Systematic Review of Outcome Measures Used After Proximal Hamstring Repair.

BACKGROUND: Patient-reported outcome measures are important to determine outcomes after orthopaedic procedures. There is currently no standard for outcome measures in the evaluation of patient outcomes after proximal hamstring repair. PURPOSE: To identify and evaluate outcome measures used after proximal hamstring repair. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A systematic review was performed to identify all English-language articles assessing outcomes after proximal hamstring repair in PubMed, Embase, CINAHL via EBSCOhost, MEDLINE via OvidSP, and Web of Science between 2000 and 2019. After duplicates were removed, studies were selected using eligibility criteria established by the authors. Image reviews, anatomic/histology studies, literature reviews, surgical technique reports, systematic reviews, narrative reviews, case studies, and studies with <5 patients were excluded. Extraction, synthesis, and analysis of outcome measure data were performed using Microsoft Excel. Quality assessment of included studies was performed using Methodological Index for Non-Randomized Studies criteria. RESULTS: After duplicate articles were removed, a total of 304 unique articles were identified and 27 met the inclusion criteria. The mean number of patients with proximal hamstring repairs per study was 40. The most frequently reported outcome measures were return to sport (14/27; 51.9%), custom survey/questionnaire (13/27; 48.1%), and isokinetic hamstring strength testing (13/27; 48.1%). Six of the 10 most commonly used outcome measures were validated and included Lower Extremity Functional Scale, 12-Item Short Form Health Survey, visual analog scale for pain, Perth Hamstring Assessment Tool (PHAT), Single Assessment Numeric Evaluation, and Tegner Activity Scale. Of those, PHAT was the only validated outcome measure designed for proximal hamstring repair. CONCLUSION: There is currently no consensus on the best outcome measurements for the evaluation of patients after proximal hamstring repair. We recommend an increased commitment to the use of return to sport, isokinetic strength testing, Lower Extremity Functional Scale, and PHAT when assessing such injuries. Future studies should aim to define the most reliable methods of outcome measurement in this patient population through consistent use of tools that are clinically relevant and important to patients and can easily be employed in a variety of clinical scenarios.

A Tale of Two Cities: What's Driving the Firearm Mortality Difference in Two Large Urban Centers?

INTRODUCTION: Per police data, the case fatality rate (CFR) of firearm assault in New Orleans (NO) over the last several years ranged between 27% and 35%, compared with 18%-22% in Philadelphia. The reasons for this disparity are unknown, and potentially reflect important system differences with broader implications for the reduction of firearm mortality. METHODS: A retrospective analysis of police and city-specific trauma databases between 2012 and 2017 was performed. Victims of firearm assaults within city limits were included. Univariate analysis was performed using chi-square for categorical and t-test for continuous variables. Bivariate analysis was conducted using logistic regression. RESULTS: Per police data, the CFR of firearm assault was 31% in NO and 20% in Philadelphia. However, per trauma registry data, the CFR of firearm assault was 14% in NO and 25% in Philadelphia. Patients in Philadelphia were older, had higher injury severity score, and lower blood pressure. Patients in NO had higher rates of head injury. 51% of patients in Philadelphia arrived via police compared to <1% in NO. There was no mortality difference between police and emergency medical service (EMS) transport. Longer EMS prehospital times were associated with increased mortality in NO but not Philadelphia. A much larger percentage of patients died on-scene in NO than Philadelphia. CONCLUSIONS: Our findings suggest that the major driver of increased mortality following firearm assault in NO compared with Philadelphia is death prior to the arrival of first responders. Interventions that shorten prehospital time will likely have the greatest impact on mortality in NO. This should include the consideration of police transport.

Sex Differences in the Massively Transfused Trauma Patient.

