Modifying diet and exercise in multiple sclerosis (MoDEMS): A randomized controlled trial for behavioral weight loss in adults with multiple sclerosis and obesity.

BACKGROUND: Obesity is a risk factor for developing multiple sclerosis (MS) and MS-related disability. The efficacy of behavioral weight loss interventions among people with MS (pwMS) remains largely unknown. OBJECTIVE: Examine whether a group-based telehealth weight loss intervention produces clinically significant weight loss in pwMS and obesity. METHODS: Seventy-one pwMS were randomized to the weight loss intervention or treatment-as-usual (TAU). The 6-month program promoted established guidelines for calorie reduction and increased physical activity. Anthropometric measurements, mobility tasks, self-report questionnaires, and accelerometry were used to assess changes at follow-up. RESULTS: Mean percent weight loss in the treatment group was 8.6% compared to 0.7% in the TAU group (p < .001). Sixty-five percent of participants in the intervention achieved clinically meaningful weight loss (⩾ 5%). Participants in the treatment group engaged in 46.2 minutes/week more moderate-to-vigorous physical activity than TAU participants (p = .017) and showed improvements in quality of life (p = .012). Weight loss was associated with improved mobility (p = .003) and reduced fatiguability (p = .008). CONCLUSION: Findings demonstrate the efficacy of a behavioral intervention for pwMS and obesity, with clinically significant weight loss for two-thirds of participants in the treatment condition. Weight loss may also lead to improved mobility and quality of life.

A pilot study evaluating the prefeasibility of a behavioral weight loss program in people with multiple sclerosis.

Weight loss interventions seldom include individuals with neurologic disease. The aims of the present study were to: 1) develop and assess the prefeasibility of a 6-month telehealth behavioral weight loss program for people with multiple sclerosis (MS) and obesity and 2) examine changes in weight loss (primary outcome), physical activity, and fruit/vegetable consumption at follow-up. Participants with obesity and MS engaged in a 24-week weight loss program. Participants followed established diet, exercise, and self-monitoring guidelines and attended weekly online group meetings. Median percentage weight loss was 10.54 % (SD = 7.19). Participants who adhered more closely to the self-monitoring guidelines (r = 0.81, p =.02), and who averaged higher weekly active minutes (r = 0.91, p =.002) achieved greater percentage weight loss. Six of the eight pilot participants achieved clinically meaningful weight loss (>5%) after 6-months.

Correlates of HIV-Related Stigmas Among African American Church-Affiliated Populations in Kansas City.

HIV-related stigmas contribute to disparities, and contact with HIV-positive individuals has been suggested to reduce stigma. Faith-based organizations have been recognized as important to stigma reduction efforts among African American populations; however, relatively few church-based studies have measured HIV-related stigma. This study uses baseline data (N = 1,448) from a study with 14 African American churches in Kansas City, Missouri and Kansas, to examine correlates of HIV-related stigmas among church members and community members accessing church social services using two previously validated scales that measure discomfort interacting with individuals with HIV and anticipated stigma or rejection. Knowing someone with HIV was associated with lower discomfort, even after adjusting for sociodemographic characteristics and sexual risk, HIV knowledge, previous communication about HIV at church, and mean drug and homosexuality stigmas. Knowing someone with HIV was not associated with anticipated stigma or rejection after adjustment. Contact-based interventions hold promise for reducing discomfort around people with HIV among church-affiliated populations.

COVID-19 Testing in African American Churches Using a Faith-Health- Academic Partnership.

Increasing access to COVID-19 testing in influential, accessible community settings is needed to address COVID-19 disparities among African Americans. We describe COVID-19 testing intervention approaches conducted in Kansas City, Missouri, African American churches via a faith-health-academic partnership. Trained faith leaders promoted COVID-19 testing with church and community members by implementing multilevel interventions using a tailored toolkit and standard education information. The local health department conducted more than 300 COVID-19 tests during or after Sunday church services and outreach ministry activities. (Am J Public Health. 2022;112(S9):S887-S891. https://doi.org/10.2105/AJPH.2022.306981).

