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Nevin Manimala Statistics

Initial validity and reliability testing of the SGBA-5

PLoS One. 2025 May 16;20(5):e0323834. doi: 10.1371/journal.pone.0323834. eCollection 2025.

ABSTRACT

BACKGROUND: A growing body of research indicates that sex (biological) and gender (sociocultural) influence health through a variety of distinct mechanisms. Sex- and Gender-Based Analysis (SGBA) techniques could examine these influences, however, there is a lack of nuanced and easily implementable measurement tools for health research. To address this gap, we created the Sex- and Gender-Based Analysis Tool – 5 item (SGBA-5).

OBJECTIVES: This research aims to assess the validity and reliability of the SGBA-5 for use in health sciences research where sex or gender are not primary variables of interest.

METHODS: A Delphi consensus study was conducted with Canadian researchers (n = 14). The Delphi experts rated the validity of each SGBA-5 item on a 5-point Likert scale each round, receiving summary statistics of other experts’ responses after the first round. A conservative threshold for consensus agreement (75% rating an item 4+ of 5) was used given the novelty of this scale’s items. Reliability was assessed through a two-armed test-retest study. The university student arm (n = 89) was conducted in-person (on paper), and the older adult arm (n = 71) was conducted online (digitally).

RESULTS: The Delphi study ended after three rounds; experts reached consensus agreement on the validity of the biological sex item of the SGBA-5 (93%) and consensus non-agreement on each of the gendered aspect of health items (identity: 64%, expression: 64%, roles: 50%, relations: 57%). Both the student arm (sex item: [Formula: see text], gendered items: [Formula: see text]) and the older adult arm (sex item: [Formula: see text], gendered items: [Formula: see text]) of the test-retest study indicated that all items were reliable.

CONCLUSIONS: The novel SGBA-5 tool demonstrated reliability across all scale items and validity of the biological sex item. The gendered aspects of health items may be valid. Future research can further develop the SGBA-5 as a tool for use in health research.

PMID:40378387 | DOI:10.1371/journal.pone.0323834

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Nevin Manimala Statistics

Seroprevalence of hepatitis A virus infection in urban and rural areas in Vietnam

PLoS One. 2025 May 16;20(5):e0323139. doi: 10.1371/journal.pone.0323139. eCollection 2025.

ABSTRACT

BACKGROUND/OBJECTIVES: The prevalence of hepatitis A virus (HAV) is associated with socioeconomic conditions, access to clean drinking water, and improvements in sanitation. In Vietnam, epidemiological data on HAV have been limited over the past two decades. This study aims to assess age-specific HAV seroprevalence across two distinct geographic regions, urban and rural areas, and identify the risk factors associated with HAV seropositivity in Vietnam.

METHODS: This cross-sectional seroprevalence study was conducted in two distinct areas in Vietnam. Serological testing for anti-HAV total antibodies was performed, and socio-demographic questionnaires were administered to all participants. The age at the midpoint of population immunity (AMPI) was calculated and analyzed.

RESULTS: A total of 1,281 participants aged 1-80 years were included, with 649 from urban areas and 632 from rural areas. Of the total participants, 33.2% were aged <15 years. Overall, HAV seropositivity was 69.2%, with urban areas exhibiting significantly lower seropositivity (57.9%) compared to rural areas (80.7%) (p < 0.001). The AMPI was 29 years, indicating Vietnam is at intermediate HAV endemicity. Multivariate analysis identified key risk factors for HAV infection, including age and rural residence. Conversely, participants with higher educational levels and those who consumed boiled drinking water were less likely to be HAV seropositive.

CONCLUSIONS: The study identified significant differences in the HAV seroprevalence between urban and rural areas, providing critical data for public health officials. These findings highlight the key role of targeted public health interventions and vaccination programs in mitigating HAV infection rates and reducing the disease burden, particularly among high-risk populations in Vietnam.