INTRODUCTION: Recent studies have suggested the female hypercoaguable state may have a protective effect in trauma. However, whether this hypercoagulable profile confers a survival benefit in massively transfused trauma patients has yet to be determined. We hypothesized that females would have better outcomes than males after traumatic injury that required massive transfusion protocol (MTP). PATIENTS AND METHODS: All trauma patients who underwent MTP at an urban, level 1, academic trauma center were reviewed from November 2007 to October 2018. Female MTP patients were compared to their male counterparts. RESULTS: There were a total of 643 trauma patients undergoing MTP. Of these, 90 (13.8%) were female and 563 (86.2%) were male. Presenting blood pressure, heart rate, shock index, and injury severity score (ISS) were not significantly different. Overall mortality and incidence of venous thromboembolism were similar. Complication profile and hospital stay were similar. On logistic regression, female sex was not associated with survival (HR: 1.04, 95% CI: 0.56-1.92, P = 0.91). Variables associated with mortality included age (HR: 1.02, 95% CI: 1.05-1.09, P = 0.03) and ISS (HR: 1.07, 95% CI: 1.05-1.09, P < 0.001). Increasing Glascow Coma Scale was associated with survival (HR: 0.85, 95% CI: 0.82-0.89, P < 0.001). On subset analysis, premenopausal women (age < 50) did not have a survival advantage in comparison with similar aged males (HR: 0.68, 95% CI: 0.36-1.28, P = 0.24). DISCUSSION: Sex differences in coagulation profile do not result in a survival advantage for females when MTP is required.

Correlation of ride sharing service availability and decreased alcohol-related motor vehicle collision incidence and fatality.

BACKGROUND: Alcohol-related motor vehicle collisions (AR-MVCs) account for ~30% of all US traffic fatalities. Ride-sharing services (RSS) have existed since 2010, but few studies to date have investigated their impact on AR-MVCs. We hypothesized that the availability of RSS would be correlated with a decrease in AR-MVCs at an urban Level I trauma center. METHODS: A retrospective chart review was conducted of all AR-MVC trauma activations at a Level I trauma center from 2012 to 2018. Additional data were gathered from regional governmental traffic and law enforcement databases, including crash incidence, fatalities, and demographics. Data were compared pre- and post-RSS and analyzed using an unpaired t test with p less than 0.05 considered significant. RESULTS: There were 1,474 patients in AR-MVCs during the study period. There was a significant decrease in the annual average proportion of MVCs that were AR-MVCs pre- vs. post-RSS (39% vs. 29%, p = 0.02) as well as a decrease in the average annual incidence of fatal AR-MVCs (11.6 vs. 5, p = 0.02). Subset analysis showed a decrease in AR-MVC incidence in 18- to 29-year-olds (12.7% vs. 7.5%; p = 0.03), which was also demonstrated by data from a local law enforcement database. Availability of RSS was also correlated with a decreased proportion of nighttime AR-MVCs (14.7% vs. 7.6%, p = 0.03) and decreased number of driving while intoxicated (1198.0 ± 78.5 vs. 612.8 ± 137.6, p = <0.01). CONCLUSION: We found that the incidence of both total AR-MVCs and fatal AR-MVCs presenting to our trauma center decreased after the introduction of RSS. Ride-sharing services may play a role in preventing AR-MVCs. Further research is needed to correlate AR-MVC incidence with granular proprietary RSS usage data and to account for any confounding factors. Future studies may identify ways to better utilize RSS availability as a targeted intervention for certain demographic groups to prevent AR-MVCs. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level IV.

Effectiveness of Reoperations for Adjacent Segment Disease Following Lumbar Spinal Fusion.

Although several options are available to address adjacent segment disease (ASD), the most effective surgical treatment has not been determined. In addition, it is important to subdivide ASD into stenosis with or without instability to determine if a decompression alone vs an extension of fusion is necessary. A systematic search of multiple medical reference databases was conducted for studies on surgical treatment of ASD. The primary outcome measures used were radiographic and clinical success rates. Meta-analysis was completed to determine effect summary values, 95% confidence intervals, and Q statistic and I2 values, using the random effects model for heterogeneity. The search yielded 662 studies, of which 657 were excluded. A total of 5 (level IV) studies with a total of 118 patients were included in this review. In 2 studies (46 patients), stenosis without instability was the indication for reoperation for ASD. However, extension of fusion was the modality of choice for the treatment of ASD in all studies. Overall clinical improvement (in back and/or leg pain scores) was noted in 71.3% of patients (95% confidence interval, 37.4-100), while radiographic fusion was noted in 89.3% of patients (95% confidence interval, 51.2-100). Following reoperation for ASD, revision surgery rates ranged from 4.5% to 23.1% at last clinical follow-up. There is variability in the clinical improvement following lumbar fusion for ASD. In addition, little literature exists regarding the optimal treatment options for patients with ASD for stenosis with or without instability. [Orthopedics. 2018; 41(2):e161-e167.].

