Category: Statistics

JCO Oncol Pract. 2026 May 29:OP2501244. doi: 10.1200/OP-25-01244. Online ahead of print.

ABSTRACT

PURPOSE: Information regarding treatment toxicity obtained from phase I clinical trials is crucial to inform drug development and patient care, yet no mandatory standards exist for adverse event (AE) reporting within early-phase studies, nor any uniform criteria that define tolerability. Management of plasma cell dyscrasias has changed dramatically in recent years, because of development of novel therapies, which may have unexpected and potentially severe side effects. Outcomes-based reporting is therefore critical to ensure the safety of new treatment regimens in plasma cell dyscrasia (PCD) and all other cancer diagnoses. We sought to assess the current practices in toxicity reporting in phase I PCD abstracts.

METHODS: Toxicity reporting was analyzed in 250 plasma cell dyscrasia phase I trial abstracts from the American Society of Hematology, ASCO, or the European Hematology Association annual conferences between 2019 and 24.

RESULTS: Significant variation in reporting was seen. Only 70.4% of abstracts reported all-grade toxicity, 80% grade ≥3 toxicity, and 36.8% reported deaths. We observed statistically significant differences in reporting of toxicity grades, deaths, severe AEs, and AEs of special interest according to study sponsor type (industry versus investigator-initiated), timing of analysis (interim versus other), and type of investigational agent. Minimizing language was identified in 77.6% of abstracts. Only 27.3% of these reported all-grade toxicity, of which 66% had an AE rate of ≥90%. Within studies using minimizing language, deaths occurred in up to 15% of patients and treatment discontinuations in up to 28%.

CONCLUSION: Toxicity reporting in phase I PCD studies demonstrates marked heterogeneity. Minimizing language is used in the majority of abstracts despite significant toxicity. Minimum standards for toxicity reporting in early phase hemato-oncology clinical trial abstracts are urgently required to improve accuracy and transparency.

PMID:42214053 | DOI:10.1200/OP-25-01244

JCO Glob Oncol. 2026 May;12(5):e2600114. doi: 10.1200/GO-26-00114. Epub 2026 May 29.

ABSTRACT

PURPOSE: Lung cancer remains the leading cause of cancer-related mortality worldwide. Immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 pathway have significantly improved survival outcomes in non-small cell lung cancer (NSCLC), and treatment selection is influenced by the degree of PD-L1 expression. Although ICI use began in 2017, there is a lack of data on PD-L1 expression in NSCLC among Jordanian patients. This study aimed to estimate the prevalence of PD-L1 expression and its association with demographic, clinical, and molecular characteristics, including EGFR mutation and ALK rearrangements.

METHODS: This retrospective observational study reviewed electronic medical records for all patients with lung cancer diagnosed at King Hussein Cancer Center from January 1, 2017, to April 1, 2024. Included patients had histologically confirmed NSCLC and were tested for PD-L1 expression. PD-L1 expression was considered positive if the tumor proportion score (TPS) was ≥1%. Descriptive statistics were performed to summarize patient characteristics. Comparisons between TPS 1%-49% and TPS ≥50% groups were performed using chi-square tests.

RESULTS: Of the 1,872 screened patients, 1,508 met the inclusion criteria and were included in the analysis. In this sample, the majority of patients were male (79%), former smokers (70%), presented with advanced disease (stage III/IV, 86%), and had adenocarcinoma histology (71%). Approximately 25% presented with squamous cell carcinoma. The prevalence of PD-L1 positivity was 68% (n = 1,022). Among the PD-L1-positive patients, 59% had TPS 1%-49% and 41% had TPS ≥50%. Among patients tested for EGFR mutation and ALK fusion, alterations were identified in 16.6% and 8.4% of tested patients, respectively. In PD-L1-positive tumors, EGFR wild-type status was significantly associated with high PD-L1 expression (TPS ≥50%) compared with EGFR-mutated tumors (56% v 44%, P = .007).

CONCLUSION: This first comprehensive analysis of PD-L1 prevalence in patients with NSCLC in Jordan demonstrates a relatively high prevalence of both PD-L1 positivity (≥1%) and high expression (≥50%) compared with reported data from other regions. Distinct molecular associations were observed, with higher PD-L1 expression in ALK-rearranged and EGFR wild-type tumors. These findings underscore the need for prospective and multicenter studies to further identify the biologic and clinical implications of PD-L1 expression in Jordanian patients with NSCLC.

