The association of inadequate mid-pregnancy weight gain and preterm birth in twin pregnancies.

OBJECTIVE: To determine whether inadequate gestational weight gain in the second trimester in twin pregnancies is associated with an increased risk of preterm birth (PTB) at <32 weeks. STUDY DESIGN: Retrospective cohort study including 489 twin pregnancies delivered between 2001 and 2013. Rates of weight gain at different gestational ages were compared with Institute of Medicine guidelines. RESULT: An inadequate rate of weight gain at <20 weeks was not associated with PTB. Patients with inadequate rates of weight gain at 20 to 28 weeks had a higher risk of PTB at <32 weeks (37.6%) compared to those with adequate weight gain (15.2%) (P<0.001). In multivariate analysis, women with inadequate weight gain at 20 to 28 weeks were 2.8 times more likely to deliver at <32 weeks (95% confidence interval 1.65 to 4.81). CONCLUSION: Inadequate gestational weight gain at 20 to 28 weeks in twin pregnancies was the strongest predictor of PTB at <32 weeks. This represents an optimal time for interventions to improve weight gain and potentially decrease rates of PTB.

The utilization of circulating cell-free fetal DNA testing and decrease in invasive diagnostic procedures: an institutional experience.

OBJECTIVE: To characterize the patient population utilizing circulating cell-free fetal DNA (ccffDNA) testing at a large academic center and evaluate trends in the performance of invasive diagnostic procedures. STUDY DESIGN: A retrospective cohort study of all patients who underwent cell-free DNA testing from May to December 2012 was performed. RESULT: During the study period, 206 patients had cell-free DNA testing. Of those, 75% (155/206) were of ages ⩾ 35 years. Of those undergoing ccffDNA testing, 41% had positive aneuploidy screening and 38% had abnormal ultrasound findings. Only 7% of the patients with negative ccffDNA testing opted for an invasive diagnostic procedure compared with 60% with positive testing (P<0.01). The rate of invasive procedures decreased from 5.9% of all visits to the center during a similar 8-month period in 2010 to 4.1% of all visits during the study period (P<0.01). CONCLUSION: Our data suggest that ccffDNA testing leads to reduced uptake of invasive procedures.

Congenital heart defects in a large, unselected cohort of monochorionic twins.

OBJECTIVE: To determine the prevalence of congenital heart defects (CHDs) in a large, unselected cohort of monochorionic (MC) twins. STUDY DESIGN: We completed a chart review of all MC twin pregnancies in the Kaiser Permanente Northern California population from 1996 to 2003. CHDs were identified by diagnostic codes and confirmed by postnatal echocardiograms. Follow-up was obtained through one year of age. RESULT: A total of 926 liveborn MC twins met inclusion criteria. The prevalence of CHDs was 7.5%, 11.6 times the general population rate (CI 9.2 to 14.5). Septal defects were most common. 20% of infants with heart defects had twin-to-twin transfusion syndrome (TTTS) versus 8% of infants without defects (P<0.01); this association remained significant when controlling for potential confounders. CONCLUSION: The prevalence of CHDs in this large cohort of MC twins was significantly higher than the general population rate, with TTTS an added risk factor.

Cost-effectiveness of combination peginterferon alpha-2a and ribavirin compared with interferon alpha-2b and ribavirin in patients with chronic hepatitis C.

BACKGROUND: Sustained virological response (SVR) is the primary objective in the treatment of chronic hepatitis C (CHC). Results from a recent clinical trial of patients with previously untreated CHC demonstrate that the combination of peginterferon alpha-2a and ribavirin produces a greater SVR than interferon alpha-2b and ribavirin combination therapy. However, the cost-effectiveness of peginterferon alpha-2a plus ribavirin in the U.S. setting has not been investigated. METHODS: A Markov model was developed to investigate cost-effectiveness in patients with CHC using genotype to guide treatment duration. SVR and disease progression parameters were derived from the clinical trials and epidemiologic studies. The impact of treatment on life expectancy and costs were projected for a lifetime. Patients who had an SVR were assumed to remain virus-free for the rest of their lives. In genotype 1 patients, the SVRs were 46% for peginterferon alpha-2a plus ribavirin and 36% for interferon alpha-2b plus ribavirin. In genotype 2/3 patients, the SVRs were 76% for peginterferon alpha-2a plus ribavirin and 61% for interferon alpha-2b plus ribavirin. Quality of life and costs were based on estimates from the literature. All costs were based on published U.S. medical care costs and were adjusted to 2003 U.S. dollars. Costs and benefits beyond the first year were discounted at 3%. RESULTS: In genotype 1, peginterferon alpha-2a plus ribavirin increases quality-adjusted life expectancy (QALY) by 0.70 yr compared to interferon alpha-2b plus ribavirin, producing a cost-effectiveness ratio of $2,600 per QALY gained. In genotype 2/3 patients, peginterferon alpha-2a plus ribavirin increases QALY by 1.05 yr in comparison to interferon alpha-2b plus ribavirin. Peginterferon alpha-2a combination therapy in patients with HCV genotype 2 or 3 is dominant (more effective and cost saving) compared to interferon alpha-2b plus ribavirin. Results weighted by genotype prevalence (75% genotype 1; 25% genotype 2 or 3) also show that peginterferon alpha-2a plus ribavirin is dominant. Peginterferon alpha-2a and ribavirin remained cost-effective (below $16,500 per QALY gained) under sensitivity analyses on key clinical and cost parameters. CONCLUSION: Peginterferon alpha-2a in combination with ribavirin with duration of therapy based on genotype, is cost-effective compared with conventional interferon alpha-2b in combination with ribavirin when given to treatment-naïve adults with CHC.

