Tertiary Care Hospital In Mumbai Research Articles

A Prospective Observational Study of Abnormal Uterine Bleeding in Females of Reproductive Age Group at a Tertiary Care Hospital in Mumbai, India

A Prospective Observational Study of Abnormal Uterine Bleeding in Females of Reproductive Age Group at a Tertiary Care Hospital in Mumbai, India

Study on the Effect of Maternal Haemoglobin on Birth Weight of Newborn Babies

Background: Anemia is a very common condition found in pregnant women, which has a deleterious effect on foetal wellbeing including weight gain of fetus. Studies indicate that anemia in pregnancy is a risk factor low birth weight and possibly for inferior neonatal health. The present study is done to determine the effect of the maternal hemoglobin on birth weight. Methods: An observational cross-sectional study was carried out at a tertiary care hospital in Mumbai. All pregnant females with single live pregnancy were included in this study. After the selection criteria was satisfied, all term babies born to pregnant females with single live pregnancy were examined and birth weight was recovered on a digital weighing scale. Results: Among the anemic mothers, 39 (27.3%) had mild anemia (Hb: 10 – 10.9), 32 (22.4%) had moderate anemia (Hb: 7 – 9.9) and 9 (6.3%) had severe anemia (Hb: <7). Of the 143 newborns born to those mothers, 74 (51.7%) weighed between 2500 – 3500 grams, 56 (39.2%) were low birth weight (<2500g) babies and only 13 (9.1%) were above 3500 grams. Conclusions: According to our study, anemic mothers delivered babies with low birth weight than nonanemic mothers. Present study showed prevalence of low-birth-weight babies to be 39.2%. Interventions to reduce low birth weight should be specific for specific populations. Approaches to improve the health of the women are needed to reduce the low-birth-weight problem in India. Keywords: Maternal haemoglobin, Anemia, Low birth weight.

IJCM_412A: Self Medication Practices Among Patient Attending Fever Opd At Tertiary Care Hospital In Mumbai.

Background: Self-medication is defined as the use of drugs to treat self- diagnosed disorders or symptoms, or the intermittent or continued use of a prescribed drug for chronic or recurrent disease or symptoms. The practice of self-medication is common worldwide in both developed and developing countries which often leads to dangerous unwarranted adverse effects, antimicrobial resistance, ultimately increasing cost burden due to health care. Objective: The study aimed to determine the prevalence of self-medication among patients; to identify risk factors that could influence self-medication practices; to identify sources of information about medications used; and to identify reasons for self-medication. Methodology: cross-sectional study was carried out among patient, information regarding self-medication use in the past six months and associated sociodemographic factors, purpose, source of drug procurement, attitude toward self-medication use were collected. The data were obtained using a validated pretested self-administered questionnaire. The collected data will be analyzed using SPSS for descriptive and inferential statistics. Results: In our study the prevalence of Self Medication practices were observed to be 45.6%. The practice was noticed more among individuals from lower middle class family with a prevalence rate of 26%. Telling the symptoms to pharmacist was the commonest method adopted to procure drugs by the users i.e. 61%Majority of the self-medication users expressed that self-medication is harmless and 32.2 % found it effective and 88.9% said they had never experienced any adverse effects, 81.3 % consider it as acceptable practice. Conclusion: Prevalence of SM practices are high. Most common reason being poverty, confidence in self – diagnosis, In order to mitigate the negative effects of SM behaviours, additional prompt measures are required.

Profile and Geospatial Analysis of Dog Bite Cases Attending the Antirabies Vaccine Outpatient Department at the Tertiary Level Hospital of Mumbai.

Dog bites pose a significant public health concern in India, necessitating an understanding of their epidemiological profile and spatial distribution. Adopting the One Health approach, which considers the interconnection of human, animal, and environmental health, is vital for developing effective interventions. The study aimed to assess the epidemiological profile and geospatial trends of dog bite cases in an urban area, focusing on the age and gender distribution of victims, severity of bites, and spatial distribution of cases to inform prevention strategies. A retrospective secondary data analysis was conducted on dog bite cases reported in 2022 at a tertiary care hospital in Mumbai. The epidemiological profile, including age, gender, and severity of bites, was examined. Quantum Geographic Information System (QGIS) was utilized for spatial distribution analysis, identifying hotspots within the urban area. Of the 3350 cases, 70.7% were below 40 years old, 81.6% were male, and 78.18% had Category III bites indicating severe injuries. Most cases (74%) were caused by stray dogs. QGIS analysis revealed five hotspots within the urban area. The study highlights the predominance of dog bites among younger males and the severity of injuries. Spatial analysis identified specific hotspots, underscoring the need for targeted interventions. Implementing a comprehensive surveillance system incorporating GIS technology and adopting a One Health approach can enhance the control and prevention of dog bite cases and reduce the risk of rabies outbreaks.

