Comparative Observational Study Research Articles

Первичная надпочечниковая недостаточность с Х-сцепленным наследованием у детей

Primary adrenal insufficiency (PAI) is a rare pathology with a prevalence of 100 to 140 cases per one million. X-linked adrenoleukodystrophy (X-ALD) and X-linked congenital adrenal hypoplasia (X-CAH) are the leading pathologies among boys (after congenital cortical dysfunction adrenal glands) and account for 3.1% and 2.0% of all PAI, respectively. Establishing the PAI etiology is necessary to predict the course of the disease and adhere to special protocols for examining patients. The purpose of this research was to compare the PAI course in diseases with an X-linked type of inheritance. Materials and methods used: a single-center, one-stage observational comparative retrospective study was conducted in 25 male patients with genetically confirmed diagnoses of X-ALD, X-CAH and who had PAI as a component of the disease. The study was conducted at the Pediatric Endocrinology Institute with the Endocrinology Research Centre of the Ministry of Healthcare of Russia (Moscow, Russia) in 2019-2022 as well as based on the patients’ medical records that have been forwarded for a genetic search for the causes of adrenal insufficiency under the “Alfa-Endo” Charity Program for children with endocrine diseases in the same period of time. Results: X-ALD was detected in 11/25 (44%) patients, median age of manifestation was 6.2 [4.5; 7.2] y/o and 2 y/o was the earliest. A single patient with X-ALD was found to have TARTs (testicular adrenal rest tumors). X-CAH was diagnosed in the remaining 14/25 (56%) patients, median age of manifestation was 1.9 [0.04; 3.9] y/o, p=0.015. The oldest age of manifestation was 14 y/o. A single patient was found to have hypogonadotropic hypogonadism (HH) and another one had bilateral cryptorchidism. There were no statistically significant differences in symptoms, adrenocorticotropic hormone (ACTH), cortisol levels during the manifestation of PAI and doses of replacement therapy (p=0.756 for ACTH, p=0.591 for cortisol, p=0.825 for hydrocortisone and p=0.148 for fludrocortisone). Conclusion: it is necessary to exclude X-ALD and X-CAH when diagnosing PAI in boys regardless of the age of the disease manifestation. It is highly recommended to conduct a genetic study of a panel of genes responsible for the development of PAI in order to establish the PAI etiology, and regardless of the established PAI etiology it is necessary to perform an ultrasonic study of the testicles with the purpose of excluding the space-occupying formations. It is necessary to evaluate ACTH levels in patients with testicular masses for timely diagnosis of PAI and optimal treatment.

Laboratory evaluation of the hormonal agents effects on the plasma hemostasis system in women of reproductive age

Background: With the evolution of hormonal contraception, such as implementation of low dose agents, new regiments and administration routes of contraceptives, the risk of thrombotic complications persists, although is decreasing. The search for an available test for hemostasis assessment, which would allow for the prediction of thrombotic complications in high risk patients, remains relevant. Global tests for hemostasis assessment, such as thrombin generation test and thrombodynamics test, are attracting the specialists' attention due to the possibility of a quick integrative assessment of plasma hemostasis, especially during choice and tailoring of an optimal version of hormonal therapy.
 Aim: To assess the value of the integral thrombodynamics test in the multifactorial assessment of hemostasis system in women of reproductive age using hormonal contraceptives.
 Materials and methods: This observational prospective comparative study included 408 women aged 18 to 49 years followed from 2018 to 2022 in The Nikiforov Russian Center of Emergency and Radiation Medicine and Centre of Miscarriage Prevention and Treatment of the Maternity Hospital No. 1, St. Petersburg. From these, 208 women (mean age, 38.0 ± 7.0 years) were taking hormonal contraceptives (HC+ group), and 200 women (mean age, 37.5 ± 9.2 years) were in the control group (HC-). In the HC+ group, 163 women were taking combination oral contraceptives, 24 had an intrauterine levonorgestrel-releasing system, 8 used vaginal rings, and 13 were using progestin only oral contraceptives. Multifactorial clinical and laboratory assessment included taking past history, measurement of pro- and anticoagulation blood parameters, fibrinolysis, and endothelial function parameters (automatic coagulometer ACL TOP 500, Instrumentation Laboratory, USA). The integral assessment of the hemostasis system was performed with Thrombodynamics Registrator T-2 (Hemacor, Russia).
 Results: The groups were similar as per their age, chronic venous insufficiency and smoking. The HC+ group had significantly higher proportion of women with cardiovascular disorders (p = 0.0037), obesity (p = 0.0004), and headache (p 0.0001), compared to the HC- group. The thrombodynamics test showed a significantly higher rate of clot formation in the women taking hormonal contraception, compared to that in the HC- group (36.2 [30.1; 43.6] and 30.3 [28.0; 33.6] mcm/min, respectively, р 0.001). Hypercoagulation identified by the thrombodynamics test was associated with slowing down of XIIа-dependent fibrinolysis (6 [5; 8] min in the HC- and 12.8 [8; 16] min in the HC+ group, p 0,001) and higher levels of endothelial dysfunction markers (FVIII, 113 [85; 156] and 150 [107; 180]%, p = 0.015; vFW, 98 [85; 133] and 146 [95; 168]%, respectively, p = 0.003). The analysis of plasma hemostasis parameters depending on the presence of thromboembolic risk factors has shown that higher number of the risk factors is associated with higher velocity parameters in the thrombodynamics test in the range of chronometric hypercoagulation.
 Conclusion: The integral thrombodynamics test for the assessment of plasma hemostasis allows for identification of hemostasis dysfunction in women taking hormonal contraceptives. To prevent the risk of thromboembolic complications, it is desirable to assess blood coagulation system parameters before administration of hormonal agents.

