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Nevin Manimala Statistics

The SureFast® Listeria 3plex ONE Kit and the SureFast® PREP Bacteria Kit in a Variety of Foods and Environmental Samples: Multi-Laboratory Validation, First Action 2025.04

J AOAC Int. 2026 Apr 3:qsag015. doi: 10.1093/jaoacint/qsag015. Online ahead of print.

ABSTRACT

BACKGROUND: The SureFast® Listeria 3plex ONE Kit uses the real-time polymerase chain reaction (PCR) technique for multiplex detection of Listeria species and Listeria monocytogenes in foods and environmental samples. The SureFast® Listeria 3plex ONE Kit can also be used with the SureFast® PREP Bacteria Kit to provide a second DNA extraction option and can be analyzed on multiple thermocyclers.

OBJECTIVE: The kit was evaluated using 25 g test portions in an unpaired study design for a single matrix, ready-to-eat smoked deli turkey as part of a harmonized validation protocol with MicroVal Certification.

METHODS: The matrix was compared to the International Organization for Standardization Technical (ISO) 11290-1:21017 reference standard. 17 participants from 16 laboratories, located within Austria, Germany, Italy, Spain, and the United States were solicited for the multi-laboratory validation (MLV), with only 10 participants submitting data. Three levels of contamination were evaluated: an uninoculated control level (0 colony forming units (CFU)/test portion), a low inoculum level (0.2-2 CFU/test portion) and a high inoculum level (2-10 CFU/test portion). Statistical analysis was conducted according to the Probability of Detection (POD) statistical model.

RESULTS: Results obtained for the low inoculum level test portions produced a dLPOD value with 95% confidence interval of -0.01 (-0.04, 0.02). The dLPOD results indicate equivalence between the candidate method and reference method for the matrix evaluated and the method demonstrated acceptable multi-laboratory reproducibility as determined in the MLV. False positive and false negative rates were determined for the matrix and produced values of 0.0% and 0.8% respectively.

CONCLUSIONS: Based on the data generated, the method demonstrated equivalence to the ISO reference method in a MLV study.

HIGHLIGHTS: The SureFast ONE 3plex method is a rapid and reliable alternative for the multiplex detection of Listeria species and Listeria monocytogenes in a broad range of foods and environmental surfaces.

PMID:41934106 | DOI:10.1093/jaoacint/qsag015

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Nevin Manimala Statistics

Incidence and Risk Factors of Delayed Chemotherapy-Induced Nausea and Vomiting Among Adult Patients: A Cross-Sectional Study

Nurs Open. 2026 Apr;13(4):e70490. doi: 10.1002/nop2.70490.

ABSTRACT

AIM: To assess the incidence of delayed chemotherapy-induced nausea and vomiting (CINV) and identify key risk factors among adult patients.

DESIGN: A descriptive cross-sectional design.

METHODS: A total of 326 adult patients undergoing chemotherapy were recruited using consecutive sampling from a nearly 4000-bed tertiary general hospital in Shanghai, China, between July 2023 and April 2024. Demographic and health status data were collected within 24 h of patient admission. Clinicopathologic information was retrieved from nursing documents and electronic medical records. Delayed CINV was measured on the third day post-chemotherapy via telephone interviews using the Common Terminology Criteria for Adverse Events (CTCAE 5.0). Statistical analyses included univariate analysis, random forest modelling, least absolute shrinkage and selection operator (LASSO) analysis and binary logistic regression.

RESULTS: Among 326 participants, 113 (34.7%) reported delayed nausea and/or vomiting, with 32.2% (n = 105) experiencing delayed nausea and 13.2% (n = 43) experiencing delayed vomiting. The step-by-step analysis identified anxiety, motion sickness and high emetogenicity of chemotherapy agents as key risk factors for delayed CINV. Post hoc analysis showed that body mass index (BMI) and history of delayed nausea or vomiting during previous chemotherapy cycles emerged as important predictors that should be considered when assessing the risk of delayed CINV.

CONCLUSIONS: Health care providers should be vigilant in recognising patients at high risk for delayed CINV. Early and targeted prophylactic interventions are recommended to mitigate the risk of delayed CINV.

