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Nevin Manimala Statistics

Incidence and two-year neurodevelopmental outcomes of small-for-gestational-age preterm infants: how do they relate to using different neonatal anthropometric charts?

Minerva Pediatr (Torino). 2023 Nov 28. doi: 10.23736/S2724-5276.23.07446-3. Online ahead of print.

ABSTRACT

BACKGROUND: The effect of different neonatal anthropometric charts on the incidence and neurodevelopmental outcomes at two years (Y) corrected age of small-for-gestational-age (SGA) preterm infants has still not been fully explored.

METHODS: All preterm infants with a gestational age (GA) between 24.0 and 31.6 weeks (W), born from Jan-2004 to Dec-2017 in the Marche region (Italy) were studied. Intergrowth-21st, Beeby, Fenton, and Bertino anthropometric charts were used to classify infants with a birth weight less than 10th centile as SGA. Disabilities and neurodevelopmental scores assessed by Bayley-III Test were recorded at the 2Y follow-up visit.

RESULTS: One thousand one hundred forty-seven preterm infants were evaluated. The incidence of SGA was significantly different among the study charts (from 12.9 to 17.5%). Nine hundred and twenty-seven study infants were assessed for neurodevelopmental outcomes at 2Y corrected age. The incidence of SGA with moderate cognitive impairment (COG Score: 70-84) and mild neurodevelopmental disability (NDD) were significantly different between the Intergrowth-21st and Bertino charts (31.7% vs. 19.6%, P=0.042; 30.8 vs. 19.2%, P=0.036; respectively). A statistically significant difference in COG Score was found between SGA preterm infants overlapping in all study charts and those classified as SGA only by the Intergrowth-21st chart (89.1±15.7 vs. 99.2±19.8; P=0.038).

CONCLUSIONS: In a large cohort of preterm infants with a GA between 24.0 and 31.6W, the incidence and neurodevelopmental outcomes at 2Y corrected age of SGAs were significantly different depending on the anthropometric charts. These differences, albeit small, should be considered both in clinical practice and trials on SGA preterm infants.

PMID:38015435 | DOI:10.23736/S2724-5276.23.07446-3

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Nevin Manimala Statistics

Non-cigarette tobacco use and stroke among West Africans: evidence from the SIREN study

Nicotine Tob Res. 2023 Nov 28:ntad239. doi: 10.1093/ntr/ntad239. Online ahead of print.

ABSTRACT

INTRODUCTION: Non-cigarette tobacco (NCT) represents a form of tobacco use with a misperceived significance in chronic disease events. Whether NCT use is sufficient to promote stroke events, especially among Africans, is yet to be understood. This study assessed the relationship between NCT use and stroke among indigenous Africans.

METHODS: A total of 7,617 respondents (NCT users: 41 vs. non-NCT: 7576) from the Stroke Investigation Research and Educational Network study were included in the current analysis. NCT use was defined as self-reported use of smoked (cigars or piper) or smokeless (snuff or chewed) tobacco in the past year preceding stroke events. Stroke was defined based on clinical presentation and confirmed with a cranial CT/MRI. Multivariable-adjusted logistic regression was applied to estimate the odds ratio (OR) and 95% confidence interval (CI) for the relationship between NCT and stroke at p<0.05.

RESULTS: Out of the 41 (0.54%) who reported NCT use, 27 (65.9%) reported using smokeless NCT. NCT users were older than non-smokers (62.8±15.7 vs 57.7±14.8 years). Overall, NCT use was associated with first-ever stroke (OR: 2.08; 95%CI: 1.02, 4.23) in the entire sample. Notably, smokeless NCT use was independently associated with higher odds of stroke (OR: 2.74; 95%CI: 1.15, 6.54), but smoked NCT use (OR: 0.16; 95%CI: 0.02, 1.63) presented a statistically insignificant association after adjusting for hypertension and other covariates.

CONCLUSIONS: NCT use was associated with higher odds of stroke, and public health interventions targeting NCT use might be promising in reducing the burden of stroke among indigenous Africans.

