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Nevin Manimala Statistics

Human papillomavirus vaccinations at recommended ages: How a middle school-based educational and vaccination program increased uptake in the Rio Grande Valley

Hum Vaccin Immunother. 2022 Oct 17:2133315. doi: 10.1080/21645515.2022.2133315. Online ahead of print.

ABSTRACT

Human papillomavirus (HPV) vaccination is recommended for U.S. adolescents at ages 11-12 requiring two or three doses depending on if the vaccine series started before age 15. The objective was to compare HPV vaccination rates among medically underserved, economically disadvantaged, students in rural middle school districts (Rio Grande Valley [RGV], Texas) by age of initiation (≤ age 11 years vs. age 12 years and older). This quasi-experimental study included 1,766 students (884 females; 882 males) who received at least one HPV vaccine dose through our school-based vaccination program between 08/2016-06/2022. Summary statistics were stratified by age at initiation and gender. The overall HPV up-to-date (UTD) rate was 59.7% (95% Confidence Interval: 57.4-62.0%). The median age at HPV UTD (range) was 12 years (9-19) and median interval between HPV vaccine doses (range) was 316 days (150-2,855). Most students received the HPV vaccine bundled with other vaccinations (72.4%, 1,279/1,766). There was a higher HPV UTD rate among students who initiated the HPV vaccine on or before age 11 than those who initiated on or after age 12 (73.6% versus 45.1%, respectively). The median age of HPV UTD was age 12 for those initiating on or before 11 years versus age 13 for those initiating on or after 12 years of age. Initiating the HPV vaccine at age ≤11 years increased completion of the HPV vaccine series. Improving HPV vaccine coverage and introduction of pan-gender vaccination programs will significantly decrease HPV-related diseases in the RGV.

PMID:36252275 | DOI:10.1080/21645515.2022.2133315

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Effectiveness of Opioid Analgesic Medicines Prescribed in or at Discharge From Emergency Departments for Musculoskeletal Pain : A Systematic Review and Meta-analysis

Ann Intern Med. 2022 Oct 18. doi: 10.7326/M22-2162. Online ahead of print.

ABSTRACT

BACKGROUND: The comparative benefits and harms of opioids for musculoskeletal pain in the emergency department (ED) are uncertain.

PURPOSE: To evaluate the comparative effectiveness and harms of opioids for musculoskeletal pain in the ED setting.

DATA SOURCES: Electronic databases and registries from inception to 7 February 2022.

STUDY SELECTION: Randomized controlled trials of any opioid analgesic compared with placebo or a nonopioid analgesic administered or prescribed to adults in or on discharge from the ED.

DATA EXTRACTION: Pain and disability were rated on a scale of 0 to 100 and pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework.

DATA SYNTHESIS: Forty-two articles were included (n = 6128). In the ED, opioids were statistically but not clinically more effective in reducing pain in the short term (about 2 hours) than placebo and paracetamol (acetaminophen) but were not clinically or statistically more effective than nonsteroidal anti-inflammatory drugs (NSAIDs) or local or systemic anesthetics. Opioids may carry higher risk for harms than placebo, paracetamol, or NSAIDs, although evidence is very uncertain. There was no evidence of difference in harms associated with local or systemic anesthetics.

LIMITATIONS: Low or very low GRADE ratings for some outcomes, unexplained heterogeneity, and little information on long-term outcomes.

CONCLUSION: The risk-benefit balance of opioids versus placebo, paracetamol, NSAIDs, and local or systemic anesthetics is uncertain. Opioids may have equivalent pain outcomes compared with NSAIDs, but evidence on comparisons of harms is very uncertain and heterogeneous. Although factors such as route of administration or dosage may explain some heterogeneity, more work is needed to identify which subgroups will have a more favorable benefit-risk balance for one analgesic over another. Longer-term pain management once dose thresholds are reached is also uncertain.

PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42021275293).

PMID:36252245 | DOI:10.7326/M22-2162

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Characteristics, utilization, and concentration of outpatient care for dual-eligible Medicare beneficiaries

Am J Manag Care. 2022 Oct 1;28(10):e370-e377. doi: 10.37765/ajmc.2022.89189.