REPORTING METHOD: The study followed the STROBE checklist.

PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

PMID:41934104 | DOI:10.1002/nop2.70490

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Nevin Manimala Statistics

Efficiency improvement in the stroke care process based on the Lean Healthcare approach

Int J Health Care Qual Assur. 2026 Apr 7:1-18. doi: 10.1108/IJHCQA-11-2025-0182. Online ahead of print.

ABSTRACT

PURPOSE: Stroke care requires coordination among medical professionals and hospital management staff in a collaboratively developed process that must be continuously improved, as care time significantly reduces the patient’s capabilities after the intervention. This article aims to quantify the efficiency improvement in the stroke care process based on a comprehensive Lean Healthcare approach.

DESIGN/METHODOLOGY/APPROACH: An ad-hoc, two-phase structured Lean intervention was validated by analysing nine years of data in a hospital as proof of concept.

FINDINGS: Mean reductions of between 2 and 4 min in key in-hospital time-based metrics were achieved for both types of strokes under study, resulting in improvements of up to 11.1%. These benefits demonstrated a statistically significant difference in mean pre- and post-Lean metrics.

PRACTICAL IMPLICATIONS: The group of patients analysed post-Lean was not only managed with tissue plasminogen activator or thrombectomy in less time but also had lower disability degrees at entry and after three months, with the jump from three levels pre-Lean to a single level according to the modified Rankin score decreasing.

SOCIAL IMPLICATIONS: It was concluded that a patient-centric continuous flow design significantly increases the likelihood of patient recovery.

ORIGINALITY/VALUE: This study offers new evidence that a patient-centric continuous flow design enhances recovery outcomes in hospital care. By applying Lean Healthcare principles to patient-centred process redesign, it links operational efficiency directly to clinical improvement. The findings provide a replicable framework for integrating process flow optimisation into quality assurance, positioning it as a driver of patient-centred excellence and overall performance.

PMID:41934094 | DOI:10.1108/IJHCQA-11-2025-0182

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Nevin Manimala Statistics

Sonazoid Contrast-Enhanced Ultrasound Hypoenhancement Characteristics and Influencing Factors of Hepatic Hemangiomas: A Multicenter Study

Ultrasound Med Biol. 2026 Apr 2:S0301-5629(26)00094-3. doi: 10.1016/j.ultrasmedbio.2026.03.003. Online ahead of print.

ABSTRACT

OBJECTIVE: Given the high hypoenhancement prevalence of hepatic hemangiomas (HHs) during the transitional phase and Kupffer phase (KP) of Sonazoid contrast-enhanced ultrasound (CEUS), this study aimed to investigate the hypoenhancement phenomenon pattern and its influencing factors.

METHODS: This was a prospective multicenter study. A total of 136 patients with HHs were enrolled from 26 medical centers, including 76 cases in the KP hypoenhancement group and 60 cases in the KP non-hypoenhancement group. Enhancement characteristics and patterns at different time points during the transitional phase were analyzed between the two groups. Statistical analyses included Mann-Whitney U test for two independent samples, chi-square test or Fisher’s exact test for categorical variables and Spearman’s rank correlation analysis for the relationship between hypoenhancement prevalence and time points. Survival analysis was used to compare differences in the start time of hypoenhancement among HHs with different characteristics. Multivariate Cox regression analysis was performed to identify the influencing factors of KP hypoenhancement.

RESULTS: The hypoenhancement prevalence of HHs in the KP was 55.9% (76/136). The proportions of hyperenhancement, isohyperenhancement, mild hypoenhancement and marked hypoenhancement were 5.9% (8/136), 38.2% (52/136), 41.9% (57/136) and 14.0% (19/136), respectively. There was a significant positive correlation between the hypoenhancement prevalence and time points (rs = 0.993, p < 0.001). The main start time of hypoenhancement was 4 min (p < 0.001). The median hypoenhancement time in the KP hypoenhancement group was 5.5 min. Two-dimensional ultrasound (2-D-US) echo type and maximum diameter were independent influencing factors for Sonazoid KP hypoenhancement: hypoechoic lesions were more likely to present hypoenhancement compared with hyperechoic ones (HR = 1.80, 95% CI: 1.10-2.95, p = 0.020); both lesions ≥5 cm and those between 2 and 5 cm had a higher likelihood of hypoenhancement compared with lesions <2 cm, with HR = 2.58 (95% CI: 1.18-5.65, p = 0.018) and HR = 2.32 (95% CI: 1.35-3.97, p = 0.002), respectively.

