Potential advantages, barriers, and facilitators of implementing a cognitive orthosis for cooking for individuals with traumatic brain injury: the healthcare providers' perspective.

PURPOSE: Considering the key role of health care providers in integrating assistive technologies into clinical settings (e.g., in/outpatient rehabilitation) and home, this study explored the care providers' perspectives on benefits, barriers and facilitators to the implementation of the Cognitive Orthosis for coOking (COOK) for adults with traumatic brain injury (TBI) within clinical contexts and homes. METHODS: Using a qualitative descriptive approach, semi-structured individual interviews and focus groups were carried out with experienced care providers of adults with TBI (n = 30) in Ontario-Canada. Qualitative analysis based on the Miles et al approach was used. RESULTS: According to the participants, COOK could potentially be used with individuals with cognitive impairments (TBI and non-TBI) to increase safety and independence in meal preparation and support healthcare providers. However, limited access to funding, clients' lack of motivation/knowledge, and the severity of their cognitive and motor impairments were perceived as potential barriers. Facilitators to the use of COOK include training sessions, availability of private/provincial financing, and comprehensive assessments by a clinical team prior to use. CONCLUSIONS: Health care providers' perspectives will help develop implementation strategies to facilitate the adoption of COOK within homes and clinical contexts for individuals with TBI and improve the next version of this technology.IMPLICATIONS FOR REHABILITATIONCOOK shows a high potential for increasing independence and safety during meal preparation with its sensor-based monitoring of the environment and cognitive-based assistance, for adults with TBI.Comprehensive clinical assessments to identify individuals' therapeutic goals, clinical characteristics, and living environments are necessary to facilitate the deployment of COOK.

Adapting two American Decision Aids for Mild Traumatic Brain Injury to the Canadian Context Using the Nominal Group Technique.

BACKGROUND: Decision aids are patient-focused tools that have the potential to reduce the overuse of head computed tomography (CT) scans. OBJECTIVE: The objective of this study was to create a consensus among Canadian mild traumatic brain injury and emergency medicine experts on modifications required to adapt two American decision aids about head CT use for adult and paediatric mild traumatic brain injury to the Canadian context. METHODS: We invited 21 Canadian stakeholders and the two authors of the American decision aids to a Nominal Group Technique consensus meeting to generate suggestions for adapting the decision aids. This method encourages idea generation and sharing between team members. Each idea was discussed and then prioritised using a voting system. We collected data using videotaping, writing material and online collaborative writing tools. The modifications proposed were analysed using a qualitative thematic content analysis. RESULTS: Twenty-one participants took part in the meeting, including researchers and clinician researchers (n = 9; 43%), patient partners (n = 3; 14%) and decision makers (n = 2; 10%). A total of 84 ideas were generated. Participants highlighted the need to clarify the purpose of the decision aids, the nature of the problem being addressed and the target population. The tools require sociocultural adaptations, better identification of their target population, better description of head CT utility, advantages and related risks, modification of the visual and written representation of the risk of brain injury and head CT use, and locally adapted, patient follow-up plans. CONCLUSIONS: This study based on a Nominal Group Technique identified several adaptations for two American decision aids about head CT use for mild traumatic brain injury to support their use in Canada's different healthcare, social, cultural and legal context. These adaptations concerned the target users of the decision aids, the information presented, and how the benefits and risks were communicated in the decision aids. Future steps include prototyping the two adapted decision aids, conducting formative evaluations with actual emergency department patients and clinicians, and measuring the impact of the adapted tools on CT scan use.

A mild traumatic brain injury (also called concussion) can happen when the brain moves around in the skull after an impact to the head. A concussion is not a brain bleed and you cannot see a concussion. Concussions do not show up on a computed tomography (CT) scan. Brain bleeds do. Computed tomography scans are specialised X-ray machines that can detect serious brain injuries. Unfortunately, CT scan use also exposes patients to radiation and a future increased risk of cancer.Shared decision making involves health professionals and patients making decisions together based on the best available evidence, health professionals' experience, and patients' values and preferences. Shared decision making improves appropriate diagnostic test use.Two decision aids created in the USA are available to facilitate shared decision making regarding the use of head CT scans for patients with concussion. These decision aids are not fully adapted for use in Canada because the healthcare, social and legal context is different. Our study brought together patients and experts in the field of concussion and shared decision making to analyse these decision aids and propose adaptations that would increase their acceptance in Canadian emergency departments. We used a technique called the Nominal Group Technique to create a consensus about the most important changes to make to both original decision aids. The main adaptations needed for the Canadian context concerned avoiding information about cost and removing any information that does not change clinical management. This project will help us adapt two decision aids for clinical use in Canada and support appropriate CT scan use for patients with concussion.