Use of a decision-analytic model to support the use of a new oral US contrast agent in patients with abdominal pain.

RATIONALE AND OBJECTIVES: The authors performed this study to compare the cost and diagnostic abilities of ultrasound (US) performed with and without the use of an oral contrast material recently approved by the U.S. Food and Drug Administration. MATERIALS AND METHODS: An interactive decision-analytic model was constructed to compare US performed with and without contrast material (SonoRx; Bracco Diagnostics) for the evaluation of patients with abdominal pain who were suspected of having pancreatic disease. The model considered all resources that might be used to evaluate a patient suspected of having pancreatic disease (eg, US, computed tomography [CT], endoscopic retrograde cholangiopancreatography, fine-needle aspiration biopsy, and open biopsy). The literature and an expert panel were the clinical data sources. Cost estimates were based on Medicare and non-Medicare reimbursements. The primary cost-effectiveness measure was the cost to achieve a diagnosis. RESULTS: SonoRx-enhanced US was less expensive than unenhanced US ($714 vs $808, respectively, with Medicare costs; $1,612 vs $1,878, respectively, with non-Medicare costs) and as effective (0.785 vs 0.782, respectively). SonoRx-enhanced US was more cost-effective than unenhanced US ($909 vs $1,034, respectively, with Medicare costs; $2,052 vs $2,401, respectively, with non-Medicare costs). This relationship was maintained throughout extensive sensitivity analyses. CONCLUSION: SonoRx-enhanced US is more cost-effective than unenhanced US, primarily because it avoids the need for CT. CT may be avoided owing to the higher probability of obtaining optimal US scans with oral contrast material.

Establishing an in-house journal.

Articles in journals such as Nursing Standard offer nurses a valuable means to keep their knowledge updated, but how many people do you know who have written an article? The majority of research undertaken by nurses remains unpublished (Humphris 1999), so much potentially useful experience, knowledge, ideas and research are lost. This article describes how the School of Health, Biological and Environmental Sciences (HeBES) at Middlesex University established an in-house journal to encourage nurses to develop their skills of writing for publication.

Cost of treating an episode of variceal bleeding in a VA setting.

OBJECTIVES: The specific aims of this study were to develop a demographic description of a sample of patients presenting with bleeding esophageal varices and determine the direct health care costs of variceal bleeding. METHODS: This was a retrospective evaluation of patients who underwent esophagogastroduodenoscopy at the Portland VA Medical Center between January 1993 and May 1997. Data sources included both electronic databases and patient medical charts. The primary unit of analysis was an episode of care, defined as an index bleed plus 6 months of follow-up or death, whichever came first. RESULTS: The total inpatient direct cost was $1,566,904 and outpatient direct cost was $104,611, for a total of $1,671,515 for 100 bleeding episodes in 79 patients. Episodes of care for patients receiving < or =2 units of packed red blood cells were approximately a third as costly as those receiving >2 units of packed red blood cells (n = 17, $6,470 and n = 83, $17,553). The difference in costs was statistically significant (p < 0.05), and primarily attributable to hospital bed costs. CONCLUSIONS: There is a substantial financial burden associated with this illness, primarily attributable to inpatient costs. In addition to severity of bleeding, Child's class, endoscopic findings, and the timing of pharmacological therapy seem to influence the overall cost of managing esophageal varices.

Review of the development, validation, and application of predictive instruments in interventional cardiology.

