Prospective Observational Comparative Study Research Articles

Comparative Study of Effectiveness of Haloperidol Versus Olanzapine among Patients with Schizophrenia

Aim: To compare the efficacy of oral Typical Antipsychotic drug [Haloperidol] Group A versus oral Atypical Antipsychotic drug [Olanzapine] Group B in patients who met the criteria for schizophrenia. This study includes observe and compare the positive symptoms and negative symptoms in Group A and Group B by using PSYRATS scale and negative symptom assessment tool. Study Design: Prospective comparative observational study. Place and Duration of Study: The study was carried from April 2023 – September 2023 at Psychiatric Outpatient Department in the Government Medical College and Hospital, Nagapattinam. Methodology: The study sample comprised 60 patients [N=60], The 30 subjects were in Group A and 30 subjects were in Group B who met the SCID – DSM V criteria and also include criteria 1. Age between 22 – 65 years. 2. Subject should have Minimum mental state examination [MMSE] score between 25 – 30. Paired and Unpaired t test was performed to observe statistical significance. Results: Out of 60 patients Olanzapine was associated with a mean baseline to endpoint improvement of ( -22.77) versus a Mean change of ( -14.39) in Haloperidol. Olanzapine [Group B] had higher mean difference than Haloperidol [Group A]. Conclusion: By using PSYRATS scale and Negative symptom assessment tool, Olanzapine treated group were numerically better than the Haloperidol treated group in both Negative and Positive Symptoms.

The Macular Pigment Optical Density (MPOD) Decrease in Chinese Primary Angle Closure Glaucoma Using the One-Wavelength Reflectometry Method

Purpose The objective of this study was to observe the macular pigment optical density (MPOD) and the relationship between MPOD and retinal thickness in Chinese primary angle-closure glaucoma (PACG) patients by the one-wavelength reflectometry method. Methods This study was a prospective comparative observational study, including 39 eyes from 39 PACG patients (15 men and 24 women, mean age 61.89 ± 12.30) and 41 eyes from 41 controls (20 men and 21 women, mean age 63.24 ± 14.02). We measured the MPOD 7-degree area by the one-wavelength reflectometry method and analyzed both the max and mean optical density (OD). The central retinal thickness (CRT) and the total thickness of the macular ganglion cell layer (GCL), and inner plexiform layer (IPL)were measured by spectral-domain-optical coherence tomography (SD-OCT). Statistical methods such as Shapiro–Wilk test, Fisher’s exact test, chi-square test, two independent samples test and Spearman’s correlation coefficient were used to observe the differences in the MPOD between normal subjects and PACG patients and the correlation between the MPOD and retinal thickness. Results The max optical density (Max OD) (PACG group: 0.302 ± 0.067d.u, control group: 0.372 ± 0.059d.u., p < .001) and mean optical density (Mean OD) (PACG group: 0.124 ± 0.035d.u., control group: 0.141 ± 0.028d.u., p < 0.05) were significantly reduced in PACG patients compared with control subjects. Significant decreases in GCL + IPL thickness (PACG group: 74.71 ± 39.56 μm, control group:113.61 ± 8.14 μm, p < 0.001) and CRT (PACG group: 254.49 ± 41.47 μm, control group:329.10 ± 18.57 μm, p < 0.001) were also observed in PACG eyes. There was no statistically significant correlation between the MPOD and GCL + IPL thickness (p = .639, p = .828). Conclusions MPOD was significantly lower in Chinese PACG patients than in the control group, potentially due to thinning of the GCL + IPL thickness. This study provides insights for the pathophysiology, assessment of PACG and potential guidance for lifestyle modifications.

MRI and Clinical Variables for Prediction of Outcomes After Pediatric Severe Traumatic Brain Injury