Effectiveness of Immune Checkpoint Inhibitors in Various Tumor Types Treated by Low, Per-Weight, and Conventional Doses at a Tertiary Care Center in Mumbai.

The cost of immune checkpoint inhibitors (ICIs) limits their accessibility to a small number of patients with cancer in low- and middle-income countries. Early-phase clinical trials have shown target inhibition and high activity at doses lower than those registered and evaluated in clinical trials. Here, we report everyday experience of using ICIs in 100 Indian patients, many of whom received lower doses of ICIs. Consecutive patients who received at least one dose of an ICI irrespective of tumor type at a tertiary care hospital in Mumbai, India, that was able to access ICIs for its patients were enrolled. The objectives were to study the doses used over a 3-year time period, and the effectiveness of therapy, assessed primarily by the overall response rate (ORR), overall survival (OS), and progression-free survival were secondary end points. Twenty-five patients were treated with conventional doses of ICIs, 29 patients received lower doses per body weight, and 46 patients received low-dose treatment. The median number of cycles received was 5 (range, 1-28). Seventy-eight patients received ICIs in a palliative setting. The median follow-up time was 10.2, 9.8, and 3.9 months for those receiving fixed approved dosing, per body weight dosing, and low-dose treatment, respectively. There was a trend with time to prescribe lower doses. Response evaluation was available for 92 patients. Twenty-one (five-adjuvant and 16-palliative) patients received ICIs only. The ORR did not differ statistically among different dosing groups, but comparisons are confounded by inclusion of different ICIs, different tumor sites, and concurrent treatments. The median OS was 6.8 (range, 4.6-9.0) months. Adoption of per-body weight and lower dosing of ICIs appears to give acceptable outcomes. Lower dosing can improve access and timely delivery of ICIs in low- and middle-income countries.

Effect of Disease-related Variables on Bone Mineral Density in Patients with Rheumatoid Arthritis.

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects the bony architecture. Nevertheless, it remains uncertain whether these effects are due to disease progression, limited mobility, or medication. We conducted this study to analyze changes in bone mineral density (BMD) in patients with RA and its relationship with various disease parameters, such as demographic factors, disease activity, functional disability, duration since onset of symptoms, cumulative steroid dose, and titers of rheumatoid factor (RF). This cross-sectional study was conducted at the Rheumatology Clinic of the Tertiary Care Hospital of Mumbai. We included 96 consecutive patients diagnosed with RA using the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria. Demographic, clinical, and biochemical data were also collected. Disease severity was assessed using the Disease Activity Score 28 with Erythrocyte Sedimentation Rate (DAS28-ESR) score, and physical disability was assessed using the Health Assessment Questionnaire (HAQ) score. BMD was calculated using dual-energy X-ray absorptiometry (DEXA). Significant variations among continuous variables were examined using the t-test, while disparities between categorical variables were evaluated using the Chi-squared test. Statistical significance was set at p < 0.05 within the 95% confidence interval (CI) range. Of the 96 patients, 77 were female, and 19 were male. The mean age of the study population was 45.28 ± 10.15 years. As the age of patients increased, BMD was found to decrease in the total lumbar spine, neck of the femur, and total hip region (p < 0.05). Sex did not seem to affect BMD. In all three regions, a decrease in BMD with increasing duration since the onset of RA symptoms was observed. Disease severity, measured using the DAS28-ESR score, did not decrease BMD. There was an increase in functional disability, calculated using the HAQ score, with a decrease in BMD at all sites. RF positivity was associated with decreased BMD at the neck of the femur and total hip region but not the total lumbar spine. Long-term use of steroids (≥30 days) decreased BMD at all three sites. Our study reiterates the effect of RA on the BMD of patients. Advanced age, duration since symptom onset, physical disability, RF positivity, and long-term corticosteroid use are disease-related factors affecting BMD in patients with RA.

