Immunogenicity, clinical efficacy and safety of additional second COVID-19 booster vaccines against Omicron and its subvariants: A systematic review.

The Omicron variant of severe acute respiratory syndrome coronavirus 2 is a new variant of concern (VOC) and an emerging subvariant that exhibits heightened infectivity, transmissibility, and immune evasion, escalating the incidence of moderate to severe coronavirus disease 2019 (COVID-19). It resists monoclonal antibodies and diminishes vaccine efficacy. Notably, new sublineages have outpaced earlier predominant sublineages. Although the primary vaccination series and initial boosters were robust against previous VOCs, their efficacy waned against Omicron and its subvariants. In this systematic review, we assessed real-world evidence on the immunogenicity, clinical efficacy, and safety of a second booster or fourth COVID-19 vaccine dose against the Omicron VOC and its subvariants. A comprehensive literature search was conducted in Medline/PubMed, Google Scholar, bioRxiv, and medRxiv, and relevant studies published between 2022 and 30 May 2023 were reviewed. We found a total of 40 relevant articles focusing on a second booster dose for COVID-19, including clinical trials and observational studies, involving 3,972,856 patients. The results consistently revealed that an additional second booster dose restored and prolonged waning immunity, activating both humoral and cellular responses against Omicron and its subvariants. A second booster treatment correlated with enduring protection against COVID-19, notably preventing substantial symptomatic disease and mortality associated with severe Omicron infection. Both monovalent messenger RNA (mRNA) and nonmRNA vaccines demonstrated similar efficacy and safety, with bivalent mRNA vaccines exhibiting broader protection against emerging subvariants of Omicron. The safety profiles of second booster were favourable with only mild systemic and local symptoms reported in some recipients. In conclusion, this systematic review underscores the additional COVID-19 vaccine boosters, particularly with bivalent or multivalent mRNA vaccines, for countering the highly infectious emerging subvariants of Omicron.

Liquid biopsy for precision diagnostics and therapeutics.

Liquid biopsy (LB) has emerged as a highly promising and non-invasive diagnostic approach, particularly in the field of oncology, and has garnered interest in various medical disciplines. This technique involves the examination of biomolecules released into physiological fluids, such as urine samples, blood, and cerebrospinal fluid (CSF). The analysed biomolecules included circulating tumour DNA (ctDNA), circulating tumour cells (CTCs), cell-free DNA (cfDNA), exosomes, and other cell-free components. In contrast to conventional tissue biopsies, LB provides minimally invasive diagnostics, offering invaluable insights into tumor characteristics, treatment response, and early disease detection. This Review explores the contemporary landscape of technologies and clinical applications in the realm of LB, with a particular emphasis on the isolation and analysis of ctDNA and/or cfDNA. Various methodologies have been employed, including droplet digital polymerase chain reaction (DDP), BEAMing (beads, emulsion, amplification, and magnetics), TAm-Seq (tagged-amplicon deep sequencing), CAPP-Seq (cancer personalized profiling by deep sequencing), WGBS-Seq (whole genome bisulfite sequencing), WES (whole exome sequencing), and WGS (whole-genome sequencing). Additionally, CTCs have been successfully isolated through biomarker-based cell capture, employing both positive and negative enrichment strategies based on diverse biophysical and other inherent properties. This approach also addresses challenges and limitations associated with liquid biopsy techniques, such as sensitivity, specificity, standardization and interpretability of findings. This review seeks to identify the current technologies used in liquid biopsy samples, emphasizing their significance in identifying tumor markers for cancer detection, prognosis, and treatment outcome monitoring.

Clinical virology and effect of Covid-19 vaccination and monoclonal antibodies against highly infectious SARS- CoV-2 omicron sub variant BF.7 (BA.5.2.1.7): A systematic review.

