No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial.

The objective of the study was to assess the safety and immunogenicity of mRNA-1273 COVID-19 booster vaccination when co-administered with an egg-based standard dose seasonal quadrivalent influenza vaccine (QIV). This was a phase 3, randomized, open-label study. Eligible adults aged ≥ 18 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and QIV 2 weeks apart (Seq group) or concomitantly (Coad group). Primary objectives were non-inferiority of haemagglutinin inhibition (HI) and anti-Spike protein antibody responses in the Coad compared to Seq group. 497/498 participants were randomized and vaccinated in the Seq/Coad groups, respectively. The adjusted geometric mean titer/concentration ratios (95% confidence intervals) (Seq/Coad) for HI antibodies were 1.02 (0.89-1.18) for A/H1N1, 0.93 (0.82-1.05) for A/H3N2, 1.00 (0.89-1.14] for B/Victoria, and 1.04 (0.93-1.17) for B/Yamagata; and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. The most frequently reported adverse events in both groups were pain at the injection site and myalgia. The 2 groups were similar in terms of the overall frequency, intensity, and duration of adverse events. In conclusion, co-administration of mRNA-1273 booster vaccine with QIV in adults was immunologically non-inferior to sequential administration. Safety and reactogenicity profiles were similar in both groups (clinicaltrials.gov NCT05047770).

What is the context? Updated booster shots against COVID-19 disease are likely to offer more protection as the virus is changing over time.It is important for doctors, other healthcare providers and patients to know whether COVID-19 booster vaccines can be given at the same time as other vaccines recommended for adults.What is new? The results of our study showed that an mRNA-based COVID-19 booster vaccine could be given at the same time as the seasonal influenza vaccine.When given together, both vaccines led to immune responses and had side effects that were similar to those observed when they were given at separate times.What is the impact? The potential benefits of administering more than 1 vaccine during a healthcare visit include improved coverage and a reduced number of doctor visits needed to receive all vaccines.Co-administration of COVID-19 booster vaccines and influenza vaccines could be an attractive option for patients and healthcare professionals.

No Immunological Interference or Safety Concerns When Adjuvanted Recombinant Zoster Vaccine Is Coadministered With a Coronavirus Disease 2019 mRNA-1273 Booster Vaccine in Adults Aged 50 Years and Older: A Randomized Trial.

BACKGROUND: There is growing consensus that coronavirus disease 2019 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. METHODS: In this phase 3, randomized, open-label study, eligible adults aged ≥50 years were randomly assigned (1:1) to receive mRNA-1273 (50 µg) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post-RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E (gE) and anti-spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. RESULTS: In total, 273 participants were randomized to the Seq group and 272 to the Coad group. Protocol-specified noninferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], .89-1.13) for anti-gE antibodies 1 month post-RZV2, and 1.09 (95% CI, .90-1.32) for anti-spike antibodies 1 month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration ≤2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. CONCLUSIONS: Coadministration of mRNA-1273 booster vaccine with RZV in adults aged ≥50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially. Clinical Trials Registration. NCT05047770.

Differences in the Treatment of Benign Prostatic Hyperplasia: Comparing the Primary Care Physician and the Urologist.

INTRODUCTION: Benign prostatic hyperplasia is a prevalent chronic condition with expenditures exceeding $1 billion each year. Little is known about management of patients by primary care physicians compared to urologists. We assessed changes in management after medication initiation in these two settings. METHODS: From the Chronic Condition Warehouse 5% sample of Medicare beneficiaries linked to Medicare Part D data, we defined a cohort of men, 66 to 90 years old, with initial prescriptions for alpha-blocker, 5-alpha reductase inhibitor (5-ARI), or both. We assessed the initial change in therapy for up to four years after medication initiation: add a medication, switch medication, stop medication, or have surgery/retention. We estimated the cumulative incidence functions from competing risks data, and tested equality across groups (primary care physician vs. urologist). RESULTS: 5714 men started medication with a primary care physician, 1970 with a urologist. The most common change in treatment after medication initiation across all groups was medication discontinuation (55% alpha blocker; 46% 5-ARI; 30% combination therapy cumulative incidence at 3 years). Patients who started with primary care physicians were more likely to discontinue BPH-related medications, than patients with urologists (HR 1.19; 95% CI 1.09 - 1.29). The majority of patients who stopped alpha blocker therapy did not have further BPH therapy. CONCLUSIONS: Men given combination therapy are most likely to have continued medication use. Surgical therapy and retention are relatively rare events. Patients who initiate care with urologists are more likely to continue medical therapy than patients with care initiated by primary care providers.

Electronic nutritional intake assessment in patients with urolithiasis: A decision impact analysis.

