Comparative Observational Study Research Articles

The Role of High-Density Lipoprotein, C-reactive Protein, and Serum Ferritin in Ischemic and Hemorrhagic Stroke: An Observational Cross-Sectional Comparative Study.

Background Stroke is a significant global health issue, with a high prevalence of morbidity, mortality, and disability. We can classify strokes into two types: ischemic and hemorrhagic, with ischemic strokes being more common. This study aims to investigate the role of high-density lipoprotein (HDL), C-reactive protein (CRP), and serum ferritin levels in people who have had ischemic and hemorrhagic strokes in order to identify possible biomarkers for diagnosis and treatment. Materials and methods This observational cross-sectional comparative study included 100 stroke patients (50 ischemic and 50 hemorrhagic) from Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth (Deemed to be University), Pune. We collected data through clinical evaluations, laboratory tests, and imaging studies. We measured and analyzed HDL, CRP, and serum ferritin levels using appropriate statistical tests, such as the chi-square test and Student t-test, with a 95% confidence interval (CI) and a 5% p-value for significance. Results The mean age for ischemic stroke patients was 55.92 years, whereas for hemorrhagic stroke patients, it was 58.68 years. The study found significant differences in HDL, CRP, and ferritin levels between the two groups. The mean HDL level for ischemic stroke patients was significantly lower at 25.10 mg/dL, compared to 40.57 mg/dL in hemorrhagic stroke patients, with a p-value of <0.001. The mean CRP level was higher in ischemic stroke patients (28.90 mg/L) compared to hemorrhagic stroke patients (22.80 mg/L), with a p-value of <0.001. Ferritin levels were also higher in hemorrhagic stroke patients (587.98 ng/mL) compared to ischemic stroke patients (473.16 ng/mL), with a statistically significant p-value of <0.001. Conclusion This study highlights the significant role of HDL, CRP, and serum ferritin levels in distinguishing between ischemic and hemorrhagic stroke patients. Elevated HDL levels may protect against ischemic strokes due to their anti-inflammatory properties, while higher CRP levels in ischemic strokes indicate a strong inflammatory response. Elevated ferritin levels in hemorrhagic strokes suggest increased oxidative stress and inflammation.

Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study.

Traditionally, diabetics have been considered patients with a high risk of aspiration due to having delayed gastric emptying; However, the evidence concerning residual gastric volume (GV) in fasting diabetic patients is inconsistent. This study aimed to compare the fasting GV of diabetic patients with or without dysautonomia with control patients scheduled for elective surgery using gastric ultrasound. This bicentric prospective single-blinded case-control study was conducted at 2 university hospitals in Spain. Patients aged over 18 years, classified as American Society of Anesthesiologists (ASA) physical statuses I to III and having similar fasting statuses, were included in the study. The primary outcome was to compare the prevalence of risk stomach using the Perlas gastric content grading scale evaluated by ultrasound in the 3 groups. Secondary outcomes included the measurement of cross-sectional area (CSA) and GV in the right lateral decubitus (RLD) position, as well as the prevalence of solid gastric residue. A total of 289 patients were recruited for the study, comprising 145 diabetic patients (83 of whom had dysautonomia) and 144 patients in the control group. The percentage of patients classified as Perlas grade 2 was 13.2% in the control group, 16.1% in diabetic patients without dysautonomia, and 22.9% in diabetic patients with dysautonomia (P = .31). Antral CSA was significantly higher in diabetic patients with dysautonomia (6.5 [4.8-8.4]) compared to the control group (5.4 [4.0-7.2]; P = .04). However, no significant differences were observed between groups in residual GV. Among diabetic patients with dysautonomia, 12% exhibited solid gastric residue, which was twice the percentage observed in diabetic patients without dysautonomia (4.8%) and 3 times higher than that in the control group (3.5%; P = .03). The presence of dysautonomia was associated with an increased odds ratio of solid gastric residue (odds ratio [OR], 3.37; 95% confidence interval [CI], 1.28-8.87; P = .01) after adjusting for confounding factors. This study offers insights into the relationship between dysautonomia in patients with diabetes mellitus and the presence of full stomach, underscoring the significance of preoperative gastric ultrasound evaluation in managing perioperative risks in this population.

