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Nevin Manimala Statistics

Impella in Cardiogenic Shock: An Updated Meta-Analysis

Crit Pathw Cardiol. 2026 Jan 30. doi: 10.1097/HPC.0000000000000409. Online ahead of print.

ABSTRACT

Despite technological advancements, mortality remains high in patients with myocardial infarction complicated by cardiogenic shock. Impella is increasingly used as an adjunct to standard treatment due to its hemodynamic benefits, though mixed study results limit its adoption. This meta-analysis aims to clarify Impella’s efficacy by focusing on high-quality data from RCTs and cohort studies. A comprehensive literature search was conducted for randomized controlled trials and cohort studies comparing Impella with intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO). Assessed metrics included mortality, clinical events, and hematologic markers. Data was analyzed using the Mantel-Haenszel random-effects model. Of 787 articles, 12 studies (4918 patients) met the inclusion criteria. Impella groups showed significant increases in thrombosis risk (RR: 4.94) and had a higher bleeding risk compared to IABP (RR: 1.98) but a lower risk compared to ECMO (RR: 0.66). All other comparisons did not reach statistical significance. Despite updated data and a stringent quality threshold, the hemodynamic benefits of Impella and the device’s risk of thrombosis and bleeding were high. Future trials should emphasize patient selection, timing of placement, and operator proficiency to evaluate Impella’s efficacy and safety better.

PMID:41641616 | DOI:10.1097/HPC.0000000000000409

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Impact of COVID-Era Emergency Department Bypass Suspension on ST Elevation Myocardial infarction System Performance in Rural Practice

Crit Pathw Cardiol. 2026 Feb 3. doi: 10.1097/HPC.0000000000000419. Online ahead of print.

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, a temporary policy change required Emergency Medical Services (EMS)-identified ST-elevation myocardial infarction (STEMI) patients to undergo COVID testing in the emergency department (ED) prior to percutaneous coronary intervention (PCI), suspending the standard ED bypass to the catheterization lab. We compared system performance metrics during this COVID-era routing to pre- and post-pandemic periods in a large rural health system.

METHODS: This was a retrospective single-center cohort study of consecutive EMS-identified STEMI activations across three periods: pre-COVID (5/27/2018-3/26/2020), COVID-era ED routing (3/27/2020-1/25/2022), and post-COVID with resumed ED bypass (1/26/2022-11/26/2023). Primary outcomes were standard STEMI system performance metrics; the secondary outcome was in-hospital mortality.

RESULTS: A total of 373 patients were included (pre-COVID: 132; COVID: 104; post-COVID: 137). Compared to pre-COVID, the median time from EMS first medical contact to device time increased by 13 minutes (p = 0.017). The median time from symptom onset to device time increased by 30 minutes (p = 0.0013). The median time of first EMS ECG to device placement was increased by 14 minutes (p=0.013). The median door to device time was increased by 6 minutes (p = 0.0007). There was a non-significant trend toward higher in-hospital mortality during the COVID era.

CONCLUSION: In a rural STEMI system, pandemic-era routing of EMS-identified patients through the ED was associated with significant delays in key reperfusion metrics. While in-hospital mortality did not differ significantly, likely due to limited statistical power, these findings underscore the importance of preserving streamlined STEMI pathways. Larger multicenter studies to assess outcomes are warranted.

PMID:41641615 | DOI:10.1097/HPC.0000000000000419

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Nevin Manimala Statistics

To Wean or Not to Wean: A Randomized Controlled Trial of Pavlik Harness Weaning in Infantile Developmental Dysplasia of the Hip

J Pediatr Orthop. 2026 Feb 5. doi: 10.1097/BPO.0000000000003227. Online ahead of print.

ABSTRACT

BACKGROUND: After successful treatment of developmental dysplasia of the hip (DDH) with a Pavlik harness, controversy exists about whether it’s best to continue harness use for an additional “weaning” period or simply terminate treatment. The purpose of this randomized controlled trial (RCT) was to compare radiographic outcomes between patients with stable hip dysplasia who were weaned (W) or not weaned (NW) after Pavlik harness treatment.

