Pilot study evaluating treatment with sumatriptan for moderate to severe post-traumatic headache: A phase 2 open-label study.

OBJECTIVE: Our primary outcome was to determine the feasibility of patients with post-traumatic headache (PTH) keeping a daily headache diary and using sumatriptan as directed. Secondary outcomes include determining if sumatriptan is effective in aborting PTH and whether headache resolution is dependent on PTH phenotype. BACKGROUND: PTH is prevalent and persistent after traumatic brain injury, yet there have been few studies evaluating the effects of pharmacological treatments in individuals with PTH. METHODS: This is a single-arm, prospective, non-randomized phase 2 clinical trial registered at Clinicaltrials.gov (NCT01854385) and conducted from 2013 to 2017. Data analysis was completed in 2022. Of the 299 participants screened, 40 were enrolled in the study. Participants kept a headache diary documenting headache characteristics and severity. Headache characteristics were used to determine PTH phenotypes of migraine-like, probable migraine-like, or non-migraine-like. Participants reported whether sumatriptan was used for their headache, their response to the medication, if a second dose was taken, and their response to the second dose. RESULTS: A total of 15 participants out of the 40 enrolled (mean [SD] age, 41.9 [14.2] years, and 53% [21/40] male), met the criteria for the use of sumatriptan, and completed all assessments. Average headache diary compliance rate for the final month of the study was 80% (372/465). While sumatriptan was used for only 19% (122/654) of all reported headaches, 72% (88/122) of those headaches resolved within 2 h of taking the medication. Resolution of headaches with sumatriptan was not significantly different among headache phenotypes (migraine-like: 22/38 [58%], probable migraine-like: 24/29 [83%], non-migraine-like: 6/15 [40%]; p = 0.154). CONCLUSIONS: A daily headache diary is feasible for tracking headache symptoms. Preliminary results also suggest that sumatriptan, a migraine-specific medication, may be beneficial for the treatment of PTH of different clinical phenotypes. Future studies, such as a phase 3 clinical trial with a larger sample size, are needed to better understand the efficacy of sumatriptan in the treatment of PTH.

Cost-Effectiveness of Sleep Apnea Diagnosis and Treatment in Hospitalized Persons With Moderate to Severe Traumatic Brain Injury.

OBJECTIVE: To assess the cost-effectiveness of alternative approaches to diagnose and treat obstructive sleep apnea (OSA) in patients with traumatic brain injury (TBI) during inpatient rehabilitation. SETTING: Data collected during the Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome (C-SAS) clinical trial (NCT03033901) on an inpatient rehabilitation TBI cohort were used in this study. STUDY DESIGN: Decision tree analysis was used to determine the cost-effectiveness of approaches to diagnosing and treating sleep apnea. Costs were determined using 2021 Centers for Medicare and Medicaid Services reimbursement codes. Effectiveness was defined in terms of the appropriateness of treatment. Costs averted were extracted from the literature. A sensitivity analysis was performed to account for uncertainty. Analyses were performed for all severity levels of OSA and a subgroup of those with moderate to severe OSA. Six inpatient approaches using various phases of screening, testing, and treatment that conform to usual care or guideline-endorsed interventions were evaluated: (1) usual care; (2) portable diagnostic testing followed by laboratory-quality testing; (3) screening with the snoring, tiredness, observed apnea, high BP, BMI, age, neck circumference, and male gender (STOP-Bang) questionnaire; (4) Multivariable Apnea Prediction Index (MAPI) followed by portable diagnostic testing and laboratory-quality testing; (5) laboratory-quality testing for all; and (6) treatment for all patients. MAIN MEASURES: Cost, Effectiveness, and Incremental Cost-Effectiveness Ratio (ICER). RESULTS: Phased approaches utilizing screening and diagnostic tools were more effective in diagnosing and allocating treatment for OSA than all alternatives in patients with mild to severe and moderate to severe OSA. Usual care was more costly and less effective than all other approaches for mild to severe and moderate to severe OSA. CONCLUSIONS: Diagnosing and treating OSA in patients with TBI is a cost-effective strategy when compared with usual care.

Patient and Caregiver Satisfaction With the Brain Injury Rehabilitation: Improving the Transition Experience (BRITE) Intervention.

