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Purpose: The Audiovisual-Assisted Therapeutic Ambience in Radiotherapy (AVATAR) trial was a prospective multicenter study (NCT03991156) examining the combination of video immersion with radiation therapy and was successfully conducted through the collaboration of pediatric radiation oncology teams at 10 institutions independent of any pre-existing consortium. We sought to analyze and report the methodology of trial conception and development, process map, and cost. Methods and Materials: The study enrolled patients aged 3 to 10 years preparing to undergo radiation therapy, integrated the combination of AVATAR-based video immersion with radiation therapy at each institution, and offered AVATAR use as an alternative to anesthesia, with rates of anesthesia use and outcomes of serial standardized anxiety and quality-of-life assessments assessed among the 81 children enrolled. A process map was created based on the trial timeline with the following components: study development time (time from conception of the trial to the accrual of the first patient, including design phase, agreement and approval phase, and site preparation phase), and accrual duration time (time from the first to last accrual). Costs and institutional success rates were calculated. Results: Time from inception of study to last accrual was 3.6 years (1313 days). The study development time was 417 days (31.7%), and accrual duration time was 896 days (68.3%), with the final 50% of accrual occurring in

Purpose: To evaluate the safety and tolerability of a single dose of axitinib injectable suspension (CLS-AX), a pan-anti-VEGF tyrosine kinase inhibitor (TKI), administered via suprachoroidal injection in patients with neovascular age-related macular degeneration (nAMD). Design: Phase I/IIa, open-label, sequential dose escalation. Participants: Anti-VEGF treatment-experienced patients with active subfoveal choroidal neovascularization secondary to nAMD. Methods: The study included 4 cohorts (0.03, 0.10, 0.50, and 1.0 mg) of approximately 5 patients each enrolled in a dose-escalating fashion. Enrolled patients received intravitreal aflibercept (2 mg) followed by a single unilateral dose of CLS-AX 1 month later. All patients were followed monthly for 3 months with the option of an additional 3 months of extended follow-up for cohorts 2 to 4. End points included systemic and ocular safety and tolerability, visual acuity, retinal thickness, and need for aflibercept therapy. Main Outcome Measures: The number of patients reporting treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), changes in ophthalmic examinations, and the number of patients qualifying for additional therapy for nAMD based on protocol-defined criteria. Results: OASIS enrolled 27 patients with nAMD with mean age of 81 years, mean duration of nAMD diagnosis of 54 months, and between 5 and 90 prior anti-VEGF treatments. Twenty-six patients completed through 3 months, with 14 entering and completing the 3-month extension. No SAEs, drug-related TEAEs, or TEAEs leading to discontinuation were observed after CLS-AX administration; there were no adverse events related to ocular inflammation, vasculitis, intraocular pressure, or dispersion of drug into the vitreous or anterior chamber. Through 6 months, stable mean best-corrected visual acuity and stable mean central subfield thickness (CST) were observed, suggestive of TKI biologic effect. No aflibercept therapy was administered up to 3 months in 58% (15/26) of patients who completed 3 months of follow-up in OASIS. In the Extension, 57% (8/14) of patients went up to 6 months without receiving aflibercept therapy. Conclusions: Up to 1.0 mg CLS-AX, a highly potent TKI targeted to the suprachoroidal space (SCS) via the SCS Microinjector, was well tolerated, with stable mean visual acuity and mean CST. A majority of patients followed for 6 months did not require aflibercept therapy. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: There are limited data regarding outcomes after stereotactic body radiation therapy (SBRT) for femur metastases, which was an exclusion criteria for the Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers (SABR-COMET) trial. We aimed to characterize clinical outcomes from a large single institution experience. Methods and Materials: Forty-eight patients with 53 lesions were consecutively treated with femur SBRT from May 2017 to June 2022. The Kaplan-Meier method and Cox proportional hazard models were used to characterize time-to-event endpoints and associations between baseline factors and clinical outcomes, respectively. Local control and locoregional control were defined as the absence of tumor progression within the radiation treatment field or within the treated femur, respectively. Results: Most patients had Eastern Cooperative Oncology Group performance status 0 to 1 (90%), prostate (52%) or breast/lung (17%) cancer, and 1 to 3 lesions (100%), including 29 proximal and 5 distal. Fifty-seven percent of the lesions were treated with concurrent systemic therapy. Median planning target volume was 49.1 cc (range, 6.6-387 cc). Planning target volume V100 (%) was 99% (range, 90-100). Fractionation included 18 to 20 Gy/1F, 27 to 30 Gy/3F, and 28.5-40 Gy/5F. Forty-two percent had Mirels score ≥7 and most (94%) did not have extraosseous extension. Acute toxicities included grade 1 fatigue (15%), pain flare (7.5%), nausea (3.8%), and decreased blood counts (1.9%). Late toxicities included fracture (1.9%) at 1.5 years and osteonecrosis (4%) from dose of 40 Gy in 5F and 30 Gy in 5F (after prior 30 Gy/10F). One patient (2%) required fixation postradiation for progressive pain. With median follow-up 19.4 months, 1- and 2-year rates of local control were 94% and 89%, locoregional control was 83% and 67%, progression-free survival were 56% and 25%, and overall survival were 91% and 73%. Fifty percent of local regional recurrence events occurred within 5 cm of gross tumor volume. Conclusions: Femur SBRT for oligometastatic disease control in well-selected patients was associated with good outcomes with minimal rates of acute and late toxicity. Patterns of local regional recurrence warrant consideration of larger elective volume coverage. Additional prospective study is needed.