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.

Effect of early prone positioning among critically ill patients admitted with acute respiratory distress syndrome during the COVID-19 pandemic: A comparative retrospective observational study

Background and objective: COVID-19 has offered an opportunity to the clinicians to try and study various oxygenation enhancing maneuvers in the patients. These included lung protective measures and prone positioning of participants admitted to the ICU with acute respiratory distress syndrome. We aimed to identify the effects of early prone positioning on the length of stay, discharge rate, and frequency of tracheostomies in the ICU patients. Methodology: This retrospective study was conducted on critically ill patients needing mechanical ventilation with lung protective strategy, admitted to the Intensive Care Units of Al-Azhar University Hospitals between March 2020 to April 2022. All patients in the study were interpreted retrospectively by examining the patient's records. Group A (n = 39) included patients who had been early placed in prone positions within 24 h of intubation, and Group B (n = 31) included patients who had not been placed in prone positions. All patients received a lung protective strategy for ARDS. In both groups, PaO2, PaCO2, pH, SpO2, and PaO2/FiO2 ratio were checked initially and later every 24 h for 6 days. Data was evaluated for the total days of both hospital and ICU length of stay, number of successful discharges to home from the hospital, and the total number of tracheostomized patients. Results: After prone positioning, lower SOFA and APACHE II scores were noticed in the prone group. There was no significant difference in the rate of discharge between the two groups. We observed non-significant shorter hospital and ICU stays and higher frequency of tracheostomy procedures in the prone group. We noticed a significant improvement in PaO2/FiO2 ratios in the prone group starting from day 2 to day 6. We observed a significant improvement in PO2 in the prone group in comparison to the non-prone group. Conclusions: Early prone positioning of patients admitted to the ICU with acute respiratory distress syndrome during COVID-19 pandemic led to a significant improvement in both PaO2 and PaO2/FiO2 ratio with a non-significant decrease in both hospital and ICU length of stay as shown by the collected data over consecutive six days. Abbreviations: ARDS- acute respiratory distress syndrome; FiO2: The fraction of inspired oxygen; CPAP: Continuous Positive Airway Pressure; PaO2: Arterial oxygen partial pressure; PEEP: Positive End-Expiratory Pressure; SOFA- Sequential Organ Failure Assessment Keywords: Prone; Lung protective measures; ARDS; APACHI II; SOFA Citation: Seyam SHA, Ahmed IMA. Effect of early prone positioning among critically ill patients admitted with acute respiratory distress syndrome during the COVID-19 pandemic: a comparative retrospective observational study. Anaesth. pain intensive care 2024;28(4):626−632; DOI: 10.35975/apic.v28i4.2504 Received: February 12, 2024; Reviewed: May 14, 2024; Accepted: May 15, 2024

Hematological and Coagulation Factors in Term and Preterm Newborns of Mothers with Pre-eclampsia

Objective: Pre-eclampsia (preE) is pregnancy-induced hypertension affecting a significant proportion of pregnant women worldwide and can cause detrimental effects on the mother and newborn. Recognition of contributing factors of health in neonates with pre-eclamptic mothers is important to reduce the burden of the problem. The aim of the study was to determine the hematologic and coagulation factors in term and preterm neonates born to mothers with pre-eclampsia. Method and Materials: In this observational cross-sectional comparative study, 104 neonates born to mothers with pre-eclampsia in Imam-Hossein Hospital from 2018 to 2021 were enrolled. The neonates were divided into term and preterm groups according to the gestational age of the mothers. Maternal and fetal parameters of neonates were collected. The hematologic and coagulation factors were recorded and compared. Results: The finding of the study demonstrated that the mean leukocyte (P=0.030), hemoglobin (P=0.0001), and platelet (P=0.0001) were significantly higher in term neonates. The mean PT (P=0.003), PPT (P=0.001), and INR (P=0.003) were significantly higher in preterm cases. Conclusion: Totally, according to the obtained results it may be concluded that CBC indexes and coagulopathy in term and preterm neonates born to mothers with pre-eclampsia are significantly different.

