Measures of Motor and Functional Skills for Children With Cerebral Palsy: A Systematic Review.

PURPOSE: To review the level of evidence of the psychometric properties of outcome measures for motor or functional skills for children with cerebral palsy classified across I to V levels of the Gross Motor Function Classification System. METHODS: A systematic search was completed in PubMed/MEDLINE, ISI Web of Science, CINAHL, and 4 complementary databases. The COSMIN Risk of Bias checklist and the updated criteria for good measurement properties were applied to assess the quality. RESULTS: Four outcome measures were identified from 12 articles: Gross Motor Function Measure, Gross Motor Performance Measure, Pediatric Evaluation of Disability Inventory, and Functional Independence Measure for Children. Evidence levels for validity, reliability, and responsiveness varied among measures. CONCLUSIONS: Gross Motor Function Measure in all versions was the most investigated measure providing the best results, with the strongest evidence for validity and responsiveness properties. Reliability evidence should be improved to determine stability.

Prevalence of resistance associated substitutions and efficacy of baseline resistance-guided chronic hepatitis C treatment in Spain from the GEHEP-004 cohort.

Treatment guidelines differ in their recommendation to determine baseline resistance associated substitutions (RAS) before starting a first-line treatment with direct-acting antivirals (DAAs). Here we analyze the efficacy of DAA treatment with baseline RAS information. We conducted a prospective study involving 23 centers collaborating in the GEHEP-004 DAA resistance cohort. Baseline NS5A and NS3 RASs were studied by Sanger sequencing. After issuing a comprehensive resistance report, the treating physician decided the therapy, duration and ribavirin use. Sustained virological response (SVR12) data are available in 275 patients. Baseline NS5A RAS prevalence was between 4.3% and 26.8% according to genotype, and NS3 RASs prevalence (GT1a) was 6.3%. Overall, SVR12 was 97.8%. Amongst HCV-GT1a patients, 75.0% had >800,000 IU/ml and most of those that started grazoprevir/elbasvir were treated for 12 weeks. In genotype 3, NS5A Y93H was detected in 9 patients. 42.8% of the HCV-GT3 patients that started sofosbuvir/velpatasvir included ribavirin, although only 14.7% carried Y93H. The efficacy of baseline resistance-guided treatment in our cohort has been high across the most prevalent HCV genotypes in Spain. The duration of the grazoprevir/elbasvir treatment adhered mostly to AASLD/IDSA recommendations. In cirrhotic patients infected with GT-3 there has been a high use of ribavirin.

[Effect of quinua (Chenopodium quinoa)consumption as a coadjuvant in nutritional intervention in prediabetic subjects]. / Efecto del consumo de quinua (Chenopodium quinoa)como coadyuvante en la intervención nutricional en sujetos prediabéticos.

INTRODUCTION: Quinoa is a pseudocereal containing low glycemic index carbohydrates, dietary fiber, high biological value protein, phytosterols, and n-3 and n-6 fatty acids, which has generated interest in prediabetes nutritional interventions. This randomized (2:1), placebo-controlled, double-blind study evaluated the effects of processed quinoa on body mass index (BMI), glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) and the satiation and fullness (complete) degree in prediabetic patients. MATERIAL AND METHOD: Thirty patients were randomized (2:1) in two study arms: Kuska Active product (processed quinoa) and placebo (maltodextrin), with an intake period of 28 days. BMI, HbA1c and FPG were determined before starting treatment and at 28-day intake. Satiety and fullness sensation were just assessed by visual analog scale (VAS) at the day 28. ANOVA was performed for repeated measures with two factors to study (within-subject factor: time; intersubject factor: product consumed) to demonstrate the effectiveness of processed quinoa on the study variables. RESULTS: Twenty-nine patients (placebo, n = 10; quinoa, n = 19) completed the study, and the quinoa group shows a significant decrease in BMI (p < 0.05) and HbA1c values (p < 0.001), and an increase in the satiation and fullness (complete) degree (p < 0.001). No significant differences were found in FPG levels from baseline to post-intake period. CONCLUSIONS: The results show that processed quinoa intake during 28 days decreases BMI and HbA1c levels, maintains FPG levels, and incr eases the satiation and fullness (complete) degree in prediabetic patients.

