Pediatric Pain Assessment in the Emergency Department: Patient and Caregiver Agreement Using the Wong-Baker FACES and the Faces Pain Scale-Revised.

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.

Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial.

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.

A Propensity Score Analysis of Homework Adherence-Outcome Relations in Cognitive Behavioral Therapy for Depression.

Little is known about whether or not a consistently high level of homework adherence over the course of therapy benefits patients. This question was examined in two samples of patients who were receiving individual Cognitive Behavioral Therapy (CBT) for depression (Ns = 128 [Sequenced Treatment Alternatives to Relieve Depression: STAR-D] and 183 [Continuation Phase Cognitive Therapy Relapse Prevention: C-CT-RP]). Logistic and linear regression and propensity score models were used to identify whether or not clinician assessments of homework adherence differentiated symptom reduction and remission, as assessed by the Hamilton Depression Rating Scale-17 (HDRS-17), the Quick Inventory of Depressive Symptomatology-Self-Reported Scale (QIDS-SR), and the QIDS-Clinician Scale (QIDS-C). CBT-related response and remission were equally likely between both high and low homework adherers in both studies and in all models. But in propensity adjusted models that adjusted for session attendance, for both the STAR-D and C-CT-RP samples, greater homework adherence was significantly associated with greater response and remission from depression in the first and last 8 sessions of CBT. Our results suggest that homework adherence can account for response and remission early and late in treatment, with adequate session attendence.

Effectiveness of Later-Stage Exercise Programs vs Usual Medical Care on Physical Function and Activity After Total Knee Replacement: A Randomized Clinical Trial.

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.

Impact of shift duration on alertness among air-medical emergency care clinician shift workers.

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.

Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite years of intense focus, inpatient and observation readmission rates remain high and largely unchanged. Hospitals have little, robust evidence to guide the selection of interventions effective at reducing 30-day readmissions in real-world settings. OBJECTIVE: To evaluate if implementation of recent recommendations for hospital transition programs is effective at reducing 30-day readmissions in a population discharged to home and at high-risk for readmission. DESIGN: A non-blinded, pragmatic randomized controlled trial ( Clinicaltrials.gov : NCT02763202) conducted at two hospitals in Charlotte, North Carolina. PATIENTS: A total of 1876 adult patients, under the care of a hospitalist, and at high risk for readmissions. INTERVENTION: Random allocation to a Transition Services (TS) program (n = 935) that bridges inpatient, outpatient, and home settings, providing patients virtual and in-person access to a dedicated multidisciplinary team for 30-days, or usual care (n = 941). MAIN MEASURE: Thirty-day, unplanned, inpatient, or observation readmission rate. KEY RESULTS: The 30-day readmission rate was 15.2% in the TS group and 16.3% in the usual care group (RR 0.93; 95% [CI, 0.76 to 1.15]; P = 0.52). There were no significant differences in readmissions at 60 and 90 days or in 30-day Emergency Department visit rates. Patients, who were referred to TS and readmitted, had less Intensive Care Unit admissions 15.5% vs. 26.8% (RR 0.74; 95% [CI, 0.59 to 0.93]; P = 0.02). CONCLUSIONS: An intervention inclusive of contemporary recommendations does not reduce a high-risk population's 30-day readmission rate. The high crossover to usual care (74.8%) reflects the challenge of non-participation that is ubiquitous in the real-world implementation of population health interventions. TRIAL REGISTRY: ClinicalTrials.gov ; registration ID number: NCT02763202, URL: https://clinicaltrials.gov/ct2/show/NCT02763202.

Real-Time Fatigue Mitigation with Air-Medical Personnel: The SleepTrackTXT2 Randomized Trial.

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 7 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.

Blood Loss Trends and Financial Implications in Adolescent Idiopathic Scoliosis.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The primary goal was to evaluate risk factors related to increased blood loss in adolescent idiopathic surgery (AIS) surgery with the secondary goal being to evaluate the financial implications around the use of intraoperative cell salvage (ICS) and the routine preallocation of autogenous blood products. SUMMARY OF BACKGROUND DATA: Deformity correction for AIS is a complex procedure and can be associated with significant blood loss. METHODS: A retrospective cohort study was conducted on consecutive patients between the ages of 10 and 18 years who underwent posterior spinal fusion of 7-12 levels over a 3-year period between January 2013 and December 2015. Demographic information and surgical characteristics were recorded. All patients had a preoperative type and cross of 2 units and ICS was used in all cases. Charges for preoperative type and cross and ICS were also measured. Univariate and multivariable analyses were performed to identify pertinent variables affecting blood loss. RESULTS: In total, 134 patients met inclusion criteria. ICS was used in all cases. In total, 51 patients were transfused cell saver blood intraoperatively/postoperatively at the discretion of the surgeon. On average 133 mL were returned to the patient. No complications related to ICS were observed. Multivariable analysis identified male sex, lower body mass index and higher surgical time to be associated with increased blood loss (P<0.05). All 134 patients had a preoperative type and cross, with an average charge to patient of $311. Patients were charged $1037 for intraoperative use of ICS and $242 for centrifugation. Patients who had allogeneic transfusion were charged $1047. CONCLUSIONS: Several blood conservation strategies, including use of ICS, exist to minimize the consequences of blood loss. Routine use of preoperative type and cross may be avoided except in cases where significant blood loss is anticipated-that is adolescent male individuals, those with a lower body mass index and in whom a longer surgical time is anticipated.

Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease.

INTRODUCTION: The high burden of cardiovascular morbidity and mortality in autosomal dominant polycystic kidney disease (ADPKD) is related to development of hypertension and left ventricular hypertrophy. Blood pressure reduction has been shown to reduce left ventricular mass in ADPKD; however, moderators and predictors of response to lower blood pressure are unknown. METHODS: This was a post hoc cohort analysis of HALT PKD study A, a randomized placebo controlled trial examining the effect of low blood pressure and single versus dual renin-angiotensin blockade in early ADPKD. Participants were hypertensive ADPKD patients 15 to 49 years of age with estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2 across 7 centers in the United States. Predictors included age, sex, baseline eGFR, systolic blood pressure, total kidney volume, serum potassium, and urine sodium, potassium, albumin, and aldosterone. Outcome was left ventricular mass index (LVMI) measured using 1.5-T magnetic resonance imaging at months 0, 24, 48, and 60. RESULTS: Reduction in LVMI was associated with higher baseline systolic blood pressure and larger kidney volume regardless of blood pressure control group assignment (P < 0.001 for both). Male sex and baseline eGFR were associated with a positive annual slope in LVMI (P < 0.001 and P = 0.07, respectively). CONCLUSION: Characteristics associated with higher risk of progression in ADPKD, including higher systolic blood pressure, larger kidney volume, and lower eGFR are associated with improvement in LVMI with intensive blood pressure control, whereas male sex is associated with a smaller slope of reduction in LVMI.

Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study.

BACKGROUND: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. OBJECTIVE: The objectives of this prospective international observational multicenter study in hematopoietic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal relationship of oral complications related to conditioning regimens (chemotherapy with or without total body irradiation), stem cell transplantation and the immunologic reactions (mainly graft-vs-host-disease) that may follow, and to determine what subjective and objective oral complications related to treatment can predict negative clinical and economic outcomes and reduced quality of life. METHODS: Adult patients at six study sites receiving full intensity conditioning, reduced intensity conditioning or nonmyeloablative conditioning, followed by autologous or allogeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, social history, patient report of oral problems, dental history, subjective oral complaints, objective measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days per week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mucositis or other oral problems are followed 1 day per week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days (SD 30 days) and at 1 year (SD 30 days) post-transplantation to identify any long-term side effects. Patients treated with allogeneic transplantation are being followed at 100 days (SD 30 days), 6 months (SD 30 days), and 12 months (SD 30 days). The follow-up assessments include cancer response to therapy, current medical conditions, medications, subjective and objective oral findings, quality of life measures and laboratory values. The targeted enrollment is 254 patients who have received HSCT. RESULTS: A total of 260 participants have been enrolled, with 233 (91%) who have received HSCT. We anticipate enrollment of 20-30 additional participants to obtain the sample size of 254 enrolled participants who have received HSCT. CONCLUSIONS: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed evidence for guidelines regarding the management of this patient cohort.

Determinants of Progression in Early Autosomal Dominant Polycystic Kidney Disease: Is it Blood Pressure or Renin-Angiotensin-Aldosterone-System Blockade?

BACKGROUND: The HALT PKD trial in early autosomal dominant polycystic kidney disease (ADPKD) showed that intensive control of systolic blood pressure to 95-110 mmHg was associated with a 14% slower rate of kidney volume growth compared to standard control. It is unclear whether this result was due to greater blockade of the renin-angiotensin-aldosterone system (RAAS) by allowing the use of higher drug doses in the low blood pressure arm, or due to the lower blood pressure per se. METHODS: In this secondary analysis of HALT PKD Study A, we categorized participants into high and low dose groups based on the median daily equivalent dose of RAAS blocking drugs used after the initial dose titration period. Using linear mixed models, we compared the percent change in total kidney volume and the slope of estimated glomerular filtration rate (eGFR) between the 2 groups. We also assessed the effects of time-varying dose and time-varying blood pressure parameters on these outcomes. RESULTS: Subjects in the high dose group (n=252) did not experience a slower increase in total kidney volume than those in the low-dose (n=225) group, after adjustment for age, sex, genotype, and BP arm. The chronic slope of eGFR decline was similar in the 2 groups. Higher time-varying systolic blood pressure was associated with a steeper decline in eGFR. CONCLUSION: ADPKD progression (as detected by eGFR decline and TKV increase) was ameliorated by intense blood pressure control as opposed to pharmacologic intensity of RAAS blockade.

