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Nevin Manimala Statistics

Treatment patterns and survival outcomes of patients admitted to the intensive care unit due to immune-related adverse events of immune checkpoint inhibitors

Cancer Med. 2024 Jun;13(12):e7302. doi: 10.1002/cam4.7302.

ABSTRACT

INTRODUCTION: Severe immune-related adverse events (irAEs) due to immune checkpoint inhibitors (ICIs) can lead to admission to the intensive care unit (ICU). In this retrospective study, we determined the incidence, treatment patterns and survival outcomes of this patient population at a comprehensive cancer center.

METHODS: All patients admitted to the ICU due to irAEs from ICI treatment between January 2015 and July 2022 were included. Descriptive statistics were reported on patient characteristics and treatment patterns during hospital admission. Overall survival (OS) from the time of ICU discharge to death was estimated using the Kaplan-Meier method.

RESULTS: Over the study period, 5561 patients received at least one ICI administration, of which 32 patients (0.6%) were admitted to the ICU due to irAEs. Twenty patients were treated with anti-PD-1 plus anti-CTLA-4 treatment, whereas 12 patients were treated with ICI monotherapy. The type of irAEs were de novo diabetes-related ketoacidosis (n = 8), immune-related gastrointestinal toxicity (n = 8), myocarditis or myositis (n = 10), nephritis (n = 3), pneumonitis (n = 2), and myelitis (n = 1). The median duration of ICU admission was 3 days (interquartile range: 2-6 days). Three patients died during ICU admission. The median OS of the patients who were discharged from the ICU was 18 months (95% confidence interval, 5.0-NA).

CONCLUSION: The incidence of irAEs leading to ICU admission in patients treated with ICI was low in this study. ICU mortality due to irAEs was low and a subset of this patient population even had long-term survival.

PMID:38899457 | DOI:10.1002/cam4.7302

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Nevin Manimala Statistics

Participation in a digital self-management intervention for osteoarthritis and socioeconomic inequalities in patient-related outcomes

Scand J Rheumatol. 2024 Jun 20:1-8. doi: 10.1080/03009742.2024.2361542. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate changes in socioeconomic inequalities in patient-related outcomes and pain medication use, following participation in a digital self-management intervention for osteoarthritis (OA) in Sweden.

METHOD: Participants with hip/knee OA enrolled in the digital intervention were included. Self-reported outcomes collected were the numerical rating scale (NRS) pain, activity impairment, general health, Knee/Hip injury and Osteoarthritis Outcome Score (KOOS-12, HOOS-12) Pain, Function, and Quality of Life subscales, 5-level EuroQol 5 Dimensions (EQ-5D-5L), Patient Acceptable Symptom State (PASS) for function, walking difficulties, fear of movement, wish for surgery, pain medication use, physical function measured by the 30s chair-stand test, and level of physical activity. Educational attainment was used as a socioeconomic measure and the concentration index was used to assess the magnitude of inequalities at baseline and 3 month follow-up.

RESULTS: The study included 21,688 participants (mean ± sd age 64.1 ± 9.1 years, 74.4% females). All outcomes except for PASS demonstrated inequalities in favour of highly educated participants at both time-points, with highly educated participants reporting better outcomes. At 3 month follow-up, the magnitude of inequality widened for activity impairment, but narrowed for NRS pain, EQ-5D-5L, KOOS-12/HOOS-12 Pain and Function, physical function, and wish for surgery. There were no statistically conclusive changes in the magnitude of inequalities for the remaining outcomes.

CONCLUSIONS: There were inequalities in patient-related outcomes in favour of those with higher education among participants of a digital self-management intervention for OA, although the magnitude of these pre-existing inequalities generally narrowed after the 3 month intervention.

PMID:38899452 | DOI:10.1080/03009742.2024.2361542

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Nevin Manimala Statistics

Boosting biodiversity monitoring using smartphone-driven, rapidly accumulating community-sourced data

Elife. 2024 Jun 20;13:RP93694. doi: 10.7554/eLife.93694.

