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Nevin Manimala Statistics

Methodological review of the design, objectives and sample size of Research for Patient Benefit (RfPB) applications that use an external randomised controlled pilot trial design: A protocol

PLoS One. 2026 Mar 3;21(3):e0343981. doi: 10.1371/journal.pone.0343981. eCollection 2026.

ABSTRACT

BACKGROUND: The National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.

METHODS: The study will be conducted on 100 applications from Competition 31-37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.

DISCUSSION: This work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.

PROTOCOL REGISTRATION: Open Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.

PMID:41774693 | DOI:10.1371/journal.pone.0343981

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Nevin Manimala Statistics

Symptom burden in dialysis patients: determinants and impact on mortality

J Nephrol. 2026 Feb 3:aajaf013. doi: 10.1093/joneph/aajaf013. Online ahead of print.

ABSTRACT

BACKGROUND: Symptom burden in chronic kidney disease (CKD) patients has a negative impact on functional status and quality of life. Despite the high prevalence among hemodialysis (HD) patients, symptoms are often underestimated. We investigated the determinants of symptoms and their impact on mortality in a large cohort of HD patients.

METHODS: We analyzed 1825 HD patients for whom at least one questionnaire about symptoms was available. Machine learning-based algorithms were used to identify longitudinal variables associated with symptoms. Univariate and multivariate Cox regression analyses were used to investigate the association between symptoms and mortality. The additional prognostic value of symptoms was explored by using C-statistics and machine learning classification analyses.

RESULTS: Appetite Rating, Non-vascular Nervous System Score and Difficulty Following Diet were the variables most associated with symptoms, both at baseline and in longitudinal analyses. Survival analyses showed an independent association between symptoms and all the considered outcomes (Death, Hazard Ratio [HR]fper 10-unit increase: 0.91, 95% confidence interval [CI] 0.87-0.96, P < 0.001; Cardiovascular hospitalizations, HRper 10-unit increase: 0.89, 95% CI 0.84-0.94, P < 0.001; infectious hospitalizations, HRper 10-unit increase: 0.91, 95% CI 0.87-0.96, P < 0.001). However, classification analyses performed by machine learning showed that adding a symptom score to a base model did not significantly improve the performance of the models. Similarly, the improvement in R2, in discrimination power, and in reclassification capability was almost null.

DISCUSSION: In the large dataset of the Hemodialysis (HEMO) trial, we found that, among the analyzed variables, those related to eating habits and previous comorbidities were the most closely associated with the symptoms score, both at baseline and during follow-up. Although symptoms were associated with severe clinical outcomes, their prognostic power was limited. However, considering symptom burden in dialysis patients, strict monitoring of eating habits may help improve quality of life in these patients.

PMID:41774670 | DOI:10.1093/joneph/aajaf013

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Nevin Manimala Statistics

Dynamic distribution entropy analysis via ultrafast intracardiac echocardiography for monitoring of cardiac radiofrequency ablation

IEEE Trans Biomed Eng. 2026 Mar 3;PP. doi: 10.1109/TBME.2026.3669561. Online ahead of print.

ABSTRACT

OBJECTIVE: To enable reliable, noise-robust monitoring of lesion formation during radiofrequency (RF) ablation with intracardiac echocardiography (ICE), this study introduces Dynamic Distribution Entropy (DDE), which quantifies temporal-spatial changes in backscatter statistics while suppressing ablation-induced interference.

METHODS: DDE integrates ultrafast plane-wave acquisition with singular value decomposition clutter filtering to stabilize entropy estimates. We evaluated DDE in (i) simulations modeling ablation-driven scatterer-size changes and (ii) ex-vivo porcine hearts imaged by ICE during RF ablation. DDE was compared with typical Shannon entropy, k-nearest neighbor entropy, cumulative residual entropy, and horizontally normalized Shannon entropy. Metrics included structural similarity (SSIM), intersection-over-union (IoU), and lesion-size agreement versus optical ground truth.

