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Artificial Intelligence (AI) and AI-driven technologies are transforming industries across the board, with the pharmaceutical sector emerging as a frontrunner beneficiary. This article explores the growing impact of AI and Machine Learning (ML) within pharmaceutical Regulatory Affairs, particularly in dossier preparation, compilation, documentation, submission, review, and regulatory compliance. By automating time-intensive tasks, these technologies streamline workflows, accelerate result generation, and shorten the product approval timeline. However, despite their immense potential, AI and ML also introduce new challenges. Issues such as AI software validation, data management security and privacy, potential biases, ethical concerns, and change management requirements must be addressed. This review highlights current AI-based tools actively used by regulatory professionals such as DocShifter, Veeva Vault, RiskWatch, Freyr SubmitPro, Litera Microsystems, cortical.io etc., examines both the benefits and obstacles of integrating these advanced systems into regulatory practices. Given the rapid pace of technological innovation, the article underscores the need for proactive collaboration with regulatory bodies to manage these developments. It also stresses the importance of adapting to evolving regulatory frameworks and embracing new technologies. Although regulatory agencies like the United Sates Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA) are working on guidelines for AI and ML adoption, clear, standardized protocols are still in the works. While the journey ahead may be complex, the integration of AI promises to fundamentally reshape regulatory processes and accelerate the approval of safe, effective pharmaceutical products., Competing Interests: Declarations. Conflict of Interest: The authors declare that they have no conflict of interest., (© 2024. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.)

Background: Bangladesh has a high rate of snakebite. In rural areas, there is a significant mortality and morbidity rate due to lack of awareness and inappropriate first aid practices. This study aims to determine the knowledge and practices of the rural population in two subdistricts of Bangladesh regarding snakebite prevention and first aid measures., Methods: This cross-sectional survey is part of an intervention study that was carried out in 250 randomly selected primary sampling units of Shibganj in the Chapainawabganj district and Kalapara in the Patuakhali district of Bangladesh. We enrolled a total of 2954 participants. The practice and knowledge were regarded adequate when the score exceeded 50%. We conducted a binomial logistic regression to identify the factors associated with inadequate knowledge and practice., Results: The community's knowledge (15.9%) and practice (14.5%) regarding snakebite prevention was insufficient. More than 77% and 45.4% of respondents believed that applying a tourniquet above the bite site and seeking a traditional healer after a snakebite were effective first aid measures. Poor knowledge was more likely to occur in farming, fishing, homemaker groups and those with lower incomes (11 000-24 000 Bangladeshi taka). Negative practices were associated with females and high family income., Conclusions: This study highlights the necessity of community intervention, with a focus on appropriate first aid and prevention measures through widespread education., (© The Author(s) 2024. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)

Background: Prior to entering the market, health authorities conduct a rigorous evaluation of compiled information for drugs delaying its entry. To address this void expedited pathways are introduced., Methods: In this study, both oncology and non-oncology drugs approved through various expedited pathways from the US and Europe have been scrutinized using the USFDA's Novel Drug approvals from 2020 to 2023 and EMA's Human Medicine Highlights 2020 to 2023. Withdrawals if any along with factors causing withdrawal have also been studied., Results: Among all the pathways accelerated approval has high oncological drug approvals and also high withdrawal for drugs approved based on surrogate endpoints. From the study conducted it was observed that intensive evaluation has to be performed both pre and post-approval for drugs approved based on surrogate endpoints as well as on the conduct of their confirmatory trials., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background:  Brain abscesses are a major health problem with significant morbidity and mortality rates. The objective of this study was to compare the surgical efficacy of endoscope-assisted evacuation of a brain abscess with that of single burr hole aspiration in a tertiary health care center., Methods:  This single-center nonrandomized clinical study was conducted during the period from July 2020 to December 2021. Male and female patients younger than 30 years who presented with brain abscess were enrolled in this study. They were divided into two groups and treated with two different techniques: conventional burr hole aspiration group and endoscope-assisted evacuation group., Results:  Thirty patients were enrolled in this study. The mean age was 13.0 ± 6.3 years in the burr hole group and 13.1 ± 6.4 years in the endoscope-assisted group. There was ≥75.0% evacuation of brain abscess on postoperative day 1 in 13 (92.9%) patients in the endoscope-assisted group and in 5 (33.3%) patients in the burr hole group. The mortality rate was 6.7% in both groups. The mean residual volume on postoperative day 30 was 0.75 mL in the endoscope-assisted group and 1.75 mL in the burr hole aspiration group. No patients treated with endoscope-assisted evacuation required a repeat surgery, whereas five patients (33.3%) treated with the conventional burr hole method required a repeat surgery., Conclusions:  This study showed that the endoscope-assisted procedure has a better rate of abscess evacuation, lower residual risk, and less chance of repeat surgeries than the conventional burr hole procedure., Competing Interests: None declared., (Thieme. All rights reserved.)

COVID-19 vaccination has been instrumental in fighting the pandemic, but evidence on the actual costs associated with delivering these vaccines in resource-constrained settings has been limited. We estimated the cost of delivering COVID-19 vaccines in Bangladesh through five delivery strategies in 2021 and 2022, including Ministry of Health (MOH) hospitals, non-MOH government hospitals, outreach at Expanded Program on Immunization (EPI) centers, mass campaigns, and schools. This was a bottom-up costing study, estimating costs from a payer and beneficiary perspective. We also mapped the funding flows for COVID-19 vaccination activities and analyzed programmatic and financial challenges. The economic cost incurred by the health system to deliver COVID-19 vaccines was $1.05 per dose, excluding vaccine costs. This was made up of a financial cost of $0.29 per dose and an opportunity cost of $0.75 per dose. School-based delivery incurred the lowest financial cost of $0.27, while outreach at EPI centers incurred the highest at $0.44 per dose. The low financial cost per dose is attributed to the high daily volumes delivered at sampled sites, minimal additional resources provided to sites to implement the COVID-19 vaccination program, and a reliance on the existing workforce. Beneficiaries spent an average of $1.63 to receive a single dose of COVID-19 vaccination at fixed sites, with transport representing the largest cost driver ($0.75 per dose). The economic cost to receive one dose of the COVID-19 vaccine was $4.78. Findings can support the Government of Bangladesh to make efficient and equitable resource allocation decisions for vaccination programs.

