Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population.

BACKGROUND AND PURPOSE: Brain stimulation is an adjuvant strategy to promote rehabilitation after stroke. Here, we evaluated the influence of inclusion/exclusion criteria on enrollment in a transcranial direct current stimulation (tDCS) trial in the context of a racially/ethnically diverse acute stroke service at University of Texas Southwestern (UTSW). METHODS: 3124 (59.7 ± 14.5 years) racially/ethnically diverse (38.4% non-Hispanic white, (W), Hispanic (H) 22%, African American (AA) 33.5%, Asian (A) 2.3%) patients were screened in the acute stroke service at UTSW. Demographics, stroke characteristics, and reasons for exclusion were recorded prospectively. RESULTS: 2327 (74.5%) patients had a verified stroke. Only 44 of them (1.9%) were eligible. Causes for exclusion included in order of importance: (1) magnitude of upper extremity (UE) motor impairment, (2) prior strokes (s), (3) hemorrhagic stroke, (4) psychiatric condition or inability to follow instructions, and (5) old age, of these (2) and (4) were more common in AA patients but not in other minorities. 31 of the 44 eligible individuals were enrolled (W 1.68%, H 1.37%, AA .77%, A 3.774%). 90.5% of verified stroke patients did not exhibit contraindications for stimulation. CONCLUSIONS: 3 main conclusions emerged: (a) The main limitations for inclusion in brain stimulation trials of motor recovery were magnitude of UE motor impairments and stroke lesion characteristics, (b) most stroke patients could be stimulated with tDCS without safety concerns and (c) carefully tailored inclusion criteria could increase diversity in enrollment.Clinical Trial Registration-URL: http://clinicaltrials.gov. Unique identifier: NCT01007136.

Long-term risk of hysterectomy and ectopic pregnancy among Vietnamese women using the quinacrine hydrochloride pellet system vs. intrauterine devices or tubal ligation for contraception.

OBJECTIVES: Determine the long-term risk of hysterectomy and ectopic pregnancy in women using the quinacrine hydrochloride pellet system of permanent contraception (QS) relative to the comparable risk in women using Copper T intrauterine device (IUD) or tubal ligation surgery (TL) for long-term or permanent contraception. METHODS: This was a retrospective cohort study, conducted in the Northern Vietnamese provinces of Ha Nam, Nam Dinh, Ninh Binh and Thai Binh. Women who had their first QS procedure, last IUD insertion or TL between 1989 and 1996 were interviewed regarding post-procedure health outcomes approximately 16 years post exposure. RESULTS: A 95% response rate resulted in 21,040 completed interviews. Overall incidence rates were low for both outcomes (91/100,000 women years of follow-up and 22/100,000 women years of follow-up for hysterectomy and ectopic pregnancy, respectively). After accounting for variations in baseline characteristics between women choosing QS vs. the other two contraceptive methods, no significant excess hazard of either hysterectomy or ectopic pregnancy was associated with QS. CONCLUSIONS: No significant excess long-term risk of hysterectomy or ectopic pregnancy was found among a large group of women using QS vs. IUD or TL for contraception after an average 16 years of follow-up.

Long-term risk of reproductive cancer among Vietnamese women using the quinacrine hydrochloride pellet system vs. intrauterine devices or tubal ligation for contraception.

OBJECTIVES: To determine the long-term risk of reproductive tract cancer in women using the quinacrine hydrochloride pellet system of permanent contraception (QS) relative to the comparable risk in women using Copper T intrauterine device (IUD) or tubal ligation surgery (TL) for long-term or permanent contraception. METHODS: This was a retrospective cohort study, conducted in the Northern Vietnamese provinces of Ha Nam, Nam Dinh, Ninh Binh and Thai Binh. Women who had their first QS procedure, last IUD insertion or TL between 1989 and 1996 were interviewed regarding post-procedure health outcomes, particularly reproductive tract cancers. RESULTS: A 95% response rate resulted in 21,040 completed interviews. Reproductive cancer incidence rates were very low (5.77/100,000 women years of follow-up time; 95%CI = 3.72-8.94). No significant excess hazard of reproductive tract cancer was associated with QS. CONCLUSIONS: No significant excess long-term risk of reproductive tract cancer was found after an average 16 years of follow-up among a large group of women using QS vs. IUD/TL for contraception.

