Hospital-based Observational Study Research Articles

A comprehensive analysis of twin births: clinical characteristics, morbidity trends, and risk determinants

Background: Twin births are often associated with increased risks and complications compared to singleton births. This study aims to analyze the clinical profile, morbidity pattern, and risk factors associated with twin births, focusing on maternal characteristics, neonatal outcomes, and the prevalence of conditions such as low birth weight (LBW) and preterm births. Methods: This hospital-based observational study was conducted at a tertiary care center, involving 25 mothers who had given birth to twins and their 50 neonates. The study assessed maternal age, antenatal care, parity, medical history, and neonatal outcomes including birth weight, gestational age, respiratory and cardiac parameters, and overall health status. Data were collected through medical records and direct observations in the neonatal intensive care unit. Results: The majority of mothers (64%) were aged between 21-30 years, with a mean age of 24.8 years. A significant proportion (92%) had regular antenatal visits, and 96% were multiparous. The majority of neonates (68%) were aged ≤12 hours at assessment, with a near-equal distribution between very low birth weight (VLBW) and LBW. Preterm births were common, affecting 84% of the neonates. Respiratory challenges were evident, with 62% of neonates having SpO2 levels below 94%. The mortality rate among the neonates was 32%. Conclusions: The study highlights the high-risk nature of twin pregnancies, characterized by a significant prevalence of LBW, VLBW, and preterm births. The findings emphasize the need for enhanced prenatal care and specialized neonatal interventions. The high mortality rate among neonates indicates the critical need for targeted strategies to improve neonatal outcomes in twin pregnancies. These insights are crucial for informing clinical practices and developing comprehensive care protocols for managing twin pregnancies and their associated risks.

Incidence of neural tube defects and associated anomalies in a tertiary care hospital

Abstract Background: Neural tube defects (NTDs) are the second most common congenital malformations after cardiac anomalies. The rate of associated malformation is reported to be 17%–80%. NTDs could also be a component of syndromic process. Objective: The objective of the study was to study the incidence of NTDs and associated anomalies. Methods: A hospital-based observational study was carried out among 6934 pregnant women referred for ultrasound. Pregnant women with NTDs were included. Detailed maternal history and clinical data were recorded. All ultrasound examinations were performed transabdominally by a radiologist using a 1–5 MHz convex array transducer (Voluson S8). Results: During this period of study, a total of 6934 pregnant women were screened and 47 cases of NTDs were detected and included, giving an incidence of 6.7 in 1000 conceptions (95% confidence interval = 5.02–8.92). NTDs were more common in mothers of age group 20–30 years. Spina bifida was the most common type of NTD in 53% of the cases. The most common type of spina bifida was meningomyelocele in 56%. The most common associated central nervous system (CNS) anomaly was Chiari II malformation. Conclusion: The most common NTD was spina bifida. CNS anomalies are more commonly associated with NTDs, followed by extremity defects.

Prevalence of anti-HLA antibodies in COVID-19 convalescent plasma donors: An Indian experience

BackgroundCOVID-19 convalescent plasma is one of the experimental therapies used widely in moderately sick COVID-19 patients. However, there are a few risks involved in plasma transfusion; notably, transfusion-related acute lung injury (TRALI) caused by antibodies against human leukocyte antigens (HLA). This study was designed to assess the prevalence of anti-HLA antibodies in convalescent plasma donors using the single antigen bead method. Study Design and MethodsThis was a hospital-based observational study of consecutive plasma donors. A total of 252 samples were screened for anti-HLA Class I and Class II antibodies using the microbead assay with the identification of anti-HLA Ab in positive samples being performed using a single antigen bead assay. Luminex-based normalized background cutoff ratios of 10.8 for Class I and 6.9 for Class II and mean fluorescence intensity cutoffs of 2500 for Class I and 1500 for Class II were used for screening and the single bead assay, respectively. ResultsOf 252 screened samples, 28 (11.1%) were positive for Class I, Class II or both Class I and Class II anti-HLA antibodies in donors with no history of a previous immunizing event. Moreover, 20/252 (7.9 %) donors without any history of prior immunization had specific anti-HLA antibodies of Class I or Class II or both by the single bead assay. ConclusionsThe high prevalence of anti-HLA antibodies in our cohort of donors raises an urgent and immediate need for anti-HLA antibody screening in all convalescent plasma donors for safe therapy of COVID-19 patients.