Traumatic brain injury (TBI) is a leading cause of death and disability in children, and predicting functional outcome after TBI is challenging. Magnetic resonance imaging (MRI) is frequently conducted after severe TBI; however, the predictive value of MRI remains uncertain. To identify early MRI measures that predict long-term outcome after severe TBI in children and to assess the added predictive value of MRI measures over well-validated clinical predictors. This preplanned prognostic study used data from the Approaches and Decisions in Acute Pediatric TBI (ADAPT) prospective observational comparative effectiveness study. The ADAPT study enrolled 1000 consecutive children (aged <18 years) with severe TBI between February 1, 2014, and September 30, 2017. Participants had a Glasgow Coma Scale (GCS) score of 8 or less and received intracranial pressure monitoring. Magnetic resonance imaging scans performed as part of standard clinical care within 30 days of injury were collected at 24 participating sites in the US, UK, and Australia. Summary imaging measures were correlated with the Glasgow Outcome Scale-Extended for Pediatrics (GOSE-Peds), and the predictive value of MRI measures was compared with the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) core clinical predictors. Data collection, image analysis, and data analyses were completed in July 2023. Pediatric severe TBI with an MRI scan performed as part of clinical care. All measures were selected a priori. Magnetic resonance imaging measures included contusion, ischemia, diffuse axonal injury, intracerebral hemorrhage, and brainstem injury. Clinical predictors included the IMPACT core measures (GCS motor score and pupil reactivity). All models adjusted for age and sex. Outcome measures included the GOSE-Peds score obtained at 3, 6, and 12 months after injury. This study included 233 children with severe TBI who were enrolled at participating sites and had an MRI scan and preselected clinical predictors available. Their median age was 6.9 (IQR, 3.0-13.3) years, and more than half of participants (134 [57.5%]) were male. In a multivariable model including MRI measures and IMPACT core clinical variables, contusion volume (odds ratio [OR], 1.13; 95% CI, 1.02-1.26), brain ischemia (OR, 2.11; 95% CI, 1.58-2.81), brainstem lesions (OR, 5.40; 95% CI, 1.90-15.35), and pupil reactivity were each independently associated with GOSE-Peds score. Adding MRI measures to the IMPACT clinical predictors significantly improved model fit and discrimination between favorable and unfavorable outcomes compared with IMPACT predictors alone (area under the receiver operating characteristic curve, 0.77; 95% CI, 0.72-0.85 vs 0.67; 95% CI, 0.61-0.76 for GOSE-Peds score >3 at 6 months after injury). In this prognostic study of children with severe TBI, the addition of MRI measures significantly improved outcome prediction over well-established and validated clinical predictors. Magnetic resonance imaging should be considered in children with severe TBI to inform prognosis and may also promote stratification of patients in future clinical trials.

Assessment of lumbar paraspinal muscle morphology using mDixon Quant magnetic resonance imaging (MRI): a cross-sectional study in healthy subjects.

Lumbar paraspinal muscles (LPM) are a part of the deep spinal stabilisation system and play an important role in stabilising the lumbar spine and trunk. Inadequate function of these muscles is thought to be an essential aetiological factor in low back pain, and several neuromuscular diseases are characterised by dysfunction of LPM. The main aims of our study were to develop a methodology for LPM assessment using advanced magnetic resonance imaging (MRI) methods, including a manual segmentation process, to confirm the measurement reliability, to evaluate the LPM morphological parameters [fat fraction (FF), total muscle volume (TMV) and functional muscle volume (FMV)] in a healthy population, to study the influence of physiological factors on muscle morphology, and to build equations to predict LPM morphological parameters in a healthy population. This prospective cross-sectional observational comparative single-centre study was conducted at the University Hospital in Brno, enrolling healthy volunteers from April 2021 to March 2023. MRI of the lumbar spine and LPM (erector spinae muscle and multifidus muscle) were performed using a 6-point Dixon gradient echo sequence. The segmentation of the LPM and the control muscle (psoas muscle) was done manually to obtain FF and TMV in a range from Th12/L1 to L5/S1. Intra-rater and inter-rater reliability were evaluated. Linear regression models were constructed to assess the effect of physiological factors on muscle FF, TMV and FMV. We enrolled 90 healthy volunteers (median age 38 years, 45 men). The creation of segmentation masks and the assessment of FF and TMV proved reliable (Dice coefficient 84% to 99%, intraclass correlation coefficient ≥0.97). The univariable models showed that FF of LPM was influenced the most by age (39.6% to 44.8% of variability, P<0.001); TMV and FMV by subject weight (34.9% to 67.6% of variability, P<0.001) and sex (24.7% to 64.1% of variability, P<0.001). Multivariable linear regression models for FF of LPM included age, body mass index and sex, with R-squared values ranging from 45.4% to 51.1%. Models for volumes of LPM included weight, age and sex, with R-squared values ranged from 37.4% to 76.8%. Equations were developed to calculate predicted FF, TMV and FMV for each muscle. A reliable methodology has been developed to assess the morphological parameters (biomarkers) of the LPM. The morphological parameters of the LPM are significantly influenced by physiological factors. Equations were constructed to calculate the predicted FF, TMV and FMV of individual muscles in relation to anthropometric parameters, age, and sex. This study, which presented LPM assessment methodology and predicted values of LPM morphological parameters in a healthy population, could improve our understanding of diseases involving LPM (low back pain and some neuromuscular diseases).

