support the effectiveness, safety, and benefits of FDCs. Simplified and protocolized treatment algorithms, team-based care, shared decision-making principles are crucial to successful utilization and implementation of FDC in clinical practice.
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http://dx.doi.org/10.1007/s11906-020-01109-2DOI Listing
October 2020

Comparison of a new 3-item self-reported measure of adherence to medication with pharmacy claims data in patients with cardiometabolic disease.

Am Heart J 2020 10 24;228:36-43. Epub 2020 Jun 24.

Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

Background: Less than half of patients with cardiometabolic disease consistently take prescribed medications. While health insurers and some delivery organizations use claims to measure adherence, most clinicians do not have access during routine interactions. Self-reported scales exist, but their practical utility is often limited by length or cost. By contrast, the accuracy of a new 3-item self-reported measure has been demonstrated in individuals with HIV. We evaluated its concordance with claims-based adherence measures in cardiometabolic disease.

Methods: We used data from a recently-completed pragmatic trial of patients with cardiometabolic conditions. After 12 months of follow-up, intervention subjects were mailed a survey with the 3-item measure that queries about medication use in the prior 30 days. Responses were linearly transformed and averaged. Adherence was also measured in claims in month 12 and months 1-12 of the trial using proportion of days covered (PDC) metrics. We compared validation metrics for non-adherence for self-report (average <0.80) compared with claims (PDC <0.80).

Results: Of 459 patients returning the survey (response rate: 43.5%), 50.1% were non-adherent in claims in month 12 while 20.9% were non-adherent based on the survey. Specificity of the 3-item metric for non-adherence was high (month 12: 0.83). Sensitivity was relatively poor (month 12: 0.25). Month 12 positive and negative predictive values were 0.59 and 0.52, respectively.

Conclusions: A 3-item self-reported measure has high specificity but poor sensitivity for non-adherence versus claims in cardiometabolic disease. Despite this, the tool could help target those needing adherence support, particularly in the absence of claims data.
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http://dx.doi.org/10.1016/j.ahj.2020.06.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7508975PMC
October 2020

Clinical Outcomes With Beta-Blocker Use in Patients With Recent History of Myocardial Infarction.

Can J Cardiol 2020 10 4;36(10):1633-1640. Epub 2020 Feb 4.

Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Division of Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

Background: It is uncertain whether beta-blockers (BBs) are beneficial in contemporary stable patients with prior myocardial infarction (MI). Therefore, we sought to examine the effectiveness of BB use in this population.

Methods: We conducted a cohort study with the use of administrative databases of patients ≥ 65 years of age, alive on April 1, 2012 (index date) with a hospital discharge diagnosis of MI within the previous 3 years. The primary outcome was time to death or hospitalization for MI or angina 1 year after the index date, with inverse probability of treatment weighting.

Results: We included 33,811 patients with prior MI, of whom 21,440 (63.4%) were dispensed a BB. The median age was 78 years, and 56% were male. There was no difference in the 1-year hazard of death/hospitalization for MI or angina (14.8% vs 14.7%, hazard ratio 1.00, 95% confidence interval 0.94-1.07; P = 0.90) in those receiving vs not receiving BB. Similarly, there was no difference in the individual end points in composite nor in 3-year outcomes. Subgroup analysis by age, sex, MI timing, MI type, heart failure, and atrial fibrillation found no benefit. Patients with a history of revascularisation treated with BBs had a lower rate of the composite outcome compared with those without such history (P = 0.006 for interaction) at 1 year but not at 3 years.

Conclusions: In this large contemporary population-based observational study of older stable patients with prior MI, BBs were not associated with a reduction in major cardiovascular events or mortality in those with MI within the previous 3 years. This study supports the need to conduct contemporary clinical trials evaluating the use of BBs after MI.
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http://dx.doi.org/10.1016/j.cjca.2020.01.024DOI Listing
October 2020

Real-World Adherence and Persistence to Direct Oral Anticoagulants in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis.

