Reproducibility and Convergent Validity of the Sitting-Rising Test in People With Multiple Sclerosis

ObjectiveTo evaluate the test-retest reproducibility and convergent validity of the sitting-rising test (SRT) in people with multiple sclerosis (PwMS).DesignObservational study comprising a test-retest design.SettingMultiple Sclerosis Center, Rehabilitation Hospital at Sheba Medical Center, Tel-Hashomer, Israel.ParticipantsA total of 50 PwMS (32 women, 18 men, N=50), mean age 44.8±7.6 years and mean disease duration of 13.8±8.5 years since diagnosis, were enrolled in the study. The median Expanded Disability Status Scale score was 4.5, indicating a mild-moderate neurologic disability.InterventionsNot applicable.Main Outcome MeasuresSRT, posturography measures, 10-repetion sit-to-stand test (10STS), timed Up and Go (TUG) test, hand grip strength, strength of hip flexion/extension/abduction, knee flexion/extension, and Fall Status Questionnaire.ResultsThe intraclass correlation coefficient value for the intrarater test-retest reproducibility (7- to 10-day interval between tests) of the SRT test, was 0.931 (95% confidence interval, 0.796-0.977). Strong correlations were found between the SRT, TUG test (ρ=−0.709), and 10STS (ρ=−0.719), and moderate correlations were found between the SRT and postural control measures (ρ∼0.4). Moderate correlations were found between the SRT and the hip and knee strength (combined) of the weaker limb (ρ=0.344). No differences were found in the SRT score between fallers and nonfallers.ConclusionsThe current study supports the convergent validity and test-retest reproducibility of the SRT in PwMS.     

Drug Treatment,Postural Control,and Falls: An Observational Cohort Study of 504 Patients With Acute Stroke,the Fall Study of Gothenburg

ObjectiveTo identify whether, and to what extent, treatment with cardiovascular drugs and neurotropic drugs are associated with postural control and falls in patients with acute stroke.DesignObservational cohort study.SettingA stroke unit at a university hospital.ParticipantsA consecutive sample of patients (N=504) with acute stroke.InterventionsNot applicable.Main Outcome MeasuresPostural control was assessed using the modified version of the Postural Assessment Scale for Stroke Patients. Data including baseline characteristics, all drug treatments, and falls were derived from medical records. Univariable and multivariable logistic regression and Cox proportional hazards models were used to analyze the association of drug treatment and baseline characteristics with postural control and with falls.ResultsIn the multivariable logistic regression analysis, factors significantly associated with impaired postural control were treatment with neurotropic drugs (eg, opioids, sedatives, hypnotics, antidepressants) with an odds ratio (OR) of 1.73 (95% confidence interval [CI], 1.01-2.97, P=.046); treatment with opioids (OR 9.23, 95% CI, 1.58-54.00, P=0.014); age (OR 1.09, 95% CI, 1.07-1.12, P<.0001), stroke severity, which had a high National Institutes of Health Stroke Scale-score (OR 1.29, 95% CI, 1.15-1.45, P<.0001), and sedentary life style (OR 4.32, 95% CI, 1.32-14.17, P=.016). No association was found between neurotropic drugs or cardiovascular drugs and falls.ConclusionsTreatment with neurotropic drugs, particularly opioids, in the acute phase after stroke, is associated with impaired postural control. Since impaired postural control is the major cause of falls in patients with acute stroke, these results suggest opioids should be used with caution in these patients.     

Brain Injury Functional Outcome Measure (BI-FOM): A Single Instrument Capturing the Range of Recovery in Moderate-Severe Traumatic Brain Injury

ObjectiveTo develop a measure of global functioning after moderate-severe TBI with similar measurement precision but a longer measurement range than the FIM.DesignPhase 1: retrospective analysis of 5 data sets containing FIM, Disability Rating Scale, and other assessment items to identify candidate items for extending the measurement range of the FIM; Phase 2: prospective administration of 49 candidate items from phase 1, with Rasch analysis to identify a unidimensional scale with an extended range.SettingSix TBI Model System rehabilitation hospitals.ParticipantsIndividuals (N=184) with moderate-severe injury recruited during inpatient rehabilitation or at 1-year telephone follow-up.InterventionsParticipants were administered the 49 assessment items in person or via telephone.Main Outcome MeasuresItem response theory parameters: item monotonicity, infit/outfit statistics, and Factor 1 variance.ResultsAfter collapsing misordered rating categories and removing misfitting items, we derived the Brain Injury Functional Outcome Measure (BI-FOM), a 31-item assessment instrument with high reliability, greatly extended measurement range, and improved unidimensionality compared with the FIM.ConclusionsThe BI-FOM improves global measurement of function after moderate-severe brain injury. Its high precision, relative lack of floor and ceiling effects, and feasibility for telephone follow-up, if replicated in an independent sample, are substantial advantages.     