CLINICAL PROFILE OF PATIENTS HAVING SUBCLINICAL AND CLINICAL HYPOTHYROIDISM ATTENDING GENERAL MEDICINE OPD OF A TERTIARY CARE MEDICAL CENTER

Objective: The objective of this study was to analyze and compare the clinical profile of patients having clinical and subclinical hypothyroidism. Methods: This was a comparative observational study in which adult patients with clinically overt and subclinical hypothyroidism were included on the basis of predefined inclusion and exclusion criteria. Written and informed consent was obtained from all the patients. Demographic details such as age gender and occupation were noted. The normal reference values of T3, T4, and TSH for diagnosis of subclinical and clinical hypothyroidism were taken to be 0.8–2 ng/mL, 5.5–12.2 μg/dL, and 0.3–4.5 μIU/mL. The cases were divided into two groups, namely, Group C (clinical hypothyroidism) and Group SC (Subclinical hypothyroidism). Mean T3, T4, and TSH levels and clinical signs and symptoms were compared in both the groups. SSPS 21.0 software was used for statistical analysis and p<0.05 was taken as statistically significant. Results: In cases of clinical hypothyroidism out, there were 42 (70%) females and 18 (30%) males, whereas in cases of subclinical hypothyroidism, there were 38 (63.33%) females and 22 (36.67%) males. There was an overall female preponderance in both the groups. The mean age of patients in group C was found to be 39.48±12.36 whereas the mean of patients in SC group was found to be 42.82±13.46. The mean T3 and T4 were low in clinical hypothyroidism and mean TSH levels were high and the difference was statistically highly significant (p<0.0001). In cases with clinical as well subclinical hypothyroidism, the most common clinical features were dry skin, fatigue, and cold intolerance. The prevalence of fatigue, weight gain, cold intolerance, dry skin, pedal edema, and thyroid swelling was more in patients with clinical hypothyroidism as compared to the patients with subclinical hypothyroidism and the difference was found to be statistically significant. Conclusion: The clinical presentation of clinical as well as subclinical hypothyroidism varies and a high index of suspicion is necessary for the diagnosis particularly in cases of subclinical hypothyroidism so that appropriate interventions can be undertaken.

Adrenal insufficiency as part of X-linked adrenoleukodystrophy

X-linked adrenoleukodystrophy (X-ALD) is a severe neurodegenerative metabolic disease with a frequency 1:17,000 in newborn boys. Being a major part of X-ALD with an incidence of 70-80% of patients, adrenal insufficiency (AI) is alife-threatening condition without timely treatment. The possibility of developing AI during the whole disease duration and the absence of any predictive factor for AI joining shows the necessity of studying AI in X-ALD patients to optimize current diagnostic and treatment algorithms. To study diagnostic and therapeutic features of primary adrenal insufficiency due to X-ALD. A retrospective observational comparative study was conducted in 66 male patients, examined and treated in the Pediatric endocrinology department of Endocrinology Research Centre, Research Centre for Medical Genetics, Research and Clinical Institute for Pediatrics of the Pirogov Russian National Research Medical University Detached Structural Unit Russian Children's Clinical Hospital (Moscow, Russia) for 2014-2022. All of patients were diagnosedwith primary AI and a genetically confirmed X-ALD. The median age of X-ALD manifestation was 6.6 years [4.7; 11.1]. The earliest age of AI diagnosis was 1.5 years atthe preclinical stage and 1 year 8 months with clinical symptoms. The renin level was studied in 22.7% at the manifestation of AI (15/66 patients), mineralocorticoid deficiency was found in 7 patients. Family history was positive in 39.4% of patients (n=66), only in 15.1% (10/66 patients) of patients the disease was established at the preclinical stage. In 59.1% (n=66) thecerebral form of the disease (cALD) was established, in 16.6% - adrenomyeloneuropathy (AMN), and in 24.2% - isolated adrenal insufficiency (PAI). Age of AI establishment in the group of patients with AMN (15.6 years) significantly differs from the establishment of AI in patients with cALD (7.4 years, p=0.001) and PAI (5.6 years, p = 0.000). Mineralocorticoid therapy was prescribed simultaneously with glucocorticoid therapy in patients with cALD, in AMN and PAI patients it was added after 11and 7 months, respectively (the differences between AMN and PAI groups were insignificant). Combined hormonal therapy receive 41% of patients with cALD, 54.5% of patients with AMN and 60% of patients with PAI. It is necessary to examine all male patients with AI regardless of the manifestation age to exclude adrenoleukodystrophy, and it is also important to examine patients for the presence of AI regardless of X-ALD manifestation age. The assessment of renin level in the manifestation of AI is also needed toprescribe mineralcorticoid therapy timely. Studying family history is the main method to detect X-ALD at the preclinical stage.

