Results of the Active by Choice Today (ACT) Randomized Trial for Increasing Physical Activity in Low-Income and Minority Adolescents

Objective - This study reports the results of the Active by Choice Today (ACT) trial for increasing moderate-to-vigorous physical activity (MVPA) in low-income and minority adolescents. Design - The ACT program was a randomized controlled school-based trial testing the efficacy of a motivational plus behavioral skills intervention on increasing MVPA in underserved adolescents. Twenty-four middle schools were matched on school size, percentage minorities, percentage free or reduced lunch, and urban or rural setting before randomization. A total of 1,563 6th grade students (mean age, 11.3 years, 73% African American, 71% free or reduced lunch, 55% female) participated in either a 17-week (over one academic year) intervention or comparison after-school program. Main Outcome Measure - The primary outcome measure was MVPA based on 7-day accelerometry estimates at 2-weeks postintervention and an intermediate outcome was MVPA at midintervention. Results - At midintervention students in the intervention condition engaged in 4.87 greater minutes of MVPA per day (95% CI: 1.18 to 8.57) than control students. Students in intervention schools engaged in 9.11 min (95% CI: 5.73 to 12.48) more of MVPA per day than those in control schools during the program time periods; indicating a 27 min per week increase in MVPA. No significant effect of the ACT intervention was found outside of school times or for MVPA at 2-weeks postintervention. Conclusions - Motivational and behavioral skills programs are effective at increasing MVPA in low-income and minority adolescents during program hours, but further research is needed to address home barriers to youth MVPA

Early ultrasound surveillance of newly-created haemodialysis arteriovenous fistula

IntroductionWe assess if ultrasound surveillance of newly-created arteriovenous fistulas (AVFs) can predict nonmaturation sufficiently reliably to justify randomized controlled trial (RCT) evaluation of ultrasound-directed salvage intervention.MethodsConsenting adults underwent blinded fortnightly ultrasound scanning of their AVF after creation, with scan characteristics that predicted AVF nonmaturation identified by logistic regression modeling.ResultsOf 333 AVFs created, 65.8% matured by 10 weeks. Serial scanning revealed that maturation occurred rapidly, whereas consistently lower fistula flow rates and venous diameters were observed in those that did not mature. Wrist and elbow AVF nonmaturation could be optimally modeled from week 4 ultrasound parameters alone, but with only moderate positive predictive values (PPVs) (wrist, 60.6% [95% confidence interval, CI: 43.9–77.3]; elbow, 66.7% [48.9–84.4]). Moreover, 40 (70.2%) of the 57 AVFs that thrombosed by week 10 had already failed by the week 4 scan, thus limiting the potential of salvage procedures initiated by that scan’s findings to alter overall maturation rates. Modeling of the early ultrasound characteristics could also predict primary patency failure at 6 months; however, that model performed poorly at predicting assisted primary failure (those AVFs that failed despite a salvage attempt), partly because patency of at-risk AVFs was maintained by successful salvage performed without recourse to the early scan data.ConclusionEarly ultrasound surveillance may predict fistula maturation, but is likely, at best, to result in only very modest improvements in fistula patency. Power calculations suggest that an impractically large number of participants (>1700) would be required for formal RCT evaluation

Surveillance arterioveNous fistulAs using ultRasound (SONAR) trial in haemodialysis patients: a study protocol for a multicentre observational study.

INTRODUCTION: Arteriovenous fistulas (AVFs) are considered the best and safest modality for providing haemodialysis in patients with end-stage renal disease. Only 20% of UK centres achieve the recommended 80% target for achieving dialysis of the prevalent dialysis population via permanent access (as opposed to a central venous catheter). This is partly due to the relatively poor maturation rate of newly created fistulas, with as many as 50% of fistulas failing to mature.The Surveillance Of arterioveNous fistulAe using ultRasound study will examine whether a protocolised programme of Doppler ultrasound (US) surveillance can identify, early after creation, potentially correctable problems in those AVFs that subsequently fail to mature. METHODS AND ANALYSIS: This is a multicentre observational study that will assess newly created AVFs by Doppler US performed at 2, 4, 6 and 10 weeks after creation. The primary outcome measure will be primary fistula patency at week 10. Secondary outcome measures include: successful use of the fistula; clinical suitability for dialysis; creation of new fistula or radiological salvage; fistula thrombosis; secondary fistula patency rate and patient acceptability. ETHICS AND DISSEMINATION: The study has been approved by the Cambridgeshire and Hertfordshire Research Ethics Committee and by the Health Research Authority (REC 18/EE/0234). The results generated from this work will be published as open access, within 3 years of trial commencement. We will also present our findings at key national/international renal meetings, as well as support volunteers at renal patient groups to disseminate the trial outcome. TRIAL REGISTRATION NUMBER: ISRCTN36033877

Outcomes of immunosuppression in IgA nephropathy based on the oxford classification

