INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury: Methods, Overview, and Principles.

INTRODUCTION: Moderate to severe traumatic brain injury (TBI) results in complex cognitive sequelae. Despite hundreds of clinical trials in cognitive rehabilitation, the translation of these findings into clinical practice remains a challenge. Clinical practice guidelines are one solution. The objective of this initiative was to reconvene the international group of cognitive researchers and clinicians (known as INCOG) to develop INCOG 2.0: Guidelines for Cognitive Rehabilitation Following TBI. METHODS: The guidelines adaptation and development cycle was used to update the recommendations and derive new ones. The team met virtually and reviewed the literature published since the original INCOG (2014) to update the recommendations and decision algorithms. The team then prioritized the recommendations for implementation and modified the audit tool accordingly to allow for the evaluation of adherence to best practices. RESULTS: In total, the INCOG update contains 80 recommendations (25 level A, 15 level B, and 40 level C) of which 27 are new. Recommendations developed for posttraumatic amnesia, attention, memory, executive function and cognitive-communication are outlined in other articles, whereas this article focuses on the overarching principles of care for which there are 38 recommendations pertaining to: assessment (10 recommendations), principles of cognitive rehabilitation (6 recommendations), medications to enhance cognition (10 recommendations), teleassessment (5 recommendations), and telerehabilitation intervention (7 recommendations). One recommendation was supported by level A evidence, 7 by level B evidence, and all remaining recommendations were level C evidence. New to INCOG are recommendations for telehealth-delivered cognitive assessment and rehabilitation. Evidence-based clinical algorithms and audit tools for evaluating the state of current practice are also provided. CONCLUSIONS: Evidence-based cognitive rehabilitation guided by these recommendations should be offered to individuals with TBI. Despite the advancements in TBI rehabilitation research, further high-quality studies are needed to better understand the role of cognitive rehabilitation in improving patient outcomes after TBI.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part I: Posttraumatic Amnesia.

INTRODUCTION: Posttraumatic amnesia (PTA) is a common occurrence following moderate to severe traumatic brain injury (TBI) and emergence from coma. It is characterized by confusion, disorientation, retrograde and anterograde amnesia, poor attention and frequently, agitation. Clinicians and family need guidelines to support management practices during this phase. METHODS: An international team of researchers and clinicians (known as INCOG) met to update the INCOG guidelines for assessment and management of PTA. Previous recommendations and audit criteria were updated on the basis of review of the literature from 2014. RESULTS: Six management recommendations were made: 1 based on level A evidence, 2 on level B, and 3 on level C evidence. Since the first version of INCOG (2014), 3 recommendations were added: the remainder were modified. INCOG 2022 recommends that individuals should be assessed daily for PTA, using a validated tool (Westmead PTA Scale), until PTA resolution. To date, no cognitive or pharmacological treatments are known to reduce PTA duration. Agitation and confusion may be minimized by a variety of environmental adaptations including maintaining a quiet, safe, and consistent environment. The use of neuroleptic medications and benzodiazepines for agitation should be minimized and their impact on agitation and cognition monitored using standardized tools. Physical therapy and standardized activities of daily living training using procedural and errorless learning principles can be effective, but delivery should be tailored to concurrent levels of cognition, agitation, and fatigue. CONCLUSIONS: Stronger recommendations regarding assessment of PTA duration and effectiveness of activities of daily living training have been made. Evidence regarding optimal pharmacological and nonpharmacological management of confusion and agitation during PTA remains limited, with further research needed. These guidelines aim to enhance evidence-based care and maximize consistency of PTA management.

Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The CAPITAL CHILL Randomized Clinical Trial.