Circ Cardiovasc Qual Outcomes 2020 03 9;13(3):e005969. Epub 2020 Mar 9.

Western University of Health Sciences, College of Pharmacy, Pomona, CA (A.F.O., A.S.C., Q.T.L., C.A.J.).

Background: Stroke reduction with direct oral anticoagulants (DOACs) in atrial fibrillation (AF) is dependent on adherence and persistence in the real-world setting. Individual study estimates of DOAC adherence/persistence rates have been discordant. Our aims were to characterize real-world observational evidence for DOAC adherence/persistence and evaluate associated clinical outcomes in patients with AF.

Methods And Results: PubMed, EMBASE, and CINAHL were searched from inception to June 2018. Observational studies that reported real-world DOAC adherence/persistence in patients with AF were included. Study quality was assessed using the Newcastle-Ottawa Scale. Meta-analyses for pooled estimates were performed using DerSimonian and Laird random-effects models. Outcomes included DOAC mean proportion of days covered or medication possession ratio, proportion of good adherence (proportion of days covered/medication possession ratio ≥80%), persistence, DOAC versus vitamin K antagonists persistence, and clinical outcomes associated with nonadherence/nonpersistence. Forty-eight observational studies with 594 784 unique patients with AF (59% male; mean age 71 years) were included. The overall pooled mean proportion of days covered/medication possession ratio was 77% (95% CI, 75%-80%), proportion of patients with good adherence was 66% (95% CI, 63%-70%), and proportion persistent was 69% (95% CI, 65%-72%). The pooled proportion of patients with good adherence was 71% (95% CI, 64%-78%) for apixaban, 60% (95% CI, 52%-68%) for dabigatran, and 70% (95% CI, 64%-75%) for rivaroxaban. Similar patterns were found for pooled persistence by agent. The pooled persistence was higher with DOACs than vitamin K antagonists (odds ratio, 1.44 [95% CI, 1.12-.86]). DOAC nonadherence was associated with an increased risk of stroke (hazard ratio, 1.39 [95% CI, 1.06-1.81]).

Conclusions: Suboptimal adherence and persistence to DOACs was common in patients with AF, with 1 in 3 patients adhering to their DOAC <80% of the time, which was associated with poor clinical outcomes in nonadherent patients. Although it is convenient that DOACs do not require laboratory monitoring, greater effort in monitoring for and interventions to prevent nonadherence may be necessary to optimize stroke prevention. Increased clinician awareness of DOAC nonadherence may help identify at-risk patients.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.005969DOI Listing
March 2020

Association of Follow-Up Care With Long-Term Death and Subsequent Hospitalization in Patients With Atrial Fibrillation Who Receive Emergency Care in the Province of Ontario.

Circ Arrhythm Electrophysiol 2019 12 16;12(12):e006498. Epub 2019 Dec 16.

ICES, Toronto, ON (C.L.A., B.Y., M.J.S., C.A.J., N.M.I., D.S.L., P.A.R., P.C.A.).

Background: Currently, 11% of patients seen in the emergency department for atrial fibrillation die within 1 year of the visit. Our objective was to examine the association of rapid (within 3 days), early (7 days), and basic (30 days) outpatient physician follow-up with short- and long-term outcomes in patients with atrial fibrillation discharged from an emergency department.

Methods: This retrospective cohort study included all adult patients discharged from one of the 163 emergency departments in Ontario, Canada with a primary diagnosis of atrial fibrillation, 2007 to 2014. We used a landmark analysis with propensity score matching, and logistic regression, to assess all-cause mortality and cardiovascular hospitalizations at 1 year and 90 days, 30-day return emergency visits, and 1-year oral anticoagulation prescription fills.

