A Systematic Review of Female Participation in Randomized Controlled Trials of Post-Stroke Upper Extremity Rehabilitation in Low- to Middle-Income Countries and High-Income Countries and Regions.

INTRODUCTION: Female participation is lower than males in both acute stroke and stroke rehabilitation trials. However, less is known about how female participation differs across countries and regions. This study aimed to assess the percentage of female participants in randomized controlled trials (RCTs) of post-stroke rehabilitation of upper extremity (UE) motor disorders in low-middle-income (LMICs) and high-income countries (HICs) as well as different high-income world regions. METHODS: CINAHL, Embase, PubMed, Scopus, and Web of Science were searched from 1960 to April 1, 2021. Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English; (2) ≥50% of participants were diagnosed with stroke; 3) included adults ≥18 years old; and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. Countries were divided into HICs and LMICs based on their growth national incomes. The HICs were further divided into the three high-income regions of North America, Europe, and Asia and Oceania. Data analysis was performed using SPSS and RStudio v.4.3.1. RESULTS: A total of 1,276 RCTs met inclusion criteria. Of them, 298 RCTs were in LMICs and 978 were in HICs. The percentage of female participants was significantly higher in HICs (39.5%) than LMICs (36.9%). Comparing high-income regions, there was a significant difference in the overall female percentages in favor of RCTs in Europe compared to LMICs but not North America or Asia and Oceania. There was no significant change in the percentage of female participants in all countries and regions over the last 2 decades, with no differences in trends between the groups. CONCLUSIONS: Sufficient female representation in clinical trials is required for the generalizability of results. Despite differences in overall percentage of female participation between countries and regions, females have been underrepresented in both HICs and LMICs with no considerable change over 2 decades.

CONNECTing Concussion Care with Research Across Ontario.

Common data elements (CDEs) for concussion, as established by international bodies, are not being widely used in Ontario, resulting in significant variability in the data being assessed and collected across clinics. CDEs support standardization of care as well as large-scale data sharing for high impact research. A collaborative network - Concussion Ontario Network: Neuroinformatics to Enhance Clinical care and Translation (CONNECT) - comprised of health care professionals, researchers, members from advocacy groups, and patients was formed to establish and implement CDEs for concussion care and research. While the seeds have been planted and initial effectiveness demonstrated, future challenges exist.

Female Enrollment in Rehabilitation Trials: A Systematic Review of Reporting Sex and Female Participation in Randomized Controlled Trials of Poststroke Upper Extremity Rehabilitation Over 50 Years.

OBJECTIVE: To systematically assess the reporting of sex and the percentage of female participants in randomized controlled trials (RCTs) examining interventions for the post-stroke rehabilitation of upper extremity (UE) motor disorders. DATA SOURCES: CINAHL, Embase, PubMed, Scopus and Web of Science were searched from 1960 to April 1, 2021. Additional articles were identified using the Evidence-Based Review of Stroke Rehabilitation. STUDY SELECTION: Studies were eligible for inclusion if they (1) were RCTs or crossovers published in English, (2) ≥50% of participants were diagnosed and affected by stroke, (3) included adults ≥18 years old, and (4) applied an intervention to the hemiparetic UE as the primary objective of the study. DATA EXTRACTION: Two investigators independently screened the title and abstracts, and duplicates were removed. A full-text review was done for studies that met all inclusion criteria. Data were extracted using a custom data extraction template in Covidence and were transferred to online Excel (V16) for data management. Study characteristics and extracted variables were summarized using standard descriptive statistics. Data analyses were performed using SPSS (V29.0). DATA SYNTHESIS: A total of 1276 RCTs met inclusion criteria, and of these, 5.2% did not report results on sex, accounting for 5.6% of participants. Women have been underrepresented in stroke RCTs, accounting for 38.8% of participants. Female participation was greater in the acute poststroke phase than in the chronic and subacute phases. Over almost 5 decades, there has been a small decrease in the proportion of female participants in these trials. CONCLUSIONS: Evidence-based medicine for the treatment and prevention of stroke is guided by results from RCTs. Generalizability depends on sufficient representation in clinical trials. Stakeholders, such as funders and journal editors, play a key role in encouraging researchers to enroll enough of both sexes and to report the presence or absence of sex differences in RCTs.

