Angiographic tool to detect pulmonary arteriovenous malformations in single ventricle physiology.

OBJECTIVE: Individuals with single ventricle physiology who are palliated with superior cavopulmonary anastomosis (Glenn surgery) may develop pulmonary arteriovenous malformations. The traditional tools for pulmonary arteriovenous malformation diagnosis are often of limited diagnostic utility in this patient population. We sought to measure the pulmonary capillary transit time to determine its value as a tool to identify pulmonary arteriovenous malformations in patients with single ventricle physiology. METHODS: We defined the angiographic pulmonary capillary transit time as the number of cardiac cycles required for transit of contrast from the distal pulmonary arteries to the pulmonary veins. Patients were retrospectively recruited from a single quaternary North American paediatric centre, and angiographic and clinical data were reviewed. Pulmonary capillary transit time was calculated in 20 control patients and compared to 20 single ventricle patients at the pre-Glenn, Glenn, and Fontan surgical stages (which were compared with a linear-mixed model). Correlation (Pearson) between pulmonary capillary transit time and haemodynamic and injection parameters was assessed using angiograms from 84 Glenn patients. Five independent observers calculated pulmonary capillary transit time to measure reproducibility (intraclass correlation coefficient). RESULTS: Mean pulmonary capillary transit time was 3.3 cardiac cycles in the control population, and 3.5, 2.4, and 3.5 in the pre-Glenn, Glenn, and Fontan stages, respectively. Pulmonary capillary transit time in the Glenn population did not correlate with injection conditions. Intraclass correlation coefficient was 0.87. CONCLUSIONS: Pulmonary angiography can be used to calculate the pulmonary capillary transit time, which is reproducible between observers. Pulmonary capillary transit time accelerates in the Glenn stage, correlating with absence of direct hepatopulmonary venous flow.

Effects of adherence to treatment for repositioning therapy, physical therapy, and cranial remolding orthoses in infants with cranial deformation.

Deformational head shapes are most often treated through repositioning therapy (RT) and/or cranial remolding orthotic (CRO) treatment. However, there is conflicting evidence about the effectiveness of each method, and treatment compliance is suspected to affect treatment effectiveness. This study examines participant adherence with these treatment methods and explores if cranial correction is related to compliance. This study also reviews effects of developmental milestones and explores other potential impacts on compliance. A total of 45 infants with cranial deformation were consented and those with congenital muscular torticollis (CMT) concurrently received physical therapy. Infants were followed from 2 to 12 months of age and initially assigned to RT. Caregivers continued RT until the head shape corrected, caregivers chose to switch to a CRO, or infants turned 12 months of age. All participants were scheduled for a final visit at 12 months of age. Throughout treatment, caregiver surveys were used to examine compliance and developmental milestones. Results show promise for future investigation into the relationship between treatment modalities and adherence with treatment for deformational head shapes. Our findings provide preliminary support that treatment adherence may be linked with treatment success and concurrent enrollment in physical therapy increases patient compliance.

HDL-C and apolipoprotein A-I are independently associated with skeletal muscle mitochondrial function in healthy humans.

