Home About us Contact
|
Home About us Contact | ||
|
|
||
Study Design. (study + design)
Selected AbstractsPediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical DevicesCONGENITAL HEART DISEASE, Issue 1 2010Jamie S. Sutherell MD ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source] The Prevalence of Headache and Its Association With Socioeconomic Status Among Schoolchildren in Istanbul, TurkeyHEADACHE, Issue 5 2009Objective., The etiology and pathogenesis of migraine and other types of headache are still under discussion. An interaction of organic, psychological, and psychosocial factors is operative. In this study, we aimed to determine the prevalence of headache and its association with socioeconomic status among schoolchildren. Study Design., A cross-sectional study was performed on 2669 schoolchildren via a parental questionnaire. Socioeconomic status was determined according to the Turkish socioeconomic status scale. Results., The mean age of the students was 8.2 ± 2.4 years. The headache prevalence was 46.2% (95% CI: 44.3-48.1). The prevalence of migraine was 3.4% (95% CI: 2.8-4.1), the prevalence of probable migraine was 8.7% (95% CI: 7.6-9.8), and that of non-migraine headache was 34.1% (95% CI: 32.3-35.9). Multivariate analysis revealed that older age, being a girl, having a family history of headache, and exposure to passive smoking at home were independently associated with headache. There was an inverse association between socioeconomic status and all 3 types of headaches after adjusting for age, sex, family history of headache, and presence of passive smoking. When the group with the lowest socioeconomic status was taken as the reference category, the odds ratios for the highest socioeconomic group were 0.33 (95% CI: 0.16-0.69, P = .003) for the migraine, 0.30 (95% CI: 0.11-0.89, P = .029) for the probable migraine, and 0.34 (95% CI: 0.16-0.72, P = 0.005) for the non-migraine headache. Conclusion., Headache is more common among children with lower socioeconomic groups. Social causation can play a role in the pathogenesis of headache. [source] Development of a Scale to Measure Patients' Trust in Health InsurersHEALTH SERVICES RESEARCH, Issue 1 2002Article first published online: 18 MAR 200 Objective.,To develop a scale to measure patients' trust in health insurers, including public and private insurers and both indemnity and managed care. A scale was developed based on our conceptual model of insurer trust. The scale was analyzed for its factor structure, internal consistency, construct validity, and other psychometric properties. Data Sources/Study Setting.,The scale was developed and validated on a random national sample (n=410) of subjects with any type of insurance and further validated and used in a regional random sample of members of an HMO in North Carolina (n=1152). Study Design.,Factor analysis was used to uncover the underlying dimensions of the scale. Internal consistency was assessed by Cronbach's alpha. Construct validity was established by Pearson or Spearman correlations and t tests. Data Collection.,Data were collected via telephone interviews. Principal Findings.,The 11-item scale has good internal consistency (alpha=0.92/0.89) and response variability (range=11,55, M=36.5/37.0, SD=7.8/7.0). Insurer trust is a unidimensional construct and is related to trust in physicians, satisfaction with care and with insurer, having enough choice in selecting health insurer, no prior disputes with health insurer, type of insurer, and desire to remain with insurer. Conclusions.,Trust in health insurers can be validly and reliably measured. Additional studies are required to learn more about what factors affect insurer trust and whether differences and changes in insurer trust affect actual behaviors and other outcomes of interest. [source] Methodologic Implications of Allocating Multiple-Race Data to Single-Race CategoriesHEALTH SERVICES RESEARCH, Issue 1 2002Article first published online: 18 MAR 200 Objective. To illustrate methods for comparing race data collected under the 1977 Federal Office of Management and Budget (OMB) directive, known as OMB-15, with race data collected under the revised 1997 OMB standard. Data Sources/Study Setting.,Secondary data from the 1993,95 National Health Interview Surveys. Multiple-race responses, available on in-house files, were analyzed. Study Design.,Race-specific estimates of employer-sponsored health insurance were calculated using proposed allocation methods from the OMB. Estimates were calculated overall and for three population subgroups: children, those in households below poverty, and Hispanics. Principal Findings.,Although race distributions varied between the different methods, estimates of employer-sponsored health insurance were similar. Health insurance estimates for the American Indian/Alaska Native group varied the most. Conclusions.,Employer-sponsored health insurance estimates for American Indian/Alaska Natives from data collected under the 1977 OMB directive will not be comparable with estimates from data collected under the 1997 standard. The selection of a method to distribute to the race categories used prior to the 1997 revision will likely have little impact on estimates of employer-sponsored health insurance for other groups. Additional research is needed to determine the effects of these methods for other health service measures. [source] Salivary bacteria and oral health status in children with disabilities fed through gastrostomyINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 3 2010ARIELA HIDAS International Journal of Paediatric Dentistry 2010; 20: 179,185 Objectives., This study examined caries level, amount