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1.
Trop Med Health ; 52(1): 10, 2024 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-38225634

RESUMO

Measles poses a significant global health threat, exacerbated by the COVID-19 pandemic. Despite the efficacy of two vaccine doses, under-5 mortality rates persist, with over 61 million delayed measles vaccinations worldwide. Nepal, striving to eliminate measles by 2023, faces a resurgence, attributing 1013 cases to inadequate vaccination and healthcare accessibility issues. Compounded by disruptions from the COVID-19 pandemic, the outbreak highlights the urgent need for vaccination promotion, improved healthcare access, and misinformation mitigation. This situation underscores the critical role of global collaboration and healthcare infrastructure investment to safeguard children's lives in Nepal and similar vulnerable regions.

2.
J Public Health (Oxf) ; 46(1): 30-40, 2024 Feb 23.
Artigo em Inglês | MEDLINE | ID: mdl-37955595

RESUMO

BACKGROUND: To explore the impacts of contextual issues encompassing social, cultural, political and institutional elements, on the operation of public health surveillance systems in Nepal concerning the monitoring of infectious diseases in the face of a changing climate. METHODS: Semi-structured interviews (n = 16) were conducted amongst key informants from the Department of Health Services, Health Information Management System, Department of Hydrology and Meteorology, World Health Organization, and experts working on infectious disease and climate change in Nepal, and data were analysed using thematic analysis technique. RESULTS: Analysis explicates how climate change is constructed as a contingent risk for infectious diseases transmission and public health systems, and treated less seriously than other 'salient' public health risks, having implications for how resources are allocated. Further, analysis suggests a weak alliance among different stakeholders, particularly policy makers and evidence generators, resulting in the continuation of traditional practices of infectious diseases surveillance without consideration of the impacts of climate change. CONCLUSIONS: We argue that along with strengthening systemic issues (epidemiological capacity, data quality and inter-sectoral collaboration), it is necessary to build a stronger political commitment to urgently address the influence of climate change as a present and exponential risk factor in the spread of infectious disease in Nepal.


Assuntos
Mudança Climática , Doenças Transmissíveis , Humanos , Nepal/epidemiologia , Doenças Transmissíveis/epidemiologia , Saúde Pública , Fatores de Risco
3.
Influenza Other Respir Viruses ; 17(12): e13234, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38149926

RESUMO

Few seroprevalence studies have been conducted on coronavirus disease (COVID-19) in Nepal. Here, we aimed to estimate seroprevalence and assess risk factors for infection in the general population of Nepal by conducting two rounds of sampling. The first round was in October 2020, at the peak of the first generalized wave of COVID-19, and the second round in July-August 2021, following the peak of the wave caused by the delta variant of SARS-CoV-2. We used cross-sectional probability-to-size (PPS)-based multistage cluster sampling to estimate the seroprevalence in the general population of Nepal at the national and provincial levels. We tested for anti-SARS-CoV-2 total antibody using the WANTAI SARS-CoV-2 Ab ELISA kit. In Round 1, the overall national seroprevalence was 14.4%, with provincial estimates ranging from 5.3% in Sudurpaschim to 27.3% in Madhesh Province. In Round 2, the estimated national seroprevalence was 70.7%, with the highest in the Madhesh Province (84.8%) and the lowest in the Gandaki Province (62.9%). Seroprevalence was comparable between males and females (Round 1, 15.8% vs. 12.2% and Round 2, 72.3% vs. 68.7%). The seroprevalence in the ecozones-Terai, hills, and mountains-was 76.3%, 65.3%, and 60.5% in Round 2 and 17.7%, 11.7%, and 4.6% in Round 1, respectively. In Nepal, COVID-19 vaccination was introduced in January 2021. At the peak of the first generalized wave of COVID-19, most of the population of Nepal remained unexposed to SARS-CoV-2. Towards the end of the second generalized wave in April 2021, two thirds of the population was exposed.