Over time, the SARS-CoV-2 virus has acquired several genetic mutations, particularly on the receptor-binding domain (RBD) spike glycoprotein. The Omicron variant is highly infectious, with enhanced immune escape activity, and has given rise to various sub-lineages due to mutations. However, there has been a sudden increase in COVID-19 reports of the Omicron subvariant BF.7 (BA.2.75.2), which has the highest number of reported cases, accounting for 76.2% of all cases worldwide. Hence, the present systematic review aimed to understand the viral mutations and factors associated with the increase in the reports of COVID-19 cases and to assess the effectiveness of vaccines and mAbs against the novel Omicron variant BF.7. The R346T mutation on the spike glycoprotein RBD might be associated with increased infection rates, severity, and resistance to vaccines and mAbs. Booster doses of COVID-19 vaccination with bivalent mRNA booster vaccine shots are effective in curtailing infections and decreasing the severity and mortality by enhancing the neutralizing antibodies (Abs) against the emerging Omicron subvariants of SARS-CoV-2, including BF.7 and future VOCs.

Global prevalence and effect of comorbidities and smoking status on severity and mortality of COVID-19 in association with age and gender: a systematic review, meta-analysis and meta-regression.

A COVID-19 patient often presents with multiple comorbidities and is associated with adverse outcomes. A comprehensive assessment of the prevalence of comorbidities in patients with COVID-19 is essential. This study aimed to assess the prevalence of comorbidities, severity and mortality with regard to geographic region, age, gender and smoking status in patients with COVID-19. A systematic review and multistage meta-analyses were reported using PRISMA guidelines. PubMed/MEDLINE, SCOPUS, Google Scholar and EMBASE were searched from January 2020 to October 2022. Cross-sectional studies, cohort studies, case series studies, and case-control studies on comorbidities reporting among the COVID-19 populations that were published in English were included. The pooled prevalence of various medical conditions in COVID-19 patients was calculated based on regional population size weights. Stratified analyses were performed to understand the variations in the medical conditions based on age, gender, and geographic region. A total of 190 studies comprising 105 million COVID-19 patients were included. Statistical analyses were performed using STATA software, version 16 MP (StataCorp, College Station, TX). Meta-analysis of proportion was performed to obtain pooled values of the prevalence of medical comorbidities: hypertension (39%, 95% CI 36-42, n = 170 studies), obesity (27%, 95% CI 25-30%, n = 169 studies), diabetes (27%, 95% CI 25-30%, n = 175), and asthma (8%, 95% CI 7-9%, n = 112). Moreover, the prevalence of hospitalization was 35% (95% CI 29-41%, n = 61), intensive care admissions 17% (95% CI 14-21, n = 106), and mortality 18% (95% CI 16-21%, n = 145). The prevalence of hypertension was highest in Europe at 44% (95% CI 39-47%, n = 68), obesity and diabetes at 30% (95% CI, 26-34, n = 79) and 27% (95%CI, 24-30, n = 80) in North America, and asthma in Europe at 9% (95% CI 8-11, n = 41). Obesity was high among the ≥ 50 years (30%, n = 112) age group, diabetes among Men (26%, n = 124) and observational studies reported higher mortality than case-control studies (19% vs. 14%). Random effects meta-regression found a significant association between age and diabetes (p < 0.001), hypertension (p < 0.001), asthma (p < 0.05), ICU admission (p < 0.05) and mortality (p < 0.001). Overall, a higher global prevalence of hypertension (39%) and a lower prevalence of asthma (8%), and 18% of mortality were found in patients with COVID-19. Hence, geographical regions with respective chronic medical comorbidities should accelerate regular booster dose vaccination, preferably to those patients with chronic comorbidities, to prevent and lower the severity and mortality of COVID-19 disease with novel SARS-CoV-2 variants of concern (VOC).

Effect of long-term yoga training on autonomic function among the healthy adults.

