A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2).

BACKGROUND: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19. MATERIALS AND METHODS: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others. RESULTS: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw. CONCLUSION: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846].

Willingness to Pay (WTP) for Newer Treatment Options for Diabetes: A Study Among Patients at a Tertiary Care Centre.

Introduction Type 2 diabetes mellitus (T2DM) poses a substantial burden globally and particularly in India, affecting health, finances, and overall quality of life. The management of this condition relies on lifestyle modifications and advanced pharmacological interventions, with emerging drugs showing promise in areas such as administration, side effects, efficacy, and cardiovascular benefits. However, their market penetration is hindered by high costs. Understanding the target population's expectations and willingness to pay (WTP) for these drugs is crucial. WTP, a key concept in behavioral science, reflects the maximum price consumers are willing to pay for a product, aiding in healthcare cost-effectiveness evaluations. Despite its relevance, only one WTP study has been conducted in the Indian context for diabetes. This study explores WTP for two novel drugs: oral semaglutide and icodec (weekly insulin). Material and methods This observational study, conducted in a diabetes specialty clinic and telemedicine facility in All India Institute of Medical Sciences, Bhopal, India, involved adults (18-80 years) diagnosed with T2DM. Data collection adhered to ethical guidelines, and participants provided written informed consent. Face-to-face interviews were employed to gather socio-economic, demographic, and medical details. Participants estimated their WTP for oral semaglutide and weekly insulin, considering reference ranges for existing antidiabetic treatments. Statistical analyses, including t-tests and analysis of variance, explored sociodemographic and clinical factors influencing WTP. Results Of 105 approached patients, 87 (74.3%) participated. The majority were males (55.2%) with an average age of 57.2 years. The average WTP for oral semaglutide was INR 9.35±5.66 per pill, significantly lower than its market price (INR 315). For weekly insulin (icodec), the WTP was INR 157.25±112.60 per dose. Subgroup analyses revealed no significant correlations based on sociodemographic or clinical parameters. Conclusion This study demonstrated the feasibility of WTP assessments in an Indian outpatient setting, revealing a substantial cost disparity between patients' WTP for oral semaglutide and its market price. The findings underscore the importance of considering WTP in introducing new diabetes medications in India, offering valuable insights for healthcare decision-makers and developers.

Assessment of the Practices and Perspectives of Healthcare Providers Towards Utilization of Telemedicine for the Care of Adult Patients With Diabetes Mellitus During the COVID-19 Pandemic in India.

Background and purpose The lockdowns and restrictions enforced periodically during the COVID-19 pandemic posed a serious challenge for non-COVID care, especially in diabetes where telediabetes, the utilization of telemedicine consultations for diabetic care, became more necessary than ever before. Although studies have shed light on the perception of patients, there is a paucity of studies from the perspective of healthcare providers, especially in an Indian context. Moving forward, it is imperative to understand the perspectives of telediabetes providers in this domain. Hence, a nationwide survey was carried out to assess providers' practices and perspectives towards using telemedicine for providing diabetes care in India during the COVID-19 pandemic and beyond. Methods An online questionnaire-based, cross-sectional study was carried out involving diabetes care physicians. The study tool was developed after the identification of broad themes and constructs from published literature, national guidelines, and diabetes experts' recommendations, following which, it was validated by six experts and pilot-tested. An online open survey, hosted on a professional platform, was circulated to internists, endocrinologists, and other diabetes care physicians of various institutions, hospitals, and clinics from both public and private sectors across the country through individual and group emails and various mobile messenger services. Results Out of the 239 doctors who responded to the survey, 195 (81.6%) had provided telediabetes services since the COVID-19 outbreak, and 84.1% were actively providing teleconsultations for diabetes at the time of the survey. The majority of participants (63.2%) were private practitioners. Telediabetes engagement was 3.5 hours per day at the peak of the pandemic and reduced significantly to one hour after the end of the pandemic. Video calling was the most preferred modality for consultation, whereas messaging services were preferred for input from the patients. Printed prescription images followed by text messages were the common modalities for sending treatment advice. The overall perception towards telediabetes was positive (50.1%). Most physicians reported being reasonably and somewhat aware (65.6% and 20.5%, respectively) of telemedicine practice guidelines but were not sure about the extent of compliance. Conclusions Our study sheds light not only on the utilization of telediabetes from physicians' perspectives and practices but also on its acceptability while identifying areas requiring clarity and focus moving forward.

