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Nevin Manimala Statistics

Urine pH and Risk of Bladder Cancer in Northern New England

Cancer Epidemiol Biomarkers Prev. 2023 Jun 23:EPI-22-0801. doi: 10.1158/1055-9965.EPI-22-0801. Online ahead of print.

ABSTRACT

BACKGROUND: Acidic urine pH is associated with rapid hydrolysis of N-glucuronide conjugates of aromatic amines into metabolites that may undergo metabolism in the bladder lumen to form mutagenic DNA adducts. We previously reported that consistently acidic urine was associated with increased bladder cancer risk in a hospital-based case-control study in Spain. Here, we conducted a separate study in northern New England to replicate these findings.

METHODS: In a large, population-based case-control study conducted in Maine, New Hampshire, and Vermont, we examined bladder cancer risk in relation to consistent urine pH, measured twice daily by participants over four consecutive days using dipsticks. In parallel, we collected spot urine samples and conducted laboratory measurements of urinary acidity using a pH meter. Unconditional logistic regression was used to estimate associations, adjusting for age, gender, race, Hispanic status, and state. Analyses were further stratified by smoking status.

RESULTS: Among 616 urothelial carcinoma cases and 897 controls, urine pH consistently≤6.0 was associated with increased bladder cancer risk (Odds Ratio(OR)=1.27; 95% Confidence Interval(CI)=1.02-1.57), with the effect limited to ever-smokers. These findings were supported by analyses of a spot urine, with statistically significant exposure-response relationships for bladder cancer risk overall (p-trend=5.1×10-3) and among ever-smokers (p-trend=1.2×10-3).

CONCLUSIONS: Consistent with a previous study in Spain, our findings suggest that acidic urine pH is associated with increased bladder cancer risk.

IMPACT: Our findings align with experimental results showing that acidic urine pH, which is partly modifiable by lifestyle factors, is linked to hydrolysis of acid-labile conjugates of carcinogenic aromatic amines.

PMID:37351876 | DOI:10.1158/1055-9965.EPI-22-0801

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Association Between New 340B Program Participation and Commercial Insurance Spending on Outpatient Biologic Oncology Drugs

JAMA Health Forum. 2023 Jun 2;4(6):e231485. doi: 10.1001/jamahealthforum.2023.1485.

ABSTRACT

IMPORTANCE: Previous studies have found that hospitals participating in the 340B Drug Pricing Program have higher Medicare Part B spending and expansion into affluent neighborhoods. Less is known about the association of 340B participation with spending by commercial insurance, where reimbursements are higher than Medicare.

OBJECTIVE: To use the Affordable Care Act expansion of eligibility for the 340B Drug Pricing Program to study the association between participation and spending on outpatient-administered oncological drugs for commercially insured patients.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included a balanced panel hospital cohort containing new and never 340B program participants between 2007 and 2019; more recent data were not included to avoid the effect of disruptions in care due to the COVID-19 pandemic. Descriptive analyses documented spending trends for patients receiving common outpatient-administered biologics used in cancer treatments (bevacizumab, filgrastim, pegfilgrastim, rituximab, and trastuzumab) at 340B (treated) and non-340B (control) hospitals. A difference-in-differences model assessed changes in episode drug spending. Analyses were conducted between December 2021 and June 2022.

EXPOSURE: New 340B program participation between 2010 and 2016.

MAIN OUTCOME AND MEASURES: Total drug episode spending, with control variables including total billed units, drug, calendar-year fixed effects, and hospital fixed effects.

RESULTS: Of 95 127 included episodes (56 917 [59.8%] episodes in female patients) across 478 hospitals, patients seen in 340B and non-340B hospitals were similar in sex and drug used, and 340B hospital patients were older than non-340B patients (median [IQR] age for all patients, 61 [51-71] years). New 340B participating hospitals were more likely to be small (<50 beds) and more likely to be in rural settings. In the difference-in-differences analysis, total episode drug spending increased by $4074.69 (95% CI, $1592.84-$6556.70; P = .001) in the year following start of 340B program participation relative to nonparticipants. Heterogeneous group time effects were seen, with earlier participants less likely to have increased episode spending.