Recent advancements in research have significantly enhanced our comprehension of the intricate immune components that contribute to multiple sclerosis (MS) pathogenesis. By conducting an in-depth analysis of complex molecular interactions involved in the immunological cascade of the disease, researchers have successfully identified novel therapeutic targets, leading to the development of innovative therapies. Leveraging pioneering technologies in proteomics, genomics, and the assessment of environmental factors has expedited our understanding of the vulnerability and impact of these factors on the progression of MS. Furthermore, these advances have facilitated the detection of significant biomarkers for evaluating disease activity. By integrating these findings, researchers can design novel molecules to identify new targets, paving the way for improved treatments and enhanced patient care. Our review presents recent discoveries regarding the pathogenesis of MS, highlights their genetic implications, and proposes an insightful approach for engaging with newer therapeutic targets in effectively managing this debilitating condition., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Understanding the distribution of type specific human papillomavirus (HPV) genotypes in screen-detected lesions is crucial to differentiate women who are at a higher risk of developing cervical cancer. This study aimed to find out high-risk HPV genotype distribution among women of the coastal districts of Bangladesh., Methods: This cross-sectional study conducted from January 2023 to December 2023 aimed to investigate the prevalence and distribution patterns of high-risk HPV genotypes among ever-married women aged 30-60 years residing in three coastal districts of Bangladesh. Sampling was purposive, with 300 participants per district. Exclusion criteria included prior cervical precancer or cancer treatment, hysterectomy, cervical amputation, and pregnancy. HPV DNA specimens were collected and tested using Cobas 4800. Positive cases underwent further genotype analysis with GenoFlowTM HPV Array Test Kit. Statistical analysis utilized SPSS version 25.0, employing Chi-square and Fisher's Exact tests., Results: Among 900 participants HR-HPV prevalence was 2.56%. HPV 16 was the most prevalent genotype (38.46%), followed by HPV 66 and HPV 68 (11.54% each). Single infections of HPV 16 predominated (39.13%), while for co-infections HPV 66 and HPV 68 were most common (13.04%). HR-HPV positivity increased with age, peaking at 5.5% in the 55-60 years' age group. Participants education level, occupation, income, and reproductive history showed no significant association with HPV positivity. District-wise prevalence varied insignificantly, with Jhalokathi exhibiting the highest (3.0%), followed by Cox's Bazar (2.7%), and Bagerhat (2.0%). HPV 16 was the predominant genotype across districts, with Cox's Bazar and Jhalokathi demonstrating greater genotype diversity than Bagerhat., Conclusion: The study concludes that among ever-married women in the coastal districts of Bangladesh, there is a low prevalence of high-risk HPV. The predominant high-risk HPV genotypes identified were HPV 16, followed by HPV 66 and 68. These findings hold significant implications for policy makers, providing guidance for targeted screening strategies and vaccination programs., Competing Interests: NO authors have competing interests., (Copyright: © 2024 Chakraborty et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Perinatal mental disorders of women have an impact on their pregnancy and their child's brain development across low and middle-income countries. However, to address this issue, there are no specific guidelines for community-level service providers in Bangladesh. Therefore, we aimed to develop a community-based mental healthcare (CBMHC) service package and test its effectiveness in reducing depression, anxiety, and stress among mothers during the perinatal period., Methods: A cluster-randomized controlled trial (cRCT) was applied to test the CBMHC package in 2017 and 2018. It was provided to one group of mothers along with routine maternal care while another group received only routine maternal care. Paired sample t-test was applied to assess mean changes at baseline and endline in the Depression, Anxiety, and Stress Scales-21 (DASS-21) and EuroQol-5 Dimension and 3 Level (EQ5D3L) scales. A linear mixed-effects model was used to assess the relationship between the DASS-21 score and EQ5D3L., Results: 1215 participants were enrolled, including 605 in the intervention group and 610 in the control group. Measures of depression, anxiety, and stress were significantly decreased in both groups. Reduction in the levels of stress, as measured by changes in the stress score, were significantly greater in the intervention than in the control group (diff: 1.2, 95 % CI: 0.1, 2.2). The EQ5D3L index improved significantly, 0.02 units more at endline in the intervention group than in the control group (diff: 0.02, 95 % CI: 0.007, 0.03). The levels of mobility, usual activities, pain or discomfort, depression, and anxiety improved by 1.4 %, 7.6 %, 4.4 %, 2.6 %, and 0.4 % more, respectively, in the intervention group compared to the control groups. These improvements were statistically significant. The DASS-21 score was negatively and significantly correlated with both the EQ-5D3L index and the Visual Analogue Scale (VAS) score for the intervention group as well as for the usual care group, indicating that EQ5D3L improved when common mental disorders decreased., Conclusion: Although the improvements were modest, a CBMHC service package was effective in reducing perinatal levels of stress among Bangladeshi rural women., Trial Registration: ClinicalTrials.gov ID: NCT03678415., Competing Interests: Declaration of Competing Interest The authors declare there are no competing interests., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: The global burden of mosquito-borne diseases transmitted by Aedes aegypti and Aedes albopictus mosquitoes has become a pressing public health concern. This study sought to quantify and evaluate about eight decades of publication data on the global epidemiological trend of the diseases transmitted by A. aegypti and A. albopictus . Methods: A comprehensive bibliographic review of literature was performed on A. aegypti and A. albopictus transmitted diseases, focusing on disease transmission, epidemiological trends, vector control strategies, surveillance and monitoring, and international collaborations and initiatives. Extensive data were collected from the Web of Science database and analyzed for citation network analysis (CNA) using VoSviewer software. Data were collected from the Web of Science database encompassing various aspects of Aedes -borne diseases. The bibliographic CNA was performed to quantify and analyze the 77 years of data on A. aegypti and A. albopictus transmitted diseases. Results: The analysis included 4149 publications contributed by 13,416 authors from 149 countries. These articles comprised research articles (91.01%), review articles (6.267%), proceeding papers (1.76%), and book chapters (0.92%). The results revealed a cumulative h-index of 134, indicating the impact of the scientific output in this field. Conclusion: This review contributes to the ongoing efforts to mitigate the impact of Aedes -borne diseases and protect public health worldwide. By synthesizing current knowledge and evidence-based practices, the study provides all information related to publications, citations, co-citations, top journal trends, high-impact publications, and collaborations among authors in one place among the data published in the past eight decades on Aedes -borne diseases.