Measurement Properties of the Activities-Specific Balance Confidence Scale in Adults From the General Population With Concussion: A Report From the Toronto Concussion Study.

OBJECTIVE: The aim of this study was to establish the internal consistency and construct validity of the Activities-specific Balance Confidence (ABC) Scale and ABC-6 in adults from the general population with concussion. DESIGN: Prospective analysis. SETTING: Outpatient concussion care clinic. PARTICIPANTS: Adults from the general population with concussion referred to a concussion care clinic within 7 days of injury (N=511). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Balance confidence was assessed with the Activities-specific Balance Confidence (ABC) Scale and the ABC-6. Concussion symptoms were characterized using the Sport Concussion Assessment Tool version 5 (SCAT5) symptom checklist. Instrumented measures of balance and gait included center of pressure velocity and double support time, respectively. Balance was also assessed using the mBESS. RESULTS: The ABC and ABC-6 were strongly correlated (ρ=0.980, P<.001). Cronbach α for ABC and ABC-6 was 0.966 and 0.940, respectively. Factor analysis verified the existence of 2 components of the ABC, 1 including all items of the ABC-6 as well as 3 additional items. ABC and ABC-6 were moderately significantly correlated with SCAT5 symptom number, severity, and symptom domain (ρ=-0.350 to -0.604). However, correlations between ABC and ABC-6 with instrumented measures of balance and gait were not statistically significant, except for double support time during dual-task gait with ABC-6 (ρ=-0.218). CONCLUSIONS: In community-dwelling adults with concussion, the ABC and ABC-6 have good internal consistency. Convergent validity is stronger for symptom endorsement measures within SCAT5 domains, which has a similar construct (subjectivity) to balance confidence. Both the ABC and ABC-6 are valid measures of balance self-efficacy in adults from the general population with concussion. The ABC-6 may be a useful tool for characterizing the effect of concussion on perceptions of the ability to perform functional tasks that challenge balance and mobility.

Psychometric Properties of Vestibular and Ocular Measures Used for Concussion Assessments: A Scoping Review.

BACKGROUND: Concussions most commonly affect the vestibular and ocular systems. Clinical measures used in the assessment of vestibular and ocular deficits should contain strong psychometric properties so that clinicians can accurately detect abnormality to guide treatment interventions. OBJECTIVES: The aim of this scoping review was: (1) to identify the measures used to evaluate the vestibular and ocular domains postconcussion and (2) to document the psychometric properties of the measures. METHODS: Two databases (Medline (Ovid) and Embase) were searched from inception to May 2023. An updated search was completed in January 2024 using the same databases and search terms. Studies were screened and data were extracted independently by 2 reviewers. Measures were categorized into vestibular, ocular, or both (vestibular and ocular) domains, and relevant psychometric properties were documented. RESULTS: Fifty-two studies were included in this review. 28 studies explored the use of vestibular measures, 12 explored ocular measures, and 12 explored both vestibular and ocular measures or explored the use of vestibulo-ocular reflex measures. Most studies explored the properties associated with balance measures, particularly the balance error scoring system. Diagnostic accuracy (sensitivity and specificity metrics) of the associated measures was the most frequently documented characteristic in the literature. CONCLUSION: Identification of clinical measures used to evaluate vestibular and ocular deficits postconcussion is needed to understand the evidence supporting their use in practice. Documenting the psychometric properties will allow clinicians and researchers to understand the status of the current literature and support for the use of certain measures in practice in terms of their ability to appropriately detect deficits in people with concussion when deficits are truly present.

Updated Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury: Behavioral Recommendations.

