Showing papers by "James Dziura published in 2013"

Strategies for dealing with missing data in clinical trials: from design to analysis.

Abstract: Randomized clinical trials are the gold standard for evaluating interventions as randomized assignment equalizes known and unknown characteristics between intervention groups. However, when participants miss visits, the ability to conduct an intent-to-treat analysis and draw conclusions about a causal link is compromised. As guidance to those performing clinical trials, this review is a non-technical overview of the consequences of missing data and a prescription for its treatment beyond the typical analytic approaches to the entire research process. Examples of bias from incorrect analysis with missing data and discussion of the advantages/disadvantages of analytic methods are given. As no single analysis is definitive when missing data occurs, strategies for its prevention throughout the course of a trial are presented. We aim to convey an appreciation for how missing data influences results and an understanding of the need for careful consideration of missing data during the design, planning, conduct, and analytic stages.

Safety of Sports for Athletes With Implantable Cardioverter-Defibrillators Results of a Prospective, Multinational Registry

Abstract: Background— The risks of sports participation for implantable cardioverter-defibrillator (ICD) patients are unknown. Methods and Results— Athletes with ICDs (age, 10–60 years) participating in organized (n=328) or high-risk (n=44) sports were recruited. Sports-related and clinical data were obtained by phone interview and medical records. Follow-up occurred every 6 months. ICD shock data and clinical outcomes were adjudicated by 2 electrophysiologists. Median age was 33 years (89 subjects <20 years of age); 33% were female. Sixty were competitive athletes (varsity/junior varsity/traveling team). A pre-ICD history of ventricular arrhythmia was present in 42%. Running, basketball, and soccer were the most common sports. Over a median 31-month (interquartile range, 21–46 months) follow-up, there were no occurrences of either primary end point—death or resuscitated arrest or arrhythmia- or shock-related injury—during sports. There were 49 shocks in 37 participants (10% of study population) during competition/practice, 39 shocks in 29 participants (8%) during other physical activity, and 33 shocks in 24 participants (6%) at rest. In 8 ventricular arrhythmia episodes (device defined), multiple shocks were received: 1 at rest, 4 during competition/practice, and 3 during other physical activity. Ultimately, the ICD terminated all episodes. Freedom from lead malfunction was 97% at 5 years (from implantation) and 90% at 10 years. Conclusions— Many athletes with ICDs can engage in vigorous and competitive sports without physical injury or failure to terminate the arrhythmia despite the occurrence of both inappropriate and appropriate shocks. These data provide a basis for more informed physician and patient decision making in terms of sports participation for athletes with ICDs. # Clinical Perspective {#article-title-44}

Teplizumab treatment may improve C-peptide responses in participants with type 1 diabetes after the new-onset period: a randomised controlled trial.

Abstract: Aims/hypothesis Type 1 diabetes results from a chronic autoimmune process continuing for years after presentation. We tested whether treatment with teplizumab (a Fc receptor non-binding anti-CD3 monoclonal antibody), after the new-onset period, affects the decline in C-peptide production in individuals with type 1 diabetes.

Safety of Sports for Athletes With Implantable Cardioverter-Defibrillators

Abstract: Background—The risks of sports participation for implantable cardioverter-defibrillator (ICD) patients are unknown. Methods and Results—Athletes with ICDs (age, 10–60 years) participating in organized (n=328) or high-risk (n=44) sports were recruited. Sports-related and clinical data were obtained by phone interview and medical records. Follow-up occurred every 6 months. ICD shock data and clinical outcomes were adjudicated by 2 electrophysiologists. Median age was 33 years (89 subjects <20 years of age); 33% were female. Sixty were competitive athletes (varsity/junior varsity/traveling team). A pre-ICD history of ventricular arrhythmia was present in 42%. Running, basketball, and soccer were the most common sports. Over a median 31-month (interquartile range, 21–46 months) follow-up, there were no occurrences of either primary end point—death or resuscitated arrest or arrhythmia- or shock-related injury—during sports. There were 49 shocks in 37 participants (10% of study population) during competition/pr...

