Charity G Moore’s research while affiliated with University of Pittsburgh and other places

Background: Obese children are vulnerable to vitamin D deficiency and impaired cardiovascular health; vitamin D replenishment might improve their cardiovascular health. Objectives: The aims were to determine, in vitamin D-deficient overweight and obese children, whether supplementation with vitamin D3 1000 or 2000 IU/d is more effective than 600 IU/d in improving arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile and to explore whether downregulation of adipocytokines and markers of systemic inflammation underlies vitamin D effects. Methods: We conducted a randomized, double-masked, controlled clinical trial in 225 10- to 18-y-old eligible children. Change in endothelial function at 6 mo was the primary outcome. Results: Dose-response increases in serum 25-hydroxyvitamin D concentrations were significant and tolerated without developing hypercalcemia. Changes at 3 and 6 mo in endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers did not differ between children receiving 1000 or 2000 IU vitamin D and children receiving 600 IU. Some secondary outcomes differed between groups. Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57 (-5.97, -1.17), and -3.28 (-5.55, -1.00) mm Hg, respectively]; insulin sensitivity increased at 3 and 6 mo and fasting glucose concentration declined at 6 mo (-2.67; 95% CI: -4.88, -0.46 mg/dL) in the 2000-IU group. Conclusions: Correction of vitamin D deficiency in overweight and obese children by vitamin D3 supplementation with 1000 or 2000 IU/d versus 600 IU/d did not affect measures of arterial endothelial function or stiffness, systemic inflammation, or lipid profile, but resulted in reductions in BP and fasting glucose concentration and in improvements in insulin sensitivity. Optimization of children's vitamin D status may improve their cardiovascular health. This trial was registered at clinicaltrials.gov as NCT01797302.

Objective: This study aimed to assess the agreement between patients presenting to the pediatric emergency department (ED) with acute pain and their caregivers when using the Wong-Baker FACES (WBF) and Faces Pain Scale-Revised (FPS-R). Methods: This was a prospective, observational study examining patients 3 to 7.5 years old presenting to a pediatric ED with acute pain. Participants completed the WBF and FPS-R twice during their ED evaluation. Caregivers rated their child's pain using both the WBF and FPS-R at the same time points. Intraclass correlations (ICCs) were calculated between caregiver and child reports at each time point, and Bland-Altman plots were created. Results: Forty-six subjects were enrolled over 5 months. Mean age was 5.5 ± 1.2 years. Average initial child pain scores were 6.6 ± 2.8 (WBF) and 6.1 ± 3.3 (FPS-R), and repeat scores were 3.3 ± 3.4 (WBF) and 3.1 ± 3.3 (FPS-R). Average initial caregiver pain scores were 6.3 ± 2.4 (WBF) and 6.2 ± 2.3 (FPS-R), and repeat scores were 3.4 ± 2.0 (WBF) and 3.4 ± 2.1 (FPS-R). On initial assessment, ICCs between children and caregivers using the FPS-R and WBF were 0.33 and 0.22, respectively. On repeat assessment, the ICCs were 0.31 for FPS-R and 0.26 for WBF. Bland-Altman plots showed poor agreement but no systematic bias. Conclusion: There was poor agreement between caregivers and children when using the WBF and FPS-R for assessment of acute pain in the ED. Caregiver report should not be used as a substitute for self-report of pain if possible.