OBJECTIVE: Behavioral changes following moderate to severe traumatic brain injury (MSTBI) are common and can include agitation or aggression, reduced arousal or apathy, and inappropriate sexual behavior. These changes can negatively affect recovery, function, and quality of life. Pharmacological and nonpharmacological interventions are often used to address these challenges; however, there is limited evidence regarding the effectiveness of these treatments. This article will summarize the updated recommendations for the assessment and management of behavioral changes in adults after MSTBI. DESIGN: A systematic search was conducted by the evidence-based review of moderate to severe acquired brain injury to identify new and relevant articles. Expert panels reviewed and discussed the new and existing evidence, evaluated its quality, and added, removed, or modified recommendations and tools as needed. A consensus process was followed to achieve agreement on recommendations. RESULTS: The 2023 Canadian Clinical Practice Guideline for the Rehabilitation of Adults with Moderate to Severe Traumatic Brain Injury (CAN-TBI 2023) includes 21 recommendations regarding best practices for the assessment and management of behavioral disorders post-MSTBI. Fifteen recommendations remained unchanged, and 6 recommendations were updated. Eight recommendations are based on level B evidence and 13 on level C evidence. There are no recommendations based on level A evidence. The guideline also includes a step-by-step algorithm for clinicians to follow outlining an approach to the assessment and management of agitation and aggression. CONCLUSION: CAN-TBI 2023 will assist clinicians in the assessment and safe and effective management of behavioral changes post-MSTBI. The guideline is informed by a growing scientific database although there is a need for additional high-quality research to better guide the assessment and management of this complex patient population.

Updated Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate to Severe Traumatic Brain Injury: Mental Health Recommendations.

OBJECTIVE: Objective: After sustaining a moderate to severe traumatic brain injury (MSTBI), individuals often experience comorbid mental health conditions that can impair the rehabilitation and recovery process. The objective of this initiative was to update recommendations on the assessment and management of mental health conditions for the Canadian Clinical Practice Guideline for the Rehabilitation of Adults with MSTBI (CAN-TBI 2023). OBJECTIVE: Design: A systematic search was conducted by the Evidence-Based Review of Moderate to Severe Acquired Brain Injury to identify new and relevant articles. Expert Panel reviewed and discussed the new and existing evidence, evaluated its quality, and added, removed, or modified recommendations and tools as needed. A consensus process was followed to achieve agreement on recommendations. OBJECTIVE: Results: CAN-TBI 2023 includes 20 recommendations regarding best practices for the assessment and management of mental health conditions post-MSTBI. About 17 recommendations were updated, 1 new recommendation was formed, and 2 recommendations remained unchanged. The Guideline emphasizes the importance of screening and assessment of mental health conditions throughout the rehabilitation continuum. The Expert Panel recommended incorporating multimodal treatments that include pharmacological and nonpharmacological approaches to manage mental health concerns. OBJECTIVE: Conclusion: The CAN-TBI 2023 recommendations for the assessment and management of mental health conditions should be used to inform clinical practice. Additional high-quality research in this area is needed, as 13 recommendations are based on level C evidence, 4 on level B evidence, and 3 on level A evidence.

Experiences and Challenges Updating a Living Evidence-Based Review of Randomized Controlled Trials on Mental Health and Behavioral Disorders in Individuals With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To describe experiences and challenges when updating a living evidence-based review database of randomized controlled trials (RCTs) on mental health and behavioral disorders in moderate to severe traumatic brain injury (MSTBI). METHOD: This commentary derives from our experience developing an extensive database of RCTs on MSTBI that has been conceptualized as a living evidence-based review. Our working group focused on mental health and behavior RCTs and reflected upon their experiences and challenges using the living systematic approach. We discuss challenges associated with metrics of study quality, injury etiology and severity, time post-injury, country of origin, and variability in outcome measures. RESULTS: RCTs were conducted almost solely in high income countries, with smaller sample sizes, and most conducted in the chronic phase post-TBI. Issues related to lack of transparency, unclear and incomplete reporting of injury severity, etiology, and time post-injury remain a concern and can lead to challenges associated with interpretation of results, validity, and reliability of the data. There was significant heterogeneity regarding the use of outcome measures and constructs, underscoring the need for standardization. CONCLUSION: Lack of standardization and incomplete reporting of injury characteristics makes it difficult to compare data between RCTs of MSTBI, perform meta-analyses, and generate evidence-based clinical recommendations.

Lessons Learned From Moving to Living Guidelines-The Canadian Clinical Practice Guideline for the Rehabilitation of Adults With Moderate-to-Severe TBI.