Neonatal complications in vacuum-assisted vaginal delivery: are they associated with number of pulls, cup detachments, and duration of vacuum application?

PURPOSE: To explore whether the characteristics of vacuum delivery are associated with the occurrence of head injury and neonatal complications. METHODS: Retrospectively cohort study of vacuum-assisted attempted vaginal deliveries of singletons. We studied the association of total duration of vacuum application and number of pulls and cup dislodgement with (1) primary outcome: the occurrence of major (subgaleal hemorrhage, skull fracture, and intracranial hemorrhage) or minor (cephalohematoma, scalp laceration more extensive than simple abrasions) neonatal head injuries and (2) secondary outcome: the occurrence of neonatal complications, including 5-min Apgar score <7, umbilical artery pH < 7.10, shoulder dystocia, or need for neonatal intensive care unit admission. Logistic regression analysis was used to control for confounders. RESULTS: Vacuum-assisted delivery was attempted in 555 women. It was successful in 515 cases, and it failed in 40 (7.2 %). Head injury occurred in 32 (6.2 %) of vaginally delivered neonates, and it was related to duration of vacuum application (P = 0.004) and birth weight (P = 0.048). However, the associations lost a statistical significance at the multivariate analysis. Neonatal complications occurred in 25 cases (5 %), and they were associated with meconium-stained amniotic fluid (P < 0.001) and duration of vacuum application (P = 0.03) at the multivariate analysis. However, most of the complications were actually associated with the need for vacuum delivery rather than the procedure itself. CONCLUSION: Neonatal head injury after vacuum application is not independently related to total duration of vacuum application, number of pulls, or cup dislodgements.

Effect of oxytocin during labor on neonatal acidemia.

OBJECTIVE: To assess the factors affecting neonatal acidemia, including occurrence of tachysystole/hypertonus in fetuses exposed to oxytocin during labour and with continuously-monitored fetal heart rate (FHR) tracings. METHODS: Prospective observational study of all women with term pregnancies who received oxytocin for induction/augmentation of labour. FHR tracings were prospectively classified using ACOG classification. Independent predictors of neonatal acidemia were identified using multivariate linear regression with p < 0.05 considered significant. RESULTS: We included 430 women, 236 of whom (54.9%) had spontaneous onset of labour. The duration of active phase of the second stage of labour and the presence of abnormal FHR tracing during labour were significantly associated with UA pH (p < 0.001) and BE (p < 0.001), while maximum dose of oxytocin (p < 0.17; p < 0.7) and tachysystole (p < 0.9; p < 0.8) were not. At logistic regression, the duration of active phase of the second stage of labour was independently predictive of neonatal acidemia (p < 0.009) while abnormal FHR tracing approached significance (p < 0.088). CONCLUSIONS: In women receiving oxytocin during labour, the duration of active phase of the second stage of labour correlates with neonatal acidemia, whereas maximum dose of oxytocin, duration of oxytocin administration and occurrence of tachysystole during labour do not.

The Renin-Angiotensin and Renal Dopaminergic Systems Interact in Normotensive Humans.

The renin-angiotensin-aldosterone (RAAS) and renal dopaminergic systems interact to maintain sodium balance. High NaCl intake increases renal synthesis of dopamine and dopaminergic receptor activity, decreasing epithelial sodium transport, whereas sodium deficit activates the RAAS, increasing epithelial sodium transport. We tested the hypothesis that attenuation of the natriuretic effect of dopamine D1-like receptors during salt restriction results in part from increased RAAS activity in seven salt-resistant normotensive adults using a double-blind placebo-controlled balanced crossover design. All subjects attained sodium balance on low (50 mmol Na(+)/day) and high (300 mmol Na(+)/day) NaCl diets, administered 4 weeks apart. Sodium, potassium, lithium, para-aminohippurate, and creatinine clearances were measured before, during, and after a 3-hour infusion of fenoldopam, a D1-like receptor agonist, with and without pretreatment with enalapril, an angiotensin converting enzyme inhibitor. On the high NaCl diet, fenoldopam-induced natriuresis was associated with the inhibition of renal proximal and distal tubule sodium transport. On the low NaCl diet, fenoldopam decreased renal distal tubule sodium transport but did not cause natriuresis. The addition of enalapril to fenoldopam restored the natriuretic effect of fenoldopam and its inhibitory effect on proximal tubule sodium transport. Thus, on a high NaCl diet fenoldopam causes natriuresis by inhibiting renal proximal and distal tubule transport, but on a low NaCl diet the increased RAAS activity prevents the D1-like receptor from inhibiting renal proximal tubule sodium transport, neutralizing the natriuretic effect of fenoldopam. These results demonstrate an interaction between the renin-angiotensin and renal dopaminergic systems in humans and highlight the influence of dietary NaCl on these interactions.

