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Clinical research in the 21st century is no less important than it was in the last century, but changes in how studies are conducted and regulated have made the business much more difficult, an expert says.
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One of the ironies of the electronic age is that while electronic data capture (EDC) makes collecting and analyzing research data a more efficient process for sponsors, it often is costly and challenging for clinical trial sites.
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Often clinical trial sites might have adequate success when recruiting minority patients to a study, but then they are faced with high attrition among those same patients.
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ED physicians responding to "code blue" alerts on inpatient units is a common practice but one that exposes them to considerable legal risks.
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After waiting 22 hours to be transferred to another facility, a homeless man committed suicide in a Douglasville, GA, ED seclusion room. An investigation by the Centers for Medicare and Medicaid Services (CMS) found that the man had not been properly monitored by ED staff.
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By nature of their training, skills, and in some hospitals, based on their job descriptions, emergency physicians often respond to hospital "Code Blue" alerts. Not surprisingly, many patients involved in Code Blue situations have poor outcomes, and patients or their families may elect to bring medical malpractice claims against the physicians involved in the resuscitation attempts.
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In April of this year the Centers for Medicare and Medicaid Services (CMS) proposed changes to the Emergency Medical Treatment and Active Labor Act (EMTALA) regulations that would once again significantly impact EMTALA's patient transfer rules.
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Diagnostic procedures range from easy and unobtrusive (maybe just a quick nasal swab, that's all), to highly obtrusive and uncomfortable (read, colonoscopy), with this spectrum largely determining patient willingness to pursue them.