Research Priorities for Optimizing Long-term Community Integration after Brain Injury.

OBJECTIVE: This paper reports on a funded summit, which convened a multidisciplinary group of experts to provide consensus on the research priorities necessary for improving long-term community integration of individuals with traumatic brain injury (TBI) and their caregivers. METHODS: The 2-day summit was directed using the World Café Methodology, to engage stakeholders and collaboratively arrive at a consensus on the problems to be targeted in research. Participants (n=54), drawn from two Canadian provinces, included an interdisciplinary group of researchers, clinicians, representatives from brain injury associations, individuals with TBI, and caregivers. In small groups, participants discussed challenges to long-term community integration and potential initiatives that would address these barriers. Field notes from the discussions were analyzed using qualitative content analysis. RESULTS: The consensus on prioritized research directions included developing interventions to optimize the functioning and participation of individuals with TBI, reducing caregiver burden, and evaluating how emerging technology can facilitate delivery of care. CONCLUSIONS: The World Café Methodology was an effective method for developing research priorities. The breadth of expertise of participants and the collegial environment allowed for the identification of a broad perspective on important future research directions with potential to enhance the long-term community integration of individuals with brain injury.

Facilitators' delivery of a psychosocial intervention in a controlled trial for men with prostate cancer and their partners: a process evaluation.

AIM: The aim of this paper was to report the process evaluation of facilitators' delivery of a psychosocial intervention (called CONNECT), in a randomized controlled trial, to men with prostate cancer and their partners. BACKGROUND: There is a lack of information on the process of implementing psychosocial interventions in controlled trials and, in particular, on the role and performance of facilitators who deliver them. Yet, this information is crucial in assessing whether these interventions are effective or not and why. DESIGN: Qualitative design. METHODS: Semi-structured qualitative interviews and diaries were used to collect data (January-October 2012) from four facilitators and a co-facilitator. Data were analysed using the Miles et al. RESULTS: Five themes were discernible. These were 'difficulties to keep to the structure of the intervention', 'selective coverage of topics', 'partner participation', 'overall impression of the group and telephone sessions' and 'perceived benefits to participants'. Issues such as not keeping to the aim of the intervention, deviating from the content and/or reluctance in discussing sensitive issues such as sexual health may mean that the psychosocial effects of the intervention may not have been fully realized. CONCLUSIONS: These findings will be useful for further development and evaluation of the intervention. A tentative conceptual framework of factors, related to facilitators, influencing the fidelity of interventions in the context of controlled trials, is offered. This model, which requires further development and testing, will be useful for researchers worldwide who are involved in developing interventions and training facilitators.

The experience and perceptions of men with prostate cancer and their partners of the CONNECT psychosocial intervention: a qualitative exploration.

AIM: To explore the experience of prostate cancer survivors and their partners of the CONNECT psychosocial intervention. BACKGROUND: There is a scarcity of evidence relating to interventions to help men and their partners cope with the after affects of prostate cancer treatment. DESIGN: This study employed a qualitative design for in depth exploration through couple interviews. The addition of a short process evaluation questionnaire was used to supplement the qualitative data. METHODS: Semi-structured interviews were conducted between January 2012-October 2012 with a purposive sample of 11 couple dyads who had participated in the CONNECT intervention. Data were analysed using inductive content analysis. Simple descriptive statistics were used to analyse the findings from the questionnaire data. RESULTS: Couples perceived benefits of participating in the intervention to include: opportunities to share experiences, gain validation, obtain information and engage in couple care. The expertise of the professional facilitator and group dynamics were highlighted as factors influencing the success of the intervention. Potential areas for improvement of the intervention were identified as being: further development of the sexual dysfunction component; incorporation of a partner specific session to better address their needs; determination of optimal delivery format and timing; and further tailoring of the components of the intervention. CONCLUSION: Although there were areas that could be further improved, this psychosocial intervention was valued by the participants. The insight gained from this qualitative exploration can be used to make the necessary changes before the intervention can be tested in a large randomised controlled trial.