Chances d'accouchement par voie basse chez les fœtus PAG sévère déclenchés avant terme : une étude observationnelle

ObjectiveIf a small for gestational age (SGA) foetus needs to be delivered because of severity (<3rd centile) attempting induction of labor theoretically increases the risk of caesarean section and neonatal acidosis, but these risks are poorly understood. This article aims to assess the risk of caesarean section and neonatal acidosis in attempted vaginal birth of a moderately preterm foetus in the setting of severe SGA. MethodA single-centre hospital-based observational study conducted over a period of 17 consecutive years in mothers with a single foetus in cephalic presentation with severe SGA (<3rd centile) needing foetal extraction. Neonatal acidosis was considered moderate if pH<7.10 and severe if pH<7.0. The degree of severity of SGA was estimated according to the birth weight ratio. ResultsFour hundred and thirty-four foetuses with severe SGA were included during the period, 140 of whom were born after induction (32.3%). In this group, 66.4% of women achieved a vaginal birth (66.4%; 95% CI [58.0-74.2]) and the risk of moderate or severe acidosis was doubled compared with the group of foetuses who had undergone a planned caesarean section (7.9% vs. 3.1%, OR=2.7 [1.1-6.7]). Neither gestational age nor the degree of growth restriction was significantly related to the risk of caesarean section or to the risk of moderate or severe neonatal acidosis. ConclusionIn cases of severe SGA before 37weeks' gestation, induction of labour allows vaginal delivery in two-thirds of cases. It is accompanied by a doubling of the risk of moderate or severe neonatal acidosis.

Clinicopathological profile and its association with endoscopic findings in dyspeptic patients in a tertiary care hospital: A cross-sectional study

Background: The prevalence of dyspepsia in general practice consultations ranges from 4% to 5%, whereas it accounts for approximately 20–40% of consultations in the field of gastroenterology. Aims and Objectives: This study was carried out with the objective of estimating the percentage of Helicobacter pylori-infected people who havedyspepsia  and exploring the relationship between infection and clinical manifestation. Materials and Methods: This was a hospital-based observational study conducted at a tertiary care teaching health-care facility from January 2023 to June 2023. All 50 patients with symptoms of dyspepsia were included in the study with the help of non-probability purposive sampling after their written and informed consent. A pre-designed and pre-tested structured pro forma was used to collect detailed history, clinical findings, and endoscopic findings from patients with dyspepsia. Gastritis and ulceration characteristics were observed by endoscopy, while histopathological examination (HPE) and rapid urease test (RUT) (for confirmation of H. pylori) were performed on endoscopy-obtained biopsy specimens. Results: Mean age of the patients was 46.69±15.78 with 65.4% (n=34) being males. The sample was classified into cases positive for H. pylori (13; 25%) and cases negative for H. pylori (39; 75%), according to the RUT outcome, 21.20% (n=11) had a history of smoking, 25% (n=13) had Type II DM, and 25% of patients presented with upper abdominal bloating and epigastric pain. On endoscopy, the majority of patients revealed grade III (n=22, 42.30%) gastritis and no ulceration (n=29, 55.80%), with the maximum showing a chronic non-specific lesion (n=20, 38.5%) on HPE. Comorbidities (χ2=12.56, P=0.028), endoscopic findings (χ2=10.50, P=0.032), and ulcerations (χ2=20.02, P&lt;0.001) were the significant findings associated with H. pylori infection. Conclusion: The timely identification and expeditious management of H. pylori infection are imperative to mitigate the occurrence of severe complications.

A Study Comparing Centchroman and Evening Primrose Oil in the Treatment of Benign Breast Disease

ABSTRACT Introduction: Females seeking medical attention at breast clinics commonly present with nonmalignant breast conditions, including nonspecific breast pain or distinct masses like fibroadenomas. Due to its variability, it may be difficult to quantify breast pain. The purpose of the research was to compare centchroman and evening primrose oil to identify a cost-effective, secure, and efficient treatment for benign breast disease. Material and Methods: In this prospective hospital-based observational study, 100 breast diseases with or without lumpiness for 1 year were included and divided into two groups with 50 cases each, Group-A (Centchroman) and Group-B (Evening primrose oil). Results: Centchroman exhibited a significantly greater treatment response for alleviating pain-free mastalgia compared to evening primrose oil. Additionally, centchroman showed an excellent response (P &lt; .05). Among participants with mastalgia, centchroman significantly reduced the number of mastalgia patients with tender nodularity post-treatment (P = .035) than evening primrose oil. On the basis of fibroadenoma, partial and complete response was significantly seen in higher number of cases in the centchroman group (P = .007). Conclusion: Centchroman therapy demonstrates that the treatment for benign breast disease is safe, effective, and economical.