RESULTS: In simulations, DDE and CRE closely tracked dynamic scatterer evolution, yielding highest SSIM over frames (0.96). In ex-vivo experiments, DDE demonstrated the most accurate lesion-size estimation under RF-ON conditions, exhibiting the lowest bias (4.85 mm2), standard deviation (1.53 mm2), and root mean square error (5.08 mm2) among all evaluated entropy-based methods. Lesion sizes derived from DDE exhibited the best agreement with optical measurements.

CONCLUSION: DDE provides robust and accurate intraoperative monitoring of lesion formation in ICE guided RF ablation, outperforming conventional entropy imaging under ablation-related noise.

SIGNIFICANCE: DDE offers a practical, noise-resistant quantitative ultrasound biomarker for real-time lesion assessment, supporting decision-making during ICE-guided cardiac ablation without requiring changes to clinical workflow.

PMID:41774665 | DOI:10.1109/TBME.2026.3669561

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Nevin Manimala Statistics

StructChart: On the Schema, Metric, and Augmentation for Visual Chart Understanding

IEEE Trans Pattern Anal Mach Intell. 2026 Mar 3;PP. doi: 10.1109/TPAMI.2026.3669664. Online ahead of print.

ABSTRACT

Charts are common in literature across various scientific fields, conveying rich information easily accessible to readers. Current chart-related tasks focus on either chart perception that extracts information from the visual charts, or chart reasoning given the extracted data, e.g. in a tabular form. In this paper, we introduce StructChart, a novel framework that leverages Structured Triplet Representations (STR) to achieve a unified and label-efficient approach to chart perception and reasoning tasks, which is generally applicable to different downstream tasks, beyond the question-answering task as specifically studied in peer works. Specifically, StructChart first reformulates the chart data from the tubular form (linearized CSV) to STR, which can friendlily reduce the task gap between chart perception and reasoning. We then propose a Structuring Chart-oriented Representation Metric (SCRM) to quantitatively evaluate the chart perception task performance. To augment the training, we further explore the potential of Large Language Models (LLMs) to enhance the diversity in both chart visual style and statistical information. Extensive experiments on various chart-related tasks demonstrate the effectiveness and potential of a unified chart perception-reasoning paradigm to push the frontier of chart understanding.

PMID:41774644 | DOI:10.1109/TPAMI.2026.3669664

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Nevin Manimala Statistics

Motion Exposure, Cognitive Impairment, and Risk Factors for Mal de Débarquement Syndrome

Otolaryngol Head Neck Surg. 2026 Mar 3. doi: 10.1002/ohn.70162. Online ahead of print.

ABSTRACT

OBJECTIVE: Determine whether shipboard motion variability relates to simulator‑sickness symptoms, Mal de Débarquement syndrome (MdDS) features, and cognition, and whether migraine or motion‑sickness history modify these vestibular effects.

STUDY DESIGN: Prospective observational cohort.

SETTING: USNS Mercy (T‑AH 19) during Pacific Partnership 2024.

METHODS: 38 Active‑Duty personnel were tested at baseline (land), after California-Hawaii (CA-HI; rougher), and after Chuuk-Hawaii (CHUUK-HI; calmer). A centrally mounted, inertial measurement unit (IMU) yielded per‑minute standard deviation of linear‑acceleration magnitude (IMU SD).

OUTCOMES: Simulator Sickness Questionnaire (SSQ); MdDS calculator mapped to Bárány criteria; Rey-Osterrieth Complex Figure (ROCF); Symbol Digit Modalities Test (SDMT); Stroop Test; linear mixed-effects model using voyage leg and IMU SD as predictors of symptom outcomes and adjusted for migraine and motion‑sickness history.

RESULTS: IMU SD was higher on CA-HI. SSQ totals were higher on CA-HI and increased with IMU SD. MdDS criteria counts, and cases were similar between legs; Migraine Disability Assessment Score (MIDAS) was positively associated with MdDS criterion burden, but not with SSQ. ROCF showed slower copy/recall and lower recall accuracy on CA-HI; SDMT and Stroop errors were largely unchanged. There were no statistical differences based on migraine or motion‑sickness history, but analyses were limited by small subgroup sizes.