Results: In the 10 657 patients with rapid follow-up care who were propensity score matched to a patient with follow-up between days 4 and 7, the hazard of a return emergency visit was reduced by 11% (HR, 0.89 [95% CI, 0.80-0.98]). It was not associated with mortality or hospitalization. In the 17 234 patients with early follow-up who were matched to a patient with care between days 8 and 30, the rate of 1-year mortality was 11% lower (HR, 0.89 [95% CI, 0.81-0.97]) and 1-year hospitalization was 6% lower (HR, 0.94 [95% CI, 0.89-1.00]). Relative to no 30-day care, basic follow-up care was associated with an increased hazard of 90-day hospitalization (HR, 1.32 [95% CI, 1.12-1.56]) but was no longer associated with mortality. In patients with early follow-up, the odds of filling an oral anticoagulation prescription a year later were 64% higher than those without it (OR, 1.64 [95% CI, 1.54-1.78]).

Conclusions: Compared with follow-up care between days 8 and 30, follow-up within a week after discharge from an emergency department with atrial fibrillation was associated with a reduction in the rate of death and hospitalization within 1 year, an association that was not present with 30-day follow-up.
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http://dx.doi.org/10.1161/CIRCEP.118.006498DOI Listing
December 2019

Prescribing of oral anticoagulants in the emergency department and subsequent long-term use by older adults with atrial fibrillation.

CMAJ 2019 Dec;191(49):E1345-E1354

ICES Central (Atzema, Jackevicius, Chong, Ivers, Austin); Division of Emergency Medicine, Department of Medicine (Atzema), Division of Cardiology, Department of Medicine (Dorian), Department of Family Medicine (Ivers) and Institute for Health Policy, Management and Evaluation (Jackevicius, Dorian, Ivers, Austin), University of Toronto; Sunnybrook Health Sciences Centre (Atzema); Women's College Hospital (Ivers); St. Michael's Hospital (Dorian), Toronto, Ont.; Western University of Health Sciences, Pomona, Calif. (Jackevicius); QEII Health Sciences Centre (Parkash), Halifax, NS.

Background: Patients with atrial fibrillation frequently seek emergency care. Rates of guideline-concordant oral anticoagulant therapy for stroke prevention are suboptimal in the community. We assessed the association between prescribing of oral anticoagulants in the emergency department (relative to referral to a longitudinal care provider for treatment initiation) and long-term use of oral anticoagulants.

Methods: This retrospective cohort study performed at 15 hospitals in Ontario, Canada, involved patients aged 65 years or older who visited the emergency department between 2009 and 2014, who had a primary diagnosis of atrial fibrillation, were discharged home, and were eligible for and willing to take stroke-prevention therapy. We used inverse probability-of-treatment weighting based on the propensity score to compare patients who were and were not given a prescription for an oral anticoagulant. The primary outcome was a prescription fill for an oral anticoagulant 6 months later. Secondary outcomes included a prescription fill at 1 year, all-cause mortality, and strokes or bleeding events leading to hospital admission.

Results: Of 2132 eligible patients, 402 (18.9%) were given a prescription for an oral anticoagulant in the emergency department. After weighting, 67.8% of these patients had filled a prescription for an oral anticoagulant at 6 months versus 37.2% of those who did not receive a prescription in the emergency department (absolute risk increase [ARI] 30.6%, number needed to treat [NNT] 3). At 1 year, the ARI was 23.2% and the NNT was 4. Rates of death, stroke and bleeding events did not differ significantly.

Interpretation: In patients with atrial fibrillation who were eligible for stroke prevention, prescribing an oral anticoagulant in the emergency department was associated with substantially higher long-term use of oral anticoagulants compared with deferring to the longitudinal care provider to initiate this therapy. Physicians working in the emergency department should consider initiating oral anticoagulation in eligible patients who are being discharged to home.
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http://dx.doi.org/10.1503/cmaj.190747DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6901271PMC
December 2019

Population Impact of Generic Valsartan Recall.

Circulation 2020 02 11;141(5):411-413. Epub 2019 Nov 11.

ICES, Toronto, Ontario, Canada (C.A.J., A.C., M.K., P.C.A., J.A.U., D.T.K.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.044494DOI Listing
February 2020

Evaluation of Patients with Heart Failure to Determine Eligibility for Treatment with Sacubitril/Valsartan: Insights from a Veterans Administration Healthcare System.