Intergrowth 21 Versus Fenton 2013 Growth Charts: Congruence in Assessing the Birth Size and the Proportion of Extra-uterine Growth Restriction in Preterm Babies

Background: Intergrowth-21st and Fenton 2013 growth charts are used for postnatal growth monitoring in preterms. There is no international consensus on which graph to refer to and why. This study is a local validation, of which graph would be plausible for the Indian population to detect small-for-gestational-age (SGA) and extra-uterine growth restriction (EUGR) babies, abetting in the settlement of this ambiguity. Objectives: The primary objective was to compare the Intergrowth-21st with Fenton 2013 growth charts for birth size classification and to detect the proportion of EUGR in preterms. The secondary objective was to assess the proportion of comorbidities in SGA babies by both these graphs. Methods: The design of the study was a prospective comparative observational study. All preterm newborns (24–&lt;37 weeks of gestation) admitted to the neonatal intensive care unit of Noble Hospital and Research Center, Maharashtra, were the participants. Weight, length, and head circumference were plotted on Intergrowth 21 and Fenton growth charts at birth and at 4 weeks of age or at 36 weeks of postmenstrual age whichever is later. Corresponding Z-scores and percentiles were calculated electronically from their respective online software. Outcome: the reliability of Intergrowth-21st when compared to Fenton 2013 growth charts in assessing the birth size was better, and detection of the proportion of EUGR in preterm babies was better with Fenton charts. Results: A total of 429 preterm babies with a mean gestational age of 33.3 ± 2.4 weeks were included in the study. Fenton (67.1%) overestimated the proportion of EUGR when compared to Intergrowth-21st (18.6%) which was statistically significant (P &lt; 0.001). On the contrary, although the proportion of SGA babies detected was higher with Intergrowth-21st (29.8%) when compared to Fenton (19.6%), there was moderate-to-high statistically significant agreement observed between the two growth charts in detecting SGA babies (Kappa = 0.716, P &lt; 0.001). The proportion of comorbidities did not vary significantly among the SGA babies between the growth charts (P &gt; 0.05). Conclusion: Fenton overestimates EUGR when compared to Intergrowth-21st, whereas both the growth charts are equally good in identifying SGA babies with no differences in the comorbidities detected. Intergrowth-21st standards look more pertinent for growth monitoring in the current study setting for Indian preterm babies.

Comparison between ultrasonography and capnography for ascertaining placement of endotracheal tube in patients undergoing general anesthesia – A prospective observational study

Background: Confirmation of the position of the endotracheal tube (ETT) is an essential step for verification of intubation. Failure to diagnose esophageal intubation may lead to fatal consequences. Capnography is the gold standard for confirmation of ETT position, but it is practically impossible to be performed in all situations. Ultrasonography (USG) or “visual stethoscope” can be used as an effective alternative for all intubators in all situations. Aims and Objectives: The study was conducted to evaluate the ultrasonography (USG) technique with respect to its efficacy to detect the proper endotracheal position of ETT compared to end-tidal capnography among patients undergoing general anesthesia; to compare the time taken by the USG technique with that of capnography for detection of proper placement of ETT; to assess the feasibility of USG to detect accidental esophageal intubation. Materials and Methods: This prospective comparative cross-sectional observational study was conducted on 68 patients. Both capnography and upper airway USG were performed immediately after intubation to confirm the ETT placement. Sensitivity, specificity, and positive and negative predictive values of upper airway USG were determined against capnography as the reference method. The time required to determine ETT placement by the two methods was found out and compared. Agreement between the methods was assessed with kappa statistics. Results: USG detected all three cases of esophageal intubation but could not detect two patients with correct tracheal intubation. Upper airway USG had a sensitivity of 96.92% (95% confidence interval [CI]: 93.54–100%), specificity of 100%, positive predictive value of 100%, and negative predictive value of 60% (95% CI: 50.4–69.6%). The Kappa value was found to be 0.735, indicating a good agreement between upper airway USG and capnography for confirmation of ETT placement. Time taken for confirmation of ETT by capnography was 21.68±2.63 s versus 11.44±1.38 s for upper airway USG (P&lt;0.001). USG demonstrated bilateral lung sliding in 60 (88.2%) patients, unilateral lung sliding in 3 (4.4%) patients, and lung sliding was absent in 5 (7.4%) patients. Conclusion: Real-time upper airway USG is an alternative method of confirmation of ETT that is not only sensitive and accurate but is faster than the current gold standard method, capnography.

Transcriptomic profile assessment for preeclampsia prediction and early diagnostics

Aim: to develop a model for predicting preeclampsia (PE) based on the clinically most significant differentially expressed plasma microRNAs.Materials and Methods. A prospective observational comparative study was conducted with 62 women, divided into two parallel groups: 32 patients with PE and 30 clinically healthy women with uncomplicated pregnancy. Transcriptomic analysis was performed to identify differentially expressed blood plasma microRNAs using next generation sequencing (NGS).Results. Calculation of risk ratios for PE development allowed to identify 14 plasma microRNAs that influence the development of PE pathology. PE-associated microRNAs hsa-miR-103a-3p, hsa-miR-451a and hsa-miR-516a-5p have a high diagnostic value when combined to assess their blood plasma expression level in early pregnancy stages.Conclusion. The developed prognostic model can be applied to pregnant women at risk for PE development, which may further reduce obstetric complications and improve perinatal outcomes.