Prior animal and cell studies have demonstrated a direct role of high-density lipoprotein (HDL) and apolipoprotein A-I (ApoA-I) in enhancing skeletal muscle mitochondrial function and exercise capacity. However, the relevance of these animal and cell investigations in humans remains unknown. Therefore, a cross-sectional study was conducted in 48 adults (67% female, 8% Black participants, age 39 ± 15.4 yr old) to characterize the associations between HDL measures, ApoA-I, and muscle mitochondrial function. Forearm muscle oxygen recovery time (tau) from postexercise recovery kinetics was used to assess skeletal muscle mitochondrial function. Lipoprotein measures were assessed by nuclear magnetic resonance. HDL efflux capacity was assessed using J774 macrophages, radiolabeled cholesterol, and apolipoprotein B-depleted plasma both with and without added cyclic adenosine monophosphate. In univariate analyses, faster skeletal muscle oxygen recovery time (lower tau) was significantly associated with higher levels of HDL cholesterol (HDL-C), ApoA-I, and larger mean HDL size, but not HDL cholesterol efflux capacity. Slower recovery time (higher tau) was positively associated with body mass index (BMI) and fasting plasma glucose (FPG). In multivariable linear regression analyses, higher levels of HDL-C and ApoA-I, as well as larger HDL size, were independently associated with faster skeletal muscle oxygen recovery times that persisted after adjusting for BMI and FPG (all P < 0.05). In conclusion, higher levels of HDL-C, ApoA-I, and larger mean HDL size were independently associated with enhanced skeletal muscle mitochondrial function in healthy humans.NEW & NOTEWORTHY Our study provides the first direct evidence supporting the beneficial role of HDL-C and ApoA-I on enhanced skeletal muscle mitochondrial function in healthy young to middle-aged humans without cardiometabolic disease.

Angiographic Tool to Detect Pulmonary Arteriovenous Malformations in Single Ventricle Physiology.

Background: Individuals with single ventricle physiology who are palliated with superior cavopulmonary anastomosis (Glenn surgery) may develop pulmonary arteriovenous malformations (PAVMs). The traditional tools for PAVM diagnosis are often of limited diagnostic utility in this patient population. We sought to measure the pulmonary capillary transit time (PCTT) to determine its value as a tool to identify PAVMs in patients with single ventricle physiology. Methods: We defined the angiographic PCTT as the number of cardiac cycles required for transit of contrast from the distal pulmonary arteries to the pulmonary veins. Patients were retrospectively recruited from a single quaternary North American pediatric center, and angiographic and clinical data was reviewed. PCTT was calculated in 20 control patients and compared to 20 single ventricle patients at the pre-Glenn, Glenn, and Fontan surgical stages (which were compared with a linear-mixed model). Correlation (Pearson) between PCTT and hemodynamic and injection parameters was assessed using 84 Glenn angiograms. Five independent observers calculated PCTT to measure reproducibility (intra-class correlation coefficient). Results: Mean PCTT was 3.3 cardiac cycles in the control population, and 3.5, 2.4, and 3.5 in the pre-Glenn, Glenn, and Fontan stages, respectively. PCTT in the Glenn population did not correlate with injection conditions. Intraclass correlation coefficient was 0.87. Conclusions: Pulmonary angiography can be used to calculate the pulmonary capillary transit time, which is reproducible between observers. PCTT accelerates in the Glenn stage, correlating with absence of direct hepatopulmonary venous flow.

A Bayesian adaptive design approach for stepped-wedge cluster randomized trials.

BACKGROUND: The Bayesian group sequential design has been applied widely in clinical studies, especially in Phase II and III studies. It allows early termination based on accumulating interim data. However, to date, there lacks development in its application to stepped-wedge cluster randomized trials, which are gaining popularity in pragmatic trials conducted by clinical and health care delivery researchers. METHODS: We propose a Bayesian adaptive design approach for stepped-wedge cluster randomized trials, which makes adaptive decisions based on the predictive probability of declaring the intervention effective at the end of study given interim data. The Bayesian models and the algorithms for posterior inference and trial conduct are presented. RESULTS: We present how to determine design parameters through extensive simulations to achieve desired operational characteristics. We further evaluate how various design factors, such as the number of steps, cluster size, random variability in cluster size, and correlation structures, impact trial properties, including power, type I error, and the probability of early stopping. An application example is presented. CONCLUSION: This study presents the incorporation of Bayesian adaptive strategies into stepped-wedge cluster randomized trials design. The proposed approach provides the flexibility to stop the trial early if substantial evidence of efficacy or futility is observed, improving the flexibility and efficiency of stepped-wedge cluster randomized trials.

A brief intervention decreases student distress.

