To assess if joint damage at 2 years after diagnosis in patients with systemic juvenile idiopathic arthritis (SJIA) can be predicted by clinical or laboratory features assessed up to 3 or 6 months ...after diagnosis.
Medical records from 70 children were retrospectively reviewed. The primary outcome measure was presence of joint damage at 2 years after diagnosis (JD2) as defined by presence of erosions or fusion in one or more joints. Potential predictor variables for JD2 in the first 3 and 6 months after diagnosis consisted of the highest observed white blood cell count, platelet count, erythrocyte sedimentation rate, active joint count, and presence of symptomatic pulmonary or cardiac disease or macrophage activation syndrome, and treatment data.
The outcome of interest, JD2, was identified in 15/70 patients. Classification-tree analysis identified a pair of variables (highest observed platelet count and number of active joints) measured within the first 3 months after diagnosis that together predicted progression to JD2 with an estimated sensitivity of 87%, specificity of 82%, and positive predictive value of 57%. Multivariate logistic regression analyses at 3 months found that higher quantities of joints with active arthritis and early use of methotrexate (MTX) were factors significantly associated with increased odds of progression to JD2 (active joints odds ratio = 1.08, 95% CI 1.00-1.16, p = 0.04; MTX OR = 11.85, 95% CI 1.89-74.26, p = 0.01). Unsupervised cluster analysis identified 2 major phenotypes of patients at 3 months characterized by different ages at onset, acute phase markers, active joint counts, and presence of serositis. These phenotypes differed 3-fold in proportion of subjects progressing to JD2 (p < 0.05).
By 3 months after diagnosis, a clinical phenotype based on active joint count and platelet count may be prognostic of an increased risk of progression to JD2. Use of corticosteroids did not appear to change the risk of joint damage. In contrast, the presence of serositis appeared to be associated with decreased risk of joint damage.
Objective Current recommendations include the use of a vaginal speculum for fetal fibronectin specimen collection. This article evaluates the equivalency of nonspeculum methods for collecting fetal ...fibronectin specimens. Study Design Two separate prospective studies of patients more than 22 weeks' gestation were performed at 2 institutions with similar hypotheses and methods. Two sequential specimens were collected on each patient: 1 with speculum and 1 with the nonspeculum method. The order of collection was reversed or randomized in both studies. Two alternative nonspeculum collection methods are described. Results The 2 study sample sizes were 169 and 31. Comparison of the fetal fibronectin test results between the speculum and nonspeculum methods demonstrated greater than 95% agreement with an intraclass Kappa coefficient greater than 0.85 in both studies. The order of collection did not result in significantly different fetal fibronectin averages. Conclusion These studies demonstrate that there is excellent agreement between fetal fibronectin results obtained by speculum and nonspeculum collection methods.
Methamphetamine dependence is an increasing public health problem in the United States. No efficacious medication for methamphetamine dependence has been developed. As ondansetron, a 5-HT3 receptor ...antagonist and modulator of cortico-mesolimbic dopamine function, has been shown to reduce some of the rewarding effects of d-amphetamine in animal and human laboratory studies, we decided to test whether it would be superior to placebo at reducing methamphetamine use. In a preliminary, multi-site, randomized, double-blind, 8-wk controlled trial, 150 methamphetamine-dependent men and women received ondansetron (0.25 mg, 1 mg, or 4 mg b.i.d.) or placebo. Participants were assessed on several measures of methamphetamine use including urine methamphetamine level up to three times per week. As a psychosocial adjunct to the medication condition, cognitive behavioural therapy also was administered three times per week. Ondansetron was well tolerated and was less likely than placebo to be associated with serious adverse events. Nevertheless, none of the ondansetron doses was superior to placebo at decreasing any of the measures of methamphetamine use, withdrawal, craving, or clinical severity of methamphetamine dependence. Our preliminary results do not support the utility of ondansetron, at the doses tested, as a treatment for methamphetamine dependence. These findings should be viewed in light of the possibility that a less intensive cognitive behavioural therapy regimen might have yielded more positive results in this initial phase II trial exploring for the efficacy of ondansetron.