A comparative observational study of Ayurveda bloodletting procedure and blood donation with special reference to RBC indices in healthy individuals

A comparative observational study of Ayurveda bloodletting procedure and blood donation with special reference to RBC indices in healthy individuals

Neuronal lipid metabolism genetics and Early‐Onset Alzheimer’s Disease: A systematic review and meta‐analysis of observational studies

AbstractBackgroundEarly Onset Alzheimer’s disease (EOAD) is associated with mutations in APP, PSEN1 and PSEN 2 genes but few studies have assessed its relationship with mutations involved in lipid metabolism and the amyloid cascade. Therefore, this study seeks to determine the association of ABCA7, SORL1 and APOE mutations with EOAD.MethodThe protocol was registered in PROSPERO(CRD42022328366). We included comparative observational studies assessing the association of ABCA7, SORL1 and APOE mutations with the development of EOAD in patients younger than 65 years old. The search strategy was performed in five databases (MEDLINE, Scopus, Web of Science, EMBASE, Opengray) from their inception to May 7th,2022. Abstract and full‐text screening, data extraction and risk of bias (RoB) assessment were performed in duplicates. RoB was assessed with Newcastle‐Ottawa Scale. We performed a random effects meta‐analysis for dichotomous outcomes by using the DerSimoniain Laird method. Effect sizes were reported as odds ratio (OR) with their corresponding 95% confidence intervals (95%CI).ResultA total of 2191 studies were screened and seven studies (n = 8992) were included; one was a retrospective cohort and six were case‐control studies. Three studies had high RoB and four had low RoB. Overall, 60% were female and the mean age ranged from 33.9(SD±17.1) to 57.4(SD±5.6). Three case‐control studies (n = 5098) found a significant association of ABCA7 mutation with EOAD (OR:2.51 95%CI[1.33‐4.73]; tau‐squared = 0.20, I‐squared = 66%). Two case‐control studies (n = 3107) found that SORL1 mutation was not associated with EOAD (OR:3.65 95%CI[0.76‐17.49]; tau‐squared = 1.15, I‐squared = 89%). Two case‐control studies and one cohort study (n = 787) found that APOE4 allelic variant mutation of the APOE gene had significant association with EOAD (OR:13.21; 95%CI[3.81‐45.85]; tau‐squared = 0.90, I‐squared = 75%) and that the APOE2 allelic variant mutation was not associated with EOAD.ConclusionDespite the high heterogeneity in our results and limited number of studies, this study shows that ABCA7 and APOE mutations may be associated with an increased risk of EOAD. Larger high‐quality cohort studies are needed to address this research question.

THE USE OF DENTAL PATIENT-REPORTED OUTCOMES AMONG COMPARATIVE OBSERVATIONAL STUDIES IN ORTHODONTICS: A METHODOLOGICAL STUDY

To identify and summarize the presence and characteristics of dental patient-reported outcomes (dPROs) and dental patient-reported outcome measures (dPROMs) within comparative observational studies published in 5 leading orthodontic journals. Electronic searching was performed to identify intervention (therapeutic or preventive) related comparative observational studies published in selected journals between 2015 and 2021. Two authors extracted the characteristics of each included study independently and in duplicate and summarized the dPROs and dPROMs used in these studies. All dPROs were classified into 2 general types (oral health-related quality of life [OHRQoL] and others), while dPROMs were divided into 3 categories (single-item questionnaires, generic multiple-item questionnaires, and specific multiple-item questionnaires). In addition, dPROMs were examined, if they evaluated the 4 dimensions of OHRQoL (oral function, orofacial pain, orofacial appearance, and psychosocial impact). A total of 683 observational studies were eligible and included of which 117 (17.1%) used dPROs and dPROMs. Seven different dPROs (OHRQoL, patients' satisfaction with treatment, preferences, concerns, compliance, duration, and unwanted events) and 33 different dPROMs (including 8 single-item questionnaires, 11 generic multiple-item questionnaires, and 14 specific multiple-item questionnaires) were identified in these studies. OHRQoL was the most commonly used dPRO (92/117, 78.6%), while Oral Health Impact Profile 14 (OHIP-14) was the most frequently used dPROM (20/92, 21.7%). In terms of study design, cross-sectional studies had the highest proportion of dPRO usage (62/148, 41.9%), followed by cohort studies (63/505, 12.5%) and case-control studies (1/30, 3.3%). Only one-sixth of comparative observational studies published in leading orthodontic journals could reflect patients' perspectives. Observational studies in orthodontics need to provide more patient-important information through the use of dPROs and dPROMs.