Tricuspid Regurgitation Impact on Outcomes (TRIO): A Simple Clinical Risk Score

ObjectiveTo determine which clinical variables infer the highest risk for mortality in patients with notable tricuspid regurgitation (TR) and to develop a clinical assessment tool (the Tricuspid Regurgitation Impact on Outcomes [TRIO] score).Patients and MethodsA single-center retrospective cohort of 13,608 patients with undifferentiated moderate to severe TR at the time of index echocardiography between January 1, 2005, and December 31, 2016, was included. Baseline demographic and clinical data were obtained. Patients were randomly assigned to a training (N=10,205) and a validation (N=3403) cohort. Median follow-up was 6.5 years (interquartile range, 0.8 to 11.0 years). Variables associated with mortality were identified by Cox proportional hazards methods. A geographically distinct cohort of 7138 patients was used for further validation. The primary end point was all-cause mortality over 10 years.ResultsThe 5-year probability of death was 53% for moderate TR, 63% for moderate-severe TR (hazard ratio [HR], 1.24 [95% CI, 1.17 to 1.31]; P<.001 vs moderate), and 71% for severe TR (HR, 1.55 [95% CI, 1.47 to 1.64]; P<.001 vs moderate). Factors associated with all-cause mortality on multivariate analysis included age 70 years or older, male sex, creatinine level greater than 2 mg/dL, congestive heart failure, chronic lung disease, aspartate aminotransferase level of 40 U/L or greater, heart rate of 90 beats/min or greater, and severe TR. Variables were assigned 1 or 2 points (HR, >1.5) and added to compute the TRIO score. The score was associated with all-cause mortality (C statistic = 0.67) and was able to separate patients into risk categories. Findings were similar in the second, independent and geographically distinct cohort.ConclusionThe TRIO score is a simple clinical tool for risk assessment in patients with notable TR. Future prospective studies to validate its use are warranted.     

Cognitive-Motor Interference Heightens the Prefrontal Cortical Activation and Deteriorates the Task Performance in Children With Hemiplegic Cerebral Palsy

ObjectiveTo compare the prefrontal cortex (PFC) activation and task performance during single- and dual-task conditions between typically developing (TD) children and children with hemiplegic cerebral palsy (HCP).DesignA prospective, comparative design.SettingResearch laboratory.ParticipantsParticipants (N=21) included 12 TD children (age, 6.0±1.1y) and 9 children with HCP (age, 7.2±3.1).InterventionsNot applicable.Main Outcome MeasuresPFC activation was assessed by measuring the concentration of oxygenated hemoglobin while the children performed a shape-matching task with their more affected arm while sitting on a stable (single task) vs dynamic surface (dual task). The task performance was assessed with the total number of shapes matched, dual-task cost, and reaction time (RT).ResultsFor both conditions, the children with HCP exhibited greater PFC activation, matched a fewer shapes, and had slower RT than the TD children. These differences were accentuated during the dual-task condition and the dual-task cost was greater. An increase in the PFC activation during the dual-task condition was tightly correlated with a higher dual-task cost in children with HCP (r=0.77, P=.01).ConclusionsChildren with HCP appear to have a heightened amount of PFC activity while performing a dual task. The greater cortical activity may be a result of the finite attentional resources that are shared between both the motor as well as cognitive demands of the task. The cognitive-motor interference is likely exacerbated in children with HCP because of the structural and functional brain changes as a result of an insult to the developing brain.     