Within the last few years, risk assessment has become an integral part of clinical practice, particularly for thoracic surgery and interventional procedures. Risk assessment statistical models are being used in medical decision making, quality improvement tools, and as aids to patient counseling. This literature review was conducted to evaluate the types of predictive models and outcomes measures that have been examined, and methods used in development, validation, and application of these models. A Medline search performed to identify articles (limited to human studies) published in English from 1980 to 1999 resulted in 89 articles, of which 71 were evaluable. Populations studied for model development included patients undergoing coronary artery bypass graft (CABG), percutaneous transluminal coronary revascularization (PTCR), cardiac catheterization, or stenting procedures and patients with angina or stroke. The models were equally developed from a single center versus multicenter and from retrospective databases versus prospective studies. In terms of model perspectives, only three of the models measured cost or cost-effectiveness as the outcome; the remainder considered only clinical outcomes. The most commonly reported types of predictive models were developed using logistic regression and Bayesian techniques, followed by neural networks, rule-based artificial intelligence, simultaneous equation system, and multiple linear regression. Factors to consider when developing or evaluating a predictive model include uniformity of definitions of outcomes, uniformity of definitions of variables, completeness of data, number and frequency of variables, timeliness and source of data, development population characteristics, development and testing (validation) cohorts, and calibration and discrimination. Application of these models to an individual patient can spur quality improvement efforts that can lead to dramatic, system-wide improvements in outcomes.

Environmental contamination and developmental abnormalities in eggs and hatchlings of the common snapping turtle (Chelydra serpentina serpentina) from the Great Lakes-St Lawrence River basin (1989-1991).

During 1989-1991, we assessed developmental abnormalities in embryos and hatchlings from eggs of the common snapping turtle (Chelydra serpentina serpentina). Eggs were collected and artificially incubated from eight sites in Ontario, Canada and Akwesasne/New York, USA. In eggs from the same clutches we measured 20 organochlorine pesticides, 48 polychlorinated biphenyl (PCBs) congeners including 6 non-ortho PCBs, 8 polychlorinated dibenzodioxins (PCDDs), 14 polychlorinated dibenzofurans (PCDFs) and total mercury. We found a significant increase in abnormal development with increasing polychlorinated aromatic hydrocarbon exposure in eggs, particularly PCDD and PCDF concentrations. In contrast, the risk of abnormality was not significantly higher as toxic equivalent concentrations increased in eggs. We also found significant 7-ethoxyresorufin O-deethylase and Cytochrome P4501A responses in livers of hatchling turtles from Lake Ontario relative to hatchlings from a clean, inland site whereas we did not find any evidence of porphyria in the hatchlings from either site.

Pharmacoeconomic analysis of selected antibiotics in lower respiratory tract infection.

An interactive pharmacoeconomic model was designed to evaluate the effects of clinical response and adverse drug events on the comparative cost and cost-effectiveness of a relatively new antibiotic, clarithromycin, compared with those of six other antibiotics used to treat community-acquired lower respiratory tract infection. The cost and cost-effectiveness analyses were based don 12 randomized, double-blind, controlled clinical trials conducted between 1987 and 1992 in regionally distributed outpatient clinics in the United States. The trials enrolled a total of 2377 patients. Of the 2377, 1102 patients were treated for acute exacerbation of chronic bronchitis, 591 for pneumonia, and 201 for either of the two conditions. Safety data for one of the antibiotics was obtained from a trial of patients with sinusitis (N = 483). The antibiotics included in the analysis were amoxicillin/clavulanate, ampicillin, cefaclor, cefixime, cefuroxime, clarithromycin, and erythromycin. The main outcome measures were the costs of resources to achieve a clinical response, costs related to managing adverse drug events, and costs of antibiotic treatment from the perspective of managed care. The mean total cost per episode ranged from approximately $137 to $267. The drug acquisition cost typically contributed a small amount to the overall cost. For the cost-effectiveness analysis, in which complication-free cure was used as a proxy for patient satisfaction, the range of mean cost per complication-free cure varied from approximately $307 for clarithromycin to $612 for cefaclor. When ranked from most to least cost-effective, the order was as follows: clarithromycin, cefixime, amoxicillin/clavulanate, erythromycin, cefuroxime, ampicillin, and cefaclor. The costs associated with clinical management (including treatment failure) and managing adverse drug events significantly contribute to the total cost and cost-effectiveness of antibiotics in the outpatient setting. Cost-effectiveness analyses are valuable in analyzing the various costs associated with the treatment of lower respiratory tract infection (acute exacerbation of chronic bronchitis or pneumonia) and may be useful tools for physicians managing patients, members of pharmacy and therapeutics committees developing formularies, and medical staff implementing practice guidelines.

Temporal and geographic variation of organochlorine residues in eggs of the common snapping turtle (Chelydra serpentina serpentina) (1981-1991) and comparisons to trends in the herring gull (Larus argentatus) in the Great Lakes basin in Ontario, Canada.