Can the unenhanced phase be eliminated from dual-phase CT angiography for chest pain? Implications for diagnostic accuracy in acute aortic intramural hematoma.

OBJECTIVE: The purposes of this study were to retrospectively assess the frequency of acute aortic intramural hematoma and evaluate whether the elimination of the unenhanced imaging acquisition series from the dual-phase MDCT angiography (CTA) protocol for chest pain might affect diagnostic accuracy in detecting intramural hematoma and justify the reduced radiation dose. MATERIALS AND METHODS: From October 2006 to November 2012, 306 patients (mean age, 65.0 years) with acute chest pain underwent emergency CTA with a 64-MDCT scanner. Two experienced cardiovascular radiologists, blinded to the diagnosis, assessed the images in two different sessions in which enhanced (single-phase CTA) and combined unenhanced and contrast-enhanced (dual-phase CTA) findings were evaluated. Sensitivity, specificity, and accuracy along with 95% CIs were calculated. Surgical and pathologic diagnoses, including findings at clinical follow-up and any subsequent imaging modality, were used as reference standards. RESULTS: Thirty-six patients were suspected of having intramural hematoma; 16 patients underwent both surgery and transesophageal echocardiography (TEE), and the remaining 20 underwent TEE. Single-phase CTA showed a higher number of false-negative and false-positive results than dual-phase CTA. With intramural hematoma frequency of 12% (95% CI, 8.38-15.91%), sensitivity, specificity, and accuracy were 94.4% (81.3-99.3%), 99.3% (97.4-99.9%), and 98.7% (96.7-99.6%) for combined dual-phase CTA and 68.4% (51.4-82.5%), 96.3% (93.2-98.2%), and 92.8% (89.3-95.4%) for single-phase CTA. Dual-phase was significantly better than single-phase CTA with respect to sensitivity (p=0.002), specificity (p=0.008), overall accuracy (p<0.001), and interrater agreement (p=0.001). CONCLUSION: The frequency of acute aortic intramural hematoma is similar to that previously reported. The acquisition of unenhanced images during the chest pain dual-phase CTA protocol significantly improves diagnostic accuracy over single-phase CTA.

Defining risk groups to yellow fever vaccine-associated viscerotropic disease in the absence of denominator data.

Several risk groups are known for the rare but serious, frequently fatal, viscerotropic reactions following live yellow fever virus vaccine (YEL-AVD). Establishing additional risk groups is hampered by ignorance of the numbers of vaccinees in factor-specific risk groups thus preventing their use as denominators in odds ratios (ORs). Here, we use an equation to calculate ORs using the prevalence of the factor-specific risk group in the population who remain well. The 95% confidence limits and P values can also be calculated. Moreover, if the estimate of the prevalence is imprecise, discrimination analysis can indicate the prevalence at which the confidence interval results in an OR of ∼1 revealing if the prevalence might be higher without yielding a non-significant result. These methods confirm some potential risk groups for YEL-AVD and cast doubt on another. They should prove useful in situations in which factor-specific risk group denominator data are not available.

Fetal hydronephrosis: natural history and risk factors for postnatal surgery.

