Author Interviews, CDC, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 05.05.2021

MedicalResearch.com Interview with: Isaac See, MD Centers for Disease Control and Prevention COVID-19 Response Team Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: On February 27, 2021 the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Janssen/Johnson & Johnson (J&J) COVID-19 Vaccine in people 18 years of age or older in the United States. The Janssen/J&J COVID-19 Vaccine uses a replication-deficient (i.e., cannot cause infections) human adenovirus vector. In mid-March, the European Medicines Agency announced that they had conducted a preliminary investigation of cases of blood clots and low counts of blood cells called platelets in patients who had recently received the Oxford/AstraZeneca COVID-19 Vaccine, which uses a replication-deficient chimpanzee adenovirus vector. This syndrome of blood clots and low platelet counts has been called thrombosis with thrombocytopenia syndrome, or TTS. The European investigation showed that over 70% of their cases specifically involved blood clots in particular veins inside the brain, a condition caused cerebral venous sinus thrombosis (CVST), in addition to low platelet counts (thrombocytopenia is the medical term for low platelet counts). CVST is already a rare condition, and CVST with thrombocytopenia is even rarer. By April 12, 2021, approximately 7 million doses of the Janssen/J&J COVID-19 Vaccine had been given in the United States, and six cases of CVST and thrombocytopenia after receipt of the Janssen/J&J COVID-19 Vaccine had been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), which is the U.S. national vaccine safety monitoring system. The next day (April 13, 2021) CDC and FDA recommended a pause in use of the vaccine recommended to allow for further investigation of these events. On April 23, 2021 data about the first 12 cases reported after authorization of the Janssen/J&J COVID-19 Vaccine were presented at an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) to decide what to recommend regarding the Janssen COVID-19 vaccine. The ACIP concluded that the benefits of resuming Janssen COVID-19 vaccination among persons aged 18 years or older outweighed the risks and reaffirmed its interim recommendation under the FDA’s Emergency Use Authorization. The FDA’s Emergency Use Authorization includes a new warning for rare clotting events among women aged 18 to 49 years. Our report provides clinical details about these first reported 12 U.S. cases of CVST and thrombocytopenia following receipt of the Janssen COVID-19 Vaccine. (more…)
Author Interviews, Emory, Health Care Systems, JAMA, Kidney Disease, Transplantation / 11.09.2019

A retraction and replacement have been issued due to a major coding error that resulted in the reporting of incorrect data in this study surrounding the difference in transplant rates between for-profit and non-profit dialysis centers. Please see link below:

Bauchner H, Flanagin A, Fontanarosa PB. Correcting the Scientific Record—Retraction and Replacement of a Report on Dialysis Ownership and Access to Kidney Transplantation. JAMA. 2020;323(15):1455. doi:10.1001/jama.2020.4368

MedicalResearch.com Interview with: Rachel Patzer, PhD, MPH Associate Professor Director, Health Services Research Center Department of Medicine Department of Surgery Emory University School of Medicine MedicalResearch.com: What is the background for this study? Response: We know that historically, for-profit dialysis facilities have been shown to have lower rates of kidney transplantation than patients who receive treatment in non-profit dialysis facilities. However, these studies are outdated, and did not examine access to living donor transplantation or include the entirety of the end-stage kidney disease population (more…)
Author Interviews, Heart Disease, JAMA / 19.03.2019

MedicalResearch.com Interview with: Dr. Carina Blomström-Lundqvist, MD Professor of Cardiology Department of Cardioloy Institution of Medical Science Uppsala, Sweden MedicalResearch.com: What is the background for this study? Response: While all previous trials comparing atrial fibrillation (AF) ablation and antiarrhythmic drugs to our best knowledge have evaluated the efficacy of these treatments in terms of atrial fibrillation (AF) recurrences (with an AF episode of 30 seconds duration as standard primary endpoint) we wanted to use quality of Life (QoL) - general health - as primary endpoint, since the indication for treatment is improving QoL. This was important since, despite the fact that the indication for treatment is to improve (QoL) and reduce symptom, all prior trials have used 30 seconds AF episodes as standard primary endpoint, which if occurred it would be defined as a failed treatment. We also wanted to assess effects on various clinical outcome events. We know from registries such as ORBIT AF registry that around 60 % of AF patients have symptoms resulting in repeated hospitalisation visits in at least 30-40% of patients annually, and that only around 5 % of the AF population are being referred for AF ablation. Previous trials have used intermittent 24 hours Holter recordings whioch does not give the true AF burden (% of time in AF). We therefore also wanted to assess and compare treatments effects on true AF burden by implanting an implantable cardiac monitor (ICM) which continuosly records the heart rhythm. We would then be able to prove that improvement in QoL was directly related to a reduction in AF burden and that treatment differences in QoL was related to a difference in reduction in AF burden. We also wanted to study an AF population in their early AF disease state so that we could offer atrial fibrillation ablation to a broader AF population before their atria have become remodelled and too damaged for a pulmonary vein isolation to be effective. (more…)