Background: Ocular disorders can arise in the advanced stages of chronic kidney disease (CKD) for various reasons, including uraemia, biochemical abnormalities, hypertension and inadequate haemodialysis treatment., Methods: We conducted a cross-sectional study at the Pediatric Nephrology Department, both inpatient and outpatient, of from January 2020 to July 2021. The study aimed to identify and compare ophthalmological changes among children at different stages of CKD to assess potential visual threats. A total of 92 children with advanced-stage CKD, aged 5-18 years, meeting the inclusion and exclusion criteria, were included in the study. Comprehensive assessments, including medical history, physical examinations, relevant tests and detailed ophthalmological examinations, were conducted., Results: The mean age of the participants was 12.1±3.68 years. Most of the children were boys (66%). Twenty-nine patients exhibited impaired visual acuity, children with (6/60-6/24) scores in Snellen's chart Lid oedema and conjunctival pallor were observed in 20.7% and 60.9% of cases, respectively, which were found to statistically significant with advancing CKD stages (p<0.001). Dry eyes were found in 9.8% of CKD stage V patients receiving dialysis (VD) (p=0.003). One patient had a posterior subcapsular cataract, and 7.6% had conjunctival congestion. Patients with conjunctival congestion and hypertensive retinopathy had significantly higher levels of serum phosphate and calcium phosphate product (p<0.001). Hypertensive retinopathy was present in 16.3% of cases, with a significantly higher proportion in the haemodialysis group (93%). Haemodialysis patients exhibited higher blood pressure, lower haemoglobin levels, and a more severe reduction in estimated glomerular filtration rate (p<0.001)., Conclusion: This study highlights the significant ocular complications associated with CKD, underscoring the need for regular ophthalmological screenings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Mucormycosis is a rare, severe fungal infection mainly affecting immunocompromised individuals. Because of limited data on its epidemiology in Oman, we present this national, multicentric, retrospective review that includes all cases of proven mucormycosis between 2006 and 2022 in Oman. There were 51 cases of mucormycosis reported in Oman. The annual incidence of mucormycosis was 0.38-0.69 cases per million population before COVID-19. During the pandemic, the incidence rose significantly to 1.76 in 2020, 5.31 in 2021, then decreased to 0.87 per million population in 2022. Diabetes was observed in 82.4% ( n = 42) of the cases, COVID-19 in 47.1% ( n = 24), and other chronic diseases in 72.6%. The use of steroids was reported in 33.3% ( n = 17) and many patients (64.7%, n = 33) had multiple risk factors. The overall mortality rate was 41.2% ( n = 21) and most deaths occurred within a month of diagnosis. Mortality rate among patients diagnosed with COVID-19 was 58.3% (14/24). Survival analysis showed a statistically significant association between COVID-19 status and patient survival ( p = 0.024). Annual incidence of mucormycosis in Oman rose during the pandemic. This study highlights the epidemiological features of mucormycosis and emphasizes the importance of its inclusion in the national notifiable communicable diseases priority list as well as the importance of enhancing diagnostic capacities to detect and improve patient outcomes.

Background: Highways represent the most significant capital asset that any country's public sector holds. A system of national highways with easy access to ambulance and trauma centers is termed emergency rescue ready and helps reduce the mortality due to road accidents. Given the rich impetus for road infrastructure development by the government of India, there is a need to consider emergency rescue readiness on highways. Previous research suggests that on typical Indian highways, an ambulance can reach the accident scene within 30 minutes; the remaining 30 minutes of golden hour is essential for saving the life of the injured by admitting to a healthcare facility with a trauma unit., Objective: To investigate the emergency rescue readiness for a stretch of highway between two cities in India. The main objective is to determine the possibility of transporting the injured due to the accident on the highway to the nearest available trauma center within 30 minutes., Methods: A Geographic Information System (GIS)-based network analysis method has been adopted to find the possibility of transporting the injured anywhere on the circuit of a national highway to the nearest healthcare unit within 30 minutes., Results: A map representing the status of emergency rescue readiness has been presented for the study area. For a circuit of national highway with a length of 805 km, in a stretch of 89.5% (718.5 km), the injured can be transported to the healthcare unit within 30 minutes. In the remaining 10.5% of the highway, the healthcare units are significantly far from the highways and may hamper the post-crash rescue operations., Conclusion: There exists a wide disparity in trauma care delivery in the study area. Currently, the healthcare units established to serve the areas with dense populations also serve as emergency rescues during accidents on the national highways. Using GIS techniques for highway stretches with difficulty reaching the trauma centers, a national-level assessment is highly recommended., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Journal of Family Medicine and Primary Care.)