BACKGROUND: The objective of this study was to assess the ability of prenatal ultrasound to predict an unfavorable outcome and the need for postnatal surgery in cases of fetal hydronephrosis (HY). METHODS: Antenatal HY was classified according to the renal pelvis anteroposterior (AP) diameter in the third trimester. Postnatal outcome was considered favorable in the presence of spontaneous resolution or postnatal diagnosis of HY <20 mm, and unfavorable in the presence of postnatal diagnosis of >20 mm HY or urinary tract pathologies. RESULTS: Prenatal diagnosis of HY was made in 120 fetuses (for a total of 161 abnormal renal units). The rates of postnatal urinary tract pathology were 14, 27 and 53% for antenatal HY of ≤7, 8-15 and >15 mm, respectively. An AP diameter ≥7 mm in the third trimester had a sensitivity of 100% and a specificity of 23% to predict unfavorable outcome. A formula inclusive of AP diameter and presence or absence of urinary tract anomalies can predict the need for postnatal surgery. CONCLUSIONS: The majority of infants with congenital HY have a favorable postnatal outcome. Risk of unfavorable outcome increases with the degree of dilatation of the renal pelvis and the presence of urinary tract anomalies. An AP diameter ≥7 mm in the third trimester warrants postnatal follow-up.

Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients.

OBJECTIVE: To extend the applicability of the Wolf Motor Function Test (WMFT) to describe the residual functional abilities of moderate to severely affected stroke patients. DESIGN: Data were collected as part of 2 double-blind, sham-controlled, randomized interventional studies: the Transcranial Direct Current Stimulation (tDCS) in Chronic Stroke Recovery and the tDCS Enhanced Stroke Recovery and Cortical Reorganization. Stroke patients were evaluated with the upper extremity Fugl-Meyer (UFM) and the WMFT in the same setting before treatment. SETTING: University inpatient rehabilitation and outpatient clinic. PARTICIPANTS: Stroke patients (N=32) with moderate to severe hemiparesis enrolled in the tDCS in Chronic Stroke Recovery and the tDCS Enhanced Stroke Recovery and Cortical Reorganization studies. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: WMFT scores were calculated using (1) median performance times and (2) a new calculation using the mean rate of performance. We compared the distribution of values from the 2 methods and examined the WMFT-UFM correlation for the traditional and the new calculation. RESULTS: WMFT rate values were more evenly distributed across their range than median WMFT time scores. The association between the WMFT rate and UFM was as good as the association between the median WMFT time scores and UFM (Spearman ρ, .84 vs -.79). CONCLUSIONS: The new WMFT mean rate of performance is valid and a more sensitive measure in describing the functional activities of the moderate to severely affected upper extremity of stroke subjects and avoids the pitfalls of the median WMFT time calculations.

A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder.

This is a preliminary report on the safety and efficacy of 1.5 ATA hyperbaric oxygen therapy (HBOT) in military subjects with chronic blast-induced mild to moderate traumatic brain injury (TBI)/post-concussion syndrome (PCS) and post-traumatic stress disorder (PTSD). Sixteen military subjects received 40 1.5 ATA/60 min HBOT sessions in 30 days. Symptoms, physical and neurological exams, SPECT brain imaging, and neuropsychological and psychological testing were completed before and within 1 week after treatment. Subjects experienced reversible middle ear barotrauma (5), transient deterioration in symptoms (4), and reversible bronchospasm (1); one subject withdrew. Post-treatment testing demonstrated significant improvement in: symptoms, neurological exam, full-scale IQ (+14.8 points; p<0.001), WMS IV Delayed Memory (p=0.026), WMS-IV Working Memory (p=0.003), Stroop Test (p<0.001), TOVA Impulsivity (p=0.041), TOVA Variability (p=0.045), Grooved Pegboard (p=0.028), PCS symptoms (Rivermead PCSQ: p=0.0002), PTSD symptoms (PCL-M: p<0.001), depression (PHQ-9: p<0.001), anxiety (GAD-7: p=0.007), quality of life (MPQoL: p=0.003), and self-report of percent of normal (p<0.001), SPECT coefficient of variation in all white matter and some gray matter ROIs after the first HBOT, and in half of white matter ROIs after 40 HBOT sessions, and SPECT statistical parametric mapping analysis (diffuse improvements in regional cerebral blood flow after 1 and 40 HBOT sessions). Forty 1.5 ATA HBOT sessions in 1 month was safe in a military cohort with chronic blast-induced PCS and PTSD. Significant improvements occurred in symptoms, abnormal physical exam findings, cognitive testing, and quality-of-life measurements, with concomitant significant improvements in SPECT.

Ghrelin agonist TZP-101/ulimorelin accelerates gastrointestinal recovery independently of opioid use and surgery type: covariate analysis of phase 2 data.