Patterns of Kidney Function Decline in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis From the HALT-PKD Trials.

BACKGROUND: Previous clinical studies of autosomal dominant polycystic kidney disease (ADPKD) reported that loss of kidney function usually follows a steep and relentless course. A detailed examination of individual patterns of decline in estimated glomerular filtration rate (eGFR) has not been performed. STUDY DESIGN: Longitudinal post hoc analysis of data collected during the Halt Progression of Polycystic Kidney Disease (HALT-PKD) trials. SETTING & PARTICIPANTS: 494 HALT-PKD Study A participants (younger; preserved eGFR) and 435 Study B participants (older; reduced eGFR) who had more than 3 years of follow-up and 7 or more eGFR assessments. MEASUREMENTS: Longitudinal eGFR assessments using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation. PREDICTORS: Demographic, clinical, laboratory, and imaging features of participants. OUTCOMES: Probability of linear and nonlinear decline patterns or of stable eGFR calculated for each participant from a Bayesian model of individual eGFR trajectories. RESULTS: Most (62.5% in Study A and 81% in Study B) participants had a linear decline in eGFR during up to 8 years of follow-up. A proportion (22% in Study A and 13% in Study B) of progressors had a nonlinear pattern. 15.5% of participants in Study A and 6% in Study B had a prolonged (≥4.5 years) period of stable eGFRs. These individuals (Study A) had significantly smaller total kidney volumes, higher renal blood flows, lower urinary albumin excretion, and lower body mass index at baseline and study end. In Study B, participants with reduced but stable eGFRs were older than the progressors. Two-thirds of nonprogressors in both studies had PKD1 mutations, with enrichment for weak nontruncating mutations. LIMITATIONS: Relatively short follow-up of a clinical trial population. CONCLUSIONS: Although many individuals with ADPKD have a linear decline in eGFR, prolonged intervals of stable GFRs occur in a substantial fraction. Lower body mass index was associated with more stable kidney function in early ADPKD.

Effect of Fatigue Training on Safety, Fatigue, and Sleep in Emergency Medical Services Personnel and Other Shift Workers: A Systematic Review and Meta-Analysis.

BACKGROUND: Fatigue training may be an effective way to mitigate fatigue-related risk. We aimed to critically review and synthesize existing literature on the impact of fatigue training on fatigue-related outcomes for Emergency Medical Services (EMS) personnel and similar shift worker groups. METHODS: We performed a systematic literature review for studies that tested the impact of fatigue training of EMS personnel or similar shift workers. Outcomes of interest included personnel safety, patient safety, personnel performance, acute fatigue, indicators of sleep duration and quality, indicators of long-term health (e.g., cardiovascular disease), and burnout/stress. A meta-analysis was performed to determine the impact of fatigue training on sleep quality. RESULTS: Of the 3,817 records initially identified for review, 18 studies were relevant and examined fatigue training in shift workers using an experimental or quasi-experimental design. Fatigue training improved patient safety, personal safety, and ratings of acute fatigue and reduced stress and burnout. A meta-analysis of five studies showed improvement in sleep quality (Fixed Effects SMD -0.87; 95% CI -1.05 to -0.69; p < 0.00001; Random Effects SMD -0.80; 95% CI -1.72, 0.12; p < 0.00001). CONCLUSIONS: Reviewed literature indicated that fatigue training improved safety and health outcomes in shift workers. Further research is required to identify the optimal components of fatigue training programs to maximize the beneficial outcomes.

Systematic Review and Meta-analysis of the Effects of Caffeine in Fatigued Shift Workers: Implications for Emergency Medical Services Personnel.

