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Nevin Manimala Statistics

Disparities in trial enrollment and outcomes of Hispanic adolescent and young adult acute lymphoblastic leukemia

Blood Adv. 2022 Jul 26;6(14):4085-4092. doi: 10.1182/bloodadvances.2022007197.

ABSTRACT

In this secondary analysis of Hispanic adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) treated on Cancer and Leukemia Group B (CALGB) 10403, we evaluated outcomes and geographic enrollment patterns relative to US population data. We used demographic, clinical, and survival data on AYAs enrolled on CALGB 10403 (N = 295, 2007-2012). Surveillance, Epidemiology, and End Results registries provided overall survival (OS) for US AYA ALL by ethnicity/race. North American Association of Cancer Registries provided AYA ALL incidence overall and proportion among Hispanics by US state. Of AYAs enrolled on CALGB 10403, 263 (89%) reported ethnicity/race: 45 (17%) Hispanic, 172 (65%) non-Hispanic White (NHW), 25 (10%) non-Hispanic Black (NHB), and 21 (8%) other. Compared with NHWs, Hispanic and NHB patients had lower household income, and Hispanic patients were more likely to harbor high-risk CRLF2 aberrations. Relative to US estimates, where Hispanic patients represented 46% of newly diagnosed AYA ALL patients and experienced inferior OS compared with NHW (P < .001), Hispanic AYAs on CALGB 10403 did as well as NHW patients (3 year OS, 75% vs 74%; P = NS). Hispanic patients also had higher rates of protocol completion (P = .05). Enrollments on CALGB 10403 differed relative to the distribution of Hispanic AYA ALL in the United States: enrollment was highest in the Midwest; t and only 15% of enrollees were from states with a high proportion of Hispanic AYA ALL patients. In summary, Hispanic patients treated on CALGB 10403 did as well as NHWs and better than population estimates. Geographical misalignment between trial sites and disease epidemiology may partially explain the lower-than-expected enrollment of Hispanic AYA ALL patients.

PMID:35838753 | DOI:10.1182/bloodadvances.2022007197

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Nevin Manimala Statistics

Infection with Ascaridia galli Does Not Significantly Alter Intestinal Microbiota and Is Cleared After Changes in the Expression of Cytokines

Avian Dis. 2022 Jul 11. doi: 10.1637/aviandiseases-D-22-00017. Online ahead of print.

ABSTRACT

Because of the trend of cage-free egg production, infections with the nematode Ascaridia galli are receiving increased attention. The aim of this study was to establish a timeline for the influence of A. galli on the expression of key cytokines related to a parasitic immune response, and on the composition of the jejunal microbiota. Twenty-eight male layer-type birds were challenged at 24, 25, and 26 days of age. An additional 28 birds were kept as uninfected controls. Starting on Day 31, three birds of each group were euthanized every week until 8 wk postinfection (PI). The number of larvae isolated from the intestinal wall decreased over time, until no larvae were seen at 7 and 8 wk PI. At 5 wk PI, there was a numerical upregulation of all cytokines (TGF-β, IFN-γ, IL-4, IL-8, IL-10, IL-13) in the infected group, but this change was only statistically significant for IL-13. At this time point, larvae were expected to have developed into adults that would have shed eggs in the feces. However, no adult worms were seen and there was no egg shedding. For the microbiota analysis, there were significant differences in the alpha diversity (Faith’s phylogenetic diversity) between challenge and control groups, and the beta diversity analysis showed slight differences between samples, suggesting that the age of the birds was the main reason for the separation of groups. These findings suggest that the upregulation of all cytokines evaluated in Week 5 might be the reason for resolution of the infection. Possible explanations are that a high infection dose and the fact that birds were fed with a more nutritionally dense feed might have contributed to the birds’ immune system clearing the infection before the worms were able to reach maturity.

PMID:35838751 | DOI:10.1637/aviandiseases-D-22-00017

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Nevin Manimala Statistics

Spatiotemporal observation of higher-order modulation instability in a recirculating fiber loop

Opt Lett. 2022 Jul 15;47(14):3560-3563. doi: 10.1364/OL.462389.

ABSTRACT

We experimentally investigate higher-order seeded modulation instability in an optical fiber experiment. The recirculating loop configuration with round trip losses compensation enables the observation in single-shot of the spatiotemporal evolution of an initially modulated continuous field revealing intricate yet deterministic dynamics. By tuning the modulation period, a continuous transition between perfectly coherent and purely noise-driven dynamics is observed that we characterize by means of a statistical study.