CONCLUSIONS AND RELEVANCE: In this cohort study, new 340B participation was associated with statistically significant higher oncological drug episode spending compared with nonparticipants after changes in 340B inclusion rules in 2010. These findings raise questions about unintended consequences of the 340B program on drug spending from the commercially insured population.

PMID:37351874 | DOI:10.1001/jamahealthforum.2023.1485

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State- and County-Level Geographic Variation in Opioid Use Disorder, Medication Treatment, and Opioid-Related Overdose Among Medicaid Enrollees

JAMA Health Forum. 2023 Jun 2;4(6):e231574. doi: 10.1001/jamahealthforum.2023.1574.

ABSTRACT

IMPORTANCE: The opioid crisis disproportionately affects Medicaid enrollees, yet little systematic evidence exists regarding how prevalence of and health care utilization for opioid use disorder (OUD) vary across geographical areas.

OBJECTIVES: To characterize state- and county-level variation in claims-based prevalence of OUD and rates of medication treatment for OUD and OUD-related nonfatal overdose among Medicaid enrollees.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from the Transformed Medicaid Statistical Information System Analytic Files from January 1, 2016, to December 31, 2018. Participants were Medicaid enrollees with or without OUD in 46 states; Washington, DC; and Puerto Rico who were aged 18 to 64 years and not dually enrolled in Medicare. The analysis was conducted between September 2022 and April 2023.

EXPOSURE: Calendar-year OUD prevalence.

MAIN OUTCOMES AND MEASURES: The main outcomes were claims-based measures of OUD prevalence and rates of medication treatment for OUD and opioid-related nonfatal overdose. Individual records were aggregated at the state and county level, and variation was assessed within and across states.

RESULTS: Of the 76 390 817 Medicaid enrollee-year observations included in our study (mean [SD] enrollee age, 36.5 [1.6] years; 59.0% female), 2 280 272 (3.0%) had a claims-based OUD (mean [SD] age, 38.9 [3.6] years; 51.4% female). Of enrollees with OUD, 41.2% were eligible due to Medicaid expansion, 46.4% had other substance use disorders, 55.8% had mental health conditions, 55.2% had claims indicating some form of OUD medication, and 5.8% had claims indicating an overdose during a calendar year. Claims-based outcomes exhibited substantial variation across states: OUD prevalence ranged from 0.6% in Arkansas and Puerto Rico to 9.7% in Maryland, rates of OUD medication treatment ranged from 17.7% in Kansas to 82.8% in Maine, and rates of overdose ranged from 0.3% in Mississippi to 10.5% in Illinois. Pronounced variation was also found within states (eg, OUD prevalence in Maryland ranged from 2.2% in Prince George’s County to 21.6% in Cecil County).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of Medicaid enrollees from 2016 to 2018, claims-based prevalence of OUD and rates of OUD medication treatment and opioid-related overdose varied substantially across and within states. Further research appears to be needed to identify important factors influencing this variation.

PMID:37351873 | DOI:10.1001/jamahealthforum.2023.1574

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68Ga-FAPI-04 PET/CT in Selected Breast Cancer Patients With Low FDG Affinity: A Head-to-Head Comparative Study

Clin Nucl Med. 2023 Jun 23. doi: 10.1097/RLU.0000000000004751. Online ahead of print.

ABSTRACT

PURPOSE: In this prospective study, PET findings of 18F-FDG PET/CT in breast cancer staging were compared with 68Ga-FAP inhibitor (FAPI) 04 PET/CT findings in selected cases with relatively low 18F-FDG uptake in the primary tumor or with suspected nodal or distant metastases.

PATIENTS AND METHODS: Twenty-four women with a median age of 45 years (range, 36-67 years) who underwent initial staging 18F-FDG PET/CT for breast cancer underwent 68Ga-FAPI-04 PET/CT imaging within the same week. SUVmax and quantities of primary tumors and locoregional and distant metastatic lesions were recorded from both images, and these data were compared statistically.