PURPOSE OF THE ARTICLE: Health professions graduate students have experienced substantial increases in stress and anxiety in recent years. This can result in decreased academic performance, poor retention, and burnout. Interventions to help students cope are therefore a critical need for academic institutions. The current study sought to demonstrate the effectiveness of a brief multimodal intervention in reducing student distress. METHOD: The study was a randomised controlled design that evaluated a brief intervention of cognitive-behavioural therapy, mindfulness, and healthy lifestyle choices. The Depression Anxiety Stress Scale-21 was administered to participants at baseline and two post-intervention time points. Control participants did not participate in any intervention. Participants were recruited from graduate students in first-year classes within the School of Health Professions at UT Southwestern Medical Center. RESULTS: Analysis revealed an overall mild to moderate decline in Depression Anxiety Stress Scale-21 total scores over three assessment periods for both treatment and control groups, with no statistical differences noted between groups; however, the treatment group's scores declined approximately 6 weeks before the control participants' scores declined. CONCLUSION: The pattern of change in the two groups suggests that our intervention facilitated the reduction in student anxiety more quickly than would have occurred normally and with sustained results.

Retrospective Evaluation of Ultrasound Guided Percutaneous Plantar Fasciotomy With and Without Platelet Rich Plasma.

Plantar fasciitis is one of the most common foot conditions presenting to a foot and ankle specialist. Surgical treatment outcomes following plantar fasciotomy vary but short-term studies have reported excellent early pain relief and significant improvements in symptoms. This study evaluates patient reported pain scores collected pre- and post-op for patients who underwent percutaneous ultrasonic microtenotomy (PUT) plantar fasciotomy with PRP injection vs without the use of PRP. We compared pain visual analog scale (VAS) scores, for patients treated surgically by Orthopedic Surgery department of foot and ankle faculty members between December 2007 and December 2022. A total of 30 patients were identified that met inclusion and exclusion criteria. Our results showed that there was a significant decrease in pain VAS scores from pre-op visit (at least 1 month prior to operation) to post-op visit (at least 1 month following operation) for both groups, with a paired t test (p value <.0001). However, patients who received PRP had a statistically significant decrease in pain level compared to the group who did not receive PRP. Statistical analysis completed with a 2-sample t test (p-value <.0325). Our results found the mean time between the initial pre-op visit and last post-op follow-up visit was 19 months. The mean for time following surgical intervention was 10 months. The findings of our study suggest that the dual use of PUT and PRP to treat plantar fasciitis, could potentially lead to an improvement in pain reduction and longevity of pain relief.

Clinical Risk Factors of Perioperative Pressure Injury in Older Adult Patients with a Hip Fracture.

OBJECTIVE: To examine the clinical risk factors of perioperative pressure injury (PrI) in older adults with a hip fracture, including preoperative chronic comorbidities and postoperative complications. METHODS: In this retrospective study, the authors queried the PearlDiver Patient Records database between January 2011 and January 2020. Data from 54,194 patients without preexisting PrI were included for analyses. Patients were separated into two groups: (1) one or more perioperative PrI and (2) no PrI. Clinical factors as outcome variables include 21 comorbidities and 10 complications. RESULTS: Univariate analyses were computed to compare the variables between groups, and two logistic regression models were developed to find comorbidity predictors and complication predictors. Of all patients, 1,362 (2.5%) developed one or more perioperative PrI. Patients with perioperative PrIs were more likely to be older men. One-year mortality for patients with perioperative PrI was 2.5 times that of patients without PrI. The regression models showed that predictors of perioperative PrI are malnutrition, hypoalbuminemia, frailty, peripheral vascular disease, dementia, urinary tract infection, perioperative red blood cell transfusion, and atrial fibrillation. CONCLUSIONS: Screening for these comorbidities and complications may assist in determining the risk of PrI in older adults undergoing hip fracture surgery. Determining PrI risk enables the appropriate prevention strategies to be applied perioperatively.