Pharmacotherapy 2019 11 10;39(11):1053-1059. Epub 2019 Oct 10.

Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.

Study Objective: Despite evidence that supports the use of sacubitril/valsartan - the first angiotensin II receptor blocker-neprilysin inhibitor - for mortality reduction in patients with heart failure (HF), it remains underprescribed. The objective of this study was to evaluate eligibility for initiation of sacubitril/valsartan treatment in patients with HF within the largest Veterans Administration healthcare system in the United States.

Design: Cross-sectional study.

Setting: Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS).

Patients: A total of 2985 patients with a HF diagnosis who were alive as of November 1, 2017.

Measurements And Main Results: Eligibility for sacubitril/valsartan initiation was based on inclusion and exclusion criteria from the Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor with Angiotensin-Converting-Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial and the VA Criteria for Use. The proportion of eligible patients was estimated, and characteristics of eligible patients were compared with those in the PARADIGM-HF trial. Of the 2985 patients with HF who were alive as of November 1, 2017, 965 (32.3%) had HF with reduced ejection fraction (HFrEF). Of these patients with HFrEF, 263 (27.3%) fulfilled eligibility criteria and were considered candidates for sacubitril/valsartan initiation. Of the 702 patients who did not fulfil eligibility criteria, the most common reasons were New York Heart Association functional class I (35.3%) and B-type natriuretic peptide level of 100 pg/ml or lower (22.2%). Compared with patients in the PARADIGM-HF trial, VAGLAHS patients were older (70.4 vs 63.8 yrs) and more likely to be male (98.5% vs 79.0%), and a higher proportion had New York Heart Association functional class III symptoms (35.4% vs 23.1%). Of the 965 patients with HFrEF, 34 (3.5%) had an active sacubitril/valsartan prescription as of November 1, 2017, of whom 27 (79.4%) did not meet criteria.

Conclusion: Whereas 27% of patients with HFrEF were eligible to initiate sacubitril/valsartan, only 3.5% of these patients were prescribed the medication. Although sacubitril/valsartan reduced morbidity and mortality in clinical trials, it remains underused within this VA healthcare system. This analysis provides important insights into the VA and other healthcare systems regarding the opportunity for optimizing guideline-directed HF therapy.
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http://dx.doi.org/10.1002/phar.2328DOI Listing
November 2019

Effectiveness of Interventions Aimed at Increasing Statin-Prescribing Rates in Primary Cardiovascular Disease Prevention: A Systematic Review of Randomized Clinical Trials.

JAMA Cardiol 2019 11;4(11):1160-1169

ICES, Toronto, Ontario, Canada.

Importance: Statins are a cornerstone medication in cardiovascular disease prevention, but their use in clinical practice remains suboptimal, with less than half of people who are indicated for statins actually taking the medication.

Objective: To perform a systematic review and synthesis of the literature on patient-oriented and physician-oriented interventions aimed at increasing statin-prescribing rates in adults without a history of cardiovascular disease.

Evidence Review: PubMed, Embase, and the Cochrane Library were searched for randomized clinical trials published between January 2000 and May 2019. Data abstraction was performed using the Cochrane Public Health Review Group's data collection template, and a narrative synthesis of study results was conducted. The risk of bias in each study was qualitatively assessed, and a funnel plot was created to further evaluate the risk of publication bias.

Findings: Among 7948 citations and 128 full-text articles reviewed, 20 studies (of 109 807 patients) were included in the review. Eight trials reported a statistically significant increases in statin-prescribing rates. Among the effective trials, absolute effect sizes ranged from 4.2% (95% CI, 2.2%-6.4%) to 23% (95% CI, 7.3%-38.9%) and odds ratios from 1.29 (95% CI, 1.01-1.66) to 11.8 (95% CI, 8.8-15.9). Patient-education initiatives were the most commonly effective intervention, with 4 of 7 trials indicating increases in statin-prescribing rates. Two trials combined electronic decision-support tools with audit-and-feedback systems, both of which were effective overall. Physician-education programs without dynamic input regarding patient risk or updated treatment recommendations were generally found to be less effective.

