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  1. Book ; Online: Factors associated with COVID-19 infections and mortality in Africa

    Otwombe, Kennedy

    A cross-sectional study using publicly available data

    2020  

    Abstract: Introduction The current COVID-19 pandemic is a global threat. This elicits questions on the level of preparedness and capacity of health systems to respond to emergencies. Relative to other parts of the world, Africa has poorly developed health systems ... ...

    Abstract Introduction The current COVID-19 pandemic is a global threat. This elicits questions on the level of preparedness and capacity of health systems to respond to emergencies. Relative to other parts of the world, Africa has poorly developed health systems with limited capacity to respond to health crises. Africa is particularly disadvantaged. Methods This cross-sectional study uses publicly available core health data for 53 African countries, to determine risk factors for cumulative COVID-19 deaths and cases per million in all countries in the continent. Descriptive statistics were determined for the indicators and a negative binomial regression was used for modelling the risk factors. Results In Sub-Saharan Africa, an increase in the number of nursing and midwifery personnel decreased the risk of COVID-19 deaths (p=0.0178) while a unit increase in UHC index of service coverage and prevalence of insufficient physical activity among adults increased the risk of COVID-19 deaths (p=0.0432 and p=0.0127). An increase in the proportion of infants initiating breastfeeding reduced the number of cases per million (p<0.0001) while an increase in higher healthy life expectancy at birth increased the number of cases per million (p=0.0340). Conclusion Despite its limited resources, Africa's preparedness and response to the COVID-19 pandemic can be improved by identifying and addressing specific gaps in the funding of health services delivery. These gaps impact negatively on service delivery but appear to have received limited funding and policy priority.

    The data is freely available and COVID-19 cases and deaths are changing by the day. Funding provided by: *Crossref Funder Registry ID: Award Number:

    Data for selected indicators were extracted from the 2018 Global Reference List of 100 Core Health Indicators. The 12 thematic areas are Mortality by Age and Sex, Mortality by Cause, Morbidity, Nutrition, Environmental Risk Factors, Non-Communicable Diseases, Immunization, Essential health services, Utilization and access, Health workforce, Health Information and Health financing. Data were extracted in .xls format for each variable and imported into STATA 15.0 software (StataCorp LLC College Station, TX). For each variable, the most recent data for all countries included in the study was retained with the corresponding year and country name and saved in .dta format. The different variables were merged using the country name as the unique identifier to obtain the final data set used for the analysis. The countries were further categorized into their assigned WHO region and World Bank income group.
    Keywords covid19
    Subject code 360
    Publishing date 2020-10-23
    Publishing country eu
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article: Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities.

    Danks, Lorraine / Semete-Makokotlela, Boitumelo / Otwombe, Kennedy / Parag, Yashmika / Walker, Stuart / Salek, Sam

    Frontiers in medicine

    2023  Volume 10, Page(s) 1265058

    Abstract: Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients' access to medicines. This study considered whether reliance review translates into swifter ... ...

    Abstract Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients' access to medicines. This study considered whether reliance review translates into swifter medicine authorization.
    Methods: Abridged review outcomes were examined for New Chemical Entity (NCE) and generic applications to the South African Health Products Regulatory Authority (SAHPRA) in Chemistry, Manufacturing and Controls (CMC) and clinical/bioequivalence (BE), as well as overall NCE authorization times.
    Results: SAHPRA NCE CMC review time was 91 days (abridged) vs. 179 days (full), applicant response time was 34 vs. 105 days, respectively, and there was a >2-fold time reduction for abridged vs. full CMC review (125 vs. 284 days). There was a 99-day decrease in clinical approval time through an abridged review (230 vs. 329 days) and a decrease in marketing authorization time for NCE abridged assessment (446 vs. 619 days). SAHPRA review time for generic applications was 97 days (abridged) vs. 191 days (full); applicant response time was 26 days (abridged) vs. 81 days (full) and there was a >2-fold time reduction for CMC and BE abridged vs. full review (122 vs. 272 days).
    Conclusion: These results clearly support World Health Organization recommendations for the use of reliance-based regulatory review to expedite the worldwide availability of safe, effective and needed medications.
    Language English
    Publishing date 2023-10-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2023.1265058
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Data quality in an HIV vaccine efficacy clinical trial in South Africa: through natural disasters and with discipline.