OBJECTIVE: To ascertain patient and caregiver satisfaction with an individualized case management intervention to improve transition from inpatient rehabilitation care to the community after traumatic brain injury (TBI). SETTING: Participants from 6 National Institute on Disability, Independent Living, and Rehabilitation Research-funded TBI Model Systems sites in the United States. PARTICIPANTS: Adult, English-speaking patients with TBI who had moderate-to-severe TBI and were discharged from a TBI Model Systems site and who were in the intervention arm of the Brain Injury Rehabilitation: Improving the Transition Experience pragmatic clinical trial, as well as their caregivers. DESIGN: A survey of participants in the intervention arm, which included an individualized case management program administered by a TBI Care Manager (TCM) who facilitated resource connection, education, and support. MAIN MEASURES: Satisfaction with intervention was measured through Likert-scaled and open-ended questions. The survey was administered verbally through telephone, audio-recorded, and transcribed. Descriptive statistics were calculated for categorical variables, and content analysis was conducted for open-ended responses. RESULTS: Patient and caregiver participants were satisfied with the intervention and highlighted the benefits of the interpersonal and practical support provided by the TCM. Participants identified the need for a more intensive intervention and clear expectations of the TCM role, as well as gaps in available medical and rehabilitation services in the community, as areas for improvement. CONCLUSION: Patients with TBI and their caregivers reported satisfaction with the individualized case management program in supporting their transition from inpatient rehabilitation to the community. Further research is needed to understand the impact on outcomes.

Stakeholder Engagement to Identify Implementation Strategies to Overcome Barriers to Delivering Chronic Pain Treatments: A NIDILRR and VA TBI Model Systems Collaborative Project.

OBJECTIVE: The purpose of this article is to illustrate the process of stakeholder-engaged intervention mapping approach to identify implementation strategies to overcome data-driven prioritized barriers to receiving chronic pain services for persons with traumatic brain injury (TBI). SETTING: Community. PARTICIPANTS: Healthcare providers (n = 63) with 2 or more years' experience treating persons with TBI, interviewed between October 2020 and November 2021 provided data for identification of barriers. TBI, chronic pain, and qualitative research subject matter experts (SMEs) participated in the mapping approach. DESIGN: Participatory-based research design, using descriptive and intervention mapping approaches. RESULTS: Four barriers to accessing chronic pain treatment by persons with TBI which emerged from provider interviews were prioritized for intervention mapping: cognitive deficits of patients (67%); patient comorbidities (63%); mental health and/or substance abuse issues (59%); and patient participation (62%). SMEs used prioritized barriers to develop 4 primary objectives and implementation strategies designed to: (1) engage consumers to validate and identify strategies; (2) tailor pain treatment and delivery to overcome barriers; (3) develop and disseminate guidelines and best practices when delivering care to persons with TBI to support spread; and (4) increase awareness, skills, and readiness of workforce to deliver pain treatment to persons with TBI. SMEs used an evidence-based approach to develop a mapping matrix of the prioritized barriers, implementation objectives, and aligned implementation strategies to impact change. CONCLUSION: Implementation science is needed to facilitate knowledge translation into practice for this complex population to overcome barriers to care. Implementation strategies to address barriers to accessing chronic pain care for individuals with TBI were chosen through a participatory approach to engaging SMEs to support these rehabilitation implementation efforts. Future work includes gathering input from individuals with TBI and chronic pain and to move the intervention (implementation) mapping matrix forward to inform future implementation research, policy, and practice.

Provider Perspectives of Facilitators and Barriers to Reaching and Utilizing Chronic Pain Healthcare for Persons With Traumatic Brain Injury: A Qualitative NIDILRR and VA TBI Model Systems Collaborative Project.