Assuntos
COVID-19 , Feminino , Masculino , Humanos , COVID-19/epidemiologia , Nepal/epidemiologia , Vacinas contra COVID-19 , Estudos Transversais , Pandemias , Estudos Soroepidemiológicos , SARS-CoV-2 , Anticorpos Antivirais
4.
IJID Reg ; 9: 120-124, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38035052

RESUMO

Objectives: Reports from other countries have indicated that severe forms and fatal cases of COVID-19 in older adults and people with underlying comorbidities. The aim of this study was to assess the risk factors associated with COVID-19 mortality in Nepal. Methods: A cross-sectional study was conducted from April 12 to July 23, 2021 to identify the underlying factors associated with COVID-19 deaths. Our sample included all cases diagnosed and registered as COVID-19-related deaths at 30 hospitals of Nepal. Results: A total of 1459 COVID-19 hospital-based death records were collected from 30 hospitals. Mean age at death was 60.2 (±15.6) years. One-third of cases were admitted with fever, cough, and shortness of breath. The computerized tomography Severity Score showed that 7.3% of the individuals who underwent high-resolution computerized tomography chest had a severe form of lung involvement, and 3.6% had mild to moderate involvement. The most common comorbidities were hypertension (43.7%) followed by diabetes mellitus (25.8%). Among the deceased, 37.7% were diagnosed as cases of COVID-19 pneumonia. The most common recorded causes of death were respiratory failure followed by cardio-pulmonary arrest. Conclusions: Individuals with comorbidities including hypertension and diabetes mellitus were at greater risk of developing complications and had a higher rate of mortality.

5.
Glob Ment Health (Camb) ; 10: e61, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37854421

RESUMO

Mental disorders are the leading cause of disease burden, affecting 13% of all people globally in 2019. However, there is scarce evidence on the burden of mental disorders in Nepal. This study used the Global Burden of Disease Study 2019 data to assess the prevalence and disability-adjusted life-years (DALYs) of mental disorders in Nepal between 1990 and 2019. In 2019, there were 3.9 million (95% UI: 3.6-4.3) people with mental disorders in Nepal. Major depressive disorders (1.1 million; 95% UI: 0.9-1.2 million) and anxiety disorders (0.9 million; 95% UI: 0.8-1.2 million) were the most prevalent mental disorders in 2019. Attention deficit hyperactive disorder, conduct disorder, and autism spectrum disorders were present twice as high in males than in females. The proportional contribution of mental disorders to the total disease burden has tripled between 1990 (1.79% of all DALYs) and 2019 (5.5% of all DALYs). In conclusion, the proportional contribution of mental disorders to total disease burden has increased significantly in the last three decades in Nepal, with apparent sex and age differentials in prevalence and DALY rates. Effective program and policy responses are required to prepare the health system for reducing the growing burden of mental health disorders in Nepal.

6.
J Nepal Health Res Counc ; 21(1): 57-62, 2023 Sep 08.
Artigo em Inglês | MEDLINE | ID: mdl-37742150

RESUMO

BACKGROUND: In Nepal, since the first detection of COVID-19 case in January 2020, the total cases have rose to almost a million with more than 12,000 deaths. Till now, WHO has classified 5 variants of SARS-Cov2 as variant of concerns at different time points causing many waves in different countries and regions at different time points. Nepal had also faced three distinct waves of COVID-19 caused by different variant of COVID 19. The objective of this study was to perform whole-genome sequencing of SARS-CoV-2 circulating in different waves of COVID-19 in Nepal and investigate its variant or lineage. METHODS: In this study, samples from 49 SARS-CoV-2 infected subjects from May 2021 to January 2022, were investigated. The methodology followed RNA extraction, real-time PCR for confirmation and whole-genome sequencing. The consensus genomes were interpreted with appropriate bioinformatics tools and databases. RESULTS: Sequence analysis of 49 genomes revealed to be of Delta (n=27) and Omicron Variant (n=22). The mutations in the consensus genomes contained the defining mutations of the respective lineages/variants. There were 20 genomes of Omicron sub-lineage BA.2, 1 of BA.1.1 and 1 of B.1.1.529. CONCLUSIONS: This study provides concise genomic evidence of presence of Delta and Omicron variant of COVID-19 in Nepal. Delta and Omicron variants were driving the second wave and the third wave of COVID-19 respectively in Nepal. Therefore, the genomic surveillance must be increased to clearly map out the pandemic and strategize vaccination approaches in the country.