    Laher, Fatima / Malahleha, Mookho / Ramirez, Shelly / Brumskine, William / Otwombe, Kennedy / Moodie, Zoe / Allen, Mary

    BMC medical research methodology

    2023  Volume 23, Issue 1, Page(s) 147

    Abstract: Background: To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging ... ...

    Abstract Background: To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging field of improvement science. We describe protocol deviations in South Africa's largest HIV vaccine efficacy trial.
    Methods: We analysed data from the HVTN 702 trial using mixed methods. We obtained descriptive statistics, from protocol deviation case report forms collected from 2016-2022, of deviation by participant, trial site, and time to site awareness. We thematically analysed text narratives of deviation descriptions, corrective and preventive actions, generating categories, codes and themes which emerged from the data.
    Results: For 5407 enrollments, 4074 protocol deviations were reported (75 [95% CI: 73.0-77.6] deviations per 100 enrolments). There was a median of 1 protocol deviation per participant (IQR 1-2). Median time from deviation to site awareness was 31 days (IQR 0-146). The most common category of deviation type was omitted data and/or procedures (69%), and 54% of these omissions were stated to have arisen because of the national lockdown at the beginning of the COVID-19 pandemic. The ratio of protocol deviations to cumulative enrolments was highest in the year 2020 (0.34). Major themes of deviations were: COVID-19 and climate disasters giving rise to deviation trends, subroutines introducing an opportunity for deviation, and document fragmentation (such as requirements dispersed across multiple guidance documents) as an obstacle. Preventive action categories were: no preventive measures; discipline, training and/or awareness; quality review, checking and verifying and changing the process and/or implementation tools. Major themes of preventive actions were that systems-based actions are unusual, with people-based actions dominating, and that root cause analysis was rarely mentioned.
    Conclusions: In the age of infectious and climate disaster risks, trials may benefit from simple study designs and trial-related documents. To optimise protocol adherence, sponsors and sites should consider ongoing training, and routinely review deviation reports with a view to adjusting processes. These data quality lessons may inform future trial design, training and implementation.
    Trial registration: HVTN 702 was registered with the South African National Clinical Trials Register (DOH-27-0916-5327) and ClinicalTrials.gov ( NCT02968849 ).
    MeSH term(s) Humans ; Communicable Disease Control ; COVID-19 ; Data Accuracy ; HIV Infections/prevention & control ; Natural Disasters ; Pandemics/prevention & control ; South Africa ; Vaccine Efficacy ; Clinical Trials as Topic
    Language English
    Publishing date 2023-06-24
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-023-01967-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Pulse wave velocity in early-treated children living with perinatal HIV infection is similar to uninfected children.

    Davies, Claire / Vaida, Florin / Otwombe, Kennedy / Cotton, Mark F / Browne, Sara H / Innes, Steve

    AIDS (London, England)

    2023  Volume 37, Issue 7, Page(s) 1115–1123

    Abstract: Introduction: HIV is associated with accelerated cardiovascular disease, due to HIV-associated metabolic abnormalities, antiretroviral therapy (ART), and HIV itself. Carotid-femoral pulse wave velocity (PWV) is the noninvasive gold standard measurement ... ...

    Abstract Introduction: HIV is associated with accelerated cardiovascular disease, due to HIV-associated metabolic abnormalities, antiretroviral therapy (ART), and HIV itself. Carotid-femoral pulse wave velocity (PWV) is the noninvasive gold standard measurement of arterial stiffness, and associated with incident vascular events in adults. It is unclear if arterial stiffness is accelerated in children living with perinatal HIV (CHIV) who initiate ART early in life. We compared the longitudinal trajectory of PWV in CHIV to children unexposed to HIV. A secondary comparison compared HIV exposed uninfected children (CHEU) to unexposed children.
    Methods: Four hundred and sixty-five children (141 CHIV, 160 CHEU, 164 unexposed) previously in the children with HIV early antiretroviral therapy (ART) (CHER) and P1060 trials were followed annually at Tygerberg Children's Hospital, South Africa between 2014 and 2020. CHIV initiated ART in infancy or early childhood, with excellent ART adherence and largely sustained viral suppression. The primary outcome was PWV, measured using the Vicorder system, and evaluated using linear mixed effects models.
    Results: Median (interquartile range) age at first PWV measurement was 8.64 (7.7-9.1) years, and median follow-up time 2.9 (1.6-4.0) years. Adjusted analyses showed no significant mean difference in PWV in CHIV and CHEU compared to unexposed [CHIV: 0.101 m/s, 95% confidence interval (CI) -0.012 to 0.214; CHEU: 0.068 m/s, 95% CI -0.047 to 0.183], after adjusting for gender, age, ethnicity, mean arterial pressure, resting average heart rate and family history of cardiovascular disease.
    Conclusions: Early-treated CHIV with sustained viral suppression have similar PWV to unexposed children. Excellent adherence and early ART initiation may protect against cardiovascular disease.
    MeSH term(s) Adult ; Pregnancy ; Female ; Humans ; Child ; Child, Preschool ; HIV Infections/complications ; HIV Infections/drug therapy ; Pulse Wave Analysis ; Cardiovascular Diseases/complications ; Anti-Retroviral Agents/therapeutic use ; Cognition ; Vascular Stiffness
    Chemical Substances Anti-Retroviral Agents
    Language English
    Publishing date 2023-02-16
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 639076-6
    ISSN 1473-5571 ; 0269-9370 ; 1350-2840
    ISSN (online) 1473-5571
    ISSN 0269-9370 ; 1350-2840
    DOI 10.1097/QAD.0000000000003525
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Liver transient elastography values in healthy South African children.

