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Nevin Manimala Statistics

Evaluation of retinal vascularization in retinopathy of prematurity regressed after intravitreal ranibizumab monotherapy or without treatment based on fluorescein angiography

Sci Rep. 2023 Nov 15;13(1):19946. doi: 10.1038/s41598-023-47212-7.

ABSTRACT

To investigate the fluorescein angiography (FA) findings and compare the extent of retinal vascularization in retinopathy of prematurity (ROP), recovered after intravitreal ranibizumab (IVR) monotherapy and those regressed spontaneously. Infants with a history of ROP who underwent FA between April 2018 and November 2021 were retrospectively included. The patients were divided into two groups based on whether they had received IVR (IVR group) or had ROP that regressed spontaneously without treatment (untreated group). The differences between the two groups in zone II ROP were also compared, to equalize the subgroups as much as possible in terms of disease severity. FA findings were recorded. The extent of vascularization was measured by the ratio of the distance from the center of the disk to the border of the vascularized zone (DB) and the distance from the center of the disk to the center of the fovea (DF). The width of the persistent avascular retina (PAR) was counted by disc diameters (DD). One hundred and ten eyes of 55 infants were included in the IVR group and 76 eyes of 38 babies in the untreated group. The ratio of abnormal shape of vessels was significantly higher in the IVR group than in the untreated group (50.9% vs. 35.5%; P = 0.038), while the linear choroidal filling pattern, tortuosity of vessels over the posterior pole, dye leakage, anomalous branching of vessels, circumferential vessels, arteriovenous shunt, abnormal capillary bed, and macular abnormalities were similarly. There was a smaller temporal DB/DF ratio (4.48 vs. 4.63; P = 0.003) and greater PAR (2.63 vs. 1.76; P < 0.001) in the IVR group compared to the untreated group. In zone II ROP, the progression of retinal vascularization was significantly larger in the IVR group than that in the untreated group (P = 0.003), while no statistical differences were observed in FA features, the DB/DF ratio, and PAR between the two subgroups. The residual vascular abnormalities and PAR may be common results of ROP regression. The DB/DF ratio of 4.0 temporally and 3.3 nasally could be used as the preliminary indicators for safe retinal vascularization in the completion of ROP regression.

PMID:37968276 | DOI:10.1038/s41598-023-47212-7

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Evaluation of pragmatic oxygenation measurement as a proxy for Covid-19 severity

Nat Commun. 2023 Nov 15;14(1):7374. doi: 10.1038/s41467-023-42205-6.

ABSTRACT

Choosing optimal outcome measures maximizes statistical power, accelerates discovery and improves reliability in early-phase trials. We devised and evaluated a modification to a pragmatic measure of oxygenation function, the [Formula: see text] ratio. Because of the ceiling effect in oxyhaemoglobin saturation, [Formula: see text] ratio ceases to reflect pulmonary oxygenation function at high [Formula: see text] values. We found that the correlation of [Formula: see text] with the reference standard ([Formula: see text]/[Formula: see text] ratio) improves substantially when excluding [Formula: see text] and refer to this measure as [Formula: see text]. Using observational data from 39,765 hospitalised COVID-19 patients, we demonstrate that [Formula: see text] is predictive of mortality, and compare the sample sizes required for trials using four different outcome measures. We show that a significant difference in outcome could be detected with the smallest sample size using [Formula: see text]. We demonstrate that [Formula: see text] is an effective intermediate outcome measure in COVID-19. It is a non-invasive measurement, representative of disease severity and provides greater statistical power.

PMID:37968269 | DOI:10.1038/s41467-023-42205-6

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Left ventricle hypertrophy and re-modeling in children with essential hypertension: does the race matter?

Cardiol Young. 2023 Nov 16:1-8. doi: 10.1017/S1047951123003840. Online ahead of print.

ABSTRACT

BACKGROUND: This is the first study to report on the impact of race on differences in the prevalence of echocardiographic left ventricular hypertrophy and left ventricular adaptation at the time of diagnosis of essential hypertension in children.