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.

Investigating Interleukin-6 Levels in Type 2 Diabetes Mellitus Patients With and Without Diabetic Nephropathy.

Diabetic nephropathy (DN), a severe complication affecting 40% of diabetic individuals, is a leading cause of chronic kidney disease (CKD). It involves a progressive increase in urinary albumin and a decline in the glomerular filtration rate. Early detection and intervention are crucial to preventing CKD progression. The current marker, albuminuria, measured as the urine albumin-to-creatinine ratio (UACR), has limitations, highlighting the need for alternative biomarkers. Researchers have linked the proinflammatory cytokine interleukin-6 (IL-6) to the progression of DN, observing elevated levels in DN patients compared to those without DN. IL-6 also regulates glucose metabolism, promoting insulin effectiveness and secretion. Inflammation and glucose control are two things that IL-6 does. This makes it a promising biomarker and therapeutic target for DN and type 2 diabetes mellitus (T2DM). This study focuses on IL-6 levels in T2DM patients with and without DN. From September 2022 to June 2024, the Department of General Medicine, Dr. D. Y. Patil Medical College, Hospitaland Research Centre, Dr. D. Y. Patil Vidyapeeth (Deemed to be University),Pune, conducted an observational cross-sectional comparative study on 80 T2DM patients, with 40 in group A (cases = T2DM patients with DN) and 40 in group B (controls = T2DM patients without DN). The study included patients with T2DM between the ages of 40 and 80. The study excludes conditions such as diabetic ketoacidosis, patients with end-stage renal disease, and conditions that increase IL-6, such as COVID-19. The study excluded autoimmune conditions with elevated IL-6, such as rheumatoid arthritis, systemic lupus erythematous, ankylosing spondylitis, psoriasis, and Crohn's disease. We obtained ethical approval and written consent from participants. In the current study, 61 patients (76.2%) were 60 years old or younger, while 19 patients (23.8%) were older than 60 years. Among the participants, 38 were females (47.5%) and 42 were males (52.5%). The case group, which consisted of 40 T2DM patients with DN, had a mean glycated hemoglobin (HbA1c) of 7.1700 ± 0.71044. In contrast, the control group, comprising 40 T2DM patients without DN, had a mean HbA1c of 6.8650 ± 0.57179. This difference was statistically significant, with a p value of 0.038. Additionally, the mean UACR in the case group was 134.34 ± 95.56, significantly higher than the control group's mean UACR of 22.32 ± 9.90. This difference was highly significant, with a p value of 0.001. Furthermore, the case group exhibited elevated mean IL-6 levels of 15.48 ± 4.27 compared to the control group's 7.02 ± 2.46, which is also highly significant, reflected by a p value of 0.001. As the concentration of IL-6 rises in diabetic patients with nephropathy, this study suggests that IL-6 may have an effect on the development of DN. This cytokine is necessary for both the initiation and progression of the condition. Using IL-6 as a supportive diagnostic test could help rule out other potential causes of DN in T2DM. Moreover, this marker does not require invasive procedures, and early measurement may help reduce mortality and morbidity.

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).

A Comparative Analysis of Sector Classification and the Impacted Canine Grading System by Kumar and Daigavane in Patients With Unilateral Cleft Lip and Palate Utilizing Orthopantomogram (OPG) as a Diagnostic Tool.