Invasive pulmonary aspergillosis in children rarely complicates life-threatening massive hemoptysis. Here, we report the case of a 15-year-old girl with acute lymphoblastic leukemia who was hospitalized for fever and medullary aplasia 1 month after beginning chemotherapy for invasive pulmonary aspergillosis. Despite voriconazole and caspofungine treatment, excavation of some lesions caused a unilateral small pneumothorax and bilateral pleural effusion, justifying intensive care management. The massive hemoptysis that occurred on day 23 was complicated with heart failure, and the patient was promptly resuscitated. Fibroscopy and computed tomography angiography (CTA) did not reveal the origin or cause of the bleeding. A second massive bleeding event occurred on day 32, and heart failure resolved after 10min of low flow. A new CTA showed 2 pseudoaneurysms of the subsegmental pulmonary arteries that were treated with embolization. Sedation was gradually decreased owing to improvement in respiratory status, but the patient did not regain consciousness because of deep brain sequelae. A limitation of care was decided upon, and the patient died in the following weeks. Massive hemoptysis is a rare life-threatening complication of invasive pulmonary aspergillosis, especially in children. Pulmonary artery pseudoaneurysms are unusual and should be detected as soon as possible to guide therapy. Intensive care management should be followed by embolization if the patient is stable; otherwise, surgery is indicated, ideally after identifying the source of bleeding by CTA or bronchoscopy. Early CTA follow-up can be proposed if the source of bleeding is still unknown as pseudoaneurysms can appear or grow rapidly.

Background:. We describe a new approach for facial reanimation after skull base tumor resection with known facial nerve sacrifice, involving simultaneous masseter nerve transfer with selective cross facial nerve grafting (CFNG) within days after tumor surgery. This preliminary study compared outcomes of this approach versus a staged procedure involving a masseter nerve “babysitter” performed in a delayed timeline. Methods:. Patients undergoing masseter nerve transfer and CFNG for facial paralysis after skull base tumor resection were consented to participate in video interviews. Facial Clinimetric Evaluation (FaCE) Scale (0–100) patient-reported outcome, eFACE, and Facial Grading Scale scores were compared. Results:. Nine patients had unilateral facial paralysis from resection of a schwannoma (56%), acoustic neuroma (33%), or vascular malformation (11%). Five underwent early simultaneous CFNG and masseter nerve transfer (mean 3.6 days after resection), whereas four underwent two-stage reanimation including a babysitter procedure (mean 218 days after resection). Postoperative FaCE scale and Facial Grading Scale scores were similar in both groups (P > 0.05). Postoperative mean eFACE scores were similar for both groups for smile (early: 71.5 versus delayed: 75.5; P = 0.08), static (76.3 versus 82.1; P = 0.32), and dynamic scores (59.7 versus 64.9; P = 0.19); however, synkinesis scores were inferior in the early group (76.4 versus 91.1; P = 0.04). Conclusions:. Early simultaneous masseter nerve transfer and CFNG provides reanimated movement sooner and in fewer stages than a staged approach in a delayed timeline. The early technique appears to result in similar clinician- and patient-reported outcomes compared with delayed procedures; however, in this preliminary study, the early approach was associated with greater synkinesis, meriting further investigation.

