Overview of randomized controlled trials of moderate to severe traumatic brain injury: A systematic review.

BACKGROUND: Given the complexity of post-TBI medical, surgical, and rehabilitative care, research is critical to optimize interventions across the continuum of care and improve outcomes for persons with moderate to severe TBI. OBJECTIVE: To characterize randomized controlled trials (RCTs) of moderate to severe traumatic brain injury (TBI) in the literature. METHOD: Systematic searches of MEDLINE, PubMed, Scopus, CINAHL, EMBASE and PsycINFO for RCTs up to December 2022 inclusive were conducted in accordance with PRISMA guidelines. RESULTS: 662 RCTs of 91,946 participants published from 1978 to 2022 met inclusion criteria. The number of RCTs published annually has increased steadily. The most reported indicator of TBI severity was the Glasgow Coma Scale (545 RCTs, 82.3%). 432 (65.3%) RCTs focused on medical/surgical interventions while 230 (34.7%) addressed rehabilitation. Medical/surgical RCTs had larger sample sizes compared to rehabilitation RCTs. Rehabilitation RCTs accounted for only one third of moderate to severe TBI RCTs and were primarily conducted in the chronic phase post-injury relying on smaller sample sizes. CONCLUSION: Further research in the subacute and chronic phases as well as increasing rehabilitation focused TBI RCTs will be important to optimizing the long-term outcomes and quality of life for persons living with TBI.

Comparing Randomized Controlled Trials of Moderate to Severe Traumatic Brain Injury in Lower to Middle Income Countries Versus High Income Countries.

Outcomes from traumatic brain injury (TBI) including death differ significantly between high-, middle-, and low-income countries. Little is known, however, about differences in TBI research across the globe. The objective of this article was to examine randomized controlled trials (RCTs) of moderate-to-severe TBI in high-income countries (HICs) compared with low- and middle-income countries (LMICs), as defined by the World Bank income per capita cutoff of $13,205 US dollars. A systematic review was conducted for articles published in the English language to December 2022 inclusive using MEDLINE, PubMed, Scopus, CINAHL, EMBASE, and PsycINFO in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria: (1) human participants with a mean age of ≥18 years; (2) ≥50% of the sample had moderate to severe TBI; and (3) the study design was a RCT. Data extracted included author, year, country, sample size, primary focus (medical/surgical management or rehabilitation), injury etiology, time post-injury, and indicator(s) used to define TBI severity. There were 662 RCTs (published 1978-2022) that met inclusion criteria comprising 91,946 participants. There were 48 countries represented: 30 HICs accounting for 451 RCTs (68.1%) and 18 LMICs accounting for 211 RCTs (31.9%). The 62.6% of RCTs from LMICs were conducted in the acute phase post-injury (≤1 month) compared with 42.1% of RCTs from HICs. Of RCTs from LMICs, 92.4% focused on medical/surgical management compared with 52.5% from HICs. Since 2016, more RCTs have been conducted in LMICs than in HICs, indicating the importance of better understanding this pattern of research output.

Cognitive behavioral therapy for managing depressive and anxiety symptoms after brain injury: a meta-analysis.

BACKGROUND: Individuals with traumatic brain injury (TBI) are at increased risk of depression and anxiety, leading to impaired recovery. While cognitive-behavioral therapy (CBT) addresses anxiety and depression maintenance factors, its efficacy among those with TBI has not been clearly demonstrated. This review aims to bridge this gap in the literature. METHODS: Several databases, including Medline, PsycInfo and EMBASE, were used to identify studies published between 1990 and 2021. Studies were included if: (1) trials were randomized controlled trials (RCT) involving CBT-based intervention targeting anxiety and/or depression; (2) participants experienced brain injury at least 3-months previous; (3) participants were ≥18 years old. An SMD ± SE, 95% CI and heterogeneity were calculated for each outcome. RESULTS: Thirteen RCTs were included in this meta-analysis. The pooled-sample analyses suggest that CBT interventions had small immediate post-treatment effects on reducing depression (SMD ± SE: 0.391 ± 0.126, p < 0.005) and anxiety (SMD ± SE: 0.247 ± 0.081, p < 0.005). Effects were sustained at a 3-months follow-up for depression. A larger effect for CBT was seen when compared with supportive therapy than control. Another sub-analysis found that individualized CBT resulted in a slightly higher effect compared to group-based CBT. CONCLUSION: This meta-analysis provides substantial evidence for CBT in managing anxiety and depression post-TBI.