Background: Occupational exposure to silica increases the risk of TB infection (TBI) and disease. This study aimed to determine the prevalence of TBI and explore challenges in TBI management in such individuals in two districts of India during 2023., Methods: This was an explanatory mixed-methods study with a quantitative cohort design and qualitative descriptive in-depth interviews., Results: Among 1,555 individuals with occupational exposure to silica, 593 (38%, 95% CI 36-41) underwent interferon-gamma release assay (IGRA) for TBI, of whom 255 (43%, 95% CI 39-47) were found IGRA-positive. Males with occupational silica exposure for ≥20 years had a significantly higher risk of TBI. Of these 160 individuals eligible for TB preventive therapy (TPT), 153 (96%, 95% CI 92-98) were initiated on TPT and 124 (81%, 95% CI 74-88) completed TPT. The low uptake of IGRA was attributed to the stigma associated with TB and reluctance to undergo any medical evaluation., Conclusions: Compared to the general population, individuals with occupational exposure to silica have an almost two times higher prevalence of TBI. Further research is required to identify the threshold of silica exposure to be considered for screening for TBI. Efforts to increase awareness and decrease stigma can improve the uptake of testing for TBI and TB disease., (© 2024 The Authors.)

Visit non-attendance is a common barrier to hypertension control in low and middle-income countries (LMICs). We aimed to evaluate the effectiveness of mobile text messaging in improving visit attendance among patients with hypertension in primary healthcare facilities in Bangladesh. A randomized A/B testing study was conducted with two patient groups: (1) patients regularly attending visits (regular patients) and (2) patients overdue for their follow-up clinic visit (overdue patients). Regular patients were randomized into three groups: a cascade of three text reminders, a single text reminder, or no text reminder. Overdue patients were randomized into two groups: a single text reminder or no text reminder. 20,072 regular patients and 12,708 overdue patients were enrolled. Among regular patients, visit attendance was significantly higher in the cascade reminder group and the single reminder group compared to the no reminder group (78.2% and 76.6% vs. 74.8%, p < 0.001 and 0.027, respectively). Among overdue patients, the single reminder group had a 5.8% higher visit attendance compared to the no reminder group (26.5% vs. 20.7%, p < 0.001). The results remained consistent in multivariable analysis; adjusted prevalence ratio (PR) was 1.04 (95% CI 1.02-1.06) for the cascade reminder group and 1.02 (95% CI 1.00-1.05) for the single reminder group among regular patients. The adjusted PR for the single reminder group vs. the no reminder group among overdue patients was 1.23 (95% CI 1.15-1.33). Text message reminders are an effective strategy for improving retention of patients in hypertension treatment in LMICs, especially for patients overdue to care., (© 2024. The Author(s).)

Background: Among 13 endemic districts, the Chittagong Hill Tracts bear more than 90% of Bangladesh's malaria burden. Despite the private sector's prominence in rural healthcare, its role in malaria management remains underutilized. This study aimed to strategize leveraging the for-profit private sector, such as diagnostic and treatment centers, to bolster national malaria surveillance and control, advancing Bangladesh toward malaria elimination by 2030., Methods: This mixed-method study commenced with a questionnaire-based cross-sectional survey followed by selected focused group discussions (FGDs) among the participants. Three FGDs were held with the for-profit service providers so that further insights and qualitative viewpoints of them can be utilized in situation analysis. Based on the endemicity and strategic priorities, a comprehensive mapping of private for-profit facilities from the regions comprising 15 sub-districts across 8 chosen districts (7 malaria endemic districts and the rest non-endemic districts) was created. For the non-endemic zone, the sub-districts were selected based on their proximity to an area with high malaria transmission., Results: Among the 104 representative participants, majority were male (n = 92, 88.5%), had a diploma in their respective fields (n = 53, 51%) and were involved either in laboratory work (n = 49, 47.1%) or as owners/managers of health centers (n = 41, 39.4%). The selected health facilities were close to the corresponding Upazila Health Complexes (mean distance 2.8 km), but were distantly located from the designated district hospitals (mean distance 48.9 km). The main sources of RDT kits (62.3%) and anti-malarial drugs (63.2%) were local wholesale markets. A large share of the corresponding facilities neither provided malaria treatment services (81.7%) nor worked with the NMEP (93.3%)., Conclusions: This study highlights challenges and recommendations for engaging private for-profit health facilities in Bangladesh's malaria elimination efforts. The identified challenges include low-quality RDTs, staff shortages, and inadequate capacity building. Recommendations emphasize effective training, stakeholder interaction, and enhanced oversight for successful malaria control efforts., (© 2024. The Author(s).)

Background: In India, an increase in malaria cases by 21% (223,961 cases) has been reported between 2022 and 2023. Madhya Pradesh ranks 10th in malaria burden, with Mandla district selected for the Malaria Elimination Demonstration Project (MEDP) to demonstrate the feasibility of malaria elimination in a hard-to-reach, tribal-dominated, and hilly forested district. A Constant Contact Community-based Epidemiological Investigation (C3EI) was undertaken by continuous engagement with the community for real-time data collection, mapping of malaria cases, identification of risk factors, and monitoring of intervention outcomes designed to drive effective strategies for malaria elimination., Methods: The study mapped 1,143,126 individuals from 248,825 households in the year 2017 in Mandla district for constant contact surveillance. Fortnightly household visits were conducted to inquire about febrile episodes, with on-spot diagnosis and treatment. Data collection was done using the SOCH mobile application, and analysis using R., Results: The constant contact household surveillance revealed that out of 956,795 individuals, 230,780 (24.12%) unique individuals reported one or more febrile episodes, with a total of 322,577 febrile episodes and 490 malaria episodes (RDT positive). Males had a higher risk of malaria infection than females (OR = 2.62; p < 0.0001). The cumulative incidence of malaria was highest among children aged 5-15 years and pregnant women. Multiple episodes of malaria infections were more common in adults over 30 years. The incidence of malaria per 100,000 persons gradually declined from 26.13 in 2018 to 11.18 in 2020, with the highest incidence during the monsoon season., Conclusion: The C3EI presents a new strategy suitable for disease elimination programmes. Implementing C3EI-type longitudinal studies in elimination projects holds promise for generating data to expedite malaria elimination efforts because the unit of observation is a 'household'. Such a comprehensive approach allows identification in the gaps in case management for prompt interventions at the household-level., (© 2024. The Author(s).)