OBJECTIVE: To identify facilitators and barriers to reaching and utilizing chronic pain treatments for persons with traumatic brain injury (TBI) organized around an Access to Care framework, which includes dimensions of access to healthcare as a function of supply (ie, provider/system) and demand (ie, patient) factors for a specified patient population. SETTING: Community. PARTICIPANTS: Clinicians (n = 63) with experience treating persons with TBI were interviewed between October 2020 and November 2021. DESIGN: Descriptive, qualitative study. MAIN MEASURES: Semistructured open-ended interview of chronic pain management for persons with TBI. Informed by the Access to Care framework, responses were coded by and categorized within the core domains (reaching care, utilizing care) and relevant subdimensions from the supply (affordability of providing care, quality, coordination/continuity, adequacy) and demand (ability to pay, adherence, empowerment, caregiver support) perspective. RESULTS: Themes from provider interviews focused on healthcare reaching and healthcare utilization resulted in 19 facilitators and 9 barriers reaching saturation. The most themes fell under the utilization core domain, with themes identified that impact the technical and interpersonal quality of care and care coordination/continuity. Accessibility and availability of specialty care and use of interdisciplinary team that permitted matching patients to treatments were leading thematic facilitators. The leading thematic barrier identified primarily by medical providers was cognitive disability, which is likely directly linked with other leading barriers including high rates of noncompliance and poor follow-up in health care. Medical and behavioral health complexity was also a leading barrier to care and potentially interrelated to other themes identified. CONCLUSION: This is the first evidence-based study to inform policy and planning for this complex population to improve access to high-quality chronic pain treatment. Further research is needed to gain a better understanding of the perspectives of individuals with TBI/caregivers to inform interventions to improve access to chronic pain treatment for persons with TBI.

Provider Perceived Facilitators and Barriers to Identifying, Perceiving, and Seeking Healthcare for Chronic Pain After TBI: A Qualitative NIDILRR and VA TBI Model Systems Collaborative Project.

OBJECTIVE: Identify determinants to chronic pain healthcare for persons with traumatic brain injury (TBI) informed by an Access to Care Framework. Findings related to the Access Framework's core domains of identifying a need, perceptions of the need, and seeking healthcare are reported. SETTING: Community. PARTICIPANTS: Healthcare providers (n = 63) with 2 or more years of experience treating persons with TBI interviewed between October 2020 and November 2021. DESIGN: Descriptive, qualitative study. MAIN MEASURES: Semi-structured interviews with open-ended questions of chronic pain management for persons with TBI. Informed by the Access Framework, responses were coded by and categorized within the domains of identifying healthcare needs, perceptions of needs, and factors related to healthcare seeking from the supply and demand perspective. RESULTS: For the overall sample, 14 facilitators and 6 barriers were endorsed by more than 20% of the provider cohort. Top facilitators included on-site availability of needed resources and treatments (94%), adequate time and provider capability to ensure patient comprehension of diagnosis and treatment plans (83%), and establishing patient motivation and buy-in with the treatment plan (75%). Barriers most endorsed included policies impacting access (46%), wait times for services (41%), and patient uncertainty regarding telehealth commonly due to cognitive and physical challenges (37%). Unique determinants are reported across civilian versus Department of Veterans Affairs (VA) healthcare systems and different provider types. CONCLUSION: This is the first evidence-based study to inform policy and planning to improve access to high-quality chronic pain treatments for persons with TBI. Results will inform future interventions at the systems, patient, and policy levels of healthcare that can be tailored to healthcare settings (VA, Civilian) and types of providers (rehabilitation therapists, psychologists, and medical). Evidence-informed interventions may help minimize healthcare disparities experienced by persons with TBI and facilitate access to high-quality, evidence-informed chronic pain care.

Characterization and Treatment of Chronic Pain After Traumatic Brain Injury-Comparison of Characteristics Between Individuals With Current Pain, Past Pain, and No Pain: A NIDILRR and VA TBI Model Systems Collaborative Project.

OBJECTIVE: To estimate the prevalence of chronic pain after traumatic brain injury (TBI) and identify characteristics that differ from those without chronic pain. SETTING: Community. PARTICIPANTS: A total of 3804 TBI Model Systems (TBIMS) participants who completed the Pain Survey at TBIMS follow-up. DESIGN: A multisite, cross-sectional observational cohort study. MAIN OUTCOME MEASURES: Functional outcomes, pain experience, and treatment. RESULTS: 46% reported current chronic pain, 14% reported past (post-injury) chronic pain, and 40% reported no chronic pain. Bivariate differences in sociodemographic and injury characteristics between the 3 pain groups were generally small in effect size, reflecting little clinical difference. However, medium effect sizes were seen for all functional outcomes, such that individuals with current chronic pain had worse functional outcomes compared with individuals in the past pain or no pain groups. Treatment utilization rates were higher for individuals with current chronic pain compared with past pain, with medical treatments being most frequently utilized. Individuals with past pain perceived more improvement with treatment than did those with current chronic pain as represented by a large effect size. CONCLUSIONS: Chronic pain affects approximately 60% of those living with TBI. The implications of chronic pain for functional outcomes support inclusion of pain metrics in prognostic models and observational studies in this population. Future research is needed to proactively identify those at risk for the development of chronic pain and determine the efficacy and access to pain treatment.