Prevalence and risk factors of hearing loss in high-risk neonates at a tertiary care hospital in Mumbai

Background: The present study was conducted to assess the prevalence of hearing loss using measurements of otoacoustic emission (OAE) in newborns admitted to NICU and to determine the risk factors predictive of hearing impairment in these newborns. Methods: This was a Prospective observational study conducted among 220 newborns admitted to the NICU over 18 months. Ethical clearance was obtained from the IEC. The sample size was obtained by the universal sampling technique. All candidates underwent hearing assessment in a sound-treated room in the department using a distortion product OAEs (DPOAE) test at the time of discharge. Babies who did not pass the initial screening underwent another OAE test within one month after being discharged. If they failed the test again, they were referred to an otologist for BERA. Results: Of the 226 neonates included in the study, 40 cases (17.7%) failed the initial screening. 29 cases (12.8%) failed the second OAE screening and were subjected to BERA. Risk factors included asphyxia (p≤0.001), mechanical ventilation (p&lt;0.0004), history of ototoxic medication (p=0.004), neonates with hyperbilirubinemia requiring exchange transfusion (p=0.005), low Apgar scores (p≤0.001). Conclusions: A two-stage OAE hearing screening can be a suitable method for early detection of hearing impairment in newborns. This method has shown high prevalence of hearing loss among high-risk neonates but needs to be confirmed with diagnostic BERA. It is crucial to have universal hearing screening to detect the large number of hearing-impaired neonates in the newborn population of our country, including those who are not considered at risk.

A study of drug prescription patterns, disease-therapy awareness and of quality of life among patients with migraine visiting a tertiary care hospital in Mumbai, India

Background: Migraine is one of the leading causes of disability globally. There is scarcity of data on disease -therapy awareness and its correlation with demographic factors. Hence its was of interest to assess those along with quality of life in these patients. Methods: A Cross-sectional observational study was conducted in108 patients attending the Neurology and headache OPD at a tertiary care hospital between March 2017 and August 2018. Disease and therapy awareness among patients were evaluated using validated questionnaires and correlation was done with demographic factors. The severity of the disease and its impact on the patients' quality of life were assessed using the migraine disability assessment scale. Results: The mean disease and therapy awareness scores were 9 and 7 respectively. Both had a positive correlation with education and socioeconomic factors. The quality of life was affected moderately in 48.1% of the patients followed by severely 32.4% of the patients. The average number of drugs prescribed per encounter was 3.05. NSAIDS were used more commonly as compared to Triptans for acute attacks. Conclusions: The disease and therapy awareness were fair and positively correlated with education/ socioeconomic status. However, a significant disability was found among patients even with treatment. This highlights the need for educating these patients for effectively controlling the disability.

Study of Caesarean Section Births in a Tertiary Care Hospital in Mumbai Using Robson Classification System.

Robson ten-group classification system is recommended by WHO (World health organization) as a global standard for assessment and monitoring caesarean section (CS) rates. This classification is simple and robust. It is prospective, easily reproducible and clinically relevant. We conducted a prospective observational study of CS births at a tertiary care institute. Caesarean births in a tertiary care hospital were classified using Robson classification system as recommended by WHO. The study was conducted for period of 6months duration. The ethics committee of the institute approved this study. We enrolled 4771 consecutive women who delivered during this study period. We included patients who had vaginal delivery as well as those who had delivery by CS. Both live births and stillbirths (of at least 500-g birth weight or at least 22weeks gestation (according to WHO recommendations) were included in this study. During this study period, we had 4771 deliveries, out of which 2231 pregnant women (46.76%) were delivered by CS as compared to 2540 vaginal deliveries. Women with previous CS (term with single cephalic pregnancy) were included in Robson group 5. Group 5 had the highest CS rate (13.41%). Robson group 5, 1 and 10 were the largest contributors to the high CS rates at our institute. In our study, 4771 deliveries were conducted during this study period (6months). Out of 4771 deliveries, CS was done in 2231 pregnant women (46.76%). 2540 women had vaginal deliveries. Group 5 (13.41%) which comprised of women with previous CS had the highest CS rate followed by group 1 and group 10. The second largest contribution was from Group 1 with CS rate of 9.01%. Robson Group 1 included nulliparous term women with single cephalic pregnancy in spontaneous labour. Group 10 was the third largest contributor to the overall CS. Group 10 included women who delivered preterm (single cephalic presentation). Group 10 contributed to 8.09% of overall CS rate. We should make every effort to provide CS for women requiring this procedure, rather than work towards achieving a specific rate for CS.