Study on Assessing Serum Lactate as an Early Prognostic Determinant in Sepsis Outcome.

BACKGROUND: Apart from being one of the main causes of death, sepsis has recently been considered a chronic critical illness. This has resulted in the implementation of standard treatment recommendations for management, with a focus on the initial phases of treatment. Early detection of sepsis and prognostic grading are now crucial for management. Despite the fact that sequential organ failure assessment score (SOFA), acute physiology, and chronic health evaluation II score (APACHE II) have been widely used in sepsis, there have been shortcomings such as feasibility and many lab parameters involved. As a result, this study was conducted to evaluate the role of serum lactate as an early marker and to compare it to current scoring systems for determining the outcome of sepsis. METHODS AND MATERIAL: This was an observational hospital-based study with 60 individuals recruited over a one-year period from July 2021 to June 2022. Serum lactate, as well as the other laboratory tests required for the computation of SOFA and APACHE II, were performed. The baseline data and the trend of lactate vs standard scores were examined in the first 48 hours, as well as their impact on outcomes in sepsis patients (as measured by mortality rates- patients were followed up for 28 days). The diagnostic accuracy of these scores was calculated using the area under the receiver operating characteristic (ROC) curve (AUROC). RESULTS: The study enrolled 60 people out of a total of 162 people who were screened. The mean age was 48.4 years, with the highest mortality occurring between the ages of 41 and 60 years. Of the total 60 participants, 34 (56.6%) were male, with the respiratory tract being the most common source of infection for sepsis (36.67%). In our study, 46 patients survived while 14 patients died. The mean lactate on admission was 3.1 mmol/L in survivors and 4 mmol/L in non-survivors, whereas APACHE II was 9 and 12.36, and SOFA was 3.63 and 7.79, respectively, in survivors and non-survivors. Serum lactate and prognosis scores were compared in the survivor and non-survivor groups, and the difference in diagnostic accuracy was found to be statistically significant. CONCLUSIONS: Serum lactate can be used as an early recognition marker in patients with a probability of sepsis and serial lactate monitoring has a similar diagnostic accuracy in predicting outcomes as the traditional prognostic scoring systems SOFA and APACHE II.

Risk Factors for Unfavorable Glycemic Control Trajectory in Type-2 Diabetes Mellitus: A Community-based Longitudinal Study in Urbanslums of Central India.

BACKGROUND: Diabetes mellitus (DM) is a chronic disease, which requires optimal glycemic control to prevent its ensuing vascular complications. Pathway to optimal glycemic control in T2DM has a complex socio-behavioral construct, especially in vulnerable populations, like slum dwellers, who have reduced health-care access and lower prioritization of health needs. OBJECTIVE: The study aimed to map trajectories of glycemic control amongst individuals with T2DM living in urban slums and identify key determinants associated with unfavourable glycaemic trajectory. METHODS: This study was a community-based longitudinal study conducted in an urban slum of Bhopal in Central India. Adult patients diagnosed with T2DM and on treatment for more than one year were included. All 326 eligible participants underwent a baseline interview, which captured sociodemographic, personal behavior, medication adherence, morbidity profile, treatment modality, anthropometric and biochemical measurements (HbA1c). Another 6-month follow-up interview was conducted to record anthropometric measurements, HbA1c and treatment modality. Four mixed effect logistic regression models (through theory-driven variable selections) were created with glycemic status as dependent variable and usage of insulin was considered as random effect. RESULTS: A total of 231 (70.9%) individuals had unfavorable glycemic control trajectory (UGCT), and only 95 (29.1%) had a favorable trajectory. Individuals with UGCT were more likely to be women, with lower educational status, non-vegetarian food preference, consumed tobacco, had poor drug adherence, and were on insulin. The most parsimonious model identified female gender (2.44,1.33-4.37), tobacco use (3.80,1.92 to 7.54), and non-vegetarian food preference (2.29,1.27 to 4.13) to be associated with UGCT. Individuals with good medication adherence (0.35,0.13 to 0.95) and higher education status (0.37,0.16 to 0.86) were found to be protective in nature. CONCLUSION: Unfavorable glycemic control trajectory seems to be an inescapable consequence in vulnerable settings. The identified predictors through this longitudinal study may offer a cue for recognizing a rational response at societal level and adopting strategy formulation thereof.