L’accouchement des femmes enceintes de jumeaux : les enseignements de l’étude nationale observationnelle prospective comparative JUMODA

ObjectivesTo summerize the results of the JUMODA study (JUmeaux MODe d’Accouchement) on the planned mode of delivery of twin pregnancy and the management of second twin delivery. MethodsJUMODA was a national observational prospective comparative study that took place between february 2014 and march 2015 in 176 french maternity units performing more than 1500 deliveries per year. Its main objectives were the comparison of neonatal and maternal morbidity according to the planned mode of delivery and the determination of the managements of second twin delivery associated with the best neonatal outcomes. To control for potential confounding factors and indication biases, statistical analyses comprized multivariate logistic regressions and matching on propensity scores. ResultsThe JUMODA study recruited 8823 women with twin delivery at or beyond 22 weeks of gestation. For twin pregnancies with a cephalic first twin at 32 weeks of gestation and beyond, severe neonatal morbidity was higher in the planned cesarean (150/2908 (5.2 %) than in the planned vaginal delivery group (199/8922 (2.2 %), aOR 1.56, 95 % CI 1.19-2.04). Increased neonatal morbidity in the planned cesarean delivery group was explained by higher severe morbidity in neonates born preterm (aOR 1.64, 95 % CI 1.13-2.39, for deliveries between 32+0 and 34+6 weeks of gestation, aOR 2.04, 95 % CI 1.22-3.41, for deliveries between 35+0 SA and 36+6 weeks of gestation) but not in neonates born at term (aOR 1.19, 95 % CI 0.58-2.44). In comparison with planned cesarean delivery, planned vaginal delivery was not associated with increased severe neonatal morbidity in case of breech presenting first twin after 32 weeks of gestation or with decreased survival witout severe neonatal morbidity in case of delivery before 32 weeks of gestation whatever the first twin presentation. In comparison with planned vaginal delivery, planned cesarean delivery was associated with increased severe maternal morbidity only in women aged 35 and higher. Delivery of non cephalic second twin was associated with similar severe neonatal morbidity rate than delivery of cephalic second twin. Finally, in case of cephalic second twin, internal version followed by total breech extraction was associated with less cesarean for the second twin but with higher severe neonatal morbidity in case of preterm birth in comparison with pushing efforts, ocytocin perfusion and artificial rupture of membranes. ConclusionsPlanned vaginal delivery is the planned mode of delivery to encourage for the majority of pregnant women with twins, whatever first twin presentation and gestational age at delivery. No management of cephalic second twin appears better than an other, its choice will rest on obstetrician preferences.

Risk Factors and Functional Outcome of Ischemic Stroke Vis-à-vis Hemorrhagic Stroke at a Tertiary Care Hospital in North India

Abstract Background: Worldwide, stroke is the most common cause of death after coronary artery disease (CAD). The risk factor stratification and prognostication of stroke patients are vital in planning and allocating health-care resources. Methods: We conducted a prospective, comparative observational study. Fifty age- and sex-matched cases each of ischemic stroke (IS) and intracerebral hemorrhage (ICH) stroke were enrolled, and baseline demographic, risk factor profile, Glasgow Coma Scale, modified Rankin scale (mRS), and Barthel Index (BI) were recorded, and the cases were followed up for 90 days or till death. We looked at the risk factors associated with IS and ICH and functional outcome of IS vis-à-vis ICH using mRS and BI at 90 days postenrollment. We also compared the mortality of IS vis-à-vis ICH. Results: The presence of hypertension (100% vs. 88%) and smoking (50% vs. 26%) was significantly higher in ICH (P < 0.05). The presence of diabetes mellitus (40% vs. 18%) and CAD (12% vs. 2%) was significantly more in IS cases (P < 0.05). Consumption of alcohol was more prevalent in ICH patients compared to IS patients (30% vs. 24%). Based on mRS and BI at 90 days, ICH cases had significantly poorer functional outcome compared to IS cases (P < 0.0001). Mortality of IS cases (4%) was also significantly less compared to ICH cases (30%). Conclusions: A combination of hypertension, smoking, and history of alcohol consumption had a higher predilection for the occurrence of ICH, whereas a combination of hypertension, diabetes mellitus, and CAD favored the occurrence of IS. The functional outcome of cases of ICH 90 days poststroke was significantly poorer compared to IS cases. The most important factors for poor outcome of ICH cases were more stroke severity at baseline compared to IS cases and the presence of intraventricular hemorrhages in some cases. Mortality was also found to be more in patients with ICH compared to IS.