RESULTS: The histological subtypes of primary tumors were 11 invasive lobular, 8 invasive ductal, and 5 mucinous subtypes. More intense 68Ga-FAPI-04 uptake (mean, 17.1 ± 7.9; 7.4-38.5) was detected in all primary tumoral lesions compared with 18F-FDG (mean, 6.3 ± 3.9; 1.5-20.5) (P = <0.001, Z = 4.107). Additional lesions showing 68Ga-FAPI-04 uptake in the breast were detected in 29.2% (n = 7) of patients. In 8.3% (n = 2) of the patients, the primary lesion showed only 68Ga-FAPI-04 uptake. In 68Ga-FAPI-04 PET/CT, 25% (n = 6) of the patients showed more lymph node involvement and more intense uptake in the ipsilateral axilla. In addition, infraclavicular (level 3) lymph nodes in 4 patients (16.7%), supraclavicular lymph nodes in 1 patient, and internal mammary lymph nodes in 1 patient were detected only on 68Ga-FAPI-04 PET/CT. In a patient with lung and bone metastases, 68Ga-FAPI-04 uptake was higher, and the lung nodule showed only 68Ga-FAPI-04 uptake.

CONCLUSIONS: In selected low-FDG-affinity breast cancer patients, 68Ga-FAPI-04 PET/CT showed the primary tumor with higher sensitivity and higher SUVmax values compared with 18F-FDG PET/CT. In addition, it is believed that this method may contribute to the management of patients’ treatment by increasing the nodal stage.

PMID:37351868 | DOI:10.1097/RLU.0000000000004751

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Effects of Nasoalveolar Molding on Maxillary Arch Dimensions and Malocclusion Characteristics of Deciduous Dentition Patients with Cleft Lip and Palate

Int J Paediatr Dent. 2023 Jun 23. doi: 10.1111/ipd.13102. Online ahead of print.

ABSTRACT

AIM: To evaluate the effects of nasoalveolar molding (NAM) therapy on maxillary arch dimensions and malocclusion characteristics in patients with unilateral (UCLP) and bilateral cleft lip and palate (BCLP).

DESIGN: Patients in deciduous dentition were referred to the institutional department of orthodontics. The NAM group consisted of 21 patients with UCLP (mean age 4.7±0.7 years) and 12 patients with BCLP (mean age 4.8±0.7 years). Sixteen patients with UCLP (mean age 4.9±0.9 years) and 5 patients with BCLP (mean age 5.4±1.1 years) were included in the non-NAM group. The plaster models of all patients were digitized. Dental arch dimensions and malocclusion characteristics were analyzed via digital software. One-way ANOVA with Bonferroni correction was used for statistical analysis.

RESULTS: Intercanine and intermolar widths showed statistically significant differences according to the cleft type (P<.01). There was no statistically significant effect of NAM therapy on maxillary arch parameters and malocclusion characteristics (P>.05). The prevalence of anterior crossbite was 12.1% in the NAM group, and 23.8% in the non-NAM group.

CONCLUSION: NAM therapy did not affect the maxillary arch dimensions and malocclusion characteristics in patients with UCLP and BCLP. The cleft type was the main factor, leading to a significant difference in maxillary widths.

PMID:37351851 | DOI:10.1111/ipd.13102

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Correlations between weight perception and overt risk-taking among Canadian adolescents

Can J Public Health. 2023 Jun 23. doi: 10.17269/s41997-023-00778-1. Online ahead of print.

ABSTRACT

OBJECTIVE: Perceptions of body weight represent an important health issue for Canadian adolescents. While associations between weight perception and mental health concerns like eating disorder symptomatology are well established, there is need for more Canadian evidence about how weight perception is associated with overt risk-taking among adolescents, and further how such associations differ by biological sex.

METHODS: We conducted a national analysis of grade 9-10 students participating in the 2017-2018 cycle of the Health Behaviour in School-aged Children (HBSC) study in Canada. This analysis described contemporary patterns of alternate weight perception and then examined the strength and statistical significance of such associations by biological sex, with tobacco, alcohol, and cannabis use, binge drinking, fighting, and illicit drug use as outcomes. Behaviours were considered both individually and in combination. Analyses were descriptive and analytical, with regression models accounting for the nested and clustered nature of the sampling approach.

RESULTS: Responses from 2135 males and 2519 females were available for a complete case series analysis. A total of 26% and 35% of males and females, respectively, perceived themselves as “too fat” while 20% and 9% identified as “too thin”. Females perceiving themselves as “too fat” reported higher likelihoods of engaging in individual and scaled indicators of overt risk-taking. Conversely, among males, alternate weight perception was associated with lower levels of such behaviours.