Importance: Comatose survivors of out-of-hospital cardiac arrest experience high rates of death and severe neurologic injury. Current guidelines recommend targeted temperature management at 32 °C to 36 °C for 24 hours. However, small studies suggest a potential benefit of targeting lower body temperatures. Objective: To determine whether moderate hypothermia (31 °C), compared with mild hypothermia (34 °C), improves clinical outcomes in comatose survivors of out-of-hospital cardiac arrest. Design, Setting, and Participants: Single-center, double-blind, randomized, clinical superiority trial carried out in a tertiary cardiac care center in eastern Ontario, Canada. A total of 389 patients with out-of-hospital cardiac arrest were enrolled between August 4, 2013, and March 20, 2020, with final follow-up on October 15, 2020. Interventions: Patients were randomly assigned to temperature management with a target body temperature of 31 °C (n = 193) or 34 °C (n = 196) for a period of 24 hours. Main Outcomes and Measures: The primary outcome was all-cause mortality or poor neurologic outcome at 180 days. Neurologic outcome was assessed using the Disability Rating Scale, with poor neurologic outcome defined as a score greater than 5 (range, 0-29, with 29 being the worst outcome [vegetative state]). There were 19 secondary outcomes, including mortality at 180 days and length of stay in the intensive care unit. Results: Among 367 patients included in the primary analysis (mean age, 61 years; 69 women [19%]), 366 (99.7%) completed the trial. The primary outcome occurred in 89 of 184 patients (48.4%) in the 31 °C group and in 83 of 183 patients (45.4%) in the 34 °C group (risk difference, 3.0% [95% CI, 7.2%-13.2%]; relative risk, 1.07 [95% CI, 0.86-1.33]; P = .56). Of the 19 secondary outcomes, 18 were not statistically significant. Mortality at 180 days was 43.5% and 41.0% in patients treated with a target temperature of 31 °C and 34 °C, respectively (P = .63). The median length of stay in the intensive care unit was longer in the 31 °C group (10 vs 7 days; P = .004). Among adverse events in the 31 °C group vs the 34 °C group, deep vein thrombosis occurred in 11.4% vs 10.9% and thrombus in the inferior vena cava occurred in 3.8% and 7.7%, respectively. Conclusions and Relevance: In comatose survivors of out-of-hospital cardiac arrest, a target temperature of 31 °C did not significantly reduce the rate of death or poor neurologic outcome at 180 days compared with a target temperature of 34 °C. However, the study may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT02011568.

The Validity of Three New Driving Simulator Scenarios: Detecting Differences in Driving Performance by Difficulty and Driver Gender and Age.

OBJECTIVE: We explored the convergent and discriminant validity of three driving simulation scenarios by comparing behaviors across gender and age groups, considering what we know about on-road driving. BACKGROUND: Driving simulators offer a number of benefits, yet their use in real-world driver assessment is rare. More evidence is needed to support their use. METHOD: A total of 104 participants completed a series of increasingly difficult driving simulation scenarios. Linear mixed models were estimated to determine if behaviors changed with increasing difficulty and whether outcomes varied by age and gender, thereby demonstrating convergent and discriminant validity, respectively. RESULTS: Drivers adapted velocity, steering, acceleration, and gap acceptance according to difficulty, and the degree of adaptation differed by gender and age for some outcomes. For example, in a construction zone scenario, drivers reduced their mean velocities as congestion increased; males drove an average of 2.30 km/hr faster than females, and older participants drove more slowly than young (5.26 km/hr) and middle-aged drivers (6.59 km/hr). There was also an interaction between age and difficulty; older drivers did not reduce their velocities with increased difficulty. CONCLUSION: This study provides further support for the ability of driving simulators to elicit behaviors similar to those seen in on-road driving and to differentiate between groups, suggesting that simulators could serve a supportive role in fitness-to-drive evaluations. APPLICATION: Simulators have the potential to support driver assessment. However, this depends on the development of valid scenarios to benchmark safe driving behavior, and thereby identify deviations from safe driving behavior. The information gained through simulation may supplement other forms of assessment and possibly eliminate the need for on-road testing in some situations.

Biomechanical Comparison of Real World Concussive Impacts in Children, Adolescents, and Adults.