Renin-Angiotensin Blockade Reduces Readmission for Acute Chest Syndrome in Sickle Cell Disease.

Rationale Acute chest syndrome (ACS) is a life-threatening complication of sickle cell disease (SCD). Current treatment is supportive-supplemental oxygen, transfusions, and antibiotics. Prevention of ACS may reduce morbidity and mortality in patients with SCD. Acute chest syndrome appears similar to pulmonary fat embolism (PFE), a complication of severe skeletal trauma or orthopedic procedures from pulmonary micro-vessel blockage by bone marrow fat. Vascular obstruction and bone marrow necrosis occur in PFE and ACS.  Pulmonary fat embolism rat models have shown that angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB) mitigate damage in PFE. These medications could work similarly in ACS. We hypothesize that time to readmission after one hospitalization for ACS will be reduced in patients taking ACEI or ARB compared to patients who are not. Methods This is a retrospective cohort study. Inclusion criteria are adults (18 to 100 years) with sickle cell anaemia (HbSS), hemoglobin SC (HbSC) disease, sickle cell thalassemia (HbSßThal), hospitalized with ACS over 16 years (January 1, 2000, to March 31, 2016); patients who take and don't take ACEI or ARB. Children (<18 years old), elderly adults (>100 years old), pregnant patients, and patients with sickle cell trait were excluded. Data was collected from the Health Facts database, which contains de-identified information from the electronic medical records of hospitals in which Cerner© has a data use agreement. Kaplan-Meier estimates explored a time-to-event model of ACS readmission. Multivariable analysis (age, gender, smoking history) was conducted using Cox proportional hazards regression. Results were reported around a 95% confidence interval. Results There were 6972 patients in total. Of which, 9.6% (n = 667) reported taking ACEI or ARB. Results for the covariates were: average age of 38 years old; 63% female (n = 4366/6969); 16% smokers (n = 1132). Readmission rates were higher for patients not taking ACEI/ARB than those who did: 0.44 (95% CI 0.43, 0.46) versus 0.28 (95% CI 0.24, 0.31) at one year, and 0.56 (95% CI 0.55, 0.58) versus 0.33 (95% CI 0.29, 0.37) at two years. Age had the strongest effect on readmission rates for patients taking ACEI/ARB (adjusted hazards ratio 0.78 [95% CI 0.68, 0.91]). Conclusion Patients with SCD who reported taking ACEI or ARB had lower readmission rates for ACS; age was the strongest covariate. Our results may have a significant impact on the prevention of ACS. Prospective studies comparing ACEI or ARB therapy versus placebo are needed to confirm this preventative effect.

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.