Associations of Chronic Pain With Psychosocial Outcomes After Traumatic Brain Injury: A NIDILRR and VA TBI Model Systems Collaborative Project.

OBJECTIVE: To examine the differences in participation, life satisfaction, and psychosocial outcomes among individuals with traumatic brain injury (TBI) endorsing current, past, or no chronic pain. SETTING: Community. PARTICIPANTS: Three thousand eight hundred four TBI Model Systems participants 1 to 30 years of age postinjury classified into 1 of 3 groups based on their pain experience: current pain, past pain, no pain completed a Pain Survey at their usual follow-up appointment which on average was approximately 8 years postinjury. DESIGN: Multisite, cross-sectional observational cohort study. MAIN OUTCOME MEASURES: Sociodemographic and injury characteristics and psychosocial outcomes (ie, satisfaction with life, depression, anxiety, posttraumatic stress disorder [PTSD], sleep quality, community participation). RESULTS: Persons with current chronic pain demonstrated higher scores on measures of PTSD, anxiety, and depression, and the lower scores on measures of sleep quality, community participation and satisfaction with life. Those with resolved past pain had mean scores for these outcomes that were all between the current and no chronic pain groups, but always closest to the no pain group. After adjusting for sociodemographic and function in multivariate analysis, having current chronic pain was associated with more negative psychosocial outcomes. The largest effect sizes (ES; in absolute value) were observed for the PTSD, depression, anxiety, and sleep quality measures (ES = 0.52-0.81) when comparing current pain to past or no pain, smaller ES were observed for life satisfaction (ES = 0.22-0.37) and out and about participation (ES = 0.16-0.18). When comparing past and no pain groups, adjusted ES were generally small for life satisfaction, PTSD, depression, anxiety, and sleep quality (ES = 0.10-0.23) and minimal for participation outcomes (ES = 0.02-0.06). CONCLUSIONS: Chronic pain is prevalent among individuals with TBI and is associated with poorer psychosocial outcomes, especially for PTSD, depression, anxiety, and sleep disturbance. The results from this study highlight the presence of modifiable comorbidities among those with chronic pain and TBI. Persons who experience persistent pain following TBI may be at greater risk for worse psychosocial outcomes.

"There's always something, and then there's more": a qualitative examination of how virtual peer led self-management can create community around the evolving SCI experience.

Introduction: Self-management programs for spinal cord injury (SCI) are a growing adjunct to traditional healthcare services aiding individuals with SCI in learning and managing symptoms and medical care. A benefit of self-management programs is that they can be facilitated by peers, offering a unique lived experience of adjusting to and managing SCI. While a growing body of literature highlights the effectiveness of peer led programs, there is limited understanding of how individuals engage with peer programs or critical components of peer support. The current study seeks to understand how individuals engaged with peers in the context of a self-management program. Methods: Secondary qualitative analysis of online forum posts resultant from a peer led self-management course for SCI. Results: Content analysis revealed several themes of how participants engaged with members of the group, including skill building, resource sharing, and problem solving. A process level theme of emotional connection to others living with similar SCI-related challenges was defined as "bearing witness." Participants commented frequently that groups were the first time they engaged with a community with lived experience, and shared experience was frequently highlighted in the responses from individuals as one of the most unique and important aspects of the intervention. Discussion: Themes identified suggest that bearing witness was a critical component of peer led intervention. While self-management content provided structure for engagement and discussion, participants report that connectedness and shared experience made content more impactful and relevant. Future research should examine if alignment of peer and participant experience increases the impact of interventions and explore if this theme is important for other chronic medical populations.