Spatiotemporal distribution of mediastinal neoplasms: A comprehensive multi-center study

ObjectivesMediastinal neoplasms are typical but uncommon thoracic diseases with increasing incidence and unfavorable prognoses. A comprehensive understanding of their spatiotemporal distribution is essential for accurate diagnosis and timely treatment. However, previous studies are limited in scale and data coverage. Therefore, this study aims to elucidate the distribution of mediastinal lesions, offering valuable insights into this disease. Materials and methodsThis multi-center, hospital-based observational study included 20 nationwide institutions. A retrospective search of electronic medical records from January 1st, 2009, to December 31st, 2020, was conducted, collecting sociodemographic data, computed tomography images, and pathologic diagnoses. Analysis focused on age, sex, time, location, and geographical region. Comparative assessments were made with global data from a multi-center database. ResultsAmong 7,765 cases, thymomas (30.7%), benign mediastinal cysts (23.4%), and neurogenic tumors (10.0%) were predominant. Distribution varied across mediastinal compartments, with thymomas (39.6%), benign cysts (28.1%), and neurogenic tumors (51.9%) most prevalent in the prevascular, visceral, and paravertebral mediastinum, respectively. Age-specific variations were notable, with germ cell tumors prominent in patients under 18 and aged 18–29, while thymomas were more common in patients over 30. The composition of mediastinal lesions across different regions of China remained relatively consistent, but it differs from that of the global population. ConclusionThis study revealed significant heterogeneity in the spatiotemporal distribution of mediastinal neoplasms. These findings provide useful demographic data when considering the differential diagnosis of mediastinal lesions, and would be beneficial for tailoring disease prevention and control strategies.

Establishing continuum in Transcranial Doppler characteristics of IIH, migraine and healthy controls- An exploratory study

BackgroundIIH is a severe form of headache that often has superimposed migraine and often it is very difficult to distinguish the two forms of headache. Intracranial hemodynamics is a relatively unexplored means of distinguishing between the two forms of headache. ObjectivesWe aimed to study intracranial flow dynamics using Transcranial Doppler in patients with IIH, migraine, and normal controls. Materials and methodsIt was a hospital-based observational study that included 51 people with IIH, 87 people with migraine, and 101 healthy controls and all were subjected to TCD study after detailed clinical examination. Results: Mean age of patients in three groups were similar with the mean age in IIH being 33.41 ± 10.75 (age in years ± SD). Vision loss was present in 66.67% of patients with IIH, and most common field defect was generalized constriction (27.5%). Neuroimaging was abnormal in 94.11% of patients of IIH with mean CSF pressure was 31.27±5.32 cm of water. Of all the TCD-measured velocities, mean flow velocity (MFV) showed a significant difference in all three groups with (p-value <0.001). The pulsatility index, both for middle cerebral arteries as well as ophthalmic arteries showed a significant difference in the three groups with the highest values in IIH patients (p-value<.001). The mean VMR in IIH (1.11±0.32) was lower than the mean VMR in migraine (1.34±0.43) as well as controls (1.49±0.46). ConclusionTCD parameters like MFV and PI are useful parameters that show considerable variation and can be used to differentiate between IIH and migraine.

Comparative study on ultrasonic placental grading among normotensive pregnancy and pregnancy-induced hypertension and its correlation with fetal outcome