PMID:40378373 | DOI:10.1371/journal.pone.0323139

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Nevin Manimala Statistics

Verity plots: A novel method of visualizing reliability assessments of artificial intelligence methods in quantitative cardiovascular magnetic resonance

PLoS One. 2025 May 16;20(5):e0323371. doi: 10.1371/journal.pone.0323371. eCollection 2025.

ABSTRACT

BACKGROUND: Artificial intelligence (AI) methods have established themselves in cardiovascular magnetic resonance (CMR) as automated quantification tools for ventricular volumes, function, and myocardial tissue characterization. Quality assurance approaches focus on measuring and controlling AI-expert differences but there is a need for tools that better communicate reliability and agreement. This study introduces the Verity plot, a novel statistical visualization that communicates the reliability of quantitative parameters (QP) with clear agreement criteria and descriptive statistics.

METHODS: Tolerance ranges for the acceptability of the bias and variance of AI-expert differences were derived from intra- and interreader evaluations. AI-expert agreement was defined by bias confidence and variance tolerance intervals being within bias and variance tolerance ranges. A reliability plot was designed to communicate this statistical test for agreement. Verity plots merge reliability plots with density and a scatter plot to illustrate AI-expert differences. Their utility was compared against Correlation, Box and Bland-Altman plots.

RESULTS: Bias and variance tolerance ranges were established for volume, function, and myocardial tissue characterization QPs. Verity plots provided insights into statstistcal properties, outlier detection, and parametric test assumptions, outperforming Correlation, Box and Bland-Altman plots. Additionally, they offered a framework for determining the acceptability of AI-expert bias and variance.

CONCLUSION: Verity plots offer markers for bias, variance, trends and outliers, in addition to deciding AI quantification acceptability. The plots were successfully applied to various AI methods in CMR and decisively communicated AI-expert agreement.

PMID:40378365 | DOI:10.1371/journal.pone.0323371

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Nevin Manimala Statistics

Chemotherapy-related adverse drug reaction and associated factors among adult cancer patient attending Jimma medical center oncology unit, Southwest Ethiopia

PLoS One. 2025 May 16;20(5):e0321785. doi: 10.1371/journal.pone.0321785. eCollection 2025.

ABSTRACT

BACKGROUND: In 2017, reports of adverse drug reactions worldwide reached an estimated 35 million.Chemotherapeutic agents were one of the most often implicated pharmacological classes in inducing adverse drug reactions. Adverse drug reactions increase the overall expense and mortality. Adverse drug reactions increase morbidity, mortality, hospitalization rate and financial expenses. Therefore, this study intended to assess chemotherapy-related adverse drug reactions and associated factors among adult cancer patients.

PATIENTS AND METHOD: A facility-based prospective observational study was conducted from July 2022 to October 2022 at Jimma Medical Center’s oncology unit. A standard data collection tool (Naranjo’s algorithm, modified Hartwig’s severity scale, and modified Schumock-Thornton criteria) was used for assessment of causality, severity, and preventability of adverse reactions, respectively. Socio-demographic profile and any adverse drug reactions reported were collected separately. The data was collected by one pharmacist and two nurses after giving training. Data was entered into Epidata version 4.6.0 and analyzed by SPSS version 25. Bivariate and multivariable logistic regression was conducted to identify independent predictors of the pattern of adverse drug reaction occurrence. A P-value of 0.05 was taken as statistically significant.

RESULT: Out of 154 patients enrolled in the study, 66.2% were female. The mean age of patients was 41.20 ± 13.54 years. From the total, 98 (63.6%) cases developed a total of 198 adverse drug reactions. Out of them, 59.2% were female. The most commonly encountered adverse drug reactions were nausea and vomiting (33.8%) and hair loss (29.3%). Most of the reactions were probable (61.1%) in causality, mild (66.2%) in severity, and not preventable (43.9%) in nature. Female sex (AOR = 1.054; 95% CI= (1.021-1.087); P = 0.001), number of chemotherapy treatments (AOR = 3.33; 95% CI= (1.301-8.52); P = 0.012), and elderly age (AOR = 3.065; 95% CI= (1.01-9.296); P = 0.048) were associated with occurrences of adverse drug reactions.