Background: Autonomic dysfunction is one of the major complications in noncommunicable diseases, and there are studies to prove yoga practice improves cardiac autonomic function. So, this present study was done to compare the autonomic functions among yoga practitioners and nonyoga practitioners. Methods: This cross-sectional comparative study was initiated among 68 healthy volunteers of both sexes, after recruiting them based on inclusion and exclusion criteria in the age group of 17-30 yrs. The autonomic reactivity tests like resting heart rate, response of heart rate to standing, Valsalva maneuver, and response of heart rate to deep breathing, response of BP to standing, and sustained hand-grip were done. Results: In the autonomic reactivity test, resting heart rate (80.92 ± 11.76 vs 69.24 ± 10.64) and sustained handgrip (16.30 ± 4.53 vs 10.20 ± 3.67) significantly decreased (P < 0.05) in the participants of the yoga group compared to control group. Deep breathing test, Valsalva maneuver, 30:15 ratio in lying to standing, and BP response to standing test did not show any significant difference between the groups (P > 0.05). Conclusion: The present study revealed diminished sympathetic activity and improved parasympathetic activity among the regular yoga practicing participants. It can be practiced regularly to reduce stress and prevent lifestyle-associated disorders in the future.

Preoperative neutrophil-lymphocyte ratio/platelet-lymphocyte ratio: A potential and economical marker for renal cell carcinoma.

Background: Emerging evidences have elucidated the crucial role of inflammation in carcinogenesis and tumor progression. In the recent years, many inflammatory biomarkers showed promising prognostic factors in renal cell carcinoma (RCC). We intended to evaluate the significance of one such inflammatory factor which is potential, noninvasive, simple, as well as economical. The preoperative neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in RCC patients have shown favorable results. Objective: The objective was to assess the prognostic role of NLR/PLR in the advanced stage and high-grade RCC. Subjects and Methods: This is a retrospective study. Ethical clearance was obtained from the institute ethics committee. One hundred and fifty histopathologically proven RCC cases during the period of January 2010-September 2018 were chosen from the pathology department and corresponding blood reports were obtained from the medical records department. We divided the cases based on their staging and grading. NLR/PLR values were calculated using formulas. Statistical Analysis: Statistical analysis was done using R software. Data were expressed as mean ± standard deviation, median, and percentage. Independent t-test, Mann-Whitney test, and Chi-square test were used. P < 0.05 was considered statistically significant. The receiver operating characteristic curve (ROC) was plotted to assess the sensitivity of NLR/PLR. Results: The elevated NLR/PLR values showed a significant relation with high-grade and advanced stage RCC. The ROC curve proved the accuracy of NLR/PLR in the advanced stage and high-grade RCC. Limitations: A multicentric, prospective study can be planned in the future. Follow-up studies are needed to assess their prognostic role. Conclusion: NLR/PLR values can become part of routine investigations for all RCC patients. The values may help to estimate pathological outcomes, chance of recovery, recurrence, and survival rates.

Prevalence of vitamin D deficiency among South Indian pregnant women.

Background: Deficiency of vitamin D is widespread across the globe. Expectant women are one of the most vulnerable groups for vitamin D deficiency (VDD). Even in South India with abundance of sunlight, pregnant women are believed to be at a high risk of this deficiency. The objectives of this study are to assess the prevalence of VDD in antenatal women, associate it with modifiable risk factors and evaluate its correlation with low birth weight. Methods: This cross-sectional study was conducted in a tertiary care hospital, in Chennai, in 100 pregnant women in their last trimester on the basis of inclusion and exclusion criteria and their vitamin D and calcium levels were assessed. A detailed history regarding physical activity, diet, and sun exposure were collected and results were analyzed. Results: The point prevalence of VDD (serum 25-hydroxyvitamin D (25(OH) D) level <20 ng/mL) among antenatal women in our study is 62%. Univariate analysis revealed that sun exposure and socioeconomic status were the significant factors associated with higher percentage of VDD. Linear regression analysis showed that only sun exposure was a significant predictor for serum 25(OH) D levels. VDD is also associated with increased risk of low-birth-weight babies. Conclusion: VDD is highly prevalent among pregnant women in South India leading to adverse health consequences in the mother and offspring. Less physical activity, decreased sun exposure, darker skin complexion, lower socioeconomic status and lack of awareness are the major risk factors associated with VDD in our study population.