Bridges self-management program for people with stroke in the community: A feasibility randomized controlled trial.

BACKGROUND: Enabling self-management behaviors is considered important in order to develop coping strategies and confidence for managing life with a long-term condition. However, there is limited research into stroke-specific self-management interventions. AIM: The aim of this randomized controlled trial was to evaluate the feasibility of delivering the Bridges stroke self-management program in addition to usual stroke rehabilitation compared with usual rehabilitation only. METHODS: Participants recruited from the referrals to a community stroke team were randomly allocated to the Bridges stroke self-management program, receiving either one session of up to one-hour per week over a six-week period in addition to usual stroke rehabilitation, or usual rehabilitation only. Feasibility was measured using a range of methods to determine recruitment and retention; adherence to the program; suitability and variability of outcome measures used; application and fidelity of the program; and acceptability of the program to patients, carers and professionals. RESULTS: Twenty-five people were recruited to the study over a 13-month period. Eight out of the 12 participants in the Bridges stroke self-management program received all six sessions; there was one withdrawal from the study. There were changes in outcomes between the two groups. Participants who received the Bridges stroke self-management program appeared to have a greater change in self-efficacy, functional activity, social integration and quality of life over the six-week intervention period and showed less decline in mood and quality of life at the three-month follow-up. Professionals found the program acceptable to use in practice, and feedback from participants was broadly positive. CONCLUSIONS: The findings from this study appear promising, but questions remain regarding the feasibility of delivering the Bridges stroke self-management program in addition to usual rehabilitation. The dose response of receiving the program cannot be ruled out, and the next stage of research should explore the feasibility of an integrated program. Exploration of the reasons behind relatively low recruitment and of the sensitivity of outcome measures to detect a change are also required. Additional investigation of intervention fidelity is required to monitor if the program is being delivered as intended.

Self-management programmes for people post stroke: a systematic review.

OBJECTIVE: To examine the evidence base underlying self-management programmes specific to stroke survivors. DATA SOURCES: Eleven electronic databases were searched using combinations of keywords related to stroke and self-management. REVIEW METHODS: Studies involving adults with a clinical diagnosis of stroke, which explored self-management interventions, were included. Study selection was verified by two reviewers who independently conducted methodological quality appraisal and data extraction using a tool developed by The American Academy for Cerebral Palsy and Developmental Medicine. RESULTS: Fifteen studies were included in this review. Significant treatment effects in favour of the self-management intervention were found in six out of nine randomized controlled trials, and three out of six non-randomized trials in our review. Four randomized controlled trials involving more than 100 participants per trial reported statistically significant results in favour of the self-management group in relation to measures of disability, confidence in recovery, the stroke specific quality of life (sub-scales of family roles and fine motor tasks), and the physical component scale of the short form SF-36 Score. The wide range of outcome measures used prevented comparison across studies. CONCLUSIONS: This review provides some preliminary support for the potential importance of self-management interventions after stroke. The most appropriate content and best approach for delivery of these interventions remains to be determined. Further high-quality randomized controlled trials are needed to test the feasibility, acceptability, and efficacy of stroke self-management programmes.

COG1410, an apolipoprotein E-based peptide, improves cognitive performance and reduces cortical loss following moderate fluid percussion injury in the rat.