7.
PLoS One ; 18(9): e0290693, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37669253

RESUMO

BACKGROUND: Nepal has been devastated by an unprecedented COVID-19 outbreak, affecting people emotionally, physically, and socially, resulting in significant morbidity and mortality. Approximately 10% of COVID-19 affected people have symptoms that last more than 3-4 weeks and experience numerous symptoms causing an impact on everyday functioning, social, and cognitive function. Thus, it is vital to know about the recovered patient's health status and undertake rigorous examinations to detect and treat infections. Hence, this study aims to assess the health status of COVID-19 post-recovery patients in Nepal. METHOD: A descriptive cross-sectional mixed-method study was conducted in all seven provinces of Nepal. A total of 552 interviews were conducted for the quantitative study, and 25 in-depth interviews were conducted for the qualitative study among above 18 years COVID-19-recovered patients. The data was gathered over the phone through the purposive sampling method The results of a descriptive and thematic analysis were interpreted. FINDING: The majority (more than 80%) of the recovered patients could routinely perform household duties, activities outside the home, and financial job accounting. However, a few of them required assistance in carrying out all of those tasks. Prior and then after COVID-19 infection, smoking habits reduced by about one-tenth and alcohol intake decreased by a twelve percent. A qualitative finding revealed that the majority of COVID-19 symptomatic patients experienced a variety of physical symptoms such as fever, headache, body pain, fatigue, tiredness, sore throat, cough, loss of taste, loss of smell, sneezing, loss of appetite, and difficulty breathing, while others felt completely fine after being recovered. Furthermore, there was no variation in the daily functional activities of the majority of the recovered patients, while a few were found conducting fewer activities than usual because they were concerned about their health. For social health, quantitative data indicated that more than half of the participants' social health was severely impacted. According to the IDI, the majority of the interviewees perceived society's ignorance and misbehavior. Family members were the most often solicited sources of support. Some participants got care and assistance, but the majority did not get affection or love from their relatives. Moreover, regarding mental health, 15 percent of participants had repeated disturbing and unwanted thoughts about COVID-19 after being recovered, 16 percent tried to avoid information on COVID-19 and 7 .7 percent of people had unfavorable ideas or sentiments about themselves. More than 16 percent of participants reported feeling some level of stress related to the workplace and home. While in-depth interviews participants revealed that COVID-infected patients who were asymptomatic didn't experience any emotional change in them but recovered patients who are symptomatic symptoms had anxiety and still being conscious of COVID-19 in fear of getting infected again Additionally, it was discovered that participants' mental health is influenced by ignorance of society, as well as by fake news posted to social media. CONCLUSION: COVID-19 infection has had an impact on physical, mental, and social well-being. Hence, to aid in the early recovery of COVID-19 patients, provision of evaluating and reporting the clinical features, early detection and management of long COVID case is needed from the local and provincial and central government of Nepal.