Biological oncology agents are vital in cancer care, but their exorbitant expenses present obstacles for patients, families, healthcare professionals, and insurance providers. The advent of biosimilars represents a transformative solution, offering more affordable alternatives after the expiration of biologics patents. Biosimilar agents, similar to biological agents in structure, function, safety, and immunogenicity, enhance healthcare accessibility, improve outcomes, and reduce costs. Thus, the safety of biosimilars in clinical settings is of utmost importance. This review provides a detailed overview of the United States (US) regulatory framework for biosimilars along with a comparative analysis of Food and Drug Administration (FDA) approved biosimilar products. The FDA's "Biosimilar product information" database and "FDA's Purple Book" database were used to retrieve data on approved biosimilars and reference biologicals respectively. The study compares biosimilars and their reference products, examining their physiological action, pharmacokinetics, indications, adverse reactions, and immunogenicity test results and concludes that biosimilars do not have significant variations from their reference biologic products. This analysis will offer critical insights for medical practitioners, clinicians, and patients. It empowers stakeholders to make informed decisions, assessing whether biosimilars offer an equivalent level of safety compared to their reference products. Biosimilars are endorsed as credible substitutes for originator biologics, improving accessibility and affordability in cancer care, and benefiting patients and healthcare systems., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: As post kala-azar Dermal Leishmaniasis (PKDL) threatens the success of the Visceral Leishmaniasis (VL) elimination initiative, we aimed to investigate the PKDL burden, including an active search for PKDL in leprosy-negative skin lesion cases. We also investigated their health-seeking behavior and perceived level of stigma., Methods: This was a cross-sectional survey among inhabitants in the VL-endemic villages of the five most VL-endemic upazilas. VL experts trained medical officers in Upazila Health Complexes (UHCs) and leprosy facilities in PKDL management. Frontline workers conducted house-to-house surveys, referring PKDL suspects to designated centers. Data analysis involved Epi Info version 7 and IBM SPSS Statistics 25., Results: Among 472,435 screened individuals, 4022 had past VL (0.85 %). Among the screened population, 82 were PKDL suspects, and 62 PKDL cases were confirmed. The overall PKDL burden was 1.3 (95 % CI: 1.0-1.7) in the 10,000 population in the endemic villages. Male predominance and macular form of PKDL were observed. Thirty-nine PKDL patients perceived stigma of different levels. Only 27 of 62 (44 %) had received PKDL treatment. Medicine's unavailability and side effects were a major reason behind treatment interruption. Active screening among 137 leprosy-negative PKDL suspects yielded 10 (7.3 %) PKDL cases., Conclusion: The existence of PKDL cases in the VL endemic areas is a concern as those are inter-epidemic reservoirs. As per the WHO roadmap, the PKDL burden must be reduced by 70 % and 100 %, respectively, by 2026 and 2030. NKEP can take the current burden of 1.3 per 10,000 people in VL endemic villages as a baseline. Integrating active case detection for PKDL in leprosy hospitals and screening centers is feasible and worth deploying nationwide., Competing Interests: Declaration of competing interest The authors have no conflicts of interest associated with the material presented in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Introduction: The current literature suggests that the frequency and complexity of public health emergencies are rising and this trend will likely continue. From 2000 to 2023, seven events have been declared as a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO). Organisational models such as the Incident Management System, Incident Response System and Incident Command System or country-specific models are essential in managing PHEIC.The review aims to achieve four key objectives. First, identify and describe the organisational models used in the South-East Asia Region (SEAR) nations defined by WHO as Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, Timor-Leste and DPR Korea for managing PHEICs. Second, explore the indicators used to gauge the effectiveness of these models. Third, assess how these indicators impact the overall success of organisational models. Finally, the review will delve into the implementation aspects gaining a deeper understanding of how the organisational models are put into practice to manage PHEICs in the SEAR region., Methods and Analysis: Following Preferred Reporting Items for Systematic review and Meta-Analysis Protocols guidelines, a qualitative evidence synthesis will be conducted. A defined search strategy will be employed to conduct a comprehensive literature search of the following academic databases: PubMed (MEDLINE), Excerpta Medica Database, Cochrane CENTRAL, Cumulative Index to Nursing and Allied Health Literature, WHO Library Database, US Centers for Disease Control and Prevention (CDC), CDC's Morbidity and Mortality Weekly Report and Web of Science; as well as non-academic databases including Google Scholar, Evidence Aid, Epistemonikos, Shodhganga and ResearchGate. This review will employ the SPIDER-D tool for searching qualitative studies. Two reviewers will check the quality of included studies and will be appraised using standard critical appraisal tools. In case of any difference between the two reviewers, a third reviewer will take the decision., Ethics and Dissemination: No ethical approval is required. Results will be published in a peer-reviewed journal and disseminated through a workshop for stakeholders and policymakers., Prospero Registration Number: CRD42023394418., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Obesity and type 2 diabetes (DM) are risk factors for severe coronavirus disease 2019 (COVID-19) outcomes, which disproportionately affect South Asian populations. This study aims to investigate the humoral and cellular immune responses to SARS-CoV-2 in adult COVID-19 survivors with overweight/obesity (Ov/Ob, BMI ≥ 23 kg/m2) and DM in Bangladesh., Methods: In this cross-sectional study, SARS-CoV-2-specific antibody and T-cell responses were investigated in 63 healthy and 75 PCR-confirmed COVID-19 recovered individuals in Bangladesh, during the pre-vaccination first wave of the COVID-19 pandemic in 2020., Results: In COVID-19 survivors, SARS-CoV-2 infection induced robust antibody and T-cell responses, which correlated with disease severity. After adjusting for age, sex, DM status, disease severity, and time since onset of symptoms, Ov/Ob was associated with decreased neutralizing antibody titers, and increased SARS-CoV-2 spike-specific IFN-γ response along with increased proliferation and IL-2 production by CD8 + T cells. In contrast, DM was not associated with SARS-CoV-2-specific antibody and T-cell responses after adjustment for obesity and other confounders., Conclusion: Ov/Ob is associated with lower neutralizing antibody levels and higher T-cell responses to SARS-CoV-2 post-COVID-19 recovery, while antibody or T-cell responses remain unaltered in DM., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Immunology.)