Cephalad-caudad vs transverse blunt expansion of low transverse hysterotomy during caesarean section and risk of severe postpartum haemorrhage: A prospective comparative study

BackgroundThe global prevalence of caesarean section as a delivery method is increasing worldwide. However, there is notable divergence among countries in their national guidelines regarding the optimal technique for blunt expansion hysterotomy of the low transverse uterine incision during caesarean section (cephalad-caudad or transverse). AimTo compare the risk of severe postpartum haemorrhage (PPH) between cephalad-caudad and transverse blunt expansion hysterotomy during caesarean section. MethodsThis prospective comparative observational study was conducted in a university maternity hospital. All women who gave birth to one infant by caesarean section after 30 weeks of gestation between November 2020 and November 2021 were included in this study. The exclusion criteria were a coagulation disorder, the presence of placenta previa, multiple pregnancies, or enlargement of the hysterotomy with scissors. The choice between cephalad-caudad or transverse blunt expansion of the low transverse hysterotomy was left to the surgeon’s discretion. The primary outcome measure was severe PPH, defined as estimated blood loss ≥ 1000 ml. Univariate and multivariate analyses were employed to assess the risk of severe PPH associated with the two methods of enlarging the low transverse hysterotomy. ResultsThe study included 850 women, of whom 404 underwent transverse blunt expansion and 446 underwent cephalad-caudad blunt expansion. The overall incidence of severe PPH was 13.3 %. Univariate analysis revealed no significant difference in the frequency of severe PPH between the cephalad-caudad and transverse blunt expansion groups (13.9 % vs 12.6 %; p = 0.61). However, the use of additional surgical sutures (mainly additional haemostatic stitches) was less common with cephalad-caudad blunt expansion (26.7 % vs 36.9 %; p < 0.05). Multivariate analysis showed no significant difference in risk between the two techniques (odds ratio 1.17, 95 % confidence interval 0.77–1.78). ConclusionNo significant difference in the risk of severe PPH was found between cephalad-caudad and transverse blunt expansion of the low transverse hysterotomy during caesarean section.

Incidence of post-dural lumbar puncture headache (PDLPH) in comparison between emergency and elective lower segment cesarean section (LSCS) with 26G Quincke-Babcock cutting-beveled spinal needle.

C-section is usually performed under spinal anesthesia also known as a subarachnoid block (SAB) over general anesthesia. Because of the lesser amount of dose used, there is a lower risk of local anesthetic toxicity and minimal transfer of drugs to the fetus. Obstetric patients have a higher risk of having post-dural puncture headache (PDPH). PDPH occurs due to leakage of the cerebrospinal fluid (CSF) through the hole created by a spinal needle. There are many elements affecting the frequency of PDPH, these elements can also consist of age, female sex, needle size, and types, pregnancy, preceding records of PDPH, median-paramedian distinction in approach, a puncture level. PDPH is commonly in the form of a frontal, occipital, or retro-orbital headache that starts in 12-72 h after the dural puncture and will increase when standing and decrease when lying down or resting. We aimed to learn about headache frequency between elective and emergency lower segment cesarean section using 26-G Quincke spinal needle in full-term pregnant patients. To study the incidence of PDPH using the 26G Quincke spinal needle. To analyze the causal factors/determinants such as adequate preloading of fluids, size of spinal needle, number of pricks, and technique of lumbar puncture effects on the incidence of PDPH. This study is a prospective questionnaire-based comparative observational study using the convenience sampling method. The patients were interviewed with a structured questionnaire at the Symbiosis University Hospital and Research Centre, Lavale, Pune. The patients observed for the study were between 20 and 40 of age group, posted for emergency or elective lower segment cesarean section, with body mass index (BMI) less than 14.5 to 24.9 and with ASA I and II grades. Patients with any comorbidities, recurrent headaches, obesity, and spine deformity were excluded. According to the review of the literature and with the help of a formula, the sample size was calculated as 20; 10 patients for elective LSCS, and 10 patients for emergency LSCS. Out of 20 patients, 10 patients were posted for elective LSCS, and the rest 10 patients were for emergency LSCS under spinal anesthesia. The incidence of PDPH was found only in 2 out of 10 emergency LSCS patients, and no patients from elective LSCS cases showed up with the incidence of PDPH.

A prospective observational comparative study to compare the diagnostic efficacy of the Fenyo Lindberg scoring system and Yash scoring system in patients of acute appendicitis in tertiary care hospitals in central India