New Media Use by Patients Who Are Homeless: The Potential of mHealth to Build Connectivity

Abstract: Background: Patients experiencing homelessness represent a disproportionate share of emergency department (ED) visits due to poor access to primary care and high levels of unmet health care needs. This is in part due to the difficulty of communicating and following up with patients who are experiencing homelessness. Objective: To determine the prevalence and types of “new media” use among ED patients who experience homelessness. Methods: This was a cross-sectional observational study with sequential enrolling of patients from three emergency departments 24/7 for 6 weeks. In total, 5788 ED patients were enrolled, of whom 249 experienced homelessness. Analyses included descriptive statistics, and unadjusted and adjusted odds ratios. Results: 70.7% (176/249) of patients experiencing homelessness own cell phones compared to 85.90% (4758/5539) of patients in stable housing (P=.001) with the former more likely to own Androids, 70% (53/76) versus 43.89% (1064/2424), and the latter more likely to have iPhones, 44.55% (1080/2424) versus 17% (13/76) (P=.001). There is no significant difference in new media use, modality, or frequency for both groups; however, there is a difference in contract plan with 50.02% (2380/4758) of stably housed patients having unlimited minutes versus 37.5% (66/176) of homeless patients. 19.78% (941/4758) of patients in stable housing have pay-as-you-go plans versus 33.0% (58/176) of homeless patients (P=.001). Patients experiencing homelessness are more likely to want health information on alcohol/substance abuse, mental health, domestic violence, pregnancy and smoking cessation. Conclusions: This study is unique in its characterization of new media ownership and use among ED patients experiencing homelessness. New media is a powerful tool to connect patients experiencing homelessness to health care.

Brief Report: social disability in autism spectrum disorder: results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network trials.

Abstract: There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to placebo and 49 subjects to risperidone under double-blind conditions. Study 2 included 49 subjects assigned to risperidone only and 75 subjects assigned to risperidone plus parent training. After 8 weeks of treatment, all active treatments were superior to placebo (effect sizes ranging from 0.42 to 0.65). The findings suggest that the Social Withdrawal subscale may be a useful measure of social disability in acute treatment trials.

Undertreatment of Tobacco Use Relative to Other Chronic Conditions

Abstract: Objectives. We compared the likelihood that a tobacco user would receive treatment with the likelihood that an adult with another common chronic condition would receive treatment for that condition at an office visit.Methods. We analyzed data from the 2005–2007 National Ambulatory Medical Care Survey to compare the proportion of US office visits at which tobacco users and individuals with hypertension, hyperlipidemia, diabetes, asthma, or depression received condition-specific treatment. We calculated the odds that a visit for a comparison condition would result in treatment relative to a visit for tobacco dependence.Results. From 2005 to 2007, 38 004 patient visits involved at least 1 study condition. Tobacco users received medication at fewer visits (4.4%) than individuals with hypertension (57.4%), diabetes (46.2%), hyperlipidemia (47.1%), asthma (42.6%), and depression (53.3%). In multivariate analyses, the odds for pharmacological treatment of these disorders relative to tobacco use were, for hyperte...

Longitudinal effects of MRI-measured hepatic steatosis on biomarkers of glucose homeostasis and hepatic apoptosis in obese youth.

Abstract: OBJECTIVE We used fast-gradient magnetic resonance imaging (MRI) to determine the longitudinal associations between the hepatic fat content (HFF), glucose homeostasis, and a biomarker of hepatocellular apoptosis in obese youth RESEARCH DESIGN AND METHODS Baseline and longitudinal liver and abdominal MRI were performed with an oral glucose tolerance test in 76 obese youth followed for an average of 19 years Cytokeratin-18 (CK-18) was measured at baseline and follow-up as a biomarker of hepatic apoptosis The relationship between baseline HFF and metabolic parameters and circulating levels of CK-18 at follow-up were assessed using a bivariate correlation RESULTS At baseline, 38% had hepatic steatosis based on %HFF ≥55% with alterations in indices of insulin sensitivity and secretion At follow-up, BMI increased in both groups and baseline %HFF correlated strongly with the follow-up %HFF ( r = 081, P r = 038, P = 0001), whole-body insulin sensitivity ( r = −0405, P = 0001), adiponectin ( r = −044, P r = 063, P r = −0272, P = 0021) at follow-up In a multivariate analysis, we showed that baseline HFF is an independent predictor of 2-h glucose and whole-body insulin sensitivity CONCLUSIONS In obese youth, the phenotype of MRI-measured hepatic steatosis is persistent Baseline HFF strongly modulates longitudinally 2-h blood glucose, biomarkers of insulin resistance, and hepatocellular apoptosis

