Enrollee Characteristics in an Intensive Tobacco Dependence Treatment Program: The Relationship of Race and Sex to Demographic Factors and Tobacco Use Patterns

Intensive tobacco treatment programs offer many advantages relative to other treatment options, particularly for more complex patients, e.g., highly nicotine dependent, or those with medical and psychiatric symptoms and disorders. Efforts to better understand those who choose to enroll in these programs, particularly regarding the characteristics they possess known to mediate outcomes, are important considerations in tailoring available services. In this study, we examined how participants differed on key descriptive and tobacco use variables within race (i.e., African-American, Caucasian) and sex subgroups. Baseline characteristics from a large group of consecutive program enrollees were examined across targeted subgroups. Strong racial effects and some sex effects were noted for marital status, education, employment and health insurance status, alcohol consumption, presence of medical and psychiatric disorders, as well as participant tobacco use patterns and tobacco use rates of family, friends and coworkers. The differences in participant tobacco use measures across race and sex factors remained significant after adjusting for the confounding effects of all other covariates. These findings have implications for characterizing key patient subgroups who present at tobacco treatment clinics. Such information may contribute to options for tailoring treatment regimens

SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings.

BACKGROUND: The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. METHODS: The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). RESULTS: We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. CONCLUSIONS: To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component

Adherence to a behavioral weight loss treatment program enhances weight loss and improvements in biomarkers

Sushama D Acharya3, Okan U Elci3, Susan M Sereika1,2,3, Edvin Music3, Mindi A Styn3, Melanie Warziski Turk3, Lora E Burke2,31Department of Biostatistics, Graduate School of Public Health, 2Department of Epidemiology, Graduate School of Public Health, 3School of Nursing, University of Pittsburgh, Pittsburgh, PA, USAObjectives: To describe participants’ adherence to multiple components (attendance, energy intake, fat gram, exercise goals, and self-monitoring eating and exercise behaviors) of a standard behavioral treatment program (SBT) for weight loss and how adherence to these components may influence weight loss and biomarkers (triglycerides, low density lipoproteins [LDL], high density lipoprotein, and insulin) during the intensive and less-intensive intervention phases. Methods: A secondary analysis of a randomized clinical trial consisting of a SBT with either fat-restricted standard or lacto-ovo vegetarian diet. The 12-month intervention was delivered in 33 group sessions. The first six months reflected the intensive phase; the second six months, the less-intensive intervention phase. We conducted the analysis without regard to treatment assignment. Eligible participants included overweight/obese adults (N = 176; mean body mass index = 34.0 kg/m2). The sample was 86.9% female, 70.5% White, and 44.4 ± 8.6 years old. The outcome measures included weight and biomarkers. Results: There was a significant decline in adherence to each treatment component over time (P < 0.0001). In the first six months, adherence to attendance, self-monitoring and the energy goal were significantly associated with greater weight loss (P < 0.05). Adherence to attendance and exercise remained significantly associated with weight loss in the second six months (P < 0.05). Adherence to attendance, self-monitoring and exercise had indirect effects through weight loss on LDL, triglycerides, and insulin (P < 0.05).Conclusions: We observed a decline in adherence to each treatment component as the intervention intensity was reduced. Adherence to multiple treatment components was associated with greater weight loss and improvements in biomarkers. Future research needs to focus on improving and maintaining adherence to all components of the treatment protocol to promote weight loss and maintenance.Keywords: adherence, obesity, diet, exercise, self-monitoring, biomarker

22q11.2 Deletion Status and Perioperative Outcomes for Tetralogy of Fallot with Pulmonary Atresia and Multiple Aortopulmonary Collateral Vessels

Deletion of 22q11.2 (del22q11) is associated with adverse outcomes in patients with tetralogy of Fallot (TOF). We sought to investigate its contribution to perioperative outcome in patients with a severe form of TOF characterized by pulmonary atresia (PA) or severe pulmonary stenosis (PS) and major aortopulmonary collateral arteries (MAPCAS). We conducted a retrospective review of patients with TOF/MAPCAS who underwent staged surgical reconstruction between 1995 and 2006. Groups were compared according to 22q11.2 deletion status using t-tests or the Wilcoxon Rank sum test. We included 26 subjects, 24 of whom survived the initial operation. Of those, 21 subjects had known deletion status and constitute the group for this analysis [15 with no deletion present (ND) and 6 del22q11 subjects]. There was no difference with respect to occurrence of palliative procedure prior to initial operation, or to timing of closure of the ventricular septal defect (VSD). Other than higher prevalence of prematurity (50%) in the del22q11 group versus no prematurity in the ND, the groups were comparable in terms of pre-operative characteristics. The intra- and post-operative course outcomes (length of cardiopulmonary bypass, use of vasopressors, duration of intensive care and length of hospital stay, tube-feeding) were also comparable. Although the del22q11 had longer mechanical ventilation than the ND, this difference was not significant [68 h (range 4-251) vs. 45 h (range 3-1005), p = 0.81]. In this detailed comparison of a small patient cohort, 22q11.2 deletion syndrome was not associated with adverse perioperative outcomes in patients with TOF, PA, and MAPCAS when compared to those without 22q11.2 deletion syndrome. These results are relevant to prenatal and neonatal pre-operative counseling and planning

