King Edward Memorial Hospital and Seth G.S. Medical College

Background Despite growing scientific evidence and health guidelines, the global health paradox persists, with rising lifestyle-related diseases and escalating healthcare costs exposing the inadequacy of current efforts. Objective Three multidisciplinary congresses were held to generate evidence-based conclusions aimed at addressing the global health paradox. Methods A total of 58 experts from 62 entities participated in the international research and knowledge-exchange panels. Experts reviewed the latest findings to develop practical strategies and identify key research and policy priorities, focusing on the Healthy Eating & Active Living (HEAL) approach. Results, conclusion, and relevance The expert consortium endorsed a 33 evidence-based consensual-statement policy roadmap for addressing global health challenges, emphasizing that the HEAL approach can significantly contribute to the “Prevention First” appeal and broad ethical, social, ecological, and economic advantages, and ultimately supporting policy change.

Abstract Background: Biologics play a pivotal role in the treatment of cancer, autoimmune disorders, and other rare diseases. In view of the high demand for affordable alternatives, the use of biosimilars has significantly increased in India. The need was felt to review the regulatory landscape of biologics and biosimilars in India. Objective: The objective of the study is to review and analyze outcomes of the review process of subject expert committee (SEC) meetings pertaining to approvals of biologics and biosimilars. Materials and Methods: A retrospective, descriptive study was conducted using publicly available minutes of SEC-Biologics division meetings (January 2022–December 2023). Data on the type of agenda items, type of sponsors, therapeutic areas, decisions (approval, recommendation, or rejection), and clinical trial (CT) waivers were extracted and analyzed. Chi-square test and odds ratios were used to determine associations. Results: A total of 137 s meetings discussed 388 items, of which 258 were related to CT and marketing applications. Biosimilars (53.9%) outnumbered biologics (46.1%). CTs made up 49.6% of agenda items, with oncology and COVID-19 as leading therapy areas. Submissions from Indian pharma sponsors were more compared to multinational companies. Overall, 65% of applications were approved, and 60% of CT waiver requests were granted. Reasons for rejections or recommendations included inadequate safety, immunogenicity, or efficacy data, particularly in the local population. Conclusion: The regulatory review process for biologics and biosimilars appears to be timely and consistent. A higher number of CT and trial waivers indicate a patient-centric facilitatory approach without compromising safety, as there is emphasis on submission of local CT data.

Abstract Objective We aimed to prospectively validate and compare published prediction models and clinician-assigned triage categories for early trauma care. Design Prospective multicentre cohort study. Setting Three public hospitals in urban India: one secondary care hospital in Mumbai and one tertiary care teaching hospitals in Delhi and Kolkata each. Participants Adult patients aged over 18 years presenting to the emergency department with a history of trauma between 2016 and 2022. A total of 13,041 patients were included in the final analysis. Methods We externally validated five published trauma prediction models (GAP, Gerdin, KTS, MGAP, and RTS) and clinician-assigned triage categories based on initial assessment. The primary outcome was 30-day all-cause mortality. Models were recalibrated using a separate updating sample prior to evaluation, and model performance was assessed in terms of discrimination (AUC), calibration (calibration slope and plots), and decision curve analysis. Results All models and clinician gestalt-based triage demonstrated excellent discrimination (AUC range: 0.90-0.96) and good calibration after updating. The GAP model achieved the highest AUC (0.96, 95% 0.94-0.97), and RTS demonstrated the highest sensitivity (0.70). Conclusion Simple, physiology-based prediction models and clinician gestalt both demonstrated excellent performance in predicting 30-day mortality among adult trauma patients in Indian emergency departments. These findings provide a practical foundation for further development of trauma triage systems.

Objectives: The objectives of the study are to assess the quality of sleep and its associated factors in newly diagnosed patients with opioid use disorder (OUD), particularly during the early stages of treatment. Material and Methods: This cross-sectional observational study was conducted at the Deaddiction Outpatient Department of KEM Hospital. Eighty participants with newly diagnosed OUD were recruited using comprehensive enumeration. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), and socio-demographic and opioid use data were collected through a semi-structured pro forma. Results: The mean global PSQI score was 10.16, with 80% of participants scoring above 5, indicating poor sleep quality. Statistical analysis revealed no significant associations between PSQI scores and variables such as age, gender, marital status, occupation, opioid use patterns, or family structure. Conclusion: Poor sleep quality is highly prevalent among patients with OUD, regardless of demographic or substance use characteristics. These findings underscore the importance of incorporating sleep-focused interventions into comprehensive substance use treatment plans.

The accurate assessment of infant and young child feeding (IYCF) practices is critical for evaluating nutritional status and guiding public health interventions. The study was planned to develop and validate a Microsoft Excel-based IYCF calculator based on the World Health Organization (WHO)-United Nations Children's Fund (UNICEF) 2021 IYCF indicators for its accuracy, consistency, and user-friendliness. The tool incorporated calculations of all 16 essential indicators. Logical and conditional functions were used to automate calculations. Validations were done using simulated and real databases from urban slums. The IYCF Excel Calculator was developed using Microsoft Excel on Windows 11 and compatible with Excel 2016 or later. The tool accurately calculated IYCF indicators and was user-friendly for individuals with basic knowledge of Microsoft Excel. It reduced the time and complexity of calculations. The developed Excel-based IYCF calculator is an accurate, accessible, and freely available tool for researchers and practitioners for academic and non-commercial use.