    Rose, Penelope C / Cotton, Mark F / Otwombe, Kennedy / Innes, Steve / Nel, Etienne D

    BMC pediatrics

    2023  Volume 23, Issue 1, Page(s) 355

    Abstract: Background: Transient elastography (TE) is a rapid noninvasive ultrasound-based technology that measures liver stiffness as a surrogate for liver fibrosis and controlled attenuation parameter (CAP) as a measure of liver steatosis. However, normal ranges ...

    Abstract Background: Transient elastography (TE) is a rapid noninvasive ultrasound-based technology that measures liver stiffness as a surrogate for liver fibrosis and controlled attenuation parameter (CAP) as a measure of liver steatosis. However, normal ranges in children are not well defined in all populations. The aim of this study was to determine transient elastography values in healthy South African children.
    Methods: From April 2019 to December 2021, children were recruited from the HIV negative control group of a cohort study. Only children neither overweight nor obese, without evidence of liver disease, no medical condition or medication associated with hepatic steatosis or fibrosis and normal metabolic profile were included in this cross-sectional analysis. Clinical data, anthropometry and blood samples were collected on the same day as transient elastography with controlled attenuation parameter was performed.
    Results: 104 children (median age 12.8 years [IQR 11.4-14.8, range 7.9-17.7 years]; 59 [57%] boys) were included. Liver stiffness was positively correlated with age (Pearson's r = 0.39, p < 0.001). Median liver stiffness in boys (5.2 kPa [5th to 95th percentiles 3.6 to 6.8 kPa]) was greater than in girls (4.6 kPa [5th to 95th percentiles 3.6 to 6.1 kPa; p = 0.004]), but there was no difference by ethnicity. Median CAP was 179dB/m (5th to 95th percentiles 158 to 233dB/m). There was a positive correlation between CAP and body mass index (BMI) z-score, but no difference by age, sex, ethnicity or pubertal status.
    Conclusion: Liver stiffness values increase with age and are higher in healthy South African boys than girls, whereas CAP values vary with BMI, but not with age or sex.
    MeSH term(s) Male ; Female ; Humans ; Child ; Adolescent ; Elasticity Imaging Techniques ; Cohort Studies ; Cross-Sectional Studies ; South Africa ; Liver/diagnostic imaging ; Fatty Liver ; Non-alcoholic Fatty Liver Disease
    Language English
    Publishing date 2023-07-13
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041342-7
    ISSN 1471-2431 ; 1471-2431
    ISSN (online) 1471-2431
    ISSN 1471-2431
    DOI 10.1186/s12887-023-04170-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Corrigendum: Diabetes-Tuberculosis Care in Eswatini: A Qualitative Study of Opportunities and Recommendations for Effective Services Integration.

    Williams, Victor / Vos-Seda, Alinda G / Haumba, Samson / Mdluli-Dlamini, Lindiwe / Calnan, Marianne / Grobbee, Diederick E / Otwombe, Kennedy / Klipstein-Grobusch, Kerstin

    International journal of public health

    2024  Volume 69, Page(s) 1606951

    Abstract: This corrects the article DOI: 10.3389/ijph.2023.1605551.]. ...