Comparing the efficacy of blind vs. ultrasound-guided injections in Lateral Epicondylitis: A prospective analysis

Lateral epicondylitis is a relatively common non-traumatic elbow disorder. It is a painful musculoskeletal condition that usually follows forceful repetitive pronation and supination. The aim of this study was to evaluate the advantages of ultrasound-guided injection in patients of Lateral Epicondylitis in comparison to non-image-guided blind injections. This comparative observational study was conducted on sixty patients who had clinical diagnosis of Lateral Epicondylitis. They were divided into two groups of thirty each (randomization done on odd even manner), one group underwent US-guided injections and the other group underwent the blind procedure by a specialist. Pain relief using the Visual Analog Scale (VAS) {score of 0–10} was recorded before the procedure, immediately after the procedure, one-week post-procedure, and six weeks post-procedure. Demographic characteristics, chief complaints, duration of symptoms, previous treatment taken, and complications post-procedure were gathered and compared between the two groups. All patients in both groups finished the period of study. Significant improvement in pain score and tenderness was found in both groups immediately after the injection, one-week post-procedure, and after six weeks post-procedure when compared to the baseline value (p value < 0.05). The US-guided group showed a better reduction in VAS scores immediately after the procedure and one-week post-procedure as compared to patients who were given blind injections, however no statistical difference was found at six weeks follow up. This study shows that US-guided injection relatively improves elbow pain and functional activities early and more effectively than blind/non-image-guided injections, although such results fade as time passes by.

Clinical effectiveness of screening for age-related macular degeneration: A systematic review

Introduction Age-related macular degeneration (AMD) is an eye disease that occurs in patients over 50 years old. Early diagnosis enables timely treatment to stabilize disease progression. However, the fact that the disease is asymptomatic in its early stages can delay treatment until it progresses. As such, screening in specific contexts can be an early detection tool to reduce the clinical and social impact of the disease. Objective Assess the effectiveness of screening methods for early detection of AMD in adults aged 50 years or older. Methods A systematic review of comparative observational studies on AMD screening methods in those aged 50 years or older, compared with no screening or any other strategy. A literature search was conducted in the MEDLINE (via PubMed), Embase, Cochrane Library and Lilacs database. Results A total of 5,290 studies were identified, three of which met the inclusion criteria and were selected for the systematic review. A total of 8,733 individuals (16,780 eyes) were included in the analysis. The screening methods assessed were based on optical coherence tomography (OCT) compared with color fundus photography, and OCT and telemedicine testing compared to a standard eye exam. Conclusion The systematized data are limited and only suggest satisfactory performance in early screening of the population at risk of developing AMD. OCT and the telemedicine technique showed promising results in AMD screening. However, methodological problems were identified in the studies selected and the level of evidence was considered low.

The Effect of Phototherapy on Various Biochemical Parameters in Neonatal Hyperbilirubinemia

Phototherapy (PT) is the current modality of choice for treatment of unconjugated hyperbilirubinemia. The effects of PT onvarious biochemical parameters including serum calcium, bilirubin profile, serum total protein, albumin, urea, creatinine,serum electrolytes in neonates are a concern in current times. Like any other treatment, PT also has its own side effects.This hospital-based, prospective, comparative observational study was conducted with the objective to assess the level ofvarious biochemical parameters like serum calcium, serum sodium, serum potassium, serum chloride, serum urea and serumcreatinine, serum total protein and serum albumin in addition to serum bilirubin before PT and after completion of 48 hoursof PT in full-term neonates with unconjugated hyperbilirubinemia at a tertiary care center. On comparing biochemicalparameters, a statistically significant difference in parameters such as bilirubin, urea, creatinine, sodium, potassium, chloride,calcium, total protein and albumin was observed after PT. On the other hand, there was a statistically nonsignificant differencein corrected calcium (p = 0.945).