Background: The hallmarks of fibromyalgia (FM), a chronic pain syndrome, include tiredness, cognitive impairment, and extensive musculoskeletal discomfort. An imbalance in the autonomic nerve system may play a major role in its pathogenesis, leading to changes in visceral and cardiovascular control, according to mounting evidence. Heart rate variability (HRV) is a sensitive, non-invasive measure of sympathovagal balance and autonomic regulation. Aims and Objectives: The purpose of this study was to compare HRV indices between FM patients and age- and sex-matched healthy controls in order to evaluate autonomic dysfunction in FM utilizing short-term HRV analysis. Materials and Methods: Thirty patients with FM diagnosed using the 2016 updated American College of Rheumatology’s criteria, and 30 healthy volunteers were included in this cross-sectional research. In accordance with Task Force standards, standardized 5-min rested electrocardiograms were obtained, and HRV characteristics were examined in the time domains and frequency domains. The data were analyzed using Statistical Package for the Social Sciences 26.0, with t-tests for between-group comparisons. P<0.05 was considered statistically significant. Results: When compared to healthy controls, FM patients showed a significant decrease in HRV indicators. The RMSSD was 19.3±7.2 ms compared to 38.7 ± 10.1 ms (P<0.001*), and the mean standard deviation of NN intervals (SDNN) was 22.6±8.1 ms rather than 41.2±9.4 ms (P<0.001*). Frequency-domain measurements revealed a higher low-frequency/high-frequency (LF/HF) ratio (1.72±0.65 vs. 1.15±0.48, P=0.003*), indicating greater sympathetic dominance and decreased parasympathetic modulation, along with significantly lower LF power (315±120 ms2 vs. 520±160 ms2, P<0.001*) and HF power (210±98 ms2 vs. 450±142 ms2, P<0.001*). Conclusion: Significantly decreased HRV in both the temporal and frequency domains is a symptom of substantial autonomic dysfunction linked to FM. The concept of impaired central autonomic control in FM is supported by these data, which highlight a condition of sympathovagal imbalance. For determining the severity of an illness and tracking treatment plans meant to restore autonomic balance, HRV may be a helpful biomarker.

Peripheral artery disease is considered as an extra-cardiac manifestation of atherosclerosis, and its clinical presentation is equated to lower limb ischemia. A similar pathogenetic mechanism plays a role in luminal stenosis or obliteration of one or more of the aortic arch arteries. This is a presentation of an uncommon case of synchronous athero-thrombotic obliteration of the right brachio-cephalic and left subclavian arteries in a hypertensive male, who had been symptomatic for only 6 hours.

Abstract Background Gastroesophageal reflux disease (GERD) is a frequent and challenging complication following bariatric surgery, often necessitating further intervention. While several surgical strategies exist, the optimal approach for symptomatic hiatus hernia post-bariatric surgery remains under debate. Method We retrospectively reviewed 11 patients who developed symptomatic GERD after bariatric procedures: 7 had undergone sleeve gastrectomy, 3 had a sleeve converted to gastric bypass for reflux, and 1 had a mini-gastric bypass. Presenting symptoms included retrosternal pain, interscapular discomfort, and dysphagia. All patients underwent comprehensive evaluation with upper GI endoscopy, 24-hour pH monitoring, and oesophageal manometry. Each underwent laparoscopic cruroplasty with meticulous oesophageal mobilisation and recreation of the phrenoesophageal ligament. Results All procedures were completed laparoscopically, with an average operative time of 74.6 minutes. The gastroesophageal junction was repositioned intra-abdominally and anchored to the crura. Two patients experienced transient left-sided pneumothorax, managed intraoperatively. Early postoperative follow-up demonstrated symptom control in 82.3% of patients, with sustained improvement in 79% at 18 months. Notably, proton pump inhibitor (PPI) dependence was markedly reduced, and GERD-Q scores improved most significantly in those with prior sleeve gastrectomy compared to gastric bypass. Conclusions Laparoscopic cruroplasty with phrenoesophageal ligament reconstruction is a safe, effective, and durable solution for hiatus hernia repair after bariatric surgery, offering substantial symptomatic relief and reduced medication dependence.

Endoscopic ultrasound (EUS)-guided liver biopsy in patients with coagulopathy remains unexplored mainly because of the lack of effective hemostatic techniques in the event of post-biopsy bleeding. This study evaluated the feasibility and safety of a novel technique, EUS-guided plugged liver biopsy (EUS-PLB), which incorporates coil embolization for tract hemostasis. In a pilot study, 20 patients with coagulopathy (platelets 20,000-50,000/μL or international normalized ratio 1.5-2.5) underwent EUS-PLB using a modified heparinized wet suction technique. Hemostasis was achieved via real-time EUS-guided deployment of 1 to 2 coils (0.035-inch, 5-cm length, 3-mm diameter coil) into the needle tract. Outcomes included technical and clinical success, sample adequacy, and adverse events. Coil placement was technically successful in all patients. Persistent needle-tract bleeding occurred in five cases and was effectively controlled. The clinical success rate for preventing significant bleeding (early or delayed) was 100%. Adequate biopsy samples were obtained in 18/20 patients (90%), with a mean total specimen length of 3.34±0.88 cm and median complete portal tracts of 18 (range, 6-25). Histological diagnosis was possible in 95% of cases. One patient experienced a mild adverse event (5%). This novel EUS-PLB technique with coil embolization may offer a safe and effective biopsy solution for patients with coagulopathy and warrants further investigation.