Prevalence and molecular characterization of carbapenem resistant gram-negative bacilli in a tertiary care hospital in Mumbai

Carbapenem (CR) among gram-negative bacteria is a worldwide problem. It is ranked in the highest priority category in the World Health Organization (WHO) global priority list of pathogens.It is responsible for therapeutic failure in both hospital and community-acquired infections.Identifying and monitoring the local epidemiology of the carbapenem resistant organisms, understanding specific mechanisms underlying the resistance and implementing measures to prevent their spread is the need of the hour.The aim of the study was to determine the prevalence and molecular epidemiology of Carbapenem resistant Gram negative bacilli in this hospital.: A retrospective study was carried out in the Department of Microbiology of a tertiary care Hospital in Mumbai from January to December 2022. All Gram negative bacilli from various specimens were identified and antimicrobial susceptibility was reported using the VITEK2 automated system (BioMerieux, Durham, North Carolina) and interpreted as per CLSI 2022 guidelines. The resistant genes in the isolates were detected by Xpert Carba-R assay (Cepheid, Sunnyvale, CA) on request by a consulting physician.: Out of 2,351 gram negative bacilli isolates, 624 were Carbapenem resistant (26.5%). (59.9%) was the most common CR isolate. Molecular testing was done for 190 of these 624 CR isolates. In which New Delhi Metallo beta lactamase (NDM (33.68%) was the most common resistant gene identified followed by NDM &amp; OXA-48(32.63%). With the prevalence of Carbapenem resistant isolates in the settings, adherence to infection control practices and stringent implementation of antimicrobial stewardship is crucial to curb the rate of infection.

A study of seroprevalence and the associated risk factors of hepatitis C at a tertiary care hospital in Mumbai

BackgroundHepatitis C is a hepatotropic virus and shows varied presentation of signs and symptoms in positive cases. The estimated global prevalence of hepatitis C is around 1%. There is lack of data in general population in India on prevalence of hepatitis C, except in targeted population like blood banks. Aims & objectivesThe study was conducted at a tertiary care hospital to estimate seroprevalence of hepatitis C in both sexes & different age groups, association of hepatitis C with signs and symptoms, possible risk factors for the transmission and co morbidities. MethodA prospective, cross-sectional study was conducted for a period of one year (2018–2019) at a tertiary care hospital and included 600 subjects at a tertiary care hospital. A detailed history of patient was recorded. Five milliliter of blood was collected for testing Hepatitis C by ELISA test. Results were analyzed statistically. ResultHepatitis C seroprevalence of 1.8% was observed in present study. It was predominantly seen in age group 0–10yrs (7%). Significant risk factors for hepatitis C were multiple blood transfusions (38.5%). Thalassemia was a statistically significant comorbidity (1.5%) associated with hepatitis C. ConclusionHepatitis C was found more prevalent in 0–10year thalassemic age group. So, a continuous periodic screening of Hepatitis C especially in high-risk groups, like cases of Thalassemia and also in blood transfusion recipients is essential for an early diagnosis.An early diagnosis can improve clinical outcome in the patient, as appropriate therapy and management can be initiated at the earliest, thus, decreasing mortality and morbidity seen in hepatitis C cases.

Assessment of Nutrient Intake and its Association with Protein Energy Wasting in Haemodialysis Patients