Background Although caregiving is considered a normal phenomenon for parents, delivering care to a child with neurodevelopmental disabilities can be taxing and disastrously impact parents' quality of life (QoL). This study explored the relationship between QoL, coping strategies, and psychosocial support status of caregivers of children with neurodevelopmental disabilities. Methodology This cross-sectional study included 906 caregivers of children having neurodevelopmental disabilities utilizing the World Health Organization Quality of Life Brief and Perceived Stress Scale. A tailored questionnaire gauged coping strategies and psychosocial support. Linear regression was used to identify significant contributors. Results Most caregivers (78.8%) experienced a moderate level of stress, and their QoL scores were 14.4 (SD = 2.5) for physical health, 12.0 (SD = 2.4) for psychological health, 14.6 (SD = 1.9) for social relationships, and 12.1 (SD = 2.1) for the environment. Mothers had the lowest QoL of all caregivers. Negative influences on QoL encompassed caregiver and child age, perceived stress, and lower socioeconomic status. A higher coping score positively predicted a high health-related QoL score. Gender differences were observed in psychosocial support sources. Conclusions The study underscores the need for policymaking considering findings to develop psychosocial intervention programs for enhancing the QoL of caregivers of children with neurodevelopmental disabilities., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Bangabandhu Sheikh Mujib Medical University issued approval BSMMU/2019/6025. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Tasnim et al.)

Background: Severe acute malnutrition (SAM) can be diagnosed using weight-for-height Z-score (WHZ) and/or mid-upper arm circumference (MUAC). Although some favor using MUAC alone, valuing its presumed ability to identify children at greatest need for nutritional care, the functional severity and physiological responses to treatment in children with varying deficits in WHZ and MUAC remain inadequately characterized., Objective: We aimed to compare clinical and biochemical responses to treatment in children with 1) both low MUAC and low WHZ, 2) low MUAC-only, and 3) low WHZ-only., Methods: A multicenter, observational cohort study was conducted in children aged 6-59 mo with nonedematous, uncomplicated SAM in Bangladesh, Burkina Faso, and Liberia. Anthropometric measurements and critical indicators were collected 3 times during treatment; metrics included clinical status, nutritional status, viability, and serum leptin, a biomarker of mortality risk in SAM., Results: Children with combined MUAC and WHZ deficits had greater increases in leptin levels during treatment than those with low MUAC alone, showing a 34.4% greater increase on the second visit (95% confidence interval [CI]: 7.6%, 43.6%; P = 0.02) and a 34.3% greater increase on the third visit (95% CI: 13.2%, 50.3%; P = 0.01). Similarly, weight gain velocity was higher by 1.56 g/kg/d in the combined deficit group (95% CI: 0.38, 2.75; P = 0.03) compared with children with low MUAC-only. Children with combined deficits had higher rates of iron deficiency and wasting while those with low WHZ alone and combined deficits had higher rates of tachypnea and pneumonia during treatment., Conclusions: Given the comparable treatment responses of children with low WHZ alone and those with low MUAC alone, and the greater vulnerability at admission and during treatment in those with combined deficits, our findings support retaining WHZ as an independent diagnostic and admission criterion of SAM, alongside MUAC. This trial was registered at www., Clinicaltrials: gov/study/NCT03400930 as NCT03400930., (Copyright © 2024 American Society for Nutrition. Published by Elsevier Inc. All rights reserved.)

Introduction Salinity intrusion is the most common global concern along coastlines, but it can happen inland also. The lack of freshwater is the primary issue affecting the coastal areas. Many health problems are prevalent among the inhabitants due to their frequent use of salted water. The health of women living along the coastline is getting progressively compromised due to salinity intrusion. Objectives The study aims to determine menstrual health practices and other health problems faced by women in the coastal region of Bangladesh. Methods The study was conducted using a survey research design from May 2023 to October 2023 on rural women aged 18 to 45 years, who lived in the Bangladeshi village of Koyra Upazila in the Khulna district. The sample size of the study was 101. Open- and closed-ended questions from a planned interview schedule were used to gather primary data. Additional information from appropriate sources, e.g., newspapers, publications, and books, was utilized to enhance the comprehensiveness of statistical analysis and support rationality. A p-value of 0.05 was considered significant. Statistical analysis was performed using STATA version 15 (StataCorp LLC, College Station, TX). Results Menstrual hygiene practices showed a higher prevalence of using fabric rags and reusing them after rinsing them in salt water (72.3%) than sanitary pads (25.7%). It was observed that the risk of diarrhea among tubewell water and rainwater users was significantly lowered by 0.25 times (95% CI = 0.06, 0.99; p = 0.049) and 0.06 times (95% CI = 0.01, 0.43; p = 0.005), respectively, compared to pond water users. Conclusion Salinity has a significant impact on the livelihoods and health of coastal women. The village women are unaware of the health risks of excessive saline water use. Establishing an adequate supply of freshwater reservoirs for the entire community throughout the year is an alternative for women to use as a source of water for hygiene necessities., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Institutional Review Board of the National Institute of Cancer Research & Hospital (NICRH), Dhaka, Bangladesh issued approval NICRH/IRB/2023/18; Dated: 15/03/2023. In addition, the participants received a thorough explanation from the researchers regarding their future publication plans and study objectives. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Sinha et al.)