CONCLUSION: Rougher sea states (greater IMU variability) were linked to higher acute symptom burden and specific visuospatial memory impairments. The incidence of persistent MdDS did not differ by leg. IMU‑informed monitoring with brief, targeted cognitive tests may support future planning and post‑voyage screening to identify at-risk individuals.

PMID:41774616 | DOI:10.1002/ohn.70162

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Nevin Manimala Statistics

Community walking speed as a new predictor of disability incidence in older adults: A prospective cohort study

Gerontology. 2026 Mar 3:1-18. doi: 10.1159/000550778. Online ahead of print.

ABSTRACT

BACKGROUND: Walking speed is widely recognised as an informative indicator of physical capability in later life, and is frequently used to evaluate mobility and functional health in older adults. Although the measurement of community walking speed (CWS) has been made possible using accelerometers, it is unclear whether discrepancies between laboratory walking speed (LWS) and CWS makes a difference in predicting the incidence of future disabilities in older adults.

OBJECTIVE: Using data from the National Center for Geriatrics and Gerontology-Study of Geriatric Syndromes (NCGG-SGS), we examined whether LWS and CWS each independently predict incident disability. The discrepancy was defined as the difference between LWS and CWS, and we further analyzed the characteristics of older adults who exhibited such discrepancies.

METHODS: Participants comprised 1,631 older adults (mean age = 70 years; 62.7% women). LWS was measured using a WalkWay device that measures the distribution of foot pressure during walking. CWS was derived using a model that estimated gait speed based on composite acceleration calculated from the mean triaxial acceleration within a single gait cycle. Participants were instructed to wear a triaxial accelerometer for at least 14 days. The incidence of disability was prospectively determined for five years.

RESULTS: The Cox proportional hazards regression models revealed a statistically significant association between the z-scores of LWS (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.41-0.72) and CWS (HR, 0.59; 95% CI, 0.41-0.83), and disability incidence. There were no statistically significant interactions between LWS and CWS for disability (HR, 1.00; 95% CI, 0.76-1.31). The area under the receiver operating characteristics curve (ROC AUC) of the LWS and CWS were 0.752 and 0.709, respectively. Regarding discrepancies between the fast LWS group and the fast CWS group, residual analysis showed that the fast LWS group had a higher proportion of women than the fast CWS group.

CONCLUSION: LWS and CWS were found to be independently associated with disability. Further research must determine how CWS should be interpreted, because participants who showed discrepancies between CWS and LWS did not exhibit a significant association with incident disability. Healthcare providers could use either CWS and LWS as a significant indicator in healthcare practice for older populations.

PMID:41774602 | DOI:10.1159/000550778

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Nevin Manimala Statistics

The impact of pre-transplant atherosclerosis and coronary artery disease on cardiovascular and graft outcomes in kidney transplant recipients: a systematic review and meta-analysis

J Nephrol. 2026 Feb 24:aajaf015. doi: 10.1093/joneph/aajaf015. Online ahead of print.

ABSTRACT

BACKGROUND: Kidney transplant recipients with pre-existing atherosclerosis or coronary artery disease (CAD) have an increased risk of adverse post-transplant outcomes. However, the extent to which pre-transplant CAD influences mortality, cardiovascular events, and graft function remains unclear. This systematic review and meta-analysis aims to evaluate the impact of pre-existing CAD on all-cause mortality, post-transplant cardiovascular events, and graft failure in kidney transplant recipients.

METHODS: A systematic literature search was conducted using PubMed, Scopus, Web of Science, Cochrane Library, and Ovid MEDLINE. Studies reporting outcomes in kidney transplant recipients with and without pre-existing CAD were included. The primary outcomes were all-cause mortality, major cardiovascular events, and graft failure post-transplantation. Risk estimates were pooled using a random-effects model, with heterogeneity assessed using the I² statistic. The study protocol was registered with PROSPERO (CRD42024600751).