Intraoperative Neuromonitoring for Anterior Cervical Spine Surgery: What Is the Evidence?

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: The goal of this study was to (i) assess the risk of neurological injury after anterior cervical spine surgery (ACSS) with and without intraoperative neuromonitoring (ION) and (ii) evaluate differences in the sensitivity and specificity of ION for ACSS. SUMMARY OF BACKGROUND DATA: Although ION is used to detect impending neurological injuries in deformity surgery, it's utility in ACSS remains controversial. METHODS: A systematic search of multiple medical reference databases was conducted for studies on ION use for ACSS. Studies that included posterior cervical surgery were excluded. Meta-analysis was performed using the random-effects model for heterogeneity. Outcome measure was postoperative neurological injury. RESULTS: The search yielded 10 studies totaling 26,357 patients. The weighted risk of neurological injury after ACSS was 0.64% (0.23-1.25). The weighted risk of neurological injury was 0.20% (0.05-0.47) for ACDFs compared with 1.02% (0.10-2.88) for corpectomies. For ACDFs, there was no difference in the risk of neurological injury with or without ION (odds ratio, 0.726; confidence interval, CI, 0.287-1.833; P = 0.498). The pooled sensitivities and specificities of ION for ACSS are 71% (CI: 48%-87%) and 98% (CI: 92%-100%), respectively. Unimodal ION has a higher specificity than multimodal ION [unimodal: 99% (CI: 97%-100%), multimodal: 92% (CI: 81%-96%), P = 0.0218]. There was no statistically significant difference in sensitivities between unimodal and multimodal [68% vs. 88%, respectively, P = 0.949]. CONCLUSION: The risk of neurological injury after ACSS is low although procedures involving a corpectomy may carry a higher risk. For ACDFs, there is no difference in the risk of neurological injury with or without ION use. Unimodal ION has a higher specificity than multimodal ION and may minimize "subclinical" intraoperative alerts in ACSS. LEVEL OF EVIDENCE: 3.

Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies.

