Time and resources of peripherally inserted central catheter insertion procedures: a comparison between blind insertion/chest X-ray and a real time tip navigation and confirmation system.

BACKGROUND: The Sherlock 3CG™ Tip Confirmation System (TCS) provides real-time peripherally inserted central catheter (PICC) tip insertion information using passive magnetic navigation and patient cardiac electrical activity. It is an alternative tip confirmation method to fluoroscopy or chest X-ray for PICC tip insertion confirmation in adults. The purpose of this study was to evaluate time and cost of the Sherlock 3CG TCS and blind insertion with chest X-ray tip confirmation (BI/CXR) for PICC insertions. METHODS: A cross-sectional, observational Time and Motion study was conducted. Data were collected at four hospitals in the US. Two hospitals used Sherlock 3CG TCS and two hospitals used BI/CXR to place/confirm successful PICC tip location. Researchers observed PICC insertions, collecting data from the beginning (ie, PICC kit opening) to catheter tip confirmation (ie, released for intravenous [IV] therapy). An economic model was developed to project outcomes for a larger population. RESULTS: A total of 120 subjects were enrolled, with 60 subjects enrolled in each arm and 30 enrolled at each of the four US hospitals. The mean time from initiation of the PICC procedure to the time to release for IV therapy was 33.93 minutes in the Sherlock 3CG arm and 176.32 minutes in the BI/CXR arm (p < 0.001). No malpositions were observed for PICC insertions using the Sherlock 3CG TCS, while 20% of subjects in the BI/CXR arm had a malposition. BI/CXR subjects had significantly more total malpositions (mean 0.23 vs. 0, p < 0.001). For a hypothetical population of 1,000 annual patients, adoption of Sherlock 3CG TCS was predicted to be cost saving compared with BI/CXR in all three analysis years. CONCLUSION: The results from this study demonstrate that Sherlock 3CG TCS, when compared with BI/CXR, is a superior alternative with regard to time to release subject to therapy, malposition rates, and minimization of X-ray exposure.

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.

BACKGROUND: Despite hemostat use, uncontrolled surgical bleeding is prevalent. Drawbacks of current hemostats include limitations with efficacy on first attempt and suboptimal ease-of-use. Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding severities. The objective of this study was to conduct a hospital cost analysis of the fibrin sealant patch versus standard of care in soft tissue and hepatic surgical bleeding. METHODS: The analysis quantified the 30-day costs of each comparator from a hospital perspective. Published US unit costs were applied to resource use (ie, initial treatment, retreatment, operating time, hospitalization, transfusion, and ventilator) reported in four trials. A "surgical" analysis included resources clinically related to the hemostatic benefit of the fibrin sealant patch, whereas a "hospital" analysis included all resources reported in the trials. An exploratory subgroup analysis focused solely on coagulopathic patients defined by abnormal blood test results. RESULTS: The surgical analysis predicted cost savings of $54 per patient with the fibrin sealant patch compared with standard of care (net cost impact: -$54 per patient; sensitivity range: -$1,320 to $1,213). The hospital analysis predicted further cost savings with the fibrin sealant patch (net cost impact of -$2,846 per patient; sensitivity range: -$1,483 to -$5,575). Subgroup analyses suggest that the fibrin sealant patch may provide dramatic cost savings in the coagulopathic subgroup of $3,233 (surgical) and $9,287 (hospital) per patient. Results were most sensitive to operating time and product units. CONCLUSION: In soft tissue and hepatic problematic surgical bleeding, the fibrin sealant patch may result in important hospital cost savings.

Biomarker use is associated with reduced clinical trial failure risk in metastatic melanoma.

Given the high morbidity and mortality associated with metastatic melanoma, considerable attention has been paid to identifying potential therapies. Until recently, few therapies have been specifically approved for treating metastatic melanoma. In an attempt to increase clinical trial successes, many therapies are implementing biomarkers for patient stratification. This strategy narrows down the population in an effort to identify appropriate subpopulations that have increased efficacy or fewer safety concerns. However, the addition of a biomarker constitutes an additional risk to clinical development and may therefore increase the overall clinical trial risk. Here, we examine the clinical trial success rate for therapies targeting metastatic melanoma. In addition, we identify the impact that biomarkers have had on the clinical development of this disease.