Indian J Med Res
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Review Meta Analysis
Burden of hepatitis B in asymptomatic blood donor population of India: A systematic review & meta-analysis.
Background & objectives India has been classified as an intermediate Hepatitis B Virus (HBV) endemic country, and the transmission is believed to mostly occur horizontally. However, community-based data on HBV prevalence among blood donors in India are limited. The burden of Hepatitis B Virus (HBV) is unknown in the asymptomatic blood donor population. ⋯ The included studies exhibited a high level of heterogeneity, probably due to different diagnostic approaches followed in different studies. Interpretation & conclusions The burden of hepatitis is profound, impacting public health, economies, and societies in India. The outcome of this study would help address such a burden and develop comprehensive strategies focused on prevention, early diagnosis, treatment, and necessary collaboration to achieve significant reductions in hepatitis-related morbidity and mortality.
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Review Meta Analysis
Burden of hepatitis B in asymptomatic blood donor population of India: A systematic review & meta-analysis.
Background & objectives India has been classified as an intermediate Hepatitis B Virus (HBV) endemic country, and the transmission is believed to mostly occur horizontally. However, community-based data on HBV prevalence among blood donors in India are limited. The burden of Hepatitis B Virus (HBV) is unknown in the asymptomatic blood donor population. ⋯ The included studies exhibited a high level of heterogeneity, probably due to different diagnostic approaches followed in different studies. Interpretation & conclusions The burden of hepatitis is profound, impacting public health, economies, and societies in India. The outcome of this study would help address such a burden and develop comprehensive strategies focused on prevention, early diagnosis, treatment, and necessary collaboration to achieve significant reductions in hepatitis-related morbidity and mortality.
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Background & objectives Timely detection of population with β-thalassemia trait (BTT) followed by genetic counselling is an advocated method of preventing the birth of a child with β-thalassemia major. In this study we aim to assess the diagnostic accuracy of Gazelle, a point-of-care (POC) testing device, in screening for BTT in hospital laboratory setting. Methods Standards for Reporting Diagnostic Accuracy (STARD) guidelines were followed in developing study design, recruiting study participants and sample size calculation for the current research. ⋯ When analyzed by the serum ferritin level the diagnostic accuracy was found to be 94.7 per cent (91.1% - 97.1%) and 95.7 per cent (91.8% - 98.1%) for participants with serum ferritin level as > 15 ng/ml and < 15 ng/ml, respectively. Interpretation & conclusions This study found Gazelle to be a good screening tool for β-thalassemia trait with high sensitivity, specificity and accuracy. However, it is recommended that the final confirmation of the diagnosis done by a diagnostic test like HPLC or Capillary Zone Electrophoresis (CZE).
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Investigator-initiated clinical trials - also known as non-regulatory or academic clinical trials, are conducted by investigators from academia or research organizations. They usually aim to address scientific questions with insufficient commercial implications and generate real-world applicable solutions, unlike trials sponsored by the pharmaceutical industry which are primarily focused on marketing approval of products that have a commercial value. For the trial results to be credible, adhering to robust methodology and the highest quality standards is paramount. ⋯ They are guided mainly by the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 published by Indian Council of Medical Research. They lack an accepted framework for review, conduct, monitoring, reporting of adverse events, and participant compensation. Considering this scenario, we discuss the challenges faced in an investigator initiated clinical trial and explore plausible solutions.