Book selection behaviors of emergent readers

Using an observational comparative case study, this study explored emergent readers’ book selection behaviors within their classrooms. Emergent literacy skills are the forefront of literacy development (Clay, 1982; Ferriero &amp; Teborsky, 1982; Teale, 1986; McNaughton, 1993; Chall, 1996; Neuman, 2000), yet reading motivation and engagement has largely focused on older students (Wigfield &amp; Guthrie, 1997; Gambrell et al. 2011; Marinak, 2013), and emergent readers’ motivation and book choice research has relied upon surveys (Saracho, 1986; Sperling, et al., 2013). This study of two pre-kindergarten and two kindergarten classrooms, along with their classroom teachers, utilized observations to examine emergent reader motivation and choice (Bronfenbrenner, 1979, 2005; Bronfenbrenner &amp; Morris, 2006; Clay, 1982, 1991, 2001; Rosenblatt, 1978, 1995). The observational data were analyzed for vertical and horizontal case analysis and findings suggest that emergent and early readers’ text selection behaviors rely on cover illustrations and familiarity with the text.

Direct oral anticoagulants versus vitamin k antagonists in patients with atrial fibrillation and bioprosthesis: a systematic review and meta-analysis

Abstract Background/Introduction The large randomized clinical trials published to date have shown that direct oral anticoagulants (DOACs) are as or more effective than vitamin K antagonists (VKAs) in the prevention of thromboembolic events in atrial fibrillation (AF) and generally show a better bleeding risk profile. However, patients with bioprosthetic valves have been underrepresented in RCTs. The aim of this study was to assess the safety and efficacy of DOAC in patients with AF and bioprosthetic valves through a systematic review and meta-analysis including recent evidence from comparative cohort studies and real-world results. Methods A systematic review of the scientific literature and a subsequent meta-analysis were carried out. We included RCTs or comparative observational studies, published from January 2017 to January 2022 comparing DOACs versus vitamin K antagonists in patients with AF or atrial flutter and bioprostheses. We collected data of all-cause mortality, major bleeding, and systemic embolism. The primary outcome of interest was all-cause mortality. Secondary outcomes were systemic embolism or stroke. The primary safety outcome was major bleeding. Results Our analysis included 12 studies, 4 RCTs and 8 observational studies that enrolled a total of 30.283 patients. All-cause mortality 6 observational and 3 RCT were combined. A 9% reduction was found for all-cause mortality in patients treated with DOACs (HR,0.91; P=.0068;95%CI,0.85–0.97;I2=8%). Stroke and systemic embolism 4 RCT and 8 observational studies were combined. No evidence showing a significant effect of DOAC therapy on risk reduction for stroke and embolism was obtained (HR, 0.87; P =.29; 95%CI, 0.67–1.14; I2=45%). Major bleeding The results of the 12 studies were combined. A robustness analysis was performed, and the ENVISAGE RCT was identified as atypical. We therefore proceeded to re-run the meta-analysis without this study’s results. The overall effect size was HR, 0.79 (P = .0001; 95%CI, 0.73-0.85; I2 = 0%), with a 21.1% reduction of major bleeding with DOAC therapy compared with VKA. The present study has several limitations. It has the inherent limitations of the studies included and the combination of findings from comparative observational cohort studies and ad hoc studies from RCTs, which entails a potential source of bias. Second, individual risks for each type of bioprosthesis were not studied. Finally, the four currently marketed DOACs were included in our meta-analysis, but their efficacy and safety were not evaluated separately. Conclusions Our study found that DOAC therapy is associated with a significant reduction of all-cause mortality with no significant increase in the risk of systemic embolism or stroke. This reduction could be attributed to a decrease in major bleeding. Our results therefore suggest that DOACs could be a safer alternative than VKAs in this group of patients.

Abstract 13801: Gender Disparity in Clinical and Management Outcomes in Patients With Pulmonary Embolism: A Systematic Review and Meta-Analysis

Introduction: Gender is a unique characteristic that may contribute significant variation in prognostic aspects and outcomes to various clinical conditions. We aim to compile all evidence from original studies relevant to sex-based disparities in pulmonary embolism (PE) associated clinical outcomes. Methods: We conducted a systematic review and meta-analysis synthesizing observational comparative studies, which were retrieved by systematically searching: PubMed, Web of Science, SCOPUS, and Cochrane through April 12 th , 2023. We reported dichotomous outcomes using risk ratio (RR) along with the corresponding 95% confidence interval (CI). Results: We included 18 studies with a total of 1,339,937 patients. There was no difference between men and women regarding all-cause mortality (RR: 0.99 with 95% CI [0.89, 1.10], P = 0.81), in-hospital mortality (RR: 0.94 with 95% CI [0.88, 1.02], P = 0.13), PE-related mortality (RR: 0.86 with 95% CI [0.68, 1.09], P = 0.21), and recurrence (RR: 1.00 with 95% CI [0.82, 1.22], P = 0.99). However, the major bleeding rate was significantly higher among women (RR: 0.69 with 95% CI [0.48, 0.98], P= 0.04). Also, there was no difference between men and women regarding catheter thrombolysis (RR: 0.96 with 95% CI [0.81, 1.14], P= 0.66) and heparin infusion (RR: 1.00 with 95% CI [0.95, 1.04], P= 0.90). Conclusion: There was no difference between men and women regarding clinical and management of PE outcomes, with a trend towards worse outcomes and decreased interventions among women, with a significant increase in major bleeding. Further policy measures are required to investigate the reasons behind this trend and if it has any clinically significant impact on patients' management and prognosis.