Assessment of WHO core drug use indicators at a tertiary care Institute of National importance in India.

Rational prescribing of medicines is an important aspect of drug prescribing which helps in safe and efficacious and cost-effective drug treatment for patients. WHO Prescription indicators are intended to evaluate the services provided to the population concerning the rational use of medicines. The study aims to study prescription practices and rational use of medicines in the department of Internal medicine, using WHO prescribing indicators in a tertiary care teaching institute of national importance. A total of 50 prescriptions were digitally photographed and analysed for prescription practices and rational drug use, using standard WHO core prescribing indicators. A total of 301 drugs with multiple and diverse diagnoses were used. Statistical analysis was done using SPSS 22 version. The average number of drugs per prescription was 3.48%. It was found that only 13.79% of prescriptions have generic names, whereas 27.58% of patient encounters had at least one drug from the National List of Essential Medicine, 6.8% of prescriptions have antibiotics and 0.7% of prescriptions were injections. The number of prescriptions with fixed drug combinations was 27.55%. Indicators such as percentage of the National List of Essential Medicine, fixed drug combinations and prescribing with a generic name are used. Hence, we will suggest regular prescription audit practices and conducting CMEs and training workshops for clinicians for the rational use of medicines in all healthcare settings to succeed in the rational use of medicine.

Rationality, Efficacy, Tolerability of Empagliflozin Plus Linagliptin Combination for the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials and Observational Studies.

BACKGROUND: Treatment of diabetes mellitus includes more than one drug of different groups, which may lead to a high pill burden and non-adherence to drugs. We have aimed to systematically analyze the clinical efficacy, safety, and pharmacoeconomic cost-effectiveness of the fixed-dose combination of empagliflozin plus a linagliptin in Type-2 Diabetes mellitus (T2DM) patients. METHODS: A literature search of PubMed/MEDLINE, SCOPUS, Google Scholar, and EMBASE was performed using the MeSH terms and/or keywords"((Single-pill combination) OR ((Fixeddose combination) OR (Combination therapy)) AND (Empagliflozin add on-to Linagliptin) OR (Empagliflozin combined with Linagliptin) OR ((Combination of Empagliflozin and Linagliptin)" from the inception to February 2021. RESULTS: Search results were found in a total of 13 clinical studies. After removing duplicates and studies not according to inclusion criteria, a total of eight clinical studies (Randomized controlled trials: 7; Observational cohort studies: 1) were included (n=7491). A significant reduction in the primary endpoint, the mean changes in baseline HbA1c at the end of 24 weeks and/or 52 weeks was found in the empagliflozin plus a linagliptin combination group in all included studies. In addition, significant efficacy was seen in decreasing the secondary endpoints such as the mean change in the fasting plasma glucose, systolic and diastolic blood pressure (DBP), and body weight with fewer adverse events than the adverse effects with either drug alone. CONCLUSION: After reviewing findings from the available clinical studies of the combination of empagliflozin plus linagliptin, we conclude that the combination is effective, safe, tolerable, and rationale cost effective compared to placebo and either drug alone for the management of T2DM in patients with inadequate glycemic control with metformin alone, patients with intolerance to metformin, increased baseline HbA1c, patients with overweight or obesity and diabetic hypertensive, CHF, atherosclerotic cardiovascular disease, and renal dysfunction patients. Future randomized controlled trials in a larger number of T2DM patients with or without CHF and renal failure patients are recommended.

Effect of Yoga on Oxidative Stress in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis.