Collaborative Care for Chronic Pain After Traumatic Brain Injury: A Randomized Clinical Trial.

Importance: Chronic pain after traumatic brain injury (TBI) is prevalent and associated with poor outcomes. By providing multidisciplinary care through expert consultation, a collaborative care (CC) treatment approach may reduce pain interference. Objective: To compare CC with usual care (UC) in decreasing pain interference. Design, Setting, and Participants: This randomized clinical trial was conducted from July 2018 through April 2021 at 2 hospital-based academic rehabilitation medicine clinics in Seattle, Washington. Participants included adults with mild-to-severe TBI (at least 6 months before enrollment) and chronic pain. Data analysis was performed from March 30, 2022, to August 30, 2023. Intervention: The CC intervention (called TBI Care) included up to 12 in-person or telephone visits over 16 weeks with a care manager (CM) who provided person-centered cognitive behavioral treatment. The CM met weekly with members of the expert team to review participants and discuss recommendations to optimize treatment. Main Outcomes and Measures: The primary outcome was pain interference on the Brief Pain Inventory at treatment conclusion (4 months after randomization). Secondary outcomes included pain interference at 8 months; pain severity; symptoms of depression, anxiety, and sleep disturbance; pain-related emergency department visits; community participation; and participant satisfaction. Linear mixed-effects regression was used for analysis. Results: A total of 1379 individuals were screened for eligibility, and 158 were randomized (79 to CC and 79 to UC). The participants were mostly women (92 participants [58%]) with a mean (SD) age of 46.8 (13.2) years and a mean (SD) of 15.3 (3.0) years of education. TBI occurred a mean (SD) of 4.0 (5.9) years (median [IQR], 1.9 [0.8-4.5] years) before enrollment. All TBI severities were included, and of 149 participants for whom TBI severity was known, the majority (97 participants [65%]) had mild TBI. In the CC group, 71 participants (90%) completed at least 11 sessions, and, at 4 months, this group had significantly lower pain interference scores compared with the UC group (mean [SD], 3.46 [2.17] vs 5.03 [2.28]). This difference was maintained at 8 months after randomization, with mean (SD) TBI care pain interference scores of 3.61 (2.22) for CC vs 4.68 (2.51) for UC. At 4 months, there was significantly lower pain severity in the CC group vs UC group (mean [SD] score, 3.63 [1.95] vs 4.90 [1.96]), as well as symptoms of depression (mean [SD] score, 8.07 [5.34] vs 11.31 [6.37]) and anxiety (mean [SD], 6.20 [5.17] vs 9.58 [6.00]). Satisfaction with pain treatment (mean [SD] score, 2.99 [1.23] vs 2.52 [1.25]), clinical care (mean [SD] score, 3.28 [1.00] vs 2.84 [1.26]), and overall health care (mean [SD] score, 3.25 [0.88] vs 2.82 [1.00]) were significantly higher in the CC group vs the UC group; global impression of change was significantly lower in the CC group vs the UC group (mean [SD] score, 2.74 [1.02] vs 3.47 [1.26]) (lower scores denote a better impression of change). Conclusions and Relevance: In this randomized clinical trial of CC compared with UC for patients with TBI, CC was effective at reducing pain interference and was sustained at 8-month follow-up. Further research is needed to examine the implementation and cost-effectiveness of CC for TBI in other health care settings. Trial Registration: ClinicalTrials.gov Identifier: NCT03523923.

A pilot randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol.

