Accuracy of fetal fibronectin to predict preterm birth in twin gestations with symptoms of labor

OBJECTIVE: To investigate accuracy of fetal fibronectin testing to predict preterm birth in twin gestations with symptoms of preterm labor. METHODS: We reviewed charts of all patients with twin gestations who underwent fetal fibronectin testing and presented with complaints of preterm labor between January 1, 2000, and June 30, 2004. We also reviewed the charts of all singleton gestations with similar complaints that had fetal fibronectin testing between January 1, 2000, and December 31, 2001. All samples were processed using a rapid fetal fibronectin detection system. We calculated the sensitivity, specificity, positive predictive value, and negative predictive value of fetal fibronectin testing in singleton and twin gestations in predicting delivery within 14 days of testing. RESULTS: Four hundred twenty-nine singletons and 87 twins met the inclusion criteria. The birth rate before 34 weeks of gestation for singletons was 3.5% compared with the rate of twin pregnancies of 28.7%. Fetal fibronectin predicted delivery within 14 days of testing with a sensitivity, specificity, and positive and negative predictive values in singleton gestations of 82%, 90%, 17%, and 99%, respectively. In twin gestations, fetal fibronectin predicted delivery within 14 days of testing with a sensitivity, specificity, and positive and negative predictive values of 71%, 74%, 19%, and 97%, respectively. CONCLUSION: As noted in singleton pregnancies, fetal fibronectin testing in twins has a high negative predictive value. Fetal fibronectin evaluation may be a useful tool in screening twins with symptoms of preterm labor, because a negative result places these women at a low risk for delivering within 2 weeks of testing.     

Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability

OBJECTIVE: To compare etanercept-induced improvement in disability of patients with recent onset of rheumatoid arthritis (RA) to that of patients with established RA. METHODS: Health Assessment Questionnaire (HAQ) scores were collected over 3 years in 2 groups of patients with RA who were treated with etanercept. The first group consisted of 207 patients with recent onset RA (mean duration of 1 year) who had not previously received methotrexate, and the second group consisted of 464 patients with established RA (mean duration of 12 years) who had failed one or more disease-modifying antirheumatic drugs. RESULTS: Baseline demographics and disease characteristics were similar in the 2 groups, except for HAQ scores and C-reactive protein levels, which were higher in the established RA group. Patients in both groups showed rapid and sustained clinical responses with etanercept therapy, but patients with recent onset RA showed significantly greater improvement in HAQ scores compared with patients with established RA. The difference in magnitude of HAQ score improvement between groups was observed as early as week 2 after initiation of etanercept and persisted throughout the 3-year time frame. At year 3, significantly more patients with recent onset RA had a HAQ score of zero (26%) versus those with established RA (14%, p = 0.0095). CONCLUSION: Although etanercept therapy significantly improved disability scores in both groups, patients with recent onset of RA showed greater benefit in HAQ scores than patients with established RA. These results support prompt treatment of RA at an early stage of disease to minimize patient disability.     

Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year,open-label,Phase III safety study

Introduction. Diclofenac is used for the treatment of osteoarthritis (OA); however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related adverse events (AEs). Low-dose SoluMatrix® diclofenac has been developed to provide efficacy at lower diclofenac doses. A recently published Phase III study evaluated the efficacy and safety of SoluMatrix diclofenac 35 mg twice daily (b.i.d.) and thrice daily (t.i.d.) in patients with OA pain treated for 12 weeks. Methods. This Phase III multicenter, open-label study assessed the safety of SoluMatrix diclofenac in patients with OA dosed up to 52 weeks (ClinicalTrials.gov: NCT01510912). The study enrolled 602 chronic NSAID/acetaminophen users, aged ≥40 years with OA of the knee or hip. Patients received SoluMatrix diclofenac 35 mg b.i.d., which could be increased to t.i.d. and subsequently reduced to b.i.d. as needed. Safety assessments included AEs, vital signs, physical examination findings, 12-lead electrocardiogram, and clinical laboratory test results. Patient-reported outcomes were evaluated by the Short Form-36 (SF-36). Results. A total of 601 patients received SoluMatrix diclofenac; 373 of 601 patients (62.1%) received treatment for ≥11 months. The most frequent AEs included upper respiratory tract infection, headache, urinary tract infection, diarrhea, nasopharyngitis, and nausea. Serious gastrointestinal, cardiovascular, renal, and hepatic AEs were uncommon. A small proportion (99 patients, 16.5%) of patients discontinued participation in the study due to AEs. Clinically meaningful improvements from baseline in Physical Component Summary Scores of the SF-36 were noted at week 12 and were sustained through week 52. Improvements in six of the eight individual physical and mental SF-36 domains were also noted. Conclusion. SoluMatrix diclofenac treatment for up to 1 year was generally well tolerated in patients with OA pain and associated with improvement in quality of life measures. Trial Registration: www.clinicaltrials.gov identifier: NCT01510912.     

Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes

OBJECTIVE: To compare the clinical and radiographic outcomes in patients with rheumatoid arthritis (RA) who received monotherapy with either etanercept or methotrexate (MTX) for 2 years and to assess the safety of this therapy. METHODS: In the Enbrel ERA (early rheumatoid arthritis) trial, 632 patients with early, active RA were randomized to receive either twice-weekly subcutaneous etanercept (10 mg or 25 mg) or weekly oral MTX (mean dosage 19 mg per week) for at least 1 year in a double-blind manner. Following the blinded phase of the trial, 512 patients continued to receive the therapy to which they had been randomized for up to 1 additional year, in an open-label manner. Radiograph readers remained blinded to treatment group assignment and the chronologic order of images. RESULTS: At 24 months, more 25-mg etanercept patients than MTX patients met American College of Rheumatology 20% improvement criteria (72% and 59%, respectively; P = 0.005), and more had no increase in total score and erosion scores on the Sharp scale (P = 0.017 and P = 0.012, respectively). The mean changes in total Sharp score and erosion score in the 25-mg etanercept group (1.3 and 0.66 units, respectively) were significantly lower than those in the MTX group (3.2 and 1.86 units, respectively; P = 0.001). Significantly more patients in the 25-mg etanercept group (55%) than in the MTX group (37%) had at least 0.5 units of improvement in the Health Assessment Questionnaire disability index (P < 0.001). Fewer patients in the etanercept group than in the MTX group experienced adverse events or discontinued treatment because of adverse events. CONCLUSION: Etanercept as monotherapy was safe and was superior to MTX in reducing disease activity, arresting structural damage, and decreasing disability over 2 years in patients with early, aggressive RA.     

Prenatal depressive symptoms and abnormalities of glucose tolerance during pregnancy among Hispanic women

The aim of this study is to prospectively examine the association between maternal depressive symptoms in early pregnancy and risk of abnormal glucose tolerance (AGT) and impaired glucose tolerance (IGT) in mid-pregnancy. We evaluated this association among 934 participants in Proyecto Buena Salud, a prospective cohort study of Hispanic (predominantly Puerto Rican) women in Western Massachusetts. Depressive symptoms were assessed in early pregnancy using the 10-item Edinburgh Postnatal Depression Scale. Scores ≥13 indicated at least probable minor depression and scores ≥15 indicated probable major depression. AGT and IGT were diagnosed using American Diabetes Association criteria. In early pregnancy, 247 (26.5 %) participants experienced at least minor depression and 163 (17.4 %) experienced major depression. A total of 123 (13.2 %) were classified with AGT and 56 (6.0 %) were classified with IGT. In fully-adjusted models, the odds ratio for AGT associated with minor depression was 1.20 (95 % CI 0.77–1.89) and for major depression was 1.34 (95 % CI 0.81–2.23). The odds ratio for IGT associated with minor depression was 1.22 (95 % CI 0.62–2.40) and for major depression was 1.53 (95 % CI 0.73–3.22). We did not observe an association with continuous screening glucose measures. Findings in this prospective cohort of Hispanic women did not indicate a statistically significant association between minor or major depression in early pregnancy and AGT or screening glucose values in mid-pregnancy. Due to the small number of cases of IGT, our ability to evaluate the association between depression and IGT risk was constrained.     