Background: Placenta is essential for the fetal well-being, growth, and development which can be evidenced as early as possible through ultrasound at 6 weeks of gestation. The placenta mediates the intrauterine interaction between a mother and her baby. Aims and Objectives: This study aims to compare the pattern of placental grading among normotensive and pre-eclampsia mothers in a tertiary care hospital. Materials and Methods: This hospital-based observational analytical study has been conducted in the labor ward and outpatient department of the Department of Obstetrics and Gynaecology, Bankura Sammilani Medical College and Hospital from April 2021 to September 2022. A total of 69 pre-eclampsia mothers (study group) and 69 normotensive mothers (control group) who fulfill inclusion and exclusion criteria were included in the study. Template was generated and analysis was done on Statistical Package for the Social Sciences software. Results: A total of 138 pregnant women with 69 pregnant normotensive and 69 pregnant preeclampsia mothers were included in the study. The mean age of the study participants was 21.3 years (standard deviation=3.6). About 81.2% and 89.9% of the normotensive and hypertensive mothers, respectively, resided in rural areas. Cesarean/instrumental delivery was higher among the hypertensive pregnant women (42.0%) when compared to normotensive pregnant women (27.5%) and it was found to be statistically significant. Birth asphyxia was observed to be higher among the neonates in the hypertensive group (15.9%) when compared to the normotensive group (4.3%) and it was found to be statistically significant. Neonatal intensive care unit admission was more among the neonates of the mother with hypertension and it was found to be statistically significant. There was no significant difference in the birth weight of the newborn with the placental grading among the normotensive pregnant women. Conclusion: Ultrasonographic placental grading could be used as a screening tool for antepartum fetal surveillance in the obstetric population. Placental grading will help us to early diagnosis and to formulate line of management and timely intervention to reduce maternal and perinatal complications.

Establishment of Labor Epidural Analgesia Service and its Assessment: An Experience in a Hospital of a Middle-Income Country.

Even though the idea of painless birth is more than 100 years old, it is still underrepresented in some parts of the world despite progress in science, education, anesthesia, spinal and epidural needles, development of catheters, new drugs, and infusion pumps. Maternal care should basically be the safety of the patient (in this case two patients) and also provide all kinds of protection in the form of a multidisciplinary team with an anesthesiologist, especially when it comes to pain therapy and anesthesia for women in labor. In this direction, our hospital departments with low or moderate volume of annual births made the decision to educate ourselves for painless childbirth and contribute more to the care of women in labor. The enthusiasm and dedication of our clinical team prevailed and today we have a high standard of labor epidural service. The aim of this study was to evaluate the establishment of the epidural labor service by comparing the effects of epidural analgesia on labor pain and the course of labor. The secondary objectives were to compare satisfaction with epidural analgesia and the impact of epidural analgesia on the delivery mode. This was a prospective observational hospital-based study conducted on100 patients after the establishment of epidural service. Parturients who were signed to receive epidural analgesia formed Group A and parturients who did not request epidural analgesia formed Group B. All parturients are induced in the delivery room with a Bishop score of 5 or higher. Pain intensity measured through the visual analog scale of pain (VAS score) was significantly lower in Group A (n = 46) compared to Group B (n = 50) at measured points of time (p<0.001). There was a fall in the mean VAS score in Group A from 7.94 to 3.86 within 20 minutes of the bolus dose and starting a continuous infusion.Labor progress according to the Bishop score and till the end of the second stage of labor, or to the transfer to the operating theatre, according to the monitored time in Group A was 176 minutes and it was lower in Group B with 155 minutes; however, by test of linearity we do not gain significance(p = 0.2). There were eight parturients in each group(17% vs 16%) who were indicated for surgical delivery. According to Pearson's correlation test for the outcome of labor between parturients receiving epidural analgesia and parturients without epidural analgesia (p = 0.8), we cannot say that epidural analgesia in labor is correlated with the outcome of surgical delivery. Establishing a new hospital procedure such as an epidural painless service for childbirth in low or moderate-volume settings of annual births is very challenging. By evaluating epidural labor services in our hospital, we created the best environment for continuous improvement and long-term efficacy and safety of our analgesic techniques aimed at providing excellent care to mothers and their babies.

Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study

BackgroundNeonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH).Material and methodologyThis was a prospective hospital-based observational study conducted at the Neonatal Ward – MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis.ResultsOut of 180 neonates, 39.4% (71/180) had birth weight between 1500 − 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82–0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland–Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement.ConclusionThe results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

Diagnostic Utility of Reticulocyte Hemoglobin Equivalent Parameter in the Evaluation of Microcytic Hypochromic Anemia – Our Experience from Northeast India