BACKGROUND: Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive problems, insomnia, anxiety, and depression. There is currently no cure for long COVID, and the average length of recovery and proportion of patients who fully recover are still unknown. Subsequently, there is a critical need to improve function. Research in other chronic conditions suggests that psychosocial self-management interventions reduce symptom severity and interference with functioning. We describe the design of our study to examine the feasibility, acceptability, appropriateness, and preliminary efficacy of an intervention designed to improve symptom management and coping in adults with long COVID. METHODS: This pilot trial (N = 50) uses a pragmatic, randomized two-group parallel design set within the University of Washington Post-COVID Rehabilitation and Recovery Clinic. The self-management intervention is a 6-week, group-based telemedicine intervention that teaches evidence-based strategies to manage common symptoms and improve stress management as well as communication and self-advocacy. The comparator is a wait-list control. Participants complete self-report measures of the primary and secondary outcomes at baseline and post-treatment/wait-list. Primary outcomes include intervention feasibility, acceptability, and appropriateness. Secondary outcomes include Patient-Reported Outcomes Measurement Information System measures of fatigue, sleep disturbance, cognitive difficulties, self-efficacy, pain interference, depression and anxiety symptoms, and a measure of long COVID symptoms and impression of change. At post-intervention, intervention participants also complete a qualitative interview to inform intervention refinement. Quantitative data will be examined using descriptive and statistical analysis including t-tests and chi-square tests to compare the intervention and wait-list groups on secondary outcomes. Qualitative data will be analyzed using the rigorous and accelerated data reduction technique (RADaR). DISCUSSION: Results of this pilot randomized controlled trial will characterize the feasibility, acceptability, and appropriateness of the self-management intervention and inform intervention refinement necessary prior to further testing. Long COVID is a public health concern, and rehabilitation approaches that equip patients to manage symptoms may improve patient function and quality of life and reduce burden on the health care system. TRIAL REGISTRATION: NCT05658536. December 16, 2022.

Prevalence of Self-Reported COVID-19 Infection in Persons with Complicated Mild to Severe Traumatic Brain Injury (TBI): A TBI Model Systems Study.

OBJECTIVE: To describe the incidence of self-reported COVID-19 history in a longitudinal cohort of individuals with complicated mild to severe traumatic brain injury (TBI) and describe demographic, injury and functional differences based on history of COVID-19 infection. DESIGN: Individuals with complicated mild to severe TBI aged 16 or older at time of injury who were enrolled in the TBI Model Systems longitudinal cohort study, completed a baseline or follow-up interview between October 1, 2021-March 31, 2023, and provided information about COVID-19 history and timing of COVID-19 infection was collected. RESULTS: Of the 3,627 individuals included in the analysis, 29.5% reported a history of COVID-19 infection. Those with reported COVID-19 history tended to be younger, not of a racial/ethnic minority background, and greater functional status at follow up based on the Glasgow Outcome Scale-Extended scale compared to those with no reported COVID-19 history (p < 0.05). Among those with COVID-19 history, 61.8% did not receive medical care, 27.6% received medical care but no hospitalization, and 10.5% were hospitalized. Of those hospitalized, 21.4% required ventilator use. CONCLUSION: Incidence of COVID-19 diagnosis and related hospitalization characteristics in persons with complicated mild to severe TBI was similar to national incidence between March 2020-2023. Secondary effects of the COVID-19 pandemic on persons with TBI require investigation.

Comparison of 2 methods for sterilization of filtering facepiece respirators worn for extended periods during the COVID-19 pandemic: An experimental laboratory study.

BACKGROUND: During the COVID-19 pandemic, there was a shortage of filtering facepiece respirators (FFR), leading to prolonged use and reuse of FFRs. METHODS: FFRs were collected in 3 hospitals after extended use (up to 15 or 30days). We assessed the physical characteristics and filtration levels of worn FFRs, before sterilization. Respirators that achieved at least 94% filtration of aerosol particles, nasal clip still attached, had no tears, had preserved elastic bands, and had no dirt were randomized to receive or not receive cleaning before being submitted to hydrogen peroxide plasma gas sterilization. RESULTS: A total of 1,055 FFRs were collected. Over 85% of them exhibited secured nose clips, preserved strap elasticity, and no tears. However, more than 78% of samples contained dirt, leaving only 101 (19.6%) eligible to undergo sterilization. After sterilization, none of the FFRs in either group achieved minimum filtration, although 72% without cleaning and 80% with cleaning had filtration between 90.0% and 93.9%. DISCUSSION: A large proportion of FFRs were ineligible for sterilization due to factors unrelated to health care (eg, dirt from makeup). CONCLUSIONS: Prolonged reuse of FFRs significantly reduced aerosol filtration efficiency. Eligible FFRs did not maintain 94% filtration after sterilization with or without cleaning.

Longitudinal Lesion Expansion in Chronic Traumatic Brain Injury.