Background: The World Health Organization (WHO) promotes the HEARTS technical package for improving hypertension control worldwide, but its effectiveness has not been rigorously evaluated., Objective: To compare hypertension outcomes in clinics implementing HEARTS versus clinics continuing usual hypertension care in rural Bangladesh., Methods: A matched-pair cluster quasi-experimental trial in Upazila Health Complexes (UHCs; primary healthcare facilities) was conducted in rural Bangladesh. A total of 3935 patients (mean age 52.3 years, 70.5% female) with uncontrolled hypertension (blood pressure (BP) ≥140/90 mm Hg regardless of treatment history) were enrolled: 1950 patients from 7 HEARTS UHCs and 1985 patients from 7 matched usual care UHCs. The primary outcome was systolic BP at 6 months measured at the patient's home; secondary outcomes were diastolic BP, hypertension control rate (<140/90 mm Hg) and loss to follow-up. Multivariable mixed-effects linear and Poisson models were conducted., Results: Baseline mean systolic BP was 158.4 mm Hg in the intervention group and 158.8 mm Hg in the usual care group. At 6 months, 95.5% of participants completed follow-up. Compared with usual care, the intervention significantly lowered systolic BP (-23.7 mm Hg vs -20.0 mm Hg; net difference -3.7 mm Hg (95% CI -5.1 to -2.2)) and diastolic BP (-10.2 mm Hg vs -8.3 mm Hg; net difference -1.9 mm Hg (95% CI -2.7 to -1.1)) and improved hypertension control (62.0% vs 49.7%, net difference 12.3% (95% CI 9.0 to 16.8)). Rate of missed clinic visits was lower in the intervention group (8.8% vs 39.3%, p<0.001)., Conclusions: After WHO-HEARTS package implementation in rural Bangladesh, BP was lowered and hypertension control improved significantly compared with usual care., Trial Registration Number: NCT04992039., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background and Aims: The emergence of the COVID-19 pandemic led to the adoption of telework modalities by individuals in Bangladesh. The study's objective was to determine the job satisfaction and performance level of employed Bangladeshi women working from home during the COVID-19 pandemic lockdown., Methods: A cross-sectional study was conducted among women employees of different professions in Dhaka city. The Minnesota Satisfaction Questionnaire (MSQ) was used to measure job satisfaction. Work arrangement satisfaction and self-reported performance were measured by two separate subscales which contain five items each. Responses from 118 employed women were analyzed using descriptive statistics, Pearson Chi-square tests, Independent t -tests, one-way analysis of variance, and Pearson Correlation tests through the Statistical Package for Social Science (SPSS), version 26., Results: The findings indicated that 51.7% of women reported a high degree of satisfaction on the MSQ scale; 61.9% expressed high satisfaction with their work arrangements at home and 66.9% reported a high level of performance. Job satisfaction was significantly associated with the number of children and the number of family members. A positive association was found between job satisfaction and total working experience and work arrangements. Work performance was strongly associated with higher educational qualifications. A statistically significant association between job satisfaction and performance was revealed., Conclusions: The findings from this study indicated a high degree of job satisfaction and a high level of performance found in women employees who worked from home during the COVID-19 pandemic. These findings encourage organizations to foster more policies for telework alternatives for employed women to help them keep a balance between work responsibilities and household chores., Competing Interests: The authors declare no conflict of interest., (© 2024 The Author(s). Health Science Reports published by Wiley Periodicals LLC.)

Background: Noncommunicable diseases (NCDs) are public health threats globally and recognized impediments to socioeconomic development. This study aimed to identify the prevalence and clustering of NCDs risk factors among Bangladeshi men and women aged 20-59 years using nationally representative data., Methods: This study was conducted in 82 rural, nonslum urban, and slum clusters across all eight administrative divisions of Bangladesh using multistage cluster sampling. A total of 4917 men and 4905 women aged 20-59 years were included in the study. Descriptive analyses were performed to report the prevalence and distribution of behavioral and clinical risk factors. Multivariable binary logistic regression was performed to identify factors associated with the coexistence of three or more NCD risk factors., Results: The prevalence of tobacco use (any form), insufficient physical activity, inadequate fruit and vegetable consumption, overweight and obesity, and central obesity were 38.3%, 13.6%, 87.1%, 42.3%, and 36.0%, respectively. Furthermore, 21.9% and 4.9% participants had hypertension and self-reported diabetes, respectively. Regarding the clustering of risk factors, 37.1% men and 50.8% women had at least three NCD risk factors. Only 3.0% men and 1.8% women reported no NCD risk factors. Age, place of residence, education, and wealth status were associated with the presence of at least three risk factors for both sexes., Conclusion: Since a large proportion of Bangladeshi 20-59 years old population had multiple risk factors, population-based programs with multisectoral approaches are essential to reduce NCDs among Bangladeshi women and men., Competing Interests: The authors declare no conflict of interest., (© 2024 The Author(s). Chronic Diseases and Translational Medicine published by John Wiley & Sons Ltd on behalf of Chinese Medical Association.)