Online psychosocial intervention for persons with spinal cord injury: A meta-analysis.

BACKGROUND: Delivery of psychosocial interventions via the Internet has the potential to overcome barriers and increase access; however, effectiveness is yet to be established among those with spinal cord injury (SCI). METHODS: The objective of this meta-analysis is to evaluate the efficacy of Internet-based psychosocial interventions on the symptoms of anxiety, depression, and pain amongst those with SCI. The databases Medline, PsycInfo, and EMBASE were used to locate studies published between 1990 and December 2020. A study was included if (1) the study involved the application of an online psychosocial intervention; (2) adults with SCI; and (3) reported outcomes on depression and/or anxiety. From each study, participant characteristics and study details were extracted. A standardized mean difference (SMD) ± standard error and 95% confidence interval (CI) was calculated for each outcome of interest and the results were pooled using a fixed-effects model. RESULTS: The search yielded 920 studies, of which five were included in the final meta-analysis; It was revealed that Internet-based psychosocial interventions had a small effect on reducing overall anxiety (SMD: 0.42 ± 0.09, p < 0.001) and depression (SMD: 0.41 ± 0.09, p < 0.001) symptoms at the end of the study period. Online psychosocial interventions also had a moderate effect in maintaining reduction of anxiety (SMD: 0.50 ± 0.1, p < 0.001) and depressive (SMD: 0.64 ± 0.10, p < 0.001) symptoms at 3-month follow-up. CONCLUSION: The results of this meta-analysis provide evidence for the use of internet-based psychosocial interventions to manage anxiety and depression symptoms among those with spinal cord injuries.

Early Versus Delayed Microdiscectomy for Chronic Sciatica Lasting 4-12 Months Secondary to Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVES: To compare the effect of delaying surgery on clinical outcome in patients with chronic sciatica secondary to lumbar disc herniation. METHODS: Patients with sciatica lasting 4-12 months and lumbar disc herniation at the L4-L5 or L5-S1 level were randomized to undergo microdiscectomy (early surgery) or to receive 6 months of nonoperative treatment followed by surgery if needed (delayed surgery). Outcomes were leg pain, Oswestry Disability Index score (ODI), back pain, SF-36 physical component (PCS) and mental component (MCS) summary scores, employment, and satisfaction measured preoperatively and at 6 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS: Of the 64 patients in the early surgery group, 56 underwent microdiscectomy an average of 3 ± 2 weeks after enrollment. Of the 64 patients randomized to nonoperative care, 22 patients underwent delayed surgery an average of 53 ± 24 weeks after enrollment. The early surgery group experienced less leg pain than the delayed surgery group, which was the primary outcome, at 6 months after surgery (early surgery 2.8 ± .4 vs delayed surgery 4.8 ± .7; difference, 2.0; 95% confidence interval, .5-3.5). The overall estimated mean difference between groups significantly favored early surgery for leg pain, ODI, SF36-PCS, and back pain. The adverse event rate was similar between groups. CONCLUSIONS: Patients presenting with chronic sciatica treated with delayed surgery after prolonging standardized non-operative care have inferior outcomes compared to those that undergo expedited surgery.

Microdiscectomy Is More Cost-effective Than a 6-Month Nonsurgical Care Regimen for Chronic Radiculopathy.