BACKGROUND: Diabetes mellitus has a significant impact on public health. Oxidative stress plays a major role in the pathophysiology of Type 2 Diabetes Mellitus (T2DM), leading to various complications of T2DM. Yoga is being widely used in the management of T2DM. The primary objective of this systematic review and meta-analysis is to understand the effects of yoga on oxidative stress parameters among adult patients diagnosed with T2DM. MATERIALS AND METHODS: Electronic databases such as PubMed, Scopus, Cochrane Library and Science Direct from start of the study till March 2020 were searched to obtain eligible studies. Study designs of all nature were included (except case studies and reviews). The primary outcome was Malondialdehyde (MDA) and secondary outcomes included fasting plasma glucose, HbA1C and Superoxide Dismutase (SOD) levels. RESULTS: A total of four trials with a total of 440 patients met the inclusion criteria. The results of meta-analysis indicated that yoga significantly reduced MDA (SMD: -1.4; 95% CI -2.66 to -0.13; P = 0.03; I2 = 97%), fasting plasma glucose levels (SMD: -1.87: 95% CI -3.83 to -0.09; P = 0.06; I2= 99%), and HbA1c (SMD: -1.92; 95% CI - 3.03 to -0.81; P = 0.0007; I2 = 92%) in patients with T2DM. No such effect was found for SOD (SMD: -1.01; 95% CI -4.41 to 2.38; P = 0.56; I2= 99%). CONCLUSION: The available evidence suggests that yoga reduces MDA, fasting plasma glucose and HbA1C, and thus would be beneficial in the management of T2DM as a complementary therapy. However, considering the limited number of studies and its heterogeneity, further robust studies are necessary to strengthen our findings and investigate the long-term benefits of yoga.

Immediate effects of the practise of Sheethali pranayama on heart rate and blood pressure parameters in healthy volunteers.

OBJECTIVES: Sheetali pranayama, a cooling pranayama is best known for its calming and relaxing nature, widely used for many conditions like depression, anxiety and hypertension. The aim of the study was to evaluate the immediate effect of the practice of Sheetali pranayama on heart rate and blood pressure parameters in healthy volunteers. METHODS: Apparently, 60 healthy volunteers were involved, from both sexes. They were split into pranayama (n=30) and control (n=30) groups at random. Sheetali pranayama was performed for 5 min (5 cycles) in the pranayama group and normal breathing (12-16 breaths/min) was permitted in the control group. Heart rate (HR) and blood pressure (BP) were recorded with RMS polyrite in the supine position after 5 min of rest. RESULTS: The HR in the pranayama group significantly decreased (p=0.04). Systolic (SBP) and diastolic blood (DBP) pressure, pulse pressure (PP) and mean arterial pressure (MAP) decreased significantly (p<0.05) relative to control after pranayama practice. Pre-Post inter-group results has also shown that the pranayama group has substantially decreased HR and BP indices. CONCLUSIONS: Present study shows that the practice of Sheetlai pranayama creates a relaxed state, and parasympathetic activity overrides sympathetic activity in this state. It indicates that in healthy volunteers, pranayama strengthens the resting cardiovascular parameters.

Effect of six months pranayama training on stress-induced salivary cortisol response among adolescents-Randomized controlled study.

BACKGROUND: A combination of yoga practices has been documented to reduce stress and stress-induced cortisol levels. The objective of the current study is to examine the effects of six months of a single pranayama practice (Bhramari [Bhr. P]) on reducing salivary cortisol response to the cold pressor test (CPT) among adolescents. METHODS: Twenty-six healthy adolescents between the ages of 11 and 19 were randomly assigned to either yoga group (n-13) or control group (n-13). Yoga group participants were trained to do Bhr. P for 45 min, thrice a week for six months. All participants underwent CPT at baseline and at end of six months. Saliva samples were collected at baseline (t0), at 20 min (t1), 40 min (t2), and 60 min after the CPT (t3). RESULTS: Contradictory to our hypothesis, participants in the yoga group exhibited a higher salivary cortisol response to the CPT at t1 (p = 0.04) when compared to the control group. However, the t3 salivary cortisol levels showed a statistically significant reduction (p = 0.03) in yoga group when compared to the control group. A significant interaction with time (F (1, 88) = 316.5, p = .001, ηp2:0.91) and between the group × time (F (3, 88) = 2.83, p = 0.04, ηp2:0.8) was found after the intervention. CONCLUSIONS: An increase in the cortisol responsiveness observed in the study is an indication of the adaptive capability achieved through regular yoga training, evidenced by an initial rise in cortisol followed by a rapid fall below baseline after 60 min. Further research is required to conclusively determine the changes in cortisol levels over time in response to stress in long-term yoga practitioners.

