Category: Nevin Manimala

P R Health Sci J. 2023 Jun;42(2):121-126.

ABSTRACT

OBJECTIVE: The aim of this study was to determine the prevalence of severely increased albuminuria and the percentage of patients with the indication for canagliflozin in the type 2 diabetes population with chronic kidney disease (CKD) and low socioeconomic status in the San Juan City Hospital.

METHODS: This cross-sectional study examined the electronic records of 129 Hispanic type 2 diabetes patients. CKD in this population was defined according to the most recent nephrology and endocrinology guidelines. Albuminuria was diagnosed with two positive urine albumin/creatinine ratio results within 3-6 months. Data was obtained from July 2017 to January 2020 and analyzed utilizing descriptive statistics and correlations.

RESULTS: The prevalence of moderately and severely increased albuminuria in patients with type 2 diabetes and CKD were 51.2% and 18.6% respectively. The number of patients with type 2 diabetes who filled the FDA indication for canagliflozin were 16.3%. The prevalence of hypertension, coronary artery disease (CAD) and heart failure (HF) was 61.2%, 15.5% and 10.1% respectively. Between albuminuria severity and decreased renal function, a tendency was observed although not statistically significant (r = -0.14, 95% CI: -0.31, 0.03; P = 0.109). While evaluating association between albuminuria groups and CAD, there was a noticeable tendency close to reaching statistical significance (P = 0.060).

CONCLUSION: There is a scarcity of studies regarding the prevalence of severely increased albuminuria in type 2 diabetics with CKD and this study contributes to the literature. On analysis of associations, statistical significance not reached likely due to small sample size.

PMID:37352533

Clin Nucl Med. 2023 Jun 23. doi: 10.1097/RLU.0000000000004745. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to compare oral and IV administrations of 18F-NaF PET/CT for detection of suspicious bone metastatic lesions of breast and prostate cancers.

PATIENTS AND METHODS: Thirty-six patients with breast (n = 23) or prostate (n = 13) cancers and high risk for bone metastases were prospectively evaluated. All patients underwent 2 PET/CT studies after IV and oral 18F-NaF administration within a 2 to 23 days interval between them. The maximum SUVs from the same suspicious lesions (≤5 index lesions per patient) in both studies were measured. The target-to-background ratio (TBR), defined as the relation between the lesion maximum SUV and the whole skeletal mean SUV, was calculated for each lesion. The TBRs in the same lesion calculated using the 2 administration routes were compared. The agreements between 2 physicians in the definition of the number of lesions in both studies were also assessed using weighted κ.

RESULTS: One hundred thirty-four pairs of lesions were analyzed. There was no significant statistical difference between the median TBRs (P = 0.212) for IV (10.33) and oral (10.85). Excellent intraobserver agreement was observed between IV and oral routes: weighted κ of 1.0 (95% confidence interval, 0.92-1.0) and 0.92 (95% confidence interval, 0.81-0.99) for physicians 1 and 2, respectively. The interobserver coefficients were 0.82 and 0.87 for “oral versus oral” and “IV versus IV,” respectively.

CONCLUSIONS: 18F-NaF PET/CT studies using oral and IV routes present comparable performance; thus, it is possible to use oral route in patients with difficult venous access.

PMID:37351903 | DOI:10.1097/RLU.0000000000004745

JAMA Netw Open. 2023 Jun 1;6(6):e2319038. doi: 10.1001/jamanetworkopen.2023.19038.

ABSTRACT

IMPORTANCE: Spouses share common socioeconomic, environmental, and lifestyle factors, and multiple studies have found that spousal diabetes status was associated with diabetes prevalence. But the association of spousal diabetes status and ideal cardiovascular health metrics (ICVHMs) assessed by the American Heart Association’s Life’s Essential 8 measures with incident diabetes has not been comprehensively characterized, especially in large-scale cohort studies.

OBJECTIVE: To explore the association of spousal diabetes status and cardiovascular health metrics with risk of incident diabetes in Chinese adults.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included individuals in the China Cardiovascular Disease and Cancer Cohort without diabetes who underwent baseline and follow-up glucose measurements and had spouses with baseline glucose measurements. The data were collected in January 2011 to December 2012 and March 2014 to December 2016. The spousal study had a mean (SD) follow-up of 3.6 (0.9) years (median [IQR], 3.2 [2.9-4.5] years). Statistical analysis was performed from July to November 2022.

EXPOSURE: Spousal diabetes status was diagnosed according to the 2010 American Diabetes Association (ADA) criteria. All participants provided detailed clinical, sociodemographic, and lifestyle information included in cardiovascular health metrics.

MAIN OUTCOMES AND MEASURES: Incident diabetes, diagnosed according to 2010 ADA criteria.

RESULTS: Overall, 34 821 individuals were included, with a mean (SD) age of 56.4 (8.3) years and 16 699 (48.0%) male participants. Spousal diabetes diagnosis was associated with an increased risk of incident diabetes (hazard ratio [HR], 1.15; 95% CI, 1.03-1.30). Furthermore, participants whose spouses had uncontrolled glycated hemoglobin (HbA1c) had a higher risk of diabetes (HR, 1.20; 95% CI, 1.04-1.39) but the risk of diabetes in participants whose spouses had controlled HbA1c did not increase significantly (HR, 1.10; 95% CI, 0.92-1.30). Moreover, this association varied with composite cardiovascular health status. Diabetes risk in individuals who had poor cardiovascular health status (<4 ICVHMs) was associated with spousal diabetes status (3 ICVHMs: HR, 1.50; 95% CI, 1.15-1.97), while diabetes risk in individuals who had intermediate to ideal cardiovascular health status (≥4 ICVHMs) was not associated with it (4 ICVHMs: HR, 1.01; 95% CI, 0.69-1.50).

