Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer matrix compared with standard care in managing diabetic foot ulcers in the US.

OBJECTIVE: To estimate the cost-effectiveness of using tri-layer porcine small intestine submucosa (SIS; Oasis Ultra) as an adjunct to standard care compared with standard care alone in managing diabetic foot ulcers (DFUs) in the US, from the perspective of Medicare. METHOD: A Markov model was constructed to simulate the management of diabetic neuropathic lower extremity ulcers over a period of one year in the US. The model was used to estimate the cost-effectiveness of initially using adjunctive SIS compared with standard care alone to treat a DFU in the US at 2016 prices. RESULTS: At 12 months after the start of treatment, the use of adjunctive SIS instead of standard care alone is expected to lead to a 42 % increase in the number of ulcer-free months, 32 % increase in the probability of healing, a 3 % decrease in the probability of developing complicated ulcers and a 1 % decrease in the probability of undergoing an amputation. Health-care resource use is expected to be reduced by 11-14 % among patients who are initially managed with adjunctive SIS compared with those initially managed with standard care alone, with the exception of debridement, which is expected to be reduced by 35 %. Hence, the total health-care cost of starting treatment with adjunctive SIS instead of standard care alone was estimated to reduce payer costs by 1% (i.e. $105 per patient) over 12 months following the start of treatment. CONCLUSION: Within the study's limitations, the use of adjunctive SIS instead of standard care alone improves outcome for less cost and thereby affords a cost-effective use of Medicare-funded resources in the management of neuropathic foot ulcers among adult patients with type 1 or 2 diabetes mellitus in the US.

Effect of education and legislation on bicycle helmet use in a multiracial population.

OBJECTIVE: To observe the effect of new legislation and a boroughwide bicycle helmet educational campaign on bicycle helmet use in a multiracial population. DESIGN: A prospective observational study. Observations were made at randomly selected sites in Queens (study group) and Brooklyn (control group), NY, in May 1994, before a New York State law affecting both boroughs was enacted and before a bicycle helmet educational campaign was conducted in Queens. Variables observed included age, sex, race, and whether the child was wearing a bicycle helmet while riding. A bicycle helmet campaign was conducted in late May 1994. New York State bicycle helmet law was effected on June 1, 1994, requiring all children aged 1 to 14 years to wear helmets while riding their bicycles. Follow-up observations were made at the same sites in July or August 1994. SETTING: Queens County, New York, which is the most racially diverse county in the United States, according to 1990 census data. PARTICIPANTS: Cross-sectional observations of children aged 1 to 14 years made at randomly selected sites. INTERVENTIONS: A boroughwide bicycle helmet educational campaign conducted in May 1994 in Queens. RESULTS: The overall use of helmets increased from 4.7% (13/276) to 13.9% (44/316) (P < .001) in the study group. Helmet use decreased from 5.6% (19/342) to 4.2% (13/312) (P = .10) in the control group during the same period. CONCLUSIONS: In a multiracial population, a statistically significant (P < .001) increase of helmet use was demonstrated after a campaign and distribution of educational material. Legislation alone is inadequate for ensuring increased bicycle helmet use.

"Incisura" of the ascending aorta and vascular pedicle width in the cardiac transplant patient.

BACKGROUND: The purpose of this study was to evaluate three findings in cardiac transplant patients: the appearance, etiology, and incidence of "incisura" (a characteristic indentation) of the ascending aorta; the vascular pedicle width, which usually appears enlarged on standard chest radiographs; and clearing of the retrosternal clear space. MATERIAL: Two hundred sixty-one cardiac transplantations were performed at the University of Minnesota before December 31, 1992. The appearance, etiology, and incidence of an incisura were studied; the vascular pedicle width was measured; and the rate of clearing of the retrosternal clear space was determined. RESULTS: Forty-six percent of the patients whose ascending aorta could be visualized on the lateral chest radiogram showed an incisura. Approximately one third of the patients showed continued opacification of the retrosternal space postoperatively. The width of the vascular pedicle in this series of cardiac transplant patients measured 60.9 +/- 22.8 mm (standard deviation, 11.4 mm), in comparison to a normal of 48 +/- 5.0 mm. CONCLUSIONS: An incisura of the ascending aorta and the widened vascular pedicle are normal postoperative chest radiographic findings in cardiac transplant patients and should not be misconstrued as abnormalities.