IMPLICATIONS: A detailed understanding of the relationship between NCT use and stroke will likely inform well-articulated policy guidance to promote evidence-based recommendations for public health prevention and management of stroke on the African continent.

PMID:38015428 | DOI:10.1093/ntr/ntad239

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Nevin Manimala Statistics

Evaluation of statistical correction strategies for corneal back surface astigmatism with toric lenses – a vector analysis

J Cataract Refract Surg. 2023 Nov 27. doi: 10.1097/j.jcrs.0000000000001370. Online ahead of print.

ABSTRACT

PURPOSE: To compare actual and formula predicted postoperative refractive astigmatism using measured posterior corneal power measurements and four different empiric posterior corneal astigmatism correction models.

SETTING: Tertiary Care Center.

DESIGN: Single-center retrospective consecutive case series.

METHODS: Using a dataset of 211 eyes before and after tIOL implantation (Hoya Vivinex), IOLMaster (IOLM) or Casia2 (CASIA) keratometric and front / back surface corneal power measurements were converted to power vector components C0 (0/90°) and C45 (45/135°). Differences between postoperative and Castrop formula predicted refraction at the corneal plane using the labelled parameters of the tIOL and the keratometric or front / back surface corneal powers were recorded as the effect of corneal back surface astigmatism (BSA).

RESULTS: Generally, the centroid of the difference shifted towards negative C0 values indicating that BSA adds some against the rule corneal astigmatism (ATR). From IOLM / CASIA keratometry, the average difference in C0 was 0.39 / 0.32 dpt. After correction with the Abulafia-Koch, Goggin, La Hood, and Castrop nomograms it was -0.18 / -0.24 dpt, 0.27 / 0.18 dpt, 0.13 / 0.08 dpt, and 0.17 / 0.10 dpt. Using corneal front / back surface data from IOLM / CASIA, the difference was 0.18 / 0.12 dpt.

CONCLUSIONS: The Abulafia-Koch method over-corrected the ATR, while the Goggin, La Hood, and Castrop models slightly under-corrected ATR, and using measurements from the Casia2 tomographer seemed to produce slightly less prediction error than IOLMaster 700.

PMID:38015426 | DOI:10.1097/j.jcrs.0000000000001370

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Nevin Manimala Statistics

Proteomic Analysis Reveals Potential Exosomal Biomarkers in Patients With Sporadic Alzheimer Disease

Alzheimer Dis Assoc Disord. 2023 Oct-Dec 01;37(4):315-321. doi: 10.1097/WAD.0000000000000589. Epub 2023 Nov 28.

ABSTRACT

BACKGROUND: Despite substantial progress made in the past decades, the pathogenesis of sporadic Alzheimer disease (sAD) and related biological markers of the disease are still controversially discussed. Cerebrospinal fluid and functional brain imaging markers have been established to support the clinical diagnosis of sAD. Yet, due to the invasiveness of such diagnostics, less burdensome markers have been increasingly investigated in the past years. Among such markers, extracellular vesicles may yield promise in (early) diagnostics and treatment monitoring in sAD.

MATERIALS AND METHODS: In this pilot study, we collected the blood plasma of 18 patients with sAD and compared the proteome of extracted extracellular vesicles with the proteome of 11 age-matched healthy controls. The resulting proteomes were characterized by Gene Ontology terms and between-group statistics.

RESULTS: Ten distinct proteins were found to significantly differ between sAD patients and controls (P<0.05, False Discovery Rate, corrected). These proteins included distinct immunoglobulins, fibronectin, and apolipoproteins.

CONCLUSIONS: These findings lend further support for exosomal changes in neurodegenerative disorders, and particularly in sAD. Further proteomic research could decisively advance our knowledge of sAD pathophysiology as much as it could foster the development of clinically meaningful biomarkers.

PMID:38015424 | DOI:10.1097/WAD.0000000000000589

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Nevin Manimala Statistics

Assessing survival post-kidney transplantation in Australia: A multivariable prediction model

Nephrology (Carlton). 2023 Nov 28. doi: 10.1111/nep.14257. Online ahead of print.