CONCLUSION: As males and females perceive and react to weight perception differently, clinical and health promotion strategies should be developed and uniquely targeted to groups of adolescents in regards to weight perception and risk-taking.

PMID:37351841 | DOI:10.17269/s41997-023-00778-1

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Evaluation of the Clinical Characteristics of Dry Eye Secondary to Different Types of Liver Diseases

Ophthalmol Ther. 2023 Jun 23. doi: 10.1007/s40123-023-00747-4. Online ahead of print.

ABSTRACT

INTRODUCTION: This study compares the clinical characteristics of dry eye secondary to primary biliary cholangitis (PBC), drug-induced liver injury (DILI), and viral hepatitis B(HBV) to evaluate the ocular surface damage caused by different types of liver diseases.

METHODS: Thirty healthy people were included as control group. Sixty patients with dry eye secondary to different types of liver disease were included, including 19 cases of PBC, 18 cases of DILI, and 23 cases of HBV. All patients were evaluated by the SPEED questionnaire, corneal fluorescein staining (CFS), noninvasive tear breakup time (NIBUT), Schirmer I test (SIt), tear meniscus height test (TMH), the area of meibomian glands dropout (MG dropout), partial blinking rate (PBR), lipid layer thickness (LLT), meibum expressibility, and meibum quality.

RESULTS: There are statistical differences in ophthalmic examination results between different types of liver diseases and normal people (P < 0.05). Compared with DILI and HBV groups, the CFS score of PBC group score was higher (P < 0.05), the PBR was higher (P < 0.05), and the SIt was lower (P < 0.01). The TMH of PBC and DILI groups were significantly lower than the HBV group, and the difference was statistically significant (P < 0.05). Compared with the PBC group, the LLT of the DILI group decreased (P < 0.01). The area of meibomian glands dropout of the three groups had mild-to-moderate defects, but there was no significant statistical difference between groups (P > 0.05).The Meibum quality score in the DILI group was significantly higher than the HBV group (P < 0.05).

CONCLUSIONS: The PBC group was more prone to aqueous-deficient dry eye. The DILI group was more prone to obstructive meibomian gland dysfunction (MGD).The HBV group was more prone to nonobstructive MGD. The symptoms of dry eye in the PBC group are mild-to-moderate discomfort, but the degree of corneal damage is higher, indicating that the corneal sensitivity is reduced, which may be related to the high rate of partial blinking.

PMID:37351838 | DOI:10.1007/s40123-023-00747-4

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Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology

Dermatol Ther (Heidelb). 2023 Jun 23. doi: 10.1007/s13555-023-00959-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Effective topical drug delivery is the essence of dermatologic treatment. The drug must be applied to the skin surface, be released from the vehicle, enter the stratum corneum, traverse the epidermis, and enter the dermis pharmacologically intact. New advances have improved emulsion-type formulation and drug delivery technology by encapsulating dispersed oil droplets in a robust multimolecular aqueous film of surfactants, oil, and water, enabling a multifold decrease in surfactant concentration compared to conventional creams. In the research reported here, we studied this new concept, termed polyaphron dispersion (PAD) technology, by comparing skin delivery of betamethasone dipropionate from a novel oil-in-water emulsion system of calcipotriene and betamethasone dipropionate (CAL/BDP) cream to that from a traditional topical suspension (CAL/BDP TS) utilizing in vitro and in vivo detection methods.

METHODS: The amount of BDP released from the CAL/BDP cream and CAL/BDP TS was evaluated using both in vitro Franz cell analysis and in vivo human tape stripping from ten female human volunteers after a single application of CAL/BDP cream or CAL/BDP TS. For the tape stripping analysis, 20 circular tape strips were taken from forearm application sites at 1, 2, 4, and 8 h after application and analyzed for the amount of BDP in the tape strip using liquid chromatography-mass spectrometry (LC-MS).