CONCLUSION: We can deduce from the data that adverse drug reactions are a significant concern for patients undergoing chemotherapy, with nearly two-thirds experiencing ADRs. The most common reactions are nausea and vomiting, which are mostly mild and probable. Age, gender, and the use of several chemotherapy drugs were associated with an increased risk of adverse drug reactions. Hence all concerned bodies should make an effort for early detection and take preventive measure of chemotherapy-related adverse drug reactions. Where feasible, use chemotherapy protocols with alower risk of ADRs. Evaluate dose adjustments for elderly patients. Implement protocols for risk assessment before initiating chemotherapy.

PMID:40378362 | DOI:10.1371/journal.pone.0321785

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Nevin Manimala Statistics

Experience of Using Electronic Inhaler Monitoring Devices for Patients With Chronic Obstructive Pulmonary Disease or Asthma: Systematic Review of Qualitative Studies

JMIR Mhealth Uhealth. 2025 May 16;13:e57645. doi: 10.2196/57645.

ABSTRACT

BACKGROUND: Electronic inhaler monitoring devices (EIMDs) can enhance medication adherence in patients with chronic obstructive pulmonary disease (COPD) and asthma, yet patient perceptions and experiences with these devices vary widely. A systematic qualitative synthesis is required to comprehensively understand patient perspectives on EIMDs, to lay the foundation for developing strategies to improve patient compliance.

OBJECTIVE: This study aims to systematically evaluate qualitative studies on the experiences of patients with COPD and asthma using EIMDs, providing insights to support their clinical application and improve patient engagement.

METHODS: This review synthesized qualitative data from reports found through a systematic search of PubMed, Web of Science, CINAHL, Embase, Cochrane Library, and PsycInfo from January 1983 to July 2024. The reports assessed patient experiences with EIMDs for COPD and asthma. The quality of the included reports was appraised using the Critical Appraisal Skills Program criteria developed by the Centre for Evidence-Based Medicine, University of Oxford, UK.

RESULTS: A total of 7 reports were included, encompassing data from 44 patients with COPD and 146 with asthma. Findings were organized into 9 sub-themes and 3 themes: positive experiences with EIMDs (usability and easy acceptance, enhanced self-management); stresses and challenges of using these devices (negative emotional stress, device trust issues, social difficulties, economic burdens, and technical challenges); and patient expectations from these devices (expectations related to device construction and function and external support).

CONCLUSIONS: Patients have positive experiences using electronic monitoring devices for inhalation devices but also face various social, psychological, and technical challenges. Health care workers should consider patient experiences with EIMDs to tailor these devices to patient needs, ultimately enhancing device acceptance and adherence. Further research should focus on increasing EIMDs convenience and usability for patients with COPD and asthma.

PMID:40378281 | DOI:10.2196/57645

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Nevin Manimala Statistics

Long-Term Safety and Effectiveness of Cold-Crosslinked Hyaluronic Acid Fillers: Multicenter, Randomized, Controlled, Double-Blind Study

Aesthet Surg J. 2025 May 16:sjaf080. doi: 10.1093/asj/sjaf080. Online ahead of print.

ABSTRACT

BACKGROUND: EVOLYSSE FORM (EVLF) and EVOLYSSE SMOOTH (EVLS) are new hyaluronic acid fillers created using an innovative cold crosslinking process.

OBJECTIVES: To collect safety and effectiveness data on new cold-crosslinked fillers to support US approval for the correction of moderate to severe dynamic facial wrinkles and folds.

METHODS: In this randomized, controlled, split-face study, 140 subjects with moderate to severe nasolabial folds received a cold-crosslinked filler in 1 nasolabial fold (EVLF = 70, EVLS = 70) and a traditionally-crosslinked filler, Restylane-L (RESL), in the contralateral fold and were followed through 12 months with an optional retreatment at that timepoint and subsequent 3 months of safety follow-up.