Point-of-Care Focused Cardiac Ultrasound for Prediction of Pulmonary Embolism Adverse Outcomes

Abstract: Background In patients with pulmonary embolism (PE), right ventricular strain (RVS) on transthoracic echocardiography by Cardiology has been shown to be an independent predictor of 30-day adverse outcomes. However, it is not known how emergency practitioner-performed point-of-care focused cardiac ultrasound (FOCUS) with assessment for RVS compares with other prognostic methods in the Emergency Department (ED). Objectives To determine whether RVS on FOCUS is a significant predictor of in-hospital adverse outcomes when compared to other risk factors and scoring systems. Methods Retrospective chart review of patients who were diagnosed with PE and had a FOCUS examination during January 1, 2007 through January 1, 2011 in an urban, academic center with a well-developed ultrasound program. Adverse outcomes were defined as shock, respiratory failure requiring intubation, death, recurrent venous thromboembolism, transition to higher level of care, or major bleeding during hospital admission. Statistical analysis included univariate and multivariate analysis to assess for prognostic significance. Results One hundred sixty-one patients were included in the final analysis. A total of 25 (16%) patients had an adverse outcome during hospitalization. On univariate analysis, only the presence of altered mental status conferred a higher positive likelihood ratio (6.4 vs. 4.0) than RVS, whereas absence of RVS had the lowest negative likelihood ratio (0.45). On multivariate analysis, RVS and cardiopulmonary disease were the only predictors of adverse outcomes that achieved statistical significance, with odds ratio of 9.2 and 3.4, respectively. Conclusion In this retrospective chart review, a FOCUS examination for RVS performed by emergency care practitioners of varying experience level was a significant predictor of in-hospital adverse outcomes among patients diagnosed with PE in the ED. Future research should be directed at exploring ways to incorporate RVS assessment into ED prognostic models for pulmonary embolism.

Distracted driving behaviors of adults while children are in the car

Abstract: BACKGROUND: Cell phone use while driving is common and can result in driver distraction. However, data on the frequency of this behavior with other occupants in the vehicle are lacking. This study investigates whether adult drivers engage in cell phone use with passengers in the car and determines whether the frequency of these behaviors was modified if the passenger was a child. METHODS: Subjects (N = 539) who have driven children during the previous 30 days were recruited to complete a survey regarding their cell phone usage while driving. The inclusion criteria of participants were as follows: 18 years or older with a valid driver's license, owns/uses a cell phone, drives with children, and reads English. Results were reported on a 4-point Likert scale (always, often, rarely, and never). RESULTS: Eighty percent of respondents reported cell phone use in some way while driving with children. As compared with similar behaviors when driving alone or with adult passengers, the odds of reporting "always" compared with "often, rarely, or never" of holding a cell phone in hand was 0.66 when driving with children. No significant differences were noted for the following variables: use of a blue tooth device or use of a cell phone to speak or text when parked. CONCLUSION: Cell phone use while driving is common. Distracted driving behaviors, although less frequent, persist when children are passengers in the vehicle. Further research into the effect of cell phone-related distracted driving behaviors of adults with child passengers is needed to address this public health concern. Keywords: Driver distraction; Language: en

Use of a Direct Observational Measure in a Trial of Risperidone and Parent Training in Children with Pervasive Developmental Disorders

Abstract: A Structured Observational Analog Procedure (SOAP), an analogue measure of parent-child interactions, was used to assess treatment outcome in children with Autism Spectrum Disorder and serious behavior problems. It served as a secondary outcome measure in a 24-week, randomized trial of risperidone (MED; N = 49) versus risperidone plus parent training (COMB; n = 75) (ages 4–13 years). At 24-weeks, there was 28 % reduction in child inappropriate behavior during a Demand Condition (p = .0002) and 12 % increase in compliance to parental requests (p = .004) for the two treatment conditions combined. Parents displayed 64 % greater use of positive reinforcement (p = .001) and fewer repeated requests for compliance (p < .0001). In the analysis of covariance (ANCOVA), COMB parents used significantly more positive reinforcement (p = .01) and fewer restrictive statements (p < .05) than MED parents. The SOAP is sensitive to change in child and parent behavior as a function of risperidone alone and in combination with PMT and can serve as a valuable complement to parent and clinician-based measures.

Overweight physicians during residency: a cross-sectional and longitudinal study.