Adult tetanus is not gone yet, but could be ready to leave: A case-series from central India.

Introduction: Adult tetanus is a neurotoxin mediated infectious disease, that continues to be seen despite availability of a highly efficacious vaccine. In India population-based burden estimates for adult tetanus are not available. Elimination of neonatal and maternal tetanus from India was achieved in 2015 with DPT (diphtheria, pertusis, and tetanus) vaccine during childhood and tetanus toxoid (TT) during antenatal care. Vaccine coverage in adults is uneven. While pregnant women receive the vaccine as part of ante-natal care, booster dose coverage in all other non-pregnant women and men is poor. Case report: We describe four cases of adult tetanus that presented to our tertiary care hospital in central India. Out of four cases, two were homemakers, one was a farmer, another was a student. Three of them were not aware regarding primary tetanus vaccination and none of the four received any booster dosages of tetanus vaccine. Conclusions: These cases highlight complexity of disease management and reinforce the need for adult booster immunization against tetanus.

Status of Hypertension Control in Urban Slums of Central India: A community Health Worker-Based Two-Year Follow-Up.

Background: Hypertension (HTN) is a leading cause of cardiovascular diseases and its control is poor. There is heterogeneity in levels of blood pressure control among various population subgroups. The present study was conducted within the framework of the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS) in India. It aims to estimate the proportion of optimal blood pressure control and identify factors associated with uncontrolled HTN consequent to initial screening. Materials and Methods: We assembled a cohort of individuals with HTN confirmed in a baseline screening in sixteen urban slum clusters of Bhopal (2017-2018). Sixteen accredited social health activists were trained from within these slums. Individuals with HTN were linked to primary care providers and followed up for the next two years. Obtaining optimal blood pressure control (defined as SBP <140 and DBP <90 mm of Hg) was a key outcome. Results: Of a total of 6174 individuals, 1571 (25.4%) had HTN, of which 813 were previously known and 758 were newly detected during the baseline survey. Two-year follow-up was completed for 1177 (74.9%). Blood pressure was optimally controlled in 301 (26%) at baseline and in 442 (38%) individuals at two years (an absolute increase of 12%; 95% CI 10.2-13.9). Older age, physical inactivity, higher body mass index, and newly diagnosed HTN were significantly associated with uncontrolled blood pressure. Conclusion: We found about six of every ten individuals with HTN were on treatment, and about four were optimally controlled. These findings provide a benchmark for NPCDCS, in terms of achievable goals within short periods of follow-up.

Melioidosis as a Mystique Infection: A Study From Central India.

INTRODUCTION: Melioidosis is caused by the Gram-negative bacilli Burkholderia pseudomallei, which is found in contaminated water and soil and spreads via inhalation, inoculation, and ingestion. Melioidosis manifests diversely in immunocompetent and immunocompromised patients, ranging from asymptomatic to life-threatening respiratory distress, septic shock, localized tissue infection, necrotizing pneumonia, and soft organ abscesses.  Methods: An 18-month observational study was conducted at a tertiary center in central India among various confirmed melioidosis cases, with data gathered and analyzed. Aerobic culture and sensitivity were performed in all studied cases, either in blood/body fluid/localized collection - using blood agar media for the culture and disc diffusion method on Mueller Hinton agar for sensitivity. Other tests, such as radiological imaging, were conducted according to symptoms and signs of localized infection. RESULTS: The melioidosis cases under study were compared on various clinical/presenting parameters. Melioidosis has a variety of risk factors, but we found that, in India, diabetic patients are at a higher risk of this infection, particularly fatal forms, as all of the patients in our study were diabetic. Melioidosis is known to have joint involvement, either as a source of infection or later in the course of the disease. All cases were successfully treated with antibiotics and surgical procedures, demonstrating the significance of determining disease etiology, early diagnosis, and rapid early management. CONCLUSION:  Melioidosis is a potentially fatal disease, particularly in diabetics, with a wide range of symptoms and complications. Physicians face a variety of challenges, including clinical symptoms resembling other chronic illnesses, such as tuberculosis, delays in laboratory confirmation, underdiagnosis, reduced reporting, and a lack of suspicion. Because there are very little data and it is a seldom reported infection from central India, we are publishing a study on seven melioidosis patients.

