User preferences need to be taken into account in order to be able to design devices that will gain acceptance both in a clinical and home setting. Sensor systems become redundant if patients or clinicians do not want to work with them. The aim of this systematic review was to determine both patients' and clinicians' preferences for non-invasive body-worn sensor systems. A search for relevant articles and conference proceedings was performed using MEDLINE, EMBASE, Current Contents Connect, and EEEI explore. In total 843 papers were identified of which only 11 studies were deemed suitable for inclusion. A range of different clinically relevant user groups were included. The key user preferences were that a body-worn sensor system should be compact, embedded and simple to operate and maintain. It also should not affect daily behavior nor seek to directly replace a health care professional. It became apparent that despite the importance of user preferences, they are rarely considered and as such there is a lack of high-quality studies in this area. We therefore would like to encourage researchers to focus on the implications of user preferences when designing wearable sensor systems.
ObjectiveTo evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.DesignSystematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Data sourcesPubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.MethodsA double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study.ResultsOf the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy.ConclusionsAll medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.
There has been a rising interest in wearable and implantable biomedical sensors over the last decade. However, many technologies have not been integrated into clinical care, due to a limited understanding of user-centered design issues. Little information is available about these issues and there is a need to adopt more rigorous evidence standards for design features to allow important medical sensors to progress quicker into clinical care. Current trends in patient preferences need to be incorporated at an early stage into the design process of prospective clinical sensors. The first comprehensive patient data set, discussing mobile biomedical sensor technology, is presented in this paper. The study population mainly consisted of individuals suffering from arthritis. It was found that sensor systems needed to be small, discreet, unobtrusive and preferably incorporated into everyday objects. The upper extremity was seen as the favored position on the body for placement, while invasive placement yielded high levels of acceptance. Under these conditions most users were willing to wear the body-worn sensor for more than 20 h a day. This study is a first step to generate research based user-orientated design criteria’s for biomedical sensors.
The objective of this study was to investigate reliability of transcranial magnetic stimulation (TMS) parameters for three coil systems; hand-held circular and figure-of-eight and navigated figure-of-eight coils. Stimulus response curves, intracortical inhibition (SICI) and facilitation (ICF) were studied in the right first dorsal interosseus muscle of 10 healthy adults. Each coil system was tested twice per subject. Navigation was conducted by a custom built system. Cortical excitability showed moderate-to-good reliability for the hand-held and navigated figure-of-eight coils (Intraclass correlation coefficients (ICCs) 0.55-0.89). The circular coil showed poor reliability for motor evoked potential (MEP) amplitude at 120% resting motor threshold (RMT; MEP(120)) and MEP sum (ICCs 0.09 & 0.48). Reliability for SICI was good for all coil systems when an outlier was removed (ICCs 0.87-0.93), but poor for ICF (ICCs < 0.3). The circular coil had a higher MEP(120) than the navigated figure-of-eight coil (p = 0.004). Figure-of-eight coils can be used confidently to investigate cortical excitability over time. ICF should be interpreted with caution. The navigation device frees the experimenter and enables tracking of the position of the coil and subject. The results help guide the choice of coil system for longitudinal measurements of motor cortex function.
Flexible sensors that can be integrated into clothing to measure everyday functional performance is an emerging concept. It aims to improve the patient's quality of life by obtaining rich, real-life data sets. One clinical area of interest is the use of these sensors to accurately measure knee motion in, e.g., osteoarthritic patients. Currently, various methods are used to formally calculate joint motion outside of the laboratory and they include electrogoniometers and inertial measurement units. The use of these technologies, however, tends to be restricted, since they are often bulky and obtrusive. This directly influences their clinical utility, as patients and clinicians can be reluctant to adopt them. The goal of this paper is to present the development process of a patient centered, clinically driven design for an attachable clothing sensor (ACS) system that can be used to assess knee motion. A pilot study using 10 volunteers was conducted to determine the relationship between the ACS system and a gold standard apparatus. The comparison yielded an average root mean square error of ∼1°, a mean absolute error of ∼3°, and coefficient of determination above (R 2 ) 0.99 between the two systems. These initial results show potential of the ACS in terms of unobtrusive long-term monitoring.
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