CONCLUSIONS AND RELEVANCE: In this study, spousal diabetes diagnosis with uncontrolled HbA1c level was associated with increased risk of incident diabetes, but strict management of spousal HbA1c level and improving ICVHM profiles may attenuate the association of spousal diabetes status with diabetes risk. These findings suggest the potential benefit of couple-based lifestyle or pharmaceutical interventions for diabetes.

PMID:37351887 | DOI:10.1001/jamanetworkopen.2023.19038

JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591.

ABSTRACT

IMPORTANCE: The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation.

OBJECTIVE: To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable.

DESIGN, SETTING, AND PARTICIPANTS: This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022.

INTERVENTIONS: Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation.

MAIN OUTCOMES AND MEASURES: The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer-specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality.

RESULTS: A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = -0.51 [95% CI, -1.05 to 0.04]; effect size [ES] = -0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = -1.39 [95% CI, -2.33 to -0.44]; ES = -0.27), and breast cancer-specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = -1.00 [95% CI, -1.95 to -0.06]; ES = -0.21) and 12 months (estimated effect = -1.01 [95% CI, -1.97 to -0.04]; ES = -0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, -0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support.

CONCLUSIONS AND RELEVANCE: Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention’s framework and investigate its potential use in clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03254875.

PMID:37351885 | DOI:10.1001/jamanetworkopen.2023.19591

JAMA Netw Open. 2023 Jun 1;6(6):e2319602. doi: 10.1001/jamanetworkopen.2023.19602.

ABSTRACT

IMPORTANCE: Nicotine dependence increases the risk of persistent smoking, which is the leading preventable cause of morbidity and death. However, evidence regarding the associations of nicotine dependence with age, psychiatric conditions, and sociodemographic characteristics is limited.

OBJECTIVE: To assess whether and how nicotine dependence among US adults with cigarette use varies by year, age, psychiatric comorbidities, and sociodemographic characteristics.

DESIGN, SETTING, AND PARTICIPANTS: This exploratory serial cross-sectional study used data from 152 354 US community-dwelling individuals 18 years or older who participated in the 2006-2019 National Surveys on Drug Use and Health. Data analyses were conducted from January 15 to February 15, 2023.

EXPOSURE: Past-month cigarette use. Past-year major depressive episode (MDE) and/or substance use disorder (SUD) based on criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), Text Revision.

MAIN OUTCOMES AND MEASURES: Past-month nicotine dependence based on criteria from the Nicotine Dependence Syndrome Scale or the Fagerström Test of Nicotine Dependence.

RESULTS: Among 152 354 adults with past-month cigarette use (54.1% male; 40.2% aged 18-34 years; 29.0% aged 35-49 years; 69.8% non-Hispanic White), the adjusted prevalence of nicotine dependence decreased from 59.52% (95% CI, 57.93%-61.10%) in 2006 to 56.00% (95% CI, 54.38%-57.60%) in 2019 (average annual percentage change [AAPC], -0.4%; 95% CI, -0.5% to -0.4%; P < .001) and among each examined age group, except for stability among those aged 18 to 25 years (AAPC, -0.5%; 95% CI, -1.4% to 0.4%; P = .27). Compared with those 50 years and older with past-month cigarette smoking, the adjusted prevalence of nicotine dependence among those aged 18 to 49 years was 32% lower for those aged 18 to 25 years (adjusted risk ratio [ARR], 0.68; 95% CI, 0.66-0.70), 18% lower for those aged 26 to 34 years (ARR, 0.82; 95% CI, 0.80-0.84), and 6% lower for those aged 35 to 49 years (ARR, 0.94; 95% CI, 0.92-0.96). The adjusted prevalence of nicotine dependence varied by age, MDE and/or SUD status, and sociodemographic characteristics. For example, by 2019, prevalence was 41.27% (95% CI, 39.21%-43.37%) among those aged 18 to 25 years and 64.43% (95% CI, 60.98%-67.74%) among those 50 years and older. Differences in nicotine dependence prevalence between those with co-occurring MDE and SUD and those without both conditions were more than 2 times larger for those 50 years and older vs those aged 18 to 49 years (eg, ages ≥50 years vs 18-25 years: 18.69 percentage point difference [83.32% vs 64.63%] vs 7.67 percentage point difference [48.88% vs 41.21%]; P < .001).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, there were significant reductions in nicotine dependence prevalence from 2006 to 2019 among US adults with cigarette use and all examined subgroups 26 years and older. Adults 50 years and older (especially those with MDE and/or SUD) had the highest nicotine dependence prevalence compared with other age groups, highlighting the importance of assisting with smoking cessation efforts and addressing nicotine dependence for this older population. Evidence-based tobacco cessation strategies tailored to age and comorbidities are needed.

PMID:37351884 | DOI:10.1001/jamanetworkopen.2023.19602

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

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

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

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

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