Accidental falls occur to people of all ages, with some resulting in concussive injury. At present, it is unknown whether children and adolescents are at a comparable risk of sustaining a concussion compared to adults. This study reconstructed the impact kinematics of concussive falls for children, adolescents, and adults and simulated the associated brain tissue deformations. Patients included in this study were diagnosed with a concussion as defined by the Zurich Consensus guidelines. Eleven child, 10 adolescent, and 11 adult falls were simulated using mathematical dynamic models(MADYMO), with three ellipsoid pedestrian models sized to each age group. Laboratory impact reconstruction was conducted using Hybrid III head forms, with finite element model simulations of the brain tissue response using recorded impact kinematics from the reconstructions. The results of the child group showed lower responses than the adolescent group for impact variables of impact velocity, peak linear acceleration, and peak rotational acceleration but no statistical differences existed for any other groups. Finite element model simulations showed the child group to have lower strain values than both the adolescent and adult groups. There were no statistical differences between the adolescent and adult groups for any variables examined in this study. With the cases included in this study, young children sustained concussive injuries at lower modeled brain strains than adolescents and adults, supporting the theory that children may be more susceptible to concussive impacts than adolescents or adults.

The concussion recovery questionnaire (CORE-Q): conceptual model development and item generation of a concussion-specific measure of functional status.

Introduction: Defining and measuring limitations in functional status post-concussion has been challenging, as generic measures do not accurately reflect issues most relevant to adults with persistent post-concussion symptoms.Purpose: To develop a new concussion-specific measure of functional status for use in clinical practice and intervention trials.Method: We developed a conceptual model of functioning based on concepts identified from a previous qualitative study with persons with concussion and clinicians. An initial set of questionnaire items was generated from the concepts, codes, and conceptual model. Items were refined using cognitive interviews elicit feedback on their relevance and acceptability.Results: We developed an initial set of 145 items categorized by concepts that were reduced to 50. Our final item set resulted in the COncussion REcovery Questionnaire, which contains a total of 53 items split into 3 separate scales: the Post-Concussion Functional Scale, Concussion Modifiers Scale, and Global Functional Recovery Scale.Conclusion: The new Concussion Recovery Questionnaire is a self-reported measure of functional status for monitoring outcomes in clinical practice and in clinical intervention trials following concussion. Further studies are necessary to provide evidence of the measure's psychometric properties and to determine the questionnaire's ability to facilitate clinical decision-making.

Risk of Motor Vehicle Collision or Driving Impairment After Traumatic Brain Injury: A Collaborative International Systematic Review and Meta-Analysis.

OBJECTIVE: To synthesize knowledge of the risk of motor vehicle collision (MVC) following a traumatic brain injury (TBI) and the associated risk of driving impairment, as measured by on-road tests, computerized simulators, and self-reported or state-recorded driving records. METHODS: Our international team searched 7 databases for studies published between 1990 and 2015 of people with TBI, controls, and data concerning either MVC or driving impairment. The included articles examined the risk of MVC among people with TBI; we excluded studies that examined the risk of having a TBI associated with being involved in an MVC. RESULTS: From 13 578 search results, we included 8 studies involving 1663 participants with TBI and 4796 controls. We found no significant difference in the risk of MVC (odds ratio = 1.24, 95% confidence interval = 0.80-1.91, P = .34). When we restricted the analysis to self-report, the risk of MVC was higher for those without a TBI (odds ratio = 1.63, 95% confidence interval = 1.21-2.22, P = .002). In contrast, participants with TBI consistently performed worse during on-road assessments and had more problems with vehicular control. CONCLUSION: Limitations of reviewed studies included small sample sizes, failure to specify TBI severity or time postinjury, and absence of objective measures of risk. Findings concerning the relationship between TBIs from non-MVC causes and crash risk are, therefore, inconclusive and do not provide evidence for major changes to existing clinical guidelines for driving with TBI.

Using Naturalistic Methods to Examine Real-World Driving Behavior in Individuals With TBI Upon Return to Driving: A Pilot Study.