PMID:35838730 | DOI:10.1364/OL.462389

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Nevin Manimala Statistics

Acceptance of Simulated Adult Patients With Medicaid Insurance Seeking Care in a Cancer Hospital for a New Cancer Diagnosis

JAMA Netw Open. 2022 Jul 1;5(7):e2222214. doi: 10.1001/jamanetworkopen.2022.22214.

ABSTRACT

IMPORTANCE: Although there have been significant increases in the number of US residents insured through Medicaid, the ability of patients with Medicaid to access cancer care services is less well known.

OBJECTIVE: To assess facility-level acceptance of Medicaid insurance among patients diagnosed with common cancers.

DESIGN, SETTING, AND PARTICIPANTS: This national cross-sectional secret shopper study was conducted in 2020 in a random sample of Commission on Cancer-accredited facilities in the United States using a simulated cohort of Medicaid-insured adult patients with colorectal, breast, kidney, and melanoma skin cancer.

EXPOSURES: Telephone call requesting an appointment for a patient with Medicaid with a new cancer diagnosis.

MAIN OUTCOMES AND MEASURES: Acceptance of Medicaid insurance for cancer care. Descriptive statistics, χ2 tests, and multivariable logistic regression models were used to examine factors associated with Medicaid acceptance for colorectal, breast, kidney, and skin cancer. High access hospitals were defined as those offering care across all 4 cancer types surveyed. Explanatory measures included facility-level factors from the 2016 American Hospital Association Annual Survey and Centers for Medicare & Medicaid Services General Information database.

RESULTS: A nationally representative sample of 334 facilities was created, of which 226 (67.7%) provided high access to patients with Medicaid seeking cancer care. Medicaid acceptance differed by cancer site, with 319 facilities (95.5%) accepting Medicaid insurance for breast cancer care; 302 (90.4%), colorectal; 290 (86.8%), kidney; and 266 (79.6%), skin. Comprehensive community cancer programs (OR, 0.4; 95% CI, 0.2-0.7; P = .007) were significantly less likely to provide high access to care for patients with Medicaid. Facilities with nongovernment, nonprofit (vs for-profit: OR, 3.5; 95% CI, 1.1-10.8; P = .03) and government (vs for-profit: OR, 6.6; 95% CI, 1.6-27.2; P = .01) ownership, integrated salary models (OR, 2.6; 95% CI, 1.5-4.5; P = .001), and average (vs above-average: OR, 6.4; 95% CI, 1.4-29.6; P = .02) or below-average (vs above-average: OR, 8.4; 95% CI, 1.5-47.5; P = .02) effectiveness of care were associated with high access to Medicaid. State Medicaid expansion status was not significantly associated with high access.

CONCLUSIONS AND RELEVANCE: This study identified access disparities for patients with Medicaid insurance at centers designated for high-quality care. These findings highlight gaps in cancer care for the expanding population of patients receiving Medicaid.

PMID:35838668 | DOI:10.1001/jamanetworkopen.2022.22214

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Nevin Manimala Statistics

Fano effect induced giant and robust enhancement of photon correlations in cavity QED systems

Opt Lett. 2022 Jul 15;47(14):3411-3414. doi: 10.1364/OL.459643.

ABSTRACT

The Fano effect arising from the interference between two dissipation channels of the radiation continuum enables tuning of the photon statistics. Understanding the role of the Fano effect and exploiting it to achieve strong photon correlations are of both fundamental and applied significance. We present an analytical description of Fano-enhanced photon correlations based on cavity quantum electrodynamics to show that the Fano effect in atom-cavity systems can improve the degree of antibunching by over four orders of magnitude. The enhancement factors and the optimal conditions are explicitly given, and found to relate to the Fano parameter q. Remarkably, the Fano enhancement manifests robustness against the decoherence processes and can survive in the weak coupling regime. We expect our work to provide insight to tuning the photon statistics through the Fano effect, which offers a new, to the best of our knowledge, route to enhance the photon correlations, as well as the possibility of generating nonclassical light in a wider diversity of systems without the need of a strong light-matter interaction.

PMID:35838692 | DOI:10.1364/OL.459643

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Nevin Manimala Statistics

Association of Access to Crisis Intervention Teams With County Sociodemographic Characteristics and State Medicaid Policies and Its Implications for a New Mental Health Crisis Lifeline

JAMA Netw Open. 2022 Jul 1;5(7):e2224803. doi: 10.1001/jamanetworkopen.2022.24803.

ABSTRACT

IMPORTANCE: The mental health crisis lifeline 988 will begin operating July 16, 2022. In the absence of appropriately trained first responders, including crisis intervention teams (CITs), persons experiencing behavioral health crises face the risk of incarceration and even death.