Efecto del consumo de quinua (Chenopodium quinoa) como coadyuvante en la intervención nutricional en sujetos prediabéticos / Effect of quinua (Chenopodium quinoa) consumption as a coadjuvant in nutritional intervention in prediabetic subjects

Introducción: la quinua es un pseudocereal que contiene hidratos de carbono de bajo índice glucémico, fibra alimentaria, proteínas de alto valor biológico, fitoesteroles y ácidos grasos n-3 y n-6, y que ha suscitado interés en la intervención nutricional de la prediabetes. Este estudio aleatorizado (2:1), controlado con placebo y doble ciego, evaluó los efectos de la quinua sobre el índice de masa corporal (IMC), hemoglobina glicada (HbA1c), glucemia basal (GB) y el grado de saciedad y plenitud en pacientes prediabéticos. Material y método: se aleatorizaron (2:1) 30 pacientes en dos ramas a estudio: el producto Kuska Active (quinua procesada) y placebo (maltodextrina). El periodo de ingesta fue de 28 días. Antes de iniciar el tratamiento y a los 28 días se determinó el IMC, HbA1c y la GB. La sensación de saciedad y plenitud se evaluó mediante escala visual analógica (EVA). Para demostrar la eficacia de la quinua procesada Kuska Active sobre las variables a estudio se realizó ANOVA para medidas repetidas con dos factores a estudio (factor intrasujeto: tiempo y factor intersujeto: producto consumido). Resultados: finalizaron el estudio un total de 29 pacientes (placebo, n = 10; quinua, n = 19). Se detectó en el grupo quinua procesada una disminución significativa en los valores de IMC (p < 0,05) y HbA1c (p < 0,001) y un aumento en la sensación de saciedad y plenitud (p < 0,001). No se encontraron diferencias significativas en los niveles de GB desde el momento basal hasta el periodo postingesta. Conclusiones: los resultados muestran que la quinua procesada disminuye el IMC y los niveles de HbA1c, mantiene los niveles de GB y aumenta la sensación de saciedad y plenitud en pacientes prediabéticos (AU)

Introduction: Quinoa is a pseudocereal containing low glycemic index carbohydrates, dietary fiber, high biological value protein, phytosterols, and n-3 and n-6 fatty acids, which has generated interest in prediabetes nutritional interventions. This randomized (2:1), placebo-controlled, double-blind study evaluated the effects of processed quinoa on body mass index (BMI), glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) and the satiation and fullness (complete) degree in prediabetic patients. Material and method: Thirty patients were randomized (2:1) in two study arms: Kuska Active product (processed quinoa) and placebo (maltodextrin), with an intake period of 28 days. BMI, HbA1c and FPG were determined before starting treatment and at 28-day intake. Satiety and fullness sensation were just assessed by visual analog scale (VAS) at the day 28. ANOVA was performed for repeated measures with two factors to study (within-subject factor: time; intersubject factor: product consumed) to demonstrate the effectiveness of processed quinoa on the study variables. Results: Twenty-nine patients (placebo, n = 10; quinoa, n = 19) completed the study, and the quinoa group shows a significant decrease in BMI (p < 0.05) and HbA1c values (p < 0.001), and an increase in the satiation and fullness (complete) degree (p < 0.001). No significant differences were found in FPG levels from baseline to post-intake period. Conclusions: The results show that processed quinoa intake during 28 days decreases BMI and HbA1c levels, maintains FPG levels, and increases the satiation and fullness (complete) degree in prediabetic patients (AU)

Efficacy and safety of daclatasvir-based antiviral therapy in hepatitis C virus recurrence after liver transplantation. Role of cirrhosis and genotype 3. A multicenter cohort study.