Conclusions And Relevance: While heterogeneous in their interventions and outcomes, a number of interventions have demonstrated increases in statin-prescribing rates, with patient-education initiatives demonstrating more promising results than those focused on physician education alone. As opposed to more education about generic recommendations, tailored patient-focused and physician-focused interventions were more effective when they provided personalized cardiovascular risk information, dynamic decision-support tools, or audit-and-feedback reports in a multicomponent program. There are a number of modestly successful approaches to implement increases in rates of statin prescribing, a proven yet underused cardiovascular disease prevention class of therapy.
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http://dx.doi.org/10.1001/jamacardio.2019.3066DOI Listing
November 2019

Cross-cultural Comparison of Pharmacy Students' Attitudes, Knowledge, Practice, and Barriers Regarding Evidence-based Medicine.

Am J Pharm Educ 2019 06;83(5):6710

Western University of Health Sciences, Pomona, California.

To explore cultural influences on US and Japanese pharmacy students' evidence-based medicine (EBM) attitudes, knowledge, and behavior. A cross-sectional study was conducted using a self-administered survey. Senior students in one pharmacy school in the United States and two pharmacy schools in Japan were invited to complete a 33-item survey instrument. Students in both countries reported having positive attitudes and understanding of EBM concepts. In their self-evaluation, American students rated their current EBM practice, EBM skills, and access to EBM resources higher than Japanese students rated themselves in these areas. The most common barriers to EBM for American students were lack of time (84.5%), lack of statistical knowledge (63.9%), and lack of critical appraisal skills (53.1%). The most common barriers to EBM for Japanese students were lack of training (92.6%), lack of clinical knowledge (90.4%), and lack of opportunity (88.8%). Although barriers to implementing EBM and confidence levels in using EBM differed between US and Japanese pharmacy students, both cohorts recognized EBM as an important skillset for the pharmacy profession. Culturally specific approaches to teaching EBM to pharmacy students are needed to improve EBM use in practice.
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http://dx.doi.org/10.5688/ajpe6710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6630851PMC
June 2019

Long-Term Vitamin K Antagonists and Cancer Risk: A Systematic Review and Meta-Analysis.

Am J Clin Oncol 2019 09;42(9):717-724

Institute of Health Policy, Management and Evaluation.

Objectives: Vitamin K antagonists (VKAs) remain one of the most commonly used anticoagulation therapies. The potential anticancer effect of long-term use of VKAs has been a matter of debate with conflicting results. Our goal was to perform a systematic review and meta-analysis examining the association between long-term VKAs use and cancer risk.

Methods: Systematic searches of multiple major databases were performed from inception until January 2018. We included studies of adults that compared incidence of any cancer between ≥6 months use of VKAs (long-term group) and <6 months use of VKAs or nonuse (control group). Primary outcome was all-cancer incidence and secondary outcomes were cancer-specific incidence, all-cause death and cancer-specific mortality. Hazard ratios (HRs) were pooled using a random-effects model, and individual studies were weighted using inverse variance.

Results: We identified 9 observational studies that included 1,521,408 patients. No randomized trials were identified. In comparison to control, long-term use of VKAs was associated with a significant reduction in incidence of all cancers (HR, 0.84; 95% confidence interval [CI], 0.81-0.88; P<0.001). In a prespecified subgroup analysis, long-term use of VKAs demonstrated a significant reduction in all-cancer incidence when compared with control in individuals whose indication for VKAs were venous thromboembolism (HR, 0.69; 95% CI, 0.52-0.90; P=0.007).

Conclusions: The use of long-term VKAs, for any indication, is associated with lower cancer incidence. This finding could have important clinical implications for the choice of oral anticoagulation therapies among specific patients with a higher baseline risk of cancer.
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http://dx.doi.org/10.1097/COC.0000000000000571DOI Listing
September 2019

Submissions from the SPRINT Data Analysis Challenge on clinical risk prediction: a cross-sectional evaluation.