Importance: The US Food and Drug Administration (FDA) uses 510(k) clearance and premarket approval (PMA) pathways to ensure device safety before marketing. Premarket approval evaluates high-risk medical devices and requires clinical trials, whereas 510(k) clearance evaluates moderate-risk devices and relies on benchtop (nonclinical and biomechanical) and descriptive data. Existing literature suggests that the clinical trials required by PMA are associated with reduced risk of recall compared with devices granted 510(k) clearance. Several investigators have found weaknesses in pivotal PMA trials, raising safety concerns. Furthermore, methodological factors may have led to a previous underestimation of recall risk for devices with PMA. Objectives: To compare risk of recall and high-risk recall between devices that received 510(k) clearance and those that received PMA and to compare the risk of recall between devices for medical specialties. Design, Setting, and Participants: This cohort study compared devices with 510(k) clearance vs those with PMA that reached the market between January 1, 2008, and December 31, 2017. Two- to 12-year follow-up was obtained from the FDA's 510(k) and PMA medical device database. Orthopedic surgery was chosen arbitrarily as the reference category for analysis between specialties because no baseline exists. Statistical analysis was performed from February 1 to November 1, 2020. Main Outcomes and Measures: The FDA issues recalls for safety concerns. These recalls are stratified into class I, II, and III, with class I representing high-risk issues for serious harm or death. The main outcome was the hazard ratio of any recall and class I recall between devices with PMA and those with 510(k) clearance. The secondary outcome was the recall hazard ratio between specialties with respect to the reference category. A single Cox proportional hazards regression model evaluating the association of medical specialty and FDA approval pathway with the risk of recall was performed. Results: During the study period, 28 246 devices received 510(k) clearance and 310 devices (10.7%) received PMA; 3012 devices (10.7%) with 510(k) clearance and 84 devices (27.1%) with PMA were recalled. A total of 216 devices (0.8%) with 510(k) clearance and 16 devices (5.2%) with PMA had class I recalls. Devices with PMA compared with those with 510(k) clearance had a hazard ratio for recall of 2.74 (95% CI, 2.19-3.44; P < .001) and a hazard ratio for high-risk recall of 7.30 (95% CI, 4.39-12.13; P < .001). Only radiologic devices were associated with an increased risk of recall (hazard ratio, 1.57; 95% CI, 1.32-1.87; P < .001), whereas 6 specialties were assocated with a decreased risk compared with the orthopedic reference category: general and plastic surgery, otolaryngology, obstetrics and gynecology, physical medicine, hematology, and general hospital. Conclusions and Relevance: This study suggests that high-risk medical devices approved via PMA are associated with a greater risk of recall than previously reported. Most recalls are for devices with 510(k) clearance, also raising safety concerns. Strengthening postmarketing surveillance strategies and pivotal trials may improve device safety.

The Use of Direct Oral Anticoagulants in the Management of Venous Thromboembolism in Patients With Obesity.

Introduction The use of direct oral anticoagulants (DOACs) has gained significant traction given the lack of therapeutic monitoring and the need for anticoagulant bridging. There is a paucity of data on their effectiveness in obese patients with venous thromboembolism (VTE). Preliminary subgroup and pharmacokinetic analyses suggest reduced efficacy in those with a bodyweight >120 kg or body mass index (BMI) ≥40 kg per m2 and it is currently not recommended that these agents be used as first-line agents. We aimed to assess the rate of VTE recurrence in obese patients diagnosed with VTE and treated with DOAC therapy. Methods We utilized the Health Facts Center National Data Warehouse (Cerner) to perform a retrospective analysis of patients with VTE (acute deep venous thrombosis (DVT) or pulmonary embolism) that presented to the hospital between 2010 and 2016 and were managed with DOACs. The cohort of patients diagnosed with DVT or PE were identified using International Classification of Disease (ICD-9-CM, ICD-10-CM). Patients were divided into two groups based on their weight: 1) weight <120 kg or 2) weight>120 kg. Six-month VTE recurrence rates were recorded. Summary and univariate statistics were performed. Results A total of 18,147 patients with a mean (±SD) age of 62 (17) years were included; 48% (n=8732) were male. A total of 2,419 (13%) patients weighed >120 kg while the rest (N=15,728, 87%) weighed <120 kg. There were significantly more female patients weighing<120 kg (54% vs 42%, p<0.0001); otherwise, there was no significant difference in age or tobacco use between both groups (p>0.05). There was no significant difference in six-month readmission rates for VTE recurrence in patients that weighed <120 kg (34%) in comparison with patients >120 kg (36%) (p=0.08). Conclusion Our study suggests that the use of DOACs in obese patients is equally efficacious with similar VTE recurrence rates in comparison with non-obese patients. This study paves the way for prospective multi-institutional randomized control trials to further reinforce the safe use of such agents in this patient population.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

BACKGROUND: The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. METHODS: Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). RESULTS: Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. CONCLUSIONS: This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

Implementation of a Quality Improvement Bundle Improves Echocardiographic Imaging after Congenital Heart Surgery in Children.