CONCLUSION: More than half of HHs show hypoenhancement in the KP of Sonazoid CEUS, and mild hypoenhancement is the main enhancement pattern among hypoenhancement cases. Hypoenhancement mostly occurs after 4 min, and the hypoenhancement prevalence gradually increases over time. The independent influencing factor for KP hypoenhancement is 2-D-US hypoechogenicity and maximum diameter greater than 2 cm.

PMID:41934080 | DOI:10.1016/j.ultrasmedbio.2026.03.003

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Nevin Manimala Statistics

Pericoronal radiolucencies: how many are diagnosed as dentigerous cysts?

Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Feb 17:S2212-4403(26)00068-4. doi: 10.1016/j.oooo.2026.02.009. Online ahead of print.

ABSTRACT

OBJECTIVE: This study tested how many patients receiving treatment for pericoronal radiolucencies were confirmed to have dentigerous cysts and also assessed factors associated with the prevalence of dentigerous cysts.

STUDY DESIGN: A retrospective chart review study of 62 patients was conducted, including panoramic radiographs, pathology reports, demographic variables, and clinical data.

RESULTS: In total, 53.2% of study patients were diagnosed with dentigerous cysts. A statistically significant correlation was found between gender and the presence of dentigerous cysts, but not between age and a diagnosis of dentigerous cysts. Unilocular/multilocular lesions and the number of involved teeth also presented statistically significant correlations to this diagnosis.

CONCLUSIONS: This study demonstrates that dentigerous cysts are the most common type of pericoronal radiolucencies and highlights the importance of radiographic and clinical data in diagnosis.

PMID:41934074 | DOI:10.1016/j.oooo.2026.02.009

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Nevin Manimala Statistics

Leadless or Transvenous pacemakers following TAVR: A systematic review and meta-analysis

Cardiovasc Revasc Med. 2026 Mar 25:S1553-8389(26)00108-9. doi: 10.1016/j.carrev.2026.03.017. Online ahead of print.

ABSTRACT

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is frequently associated with conduction disturbances and arrhythmias, often requiring permanent pacemaker (PPM) implantation in an elderly, high-bleeding-risk population. Leadless pacemakers (LPMs) reduce pocket and lead-related complications and have demonstrated noninferior safety compared with transvenous pacemakers (TVP) in non-TAVR populations. However, comparative data in the post-TAVR setting are lacking.

METHODS: We systematically searched Pubmed, Cochrane, Embase, Web of Sciences and Scopus for studies comparing LPM vs. TVP following TAVR. Random effects models were used to calculate risk ratios (RRs) with 95% confidence intervals (CIs) for all-cause mortality, device-related complications, re-hospitalization and vascular access site complications. Statistical analysis was performed with R software, version 4.2.3.

RESULTS: Six retrospective studies comprising 10,681 patients were included, of whom 874 (7.56%) underwent LPM implantation. Compared with TVP, LPM was associated with a significant reduction in device related complications (RR 0.46; 95% 0.25-0.83; p < 0.011) and vascular access site complications (RR 0.15; 95% CI 0.03-0.68; p = 0.011). There was no significant difference in re-hospitalization (RR 0.82; 95% CI 0.23-3.12; p = 0.76). LPM was associated with a higher risk of all-cause mortality (RR 1.61; 95% CI 1.01-2.57; p = 0.047).

CONCLUSIONS: Among these six retrospective studies, LPM use following TAVR was associated with fewer device-related and vascular access complications compared with TVP, albeit with a higher risk of all-cause mortality at 2 years. However, this finding likely reflects a selection bias in non-adjusted baseline characteristics rather than device inferiority. No significant differences were observed in re-hospitalization between the two strategies. Prospective studies are required to confirm or refute these findings.