PURPOSE: To evaluate a physician's impression of a urinary stone patient's dietary intake and whether it was dependent on the medium through which the nutritional data were obtained. Furthermore, we sought to determine if using an electronic food frequency questionnaire (FFQ) impacted dietary recommendations for these patients. MATERIALS AND METHODS: Seventy-six patients attended the Stone Clinic over a period of 6 weeks. Seventy-five gave consent for enrollment in our study. Patients completed an office-based interview with a fellowship-trained endourologist, and a FFQ administered on an iPad. The FFQ assessed intake of various dietary components related to stone development, such as oxalate and calcium. The urologists were blinded to the identity of patients' FFQ results. Based on the office-based interview and the FFQ results, the urologists provided separate assessments of the impact of nutrition and hydration on the patient's stone disease (nutrition impact score and hydration impact score, respectively) and treatment recommendations. Multivariate logistic regressions were used to compare pre-FFQ data to post-FFQ data. RESULTS: Higher FFQ scores for sodium (odds ratio [OR], 1.02; p=0.02) and fluids (OR, 1.03, p=0.04) were associated with a higher nutritional impact score. None of the FFQ parameters impacted hydration impact score. A higher FFQ score for oxalate (OR, 1.07; p=0.02) was associated with the addition of at least one treatment recommendation. CONCLUSIONS: Information derived from a FFQ can yield a significant impact on a physician's assessment of stone risks and decision for management of stone disease.

Limited use of surveillance imaging following nephrectomy for renal cell carcinoma.

OBJECTIVES: To evaluate the utilization of follow-up imaging after nephrectomy for renal cell carcinoma (RCC) in nationally representative data. PATIENTS AND METHODS: Using Surveillance, Epidemiology, End Results data linked to Medicare records, we identified patients with RCC who received nephrectomy from 1991 to 2007. Patients were stratified by tumor stage. Postoperative chest and abdominal imaging (including chest x-ray, computed tomography scan, and magnetic resonance imaging; abdominal ultrasound, computed tomography scan, and magnetic resonance imaging) was assessed. Observed surveillance imaging frequency was compared to published protocols. Predictors of initial and continued yearly surveillance imaging were identified. RESULTS: Agreement between observed imaging frequency and evidence-based surveillance protocols was low, particularly for patients with T2-T4 disease. For patients who were not censored before 13 months, initial abdominal and chest surveillance imaging was obtained in 69% and 78% of patients, respectively. By year 5, 28% and 39% of patients with high-risk disease (T3 or T4), as compared to 21% and 25% of patients with low to moderate risk disease (T1 and T2), received yearly surveillance abdominal and chest imaging, respectively. High-risk disease was predictive of initial chest (odds ratio [OR] = 1.38) and abdominal (OR = 1.6) imaging, as well as continued yearly chest (hazard ratio [HR] = 0.73) and abdominal (HR = 0.74) imaging surveillance. For abdominal imaging, more contemporary year of surgery was predictive of initial (1997-2001, OR = 1.6; 2002-2007, OR = 2.4) and continued yearly surveillance (1997-2001, HR = 0.82; 2002-2007; HR = 0.67). CONCLUSIONS: In the Medicare population, surveillance imaging is performed in a limited number of patients following nephrectomy for RCC. However, increasing tumor stage is predictive of both increased chest and abdominal imaging surveillance.

Cost and Mortality Associated With Postoperative Acute Kidney Injury.

OBJECTIVE: To determine the incremental hospital cost and mortality associated with the development of postoperative acute kidney injury (AKI) and with other associated postoperative complications. BACKGROUND: Each year 1.5 million patients develop a major complication after surgery. Postoperative AKI is one of the most common postoperative complications and is associated with an increase in hospital mortality and decreased survival for up to 15 years after surgery. METHODS: In a single-center cohort of 50,314 adult surgical patients undergoing major inpatient surgery, we applied risk-adjusted regression models for cost and mortality using postoperative AKI and other complications as the main independent predictors. We defined AKI using consensus Risk, Injury, Failure, Loss and End-Stage Renal Disease criteria. RESULTS: The prevalence of AKI was 39% among 50,314 patients with available serum creatinine. Patients with AKI were more likely to have postoperative complications and had longer lengths of stay in the intensive care unit and the hospital. The risk-adjusted average cost of care for patients undergoing surgery was $42,600 for patients with any AKI compared with $26,700 for patients without AKI. The risk-adjusted 90-day mortality was 6.5% for patients with any AKI compared with 4.4% for patients without AKI. Serious postoperative complications resulted in increased cost of care and mortality for all patients, but the increase was much larger for those patients with any degree of AKI. CONCLUSIONS: Hospital costs and mortality are strongly associated with postoperative AKI, are correlated with the severity of AKI, and are much higher for patients with other postoperative complications in addition to AKI.