PMID:42214046 | DOI:10.1200/GO-26-00114

JCO Glob Oncol. 2026 May;12(5):e2600137. doi: 10.1200/GO-26-00137. Epub 2026 May 29.

ABSTRACT

PURPOSE: Cancer represents a growing public health challenge in Kyrgyzstan, with increasing incidence and cumulative prevalence in recent years. This study aimed to evaluate national cancer prevalence and incidence trends in Kyrgyzstan between 2020 and 2026 and to assess epidemiologic patterns and public health implications.

METHODS: A population-based descriptive analysis was conducted using publicly available national oncology registry reports, Ministry of Health statistical publications, and international cancer databases. Annual incidence, prevalence, and crude incidence rates per 100,000 population were calculated using national demographic estimates. Temporal trends were evaluated using joinpoint regression modeling.

RESULTS: Annual newly diagnosed cancer cases increased from approximately 5,471 in 2020 to 6,651 in 2024. Crude incidence rates rose from 83 per 100,000 population in 2020 to more than 92 per 100,000 in 2024. National registry estimates indicate that over 35,000 individuals will be living with a cancer diagnosis by 2025. Stomach, breast, lung, cervical, and colorectal cancers accounted for the largest proportion of cases. A temporary stabilization in incidence was observed between 2022 and 2023, followed by an increase again in 2024.

CONCLUSION: Cancer burden in Kyrgyzstan increased steadily during the study period, with rising incidence and expanding national prevalence. These findings highlight the importance of strengthening national cancer surveillance systems, expanding screening programs, and improving oncology care infrastructure.

PMID:42214045 | DOI:10.1200/GO-26-00137

J Magn Reson Imaging. 2026 May 29. doi: 10.1002/jmri.70356. Online ahead of print.

ABSTRACT

BACKGROUND: MRI is sensitive for detecting hepatocellular carcinoma (HCC), but its routine use is hindered by low accessibility.

PURPOSE: To evaluate the performance of non-contrast abbreviated MRI (NC-AMRI) alone and in combination with alpha-fetoprotein (AFP) and protein induced by vitamin K absence II (PIVKA-II) compared to a complete MRI protocol for intrahepatic recurrent HCC detection.

STUDY TYPE: Retrospective.

POPULATION: 190 patients (male = 167, mean age 56.7 ± 11.2 years) undergoing post-hepatectomy MRI surveillance, including 88 with recurrent HCCs.

FIELD STRENGTH/SEQUENCE: T2-weighted fast spin echo (conventional and PROPELLER), diffusion-weighted imaging (DWI), and dynamic T1-weighted gradient echo sequences at 1.5 T and 3.0 T.

ASSESSMENT: The NC-AMRI set consisted of T2WI and DWI data and was extracted from the complete MRI study. Three radiologists independently evaluated the presence of recurrent HCC in two separate reading sessions (NC-AMRI and complete MRI). Pairwise comparisons were then made among three strategies: a combination of NC-AMRI, AFP, and PIVKA-II; NC-AMRI alone; and complete MRI.

STATISTICAL TESTS: The diagnostic performance of the three strategies was compared using a marginal logistic regression with generalized estimating equations and McNemar test. Significance level was p < 0.05.

RESULTS: The sensitivity of NC-AMRI was not significantly different to that of complete MRI for detecting recurrent HCC (Reviewer 1: 94.3% vs. 95.5%, p = 0.655; Reviewer 2: 96.6% vs. 96.6%, p > 0.999; Reviewer 3: 95.5% vs. 94.3%, p = 0.655), including small and medium size HCCs (p > 0.999 for all comparisons). Adding tumor markers to NC-AMRI did not significantly improve HCC detection compared to NC-AMRI alone or complete MRI.

DATA CONCLUSION: NC-AMRI demonstrated no significant difference in diagnostic performance compared to that of complete MRI in detecting intrahepatic recurrent HCCs, including small-sized lesions. Additionally, the incorporation of AFP and PIVKA-II did not significantly improve the diagnostic sensitivity of NC-AMRI.

EVIDENCE LEVEL: 3.

TECHNICAL EFFICACY: Stage 2.

PMID:42214033 | DOI:10.1002/jmri.70356

JMIR Mhealth Uhealth. 2026 May 29;14:e73019. doi: 10.2196/73019.