Case Report: Lepromatous Leprosy Masquerading as Acute Suppurative Lymphadenitis.

Leprosy is a chronic cutaneous infection. It is usually characterized by thickened nerves and maculo-anesthetic patches. Leprosy often has an unusual presentation, which is a diagnostic challenge. In this case report, we present a case of an elderly male who presented with fever and chronic pus-draining axillary, cervical, and inguinal lymph nodes. He also had a weak left foot for the previous 5 months. During his hospital stay, he developed additional papular lesions over his extremities. We performed fine needle aspiration from the lymph nodes and skin biopsy, which were suggestive of lepromatous leprosy. We initiated him on antileprosy medication. On follow-up, he was responsive to therapy. Although skin and nerve involvement in leprosy is common, this case had an atypical presentation of discharging lymph nodes.

Aetiologies of Acute Complications in Autoimmune Rheumatologic Diseases: A Hospital-Based Cross-Sectional Study.

BACKGROUND: Autoimmune rheumatic diseases (ARD) present unique challenges in clinical practice. Many of them present in medical emergencies in an unstable state and need immediate evaluation for further plans of action. The clinical conundrum is to distinguish between sepsis, disease flare, or Addisonian crisis (AC) (secondary to steroid withdrawal). This may be further complicated by overlapping clinical features like shock/fever and the coexistence of a combination of the above pathophysiologic mechanisms (e.g. AC with sepsis or AC with disease flare). The known biomarkers may not perform optimally to distinguish them and additional supportive investigations like imaging, cultures, autoimmune serological markers, etc. are needed. Ultimately the boundaries between "the art of medicine" and "the science of medicine" may get blurred, as the established literature evidence falls short and the expert opinion is needed in a time-sensitive manner. In this pragmatic study, researchers have attempted to explore the presentation of rheumatologic emergencies on the above three differentials (sepsis, disease flare, and AC). MATERIALS AND METHODS:  In this hospital-based cross-sectional study, adult patients (age >18 years) with ARD who had unplanned hospital admission due to acute worsening were enrolled. This study was conducted over one year, after getting the Institutional Human Ethics Committee's approval. All relevant hematological, immunological, and hormonal parameters (specifically morning cortisol) were collected and analyzed. The aim was to find the individual and combined prevalence of sepsis, disease flare, or AC in this study group. RESULTS: Forty-one patients were analyzed, with females in the majority (95%) and the dominant age group being 26-49 years (56.1%). A majority had a diagnosis of rheumatoid arthritis (RA) (56.1%) or systemic lupus erythematosus (SLE) (31.7%); the rest were other connective tissue diseases (12.2%). High-risk Quick Sequential Organ Failure Assessment score (qSOFA) score 2-3 was present in 29.3% while the rest had low-risk scores (qSOFA score 0-1). Thirty-two percent had severe disease activity, 46% had mild to moderate disease activity, and 22% of patients had no disease activity. While 78% of patients had low procalcitonin (PCT) values <0.5 microgm/L (low risk of sepsis), 15% had <20 microgm/L, and 7% percentage of patients had serum levels >20 microgm/L (high risk of sepsis). A total of 73.2% of patients had no evidence of infection while 26.8% had either microbiological/radiological evidence of infection. Only 7% of all patients had the presence of an AC. qSOFA scores didn't statistically correlate with a diagnosis of infection or AC but positively correlated with PCT and C-reactive protein (CRP) values. Serum PCT didn't correlate with the presence of infection with statistically significance (p-value 0.217). CONCLUSION: Infections and sepsis are the most important considerations in the emergency presentations of ARDs. Disease flare and AC are also important differentials. Current inflammatory biomarkers like serum CRP and PCT may be less valuable for discriminating between infectious and non-infectious sepsis, especially in chronic inflammatory diseases like ARDs. qSOFA scores may have a prognostic role with less discriminant value. Management of ARD emergencies needs better biomarkers and more research is warranted.

Quantum of Stress Hyperglycemia at the Time of Initial Diagnosis of Tuberculosis.