BMJ Open 2019 03 23;9(3):e025936. Epub 2019 Mar 23.

Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut, USA.

Objectives: To collate and systematically characterise the methods, results and clinical performance of the clinical risk prediction submissions to the Systolic Blood Pressure Intervention Trial (SPRINT) Data Analysis Challenge.

Design: Cross-sectional evaluation.

Data Sources: SPRINT Challenge online submission website.

Study Selection: Submissions to the SPRINT Challenge for clinical prediction tools or clinical risk scores.

Data Extraction: In duplicate by three independent reviewers.

Results: Of 143 submissions, 29 met our inclusion criteria. Of these, 23/29 (79%) reported prediction models for an efficacy outcome (20/23 [87%] of these used the SPRINT study primary composite outcome, 14/29 [48%] used a safety outcome, and 4/29 [14%] examined a combined safety/efficacy outcome). Age and cardiovascular disease history were the most common variables retained in 80% (12/15) of the efficacy and 60% (6/10) of the safety models. However, no two submissions included an identical list of variables intending to predict the same outcomes. Model performance measures, most commonly, the C-statistic, were reported in 57% (13/23) of efficacy and 64% (9/14) of safety model submissions. Only 2/29 (7%) models reported external validation. Nine of 29 (31%) submissions developed and provided evaluable risk prediction tools. Using two hypothetical vignettes, 67% (6/9) of the tools provided expected recommendations for a low-risk patient, while 44% (4/9) did for a high-risk patient. Only 2/29 (7%) of the clinical risk prediction submissions have been published to date.

Conclusions: Despite use of the same data source, a diversity of approaches, methods and results was produced by the 29 SPRINT Challenge competition submissions for clinical risk prediction. Of the nine evaluable risk prediction tools, clinical performance was suboptimal. By collating an overview of the range of approaches taken, researchers may further optimise the development of risk prediction tools in SPRINT-eligible populations, and our findings may inform the conduct of future similar open science projects.
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http://dx.doi.org/10.1136/bmjopen-2018-025936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475140PMC
March 2019

Student pharmacists' performance and perceptions on an evidence-based medicine objective structured clinical examination.

Curr Pharm Teach Learn 2019 03 4;11(3):302-308. Epub 2019 Jan 4.

Western University of Health Sciences, College of Pharmacy, 309 E. Second St., Pomona, CA, United States; VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; University Health Network, Toronto, Ontario, Canada; University of Toronto, Toronto, Ontario, Canada. Electronic address:

Background And Purpose: Studies have examined evidence-based medicine (EBM) focused objective structured clinical examinations (OSCEs) in medical training, but data are lacking in pharmacy trainees. This study sought to assess student pharmacists' performance on and perceptions of a novel EBM OSCE.

Educational Activity And Setting: This EBM OSCE included answering a drug-information inquiry, researching background questions, calling a simulated provider to acquire specific patient information, developing a foreground clinical question, reviewing pre-appraised trial synopses, and applying evidence to write a recommendation. Pharmacy faculty served as simulated providers and assessed students on knowledge/analytical (AC) and global communication (GC) skills. Students completed a worksheet (WS) that included developing a patient, intervention, comparison, outcome (PICO) statement, trial selection, and clinical recommendation. After OSCE completion, students were surveyed regarding perceptions of their performance and OSCE applicability. Outcomes assessed were performance scores (AC, GC, WS) and student perceptions.

Findings: One-hundred twenty-nine students completed the survey and were included in analysis. AC, WS, and GC performance [median (IQR)] were 75.0 (37.8), 86.4 (36.9), and 88.9 (22.2), respectively, on a 100-point scale. On the WS, 89% of students developed a suitable searchable clinical question and 61% selected the correct trial synopsis to apply to the case. Students felt literature application and WS development were most challenging. A majority of students felt this OSCE increased comfort in engaging with providers (74%) and that these skills correlate with real clinical scenarios (77%).