Background: Protein Energy Wasting (PEW) is one of the complications associated with HD, a multi-factorial, maladaptive metabolic state characterized by loss of body protein mass and energy reserves, which is a major cause of morbidity and mortality amongst these patients. Adequate nutrient intake in dialysis patients is, therefore, a challenge due to poor appetite, and anorexia because of the build-up of uremic toxins. Therefore, this study aims to assess PEW and nutrient intake consumption in the HD population to add to the Indian database. Methods: The study adopted a cross-sectional design conducted at a tertiary care hospital in Mumbai, India. A total of 54 chronic haemodialysis patients were recruited for the study through convenience sampling. Post dialysis session, measurement of weight was recorded. An interviewer-administered questionnaire was used to record the patient details. Results: The nutrient intake on dialysis day was observed to be lower as compared to non-dialysis day. Only 5% of patients were diagnosed with PEW. A significant correlation between Energy, Protein on dialysis, and non dialysis day, along with Carbohydrate, Sodium, and Potassium intake (p-value 0.001) was observed. Conclusion: The present study found that nutrient intake of Energy, Protein, CHO, Fats, Sodium and Potassium were lower on dialysis day as compared to non dialysis day. Majority of the patients were well nourished and only 5% of patients were Protein Energy Wasted. Keywords: Protein Energy Wasting (PEW), Nutrient intake, Haemodialysis, Appetite, Diet.

Predominant polarity in bipolar affective disorder and its impact on cognition and quality of life.

Bipolar mood disorder or bipolar affective disorder (BPAD) is a chronic illness characterized by phases of mania/hypomania, depression, or mixed episodes. The course of bipolar mood disorder is relapsing in nature. It is associated with high comorbidity rates, a large number of premature deaths due to suicide, and a worse social and work performance. All of those characteristics entail a significant economic impact due to both direct and indirect costs and require an effective diagnostic and therapeutic approach. Lifetime prevalence of BPAD is approximately 4% worldwide. Various attempts have been made to define "predominance" of polarity in BPAD. Our study tries to highlight the existence of predominant polarity by comparing effects of the same on substance consumption, cognitive abilities, quality of life, and preponderance of specific polarity to specific gender. After Institutional Ethics Committee Approval and written informed consent, patients who were diagnosed with BPAD attending out-patient department of a tertiary care hospital in Mumbai were recruited. A total of 57 participants were enrolled. The World Health Organization Quality of Life - Brief Scale (WHOQOL BREF) and the Montréal Cognitive Assessment (MoCA) were both used to evaluate the patients' quality of life and cognitive ability, respectively. Men exhibited manic predominant polarity, while women had depressive predominant polarity, with P value of. 003. Regarding age, illness length, education, substance abuse, family history, and suicide attempts, there was no discernible difference in the polarities. The outcome of female bipolar patients may be improved if the clinician is mindful of the burden of depression, risk of misdiagnosis, and variable therapy response. Interestingly, our study found no significant difference between MoCA scores of those with depressive and manic polarity. Substantial MoCA score differences were found between the groups with depressive polarity and no polarity. Men were observed to experience more manic episodes. More women in the study experienced predominantly depressive polarity, highlighting the need to probe for a past history of hypomania or mixed episodes to avoid misdiagnosis as unipolar depression in them. Manic predominate polarity performed better in the physical and psychological domains of the post hoc test for quality-of-life BREF scale. There were substantial MoCA score differences between the groups with depressive polarity and no polarity, with the depressive polarity showing more cognitive decline.

Risk Factors associated with COVID-19 Patients in India: A Single Center Retrospective Cohort Study.

The coronavirus disease 2019 (COVID-19) outbreak has caused a worldwide pandemic, resulting in &gt;3.8 million deaths. Our aim is to identify the risk factors associated with in-hospital mortality using survival analysis considering the characteristics and outcomes of COVID-19 patients admitted to a dedicated tertiary-care hospital in Mumbai, India. In a retrospective cohort study, 565 patients admitted from 28th March 2020 to 30th June 2020 were enrolled, and a follow-up was conducted till August 2020. To investigate the impact of COVID-19, survival analysis was performed using the Kaplan-Meier method. Potential risk factors associated with mortality were analyzed using logistic regression models for multivariate analysis and the Cox proportional hazards model for estimating hazard ratios (HRs). From the 565 positive COVID-19 cases, 49 patients died (8.7%) and 516 (91.3%) were discharged. Overall, 119 patients (20%) required intensive care unit (ICU) admission, of which 70 (58%) patients survived. The Kaplan-Meier survival curve showed a significant association of COVID-19 infection with age (≥60; p = 0.008), hypertension (p = 0.03), dialysis (p = 0.0001), lung commodities (p = 0.01), breathlessness (p = 0.0001), severe disease upon high-resolution computed tomography (HRCT) analysis (p = 0.0001), ICU admission (p = 0.0001), and low lymphocyte count at admission (p = 0.0001). Additionally, patients receiving tocilizumab (p = 0.0001) and deprived of hydroxychloroquine (HCQ) + azithromycin (azee) (p = 0.0001) were estimated at a high risk of mortality. Coronavirus disease 2019 (COVID-19) increased the risk of mortality in patients with increased age, comorbidities, and severe symptoms upon treatment with an immunosuppressant (tocilizumab). However, patients treated with HCQ + azee showed favorable results due to their antiviral effects in vitro.