RESULTS: The primary endpoint of mean Wrinkle Severity Rating Scale change from baseline to Month 6 as rated by photographic review panel demonstrated non-inferiority and statistical superiority for the cold-crosslinked fillers. Blinded evaluator Wrinkle Severity Rating Scale assessments showed a mean change from baseline that was statistically significantly better than RESL for EVLF at all visits through 12 months and for EVLS at 6 and 9 months. Most subjects were responders on the Global Aesthetic Improvement Scale throughout the study according to ratings by blinded evaluators, treating investigators, and subjects. The FACE-Q Appraisal of Nasolabial Folds overall mean score showed significant improvement from baseline (p < 0.0001) at all timepoints through Month 12 for all treatment groups. All treatments were well tolerated.

CONCLUSIONS: The new cold-crosslinked fillers were shown to be safe and effective for correction of nasolabial folds, with results lasting for 1 year.

PMID:40378267 | DOI:10.1093/asj/sjaf080

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Nevin Manimala Statistics

A Personalized Predictive Model That Jointly Optimizes Discrimination and Calibration

Stat Med. 2025 May;44(10-12):e70077. doi: 10.1002/sim.70077.

ABSTRACT

Precision medicine is accelerating rapidly in the field of health research. This includes fitting predictive models for individual patients based on patient similarity in an attempt to improve model performance. We propose an algorithm which fits a personalized predictive model (PPM) using an optimal size of a similar subpopulation that jointly optimizes model discrimination and calibration, as it is criticized that calibration is not assessed nearly as often as discrimination despite poorly calibrated models being potentially misleading. We define a mixture loss function that considers model discrimination and calibration, and allows for flexibility in emphasizing one performance measure over another. We empirically show that the relationship between the size of subpopulation and calibration is quadratic, which motivates the development of our jointly optimized model. We also investigate the effect of within-population patient weighting on performance and conclude that the size of subpopulation has a larger effect on the predictive performance of the PPM compared to the choice of weight function.

PMID:40378188 | DOI:10.1002/sim.70077

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Nevin Manimala Statistics

Bacterial profile and antimicrobial susceptibility pattern of community and hospital-acquired urinary tract infections among UTI suspected geriatrics in Gondar town, Northwest Ethiopia

PLoS One. 2025 May 16;20(5):e0323570. doi: 10.1371/journal.pone.0323570. eCollection 2025.

ABSTRACT

BACKGROUND: Bacterial urinary tract infection (UTI) is the second most frequent infection next to respiratory tract infection within the geriatric population both in the community and hospital settings. There is a limited data regarding geriatrics UTI in this study area. Therefore, the current study aimed to assess the status of the community and hospital-acquired urinary tract infections, and antimicrobial susceptibility patterns among UTI suspected geriatrics which is essential to physicians and health care workers to implement appropriate intervention.

METHODS: A comparative cross-sectional study was conducted among 460 UTI suspected geriatrics admitted at the University of Gondar Comprehensive Specialized Hospital and attended in Gondar town (Kallen Bnakafl and Menna Geriatrics Support Center Clinics) from 1st May 2022-14th July 2022. Socio-demographic data were collected using structured questionnaires. Urine culture was performed and isolates were counted for significant growth by a colony counter, and their antibiotic susceptibility was done by the Kirby-Bauer disc diffusion method. Data were entered using Epi Data version 4.0.0 and analyzed by Stata/IC version 14.0. P-value < 0.05 at 95% CI was considered statistically significant.

RESULT: The overall prevalence of UTI in geriatrics was 44.4%. The prevalence of UTI among community and hospitalized suspected patients was 38.7% and 50%, respectively. Escherichia coli (E. coli) (38.6%) predominated across the two groups, followed by Klebsiella spp. (15.8%), S. saprophyticus (12.2%), P. mirabilis (9.1%), S. aureus (5.9%), and Citrobacter spp. (2.8%). Pseudomonas spp. (7.1%), K. rhinoscleromatis (5.1%), and P. vulgaris (2.8%), were isolated from only hospitalized patients. Piperacillin-tazobactam susceptibly was 100% in both study groups. Nalidixic acid resistance was 50% to 87.5% and 50% to 100% in the isolates from community and hospitalized UTI suspects, respectively.