Introduction Non-syndromic oral clefts, affecting one in 700 newborns in India, are the most prevalent craniofacial anomalies, with genetic or environmental causes impacting various life aspects. Studies indicate higher dental disturbances, particularly impacted canines, in cleft lip and palate (CLP) patients compared to non-cleft individuals. Impacted canines, trapped by hard tissues, require early diagnosis to prevent orthodontic issues. The widely used Ericson and Kurol method employs orthopantomograms (OPGs) to classify canine impaction in typical children. However, diagnosing canines in CLP patients is challenging due to palate defects and post-grafting complications. This study aims to compare the utility of the Kumar and Daigavane (KD) grading system and the sector classification to determine the best method for diagnosing impacted canine eruption paths. Method This cross-sectional comparative observational study was conducted at Sharad Pawar Dental College's Department of Orthodontics and Dentofacial Orthopaedics. The sample size, calculated using a significance level of 5% and a prevalence of 1%, required a minimum of 16 participants aged 9-11 years with non-syndromic clefts and impacted canines. Patients with systemic diseases or over 12 years of age were excluded. The sectoral and KD classification systems collected and evaluated OPGs from qualifying cleft patients. Sector classification considered the angle between the occlusal plane or canine tip and the adjacent tooth's long axis, while KD's classification considered the Frankfort horizontal plane, occlusal plane, vertical height from the occlusal plane, canine apex root position, and canine exposure to the cleft defect. Results The study found an 81.25% agreement between the KD grading system and the sector classification, with a Cohen's kappa value of 0.586, indicating a moderate agreement. The KD system showed 81.82% sensitivity and 80.00% specificity, with positive and negative predictive values of 90.00% and 66.67%, respectively. The receiver operating characteristic (ROC) curve analysis revealed the KD system's superior performance in identifying impacted and non-impacted canines compared to the sector classification. Conclusion The KD grading system demonstrated higher efficacy than the sector classification for evaluating the impacted canines in children with unilateral cleft lip and palate (UCLP). The KD system's high sensitivity and specificity make it a valuable tool for predicting canine eruption paths and addressing anatomical challenges in cleft conditions. This study highlights the need for accurate diagnostic tools tailored to cleft patients and contributes to advancing orthodontic treatment outcomes through improved classification systems.

Comparison between abdominal core muscle strength in males with and without frozen shoulder: A pilot study

Background: The impact of adhesive capsulitis starts from the structures surrounding the shoulder complex and extends to overall deconditioning and affects neuromuscular control due to reduced daily living activities which may be passed along further in the kinetic chain. Context: Studies show there may be a certain link between core muscle activation and shoulder function, however, the literature is scanty in this regard. Aims: To compare the abdominal core muscle strength in males with and without frozen shoulder. Settings and Design: In this observational comparative study, 20 males (40-60 yrs) from a tertiary care hospital visiting the physiotherapy department for the treatment of frozen shoulder were included along with age, Body Mass Index (BMI) and Waist to Hip Ratio (WHR) matched healthy controls. Methods and Material: Abdominal core muscle strength was measured using a pressure biofeedback unit while progressive limb loading was performed. Statistical analysis used: The ordinal data was compared using SPSS Version 24 and Man Whitney U and Wilcoxon W were obtained. Results: The abdominal core muscle strength of male patients with frozen shoulder was weaker compared with healthy controls (p &gt; 0.0001) Conclusions: The abdominal core muscle strength was significantly weaker in the males with frozen shoulder compared to age, BMI and WHR matched healthy controls. Thus Inclusion of core muscle strengthening in the rehabilitation of patients with frozen shoulder may lead to better outcomes in rehabilitation.