METHODS: This was a single-center RCT of infants with stable ultrasonographic dysplasia in whom a Pavlik harness was initiated at <3 months of age. After 23 hours/day of harness treatment and normalization of ultrasound indices, patients were randomized into W or NW groups. W patients continued harness use for an additional 4 to 6 weeks, progressively decreasing daily use. Primary outcome was acetabular index (AI) on AP radiographs of the pelvis at 6 months of age. Secondary outcomes were number of hips with AI ≥ 30 degrees at 6 months (our threshold for prescribing part-time abduction bracing for residual dysplasia) and AI at 1 year of age.

RESULTS: Seventy-two patients (36 W, 36 NW) met inclusion criteria. There were no differences between W and NW cohorts in age at Pavlik initiation or baseline alpha angle or percent femoral head coverage. At time of ultrasonographic normalization, there was no significant difference in mean time spent in the harness between W and NW cohorts (35.0 vs. 34.9 d, P=0.84). At 6 months, mean AI was significantly lower in the W cohort (24.8±3.9 deg.) compared with the NW cohort (26.9±3.4 deg.) (P=0.02). Fewer braces were prescribed for residual dysplasia at 6 months in the W versus NW cohort (17% vs. 22%), but this was not statistically significant (P=0.56). AI at 1 year of age was not significantly different between groups (W 24.6±3.4 deg.; NW 25.3±2.3 deg., P=0.84) but this likely was affected by the use of additional bracing.

CONCLUSIONS: A Pavlik weaning protocol resulted in improved AI at 6 months of age versus immediate termination of treatment. At 1 year, AI was not significantly different between W and NW cohorts, likely due to the use of additional part-time bracing in those who were dysplastic at 6 months.

LEVEL OF EVIDENCE: Level I-randomized controlled trial.

PMID:41641599 | DOI:10.1097/BPO.0000000000003227

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White matter lesions modifying endovascular therapy outcomes in large ischemic core stroke: A secondary analysis of the ANGEL-ASPECT trial

Chin Med J (Engl). 2026 Feb 4. doi: 10.1097/CM9.0000000000003993. Online ahead of print.

ABSTRACT

BACKGROUND: Severe white matter lesions (WMLs) have been linked to poorer functional outcomes following endovascular therapy (EVT) in patients with acute ischemic stroke (AIS) due to large-vessel occlusion (LVO). However, the absence of a control group in previous studies has limited the ability to determine the benefit of EVT to patients with severe WMLs.

METHODS: This work is a secondary analysis of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core trial, a multicenter, randomized controlled trial conducted at 46 comprehensive stroke centers across China, which enrolled 456 patients with AIS with anterior-circulation LVO and large ischemic cores between October 2020 and May 2022. WML severity was graded using the van Swieten Scale on pretreatment noncontrast computed tomography (CT). For supplementary analyses, WML severity was further assessed using T2 fluid-attenuated inversion recovery (T2-FLAIR) magnetic resonance imaging (MRI) and graded according to the Fazekas scale, with WMLs categorized into periventricular and deep subtypes. Treatment effect on the primary outcome (90-day modified Rankin Scale [mRS] score) was assessed using multivariable ordinal logistic regression, and a treatment-by-WML interaction term was tested to evaluate effect modification.

RESULTS: In patients with absent-to-moderate WMLs, EVT was associated with a favorable shift in the distribution of 90-day mRS scores (adjusted common odds ratio [cOR] 2.15, 95% confidence interval [CI, 1.48-3.13], P <0.001). However, this benefit was less pronounced in those with severe WMLs (adjusted cOR 2.25, 95% CI [0.95-5.30], P = 0.065). No significant interaction between WML severity and treatment effect was detected (Pinteraction = 0.888). Similarly, only among patients with absent-to-moderate WMLs, EVT significantly increased rates of mRS scores of 0-2 (adjusted OR 4.86, 95% CI [2.66-8.86], P <0.001), the rates of mRS scores of 0-3 (adjusted OR 2.23, 95% CI [1.39-3.57], P = 0.001), and the rates of early neurological improvement (adjusted OR 5.22, 95% CI [1.31-20.79], P = 0.019) compared to medical management alone. Supplementary analyses using T2-FLAIR MRI to stratify patients by WML burden yielded results consistent with those of the primary analyses.

CONCLUSIONS: EVT significantly improved functional outcomes in patients with LVO-AIS with absent-to-moderate WMLs, while the benefit in those with severe WMLs appeared less pronounced. However, estimates within subgroups were underpowered. Future pooled analyses of randomized clinical trials with adequate statistical power are needed to clarify the impact of WML severity on EVT outcomes and to refine patient selection criteria.

