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Site Investigators Missed Clinical Events in GLOBAL LEADERS


February 12, 2021
In an international pragmatic study testing a strategy of shortened dual antiplatelet therapy (DAPT) for patients who receive a drug-eluting stent, nearly one in five clinical outcome events were missed by site investigators, according to an analysis from the GLOBAL LEADERS Adjudication Substudy (GLASSY).
Overall, the diagnostic accuracy of clinical events reported by site investigators was modest, while the concordance was generally weak between investigator-reported MIs, strokes, bleeding events, and stent thromboses and those captured by the formal clinical event committee (CEC). 
“We did see that relying exclusively on investigator-reported events is very suboptimal, as events were reported by investigators which were not confirmed by the central process and, also vice versa, that the central process detected a considerable number of events which were not reported originally by the investigators,” said senior author Marco Valgimigli, MD, PhD ....

United Kingdom , San Francisco , United States , City Of , David Newby , Marco Valgimigli , Sanket Dhruva , Policlinicos Matteo , Cardiocentro Ticino , Sergio Leonardi , Phd University Of Edinburgh , Md University Of Pavia , Md University Of California , Biosensors International , University Of Edinburgh , National Health Service , Cardiovascular Quality , Incentivize Site Investigators , ஒன்றுபட்டது கிஂக்டம் , சான் பிரான்சிஸ்கோ , ஒன்றுபட்டது மாநிலங்களில் , நகரம் ஆஃப் , டேவிட் புதியவர் , சங்கெட் திருவா , செர்ஜியோ லியோனார்டி , ஃப்ட் பல்கலைக்கழகம் ஆஃப் எடின்பர்க் ,