Category: Nevin Manimala

J Biopharm Stat. 2026 Jun 8:1-34. doi: 10.1080/10543406.2026.2670526. Online ahead of print.

ABSTRACT

Analysis of data from randomized controlled trials in vulnerable populations requires special attention when assessing treatment effect by a score measuring, e.g. disease stage or activity, together with onset of prevalent terminal events. In reality, it is impossible to disentangle a disease score from the terminal event, since the score is not clinically meaningful after this event. In this work, we propose to assess treatment interventions simultaneously on the terminal event and the disease score in the absence of a terminal event. Our proposal is based on a natural data-generating mechanism respecting that a disease score does not exist beyond the terminal event. We use modern semi-parametric statistical methods to provide robust and efficient estimation of the risk of terminal event and expected disease score conditional on no terminal event at a pre-specified landmark time. We also use the simultaneous asymptotic behavior of our estimators to develop a powerful closed testing procedure for confirmatory assessment of treatment effect on both onset of terminal event and level of disease score in the absence of a terminal event. A simulation study mimicking a large-scale outcome trial in chronic kidney patients as well as an analysis of that trial is provided to assess performance.

PMID:42253045 | DOI:10.1080/10543406.2026.2670526

Stat Med. 2026 Jun;45(13-14):e70633. doi: 10.1002/sim.70633.

ABSTRACT

When analyzing gait and other human movements, often one-dimensional (1D) functional data are considered, where a variable like joint angle changes smoothly over time from movement start to end. Interpretation of effect sizes in functional data like these generally follows the widely-cited Cohen/Sawilowsky rules of thumb. A key problem is that a given effect size occurs with greater probability for functional data than for the simple scalar (0D) case of Cohen/Sawilowsky. Here, we propose both (i) functional effect size rules of thumb that are probabilistically consistent with the Cohen/Sawilowsky guidelines for a benchmark, two-sample scenario, and (ii) a framework for adapting the benchmark interpretations to arbitrary experimental scenarios with probabilistic consistency. Analysis of an open total hip arthroplasty gait dataset showed that post-surgery effect sizes would be interpreted as ‘medium’ and ‘less than very small’ for the Cohen/Sawilowsky and proposed functional rules of thumb, respectively. Adapting the benchmark case to the actual experimental case (paired design with $n$ = 52 and highly smooth functional residuals) contrastingly yielded an effect size interpretation of ‘very large’. These stark interpretation contrasts suggest that a single set of interpretation guidelines should not be applied to arbitrary experimental scenarios. We recommend using the Cohen/Sawilowsky and proposed functional rules of thumb only for a priori power analysis, and only in the absence of information regarding population variance and smoothness. For all other cases, especially post hoc effect size interpretation, we recommend using the proposed framework to yield probabilistically consistent results, and thus more meaningful cross-study interpretations. Code replicating all results is available at https://github.com/0todd0000/esrot1d.

PMID:42253039 | DOI:10.1002/sim.70633

J Prev Interv Community. 2026 Jun 8:1-12. doi: 10.1080/10852352.2026.2676383. Online ahead of print.

ABSTRACT

Peer recovery counseling (PRC) programs increasingly incorporate structured goal-setting frameworks, such as SMART, yet the fidelity of goals produced in real-world mental health crisis settings remains under explored. This study evaluated 128 counseling sessions from 20 clients across two PRC programs using the SMART-GEM framework to assess goal quality. Nonparametric analyses indicated that goal fidelity scores significantly improved over time. A series of multilevel models (MLMs) confirmed that 27.4% of variance in fidelity scores was attributable to differences between clients. Session timing emerged as the strongest predictor. Session timing accounted for the majority of between-client variance, suggesting that sustained engagement drives goal quality. Staff identity also emerged as a modest but statistically significant predictor. In contrast, neither program site nor delivery modality predicted SMART goal quality. Implications include the need for targeted staff development and the integration of retention-focused interventions to optimize SMART goal use in recovery services.

PMID:42253029 | DOI:10.1080/10852352.2026.2676383

Ann Afr Med. 2026 Jun 5. doi: 10.4103/aam.aam_69_26. Online ahead of print.

ABSTRACT

OBJECTIVES: To analyze the histopathological features and spectrum of lichenoid interface dermatitis with emphasis on epidermal changes and inflammatory patterns. To study the spectrum of lichenoid lesions and estimate the clinical correlation with the histopathological diagnosis of lichenoid interface dermatitis.