Background: Obstructive sleep apnea (OSA) is a serious, common, and underdiagnosed disorder that challenges health care resources. While polysomnography (PSG) represents the standard diagnostic test ...for OSA, portable devices provide an alternative diagnostic tool when issues of cost, time, geographic availability, or other constraints pose impediments to in-lab testing. This study compares the NovaSom QSG™, a new sleep apnea home diagnostic system, to PSG both in the laboratory and in the home.
Methods: Fifty-one consecutive adults referred to the sleep lab for suspicion of OSA underwent one night of in-lab, simultaneous recording of PSG and NovaSom QSG in addition to using the NovaSom QSG at home for three nights. Two separate comparisons were made using the apnea–hypopnea index (AHI): in-lab PSG to in-lab NovaSom QSG and in-lab PSG to home NovaSom QSG.
Results: Using a clinical cut-off of AHI=15, the sensitivity and specificity of the in-lab NovaSom QSG vs. PSG were 95% and 91%, respectively. For home NovaSom QSG vs. in-lab PSG, the sensitivity was 91% and specificity was 83%. The intra-class correlation coefficient for the agreement between three separate nights of NovaSom QSG home data was 0.88.
Conclusions: In a patient population suspected of having OSA, the NovaSom QSG demonstrated acceptable sensitivity and specificity both in the lab and self-administered in the home, when compared to PSG.
With the advent of therapies aimed at young patients with cystic fibrosis, who have mildly reduced pulmonary function, the need for improved outcome measures that discriminate treatment effects has ...become important. Pulmonary function measurements or chest high-resolution computed tomography (HRCT) scores have been separately used to assess interventions. We evaluated these modalities separately and together during a treatment study to develop a more sensitive outcome measure. In a 1-year trial, 25 children randomized either to daily Pulmozyme or to normal saline aerosol were evaluated at randomization and at 3 and 12 months. Outcome variables were pulmonary function test (PFT) results, a global HRCT score, and a composite score incorporating PFTs and HRCT scoring. Regression analyses with generalized estimating equations permitted estimation of the difference in treatment effect between groups over time for each outcome. The largest difference in treatment effects observed at 12 months, measured by the percentage change from baseline, were with the composite total and maximal CT/PFT scores (35.4 and 30.4%), compared with mean forced expiratory flow during the middle half of the FVC (FEF25-75%) (13.0%) and total and maximal global HRCT scores (6.2%, 7.2%). The composite total and maximal CT/PFT scores were the most sensitive outcome measures for discriminating a treatment effect in children with cystic fibrosis with normal or mildly reduced pulmonary function during a 1-year trial of Pulmozyme.
ABSTRACT
Aims To conduct a preliminary evaluation of the safety and efficacy of reserpine, gabapentin or lamotrigine versus an unmatched placebo control as a treatment for cocaine dependence.
Design ... A 10‐week out‐patient study using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design.
Setting The study was conducted at the Cincinnati Medication Development Research Unit (MDRU).
Participants Participants met Diagnostic and Statistical Manual version IV (DSM‐IV) criteria for cocaine dependence. Sixty participants were enrolled, with 50 participants completing the final study measures.
Intervention The targeted daily doses of medication were reserpine 0.5 mg, gabapentin 1800 mg and lamotrigine 150 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis.
Measurements Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression scale—observer and self‐report of cocaine use. Safety measures included adverse events, electrocardiograms (ECGs), vital signs and laboratory tests.
Findings Subjective measures of cocaine dependence indicated significant improvement for all study groups. Urine BE results indicated a significant improvement for the reserpine group (P < 0.05) and non‐significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures. The medications appeared to be tolerated well.
Conclusions The present findings suggest that reserpine may be worthy of further study as a cocaine dependence treatment.
PDF