Potassium Magnesium Citrate Is Superior to Potassium Chloride in Reversing Metabolic Side Effects of Chlorthalidone.

BACKGROUND: Thiazide diuretics (TD) are the first-line treatment of hypertension because of its consistent benefit in lowering blood pressure and cardiovascular risk. TD is also known to cause an excess risk of diabetes, which may limit long-term use. Although potassium (K) depletion was thought to be the main mechanism of TD-induced hyperglycemia, TD also triggers magnesium (Mg) depletion. However, the role of Mg supplementation in modulating metabolic side effects of TD has not been investigated. Therefore, we aim to determine the effect of potassium magnesium citrate (KMgCit) on fasting plasma glucose and liver fat by magnetic resonance imaging during TD therapy. METHODS: Accordingly, we conducted a double-blinded RCT in 60 nondiabetic hypertension patients to compare the effects of KCl versus KMgCit during chlorthalidone treatment. Each patient received chlorthalidone alone for 3 weeks before randomization. Primary end point was the change in fasting plasma glucose after 16 weeks of KCl or KMgCit supplementation from chlorthalidone alone. RESULTS: The mean age of subjects was 59±11 years (30% Black participants). Chlorthalidone alone induced a significant rise in fasting plasma glucose, and a significant fall in serum K, serum Mg, and 24-hour urinary citrate excretion (all P<0.05). KMgCit attenuated the rise in fasting plasma glucose by 7.9 mg/dL versus KCl (P<0.05), which was not observed with KCl. There were no significant differences in liver fat between the 2 groups. CONCLUSIONS: KMgCit is superior to KCl, the common form of K supplement used in clinical practice, in preventing TD-induced hyperglycemia. This action may improve tolerability and cardiovascular safety in patients with hypertension treated with this drug class.

Utility of standing office blood pressure in detecting hypertension in healthy adults.

Current guidelines recommend office blood pressures (BP) be taken in a seated position when screening for hypertension (HTN). Seated BP is known to have limited accuracy in detecting high BP, while the utility of standing BP in diagnosing HTN is unknown. We conducted a cross-sectional study to determine the incremental value of standing BP in diagnosing HTN. Seated, standing, and 24-h ambulatory BPs (ABPM) were obtained in adults without known cardiovascular disease, HTN, or BP medication use. Presence of HTN was defined by the 2017 ACC/AHA and the 2023 ESH HTN guidelines based on ABPM. Area under the receiver-operating-characteristic curve (AUROC) was used to evaluate the diagnostic accuracy of seated and standing BP. Sensitivity and specificity of standing BP was determined using cut-offs derived from Youden's Index, while sensitivity and specificity of seated BP was determined using the cut-off of 130/80 mmHg and by 140/90 mmHg. Among 125 participants (mean age 49 ± 17 years; 62% female; 24% Black), 33.6% of them had HTN. Sensitivity and specificity of seated systolic BP (SBP) was 43% and 92%, respectively. Cut-offs selected by Youden's index for standing SBP/diastolic BP (DBP) were 124/81 mmHg according to the 2017 ACC/AHA HTN guidelines, and 123.5/83.5 mmHg according to the 2023 ESH HTN guidelines. Sensitivity and specificity of standing SBP was 71% and 67%, respectively. The AUROC of standing SBP (0.81 [0.71-0.92]) was significantly higher than seated SBP (0.70 [0.49-0.91]), when HTN was defined as average 24-h SBP ≥ 125 mmHg. Moreover, the addition of standing to seated SBP (0.80 [0.68-0.92]) improved HTN detection when compared to seated SBP. These patterns were consistent for both the 2017 ACC/AHA and the 2023 ESH definitions for HTN. In summary, standing BP, alone or in combination with seated BP, outperformed seated BP alone in diagnosing HTN in adults.

Predictors of one year pressure injury outcomes in hospitalized spinal cord injured veterans with one stage 3 or 4 pressure injury.

