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.

Liver disease is a major health problem for individuals with a history of injection drug use. This is mainly from the hepatitis C virus (HCV), with or without co-infection with HIV. HCV-associated liver disease takes decades to develop into cirrhosis, from which it can adversely affect health. HIV coinfection is among the factors that are often associated with liver disease progression, and efforts to understand liver disease progression in HIV-HCV coinfected patients remain important. Maintaining high CD4 counts and avoiding alcohol intake are associated with slower liver disease progression. Pegylated interferon and ribavirin combination therapy has the potential to clear HCV, which provides the strongest health benefit to patients affected by the virus, although this can be difficult to accomplish for many reasons. Steatosis, fat within the liver, may also have important pathological implications for liver disease related to HCV. Limiting liver disease progression in IDUs with hepatitis C may well be best accomplished through promoting their full utilization of health care.

Several methods of treatment for hepatocellular carcinoma (HCC) are often used in combination for either palliation or cure. We established a multidisciplinary treatment team (MDTT) at the San Francisco Veterans Affairs Medical Center in November 2003 and assessed whether aggressive multimodality treatment strategies may affect survival. A prospective database was established and follow-up information from patients with presumed HCC was collected up to November 2006. Information from the American College of Surgeons (ACS) cancer registry from January 2000 to November 2003 identified patients with HCC that were evaluated at the same institution prior to the establishment of the MDTT. The establishment of a MDTT resulted in the doubling of patient referrals for treatment. Significantly more patients were evaluated at earlier stages of disease and received either palliative or curative therapies. The overall survival (p<0.0001) and length of follow-up (p<0.05) were significantly improved after the establishment of the MDTT. Stage-by-stage comparisons indicate that aggressive multimodality therapy conferred significant survival advantage to patients with American Joint Commission on Cancer (AJCC) stage II HCC (odds ratio 15.50, p<0.001). Multidisciplinary collaboration and multimodality treatment approaches are important in the management of hepatocellular carcinoma and improves patient survival.

Optimizing duration of participation in health promotion programs has important implications for program reach and costs. We examined data from 355 participants in EnhanceWellness (EW) to determine whether improvements in disability risk factors (depression, physical inactivity) occurred early or late in the enrollment period. Participants had a mean age of 74 years; 76% were women, and 16% were non-white. The percent depressed declined from enrollment to six months (35% to 28%, p = .001) and from six to 12 months (28% to 22%, p = .03). The percent physically inactive declined over the first six months, without substantial change thereafter (47%, 29%, and 29%). Those remaining inactive at six months had worse self-rated health and more depressive symptoms initially; a subset of those increased their physical activity by 12 months. These data suggest that enrollment could be reduced from 12 to six months without compromising favorable effects of EW participation, although additional benefits may accrue beyond six months.