Numerous studies have addressed the predictive value of pathology findings from the Oxford Classification. Whether this influences treatment choice has not been determined. We evaluated patients with IgA nephropathy who were immunosuppressed and correlated our findings with both clinical and histological features as per the Oxford Classification. This was a retrospective observational study of 45 patients who had biopsy-proven IgA nephropathy with a mean follow-up of 2.6 years. Primary outcomes were time to end-stage renal disease (ESRD) or a 50% rise in serum creatinine. Immunosuppression was not associated with lower hazards for both ESRD and 50% rise in serum creatinine. From the Oxford Classification, only T0 was associated with significantly lower hazards for ESRD [hazard ratio (HR), 0.067; confidence interval (CI) 0.01–0.58]. Patients who had crescents and/or necrotizing lesions on biopsy were more likely to be immunosuppressed (odds ratio 9.99; 95% CI 1.99–50.06, P = 0.005) but demonstrated a statistically nonsignificant higher hazard for both renal end points (HR, 1.61; CI 0.19-13.89). Such lesions were also associated with a higher incidence of hypertension (149 vs. 135 mm Hg) and greater proteinuria (2.7 vs. 1.9 g/day) at presentation. The use of the Oxford Classification did not aid decision-making with regard to the use of immunosuppression. Crescents and/or necrosis identified on histology were associated with the use of immunosuppression. Hence, there is a need for these lesions to be evaluated further in large cohorts and incorporated into future disease classifications

Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE):study protocol for a randomised controlled trial

BACKGROUND: The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40–50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae. METHODS/DESIGN: We have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1 year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30 % or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research. DISCUSSION: We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis. TRIAL REGISTRATION: ISRCTN14284759. Registered on 28 October 2015

NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease.

BACKGROUND: Intravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients. METHODS: This real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ?12?months. Iron dose and the need for retreatment were determined at the investigators' discretion. The primary study outcome was the need for retreatment at 52?weeks compared between patients who received >1000?mg of iron during Course 1 and those who received ?1000?mg. Safety was evaluated through adverse drug reactions. RESULTS: The probability of retreatment at Week 52 was significantly lower in the >1000?mg iron group (n?=?58) versus the ?1000?mg group (n?=?198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p?=?0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ?1000?mg group and by 10.59 (7.52, 13.66) g/L in the >1000?mg group (p?=?0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000?mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ?1000?mg. No serious adverse drug reactions were reported. Of the patients who received ?1000?mg of iron in this study, 82.3% were eligible for a dose >1000?mg. CONCLUSIONS: The >1000?mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ?1000?mg regimen. Many of the patients who received ?1000?mg of iron were eligible for >1000?mg, indicating that there was considerable underdosing in this study. TRIAL REGISTRATION: ClinicalTrials.gov NCT02546154 , 10 September 2015.The article is available via Open Access. Click on the 'Additional link' above to access the full-text.Published version, accepted versio

Effects of Exogenous and Endogenous Distracters on Immediate and Long-Term Recall in Toddlers: Distractions and Recall

We explored the role that exogenous and endogenous competitors for attention play in infants’ abilities to encode and retain information over a 6‐month period. Sixty‐six children visited the laboratory at 15 months, and 32 returned for a second visit at 21 months. Children observed models of conventional‐ relation and enabling‐relation action sequences. Half the children were distracted by a “Mister Monkey” mechanical toy during the conventional‐relation sequence, while the other half was distracted during the enabling‐relation sequence. The Early Childhood Behavior Questionnaire indexed endogenous factors at both ages. Immediate postmodel production of target actions indexed encoding efficiency, and 6‐month production of target actions indexed long‐term recall. The exogenous distracter impacted encoding efficiency (i.e., immediate recall), but not long‐term recall. Endogenous factors (i.e., temperament) were primarily associated with long‐term recall. Of special interest was our finding that endogenous factors, especially surgency, moderated the effect of the exogenous distracter. It appears that when learning conventional‐relation sequences in the presence of exogenous distracters, surgency mobilizes attentional resources toward the learning objective; however, when learning enabling‐relation sequences under the same conditions, surgency either boosts the saliency of the distracters or boosts children’s susceptibility to them

An overview of the “Positive Action for Today's Health” (PATH) trial for increasing walking in low income, ethnic minority communities

Ethnic minorities and lower-income adults have among the highest rates of obesity and lowest levels of regular physical activity (PA). The Positive Action for Today's Health (PATH) trial compares three communities that are randomly assigned to different levels of an environmental intervention to improve safety and access for walking in low income communities. Three communities matched on census tract information (crime, PA, ethnic minorities, and income) were randomized to receive either: an intervention that combines a police-patrolled-walking program with social marketing strategies to promote PA, a police-patrolled-walking only intervention, or no-walking intervention (general health education only). Measures include PA (7-day accelerometer estimates), body composition, blood pressure, psychosocial measures, and perceptions of safety and access for PA at baseline, 6, 12, 18, and 24months. The police-patrolled walking plus social marketing intervention targets increasing safety (training community leaders as walking captains, hiring off-duty police officers to patrol the walking trail, and containing stray dogs), increasing access for PA (marking a walking route), and utilizes a social marketing campaign that targets psychosocial and environmental mediators for increasing PA. It is hypothesized that the police-patrolled walking plus social marketing intervention will result in greater increases in moderate-to-vigorous PA as compared to the police-patrolled-walking only or the general health intervention after 12months and that this effect will be maintained at 18 and 24months. Implications of this community-based trial are discussed