Earthquake-related isolated blunt thoracic trauma patients: A special population study in the emergency department

ObjectiveThe objective of this study is to compare patients with severe and mild blunt thoracic trauma, who survived an earthquake and presented to the emergency department (ED), in order to identify factors influencing the severity of trauma in earthquake-related thoracic injuries. MethodsThis retrospective, cross-sectional, observational comparative study included patients with isolated thoracic injuries due to the February 6th Kahramanmaraş earthquake. The patients were categorized into severe and mild groups based on chest trauma scoring (CTS), and their characteristics were compared. ResultsThe study included 53 patients, with 43 (88.1%) classified as having mild thoracic trauma and 10 (18.9%) classified as having severe thoracic trauma. There was no significant difference in the duration of entrapment between the groups (p = 0.824). The incidence of hemothorax, pneumothorax, rib fractures, and pneumomediastinum did not differ significantly between the two groups (p > 0.05). However, severe thoracic trauma was associated with a higher rate of lung contusion compared to the mild group (p = 0.045). The severe group exhibited significantly higher median scores for lung contusion, rib fractures, and total CTS compared to the mild group (p < 0.001). The mortality rate was significantly higher in the severe group (40%, n = 4) compared to the mild group (2.3%, n = 1) (p = 0.003). ConclusionThe duration of entrapment did not significantly affect the severity of thoracic injuries in earthquake-related blunt thoracic trauma. However, lung contusion was found to be a more prominent feature in these injuries compared to other clinical conditions such as hemothorax and pneumothorax. These findings highlight the distinct clinical implications of earthquake-related thoracic trauma and may have implications for management strategies in these cases.

Assessing safety and efficacy of microscopic and laparoscopic varicocoelectomy for varicocoele treatment: A comparative cohort study

Surgical is appropriate for 35-40% of varicocoele-induced infertility. This comparative observational study presents a comparative assessment of microscopic or laparoscopic varicocoelectomy (grade II varicocoele; n=132 cases). Sperm count, density, total motility, and forward motility rate (preoperative and postoperative 6 months), operation duration, pain at 1 month, testicular atrophy (by scrotal ultrasound at 3 months), recurrence (angiography at 6 months), and scrotal edema (at 12 months) were measured. The preoperative semen parameters were comparable between groups (P>0.05), as were certain postoperative results (total sperm count [median 162 (range 100-242) compared with median 182 (range 84-253)]; sperm density [median 47 (range 38-83) compared with median 42 (range 27-88)]; forward motility (37.18±4.14 compared with 34.13±7.79); P>0.05). However, sperm motility was higher in the microscope group (52.79±8.21 compared with 46.64±10.04; t=2.304, P=0.040). Within the microscope group, postoperative sperm density [median 47 (range 38-83)], total sperm motility (53.79±8.25), and forward motility sperm rate (37.19±4.14) demonstrated significant improvements compared with preoperative values (Z=-2.679, P=0.005; t=-4.548, P<0.001; t=-5.029, P<0.001). In contrast, the postoperative forward motility sperm rate (34.13±7.78) displayed substantial improvements compared with preoperative values (27.74±14.42) within the laparoscopic group (t=-3.895, P=0.001). Testicular atrophy occurred in neither group. Microscopic varicocoelectomy may be safer and more effective.

Comparison of Thrombocyte Indices and Immature Platelet between Preeclampsia and Normal Pregnancy