Assuntos
COVID-19 , Status Social , Humanos , Síndrome de COVID-19 Pós-Aguda , Estudos Transversais , Nepal
8.
Glob Health Epidemiol Genom ; 2023: 3700094, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37377984

RESUMO

Cardiovascular diseases (CVDs) have emerged as the leading cause of deaths worldwide in 2019. Globally, more than three-quarters of the total deaths due to CVDs occur in low- and middle-income countries like Nepal. Although increasing number of studies is available on the prevalence of CVDs, there is limited evidence presenting a complete picture on the burden of CVDs in Nepal. In this context, this study aims to provide comprehensive picture on the burden of CVDs in the country. This study is based on the Global Burden of Disease (GBD) study 2019, which is a multinational collaborative research covering 204 countries and territories across the world. The estimations made from the study are publicly available in the GBD Compare webpage operated by the Institute for Health Metrics and Evaluation (IHME), University of Washington. This article makes use of those data available on the GBD Compare page of IHME website to present the comprehensive picture of the burden of CVDs in Nepal. Overall, in 2019, there were an estimated 1,214,607 cases, 46,501 deaths, and 1,104,474 disability-adjusted life years (DALYs) due to CVDs in Nepal. The age-standardized mortality rates for CVDs witnessed a marginal reduction from 267.60 per 100,000 population in 1990 to 245.38 per 100,000 population in 2019. The proportion of deaths and DALYs attributable to CVDs increased from 9.77% to 24.04% and from 4.82% to 11.89%, respectively, between 1990 and 2019. Even though there are relatively stable rates of age-standardized prevalence, and mortality, the proportion of deaths and DALYs attributed to CVDs have risen sharply between 1990 and 2019. Besides implementing the preventive measures, the health system also needs to prepare itself for the delivery of long-term care of patients with CVDs which could have significant implications on resources and operations.


Assuntos
Doenças Cardiovasculares , Carga Global da Doença , Humanos , Doenças Cardiovasculares/epidemiologia , Nepal/epidemiologia
9.
Lancet Reg Health Southeast Asia ; 12: 100168, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37384065

RESUMO

Background: Rare cancers (RCs) are challenging to manage and are "forgotten cancers" though they collectively constitute a significant proportion of all cancers (∼20%). As a first step towards streamlining care, there is an unmet need to map the epidemiology of RCs in South Asian Association for Regional Collaboration (SAARC) countries. Methods: The authors collected data from 30 Population-Based Cancer Registries (PBCR) of India and the published national registries of Nepal, Bhutan and Sri Lanka (SL) and compared them with the standard RARECAREnet RC list. Findings: With the standard definition of crude incidence rates (CR) ≤6/100,0000 per population, 67.5%, 68.3%, 62.3% and 37% of all incident cancers qualify as RCs in India, Bhutan, Nepal and SL, respectively. An arbitrary cut-off CR ≤3 appears more appropriate with 43%, 39.5%, 51.8% and 17.2% of cancers identified as RCs, respectively, due to the lower cancer incidence.There are similarities and notable differences between the RC lists of the SAARC region with that of the European RC list. Oral cavity cancers are rare in Europe, while pancreas, rectum, urinary bladder and melanomas are common. In addition, uterine, colon and prostatic cancers are rare in India, Nepal and Bhutan. In SL, thyroid cancer is common. There are gender-related and regional differences in RC trends in the SAARC countries. Interpretation: There is an unmet need in SAARC nations to capture epidemiological nuances in rare cancers. Understanding the unique issues in the developing world may guide policymakers to adopt appropriate measures to improve RC care and tailor public health interventions. Funding: None.