METHODS: This cross-sectional, single-centre study included patients aged 3-18 years who had newly diagnosed essential hypertension. Echocardiography was used to assess left ventricular mass index and left ventricular relative wall thickness. An left ventricular mass index > the 95th percentile for age and gender, and an left ventricular relative wall thickness > 0.42, were used to diagnose left ventricular hypertrophy and concentric adaptation. Various echocardiographic parameters were compared between African Americans and Caucasians.

RESULTS: The study included 422 patients (289 African Americans and 133 Caucasians) diagnosed with essential hypertension at a median age of 14.6 (interquartile range; 12.1-16.3) years. Eighty-eight patients (20.9%) had left ventricular hypertrophy. There was no statistically significant difference in the prevalence of left ventricular hypertrophy between African Americans and Caucasians (22.5% versus 17.3%, p=0.22). The median left ventricular relative wall thickness was 0.35 (0.29-0.43), and 114 patients (27.0%) had an left ventricular relative wall thickness > 0.42. The presence of an left ventricular relative wall thickness > 0.42 was significantly higher among African Americans compared to Caucasians (30.1% versus 20.3%, p = 0.04). The African American race was a strong predictor for an left ventricular relative wall thickness > 0.42 (odds ratio 1.7, p = 0.04), but not for left ventricular mass index > the 95th percentile (p = 0.22). Overweight/obesity was a strong predictor for an left ventricular mass index > the 95th percentile.

CONCLUSIONS: There was no difference in the prevalence of left ventricular hypertrophy in children with essential hypertension of different races. Obesity, rather than being African American, is associated with left ventricular hypertrophy.

PMID:37968238 | DOI:10.1017/S1047951123003840

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Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants

Hum Vaccin Immunother. 2023 Dec 15;19(3):2278346. doi: 10.1080/21645515.2023.2278346. Epub 2023 Nov 15.

ABSTRACT

The WHO pre-qualified rotavirus vaccine, ROTAVAC®, is derived naturally from the neonatal 116E rotavirus strain, and stored at -20°C. As refrigerator storage is preferable, immunogenicity and safety of liquid formulations kept at 2-8°C, having excipients to stabilize the rotavirus, with or without buffers, were compared with ROTAVAC® in different clinical studies. Study-1, the pivotal trial for this entire product development work, was a randomized, single-blind trial with two operationally seamless phases: (i) an exploratory phase involving 675 infants in which two formulations, ROTAVAC 5C (LnHRV-1.5 mL and LnHRV-2.0 mL) containing buffer and excipients to stabilize the virus against gastric acidity and temperature, were compared with ROTAVAC®. As the immune response of ROTAVAC 5C (LnHRV-2.0 mL) was non-inferior to ROTAVAC®, it was selected for (ii) confirmatory phase, involving 1,302 infants randomized 1:1:1:1 to receive three lots of LnHRV-2.0 mL, or ROTAVAC®. Primary objectives were the evaluation of non-inferiority and lot-to-lot consistency. The secondary objectives were to assess the safety and interference with the concomitant pentavalent vaccine. As it was separately established that buffers are not required for ROTAVAC®, in Study-2, the safety and immunogenicity of ROTAVAC 5D® (with excipients) were compared with ROTAVAC® and lot-to-lot consistency was assessed in another study. All lots elicited consistent immune responses, did not interfere with UIP vaccines, and had reactogenicity similar to ROTAVAC®. ROTAVAC 5C and ROTAVAC 5D® were immunogenic and well tolerated as ROTAVAC®. ROTAVAC 5D® had comparable immunogenicity and safety profiles with ROTAVAC® and can be stored at 2-8°C, leading to WHO pre-qualification.Clinical Trials Registration: Clinical Trials Registry of India (CTRI): CTRI/2015/02/005577CTRI/2016/11/007481 and CTRI/2019/03/017934.

