Given the convergence of the long and challenging development path for medical devices with the need for diagnostic capabilities for mild traumatic brain injury (mTBI/concussion), the effective role of public–private partnership (PPP) can be demonstrated to yield Food and Drug Administration (FDA) clearances and innovative product introductions. An overview of the mTBI problem and landscape was performed. A detailed situation analysis of an example of a PPP yielding an innovative product was further demonstrated. The example of PPP has led to multiple FDA clearances and product introductions in the TBI diagnostic product category where there was an urgent military and public need. Important lessons included defining the primary public and military health objective for new product introduction, the importance of the government–academia–industry PPP triad with a “collaboration towards solutions” Quality-by-Design (QbD) mindset to assure clinical validity with regulatory compliance, the development of device comparators and integration of measurements into a robust, evidence-based statistical and FDA pathway, and the utility of top-down, flexible, practical action while operating within governmental guidelines and patient safety.

The purpose of this review was to explore how vocal affect recognition deficits impact the psychosocial functioning of people with moderate to severe traumatic brain injury (TBI). A systematic review following the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines was conducted, whereby six databases were searched, with additional hand searching of key journals also completed. The search identified 1847 records after duplicates were removed, and 1749 were excluded through title and abstract screening. After full text screening of 65 peer-reviewed articles published between January 1999 and August 2019, only five met inclusion criteria. The methodological quality of selected studies was assessed using the Mixed Methods Appraisal Tool (MMAT) Version 2018 with a fair level of agreement reached. A narrative synthesis of the results was completed, exploring vocal affect recognition and psychosocial functioning of people with moderate to severe TBI, including aspects of social cognition (i.e., empathy; Theory of Mind) and social behaviour. Results of the review were limited by a paucity of research in this area, a lack of high-level evidence, and wide variation in the outcome measures used. More rigorous study designs are required to establish more conclusive evidence regarding the degree and direction of the association between vocal affect recognition and aspects of psychosocial functioning. This review is registered with Prospero.

This article presents early findings from the implementation and ongoing evaluation of a new model of care that employs a comprehensive approach to rehabilitation case management for clients with traumatic brain injury, with the aim of improving transition from inpatient rehabilitation to community settings. The evaluation explores the design, implementation, utility and acceptability of the new model using clinicians’ perceptions and experiences. Method: The evaluation framework employs a participatory evaluation approach, drawing on semistructured interview data. Interviews were conducted with brain injury unit clinicians, rehabilitation case managers and external stakeholders at the model's implementation and four months later, as part of a 12-month evaluation period. The data were descriptively organised, then coded and subjected to interpretative analysis to identify key issues. Results: Early findings suggest that the new model provides increased consistency for staff, clients and carers; promotes efficiency in discharge planning and facilitates a more streamlined and seamless transition between inpatient rehabilitation and community services. Data gathered across the remainder of the implementation trial will extend understanding of this comprehensive rehabilitation case management model and its potential utility in other services and settings.

This article reports on the design of a three-arm, nonrandomised controlled trial of interventions targeting social communication skills following traumatic brain injury (TBI) in adult participants. People with severe TBI were allocated to one of the three groups: the TBI group, where only the person with TBI was trained, the JOINT group where both the everyday communication partner (ECP) and the person with TBI were trained together, and a delayed treatment control condition. The trial is comparing whether including everyday communication partners in the training process provide additional benefit when compared to training the person with TBI alone; and additionally, whether training the person with TBI alone is more effective than no training. A range of primary and secondary outcome measures will be used to evaluate outcomes. Publishing the protocol prior to the results of the trial being available has several important benefits (Godlee, 2001). The original hypotheses and intentions of the research are made explicit to ensure that the process of conducting this clinical trial is transparent to readers, and so that comments may be made before results are finalised. It provides the opportunity to outline a detailed description of this intervention and methodology, or to acknowledge changes to methodology, which may assist with eventual clinical application of the intervention. This article also informs the research community of the work that is underway to promote opportunities for collaboration and reduce unnecessary duplication of research. The protocol for this trial has previously been registered on Current Controlled Trials (http://www.controlled-trials.com/ISRCTN57815281).

Many rehabilitation protocols following traumatic brain injury (TBI) utilize reinforcement and reward to influence behavior and facilitate recovery; however, previous studies suggest survivors of severe TBI demonstrate impairments in contingency utilization and sensitivity. The precise neurobiological mechanisms underlying these deficits have not been thoroughly explored, but can be examined using the “feedback-related negativity” (FRN)— an event-related potential (ERP) component evoked following performance or response feedback (e.g., whether a monetary reward is obtained) with a larger FRN following unfavorable than favorable outcomes—particularly when unfavorable feedback occurs in the context of high reward probability. We examined ERPs elicited by favorable (monetary gain: “reward”) and unfavorable (no monetary gain: “non-reward”) feedback during a guessing task where probability of reward outcome was manipulated in survivors of severe TBI and demographically matched healthy participants. Consistent with previous findings, controls showed larger amplitude FRN to non-reward feedback and the largest amplitude FRN following a non-reward when reward probability context was greatest. In contrast, FRN in TBI participants did not significantly differentiate non-reward from reward trials and their FRN was largest to reward trials in the low reward probability context. Findings implicate an electrophysiological marker of impaired reward context sensitivity following severe TBI. (JINS, 2007, 13, 615–625.)