OBJECTIVES: To characterize the real-world driving habits of individuals with traumatic brain injury (TBI) using naturalistic methods and to demonstrate the feasibility of such methods in exploring return to driving after TBI. METHODS: After passing an on-road driving assessment, 8 participants with TBI and 23 matched controls had an in-vehicle device installed to record information regarding their driving patterns (distance, duration, and start/end times) for 90 days. RESULTS: The overall number of trips, distance and duration or percentage of trips during peak hour, above 15 km from home or on freeways/highways did not differ between groups. However, the TBI group drove significantly less at night, and more during the daytime, than controls. Exploratory analyses using geographic information system (GIS) also demonstrated significant within-group heterogeneity for the TBI group in terms of location of travel. CONCLUSIONS: The TBI and control groups were largely comparable in terms of driving exposure, except for when they drove, which may indicate small group differences in driving self-regulatory practices. However, the GIS evidence suggests driving patterns within the TBI group were heterogeneous. These findings provide evidence for the feasibility of employing noninvasive in-car recording devices to explore real-world driving behavior post-TBI.

Self-regulation upon return to driving after traumatic brain injury.

The aim of this study was to explore self-reported driving habits and the factors associated with these within the first three months of return to driving following traumatic brain injury (TBI). Participants included 24 individuals with moderate to severe TBI (post-traumatic amnesia duration M = 33.26, SD = 29.69 days) and 28 healthy age, education, and gender-matched controls who completed an on-road assessment. Driving frequency and avoidance questionnaires were administered to assess premorbid driving, anticipated driving upon resuming, and driving at three months post-assessment. There were no differences between groups for premorbid driving frequency or avoidance. Individuals with TBI anticipated greater reductions in driving frequency, t(29.57) = -3.95, p < .001, and increases in avoidance, U = 171.00, z = -2.69, p < .01. On follow up, significant reductions in frequency, t(48) = -3.03, p < .01, but not avoidance, U = 239.00, z = -1.35, p = .18, were observed. Females were more likely to reduce their driving frequency, rs = -.43, p < .05, while increased anxiety was associated with increased avoidance r = .63, p < .05, and reduced frequency r = -.43, p < .05. It was concluded that individuals with TBI anticipated changes in their driving habits upon return to driving, indicating an expectation for post-injury changes to their driving lifestyle. On follow up, many of these intended changes to driving habits, particularly in relation to driving frequency, were reported by individuals with TBI, suggestive of some strategic self-regulation.

Identifying the concepts contained within health-related quality of life outcome measures in concussion research using the International Classification of Functioning, Disability, and Health as a reference: a systematic review.

PURPOSE: To identify the concepts contained within health-related quality of life (HRQOL) outcome measures used in concussion-specific research using the International Classification of Functioning, Disability, and Health (ICF) as a reference. METHODS: Eight electronic databases were searched from January 1, 1992 to March 12, 2017. Gray literature was searched, reference lists scanned, and relevant journals hand-searched. Agreement for inclusion was reached by consensus by two reviewers. A standardized data extraction tool was used to document study design, population, and key findings. Questionnaire items were linked as concepts to the corresponding second-level category of the ICF. Quality of studies was not assessed, as review was exploratory. RESULTS: Five outcome measures met the inclusion criteria, including the Perceived Quality of Life Scale, EuroQoL-5 dimensions, Quality of Life after Brain Injury, WHOQOL-100, and WHOQOL-BREF. A total of 373 concepts were extracted. 34 questions were linked to activities and participation (50.7%), 16 questions (23.9%) referred to body functions, and 17 questions (25.4%) were related to the environment. CONCLUSIONS: The wide range of concepts covered by different outcome measures demonstrates the complexity of recovery post-concussion and a lack of universal agreement in terms of what should be measured in this population. A working conceptual model of HRQOL post-concussion is proposed. Registration Prospero #CRD42017068241 (June 15, 2017).

Why Do We Need a New Clinical Practice Guideline for Moderate to Severe Traumatic Brain Injury?

OBJECTIVE: Clinical practice guidelines (CPGs) aim to improve quality and consistency of healthcare services. A Canadian group of researchers, clinicians, and policy makers developed/adapted a CPG for rehabilitation post-moderate to severe traumatic brain injury (MSTBI) to respond to end users' needs in acute care and rehabilitation settings. METHODS: The rigorous CPG development process began assessing needs and expectations of end users, then appraised existing CPGs, and, during a consensus conference, produced fundamental and priority recommendations. We also surveyed end users' perceptions of implementation gaps to determine future implementation strategies to optimize adherence to the CPG. RESULTS: The unique bilingual (French and English) CPG consists of 266 recommendations (of which 126 are new recommendations), addressing top priorities for MSTBI, rationale, process indicators, and implementations tools (eg, algorithms and benchmarks). CONCLUSION: The novel approach of consulting and working with end users to develop a CPG for MSTBI should influence knowledge uptake for clinicians wanting to provide evidence-based care.