BACKGROUND: A recent randomized controlled trial (RCT), performed by the authors, comparing early surgical microdiscectomy with 6 months of nonoperative care for chronic lumbar radiculopathy showed that early surgery resulted in improved outcomes. However, estimates of the incremental cost-utility ratio (ICUR), which is often expressed as the cost of gaining one quality-adjusted life year (QALY), of microdiscectomy versus nonsurgical management have varied. Radiculopathy lasting more than 4 months is less likely to improve without surgical intervention and may have a more favorable ICUR than previously reported for acute radiculopathy. QUESTION/PURPOSE: In the setting of chronic radiculopathy caused by lumbar disc herniation, defined as symptoms and/or signs of 4 to 12 months duration, is surgical management more cost-effective than 6 months of nonoperative care from the third-party payer perspective based on a willingness to pay of less than CAD 50,000/QALY? METHODS: A decision analysis model served as the vehicle for the cost-utility analysis. A decision tree was parameterized using data from our single-center RCT that was augmented with institutional microcost data from the Ontario Case Costing Initiative. Bottom-up case costing methodology generates more accurate cost estimates, although institutional costs are known to vary. There were no major surgical cost drivers such as implants or bone graft substitutes, and therefore, the jurisdictional variance would be minimal for tertiary care centers. QALYs derived from the EuroQoL-5D were the health outcome and were derived exclusively from the RCT data, given the paucity of studies evaluating the surgical treatment of lumbar radiculopathy lasting 4 to 12 months. Cost-effectiveness was assessed using the ICUR and a threshold of willingness to pay CAD 50,000 (USD 41,220) per QALY in the base case. Sensitivity analyses were performed to account for the uncertainties within the estimate of cost utility, using both a probabilistic sensitivity analysis and two one-way sensitivity analyses with varying crossover rates after the 6-month nonsurgical treatment had concluded. RESULTS: Early surgical treatment of patients with chronic lumbar radiculopathy (defined as symptoms of 4 to 12 months duration) was cost-effective, in that the cost of one QALY was lower than the CAD 50,000 threshold (note: the purchasing power parity conversion factor between the Canadian dollar (CAD) and the US dollar (USD) for 2019 was 1 USD = 1.213 CAD; therefore, our threshold was USD 41,220). Patients in the early surgical treatment group had higher expected costs (CAD 4118 [95% CI 3429 to 4867]) than those with nonsurgical treatment (CAD 2377 [95% CI 1622 to 3518]), but they had better expected health outcomes (1.48 QALYs [95% CI 1.39 to 1.57] versus 1.30 [95% CI 1.22 to 1.37]). The ICUR was CAD 5822 per QALY gained (95% CI 3029 to 30,461). The 2-year probabilistic sensitivity analysis demonstrated that the likelihood that early surgical treatment was cost-effective was 0.99 at the willingness-to-pay threshold, as did the one-way sensitivity analyses. CONCLUSION: Early surgery is cost-effective compared with nonoperative care in patients who have had chronic sciatica for 4 to 12 months. Decision-makers should ensure adequate funding to allow timely access to surgical care given that it is highly likely that early surgical intervention is potentially cost-effective in single-payer systems. Future work should focus on both the clinical effectiveness of the treatment of chronic radiculopathy and the costs of these treatments from a societal perspective to account for occupational absences and lost patient productivity. Parallel cost-utility analyses are critical so that appropriate decisions about resource allocation can be made. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Postural neurologic deficits after decompressive craniectomy: A case series of sinking skin flap syndrome in traumatic brain injury.