COG1410, a small, novel ApoE-mimetic peptide derived from the receptor binding region of apolipoprotein E (ApoE), has been classified as anti-inflammatory in nature and improves motor, sensorimotor, and cognitive dysfunction following cortical contusion injury (CCI). In order to further examine COG1410's preclinical efficacy on cognitive recovery, the present study evaluated COG1410 following moderate fluid percussion injury (FPI). Animals were prepared with a moderate, unilateral FPI over the hippocampus. Following FPI, animals received a regimen of five doses of COG1410 or vehicle at 2 and 4h (1.0mg/kg, i.v.) followed by additional doses administered 24, 48, and 72 h (1.0mg/kg, i.p.). Prior to injury, animals were trained for 4 days (4 trials/day) in the Morris water maze (MWM) and then tested for retrograde amnesia on post-FPI day 11 and then on a working memory task on day 18. Testing for motor dysfunction on the tapered balanced beam began on day 2 post-FPI. Administration of this regimen of COG1410 significantly improved retention of memory in the retrograde amnesia test compared to vehicle post-FPI. However, COG1410 did not significantly improve acquisition of working memory in the MWM. Motor dysfunction on the tapered beam post-FPI was improved in the COG1410-treated group compared to vehicle treatment. Cortical lesion analysis revealed that the COG1410-treated animals demonstrated significantly less tissue loss compared to vehicle-treated animals. The results of this study suggest that COG1410 significantly limited the behavioral dysfunction and tissue loss associated with FPI and demonstrated continued preclinical efficacy for TBI.

COG1410 improves cognitive performance and reduces cortical neuronal loss in the traumatically injured brain.

We have previously shown that a single dose of COG1410, a small molecule ApoE-mimetic peptide derived from the apolipoprotein E (ApoE) receptor binding region, improves sensorimotor and motor outcome following cortical contusion injury (CCI). The present study evaluated a regimen of COG1410 following frontal CCI in order to examine its preclinical efficacy on cognitive recovery. Animals were prepared with a bilateral CCI of the frontal cortex. A regimen of COG1410 (0.8mg/kg intravenously [IV]) was administered twice, at 30min and again at 24h post-CCI. Starting on day 11, the animals were tested for their acquisition of a reference memory task in the Morris water maze (MWM), followed by a working memory task in the MWM on day 15. Following CCI, the animals were also tested on the bilateral tactile adhesive removal test to measure sensorimotor dysfunction. On all of the behavioral tests the COG1410 group was no different from the uninjured sham group. Administration of the regimen of COG1410 significantly improved recovery on the reference and working memory tests, as well as on the sensorimotor test. Lesion analysis revealed that COG1410 significantly reduced the size of the injury cavity. Administration of COG1410 also reduced the number of degenerating neurons, as measured by Fluoro-Jade C staining, in the frontal cortex at 48h post-CCI. These results suggest that a regimen of COG1410 appeared to block the development of significant behavioral deficits and reduced tissue loss. These combined findings suggest that COG1410 appears to have strong preclinical efficacy when administered following traumatic brain injury (TBI).

COG1410, a novel apolipoprotein E-based peptide, improves functional recovery in a murine model of traumatic brain injury.

Traumatic brain injury (TBI) is a silent epidemic affecting approximately 1.4 million Americans annually, at an estimated annual cost of $60 billion in the United States alone. Despite an increased understanding of the pathophysiology of closed head injury, there remains no pharmacological intervention proven to improve functional outcomes in this setting. Currently, the existing standard of care for TBI consists primarily of supportive measures. Apolipoprotein E (apoE) is the primary apolipoprotein synthesized in the brain in response to injury, where it modulates several components of the neuroinflammatory cascade associated with TBI. We have previously demonstrated that COG133, an apoE mimetic peptide, improved functional outcomes and attenuated neuronal death when administered as a single intravenous injection at 30 min post-TBI in mice. Using the principles of rational drug design, we developed a more potent analog, COG1410, which expands the therapeutic window for the treatment of TBI by a factor of four, from 30 min to 2 h. Mice that received a single intravenous injection of COG1410 at 120 min post-TBI exhibited significant improvement on a short term test of vestibulomotor function and on a long term test of spatial learning and memory. This was associated with a significant attenuation of microglial activation and neuronal death in the hippocampus, the neuroanatomical substrate for learning and memory. Rationally derived apoE mimetic peptides have been demonstrated to exert neuroprotective and anti-inflammatory effects in vitro and in clinically relevant models of brain injury. This represents a novel therapeutic strategy in the treatment of TBI.