Background Acute appendicitis is a typical surgical emergency requiring prompt and accurate diagnosis for timely intervention. This prospective observational comparative study aims to assess the diagnostic efficacy of two scoring systems, the Yash scoring system and the Fenyo-Lindberg scoring system, compared to the gold standard of histopathological diagnosis. The study is conducted at A.V.B.R.H., a tertiary care hospital in Central India, focusing on providing valuable insights into the comparative performance of these scoring systems in the local patient population. Methods The study adopts a prospective observational comparative design, enrolling clinically diagnosed cases of acute appendicitis from the outpatient and inpatient departments of the Surgery department at A.V.B.R.H. Patients willing to undergo surgery are included. At the same time, those with complicating factors or contraindications are excluded. Data collection involves thorough clinical evaluations, scoring system assessments, and comprehensive investigations, with histopathology as the reference standard. Statistical analyses include descriptive statistics, comparative analyses, primary outcome assessments, and regression analyses, ensuring a robust evaluation of the diagnostic efficacy of the scoring systems. Expected Outcome Anticipated outcomes include a comprehensive understanding of the diagnostic efficacy of the Yash and Fenyo-Lindberg scoring systems in acute appendicitis. The study aims to identify which scoring system demonstrates superior accuracy, sensitivity, and specificity, providing valuable information for clinical decision-making. The results will contribute to optimizing diagnostic protocols for acute appendicitis, potentially influencing patient management and surgical interventions. This study’s findings are expected to be relevant to the local setting and broader contexts, enhancing the knowledge surrounding acute appendicitis diagnosis.

Comparison of Pharmacoinvasive PCI and Delayed Regular PCI in ST-Elevation Myocardial Infarction Patients with Short-Term Hospital Outcomes

Background: Primary PCI remains a challenge due to the factors like few PCI performing centres, financial issues, delay in timely transfer to such centres. Thus, thrombolytic therapy continues to be the most common reperfusion modality in our setup. The optimal treatment after thrombolysis is still unclear. Objective: To comparison between pharmacoinvasive PCI and delayed routine PCI in ST-elevation myocardial infarction patients with short-term hospital outcomes. Materials and Method: This was a prospective observational comparative study which was conducted in Department of Cardiology, Northeast Medical College, Sylhet, We enrolled total of 120 thrombolysed ST- segment elevation myocardial infarction (STEMI) patients that underwent PCI after considering inclusion and exclusion criteria. Depending on the timing of PCI performed after thrombolysis, two groups were divided as pharmacoinvasive PCI group (refers as PCI performed within 3-24 hrs after thrombolytic therapy) and delayed routine PCI group (refers to PCI performed &gt;24 h to 2 weeks after thrombolytic therapy). In-hospital MACEs (Myocardial re-infarction, target vessel revascularization, heart failure, stroke, and cardiac death) were observed and recorded. All patients were followed up for a period of 30 days. Then findings of 2 groups were compared. Result: In-hospital outcome comparing two groups: incidence of cardiac re-infarction, target vessel revascularization, heart failure and cardiac death were higher in delayed routine PCI group than pharmacoinvasive PCI group (8.2% vs 4.0%, 4.1% vs 2.0%, 10.2% vs 6.0% and 4.1% vs 2.0) and p value (0.329, 0.492, 0.346 and 0.492) respectively, which did not show statistically significant difference. Conclusion: Even after 24 h of thrombolytic treatment in STEMI patients, delayed routine PCI can be performed with comparable outcome to that of PCI within 24 h.

Colposacropexia robótica para el tratamiento del prolapso de órganos pélvicos en mujeres de edad avanzada: análisis comparativo de la seguridad y eficacia frente a mujeres jóvenes

IntroductionPelvic organ prolapse is a condition with high prevalence in elderly women. With increasing life expectancy and a desire for improved quality of life, a rise in the frequency of surgical treatments for these women is anticipated. The aim is to compare complication, success, and satisfaction rates among elderly patients (aged>70 years) in comparison to younger women undergoing robotic sacrocolpopexy, thereby assessing the safety and efficacy of this surgery in this group of patients. MethodA prospective observational comparative study of 123 robotic sacrocolpopexies conducted between December 2016 and June 2022. Patients were stratified by age (cutoff point: 70 years). Baseline characteristics, type, and grade of prolapse, intra and postoperative data, complications, functional and anatomical outcomes, and satisfaction levels were collected. ResultsAmong the 123 patients, 62.6% were under 70 years old, while 37.4% were 70 years or older, exhibiting similar baseline characteristics, prolapse grade, and type. The percentages of intraoperative (6.5%) and postoperative complications (4.4-9%) were comparable in both age groups. Furthermore, success and satisfaction rates exceeded 90%, with no significant differences between women under and over 70 years during a two-year follow-up. ConclusionRobotic sacrocolpopexy is at least as effective and safe in women aged 70 years or older as in younger individuals, with no higher rates of intra and postoperative complications and similar rates of anatomical and subjective success.