ABSTRACT

Comprehensive biodiversity data is crucial for ecosystem protection. The Biome mobile app, launched in Japan, efficiently gathers species observations from the public using species identification algorithms and gamification elements. The app has amassed >6 million observations since 2019. Nonetheless, community-sourced data may exhibit spatial and taxonomic biases. Species distribution models (SDMs) estimate species distribution while accommodating such bias. Here, we investigated the quality of Biome data and its impact on SDM performance. Species identification accuracy exceeds 95% for birds, reptiles, mammals, and amphibians, but seed plants, molluscs, and fishes scored below 90%. Our SDMs for 132 terrestrial plants and animals across Japan revealed that incorporating Biome data into traditional survey data improved accuracy. For endangered species, traditional survey data required >2000 records for accurate models (Boyce index ≥ 0.9), while blending the two data sources reduced this to around 300. The uniform coverage of urban-natural gradients by Biome data, compared to traditional data biased towards natural areas, may explain this improvement. Combining multiple data sources better estimates species distributions, aiding in protected area designation and ecosystem service assessment. Establishing a platform for accumulating community-sourced distribution data will contribute to conserving and monitoring natural ecosystems.

PMID:38899444 | DOI:10.7554/eLife.93694

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Nevin Manimala Statistics

Comparison of Postoperative Outcomes and Long-Term Survival Rates between Patients Who Underwent Robotic and Laparoscopic Complete Mesocolic Excision for Right-Sided Colon Cancer

J Laparoendosc Adv Surg Tech A. 2024 Jun 20. doi: 10.1089/lap.2024.0144. Online ahead of print.

ABSTRACT

Introduction: Right colon cancer often requires surgical intervention, and complete mesocolic excision (CME) has emerged as a standard procedure. The study aims to evaluate and compare the safety and efficacy of robotic and laparoscopic CME for patients with right colon cancer and 5-year survival rates examined to determine the outcomes. Materials and Methods: Patients who underwent CME for right-sided colon cancer between 2014 and 2021 were included in this study. Group differences of age, body mass index, operation time, bleeding amount, total harvested lymph nodes, and postoperative stay were analyzed by the Mann-Whitney U test. Group differences of sex, American Society of Anesthesiology, and tumor, node, and metastasis stage were analyzed by the Chi-squared test. Disease-free and overall survival were assessed using Kaplan-Meier curves with the log-rank Mantel-Cox test. Results: From 109 patients, 74 of them were 1:1 propensity score matched and used for analysis. Total harvested lymph node (P ≤ .001) and estimated blood loss (P = .031) were found to be statistically significant between the groups. We found no statistically significant difference between the groups in terms of disease-free and overall survival (P = .27, .86, respectively), and the mortality rate was 9.17%, with no deaths directly attributed to the surgery. Conclusions: Study shows that minimally invasive surgery is a feasible option for CME in right colon cancers, with acceptable overall survival rates. Although the robotic approach has a higher lymph node yield, there was no significant difference in survival rates. Further randomized trials are needed to determine the clinical significance of both approaches.

PMID:38899434 | DOI:10.1089/lap.2024.0144

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Nevin Manimala Statistics

Human umbilical cord-derived mesenchymal stem cell transplantation improves the long COVID

J Med Virol. 2024 Jun;96(6):e29757. doi: 10.1002/jmv.29757.

ABSTRACT

No effective treatments can ameliorate symptoms of long COVID patients. Our study assessed the safety and efficacy of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) in the treatment of long COVID patients. Ten long COVID patients were enrolled and received intravenous infusions of UC-MSCs on Days 0, 7, and 14. Adverse events and clinical symptoms were recorded, and chest-high-resolution CT (HRCT) images and laboratory parameters were analyzed. During UC-MSCs treatment and follow-up, we did not observe serious adverse events, the symptoms of long COVID patients were significantly relieved in a short time, especially sleep difficulty, depression or anxiety, memory issues, and so forth, and the lung lesions were also repaired. The routine laboratory parameters did not exhibit any significant abnormalities following UC-MSCs transplantation (UMSCT). The proportion of regulatory T cells gradually increased, but it was not statistically significant until 12 months. The proportion of naive B cells was elevated, while memory B cells, class-switched B-cells, and nonswitched B-cells decreased at 1 month after infusion. Additionally, we observed a transient elevation in circulating interleukin (IL)-6 after UMSCT, while tumor necrosis factor (TNF)-α, IL-17A, and IL-10 showed no significant changes. The levels of circulating immunoglobulin (Ig) M increased significantly at month 2, while IgA increased significantly at month 6. Furthermore, the SARS-CoV-2 IgG levels remained consistently high in all patients at Month 6, and there was no significant decrease during the subsequent 12-month follow-up. UMSCT was safe and tolerable in long COVID patients. It showed potential in alleviating long COVID symptoms and improving interstitial lung lesions.