Prospective Blinded Evaluation of Patient-Physician Agreement Using the Summary Outcome Determination (SOD) Score

ObjectiveTo determine whether the Summary Outcome Determination (SOD) score demonstrates a high level of physician-patient agreement in a prospective setting with multiple raters.Patients and MethodsFor this study, 100 patients who were being evaluated at various intervals following shoulder or elbow surgery were prospectively enrolled from May 30, 2017, through August 31, 2017. The patients’ attending physicians and a member of their team (physician assistant, resident, fellow, medical student) assigned categorical and numerical SOD scores while blinded to the scores given by each other. All scores were analyzed among raters, assessing internal consistencies, agreement, and reliability.ResultsThe mean follow-up (interval between surgery and completion of the survey) was 31 months, with a range of 1 to 220 months. The intraclass correlation coefficient for patient and physician numerical scores was excellent at 0.82. The weighted κ value for categorical scores was 0.64. Bland-Altman analysis revealed low average discrepancy at 0.6 with a 95% CI of −3.3 to 4.5. The Cronbach α value was 0.94, indicating strong internal validity. The categorical physician-patient agreement occurred within one category 96% of the time.ConclusionThis study found that the SOD score has strong agreement with excellent intraclass correlation coefficient and weighted κ values, indicating substantial agreement, reproducibility (shown by low average error), and strong internal validity. With promising results in the prospective setting, the SOD score was found to be an easy to use outcome measure with reliable agreement between patient and physician. This score has potential to be a metric revealing the “value” of a specific surgical intervention.     

Intradialytic Resistance Training Improves Functional Capacity and Lean Mass Gain in Individuals on Hemodialysis: A Randomized Pilot Trial

ObjectiveTo compare the effects of high vs moderate loads of intradialytic resistance training (RT) on body composition, sarcopenia prevalence, functional capacity, inflammatory markers, and quality of life (QoL) in individuals on hemodialysis.DesignA pilot randomized clinical trial.SettingTwo hemodialysis centers.ParticipantsIndividuals on hemodialysis (N=80; 51% men, aged 30-75y) in treatment for at least 3 months, adequately dialyzed (Kt/V≥1.2, where K is dialyzer clearance in mL/min, t is time, and V is volume of water) with vascular access via arteriovenous fistula.InterventionsThe 12 weeks of intradialytic RT was performed 3 times per week. The training groups were: high-load intradialytic group (HLG, 8-10 repetitions), moderate-load intradialytic group (MLG, 16-18 repetitions), and control group (CG, stretching exercise). The total training volume was equalized among training groups.Main Outcome MeasuresLean leg mass was assessed by a dual-energy x-ray absorptiometry; functional capacity was assessed by Short Physical Performance Battery and Timed Up and Go test; and QoL was assessed by Kidney Disease QoL Instrument, inflammatory markers, and sarcopenia.ResultsAfter the training period, the HLG increased lean leg mass compared with the CG. The HLG also displayed improvements in the pain and physical function domains. The skeletal muscle index and functional capacity increased in both RT protocols. The prevalence of sarcopenia was reduced 14.3% and 25% in the MLG and HLG, respectively, while there was an increase of 10% in the CG. No differences were observed in cytokines after intervention.ConclusionsHigh-load intradialytic RT was associated with gains in lean leg mass and QoL while functional capacity, appendicular muscle mass, and sarcopenia status were improved regardless of the RT load.     

Association of Right Ventricular Functional Parameters With Adverse Cardiopulmonary Outcomes: A Meta-analysis

Better association of 3D echocardiography–derived RVEF versus conventional metrics of RV systolic function with adverse clinical outcomes: a meta-analysis of 10 studies.

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Real-Life Evaluation of an Algorithm for the Diagnosis of Cardiac Amyloidosis

ObjectiveTo evaluate the real-life use of a modified Gillmore algorithm with a "one-stop-shop” approach, bone scintigraphy (BS), a monoclonal gammopathy test (GT), a salivary gland biopsy (SGB), and genetic testing performed at the same time for the diagnosis of cardiac amyloidosis at the French National Reference Centre for Cardiac Amyloidosis (Henri Mondor Hospital, Créteil, France).MethodsThis retrospective cohort study included a total of 1222 patients with suspected amyloidosis who underwent BS and GT between June 2008 and May 2019.ResultsOf 1222 patients, 349 had no cardiac uptake on BS and negative GT (BS?/GT?), 276 were BS?/GT positive (GT+), 420 patients were BS+/GT?, and 177 were BS+/GT+. Our one-stop-shop check-up enabled us to diagnose 892 (72.9%) patients; 330 (27.0%) patients required additional examinations, such as mass spectrometry and/or a cardiac biopsy. This subset notably included 112 patients with amyloid light chain amyloidosis. More than 64% of the patients with transthyretin amyloidosis or another type of amyloidosis were diagnosed during the one-stop shop visit. Sensitivity and specificity of BS for transthyretin amyloidosis diagnosis was 99% and 96%, respectively. For amyloid light chain diagnosis, sensitivity and specificity were 100% and 76%, respectively, for GT and 54% and 100%, respectively, for SGB. Of 910 transthyretin genetic tests, 205 (17%) detected mutations.ConclusionThe results of our real-life cohort study confirmed the ability of a one-stop-shop approach with a modified Gillmore algorithm to diagnose cardiac amyloidosis and the interest of simultaneous testing for earlier diagnosis. The SGB has diagnostic value because it is easy, quick, and less invasive than a cardiac biopsy.     