Background India has a high burden of both tuberculosis (TB) and diabetes mellitus (DM). The National TB Elimination Program recommends testing for glycemic status at the initiation of therapy; however, some individuals with elevated sugar levels might have stress hyperglycemia (SH) instead of true DM. Our aim was to perform a longitudinal glycemic assessment of individuals with TB to identify those with true newly diagnosed DM and those with SH. Methods We identified newly diagnosed adults with TB and abstracted information about demography, co-morbidities, disease severity, and glucose-lowering agents. A glycemic assessment was performed at baseline and at the end of six months. Results We included 150 patients with TB, and based on their initial HbA1c values, 82 (54.6%, 95% CI: 46-62%) had dysglycemia (30% had HbA1c levels above 6.4% and 24.6% had values between 5.9% and 6.4%) and 31 (20.7%, 95% CI: 14-18%) had SH. Among individuals with both baseline and follow-up glycemic values, 30% of the individuals previously defined as DM were characterized as SH. The proportion of true SH was 43% (95% CI: 33-60%). Conclusion Most individuals who have dysglycemia at the time of their TB diagnosis have SH. A close follow-up of such individuals will identify those who really require long-term glucose-lowering therapy.

Characteristics, clinical practice patterns, and outcomes of strokes in India: INSPIRE-A multicentre prospective study.

BACKGROUND: India has a high burden of stroke, but there are limited data available on the characteristics of patients presenting with stroke in India. AIMS: We aimed to document the clinical characteristics, practice patterns, and outcomes of patients presenting with acute stroke to Indian hospitals. METHODS: A prospective registry study of patients admitted with acute clinical stroke was conducted in 62 centers across different regions in India between 2009 and 2013. RESULTS: Of the 10,329 patients included in the prescribed registry, 71.4% had ischemic stroke, 25.2% had intracerebral hemorrhage (ICH), and 3.4% had an undetermined stroke subtype. Mean age was 60 years (SD = 14) with 19.9% younger than 50 years; 65% were male. A severe stroke at admission (modified-Rankin score 4-5) was seen in 62%, with 38.4% of patients having severe disability at discharge or dying during hospitalization. Cumulative mortality was 25% at 6 months. Neuroimaging was completed in 98%, 76% received physiotherapy, 17% speech and language therapy (SLT), 7.6% occupational therapy (OT), with variability among sites; 3.7% of ischemic stroke patients received thrombolysis. Receipt of physiotherapy (odds ratio (OR) = 0.41, 95% confidence interval (CI): 0.33-0.52) and SLT (OR = 0.45, 95% CI: 0.32-0.65) was associated with lower mortality, while a history of atrial fibrillation (OR = 2.22, 95% CI: 1.37-3.58) and ICH (OR = 2.00, 95% CI: 1.66-2.40) were associated with higher mortality. CONCLUSION: In the INSPIRE (In Hospital Prospective Stroke Registry) study, one-in-five patients with acute stroke was under 50 years of age, and one-quarter of stroke was ICH. There was a low provision of thrombolysis and poor access to multidisciplinary rehabilitation highlighting how improvements are needed to reduce morbidity and mortality from stroke in India.

Accuracy of Critical Care Ultrasonography Plus Arterial Blood Gas Analysis Based Algorithm in Diagnosing Aetiology of Acute Respiratory Failure.

Introduction: Lung ultrasound when used in isolation, usually misses out metabolic causes of dyspnoea and differentiating acute exacerbation of COPD from pneumonia and pulmonary embolism is difficult, hence we thought of combining critical care ultrasonography (CCUS) with arterial blood gas analysis (ABG). Aim of the study: The objective of this study was to estimate accuracy of Critical Care Ultrasonography (CCUS) plus Arterial blood gas (ABG) based algorithm in diagnosing aetiology of dyspnoea. Accuracy of traditional Chest X-ray (CxR) based algorithm was also validated in the following setting. Methods: It was a facility based comparative study, where 174 dyspneic patients were subjected to CCUS plus ABG and CxR based algorithms on admission to ICU. The patients were classified into one of five pathophysiological diagnosis 1) Alveolar( Lung-pneumonia)disorder ; 2) Alveolar (Cardiac-pulmonary edema) disorder; 3) Ventilation with Alveolar defect (COPD) disorder ;4) Perfusion disorder; and 5) Metabolic disorder. We calculated diagnostic test properties of CCUS plus ABG and CXR based algorithm in relation to composite diagnosis and correlated these algorithms for each of the defined pathophysiological diagnosis. Results: The sensitivity of CCUS and ABG based algorithm was 0.85 (95% CI-75.03-92.03) for alveolar (lung) ; 0.94 (95% CI-85.15-98.13) for alveolar (cardiac); 0.83 (95% CI-60.78-94.16) for ventilation with alveolar defect; 0.66 (95% CI-30-90.32) for perfusion defect; 0.63 (95% CI-45.25-77.07) for metabolic disorders.Cohn's kappa correlation coefficient of CCUS plus ABG based algorithm in relation to composite diagnosis was 0.7 for alveolar (lung), 0.85 for alveolar (cardiac), 0.78 for ventilation with alveolar defect, 0.79 for perfusion defect and 0.69 for metabolic disorders. Conclusion: CCUS plus ABG algorithm is highly sensitive and it's agreement with composite diagnosis is far superior. It is a first of it's kind study, where authors have attempted combining two point of care tests and creating an algorithmic approach for timely diagnosis and intervention.

