Research Spotlight

Posted September 20th 2020

Relative effectiveness of high dose versus standard dose influenza vaccines in older adult outpatients over four seasons, 2015-16 to 2018-19.

Manjusha Gaglani M.D.

Manjusha Gaglani M.D.

Balasubramani, G.K., Choi, W.S., Nowalk, M.P., Zimmerman, R.K., Monto, A.S., Martin, E.T., Belongia, E.A., McLean, H.Q., Gaglani, M., Murthy, K., Jackson, M.L., Jackson, L.A., Chung, J.R., Spencer, S., Fry, A.M., Patel, M. and Flannery, B. (2020). “Relative effectiveness of high dose versus standard dose influenza vaccines in older adult outpatients over four seasons, 2015-16 to 2018-19.” Vaccine Aug 12;S0264-410X(20)31032-X. [Epub ahead of print.].

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BACKGROUND: New influenza vaccine formulations are designed to improve vaccine effectiveness and protect those most vulnerable to infection. High dose trivalent inactivated influenza vaccine (HD-IIV3), licensed for ages ≥65 years, produces greater antibody responses and efficacy in clinical trials, but post-licensure vaccine effectiveness (VE) compared to standard dose (SD-IIV3/4) vaccine remains an open question. METHODS: Using a test-negative, case control design and propensity analyses to adjust for confounding, US Influenza VE Network data from the 2015-2016 through 2018-2019 seasons were analyzed to determine relative VE (rVE) between HD-IIV3 and SD-IIV3/4 among outpatients ≥65 years old presenting with acute respiratory illness. Influenza vaccination status was derived from electronic medical records and immunization registries. RESULTS: Among 3861 enrollees, 2993 (78%) were vaccinated; 1573 (53%) received HD-IIV3 and 1420 (47%) received SD-IIV3/4. HD-IIV3 recipients differed from SD-IIV3/4 recipients by race, previous vaccination, number of outpatient visits in the previous year and timing of vaccination, and were balanced in the propensity model except the timing of vaccination. Compared with no vaccination, significant protection against any influenza A was observed from both HD-IIV3 (VE = 29%; 95%CI = 10%, 44%) and SD-IIV3/4 (VE = 24%; 95%CI = 5%, 39%); rVE = 18% (95%CI = 0%, 33%, SD as referent). When stratified by virus type, against A/H1N1, HD-IIV3 VE was 30% (95%CI = -7%, 54%), SD-IIV3/4 VE was 40% (95%CI = 10%, 61%), and rVE = -32%; (95%CI = -94%, 11%); Against A/H3N2, HD-IIV3 VE was 31% (95%CI = 9%, 47%), SD-IIV3/4 VE was 19% (95%CI = -5%, 37%), and rVE = 27%; (95% CI = 9%, 42%). CONCLUSIONS: Among adults ≥65 years of age, recipients of standard and high dose influenza vaccines differed significantly in their characteristics. After adjusting for these differences, high dose vaccine offered more protection against A/H3N2 and borderline significant protection against all influenza A requiring outpatient care during the 2015-2018 influenza seasons.


Posted September 20th 2020

Is a “petticoat” just cosmetic or like a “belt and suspenders”?

John F. Eidt M.D.

John F. Eidt M.D.

Eidt, J.F. (2020). “Is a “petticoat” just cosmetic or like a “belt and suspenders”?” J Vasc Surg 72(3): 1121.

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Although it is clear that proximal thoracic endografting has improved the management of dissections involving the descending thoracic aorta, there remain significant challenges with the management of this condition. In the acute setting, excluding patients with impending or frank rupture, it is the treatment of malperfusion that takes first priority. In the chronic phase, aneurysmal degeneration in the uncovered visceral and infrarenal aorta occurs in 30% to 50% of patients and represents the Achilles heel of current endovascular management strategies. With the dual goals of reducing visceral malperfusion acutely and improving long-term aortic remodeling, a number of authors have proposed the placement of a bare-metal stent extension distal to the proximal thoracic endograft. The current article was designed to compare the outcomes of combined proximal covered stent grafting either with or without distal bare stenting. [No abstract; excerpt from article.].


Posted September 20th 2020

Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke.

Simon Driver Ph.D.

Simon Driver Ph.D.

Driver, S., McShan, E., Swank, C., Grobe, K., Calhoun, S., Bailey, R. and Kramer, K. (2020). “Creating an appropriate adaptation of a healthy lifestyle intervention for people after stroke.” Brain Inj Aug 19;1-7. [Epub ahead of print.].

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PRIMARY OBJECTIVE: To describe (1) an evidence-based approach to promoting a healthy lifestyle, the Diabetes Prevention Program Group Lifestyle Balance intervention, and (2) our work with input from an Advisory Board of stakeholders to modify the program to meet the unique needs of people post stroke. RESEARCH DESIGN: Community-Based Participatory Research. METHODS AND PROCEDURES: An Advisory Board of stakeholders was convened to modify the Group Lifestyle Balance intervention to meet the unique needs of people post stroke. MAIN OUTCOMES AND RESULTS: The primary adaptations that emerged from the Advisory Board included (1) curriculum emphasis on heart health after stroke, (2) care partner participation, (3) physical activity, dietary, and weight loss modifications specific to people after stroke, and (4) general programmatic recommendations (e.g., wider age range of participants; eligibility based on time since stroke; alternative modes of delivery). CONCLUSIONS: Feedback from the diverse group of stakeholders provides the basis for modifying an evidence-based healthy lifestyle intervention to meet the unique needs of people after stroke. Future research efforts should examine the efficacy and effectiveness of the adapted program to prevent weight gain after stroke and reduce the risk of chronic conditions including diabetes, metabolic syndrome, and heart disease.


