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.

Previous studies have shown that COPD adversely affects distant organs and body systems, including the brain. This pilot study aims to model the relationships between respiratory insufficiency and domains related to brain function, including low mood, subtly impaired cognition, systemic inflammation, and brain structural and neurochemical abnormalities. Nine healthy controls were compared with 18 age- and education-matched medically stable-COPD patients, half of whom were oxygen-dependent. Measures included depression, anxiety, cognition, health status, spirometry, oximetry at rest and during 6-minute walk, and resting plasma cytokines and soluble receptors, brain MRI, and MR spectroscopy in regions relevant to mood and cognition. ANOVA was used to compare controls with patients and with COPD subgroups (oxygen users [n = 9] and nonusers [n = 9]), and only variables showing group differences at p < or = 0.05 were included in multiple regressions controlling for age, gender, and education to develop the final model. Controls and COPD patients differed significantly in global cognition and memory, mood, and soluble TNFR1 levels but not brain structural or neurochemical measures. Multiple regressions identified pathways linking disease severity with impaired performance on sensitive cognitive processing measures, mediated through oxygen dependence, and with systemic inflammation (TNFR1), related through poor 6-minute walk performance. Oxygen desaturation with activity was related to indicators of brain tissue damage (increased frontal choline, which in turn was associated with subcortical white matter attenuation). This empirically derived model provides a conceptual framework for future studies of clinical interventions to protect the brain in patients with COPD, such as earlier oxygen supplementation for patients with desaturation during everyday activities.

OBJECTIVE

Homelessness and hunger are associated with poor health care access among children. Housing instability and food insecurity represent milder and more prevalent forms of homelessness and hunger. The aim of this study was to determine the association between housing instability and food insecurity with children's health care access and acute health care utilization.

METHODS

We conducted a cross-sectional analysis of 12,746 children from low-income households included in the 2002 National Survey of America's Families (NSAF). In multivariate models controlling for important covariates, we measured the association between housing instability and food insecurity with 3 health care access measures: 1) no usual source of care, 2) postponed medical care, and 3) postponed medications. We also measured 3 health care utilization measures: 1) not receiving the recommended number of well-child care visits, 2) increased emergency department visits, and 3) hospitalizations.

RESULTS

Our analysis showed that 29.5% of low-income children lived in households with housing instability and 39.0% with food insecurity. In multivariate logistic regression models, housing instability was independently associated with postponed medical care, postponed medications, and increased emergency department visits. Food insecurity was independently associated with no usual source of care, postponed medical care, postponed medications, and not receiving the recommended well-child care visits.

CONCLUSION

Families that experience housing instability and food insecurity, without necessarily experiencing homelessness or hunger, have compromised ability to receive adequate health care for their children. Policy makers should consider improving programs that decrease housing instability and food insecurity, and clinicians should consider screening for housing instability and food insecurity so as to provide comprehensive care.