Predictors of Mortality among Patients Hospitalized with COVID-19 during the First Wave in India: A Multisite Case-Control Study.

Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused more than 6 million deaths globally. Understanding predictors of mortality will help in prioritizing patient care and preventive approaches. This was a multicentric, unmatched, hospital-based case-control study conducted in nine teaching hospitals in India. Cases were microbiologically confirmed COVID-19 patients who died in the hospital during the period of study and controls were microbiologically confirmed COVID-19 patients who were discharged from the same hospital after recovery. Cases were recruited sequentially from March 2020 until December-March 2021. All information regarding cases and controls was extracted retrospectively from the medical records of patients by trained physicians. Univariable and multivariable logistic regression was done to assess the association between various predictor variables and deaths due to COVID-19. A total of 2,431 patients (1,137 cases and 1,294 controls) were included in the study. The mean age of patients was 52.8 years (SD: 16.5 years), and 32.1% were females. Breathlessness was the most common symptom at the time of admission (53.2%). Increasing age (adjusted odds ratio [aOR]: 46-59 years, 3.4 [95% CI: 1.5-7.7]; 60-74 years, 4.1 [95% CI: 1.7-9.5]; and ≥ 75 years, 11.0 [95% CI: 4.0-30.6]); preexisting diabetes mellitus (aOR: 1.9 [95% CI: 1.2-2.9]); malignancy (aOR: 3.1 [95% CI: 1.3-7.8]); pulmonary tuberculosis (aOR: 3.3 [95% CI: 1.2-8.8]); breathlessness at the time of admission (aOR: 2.2 [95% CI: 1.4-3.5]); high quick Sequential Organ Failure Assessment score at the time of admission (aOR: 5.6 [95% CI: 2.7-11.4]); and oxygen saturation < 94% at the time of admission (aOR: 2.5 [95% CI: 1.6-3.9]) were associated with mortality due to COVID-19. These results can be used to prioritize patients who are at increased risk of death and to rationalize therapy to reduce mortality due to COVID-19.

Assessment of Pulmonary Functions and Dysfunctions in Type II Diabetes Mellitus: A Comparative Cross-Sectional Study.

Background Diabetes mellitus causes microvascular complications in the eyes and kidneys as well as the nervous system, among other parts of the body. Lungs are a potential target organ for diabetic microvascular complications and remain the least researched among diabetic patients. The aim of this study was to explore whether there is any difference in pulmonary functions in patients with diabetes mellitus compared to those without. Methodology A comparative cross-sectional study was conducted on 50 participants each with and without type II diabetes mellitus. Pulmonary function parameters, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1 as a percentage of FVC in percentage (FEV1%), peak expiratory flow rate in L/second (PEFR), forced expiratory flow rate in L/second in 25% of FVC (FEF25%), forced expiratory flow rate in L/second in 50% of FVC (FEF50%), forced expiratory flow rate in L/second in 75% of FVC (FEF75%), forced expiratory flow rate during 25-75% of expiration (FEF25-75%), and maximal voluntary ventilation (MVV), of both groups were analyzed using the NDD Large True Flow (Easy One) spirometer (NDD Meditechnik AG., Switzerland). A fully automated chemistry analyzer and linear chromatography were used for glycemic control measurements. Results All pulmonary function test parameter values were lower in participants with diabetes mellitus compared to those without, except FEV1% and PEFR, which indicates a mixed pattern of lung dysfunction. FVC had a significant negative correlation with the duration of diabetes (r = -0.299, p = 0.034). Conclusions Type II diabetes mellitus patients had significant dysfunction in pulmonary functions with early involvement of restrictive parameters which can be monitored/diagnosed by regularly following up patients by measuring pulmonary functions, and, hence, can be taken care of.

