The Infant KIdney Dialysis and Utrafiltration (I-KID) Study: A Stepped-Wedge Cluster-Randomized Study in Infants, Comparing Peritoneal Dialysis, Continuous Venovenous Hemofiltration, and Newcastle Infant Dialysis Ultrafiltration System, a Novel Infant Hemodialysis Device.

OBJECTIVES: Renal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformité Européenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH). DESIGN: Nonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence. SETTING: Clusters were six U.K. PICUs. PATIENTS: Babies less than 8 kg requiring RRT for fluid overload or biochemical disturbance. INTERVENTIONS: In controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances. MEASUREMENTS AND MAIN RESULTS: At closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd ) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between. CONCLUSIONS: NIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.

An Internet-Based Self-Management Intervention to Reduce Fatigue Among People With Traumatic Brain Injury: A Pilot Randomized Controlled Trial.

IMPORTANCE: Fatigue is a chronic and distressing sequela of traumatic brain injury (TBI). Little evidence exists for the efficacy of interventions that address post-TBI fatigue. OBJECTIVE: To evaluate the preliminary efficacy of a self-management intervention (Maximizing Energy; MAX) for reducing the impact (primary outcome) and severity of fatigue on daily life, improving fatigue experience, and increasing participation compared with a health education (HE) intervention. DESIGN: Pilot randomized controlled trial (RCT). SETTING: Community. PARTICIPANTS: Forty-one participants randomly assigned to the MAX (n = 20) or HE (n = 21) intervention. INTERVENTIONS: The MAX intervention included problem-solving therapy with energy conservation education to teach participants fatigue management. The HE intervention included diet, exercise, and energy conservation education. Both interventions (30 min/day, 2 days/wk for 8 wk) were delivered online by occupational therapists. OUTCOME AND MEASURES: The primary outcome was the modified Fatigue Impact Scale (mFIS). Outcome measures were collected at baseline, postintervention, and 4- and 8-wk postintervention. RESULTS: At 8 wk postintervention, participants in the MAX group reported significantly lower levels of fatigue impact (mFIS) than those in the HE group, F(1, 107) = 29.54, p = .01; Cohen's d = 0.87; 95% confidence interval [0.18, 1.55]. CONCLUSIONS AND RELEVANCE: These findings provide preliminary evidence that the MAX intervention may decrease the impact of fatigue on daily life among people with post-TBI fatigue. What This Article Adds: An internet-based, self-management intervention combining occupational therapy- delivered energy conservation education with cognitive-behavioral therapy seems to reduce fatigue impact and severity among people with post-TBI fatigue. Future appropriately powered RCTs could positively contribute to the evidence available to occupational therapy practitioners for this chronic, debilitating, and often overlooked symptom.

Measuring and Describing Occupational Therapists' Perceptions of the Impact of High-Fidelity, High-Technology Simulation Experiences on Performance.

IMPORTANCE: As the use of simulation in occupational therapy education continues to increase, so too does the need for continued research on its impact on clinical practice performance and the value of simulation as a pedagogic method. OBJECTIVE: To develop a survey to measure the perceived impact of high-fidelity, high-technology simulation experiences during occupational therapy education on occupational therapists' performance and to describe occupational therapists' perceptions of the impact of simulation on clinical skills. DESIGN: Cross-sectional descriptive study. SETTING: Online survey administration. PARTICIPANTS: Occupational therapists completed an online survey to measure their perceptions of the impact of high-fidelity, high-technology simulation experiences on essential skills in four performance domains: confidence, knowledge, clinical skills, and patient safety skills. RESULTS: Sixty-seven occupational therapists perceived participation in simulation experiences during occupational therapy education had more impact on transferring clients and using safe body mechanics than on communicating with clients, assessing vital signs, or applying clinical reasoning. The survey items had evidence of content validity, and scores showed good internal consistency reliability. CONCLUSIONS: Survey results suggested high-fidelity, high-technology simulation during occupational therapy education may affect clinical practice performance. Additional research is needed to determine the effectiveness of simulation education in preparing occupational therapists for clinical practice. WHAT THIS ARTICLE ADDS: The survey developed in this study is a reliable measure of the impact of simulation experiences on clinical practice performance of occupational therapists.

Low-dose rituximab is no less effective for nephrotic syndrome measured by 12-month outcome.

OBJECTIVE: Rituximab is an effective treatment for children with steroid dependent or frequently relapsing nephrotic syndrome. The optimum dosing schedule for rituximab has not been established. We hypothesized that a single low dose of 375 mg/m2 would have comparable outcomes to higher doses in reducing the frequency of relapse and time to B cell reconstitution. METHODS: We conducted a multicenter retrospective observational cohort study of children with steroid-sensitive frequently relapsing nephrotic syndrome. Data were extracted from clinical records including the dates of diagnosis, treatment, relapses, the use of concomitant immunosuppression, and lymphocyte subset profiling. Patients treated earlier received variable doses of rituximab, although typically two doses of 750 mg/m2. Later, patients received the current regimen of a single dose of 375 mg/m2. The primary outcome was an absence of clinically confirmed relapse 12 months following rituximab administration. Secondary outcomes were median time to relapse, probability of being relapse-free at 6 and 24 months and time to reconstitution of CD19+ B cells. RESULTS: Sixty patients received 143 courses of rituximab. Seven different dosing regimen strategies were used, ranging between 375 and 750 mg/m2 per dose, with administration of 1-4 doses. There was no significant difference in event-free survival at 12 months between dosing strategies. The median time to reconstitution of B cells was not significantly different between groups. CONCLUSIONS: Use of a single low-dose regimen of rituximab in the management of frequently relapsing nephrotic syndrome does not affect the probability of relapse at 12 months or time to B cell reconstitution compared to a conventional higher dose.

Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study.

OBJECTIVE: To evaluate the feasibility of conducting a randomized clinical trial of an Internet-based manualized intervention to teach individuals with traumatic brain injury to manage their fatigue. SETTING: Community dwelling. PARTICIPANTS: Forty-one participants randomized to Maximizing Energy (MAX) intervention group (n = 20) and Health Education group (n = 21). INTERVENTION: The experimental group (MAX intervention) received an 8-week program that combined education and Problem-Solving Therapy to teach individuals to manage fatigue-related problems. The attention control group received health education. MEASURES: Primary outcome measures pertained to the feasibility of conducting the trial. Secondary outcomes were fatigue impact and fatigue severity assessed at baseline and postintervention. RESULTS: Of the 65 participants referred, 41 were enrolled (63% recruitment rate), of which 3 withdrew (92% retention rate). Participants in the experimental and control groups completed their homework 75% and 85% of the time, respectively, and were equally engaged in the sessions. Participants in the experimental group were able to learn and implement the MAX intervention steps. Effect sizes for all measures ranged from small (-0.17) to medium (-0.58) in favor of the intervention group. CONCLUSION: Findings from the study suggest that the MAX intervention is feasible to administer to individuals with post-traumatic brain injury fatigue.

Evaluating capacity to live independently and safely in the community: Performance Assessment of Self-care Skills.

To determine clients' capacity for community living, occupational therapists must use measures that capture the person-task-environment transaction and compare clients' task performance to a performance standard. The Performance Assessment of Self-care Skills, a performance-based, criterion-referenced, observational tool, fulfills this purpose. In this practice analysis, using data from this tool from multiple clinical studies (N = 941), the authors describe tasks that clients from various diagnostic populations could and could not perform independently and safely. For clinicians, the Performance Assessment of Self-care Skills can be used to identify which daily tasks are compromised and the point of task breakdown, as well as to provide guidance about potential interventions.

Cognition in older adults with bipolar disorder versus major depressive disorder.

OBJECTIVES: Bipolar disorder (BD) and major depressive disorder (MDD) are associated with cognitive dysfunction in older age during both acute mood episodes and remitted states. The purpose of this study was to investigate for the first time the similarities and differences in the cognitive function of older adults with BD and MDD that may shed light on mechanisms of cognitive decline. METHODS: A total of 165 subjects with BD (n = 43) or MDD (n = 122), ages ≥ 65 years [mean (SD) 74.2 (6.2)], were assessed when euthymic, using comprehensive measures of cognitive function and cognitive-instrumental activities of daily living (C-IADLs). Test results were standardized using a group of mentally healthy individuals (n = 92) of comparable age and education level. RESULTS: Subjects with BD and MDD were impaired across all cognitive domains compared with controls, most prominently in Information Processing Speed/Executive Function. Despite the protective effects of having higher education and lower vascular burden, BD subjects were more impaired across all cognitive domains compared with MDD subjects. Subjects with BD and MDD did not differ significantly in C-IADLs. CONCLUSION: In older age, patients with BD have worse overall cognitive function than patients with MDD. Our findings suggest that factors intrinsic to BD appear to be related to cognitive deterioration and support the understanding that BD is associated with cognitive decline.

A 12-week open-label pilot study of donepezil for cognitive functioning and instrumental activities of daily living in late-life bipolar disorder.

OBJECTIVE: To determine whether donepezil is effective in enhancing cognitive functioning and instrumental activities of daily living (IADLs) in older adults with bipolar disorder. METHODS: Twelve elderly patients with bipolar I or II disorder, with evidence of mild cognitive decrements, were administered donepezil 5-10 mg daily for 3 months. Participants had cognitive and functional evaluation pre-, on-, and 3-months post donepezil administration. RESULTS: Three subjects dropped out of the study. In the remaining nine subjects, no significant effects were observed in cognitive and functional measures. Seven of the nine participants asked to resume the medication after completion of the study because of the perceived beneficial effects. CONCLUSIONS: In this small pilot study of older adults with bipolar disorder, acute treatment with donepezil was not associated with improvements in cognitive and IADL functioning. Given limitations of the study design, placebo effects could not be ruled out in the subjects who asked to resume donepezil.

Cognitive functioning and instrumental activities of daily living in late-life bipolar disorder.

OBJECTIVE: The authors report on the relationship between cognitive functioning and instrumental activities of daily living (IADLs) in elderly, clinically euthymic adults with bipolar disorder. METHODS: Twenty patients with bipolar disorder (age range: 61-86 years) were administered comprehensive neuropsychologic testing. Structured in-home performance-based assessments of IADLs were performed in 19 of these patients. RESULTS: Relative to age-equated comparators, bipolar subjects performed worse in information-processing speed and executive functioning. IADL performance was strongly correlated with these cognitive domains. CONCLUSIONS: In euthymic elderly patients with bipolar disorder, decrements in information processing speed and executive functioning characterize cognitive function and are associated with poorer IADL performance.