Direct-acting antiviral agents (DAA) combining daclatasvir (DCV) have reported good outcomes in the recurrence of hepatitis C virus (HCV) infection after liver transplant (LT). However, its effect on the severe recurrence and the risk of death remains controversial. We evaluated the efficacy, predictors of survival, and safety of DAC-based regimens in a large real-world cohort. A total of 331 patients received DCV-based therapy. Duration of therapy and ribavirin use were at the investigator's discretion. The primary end point was sustained virological response (SVR) at week 12. A multivariate analysis of predictive factors of mortality was performed. Intention-to-treat (ITT) and per-protocol SVR were 93.05% and 96.9%. ITT-SVR was lower in cirrhosis (n = 163) (96.4% vs. 89.6% P = 0.017); the SVR in genotype 3 (n = 91) was similar, even in advanced fibrosis (96.7% vs. 88%, P = 0.2). Ten patients (3%) experienced virological failure. Therapy was stopped in 18 patients (5.44%), and ten died during treatment. A total of 22 patients (6.6%) died. Albumin (HR = 0.376; 95% CI 0.155-0.910) and baseline MELD (HR = 1.137; 95% CI: 1.061-1.218) were predictors of death. DCV-based DAA treatment is efficacious and safe in patients with HCV infection after LT. Baseline MELD score and serum albumin are predictors of survival irrespective of viral response.

Three-Dimensional Morphology of the Left Ventricular Outflow Tract: Impact on Grading Aortic Stenosis Severity.

BACKGROUND: Left ventricular outflow tract (LVOT) measurement is a critical step in the quantification of aortic valve area. The assumption of a circular morphology of the LVOT may induce some errors. The aim of this study was to assess the three-dimensional (3D) morphology of the LVOT and its impact on grading aortic stenosis severity. METHODS: Fifty-eight patients with aortic stenosis were studied retrospectively. LVOT dimensions were measured using 3D transesophageal echocardiography at three levels: at the hinge points (HP) of the aortic valve and at 4 and 8 mm proximal to the annular plane. Results were compared with standard two-dimensional echocardiographic measurements. RESULTS: Three-dimensional transesophageal echocardiography showed a funnel shape that was more circular at the HP and more elliptical at 4 and 8 mm proximal to the annular plane (circularity index = 0.92 vs 0.83 vs 0.76, P < .001). Cross-sectional area was smaller at the HP and larger at 4 and 8 mm from the annular plane (3.6 vs 3.9 vs 4.1 cm2, P = .001). The best correlation between two-dimensional and 3D transesophageal echocardiographic dimensions was at the HP (intraclass correlation coefficient = 0.75; 95% CI, 0.59-0.86). When the HP approach was selected, there was a reduction in the percentage of patients with low flow (from 41% to 29%). CONCLUSIONS: A large portion of patients with aortic stenosis have funnel-shaped and elliptical LVOTs, a morphology that is more pronounced in the region farther from the annular plane. Two-dimensional LVOT measurement closer to the annular plane has the best correlation with 3D measurements. Measurement of the LVOT closer to the annular plane should be encouraged to reduce measurement errors.

Digestion-resistant maltodextrin effects on colonic transit time and stool weight: a randomized controlled clinical study.

PURPOSE: Increased awareness of the importance of dietary fibre has led to increased interest in "functional" fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). METHODS: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. RESULTS: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline (p < 0.01 each; -13.3, -4.7, -8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume (p = 0.014), increasing 56 % compared to baseline (p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group (p < 0.01). No adverse effects related to study products were observed. CONCLUSIONS: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population.

Impact of tacrolimus and mycophenolate mofetil regimen vs. a conventional therapy with steroids on cardiovascular risk in liver transplant patients.

The aim of this study was to evaluate the impact of a steroid-free regimen with tacrolimus and mycophenolate mofetil (modified therapy) vs. a standard regimen of tacrolimus and steroids on the cardiovascular risk score of liver transplant recipients. Patients who received a liver transplant were randomized to a modified therapy (n = 58) or a standard regimen (n = 59). Both groups were balanced at baseline, except for a higher prevalence of diabetes mellitus (DM) (p < 0.01) and a higher serum creatinine concentration (p < 0.05) in the modified therapy group. After 12 months, the prevalence of new-onset DM, arterial hypertension, hypercholesterolemia, hypertriglyceridemia, and changes in cardiovascular risk factors was similar in both groups. The increase in serum creatinine (mg/dL) compared to baseline at one yr post-transplantation was numerically lower in the modified therapy group (0.22 ± 0.42) than in the standard regimen group (0.41 ± 0.67) (p = 0.068). Although estimated cardiovascular risk score did not vary significantly compared to baseline in either group, there was a slight reduction in the modified regimen (-0.27 ± 2.87) vs. a mild increase (0.17 ± 2.94) in the standard regimen (p = 0.566). In conclusion, a steroid-free regimen with tacrolimus and mycophenolate mofetil was associated with a trend toward better preservation of kidney function and reduction of cardiovascular risk score.