Assessment of Users' Needs and Expectations Toward Clinical Practice Guidelines to Support the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: Stakeholder engagement in clinical practice guideline (CPG) creation is thought to increase relevance of CPGs and facilitate their implementation. The objectives were to survey stakeholders involved in the care of adults with traumatic brain injury (TBI) regarding general perceptions of CPGs, key elements to be included, and needs and expectations about format and implementation strategy. SETTINGS: Hospitals and inpatient and outpatient rehabilitation facilities providing services to persons with TBI. PARTICIPANTS: Stakeholders identified as primary end users of the CPG: clinicians, hospital leaders, health system managers, and funders in Quebec and Ontario (Canada). DESIGN: Cross-sectional online survey conducted between May and September 2014. RESULTS: In total, 332 individuals expressed their needs and expectations. Despite positive perceptions of CPGs, only a small proportion of respondents used them. Intensity and frequency of interventions, behaviors disorders and cognitive function impairment, and social participation and community life were important subjects to cover in the CPG. Finally, respondents asked for specific recommendations including a ranking of recommendations based on level of underlying evidence. CONCLUSION: Respondents have important expectations toward a CPG. We anticipate that early and meaningful engagement of end users could facilitate CPG implementation.

A Survey of Perceived Implementation Gaps for a Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: Appraising current practice is an important prerequisite for implementation of clinical practice guidelines (CPGs). The study objective was to determine the perceived level of implementation, priority, and feasibility of a subset of key CPG recommendations for the rehabilitation of individuals with moderate to severe traumatic brain injury (MSTBI). METHODS: Fifty-one teams at acute care and rehabilitation facilities were invited to complete an electronic survey addressing the perceived level of implementation, priority, and feasibility of 109 fundamental and priority recommendations from the CPG-MSTBI. RESULTS: Forty-four clinical teams responded across 2 Canadian provinces. Most of the recommendations were deemed as "fully" or "mostly" implemented, while relative gaps in implementation were perceived in recommendations regarding coordination with mental health and addiction providers (>75% of respondents indicated low levels of implementation), "Caregivers and Families" (26%), and "Psychosocial and Adaptation Issues" (25%). Priority levels and perceived feasibility were generally high (>60% and >86%, respectively) for recommendations with low levels of implementation. Priority recommendations for implementation were identified for both acute care and rehabilitation settings in Québec and Ontario. CONCLUSIONS: Assessment of clinician perception provides a helpful perspective for implementation. Exploring perceived implementation gaps based on users' needs and expectation should be a part of an implementation process.

Unique Features of the INESSS-ONF Rehabilitation Guidelines for Moderate to Severe Traumatic Brain Injury: Responding to Users' Needs.

OBJECTIVE: Traumatic brain injury (TBI) clinical practice guidelines are a potential solution to rapidly expanding literature. The project objective was to convene experts to develop a unique set of TBI rehabilitation recommendations incorporating users' priorities for format and implementation tools including indicators of adherence. METHODS: The Guidelines Adaptation & Development Cycle informed recommendation development. Published TBI recommendations were identified and tabulated. Experts convened to adapt or, where appropriate, develop new evidence-based recommendations. These draft recommendations were validated by systematically reviewing relevant literature. Surveys of experts and target users were triangulated with strength of evidence to identify priority topics. RESULTS: The final recommendation set included a rationale, implementation tools (algorithms/adherence indicators), key process indicators, and evidence summaries, and were divided in 2 sections: Section I: Components of the Optimal TBI Rehabilitation System (71 recommendations) and Section II: Assessment and Rehabilitation of Brain Injury Sequelae (195 recommendations). The recommendations address top priorities for the TBI rehabilitation system: (1) intensity/frequency of interventions; (2) rehabilitation models; (3) duration of interventions; and (4) continuity-of-care mechanisms. Key sequelae addressed (1) behavioral disorders; (2) cognitive dysfunction; (3) fatigue and sleep disturbances; and (4) mental health. CONCLUSION: This TBI rehabilitation guideline used a robust development process to address users' priorities.