BACKGROUND: Postoperative echocardiography after congenital heart disease surgery is of prognostic importance, but variable image quality is problematic. We implemented a quality improvement bundle comprising of focused imaging protocols, procedural sedation, and sonographer education to improve the rate of optimal imaging (OI). METHODS: Predischarge echocardiograms were evaluated in 116 children (median age, 0.51 years; range, 0.01-5.6 years) from two centers after tetralogy of Fallot repair, arterial switch operation, and bidirectional Glenn and Fontan procedures. OI rates were compared between the centers before and after the implementation of a quality improvement bundle at center 1, with center 2 serving as the comparator. Echocardiographic images were independently scored by a single reader from each center, blinded to center and time period. For each echocardiographic variable, quality score was assigned as 0 (not imaged or suboptimally imaged) or 1 (optimally imaged); structures were classified as intra- or extracardiac. The rate of OI was calculated for each variable as the percentage of patients assigned a score of 1. RESULTS: Intracardiac structures had higher OI than extracardiac structures (81% vs 57%; adjusted odds ratio [OR], 3.47; P < .01). Center 1 improved overall OI from 48% to 73% (OR, 4.44; P < .01), intracardiac OI from 69% to 85% (OR, 3.53; P = .01), and extracardiac OI from 35% to 67% (OR, 5.16; P < .01). There was no temporal difference for center 2. CONCLUSIONS: After congenital heart disease surgery in children, intracardiac structures are imaged more optimally than extracardiac structures. Focused imaging protocols, patient sedation, and sonographer education can improve OI rates.

Evaluation of the Impact of Corticosteroid Dose on the Incidence of Hyperglycemia in Hospitalized Patients with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

PURPOSE: Guidelines recommend systemic corticosteroids for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) albeit in lower doses than studies that cemented corticosteroids' place in therapy. Corticosteroids potentiate hyperglycemia, however it is undetermined how corticosteroid dose impacts hyperglycemia incidence. OBJECTIVES: To establish whether a greater incidence of steroid-induced hyperglycemia (SIHGLY) exists for high- versus low-dose corticosteroids. METHODS: Patients with primary discharge diagnosis 491.21/491.22 in a community hospital were retrospectively reviewed and divided into tertiles based on corticosteroid dosage. Baseline characteristics and primary endpoint were statistically assessed between tertiles using logistic regression analysis. A Cox proportional hazards (CPH) model adjusted for potential covariates. Post hoc analysis for primary outcome and CPH model was run removing non-insulin dependent diabetics because of disproportionate event count. A secondary endpoint used a Kaplan-Meier curve to evaluate time to event between tertiles. RESULTS: Tertile divisions were 125 and 187.5 mg methylprednisolone equivalents. The primary outcome for incidence of SIHGLY was insignificant; post hoc analysis removing non-insulin-dependent diabetics narrowly missed significance between tertiles 1 and 3 (P = .056). CPH analysis found significant differences in SIHGLY between tertiles 1 and 2 (hazard ratio [HR], 1.68; 95% CI, 1.02-2.76) and tertile 1 and 3 (HR, 1.79; 95% CI, 1.13-2.84), further post hoc analysis resulted in a loss of significance for the CPH analysis. Of 21 non-insulin-dependent diabetics, 20 met event status. The Kaplan-Meier analysis results were insignificant. CONCLUSIONS: Study results suggest that a link between larger corticosteroid doses and hyperglycemia incidence may exist, but it requires further study. RESULTS in non-insulin-dependent diabetics provide evidence for increased glucose monitoring upon initiation of corticosteroid therapy.

Impact of Variability in Echocardiographic Interpretation on Assessment of Adequacy of Repair Following Congenital Heart Surgery: A Pilot Study.