REGISTRATION: ClinicalTrials.gov, No. NCT04551664.

PMID:41641580 | DOI:10.1097/CM9.0000000000003993

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The African Coalition for Research and Communication on Abortion: shifting power, building capacity, defending rights

Sex Reprod Health Matters. 2026 Feb 5:1-7. doi: 10.1080/26410397.2026.2622222. Online ahead of print.

NO ABSTRACT

PMID:41641571 | DOI:10.1080/26410397.2026.2622222

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Nevin Manimala Statistics

Marginally Interpretable Spatial Logistic Regression With Bridge Processes

Stat Med. 2026 Feb;45(3-5):e70399. doi: 10.1002/sim.70399.

ABSTRACT

In including random effects to account for dependent observations, the odds ratio interpretation of logistic regression coefficients is changed from population-averaged to subject-specific. This is unappealing in many applications, motivating a rich literature on methods that maintain the marginal logistic regression structure without random effects, such as generalized estimating equations. However, for spatial data, random effect approaches are appealing in providing a full probabilistic characterization of the data that can be used for prediction. We propose a new class of spatial logistic regression models that maintain both population-averaged and subject-specific interpretations through a novel class of bridge processes for spatial random effects. These processes are shown to have appealing computational and theoretical properties, including a scale mixture of normal representation. The new methodology is illustrated with simulations and an analysis of childhood malaria prevalence data in Gambia.

PMID:41641506 | DOI:10.1002/sim.70399

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Nevin Manimala Statistics

An Improved Misclassification Simulation Extrapolation (MC-SIMEX) Algorithm

Stat Med. 2026 Feb;45(3-5):e70418. doi: 10.1002/sim.70418.

ABSTRACT

Misclassification Simulation-Extrapolation (MC-SIMEX) is an established method to correct for misclassification in binary covariates in a model. It involves the use of a simulation component which simulates pseudo-datasets with added degree of misclassification in the binary covariate and an extrapolation component which models the covariate’s regression coefficients obtained at each level of misclassification using a quadratic function. This quadratic function is then used to extrapolate the covariate’s regression coefficients to a point of “no error” in the classification of the binary covariate under question. However, extrapolation functions are not usually known accurately beforehand and are therefore only approximated versions. In this article, we propose an innovative method that uses the exact (not approximated) extrapolation function through the use of a derived relationship between the naïve regression coefficient estimates and the true coefficients in generalized linear models. Simulation studies are conducted to study and compare the numerical properties of the resulting estimator to the original MC-SIMEX estimator. Real data analysis using colon cancer data from the MSKCC cancer registry is also provided.

PMID:41641478 | DOI:10.1002/sim.70418

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Nevin Manimala Statistics

Reorganization of the sensorimotor cortex in patients with Ph-negative myeloproliferative neoplasms according to functional MRI

Front Neurosci. 2026 Jan 14;19:1677038. doi: 10.3389/fnins.2025.1677038. eCollection 2025.

ABSTRACT

INTRODUCTION: Myeloproliferative neoplasms (MPN) may contribute to cerebrovascular disease via cellular and endothelial pathology leading to impairment at the neurovascular unit (NVU) level. Studies targeting this patient cohort form a neuroscientific viewpoint are scarce.

OBJECTIVE: We aimed at elucidating possible neuroimaging correlates of NVU alterations in MPNs patients.

MATERIALS AND METHODS: We initially included 187 patients with MPNs in this study, retaining 39 patients as per eligibility criteria (25.6% males, median age – 43 years), who were matched with a control group of 11 healthy subjects (36.4% males, median age – 41 years). Structural and task-based (motor paradigm) functional MRI were performed in both groups, along with the evaluation of baseline blood parameters (hemoglobin, hematocrit and platelet count), comorbidities (arterial hypertension, diabetes mellitus, atherosclerosis) and antiplatelet use: these factors were then used as covariates in statistical analysis.

RESULTS: fMRI data analysis in the group of MPN patients revealed activation in the left primary sensorimotor cortex (pre- and post-central gyri); the right supramarginal gyrus showed significant activation (T = 5.99, pFWEcorr = 0.015) in the MPN group only. Group fMRI data analysis in healthy volunteers showed two main clusters of activation in the left precentral gyrus and right hemisphere of the cerebellum during task execution. Second-level analysis of activation differences between MPN patients and healthy volunteers showed greater activation in the right primary sensorimotor cortex in MPN (Puncorr = 0.014 and <0.001 at cluster and peak level respectively).