Validation of Internal structure of Self-Directed Learning Readiness Scale among Indian Medical Students using factor analysis and the Structural equation Modelling Approach.

BACKGROUND: The Self-Directed Learning Readiness Scale (SDLRS) is a tool that helps in the assessment of the readiness of the students to pursue Self-Directed Learning (SDL). There are no documented studies on the validation of internal structure of the SDLRS among Indian medical students. Hence, the objective of this study is to validate the internal structure of SDLRS among Indian medical students using factor analysis and the Structural Equation Modelling (SEM) approach. METHODS: We administered Fisher's 40-item SDLRS to 750 students after receiving the ethics clearance and the author's permission and taking written informed consent from all the study participants (response rate: 92%). The exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Cronbach's alpha were performed using SPSS version 25 and the Lavaan package of R version 3.1.2. RESULTS: The values of the comparative fit index (CFI), standardised root-mean-square residual (SRMR), and root mean square error of approximation (RMSEA) were ≥ 0.9, ≤ 0.08, and ≤ 0.08, respectively, for a model fit to be acceptable. EFA showed that except for Q2 (loading score: 0.210), Q12 (loading score: 0.384), Q13 (loading score: 0.362), and Q25 (loading score: -0.219), all the items loaded well. After the exclusion of the aforementioned items, the factor loading scores for the items in the self-management, desire for learning, and self-control factors ranged from 0.405 to 0.753 (Cronbach α: 0.775), 0.396 to 0.616 (Cronbach α: 0.730), and 0.427 to 0.556 (Cronbach α: 0.799), respectively. The updated model was used for CFA, which displayed a good model fit. CONCLUSIONS: The resultant model consisting of 36 items is shown to have internal structure validity for Indian version of SDLRS, which can be used to assess medical students.

Evaluation of workshop on teaching skills for medical postgraduates (Ramachandra Annual Postgraduate Teaching Skills).

BACKGROUND: Postgraduate medical curriculum is usually devoted to developing competencies in the specialty concerned, patient care, and submitting dissertations. The need to impart teaching skills during postgraduation has gone unnoticed, hence Ramachandra Annual Postgraduate Teaching Skills (RAPTS), a teaching skills workshop, was conceptualized and implemented as postgraduate students serve as tutors/residents in the department to teach undergraduate medical students. This study is aimed to evaluate the effectiveness of the teaching skills workshop for postgraduates. MATERIALS AND METHODS: One hundred and seventy-eight postgraduate students of pre- and paraclinical department underwent the training in medical education principles and participated in the feedback. RAPTS Workshop was implemented as per the six-step approach. The learning was evaluated through a pre- and posttest scores. Student feedback was also obtained on the process overall objectives and contents of the workshop. Force-field analysis was performed. RESULTS: There was a significant learning by the postgraduates on various medical education principles as evidenced by significant improvement in the posttest scores (P < 0.05). Feedback regarding the general aspects of the workshop showed that 92% of the participants felt that the contents of the workshop suited their learning. Eighty-four percent of the participants opined that the presentations of the sessions were good and 91% felt that time management was good. Force-field analysis indicated that the factors favoring teaching skills workshop were higher. CONCLUSION: This study has highlighted the importance of including teaching methodology training in the postgraduate curriculum that helps in grooming the future teachers in the right direction, in the right time. Competencies related to teaching skills based on medical education principles can be included in the postgraduate curriculum.

The safety, tolerability and mortality reduction efficacy of remdesivir; based on randomized clinical trials, observational and case studies reported safety outcomes: an updated systematic review and meta-analysis.