Development and psychometric evaluation of the Khaini Smokeless Tobacco Dependence Scale.

Khaini is a smokeless tobacco (SLT) product commonly used in the South-Asian region. It is the most common smokeless tobacco product used in India, having a prevalence of 11.2% and is used by 104.1 million adults. No scales exist to assess khaini dependence. Existing scales available to assess dependence on smokeless tobacco products are not ideal as these are adapted from cigarette dependence scales and developed for western populations. This study aimed to develop a khaini dependence scale and assess its reliability and validity. Recommended methods for scale development were followed for item development, scale development and scale evaluation. Scale development was guided by a theoretical framework, a review of existing scales and in-depth interviews with 21 khaini users recruited from a tertiary care hospital in Mumbai, India. The process involved the identification of domains for dependence and the development of an item pool. Cognitive interviews and pre-testing were conducted with 20 khaini users to assess content validity. A cross-sectional survey with 323 khaini users was conducted, and Exploratory Factor Analysis (EFA) was used to determine the factor structure of the draft scale. The content validity, criterion validity (by cross-referencing with the cotinine level of users), convergent validity and internal consistency of the new scale were assessed. The final version of the Khaini SLT Dependence Scale (KSLTDS) had 20 items. EFA indicated an acceptable goodness of fit for a three-factor structure with physical, psychological and sociocultural-behavioral sub-scales. It showed evidence of acceptable criterion validity with cotinine (ρ=0.43, p=0.0002), convergent validity with FTND-ST (ρ=0.51, p<0.0001) and frequency of khaini use (ρ=0.38, p<0.0001). The sub-scales (α=0.87-0.90) showed acceptable internal consistency. The psychometric evaluation of the KSLTDS showed preliminary validity and reliability for assessing dependence on khaini, and therefore, it is appropriate for clinical and research purposes. Re-validation studies are required with various khaini user populations.

SEROPREVALENCE OF DENGUE IN A TERTIARY CARE HOSPITAL: CROSS SECTIONAL STUDY

Background: Dengue is endemic and an important emerging public health problem in India. Dengue illness is major concern causing increased morbidity and mortality. Disease burden is highly variable between different places within a country. This study was conducted to determine the age wise seroprevalence of dengue and seasonal variation of dengue infection in tertiary care hospital in Mumbai. Materials And Methods: The present cross sectional study was conducted from January 2021 to March 2022 for a period of 15 months. Total 1550 serum samples were collected from suspected dengue cases. All the samples were subjected to ELISA for detection of dengue NS1 antigen and IgM antibody. Results: Out of 1550 suspected dengue patients 187 (12.06%) were seropositive for NS1antigen or IgM antibody or both NS1 antigen &amp; IgM antibody. Of 187 seropositive dengue cases 121 (64.71%) were male and 66 (35.29%) were female. The maximum dengue cases (31.55%) were from 31-40 years age group, followed by 21-30 (23.52%) years. Most dengue positive cases were seen in monsoon period. The monsoon peak was observed in September (22.00%) followed by August (17.11%). However, in May (dry season) few cases were reported. Conclusion: Dengue illness is a major public health concern. With early diagnosis and treatment, morbidity and mortality can be reduced. Knowledge of prior infection is also very important if vaccination strategy by WHO is implemented in future. Maximum cases were observed in monsoon period but dengue cases were seen throughout the year. Hence continuous surveillance of cases is required for early diagnosis and treatment, to know the prevalence throughout the year, for vector control measures &amp; administration of dengue vaccine as per WHO strategy if implemented in future in our country

Clinical characteristics &amp; severity profile of children with COVID-19 during the second wave pandemic