    Abstract [This corrects the article DOI: 10.3389/ijph.2023.1605551.].
    Language English
    Publishing date 2024-01-24
    Publishing country Switzerland
    Document type Published Erratum
    ZDB-ID 2274130-6
    ISSN 1661-8564 ; 1661-8556
    ISSN (online) 1661-8564
    ISSN 1661-8556
    DOI 10.3389/ijph.2024.1606951
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Contracting of private medical practitioners in a National Health Insurance pilot district: What has been the effect on primary healthcare utilisation indicators?

    Mukudu, Hillary / Otwombe, Kennedy / Fusheini, Adam / Igumbor, Jude

    African journal of primary health care & family medicine

    2020  Volume 12, Issue 1, Page(s) e1–e10

    Abstract: Background: In 2012, the National Department of Health in South Africa started contracting of private medical practitioners (MPs) as part of the first phase of National Health Insurance (NHI) in 11 pilot districts to improve access to healthcare.: Aim! ...

    Abstract Background: In 2012, the National Department of Health in South Africa started contracting of private medical practitioners (MPs) as part of the first phase of National Health Insurance (NHI) in 11 pilot districts to improve access to healthcare.
    Aim: The aim of this study was to describe the effect of contracting private MPs on the utilisation of primary healthcare (PHC) services in public healthcare facilities.
    Setting: A National Health Insurance pilot district compared to a non-pilot district.
    Methods: A quasi-experimental ecological study design was used to compare selected PHC utilisation indicators in the District Health Management Information System from June 2010 to May 2014 between a pilot and a non-pilot district. Both single and controlled interrupted time series analyses were used for comparing before and after implementation of the intervention.
    Findings: Single interrupted time series analysis showed an increase in adults remaining on anti-retroviral therapy, clients seen by a nurse practitioner and clients 5 years of age and older in both districts. However, controlled interrupted time series analysis found no difference in all parametres. Despite a decrease in total headcounts in both districts using single interrupted time series analysis, controlled interrupted time series analysis found no differences in all parameters before and after the intervention.
    Conclusions: The increase in utilisation of PHC services in the pilot district may not be attributable to the implementation of contracting private MPs, but likely the result of other healthcare reforms and transitions taking place in both districts around the same time.
    MeSH term(s) Adult ; Delivery of Health Care ; Health Care Reform ; Health Personnel ; Humans ; National Health Programs ; Patient Acceptance of Health Care
    Language English
    Publishing date 2020-10-28
    Publishing country South Africa
    Document type Journal Article
    ZDB-ID 2526836-3
    ISSN 2071-2936 ; 2071-2928
    ISSN (online) 2071-2936
    ISSN 2071-2928
    DOI 10.4102/phcfm.v12i1.2563
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Factors associated with COVID-19 infections and mortality in Africa: a cross-sectional study using publicly available data.

    Okeahalam, Charles / Williams, Victor / Otwombe, Kennedy

    BMJ open

    2020  Volume 10, Issue 11, Page(s) e042750

    Abstract: Introduction: The current COVID-19 pandemic is a global threat. This elicits questions on the level of preparedness and capacity of health systems to respond to emergencies relative to other parts of the world.: Methods: This cross-sectional study ... ...

    Abstract Introduction: The current COVID-19 pandemic is a global threat. This elicits questions on the level of preparedness and capacity of health systems to respond to emergencies relative to other parts of the world.
    Methods: This cross-sectional study uses publicly available core health data for 53 African countries to determine risk factors for cumulative COVID-19 deaths and cases per million in all countries in the continent. Descriptive statistics were determined for the indicators, and a negative binomial regression was used for modelling the risk factors.
    Results: In sub-Saharan Africa, an increase in the number of nursing and midwifery personnel decreased the risk of COVID-19 deaths (p=0.0178), while a unit increase in universal healthcare (UHC) index of service coverage and prevalence of insufficient physical activity among adults increased the risk of COVID-19 deaths (p=0.0432 and p=0.0127). An increase in the proportion of infants initiating breast feeding reduced the number of cases per million (p<0.0001), while an increase in higher healthy life expectancy at birth increased the number of cases per million (p=0.0340).
    Conclusion: Despite its limited resources, Africa's preparedness and response to the COVID-19 pandemic can be improved by identifying and addressing specific gaps in the funding of health services delivery. These gaps impact negatively on service delivery in Africa, which requires more nursing personnel and increased UHC coverage to mitigate the effects of COVID-19.
    MeSH term(s) Africa/epidemiology ; Betacoronavirus ; Breast Feeding ; COVID-19 ; Coronavirus Infections/epidemiology ; Coronavirus Infections/mortality ; Cross-Sectional Studies ; Exercise ; Health Status Indicators ; Health Workforce ; Humans ; Life Expectancy ; Midwifery ; Nurses/supply & distribution ; Pandemics ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/mortality ; SARS-CoV-2 ; Universal Health Care
    Keywords covid19
    Language English
    Publishing date 2020-11-11
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2020-042750
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Considerations for Establishing Successful Coronavirus Disease Vaccination Programs in Africa.

