BackgroundThe current vaccine against tuberculosis, BCG, is effective when given in most TB-endemic countries at birth but has diminished efficacy against pulmonary TB after 15–20 years. As a result, new booster vaccines for adolescents and adults are being developed to realize the World Health Organization target of global elimination of TB by 2035. Multiple TB candidates thus are in active clinical development.MethodsOne of these, DAR-901, is advancing in human clinical trials. These clinical trials are conducted in BCG immunized adults with and without HIV infection in order to assess safety and efficacy among the people most in need of a new vaccine. A Phase I dose escalation trial of DAR-901 in BCG-immunized adults with or without HIV infection was conducted between 2014 and 2016. This offered an unusual opportunity to qualitatively examine why foreign-born adults living in the United States – a poorly studied population – decide to participate, or not, in clinical trials.ResultsWe conducted a qualitative study of individuals who were recruited to participate in this Phase I vaccine trial, interviewing those who agreed and declined to participate. We found diverse motivations for participation or refusal; varied understandings of tuberculosis and vaccines; and complex views about how ‘informed consent’ can be at odds with cultural understandings of power, authority, and medical decision-making. These dynamics included: knowledge (direct or indirect) of tuberculosis, a desire to be altruistic and simultaneous hopes for personal gain as well as concerns over what remuneration for participation could mean, the importance of personal relationships with care providers in shaping volunteerism, concerns over privacy, and evidence of how culture and history shape medical decision-making.ConclusionsThis US-based trial, aimed at addressing a crucible global health issue, raises productive questions about the interface between altruism and scepticism regarding clinical research participation.Trial registrationNCT02063555.
BACKGROUND: Ultrasound(USG) is the initial imaging tool for the assessment of thyroid lesions, due to its easy
availability and no radiation risk.USG based TIRADS uses particular lexicons for reporting a focal thyroid nodule,based
on which risk of malignancy is calculated and finally a TIRADS category is assigned.The lexicons used are helpful for
effective communication between the practitioners.
OBJECTIVE:To determine the efficacy of ACR based TIRADS in predicting suspicious thyroid nodules and categorizing
the patients in need of further evaluation with FNAC or follow up.
MATERIALS AND METHODS: This prospective study was done over a period of 1 year (January 2019–January
2020)and include 50 patients. Patients having thyroid nodules in B-mode ultrasound were included in the study. The
nodules were then grouped into their respective categories based on ACR TI-RADS and further management was
decided. Pathological correlation using Bethesda classification and cancer risk of each TIRADS category was
determined in the follow-up period simultaneously.
RESULTS:All the 6 nodules classified under the TIRADS 5 category were found to be malignant while none of the TIRADS
2 nodules out of 29 were malignant i.e.Bethesda IV or higher.The risk of malignancy for ACR TI-RADS categories 1,2,3,4
and 5 was 0, 14.3, 62.5 and 100%, respectively.The risk of cancer in our study is almost comparable to other prominent
studies.
CONCLUSION:ACR based TIRADS classification is reliable in predicting thyroid malignancy.
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