Technical Performance Score (TPS) is based largely on the presence and magnitude of residual lesions on postoperative echocardiograms; this score correlates with outcomes following repair of congenital heart defects. We evaluated reader variability for echocardiographic components of TPS for complete repair of tetralogy of Fallot (TOF) and arterial switch operation (ASO) in two centers and measured its effect on TPS. Postoperative echocardiograms were evaluated in 67 children (39 TOF and 28 ASO). Two readers (one per center) interpreted each echocardiogram. Reader variability in image quality assessments and measurements was compared using weighted kappa (κ), percent agreement, and intra-class correlation. TPS class (1 optimal-no residua, 2 adequate-minor residua, 3 inadequate-major residua) was assigned for each echocardiographic review by an independent investigator. The effect of reader interpretation variability on TPS classification was measured. There was strong agreement for TPS between the two readers (κ = 0.88). The readers were concordant for TPS classes for 57 children (85%) and discordant for classes 2 (minor residua) versus 3 (major residua) in six (9%). Coronary arteries and branch pulmonary arteries were frequently suboptimally visualized. Although inter-reader agreement for TPS was strong, inter-reader variation in echocardiographic interpretations had a small, but important effect on TPS for TOF and ASO, particularly for the distinction between minor and major residua. Further studies of generalizability and reproducibility of TPS and refinement of scoring modules may be needed before it can be used as a tool to assess pediatric cardiac surgical performance and outcomes.

Effect of mild-to-moderate smoking on viral load, cytokines, oxidative stress, and cytochrome P450 enzymes in HIV-infected individuals.

Mild-to-moderate tobacco smoking is highly prevalent in HIV-infected individuals, and is known to exacerbate HIV pathogenesis. The objective of this study was to determine the specific effects of mild-to-moderate smoking on viral load, cytokine production, and oxidative stress and cytochrome P450 (CYP) pathways in HIV-infected individuals who have not yet received antiretroviral therapy (ART). Thirty-two human subjects were recruited and assigned to four different cohorts as follows: a) HIV negative non-smokers, b) HIV positive non-smokers, c) HIV negative mild-to-moderate smokers, and d) HIV positive mild-to-moderate smokers. Patients were recruited in Cameroon, Africa using strict selection criteria to exclude patients not yet eligible for ART and not receiving conventional or traditional medications. Those with active tuberculosis, hepatitis B or with a history of substance abuse were also excluded. Our results showed an increase in the viral load in the plasma of HIV positive patients who were mild-to-moderate smokers compared to individuals who did not smoke. Furthermore, although we did not observe significant changes in the levels of most pro-inflammatory cytokines, the cytokine IL-8 and MCP-1 showed a significant decrease in the plasma of HIV-infected patients and smokers compared with HIV negative non-smokers. Importantly, HIV-infected individuals and smokers showed a significant increase in oxidative stress compared with HIV negative non-smoker subjects in both plasma and monocytes. To examine the possible pathways involved in increased oxidative stress and viral load, we determined the mRNA levels of several antioxidant and cytochrome P450 enzymes in monocytes. The results showed that the levels of most antioxidants are unaltered, suggesting their inability to counter oxidative stress. While CYP2A6 was induced in smokers, CYP3A4 was induced in HIV and HIV positive smokers compared with HIV negative non-smokers. Overall, the findings suggest a possible association of oxidative stress and perhaps CYP pathway with smoking-mediated increased viral load in HIV positive individuals.

Does active dissemination of evidence result in faster knowledge transfer than passive diffusion?: An analysis of trends of the management of pediatric asthma and croup in US emergency departments from 1995 to 2009.