ABSTRACT

AIM: Kidney transplantation remains the preferred standard of care for patients with kidney failure. Most patients do not access this treatment and wide variations exist in which patients access transplantation. We sought to develop a model to estimate post-kidney transplant survival to inform more accurate comparisons of access to kidney transplantation.

METHODS: Development and validation of prediction models using demographic and clinical data from the Australia and New Zealand Dialysis and Transplant Registry. Adult deceased donor kidney only transplant recipients between 2000 and 2020 were included. Cox proportional hazards regression methods were used with a primary outcome of patient survival. Models were evaluated using Harrell’s C-statistic for discrimination, and calibration plots, predicted survival probabilities and Akaike Information Criterion for goodness-of-fit.

RESULTS: The model development and validation cohorts included 11 302 participants. Most participants were male (62.8%) and Caucasian (79.2%). Glomerulonephritis was the most common cause of kidney disease (45.6%). The final model included recipient, donor, and transplant related variables. The model had good discrimination (C-statistic, 0.72; 95% confidence interval (CI) 0.70-0.74 in the development cohort, 0.70; 95% CI 0.67-0.73 in the validation cohort and 0.72; 95% CI 0.69-0.75 in the temporal cohort) and was well calibrated.

CONCLUSION: We developed a statistical model that predicts post-kidney transplant survival in Australian kidney failure patients. This model will aid in assessing the suitability of kidney transplantation for patients with kidney failure. Survival estimates can be used to make more informed comparisons of access to transplantation between units to better measure equity of access to organ transplantation.

PMID:38014653 | DOI:10.1111/nep.14257

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Is platelet to lymphocyte ratio predictive of preeclampsia? A systematic review and meta-analysis

J Obstet Gynaecol. 2023 Dec;43(2):2286319. doi: 10.1080/01443615.2023.2286319. Epub 2023 Nov 28.

ABSTRACT

BACKGROUND: To evaluate the value of the platelet-to-lymphocyte ratio (PLR) in predicting preeclampsia (PE) in pregnant women.

METHODS: PubMed, EMBASE and Web of Science databases were searched for observational studies (cohort, case-control or cross-sectional) that reported pre-treatment maternal PLR values in women with and without PE. The analysis was done using a random effects model. Pooled effect sizes were reported as weighted mean difference (WMD) with 95% confidence intervals (CIs). Newcastle-Ottawa Scale (NOS) was used to evaluate the risk of bias.

RESULTS: Twenty-five studies with 7755 patients were included in this meta-analysis. PLR was comparable in patients with PE and healthy pregnant women (WMD -2.97; 95% CI: -11.95 to 6.02; N = 16). Patients with mild (WMD -3.00; 95% CI: -17.40 to 11.41; N = 12) and severe PE (WMD -5.77; 95% CI: -25.48 to 13.94; N = 14) had statistically similar PLR, compared to healthy controls.

CONCLUSIONS: Our findings show similar PLR in PE and healthy pregnancies. PLR, therefore, may not be used to differentiate between PE and normal pregnancy or for assessing the severity of PE. The majority of included studies were case-control, potentially introducing bias, and we identified evidence of publication bias as well.

PMID:38014649 | DOI:10.1080/01443615.2023.2286319

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Effects of Mobile Stroke Unit dispatch on blood pressure management and outcomes in patients with intracerebral haematoma: Results from the Berlin_Prehospital Or Usual Care Delivery in acute Stroke (B_PROUD) controlled intervention study

Eur Stroke J. 2023 Nov 28:23969873231213156. doi: 10.1177/23969873231213156. Online ahead of print.

ABSTRACT

INTRODUCTION: In patients with acute intracerebral haemorrhage (ICH) and elevated systolic blood pressure (BP), guidelines suggest that systolic BP reduction to <140 mmHg should be rapidly initiated. Compared with conventional care, Mobile Stroke Units (MSUs) allow for earlier ICH diagnosis through prehospital imaging and earlier BP lowering.