Introduction: Colorectal cancer (CRC) constitutes the third most frequently diagnosed cancer in Oman.  This study report the result of a community based screening campaign to promote the early detection and explore the associated risk factors of CRC amongst Omani population., Methods: We launched a colorectal cancer awareness campaign in Oman's South Ash Sharqiyah Governorate between January and March, 2023. We conducted a stratified random study including 688 adult Omani participants aged over 40 years old. Local Health Centers collected the questionnaire forms. Fecal occult blood tests (FOBTs) were carried out at Local Health Centers; while medical professionals performed the colonoscopy examination in Sur University Hospital., Results: Overall, the screening response rate was 68.8%. The data indicated that 8.1% of the total sample yielded positive FOBTs; of whom, 85.7% were aged 40-59 years old and 67.9% were obese or overweight. Abnormal colonoscopy was reported in 7 participants. One participant had a confirmed CRC of stage I., Conclusion: Screening and early detection campaign can have effect and increase the rate of early detection among population in Oman.

Introduction: Immunotherapies have revolutionized cancer treatment, but often fail to produce desirable therapeutic outcomes in all patients. Due to the inter-patient heterogeneity and complexity of the tumor microenvironment, personalized treatment approaches are gaining demand. Researchers have long been using a range of in-vitro assays including 2D models, organoid co-cultures, and cancer-on-a-chip platforms for cancer drug screening. A comparative analysis of these assays with their suitability, high-throughput capacity, and clinical translatability is required for optimal translational use., Areas Covered: The review summarized in-vitro platforms with their comparative advantages and limitations including construction strategies, and translational potential for immuno-oncology drug efficacy assessment. We also discussed end-point analysis strategies so that researchers can contextualize their usefulness and optimally design experiments for personalized immunotherapy efficacy prediction., Expert Opinion: Researchers developed several in-vitro platforms that can provide information on personalized immunotherapy efficacy from different angles. Image-based assays are undoubtedly more suitable to gather a wide range of information including cellular morphology and phenotypical behaviors but need significant improvement to overcome issues including background noise, sample preparation difficulty, and long duration of experiment. More studies and clinical trials are needed to resolve these issues and validate the assays before they can be used in real-life scenarios.

Background: Bangladesh is making progress toward achieving zero dog-mediated rabies deaths by 2030, a global goal set in 2015., Methods: Drawing from multiple datasets, including patient immunisation record books and mass dog vaccination (MDV) databases, we conducted a comprehensive analysis between 2011 and 2023 to understand the effectiveness of rabies control programmes and predict human rabies cases in Bangladesh by 2030 using time-series forecasting models. We also compared rabies virus sequences from GenBank in Bangladesh and other South Asian countries., Findings: The estimated dog population in Bangladesh was determined to be 1,668,140, with an average dog population density of 12.83 dogs/km 2 (95% CI 11.14-14.53) and a human-to-dog ratio of 86.70 (95% CI 76.60-96.80). The MDV campaign has led to the vaccination of an average of 21,295 dogs (95% CI 18,654-23,935) per district annually out of an estimated 26,065 dogs (95% CI 22,898-29,230). A declining trend in predicted and observed human rabies cases has been identified, suggesting that Bangladesh is poised to make substantial progress towards achieving the 'Zero by 30' goal, provided the current trajectory continues. The phylogenetic analysis shows that rabies viruses in Bangladesh belong to the Arctic-like-1 group, which differs from those in Bhutan despite sharing a common ancestor., Interpretation: Bangladesh's One Health approach demonstrated that an increase in MDV and anti-rabies vaccine (ARV) resulted in a decline in the relative risk of human rabies cases, indicating that eliminating dog-mediated human rabies could be achievable., Funding: The study was supported by the Communicable Disease Control (CDC) Division of the Directorate General of Health Services (DGHS) of the People's Republic of Bangladesh., Competing Interests: The authors declared that they have no competing interests., (© 2024 The Authors.)

Introduction: India's contribution to the malaria burden was highest in South-East Asia Region in 2021, accounting for 79% of the estimated malaria cases and 83% of malaria-related deaths. Intensified Malaria Control Programme supported by Global Funds to Fight against AIDS, Tuberculosis and Malaria has deployed crucial interventions to reduce the overall burden of malaria in India. Evaluation of utilisation of malaria elimination interventions by the community and assessment of the healthcare system is underway in eleven high malaria endemic states in India. Health system preparedness for malaria elimination, logistics, and supply chain management of diagnostic kits and anti-malarial drugs in addition to the knowledge, attitude and practice of the healthcare workers is also being assessed., Methods and Analysis: The study is being undertaken in 11 malaria endemic states with a variable annual parasite incidence of malaria. In total, 47 districts (administrative unit of malaria control operations) covering 37 976 households are to be interviewed and assessed. We present here the protocol following which the study is being undertaken at the behest and approval of Ministry of Health and Family Welfare in India., Ethics and Dissemination: No patients were involved in the study. Study findings will be shared with Institutional ethics board of National Institute for Malaria Research New Delhi (NIMR) in a timely, comprehensive, accurate, unbiased, unambiguous and transparent manner and to the National Vector-borne Disease (Malaria) Control Programme officers and the Community public who participated. Important findings will be communicated through community outreach meetings which are existing in the Health system. Results will be informed to study participants via local fieldwork supervised by District Malaria Officers. Also findings will be published in reputed journals based on Indian Council of Medical Research (ICMR) publication policy.The ICMR-NIMR ethics committee approved the study via letter No. NIMR/ECM/2023/Feb/14 dated 24 April 2023 for version 5. All standard ethical practices will be followed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)