BACKGROUND: Hemicraniectomy to manage raised intracranial pressure following traumatic brain injury (TBI) has improved survival but may increase the incidence of Sinking Skin Flap Syndrome (SSFS). SSFS is a clinical syndrome in which patients with craniectomy develop objective neurologic abnormalities due to the pressure of the atmosphere on the unprotected brain, often presenting with postural headaches and neurologic deficits that localize to the craniectomy site. Previously thought to be a rare complication of craniectomy after TBI, evidence suggests SSFS is under-recognized. OBJECTIVE: To describe the clinical and radiographic features leading to diagnosis and the impact of temporizing and definitive management of SSFS on outcomes in inpatients with moderate/severe TBI. METHODS: Two patients' symptoms, qualitative behaviour observation, physical and cognitive outcome measures, and neuroimaging pre- and post-temporizing measures and cranioplasty are presented. RESULTS: Both patients demonstrated partial improvements with temporizing measures and substantial improvements in functional, cognitive, physical, and rehabilitation outcomes from the cranioplasty and resolution of SSFS. CONCLUSIONS: Rehabilitation care providers are critical to the timely diagnosis and management of SSFS, including the use of temporizing measures and advocacy for definitive treatment with cranioplasty. These cases highlight the diverse clinical presentations and importance of SSFS diagnosis to improve patient outcomes.

Discectomy Compared with Standardized Nonoperative Care for Chronic Sciatica Due to a Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial with 2-Year Follow-up.

BACKGROUND: Randomized controlled trials evaluating acute sciatica have not demonstrated prolonged improvements in terms of patient-reported pain and function. For chronic sciatica, however, microdiscectomy has been found to be superior at 1 year. Whether this effect persists during the second year is not known. The purpose of the present study was to report the 2-year outcomes following lumbar microdiscectomy as compared with standardized nonoperative care for the treatment of chronic sciatica resulting from a lumbar disc herniation. METHODS: The present study is a secondary analysis of a previously reported randomized controlled trial with extension to 2 years of follow-up. Patients with radiculopathy for 4 to 12 months resulting from an L4-L5 or L5-S1 disc herniation were randomized to microdiscectomy or 6 months of nonoperative care followed by surgery if needed. Intention-to-treat analysis was performed at 2 years for the primary outcome (the intensity of leg pain) (range of possible scores, 0 [no pain] to 10 [worst pain]) as well as for secondary outcomes (including the Oswestry Disability Index score, the intensity of back pain, and quality of life). RESULTS: One hundred and twenty-eight patients were randomized in the present study. Twenty-four (38%) of the 64 patients who had been randomized to nonoperative care crossed over to surgical treatment by 2 years following enrollment. At the 2-year time point, the follow-up rate was approximately 70%. At 2 years, the operative group had less leg pain than the nonoperative group (mean, 2.8 ± 0.4 compared with 4.2 ± 0.4; treatment effect, 1.3 [95% confidence interval, 0.3 to 2.4]). The treatment effect favored surgery for all secondary outcome measures at 6 months and 1 year and for back pain intensity and physical function at 2 years. CONCLUSIONS: At 2 years, the present study showed that microdiscectomy was superior to nonoperative care for the treatment of chronic sciatica resulting from an L4-L5 or L5-S1 disc herniation. However, the difference between the groups did not surpass the minimal clinically important difference at 2 years as was reached at earlier follow-up points, likely as the result of patients crossing over from nonoperative to operative treatment. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

The Relationship between Higher Chronic Opioid Therapy Dose and Specific Personality Traits in Individuals with Chronic Pain.

Objective: To evaluate the relationship between opioid use and specific personality traits among individuals with chronic pain stratified by morphine equivalent doses (MEQ). Design: Observational cohort study. Setting. Chronic pain outpatient clinic in Canada (2017-2019). Patients. Participants were included if they (1) were at least 18 years old, (2) had been diagnosed with chronic pain (pain >3 months), and (3) were able to read and write in English. Interventions. None. Main Outcome Measures. Completion of the following outcome measures: Acceptance and Action Questionnaire, Anxiety Sensitivity Index, Brief-Coping with Problems Experience 28-item, Brief Pain Inventory Short Form, CAGE-AID substance misuse screening tool, EuroQol-5D, Generalized Anxiety Disorder 7-item, and Patient Health Questionnaire 9-item. One-way analysis of variance compared outcomes between MEQ groups. Results: 215 individuals (64.2% female) were included with a mean age of 52.7 ± 11.7 years and time since pain onset of 14.1 ± 10.2 years (range 1-45). There were no significant differences between MEQ groups with respect to sociodemographic and clinical health variables except for gender and employment status and time since pain onset. After controlling for gender, time since pain onset, and average pain severity, patients with MEQ 90+ mg had significantly higher scores for experiential avoidance and anxiety sensitivity in addition to increased pain interference, greater depressive and anxiety symptoms, more dysfunctional coping, and poorer QoL than those with MEQ 1-89 mg or MEQ 0 mg. Conclusions: Compared to individuals using no or lower-dose opioids to treat chronic pain, those using high-dose opioids had higher scores on two maladaptive personality traits (i.e., anxiety sensitivity and experiential avoidance) which was associated with poorer mood, greater pain interference, lower quality of life, and dysfunctional coping. These maladaptive personality traits may help to explain how individuals with chronic pain utilize higher doses of opioid analgesics.