Robotic sacrocolpopexy for the treatment of pelvic organ prolapse in elderly women: comparative analysis of safety and efficacy versus younger women

IntroductionPelvic organ prolapse is a condition with high prevalence in elderly women. With increasing life expectancy and a desire for improved quality of life, a rise in the frequency of surgical treatments for these women is anticipated. The aim is to compare complication, success, and satisfaction rates among elderly patients (aged >70 years) in comparison to younger women undergoing robotic sacrocolpopexy, thereby assessing the safety and efficacy of this surgery in this group of patients. MethodA prospective observational comparative study of 123 robotic sacrocolpopexies conducted between December 2016 and June 2022. Patients were stratified by age (cutoff point: 70 years). Baseline characteristics, type, and grade of prolapse, intra and postoperative data, complications, functional and anatomical outcomes, and satisfaction levels were collected. ResultsAmong the 123 patients, 62.6% were under 70 years old, while 37.4% were 70 years or older, exhibiting similar baseline characteristics, prolapse grade, and type. The percentages of intraoperative (6.5%) and postoperative complications (4.4–9%) were comparable in both age groups. Furthermore, success and satisfaction rates exceeded 90%, with no significant differences between women under and over 70 years during a two-year follow-up. ConclusionRobotic sacrocolpopexy is at least as effective and safe in women aged 70 years or older as in younger individuals, with no higher rates of intra and postoperative complications and similar rates of anatomical and subjective success.

A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology

This study protocol outlines a prospective cross-sectional observational investigation aimed at assessing the correlation between Sonomammography Breast Imaging Reporting and Data System (BI-RADS) scores and Fine-Needle Aspiration Cytology (FNAC) findings in diagnosing benign and malignant palpable breast lumps among patients admitted to AVBRH. The primary objective is to understand the diagnostic accuracy of FNAC and Sonomammography BI-RADS scoring in identifying breast lumps’ nature. Four specific objectives guide this study: 1) To determine the diagnostic accuracy of FNAC; 2) To evaluate the diagnostic precision of Sonomammography BI-RADS scores; 3) To compare the diagnostic outcomes of sonomammography and FNAC with HPE, and 4) To examine the age-wise distribution of benign and malignant palpable breast diseases. The study will be conducted at AVBRH, Sawangi (Meghe), Wardha, over three years, commencing in June 2022. The anticipated findings from this study will significantly contribute to refining the diagnostic strategies for palpable breast lumps, enhancing patient care and decision-making.

Multidrug-resistant pathogens and ventilator-associated pneumonia in critically ill COVID-19 and non-COVID-19 patients: a prospective observational monocentric comparative study

BackgroundThe COVID-19 pandemic has increased the incidence of ventilator-associated pneumonia (VAP) among critically ill patients. However, a comparison of VAP incidence in COVID-19 and non-COVID-19 cohorts, particularly in a context with a high prevalence of multidrug-resistant (MDR) organisms, is lacking.Material and MethodsWe conducted a single-center, mixed prospective and retrospective cohort study comparing COVID-19 patients admitted to the intensive care unit (ICU) of the “Città della Salute e della Scienza” University Hospital in Turin, Italy, between March 2020 and December 2021 (COVID-19 group), with a historical cohort of ICU patients admitted between June 2016 and March 2018 (NON-COVID-19 group). The primary objective was to define the incidence of VAP in both cohorts. Secondary objectives were to evaluate the microbial cause, resistance patters, risk factors and impact on 28 days, ICU and in-hospital mortality, duration of ICU stay, and duration of hospitalization).ResultsWe found a significantly higher incidence of VAP (51.9% - n = 125) among the 241 COVID-19 patients compared to that observed (31.2% - n = 78) among the 252 NON-COVID-19 patients. The median SOFA score was significantly lower in the COVID-19 group (9, Interquartile range, IQR: 7–11 vs. 10, IQR: 8–13, p < 0.001). The COVID-19 group had a higher prevalence of Gram-positive bacteria-related VAP (30% vs. 9%, p < 0.001), but no significant difference was observed in the prevalence of difficult-to-treat (DTR) or MDR bacteria. ICU and in-hospital mortality in the COVID-19 and NON-COVID-19 groups were 71% and 74%, vs. 33% and 43%, respectively. The presence of COVID-19 was significantly associated with an increased risk of 28-day all-cause hospital mortality (Hazard ratio, HR: 7.95, 95% Confidence Intervals, 95% CI: 3.10-20.36, p < 0.001). Tracheostomy and a shorter duration of mechanical ventilation were protective against 28-day mortality, while dialysis and a high SOFA score were associated with a higher risk of 28-day mortality.ConclusionCOVID-19 patients with VAP appear to have a significantly higher ICU and in-hospital mortality risk regardless of the presence of MDR and DTR pathogens. Tracheostomy and a shorter duration of mechanical ventilation appear to be associated with better outcomes.

Comparison of Clinical Characteristics and Biomarkers in Culture-Positive and Culture-Negative Sepsis Patients.