Abstract Background: Reticulocytes are red blood cell precursors with an average lifespan of 1–2 days. Reticulocyte hemoglobin equivalent (Ret-He) is an early marker of iron deficiency (ID) erythropoiesis and reflects real-time information regarding the synthesis of young erythrocytes in the bone marrow. The objective of this study is to determine the diagnostic utility of Ret-He in patients having microcytic hypochromic anemia in comparison with serum ferritin and iron studies. Objectives: The objective of this study is to determine the diagnostic utility of the Ret-He parameter in patients having microcytic hypochromic anemia in comparison with the serum ferritin, iron studies and its role in routine hematological screening for nutritional deficiency anemia like ID. Design and Settings: The design involves observational study Materials and Methods: A hospital-based observational study was carried out in a referral hospital. Hematological parameters were processed using Sysmex XN1000 (Sysmex Corporation, Kobe, Japan) analyzer and were compared with Serum iron studies using biochemistry analyzer (VITROS® 250 Chemistry System) from 201 participants who presented with microcytic hypochromic anemia. Main Outcome and Measures: Relationship of Ret-He parameter and its diagnostic utility for screening of iron-deficient states. Sample Size: The sample size was 201. Results: When serum ferritin is taken as “the gold standard” to detect ID, with Ret-He cutoff of 27.15 pg/cell, we found a statistically significant positive correlation between Ret-He and serum ferritin (P &lt; 0.001). We found a sensitivity of 57.37% and specificity of 75.95% with area under the curve of 0.681, positive predictive value of 100%, negative predictive value of 3.8%, and accuracy of 62.19% for Ret-He in detecting ID anemia (IDA). Also found a statistically significant negative correlation between Ret-He and total iron binding capacity (P &lt; 0.001). There was no statistical correlation between Ret-He and serum iron levels in our study. Conclusions: The present study suggests Ret-He is one of the better and more reliable hematological parameters indicating ID and, when used along with biochemical parameters like serum ferritin, can give valuable inputs in a better screening and diagnosis of IDA; hence proper treatment is possible. Limitations: The multicentric study is required to standardize Ret-He reference values, and follow-up to therapy of the subjects was not done. Additional hemoglobin variant analysis data would have been favorable to the study.

Effects of hospice-shared care on terminal cancer patients in Taiwan: A hospital-based observational study

PurposeTo assess how hospice-shared care (HSC) affected the likelihood of aggressive medical treatments and the life quality among terminal cancer patients. MethodsIn the first part, a cohort of 160 late-stage cancer patients who died in non-hospice wards were identified to review their charts in their last 22 days before death. In the second part, a total of 19 late-stage cancer patients with clear consciousness admitted to non-hospice wards were identified to investigate their quality of life for the final 2 weeks before death. ResultsThe utilization rate of HSC was 55.6%. Among these, the rate for late referral to HSC (≤7 days before death) was 43.8% and early referral (>3 months before death) was 5.6%. Compared to the non-HSC group, in the last few weeks of life, the HSC group underwent lower incidence of chemotherapy use (10.1% vs. 39.4%, p < .001), signed do-not-resuscitate orders (0% vs. 21.1%, p < .001), emergency room visits (13.5% vs. 40.8%, p < .001), intensive care unit admission or ventilator use (2.2% vs. 11.3%, p = .019), and endotracheal intubation (2.2% vs. 9.9%, p = .038). However, the quality of life did not appear to have obvious differences between the two groups (p > .05). ConclusionIn Taiwan, late HSC referral in terminal cancer patients is common. HSC is associated with a reduced likelihood of aggressive medical utilization. However, the effect of HSC in improving patients’ quality of life in the last few weeks needs to be further evaluated.

Four-Year Progression of Myopic Maculopathy in Children and Adolescents With High Myopia