This retrospective observational study was aimed at defining the demographic and clinical characteristics as well as severity profile of COVID-19 disease in children admitted to dedicated COVID-19 tertiary care hospital in Mumbai, India, during the second wave. COVID-19 infection detected in children (1 month-12 years) by the rapid antigen test or reverse transcriptase polymerase chain reaction or TRUENAT from March 1 to July 31, 2021 on throat/nasopharyngeal samples were enrolled and their clinical features and outcomes were studied. During the study period, 77 children with COVID-19 infection were admitted, of whom two-third (59.7%) were <5 yr old. The common presenting symptom was fever (77%), followed by respiratory distress. Comorbidities were noted in 34 (44.2%) children. Most of the patients belonged to the mild severity category (41.55%). While 25.97 per cent of patients presented in severe category and 19.48 per cent were asymptomatic. Admission to intensive care was needed in 20 (25.9%) patients, with 13 patients needing invasive ventilation. Nine patients succumbed while 68 were discharged. The results might help understand the course, severity profile and outcomes of the second wave of the COVID-19 pandemic in the paediatric population.

Investigator knowledge, awareness, and registrations of academic clinical trials with the Clinical Trial Registry of India: An observational study.

In 2019, the Central Drugs Standard Control Organization (CDSCO) introduced the New Drugs and Clinical Trials Rules 2019 (NDCTR), which separated the research guidelines for "Clinical Trials" and "Biomedical and Health Research." As a result, guidelines issued by Indian Council of Medical Research were stated to apply to academic clinical trials (ACTs). This change is important because academic studies are crucial for scientific advancement and repurposing of approved drugs in health-care industry. However, conducting an ACT can pose challenges. We assessed the level of awareness, knowledge, and challenges faced by investigators. Our aim is to overcome some of these challenges and encourage more academic studies for the betterment of healthcare and scientific knowledge in India. The study was conducted in two phases after obtaining approval from the Institutional Ethics Committee (EC) of three tertiary care hospitals in Mumbai. In the first phase, the number of ACTs was assessed from the clinical trial registry India website, while the number of registered and re-registered ECs were assessed from the CDSCO website. The second phase involved assessing investigator awareness and knowledge about ACTs using a prevalidated questionnaire with a content validity index score of 0.93. In 2020, the highest numbers of studies were registered, with the highest numbers of registered and re-registered ECs from Maharashtra. All participants completed the questionnaire and were aware of the need to follow guidelines for clinical trials. Sixty-seven percent of participants knew that the guidelines for ACTs differed from those of sponsored clinical trials, but only 58% were aware of the exact definition of an ACT as per NDCTR, 2019. Eighty-five percent of participants knew who could initiate an ACT, but only 27% knew about the applicability of results of an ACT and 33% had in-depth knowledge about the required approvals, while only 10% knew the archival period. Although 71% of participants had knowledge about serious adverse event reporting, few answered in-depth questions correctly. Only 31 participants reported facing varied challenges. To conduct ACTs effectively and contribute to healthcare and scientific advancement, it is crucial to enhance investigators' existing knowledge about ACTs.

Clinical Profile of Nonalcoholic Fatty Liver Disease and its Correlation with Metabolic Syndrome and Cardiovascular Risk.

Nonalcoholic fatty liver disease (NAFLD) has been projected, within the next 20 years, to become the major cause of liver-related morbidity and mortality as well as a leading indication for liver transplantation. Affected South Asian Indians are at higher risk for the development of metabolic syndrome (MS), type 2 diabetes, and cardiovascular disease. There is a dearth of data related to NAFLD and its various sequelae and correlation with cardiovascular disease in South Asia. It was an observational, prospective study conducted over 2 years on 80 patients in a tertiary care hospital in Mumbai. All patients diagnosed with NAFLD were investigated for MS according to the National Cholesterol Education Program Adult Treatment Panel III criteria, and a relationship between NAFLD and MS was correlated. MS was found to be present in 72.5% of the patients. Significant results were obtained while correlating MS parameters and fatty liver grading, implying that patients with a higher fatty liver grading were more likely to have derangements in metabolic markers. NAFLD was found to be associated with an increased incidence of MS and thereby a higher risk of cardiovascular disease, warranting a high index of suspicion for both. A higher ultrasound grading of fatty liver was found to be associated with an increased incidence of MS.

Profile of pulmonary hypertension in patients presenting with respiratory symptoms at a tertiary care hospital in Mumbai

Profile of pulmonary hypertension in patients presenting with respiratory symptoms at a tertiary care hospital in Mumbai