Publications

INTRODUCTION

The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny.

OBJECTIVE

To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices?

CONCLUSIONS

Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.

Forty medical residents from major teaching hospitals in Boston, Massachusetts, participated in small group teaching sessions about caregiver stress. A teaching tool was developed that included a teaching handout, interactive cases, standard instruments for assessing caregiver stress, peer-reviewed articles about caregiving, and a list of resources that would be useful to a caregiver. These materials and teaching format were evaluated using a pre- and posttest and a feedback form. Forty residents completed the pretest and posttest. They scored significantly higher on the posttest for questions that covered estimated cost of caregiving (p = 0.0073), physical stress from caregiving (p = 0.0196), and identifying elder abuse (p = 0.0006). Ninety percent of the residents completed the evaluation form and rated the intervention highly. Teaching medical residents about caregiver stress resulted in a significant increase in knowledge about this topic. This study makes the case for the integration of "Caregiver Stress" into the primary care residency curriculum.