PMID:38899432 | DOI:10.1002/jmv.29757

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Nevin Manimala Statistics

Efgartigimod in refractory autoimmune myasthenia gravis

Muscle Nerve. 2024 Jun 20. doi: 10.1002/mus.28184. Online ahead of print.

ABSTRACT

INTRODUCTION/AIMS: Efgartigimod, a neonatal Fc-receptor inhibitor, has recently been approved as treatment for myasthenia gravis (MG). In this retrospective cohort study, we aimed to systematically assess short- and long-term effectiveness of efgartigimod in patients with refractory MG.

METHODS: Sixteen patients with refractory autoimmune acetylcholine receptor MG were treated with efgartigimod. Data were collected from January 2021 to March 2023 on Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis score (QMG), Myasthenia Gravis Composite score (MGC) and the 15-item revised version of the Myasthenia Gravis Quality of Life questionnaire (MG-QoL15r).

RESULTS: A favorable outcome was seen in 56% of patients at the last measurement. Out of 16 patients, 50% were an MG-ADL responder after the first treatment cycle. After 4 weeks, a clinically meaningful improvement compared to baseline was seen on the MG-ADL, QMG, and MGC. There was a statistically significant improvement on the MGQoL15r from baseline to week 4. The improvement was maintained until the last measurement for the MGC and the MGQoL15r. At the last visit, all patients had discontinued 4-weekly dosages, shifting to administration frequencies of 1, 2, or 3 weeks. Drug doses could be decreased for prednisolone (n = 7), azathioprine (n = 2), and intravenous immunoglobulin (n = 9). Frequency of plasma exchange was decreased in nine patients.

DISCUSSION: In patients with refractory MG, efgartigimod was effective for at least half of all patients. Patients required more frequent dosing compared to the ADAPT phase 3 trial. In 80% of the patients concurrent medication could be reduced or discontinued.

PMID:38899431 | DOI:10.1002/mus.28184

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Nevin Manimala Statistics

Robust optimization of the Gross Tumor Volume compared to conventional Planning Target Volume-based planning in photon Stereotactic Body Radiation Therapy of lung tumors

Acta Oncol. 2024 Jun 20;63:448-455. doi: 10.2340/1651-226X.2024.40049.

ABSTRACT

BACKGROUND: Robust optimization has been suggested as an approach to reduce the irradiated volume in lung Stereotactic Body Radiation Therapy (SBRT). We performed a retrospective planning study to investigate the potential benefits over Planning Target Volume (PTV)-based planning.

MATERIAL AND METHODS: Thirty-nine patients had additional plans using robust optimization with 5-mm isocenter shifts of the Gross Tumor Volume (GTV) created in addition to the PTV-based plan used for treatment. The optimization included the mid-position phase and the extreme breathing phases of the 4D-CT planning scan. The plans were compared for tumor coverage, isodose volumes, and doses to Organs At Risk (OAR). Additionally, we evaluated both plans with respect to observed tumor motion using the peak tumor motion seen on the planning scan and cone-beam CTs.

RESULTS: Statistically significant reductions in irradiated isodose volumes and doses to OAR were achieved with robust optimization, while preserving tumor dose. The reductions were largest for the low-dose volumes and reductions up to 188 ccm was observed. The robust evaluation based on observed peak tumor motion showed comparable target doses between the two planning methods. Accumulated mean GTV-dose was increased by a median of 4.46 Gy and a non-significant increase of 100 Monitor Units (MU) was seen in the robust optimized plans.

INTERPRETATION: The robust plans required more time to prepare, and while it might not be a feasible planning strategy for all lung SBRT patients, we suggest it might be useful for selected patients.

PMID:38899392 | DOI:10.2340/1651-226X.2024.40049

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Nevin Manimala Statistics

Disparities and Biases in Food Insecurity Screening Among Admitted Children

Hosp Pediatr. 2024 Jun 20:e2023007602. doi: 10.1542/hpeds.2023-007602. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Food insecurity (FI) has increasingly become a focus for hospitalized patients. The best methods for screening practices, particularly in hospitalized children, are unknown. The purpose of the study was to evaluate results of an electronic medical record (EMR) embedded, brief screening tool for FI among inpatients.