Summary: OSCEs can be a valuable tool for simulating clinical scenarios and assessing student pharmacists' EBM skills.
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http://dx.doi.org/10.1016/j.cptl.2018.12.012DOI Listing
March 2019

A Longitudinal Evidence-Based Medicine Curriculum and Its Impact on the Attitudes and Perceptions of Student Pharmacists.

Am J Pharm Educ 2019 02;83(1):6510

Western University of Health Sciences College of Pharmacy, Pomona, California.

To describe a longitudinal evidence-based medicine (EBM) curriculum and to evaluate its impact on the attitudes and perceptions of student pharmacists toward EBM. Western University of Health Sciences has had a structured, longitudinal, EBM curriculum for more than 10 years, spanning the first to third years, including the introductory experiential experiences. A survey was administered prior to the main EBM course and at the completion of the course at three time periods to assess student pharmacists' attitudes and perceptions of EBM and interactive pedagogical methods. Student pharmacists at Western University of Health Sciences voluntarily participated in the self-administered survey. The three time periods examined included: directly after completion of the EBM course, after completion of the didactic curriculum, and after completion of the advanced pharmacy practice experiences (APPE). The response rates were: pre-survey 94% and post-survey 53%. The three classes surveyed had similar baseline characteristics. Students' perceptions of EBM skills and attitudes improved at all time periods post-course. Students felt strongly both before and after exposure to the EBM course and the longitudinal EBM curriculum about learning new EBM skills and that all pharmacists should have these skills. Significantly more students appreciated all the interactive pedagogical methods after APPE completion (>85% of students), as compared with over 74% of students directly after the EBM course, and over 79% of students after didactic completion. The attitudes and perceptions of student pharmacists toward EBM improved after exposure to a longitudinal EBM curriculum.
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http://dx.doi.org/10.5688/ajpe6510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6418856PMC
February 2019

Key Articles and Guidelines in the Management of Heart Failure: 2018 Update.

J Pharm Pract 2019 Feb 19;32(1):77-92. Epub 2018 Dec 19.

7 University of Missouri Kansas City, Kansas City, MO, USA.

Heart failure is one of the leading causes of hospitalizations in the United States, with >1 million admissions yearly and a 25% risk of readmissions within 1 month. In order to assist clinicians, we provide an update of the heart failure bibliography that was published in Pharmacotherapy in 2008, which followed the original bibliography published in 2004. A significant number of clinical trials and observational studies have been conducted since the early 1980s to guide management of heart failure patients. Major advances have occurred in the past 10 years, and our understanding of the diagnosis, prevention, and management of heart failure has evolved substantially during this time period. Specific areas of this review include heart failure risk factors, management of comorbid conditions, acute heart failure management, chronic heart failure management, advanced heart failure, device therapy, lifestyle modification, and medication and therapy management, including medication adherence. Key consensus guidelines and statements are also included. This bibliography of key heart failure papers aims to provide clinicians and their trainees with a valuable clinical reference resource and teaching tool that may be used to optimize the care of patients with heart failure.
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http://dx.doi.org/10.1177/0897190018819413DOI Listing
February 2019

Eligibility, Clinical Outcomes, and Budget Impact of PCSK9 Inhibitor Adoption: The CANHEART PCSK9 Study.