ABSTRACT

OBJECTIVES: To characterize the (1) distribution of outpatient care for dual-eligible Medicare beneficiaries (“duals”) and (2) intensity of outpatient care utilization of duals vs non-dual-eligible beneficiaries (“nonduals”).

STUDY DESIGN: Using data preceding the introduction of several outpatient alternative payment models, as well as Medicaid expansion, we evaluated the distribution of outpatient care across physician practices using a Lorenz curve and compared utilization of different outpatient services between duals and nonduals.

METHODS: We defined practices that did (high dual) and did not (low dual and no dual) account for the large majority of visits based on the Lorenz curve and then performed descriptive statistics between these groups of practices. Practice-level outcomes included patient demographics, practice characteristics, and county measures of structural disadvantage and population health. Patient-level outcomes included number of outpatient visits and unique outpatient physicians, primary vs subspecialty care visits, and expenditures.

RESULTS: Nearly 80% of outpatient visits for duals were provided by 35% of practices. Compared with low-dual and no-dual practices, high-dual practices served more patients (1117.6 patients per high-dual practice vs 683.8 patients per low-dual practice and 447.5 patients per no-dual practice; P < .001) with more comorbidities (3.9 mean total Elixhauser comorbidities among patients served by high-dual practices vs 3.6 among low-dual practices and 3.3 among no-dual practices; P < .001). With regard to utilization, duals had 2 fewer outpatient visits per year compared with nonduals (13.3 vs 15.2; P < .001), with particularly fewer subspecialty care visits (6.5 vs 7.9; P < .001) despite having more comorbidities (3.5 vs 2.7; P < .001).

CONCLUSIONS: Outpatient care for duals was concentrated among a small number of practices. Despite having more chronic conditions, duals had fewer outpatient visits. Duals and the practices that serve them may benefit from targeted policies to promote access and improve outcomes.

PMID:36252177 | DOI:10.37765/ajmc.2022.89189

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Impact of diabetes mellitus on periprocedural and 18-month clinical outcomes in Korean patients requiring rotational atherectomy: results from the ROCK Registry

Ann Saudi Med. 2022 Sep-Oct;42(5):291-298. doi: 10.5144/0256-4947.2022.291. Epub 2022 Oct 6.

ABSTRACT

BACKGROUND: Diabetes mellitus (diabetes) increases the risk of severe coronary artery calcification, which increases the complexity of percutaneous coronary intervention requiring rotational atherectomy (RA) by interfering with lesion preparation, and limiting final stent expansion.

OBJECTIVE: Investigate 30-day and 18-month clinical outcomes in patients with and without diabetes treated with percutaneous coronary intervention requiring RA.

DESIGN: Medical record review SETTING: Multicenter registry in South Korea PATIENTS AND METHODS: The ROtational atherectomy in Calcified lesions in Korea (ROCK) registry was a large, retrospective, multicenter study to assess RA treatment of severe coronary artery calcification.

MAIN OUTCOME MEASURES: The primary endpoint was target-vessel failure including cardiac death, target-vessel myocardial infarction, and target-vessel revascularization.

SAMPLE SIZE: 540 patients followed for a median of 16.1 months.

RESULTS: Of the 540 patients, 305 had diabetes (56.5%). The diabetes group had a significantly higher frequency of multivessel disease; comorbidities such as hypertension, dyslipidemia, and chronic kidney disease; and lower ejection fraction of the left ventricle compared to the non-diabetes group (n=235). There were no significant differences in procedure success and complications observed between the two groups. Target vessel failure at 30 days between the diabetes and non-diabetes groups was not statistically significant in a multivariate Cox regression analysis (1.6% vs. 2.6%, adjusted hazard ratio [HR] 0.595, 95% confidence interval [CI] 0.154-2.300, P=.451). During an 18-month follow-up, the risk of target vessel failure was higher (12.5% vs. 8.9%) but the difference was not statistically significant (adjusted HR 1.393, 95% CI 0.782-2.482, P=.260).

CONCLUSIONS: Patients with diabetes have a risk of complications comparable to patients without diabetes, and 30-day and 18-month clinical outcomes are similar in severe coronary artery calcification requiring RA, despite having more comorbidities.

LIMITATIONS: Retrospective design. Sample size not based on power calculation.

CONFLICT OF INTEREST: None.

