Actigraphy methodology in the Kids Mod PAH trial: Physical activity as a functional endpoint in pediatric clinical trials.

Pulmonary vasodilator treatment can improve hemodynamics, right ventricular function, symptoms, and survival in pediatric pulmonary hypertension (PH). However, clinical trial data are lacking due to many constraints. One major limitation is the lack of relevant trial endpoints reflective of hemodynamics or functional status in patients in whom standard exercise testing is impractical, unreliable, or not reproducible. The Kids Mod PAH trial (Mono- vs. Duo Therapy for Pediatric Pulmonary Arterial Hypertension) is an ongoing multicenter, Phase III, randomized, open-label, pragmatic trial to compare the safety and efficacy of first-line combination therapy (sildenafil and bosentan) to first-line monotherapy (sildenafil alone) in 100 pediatric patients with PH across North America. Investigators will measure participants' physical activity with a research-grade, wrist-worn actigraphy device at multiple time points as an exploratory secondary outcome. Vector magnitude counts per minute and activity intensity will be compared between the treatment arms. By directly and noninvasively measuring physical activity in the ambulatory setting, we aim to identify a novel, simple, inexpensive, and highly reproducible approach for quantitative assessment of exercise tolerance in pediatric PH. These data will increase the field's understanding of the effect of pulmonary vasodilator treatment on daily activity - a quantitative measure of functional status and wellbeing in pediatric PH and a potential primary outcome for future clinical trials in children with cardiopulmonary disorders.

Depression Characterization and Race Among Stroke Survivors Receiving Inpatient Rehabilitation.

Race and ethnicity play a significant role in poststroke outcomes. This brief report describes the presence of depression among stroke survivors who received inpatient rehabilitation and whether depression differs by race. Data from eRehabData and electronic medical records were analyzed for patients who received rehabilitation after an acute ischemic or hemorrhagic stroke. Of 1501 stroke patients, 61.3% were white, 33.9% were African American, and 4.8% were of other race/ethnic backgrounds. By retrospective clinical review, depression was documented for 29.7% of stroke patients. Premorbid versus new onset of poststroke depression was documented for 13.4% and 21.6% of whites, 7.5% and 11.5% of African American, and 0% and 16.7% of patients of other race/ethnic groups. Compared with whites, African American and people of other races had a lower odds of poststroke depression (African American adjusted odds ratio = 0.52, 95% confidence interval = 0.41-0.68; other races odds ratio = 0.37, 95% confidence interval = 0.19-0.71), after adjusting for all other significant risk factors identified in the bivariate analysis (sex, hyperlipidemia, cognitive deficit, neglect). Depression was documented for one in three stroke survivors who received inpatient rehabilitation and highest among whites especially for prestroke depression. Addressing depression in rehabilitation care needs to consider individual patient characteristics and prestroke health status.

Turning Data Into Information: Opportunities to Advance Rehabilitation Quality, Research, and Policy.

Attention to health care quality and safety has increased dramatically. The internal focus of an organization is not without influence from external policy and research findings. Compared with other specialties, efforts to align and advance rehabilitation research, practice, and policy using electronic health record data are in the early stages. This special communication defines quality, applies the dimensions of quality to rehabilitation, and illustrates the feasibility and utility of electronic health record data for research on rehabilitation care quality and outcomes. Using data generated at the point of care provides the greatest opportunity for improving the quality of health care, producing generalizable evidence to inform policy and practice, and ultimately benefiting the health of the populations served.

Fundamentals and Catalytic Innovation: The Statistical and Data Management Center of the Antibacterial Resistance Leadership Group.

The Statistical and Data Management Center (SDMC) provides the Antibacterial Resistance Leadership Group (ARLG) with statistical and data management expertise to advance the ARLG research agenda. The SDMC is active at all stages of a study, including design; data collection and monitoring; data analyses and archival; and publication of study results. The SDMC enhances the scientific integrity of ARLG studies through the development and implementation of innovative and practical statistical methodologies and by educating research colleagues regarding the application of clinical trial fundamentals. This article summarizes the challenges and roles, as well as the innovative contributions in the design, monitoring, and analyses of clinical trials and diagnostic studies, of the ARLG SDMC.

Depression and Functional Status Among African American Stroke Survivors in Inpatient Rehabilitation.

PURPOSE: To examine the prevalence of poststroke depression (PSD) among African American stroke survivors and the association of depression with functional status at inpatient rehabilitation facility (IRF) discharge. METHODS: Secondary data analysis was conducted of a patient cohort who received care at 3 IRFs in the United States from 2009 to 2011. Functional status was measured by the Functional Independence Measure (FIM). Multiple linear regression models were used to examine associations of PSD and FIM motor and cognitive scores. RESULTS: Of 458 African American stroke survivors, 48.5% were female, 84% had an ischemic stroke, and the mean age was 60.8 ± 13.6 years. Only 15.4% (n = 71) had documentation of PSD. Bivariate analyses to identify factors associated with depression identified a higher percentage of patients with depression than without who were retired due to disability (17.1% versus 11.6%) or employed (31.4% versus 19.6%) prestroke (P = .041). Dysphagia, cognitive deficits, and a lower admission motor FIM score were also significantly more common among those with depression. There was no significant relationship between depression and functional status after adjusting for patient characteristics. CONCLUSIONS: In this study, 15% of the African Americans who received rehabilitation after a stroke had documentation of PSD but this was not associated with functional status at discharge.