J Am Heart Assoc 2018 11;7(21):e010007

1 Institute for Clinical Evaluative Sciences Toronto Ontario Canada.

Background The FOURIER (Further Cardiovascular Outcomes Research With PCSK9i [Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors] in Subjects With Elevated Risk) trial found a reduction in cardiovascular events in patients with atherosclerotic cardiovascular disease ( ASCVD ). Our objective was to estimate the eligibility, clinical outcomes, and budget impact of adopting PCSK 9i in a large healthcare system. Methods and Results Ontario, Canada, residents alive in 2011, aged 40 to 85 years, were eligible for inclusion. PCSK 9i eligibility was determined on the basis of FOURIER trial definition. Hazard ratios observed in the FOURIER trial were applied to assess the number of events that could be avoided. Budget impact was calculated as the difference between projected costs of treatment adoption and events avoided if PCSK 9i were used. Of the 2.4 million included individuals, 5.3% had a history of ASCVD . We estimated that 2.7% of the general population and 51.9% of the patients with ASCVD would be eligible for PCSK 9i. Adoption of PCSK 9i in all eligible patients with ASCVD was projected to reduce primary events rates by 1.8% after 3 years. Despite cost reduction of $44 million in events, PCSK 9i adoption would have a net budget impact of $1.5 billion over 3 years. Potential benefits of PCSK 9i varied widely across subgroups, with the largest absolute risk reduction estimated to be 4.3% at 3 years in peripheral artery disease. In this subgroup of 5601 patients, the budget impact of treatment adoption was $116 million. Conclusions We estimated that ≈1 in 2 patients with ASCVD would be eligible for PCSK 9i. The budget impact of adopting PCSK 9i for all patients with ASCVD is substantial. Selective adoption to high-risk patients will lessen the overall budgetary impact of PCSK 9i treatment.
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http://dx.doi.org/10.1161/JAHA.118.010007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6404170PMC
November 2018

Effect of early physician follow-up on mortality and subsequent hospital admissions after emergency care for heart failure: a retrospective cohort study.

CMAJ 2018 12;190(50):E1468-E1477

ICES (Atzema, Austin, Yu, Schull, Jackevicius, Ivers, Rochon, Lee); Divisions of Emergency Medicine (Atzema, Schull) and Cardiology (Lee), Departments of Medicine and Family Medicine (Ivers), and the Institute for Health Policy, Management and Evaluation (Atzema, Austin, Schull, Jackevicius, Ivers, Rochon, Lee), University of Toronto; Sunnybrook Health Sciences Centre (Atzema, Schull, Austin); Women's College Hospital (Ivers, Rochon); University Health Network (Jackevicius, Lee); Toronto, Ont.; Western University of Health Sciences (Jackevicius), Pomona, Calif.; Veteran's Affairs Greater Los Angeles Healthcare System ( Jackevicius), Los Angeles, Calif.

Background: The 1-year mortality rate in patients with heart failure who are discharged from an emergency department is 20%. We sought to determine whether early follow-up after discharge from the emergency department was associated with decreased mortality or subsequent admission to hospital.

Methods: This retrospective cohort study conducted in Ontario, Canada, included adult patients who were discharged from 1 of 163 emergency departments between April 2007 and March 2014 with a primary diagnosis of heart failure. Using a propensity score-matched landmark analysis, we assessed follow-up in relation to mortality and admissions to hospital for cardiovascular conditions.

Results: Of 34 519 patients, 16 274 (47.1%) obtained follow-up care within 7 days and 28 846 (83.6%) within 30 days. Compared with follow-up between day 8 and 30, patients with follow-up care within 7 days had a lower rate of mortality over 1 year (hazard ratio [HR] 0.92; 95% confidence interval [CI] 0.87-0.97), and a reduced rate of admission to hospital over 90 days (HR 0.87, 95% CI 0.80-0.94) and 1 year (HR 0.92; 95% CI 0.87-0.97); the mortality rate over 90 days in this group trended to a lower rate (HR 0.90, 95% CI 0.10-1.00). Follow-up care within 30 days, compared with patients without 30-day follow-up, was associated with a reduction in 1-year mortality (HR 0.89, 95% CI 0.82-0.97) but not admission to hospital (HR 1.02, 95% CI 0.94-1.10). In this group, there was a trend toward an increase in 90-day admission to hospital (HR 1.14, 95% CI 1.00-1.29).

Interpretation: Follow-up care within 7 days of discharge from the emergency department was associated with lower rates of long-term mortality, as well as subsequent hospital admissions, and a trend to lower short-term mortality rates. Timely access to longitudinal care for patients with heart failure who are discharged from the emergency setting should be prioritized.
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http://dx.doi.org/10.1503/cmaj.180786DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291388PMC
December 2018
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