OBJECTIVE: The purpose of this study is to investigate predictors of pressure injury (PrI) outcomes at one year after discharge for Veterans with spinal cord injury (SCI) hospitalized with a Stage 3 or 4 PrI. DESIGN/SETTING/PARTICIPANTS: This is a retrospective medical record review from one VA Health Care System SCI unit. Participants were Veterans with traumatic or non-traumatic SCI admitted with one Stage 3 or 4 pelvic PrI treated medically (e.g. without flap surgery). Logistic models were used to select the significant predictors of PrI healing outcomes. OUTCOME MEASURE: One year after discharge wound outcomes (healed vs non-healed) for Veterans with SCI hospitalized with a Stage 3 or 4 PrI. RESULTS: A total of 62 hospitalizations were included for analyses resulting in 33 healed and 29 non-healed PrIs. Three significant predictors of non-healed PrI outcomes included use of pressure mapping during hospitalization, greater PrI depth, and usage of alginate dressings. Two significant predictors of healed PrI outcomes included the use of animal-based tissue and hydrocolloid dressings. Area under curve of this logistic regression model was 79.98%. CONCLUSION: The clinical decision of having a patient pressure mapped predicts that the PrI may not heal at one year of discharge. Pressure mapping protocol correlated with another variable that could not serve as a predictor by itself, including using powered pressure relief techniques. The three PrI treatment predictors may represent characteristics of the PrI itself, rather than the efficacy of the product. Further investigation on these clinical decision-making factors is warranted to ensure efficient and cost-effective treatment strategies for individuals with SCI hospitalized with PrIs.

Statin therapy for primary prevention in men: What is the role for coronary artery calcium?

Current cholesterol guidelines for primary prevention of atherosclerotic cardiovascular disease (ASCVD) base statin treatment decisions on multiple risk factor algorithms (e.g., Pooled Cohort Equations [PCEs]). By available PCEs, most older middle-aged men are statin eligible. But several studies cast doubt on predictive accuracy of available PCEs for ASCVD risk assessment. Recent studies suggest that accuracy can be improved by measurement of coronary artery calcium (CAC). This method has the advantage of identifying men at low risk in whom statin therapy can be delayed for several years, provided they are monitored periodically for progression of CAC. Thus, there are two approaches to statin therapy in men ≥ 55 years: first all men could be treated routinely, or second, treatment can be based on the extent of coronary calcium. The latter could allow a sizable fraction of men to avoid treatment for several years or indefinitely. Whether with initial CAC scan or with periodic rescanning, a CAC score ≥ 100 Agatston units is high enough to warrant statin therapy. In otherwise high-risk men (e.g., diabetes, severe hypercholesterolemia, 10-year risk by PCE ≥ 20%), a statin is generally indicated without the need for CAC; but in special cases, CAC measurement may aid in treatment decisions.

Utilisation of skin blood flow as a precursor for pressure injury development in persons with acute spinal cord injury: A proof of concept.

People with spinal cord injury (SCI) are at high risk of developing a pressure injury. It is unclear why some people with SCI develop pressure injury while others with similar predisposing risk factors do not during acute hospitalisation. This may hinder healthcare utilisation to prevent pressure injuries. The purpose of the study was to examine the proof-of-concept objective bedside skin blood flow measurements before a pressure injury develops in spinal cord injured patients during acute hospitalisation. This was an observational study. All participants had acute traumatic SCI and were pressure injury-free upon enrollment. Skin blood flow patterns were collected at both heels under two circumstances: localised pressure for reactive hyperemia, and localised heating for heat hyperemia. Our results showed that reactive and heat hyperemia were successfully induced in all eleven participants. Two participants developed pressure injury and nine did not have pressure injury at discharge. Heat hyperemia was smaller in participants with pressure injury. No difference was observed in reactive hyperemia between the groups. In conclusion, skin blood flow measurements could be obtained at bedside during acute hospitalisation of SCI for the purpose of research. Further examination of a larger group is warranted to determine clinical use of heat hyperemia pattern as predictor for pressure injury development.