Use of CGRP receptor blocker erenumab in the management of post-traumatic headache: a case series of 5 women.

CONTEXT: Post-traumatic headache (PTH) is a disabling headache disorder and the most common sequela of mild traumatic brain injury. The pathophysiology of PTH is poorly understood and there is limited available evidence to guide prophylactic medication selection. Emerging understanding of the pathophysiology of migraine headaches has led to the development of monoclonal antibodies, including erenumab. Erenumab has shown promise for the prevention of primary migraine headache; however, it has not yet been studied in PTH. CASE SERIES: five women (average age 43.0 ± 17.9y) received treatment with erenumab for PTH secondary to mTBI. The average duration of PTH prior to starting erenumab was 32.0 ± 18.2 months. All patients were taking at least one daily headache prophylactic therapy prior to erenumab. The average pre-erenumab headache intensity was 86/100. On erenumab, the average reported reduction in headache intensity was 51.1%. After starting erenumab, all five patients were able to discontinue one or more medication(s). The most common side effect was constipation (three patients). There were no serious adverse events after an average follow-up of 3.4 ± 1.5 months. One patient discontinued erenumab during this period of follow-up after the resolution of her headaches. CONCLUSION: Erenumab appears to be safe and effective for the management of PTH.

Anxiety, depression, and quality of life among subgroups of individuals with acquired brain injury: The role of anxiety sensitivity and experiential avoidance.

OBJECTIVES: The objectives of this observational cohort study were to 1) cluster individuals with acquired brain injury (ABI) into subgroups according to their level of anxiety sensitivity (AS) and experiential avoidance (EA), and 2) compare subgroups with respect to anxiety, depression, and quality of life (QoL). METHODS: Individuals were recruited from an ABI outpatient clinic in Ontario, Canada and completed comprehensive psychosocial questionnaires. A two-step cluster analysis was performed to identify unique subgroups based on the clustering variables Anxiety Sensitivity Index (ASI) and Acceptance and Action Questionnaire (AAQ) which measure AS and EA, respectively. Clinical outcome measures were compared between clusters using multivariate analysis of variance: Generalized Anxiety Disorder 7 item (anxiety); Patient Health Questionnaire-9 (depression), and EQ-5D overall health item (QoL). RESULTS: Among 86 participants included for analysis (mean age 47.1±14.2 years, 54.7% female), three unique clusters were produced. ASI and AAQ were significantly different among all groups (p < 0.001). Cluster 1 (n = 26) had the lowest levels of AS and EA whereas Cluster 3 (n = 24) had the highest levels of AS and EA; Cluster 2 (n = 36) had moderate levels of AS and EA. There was no significant difference between groups in age, gender, time since injury, or Glasgow Coma Scale scores. Cluster 3 had significantly higher anxiety and depression scores than Cluster 1 and 2 (p < 0.001 for all). Further, Cluster 2 had significantly higher anxiety and depression scores than Cluster 1 (p < 0.001 for all). There was no significant difference in EQ-5D scores between Clusters 1 and 2 or Cluster 2 and 3; however, Cluster 3 scored significantly lower on EQ-5D than Cluster 1 (p = 0.032). CONCLUSIONS: There exists a subgroup of individuals with ABI that have high levels of AS and EA; this was associated with greater symptoms of anxiety and depression, and poorer QoL. Interventions to address AS and EA may improve mood and QoL in this population.