INTRODUCTION: Remdesivir, an experimental antiviral drug has shown to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), both in vitro and in vivo. The present systematic review and meta-analysis were performed to quantify the safety and tolerability of remdesivir, based on safety outcome findings from randomized controlled trials, observational studies and case reports of remdesivir in coronavirus disease 2019 (COVID-19) patients. METHODS: We have performed a systematic search in the PubMed, Google Scholar and Cochrane Library using specific keywords such as 'COVID-19' OR 'SARS CoV-2' AND 'Remdesivir'. The study endpoints include total adverse events (AEs), serious adverse events (SAEs), grade 3 and grade 4 AEs, mortality and drug tolerability. Statistical analysis was carried out by using Revman 5.4 software. RESULTS: Total 15 studies were included for systematic review, but only 5 randomized clinical trials (RCTs) (n = 13,622) were included for meta-analysis. Visual inspection of the forest plots for remdesivir 10-day versus placebo and remdesivir 10-day versus 5-day groups revealed that there is a significant difference in SAEs [10-day remdesivir versus control (odds ratio [OR] = 0.55, 0.40-0.74) p = 0.0001; I 2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 0.56, 0.38-0.84) p = 0.005; I 2 = 13%]. In grade 4 AEs, there is a significant difference in 10-day remdesivir versus control (OR = 0.32, 0.19-0.54) p = 0.0001; I 2 = 0%, but not in comparison to 5-day remdesivir (OR = 0.95, 0.59-1.54) p = 0.85; I 2 = 0%. But there is no significant difference in grade 3 AEs [remdesivir 10 day versus control (OR = 0.81, 0.59-1.11) p = 0.19; I 2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.24, 0.86-1.80) p = 0.25; I 2 = 0%], in total AEs [remdesivir 10 day versus control (OR = 1.07, 0.66-1.75) p = 0.77; I 2 = 79%; remdesivir 10 day versus 5 day (OR = 1.08, 0.70-1.68) p = 0.73; I 2 = 54%)], in mortality [10-day remdesivir versus control (OR = 0.93, 0.80-1.08) p = 0.32; I 2 = 0%; 10-day remdesivir versus 5-day remdesivir (OR = 1.39, 0.73-2.62) p = 0.32; I 2 = 0%)] and tolerability [remdesivir 10 day versus control (OR = 1.05, 0.51-2.18) p = 0.89; I 2 = 65%, 10-day remdesivir versus 5-day remdesivir (OR = 0.86, 0.18-4.01) p = 0.85; I 2 = 78%]. DISCUSSION & CONCLUSION: Ten-day remdesivir was a safe antiviral agent but not tolerable over control in the hospitalized COVID-19 patients with a need of administration cautiousness for grade 3 AEs. There was no added benefit of 10- or 5-day remdesivir in reducing mortality over placebo. To avoid SAEs, we suggest for prior monitoring of liver function tests (LFT), renal function tests (RFT), complete blood count (CBC) and serum electrolytes for those with preexisting hepatic and renal impairments and patients receiving concomitant hepatotoxic or nephrotoxic drugs. Furthermore, a number of RCTs of remdesivir in COVID-19 patients are suggested. PLAIN LANGUAGE SUMMARY: Ten-day remdesivir is a safe antiviral drug with common adverse events in comparison to placebo.The rate of serious adverse events and grade 3 adverse events were significantly lower in 10-day remdesivir in comparison to placebo/5-day remdesivir.There was no significant difference in the rate of tolerability and mortality reduction in 10-day remdesivir over placebo/5-day remdesivir.There were no new safety signals reported in vulnerable populations, paediatric, pregnant and lactating women.

Development and validation of a structured feedback questionnaire from postgraduates on various elements of postgraduate medical curriculum.