OBJECTIVE: To assess county-level access to CIT in 2015 and 2020 and its association with area characteristics and state policies in 2020.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included 10 430 facilities from the 2015 National Directory of Mental Health Treatment Facilities and 10 591 facilities from the 2020 National Directory of Mental Health Treatment Facilities, attributed to 3142 US counties.

EXPOSURES: Area measures included need (suicide, drug-related overdose mortality), rurality, and demographic characteristics. State-level policies included 5 Medicaid policies enacted prior to 2020 and 2 recent policies intended to assist implementation of the 988 lifeline.

MAIN OUTCOMES AND MEASURES: Whether there was at least 1 facility that reported offering a CIT that handled acute mental health issues at the facility or off-site for each county in 2015 and, separately, in 2020.

RESULTS: Most US residents (88%) resided in a county with at least 1 facility offering CIT, although half of US counties had no facility offering CIT (2015: 1537 of 3142 [49%]; 2020: 1512 [48%]). Almost 1 in 5 counties, representing 9% of the population, experienced a change in county-level access from 2015 to 2020. Unadjusted analyses indicated residents of counties without vs with CIT access were more likely to be older and uninsured (top quartile of percentage of residents aged >55 years: 502 of 1512 [33%] vs 283 of 1630 [17%]; P < .001; top quartile of percentage of residents uninsured: 500 [33%] vs 285 [17%]; P < .001) and were more likely be rural (frontier: 500 [33%] vs 144 [9%]; P < .001). Similar results, excluding counties in the top quartile of residents aged older than 55 years, were found in adjusted analyses. Counties without vs with CIT access were less likely to be in states that expanded Medicaid (788 [52%] vs 1102 [68%]; P = .01) and in states that allow Medicaid to pay for short-term stays in psychiatric hospitals (34 [2%] vs 73 [4%]; P = .02). Other Medicaid-related associations were not statistically significant in adjusted analyses.

CONCLUSIONS AND RELEVANCE: In this study, most US residents lived in counties with access to at least 1 CIT, but fewer than half of US counties had such access. Policies to encourage facilities in rural counties to offer CIT may help realize the potential of the new lifeline.

PMID:35838666 | DOI:10.1001/jamanetworkopen.2022.24803

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Nevin Manimala Statistics

Statistical considerations for analyses of time-to-event endpoints in oncology clinical trials: Illustrations with CAR-T immunotherapy studies

Clin Cancer Res. 2022 Jul 15:CCR-22-0560. doi: 10.1158/1078-0432.CCR-22-0560. Online ahead of print.

ABSTRACT

Chimeric antigen receptor T-cell (CAR-T) therapy is an exciting development in the field of cancer immunology and has received a lot of interest in recent years. Many time-to-event (TTE) endpoints related to relapse, disease progression, and remission are analyzed in CAR-T studies to assess treatment efficacy. Definitions of these TTE endpoints are not always consistent, even for the same outcomes (e.g., progression-free survival), which often stems from analysis choices regarding which events to consider as part of the composite endpoint, censoring or competing risk in the analysis. Subsequent therapies such as hematopoietic stem cell transplantation are common but are not treated the same in different studies. Standard survival analysis methods are commonly applied to TTE analyses but often without full consideration of the assumptions inherent in the chosen analysis. We highlight two important issues of TTE analysis that arise in CAR-T studies, as well as in other settings in oncology: the handling of competing risks and assessing the association between a time-varying (post-infusion) exposure and the TTE outcome. We review existing analytical methods, including the cumulative incidence function and regression models for analysis of competing risks, and landmark and time-varying covariate analysis for analysis of post-infusion exposures. We clarify the scientific questions that the different analytical approaches address and illustrate how the application of an inappropriate method could lead to different results using data from multiple published CAR-T studies. Codes for implementing these methods in standard statistical software are provided.

PMID:35838646 | DOI:10.1158/1078-0432.CCR-22-0560

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Nevin Manimala Statistics

Transurethral flexible ureteroscopic incision and drainage with holmium laser in the treatment of parapelvic renal cysts: A retrospective study

Int Braz J Urol. 2022 Sep-Oct;48(5):842-849. doi: 10.1590/S1677-5538.IBJU.2022.0142.

ABSTRACT

BACKGROUND: We aimed to investigate the clinical efficacy and safety of transurethral flexible ureteroscopic incision and drainage with holmium laser in the treatment of parapelvic renal cysts.