BACKGROUND: Delayed recovery of gastrointestinal (GI) motility is a common complication following surgery. TZP-101/ulimorelin is a macrocyclic peptidomimetic ghrelin receptor agonist with GI promotility effects that significantly accelerates time to recovery of GI motility compared to placebo following partial colectomy. It is also well tolerated. The objectives of this analysis were to identify predictors of GI motility recovery in patients undergoing partial colectomy and to evaluate whether these factors affect ulimorelin acceleration of GI recovery. METHODS: Covariate analysis assessed the effect of eight variables-age, sex, body mass index, type of surgery (right colectomy, left colectomy, other), duration of surgery, blood loss, total opioid consumption, country-on recovery of GI motility in 236 patients randomized to ulimorelin (n = 168) or placebo (n = 68). The primary endpoint was the recovery of GI function (time from the end of surgery to first bowel movement). Stepwise regression identified a parsimonious model of the smallest subset of variables best predicting GI recovery. RESULTS: Recovery was shorter for segmental/subtotal colectomies vs. right colectomies (P = 0.016) and longer with increased total opioid use (P = 0.037). The remaining variables had no statistically significant effect on GI recovery. Effects of ulimorelin 480 µg/kg (the most effective dose) on time to GI tract recovery remained statistically and clinically significant (hazard ratio = 1.81, P = 0.014) when adjusted for surgery type and/or total opioid use. CONCLUSIONS: Two factors, type of surgery and total opioid use, independently modified times to recovery of GI motility following partial large bowel resection surgery. Acceleration of recovery of GI motility by ulimorelin was independent of these factors.

Variability in rate of cervical dilation in nulliparous women at term.

BACKGROUND: Cervical dilatation is commonly documented on a partogram indicating the expected rate of progress of labor. Although deviations from such a line can be used to indicate abnormal progress, what constitutes the "normal" rate of cervical dilation is still largely unknown. The objectives of this study were to assess the variability of the rate of cervical dilation in nulliparous women and to determine whether the rate of labor was independent of dilation on admission. METHODS: We analyzed a cohort of consecutive nulliparous women with spontaneous labor at term and singleton fetuses in cephalic presentation. Exclusion criteria were gestational age less than 37 weeks, induction of labor, or the presence of a uterine scar. Management of labor was standardized using set protocols of care. Active labor was diagnosed as regular contractions every 10 minutes or less, lasting more than 40 seconds, with cervical effacement more than 80 percent and dilation of 2 cm. Vaginal examinations were performed by a dedicated midwife every 2 hours. Amniotomy was performed for slow progress or arrest of dilation over 2 hours. Oxytocin was administered for arrest of cervical dilation for 2 hours with membranes ruptured. Data pertaining to cases ending in cesarean delivery were included up to the time of cesarean section. RESULTS: The study sample comprised 1,119 women at 39.7 ± 1.1 weeks with an average duration of labor of 4.1 ± 2.4 hours. The rate of oxytocin use was 27 percent and of epidural analgesia 5 percent. The rate of oxytocin use was inversely related to cervical dilation on admission. Cesarean delivery was performed in 6 percent of women. Duration of labor at each centimeter of cervical dilation on admission showed a broad distribution (e.g., at 4 cm: median = 5.5, range: 0.8-12.5 hr). The rate of labor progression (expressed as the slope of the dilation-vs-time curve) was approximately 1.5 cm/hr, and it was essentially independent of cervical dilation on admission (r = 0.034, p = 0.267). A deceleration phase seemed to be present toward the end of the active phase of labor (approximately 9 cm). CONCLUSION: In our setting, the rate of labor in nulliparous women at term was highly variable, and it did not appear to be affected by cervical dilation on admission.

Hospital length of stay--does 1% TBSA really equal 1 day?