Importance: Several functional limitations persist after total knee replacement (TKR). Intensive exercise programs could resolve these limitations but are not well tolerated by many patients until a later stage (>2 months) after surgery. Evidence for exercise at a later stage after TKR is limited. Objectives: To compare the effectiveness of later-stage exercise programs after TKR and to explore heterogeneity of treatment effects. Design, setting, and participants: Three-arm single-blind randomized clinical trial (January 7, 2015, to November 9, 2017) using an intent-to-treat approach with follow-ups at 3 months and 6 months. The setting was Allegheny County, Pennsylvania (an outpatient physical therapy clinic and 4 community centers). Participants had primary TKR performed more than 2 months previously, were 60 years or older, experienced moderate functional limitations, and were medically cleared to exercise. Interventions: Clinic-based physical therapy exercise (physical therapy arm), community-based group exercise (community arm), and usual care (control arm). The control arm continued their usual care, whereas the exercise arms participated in supervised exercise programs lasting 12 weeks. Main outcomes and measures: The primary outcome was arm differences in the Western Ontario and McMaster Universities Osteoarthritis Index-Physical Function (WOMAC-PF) at 3 months. The secondary outcomes included performance-based tests germane to knee replacement and additional surveys of physical function. Data were analyzed by linear mixed models and responder analysis. Results: A total of 240 participants (mean [SD] age, 70 [7] years; 61.7% female) were allocated to physical therapy (n = 96), community exercise (n = 96), or control (n = 48). All 3 arms demonstrated clinically important improvement. At 3 months, between-arm analyses for the WOMAC-PF demonstrated no differences between physical therapy and community (-2.2; 98.3% CI, -4.5 to 0.1), physical therapy and control (-2.1; 98.3% CI, -4.9 to 0.7), and community and control (0.1; 98.3% CI, -2.7 to 2.9). Performance-based tests demonstrated greater improvement in the physical therapy arm compared with both the community (0.1 z score units; 98.3% CI, 0.0-0.2) and control (0.3 z score units; 98.3% CI, 0.1-0.4) arms and the community arm compared with the control arm (0.2 z score units; 98.3% CI, 0.0-0.3). The physical therapy arm had more than 17.7% responders than the community arm and more than 19.0% responders than the control arm. There was no difference in responder rates between the community and control arms. Conclusions and relevance: Based on the primary outcome, participation in late-stage exercise programs after TKR offered no benefit over usual care. The benefits of physical therapy identified by the secondary outcomes and responder analysis require confirmation. Trial registration: ClinicalTrials.gov Identifier: NCT02237911.

Background Greater than half of Emergency Medical Services (EMS) shift workers report fatigue at work and most work long duration shifts. We sought to compare the alertness level of EMS shift workers by shift duration. Methods We used a multi‐site, 14‐day prospective observational cohort study design of EMS clinician shift workers at four air‐medical EMS organizations. The primary outcome was behavioral alertness as measured by psychomotor vigilance tests (PVT) at the start and end of shifts. We stratified shifts by duration (< 24 h and 24 h), night versus day, and examined the impact of intra‐shift napping on PVT performance. Results One hundred and twelve individuals participated. The distribution of shifts <24 h and 24 h with complete data were 54% and 46%, respectively. We detected no differences in PVT performance measures stratified by shift duration (P > 0.05). Performance for selected PVT measures (lapses and false starts) was worse on night shifts compared to day shifts (P < 0.05). Performance also worsened with decreasing time between waking from a nap and the end of shift PVT assessment. Conclusions Deficits in performance in the air‐medical setting may be greatest during night shifts and proximal to waking from an intra‐shift nap. Future research should examine alertness and performance throughout air‐medical shifts, as well as investigate the timing and duration of intra‐shift naps on outcomes.

Introduction Recruitment of sufficient patients with Parkinson disease into clinical trials is a barrier to successful, timely study completion. Non-pharmacologic studies have shown to be even more challenging for recruitment, despite some studies focusing on de novo Parkinson disease populations. This paper describes successful recruitment techniques from a randomized exercise clinical trial in Parkinson disease. Methods Several recruitment strategies were used to enroll de novo patients with Parkinson disease into a year-long clinical trial. Strategies focused on infrastructure included fast-track clinic scheduling, weekly research meetings, an established clinical repository, real-time clinic recruitment, and outreach to the community. The nature of the study facilitated recruitment by offering a wait-listed control group, exercise at a local fitness center with a paid membership, and collection of data by shipping equipment foregoing some visits. An experienced nurse study coordinator involved in recruitment and training of the principal investigator in recruitment of minorities enhanced overall recruitment. Finally, the patient population chosen for this study, patients with de novo Parkinson disease, may be more likely to enroll in an exercise study than patients with later stage disease. Results Seventy-six patients with de novo Parkinson disease were successfully enrolled into the exercise clinical trial from a single site. Conclusion Targeted recruitment strategies were successful in this study. Additional modifications to the study protocol, such as eliminating treadmill stress tests before randomization, travel to an urban downtown location for study visits, and a relatively healthy Parkinson disease population, may also have impacted this study. These strategies could all be adopted for other studies in Parkinson disease, neurodegenerative diseases, or other chronic disorders. Trial registration Clinicaltrials.gov, NCT01506479. Registered on 10 January 2012. Electronic supplementary material The online version of this article (10.1186/s13063-018-2958-z) contains supplementary material, which is available to authorized users.