PATIENTS AND METHODS: ICH patients were prospectively evaluated as a cohort of the controlled B_PROUD-study in which MSU availability alone determined MSU dispatch in addition to conventional ambulance. We used inverse probability of treatment weighting to adjust for confounding to estimate the effect of additional MSU dispatch in ICH patients. Outcomes of interest were 7-day mortality (primary), systolic BP (sBP) at hospital arrival, dispatch-to-imaging time, largest haematoma volume, anticoagulation reversal, length of in-hospital stay, 3-month functional outcome.

RESULTS: Between February 2017 and May 2019, MSUs were dispatched to 95 (mean age: 72 ± 13 years, 45% female) and only conventional ambulances to 78 ICH patients (mean age: 71 ± 12 years, 44% female). After adjusting for confounding, we found shorter dispatch-to-imaging time (mean difference: -17.75 min, 95% CI: -27.16 to -8.21 min) and lower sBP at hospital arrival (mean difference = -16.31 mmHg, 95% CI: -30.64 to -6.19 mmHg) in the MSU group. We found no statistically significant difference for the other outcomes, including 7-day mortality (adjusted odds ratio: 1.43, 95% CI: 0.68 to 3.31) or favourable outcome (adjusted odds ratio = 0.67, 95% CI: 0.27 to 1.67).

CONCLUSIONS: Although MSU dispatch led to sBP reduction and lower dispatch-to-imaging time compared to conventional ambulance care, we found no evidence of better outcomes in the MSU dispatch group.

PMID:38014623 | DOI:10.1177/23969873231213156

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Safety and Clinical Effects of a Muse Cell-Based Product in Patients With Amyotrophic Lateral Sclerosis: Results of a Phase 2 Clinical Trial

Cell Transplant. 2023 Jan-Dec;32:9636897231214370. doi: 10.1177/09636897231214370.

ABSTRACT

Amyotrophic lateral sclerosis (ALS) is characterized by progressive loss of motor neurons. Multilineage-differentiating stress-enduring (Muse) cells are unique endogenous stem cells that show therapeutic effects on motor function in ALS mouse models. We conducted a single-center open phase II clinical trial to evaluate the safety and clinical effects of repeated intravenous injections of an allogenic Muse cell-based product, CL2020, in patients with ALS. Five patients with ALS received CL2020 intravenously once a month for a total of six doses. The primary endpoints were safety and tolerability, and the secondary endpoint was the rate of change in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score. In addition, serum tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), sphingosine-1-phosphate (S1P), cerebrospinal fluid chitotriosidase-1 (CHIT-1), and neurofilament light chain (NfL) levels were evaluated. The CL2020 treatment was highly tolerated without serious side effects. The ALSFRS-R score change trended upward at 12 months post-CL2020 treatment compared with that at 3 months pre-administration, but the difference was not statistically significant. Among five patients diagnosed with ALS, three exhibited a decrease in the rate of ALSFRS-R score change, one demonstrated an increase, and another showed no change. In addition, the patients’ serum IL-6 and TNF-α levels and cerebrospinal fluid CHIT-1 and NfL levels increased for up to 6 months post-treatment; however, their serum S1P levels continuously decreased over 12 months. These findings indicate a favorable safety profile of CL2020 therapy. In the near future, a double-blind study of a larger number of ALS patients should be conducted to confirm the efficacy of ALS treatment with CL2020.

PMID:38014622 | DOI:10.1177/09636897231214370

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Prevalence of congenital anomalies according to maternal race and ethnicity, Texas, 1999-2018

Birth Defects Res. 2023 Nov 28. doi: 10.1002/bdr2.2274. Online ahead of print.

ABSTRACT

BACKGROUND: Few studies of congenital anomalies provide prevalence estimates stratified by maternal race/ethnicity. We sought to determine whether the prevalence of a broad spectrum of anomalies varies among offspring of women from different race/ethnic groups.

METHODS: We obtained information on cases with anomalies from the population-based Texas Birth Defects Registry, and denominator data on livebirths among Texas residents during 1999-2018 from the Texas Center for Health Statistics. We estimated the prevalence ratio (PR) and 95% confidence interval (CI) of N = 145 anomalies among offspring of Hispanic and non-Hispanic Black relative to non-Hispanic White women using Poisson regression, adjusting for maternal age, education, body mass index, and previous livebirths. We performed a two-stage analysis with a Bonferroni-adjusted p < 1.7 × 10-4 in the initial screening phase to identify anomalies with statistically significant variation.