10.
PLOS Glob Public Health ; 3(5): e0001841, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37228001

RESUMO

Essential medicines are those medicines that satisfy the primary health care needs of the citizens. Poor quality of essential medicines can have serious impact on public health. Thus, this study is aimed to assess the quality of essential medicines available in public health care facilities of Nepal. A cross sectional descriptive study was carried out in 62 health facilities across 21 districts, representing all seven provinces of Nepal and selected proportionately from all three ecological regions i.e. Terai, Hill and Mountain using lottery method. Health facilities in selected districts were chosen using random number generator. Face to face interview was taken with health facility in charge using structured questionnaire. All storage conditions information was recorded through observation checklists. Temperature and humidity were measured using a digital instrument. Similarly, 20 different generic medicines were collected for quality testing. The obtained data were entered in Epidata version 3.1, cleaned in Microsoft Excel 2007 and analyzed in SPSS version 16.0. Among 62 health facilities, only 13% of health facilities were found to follow the medicine storage guidelines, with temperature and humidity levels exceeding recommended limits. Out of 244 batches of 20 different generics of essential medicines, 37 batches were found to be substandard. These substandard medicines were- Ciprofloxacin hydrochloride eye/ear drop, Iron supplement tablets, Metformin Hydrochloric tablet, Metronidazole Tablets, Paracetamol Oral suspension, Paracetamol tablet and Povidone Iodine solution. The study recommends the urgent need for the Government of Nepal to prioritize ensuring the quality of essential medicines in the country.

11.
Microbiol Insights ; 16: 11786361231167239, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37066121

RESUMO

Antimicrobial resistance (AMR) is increasing and it is a serious public health problem worldwide. Nepal is considered as one of the contributors for rising AMR due to the most prevalent irrational use of antibiotics. In this review, we have assessed the practices of antibiotic prescription and dispensing, and antibiotic resistance of commonly encountered bacteria in Nepal. There is exponential increase of therapeutic consumption of antibiotics either without clinician's prescription or irrational prescription. Almost half of the population in Nepal was found to purchase antibiotics easily from the nearby pharmacies without clinician's prescription. Irrational prescription is exceeded in remote areas which could be due to lack of access with health posts and hospitals. The third generation cephalosporins, which are considered as the last resort antibiotics were found to be relatively prescribed and dispensed higher as compared to other classes of antibiotics. Despite the existing limited functional surveillance system, antibiotic resistance among bacteria is increasing in Nepal because of irrational prescription, dispensing and consumption of antibiotics without prescription.

14.
J Nepal Health Res Counc ; 20(3): 593-598, 2023 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-36974843

RESUMO

BACKGROUND: The worldwide containment strategy for COVID-19 outbreak includes laboratory-confirmed cases, and their isolation and management in health care institutions or at home. The spread of the COVID-19 virus has mandated home isolation for mild cases, as recommended by the Government of Nepal. Isolation is a situation that can have a substantial influence on physical and mental health of isolated people. This study is aimed to assess physical and mental well-being of COVID-19 home isolated patients, and their home management practices. METHODS: A descriptive cross-sectional research using quantitative methods was carried out. Purposive sampling was used to select COVID-19 patients. Total 536 COVID-19 home isolated patients were included in this study. Telephonic interview was conducted to obtain the data. Descriptive analysis was done and interpreted. RESULTS: About 34 % of the participants were symptomatic. The most common symptoms experienced were fever (22.6%), followed by cough (19.4%) and cold (16.1%). About 20 % indicated having difficulties isolating at home due to lack of separate room. Furthermore, 4 percent of the participants didn't have anyone to take care of them at home. Also almost 2 percent of participants didn't get family support when infected. Moreover, majorities of individuals had normal stress, depression and anxiety level. CONCLUSIONS: Most of the participants' physical and mental health was found to be normal though some of them experienced difficulties for management during home isolation. Hence, Interventions should focus resilience building by improving communication to address fears and concerns, encouraging routines and physical activities, and taking measures to reduce loneliness.


Assuntos
COVID-19 , Humanos , Adulto , COVID-19/epidemiologia , Estudos Transversais , Nepal/epidemiologia , SARS-CoV-2 , Nível de Saúde
16.
Mol Ecol ; 32(2): 350-368, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36305220

