Measuring Soldier Performance During the Patrol-Exertion Multitask: Preliminary Validation of a Postconcussive Functional Return-to-Duty Metric

Objective: To assess the discriminant validity of the Patrol-Exertion Multitask (PEMT), a novel, multidomain, functional return-to-duty clinical assessment for active duty military personnel

Development and Preliminary Reliability of a Multitasking Assessment for Executive Functioning After Concussion

OBJECTIVES. Executive functioning deficits may result from concussion. The Charge of Quarters (CQ) Duty Task is a multitask assessment designed to assess executive functioning in servicemembers after concussion. In this article, we discuss the rationale and process used in the development of the CQ Duty Task and present pilot data from the preliminary evaluation of interrater reliability (IRR)

Development of a Measure to Inform Return-to-Duty Decision Making After Mild Traumatic Brain Injury

Mild traumatic brain injury (mTBI), a principal injury of the wars in Iraq and Afghanistan, can result in significant morbidity. To make accurate return-to-duty decisions for soldiers with mTBI, military medical personnel require sensitive, objective, and duty-relevant data to characterize subtle cognitive and sensorimotor injury sequelae. A military-civilian research team reviewed existing literature and obtained input from stakeholders, end users, and experts to specify the concept and develop a preliminary assessment protocol to address this need. Results of the literature review suggested the potential utility of a test based on dual-task and multitask assessment methods. Thirty-three individuals representing a variety of military and civilian stakeholders/experts participated in interviews. Interview data suggested that reliability/validity, clinical feasibility, usability across treatment facilities, military face validity, and capacity to challenge mission-critical mTBI vulnerabilities were important to ultimate adoption. The research team developed the Assessment of Military Multitasking Performance, a tool composed of eight dual and multitasking test-tasks. A concept test session with 10 subjects indicated preliminary face validity and informed modifications to scoring and design. Further validation is needed. The Assessment of Military Multitasking Performance may fill a gap identified by stakeholders for complex cognitive/motor testing to assist return-to-duty decisions for service members with mTBI

Toward Return to Duty Decision-Making After Military Mild Traumatic Brain Injury: Preliminary Validation of the Charge of Quarters Duty Test

Determining duty-readiness after mild traumatic brain injury (mTBI) remains a priority of the United States Department of Defense as warfighters in both deployed and non-deployed settings continue to sustain these injuries in relatively large numbers. Warfighters with mTBI may experience unresolved sensorimotor, emotional, cognitive sequelae including problems with executive functions, a category of higher order cognitive processes that enable people to regulate goal-directed behavior. Persistent mTBI sequelae interfere with warfighters’ proficiency in performing military duties and signal the need for graded return to activity and possibly rehabilitative services. Although significant strides have been carried out in recent years to enhance the identification and management of mTBI in garrison (EXORD 165–13) and deployed settings (EXORD 242–11; DoDI 6,490.11), the Department of Defense still lacks reliable, valid, and clinically feasible functional assessments to help inform duty-readiness decisions. Traditional functional assessments lack face validity for warfighters and may have ceiling effects, especially as related to executive functions. Performance-based multitasking assessments have been shown to be sensitive to executive dysfunction after acquired brain injury but no multitasking assessments have been validated in adults with mTBI. Existing multitasking assessments are not ecologically valid relative to military contexts. A multidisciplinary military–civilian team of researchers developed and evaluated a performance-based assessment called the Assessment of Military Multitasking Performance. One of the Assessment of Military Multitasking Performance multitasks, the Charge of Quarters Duty Test (CQDT), was designed to challenge the divided attention, foresight, and planning dimensions of executive functions. Here, we report on the preliminary validation results of the CQDT

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

Effect on Gait Speed, Balance, Motor Symptom Rating, and Quality of Life in Those with Stage I Parkinson’s Disease Utilizing LSVT BIG®

Individuals with Parkinson’s Disease (PD) are often not referred to Physical Therapy (PT) until there are issues with mobility in later Hoehn and Yahr Stages. There have been no studies outlining the benefits of PT intervention in Stage I only. For persons with PD, deficits in motor function increase over time due to destruction of dopamine-producing cells. LSVT BIG, an exercise program for PD, has been shown to be effective in improving mobility. The purpose of this study was to assess participants functional improvement at a level of minimal clinically important difference (MCID) in one of four outcome measures: Gait Speed, Berg Balance Assessment, Functional Gait Assessment, and Unified Parkinson’s Disease Rating Scale Motor Section. Case Description. Nine participants with Stage I PD received LSVT BIG 4x/week for 4 weeks followed by bimonthly participation in a community class. Outcome measurement occurred at baseline, after LSVT BIG, and three months after LSVT BIG. Outcomes. Eight of nine participants (88.9%) achieved MCID in at least one of the four measures at both after and 3 months after LSVT BIG training indicating improvement based on our criteria. Participants in Stage I of PD in this study completed LSVT BIG and demonstrated improved function

Composition of a Vision Screen for Servicemembers With Traumatic Brain Injury: Consensus Using a Modified Nominal Group Technique MeSH TERMS brain injuries military personnel vision disorders vision screening

Vision impairment is common in the first year after traumatic brain injury (TBI), including among service members whose brain injuries occurred during deployment in Iraq and Afghanistan. Occupational therapy practitioners provide routine vision screening to inform treatment planning and referral to vision specialists, but existing methods are lacking because many tests were developed for children and do not screen for vision dysfunction typical of TBI. An expert panel was charged with specifying the composition of a vision screening protocol for servicemembers with TBI. A modified nominal group technique fostered discussion and objective determinations of consensus. After considering 29 vision tests, the panel recommended a nine-test vision screening that examines functional performance, self-reported problems, far-near acuity, reading, accommodation, convergence, eye alignment and binocular vision, saccades, pursuits, and visual fields. Research is needed to develop reliable, valid, and clinically feasible vision screening protocols to identify TBI-related vision disorders in adults

Feasibility of Early Functional Rehabilitation in Acute Stroke Survivors using the Balance-Bed – A Technology that Emulates Microgravity

Evidence-based guidelines recommend early functional rehabilitation of stroke patients when risk of patient harm can be managed. Current tools do not allow balance training under load conditions sufficiently low for acute stroke patients. This single-arm pilot study tested feasibility and safety for acute stroke survivors to use Balance-Bed, a technology for balance exercises in supine initially developed to emulate microgravity effects on balance. Nine acute stroke patients (50-79 yrs.) participated in 3-10 sessions over 16-46 days as part of their rehabilitation in a hospital inpatient setting. Standard inpatient measures of outcome were monitored where lack of progress from admission to discharge might indicate possible harm. Total FIM scores at admission (median 40, range 22-53) changed to (74, 50-96), Motor FIM scores from (23, 13-32) to (50, 32-68) and Berg Balance scores from (3, 0-6) to (19, 7-43) at discharge. Changes reached Minimal Clinical Important Difference for a sufficient proportion (>0.6) of the patients to indicate no harm to the patients. In addition, therapists reported the technology was safe, provided a positive experience for the patient and fit within the rehabilitation program. They reported the device should be easier to set up and exit. We conclude acute stroke patients tolerated Balance-Bed exercises such as standing on one or two legs, squats, stepping in place as well as balance perturbations provided by the therapist. We believe this is the first time it has been demonstrated that acute stroke patients can safely perform whole body balance training including balance perturbations as part of their rehabilitation program. Future studies should include a control group and compare outcomes from best practices to interventions using the Balance-Bed. In addition, the technology is relevant for countermeasure development for spaceflight and as a test-bed of balance function under microgravity-like conditions