Prevalence, Metabolic Profile, and Associated Risk Factors of Non-alcoholic Fatty Liver Disease in an Adult Population of India.

Introduction Non-alcoholic fatty liver disease (NAFLD) is the main cause of chronic liver disease worldwide. NAFLD refers to a group of diseases that includes simple steatosis, nonalcoholic steatohepatitis, cirrhosis, and hepatocellular carcinoma. Unfortunately, there aren't many studies on NAFLD conducted in India. The majority of research involved specific populations, such as diabetics, pregnant women with gestational diabetes, and obese or non-obese people. When the current study was being planned, there were few population-based studies available. In almost all of the research, ultrasound was employed to identify NAFLD, and the whole spectrum of NAFLD was not assessed. The full spectrum of NAFLD in India must have been considered, including all stages of steatosis as well as hepatic damage as shown by high alanine aminotransferase levels and fibrosis. The purpose of this study was to determine the prevalence, spectrum, and metabolic determinants of NAFLD as assessed by FibroScan® (FibroScan® expert 630 machine; Echosens, Paris, France) in adults of Central India. Methods This cross-sectional study was conducted among 236 adults aged 18 years and above in three localities of Bhopal, India from March 2022 to October 2022. The study included males and females who provided informed consent and fulfilled inclusion criteria. One research assistant and one staff nurse solicited people to participate in the FibroScan® test during the community screening and shared information about the programme. All participants were subjected to the FibroScan® test. Results A total of 322 healthy adults were approached for possible inclusion in the study. Data from 236 subjects were available for analysis after meeting the inclusion and exclusion criteria. According to this study, 43.6% of the study population had NAFLD as detected by FibroScan®. Out of the total, 12.7% of subjects had steatosis grade 1 (S1), 12.3% of subjects had steatosis grade 2 (S2), and 18.6% of subjects had steatosis grade 3 (S3). High body weight, high waist circumference, high waist-to-hip ratio, high fasting sugar, high serum glutamate pyruvate transaminase (SGPT), high triglyceride levels and high very low-density lipoprotein (VLDL) levels were significantly associated with NAFLD. Conclusion In conclusion, 43.6% of the adult population of Bhopal, India is suffering from NAFLD. NAFLD is a severe burden in the Indian community despite being historically associated with the western world. Obesity, diabetes and dyslipidemia are significantly associated with NAFLD.

Association of tobacco use with the tobacco-related built environment: an ecological study from urban slums of Bhopal, India.

INTRODUCTION: Tobacco is one of the biggest public health problems and a major risk factor for various non-communicable diseases (NCDs). An important aspect of tobacco control strategy could include modifications in the tobacco-related built environment. This study investigated the association between tobacco shop density and tobacco use prevalence in the urban slums of Bhopal city, India. METHODS: We conducted a cross-sectional survey to obtain the distribution of tobacco-related built environment (tobacco shops) in the neighbourhood (400-m service area) of 32 urban slum clusters of Bhopal. We plotted this distribution using the 'network service area analysis' in ArcMap 10.7.1 software. Then, we used an ecological design to determine the association between tobacco shop density and tobacco use prevalence in these 32 clusters (N = 6214 adult inhabitants). We used multiple linear regression analysis to estimate the regression coefficient (adjusted for socio-demographic variables) between tobacco use and tobacco shop density at the cluster level. RESULTS: The prevalence of tobacco use among all 32 slum clusters ranged from 22.1 to 59.6% (median 40.9% with IQR 31.8-44.2). There were 194 tobacco shops situated in the neighbourhood of all clusters. The median density of tobacco shops was 59.40/km2 (IQR 39.9-108.1/km2) in the neighbourhoods of slum clusters. Tobacco use prevalence was significantly associated with tobacco shop density (estimate or B = 0.071, p value = 0.002) after adjusting for age, literacy, wealth index, and gender ratio. CONCLUSIONS: Tobacco use prevalence is significantly associated with tobacco shop density in the slums of Bhopal city in central India. We need to develop appropriate built environment interventions to control rampant tobacco use.