PMID:36252142 | DOI:10.5144/0256-4947.2022.291

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Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes

Hypertension. 2022 Oct 12. doi: 10.1161/HYPERTENSIONAHA.122.19744. Online ahead of print.

ABSTRACT

BACKGROUND: Chronic kidney disease is frequently associated with hypertension and poorly controlled blood pressure can lead to chronic kidney disease progression. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly improves cardiorenal outcomes in patients with chronic kidney disease and type 2 diabetes. This analysis explored the relationship between office systolic blood pressure (SBP) and cardiorenal outcomes with finerenone in FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease).

METHODS: Patients with type 2 diabetes, urine albumin-to-creatinine ratio 30 to 5000 mg/g, and estimated glomerular filtration rate of 25 to <75 mL/min per 1.73 m2 receiving optimized renin-angiotensin system blockade, were randomized to finerenone or placebo. For this analysis, patients (N=5669) were grouped by baseline office SBP quartiles.

RESULTS: Finerenone reduced office SBP across the baseline office SBP quartiles, including patients with baseline office SBP of >148 mm Hg. Overall, patients with lower baseline office SBP quartile and greater declines from baseline in SBP were associated with better cardiorenal outcomes. The risk of primary kidney and key secondary cardiovascular composite outcomes was consistently reduced with finerenone versus placebo irrespective of baseline office SBP quartiles (P value for interaction 0.87 and 0.78, respectively). A time-varying analysis revealed that 13.8% and 12.6% of the treatment effect with finerenone was attributed to the change in office SBP for the primary kidney composite outcome and the key secondary cardiovascular outcome, respectively.

CONCLUSIONS: In FIDELIO-DKD, cardiorenal outcomes improved with finerenone irrespective of baseline office SBP. Reductions in office SBP accounted for a small proportion of the treatment effect on cardiorenal outcomes.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT02540993.

PMID:36252131 | DOI:10.1161/HYPERTENSIONAHA.122.19744

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Prognostic Implications of Exercise-Induced Hypertension in Adults With Repaired Coarctation of Aorta

Hypertension. 2022 Oct 12. doi: 10.1161/HYPERTENSIONAHA.122.19735. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to assess the relationship between exercise-induced hypertension (EIH) and cardiovascular events, and to determine whether exercise blood pressure (BP) improved risk stratification in adults with repaired coarctation of aorta.

METHODS: Retrospective study of patients with repaired coarctation of aorta on antihypertensive therapy that underwent exercise testing and exercise test (2003-2019). BP was measured at rest in 3 different clinical settings and averaged to determine the resting BP. Indices of left ventricular function and afterload were obtained from the echocardiogram. EIH was defined as systolic BP >210 (males) or >190 (females) at peak exercise. Cardiovascular event was defined as atrial fibrillation, ventricular tachycardia, heart failure hospitalization, heart transplant, and cardiovascular death.

RESULTS: Of 327 patients (age 35±13 years), 116 (35%) had EIH. Although the resting BP was similar between patients with versus without EIH, the EIH group had higher pulsatile arterial load, more advanced left ventricular remodeling, and were less likely to be on angiotensin converting enzyme inhibitor/angiotensin receptor blocker. EIH was associated with cardiovascular events (hazard ratio, 1.06 [95% CI, 1.02-1.08]) independent of resting systolic BP, and improved prognostic accuracy above resting systolic BP (C statistic, 0.671 [95% CI, 0.645-0.694] to 0.727 [95% CI, 0.709-0.750]; P=0.01). Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker was associated with a lower risk of cardiovascular events.

CONCLUSIONS: EIH was associated with cardiovascular events independent of resting BP, and patients receiving angiotensin-converting enzyme inhibitor/angiotensin receptor blocker had lower risk of cardiovascular events. These data suggest that exercise BP could be used to assess adequacy of antihypertensive therapy, and to guide titration of antihypertensive therapy.

PMID:36252107 | DOI:10.1161/HYPERTENSIONAHA.122.19735

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Influence of age, gender characteristics, chronotype on the expression of core clock genes Per1, Clock, Bmal1 and Cry1 in buccal epithelium

Acta Biochim Pol. 2022 Oct 17. doi: 10.18388/abp.2020_6408. Online ahead of print.