Purpose: To establish the safety, tolerability, pharmacokinetics, and pharmacodynamics of an intravitreal injection of recombinant human complement factor H (CFH), GEM103, in individuals with genetically defined age-related macular degeneration (AMD) and geographic atrophy (GA). Design: Phase I single ascending-dose, open-label clinical trial (ClinicalTrials.gov identifier, NCT04246866). Participants: Twelve individuals 50 years of age or older with a confirmed diagnosis of foveal GA in the study eye. Methods: Participants were assigned to the increasing dose cohorts and received 1 50-μl intravitreal injection of GEM103 at doses of 50 μg/eye, 100 μg/eye, 250 μg/eye, or 500 μg/eye; dose escalation was dependent on the occurrence of dose-limiting toxicities. Main Outcome Measures: Safety assessments included ocular and systemic adverse events (AEs), ocular examinations, clinical laboratory and vital signs, and serum antidrug antibody levels. Biomarkers, measured in the aqueous humor (AH), included CFH and complement activation biomarkers factor Ba and complement component 3a. Results: No dose-limiting toxicities were reported, enabling escalation to the maximum study dose. No anti-GEM103 antidrug antibodies were detected during the study. Four participants experienced AEs; these were nonserious, mild or moderate in severity, and unrelated to GEM103. The AEs in 2 of these participants were related to the intravitreal injection procedure. No clinically significant ophthalmic changes and no ocular inflammation were observed. Visual acuity was maintained and stable throughout the 8-week follow-up period. No choroidal neovascularization occurred. CFH levels increased in a dose-dependent manner after GEM103 administration with supraphysiological levels observed at week 1; levels were more than baseline for 8 weeks or more in all participants receiving single doses of 100 μg or more. Complement activation biomarkers were reduced 7 days after dose administration. Conclusions: A single intravitreal administration of GEM103 (up to 500 μg/eye) was well tolerated in individuals with GA. Of the few mild or moderate AEs reported, none were determined to be related to GEM103. No intraocular inflammation or choroidal neovascularization developed. CFH levels in AH were increased and stable for 8 weeks, with pharmacodynamic data suggesting that GEM103 restored complement regulation. These results support further development in a repeat-dose trial in patients with GA with AMD.

This case demonstrates the importance of considering septic pulmonary embolism (SPE) on the differential for chest pain in the pediatric population, especially in patients with a history of skin and soft tissue infection. The adolescent patient in this report, with a history of axillary hidradenitis suppurativa complicated by methicillin-resistant Staphylococcus aureus (MRSA) superinfection and recent completion of a 3-month course of doxycycline, presented with isolated focal chest pain in the absence of other infectious or respiratory signs or symptoms. Initial pulmonary imaging revealed multiple bilateral wedge-shaped nodules. Three specialty teams were consulted in the patient's evaluation, resulting in biopsy of a suspicious lesion that confirmed the diagnosis of MRSA SPE. Following a course of targeted antibiotic therapy, the patient's chest pain resolved and imaging findings improved. Insights gleaned from the workup of this patient are useful in formulating a framework for recognition of SPE in children presenting with chest pain, and also highlight the importance of considering insidious SPE presentation in the setting of antibiotic pretreatment.

Background: Atrial fibrillation (AF), a common cause of stroke, often is asymptomatic. Smartphones and smartwatches can detect AF using heart rate patterns inferred using photoplethysmography (PPG); however, enhanced accuracy is required to reduce false positives in screening populations. Objective: The purpose of this study was to test the hypothesis that a deep learning algorithm given raw, smartwatch-derived PPG waveforms would discriminate AF from normal sinus rhythm better than algorithms using heart rate alone. Methods: Patients presenting for cardioversion of AF (n = 51) were given wrist-worn fitness trackers containing PPG sensors (Jawbone Health). Standard 12-lead electrocardiograms over-read by board-certified cardiac electrophysiologists were used as the reference standard. The accuracy of PPG signals to discriminate AF from sinus rhythm was evaluated by conventional measures of heart rate variability, a long short-term memory (LSTM) neural network given heart rate data only, and a deep convolutional-recurrent neural net (DNN) given the raw PPG data. Results: From among 51 patients with persistent AF (age 63.6 ± 11.3 years; 78% male; 88% white), we randomly assigned 40 to train and 11 to test the algorithms. Whereas logistic regression analysis of heart rate variability yielded an area under the receiver operating characteristic curve (AUC) of 0.717 (sensitivity 0.741; specificity 0.584), the LSTM model given heart rate data exhibited AUC of 0.954 (sensitivity 0.810; specificity 0.921), and the DNN model given raw PPG data yielded the highest AUC of 0.983 (sensitivity 0.985; specificity 0.880). Conclusion: A deep learning model given the raw PPG-based signal resulted in AF detection with high accuracy, performing better than conventional analyses relying on heart rate series data alone.