    Williams, Victor / Edem, Bassey / Calnan, Marianne / Otwombe, Kennedy / Okeahalam, Charles

    Emerging infectious diseases

    2021  Volume 27, Issue 8, Page(s) 2009–2016

    Abstract: The accelerated development of coronavirus disease (COVID-19) candidate vaccines is intended to achieve worldwide immunity. Ensuring COVID-19 vaccination is crucial to stemming the pandemic, reclaiming everyday life, and helping restore economies. ... ...

    Abstract The accelerated development of coronavirus disease (COVID-19) candidate vaccines is intended to achieve worldwide immunity. Ensuring COVID-19 vaccination is crucial to stemming the pandemic, reclaiming everyday life, and helping restore economies. However, challenges exist to deploying these vaccines, especially in resource-limited sub-Saharan Africa. In this article, we highlight lessons learned from previous efforts to scale up vaccine distribution and offer considerations for policymakers and key stakeholders to use for successful COVID-19 vaccination rollout in Africa. These considerations range from improving weak infrastructure for managing data and identifying adverse events after immunization to considering financing options for overcoming the logistical challenges of vaccination campaigns and generating demand for vaccine uptake. In addition, providing COVID-19 vaccination can be used to promote the adoption of universal healthcare, especially in sub-Saharan Africa countries.
    MeSH term(s) Africa South of the Sahara/epidemiology ; COVID-19 ; COVID-19 Vaccines ; Humans ; Immunization Programs ; SARS-CoV-2 ; Vaccination
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-06-17
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1380686-5
    ISSN 1080-6059 ; 1080-6040
    ISSN (online) 1080-6059
    ISSN 1080-6040
    DOI 10.3201/eid2708.203870
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Perceived quality of primary healthcare post-National Health Insurance pilot implementation.

    Mukudu, Hillary / Otwombe, Kennedy / Moloto, Caiphus / Fusheini, Adam / Igumbor, Jude

    Health SA = SA Gesondheid

    2021  Volume 26, Page(s) 1580

    Abstract: Background: Contracting private medical practitioners for the National Health Insurance pilot project in 2012 by the National Department of Health in South Africa was envisaged to reduce workload at referral district hospitals by reducing self-referral ... ...

    Abstract Background: Contracting private medical practitioners for the National Health Insurance pilot project in 2012 by the National Department of Health in South Africa was envisaged to reduce workload at referral district hospitals by reducing self-referral by clients as the perceived quality of care at the primary healthcare level improves.
    Aim: To describe the effect of contracting private medical practitioners at primary healthcare facilities on the self-referral rate of clients at district hospitals as a proxy for perceived quality of care in a National Health Insurance pilot district.
    Setting: The study was set in Tshwane National Health Insurance pilot district compared to Ekurhuleni district.
    Methods: We compared findings before and after implementing the National Health Insurance private medical practitioners contracting between a pilot and a non-pilot district. A quasi-experimental ecological study design was used to compare district hospital outpatient department indicators of clients follow-up, self-referral, self-referral rate and referred in the two districts from June 2012 to May 2014 using single and controlled interrupted time-series analyses.
    Results: Controlled interrupted time series analysis found decreases in self-referral rate (-1.8 [-2.2, -1.1] [
    Conclusion: We concluded that the implementation of contracting private medical practitioners in primary healthcare facilities might have resulted in an improved perceived quality of care at primary health care facilities. However, the higher number of outpatient department headcounts for follow-up and the increase in referred cases in the pilot district would need to be investigated.
    Language English
    Publishing date 2021-05-31
    Publishing country South Africa
    Document type Journal Article
    ZDB-ID 2114588-X
    ISSN 2071-9736 ; 2071-9736
    ISSN (online) 2071-9736
    ISSN 2071-9736
    DOI 10.4102/hsag.v26i0.1580
    Database MEDical Literature Analysis and Retrieval System OnLINE

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