Evaluation of the effectiveness of combination therapy of recurrent anogenital (venereal) warts: results of an observational comparative clinical study

Background. Destruction of anogenital warts lead to their removal, but do not eliminate the risk of their recurrence. In case of recurrent forms of the disease, combination therapy with the use of inducers interferons may be recommended. Aims: to study the effectiveness of topical application of polysaccharides of Solanum tuberosum shoots (Panavir gel, 0.002%) in the combined therapy of recurrent anogenital warts. Methods: 60 patients with recurrent anogenital warts: group 1 (n=30) underwent radiowave destruction and therapy with Panavir gel, 0.002% externally 2 times a day for 5 days before and 10 days after destruction), group 2 (n=30) – radiowave destruction. The patients were monitored for 3 months. Results. Absence of itching and pain in the destruction zone by day 5 was recorded in 27 (90.0%) patients of group 1 and 12 (40.0%) patients of group 2, after 10 days – in 30 (100%) and 26 (86.7%) (χ2=4,285). Inflammatory erythema, edema and infiltration were absent after 10 days in all patients of group 1, but persisted in 7 (23,3%), 12 (40,0%) and 2 (6.7%) patients of group 2 (χ2=7,924). Epithelialization was observed for 5 days in 18 (60.0%) patients of group 1 and 10 (33.3%) patients of group 2, after 10 days in 30 (100%) and 28 (93.3%) patients (χ2=4,285). 90 days after therapy, relapses of the disease were recorded in 2 (6.7%) patients of group 1 and 6 (20.0%) patients of group 2 (p=0,499), HPV elimination was observed in 11 (36.7%) and 10 (33.3%) patients (p=0,967). Conclusions. The effectiveness of the use of Panavir gel, 0.002% in the complex therapy of anogenital warts has been established in terms of reducing the severity of subjective and objective symptoms of inflammation in the affected areas, the timing of tissue epithelialization after destruction, as well as reducing the frequency of recurrence of rashes

PROMRIINE (PRe-operatory Magnetic Resonance Imaging is INEffective) Study: A Systematic Review and Meta-analysis of the Impact of Magnetic Resonance Imaging on Surgical Decisions and Clinical Outcomes in Women with Breast Cancer.

The purpose of this study was to review and summarize the association between preoperative magnetic resonance imaging (MRI) and surgical outcomes in women with newly diagnosed invasive breast cancer from published randomized controlled trials (RCT). Two independent researchers conducted a systematic review through a comprehensive search of electronic databases, including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science. If there was disagreement between the two reviewers, a third reviewer assessed the manuscript to determine whether it should be included for data extraction. The quality of the papers was assessed using the risk of bias tool, and the evidence was analyzed using GRADE. Meta-analyses using a fixed-effects model were used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI). Initially, 21 studies were identified, 15 of which were observational comparative studies. A total of five RCTs were included, and they suggested that preoperative MRI significantly reduced the rate of immediate breast-conserving surgery and increased the risk for mastectomy. From the RCT perspective, preoperative MRI for newly diagnosed invasive breast cancer did not improve surgical outcomes and may increase the risk of mastectomy.

Minimizing confounding in comparative observational studies with time-to-event outcomes: An extensive comparison of covariate balancing methods using Monte Carlo simulation.

Observational studies are frequently used in clinical research to estimate the effects of treatments or exposures on outcomes. To reduce the effects of confounding when estimating treatment effects, covariate balancing methods are frequently implemented. This study evaluated, using extensive Monte Carlo simulation, several methods of covariate balancing, and two methods for propensity score estimation, for estimating the average treatment effect on the treated using a hazard ratio from a Cox proportional hazards model. With respect to minimizing bias and maximizing accuracy (as measured by the mean square error) of the treatment effect, the average treatment effect on the treated weighting, fine stratification, and optimal full matching with a conventional logistic regression model for the propensity score performed best across all simulated conditions. Other methods performed well in specific circumstances, such as pair matching when sample sizes were large (n = 5000) and the proportion treated was < 0.25. Statistical power was generally higher for weighting methods than matching methods, and Type I error rates were at or below the nominal level for balancing methods with unbiased treatment effect estimates. There was also a decreasing effective sample size with an increasing number of strata, therefore for stratification-based weighting methods, it may be important to consider fewer strata. Generally, we recommend methods that performed well in our simulations, although the identification of methods that performed well is necessarily limited by the specific features of our simulation. The methods are illustrated using a real-world example comparing beta blockers and angiotensin-converting enzyme inhibitors among hypertensive patients at risk for incident stroke.

Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis.

The proliferation of digital technology has the potential to transform diabetes management. One of the critical aspects of modern diabetes management remains the achievement of glycemic targets to avoid acute and long-term complications. This study aims to describe the landscape of evidence pertaining to the relative effectiveness or efficacy and safety of various digital interventions for the self-management of type 2 diabetes mellitus (T2DM), with a primary focus on reducing glycated hemoglobin A1c (HbA1c) levels. A systematic literature review (SLR) was conducted by searching Embase, MEDLINE, and CENTRAL on April 5, 2022. Study selection, data extraction, and quality assessment were performed by 2 independent reviewers. Eligibility criteria for the SLR included randomized controlled trials (RCTs) and comparative observational studies evaluating interventions containing both human (eg, coaching) and digital components (eg, glucose meter) in adult patients with T2DM. The primary meta-analysis was restricted to studies that reported laboratory-measured HbA1c. In secondary analyses, meta-regression was performed with the intensity of coaching in the digital intervention as a categorical covariate. In total, 28 studies were included in this analysis. Most studies (23/28, 82%) used the reduction of HbA1c levels as the primary end point, either directly or as a part of a multicomponent outcome. In total, 21 studies reported statistically significant results with this primary end point. When stratified into 3 intervention categories by the intensity of the intervention supporting the digital health technology (analyzing all 28 studies), the success rate appeared to be proportional to the coaching intensity (ie, higher-intensity studies reported higher success rates). When the analysis was restricted to RCTs using the comparative improvement of HbA1c levels, the effectiveness of the interventions was less clear. Only half (12/23, 52%) of the included RCTs reported statistically significant results. The meta-analyses were broadly aligned with the results of the SLR. The primary analysis estimated a greater reduction in HbA1c associated with digital interventions compared with usual care (-0.31%, 95% CI -0.45% to -0.16%; P<.001). Meta-regression estimated reductions of -0.45% (95% CI -0.81% to -0.09%; P=.02), -0.29% (95% CI -0.48% to -0.11%; P=.003), and -0.28% (95% CI -0.65% to 0.09%; P=.20) associated with high-, medium-, and low-intensity interventions, respectively. These findings suggest that reducing HbA1c levels in individuals with T2DM with the help of digital interventions is feasible, effective, and acceptable. One common feature of effective digital health interventions was the availability of timely and responsive personalized coaching by a dedicated health care professional.

How reliable is the distinction between thoracolumbar AO type A3 and A4 fractures? A systematic literature review.

The AOSpine classification divides thoracolumbar burst fractures into A3 and A4 fractures; nevertheless, past research has found inconsistent interobserver reliability in detecting those two fracture patterns. This systematic analysis aims to synthesize data on the reliability of discriminating between A3 and A4 fractures. We searched PubMed, Scopus, and the Web of Science for studies reporting the inter- and intra-observer reliability of detecting thoracolumbar AO A3 and A4 fractures using computed tomography (CT). The search spanned 2013 to 2023 and included both primarily reliability and observational comparative studies. We followed the PRISMA guidelines and used the modified COSMIN checklist to assess the studies' quality. Kappa coefficient (k) values were categorized according to Landis and Koch, from slight to excellent. Of the 396 identified studies, nine met the eligibilitycriteria; all were primarily reliability studies except one observational study. Interobserver k values for A3/A4 fracturesvaried widely among studies (0.19-86). The interobserver reliability was poor in two studies, fair in one study, moderate in four studies, and excellent in two studies. Only two studies reported intra-observer reliability, showing fair and excellent agreement. The included studies revealed significant heterogeneity in study design, sample size, and interpretation methods. Considerable variability exists in interobserver reliability for distinguishing A3 and A4 fractures from slight to excellent agreement. This variability might be attributed to methodological heterogeneity among studies, limitations of reliability analysis, or diagnostic pitfalls in differentiating between A3 and A4. Most observational studies comparing the outcome of A3 and A4 fractures do not report interobserver agreement, and this should be considered when interpreting their results.