A 48-year-old woman with paroxysmal atrial fibrillation (AF) underwent an electrophysiology study after 2 previous failed ablations. Noninvasive mapping suggested AF initiation from the right atrial appendage (RAA) with rotational drivers of AF in the RAA. Invasive mapping confirmed these findings. The patient was successfully treated with cryoballoon RAA isolation. (Level of Difficulty: Intermediate.)

Summary. The paramedian forehead flap is a historic cornerstone of plastic surgery and a mainstay of complex nasal reconstruction. Although initially described as a 2-stage procedure, several procedural advancements and modifications have been proposed, with the most notable being the addition of a third, intermediate stage. Proponents of this 3-stage approach argue that the addition of an intermediate stage improves flap perfusion, expands lining and structural support options, and provides superior aesthetic outcomes. Although this technique has grown in popularity, studies comparing the 2- versus 3-stage approach are relatively scarce in the literature. Existing comparative studies seem to suggest that the 3-stage paramedian forehead flap may have advantages in large, complex nasal defects and patients at high risk for vascular compromise. Additionally, comparative analyses with respect to aesthetic outcome were found to be largely equivocal, suggesting that surgeon comfort and preference should guide flap selection.

Summary. Small-to-medium cutaneous defects of the distal nose pose a significant challenge to reconstructive surgeons, and commonly described reconstructive techniques have their limitations. As the skin of this region is characteristically rigid and sebaceous, care must be taken to avoid introducing unfavorable tension vectors that can result in functional or anatomic distortion of the nasal free margins. With this in mind, the authors discuss 3 alternative reconstructive options, the East-West, nasalis sling, and trilobed flaps, which have wide utility in the repair of distal nasal cutaneous defects and can result in excellent cosmesis. The indications, surgical technique, and limitations of each are discussed in detail, and are compared with several of the more commonly described options in the context of distal nasal reconstruction.

Background:. In response to the devastating effects of the coronavirus disease 2019 pandemic, several vaccine prototypes have been developed, with the Pfizer/BioNTech (BNT162b2) platform being the first to receive emergency use authorization. Although taken to market on an unprecedented timeline, the safety profile of the drug during clinical trials was shown to be favorable. Shortly after release, reports from the Centers for Disease Control and Prevention demonstrated a higher-than-average rate of anaphylaxis to the vaccine that has been the cause for concern for safety officials and the general public alike. Here, we present a unique case of protracted anaphylaxis in a recipient of the BNT162b2. Case Summary:. The patient is a 55-year-old female with a history of multiple allergic reactions who presented with respiratory distress and hives after receiving the first dose of the BNT162b2, despite premedication with IV steroids and diphenhydramine. The refractory nature of her reaction was demonstrated by edema of her tongue (visualized on nasolaryngoscopy), requiring an epinephrine infusion for nearly 3 days. She was discharged from the hospital with instructions not to receive the second dose of the vaccine. Conclusion:. Although the exact etiology of anaphylaxis secondary to this messenger RNA-based vaccine is not completely clear, our literature search and review of the patient’s course support either polyethylene glycol versus other excipient-related allergy as a possible cause. Based on the protracted nature to our patient’s anaphylaxis, critical care management for patients with a true anaphylactic reaction to BNT162b2 may require monitoring for an extended period of time.

Background:. Tissue expansion is a versatile reconstructive technique providing well-vascularized local tissue. The current literature focuses largely on tissue expansion for breast reconstruction and in the context of burn and pediatric skin/soft tissue replacement; however, less traditional applications are also prevalent. The aim of this study was to systematically review the utilization of tissue expansion in such less well-characterized circumstances. Methods:. The authors conducted a systematic review of all publications describing non-breast applications of tissue expansion. Variables regarding expander specifications, expansion process, and complications were collected and further analyzed. Results:. A total of 565 publications were identified. Of these, 166 publications described tissue expansion for “less traditional” indications, which fell into 5 categories: ear reconstruction, cranioplasty, abdominal wall reconstruction, orthopedic procedures, and genital (penile/scrotal and vaginal/vulva) reconstruction. While lower extremity expansion is known to have high complication rates, tissue expander failure, infection, and exposure rates were in fact highest for penile/scrotal (failure: 18.5%; infection: 15.5%; exposure: 12.5%) and vaginal/vulva (failure: 20.6%; infection: 10.3%; exposure: 6.9%) reconstruction. Conclusions:. Tissue expansion enables index operations by providing additional skin before definitive reconstruction. Tissue expanders are a valuable option along the reconstructive ladder because they obviate the need for free tissue transfer. Although tissue expansion comes with inherent risk, aggregate outcome failures of the final reconstruction are similar to published rates of complications without pre-expansion. Thus, although tissue expansion requires a staged approach, it remains a valuable option in facilitating a variety of reconstructive procedures.

HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and acceptable mechanism for delivering age-appropriate social learning for healthy eating and physical activity among an ethnically diverse group of middle school students across the United States.

Background:. Nasal airway obstruction (NAO) due to nasal anatomic deformities is known to be more common among cleft patients than the general population, yet information is lacking regarding severity and variability of cleft-associated nasal obstruction relative to other conditions causing NAO. This preliminary study compares differences in NAO experienced by unilateral cleft lip nasal deformity (uCLND) subjects with noncleft subjects experiencing NAO. Methods:. Computational modeling techniques based on patient-specific computed tomography images were used to quantify the nasal airway anatomy and airflow dynamics in 21 subjects: 5 healthy normal subjects; 8 noncleft NAO subjects; and 8 uCLND subjects. Outcomes reported include Nasal Obstruction Symptom Evaluation (NOSE) scores, cross-sectional area, and nasal resistance. Results:. uCLND subjects had significantly larger cross-sectional area differences between the left and right nasal cavities at multiple cross sections compared with normal and NAO subjects. Median and interquartile range (IQR) NOSE scores between NAO and uCLND were 75 (IQR = 22.5) and 67.5 (IQR = 30), respectively. Airflow partition difference between both cavities were: median = 9.4%, IQR = 10.9% (normal); median = 31.9%, IQR = 25.0% (NAO); and median = 29.9%, IQR = 44.1% (uCLND). Median nasal resistance difference between left and right nasal cavities were 0.01 pa.s/ml (IQR = 0.03 pa.s/ml) for normal, 0.09 pa.s/ml (IQR = 0.16 pa.s/ml) for NAO and 0.08 pa.s/ml (IQR = 0.25 pa.s/ml) for uCLND subjects. Conclusions:. uCLND subjects demonstrated significant asymmetry between both sides of the nasal cavity. Furthermore, there exists substantial disproportionality in flow partition difference and resistance difference between cleft and noncleft sides among uCLND subjects, suggesting that both sides may be dysfunctional.

Background: Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression. Objectives: We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance. Methods: Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed. Results: For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (β = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (β = –1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication. Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

Childhood and adolescence are critical periods of neural development and physical growth. The malnutrition and related medical complications resulting from eating disorders such as anorexia nervosa (AN), bulimia nervosa (BN) and eating disorder not otherwise specified may have more severe and potentially more protracted consequences during youth than during other age periods. The consensus opinion of an international workgroup of experts on the diagnosis and treatment of child and adolescent eating disorders is that (a) lower and more developmentally sensitive thresholds of symptom severity (e.g. lower frequency of purging behaviours, significant deviations from growth curves as indicators of clinical severity) be used as diagnostic boundaries for children and adolescents, (b) behavioural indicators of psychological features of eating disorders be considered even in the absence of direct self-report of such symptoms and (c) multiple informants (e.g. parents) be used to ascertain symptom profiles. Collectively, these recommendations will permit earlier identification and intervention to prevent the exacerbation of eating disorder symptoms. [ABSTRACT FROM AUTHOR]

OBJECTIVE: In light of recent research indicating the clinical significance of eating disorder not otherwise specified-purging only (EDNOS-P), differences between women with lifetime bulimia nervosa purging subtype (BN-P) and EDNOS-P were examined. METHOD: Three groups of women were examined, a control group (n = 684) and two groups with lifetime eating disorders: BN-P (n = 22), and EDNOS-P (n = 53). RESULTS: Women with lifetime BN-P were significantly more likely to use vomiting than women with EDNOS-P but the latter group relied more on laxative abuse. Compared with controls, women with both eating disorders had higher weight and shape concern, dietary restraint, lifetime major depression, and suicidality. The BN-P group had significantly higher eating concern, dietary restraint, and suicidality than the EDNOS-P group. CONCLUSION: In accordance with previous research examining women with current eating disorders, EDNOS-P is indicated to be clinically significant. On the whole, the pattern of results indicated that EDNOS-P lies somewhere between BN-P and healthy controls in its clinical significance. (c) 2006 by Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