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months.

BACKGROUND: The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months. METHODS: In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed. Surgery was performed by spine surgeons who used conventional microdiskectomy techniques. The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment. Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year. RESULTS: From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group. Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment. At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group. The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001). Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome. Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation. CONCLUSIONS: In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

Stress in patients diagnosed with rheumatoid arthritis compared to chronic pain.

PURPOSE/OBJECTIVE: To examine potential differences in cognitions and traitlike factors that relate to stress among individuals diagnosed with rheumatoid arthritis (RA) compared to those with chronic pain (CP). Research Method/Design: A cross-sectional study was conducted with participants recruited from outpatient rheumatology and CP clinics. Participants completed self-report questionnaires of demographics, disease characteristics, cognitions, and traitlike constructs. Correlates of patient stress were considered using hierarchical multiple regression. RESULTS: Analyses included 445 participants: 226 patients diagnosed with RA and 229 patients diagnosed with CP. In participants with RA, excessive worrying and anxiety sensitivity were independently associated with feeling stressed (p < .001), and 29% of the variance in stress scores was explained after adjusting for age, gender, years of education, and average pain intensity. In participants with CP, fear of relaxation, anxiety sensitivity, and pain catastrophizing were independently associated with feeling stressed (p < .001), and 31% of variance in stress scores was explained after adjusting for age, gender, years of education, and average pain intensity. Comparison of the fit of the model in both groups of patients through use of Fisher's z test found that the set of variables did similarly well for both patients with RA and those with CP, with no significant difference between R2 values (z = .88, p = .388). CONCLUSIONS/IMPLICATIONS: This study establishes cognitions and traitlike factors that are related to reports of stress among patients with RA and CP. These factors should be considered when treating and developing interventions for patients who experience increased feelings of stress. (PsycINFO Database Record

Impact of Abuse on Adjustment and Chronic Pain Disability: A Structural Equation Model.

INTRODUCTION/AIM: Sexual abuse, state and trait psychosocial factors, pain intensity, and pain-related disability have been shown to be correlated among individuals with chronic pain. However, the interacting relationships among these factors are poorly understood. The current study aims to test model which examines the effect of abuse, state and trait psychosocial factors, and pain intensity on pain-related disability among individuals with chronic pain. METHODS: In total, 229 participants diagnosed with chronic pain were recruited from a specialist chronic pain hospital in London, Ontario. Participants completed self-report measures related to sexual abuse history, pain intensity, personality (anxiety sensitivity, experiential avoidance, perfectionism), and adjustment (depression, anxiety, disability, maladaptive worrying). A path analysis was used to test the relationship among these variables. RESULTS: The model provided a close fit to the data (χ21=17.02; P=0.71; root-mean-square error of approximation=0.00; normal fit index=0.97; comparative fit index=1.0). The model demonstrates the direct and indirect effects of childhood sexual abuse on state and trait psychosocial factors among individuals with chronic pain. Pain anxiety, maladaptive worrying, and pain intensity were the main determinants of pain-related disability. DISCUSSION/CONCLUSIONS: The current model has important implications in understanding the interplay of factors involved in adjustment of individuals with chronic pain. Sexual abuse did not have a direct effect on pain-related disability. However, indirect effects through other psychosocial factors were demonstrated.

Pharmacotherapy for Depression Posttraumatic Brain Injury: A Meta-analysis.