Sepsis is one of the leading causes of morbidity and mortality worldwide, and culture-negative sepsis, despite its prevalence, is largely understudied. The current study intends to examine clinical characteristics and biomarkers in culture-positive and culture-negative sepsis, focusingon 30-day mortality and duration of hospital stay in both groups. Materials and methods: A prospective observational comparative cohort study was done on 150 patients admitted to theintensive care unit (ICU) and wards of Jaipur Golden Hospital. Patients with documented fungal, viral, or parasitic infections, as well as those who had undergone surgery or experienced trauma, were excluded. Results: The mean age of the patients was 51.31±18.94 years. Of150 patients, 95 (63.3%) were culture-negative, whereas 55 (36.7%) were culture-positive, with more men in the former and more women in the latter. Patients with negative cultures had fewer comorbidities. The levels of procalcitonin (PCT), C-reactive protein (CRP), and serum lactate were within the prescribed limit for both culture-negative and positive patients. A higher proportion (87.3%) of the organisms isolatedfrom culture-positive individuals were gram-negative, with Escherichia coli (E. coli) having the highest prevalence (27.3%), followed by Klebsiella (20%). There were 12.7% gram-positive isolates. The culture-negative patients had significantly better outcomes (P=0.003) as well as the duration of hospital stay (P<0.001) than the culture-positive patients. Culture-positive patients had a more severe illness, a higher incidence of septic shock, and a higher fatality rate than culture-negative patients. It can be concludedthat CRP and PCT can be used as clinically reliable sepsis biomarkers in both culture-positive and culture-negative patients. The study found that culture-negative sepsis is more prevalent and that there are substantial differences between culture-negative and culture-positive sepsis, with the former group having fewer comorbidities, less severe illness, a shorter duration of hospital stays, lower death rates, and better outcomes.

Impact of COVID-19 on posttraumatic stress disorder in ICU survivors: a prospective observational comparative cohort study

BackgroundPosttraumatic stress disorder (PTSD) after a stay in the intensive care unit (ICU) can affect one in five ICU survivors. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, admission to the ICU for COVID-19 was stressful due to the severity of this disease. This study assessed whether admission to the ICU for COVID-19 was associated with a higher prevalence of PTSD compared with other causes of ICU admission after adjustment for pre-ICU psychological factors.MethodsThis prospective observational comparative cohort study included 31 ICUs. Eligible patients were adult ICU survivors hospitalized during the first wave of COVID-19 pandemic in France, regardless of the reason for admission. The prevalence of presumptive diagnosis of PTSD at 6 months was assessed using the PTSD Checklist for DSM-5 (PCL-5). Sociodemographics, clinical data, history of childhood trauma (Childhood Trauma Questionnaire [CTQ]), and exposure to potentially traumatic events (Life Events Checklist for DSM-5 [LEC-5]) were assessed.ResultsOf the 778 ICU survivors included during the first wave of COVID-19 pandemic in France, 417 and 361 were assigned to the COVID-19 and non-COVID-19 cohorts, respectively. Fourteen (4.9%) and 11 (4.9%), respectively, presented with presumptive diagnosis of PTSD at 6 months (p = 0.976). After adjusting for age, sex, severity score at admission, use of invasive mechanical ventilation, ICU duration, CTQ and LEC-5, COVID-19 status was not associated with presumptive diagnosis of PTSD using the PCL-5. Only female sex was associated with presumptive diagnosis of PTSD. However, COVID-19 patients reported significantly more intrusion and avoidance symptoms than non-COVID patients (39% vs. 29%, p = 0.015 and 27% vs. 19%, p = 0.030), respectively. The median PCL-5 score was higher in the COVID-19 than non-COVID-19 cohort (9 [3, 20] vs. 4 [2, 16], p = 0.034).ConclusionAdmission to the ICU for COVID-19 was not associated with a higher prevalence of PTSD compared with admission for another cause during the first wave of the COVID-19 pandemic in France. However, intrusion and avoidance symptoms were more frequent in COVID-19 patients than in non-COVID-19 patients.Trial Registration: Clinicaltrials.gov Identifier NCT03991611, registered on June 19, 2019.

Transcriptional profile features in patients with early and late preeclampsia

Aim: to assess the molecular mechanisms in developing various clinical phenotypes of preeclampsia (PE) by analyzing specific placental tissue transcriptome patterns. Materials and Methods. The prospective observational comparative study in parallel groups enrolled 43 pregnant women divided into 2 groups: main group – 23 pregnant women with diagnosed PE and control group – 20 apparently healthy women with uncomplicated pregnancy course, delivery and the postpartum period. To examine PE phenotypic features, the main group of pregnant women with PE was subsequently divided into 2 subgroups according to the date of pathology onset: early (n = 10) and late (n = 13) PE. Using the whole-genome next-generation sequencing (NGS), a comparative analysis of altered 18 microRNA level in placental tissue was carried out. Results. Pregnant women with early PE compared to the control group were characterized by significantly low expression level for hsa-miR-656-3p (p &lt; 0.001), hsa-miR-323a-5p (p = 0.017), hsa-miR-519c-3p (p = 0.019), hsa-let-7i-5p (p = 0.019), hsa-miR-433-3p (p = 0.019), hsa-let-7g-5p (p = 0.030), hsa-miR-214-5p (p = 0.030), hsa-miR-27a-5p (p = 0.031), hsa-miR-339-5p (p = 0.041), hsa-miR-524-5p (p = 0.045), hsa-miR-1283 (p = 0.049) and high expression for hsa-miR-151a-5p (p = 0.007), hsa-miR-4521 (p = 0.018), hsa-miR-30d-5p (p = 0.026), hsa-miR-548l (p = 0.027), hsa-miR-133b (p = 0.034), hsa-miR-424-5p (p = 0.042), hsa-miR-211-5p (p = 0.049). Patients with late PE had significantly decreased expression for hsa-miR-656-3p (p = 0.050) andhsa-miR-574-3p (p = 0.017) as well as a significantly higher for hsa-miR-211-5p (p = 0.001) compared to the control group. Subgroup of women with early vs. late onset PE was characterized by significantly decreased expression level for hsa-miR-323-5p (p = 0.007) and overexpressed hsa-miR-30d-5p (p = 0.002), hsa-miR-5481 (p = 0.027). Conclusion. The noted multidirectional expression for some microRNAs in subgroups of PE patients confirms the validity for stratification of such pathology based on two distinct phenotypic manifestations (early and late forms) and indicates the existence of different pathophysiological vectors in PE formation.