OBJECTIVE: It is often challenging for providers to remain up to date with best practices gleaned from clinical research. Consequently, patients may receive inappropriate, suboptimal, and costly care. Living clinical practice guidelines (CPGs) maintain the methodological rigor of traditional CPGs but are continuously updated in response to new research findings, changes in clinical practice, and emerging evidence. The objective of this initiative was to discuss the lessons learned from the transformation of the Canadian Clinical Practice Guideline for the Rehabilitation of Adults with Traumatic Brain Injury (CAN-TBI) from a traditional guideline update model to a living guideline model. DESIGN: The CAN-TBI Guideline provides evidence-based rehabilitative care recommendations for individuals who have sustained a TBI. The Guideline is divided into 2 sections: Section I, which provides guidance on the components of the optimal TBI rehabilitation system, and Section II, which focuses on the assessment and rehabilitation of brain injury sequelae. A comprehensive outline of the living guideline process is presented. RESULTS: The CAN-TBI living guideline process has yielded 351 recommendations organized within 21 domains. Currently, 30 recommendations are supported by level A evidence, 81 recommendations are supported by level B evidence, and 240 consensus-based recommendations (level C evidence) comprise 68% of the CAN-TBI Guideline. CONCLUSION: Given the increasing volume of research published on moderate-to-severe TBI rehabilitation, the CAN-TBI living guideline process allows for real-time integration of emerging evidence in response to the fastest-growing topics, ensuring that practitioners have access to the most current and relevant recommendations.

Evidence-Based Review of Randomized Controlled Trials of Interventions for Mental Health Management Post-Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To present an evidence-based review of randomized controlled trials (RCTs) evaluating interventions for mental health post-moderate to severe traumatic brain injury (post-MSTBI), as part of an extensive database that has been conceptualized as a living systematic review. METHODS: Systematic searches were conducted for RCTs published in the English language in MEDLINE, PubMed, Scopus, CINAHL, EMBASE, and PsycINFO, up to and including December 2022, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The methodological quality of RCTs was assessed using the Physiotherapy Evidence Database scale, and the level of evidence was assigned using a modified Sackett scale. RESULTS: Eighty-seven RCTs examining mental health interventions and outcome measures post-MSTBI were included. These studies collectively enrolled 6471 participants. A total of 41 RCTs (47.1%) were conducted in the United States and 56 studies (64.4%) were published after 2010. A total of 62 RCTs (71.3%) examined nonpharmacological interventions and 25 RCTs (28.7%) examined pharmacological interventions. Effective pharmacological treatments included desipramine and cerebrolysin; methylphenidate and rivastigmine showed conflicting evidence. Cognitive behavioral therapy (CBT) was found to be effective for hopelessness, stress, and anxiety, compared to usual care; however, it may be as effective as supportive psychotherapy for depression. CBT combined with motivational interviewing may be as effective as CBT combined with nondirective counseling for depression, stress, and anxiety. Acceptance and commitment therapy was effective for anxiety, stress, and depression. Tai Chi, dance, and walking appeared to be effective for depression and stress, while other nonpharmacological treatments such as peer mentoring showed limited effectiveness. CONCLUSION: This evidence-based review provides a comprehensive overview of the research landscape of RCTs addressing mental health post-MSTBI. The findings from these RCTs may be valuable for health care professionals, researchers, and policymakers involved in the field of mental health and neurorehabilitation.

INTIMASY-TBI Guideline: Optimization of INTIMAcy, SexualitY, and Relationships Among Adults With Traumatic Brain Injury.

INTRODUCTION: Traumatic brain injury (TBI) can negatively impact intimacy, relationships, and sexual functioning through changes in physical, endocrine, cognitive, behavioral, and emotional function. Without intervention, diminished intimacy and/or sexual functioning in individuals with TBI may persist. Although most health care professionals agree that sexuality and intimacy in relationships are significant concerns and should be addressed in rehabilitation, these concerns are not typically discussed during rehabilitation and discharge planning for people with TBI. To address this gap, an expert panel of North American clinicians and researchers convened to develop evidence-informed recommendations to assist clinicians in providing a framework and guidance on how clinicians can support individuals after TBI. METHODS: A systematic search of multiple databases was conducted to identify relevant evidence published from 2010 to 2023. The INTIMASY-TBI Expert Panel developed recommendations for optimizing discussions and interventions related to intimacy and sexuality for people with TBI in rehabilitation and community-based programs. For each recommendation, the experts evaluated the evidence by examining the study design and quality to determine the level of evidence. RESULTS: A total of 12 recommendations were developed that address the following topic areas: (1) interprofessional team training, (2) early education on the effects of TBI on intimacy, relationships, and sexuality, (3) creating individualized interventions, (4) education, assessment, and management of the causes of sexual dysfunction, and (5) providing written materials and relationship coaching to persons with TBI and their partners. Two recommendations were supported by Level A evidence, 1 was supported by Level B evidence, and 9 were supported by Level C (consensus of the INTIMASY-TBI Expert Panel) evidence. A decision algorithm was developed to assist clinicians in navigating through the recommendations. CONCLUSION: The INTIMASY-TBI Guideline is one of the first comprehensive clinical practice guidelines to offer strategies to trained clinicians to discuss the physical, psychosocial, behavioral, and emotional aspects of intimacy and sexuality with persons with TBI.