OBJECTIVE: To examine the effectiveness of pharmacotherapy for the treatment of depression following traumatic brain injury (TBI). DESIGN: Systematic review and meta-analysis. Multiple electronic databases were searched to identify relevant studies examining effectiveness of pharmacotherapy for depression post-TBI. Clinical trials evaluating the use of pharmacotherapy in individuals with depression at baseline and using standardized assessments of depression were included. Data abstracted included sample size, antidepressant used, treatment timing/duration, method of assessment, and results pertaining to impact of treatment. Study quality was assessed using a modified Jadad scale. RESULTS: Nine studies met criteria for inclusion. Pooled analyses based on reported means (standard deviations) from repeated assessments of depression showed that, over time, antidepressant treatment was associated with a significant effect in favor of treatment (Hedges g = 1.169; 95% confidence interval, 0.849-1.489; P < .001). Similarly, when limited to placebo-controlled trials, treatment was associated with a significant reduction in symptoms (standardized mean difference = 0.84; 95% confidence interval, 0.314-1.366; P = .002). CONCLUSION: Pharmacotherapy after TBI may be associated with a reduction in depressive symptomatology. Given limitations within the available literature, further well-powered, placebo-controlled trials should be conducted to confirm the effectiveness of antidepressant therapy in this population.

Effects of a Functional Electrical Stimulation-Assisted Cycling Program on Immune and Cardiovascular Health in Persons with Spinal Cord Injury.

Background: Spinal cord injury (SCI) is associated with both a state of chronic inflammation and an increased prevalence of cardiovascular disease (CVD). These disorders are closely linked and have been shown to negatively influence one another. Participation in regular exercise has been shown to be an effective intervention strategy in the treatment of each of these disorders. For individuals with SCI who may lack the lower limb motor capabilities to perform certain traditional exercise modalities, functional electrical stimulation (FES) cycling may provide an effective alternative. Objective: The purpose of this study was to examine the effects of 12 weeks of FES training performed 3 times per week on physiological indices of cardiovascular function as well as molecular indices of inflammation and cardiovascular health. Methods: Ten individuals with chronic SCI were included. Measures of central and peripheral cardiovascular function as well as hematological and immunological markers were assessed before and after the 12-week exercise program. Results: Enhancements in exercise performance as well as a corresponding increase in peripheral cardiovascular function were achieved, as shown by a significant 34% increase in pulse volume (P = .04) and trends toward increases in cross-sectional area (P = .09) and arterial inflow volume (P = .11) of the common femoral artery. Despite this, no change in any hematological or immunological markers was evident. Conclusion: Although the efficacy of FES exercise in enhancing exercise performance (time and distance to fatigue) and peripheral cardiovascular function has been reaffirmed, no alterations in any molecular indices of cardiovascular risk were achieved.

Peri-Incisional Botulinum Toxin for Chronic Postcraniotomy Headache After Traumatic Brain Injury: A Case Series.

Botulinum neurotoxin (BoNT) has been used successfully to treat primary headache syndromes, but there are no published data on its use for chronic postcraniotomy headache. Botulinum neurotoxin type A (BoNT-A) (4:1 dilution) was injected at a dose of 15-50 units into peri-incisional sites of the scalp in 3 patients who had undergone craniotomy remotely for traumatic epidural hematoma. All patients reported reductions in headache lasting at least 2.5 months. Repeat injections were performed in all cases with favorable outcomes. There were no complications. Peri-incisional BoNT-A appears to be a potentially valuable tool in the chronic management of post craniotomy headache after traumatic brain injury.

The management of agitation among inpatients in a brain injury rehabilitation unit.

OBJECTIVE: Agitation post-acquired brain injury (ABI) is common and should be appropriately managed to optimize the patients' rehabilitation progress. The objective of this study was to assess how agitation is managed in current practice on an ABI rehabilitation unit. METHODS: A retrospective chart audit was conducted of patients admitted to an ABI rehabilitation unit to assess current practices. All information pertaining to agitation was abstracted from the patients' medical chart (e.g. behavioural incidences, medication information and behavioural outcome measures). The Agitated Behavior Scale (ABS) was the only assessment tool regularly utilized and, therefore, its use was evaluated. RESULTS: A total of 102 patient charts were reviewed. Fifty-one patients received medication for agitated behaviour. The ABS was administered to 28 patients; a total of 124 ABS tests were completed for these patients. Twenty-one of the 28 individuals never scored outside the 'normal' range; however, medications were given to 50%. CONCLUSIONS: The ABS and similar behavioural tools allow for a patient's behavioural patterns to be monitored and care plans to be created and executed according to evidence-based practices. There is a need to educate on the proper use and interpretation of assessment tools in order to improve care.