PMID:37968237 | DOI:10.1080/21645515.2023.2278346

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The association between parental age differences and perinatal outcomes

Hum Reprod. 2023 Nov 15:dead236. doi: 10.1093/humrep/dead236. Online ahead of print.

ABSTRACT

STUDY QUESTION: Are there significant associations existing between parental age differences and adverse perinatal outcomes?

SUMMARY ANSWER: Large differences in parental age are associated with adverse perinatal outcomes, particularly with older mothers paired with younger fathers.

WHAT IS KNOWN ALREADY: The association between advanced maternal age and perinatal outcomes is well-documented with women over 35 years showing an increased risk of several adverse outcomes. Other studies have identified potential associations between advanced paternal age and adverse perinatal outcomes.

STUDY DESIGN, SIZE, DURATION: A historical (retrospective) cohort analysis was performed utilizing a multivariable logistic regression model to evaluate the association between varying differences in parental age and adverse perinatal outcomes while controlling for demographic and health-related covariates. Data were compiled from the National Vital Statistics System for 20 613 704 births between 2012 and 2018.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Parental age differences, categorized into eleven 4-year intervals, were stratified by seven maternal age categories and evaluated for their associations with adverse perinatal outcomes. Main outcome measures included low birth weight, very low birth weight, preterm birth, very preterm birth, small size for gestational age, low 5-min appearance, pulse, grimace, activity, and respiration score, congenital defects, and chromosomal anomalies.

MAIN RESULTS AND THE ROLE OF CHANCE: Increased parental age differences, in either direction, were associated with significant risks for all adverse outcomes, aside from congenital defects, even when controlling for maternal age. Restricting maternal age to the reference range of 25-29 years, infants born to fathers aged 9-12 years younger (n = 3773) had 27% (odds ratio (OR) 1.27, 95% CI, 1.17-1.37) higher odds of having any adverse perinatal outcome. Infants born to fathers aged >16 years older (n = 98 555) had 14% (OR 1.14, 95% CI, 1.12-1.16) higher odds of having any adverse perinatal outcome.

LIMITATIONS, REASONS FOR CAUTION: Data extracted from US birth certificates may be compromised by errors in reporting or documentation. Information regarding the mother’s socioeconomic status was estimated using proxy variables and may be susceptible to uncontrolled factors. Use of a pre-compiled dataset may potentially exclude additional maternal comorbidities that could impact perinatal outcomes.

WIDER IMPLICATIONS OF FINDINGS: Older mothers paired with younger fathers demonstrated the highest risk, even when maternal age was below the threshold of 35 years. For the clinical setting, parental age differences should be considered alongside maternal and paternal age when assessing risks of adverse perinatal outcomes for potential parents. This is particularly relevant for older women with younger male partners as this may exacerbate the impact of advanced maternal age.

STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the NIH Research Fellowship T35 Training Grant. There are no competing interests.

TRIAL REGISTRATION NUMBER: N/A.

PMID:37968231 | DOI:10.1093/humrep/dead236

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Deep Parasternal Intercostal Plane Block for Postoperative Analgesia After Sternotomy for Cardiac Surgery-A Retrospective Cohort Study

J Cardiothorac Vasc Anesth. 2023 Oct 4:S1053-0770(23)00829-7. doi: 10.1053/j.jvca.2023.09.044. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the analgesic efficacy of postoperative deep parasternal intercostal plane (DPIP) blocks for patients having cardiac surgery via median sternotomy.

DESIGN: This single-center retrospective study compared patients receiving bilateral DPIP blocks with a matched cohort of patients not receiving DPIP blocks.

SETTING: Large quaternary referral center.

PARTICIPANTS: Adult patients admitted to the authors’ institution from January 1, 2016, to August 14, 2020, for elective cardiac surgery via median sternotomy.

INTERVENTIONS: Patients received ultrasound-guided bilateral DPIP blocks.