Traumatic brain injury (TBI) is a risk factor for neurodegeneration and cognitive decline, yet the underlying pathophysiologic mechanisms are incompletely understood. This gap in knowledge is in part related to the lack of analytic methods to account for cortical lesions in prior neuroimaging studies. The objective of this study was to develop a lesion detection tool and apply it to an investigation of longitudinal changes in brain structure among individuals with chronic TBI. We identified 24 individuals with chronic moderate-to-severe TBI enrolled in the Late Effects of TBI (LETBI) study who had cortical lesions detected by T1-weighted MRI at two time points. Initial MRI scans were performed more than 1-year post-injury and follow-up scans were performed 3.1 (IQR=1.7) years later. We leveraged FreeSurfer parcellations of T1-weighted MRI volumes and a recently developed super-resolution technique, SynthSR, to identify cortical lesions in this longitudinal dataset. Trained raters received the data in a randomized order and manually corrected the automated lesion segmentation, yielding a final lesion mask for each scan at each timepoint. Lesion volume significantly increased between the two time points with a median volume change of 3.2 (IQR=5.9) mL (p<0.001), and the increases significantly exceeded the possible variance in lesion volume changes due to manual tracing errors (p < 0.001). Lesion volume significantly expanded longitudinally in 23 of 24 subjects, with all FDR corrected p-values ≤ 0.02. Inter-scan duration was not associated with the magnitude of lesion growth. We also demonstrated that the semi-automated tool showed a high level of accuracy compared to "ground truth" manual lesion segmentation. Semi-automated lesion segmentation is feasible in TBI studies and creates opportunities to elucidate mechanisms of post-traumatic neurodegeneration.

Relevance of learning health systems to physiatrists and its synergy with implementation science: A commentary.

As health care attempts to bridge the gap between evidence and practice, the concept of the learning health system (LHS) is becoming increasingly relevant. LHS integrates evidence with health systems data, driving health care quality and outcomes through updates in policy, practice, and care delivery. In addition, LHS research is becoming critically important as there are several initiatives underway to increase research capacity, expertise, and implementation, including attempts to stimulate increasing numbers of LHS researchers. Physical Medicine & Rehabilitation (PM&R) physicians (physiatrists), nurses, therapists (physical therapists, occupational therapists, speech therapists, clinical psychologists), and scientists are affiliated with LHSs. As LHS research expands in health care systems, better awareness and understanding of LHSs and LHS research competencies are key for rehabilitation professionals including physiatrists. To address this need, the Agency of Healthcare Research and Quality (AHRQ) identified 33 core competencies, grouped into eight domains, for training LHS researchers. The domains are: (1) Systems Science; (2) Research Questions and Standards of Scientific Evidence; (3) Research Methods; (4) Informatics; (5) Ethics of Research and Implementation in Health Systems; (6) Improvement and Implementation Science; (7) Engagement, Leadership, and Research Management; and the recently added (8) Health and Healthcare Equity and Justice. The purpose of this commentary is to define LHS and its relevance to physiatrists, present the role of implementation science (IS) in LHSs and application of IS principles to design LHSs, illustrate current LHS research in rehabilitation, and discuss potential solutions to improve awareness and to stimulate interest in LHS research and IS among physiatrists in LHSs.

Somatic and cognitive-affective depressive symptoms among patients with heart disease: differences by sex and age / Sintomas depressivos somáticos e cognitivo-afetivos entre pacientes com doença cardíaca: diferenças por sexo e idade / Síntomas depresivos somáticos y cognitivo-afectivos entre pacientes con enfermedad cardíaca: diferencias por sexo y edad

OBJECTIVE: this study investigated the association of somatic and cognitive-affective symptoms with sex and age, among patients hospitalized with heart disease. METHOD: this study was a secondary analysis of two previous observational studies totaling 531 patients with heart disease, hospitalized from 2005 to 2011 in two public hospitals in Ribeirão Preto, state of São Paulo, Brazil. Somatic and cognitive-affective symptoms were assessed using the subscales of the Beck Depression Inventory - I (BDI-I). RESULTS: of 531 participants, 62.7% were male, with a mean age 57.3 years (SD= 13.0) for males and 56.2 years (SD= 12.1) for females. Analyses of variance showed an effect of sex (p<0.001 for somatic and p=0.005 for cognitive-affective symptoms), but no effect of age. Women presented with higher mean values than men in both BDI-I subscales: 7.1 (4.5) vs. 5.4 (4.3) for somatic, and 8.3 (7.9) vs. 6.7 (7.2) for cognitive-affective symptoms. There were no differences by age for somatic (p=0.84) or cognitive-affective symptoms (p=0.84). CONCLUSION: women hospitalized with heart disease had more somatic and cognitive-affective symptoms than men. We found no association of somatic and cognitive-affective symptoms with age. Future research for these patients could reveal whether these differences according to sex continue throughout the rehabilitation process. .