ABSTRACT

BACKGROUND: Lupus erythematosus (LE) is a chronic autoimmune disease that significantly impacts patients’ quality of life. Photosensitivity is a key impairment that severely limits the quality of life, especially in cutaneous lupus erythematosus (CLE), where exposure to sunlight can lead to rashes, exacerbations, and pain. In systemic lupus erythematosus (SLE), other manifestations such as joint pain, fatigue, and organ damage may contribute to decreased physical function and emotional distress. Mobile health apps (MHA) offer potential support for comprehensive disease management for the symptoms mentioned above. However, there is a lack of systematic analysis of available lupus management apps.

OBJECTIVE: This study aims to systematically identify publicly available German or English MHA for lupus management as well as to assess their quality by surveying both patients and physicians.

METHODS: A systematic search and assessment of German or English mobile apps for patients with lupus, available in the Google Play Store and Apple App Store, was conducted independently by two reviewers. The two apps that met all relevant criteria were then reviewed independently by seven physicians using the German Mobile Application Rating Scale (MARS) and the System Usability Scale (SUS). Subsequently, they were reviewed by five patients (three with SLE and two with CLE), using the user version of MARS (uMARS) and SUS. Additionally, the Affinity for Technology Interaction (ATI) scale was collected from both patients and physicians to evaluate the technical affinity in both groups.

RESULTS: In total, 29 apps were available on the Apple Store and 26 on the Google Store, with 18 apps being present and downloadable on both platforms. Of the 18 apps, 16 were excluded because they did not meet the inclusion and exclusion criteria. Only two apps, Lupus Log and Lupus Minder met all the required criteria and were included in the study. The mean MARS scores varied from 2.61/5 to 4.17/5 and mean SUS from 17.5/100 to 100/100 between physicians. The app with the highest mean overall MARS score was Lupus Log, which was rated with 3.91/5 on average by the physicians. Patients evaluated the app with a comparably mean uMARS score (3.95/5). Technical affinity, objectified by ATI, was higher in patients than physicians (3.9 vs 3.68).

CONCLUSIONS: Systematic identification and evaluation showed high-quality apps for patient-centered lupus MHA as indicated by MARS and uMARS scores greater than 3 for both Lupus Log and Lupus Minder.

PMID:42214032 | DOI:10.2196/73019

Am J Hum Biol. 2026 Jun;38(6):e70285. doi: 10.1002/ajhb.70285.

ABSTRACT

Occupational heat exposure is considered a major health concern for workers performing strenuous work during hot environmental conditions. This cross-sectional study aimed to assess the biochemical and physiological responses to occupational heat exposure among agricultural and brick-field workers working in hot environmental conditions in eastern India. A sub-sample of 20 agricultural workers and 20 brick-field workers was selected from the larger sample of 200 workers each to assess the physiological and biochemical responses to hot environmental conditions during the summer and winter seasons. Environmental heat exposure was measured using the time-weighted average Wet Bulb Globe Temperature (TWA-WBGT in °C). Venous blood samples were collected to measure the levels of sodium, potassium, and aldosterone. Active sweat gland responses were measured using the modified starch-iodine technique. Multivariate general linear models of repeated measures were used to measure the effect of the following factors: season, exposure day, and occupation. The multivariate analysis showed significant seasonal effects on serum potassium, sodium, and aldosterone levels, and that exposure day influenced only potassium, not occupation. The monitoring sessions showed normal physiological levels of electrolytes in both occupational groups. Sweat gland activation was also significantly higher during the summer season. TWA-WBGT values above 23°C-25°C are associated with a higher probability of hyponatremia, as revealed by the receiver operating characteristic (ROC) analysis. These findings highlight the physiological adjustments associated with occupational heat exposure and emphasize the importance of hydration and heat mitigation strategies for outdoor workers.

PMID:42214031 | DOI:10.1002/ajhb.70285

Eur J Gastroenterol Hepatol. 2026 May 7. doi: 10.1097/MEG.0000000000003214. Online ahead of print.