CONCLUSION: Additional task-specific cortical activation in MPN patients may be potentially linked to NVU disturbance, even in otherwise unchanged cerebral activation patterns. Our findings also suggest that fMRI data in MPN may be confounded by higher blood cell count that needs to be controlled for in this cohort of patients.

PMID:41641456 | PMC:PMC12864983 | DOI:10.3389/fnins.2025.1677038

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Self-report Assessment of Metacognition Among Schizophrenia Patients: A Systematic Review

Indian J Psychol Med. 2026 Feb 1:02537176261415588. doi: 10.1177/02537176261415588. Online ahead of print.

ABSTRACT

PURPOSE OF THE REVIEW: Metacognition is the ability to reflect on and regulate one’s own cognitive processes. It is increasingly recognized as a critical factor in schizophrenia, influencing insight, treatment adherence, and functional outcomes. Self-report tools are widely used to assess metacognition, but their reliability, validity, and clinical applicability remain debated.

COLLECTION AND ANALYSIS OF DATA: This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with International Prospective Register of Systematic Reviews (PROSPERO). A total of five electronic databases (PubMed, PsycINFO, Embase, Web of Science, and Scopus) were searched for studies published between 2014 and 2024. Eligibility was defined by the Population, Intervention, Comparison, Design (PICO-D) framework, focusing on adults with schizophrenia or schizoaffective disorder assessed with self-report metacognition measures. Study quality was appraised using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. Of 2,437 records screened, 36 studies were included. Data were narratively synthesized, with statistical properties such as internal consistency (Cronbach’s α), test-retest reliability, and factor structures summarized. Most tools, including the Beck Cognitive Insight Scale (BCIS), Metacognition Assessment Scale (MAS), and Metacognitions Questionnaire (MCQ-30), demonstrated high internal consistency (α = 0.70-0.95) and satisfactory construct validity. Findings consistently linked metacognitive deficits to greater symptom severity, poor social functioning, and reduced treatment response, while higher self-reflection and cognitive flexibility predicted improved clinical and vocational outcomes. However, limitations included reliance on self-report accuracy, limited longitudinal validation, and inadequate cross-cultural adaptation.

CONCLUSIONS: Self-report measures of metacognition in schizophrenia exhibit strong psychometric support and clear clinical utility for diagnosis, symptom monitoring, and rehabilitation planning.

PMID:41641442 | PMC:PMC12864021 | DOI:10.1177/02537176261415588

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Patient Preference for Non-operative Treatment Strategy in Locally Advanced Rectal Cancers: A Cross-sectional Survey

Indian J Surg Oncol. 2026 Jan;17(1):72-79. doi: 10.1007/s13193-025-02280-1. Epub 2025 Apr 15.

ABSTRACT

Total neoadjuvant therapy (TNT) involves incorporating systemic chemotherapy in the interval between radiation and TME surgery for locally advanced rectal cancers (LARC). Patients who achieve complete clinical response can be considered for organ preservation by opting for watch and wait strategy. The studies focusing on patient’s preferences for treatment are scarce. This is a cross-sectional study among patients with LARC and addresses their treatment preferences in correlation with psychological parameters. All LARC (mid or lower third) patients planned for multimodality treatment were included in the study. Patients were explained about standard treatment and non-operative management. They were then interviewed with questionnaires for the assessment of their preference. In our study, a total of 60 patients with LARC planned for neoadjuvant chemo radiation were included. Non-operative management (NOM) was preferred by about 35.0% of the subjects. NOM was preferred more by patients ≤ 65 years age group (66.7%), those with less education status (43%) (p = 0.024), and those from rural background (66.7%) (p = 0.011). Psychosocial factors like fear of progression (FOP) had statistically significant association (p = 0.001) with preference for NOM, while other factors like life orientation and locus of control failed to show significant association. Our study underlines the patient preferences and factors affecting the decision making and shows the importance of the concept of “shared decision-making” by discussing the treatment options, and its related side effects and outcomes to choose a treatment strategy.

SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13193-025-02280-1.

PMID:41641431 | PMC:PMC12864614 | DOI:10.1007/s13193-025-02280-1