BACKGROUND: Medical Council of India, introduced the Post Graduate (PG) curriculum as 'Competency Based Medical Education' (CBME). Feedback from the end users is a vital step in curriculum evaluation. Therefore, the primary objective of this study was to develop and validate a Structured Feedback Questionnaire (SFQ) for postgraduates, encompassing all the components of the PG-CBME curriculum. METHODS: SFQ was developed with 23 Likert based questions and four open ended questions. Content validation was done by Lawshe method. After getting institutional ethics clearance and informed consent, SFQ was administered to 121 final year PGs (response rate 100%). We performed Principal component analysis (PCA), Structural equation modeling (SEM), Chi squared test (χ2/df); goodness-of-fit index (GFI); adjusted GFI; comparative fit index (CFI) and root mean square error of approximation (RMSEA). Cronbach's alpha was done for estimating the internal consistency. RESULTS: The validation resulted in a three-factor model comprising of "curriculum" (42.1%), "assessment" (28%), and "support" (18.5%). Chi squared test (χ2/df ratio) < 2, CFI (0.78), GFI (0.72) and RMSEA (0.09) indicated superior goodness of fit for the three-factor model for the sample data. All the extracted factors had good internal consistency of ≥0.9. CONCLUSION: We believe that this 23 item SFQ is a valid and reliable tool which can be utilized for curriculum evaluation and thereby formulating recommendations to modify the existing curriculum wherever required, facilitating enriched program outcomes.

Impaired pupillary light reflex indices in Orbital Apex Syndrome - A rare case report.

BACKGROUND: The clinical presentation of reduced pupillary responses in orbital apex syndrome is currently not well understood clinically. The pupillary light reflex (PLR) is determined using dynamic pupillometry. CASE DETAILS: A newly diagnosed 35-year-old diabetic female patient had ocular symptoms including orbital pain and ptosis, but no visual loss. Cranial nerve autonomic impairment was identified with dynamic pupillometry and compared with cardiac autonomic activity using heart rate variability (HRV). RESULTS: PLR showed that pupil size and response were severely affected, with a small resting pupil size, and minimal response to a bright white light flash was seen, due to decreased sympathetic activity. However, HRV showed normal cardiac sympathetic activity. CONCLUSION: These findings suggest that orbital apex syndrome may lead to changes in pupil size and response due to compression of sympathetic fibers at the apex of the orbit. Quantitative PLR measurements help to reveal relevant information on anatomical reflex pathways.

Assessment of pulmonary functions among traffic police personnel in Chennai city - A comparative cross-sectional study.

BACKGROUND: Air pollution due to road traffic is a solemn health hazard and vehicular emissions due to huge population in the cities are the main reason for the air quality crisis. The study was conducted to assess the degree of impairment in lung function in traffic police personnel exposed to traffic pollution compared to less-exposed healthy subjects. MATERIALS AND METHODS: This comparative cross-sectional study was conducted among 250 traffic police personnel, aged 20-55 years, working in Chennai city, as compared to a matched control group, consisting of 250 less-exposed subjects. Measurement of pulmonary function testing was done with an RMS Helio 401. Statistical analysis was carried out with R statistical software. RESULTS: The traffic police personnel had significantly (P < 0.05) declined FEV1 and FEV1/FVC ratio and FEF 25-75% (L/s) as compared to controls. Traffic personnel with longer duration of exposure showed significantly (P < 0.05) reduced lung functions than those with shorter duration. We have found a significant negative correlation with all pulmonary function parameters such as FVC, FEV1, FEV1/FVC, PEFR, and FVC 25%-75% among the traffic police personnel. CONCLUSION: The impairment of pulmonary function among the traffic police personnel might be due to the effect of pollution by vehicular exhausts and they should be offered personal protective or preventive measures.

Development and validation of an integrated portable heart rate variability (HRV) analysis system - STREME.

In this paper, we introduce an integrated, portable, affordable and simple to use heart rate variability (HRV) analysis tool STREME. The system consists of an ECG acquisition device and software for HRV analysis. We assessed the reliability and validity of using STREME against the reference standards RMS VarioWin and Kubios HRV for the short term HRV analysis. The validation study was carried out with the participation of 46 healthy subjects that included 15 men and 31 women with an average age of 27.67 ± 7.75yrs. The results showed that there is a significantly strong correlation (r > 0.95, p < 0.001) between STREME and reference systems in HRV indices. The Bland-Altman analysis of all features computed from STREME and reference system represent a close agreement for all the parameters. Hence STREME HRV analysis tool can be recommended to researchers and other professionals for the evaluation of autonomic function using short term HRV.