Common Data Elements for Concussion in Tertiary Care: Phase One in Ontario.

BACKGROUND: Standardized data collection for traumatic brain injury (TBI) (including concussion) using common data elements (CDEs) has strengthened clinical care and research capacity in the United States and Europe. Currently, Ontario healthcare providers do not collect uniform data on adult patients diagnosed with concussion. OBJECTIVE: The Ontario Concussion Care Strategy (OCCS) is a collaborative network of multidisciplinary healthcare providers, brain injury advocacy groups, patient representatives, and researchers with a shared vision to improve concussion care across the province, starting with the collection of standardized data. METHODS: The International Framework of Functioning Disability and Health was selected as the conceptual framework to inform the selection of CDEs. The CDEs recommended by the OCCS were identified using key literature, including the National Institute of Neurological Disorders and Stroke-Zurich Consensus Statements for concussion in sport and the Ontario Neurotrauma Foundation Concussion/mTBI clinical guidelines. RESULTS: The OCCS has recommended and piloted CDEs for Ontario that are readily available at no cost, clinically relevant, patient friendly, easy to interpret, and recognized by the international scientific community. CONCLUSIONS: The implementation of CDEs can help to shift Ontario toward internationally recognized standard data collection, and in so doing yield a more comprehensive evidence-based approach to care while also supporting rigorous research.

Self-Awareness and Self-Ratings of On-Road Driving Performance After Traumatic Brain Injury.

OBJECTIVE: To examine self-rated, clinician-rated, and self-awareness of on-road driving performance in individuals with traumatic brain injury (TBI) deemed fit and unfit to resume driving and healthy controls, and to explore their associations with demographic, injury, cognitive, and mood variables. METHODS: Participants included 37 individuals with moderate to severe TBI, and 49 healthy age, sex, and education-matched controls from Australia and Canada. Participants completed an on-road assessment, the Brain Injury Driving Self-Awareness Measure (BIDSAM), and a comprehensive neuropsychological assessment. RESULTS: Awareness scores on the BIDSAM were significantly different between groups, F(2, 83) = 28.44 (P < .001; η = 0.41), with post hoc tests indicating TBI participants who failed the on-road assessment had worse scores compared with those who passed and controls. Poor self-awareness was significantly correlated with reduced psychomotor speed (rs = -0.37; P < .01) and attentional switching (rs = 0.28; P < .01). Worse self-ratings of driving were associated with depression (rs = 0.42; P < .01) and anxiety (rs = 0.38; P < .01). CONCLUSIONS: Individuals with TBI who failed an on-road assessment significantly overestimated their driving ability. Impaired cognitive function was associated with reduced self-awareness of driving. These findings suggest impaired awareness of driving may need to be addressed as part of driver rehabilitation programs.

The development and initial validation of a new tool to measure self-awareness of driving ability after brain injury.

AIM: The aim of this study was to develop and provide initial validation data for a self-awareness of on-road driving ability measure for individuals with brain injury. METHOD: Thirty-nine individuals with Traumatic Brain Injury completed an on-road driving assessment, the Self-Regulation Skills Interview (SRSI) and the newly developed Brain Injury Driving Self-Awareness Measure (BIDSAM). RESULTS: BIDSAM self, clinician and discrepancy scales demonstrated high levels of internal consistency (α = 0.83-0.92). Criterion-related validity was established by demonstrating significantly higher correlations between clinician ratings and on-road performances, rs  = 0.82, P < 0.01, compared to self-ratings, rs  = 0.45, P < 0.05. Discrepancy scores were significantly correlated with the SRSI emergent, rs  = 0.52, P < 0.01, and anticipatory awareness scores, rs  = 0.37, P < 0.05, indicative of convergent validity. CONCLUSIONS: These results provide initial support for the BIDSAM as a reliable and valid measure of self-awareness of on-road driving ability following TBI.