RESUMO

Driven by globalization, urbanization and climate change, the distribution range of invasive vector species has expanded to previously colder ecoregions. To reduce health-threatening impacts on humans, insect vectors are extensively studied. Population genomics can reveal the genomic basis of adaptation and help to identify emerging trends of vector expansion. By applying whole genome analyses and genotype-environment associations to populations of the main dengue vector Aedes aegypti, sampled along an altitudinal gradient in Nepal (200-1300 m), we identify putatively adaptive traits and describe the species' genomic footprint of climate adaptation to colder ecoregions. We found two differentiated clusters with significantly different allele frequencies in genes associated to climate adaptation between the highland population (1300 m) and all other lowland populations (≤800 m). We revealed nonsynonymous mutations in 13 of the candidate genes associated to either altitude, precipitation or cold tolerance and identified an isolation-by-environment differentiation pattern. Other than the expected gradual differentiation along the altitudinal gradient, our results reveal a distinct genomic differentiation of the highland population. Local high-altitude adaptation could be one explanation of the population's phenotypic cold tolerance. Carrying alleles relevant for survival under colder climate increases the likelihood of this highland population to a worldwide expansion into other colder ecoregions.


Assuntos
Aedes , Dengue , Humanos , Animais , Aedes/genética , Dengue/genética , Dengue/epidemiologia , Nepal/epidemiologia , Mosquitos Vetores/genética , Genômica
17.
J Diabetes Res ; 2022: 4701796, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36582811

RESUMO

Globally, the number of people living with diabetes mellitus (DM) increased by 62% between 1990 and 2019, affecting 463 million people in 2019, and is projected to increase further by 51% by 2045. The increasing burden of DM that requires chronic care could have a considerable cost implication in the health system, particularly in resource constraint settings like Nepal. In this context, this study attempts to present the burden of DM in terms of prevalence, mortality, and disability adjusted life years (DALYs). The study is based on the Global Burden of Disease Study 2019, a multinational collaborative research, led by the Institute for Health Metrics and Evaluations. In the study, the overall prevalence of DM was estimated using DisMod MR-2.1, a Bayesian metaregression model. DALYs were estimated summing years of life lost due to premature death and years lived with disability. There were a total of 1,412,180 prevalent cases of DM, 3,474 deaths and 189,727 DALYs, due to DM in 2019. All-age prevalence rate and the age-standardized prevalence rate of DM stood at 4,642.83 (95% uncertainty interval (UI): 4,178.58-5,137.74) and 5,735.58 (95% UI: 5,168.74-6327.73) cases per 100,000 population, respectively, in 2019. In 2019, 1.8% (95% UI: 1.54, 2.07) of total deaths were from DM, which is a more than three-fold increase from the proportion of deaths attributed in 1990 (0.43%, 95% UI: 0.36, 0.5) with most of these deaths being from DM type 2. In 2019, a total of 189,727 disability adjusted life years (DALYs) were attributable to DM of which 105,950 DALYs were among males, and the remaining 83,777 DALYs were among females. Overall, between 1990 and 2019, the DALYs, attributable to Type 1 and 2 DM combined and for Type 2 DM only, have increased gradually across both sexes. However, the DALYs per 100,000 attributable to DM have slightly reduced across both sexes in that time. There is a high burden of DM in Nepal in 2019 with a steep increase in the proportion of deaths attributable to DM in Nepal which could pose a serious challenge to the health system. Primary prevention of DM requires collaborative efforts from multiple sectors. Meanwhile, the current federal structure could be an opportunity for integrated, locally tailored public health and clinical interventions for the prevention of the disease and its consequences.


Assuntos
Diabetes Mellitus Tipo 2 , Carga Global da Doença , Masculino , Feminino , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Nepal/epidemiologia , Teorema de Bayes , Prevalência , Diabetes Mellitus Tipo 2/epidemiologia
18.
J Nepal Health Res Counc ; 20(2): 431-435, 2022 Nov 02.
Artigo em Inglês | MEDLINE | ID: mdl-36550724