of calculus, and oral microbial environment in gastrostomy tube (GT)-fed children compared with healthy children and children with disabilities orally fed (PO). Study design., The study group consisted of 12 GT-fed children and the two control groups consisted of 16 children with disabilities orally fed and 17 healthy children. DMF-T/dmf-t index, calculus index, Mutans Streptococci (MS), Lactobacilli (LB) levels and salivary buffer capacity were examined. Results., DMF-T/dmf-t index was significantly lower in the tube-fed group. Calculus index was highest in the tube-fed group. MS and LB levels were the lowest in the tube-fed children. Correlation was found between MS and DMF-T/dmf-t. Conclusions., Tube-fed children demonstrated significantly higher calculus levels and less caries, MS, and LB levels then healthy children or children with disabilities eating PO. [source] Effect of xylitol and xylitol,fluoride lozenges on approximal caries development in high-caries-risk childrenINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 3 2008CHRISTINA STECKSÉN-BLICKS Aim., To evaluate the effect of xylitol- and xylitol/fluoride-containing lozenges on approximal caries development in young adolescents with high caries risk. Study design., A 2-year double-blind trial with two parallel arms and a nonrandomized reference group. Material and methods., One hundred and sixty healthy 10- to 12-year-old children with high caries risk were selected. After informed consent, they were randomly assigned into a xylitol and a xylitol/fluoride group. They were instructed to take two tablets three times a day (total xylitol and fluoride dose 2.5 g and 1.5 mg, respectively). The compliance was checked continuously and scored as good, fair, or poor. A reference no-tablet group was also selected (n = 70) for group comparison. The outcome measure was approximal caries incidence. Results., The dropout rate was 28%, and 41% exhibited a good compliance with the study protocol. No statistically significant differences in caries incidence could be found between the study groups (P > 0.05). Among a subgroup of children who demonstrated good compliance, the mean ,DMFSa value was significantly lower in the xylitol/fluoride group compared to the xylitol group, 1.0 ± 2.3 vs. 3.3 ± 4.6 (P < 0.05), while no difference could be displayed between any of the study groups and the reference group (P > 0.05). Conclusion., The results from this 2-year trial did not support a self-administered regimen of xylitol- or xylitol/fluoride-containing lozenges for the prevention of approximal caries in young adolescents with high caries risk. [source] IGFBP-1 levels in adult women born small for gestational age suggest insulin resistance in spite of normal BMIJOURNAL OF INTERNAL MEDICINE, Issue 1 2004A. Kistner Abstract. Objective., Impaired fetal development may contribute to decreased insulin sensitivity. This study was designed to characterize serum markers of insulin resistance in adults born small for date or born prematurely. Study design., Fifty subjects, all women, were evaluated at a mean age ± SD of 26 ± 2 years (range: 23,30 years). They were allocated to three groups: (i) born fullterm with birth weight <2600 g (n = 18) (small for gestational age, SGA), (ii) born before gestational week 32 (n = 15) (ex-preterm), and (iii) controls, born fullterm with appropriate birth weight (n = 17). Anthropometric data as well as fasting serum samples of plasma B-glucose, serum lipids, insulin, insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-1 (IGFBP-1) levels were determined. Results., In the SGA group final height was lower and they weighed less compared with the controls. Fasting insulin and glucose levels did not differ amongst the groups. Triglycerides were lower in the SGA group and in the ex-preterm group compared with the controls (P < 0.05). The SGA group showed lower IGFBP-1 levels compared with the controls median 17 (range 3,121) vs. 26 (7,67) ,g L,1; P < 0.05]. The IGF-I levels in the SGA, ex-preterm and control groups were 212 ± 58, 259 ± 37 and 216 ± 32 ,g L,1, respectively, corresponding to a mean SD score of ,0.8 ± 1.0, 0.1 ± 0.6 and ,0.6 ± 0.6. Conclusion., As IGFBP-1 is a marker of insulin sensitivity, the low levels observed in adult women with normal BMI, born small for date, suggest relative insulin resistance in spite of normal BMI. [source] Types of article published in physiotherapy journals: a quantitative analysisPHYSIOTHERAPY RESEARCH INTERNATIONAL, Issue 4 2009Matteo Paci Abstract Background and Purpose.,The aim of this study was to quantify and assess the types of research and review articles published in physiotherapy professional journals with international circulations.,Method.,Selected articles from nine physiotherapy journals in a period of five years were classified according to their study design.,Results.,A total number of 1627 articles were included in this study of which 205 (12.60%) were randomized controlled trial (RCT). Articles published with the highest frequency were ,observational/descriptive studies' (n = 305, 18.75%), whereas ,meta-analyses' were the rarest ones (n = 21, 1.29%). Many articles were validation studies (n = 216, 13.28%) and articles classified as ,others' (n = 217, 13.34%). High heterogeneity was found in terms of distribution over years and journals with an improvement of the number of RCTs among years.,Conclusion.,The distribution of different types of article in physiotherapy journals is similar to other disciplines. The improvement of RCTs represents an important move in the right direction for evidence-based physiotherapy research. Copyright © 2009 John Wiley & Sons, Ltd. [source] | ||||||||||