Evidence-Based Review of Randomized Controlled Trials of Interventions for the Management of Behavioral Issues in Individuals With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To present an evidence-based review of randomized controlled trials (RCTs) evaluating interventions for the management of behavioral issues post moderate to severe traumatic brain injury (MSTBI), as part of an extensive database that has been conceptualized as a living systematic review. METHODS: Systematic searches were conducted in MEDLINE, PubMed, Scopus, CINAHL, EMBASE and PsycINFO, up to and including December 2022, for articles published in the English language, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The quality of RCT was assessed using the Physiotherapy Evidence Database (PEDro) scale, and level of evidence was assigned using a modified Sackett scale. RESULTS: Forty-six RCTs examining interventions and outcome measures related to behavioral issues post-MSTBI were included. These studies collectively enrolled 3,267 participants. The majority of RCTs were conducted in the United States (n = 27; 58.7%) and 28 (60.9%) were conducted after 2010. Of these, 27 RCTs examined non-pharmacological interventions and 19 examined pharmacological interventions. Effective pharmacological treatments included amantadine and dexmedetomidine. Effective non-pharmacological interventions included sensory stimulation in the acute phase, anger self-management programs, peer mentoring, problem-solving, and emotional regulation. Psychotherapy showed conflicting evidence. CONCLUSION: This evidence-based review provides a comprehensive overview of the research landscape of RCTs addressing behavior post-MSTBI. The findings from these RCTs may be valuable for health care professionals, researchers, and policymakers involved in the field of TBI and behavior.

Efficacy of restitutive interventions for oculomotor deficits in adults with mild traumatic brain injury: a systematic review and meta-analysis.

BACKGROUND: Mild traumatic brain injury (mTBI) can cause persistent symptoms suggestive of oculomotor deficits. This research synthesized evidence on restitutive interventions for reducing oculomotor deficits in adults with mTBI to understand if these interventions have clinical utility for improving recovery. METHODS: Medline, EMBASE, CINHAL, PsychInfo, and Scopus, databases were searched for experimental studies published in English. We rated risk of bias (RoB) using recommended tools, and the certainty of the evidence according to GRADE guidelines. We conducted meta-analyses for similar outcomes reported in at least two studies. RESULTS: Out of 5,328 citations, 12 studies (seven case series and five crossover design), with a combined sample size of 354 participants; (43% males) met the inclusion criteria and were analyzed. The analysis revealed a trend toward improvement of oculomotor deficits and visual tasks in response to restitutive intervention. None of the studies addressed sex or gender effects. All studies had high RoB, suggesting low certainty in the reported results. DISCUSSION: Restitutive interventions may be beneficial for adults with oculomotor deficits after mTBI, however overall certainty of the evidence remains low. Future efforts must include enhancing attention to study methodology and reporting, sex and gender analyses, and reaching a consensus on outcome measures. PROSPERO REGISTRATION NUMBER: CRD42022352276.

Graded exposure therapy for adults with persistent symptoms after mTBI: A historical comparison study.