PMID:41934056 | DOI:10.1016/j.carrev.2026.03.017

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Prospective association of waist-thigh-ratio and cardiovascular disease mortality among the US adults: NHANES 1999-2002 linked mortality study

Nutr Metab Cardiovasc Dis. 2026 Feb 23:104639. doi: 10.1016/j.numecd.2026.104639. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Anthropometric measures and derived ratios effectively predict cardiovascular disease (CVD) mortality. In this study, we aimed to compare waist-to-thigh ratio (WTR) with more common measures for predicting CVD mortality.

METHODS AND RESULTS: This study included 5661 U.S. adults from the 1999-2002 National Health and Nutrition Examination Survey, linked with 2019 mortality status from the National Death Index (768 CVD deaths). Anthropometric measures, including waist circumference (WC), thigh circumference (TC), BMI, waist-to-BMI ratio (WBR), waist-to-height ratio (WHtR), and WTR, were assessed at baseline. Hazards ratios (HR) and 95th confidence intervals (CI) were calculated for each anthropometric measure across quartiles in relation to CVD mortality after adjusting for traditional CVD risk factors and accounting for multi-stage sampling design. Study results showed that, compared to the lowest quartile, successive quartiles of WTR were significantly associated with greater HRs for CVD mortality (1.34 (0.88-2.03), 1.26 (0.90-1.76), and 1.62 (1.21-2.16, respectively, p trend = 0.003). Stronger associations were observed among adults aged 75 and above, with HR (95% CI) for the highest versus lowest WTR quartile of 2.34 (1.70-3.22) (p trend <0.001). However, no significant associations were observed for other anthropometric measures and CVD mortality.

CONCLUSIONS: In this nationally representative U.S. cohort, WTR was a stronger predictor of CVD mortality than WC, TC, BMI, WBR, or WHtR, particularly among participants aged ≥75 years. Incorporating WTR into traditional CVD risk models may more sensitively identify individuals at risk of CVD death.

PMID:41934045 | DOI:10.1016/j.numecd.2026.104639

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Nevin Manimala Statistics

Content Validation of a Medication Adherence Risk Score (MARS) for Mortality Risk Prediction: A Delphi Consensus

Clin Pharmacol Ther. 2026 Apr 3. doi: 10.1002/cpt.70274. Online ahead of print.

ABSTRACT

The Medication Adherence Risk Score (MARS) is an objective adherence-based score, derived from transactional dispensary data. This study provides expert consensus to validate the use of the MARS as a predictor of mortality risk. A systematic review and assessment of South African health legislation and professional guidelines informed the development of consensus statements regarding the relevance, validity, predictive power, and implementation feasibility of the MARS. A two-round modified Delphi approach using a 5-point Likert scale was employed. Consensus was reached if at least 80% of respondents selected “agree” or “strongly agree.” Nonconsensus statements were revised based on qualitative feedback and subsequently reevaluated in a second round. Thirteen clinical, actuarial, and academic experts were successfully recruited. Consensus was achieved for 20 of the 28 statements in Round 1. Five of 18 (27.8%; risk score components), 1 of 3 (33.3%, validity/predictive power), and 2 of 7 statements (26.5%, real-world implementation) did not initially reach consensus. Nonconsensus statements were revised to provide clarity, after which consensus was achieved for all statements by the end of Round 2. Expert consensus supports the inclusion, exclusion, and weighting of MARS risk factors. The panel agreed that the score offers predictive value for mortality outcomes, and that real-world application for enhancing risk stratification and reducing healthcare costs is feasible. Future statistical analysis is necessary to demonstrate its relationship with mortality risk. Developing practical implementation strategies will facilitate incorporation into clinical practice and public health interventions.

PMID:41933437 | DOI:10.1002/cpt.70274

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Impact of the COVID-19 pandemic on the incidence of Clostridioides difficile infection based on hospital surveillance data: a systematic review and meta-analysis

Antimicrob Resist Infect Control. 2026 Apr 3. doi: 10.1186/s13756-026-01737-4. Online ahead of print.

ABSTRACT

BACKGROUND: Clostridioides difficile infection (CDI) remains a substantial burden on healthcare systems worldwide. The COVID-19 pandemic has had profound and multifaceted effects on healthcare delivery and infection control practices, potentially influencing the epidemiology of CDI.