Common snapping turtle (Chelydra serpentina serpentina) eggs from five sites within the Great Lakes basin, and from a reference site in north-central Ontario were collected during 1981-1991 and analyzed for four organochlorine pesticides, polychlorinated biphenyls (PCBs) including six non-ortho PCBs, polychlorinated dibenzodioxins (PCDDs), and polychlorinated dibenzofurans (PCDFs). The pattern of geographic variation was consistent over time in eggs with Cootes Paradise/ Hamilton Harbour and Lynde Creek eggs on Lake Ontario containing the highest concentrations and most PCDD and PCDF congeners among all sites. Eggs from Cranberry Marsh on Lake Ontario contained organochlorine concentrations similar to those from Big Creek Marsh and Rondeau Provincial Park on Lake Erie except PCDDs and PCDFs which occurred at higher concentrations and more congeners were detectable in Cranberry Marsh eggs. Concentrations of most contaminants in turtle eggs from Algonquin Park, the reference site, have significantly decreased in the past decade. Dieldrin concentrations, however, increased in Algonquin Park eggs from 1981 to 1989. Significant decreases in concentrations of hexachlorobenzene, mirex and PCBs occurred between turtle eggs collected in 1981/84 and 1989 at Big Creek Marsh and Rondeau Provincial Park, whereas there was no significant change in concentrations of p,p'-DDE and dieldrin. In Lake Ontario eggs, concentrations of PCBs, p,p'-DDE and dieldrin increased significantly between 1984 and 1991. Differences were also found in patterns of temporal variation in contamination between herring gulls (Larus argentatus) and snapping turtles which were attributed to differences in diet. Elevated and continued contamination in turtle eggs from Lake. Ontario is probably due to a combination of local sources of chemicals and consumption of large migratory fish that spawn in wetlands inhabited by these turtles.

Polychlorinated dibenzo-p-dioxins (PCDDs) and furans (PCDFs) in urban air and deposition in the United Kingdom.

Polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs) have been monitored in air and deposition at four UK urban sites (London, Cardiff, Manchester and Stevenage) since the beginning of 1991; data from the first 2 years are presented here. Median Σ2,3,7,8-substituted PCDD/F concentrations in air were 3.2, 4.0, 3.5 and 2.6 pg/m(3) respectively for London, Cardiff, Manchester and Stevenage. Median Σ2,3,7,8-substituted PCDD/F deposition fluxes were 1.5 ng/m(2)/day in London, 1.4 ng/m(2)/day in Cardiff and Manchester and 0.79 ng/m(2)/day in Stevenage. Seasonal variations in the PCDD/F concentrations were observed at all sites for both air and deposition, with concentrations/fluxes generally elevated during the winter.

Comparative evaluation of detection assays for Chlamydia trachomatis.

The performances of a commercial nucleic acid hybridization test (Gen-Probe Pace 2 Chlamydia trachomatis) and two commercial enzyme immunoassays (EIAs) (Abbott Chlamydiazyme and Pharmacia Chlamydia EIA) were evaluated against cell culture for the detection of C. trachomatis infection, with cervical swabs obtained from 1,037 women visiting a public sexual health center. The positivity rate by cell culture was 4.7%. Sensitivity and specificity for each test were as follows: Gen-Probe, 95.8 and 98.3%; Chlamydiazyme, 80.4 and 99.3%; Pharmacia EIA, 80.8 and 99.1%. Analysis of discrepant results with probe confirmation assay (Gen-Probe) and direct immunofluorescence (Syva Microtrak) revealed 12 cases of C. trachomatis infection for which culture was negative, resulting in the definition of a true-positive case as opposed to a culture positive. The positivity rate by true-positive definition was 5.9%, and sensitivity and specificity for each test were as follows: Gen-Probe, 96.7 and 99.6%; Chlamydiazyme, 77.5 and 100%; Pharmacia EIA, 77.0 and 100%; cell culture, 80.0 and 100%. We conclude that the Gen-Probe Pace 2 C. trachomatis test is a sensitive and specific alternative to cell culture for the detection of C. trachomatis.

Sensory integration and ego development in a schizophrenic adolescent male.

This single case study of a schizophrenic adolescent presents a detailed analysis of gains in ego functions and clinical observations. A time out record was retrospectively compiled. The purpose of the time out record was to evaluate the generalized effects of sensory integrative treatment procedures on the client's ability to deal with anger and frustration in his living environment. Statistical analysis did not yield a significant difference between pre- and posttreatment data. The results of this study demonstrate the usefulness of statistical analysis verses visual comparison of pre- and post-treatment data in the validation of treatment effectiveness. Visual inspection might support a conclusion of a significant difference, when statistic analysis will not. Although marked decreases were noted in the client's time out record as he mastered hypersensitivity to movement, dcvelopment of protective extension, and gravitational security, no direct statistical link could be made to the sensory integration treatment intervention. This case study does however, lay a foundation for relating ego development to vestibular system function.