RESULTS: The in vitro Franz cell analysis demonstrated that the cumulative amount of BDP that diffused through the epidermis was statistically significantly greater for the CAL/BDP cream compared to the CAL/BDP TS at all time points. In addition, consistently higher amounts of BDP were recovered following CAL/BDP cream application than following CAL/BDP TS application at 1, 2, 4, and 8 h following application utilizing the in vivo tape stripping technique.

CONCLUSION: The novel PAD technology-based cream formulation delivered more BDP into the upper stratum corneum and lower epidermis than a traditional topical suspension.

PMID:37351830 | DOI:10.1007/s13555-023-00959-3

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Prediction of in-hospital deterioration in normotensive pulmonary embolism remains elusive: external validation of the calgary acute pulmonary embolism score

J Thromb Thrombolysis. 2023 Jun 23. doi: 10.1007/s11239-023-02853-3. Online ahead of print.

ABSTRACT

Acute pulmonary embolism (PE) is a frequently diagnosed condition. Prediction of in-hospital deterioration is challenging with current risk models. The Calgary Acute Pulmonary Embolism (CAPE) score was recently derived to predict in-hospital adverse PE outcomes but has not yet been externally validated. Retrospective cohort study of normotensive acute pulmonary embolism cases diagnosed in our emergency department between 2017 and 2019. An external validation of the CAPE score was performed in this population for prediction of in-hospital adverse outcomes and a secondary outcome of 30-day all-cause mortality. Performance of the simplified Pulmonary Embolism Severity Index (sPESI) and Bova score was also evaluated. 712 patients met inclusion and exclusion criteria, with 536 patients having a sPESI score of 1 or more. Among this population, the CAPE score had a weak discriminative power to predict in-hospital adverse outcomes, with a calculated c-statistic of 0.57. In this study population, an external validation study found weak discriminative power of the CAPE score to predict in-hospital adverse outcomes among normotensive PE patients. Further efforts are needed to define risk assessment models that can identify normotensive PE patients at risk for in hospital deterioration. Identification of such patients will better guide intensive care utilization and invasive procedural management of PE.

PMID:37351823 | DOI:10.1007/s11239-023-02853-3

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Venous thromboembolism and bleeding after hepatectomy: role and impact of risk adjusted prophylaxis

J Thromb Thrombolysis. 2023 Jun 23. doi: 10.1007/s11239-023-02847-1. Online ahead of print.

ABSTRACT

Venous thromboembolism (VTE) occurs in 2-6% of post-hepatectomy patients and is associated with increased mortality and morbidity. The use of VTE risk assessment models in hepatectomy cases remains unclear. Our study aimed to determine the use and impact of Caprini guideline indicated VTE prophylaxis following hepatectomy. Hepatectomy cases performed during 2016-2021 were included. Caprini score and VTE prophylaxis were determined retroactively, and VTE prophylaxis was categorized as appropriate or inappropriate. The primary outcome was the receipt of appropriate prophylaxis, and secondary outcomes were postoperative VTE and bleeding. Statistical analyses included Fisher Exact test, Kruskal-Wallis, Pearson Chi-Square test, and multivariate regression models. R Statistical software was used for analysis. A p-value < 0.05 or 95% Confidence Interval (CI) excluding 1 was considered significant. A total of 1955 hepatectomy cases were analyzed. Patient demographics were similar between study cohorts. Inpatient, 30- and 90-day VTE rates were 1.28%, 0.56%, and 1.24%, respectively. By Caprini guidelines, 59% and 4.3% received appropriate in-hospital and discharged VTE prophylaxis, respectively. Inpatient VTE (4.5-fold) and mortality (9.5-fold) were lower in patients receiving appropriate prophylaxis. All discharged VTE and mortality occurred in patients not receiving appropriate prophylaxis. Inpatient, 30- and 90-day bleeding rates were 8.4%, 0.62%, and 0.68%, respectively. Appropriate prophylaxis did not increase postoperative bleeding. Increasing Caprini score inversely correlated with receiving appropriate prophylaxis (OR 0.38, CI 0.31-0.46) at discharge, and appropriate prophylaxis did not correlate with bleeding risk (OR 0.79, CI 0.57-1.12). Caprini guideline indicated prophylaxis resulted in reduced VTE complications without increasing bleeding risk.

PMID:37351821 | DOI:10.1007/s11239-023-02847-1