OBJECTIVE: To assess whether the coronavirus disease 2019 (COVID-19) pandemic has influenced the incidence of CDI and to explore potential contributing factors.

METHODS: This systematic review and meta-analysis was conducted in accordance with the PRISMA guidelines. Seven databases were searched for relevant literature published from December 2019 to October 2025. Study quality was assessed via the Newcastle‒Ottawa Scale (NOS) and the Joanna Briggs Institute (JBI) critical appraisal tools. Random- or fixed-effects models were selected according to heterogeneity. Publication bias was evaluated via funnel plots and Egger’s test, and sensitivity analyses were conducted. The primary outcome was the incidence rate of CDI, expressed as cases per 10,000 patient-days. Incidence rate ratios (IRR) were calculated to compare the incidence of CDI between the prepandemic and pandemic periods.

RESULTS: Sixteen studies were included. The pooled CDI incidence rate was 4.42 (95% CI: 3.37-5.46) per 10,000 patient-days in the prepandemic period and 3.80 (95% CI: 2.63-4.96) per 10,000 patient-days during the pandemic. The pooled incidence rate ratio was 0.80 (95% CI: 0.67-0.97), indicating a significant reduction in the incidence of CDI. This decline was associated with changes in medical practices (e.g., the suspension of nonurgent and high-risk procedures), antimicrobial stewardship practices, and strengthened infection control measures (e.g., enhanced hand hygiene and environmental disinfection) during the pandemic.

CONCLUSION: Compared with the prepandemic period, the incidence of CDI decreased significantly during the COVID-19 pandemic. This finding suggests that strengthened infection prevention measures, improved antimicrobial stewardship, and adaptations in healthcare delivery may have contributed to reduced CDI transmission. Reinforcing these evidence-based foundational strategies may help mitigate ‌the risk of CDI and other healthcare-associated infections during future public health emergencies.

PMID:41933426 | DOI:10.1186/s13756-026-01737-4

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Primary versus rerupture of the anterior cruciate ligament: rupture site patterns and graft elongation-a systematic review and meta-analysis

Knee Surg Relat Res. 2026 Apr 3;38(1):15. doi: 10.1186/s43019-026-00313-9.

ABSTRACT

BACKGROUND: While the rupture pattern of the native anterior cruciate ligament (ACL) has been well characterized-most frequently occurring in the proximal third of the ligament-there is limited consensus on whether reconstructed ACLs fail in a similar fashion. The purpose of this meta-analysis is to compare rupture localization patterns between first ruptures and reruptures.

MATERIALS AND METHODS: MEDLINE (PubMed), Embase, and the Cochrane Library databases were searched to identify studies analyzing rupture locations after both first rupture and rerupture. The main extracted outcome was the anatomical site of ACL rupture, categorized as proximal, mid-substance, distal, or elongation. A random-effects meta-analysis was performed to calculate pooled proportions and odds ratios (ORs), with between-study heterogeneity assessed using the I2 statistic.

RESULTS: The pooled meta-analysis revealed no significant differences (p > 0.05) in the distribution of proximal, mid-substance, or distal rupture locations between the first rupture and rerupture groups. However, graft elongation was significantly more frequent in reruptures (p < 0.05). Using first rupture as the reference, the odds of elongation were 1.63-fold higher in the rerupture group (OR 1.63, 95% CI 1.46-1.83; p < 0.001).

CONCLUSIONS: This meta-analysis found no statistically significant differences in rupture-site localization between first ruptures and reruptures, indicating that reconstructed ACLs tend to fail in anatomical patterns resembling those of the native ligament. However, the markedly higher incidence of graft elongation observed in the rerupture cohort suggests a distinct mode of failure. These findings highlight graft elongation as a specific mechanism that may be influenced by surgical or biological factors, warranting further investigation.

LEVEL OF EVIDENCE: Systematic review and meta-analysis of Level 4 studies.

STUDY REGISTRATION: PROSPERO Registry CRD420251073835.

PMID:41933414 | DOI:10.1186/s43019-026-00313-9