RESULTS: A total of 16 studies involving 112,416 kidney transplant recipients were included. Patients with pre-transplant CAD had a significantly higher risk of all-cause mortality compared to those without CAD (hazard ratio [HR] = 1.68, 95% confidence Interval [CI]: 1.38-2.06, P < .01), with high heterogeneity (I² = 60.0%). The risk of post-transplant cardiovascular events was also significantly increased in patients with CAD (HR = 2.78, 95% CI: 2.00-3.86, P < .01), with moderate heterogeneity (I² = 36.1%). Graft failure was more common in recipients with pre-transplant CAD, although the effect size was smaller (HR = 1.09, 95% CI: 1.03-1.16, P < .01), with no observed heterogeneity (I² = 0%).

CONCLUSIONS: Pre-existing CAD in kidney transplant recipients is associated with a significantly increased risk of all-cause mortality and post-transplant cardiovascular events, as well as a modestly but significantly increased risk of graft failure. These findings stress the need for enhanced cardiovascular risk assessment and management strategies in transplant candidates with CAD to improve long-term outcomes.

PMID:41774596 | DOI:10.1093/joneph/aajaf015

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Nevin Manimala Statistics

Comment on the article: “Incidence of pulmonary thromboembolism in patients with COVID-19 pneumonia”

Rev Med Inst Mex Seguro Soc. 2026 Mar 3;64(2):e6893. doi: 10.5281/zenodo.17543983.

ABSTRACT

This letter to the editor presents key concepts on research designs, prevalence and incidence, as well as statistics for comparing dichotomous variables, highlighting the difference with likelihood ratio. A Chi2 exercise with the study data is included to illustrate the methodology. Finally, a brief description of the pathophysiological mechanism linking COVID-19 infection with pulmonary thromboembolism is provided.

PMID:41774473 | DOI:10.5281/zenodo.17543983

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Nevin Manimala Statistics

The effect of cardiopulmonary bypass prime solution volume on blood transfusion: how do perfusionists manage fluid and what is the optimal prime solution volume?

Cardiovasc J Afr. 2025 Sep 3;36(3):374-379. doi: 10.5830/CVJA-2025-056. Epub 2025 Sep 2.

ABSTRACT

INTRODUCTION: During cardiopulmonary bypass (CPB), adequate prime solution allows pre-treatment of the tubing line, oxygenator and blood pump, evacuation of air from the arterial conduit, and appropriate blood dilution. However, the volume of prime solution may also affect the blood transfusion rate.

OBJECTIVE: This study evaluated the effect of different volumes of CPB prime solution used in two different cardiac surgery centres on blood transfusion rate, as well as the relationship between the volume of CPB prime solution and early clinical outcomes.

METHODS: A total of 323 patients who underwent CPB-guided cardiac surgery were included in this retrospective study. Patients with different prime solution volumes in two different cardiac surgery centres were included in the study. Each centre was considered as a separate study group. The data of the groups were compared statistically.

RESULTS: There were 195 patients in group 1 and 128 patients in group 2. The preoperative characteristics and laboratory variables of the two groups were similar (p > 0.05). The amount of additional fluid given during CPB, the amount of urine and haemofiltrate removed by the patients, intraoperative bleeding drainage rate, postoperative platelet and erythrocyte values, need for intracardiac defibrillation, need for inotropic support and intra-aortic balloon pump (IABP) requirement during CPB weaning, duration of postoperative mechanical ventilation support, and duration of intensive care unit (ICU) stay were similar in both groups (p > 0.05). However, intraoperative erythrocyte transfusion rates, postoperative bleeding drainage rates, postoperative erythrocyte transfusion rates, postoperative leukocyte value and length of hospital stay were significantly higher in group 2 (p = 0.000; p = 0.006; p = 0.000; p = 0.009; p = 0.037, respectively). Additionally, postoperative haemoglobin and haematocrit values were significantly lower in group 2 (p = 0.034; p = 0.047, respectively).

CONCLUSION: As a result of this study, we observed that low prime solution volume vs. high prime solution volume impacts the negative variables of CPB patients. We believe that perfusionists avoiding high prime solution volumes in fluid management during CPB will positively reduce the blood transfusion rate/amount, and also reduce other negative variables.