OBJECTIVE: This study aimed to compare knowledge transfer (KT) in the emergency department (ED) management of pediatric asthma and croup by measuring trends in corticosteroid use for both conditions in EDs. METHODS: A retrospective, cross-sectional study of the National Hospital Ambulatory Medical Care Survey data between 1995 and 2009 of corticosteroid use at ED visits for asthma or croup was conducted. Odds ratios (OR) were calculated using logistic regression. Trends over time were compared using an interaction term between disease and year and were adjusted for all other covariates in the model. We included children aged 2 to 18 years with asthma who received albuterol and were triaged emergent/urgent. Children aged between 3 months to 6 years with croup were included. The main outcome measure was the administration of corticosteroids in the ED or as a prescription at the ED visit. RESULTS: The corticosteroid use in asthma visits increased from 44% to 67% and from 32% to 56% for croup. After adjusting for patient and hospital factors, this trend was significant both for asthma (OR, 1.07; 95% confidence interval [CI], 1.04-1.10) and croup (OR, 1.07; 95% CI, 1.03-1.12). There was no statistical difference between the 2 trends (P = 0.69). Hospital location in a metropolitan statistical area was associated with increased corticosteroid use in asthma (OR, 1.76; 95% CI, 1.10-2.82). Factors including sex, ethnicity, insurance, or region of the country were not significantly associated with corticosteroid use. CONCLUSIONS: During a 15-year period, knowledge transfer by passive diffusion or active guideline dissemination resulted in similar trends of corticosteroid use for the management of pediatric asthma and croup.

Impact of brain tissue filtering on neurostimulation fields: a modeling study.

Electrical neurostimulation techniques, such as deep brain stimulation (DBS) and transcranial magnetic stimulation (TMS), are increasingly used in the neurosciences, e.g., for studying brain function, and for neurotherapeutics, e.g., for treating depression, epilepsy, and Parkinson's disease. The characterization of electrical properties of brain tissue has guided our fundamental understanding and application of these methods, from electrophysiologic theory to clinical dosing-metrics. Nonetheless, prior computational models have primarily relied on ex-vivo impedance measurements. We recorded the in-vivo impedances of brain tissues during neurosurgical procedures and used these results to construct MRI guided computational models of TMS and DBS neurostimulatory fields and conductance-based models of neurons exposed to stimulation. We demonstrated that tissues carry neurostimulation currents through frequency dependent resistive and capacitive properties not typically accounted for by past neurostimulation modeling work. We show that these fundamental brain tissue properties can have significant effects on the neurostimulatory-fields (capacitive and resistive current composition and spatial/temporal dynamics) and neural responses (stimulation threshold, ionic currents, and membrane dynamics). These findings highlight the importance of tissue impedance properties on neurostimulation and impact our understanding of the biological mechanisms and technological potential of neurostimulatory methods.

Assessment of HIV-related stigma in a US faith-based HIV education and testing intervention.

INTRODUCTION: The African American church is a highly influential institution with the potential to greatly increase the reach of HIV prevention interventions and address HIV-related stigma in US African American communities. However, there are few studies on HIV-related stigma and African American church populations. This study explored HIV-related stigma among church and community members participating in an HIV education and testing intervention pilot study in African American churches, named Taking It to the Pews. METHODS: Four African American churches located in Kansas City, MO and KS, were randomized to either intervention or comparison groups. Churches assigned to the intervention group received religiously tailored HIV education, testing and compassion messages/activities (e.g. sermons, brochures/church bulletins, testimonials) via the Taking It to the Pews HIV Tool Kit. Comparison churches received non-religiously tailored HIV information. HIV-related stigma was assessed with 543 church members and with community members served through church outreach services (e.g. food/clothing pantries, social services) in the four churches. Participants completed surveys at baseline, 6 months and 12 months to assess their HIV-related stigma beliefs, exposure to intervention components and satisfaction with the study. RESULTS: At baseline, HIV-related stigma beliefs were similar across experimental groups and were quite low. Mean HIV-related stigma scores were not significantly different between experimental groups at 6 months (p=0.92) or at 12 months (p=0.70). However, mean HIV-related stigma scores within both groups showed decreasing trends at six months, which approached significance. Analysis of previously studied HIV-related stigma factors (e.g. age, gender, income, HIV knowledge, religiosity) did not yield changes in the null findings. Intervention group participants were highly exposed to several intervention components (sermons, HIV resource tables, posters, brochures/church bulletins). Overall, participants were highly satisfied with the intervention pilot study. CONCLUSIONS: African American churches may be well positioned to increase the reach of HIV prevention interventions to church and community members and could serve an important role in addressing HIV-related stigma in their church communities. Future research is needed on measuring HIV-related stigma beliefs and on testing intensive, scalable, religiously tailored HIV interventions to impact HIV-related stigma in African American churches.

