Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Michael Farias, MD, MS, MBA and Rahul H. Rathod, MD
A distinguishing feature of a SCAMP is its ability to capture knowledge-based diversions from a recommended pathway and to “learn” from such individualized patient management.
Anne Drapkin Lyerly, MD, MA and Ruth R. Faden, PhD, MPH
Participation in a research study—in which there are rigorous standards and close monitoring—may be a safer context for the use of medications in pregnancy than the clinical setting, where the evidence base is lacking.
Shivan J. Mehta, MD, MBA and David A. Asch, MD, MBA
Outcome-based payment more closely aligns payments with what patients want, which is better health rather than more health care. But these approaches remain challenging to implement.
Measuring outcomes alone is not the answer. There should be a way to reward the doctor for educating a patient about lifestyle modifications and then documenting that the care provided followed patient preferences.
Is this a conflict over a team member’s practice style or is it a breach professional boundaries? Is it appropriate for team members to make this judgment, or should it instead come from the team leader?