Background/Purpose: Guidelines recommend 150 minutes a week in moderate-intensity physical activity (PA) to improve health in knee osteoarthritis (KOA). Despite that, individuals with KOA do not engage in the recommended amount of PA and physicians refrain from prescribing the PA recommendations due to concerns that large amounts of PA may worsen KOA. Only few studies have investigated the effects of PA on cartilage health and this issue needs further clarification. Serum biomarkers have been validated to identify cartilage degradation. The aim of this study was to determine the associations between changes in PA and changes in concentration of a biomarker of cartilage degradation. Methods: This is a secondary analysis from a randomized trial that compared the effects of an intensive exercise program (comprehensive behavioral intervention [CBI]) to a less intensive program (standard of care exercise [SCE]) on physical function and PA after total knee replacement. Subjects with available serum and PA measured at baseline and 3-month follow-up were included. Blood samples were collected in the morning after a 12-hour fasting. Samples were frozen for future analysis. Cartilage degradation was assessed by analyzing the concentration of cartilage oligomeric matrix protein (COMP) using standardized enzyme-linked immunosorbent assay (ELISA). Daily time in moderate PA was assessed using the Sensewear Armband activity monitor worn for 7 days. Pearson correlation coefficients were used to determine associations between changes in PA and changes in COMP. Results: Data on 33 subjects were available and analyzed. Subjects were 67±6 years old, 67% female and 92% white, with BMI of 30±4 kg/m2. They had mild pain on surgical (2±2) and non-surgical (3±3) knees, and moderate functional limitations (17.9±9.5) measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function subscale. Demographics between CBI (n=14) and SCE (n=19) were similar at baseline. Forty three percent of the subjects in the CBI arm improved PA above the standard error of measurement (11 minutes of moderate PA per day) and experienced an increase in COMP (145±418 ng/ml), while only 26% of the subjects in the SCE improved PA and showed a slight decrease in COMP (-49±725 ng/ml), suggesting that perhaps more PA may increase cartilage degradation. However, upon further assessment of the direct associations between changes in PA and COMP, we observed negative associations between changes in PA and changes in COMP in the CBI (r=-.65; p=.012) and in the SCE (r=-.45; p=.056), indicating that individuals who increased PA actually had a decrease in COMP concentration. Conclusion: These preliminary results indicate that moderate PA does not seem to contribute to cartilage degradation in individuals with KOA and strengthen to body of evidence in this area. In this study, individuals with KOA appear to engage in activities of low impact such as brisk walk, which may not be detrimental to the knee joint. A larger study is warranted to validate our findings. Participation in moderate PA could be encouraged by physicians since its benefits outweigh the harms.

Objective: The aims of this study were: 1) to determine the short-term impact of the SleepTrackTXT2 intervention on air-medical clinician fatigue during work shifts; and 2) determine the longer-term impact on sleep quality over 120 days. Methods: We used a multi-site randomized controlled trial study design with a targeted enrollment of 100 (ClinicalTrials.gov NCT02783027). The intervention was behavioral (non-pharmacological) and participation was scheduled for 120 days. Participation was voluntary. All consented participants answered baseline as well as follow-up surveys. All participants answered text message queries, which assessed self-rated fatigue, sleepiness, concentration, recovery, and hours of sleep. Intervention participants received additional text messages with recommendations for behaviors that can mitigate fatigue. Intervention participants received weekly text messages that promoted sleep. Our analysis was guided by the intent-to-treat principle. For the long-term outcome of interest (sleep quality at 120 days), we used a two-sample t-test on the change in sleep quality to determine the intervention effect. Results: Eighty-three individuals were randomized and 2,828 shifts documented (median shifts per participant = 37, IQR 23-49). Seventy-one percent of individuals randomized (n = 59) participated up to the 120-day study period and 52% (n = 43) completed the follow-up survey. Of the 69,530 text messages distributed, participants responded to 61,571 (88.6%). Mean sleep quality at 120 days did not differ from baseline for intervention (p > 0.05) or control group participants (p > 0.05), and did not differ between groups (p > 0.05). There was no change from baseline to 120 days in the proportion with poor sleep quality in either group. Intra-shift fatigue increased (worsened) over the course of 12-hour shifts for participants in both study arms. Fatigue at the end of 12-hour shifts was higher among control group participants than participants in the intervention group (p < 0.05). Pre-shift hours of sleep were often less than seven hours and did not differ between the groups over time. Conclusions: The SleepTrackTXT2 behavioral intervention showed a positive short-term impact on self-rated fatigue during 12-hour shifts, but did not impact longer duration shifts or have a longer-term impact on sleep quality among air-medical EMS clinicians.