Complications of Superomedial Versus Inferior Pedicle Reduction Mammaplasty: A Systematic Review and Meta-Analysis.

The superomedial pedicle reduction mammoplasty has gained popularity and is an important alternative approach for reduction mammoplasty, while the inferior pedicle reduction mammaplasty remains by far the most performed as it is considered to provide the best vascularization to the nipple-areola complex, allowing safe removal of large amount of redundant tissue. The authors conducted the first systematic review and meta-analysis in an attempt to declare the differences of the superomedial pedicle versus the inferior pedicle reduction technique by comparing the postoperative complications. PubMed, MEDLINE, and Cochrane Library for clinical studies were queried from inception to January 1, 2024. Review Manager Version 5.4 was used for this meta-analysis. A random effects model was applied to OR, and 95%CI were determined using the Mantel-Haenszel method. The I2 test was used to assess heterogeneity, and the Newcastle-Ottawa scale was used to assess the risk of bias in the nonrandomized studies. Twelve observational comparative studies were included. The superomedial pedicle technique had a statistically lower rate of overall complications (OR 0.59, 95% CI 0.47-0.75; p < 0.0001) and delayed wound healing (OR 0.46, 95% CI 0.33-0.64; p < 0.00001) than the inferior pedicle technique. No significant differences in wound dehiscence, infection, seroma, hematoma, skin necrosis, fat necrosis, NAC necrosis, nipple sensation decrease or loss, asymmetry, hypertrophic scarring, and reoperation were noted. Both two techniques are equally safe and reliable, while the superomedial pedicle technique resulted in a statistically lower rate of overall complications and delayed wound healing. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Evaluating the effects of comprehensive simulation on central venous catheterization training: a comparative observational study

BackgroundSimulation-based training (SBT) is vital to complex medical procedures such as ultrasound guided central venous catheterization (US-IJCVC), where the experience level of the physician impacts the likelihood of incurring complications. The Dynamic Haptic Robotic Trainer (DHRT) was developed to train residents in CVC as an improvement over manikin trainers, however, the DHRT and manikin trainer both only provide training on one specific portion of CVC, needle insertion. As such, CVC SBT would benefit from more comprehensive training. An extended version of the DHRT was created, the DHRT + , to provide hands-on training and automated feedback on additional steps of CVC. The DHRT + includes a full CVC medical kit, a false vein channel, and a personalized, reactive interface. When used together, the DHRT and DHRT + systems provide comprehensive training on needle insertion and catheter placement for CVC. This study evaluates the impact of the DHRT + on resident self-efficacy and CVC skill gains as compared to training on the DHRT alone.MethodsForty-seven medical residents completed training on the DHRT and 59 residents received comprehensive training on the DHRT and the DHRT + . Each resident filled out a central line self-efficacy (CLSE) survey before and after undergoing training on the simulators. After simulation training, each resident did one full CVC on a manikin while being observed by an expert rater and graded on a US-IJCVC checklist.ResultsFor two items on the US-IJCVC checklist, “verbalizing consent” and “aspirating blood through the catheter”, the DHRT + group performed significantly better than the DHRT only group. Both training groups showed significant improvements in self-efficacy from before to after training. However, type of training received was a significant predictor for CLSE items “using the proper equipment in the proper order”, and “securing the catheter with suture and applying dressing” with the comprehensive training group that received additional training on the DHRT + showing higher post training self-efficacy.ConclusionsThe integration of comprehensive training into SBT has the potential to improve US-IJCVC education for both learning gains and self-efficacy.