RESULTS: There were 7,698,768 livebirths and 1,187,385 anomalies diagnosed in 368,393 cases. The prevalence of any monitored congenital anomaly was similar among offspring of non-Hispanic White (referent), non-Hispanic Black (PR 0.98, CI 0.96-1.00), and Hispanic (PR 0.95, CI 0.93-0.96) women. We observed statistically significant racial/ethnic variation for 42 anomalies. Marked differences were observed when comparing offspring of non-Hispanic Black to non-Hispanic White women with respect to polydactyly (PR 4.38, CI 4.07-4.72), pyloric stenosis (PR 0.34, CI 0.29-0.40), and aortic valve atresia/stenosis (PR 0.51, CI 0.36-0.72).

CONCLUSIONS: Birth prevalence of many major congenital anomalies varies by maternal race and ethnicity. While the reasons for these differences are likely multifactorial, a thorough understanding of racial and ethnic disparities is useful to stimulate etiologic research.

PMID:38014617 | DOI:10.1002/bdr2.2274

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Identification of depression and anxiety during pregnancy: A systematic review and meta-analysis of test accuracy

Acta Obstet Gynecol Scand. 2023 Nov 28. doi: 10.1111/aogs.14734. Online ahead of print.

ABSTRACT

INTRODUCTION: Depression and anxiety are significant contributors to maternal perinatal morbidity and a range of negative child outcomes. This systematic review and meta-analysis aimed to review and assess the diagnostic test accuracy of selected screening tools (Edinburgh Postnatal Depression Scale [EPDS], EPDS-3A, Patient Health Questionnaire [PHQ-9]-, PHQ-2, Matthey Generic Mood Question [MGMQ], Generalized Anxiety Disorder scale [GAD-7], GAD-2, and the Whooley questions) used to identify women with antenatal depression or anxiety in Western countries.

MATERIAL AND METHODS: On January 16, 2023, we searched 10 databases (CINAHL, Cochrane Library, CRD Database, Embase, Epistemonikos, International HTA Database, KSR Evidence, Ovid MEDLINE, PROSPERO and PsycINFO); the references of included studies were also screened. We included studies of any design that compared case-identification with a relevant screening tool to the outcome of a diagnostic interview based on the Diagnostic and Statistical Manual of Mental Disorders, fourth or fifth edition (DSM-IV or DSM-5), or the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10). Diagnoses of interest were major depressive disorder and anxiety disorders. Two authors independently screened abstracts and full-texts for relevance and evaluated the risk of bias using QUADAS-2. Data extraction was performed by one person and checked by another team member for accuracy. For synthesis, a bivariate model was used. The certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

REGISTRATION: PROSPERO CRD42021236333.

RESULTS: We screened 8276 records for eligibility and included 16 original articles reporting on diagnostic test accuracy: 12 for the EPDS, one article each for the GAD-2, MGMQ, PHQ-9, PHQ-2, and Whooley questions, and no articles for the EPDS-3A or GAD-7. Most of the studies had moderate to high risk of bias. Ten of the EPDS articles provided data for synthesis at cutoffs ≥10 to ≥14 for diagnosing major depressive disorder. Cutoff ≥10 gave the optimal combined sensitivity (0.84, 95% confidence interval [CI]: 0.75-0.90) and specificity (0.87, 95% CI: 0.79-0.92).

CONCLUSIONS: Findings from the meta-analysis suggest that the EPDS alone is not perfectly suitable for detection of major depressive disorder during pregnancy. Few studies have evaluated the other instruments, therefore, their usefulness for identification of women with depression and anxiety during pregnancy remains very uncertain. At present, case-identification with any tool may best serve as a complement to a broader dialogue between healthcare professionals and their patients.

PMID:38014572 | DOI:10.1111/aogs.14734