ABSTRACT

The purpose of the study is to determine the expression of the core clock genes in buccal epithelial cells of healthy people with different chronotypes.

MATERIALS AND METHODS: Fourteen healthy volunteers with a healthy periodontium and oral mucosa (7 women and 7 men) were selected for participation in the trial. The buccal epithelium sampling was performed at 07:00 am and 07:00 pm in one day by cytological brush. The surveyed patients were examined chronotypically using the Horn-Ostberg test. The determination of the mRNA expression of the Per1, Clock, Bmal1, Cry1 genes was performed by quantitative real-time PCR. Statistical analysis was performed using two-way analysis of variance followed by Bonferroni post hoc tests.

RESULTS: Per1 expression was higher in the morning, regardless of chronotype, age, and gender. The expression of the Clock demonstrated the prevalence of the evening in both chronotypes, in both men and women. Bmal1 was better expressed in the evening, regardless of age, gender, and chronotype. The expression of Cry1 did not show statistically significant differences between the indicators.

CONCLUSIONS: The evening expression of Clock was higher in people with the evening chronotype than in people with the morning chronotype. The chronotype did not show any effect on the expression of Per1, Bmal1, and Cry1. Age and sex did not show any effect on the expression of the core clock genes.

PMID:36252103 | DOI:10.18388/abp.2020_6408

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Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs

Epidemiology. 2022 Oct 18. doi: 10.1097/EDE.0000000000001561. Online ahead of print.

ABSTRACT

BACKGROUND: Traditional surveillance of adverse infant outcomes following maternal medication exposures relies on pregnancy exposure registries, which are often underpowered. We characterize the statistical power of TreeScan™, a data mining tool, to identify potential signals in the setting of perinatal medication exposures and infant outcomes.

METHODS: We used empirical data to inform background incidence of major congenital malformations and other birth conditions. Statistical power was calculated using two probability models compatible with TreeScan, Bernoulli, and Poisson, while varying the sample size, magnitude of the risk increase, and incidence of a specified outcome. We also simulated larger exposure to referent matching ratios when using the Bernoulli model in the setting of fixed N:1 propensity score matching. Finally, we assessed the impact of outcome misclassification on power.

RESULTS: The Poisson model demonstrated greater power to detect signals than the Bernoulli model across all scenarios and suggested a sample size of 4,000 exposed pregnancies is needed to detect a twofold increase in risk of a common outcome (approximately 8 per 1,000) with 85% power. Increasing the fixed matching ratio with the Bernoulli model did not reliably increase power. An outcome definition with high sensitivity is expected to have somewhat greater power to detect signals than an outcome definition with high positive predictive value.

CONCLUSIONS: Use of the Poisson model with an outcome definition that prioritizes sensitivity may be optimal for signal detection. TreeScan is a viable method for surveillance of adverse infant outcomes following maternal medication use.

PMID:36252086 | DOI:10.1097/EDE.0000000000001561

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Interference of nuclear wavepackets in a pair of proton transfer reactions

Proc Natl Acad Sci U S A. 2022 Oct 25;119(43):e2212114119. doi: 10.1073/pnas.2212114119. Epub 2022 Oct 17.

ABSTRACT

Quantum mechanics revolutionized chemists’ understanding of molecular structure. In contrast, the kinetics of molecular reactions in solution are well described by classical, statistical theories. To reveal how the dynamics of chemical systems transition from quantum to classical, we study femtosecond proton transfer in a symmetric molecule with two identical reactant sites that are spatially apart. With the reaction launched from a superposition of two local basis states, we hypothesize that the ensuing motions of the electrons and nuclei will proceed, conceptually, in lockstep as a superposition of probability amplitudes until decoherence collapses the system to a product. Using ultrafast spectroscopy, we observe that the initial superposition state affects the reaction kinetics by an interference mechanism. With the aid of a quantum dynamics model, we propose how the evolution of nuclear wavepackets manifests the unusual intersite quantum correlations during the reaction.

PMID:36252025 | DOI:10.1073/pnas.2212114119

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Commuter Cycling and Risk of Type 2 Diabetes: A Cohort Study in Japan

Diabetes Care. 2022 Oct 17:dc221267. doi: 10.2337/dc22-1267. Online ahead of print.

NO ABSTRACT

PMID:36251985 | DOI:10.2337/dc22-1267