MEASUREMENTS AND MAIN RESULTS: A total of 113 patients received a DPIP block; 3,461 patients did not. The estimated multiplicative change in cumulative opioid consumption through 24 hours was 0.42 (95% CI 0.32-0.56; p < 0.001), indicating that patients receiving DPIP blocks required 60% fewer opioids than patients who did not. Proportional odds ratios for the average pain score on postoperative day (POD) 0 was 0.46 (95% CI 0.32-0.65; p < 0.001), and POD 1 was 0.67 (95% CI 0.47-0.94; p = 0.021), indicating lower pain scores for patients receiving blocks. The exploratory analysis identified an inverse correlation between DPIP blocks and atrial fibrillation incidence (2% v 15%; inverse probability of treatment weighting odds ratio 0.088, 95% CI 0.02-0.41; p = 0.002).

CONCLUSIONS: The use of DPIP blocks in patients undergoing cardiac surgery via median sternotomy was associated with less opioid use and improved pain scores in the early postoperative period compared with patients not receiving blocks. Prospective randomized controlled studies should further elucidate the efficacy and risks of DPIP blocks in cardiac surgery.

PMID:37968198 | DOI:10.1053/j.jvca.2023.09.044

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Prognosis of acute heart failure in patients followed up in nursing homes in Spain: Results from the RICA registry

Med Clin (Barc). 2023 Nov 13:S0025-7753(23)00604-8. doi: 10.1016/j.medcli.2023.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with chronic diseases such as heart failure (HF) are at risk of hospital admission. We evaluated the impact of living in nursing homes (NH) on readmissions and all-cause mortality of HF patients during a one-year follow up.

METHODS: An observational and multicenter study from the Spanish National Registry of Heart Failure (RICA) was performed. We compared clinical and prognostic characteristics between both groups. Bivariate analyses were performed using Student’s t-test and Tukey’s method and a Kaplan-Meier survival at one-year follow up. A multivariate proportional hazards analysis of [Cox] regression by the conditional backward method was conducted for the variables being statistically significant related to the probability of death in the univariate.

RESULTS: There were 5644 patients included, 462 (8.2%) of whom were nursing home residents. There were 52.7% women and mean age was 79.7±8.8 years. NH residents had lower Barthel (74.07), Charlson (3.27), and Pfeiffer index (2.2), p<0.001). Mean pro-BNP was 6686pg/ml without statistical significance differences between groups. After 1-year follow-up, crude analysis showed no differences in readmissions 74.7% vs. 72.3%, p=0.292, or mortality 63.9% vs. 61.1%, p=0.239 between groups. However, after controlling for confounding variables, NH residents had a higher 1-year all-cause mortality (HR 1.153; 95% CI 1.011-1.317; p=0.034). Kaplan-Meier analysis showed worse survival in nursing home residents (log-rank of 7.12, p=0.008).

CONCLUSIONS: Nursing home residents with heart failure showed higher one-year mortality which could be due to worse functional status, higher comorbidity, and cognitive deterioration.

PMID:37968173 | DOI:10.1016/j.medcli.2023.10.003

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Executive functions and daily functioning in myotonic dystrophy type 1 ecological assessment with virtual reality

Neuromuscul Disord. 2023 Oct 18:S0960-8966(23)00751-4. doi: 10.1016/j.nmd.2023.10.006. Online ahead of print.

ABSTRACT

Central nervous system dysfunction is characteristic of patients with myotonic dystrophy type 1 (DM1). Although no consensus exists regarding the exact cognitive profile of these patients, executive dysfunction has been suggested to play a role. Due to the impact of executive functions on daily performance, this study aimed to describe executive functioning in an ecological manner and to analyze its impact – and that of other clinical variables – on the functional performance of DM1 patients. A Virtual Reality executive functioning test (Nesplora Ice Cream), the Wechsler Adult Intelligence Scale-Fourth Edition, and self-report questionnaires (AES, FSS, ESS and LIFE-H) were administered to 20 patients. Statistical analyses included correlation and multiple regression analyses to analyze the best predictors of daily performance. DM1 patients did not show major difficulties in the executive functioning tasks or in their overall performance on daily habits. However, both cold and hot executive functions still seem necessary for the correct accomplishment of life habits, since planning and level of apathy explained 47.6% of the total variance of daily functioning. This was the first study to assess executive functions in DM1 using Virtual Reality, and our findings open a debate about their actual impairment in this population.