ABSTRACT

This meta-analysis aimed to systematically evaluate the efficacy (including improvement of biochemical indicators and clinical outcomes) and safety of the molecular adsorbent recirculating system (MARS) in the treatment of hepatic encephalopathy associated with liver failure. PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP databases were systematically searched from inception to April 2024. Predefined inclusion criteria were used to assess study quality, and statistical analyses were performed using RevMan 5.4. Seven studies were included. Results showed that MARS significantly improved hemoglobin [standard mean difference (SMD): -0.81, 95% confidence interval (CI): -1.42 to -0.19, P = 0.01], creatinine (SMD: -0.46, 95% CI: -0.68 to -0.24, P < 0.0001), and international normalized ratio (INR) (SMD: -0.22, 95% CI: -0.43 to -0.01, P = 0.004). However, effects on albumin (SMD: 0.60, 95% CI: -0.22 to 1.41, P = 0.15) and bilirubin (SMD: -0.21, 95% CI: -0.78 to 0.35, P = 0.46) were NS. No significant association was observed between MARS treatment and increased risk of bleeding (risk ratio: 1.23, 95% CI: 0.83 to 1.81, P = 0.30) or infection (risk ratio: 1.23, 95% CI: 0.97 to 1.56, P = 0.09). In conclusion, preliminary analysis suggests that MARS may help improve creatinine and INR levels in hepatic encephalopathy patients without significantly increasing bleeding or infection risks. However, because of the limited number and suboptimal quality of included studies and presence of heterogeneity, current evidence is insufficient. Rigorously designed, adequately powered, high-quality randomized controlled trials are needed to validate the precise efficacy and safety of MARS in hepatic encephalopathy treatment.

PMID:42214012 | DOI:10.1097/MEG.0000000000003214

Amyotroph Lateral Scler Frontotemporal Degener. 2026 May 29:1-7. doi: 10.1080/21678421.2026.2671162. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate how respiratory dysfunction and site of onset influences changes in sleep architecture in people with ALS (pwALS).

METHODS: We conducted a retrospective observational study, analyzing demographic data, lung function tests, and polysomnography (PSG) measures. Descriptive statistics, correlation analyses, and survival analyses were performed.

RESULTS: Our cohort had 240 pwALS, 63% male, median age at onset 59.3 (IQR 16.5) years. Median time from onset to PSG was 27.5 (IQR 25) months. Most pwALS had spinal onset (79%). Spirometry at time of PSG showed a reduced Forced Vital Capacity (FVC) (58; (IQR 26) %). We saw a significant FVC decline (3.9; (IQR 4) % per month) in the months before PSG. The sleep quality assessment in pwALS revealed a reduced total sleep time (339; (IQR 144.7) minutes), diminished sleep efficiency (62.8; (IQR 26.5)%) and increased wake after sleep onset (172; (IQR 130.2) minutes) when compared to normal values of healthy age-matched adults. The spinal onset group had a higher number of arousals. In the multivariate linear regression model adjusted for age and sex, FVC is a significant predictor for sleep efficiency (β = 3.359, p = 0.0059). Spinal onset, a slower rate of FVC decline in the months preceding PSG and a preserved FVC (≥ 70%) at the time of PSG were associated with improved survival.

CONCLUSION: We observed substantial sleep disturbances in our cohort overall with substantially increased arousals in the spinal group. FVC is a significant predictor for sleep efficiency and the decline in FVC is linked to survival.

PMID:42214007 | DOI:10.1080/21678421.2026.2671162

Phys Rev Lett. 2026 May 15;136(19):196101. doi: 10.1103/mcf7-xfrd.

ABSTRACT

We derive exact analytical expressions for higher-order correlations of Gaussian level-set interfaces, establishing a direct link between bulk field statistics and interface geometry. This framework enables efficient reconstruction of disordered media, detailed modeling of Gaussian foams-structured, double-thresholded interfaces with tunable morphology-and analysis of memory-enhanced anisotropy reflecting directional persistence in the surface structure. These results open new possibilities for characterizing complex transport, guiding stochastic reconstructions, designing materials with desired properties, quantifying the information content of correlation functions, and modeling directional processes on irregular boundaries.

PMID:42213940 | DOI:10.1103/mcf7-xfrd

Phys Rev Lett. 2026 May 15;136(19):197301. doi: 10.1103/156q-3ngc.

ABSTRACT

Closed-loop learning is the process of repeatedly estimating a model from data generated from the model itself. It is receiving great attention due to the possibility that large neural network models may, in the future, be primarily trained with data generated by artificial neural networks themselves. We study this process for models that belong to exponential families, deriving equations of motion that govern the dynamics of the parameters. We show that maximum likelihood estimation of the parameters endows sufficient statistics with the martingale property and that as a result the process converges to absorbing states that amplify initial biases present in the data. However, we show that, for exponential families, this outcome may be prevented if, at each closed-loop retraining iteration, the data contains at least one data point generated from a ground truth model, by relying on maximum a posteriori estimation or by introducing regularization.

PMID:42213932 | DOI:10.1103/156q-3ngc