OBJETIVO: investigar a associação de sintomas somáticos e cognitivo-afetivos ao sexo e à idade de pacientes hospitalizados com doença cardíaca. MÉTODO: este estudo é resultado de uma análise secundária de dois estudos observacionais anteriores, totalizando 531 pacientes com doença cardíaca, internados de 2005 a 2011, em dois hospitais públicos em Ribeirão Preto, estado de São Paulo, Brasil. Os sintomas somáticos e cognitivo-afetivos foram avaliados utilizando-se as subescalas do Inventário de Depressão de Beck - I (IDB-I). RESULTADOS: dos 531 participantes, 62,7% são do sexo masculino, com média de idade de 57,3 anos (DP= 13,0) para os homens e 56,2 anos (DP = 12,1) para as mulheres. A análise da variância mostrou um efeito relacionado ao sexo do paciente (p<0,001 para sintomas somáticos e p=0,005 para os sintomas cognitivo-afetivos), mas nenhum efeito relacionado à idade. As mulheres apresentaram maiores escores do que os homens em ambas subescalas IDB-I: 7,1 (4,5) e 5,4 (4,3) para os sintomas somáticos, e 8,3 (7,9) e 6,7 (7,2) para os sintomas cognitivo-afetivos, respectivamente. Não houve diferenças referentes à idade para sintomas somáticos (p=0,84) ou sintomas cognitivo-afetivos (p=0,84). CONCLUSÃO: as mulheres internadas com doença cardíaca apresentaram mais sintomas somáticos e cognitivo-afetivos do que os homens. Não houve associação dos sintomas somáticos e cognitivo-afetivos com a idade. Pesquisas futuras desses pacientes poderiam revelar se essas diferenças de acordo com o sexo permanecem durante todo o processo de reabilitação. .

OBJETIVO: este estudio investigó la asociación de síntomas somáticos y cognitivo-afectivos con el sexo y la edad en pacientes hospitalizados con enfermedad cardíaca. MÉTODO: este estudio fue un análisis secundario de dos estudios observacionales anteriores, totalizando 531 pacientes con enfermedad cardíaca, internados de 2005 a 2011, en dos hospitales públicos en Ribeirão Preto, estado de São Paulo, Brasil. Los síntomas somáticos y cognitivo-afectivos fueron evaluados utilizándose las subescalas del Inventario Beck de Depresión - I (IBD-I). RESULTADOS: de los 531 participantes, 62,7% era del sexo masculino, con promedio de edad de 57,3 años (DE= 13,0) para los hombres y 56,2 años (DE = 12,1) para el sexo femenino. El análisis de variancia mostró un efecto del sexo (p<0,001 para síntomas somáticos y p=0,005 para los síntomas cognitivo-afectivos), pero ningún efecto de la edad. Las mujeres presentaron valores medios más altos que los hombres en ambas subescalas IBD-I: 7,1 (4,5) vs. 5.4 (4.3) para los síntomas somáticos, y 8,3 (7,9) vs. 6,7 (7,2) para los síntomas cognitivo-afectivos. No fueron encontradas diferencias por edad para síntomas somáticos (p=0,84) o síntomas cognitivo-afectivos (p=0,84). CONCLUSIÓN: las mujeres internadas con enfermedad cardíaca tenían más síntomas somáticos y cognitivo-afectivos que los hombres. No fue encontrada asociación de los síntomas somáticos y cognitivo-afectivos con la edad. Investigaciones futuras de esos pacientes podrían revelar si esas diferencias por sexo continúan durante todo el proceso de rehabilitación. .