Abstract: Background Resident physicians are at risk for increasing weight status given their changes in environment, resources, and stress level. Objective To describe body mass index (BMI), blood pressure, eating habits, and physical activity during postgraduate training and to compare the findings to data for nationally matched controls. Methods This was a combined cross-sectional study and longitudinal cohort, with a comparison to matched controls in 2 academic hospital centers in the eastern and western United States. BMI and blood pressure were objectively measured, and an eating and exercise habits recall was obtained for 375 enrolled medical and surgical residents (93 longitudinally) at the onset of each postgraduate year (PGY) in 2006, 2007, and 2008. Results Nearly half (43%) of overweight residents described themselves as normal weight. Residents were more likely to be overweight (BMI ≥25) at the beginning of PGY-3 than at the beginning of PGY-1 (49% versus 30%; odds ratio 2.26; 95% confidence i...

Left ventricular ejection fraction and left ventricular end-diastolic volume in patients with diastolic dysfunction

Abstract: Diastolic dysfunction can be diagnosed on equilibrium radionuclide angiocardiography (ERNA) by a low peak filling rate (PFR) in the setting of a normal left ventricular ejection fraction (LVEF) The authors evaluated the relationship between diastolic dysfunction, LVEF, and end-diastolic volume (EDV) A total of 408 predominantly asymptomatic patients with an LVEF ≥50% by ERNA were studied LVEF of patients with a low PFR was compared with the LVEF of patients with a normal PFR Correlation analyses to evaluate the association between PFR and EDV were also performed The LVEF of patients with a low PFR was lower than the LVEF of patients with normal PFR (59±7 vs 63%±7%; P<01) There was no correlation between EDV and PFR (r=−004; P=32) The results did not change when the EDV indices were used In patients who had repeat scans, there was no correlation between the change in EDV and the change in PFR (r=016; P=2) In asymptomatic patients undergoing ERNA who have normal systolic function, a low PFR can be associated with a lower LVEF, but it is not associated with changes in EDV This suggests that diastolic dysfunction is associated with mild systolic dysfunction

Effect of Contact Lens Power on Optic Disc Parameters Measured with Optical Coherence Tomography

Abstract: Purpose: To investigate the effect of spherical contact lens (CL) power on optical coherence tomography (OCT) measurements of optic nerve head (ONH) parameters in healthy subjects.Methods: Fifteen subjects without ocular disease underwent ONH analysis using OCT. Measurements were obtained without and with soft CL of different spherical powers (−10 diopters (D), −4 D, +4 D, +10 D). The following parameters were measured and statistically analyzed: vertical disc and cup diameters; cup area, disc area, rim area; area cup-to-disc (C/D) ratio, as well as horizontal and vertical C/D ratio.Results: Subject age was 30.5 ± 3.2 years (mean ± SD). Eight right and 7 left eyes were studied. Mean refractive error (spherical equivalent) was −3.9 ± 4.7 D. Without CL, median (first, third quartiles) vertical disc and cup diameters were 1.83 (1.69, 1.96) mm and 0.74 (0.58, 1.11) mm, respectively. Cup area was 0.72 (0.56, 1.17) mm2, disc area was 2.30 (2.10, 2.72) mm2, and rim area was 1.49 (1.23, 1.75) mm2. Area C/D ratio ...

Behaviors increasing the risk of crash injury in latino adolescent males: the influence of acculturation and parent connectedness.

Abstract: Motor vehicle crashes (MVC) are the leading cause of death for U.S. teens and cause the largest proportion of mortality among Latino adolescent males. MVC-related injury disparities persist and are growing among U.S. Latino adolescent males, where current mortality rates exceed those of their non-Latino white peers. For adolescent drivers, substance use is a known risk factor for a serious or fatal MVC. The study sought to assess the effects of acculturation and parent connectedness on behaviors increasing the risk of crash injury in Latino adolescent males. The study included a total of 138 Latino adolescent males with an overall mean age of 16.9 years. Males of Puerto Rican descent represented the largest portion of the sample (59.1%) and although the majority of participants were US-born (61.6%), most had at least one parent that was foreign born (84.1%). Few adolescents had a driver’s license or permit (10.1%) and many reported unlicensed driving (55.1%). The results show strong relationships between parent connectedness, acculturation, and substance use behaviors placing Latino teen males at increased risk for MVCs.