No Differences in Kidney Function Decline Between People With Type 2 Diabetes Starting a Sodium-Glucose Cotransporter 2 Inhibitor or a Glucagon-like Peptide-1 Receptor Agonist: A Real-world Retrospective Comparative Observational Study

Diabetic nephropathy represents the leading cause of end-stage kidney disease in developed countries. Cardiovascular outcome trials have found that in participants who received a glucagon-like peptide-1 receptor agonist (GLP1RA) and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), the risk of incidence and progression of diabetic nephropathy in type 2 diabetes mellitus was reduced. The aim of this study was to compare the decline in estimated glomerular filtration rate (eGFR) among people taking a GLP1RA with that among people taking an SGLT2i in a real-world setting. Data for 478 patients with type 2 diabetes mellitus who initiated therapy with a GLP1RA (n = 254) or an SGLT2i (n = 224) between January 1, 2018 and December 31, 2021 were extracted. The primary outcome was any reduction ≥30% in eGFR after the start of therapy. Weight loss and drug discontinuation were also assessed. Over a median follow-up of 24 months, an eGFR reduction ≥30% occurred in 34 of 254 patients (13.4%) starting a GLP1RA and in 26 of 223 patients (11.6%) starting an SGLT2i (hazard ratio = 0.89; 95% CI, 0.54-1.49; P = 0.67). Median eGFR change over the whole follow-up was similar between groups (SGLT2i: median, -2 mL/min/1.73 m2; 25th, 75th percentile, -13, 8 mL/min/1.73 m2; GLP1RA: median, 0 mL/min/1.73 m2; 25th, 75th percentile, -10, 7 mL/min/1.73 m2; P = 0.54). No worsening of kidney function was observed, even when considering the ratio eGFR mean. The value of eGFR at baseline indicated a statistically significant indirect correlation with the observed absolute value of eGFR change over the follow-up (ρ = -0.36; P < 0.001). The difference in eGFR changes over time observed by eGFR categories was statistically significant (P = 0.0001) in both treatment groups. No significant differences in weight loss and drug discontinuations were observed between groups. Although acting on different molecular mechanisms, both GLP1RA and SGLT2i might have similar effects on eGFR decline in diabetes, as suggested by the results of the present study conducted in a real-world setting. (Clin Ther. 2024;46:XXX-XXX) © 2024 Elsevier HS Journals, Inc.

Clinical Profile of Patients Presenting With Eclampsia at a Semi-urban Tertiary Care Center.

Introduction Pregnancies complicated by hypertensive disorders contribute to enormous burden on economy and health-care facilities.Eclampsia is one of the clinical markers of near-miss mortality. To achieve optimal outcomes, efforts should be directed at both periphery and tertiary care levels. This study aimed to compare the feto-maternal outcome in patients presenting with eclampsia and a matched control population. Methodology A comparative observational study was conducted among 70 cases and 70 controls. Detailed historyand general and obstetrical examinations were carried out. Data was extracted from case files, labor room, and ICU records. Maternal and fetal outcomes were noted from January 2023 to January 2024. Statistical software STATA 14.2 (StataCorp LLC, College Station, Texas, USA) was used for data analysis. Observational descriptive statistics and chi-square and Fisher extract tests were applied. Results In our study, the incidence of eclampsia was 0.7% (70 per 1000 live births). The maternal mortality rate was 102.8/100000 live births and the perinatal mortality rate was 10.2/ 1000 live births in our study. The study observed a relatively young aged population and a significant bulk of cases belonged to late gestation or post-partum. Events like HELLP syndrome, abruption, liver, and renal failure were found to be frequently linked to eclampsia. Neonatal asphyxia (P-0.005), NICU requirement 41.43% vs 29% (P<0.01) preterm delivery 45.7% vs 14% (P=<0.001), and low birth weight were more commonly observed among the cases than the controls. Conclusions Eclampsia was found to be a significant contributor to elevated rates of morbidity and mortality in mothers and newborns. Poor antenatal care, severe anemia, and late referrals were some of the modifiable risk factors. Health care and economic burden on society is immense due to the significant utilization of intensive care and high dependency units.

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.