OBJECTIVE: In this study, we examined the effects of an exercise intervention in the treatment of obese women with binge eating disorder (BED). METHOD: Subjects were randomized to one of two 6-month treatment programs that included an identical exercise component (n = 44) or to a delayed treatment control condition (n = 33). Exercise level, binge eating frequency, and depressive symptomatology were assessed pre- and posttreatment. RESULTS: Women who received active treatment reported significantly greater increases in their weekly exercise frequency than did control subjects. At posttreatment, 81.4% of subjects who had received treatment were abstinent from binge eating. Compared to women who were not abstinent at posttreatment, abstinent women evidenced significant changes in exercise frequency and caloric expenditure. However, weight loss and improvements in depressive symptomatology were not related to exercise participation. DISCUSSION: These results suggest that exercise may be an important aspect of BED treatment and useful in promoting abstinence from binge eating. [ABSTRACT FROM AUTHOR]

Objective: The study objective was to examine the prevalence of depressive symptoms and relationships to quality of life and demographics in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study's large, ethnically diverse youth with type 2 diabetes.Research Design and Methods: A total of 704 youth with type 2 diabetes <2 years' duration, aged 10-17 years, and BMI ≥85th percentile completed depressive symptoms and quality of life measures.Results: Some 14.8% reported clinically significant depressive symptoms, and older girls had significantly higher rates than older boys.Conclusions: Rates of significant depressive symptoms were similar to those of healthy adolescents and lower than those of teens with type 1 diabetes. Elevated depressive symptoms, particularly in older girls, suggest clinicians assess vulnerability. [ABSTRACT FROM AUTHOR]

Objective: HEALTHY is a 3-year middle school intervention program designed to reduce risk factors for type 2 diabetes. The prevalence of diabetes risk factors at baseline in a cohort of 6,358 sixth-grade students is reported.Research Design and Methods: Forty-two schools at seven U.S. sites were randomly assigned to intervention or control. Students participated in baseline data collection during fall of 2006.Results: Overall, 49.3% of children had BMI >or=85th percentile, 16.0% had fasting blood glucose >or=100 mg/dl (<1% had fasting blood glucose >or=126 mg/dl), and 6.8% had fasting insulin >or=30 microU/ml. Hispanic youth were more likely to have BMI, glucose, and insulin levels above these thresholds than blacks and whites.Conclusions: Sixth-grade students in schools with large minority populations have high levels of risk factors for type 2 diabetes. The HEALTHY intervention was designed to modify these risk factors to reduce diabetes incidence. [ABSTRACT FROM AUTHOR]

The pro- and antiarrhythmic effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) have been extensively studied in preclinical and human trials. Despite early evidence of an antiarrhythmic role of n-3 PUFA in the prevention of sudden cardiac death and postoperative and persistent atrial fibrillation (AF), subsequent well-designed randomized trials have largely not shown an antiarrhythmic benefit. Two trials that tested moderate and high-dose n-3 PUFA demonstrated a reduction in sudden cardiac death, but these findings have not been widely replicated, and the potential of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to reduce arrhythmic death in combination, or as monotherapy, remains uncertain. The accumulated clinical evidence does not support supplementation of n-3 PUFA for postoperative AF or secondary prevention of AF. Several large, contemporary, randomized controlled trials of high-dose n-3 PUFA for primary or secondary cardiovascular prevention have demonstrated a small, significant, dose-dependent increased risk of incident AF compared with mineral oil or corn oil comparator. These findings were reproduced with both icosapent ethyl monotherapy and a mixed EPA+DHA formulation. The proarrhythmic mechanism of increased AF in contemporary cohorts exposed to high-dose n-3 PUFA is unknown. EPA and DHA and their metabolites have pleiotropic cardiometabolic and pro- and antiarrhythmic effects, including modification of the lipid raft microenvironment; alteration of cell membrane structure and fluidity; modulation of sodium, potassium, and calcium currents; and regulation of gene transcription, cell proliferation, and inflammation. Further characterization of the complex association between EPA, EPA+DHA, and DHA and AF is needed. Which formulations, dose ranges, and patient subgroups are at highest risk, remain unclear., Competing Interests: None.