BACKGROUND: Emergency Medical Services (EMS) workers may experience fatigue as a consequence of shift work. We reviewed the literature to determine the impact of caffeine as a countermeasure to fatigue in EMS personnel and related shift workers. METHODS: We employed the GRADE methodology to perform a systematic literature review and search multiple databases for research that examined the impact of caffeine on outcomes of interest, such as patient and EMS personnel safety. For selected outcomes, we performed a meta-analysis of pooled data and reported the pooled effect in the form of a Standardized Mean Difference (SMD) with corresponding 95% confidence intervals. RESULTS: There are no studies that investigate caffeine use and its effects on EMS workers or on patient safety. Four of 8 studies in shift workers showed that caffeine improved psychomotor vigilance, which is important for performance. Caffeine decreased the number of lapses on a standardized test of performance [SMD = 0.75 (95% CI: 0.30 to 1.19), p = 0.001], and lessened the slowing of reaction time at the end of shifts [SMD = 0.52 (95% CI: 0.19 to 0.85); p = 0.002]. Finally, 2 studies reported that caffeine reduced sleep quality and sleep duration. CONCLUSIONS: Although the quality of evidence was judged to be low to moderate, when taken together, these studies demonstrate that caffeine can improve psychomotor performance and vigilance. However, caffeine negatively affects sleep quality and sleep duration. More systematic, randomized studies need to be conducted in EMS workers in order to address the critical outcomes of health and safety of EMS personnel and patients. The risk/benefit ratio of chronic caffeine use in shift workers is currently unknown.

Effects of Napping During Shift Work on Sleepiness and Performance in Emergency Medical Services Personnel and Similar Shift Workers: A Systematic Review and Meta-Analysis.

BACKGROUND: Scheduled napping during work shifts may be an effective way to mitigate fatigue-related risk. This study aimed to critically review and synthesize existing literature on the impact of scheduled naps on fatigue-related outcomes for EMS personnel and similar shift worker groups. METHODS: A systematic literature review was performed of the impact of a scheduled nap during shift work on EMS personnel or similar shift workers. The primary (critical) outcome of interest was EMS personnel safety. Secondary (important) outcomes were patient safety; personnel performance; acute states of fatigue, alertness, and sleepiness; indicators of sleep duration and/or quality; employee retention/turnover; indicators of long-term health; and cost to the system. Meta-analyses were performed to evaluate the impact of napping on a measure of personnel performance (the psychomotor vigilance test [PVT]) and measures of acute fatigue. RESULTS: Of 4,660 unique records identified, 13 experimental studies were determined relevant and summarized. The effect of napping on reaction time measured at the end of shift was small and non-significant (SMD 0.12, 95% CI -0.13 to 0.36; p = 0.34). Napping during work did not change reaction time from the beginning to the end of the shift (SMD -0.01, 95% CI -25.0 to 0.24; p = 0.96). Naps had a moderate, significant effect on sleepiness measured at the end of shift (SMD 0.40, 95% CI 0.09 to 0.72; p = 0.01). The difference in sleepiness from the start to the end of shift was moderate and statistically significant (SMD 0.41, 95% CI 0.09 to 0.72; p = 0.01). CONCLUSIONS: Reviewed literature indicated that scheduled naps at work improved performance and decreased fatigue in shift workers. Further research is required to identify the optimal timing and duration of scheduled naps to maximize the beneficial outcomes.

Skeletal Muscle Fat and Its Association With Physical Function in Rheumatoid Arthritis.

OBJECTIVE: To characterize skeletal muscle fat (SMF), intermuscular adipose tissue (IMAT), and subcutaneous adipose tissue (SAT) in individuals with rheumatoid arthritis (RA), and assess the associations between these fat depots and physical function and physical activity. METHODS: In a cross-sectional analysis from an RA cohort, SMF, IMAT, and SAT were measured using computed tomography imaging of the midthigh cross-sectional region. Physical function was measured using the Health Assessment Questionnaire (HAQ) and a battery of performance-based tests that included quadriceps muscle strength, gait speed, repeated chair-stands, stair ascent, and single-leg stance. Physical activity was assessed using an activity monitor. Associations between SMF, IMAT, and SAT and physical function and activity were assessed by multiple linear regression models adjusted for potential confounders such as age, sex, body mass index (BMI), muscle area, and muscle strength. RESULTS: Sixty subjects with RA (82% female, mean ± SD age 59 ± 10 years, mean ± SD BMI 31.79 ± 7.16 kg/m2 ) were included. In the adjusted models, lower SMF was associated with greater gait speed, single-leg stance, quadriceps strength, and physical activity, and less disability (R2 Δ range 0.06-0.25; P < 0.05), whereas IMAT was not associated with physical function or physical activity and SAT was negatively associated with disability (HAQ) (R2 Δ = 0.13; P < 0.05) and weakly but positively associated with muscle strength (R2 Δ = 0.023; P < 0.05). CONCLUSION: Fat infiltration within the muscle seems to independently contribute to low physical function and physical activity, contrary to IMAT or SAT accumulation. Longitudinal studies are necessary to confirm the impact of SMF on disability and health promotion in persons with RA.

Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial.

Importance: Parkinson disease is a progressive neurologic disorder. Limited evidence suggests endurance exercise modifies disease severity, particularly high-intensity exercise. Objectives: To examine the feasibility and safety of high-intensity treadmill exercise in patients with de novo Parkinson disease who are not taking medication and whether the effect on motor symptoms warrants a phase 3 trial. Design, Setting, and Participants: The Study in Parkinson Disease of Exercise (SPARX) was a phase 2, multicenter randomized clinical trial with 3 groups and masked assessors. Individuals from outpatient and community-based clinics were enrolled from May 1, 2012, through November 30, 2015, with the primary end point at 6 months. Individuals with idiopathic Parkinson disease (Hoehn and Yahr stages 1 or 2) aged 40 to 80 years within 5 years of diagnosis who were not exercising at moderate intensity greater than 3 times per week and not expected to need dopaminergic medication within 6 months participated in this study. A total of 384 volunteers were screened by telephone; 128 were randomly assigned to 1 of 3 groups (high-intensity exercise, moderate-intensity exercise, or control). Interventions: High-intensity treadmill exercise (4 days per week, 80%-85% maximum heart rate [n = 43]), moderate-intensity treadmill exercise (4 days per week, 60%-65% maximum heart rate [n = 45]), or wait-list control (n = 40) for 6 months. Main Outcomes and Measures: Feasibility measures were adherence to prescribed heart rate and exercise frequency of 3 days per week and safety. The clinical outcome was 6-month change in Unified Parkinson's Disease Rating Scale motor score. Results: A total of 128 patients were included in the study (mean [SD] age, 64 [9] years; age range, 40-80 years; 73 [57.0%] male; and 108 [84.4%] non-Hispanic white). Exercise rates were 2.8 (95% CI, 2.4-3.2) days per week at 80.2% (95% CI, 78.8%-81.7%) maximum heart rate in the high-intensity group and 3.2 (95% CI, 2.8-3.6; P = .13) days per week at 65.9% (95% CI, 64.2%-67.7%) maximum heart rate in the moderate-intensity group (P < .001). The mean change in Unified Parkinson's Disease Rating Scale motor score in the high-intensity group was 0.3 (95% CI, -1.7 to 2.3) compared with 3.2 (95% CI, 1.4 to 5.1) in the usual care group (P = .03). The high-intensity group, but not the moderate-intensity group, reached the predefined nonfutility threshold compared with the control group. Anticipated adverse musculoskeletal events were not severe. Conclusions and Relevance: High-intensity treadmill exercise may be feasible and prescribed safely for patients with Parkinson disease. An efficacy trial is warranted to determine whether high-intensity treadmill exercise produces meaningful clinical benefits in de novo Parkinson disease. Trial Registration: clinicaltrials.gov Identifier: NCT01506479.

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial.

BACKGROUND: Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown to improve selected CVD risk factors in individuals with SCI, but using nutrition education as an intervention has not been evaluated in this population. This paper describes our research plan for evaluating the effect of nutrition education on individuals with SCI. In the present study, called Eat Smart, Live Better, we are using a randomized controlled design to test an intervention adapted from an existing evidence-based program that showed a positive effect on nutrition knowledge and behavior of older adults from the general population. There will be an inpatient group (n = 100) and a community group (n = 100). The aims of our study are to compare the intervention and control groups for (1) changes in nutritional behavior, nutritional knowledge, and dietary quality by participants in the program; (2) levels of adiposity and metabolic CVD risk factors at 12-month follow-up; and (3) differential effects among individuals with SCI in the acute rehabilitation setting and those living in the community. METHODS/DESIGN: This is a randomized controlled trial of nutrition education. The treatment groups receive six nutrition education sessions. The control groups receive the one "standard of care" nutrition lecture that is required by the Commission on Accreditation of Rehabilitation Facilities. Treatment groups include both an inpatient group, comprising patients who have been admitted to an acute rehabilitation facility because of their recent SCI, and an outpatient group, consisting of community-dwelling adults who are at least 1 year after their SCI. A total of 200 participants will be randomized 1:1 to the intervention or control group, stratified by location (acute rehabilitation facility or community dwelling). DISCUSSION: To our knowledge, this will be the first reported study of nutrition education in individuals with SCI. The low cost and feasibility of the intervention, if shown to improve nutritional behavior, suggests that it could be implemented in rehabilitation facilities across the country. This has the potential of lowering the burden of CVD and CVD risk factors in this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02368405 . Registered on February 10, 2015.