RESUMO

BACKGROUND: The novel coronavirus has caused significant global impacts and is still continuing. Social distancing, the use of face mask and sanitizer (SMS) measures have become the prominent security measures to diminish the COVID-19 transmission. Hence, this study aims to assess the general public's compliance towards SMS measures set by the Government of Nepal against COVID-19 in Kathmandu Valley. METHODS: This cross-sectional study was conducted in selected public places of Kathmandu valley, Nepal employing an observational checklist from 5-6 August 2020. The practice of using facemask and its types were observed at the individual levels (malls, groceries, shops and 30 vehicles). The practice of SMS was studied in 23 public places that included banks, hospitals, vegetable markets, shopping malls, temples, restaurants and public buses. RESULTS: A total of 23 public places and 4502 individuals were included in the study. More than two-third (72.6%) participants were observed using mask. Among the mask users, 27% did not follow the appropriate technique. Maintaining social distance of 2 meters was less followed by the people in the public places, hospitals and public vehicles. Only 37.5% institutions had set the marking of the social distance of 2 meters. Availability of hand washing facilities with soap or sanitizer was found less in the public places. CONCLUSIONS: Overall, the compliance measures of SMS set by the Government of Nepal against COVID-19 were not followed appropriately. Efforts are needed to improve the proper practice of using the mask and conveying the SMS message by the Nepal Government which is important step for the prevention of COVID-19 in Nepal.


Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Máscaras , Distanciamento Físico , Estudos Transversais , Nepal/epidemiologia
19.
Medicine (Baltimore) ; 101(47): e31452, 2022 Nov 25.
Artigo em Inglês | MEDLINE | ID: mdl-36451377

RESUMO

INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a common chronic condition with significant health and socioeconomic consequences. In Nepal, T2DM is a common disease for which people consult ayurvedic (traditional medical system) practitioners and use ayurvedic medicines. Strong concerns remain about the suboptimal T2DM management of many patients by ayurvedic practitioners, and therefore, based on the best available scientific evidence, we have developed a clinical guideline for managing T2DM by ayurvedic practitioners. The research question to be addressed by a definitive cluster randomized controlled trial (RCT) is whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners in Nepal as compared to usual ayurvedic management (i.e., without any clinical guideline). In preparation for this future work, this current study aims to determine the feasibility of undertaking the definitive cluster RCT. METHODS: This is a 2-arm, feasibility cluster RCT with a blinded outcome assessment and a qualitative evaluation. The study is conducted in 12 public and private ayurveda centers in and outside the Kathmandu Valley in Nepal (1:1 intervention:control). Eligible participants should be new T2DM adult patients (i.e., treatment naïve) - the glycated hemoglobin level should be 6.5% or above but less than 9%. At least 120 participants (60/group) will be recruited and followed up for 6 months. Important parameters, needed to design the definitive trial, will be estimated, such as the standard deviation of the outcome measure (i.e., glycated hemoglobin level at 6-month follow-up), intraclass correlation coefficient, cluster size, recruitment, the time needed to recruit participants, follow-up, and adherence to the recommended ayurvedic medicine. Semi-structured qualitative interviews will be conducted with around 20 to 30 participants and all the participating ayurvedic practitioners to explore their experiences and perspectives of taking part in the study and of the intervention and a sample of eligible people declining to participate in the study to explore the reasons behind nonparticipation. DISCUSSION: We are now conducting a feasibility cluster RCT in Nepal to determine the feasibility of undertaking the definitive cluster trial. The first participant was recruited on 17 July 2022. If the feasibility is promising (such as recruitment, follow-up, and adherence to the recommended ayurvedic medicine), then the parameters estimated will be used to design the definitive cluster trial. Decisions over whether to modify the protocol will mainly be informed by the qualitative data.


Assuntos
Diabetes Mellitus Tipo 2 , Adulto , Humanos , Nepal , Estudos de Viabilidade , Hemoglobinas Glicadas , Diabetes Mellitus Tipo 2/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto
20.
Contemp Clin Trials Commun ; 30: 101038, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36407842

RESUMO

Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.

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