Healthcare utilization and outcomes of spinal cord injured veterans with stage 3-4 pressure injuries.

BACKGROUND: Pressure injuries (PI) are a significant source of morbidity for individuals with spinal cord injury/disease (SCI/D). They are also associated with significant healthcare resource utilization including prolonged hospitalizations. However, the long-term outcomes in terms of wound recurrence-free survival, hospital readmission rates, and all-cause mortality in this population remain largely unknown. OBJECTIVE: To examine the clinical characteristics, healthcare utilization and outcomes of SCI Veterans hospitalized at the VA North Texas Health Care System (VANTHCS) SCI inpatient unit with stage 3 and 4 PI, and compare these between those who received a myocutaneous flap surgery (flap patients (FP)) and those treated medically (non-flap patients (NFP)). METHODS: A retrospective chart review was conducted of all adult patients admitted to the VANTHCS SCI/D unit with stage 3 or 4 pelvic PI between 1/1/2013 and 12/31/2018. Healthcare utilization and outcome information was extracted for pre-specified time points. RESULTS: 78 patients met criteria (113 hospitalizations; 27 FP; 51 NFP). Average length of stay (LOS) was 122 days; FP had a significantly higher LOS than NFP (P = 0.01). Average number of consults was 24. Estimated cost per hospitalization was $175,198. Readmission rate within 30 days was 12.39%. The mortality rate within 1 year of discharge was 21.57% for NFP, as opposed to 3.70% in the FP group. Only 5.00% of NFP wounds were healed at discharged with sustained healing at 1 year, significantly less than FP wounds (55.26%, P < 0.01). CONCLUSIONS: Despite the high investment in terms of healthcare utilization, outcomes in terms of wound healing are poor. Additionally, nearly 22% of NFP died within one year of discharge. This calls into question the utility of prolonged hospitalizations for PI in the SCI/D population in terms of wound treatment efficacy, healthcare costs, and patient morbidity/mortality.

Development and Validation of a Prediction Model for the Treatment Time of Deformational Head Shapes Using a Cranial Remolding Orthosis.

The cranial remolding orthosis (CRO) has been shown in previous studies to be an effective method of treatment for deformational head shapes. Many studies have shown younger infants achieve greater correction than older infants and generally have a shorter treatment duration. The goal of this study is to develop and validate a prediction equation for the maximum treatment time for deformational head shapes when utilizing a CRO. This retrospective study included subjects with deformational plagiocephaly (DP), deformational brachycephaly (DB), or deformational asymmetrical brachycephaly (DAB) who began CRO treatment between 3 and 18 months of gestational age. Prediction models were derived from 1250 subjects with DP, DB, and DAB and the validation used data from 210 different subjects. Actual treatment time was less than or equal to predicted treatment time in 85.19% (DP), 56.67% (DB), and 75.40% (DAB) of the cases when rounding the prediction up to the nearest month. The prediction equation has moderate accuracy for predicting the likely maximum amount of CRO treatment time for patients with DP, DB, and DAB and may be used clinically to give caregivers an estimated treatment duration for a patient who is indicated for a CRO, if treatment was initiated immediately.

Neurobehavioral Symptoms and Heart Rate Variability: Feasibility of Remote Collection Using Mobile Health Technology.