Outcomes of Severe ARDS COVID-19 Patients Denied for Venovenous ECMO Support: A Prospective Observational Comparative Study.

Background: Few data are available concerning the outcome of patients denied venovenous extracorporeal membrane oxygenation (VV-ECMO) relative to severe acute respiratory distress syndrome (ARDS) due to COVID-19. Methods: We compared the 90-day survival rate of consecutive adult patients for whom our center was contacted to discuss VV-ECMO indication. Three groups of patients were created: patients for whom VV-ECMO was immediately indicated (ECMO-indicated group), patients for whom VV-ECMO was not indicated at the time of the call (ECMO-not-indicated group), and patients for whom ECMO was definitely contraindicated (ECMO-contraindicated group). Results: In total, 104 patients were referred for VV-ECMO support due to severe COVID-19 ARDS. Among them, 32 patients had immediate VV-ECMO implantation, 28 patients had no VV-ECMO indication, but 1 was assisted thereafter, and 44 patients were denied VV-ECMO for contraindication. Among the 44 patients denied, 30 were denied for advanced age, 24 for excessive prior duration of mechanical ventilation, and 16 for SOFA score >8. The 90-day survival rate was similar for the ECMO-indicated group and the ECMO-not-indicated group at 62.1 and 61.9%, respectively, whereas it was significantly lower (20.5%) for the ECMO-contraindicated group. Conclusions: Despite a low survival rate, 50% of patients were at home 3 months after being denied for VV-ECMO for severe ARDS due to COVID-19.

Comparison of Opioid-Based Versus Opioid-Sparing Anesthesia in Patients Undergoing Glioma Surgery.

Background In the neurosurgical population, opioids may cause respiratory depression, leading to hypercapnia, increased cerebral blood flow (CBF), and ultimately increased intracranial pressure (ICP), which can mask early signs of intracranial complications and delayed emergence. This study was designed to compare perioperative hemodynamic stability, analgesia, and recovery parameters in opioid-based (fentanyl) general anesthesia versus opioid-sparing (dexmedetomidine) general anesthesia in patients undergoing glioma surgeries. Methodology This prospective observational comparative study compared 52 patients in two groups. Twenty-six (50%) patients in group F received Inj. fentanyl IV (intravenous; bolus 2 mcg/kg 10 minutes before induction and then infusion 1 mcg/kg/hour till 30 minutes before skin closure), whereas 26(50%) patients in group D received Inj. dexmedetomidine IV (0.5 mcg/kg infusion 10 minutes before induction and then maintenance with a 0.5 mcg/kg/hour infusion till 30 minutes before skin closure). Perioperative heart rate (HR), mean arterial pressure (MAP), Numerical Rating Scale for Pain (NRS) assessment and postoperative emergence time, modified Aldrete score,patient satisfaction, and surgeon satisfaction score were estimated and compared in both groups. Results The mean HR was less in group D compared to group F at following time points - 10 minutes after infusion (P= 0.006), laryngoscopy and intubation (P= 0.003), pinning of the skull (P< 0.001), one hour after dura opening (P= 0.007), two hours after dura opening (P = 0.006), five minutes after extubation (P< 0.001), and 30 minutes after extubation (P= 0.011). MAP was lower in group D compared to group F at the following time intervals: 10 minutes after infusion (P= 0.008), five minutes after extubation (P= 0.007), 30 minutes after extubation (P< 0.001), and one hour after extubation (P= 0.023). A significant decrease in emergence time in group D compared to group F (P< 0.001) was noted. NRS was lower in group D at eight hours (P= 0.005) and 12 hours (P< 0.001) post-extubation. Conclusions Dexmedetomidine can be used as an alternative to fentanyl in terms of perioperative hemodynamic stability, perioperative analgesia, smooth early recovery from anesthesia, patient satisfaction, and surgeon satisfaction.