Individuals with high myopia younger than 18 years are at relatively high risk of progressively worsening myopic maculopathy. Additional studies are needed to investigate the progression of myopic maculopathy in this age group, as well as the risk factors associated with progression. To investigate the 4-year progression of myopic maculopathy in children and adolescents with high myopia, and to explore potential risk factors. This hospital-based observational study with 4-year follow-up included a total of 548 high myopic eyes (spherical power -6.00 or less diopters) of 274 participants aged 7 to 17 years. Participants underwent comprehensive ophthalmic examination at baseline and 4-year follow-up. Myopic maculopathy was accessed by the International Photographic Classification and Grading System. The data analysis was performed from August 1 to 15, 2023. The progression of myopic maculopathy progression over 4 years and associated risk factors. The 4-year progression of myopic maculopathy was found in 67 of 548 eyes (12.2%) of 274 participants (138 girls [50.4%] at baseline and 4-year follow-up) with 88 lesion changes, including new signs of the tessellated fundus in 16 eyes (18.2%), diffuse atrophy in 12 eyes (13.6%), patchy atrophy in 2 eyes (2.3%), lacquer cracks in 9 eyes (10.2%), and enlargement of diffuse atrophy in 49 eyes (55.7%). By multivariable analysis, worse best-corrected visual acuity (odds ratio [OR], 6.68; 95% CI, 1.15-38.99; P = .04), longer axial length (AL) (OR, 1.73; 95% CI, 1.34-2.24; P < .001), faster AL elongation (OR, 302.83; 95% CI, 28.61-3205.64; P < .001), and more severe myopic maculopathy (diffuse atrophy; OR, 4.52; 95% CI, 1.98-10.30; P < .001 and patchy atrophy; OR, 3.82; 95% CI, 1.66-8.80; P = .002) were associated with myopic maculopathy progression. In this observational study, the progression of myopic maculopathy was observed in approximately 12% of pediatric high myopes for 4 years. The major type of progression was the enlargement of diffuse atrophy. Risk factors for myopic maculopathy progression were worse best-corrected visual acuity, longer AL, faster AL elongation, and more severe myopic maculopathy. These findings support consideration of follow-up in these individuals and trying to identify those at higher risk for progression.

Outcomes of 3-year follow up with induction vs first line chemotherapy in oral cancer patients: An observational hospital-based study.

Our study aims to analyse and compare the efficacy, adverse effect profile and survival among the Paclitaxel/Cisplatin/5-Flurouracil (TPF) induction chemotherapy and Paclitaxel/carboplatin (PC) first line or cisplatin chemotherapy in a high-volume tertiary care cancer centre. 215 patients with oral cavity cancer were recruited in this study. Patients with stages I-IIc underwent surgical resection or radiation therapy 66-74 GY/fraction. Patients of Stages III-IV were administered with either induction chemotherapy TPF or PC or cisplatin regimen. Treatment responses were assessed by CT and MRI. Response rates, survival and adverse effects data were tabulated and analysed. The mean age was 49.2 ± 11.68 years. Symptoms were ulceration (33.5%), growth (20.5%), pain (13%), ulcer-proliferative growth (8.4%) and swelling (13, 6%). The tumour site was found at the base of the tongue, C01 (42.2%) followed by C06 (35.8%), C08 (6.5%), C07 (5.2%) and C05 (4.6%). There were no significant differences (P > 0.05) in efficacy and survival outcomes between the different groups of treatment. Median survival was achieved within 36 months. The major side effect observed were anaemia (15.81%), diarrhoea (36.2%), dyspepsia (28.8%), fever (33.95%), mucositis (28.85%), myalgia (33.95%) and nausea (7.9%). Survival among the responder categories (CR, PR and NR) was significantly different as per Log-rank analysis (P = 0.015). TPF induction therapy and PC first line chemotherapy showed similar efficacy, safety profile and survival whereas cisplatin shows poor efficacy and safety and survival in Indian oral cancer patients.

Predictive Performance of Machine Learning–Based Models for Poststroke Clinical Outcomes in Comparison With Conventional Prognostic Scores: Multicenter, Hospital-Based Observational Study

Background Although machine learning is a promising tool for making prognoses, the performance of machine learning in predicting outcomes after stroke remains to be examined. Objective This study aims to examine how much data-driven models with machine learning improve predictive performance for poststroke outcomes compared with conventional stroke prognostic scores and to elucidate how explanatory variables in machine learning–based models differ from the items of the stroke prognostic scores. Methods We used data from 10,513 patients who were registered in a multicenter prospective stroke registry in Japan between 2007 and 2017. The outcomes were poor functional outcome (modified Rankin Scale score &gt;2) and death at 3 months after stroke. Machine learning–based models were developed using all variables with regularization methods, random forests, or boosted trees. We selected 3 stroke prognostic scores, namely, ASTRAL (Acute Stroke Registry and Analysis of Lausanne), PLAN (preadmission comorbidities, level of consciousness, age, neurologic deficit), and iScore (Ischemic Stroke Predictive Risk Score) for comparison. Item-based regression models were developed using the items of these 3 scores. The model performance was assessed in terms of discrimination and calibration. To compare the predictive performance of the data-driven model with that of the item-based model, we performed internal validation after random splits of identical populations into 80% of patients as a training set and 20% of patients as a test set; the models were developed in the training set and were validated in the test set. We evaluated the contribution of each variable to the models and compared the predictors used in the machine learning–based models with the items of the stroke prognostic scores. Results The mean age of the study patients was 73.0 (SD 12.5) years, and 59.1% (6209/10,513) of them were men. The area under the receiver operating characteristic curves and the area under the precision-recall curves for predicting poststroke outcomes were higher for machine learning–based models than for item-based models in identical populations after random splits. Machine learning–based models also performed better than item-based models in terms of the Brier score. Machine learning–based models used different explanatory variables, such as laboratory data, from the items of the conventional stroke prognostic scores. Including these data in the machine learning–based models as explanatory variables improved performance in predicting outcomes after stroke, especially poststroke death. Conclusions Machine learning–based models performed better in predicting poststroke outcomes than regression models using the items of conventional stroke prognostic scores, although they required additional variables, such as laboratory data, to attain improved performance. Further studies are warranted to validate the usefulness of machine learning in clinical settings.