Posted September 20th 2020

An observational study of drug utilization and associated outcomes among adult patients diagnosed with BRAF-mutant advanced melanoma treated with first-line anti-PD-1 monotherapies or BRAF/MEK inhibitors in a community-based oncology setting.

Charles L. Cowey M.D.

Charles L. Cowey M.D.

Cowey, C.L., Boyd, M., Aguilar, K.M., Beeks, A., Krepler, C. and Scherrer, E. (2020). “An observational study of drug utilization and associated outcomes among adult patients diagnosed with BRAF-mutant advanced melanoma treated with first-line anti-PD-1 monotherapies or BRAF/MEK inhibitors in a community-based oncology setting.” Cancer Med Sep 1. [Epub ahead of print.].

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INTRODUCTION: Anti-PD-1 monotherapies (aPD-1) and BRAF/MEK inhibitors (BRAF/MEKi) changed the BRAF-mutant advanced melanoma treatment landscape. This study aimed to improve the understanding of real-world treatment patterns and optimal treatment sequence. METHODS: This was a retrospective study of BRAF-mutant advanced melanoma patients who initiated 1L aPD-1 or BRAF/MEKi in the US Oncology Network between 1 January 2014 and 31 December 2017, followed through 31 December 2018. Patient and treatment characteristics were assessed descriptively, with Kaplan-Meier methods used for time-to-event endpoints. As the primary analysis, overall survival (OS) and physician-assessed progression-free survival (rwPFS) were evaluated with Cox proportional hazard regression models and propensity score matching (n = 49). RESULTS: A total of 224 patients were included (median age 61 years, 62.9% male, 89.7% white): 36.2% received aPD-1 and 63.8% BRAF/MEKi. Median OS and rwPFS were longer among aPD-1 vs BRAF/MEKi patients (OS: not reached vs 13.9 months, log-rank P = .0169; rwPFS: 7.6 vs 6.5 months, log-rank P = .0144). Receipt of aPD-1 was associated with improved OS (HR = 0.602 vs BRAF/MEKi [95%CI 0.382-0.949]; P = .0287). Among patients without an event within 6 months of 1L initiation, receipt of aPD-1 was associated with a decreased risk of progression or death from 6 months onwards (HR = 0.228 [95%CI 0.106-0.493]; P = .0002). This association was not observed among patients within 6 months of 1L initiation (HR = 1.146; 95% CI 0.755-1.738). Results from the propensity score-matched pairs were consistent with these trends. CONCLUSION: These results suggest a clinical benefit of 1L aPD-1 compared to BRAF/MEKi after 6 months of treatment for BRAF-mutant advanced melanoma. Future research should explore factors associated with early progression and their relationship with clinical outcomes.


Posted September 20th 2020

Impact of Pharmacist Intervention in Response to Automated Molecular Diagnostic Tests of Blood Culture Results.

Peter Colley, PharmD

Peter Colley, PharmD

McCarthy, L., Colley, P., Nguyen, H.L. and Berhe, M. (2020). “Impact of Pharmacist Intervention in Response to Automated Molecular Diagnostic Tests of Blood Culture Results.” J Pharm Pract Aug 13;897190020943369. [Epub ahead of print.].

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BACKGROUND: Rapid molecular diagnostic tests can aid in deescalating antimicrobial therapy prior to final culture and susceptibility reports. OBJECTIVE: The purpose of this study was to determine whether a new workflow that incorporated pharmacist review of these results reduced time to change in antimicrobial therapy. METHODS: This retrospective study analyzed pre- and post-implementation of pharmacist review of positive blood cultures analyzed by rapid diagnostics with clinical recommendations paged to providers. Patients 18 years of age or older initiated on empiric antibiotics were included. The primary outcome was the time to change to targeted antimicrobials. Other outcomes evaluated were rates of Clostridioides difficile (C difficile) infection, inpatient mortality, and intensive care unit and hospital lengths of stay. RESULTS: A total of 199 patients were included, with 98 and 101 patients in the pre- and post-implementation groups, respectively. The median time to change to targeted antimicrobials was significantly reduced with pharmacist intervention from 18.35 to 8.43 hours (P = 0.042). The groups had similar rates of C difficile infection (1% vs 0%, P = 0.492) and mortality (7.1% vs 5%, P = 0.564). The post-group also had significant reductions in antibiotic days of therapy (10.5 vs 9 days, P = 0.014) and intensive care unit length of stay (3.04 vs 1.44 days, P = 0.046). Median hospital length of stay was similar between the pre- and post-groups (8.5 vs 8 days, P = 0.106), respectively. CONCLUSION: Incorporating pharmacist review of rapid molecular results of blood cultures decreased time to change to targeted antimicrobials and reduced inpatient antibiotic days of therapy.