Fear avoidance behaviour is associated with slow recovery from mild traumatic brain injury (mTBI). This study is a preliminary evaluation of graded exposure therapy (GET), which directly targets fear avoidance behaviour, for reducing post-concussion symptoms (PCS) and disability following mTBI. In a historical comparison design, we compared two groups from independent randomized trials. The GET + UC group (N = 34) received GET (delivered over 16 videoconference sessions) in addition to usual care (UC). The historical comparison group (N = 71) received UC only. PCS severity (Rivermead Post Concussion Symptoms Questionnaire; RPQ) and disability (World Health Organization Disability Assessment Schedule; WHODAS 2.0 12-item) were measured at clinic intake (M = 2.7, SD = 1.1 months after injury) and again at M = 4.9 (SD = 1.1) months after injury. Between-group differences were estimated using linear mixed effects regression, with a sensitivity analysis controlling for injury-to-assessment intervals. The estimated average change on the RPQ was -14.3 in the GET + UC group and -5.3 in the UC group. The estimated average change on the WHODAS was -5.3 in the GET + UC group and -3.2 in the UC group. Between-group differences post-treatment were -5.3 on the RPQ and -1.5 on the WHODAS. Treatment effects were larger in sensitivity analyses. Findings suggest that a randomized controlled trial is warranted.

Do air-breathing fish suffer branchial oxygen loss in hypoxic water?

In hypoxia, air-breathing fish obtain O2 from the air but continue to excrete CO2 into the water. Consequently, it is believed that some O2 obtained by air-breathing is lost at the gills in hypoxic water. Pangasionodon hypophthalmus is an air-breathing catfish with very large gills from the Mekong River basin where it is cultured in hypoxic ponds. To understand how P. hypophthalmus can maintain high growth in hypoxia with the presumed O2 loss, we quantified respiratory gas exchange in air and water. In severe hypoxia (PO2: ≈ 1.5 mmHg), it lost a mere 4.9% of its aerial O2 uptake, while maintaining aquatic CO2 excretion at 91% of the total. Further, even small elevations in water PO2 rapidly reduced this minor loss. Charting the cardiovascular bauplan across the branchial basket showed four ventral aortas leaving the bulbus arteriosus, with the first and second gill arches draining into the dorsal aorta while the third and fourth gill arches drain into the coeliacomesenteric artery supplying the gut and the highly trabeculated respiratory swim-bladder. Substantial flow changes across these two arterial systems from normoxic to hypoxic water were not found. We conclude that the proposed branchial oxygen loss in air-breathing fish is likely only a minor inefficiency.

Current Use and Future Considerations for Concussion Telemedicine Healthcare in Canada.

OBJECTIVE: To examine the use of telemedicine among Canadian concussion providers and clinics before and after the COVID-19 pandemic onset and identify barriers and facilitators for future use. METHODS: Ninety-nine concussion clinics and healthcare providers across Canada that offered one or more clinical concussion-related service were identified using standardized online searches and approached to complete a cross-sectional online survey. RESULTS: Thirty clinics or providers completed the survey and two completed subsections of the survey (response rate of 32.3%). Only 28.1% of respondents indicated that they used telemedicine to provide care prior to the COVID-19 pandemic. Providers most commonly using telemedicine prior to the pandemic were occupational therapists and physicians, while the most commonly used services were in-person videoconferencing and eConsultation. Most respondents (87%) indicated their clinic's use of telemedicine changed following the onset of the COVID-19 pandemic including new use of in-person video-conferencing, telephone calls, and eConsultation. Ninety-three percent indicated that they would consider using telemedicine to provide care to their concussion patients once the pandemic was over. Barriers needed to be overcome to facilitate use or greater use of telemedicine-based services were the inability to conduct a complete physical examination, lack of appropriate reimbursement, lack of start-up, and maintenance funding and medico-legal risk. CONCLUSION: Telemedicine was used by a minority of Canadian concussion clinics and providers prior to the COVID-19 pandemic but was rapidly adopted by many facilities. This study provides important insight into the factors that must be considered to optimize use of telemedicine in concussion care in the future.

The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild Traumatic Brain Injury.

OBJECTIVE: To develop new diagnostic criteria for mild traumatic brain injury (TBI) that are appropriate for use across the lifespan and in sports, civilian trauma, and military settings. DESIGN: Rapid evidence reviews on 12 clinical questions and Delphi method for expert consensus. PARTICIPANTS: The Mild Traumatic Brain Injury Task Force of the American Congress of Rehabilitation Medicine Brain Injury Special Interest Group convened a Working Group of 17 members and an external interdisciplinary expert panel of 32 clinician-scientists. Public stakeholder feedback was analyzed from 68 individuals and 23 organizations. RESULTS: The first 2 Delphi votes asked the expert panel to rate their agreement with both the diagnostic criteria for mild TBI and the supporting evidence statements. In the first round, 10 of 12 evidence statements reached consensus agreement. Revised evidence statements underwent a second round of expert panel voting, where consensus was achieved for all. For the diagnostic criteria, the final agreement rate, after the third vote, was 90.7%. Public stakeholder feedback was incorporated into the diagnostic criteria revision prior to the third expert panel vote. A terminology question was added to the third round of Delphi voting, where 30 of 32 (93.8%) expert panel members agreed that 'the diagnostic label 'concussion' may be used interchangeably with 'mild TBI' when neuroimaging is normal or not clinically indicated.' CONCLUSIONS: New diagnostic criteria for mild TBI were developed through an evidence review and expert consensus process. Having unified diagnostic criteria for mild TBI can improve the quality and consistency of mild TBI research and clinical care.