Variation and trends in ED use of radiographs for asthma, bronchiolitis, and croup in children.

OBJECTIVES: The objectives were (1) to determine trends in radiograph use in emergency department (ED) care of children with asthma, bronchiolitis, and croup; and (2) to examine the association of patient and hospital factors with variation in radiograph use. METHODS: A retrospective, cross-sectional study of National Hospital Ambulatory Medical Care Survey data between 1995 and 2009 on radiograph use at ED visits in children aged 2 to 18 years with asthma, aged 3 months to 1 year with bronchiolitis, and aged 3 months to 6 years with croup. Odds ratios (ORs) were calculated and adjusted for all factors studied. RESULTS: The use of radiographs for asthma increased significantly over time (OR: 1.06; 95% confidence interval [CI]: 1.03-1.09; P < .001 for trend) but were unchanged for bronchiolitis and croup. Pediatric-focused EDs had lower use for asthma (OR: 0.44; 95% CI: 0.29-0.68), bronchiolitis (OR: 0.37; 95% CI: 0.23-0.59), and croup (OR: 0.34; 95% CI: 0.17-0.68). Compared with the Northeast region, the Midwest and South had statistically higher use of radiographs for all 3 conditions. The Western region had higher use only for asthma (OR: 1.67; 95% CI: 1.07-2.60), and bronchiolitis (OR: 2.94; 95% CI: 1.48-5.87). No associations were seen for metropolitan statistical area or hospital ownership status. CONCLUSIONS: The ED use of radiographs for children with asthma increased significantly from 1995 to 2009. Reversing this trend could result in substantial cost savings and reduced radiation. Pediatric-focused EDs used significantly fewer radiographs for asthma, bronchiolitis, and croup. The translation of practices from pediatric-focused EDs to all EDs could improve performance.

A prospective, randomized, double-blind comparison of the injection pain and anesthetic onset of 2% lidocaine with 1:100,000 epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations.

INTRODUCTION: Local anesthetics can be buffered to a physiological pH before injection to decrease the time of onset and reduce injection pain. METHODS: Thirty subjects with intact maxillary canines were included. The subjects randomly received, in a double-blind manner, 1 of the 3 maxillary infiltration injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine buffered at 5% and 10% with sodium bicarbonate by volume at 3 separate appointments. Pain on needle penetration and deposition of anesthetic solution was recorded by using a Heft-Parker visual analogue scale. Anesthetic onset was determined by 2 consecutive negative responses to electronic pulp test. RESULTS: The mean anesthetic onset for nonbuffered anesthetics was 119 seconds, 116 seconds for the 5% buffered solutions, and 121 seconds for the 10% buffered solutions. There was no significant difference between the 3 groups. There was also no significant difference in pain on needle penetration or anesthetic deposition between the 3 anesthetic solutions tested. CONCLUSIONS: Two percent lidocaine with 1:100,000 epinephrine buffered with 5% or 10% sodium bicarbonate did not differ from nonbuffered solutions in anesthetic onset or injection pain in maxillary infiltrations of canines with healthy pulps.

On the Existence of Constant Accrual Rates in Clinical Trials and Direction for Future Research.

Many clinical trials fall short of their accrual goals. This can be avoided with accurate accrual prediction tools. Past researchers provide important methodological alternative models for predicting accrual in clinical trials. One model allows for slow accrual at the start of the study, which eventually reaches a threshold. A simpler model assumes a constant rate of accrual. A comparison has been attempted but we wish to point out some important considerations when comparing these two models. In fact, we can examine the reasonableness of a constant accrual assumption (simpler model) which had data 239 days into a three-year study. We can now update that and report accumulated from the full three years of accrual data and we can demonstrate that constant accrual rate assumption was met in this particular study. We will use this report to frame future research in the area of accrual prediction.