Prevalence of Mycoplasma bacteria in amniotic fluid at the time of genetic amniocentesis using the polymerase chain reaction

OBJECTIVE: To use the polymerase chain reaction (PCR) to detect the presence of bacteria and Mycoplasma in amniotic fluid at the time of genetic amniocentesis and to assess their relationship to amniotic fluid interleukin-6 (IL-6) concentration and preterm delivery. STUDY DESIGN: A prospective study was performed on 78 asymptomatic pregnancies presenting for genetic amniocentesis. Amniotic fluid samples were analyzed by PCR for the detection of bacterial 16S ribosomal RNA, by PCR/enzyme-linked immunosorbent assay (ELISA) for Mycoplasma and by ELISA analysis for IL-6 concentration. RESULTS: All 78 samples were analyzed, and bacterial RNA was detected in 18% of them. However, no sample tested positive for Mycoplasma. The mean IL-6 concentration was 435 pg/mL. There was no difference in IL-6 levels or gestational age between bacteria-positive and -negative groups. CONCLUSION: Amniotic fluid may not be sterile in the midtrimester, yet the presence of bacteria, as detected by PCR, does not always result in an inflammatory response or adverse perinatal outcome.     

Assessment of pediatric patients by emergency medical technicians-basic

OBJECTIVE: To determine whether emergency medical technicians-basic can accurately assess children and whether this ability varies with the patient's age or diagnosis. This determination is important for educational program design for emergency medical technicians in pediatrics and for evaluation of the possibility of expanding their scope of practice. DESIGN: Retrospective chart review. SETTING: Pediatric emergency department in a large, urban hospital. PARTICIPANTS: Patients (n = 2430) presenting to the pediatric emergency department via basic life support ambulance during a 12-month period. MEASUREMENTS: Data collected were name, age, field assessment (FA), and emergency department (ED) diagnosis. Patient's ages were organized into five groups: infant (0-1 y), toddler (1-3 y), preschool (3-6 y), school-aged (6-11 y), and adolescent (> 11 y), and the ED diagnoses were divided into seven categories. The accuracy of the FA was compared with the ED diagnosis. We then analyzed FA accuracy by patient's age and type of diagnosis. The chi(2) contingency table analysis was used for dichotomous variables (P < 0.05). In addition, logistic regression and stratified analysis were used. Both ambulance and hospital charts were available for 2064 patients. Age ranged from birth to 19 years with a bimodal distribution at the extremes of patient age and a mean age of 8.25 (SD, 5.64). The distribution was 11.7% (241) infants, 14.7% (303) toddlers, 14.9% (307) preschool, 21.2% (437) school-aged, and 37.6% (776) adolescents. RESULTS: Overall emergency medical technician-basic assessment was accurate 81.5% (1683) of the time. There was a statistically significant variation in accuracy with both age group (chi(2) = 40.07, P < 0.05) and diagnostic category (chi(2) = 185.7, P < 0.05). By age group, the accuracy of field assessment was 69.7% (168) infants, 75.9% (230) toddlers, 82.7% (254) preschool, 86.7% (379) school-aged, and 84.0% (652) adolescents. By category of diagnosis, the accuracy of the field assessment was 92.4% (292) major trauma, 91.4% (478) minor trauma, 88.9% (112) psychologic and social, 85.1% (229) major medical, 81.1% (180) wheezing-associated respiratory illness, 65.4% (350) minor medical, and 57.5% (42) non-wheezing-associated respiratory illness. CONCLUSIONS: Emergency medical technicians-basic were highly successful in assessing children with wheezing, serious illness, injuries, and psychologic and social conditions. Consideration should be given to expanding their scope of practice in these areas. They were less successful in assessing minor medical conditions and respiratory emergencies other than wheezing. They require additional training in these areas.     

Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib.

STUDY OBJECTIVE: To evaluate the functional status of patients with signs and symptoms of osteoarthritis of the knee after treatment with celecoxib compared with placebo and naproxen. DESIGN: Prospective, randomized, double-blind, parallel-group, 12-week trial. SETTING: Multicenter study conducted at 71 sites in the United States and Canada. PATIENTS: One thousand four patients with active osteoarthritis of the knee in a flare state. INTERVENTIONS: Patients were assigned randomly to one of five treatment groups: placebo; celecoxib 50 mg twice/day, 100 mg twice/day, and 200 mg twice/day; and naproxen 500 mg twice/day. MEASUREMENTS AND MAIN RESULTS: The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. At the end of the treatment period, patients in the four active treatment groups had significantly better functional status than those receiving placebo. Patients treated with celecoxib 100 mg twice/day had significantly better improvements in pain scores than those treated with placebo and naproxen. CONCLUSION: Celecoxib was better than placebo and comparable with naproxen in improving aspects of functional status in patients with osteoarthritis.