IR808@MnO nano-near infrared fluorescent dye’s diagnostic value for malignant pleural effusion

BackgroundMalignant pleural effusion is mostly a complication of advanced malignant tumors. However, the cancer markers such as carbohydrate antigen 125 (CA 125), carbohydrate antigen 15-3 (CA 15-3), carbohydrate antigen 19-9 (CA 19-9), and cytokeratin fragment 21-1 (CYFRA 21-1) have low sensitivity and organ specificity for detecting malignant pleural effusion.Research questionIs IR808@MnO nano-near infrared fluorescent dye worthy for the diagnosis in differentiating benign and malignant pleural effusions.Study design and methodsThis experiment was carried out to design and characterize the materials for in vitro validation of the new dye in malignant tumor cells in the A549 cell line and in patients with adenocarcinoma pleural effusion. The dye was verified to possess tumor- specific targeting capabilities. Subsequently, a prospective hospital-based observational study was conducted, enrolling 106 patients and excluding 28 patients with unknown diagnoses. All patients underwent histopathological analysis of thoracoscopic biopsies, exfoliative cytological analysis of pleural fluid, and analysis involving the new dye. Statistical analyses were performed using Microsoft Excel, GraphPad Prism, and the R language.ResultsThe size of IR808@MnO was 136.8 ± 2.9 nm, with peak emission at 808 nm, and it has near-infrared fluorescence properties. Notably, there was a significant difference in fluorescence values between benign and malignant cell lines (p < 0.0001). The malignant cell lines tested comprised CL1-5, A549, MDA-MB-468, U-87MG, MKN-7, and Hela, while benign cell lines were BEAS-2B, HUVEC, HSF, and VE. The most effective duration of action was identified as 30 min at a concentration of 5 μl. This optimal duration of action and concentration were consistent in patients with lung adenocarcinoma accompanied by pleural effusion and 5 μl. Of the 106 patients examined, 28 remained undiagnosed, 39 were diagnosed with malignant pleural effusions, and the remaining 39 with benign pleural effusions. Employing the new IR808@MnO staining method, the sensitivity stood at 74.4%, specificity at 79.5%, a positive predictive value of 69.2%, and a negative predictive value of 82.1%. The area under the ROC curve was recorded as 0.762 (95% CI: 0.652–0.872). The confusion matrix revealed a positive predictive value of 75.7%, a negative predictive value of 75.6%, a false positive rate of 22.5%, and a false negative rate of 26.3%.InterpretationThe IR808@MnO fluorescent probe represents an efficient, sensitive, and user-friendly diagnostic tool for detecting malignant pleural fluid, underscoring its significant potential for clinical adoption.

Cervical cancer awareness, knowledge, behavioural patterns, and practice of screening and vaccination in females of hilly regions of North India - A hospital-based observational study.

The mainstay of cervical cancer elimination and control is an effective screening and education program. The present study was conducted to assess awareness about cervical cancer, knowledge of cervical cancer symptoms, risk factors, screening and vaccination, attitude towards various aspects of cervical cancer, and screening and vaccination practices amongst women of Uttarakhand. The present study was a prospective observational study. A total of 215 patients were recruited from Gynecology OPD, AIIMS, Rishikesh, from January to December 2021, and 195 women meeting the eligibility criterion were finally analyzed based on the KAP questionnaire interview method. The study population had 40% illiterate participants. Of all participants, 87% were aware of cervical cancer as a disease entity, only 0.5% had good knowledge, and 99.5% had poor knowledge of symptoms, risk factors, screening, and vaccination for cervical cancer. 87% showed a favourable attitude. Only 1 out of 195 participants was ever screened previously, and none of them were vaccinated. The main hindrance in the context of hilly or challenging-to-serve areas is mainly the education and information services. The resource allocation to difficult health-inaccessible areas is required to bring a major change in practices for prevention of cervical cancer; this can be dramatically improved by population-based screening and vaccination programs at affordable prices.

