Study design and ethical considerations related to using direct observation to evaluate physician behavior: reflections after a recent study.

In a recent study using direct observation of physicians, we demonstrated that physician-generated clinical documentation is vulnerable to error. In fact, we found that physicians consistently overrepresented their actions in certain areas of the medical record, such as the physical examination. Because of our experiences carrying out this study, we believe that certain investigations, particularly those evaluating physician behavior, should not rely on documentation alone. Investigators seeking to evaluate physician behavior should instead consider using observation to obtain objective information about occurrences in the patient-physician encounter. In this article, we describe our experiences using observation, and we offer investigators our perspectives related to study design and ethical questions to consider when performing similar work.