Research Spotlight

Driver, S., M. Reynolds and K. Kramer (2017). “Modifying an evidence-based lifestyle programme for individuals with traumatic brain injury.” Brain Inj: 1-5.

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OBJECTIVE: Individuals with traumatic brain injury (TBI) are at a risk of obesity-related chronic diseases; yet, no evidence-based strategies exist to support weight management in this population. The purpose of this study was to use participatory action research to modify the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) programme for overweight/obese people with TBI. The DPP-GLB programme provides education and self-management skills for individuals to reach their lifestyle goals through healthy eating and physical activity. METHODS: A committee of 10 stakeholders including clinicians, patients and caregivers reviewed and modified the DPP-GLB for overweight/obese individuals with TBI. Stakeholders suggested modifications to the content, layout, format, language, behaviour-changing strategies and delivery approaches. The group also provided input on research applications of the modified DPP-GLB including recruitment strategies, study design and patient-centred outcome measures. RESULTS: Strategies for successful implementation in this population focused on determining (1) eligibility criteria for programme inclusion and (2) adaptations to the DPP-GLB curriculum including caregiver involvement, TBI-specific physical activity and nutrition recommendations and tracking and presentation of the content. CONCLUSIONS: If it is shown to be effective in this population, the modified DPP-GLB for TBI will provide a model for implementation in a variety of community settings.

Fox, R. J., R. Gold, J. T. Phillips, M. Okwuokenye, A. Zhang and J. L. Marantz (2017). “Efficacy and tolerability of delayed-release dimethyl fumarate in black, hispanic, and asian patients with relapsing-remitting multiple sclerosis: Post hoc integrated analysis of define and confirm.” Neurol Ther: 2017 Aug [Epub ahead of print].

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INTRODUCTION: Clinical course and treatment response may vary according to race/ethnicity in multiple sclerosis (MS) patients. Delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) demonstrated significant efficacy and a favorable benefit-risk profile in relapsing-remitting MS (RRMS) patients in the 2-year phase III DEFINE/CONFIRM studies. METHODS: In this post hoc analysis of integrated data from DEFINE/CONFIRM, we assessed clinical efficacy and safety/tolerability in black, Hispanic, and Asian patients treated with DMF 240 mg twice daily (approved dosage) or placebo. Eligible patients were 18-55 years of age with an Expanded Disability Status Scale score of 0-5.0. In the integrated intention-to-treat population, 769 and 771 patients were treated with DMF or placebo, respectively, of whom 10 and 19 were black, 31 and 23 were Hispanic, and 66 and 70 were Asian. RESULTS: In the black, Hispanic, and Asian subgroups, DMF was associated with lower annualized relapse rates at 2 years compared with placebo [rate ratio (95% confidence interval (CI)), 0.05 (0.00-1.07); 0.31 (0.10-0.95); and 0.64 (0.30-1.34), respectively]. The percentage of black, Hispanic, and Asian patients with 12-week confirmed disability progression was lower with DMF (43%, 8%, and 20%, respectively) compared with placebo [57%, 30%, and 25%, respectively; hazard ratio (95% CI), 0.53 (0.02-1.39); 0.17 (0.00-0.60); and 0.71 (0.32-1.58), respectively]. The safety/tolerability profile of DMF was generally consistent with that in the overall population of DEFINE/CONFIRM. The incidence of adverse events leading to treatment discontinuation in black, Hispanic, and Asian patients was 2/10, 2/31, and 3/66, respectively, with DMF, and 2/19, 1/23, and 8/70, respectively, with placebo. CONCLUSION: DMF may be an efficacious treatment with a favorable benefit-risk profile in black, Hispanic, and Asian patients with RRMS. Further clinical studies are needed to characterize differences in MS presentation and treatment outcomes across ethnic and racial groups.

Gable, D. R. (2017). “Managing claudication in the community setting.” J Vasc Surg 66(2): 638-641.

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Advances made in medical management and treatment options in addressing lower extremity claudication and vascular disease have skyrocketed during the last decade. Given the recent advances in treatment options, there is often the perception within the medical community and general community that to get the most “cutting edge” treatment, one must go to an academic center or practitioner. The goal of this portion of the discussion is to explore the question of what differences in treatment options there are between a community practice and an academic practice within those members of the vascular surgery specialty. Are there really any differences in the types of treatments offered or availability of the different modalities, and what drives us as practitioners to one over the other?

Gandhi, M. J., D. Ferriola, C. Lind, J. L. Duke, A. Huynh, A. Papazoglou, K. Mackiewicz, M. Christiansen, W. Dong, S. Hsu, D. Thomas, B. Schneider, E. Pierce, J. Kearns, M. Kamoun, D. Monos and M. Askar (2017). “Assessing a single targeted next generation sequencing for human leukocyte antigen typing protocol for interoperability, as performed by users with variable experience.” Hum Immunol: 2017 Jul [Epub ahead of print].

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BACKGROUND: A simplified protocol for HLA-typing -by NGS, developed for use with the Illumina MiSeq, was performed by technologists with varying NGS experience to assess accuracy and reproducibility. METHODS: Technologists from six laboratories typed the same 16 samples at HLA-A, B, C, DRB1, and DQB1. The protocol includes long range PCR, library preparation, and paired-end 250bp sequencing. Two indexing strategies were employed: locus-specific indexing whereby each locus was tagged uniquely and sample-specific indexing whereby all 5 loci for a sample were pooled prior to library preparation. Sequence analysis was performed with two software packages, Target HLA (Omixon) and NGSengine (GenDx). RESULTS: The average number of sequence reads per library was 387,813; however, analysis was limited to 40,000 reads for locus-indexed libraries and 200,000 reads for sample-indexed libraries resulting in an average depth of coverage of 1444 reads per locus. Sufficient reads for genotype analysis were obtained for 98.4% of libraries. Genotype accuracy was >97% in pooled amplicons and >99% in individual amplicons by both software analysis. Inter-laboratory reproducibility was 99.7% and only cause of discordance was cross-contamination of a single amplicon. CONCLUSIONS: This NGS HLA-typing protocol is simple, reproducible, scalable, highly accurate and amenable to clinical testing.

Carmichael, J. C., D. S. Keller, G. Baldini, L. Bordeianou, E. Weiss, L. Lee, M. Boutros, J. McClane, L. S. Feldman and S. R. Steele (2017). “Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the american society of colon and rectal surgeons and society of american gastrointestinal and endoscopic surgeons.” Dis Colon Rectum 60(8): 761-784.

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This clinical practice guideline represents a collaborative effort between the American Society of Colon and Rectal Surgeons (ASCRS) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The Clinical Practice Guidelines Committee of the ASCRS is composed of society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. In a collaborative effort, the ASCRS Clinical Practice Guidelines Committee and members of the SAGES SMART (Surgical Multimodal Accelerated Recovery Trajectory) Enhanced Recovery Task Force and Guidelines Committee have joined together to produce this guideline written and approved by both societies. The combined ASCRS/SAGES panel worked together to develop the statements in this guideline and approved these final recommendations. Through this effort, the ASCRS and SAGES continue their dedication to ensuring high quality perioperative patient care.