Issues Surrounding Adverse Event Reporting

Changing landscape affects clinical practice and research

Stuart B. Goodman, MD, PhD; William M. Mihalko, MD, PhD; William J. Robb III, MD; Kevin J. Bozic, MD, MBA; and Michael J. Goldberg, MD

The reporting of adverse events during the practice of medicine has received increasing attention by government agencies, insurance companies, industry, state and hospital credentialing committees, medical societies, and patient advocacy groups. Previously, the clinical results of various nonsurgical or surgical treatments for a specific disease or medical condition focused on the patient’s level of pain and other predefined functional variables, often tabulated in an outcome score. Less emphasis was placed on adverse events and complications that occurred during the delivery of a particular treatment.

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