PMID:41774456 | DOI:10.5830/CVJA-2025-056

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Nevin Manimala Statistics

RSV Detection and Antibiotic Prescribing Decisions for Pediatric Respiratory Tract Infections

JAMA Netw Open. 2026 Mar 2;9(3):e260409. doi: 10.1001/jamanetworkopen.2026.0409.

ABSTRACT

IMPORTANCE: Respiratory syncytial virus (RSV) is a leading cause of pediatric viral lower respiratory tract infections (VLRTIs), often leading to inappropriate antibiotic use. Although rapid antigen diagnostic tests (Ag-RDTs) support clinical diagnosis, their effect on antibiotic prescribing in community settings remains uncertain.

OBJECTIVE: To evaluate the association of RSV Ag-RDT implementation with antibiotic prescribing practices for infants and children assessed for LRTIs.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used data from a community-based primary care setting involving family pediatricians in Italy participating in the Pedianet network. Data were collected between December 2023 and May 2024 from children aged 9 to 36 months with symptoms of VLRTI who underwent RSV Ag-RDT during the 2023-2024 respiratory epidemiologic season and historical matched cohorts.

EXPOSURE: Children with RSV-positive and RSV-negative Ag-RDT results were compared with each other and with matched historical (2022-2023) and contemporaneous (2023-2024) cohorts of children with clinically diagnosed VLRTIs or bronchiolitis who did not undergo laboratory testing.

MAIN OUTCOMES AND MEASURES: The primary outcome was antibiotic prescribing within 14 days of diagnosis. Prescriptions associated with suspected or confirmed bacterial infections (such as elevated C-reactive protein levels or documented coinfections) were excluded. Relative risks (RRs) and 95% CIs were estimated using log-binomial regression models.

RESULTS: Among 256 cases (median age, 15.06 [IQR, 11.61-22.72] months; 133 males [51.95%]), 79 (30.86%) were RSV positive and 177 (69.14%) were RSV negative. These 2 groups were comparable in age, with RSV-negative children slightly younger (median age, 14.95 [IQR, 11.66-22.67] vs 15.34 [IQR, 11.40-23.10] months), and in sex distribution, with a higher proportion of females among RSV-positive cases (41 [51.90%] vs 82 [46.33%]). Antibiotic prescribing was lower in RSV-positive than RSV-negative children (0.18 [95% CI, 0.10-0.25] vs 0.29 [95% CI, 0.22-0.35] prescriptions per 10 person-days) and was associated with a reduction in risk of receiving an antibiotic prescription (RR, 0.52; 95% CI, 0.33-0.83). Implementation of RSV Ag-RDT was associated with lower antibiotic use for VLRTIs compared with a matched untested cohort (RR, 0.54 [95% CI, 0.44-0.66] in 2022-2023 and 0.61 [95% CI, 0.50-0.75] in 2023-2024) and for bronchiolitis in 2022-2023 (RR, 0.56 [95% CI, 0.33-0.95]) but not in 2023-2024 (RR, 0.75 [95% CI, 0.42-1.33]). Reductions were greater among RSV-positive cases: for VLRTIs, the RR was 0.33 (95% CI, 0.20-0.52) in 2022-2023 and 0.41 (95% CI, 0.25-0.67) in 2023-2024; for bronchiolitis, the RR was 0.33 (95% CI, 0.15-0.76) in 2022-2023, but the reduction was not significant in 2023-2024 (RR, 0.43 [95% CI, 0.18-1.00]).

CONCLUSIONS AND RELEVANCE: In this cohort of 256 VLRTI cases, the findings suggest that RSV contributed to a broad range of VLRTIs across ages and that RSV Ag-RDT was a useful outpatient antimicrobial stewardship tool, particularly in bronchiolitis. Combined with universal immunoprophylaxis, widespread Ag-RDT use may improve diagnostic accuracy, resource allocation, and clinical outcomes.

PMID:41774441 | DOI:10.1001/jamanetworkopen.2026.0409