MATERIALS AND METHODS: Between October 2017 and April 2021, the clinical data of 65 patients with parapelvic renal cysts were evaluated retrospectively. Thirty-one patients with parapelvic cysts (Group 1) underwent a transurethral flexible ureteroscopic incision and drainage with a holmium laser, whereas the other 34 patients (Group 2) underwent retroperitoneal laparoscopic unroofing. The patients’ clinical features were documented. The surgery time, intraoperative blood loss, hospitalization time, complications and cyst size were recorded and statistically assessed one year following the procedure.

RESULTS: All of the patients were successfully treated with flexible ureteroscopic incision and drainage or retroperitoneal laparoscopic unroofing. In terms of clinical parameters, such as age, gender, BMI, location, cyst size, and Bosniak classification of renal cysts, no statistically significant difference was detected between Groups 1 and 2. Compared to the control group (Group 2), Group 1 demonstrated a shorter surgery duration, less intraoperative blood loss, and a shorter hospital stay (p < 0.001). However, no significant differences in complications and cyst size were observed between the two groups one year after the surgery (p > 0.05).

CONCLUSIONS: Transurethral flexible ureteroscopic incision and drainage with holmium laser in the treatment of parapelvic renal cysts has obvious advantages over traditional surgery, and is worthy of advancement and application, but its long-term effect needs further follow-up studies.

PMID:35838511 | DOI:10.1590/S1677-5538.IBJU.2022.0142

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Nevin Manimala Statistics

Assessment of depression in children and adolescents with sickle cell anemia in a low-resource setting: a comparative study

Pediatr Hematol Oncol. 2022 Jul 15:1-11. doi: 10.1080/08880018.2022.2071510. Online ahead of print.

ABSTRACT

Children with sickle cell anemia (SCA) usually face psychological complications especially depression. Assessment of depression in resource-limited settings may help identify the extent to which the children with SCA in such settings may need its introduction as part of routine care. This study aimed to assess depression in children and adolescents with SCA in a low-resource setting. This cross-sectional observational study involved 84 children and adolescents with SCA aged 7-17 years who were selected using a systematic random sampling technique. Their controls were 84 age- and sex-matched individuals with AA hemoglobin genotype. A structured questionnaire was used to collect socio-demographic data while depression was assessed with the Children’s Depression Inventory. The prevalence of depression was non-significantly higher in subjects compared to the controls (8.3% vs. 2.4%) (Fisher’s χ2 = 1.88, p = 0.171). Though not statistically significant, the subjects had 3.7 times higher odds of having depression compared to the controls (OR = 3.7; 95% CI 0.75-18.50; p = 0.107). Of the 5 depression subscales, the subjects had a significantly higher difference in the negative mood (p = 0.042). Despite the comparable prevalence of depression with their normal controls, children and adolescents with SCA had a higher negative mood and higher odds of having depression than normal individuals. Thus, there is a need for the introduction of depression assessment as a complement to routine care of these children with SCA in resource-poor settings.

PMID:35838017 | DOI:10.1080/08880018.2022.2071510

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Nevin Manimala Statistics

Internal evaluation of risk stratification tool using serial procalcitonin and clinical risk factors in pediatric febrile neutropenia: The non-interventional, single institution experience prior to clinical implementation

Pediatr Hematol Oncol. 2022 Jul 15:1-9. doi: 10.1080/08880018.2022.2079785. Online ahead of print.

ABSTRACT

Risk stratification of pediatric febrile neutropenia (FN) is an established concept, yet clinical risk tools misclassify nearly 5% of clinical standard-risk episodes with severe outcomes. The internal evaluation of a clinical risk tool before implementation has not been well-described. In this noninterventional cohort study, we evaluated a study decision rules (SDR) tool; a clinical risk tool with serial procalcitonin. The study standard-risk (SSR) group met clinical standard-risk criteria with two serial procalcitonin <0.4 ng/mL. The study high-risk (SHR) group met clinical high-risk criteria or clinical standard-risk with a procalcitonin ≥0.4 ng/mL. Descriptive and bivariate statistics compared the groups and outcomes. Clinical criteria alone identified 39.1% (238/608) standard-risk episodes; 5.9% (14/238) had severe events. Prospectively using the SDR, the SHR group encompassed 76.6% (92/120) of episodes; severe events occurred in 20% (3/15) of standard-risk episodes included due to elevated procalcitonin ≥0.4 ng/mL. The SHR group had more blood stream infections [21.7% (20/92) vs. 0% (0/28); P = 0.007] and intensive care admissions [13% (12/92) vs. 3.6% (1/28); P = 0.158]. In conclusion, the SDR with serial procalcitonin aided in identifying severe events in clinical standard-risk episodes, but analysis was limited. Institutions may consider similar internal evaluation methodology before FN episode risk stratification.

PMID:35838022 | DOI:10.1080/08880018.2022.2079785