Large-scale real-world data analysis of source plasma collections using a novel technology-enabled nomogram.

BACKGROUND: Source plasma collections are needed to satisfy the growing demand for plasma-derived medicinal products. The US plasma collection target volume has been guided by a standard weight-based FDA-issued nomogram (STAN) since 1992. In this research, large-scale US-based real-world data (RWD) were analyzed to confirm the safety and volume gains of a newly introduced personalized nomogram (PERS) that was previously studied in a premarket randomized controlled environment. STUDY DESIGN AND METHODS: A non-inferiority (NI) analysis was conducted to compare the novel nomogram's significant hypotensive adverse event (AE) incidence rate with large historical standard nomogram AE datasets. Additionally, the average target volumes and donor return rates were compared for collections following PERS and STAN. RESULTS: A total of 4,816,784 donations (PERS) by 414,957 donors resulted in a rate of 0.0998% (95% CI [0.0970, 0.1027]) significant hypotensive AEs. NI analysis suggested strong non-inferiority of the new technology (Δ = -0.0082%, 95% CI [-0.0113, -0.0050], prespecified NI margin = 0.1080). Average plasma collection target volumes increased by 66.39 mL (8.49%; p < .0001). Consecutive weekly donor return rates were consistent between the two nomograms (PERS: 73.6%, 95% CI [69.6%-76.7%]; STAN: 74.1%, 95% CI [66.1%-77.2%]). DISCUSSION: This analysis confirms in a large-scale real-world dataset the key safety parameter and collection benefit of a novel, technology-enabled nomogram. The nomogram may help meet the growing demand for plasma-derived therapies by providing approximately 8.5% more plasma per donation on average while maintaining donor safety and return rates.

Initial phantom studies for an office-based low-field MR system for prostate biopsy.

PURPOSE: Prostate cancer is the second most prevalent cancer in US men, with about 192,000 new cases and 33,000 deaths predicted for 2020. With only a 31% 5-year survival rate for patients with an initial diagnosis of stage-four prostate cancer, the necessity for early screening and diagnosis is clear. In this paper, we present navigation accuracy results for Promaxo's MR system intended to be used in a physician's office for image-guided transperineal prostate biopsy. METHODS: The office-based low-field MR system was used to acquire images of prostate phantoms with needles inserted through a transperineal template. Coordinates of the estimated sample core locations in the office-based MR system were compared to ground truth needle coordinates identified in a 1.5T external reference scan. The error was measured as the distance between the planned target and the ground truth core center and as the shortest perpendicular distance between the planned target and the ground truth trajectory of the whole core. RESULTS: The average error between the planned target and the ground truth core center was 2.57 ± 1.02 mm, [1.93-3.21] 95% CI. The average error between the planned target to the actual core segment was 2.05 ± 1.24 mm, [1.53-2.56] 95% CI. CONCLUSION: The average navigation errors were below the clinically significant threshold of 5 mm. The initial phantom results demonstrate the feasibility of the office-based system for prostate biopsy.

The Impact of Postgraduate Health Technology Innovation Training: Outcomes of the Stanford Biodesign Fellowship.

Stanford Biodesign launched its Innovation Fellowship in 2001 as a first-of-its kind postgraduate training experience for teaching biomedical technology innovators a need-driven process for developing medical technologies and delivering them to patients. Since then, many design-oriented educational programs have been initiated, yet the impact of this type of training remains poorly understood. This study measures the career focus, leadership trajectory, and productivity of 114 Biodesign Innovation Fellowship alumni based on survey data and public career information. It also compares alumni on certain publicly available metrics to finalists interviewed but not selected. Overall, 60% of alumni are employed in health technology in contrast to 35% of finalists interviewed but not selected. On leadership, 72% of alumni hold managerial or higher positions compared to 48% of the finalist group. A total of 67% of alumni reported that the fellowship had been "extremely beneficial" on their careers. As a measure of technology translation, more than 440,000 patients have been reached with technologies developed directly out of the Biodesign Innovation Fellowship, with another 1,000,000+ aided by solutions initiated by alumni after their training. This study suggests a positive impact of the fellowship program on the career focus, leadership, and productivity of its alumni.