CONCLUSION: This study found a high prevalence of bacterial UTI in geriatrics and a high rate of bacterial resistance was observed to most antimicrobial drugs tested. Piperacillin-tazobactam and meropenem were the most active antimicrobials for UTI. Therefore, expanding routine bacterial culture and antimicrobial susceptibility testing and strengthening regular surveillance systems are essential for appropriate patient care.

PMID:40378179 | DOI:10.1371/journal.pone.0323570

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Nevin Manimala Statistics

Integrating Multimodal EHR Data for Mortality Prediction in ICU Sepsis Patients

Stat Med. 2025 May;44(10-12):e70060. doi: 10.1002/sim.70060.

ABSTRACT

Rapid and accurate prediction of mortality risk among intensive care unit (ICU) sepsis patients is crucial for timely intervention and improving patient outcomes. However, due to the multimodal and dynamic time-series nature of patient visit information and the limited data samples, it is challenging to obtain discriminative patient representations, leading to suboptimal mortality prediction results. To address this issue, we design a time-aware graph embedding attention model (TGAM) to integrate multimodal data and predict mortality in ICU sepsis patients. Our approach involves modeling and generating patient representations that encompass not only demographic information but also dynamic time-series data reflecting patient health status. Additionally, the graph convolutional network is used to obtain informative concept embeddings from medical ontologies, and an improved transformer is used to capture the temporal information of the patient’s health status and handle missing values, overcoming the limitations of small samples. The experimental results on the MIMIC-III and MIMIC-IV datasets demonstrate that TGAM significantly improves prediction accuracy, with AUROC scores of 87.65% and 87.00% on the MIMIC-III and MIMIC-IV datasets, respectively, outperforming baseline models by over 5 percentage points. TGAM also achieves higher sensitivity, specificity, and AUPRC metrics, and lower Brier Score compared with baseline models, highlighting its effectiveness in identifying high-risk patients. These findings suggest that TGAM has the potential to become a valuable tool for identifying high-risk sepsis patients, enabling clinicians to make more informed and timely intervention decisions.

PMID:40378163 | DOI:10.1002/sim.70060

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Nevin Manimala Statistics

Incidence and predictors of cardiovascular disease mortality and all-cause mortality in patients with type II diabetes with peripheral arterial disease

PLoS One. 2025 May 16;20(5):e0322502. doi: 10.1371/journal.pone.0322502. eCollection 2025.

ABSTRACT

OBJECTIVE: This cohort study estimated the incidence and predictors of cardiovascular disease (CVD) and all-cause mortality among patients with type 2 diabetes mellitus (T2DM) and various stages of peripheral arterial disease (PAD) at the largest tertiary referral hospitals in upper-northern Thailand.

METHODS: This study recruited 278 T2DM and PAD patients for a 7-year cohort study. These patients completed health questionnaires and underwent physical examinations including ankle-brachial index measurements and clinical assessment to determine PAD severity. Mortality endpoints were determined using hospital death registers and national death records. The Cox proportional hazards and subdistribution hazard models were used to estimate PAD’s effect on mortality, quantifying the association with hazard ratios (HR) and subdistribution hazard ratios (SHR).

RESULTS: PAD patients were categorized into three subgroups. Over seven years, the cumulative all-cause mortality rate was 36%, or 6.4 deaths per 100 person-years. Multivariable analysis revealed critical limb ischemia (CLI) patients had significantly higher risks of all-cause (HR 5.26, 95%CI 3.10-8.94) and CVD mortality (SHR 6.20, 95%CI 3.20-12.03) compared to their asymptomatic peers. No statistically significant differences in non-CVD mortality were noted across PAD subgroups.

CONCLUSION: CLI, chronic kidney disease, and underweight (body mass index < 18.5 kg/m2) emerged as independent mortality predictors. Conversely, asymptomatic PAD patients had a similar overall mortality risk as those with intermittent claudication. These findings highlight the need for risk stratification and patient empowerment to optimize management of these complex conditions.

PMID:40378162 | DOI:10.1371/journal.pone.0322502