MATERIALS AND METHODS: This research was a retrospective observational study conducted in the Department of Pathology, Vinayaka Mission Kirupanandha Variyar Medical College and Hospital, from January 2023 to April 2025. The study included all patients with lichenoid tissue reactions. Biopsies were processed and studied under a microscope for histopathological assessment. The histopathological evaluation focused on key features of the epidermal and dermoepidermal junction.

STATISTICS: Categorical variables were presented as frequencies and percentages to enable comparisons with other studies. Data analysis was performed using SPSS 21.0, and graphs and tables were created using Microsoft Word and Excel.

RESULTS: We had 70 cases of histopathologically diagnosed lichenoid dermatitis. The age ranged from 1 to 70 years, with the most common being 20-29 years. Females were more affected with M: F ratio of 2:3. We encountered more lichen planus and its variants as the common entity of lichenoid dermatitis, which accounts for 65.7%. The epidermal changes, such as vacuolar degeneration, hyperkeratosis, and acanthosis, are the common findings. Band-like inflammatory infiltrate was seen in 87.2% of cases.

CONCLUSION: The histopathological features may vary depending on the specific subtype of lichenoid dermatitis and the disease stage. It provides valuable insights into its diagnosis, and it should be correlated with clinical presentation and other investigative methods for a comprehensive diagnosis.

PMID:42253009 | DOI:10.4103/aam.aam_69_26

Ann Afr Med. 2026 Jun 5. doi: 10.4103/aam.aam_98_26. Online ahead of print.

ABSTRACT

BACKGROUND: Women with systemic lupus erythematosus (SLE) are at increased risk of adverse maternal and fetal outcomes, particularly when pregnancy occurs during periods of active disease. Effective contraception is therefore essential, yet data on sexual activity and contraceptive practices among women with SLE in Nigeria are limited.

METHODS: A cross-sectional survey was conducted between April and July 2025 among women aged 18-48 years with rheumatologist-diagnosed SLE in Nigeria. Participants were recruited through rheumatology clinics and an online survey platform. Information obtained included sociodemographic characteristics, disease duration, disease activity assessed using the Mexican SLE Disease Activity Index, sexual activity, reproductive intentions, contraceptive use, and perceived risk of unintended pregnancy. Descriptive statistics were used, and Kendall’s tau-b assessed the association between sexual activity and disease activity.

RESULTS: Eighty-five women were analyzed. The mean age was 35.0 ± 7.7 years, and the median disease duration was 50 months (interquartile range: 22-108). Fifty-eight participants (68.2%) were sexually active. Among these, 39 (67.2%) reported using contraception, although only 19 (48.7%) used it consistently. Barrier methods, predominantly condoms, were the most commonly used (31.1%). Most contraceptive users (74.4%) did not intend pregnancy within the next 12 months. Sexual activity was inversely associated with disease activity (Kendall’s tau-b = -0.184, P = 0.048). Despite low perceived risk, 23.2% reported at least one episode of unintended pregnancy risk in the preceding year.

CONCLUSION: This study demonstrates that women with SLE in Nigeria remain sexually active and, despite their strong pregnancy avoidance intentions, frequently rely on barrier methods and inconsistently use contraception. These patterns closely mirror global experience and highlight the urgent need to integrate structured, disease-specific contraceptive counseling into routine SLE care in Nigeria to reduce potentially unintended pregnancy and associated maternal-fetal risks.

PMID:42253002 | DOI:10.4103/aam.aam_98_26

Ann Afr Med. 2026 Jun 5. doi: 10.4103/aam.aam_309_26. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Different formulas are being used to determine the internal diameter (ID) of the cuffed endotracheal (ET) tube in pediatric patients. Recently, a new formula was proposed to predict the ET tube size based on middle finger length (MFL). The aim of this study was to determine the accuracy of this new formula in predicting the cuffed ET tube and to compare it with other commonly used formulas.

MATERIALS AND METHODS: This comparative observational study was carried out among 120 samples of children up to 12 years of age undergoing surgery under general anesthesia after taking their consent. All the details regarding the patient’s age, height, weight, and MFL were collected a day before surgery and the ET tube details and the predicted ET tube size by the five formulae were collected on the day of surgery. They were entered into Microsoft Excel sheet and analyzed using STATA software version 17.