Changing Critical Care Patterns and Associated Outcomes in Mechanically Ventilated Severe COVID-19 Patients in Different Time Periods: An Explanatory Study from Central India.

Background: The outcomes in critical illness depend on disease severity, practice protocols, workload, and access to care. This study investigates the factors affecting outcomes in mechanically ventilated coronavirus disease-2019 acute respiratory distress syndrome (COVID-19 ARDS) patients admitted in a tertiary teaching hospital intensive care unit (ICU) in Central India with reference to different time periods in pandemic. This is one of the largest series of mechanically ventilated COVID-19 ARDS patients, globally. Methods: This retrospective cohort study classified the entire data into four time periods (Period 1: April 2020 to June 2020; Period 2: July 2020 to September 2020; Period 3: October 2020 to December 2020; and Period 4: January 2021 to April 2021). We performed a multivariable-adjusted analysis to evaluate predictors of mortality, adjusted for baseline-severity, sequential organ failure assessment (SOFA score) and time period. We applied mixed-effect binomial logistic regression to model fixed-effect variables with incremental complexity. Results: Among the 56 survivors (19.4%) out of 288 mechanically ventilated patients, there was an up-gradient of survival proportion (0, 18.2, 17.4, and 28.6%) in four time periods. Symptom-intubation interval (OR 1.16; 95% CI 1.03-1.31) and driving pressures (DPs) (OR 1.17; 95% CI 1.07-1.28) were significant predictors of mortality in the model having minimal AIC and BIC values. Patients aged above 60 years also had a larger effect, but statistically insignificant effect favoring mortality (OR 1.99; 95% CI 0.92-4.27). The most complex but less parsimonious model (with higher AIC/BIC) indicated the protective odds of high steroid on mortality (OR 0.59; 95% CI 0.59-0.82). Conclusion: The outcomes in mechanically ventilated COVID-19 ARDS patients are heterogeneous across time windows and may be affected by the complex interaction of baseline risk and critical care parameters. How to cite this article: Saigal S, Joshi A, Panda R, Goyal A, Kodamanchili S, Anand A, et al. Changing Critical Care Patterns and Associated Outcomes in Mechanically Ventilated Severe COVID-19 Patients in Different Time Periods: An Explanatory Study from Central India. Indian J Crit Care Med 2022;26(9):1022-1030.

Patterns and Trajectories of Pulmonary Function in Coronavirus Disease 2019 Survivors: An Exploratory Study Conducted in Central India.

BACKGROUND: The ongoing pandemic of coronavirus disease 2019 (COVID-19) has negatively impacted respiratory health worldwide. The severity of the disease varies considerably, and patients may present with bronchitis, pneumonia, and acute respiratory distress syndrome. This study aims to quantify the parameters of the pulmonary function test (PFT) with regard to the severity of COVID-19 and understand the pattern of PFT in reference to the status of selected morbidities and body mass index. MATERIALS AND METHODS: This is a hospital-based, comparative, cross-sectional study. A total of 255 COVID-19 survivors underwent clinical assessment, a PFT, and a 6-minute walk test. Participants were divided into mild, moderate, and severe disease groups. The parameters were compared between these groups. The PFT and 6-minute walk tests were conducted using an NDD Digital computerized spirometer (NDD Meditechnik AG., Switzerland) and a fingertip pulse oximeter (Hasely Inc., India), respectively. RESULTS: All PFT parameters showed significant differential distribution among the severity groups (p<0.001) except for forced expiratory volume in 1 s/ forced vital capacity (FEV1/FVC) and forced expiratory flow (FEF) during 25%-75% expiration and peak expiratory flow (PEF). Among severe category participants forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, were significantly reduced as compared to mild and moderate. Severity was significantly affected by age >50 years. Severe category participants were seen in 31% of normal, 58% of pre-obese, and 53% of obese participants; however, this difference was insignificant. A significant reduction in SPO2 on the 6-minute walk test was observed in severely sick participants. CONCLUSIONS: COVID-19 is associated with a mixed pattern of spirometry. Poor prognosis is associated with older age, obesity, and multimorbidity.