A Clinico-Epidemiological Study of Fixed Drug Eruption with a Special Focus on the Causative Agent and the Clinical Patterns.

Fixed drug reaction (FDE) is characterized by the development of well-circumscribed, round, erythematous macules and plaques on cutaneous or mucosal surface following ingestion of the offending drug. To study the etiological agents responsible for FDE and to study the clinical patterns of FDE due to different drugs. It was a hospital-based observational cross-sectional clinical study. The study period was 24 months. Fifty patients were included. The study was done after a literature search, hypothesis generation, protocol write-up, ethical submission, ethical clearance, patient enrollment, data collection, data analysis, and research. The patients were selected on the basis of the Naranjo scoring system. The patients with a history of combination drug intake were not included in the study. A total of 0.11% patients presented with FDE in the study period. Out of them, 52% of the patients belonged to 20-39 years age group, having sex ratio of 1.6:1. About 64% of the patients presented with multiple lesions, whereas 36% had a single lesion. A total of 46% patients presented with first episode and 54% had recurrent episodes. The mean time intervals of first and subsequent episodes were 6.5 days and 4.3 hours, respectively. Also, 16% patients had a history of herpes infection. Extremities were more affected followed by trunk and mucosa. Fluoroquinolones were the most common etiological agent found in 56% patients having cutaneous (48%) and mucosal lesions (14%). The most common drug was norfloxacin (36%) followed by both paracetamol (12%) and metronidazole (12%). Fluoroquinolones were the most common drugs implicated in bullous lesions and generalized bullous FDE. The study population was small and the study was for a limited period of time. The patient should be aware of the offending drug and opt for any alternative agent after visiting the physician.

The Hidden Battle Within: Shedding Light on the Co-existence of Sarcopenia and Sarcopenic Obesity among Participants with Type 2 Diabetes in a Tertiary Care Hospital, Gujarat.

Type 2 diabetes (T2DM) is characterised by chronic hyperglycaemia due to abnormal insulin secretion and/or utilisation. Currently, sarcopenia has emerged as a new complication of T2DM, which increases the risk of physical disability, and even death. The study aims to estimate the prevalence of sarcopenia and sarcopenic obesity (SO) as well as their association with various other factors related to T2DM. The study was an observational hospital-based cross-sectional study conducted among diabetic patients who came to the non-communicable diseases (NCD) clinic of a tertiary care hospital in Gujarat, India, from April 2023 to June 2023. Adult patients with T2DM attending follow-ups were included, with a diagnosis of T2DM for at least 1 year from the date of their electronic medical records, regardless of their mode of therapeutic treatment. They were on regular medical reviews with two or more visits to the study site in the past 1 year. Then a self-structured standard questionnaire was used to collect the data, containing socio-demographic characteristics, clinical profiles, anthropometric assessment (comprising weight, height and body mass index [BMI]), bio-impedance indices like body fat%, skeletal muscle% and handgrip by hand dynamometer. In the study, a total of 404 participants participated. Their mean age was 55 ± 13.5 years and their mean body fat (BF) % was 30 ± 7.4%. BF%-defined obesity was found in 260 (64.4%) participants. A total of 362 (89.6%) had possible sarcopenia, 183 (45.3%) had sarcopenia and 124 (30.7%) had SO. Age (OR: 2.6, CI: 1.7-3.9), duration of diabetes for more than 7 years (OR: 7.5, CI: 3.65-15.4) and BF%-defined obesity (OR: 2.2, CI: 3.6-15) were statistically associated with Sarcopenia, in similar pattern age (OR: 2.4, CI: 1.5-3.7), and duration of diabetes more than 7 years (OR: 18.9, CI: 5.7-62) were associated with SO (P < 0.05). Older age, longer diabetes duration and BF%-defined obesity are associated with an increased likelihood of developing sarcopenia and sarcopenic obesity. Healthcare providers should prioritise regular screening for sarcopenia and SO in elderly individuals with diabetes to facilitate early detection and intervention.