RESULTS: Out of 120 study participants, the fraction of patients in whom the exact ID of cuffed ET tube was correctly predicted with the MFL, age-based formulas (ABFs), height-based formula (HBF), weight-based formula (WBF), and Multivariate prediction tool (MPT) formula were 20%, 18.3%, 0%, 3.3%, and 0.8%, respectively. The predicted ID size within 0.5 mm difference excluding the exact fit for MFL formula, ABF, HBF, WBF, and MPT formula was 20.8%, 57.5%, 12.5%, 30.8%, and 22.5%, respectively. The predicted ID size potentially too big >0.5 mm difference for MFL formula, ABF, HBF, WBF, and MPT formulas were 59.2%, 24.2%, 87.5%, 65.8%, and 76.7%, respectively. Pearson correlation coefficient for all the formulas was r > 0.80 and shows a strong positive correlation which was statistically significant (P < 0.001).

CONCLUSION: ABFs were more accurate compared to other formulae in predicting the ET tube size in case of pediatric patients, but in children less than 5 years of age, MFL formula was a better predictor than other formulas.

PMID:42252986 | DOI:10.4103/aam.aam_309_26

J Microbiol. 2026 May;64(5):e2603014. doi: 10.71150/jm.2603014. Epub 2026 May 14.

ABSTRACT

16S rRNA gene amplicon sequencing is the most widely used approach for characterizing microbial communities, yet analyzing such data requires navigating a fragmented landscape of bioinformatics tools with distinct installation requirements, parameter settings, and data formats. Here we present 16S-Pipeline, an open-source, web-based platform that provides a complete workflow from raw FASTQ files to publication-ready statistical analyses. 16S-Pipeline automatically detects sequencing type (paired-end, single-end, long-read), variable region, and sequencing platform (Illumina, PacBio HiFi, Nanopore), then performs quality filtering, primer trimming, amplicon sequence variant (ASV) inference via DADA2, taxonomy assignment against SILVA v138.1, phylogenetic tree construction, and optional functional prediction via PICRUSt2. Downstream analyses include alpha and beta diversity, taxonomic composition visualization, differential abundance testing using five complementary methods (ALDEx2, DESeq2, ANCOM-BC2, LinDA, MaAsLin2) with consensus reporting, and KEGG pathway mapping. Built-in NCBI SRA integration enables downloading public datasets for re-analysis and generates submission metadata spreadsheets for data deposition. The interactive web interface built on FastAPI and Plotly Dash enables researchers to perform complex microbiome analyses without command-line expertise. 16S-Pipeline is freely available at https://github.com/tatsu1207/16S-Pipeline under the MIT License.

PMID:42252976 | DOI:10.71150/jm.2603014

Infect Control Hosp Epidemiol. 2026 Jun 8:1-8. doi: 10.1017/ice.2026.10480. Online ahead of print.

ABSTRACT

OBJECTIVE: Antimicrobial Stewardship Programs (ASPs) need healthcare economic analyses to support and inform ASP strategies. This work aimed to determine whether widely available artificial intelligence (AI) platforms like Microsoft Copilot^TM could facilitate healthcare economics analyses for ASP programs without dedicated healthcare economic supports.

DESIGN: AI (Microsoft Copilot^TM) was prompted to develop a cytomegalovirus prophylaxis protocol for lung transplant recipients using only PubMed-indexed articles. Copilot^TM was then prompted to produce probabilistic samples of simulated patients from aggregate statistics of a 165-patient cohort from Vanderbilt University Medical Center and to analyze cost-effectiveness across four distinct cytomegalovirus prophylaxis protocols, including its own.

SETTING: Tertiary care academic medical center, including outpatient and inpatient environments.

PATIENTS OR PARTICIPANTS: Simulated patient data was developed via random, single-blind, probabilistic selection from pre-defined aggregate cohort statistics.

RESULTS: The AI-generated prophylaxis protocol was evidence-based without hallucination, but this conservative protocol relied on outdated evidence and was associated with significant increases in expected per-patient cost (mean +$4740, P < .01) compared to recent guideline-based and institutional protocols. AI independently identified and executed sensitivity analyses, which revealed that in this simplified model, letermovir use had a large impact on expected per-patient cost.

CONCLUSIONS: The AI-proposed protocol was less cost-effective, but data suggest that careful prompting can provide appropriate PubMed-indexed literature to support ASP protocol development. Additionally, CoPilot^TM provided a thorough cost-effectiveness analysis comparing all potential and existing protocols. With appropriate oversight, AI and Microsoft Copilot^TM can conduct healthcare economic analyses suitable for ASP strategic planning and implementation.

