IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage

OBJECTIVE: To extend the IDEAL Framework for device innovation, IDEAL-D, to include the preclinical stage of development (Stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL Framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects and minimisation of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness prior to progression to clinical studies (Stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice

A review of wearable motion tracking systems used in rehabilitation following hip and knee replacement

Clinical teams are under increasing pressure to facilitate early hospital discharge for total hip replacement and total knee replacement patients following surgery. A wide variety of wearable devices are being marketed to assist with rehabilitation following surgery. A review of wearable devices was undertaken to assess the evidence supporting their efficacy in assisting rehabilitation following total hip replacement and total knee replacement. A search was conducted using the electronic databases including Medline, CINAHL, Cochrane, PsycARTICLES, and PubMed of studies from January 2000 to October 2017. Five studies met the eligibility criteria, and all used an accelerometer and a gyroscope for their technology. A review of the studies found very little evidence to support the efficacy of the technology, although they show that the use of the technology is feasible. Future work should establish which wearable technology is most valuable to patients, which ones improve patient outcomes, and the most economical model for deploying the technolog

Enhanced recovery after surgery: Current research insights and future direction.

Since the concept of enhanced recovery after surgery (ERAS) was introduced in the late 1990s the idea of implementing specific interventions throughout the peri-operative period to improve patient recovery has been proven to be beneficial. Minimally invasive surgery is an integral component to ERAS and has dramatically improved post-operative outcomes. ERAS can be applicable to all surgical specialties with the core generic principles used together with added specialty specific interventions to allow for a comprehensive protocol, leading to improved clinical outcomes. Diffusion of ERAS into mainstream practice has been hindered due to minimal evidence to support individual facets and lack of method for monitoring and encouraging compliance. No single outcome measure fully captures recovery after surgery, rather multiple measures are necessary at each stage. More recently the pre-operative period has been the target of a number of strategies to improve clinical outcomes, described as prehabilitation. Innovation of technology in the surgical setting is also providing opportunities to overcome the challenges within ERAS, e.g., the use of wearable activity monitors to record information and provide feedback and motivation to patients peri-operatively. Both modernising ERAS and providing evidence for key strategies across specialties will ultimately lead to better, more reliable patient outcomes

A systematic recurrent theme analysis of the reported limitations of facial electromyography

Background Advances in digital technology hold promise in expanding the clinical and consumer applications of facial electromyography (EMG) through thedevelopment of wireless pervasive systems capable of operating in a nonclinical environment. This systematic review aims to appraise the most commonly reported limitations of the technology in clinical research and practice. Methods A systematic search for clinical facial EMG literature was performed using MEDLINE, EMBASE, PsychINFO and CINAHL. No language limits were applied. Search results were screened using defined criteria by two authors with disagreements resolved by a third. Practical limitations in the technology, as reported by the authors, were recorded and characterised using recurrent theme analysis. Results A total of 4,983 records were identified. Of those, 1,061 articles met eligibility criteria and were subsequently reviewed. In the medical domain, the most common area of application was in psychosocial studies (28% of medical studies); in the surgical domain monitoring of facial nerve integrity was the most common application of facial electromyography (27% of surgical studies). Collectively, the three most commonly reported limitations were motion artefact (13.7%), inter-subject variability in response and anatomy (13.1%), and muscle crosstalk (12.0%). Conclusions This is the first study to evaluate the limitations of facial EMG using a systematic analysis of author reports. Highlighting technology limitations in this non-biased manner raises awareness to users key issues and reliably informs the development of future systems

The relationship between physical activity and post-operative length of hospital stay: A systematic review

Background Recovery from surgery has traditionally been measured using specific outcome measures, such as length of hospital stay. However, advances in technology have enabled the measurement of continuous, objective physical activity data in the perioperative period. The aim of this systematic review was to determine the relationship between length of hospital stay and physical activity data for patients undergoing surgery. Methods A systematic search of EMBASE, Medline and the Cochrane Library, from inception until January 2017, was performed to identify all study designs that evaluated physical activity after surgery. Studies were included if a wearable sensor measured patient activity as an in-patient and the length of hospital stay was reported. Only English articles were included. Results Six studies with a total of 343 participants were included in this review. All the studies were prospective observational studies. Each study used a different sensor, with the commonest being a tri-axial accelerometer, and multiple different physical activity outcome measures were used, thereby prohibiting meta-analysis. Four of the studies demonstrated a relationship between physical activity levels and length of hospital stay, while two studies did not show any significant relationship. Conclusion The amount of physical activity performed post-operatively negatively correlates with the length of hospital stay. This suggests that objective physical activity data collected by body worn sensors may be capable of predicting functional recovery post-operatively