Using Simultaneous Confidence Bands to Calculate the Margin of Error in Estimating Typical Biomechanical Waveforms.

Studies of human movement usually collect data from multiple repetitions of a task and use the average of all movement trials to approximate the typical kinematics or kinetics pattern for each individual. Few studies report the expected accuracy of these estimated mean kinematics or kinetics waveforms for each individual. The purpose of this study is to demonstrate how simultaneous confidence bands, which is an approach to quantify uncertainty across an entire waveform based on limited data, can be used to calculate margin of error (MOE) for waveforms. Bilateral plantar pressure data were collected from 70 participants as they walked over 4 surfaces for an average of at least 300 steps per surface. The relationship between MOE and the number of steps included in the analysis was calculated using simultaneous confidence bands, and 3 methods commonly used for pointwise estimates: intraclass correlation, sequential averaging, and T-based MOE. The conventional pointwise approaches underestimated the number of trials required to estimate biomechanical waveforms within a desired MOE. Simultaneous confidence bands are an objective approach to more accurately estimate the relationship between the number of trials collected and the MOE in estimating typical biomechanical waveforms.

Customizable document control solution for 3D printing at the point-of-care.

BACKGROUND: The rapid expansion and anticipated U.S Food and Drug Administration regulation of 3D printing at the point-of-care necessitates the creation of robust quality management systems. A critical component of any quality management system is a document control system for the organization, tracking, signature collection, and distribution of manufacturing documentation. While off-the-shelf solutions for document control exist, external programs are costly and come with network security concerns. Here, we present our internally developed, cost-effective solution for an electronic document control system for 3D printing at the point-of-care. METHODS: We created a hybrid document control system by linking two commercially available platforms, Microsoft SharePoint and Adobe Sign, using a customized document approval workflow. RESULTS: Our platform meets all Code of Federal Regulations Title 21, Part 11 guidances. CONCLUSION: Our hybrid solution for document control provides an affordable system for users to sort, manage, store, edit, and sign documents. The system can serve as a framework for other 3D printing programs to prepare for future U.S Food and Drug Administration regulation, improve the efficiency of 3D printing at the point-of-care, and enhance the quality of work produced by their respective program.

Use of patient-specific 3D printed models in pre-operative counseling for pediatric skull base surgery.

OBJECTIVES: Pediatric cranial base pathology is anatomically complex and surgical treatment is oftentimes difficult to conceptualize for patients and their families. Three-dimensional (3D) models of the sinuses and cranial base have the potential to enhance patient understanding in numerous domains. Our objective is to assess the use of 3D models in pre-operative parental and patient counseling prior to endoscopic endonasal skull base surgery in the pediatric population. METHODS: A survey was designed to assess parent and patient-perceived utility of 3D-printed models in surgical counseling prior to pediatric skull base surgery. RESULTS: A total of 10 patients were included. The median age was 9 years (range = 5 months-15 years). Pathology included juvenile nasopharyngeal angiofibroma (JNA) (N = 4), fibrous dysplasia of the maxilla and sphenoid (N = 1), juvenile ossifying fibroma (N = 1), nasal dermoid (N = 2, one with intracranial extension), encephalocele (N = 1), and parapharyngeal ectopic glial tissue (N = 1). Nearly all parents agreed or strongly agreed that 3D printed models were helpful in explaining the patient's skull base pathology (N = 10), surgical plan (N = 10), and possible complications (N = 9). All parents strongly agreed that 3D models should be used routinely in pre-operative counseling for endoscopic endonasal surgery. According to a majority of parents, patients older than 4 years old found the models helpful in understanding their pathology (75%) and surgery (88%). CONCLUSION: By allowing direct three-dimensional visualization of the target pathology, 3D models serve as a useful adjunct in enhancing patient comprehension of the pathologic entity, planned surgery, and potential complications prior to pediatric endoscopic endonasal skull base surgery.