PMID:42252971 | DOI:10.1017/ice.2026.10480

Am J Surg Pathol. 2026 Jun 8. doi: 10.1097/PAS.0000000000002576. Online ahead of print.

ABSTRACT

Giant cell urothelial carcinoma (GCUC) is an exceedingly rare histologic subtype with 50+ reported cases. To date, 3 case series have been reported. Scant chemotherapy and immunotherapy responses were reported with variable results. We report the largest GCUC series, including 27 GCUC and 27 matched control urothelial carcinoma (CoUC) patients, most (>90%) of whom had more than 5 years of follow-up, including neoadjuvant and adjuvant therapy status. We further characterized the nuclear size ratio of giant tumor cells to background tumor cells and analyzed urothelial differentiation markers (GATA3, CK5/6), p53, tumor-infiltrating lymphocytes (CD19 and CD3), and therapeutic targets (TROP2, Nectin4, PDL1, and HER2). Morphometric analysis of giant tumor cells demonstrated that they were, on average, 12 times larger than surrounding nongiant tumor cells. GCUC showed many histologic and immunophenotypic features similar to CoUC. GCUC was enriched for higher stages (T3/4 and metastatic disease) than CoUC and showed a trend toward worse OS than conventional urothelial carcinoma, but was similar to urothelial carcinoma with variant histology. GCUC included 3 low-stage (T1/2) patients, who had significantly worse OS than low-stage CoUC, suggesting early extensive workup and oncologic intervention. Chemotherapy slightly improved OS in both GCUC and CoUC patients without statistical significance. Compared with CoUC, GCUC appeared to have more tumor-infiltrating T cells, but without statistical significance. There were no expression differences in TROP2, Nectin4, PDL1, and HER2. However, a subset of GCUC patients might benefit from target therapies (PDL1, Nectin4), warranting more cohort studies.

PMID:42252958 | DOI:10.1097/PAS.0000000000002576

Brain Behav. 2026 Jun;16(6):e71330. doi: 10.1002/brb3.71330.

ABSTRACT

BACKGROUND: Thirdhand smoke (THS) is a persistent environmental toxin that poses significant health risks, especially to vulnerable populations such as pregnant women and their fetuses. Effective interventions to enhance knowledge, modify beliefs, and improve protective practices are crucial. This study aimed to evaluate the impact of a structured, multi-component educational intervention on knowledge, beliefs, and self-reported practices related to THS among pregnant women.

METHODS: A randomized controlled trial was conducted with 100 pregnant women in their second or third trimester, recruited from comprehensive health centers in Isfahan, Iran. Participants were randomly assigned to an intervention group (n = 50) or a control group (n = 50). The intervention group received a multi-faceted educational program consisting of four face-to-face group sessions, one spousal session, educational pamphlets, and reinforcement messages via a social media group. The control group received routine prenatal care. Data were collected using validated questionnaires assessing knowledge (11 items), beliefs (using the Beliefs About Thirdhand Smoke-BATHS scale, 9 items), and self-reported practices (9 items) at baseline and two months post-intervention. Data were analyzed using paired t-test, Wilcoxon signed-rank test, and Analysis of Covariance (ANCOVA) in SPSS v.23.

RESULTS: The intervention group demonstrated significant improvements in mean scores of knowledge (from 13.30 ± 2.68 to 21.52 ± 5.23, p < 0.001), beliefs (from 25.60 ± 8.12 to 38.46 ± 4.01, p < 0.001), and self-reported practices (from 10.50 ± 1.50 to 13.52 ± 2.10, p < 0.001) after the intervention. No significant changes were observed in the control group. ANCOVA results, while controlling for baseline scores, confirmed a statistically significant effect of the intervention on post-intervention scores for knowledge (F = 179.61, p < 0.001), beliefs (F = 77.52, p < 0.001), and practices (F = 54.14, p < 0.001).

CONCLUSION: A structured, theory-based educational intervention significantly improved knowledge, beliefs, and self-reported protective practices concerning THS among pregnant women. Integrating such comprehensive programs into routine prenatal care is strongly recommended to mitigate THS exposure risks and promote maternal and fetal health.

TRIAL REGISTRATION: This randomized controlled trial was prospectively registered in the Iranian Registry of Clinical Trials (IRCT) on 25/04/2025, prior to participant recruitment (Identifier: IRCT20250105064282N1). https://irct.behdasht.gov.ir/trial/81695.

PMID:42252955 | DOI:10.1002/brb3.71330