PMID:37968165 | DOI:10.1016/j.nmd.2023.10.006

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Inguinal Hernia in Premature Infants: To Operate Before or After Discharge from Hospital?

J Pediatr Surg. 2023 Oct 20:S0022-3468(23)00637-1. doi: 10.1016/j.jpedsurg.2023.10.027. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aims to find out the optimal timing for herniotomy for premature infants with inguinal hernia (IH): early during hospitalisation or delayed after hospital discharge.

METHOD: A retrospective cohort study was conducted on premature infants diagnosed with IH during their initial hospitalization between 2015 and 2020. Demographic data and clinical outcomes were compared between infants undergoing herniotomy before discharge (“early”) and those who were discharged without herniotomy (“delayed”). Student’s t-test or Mann-Whitney U test and Fisher’s exact test were used for statistical analysis.

RESULTS: Of 219 premature infants, 189 (86.3%) underwent early herniotomy, while 30 were discharged with unoperated IH. In the delayed group, 15 (50%) underwent planned delayed herniotomy, and the remaining 15 experienced spontaneous resolution (absence of inguinal bulge over at least 1-year follow-up). The gestational age and birth weight of both groups were similar. At surgery, the delayed group median (interquartile range) was significantly older (42.1[38-49] vs 37.7 [36-40] weeks, p < 0.001) and heavier (3.27 [2.21-4.60] vs 2.22 [2.00-2.70] kg, p < 0.001). Two infants (1%) in the early group presented with incarcerated IH requiring urgent operation. In the delayed group, no infant developed incarcerated IH while awaiting elective operation (time from diagnosis to operation 44 [21-85] days). There was no statistically significant difference in respiratory and surgical complications between the two groups, although the delayed group had lesser surgical complications (0% vs 9.5%).

CONCLUSION: Deferring herniotomy after discharge for premature infants is safe with close monitoring and associated with a chance of spontaneous resolution.

LEVEL OF EVIDENCE: Level III, treatment study.

PMID:37968149 | DOI:10.1016/j.jpedsurg.2023.10.027

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Performance of Google bard and ChatGPT in mass casualty incidents triage

Am J Emerg Med. 2023 Oct 29;75:72-78. doi: 10.1016/j.ajem.2023.10.034. Online ahead of print.

ABSTRACT

AIM: The objective of our research is to evaluate and compare the performance of ChatGPT, Google Bard, and medical students in performing START triage during mass casualty situations.

METHOD: We conducted a cross-sectional analysis to compare ChatGPT, Google Bard, and medical students in mass casualty incident (MCI) triage using the Simple Triage And Rapid Treatment (START) method. A validated questionnaire with 15 diverse MCI scenarios was used to assess triage accuracy and content analysis in four categories: “Walking wounded,” “Respiration,” “Perfusion,” and “Mental Status.” Statistical analysis compared the results.

RESULT: Google Bard demonstrated a notably higher accuracy of 60%, while ChatGPT achieved an accuracy of 26.67% (p = 0.002). Comparatively, medical students performed at an accuracy rate of 64.3% in a previous study. However, there was no significant difference observed between Google Bard and medical students (p = 0.211). Qualitative content analysis of ‘walking-wounded’, ‘respiration’, ‘perfusion’, and ‘mental status’ indicated that Google Bard outperformed ChatGPT.

CONCLUSION: Google Bard was found to be superior to ChatGPT in correctly performing mass casualty incident triage. Google Bard achieved an accuracy of 60%, while chatGPT only achieved an accuracy of 26.67%. This difference was statistically significant (p = 0.002).

PMID:37967485 | DOI:10.1016/j.ajem.2023.10.034