The primary pathophysiology of preeclampsia is abnormal trophoblast invasion, vasospasm, and endothelial dysfunction occurring, as well as platelet activation, increased platelet consumption, and the stimulation of the release of new platelets, which affects the platelet indices and immature platelets. This study compared the platelet indices (Mean Platelet Volume=MPV, Platelets Distribution Width=PDW, Platelet Large Cell Ratio=PLCR, and Immature Platelet Fraction (IPF) between preeclampsia and normal pregnancy. This research was an unpaired comparative analytic observational study with a cross-sectional design conducted in the Tangerang District General Hospital from February to August 2020. The platelet indices (MPV, PDW, PLCR) and IPF of preeclampsia subjects (n=33) at Tangerang District General Hospital and normal pregnant subjects (n=38) at Annisa Hospital Tangerang were examined using the Sysmex XN-1000 automatic hematology analyzer. Comparative platelet indices and IPF analysis were carried out by independent T-test or Man-Whitney test. Receiver Operating Characteristics (ROC) analysis was performed to obtain the cut-off value of the platelet indices and IPF to differentiate preeclampsia and normal pregnancy. The platelet indices and IPF were significantly higher in preeclampsia. The mean (SD) MPV was 10.86 (0.9) fL and 10. (0.89) fL, p&lt;0.001; PDW 12.7 (8.7-19.1) fL and 10.85 (8.5-15.7) fL, p&lt;0.001; PLCR 31.96 (7.02) % and 25.06 (6.92) %, p&lt;0.001; and IPF 8.50 (3.10-20.40)% and 2.75 (1.2-9.4)%, p&lt;0.001, respectively in preeclampsia and normal pregnancy. ROC analysis showed that an IPF with an AUC of 0.88 (95% confidence interval (CI) 0.78-0.95) with an IPF cut-off value of &gt;6.5% was a good marker, while the MPV cut-off &gt;10.2 fL, AUC 0.75(95% CI 0.63-0.84), PDW cut-off &gt;11.3fL, AUC 0.77 (95%CI 0.65-0.86) and PLCR cut-off &gt;26.1%, AUC 0.76 (95% CI 0.65-0.85) were good enough markers to differentiate preeclampsia from normal pregnancy. Platelet indices and IPF were statistically significantly higher in preeclampsia. The IPF parameter is a good marker, while the platelet indices can be a pretty good marker to distinguish preeclampsia and normal pregnancy. The IPF parameter and platelet indices can be proposed as a routine examination in pregnancy. Changes in IPF and platelet indices can be early signs of preeclampsia or the development of preeclampsia.

Reducing stress and anxiety in cancer patients with the use of virtual reality.

303 Background: Applications of virtual reality (VR) have impacted every sphere of civilization, from speculative architecture to the practice of medicine. Building on the body of research already showing the benefits of immersive VR experiences, the goal of our study was to determine whether the stress and anxiety experience of different types of cancer could be mitigated by using virtual reality, specifically through relaxing VR experiences. Methods: A comparative observational study was conducted at community outpatient offices for patients who wanted to improve patient experience throughout their cancer treatment. Patients who had symptoms of nausea, dizziness, and vision issues were excluded from the study. The VR intervention consisted of patients watching a relaxation VR 360 video on the YouTube app every day for one week on the Google Cardboard VR headset. Pre- and post VR intervention scores were recorded using a DASS21 questionnaire. The mean differences in scores as well as t-tests were compared between individuals to see if VR improved patient’s experience through one’s cancer treatment. Results: There were 115 subjects ( n = 115). There was an average reduction score of 6.50 points with stress seeing the biggest drop in score of 2.71 points. Breast cancer was the most common cancer diagnosis. Metastatic cancer was the cancer with the biggest change in VR intervention with an average decrease of 12.83 points. Conclusions: Virtual reality (VR) has been proven to significantly reduce the psychological discomfort, including stress, anxiety, and depression experienced during treatment, in the context of caring for cancer patients. The empirical results strongly imply that VR is an effective therapeutic intervention modality in the inpatient setting, with compelling implications for the use of VR technology in the future to lessen the physical and psychological suffering of cancer patients.[Table: see text]

Homeopathic Medicines in the Management of Dermatophytosis (Tinea Infections): A Clinico-epidemiological Study with Pre-post Comparison Design.

Dermatophytosis is a common fungal infection of the skin and nails. Insufficient data exist regarding the clinico-epidemiological profile of dermatophytosis and the usefulness of individualized homeopathic medicines (IHMs) for patients visiting a homeopathy outpatient department (OPD). This article undertakes a clinico-epidemiological profiling of dermatophytosis and the usefulness of IHMs in its management. This open-label, pre-post, comparative observational study was conducted in a homeopathy OPD from November 2018 to February 2020. IHMs were prescribed based on symptom totality and repertorization. A numeric rating scale (NRS) and the Dermatology Life Quality Index (DLQI) patient questionnaires were used, and results were analyzed using SPSS-IBM version 20. Data from a total of 103 patients, mean age 29.65 ± 15.40 years, were analyzed. Tinea cruris was the most common infection (29.1%), followed by tinea corporis (13.6%). After 3 months of treatment, significant reductions in NRS and DLQI scores were observed (8.51 ± 1.24 to 0.59 ± 0.83, p < 0.001, and 16.28 ± 5.30 to 1.44 ± 1.56, p < 0.001, respectively), with Sepia (15.5%), Sulphur (14.6%), Calcarea carbonica (11.7%), Natrum muriaticum (9.7%) and Bacillinum (8.7%) being the most frequently prescribed medicines. There was no significant correlation between occupation, sex, home location or marital status and the clinical types of dermatophytosis. No adverse events were reported. T. cruris and T. corporis were prevalent dermatophytic infections. The decrease in NRS and DLQI scores associated with homeopathy indicates its usefulness as an integrative treatment option for dermatophytosis. Further research in larger and more diverse population samples is needed.