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 IV: Cognitive-Communication and Social Cognition Disorders.

INTRODUCTION: Moderate to severe traumatic brain injury causes significant cognitive impairments, including impairments in social cognition, the ability to recognize others' emotions, and infer others' thoughts. These cognitive impairments can have profound negative effects on communication functions, resulting in a cognitive-communication disorder. Cognitive-communication disorders can significantly limit a person's ability to socialize, work, and study, and thus are critical targets for intervention. This article presents the updated INCOG 2.0 recommendations for management of cognitive-communication disorders. As social cognition is central to cognitive-communication disorders, this update includes interventions for social cognition. METHODS: An expert panel of clinicians/researchers reviewed evidence published since 2014 and developed updated recommendations for interventions for cognitive-communication and social cognition disorders, a decision-making algorithm tool, and an audit tool for review of clinical practice. RESULTS: Since INCOG 2014, there has been significant growth in cognitive-communication interventions and emergence of social cognition rehabilitation research. INCOG 2.0 has 9 recommendations, including 5 updated INCOG 2014 recommendations, and 4 new recommendations addressing cultural competence training, group interventions, telerehabilitation, and management of social cognition disorders. Cognitive-communication disorders should be individualized, goal- and outcome-oriented, and appropriate to the context in which the person lives and incorporate social communication and communication partner training. Group therapy and telerehabilitation are recommended to improve social communication. Augmentative and alternative communication (AAC) should be offered to the person with severe communication disability and their communication partners should also be trained to interact using AAC. Social cognition should be assessed and treated, with a focus on personally relevant contexts and outcomes. CONCLUSIONS: The INCOG 2.0 recommendations reflect new evidence for treatment of cognitive-communication disorders, particularly social interactions, communication partner training, group treatments to improve social communication, and telehealth delivery. Evidence is emerging for the rehabilitation of social cognition; however, the impact on participation outcomes needs further research.

INCOG 2.0 Guidelines for Cognitive Rehabilitation Following Traumatic Brain Injury, Part III: Executive Functions.

INTRODUCTION: Moderate-to-severe traumatic brain injury (MS-TBI) causes debilitating and enduring impairments of executive functioning and self-awareness, which clinicians often find challenging to address. Here, we provide an update to the INCOG 2014 guidelines for the clinical management of these impairments. METHODS: An expert panel of clinicians/researchers (known as INCOG) reviewed evidence published from 2014 and developed updated recommendations for the management of executive functioning and self-awareness post-MS-TBI, as well as a decision-making algorithm, and an audit tool for review of clinical practice. RESULTS: A total of 8 recommendations are provided regarding executive functioning and self-awareness. Since INCOG 2014, 4 new recommendations were made and 4 were modified and updated from previous recommendations. Six recommendations are based on level A evidence, and 2 are based on level C. Recommendations retained from the previous guidelines and updated, where new evidence was available, focus on enhancement of self-awareness (eg, feedback to increase self-monitoring; training with video-feedback), meta-cognitive strategy instruction (eg, goal management training), enhancement of reasoning skills, and group-based treatments. New recommendations addressing music therapy, virtual therapy, telerehabilitation-delivered metacognitive strategies, and caution regarding other group-based telerehabilitation (due to a lack of evidence) have been made. CONCLUSIONS: Effective management of impairments in executive functioning can increase the success and well-being of individuals with MS-TBI in their day-to-day lives. These guidelines provide management recommendations based on the latest evidence, with support for their implementation, and encourage researchers to explore and validate additional factors such as predictors of treatment response.