Influence of aortic regurgitation after TAVI on left ventricular filling pattern.

BACKGROUND: Paravalvular aortic regurgitation after transcatheter aortic valve implantation is associated with a hemodynamic deterioration and a poor outcome. We aim to determine the early hemodynamic effect of paravalvular aortic regurgitation in relation with the change in the left ventricle filling pattern and to assess their clinical outcome. MATERIAL AND METHODS: Eighty-two consecutive patients referred for transcatheter aortic valve implantation were included. Patients were classified according to the change in the left ventricular filling pattern, and significant paravalvular aortic regurgitation (grade ≥ 2) was reported. Follow-up and incidence of death and hospitalization for heart failure were reported. RESULTS: Sixteen patients (19·5%) presented a worsening of left ventricular filling pattern. The incidence of significant paravalvular aortic regurgitation was higher in the group with a worsening of left ventricular filling pattern (56·3% vs. 19·7%; P = 0·009). In the multivariate analysis, the only variable significantly associated with the worsening of left ventricular filling pattern was the significant paravalvular aortic regurgitation (OR 4·84; 95% CI 1·23 - 19·1; P = 0·024). During the follow-up (642·5 days), there was a higher incidence of the endpoint of death or hospitalization for heart failure in the group with a worsening of left ventricular filling pattern (62·5% vs. 31·8%; P = 0·042) and a lower event-free survival rate (long rank test = 0·013). CONCLUSIONS: The presence of a significant paravalvular aortic regurgitation is associated with a worsening in parameters of diastolic function. This finding should alert the cardiologist as patients with a worsening of left ventricular filling pattern present a higher incidence of paravalvular aortic regurgitation and a less favourable outcome.

Peginterferon alpha-2a and ribavirin in patients with hepatitis C virus genotype 1 infection with persistently normal alanine aminotransferase levels.

BACKGROUND AND AIM: To evaluate the efficacy and safety of peginterferon α-2a plus ribavirin at standard doses in patients with hepatitis C virus (HVC) genotype 1 infection with persistently normal alanine aminotransferase (ALT) levels. METHODS: Patients aged 18 to 65 years were included in this observational, prospective study if they had evidence of a HCV genotype 1 infection. The serum HCV RNA concentration was determined at baseline and week 12. A qualitative HCV RNA test was performed at baseline and at weeks 48 and 72. Liver function tests were performed at each study visit. The primary efficacy measure was the sustained virological response in the intention-to-treat population. Logistic regression analyses were also performed to explore predictors of virological response. RESULTS: A sustained virological response was observed in 100 of the 175 patients (57%). An early virological response and end-of-treatment response were seen in 159 patients (91%) and 133 patients (76%), respectively. Thirty-seven of the 122 evaluable patients for this outcome (30%) showed a rapid virological response. A higher viral load was a significant predictor for a lack of rapid virological response and lack of sustained virological response. There were not any unexpected safety or tolerability findings. CONCLUSIONS: Our study suggests that the efficacy of the combination of peginterferon α-2a and ribavirin in patients with HCV genotype 1 infection and normal ALT levels is at least similar to that reported in patients with elevated ALT levels.

Intraoperative myocardial rupture heralded by contrast echocardiography.

This case report shows the use of bedside transthoracic contrast echocardiography in the diagnosis of subacute myocardial rupture after acute myocardial infarction and indication of urgent surgery. Usefulness of intraoperative transesophageal echocardiography for detection of sudden complete myocardial rupture leading to pericardial tamponade during anesthetic induction, and prompt lifesaving surgical procedure are also presented.