Functional Regurgitation of Atrioventricular Valves and Atrial Fibrillation: An Elusive Pathophysiological Link Deserving Further Attention

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Tracking Spinal Cord Injury Functional Outcomes Across the Lifespan: Validation of Linking Coefficients

ObjectiveValidation of linking coefficients to transform Pediatric Spinal Cord Injury Activity Measure (PEDI-SCI/AM) scores to adult Spinal Cord Injury-Functional Index (SCI-FI) scores.DesignThis cross-sectional study administered PEDI-SCI/AM and SCI-FI computerized adaptive tests (CATs) and short forms (SFs) to children with SCI and parents or caregivers.SettingHospitals, university, and rehabilitation institute.ParticipantsAbout 107 children with SCI and 96 parent or caregivers.InterventionsNot applicable.Main Outcome MeasuresLinking coefficients estimated SCI-FI (est-SCI-FI) scores from PEDI-SCI/AM scores for matched domains. Correlations between est-SCI-FI and actual SCI-FI scores were calculated. If correlations exceeded the criterion linking (0.866), the following analyses to compare est-SCI-FI and actual SCI-FI scores were conducted: paired t tests, intraclass correlation coefficients (ICCs 3, 1), percent of cases with absolute score differences at different thresholds.ResultsTwo matched domains, PEDI-SCI/AM Daily Routine/SCI-FI Self-Care and PEDI-SCI/AM General Mobility/SCI-FI Basic Mobility, met the linking criterion for both respondent-types (parent and child) and administration modes (CAT and SF). PEDI-SCI/AM Daily Routine and SCI-FI Fine Motor Function did not meet linking criterion for respondent type or mode. The linking criterion was met for wheelchair domains (child SF and CAT) and ambulation domains (child SF only). Significant differences between est-SCI-FI and actual SCI-FI scores were noted for all matched domains except Daily Routine/Self-Care (child SF only; parent SF and CAT). ICC values showed excellent agreement (range=0.75-0.89). Absolute differences between est-SCI-FI and actual SCI-FI scores were less than 1 standard deviation (except wheelchair CAT child).ConclusionsLinking coefficients applied to PEDI-SCI/AM scores can provide valid SCI-FI estimates that vary by domain, mode, and respondent type.     

Drug use investigation on the safety and efficacy of tigecycline in Japan (all-case post-marketing surveillance)

IntroductionWe conducted a drug use investigation to investigate the safety and efficacy of tigecycline, which has been approved for clinical use for the treatment of multidrug-resistant gram-negative infections in Japan.MethodsThis was an open-label, observational, multicenter cohort study that included all patients who received tigecycline.ResultsA total of 116 patients were registered between December 2012 and April 2016 and all of them were evaluated for safety and efficacy. Among them, 64 patients aged ≥65 years (55.2%) and five children aged <15 years (4.3%) were included. Of these patients, 47 (40.5%) met the approved indications of tigecycline. Adverse drug reactions (ADRs) were observed in 41 patients (35.3%) with a total of 74 events. Serious ADRs were observed in 15 patients (12.93%) with a total of 33 events. There were 42 deaths, and 6 of these were considered to be caused by ADRs. Among the 116 patients, 65 achieved clinical response at the end of the observation period, and the efficacy rate was 73.9%. Furthermore, 46 patients were assessed as “cure” at the test of cure visit, and the cure rate was 59.0%. The eradication rate was 47.5% at the end of the observation period. Classified by pathogenic bacteria, the eradication rate of patients infected with the approved pathogens was 54.5%.ConclusionsTigecycline was well-tolerated, and no additional safety concerns were noted. It was effective considering that most patients had poor physical conditions. The overall benefit–risk balance of tigecycline was favorable.