OBJECTIVES: To determine the covariance of heart rate variability (HRV) and self-reported neurobehavioral symptoms after traumatic brain injury (TBI) collected using mobile health (mHealth) technology. SETTING: Community. PARTICIPANTS: Adults with lifetime history of TBI (n = 52) and adults with no history of brain injury (n = 12). DESIGN: Two-week prospective ecological momentary assessment study. MAIN MEASURES: Behavioral Assessment Screening Tool (BASTmHealth) subscales (Negative Affect, Fatigue, Executive Dysfunction, Substance Abuse, and Impulsivity) measured frequency of neurobehavioral symptoms via a RedCap link sent by text message. Resting HRV (root mean square of successive R-R interval differences) was measured for 5 minutes every morning upon waking using a commercially available heart rate monitor (Polar H10, paired with Elite HRV app). RESULTS: Data for n = 48 (n = 38 with TBI; n = 10 without TBI) participants were included in covariance analyses, with average cross-correlation coefficients (0-day lag) varying greatly across participants. We found that the presence and direction of the relationship between HRV and neurobehavioral symptoms varied from person to person. Cross-correlation coefficients r ≤ -0.30, observed in 27.1% to 29.2% of participants for Negative Affect, Executive Dysfunction, and Fatigue, 22.9% of participants for Impulsivity, and only 10.4% of participants for Substance Abuse, supported our hypothesis that lower HRV would covary with more frequent symptoms. However, we also found 2.0% to 20.8% of participants had positive cross-correlations (r ≥ 0.30) across all subscales, indicating that higher HRV may sometimes correlate with more neurobehavioral symptoms, and 54.2% to 87.5% had no significant cross-correlations. CONCLUSIONS: It is generally feasible for community-dwelling adults with and without TBI to use a commercially available wearable device to capture daily HRV measures and to complete a short, electronic self-reported neurobehavioral symptom measure for a 2-week period. The covariance of HRV and neurobehavioral symptoms over time suggests that HRV could be used as a relevant physiological biomarker of neurobehavioral symptoms, though how it would be interpreted and used in practice would vary on a person-by-person and symptom domain basis and requires further study.

Side Effects of Cranial Remolding Orthoses: A Multi-Site Review.

ABSTRACT: Infants with deformational head shapes may be treated with a Cranial Remolding Orthosis (CRO). Risks of CROs include skin irritations and other minor side effects. It is important to examine the incidence of complications with CRO treatment to determine if the potential benefits outweigh the risks.This study retrospectively examined surveys provided by both practitioners and caregivers regarding orthotic treatment side effects and wear time at four clinics in Canada. Statistical analysis including the Chi-square test and Fisher's exact tests were performed to examine how the side effects varied by treatment site and by reported orthotic wear time.In total, 5,025 surveys about the CRO treatment of 453 patients were reviewed. The most common side effects were pressure spots, redness lasting for more than 1 hour, excessive sweat , and foul odor; however, the vast majority reported no significant issues (87.08%). Only 2.81% of surveys reported multiple side effects, which was about three times more like to happen when the CRO was reported to have fit problems. Wear time is correlated with the report of side effects; infants who wore the CRO 18 to 23.5 hours had statistically fewer side effects than those who wore the CRO for less time. The reported incidence of side effects may be artificially inflated because infants experiencing side effects are more likely to have more frequent follow-up.Overall, the side effects of CRO treatment reported in this cohort were relatively rare and minimal, indicating CRO treatment is a safe way to treat deformational head shapes.

Prevalence and significance of risk enhancing biomarkers in the United States population at intermediate risk for atherosclerotic disease.