Supplementary tables -Supplemental material for Right ventricular function mirrors clinical improvement with use of prostacyclin analogues in pediatric pulmonary hypertension

<p>Supplemental material, Supplementary tables for Right ventricular function mirrors clinical improvement with use of prostacyclin analogues in pediatric pulmonary hypertension by Rachel K. Hopper, Yan Wang, Valerie DeMatteo, Ashley Santo, Steven M. Kawut, Okan U. Elci, Brian D. Hanna and Laura Mercer-Rosa in Pulmonary Circulation</p

Physical activity self-monitoring and weight loss: 6-month results of the SMART trial

Weight loss has been associated with higher physical activity (PA) levels and frequent dietary self-monitoring. Less is known about how PA self-monitoring affects adherence to PA goals, PA levels, and weight change. Methods: The SMART Trial is a clinical weight loss trial in which 210 overweight adults were randomized equally to one of three arms: 1) paper record (PR), 2) personal digital assistant with self-monitoring software (PDA), and 3) PDA with daily tailored feedback message (PDA + FB). PA self-monitoring and adherence to PA goals were based on entries in weekly submitted diaries. PA levels were measured via self-report by the past 6-month Modifiable Activity Questionnaire at baseline and 6 months. Results: Data are presented on 189 participants with complete 6-month PA data (84% female, 77% white, mean age = 47.3 ± 8.8 yr, mean body mass index = 34.1 ± 4.5 kg·m -2). Median PA level was 7.96 MET·h·wk -1 at baseline and 13.4 MET·h·wk -1 at 6 months, with significant PA increases in all three arms. PDA + FB arm had a higher mean number of weekly self-monitoring entries than the PR arm (3.4 vs 2.4, P = 0.003) and were more likely to maintain high (i.e., 100%) adherence to PA goals over time than the PDA (P = 0.02) or PR arms (P = 0.0003). Both PA self-monitoring and adherence to PA goals were related to higher PA levels at 6 months. A higher mean rate of PA self-monitoring was associated with a greater percentage of weight decrease (ρ = -0.49, P < 0.0001) at 6 months. Conclusions: PA self-monitoring and adherence to PA goals were more likely in participants in the PDA + FB arm and in turn predicted higher PA levels and weight loss. Copyright © 2011 by the American College of Sports Medicine

The Natural History of Inherited Retinal Dystrophy Due to Biallelic Mutations in the RPE65 Gene

International audiencePURPOSE:To delineate the natural history of visual parameters over time in individuals with biallelic RPE65 mutation-associated inherited retinal dystrophy (IRD); describe the range of causative mutations; determine potential genotype/phenotype relationships; and describe the variety of clinical diagnoses.DESIGN:Global, multicenter, retrospective chart review.METHODS:Study Population: Seventy individuals with biallelic RPE65 mutation-associated IRD.PROCEDURES:Data were extracted from patient charts.MEASUREMENTS:Visual acuity (VA), Goldmann visual field (GVF), optical coherence tomography, color vision testing, light sensitivity testing, and electroretinograms (retinal imaging and fundus photography were collected and analyzed when available).RESULTS:VA decreased with age in a nonlinear, positive-acceleration relationship (P < .001). GVF decreased with age (P < .0001 for both V4e and III4e), with faster GVF decrease for III4e stimulus vs V4e (P = .0114, left eye; P = .0076, right eye). On average, a 1-year increase in age decreased III4e GVF by ∼25 sum total degrees in each eye while V4e GVF decreased by ∼37 sum total degrees in each eye, although individual variability was observed. A total of 78 clinical diagnoses and 56 unique RPE65 mutations were recorded, without discernible RPE65 mutation genotype/phenotype relationships.CONCLUSIONS:The number of clinical diagnoses and lack of a consistent RPE65 mutation-to-phenotype correlation underscore the need for genetic testing. Significant relationships between age and worsening VA and GVF highlight the progressive loss of functional retina over time. These data may have implications for optimal timing of treatment for IRD attributable to biallelic RPE65 mutations

Safety and durability of effect of contralateral-eye administration of AAV2 gene therapy in patients with childhood-onset blindness caused by RPE65 mutations: a follow-on phase 1 trial

Safety and efficacy have been shown in a phase 1 dose-escalation study involving a unilateral subretinal injection of a recombinant adeno-associated virus (AAV) vector containing the RPE65 gene (AAV2-hRPE65v2) in individuals with inherited retinal dystrophy caused by RPE65 mutations. This finding, along with the bilateral nature of the disease and intended use in treatment, prompted us to determine the safety of administration of AAV2-hRPE65v2 to the contralateral eye in patients enrolled in the phase 1 study