METHODS: This was a cross-sectional study from August 2020 to September 2022 for all children admitted to a quaternary children’s hospital. Primary outcomes were proportion of those screened for FI and those identified to have a positive screen. FI was evaluated by The Hunger Vital Sign, a validated 2-question screen verbally obtained in the nursing intake form in the EMR. Covariates include demographic variables of age, sex, race, ethnicity, primary language, and insurance. Statistical analyses including all univariate outcome and bivariate comparisons were performed with SAS 9.4.

RESULTS: There were 31 553 patient encounters with 81.7% screened for FI. Patients had a median age of 6.3 years, were mostly male (54.2%), White (60.6%), non-Hispanic (92.7%), English-speaking (94.3%), and had government insurance (79.8%). Younger (0-2 years), non-White, and noninsured patients were all screened significantly less often for FI (all P < .001). A total of 3.4% were identified as having FI. Patients who were older, non-White, Hispanic, non-English speaking, and had nonprivate insurance had higher FI (all P < .001).

CONCLUSIONS: Despite the use of an EMR screening tool intended to be universal, we found variation in how we screen for FI. At times, we missed those who would benefit the most from intervention, and thus it may be subject to implementation bias.

PMID:38899389 | DOI:10.1542/hpeds.2023-007602

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Nevin Manimala Statistics

Establishment and evaluation of a new fluorescent probe method based on loop-mediated isothermal amplification for the detection of Mycobacterium tuberculosis complex

Luminescence. 2024 Jun;39(6):e4795. doi: 10.1002/bio.4795.

ABSTRACT

We aimed to develop a novel diagnostic method called multiplex fluorescence of loop primer upon self-dequenching loop-mediated isothermal amplification (mFLOS-LAMP) for the rapid detection of Mycobacterium tuberculosis complex (MTBC). A set of specific primers was designed to target the detection of IS1081 and IS6110 genes, which are insertion sequences within the MTBC. The 110 sputum specimens collected were assessed using the established mFLOS-LAMP method, multiplex polymerase chain reaction, Xpert MTB/RIF, and smear microscopy. The optimal reaction temperature and duration for mFLOS-LAMP were determined to be 65°C and 30 min, respectively, by optimizing the entire system. The detection sensitivity of mFLOS-LAMP was 6.0 × 101 CFU/mL, by Bacillus Calmette-Guerin, and the mFLOS-LAMP sensitivity of M. tuberculosis H37Rv genomic DNA was 500 fg, and the specificity was 100%. The sensitivity of mFLOS-LAMP was 94.2% and the specificity was 96.6%, when Xpert MTB/RIF was used as the reference method. There was no statistically significant difference in their detection rate (χ2 = 0, P = 1.000), and the consistency was good (kappa = 0.909, P < 0.001). The receiver operating characteristic analysis yielded the maximum area under the curve of 0.954. The mFLOS-LAMP method demonstrated high sensitivity and specificity, allowing for swift and accurate detection of MTBC.

PMID:38899381 | DOI:10.1002/bio.4795

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Nevin Manimala Statistics

A statistical primer on classical period-finding techniques in astronomy

Rep Prog Phys. 2024 Jun 20;87(7). doi: 10.1088/1361-6633/ad4586.

ABSTRACT

The aim of our paper is to investigate the properties of the classical phase-dispersion minimization (PDM), analysis of variance (AOV), string-length (SL), and Lomb-Scargle (LS) power statistics from a statistician’s perspective. We confirm that when the data are perturbations of a constant function, i.e. under the null hypothesis of no period in the data, a scaled version of the PDM statistic follows a beta distribution, the AOV statistic follows an F distribution, and the LS power follows a chi-squared distribution with two degrees of freedom. However, the SL statistic does not have a closed-form distribution. We further verify these theoretical distributions through simulations and demonstrate that the extreme values of these statistics (over a range of trial periods), often used for period estimation and determination of the false alarm probability (FAP), follow different distributions than those derived for a single period. We emphasize that multiple-testing considerations are needed to correctly derive FAP bounds. Though, in fact, multiple-testing controls are built into the FAP bound for these extreme-value statistics, e.g. the FAP bound derived specifically for the maximum LS power statistic over a range of trial periods. Additionally, we find that all of these methods are robust to heteroscedastic noise aimed to mimic the degradation or miscalibration of an instrument over time. Finally, we examine the ability of these statistics to detect a non-constant periodic function via simulating data that mimics a well-detached binary system, and we find that the AOV statistic has the most power to detect the correct period, which agrees with what has been observed in practice.

PMID:38899367 | DOI:10.1088/1361-6633/ad4586