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  1. Banerjee I, Sathian B, Gupta RK, Amarendra A, Roy B, Bakthavatchalam P, et al.
    Nepal J Epidemiol, 2016 Jun;6(2):574-581.
    PMID: 27774346
    In developing countries like Nepal medicines can be acquired from the chemist's without of a prescription which sometime may have many drawbacks due to intake of excessive drugs without a proper diagnosis. The primary objective of the study was to find out the pattern of self-medication practice among the preclinical medical students at Manipal College of Medical Sciences.
  2. Sathian B, van Teijlingen E, Roy B, Kabir R, Banerjee I, Simkhada P, et al.
    Nepal J Epidemiol, 2023 Dec;13(4):1292-1293.
    PMID: 38299043 DOI: 10.3126/nje.v13i4.61271
  3. Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, et al.
    Nepal J Epidemiol, 2020 Sep;10(3):878-887.
    PMID: 33042591 DOI: 10.3126/nje.v10i3.31622
    Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants' inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19" AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.
  4. Sathian B, Menezes RG, Asim M, Mekkodathil A, Sreedharan J, Banerjee I, et al.
    Nepal J Epidemiol, 2020 Mar;10(1):821-829.
    PMID: 32257512 DOI: 10.3126/nje.v10i1.28277
    Background: Worldwide, tobacco smoking is a major risk factor for morbidity and early mortality among adult population. The present study aimed to find out the association between current smoking and suicidal ideation among young people in Nepal.

    Materials and Methods: A cross-sectional questionnaire-based survey was carried out among 452 youths from Pokhara, Nepal. The present study included both genders (age 18-24 years) who were smokers as well as non-smokers.

    Results: Across the study period, 452 participants were identified after matching for age, and sex (226 in the smoking group and 226 in the non-smoking group). The mean age of participants was 21.6±1.2 years and 58.8% were males. The overall rate of suicidal ideation in our cohort was 8.9%. Smokers were slightly more likely to report suicidal ideation than non-smokers (aOR 1.12). The risk of developing suicidal ideation was 3.56 (95% CI 1.26-10.09) times more in individuals who smoked greater than 3.5 cigarettes per week (p=0.01).

    Conclusion: The rate of suicidal ideation was slightly higher among smokers and a dose-response relationship was identified with the number of cigarettes smoked per week. Being aware of the link between smoking and suicidal ideation may help health care professionals working with young people to address more effectively the issues of mental well-being and thoughts about suicide.

  5. Sathian B, Asim M, Banerjee I, Roy B, Pizarro AB, Mancha MA, et al.
    Nepal J Epidemiol, 2021 Mar;11(1):959-982.
    PMID: 33868742 DOI: 10.3126/nje.v11i1.36163
    Background: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines.

    Methods: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020.

    Results: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time.

    Conclusion: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.

  6. Dimitri P, Fernandez-Luque L, Banerjee I, Bergadá I, Calliari LE, Dahlgren J, et al.
    J Med Internet Res, 2021 05 20;23(5):e27446.
    PMID: 34014174 DOI: 10.2196/27446
    BACKGROUND: The use of technology to support health and health care has grown rapidly in the last decade across all ages and medical specialties. Newly developed eHealth tools are being implemented in long-term management of growth failure in children, a low prevalence pediatric endocrine disorder.

    OBJECTIVE: Our objective was to create a framework that can guide future implementation and research on the use of eHealth tools to support patients with growth disorders who require growth hormone therapy.

    METHODS: A total of 12 pediatric endocrinologists with experience in eHealth, from a wide geographical distribution, participated in a series of online discussions. We summarized the discussions of 3 workshops, conducted during 2020, on the use of eHealth in the management of growth disorders, which were structured to provide insights on existing challenges, opportunities, and solutions for the implementation of eHealth tools across the patient journey, from referral to the end of pediatric therapy.

    RESULTS: A total of 815 responses were collected from 2 questionnaire-based activities covering referral and diagnosis of growth disorders, and subsequent growth hormone therapy stages of the patient pathway, relating to physicians, nurses, and patients, parents, or caregivers. We mapped the feedback from those discussions into a framework that we developed as a guide to integration of eHealth tools across the patient journey. Responses focused on improved clinical management, such as growth monitoring and automation of referral for early detection of growth disorders, which could trigger rapid evaluation and diagnosis. Patient support included the use of eHealth for enhanced patient and caregiver communication, better access to educational opportunities, and enhanced medical and psychological support during growth hormone therapy management. Given the potential availability of patient data from connected devices, artificial intelligence can be used to predict adherence and personalize patient support. Providing evidence to demonstrate the value and utility of eHealth tools will ensure that these tools are widely accepted, trusted, and used in clinical practice, but implementation issues (eg, adaptation to specific clinical settings) must be addressed.

    CONCLUSIONS: The use of eHealth in growth hormone therapy has major potential to improve the management of growth disorders along the patient journey. Combining objective clinical information and patient adherence data is vital in supporting decision-making and the development of new eHealth tools. Involvement of clinicians and patients in the process of integrating such technologies into clinical practice is essential for implementation and developing evidence that eHealth tools can provide value across the patient pathway.

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