The novel apolipoprotein E-based peptide COG1410 improves sensorimotor performance and reduces injury magnitude following cortical contusion injury.

It has previously been shown that small peptide molecules derived from the apolipoprotein E (ApoE) receptor binding region are anti-inflammatory in nature and can improve outcome following head injury. The present study evaluated the preclinical efficacy of COG1410, a small molecule ApoE-mimetic peptide (1410 daltons), following cortical contusion injury (CCI). Animals were prepared with a unilateral CCI of the sensorimotor cortex (SMC) or sham procedure. Thirty mins post-CCI the animals received i.v. infusions of 0.8 mg/kg COG1410, 0.4 mg/kg COG1410, or vehicle. Starting on day 2, the animals were tested on a battery of behavioral measures to assess sensorimotor (vibrissae-forelimb placing and forelimb use-asymmetry), and motor (tapered balance beam) performance. Administration of the 0.8 mg/kg dose of COG1410 significantly improved recovery on the vibrissae-forelimb and limb asymmetry tests. However, no facilitation was observed on the tapered beam. The low dose (0.4 mg/kg) of COG1410 did not show any significant differences compared to vehicle. Lesion analysis revealed that the 0.8 mg/kg dose of COG1410 significantly reduced the size of the injury cavity compared to the 0.4 mg/kg dose and vehicle. The 0.8 mg/kg dose also reduced the number of glial fibrillary acid protein (GFAP+) reactive cells in the injured cortex. These results suggest that a single dose of COG1410 facilitates behavioral recovery and provides neuroprotection in a dose and task-dependent manner. Thus, the continued clinical development of ApoE based therapeutics is warranted and could represent a novel strategy for the treatment of traumatic brain injuries.

Apolipoprotein E-derived peptides ameliorate clinical disability and inflammatory infiltrates into the spinal cord in a murine model of multiple sclerosis.

Apolipoprotein E (apoE), well known to play a role in lipid transport and cholesterol metabolism, also exerts anti-inflammatory and neuroprotective effects in the central nervous system. Recent clinical and genetic studies display an association between apoE genotype (APOE) and the progression and severity of multiple sclerosis, raising the possibility that modulation of apoE may be a novel treatment for multiple sclerosis. Using a murine experimental autoimmune encephalomyelitis (EAE) model of human multiple sclerosis, we found that a peptidomimetic of apoE protein, COG133, substantially reduces the clinical symptoms of EAE and promotes remission from the disability when administered before or after onset of disease. Most notably, fusion of COG133 to a protein transduction domain creates COG112, a modified apoE-mimetic peptide with significantly enhanced anti-inflammatory bioactivities in vitro, and improved therapeutic effects on EAE in vivo, which renders a nearly full remission from the disability. Histopathological analysis showed that COG112 and COG133 attenuated demyelination and significantly diminished the number of peripheral cells infiltrating into the spinal cord. ApoE mimetics also interfered with several mechanisms relevant to the pathogenesis of EAE and multiple sclerosis, including activation of macrophages, subsequent production of nitric oxide and inflammatory cytokines, and lymphocyte proliferation. These data suggest that apoE mimetics represent a multidimensional therapeutic for multiple sclerosis capable of inhibiting the inflammatory cascade, modulating immune cell function, and reducing clinical signs, which may have novel utility for the treatment of inflammatory autoimmune diseases.

A novel therapeutic derived from apolipoprotein E reduces brain inflammation and improves outcome after closed head injury.

Although apolipoprotein E4 (APOE4) was initially identified as a susceptibility gene for the development of Alzheimer's disease, the presence of the APOE4 allele is also associated with poor outcome after acute brain injury. One mechanism by which apoE may influence neurological outcome is by downregulating the neuroinflammatory response. Because it does not readily cross the blood-brain barrier, the apoE holoprotein has limited therapeutic potential. We demonstrate that a single intravenous injection of a small peptide derived from the apoE receptor binding region crosses the blood-brain barrier and significantly improves histological and functional outcomes after traumatic brain injury (TBI). The development of an apoE-based intervention represents a novel therapeutic strategy in the management of acute brain injury.