BACKGROUND: Pooled cohort equations (PCEs) estimate 10-year risk for atherosclerotic cardiovascular disease (ASCVD) in US adults. One use is to guide statin eligibility. However, PCEs risk estimate is inaccurate in some US subpopulations. OBJECTIVE: Recent cholesterol guidelines proposed addition of risk enhancing factors to improve risk assessment for selection of statin therapy. This study examines frequencies of several risk enhancing biomarkers in NHANES subjects at intermediate risk (7.5 -<20% 10-year risk for ASCVD) and considers how they may be used to better assess risk for individuals. METHODS: Prevalence of the following biomarkers were determined; elevations in apolipoprotein B-containing lipoproteins, i.e., LDL cholesterol (LDL-C) (160-189 mg/dL), non-HDL-cholesterol (non-HDL-C) (190-219 mg/dL), or total apolipoprotein B (apoB) (≥ 130 mg/dL), serum triglyceride (≥175 mg/dL), hemoglobin A1c (5.7-6.4%), high sensitivity C-reactive protein (2-10 mg/L), and waist circumference ≥ 102 cm, and abnormal estimated glomerular filtration rate (15 - ≤ 60 mg/min/1.73 m2). RESULTS: 25% of NHANES population had intermediate risk. In this subpopulation, 85% had ≥ 1 biomarkers-similarly in women and men-with a third having ≥3 abnormal markers. Frequencies were not age-related, except in those 40-49 years, in whom > 40% had ≥3 abnormal biomarkers. It made little difference whether LDL-C, non-HDL-C or apoB was used as the atherogenic lipoprotein. CONCLUSION: Three or more enhancing risk factors in intermediate risk subjects can complement PCE-estimated 10-year risk and guide the patient-provider discussion toward use of lipid-lowering medication. Future research is needed to integrate risk estimates by PCE and multiple risk enhancers.

Evaluating student food selections after a nutrition education intervention in a montessori community school.

Context: Schools are unique sites for nutrition education interventions due to their ability to provide educational activities as well as meals, allowing for observation of behavior change. Nutrition education and physical activity awareness programs implemented in the school setting have the potential to positively impact students' eating habits. Eating habits are developed at a young age, but few efforts have been made to deliver and assess education interventions in the pre-K through grade 3 age group. Objective: The purpose of this study was to evaluate student food selections before and after a nutrition education intervention was implemented in a Montessori school. Human Subjects Review: Approved as non-regulated research by the UTSW IRB. Study Design: Retrospective exploratory analysis. Setting: A single Montessori community school with students in grades pre-K through grade 3. Instrument: Aggregate lunch food selection data, including total food items offered and total food items left over, via daily production records. Main Outcome Measures: Records were collected from three school years to compare the food acceptability - the percent of food item taken from the total offered - of fruit (F), vegetable (V), F&V, 0% milk, 1% milk, and all milks before and after the implementation of the intervention program. Food acceptability served as a proxy for food consumption. Results: In all years, fruit (82.88%) and all milks (81.74%) were well accepted by students, but vegetables (62.00%) were not. The study found that from year 1 to year 2, there were statistically significant (p <0.0001) decreases in intake in all categories. This trend continued when comparing year 1 to year 3. Conclusions: Prior studies show that even in successful interventions, when vegetable or F&V intake does increase, changes are minimal. These findings corroborate the difficulties prior studies have demonstrated in changing students' food selections for the better, particularly regarding vegetable consumption. This analysis of production records showed a decline in acceptability of foods over the three years. It is unclear if these changes are directly related to the instructional program, due to the presence of confounding factors. Future studies should attempt to reevaluate nutrition education and subsequently conduct a plate-waste study for a more accurate representation of food consumption before and after an intervention.

A flexible sample size solution for longitudinal and crossover cluster randomized trials with continuous outcomes.

Longitudinal cluster randomized trial (LCRT) and crossover cluster randomized trial (CCRT) are two variants of cluster randomized trials. In LCRTs, clusters of subjects are randomly assigned to different treatment groups and each subject has repeated measurements over the study period. In CCRTs, clusters of subjects are randomly assigned to different sequences. Within each sequence, clusters receive all treatments in a particular order. Both LCRTs and CCRTs lead to complicated correlation structures that involve longitudinal and intracluster correlations. Generalized linear mixed model (GLMM) and generalized estimating equation (GEE) approaches have been frequently employed in data analysis and sample size estimation. In this study we propose closed-form sample size and power formulas for LCRTs and CCRTs based on the GEE approach. These formulas are flexible to incorporate unbalanced randomization, different missing patterns, arbitrary correlation structures, and randomly varying cluster sizes, providing a practical yet robust sample size solution. Simulation studies show that the proposed methods achieve good performance with empirical powers and type I errors close to their nominal values.