The validity and reliability of the neurogenic bladder symptom score.

PURPOSE: The neurogenic bladder symptom score is a tool to measure urinary symptoms and consequences in patients with acquired or congenital neurogenic bladder. We describe score validity and reliability. MATERIALS AND METHODS: Exploratory factor analysis was used to assess item variability and subscale structure. Reliability was assessed by the Cronbach α and correlation with retest data. Validity was assessed with a priori hypotheses specifying relationships with the AUASS (American Urological Association symptom score), ICIQ-UI (International Consultation on Incontinence-Urinary Incontinence) and urinary specific quality of life SF-Qualiveen questionnaires, and a self-assessed global bladder problem score. Known groups analysis was used to further assess construct validity. RESULTS: A cohort of 230 patients with spinal cord injury (35%), multiple sclerosis (59%) and congenital neurogenic bladder (6%) were included in study. Factor analysis suggested 3 neurogenic bladder symptom score domains, including incontinence, storage and voiding symptoms, and consequences. Overall internal consistency was high (Cronbach α=0.89). Test-rest reliability was also excellent with an ICC2,1 of 0.91. Validity was demonstrated by the confirmation of hypothesized correlations with the AUASS, ICIQ-UI and SF-Qualiveen, and significant differences in neurogenic bladder symptom score scores among known groups. Patients with a history of seeing a urologist had a significantly higher mean score, as did those with a higher global bladder problem score (22.1 vs 17.1 and 22.1 vs 12.6, respectively, each p<0.001). CONCLUSIONS: The neurogenic bladder symptom score, developed specifically to assess symptoms and consequences associated with neurogenic bladder dysfunction, has appropriate psychometric properties. Depending on the measurement need individual domains may be selected or it can be used as a comprehensive score.

Treatment with botulinum toxin improves upper-extremity function post stroke: a systematic review and meta-analysis.

OBJECTIVE: To examine whether treatment with botulinum toxin type A (BTX-A) is associated with improvements in activity capacity or performance associated with poststroke spasticity in the upper extremity. DATA SOURCES: MEDLINE, EMBASE, Scopus, and ISI Web of Science databases were searched from 1985 to November 2011. DATA SELECTION: Studies were included if (1) the study design was a randomized controlled trial comparing injection of BTX-A with placebo or a nonpharmacologic treatment condition; (2) at least 60% of the sample was composed of adult subjects recovering from either first or subsequent stroke; (3) subjects presented with moderate to severe upper-extremity spasticity of the wrist, finger, or shoulder; and (4) activity was assessed as an outcome. Studies were limited to those published in the English language. DATA EXTRACTION: Data pertaining to participant characteristics, treatment contrasts, and outcomes assessing activity limitations were extracted from each trial. The World Health Organization's International Classification of Functioning, Disability and Health was used to identify outcomes that captured the domain of activity used within each of the included studies. Where possible, a treatment effect size was calculated for each study using the standardized mean difference ± standard error (95% confidence interval) and the results pooled. DATA SYNTHESIS: Sixteen randomized controlled trials were identified, 10 of which reported sufficient data for inclusion in the pooled analysis (n=1000). Six different outcomes that assessed activity limitations had been used, including the Disability Assessment Scale, the Action Research Arm Test, and the Barthel Index. Overall, BTX-A was associated with a moderate treatment effect (standardized mean difference=.536±.094, 95% confidence interval=.352-.721, P<.0001). CONCLUSIONS: The use of BTX-A was associated with moderate improvement in upper-extremity activity capacity or performance after stroke.