OBJECTIVES: Phase I (PhI): assess the safety of Polyphenon E in people with multiple sclerosis (MS) and determine the futility of Polyphenon E as a neuroprotective agent. Correlate plasma levels of EGCG with neuroprotective effects. Phase II (PhII): Further assess safety and confirm the neuroprotective effects of Polyphenon E. DESIGN: PhI: single group futility study. PhII: parallel group randomized double-blind placebo-controlled study. PARTICIPANTS: Recruitment area (both studies): LSU MS Center, New Orleans, LA and general public from surrounding areas. Inclusion criteria (both studies): 1) MS per 2005 McDonald criteria; 2) relapsing remitting or secondary progressive MS; 3) stable for six months prior to enrollment on either no therapy or glatiramer acetate (GA) for the PhI study and on either on GA or Interferon ß for the PhII study. Exclusion criteria (both studies): 1) complete bone marrow ablation or alentuzumab use at any time; 2) mitoxantrone, cyclophosphamide, natalizumab or fingolimod use in the prior nine months; 3) liver problems or significant medical problems. INTERVENTIONS: PhI: Polyphenon E, a green tea extract containing 50% of the antioxidant Epigallocatechin-gallate (EGCG), two capsules twice daily (200mg of EGCG per capsule; total daily dose 800mg) for six months. PhII: Polyphenon E or matching placebo capsules, same dose for one year. Only the research pharmacist knew treatment assignment and she randomized participants (one-to-one, stratified by GA or Interferon ß, blocks of 4 or 6). Outcome evaluators did not discuss side effects with participants. OUTCOME MEASURES: PhI: 1) adverse events (AE); 2) futility: decrease in N-acetyl aspartate (NAA) from baseline to six months of 10% or more; 3) association between EGCG plasma levels and change in NAA. PhII: 1) AEs; 2) difference in the rate of change of NAA-levels over twelve months.We measured NAA using a point resolved magnetic resonance spectroscopic imaging sequence (TE30/TR2000) on a 10cm×10cm×1cm volume of interest (VOI) located just superior to the lateral ventricles. The field of view was 16×16 resulting in 1cm(3) voxels. We quantified NAA and creatine/phosphocreatine (Cr) levels using LCModel for post-processing. RESULTS: PhI: Ten participants enrolled and completed all assessments with no serious AEs. One discontinued therapy due to grade (G) I abnormal liver function tests (LFTs). We included all participants in the analysis. NAA adjusted for creatine increased by 10% [95% CI(3.4%,16.2%), p<0.01] rejecting the futility endpoint. PhII: Thirteen participants enrolled and twelve started treatment. The DSMB stopped the study because 5/7 participants on Polyphenon E had abnormal LFTs (G I, and 1G III). Median time to onset of abnormal LFTs was 20 weeks [Inter-Quartile Range (IQR) (10,23)]. Only two participants completed the six-month visit, so we could not analyze the NAA levels. PhI participants took capsules from lot 189I1107 while 6/7 PhII participants took capsules from a new lot (L0206306). Both lots had similar levels of EGCG but differed in the levels of minor catechins. There were no significant differences between the lots on participants' median free EGCG plasma levels at either 3h or 8h as well as conjugated EGCG levels at 3h (all p>0.4, Wilcoxon exact test). Free EGCG levels at 8h correlated with changes in NAA adjusted by water content. A 1ng/ml higher EGCG plasma concentration correlated with a 0.9% increase in NAA[95% CI(0.5%,1.4%), visit*level interaction F=14.4, p<0.001]. However, EGCG plasma concentrations did not correlate with NAA adjusted by creatine (1ng/ml higher EGCG was associated with 0.02%,[95% CI(-0.27%,0.3%) change in NAA, p>0.5]). There was a trend towards an increase in creatine levels (referenced to water content) from baseline to exit (1 5% increase, [95% CI(-6%,17%), p=0.4]). The free EGCG levels at 8hours correlated significantly with change in creatine levels (1ng/ml higher EGCG level at 8h was associated with a 1.1% increase in creatine [95% CI(0.6%,1.6%)]). Thus it is possible that the discrepancy between the correlation of the EGCG 8h levels with NAA changes referenced to water and the 8h EGCG levels with NAA changes referenced to creatine was due to a change in creatine among the subjects with higher EGCG levels. Conjugated 3h and 8h levels and free 3h levels did not correlate with NAA changes (all p >0.5). CONCLUSIONS/CLASSIFICATION OF EVIDENCE: Class III evidence: Polyphenon E at a dose of 400mg of EGCG twice a day is not futile at increasing brain NAA levels. Class I evidence: some lots of Polyphenon E have a high risk of hepatotoxicity. FUNDING: National Center for Complementary and Alternative Medicine K23AT004433, National Multiple Sclerosis Society RG4816-A-1 and National Institute of General Medical Sciences 1 U54 GM104940. Mitsui Norin provided Polyphenon E and placebo and their representative reviewed the manuscript prior to publication. Mitsui Norin was not involved in other aspects of the study. The decision to submit the manuscript remained with the investigators. REGISTRATION: NCT00836719 and NCT01451723

Stress in multiple sclerosis: review of new developments and future directions.

In the experimental autoimmune encephalitis model of multiple sclerosis, the effects of stress on disease severity depend on multiple factors, including the animal's genetics and the type of stressor. The studies in humans relating stress to the risk of developing multiple sclerosis have found discordant results. The studies looking at the association of stress with relapses show a fairly consistent association, where higher stress is associated with a higher risk of relapse. Higher stress levels also appear to increase the risk of development of gadolinium-enhancing lesions. A recent randomized trial shows that reducing stress using stress management therapy (SMT), a cognitive-behavioral therapy approach, results in a statistically significant reduction in new magnetic resonance imaging lesions. The magnitude of this effect is large and comparable to the effects of existent disease-modifying therapies, but no data exist yet proving that SMT reduces relapses or clinical progression; the effect of SMT appears to be short-lived. Additional work is needed to improve the duration of this effect and make this therapy more widely accessible.