Length of stay (LOS) continues to be a standard variable when evaluating progress and outcomes in burn care. Common wisdom would dictate that this measure is linearly related to TBSA. Is this truly the case? A retrospective review of the National Burn Repository was conducted to evaluate factors that affect hospital LOS. The National Burn Repository data set was obtained from the American Burn Association. Data from the years 2002-2007 were extracted. Unique patients were identified by removing readmissions, outpatients, and patients not admitted. Patients whose "HOSPLOS" and/or "AREATOT" field was blank or 0 were excluded, as were nonthermally injured patients. Patients without an entry for age and dead patients were also excluded. This left a final data set of 52,712 patients for analysis. The data were then analyzed, with %TBSA burned as the independent variable. In patients who survived their entire LOS, the mean LOS increased linearly by decile. Females with a TBSA <40% have a trend toward increased LOS relative to their male counterparts of the same TBSA; however, this trend reverses for TBSA ≥40%. Age alone is not a significant predictor of increasing LOS. The cause of burns was predominantly flame related across all deciles of TBSA, and most etiologies for burn demonstrate the predicted increase in LOS per %TBSA. LOS was not significantly affected by insurance type or whether the injury was work related or not. This analysis was confounded by the small numbers of patients with burns >60% and age older than 70 years. Anticipating hospital LOS is not a simple task. Using complex statistical analysis, a linear trend associated with %TBSA can be seen; however, other variables do contribute. Until the precise role of these variables can be elucidated, anticipating patient LOS to be 1 day for every %TBSA is still a useful exercise.

Diet as prophylaxis and treatment for venous thromboembolism?

BACKGROUND: Both prophylaxis and treatment of venous thromboembolism (VTE: deep venous thrombosis (DVT) and pulmonary emboli (PE)) with anticoagulants are associated with significant risks of major and fatal hemorrhage. Anticoagulation treatment of VTE has been the standard of care in the USA since before 1962 when the U.S. Food and Drug Administration began requiring randomized controlled clinical trials (RCTs) showing efficacy, so efficacy trials were never required for FDA approval. In clinical trials of 'high VTE risk' surgical patients before the 1980s, anticoagulant prophylaxis was clearly beneficial (fatal pulmonary emboli (FPE) without anticoagulants = 0.99%, FPE with anticoagulants = 0.31%). However, observational studies and RCTs of 'high VTE risk' surgical patients from the 1980s until 2010 show that FPE deaths without anticoagulants are about one-fourth the rate that occurs during prophylaxis with anticoagulants (FPE without anticoagulants = 0.023%, FPE while receiving anticoagulant prophylaxis = 0.10%). Additionally, an FPE rate of about 0.012% (35/28,400) in patients receiving prophylactic anticoagulants can be attributed to 'rebound hypercoagulation' in the two months after stopping anticoagulants. Alternatives to anticoagulant prophylaxis should be explored. METHODS AND FINDINGS: The literature concerning dietary influences on VTE incidence was reviewed. Hypotheses concerning the etiology of VTE were critiqued in relationship to the rationale for dietary versus anticoagulant approaches to prophylaxis and treatment.Epidemiological evidence suggests that a diet with ample fruits and vegetables and little meat may substantially reduce the risk of VTE; vegetarian, vegan, or Mediterranean diets favorably affect serum markers of hemostasis and inflammation. The valve cusp hypoxia hypothesis of DVT/VTE etiology is consistent with the development of VTE being affected directly or indirectly by diet. However, it is less consistent with the rationale of using anticoagulants as VTE prophylaxis. For both prophylaxis and treatment of VTE, we propose RCTs comparing standard anticoagulation with low VTE risk diets, and we discuss the statistical considerations for an example of such a trial. CONCLUSIONS: Because of (a) the risks of biochemical anticoagulation as anti-VTE prophylaxis or treatment, (b) the lack of placebo-controlled efficacy data supporting anticoagulant treatment of VTE, (c) dramatically reduced hospital-acquired FPE incidence in surgical patients without anticoagulant prophylaxis from 1980 - 2010 relative to the 1960s and 1970s, and (d) evidence that VTE incidence and outcomes may be influenced by diet, randomized controlled non-inferiority clinical trials are proposed to compare standard anticoagulant treatment with potentially low VTE risk diets. We call upon the U. S. National Institutes of Health and the U.K. National Institute for Health and Clinical Excellence to design and fund those trials.

Prevalence of pediatric dyslipidemia: comparison of a population-based claims database to national surveys.

OBJECTIVE: To determine the prevalence of pediatric dyslipidemia in a large US medical insurance claims database and to compare the resulting estimate to the prevalence from the National Health and Nutrition Examination Survey (NHANES). PATIENTS AND METHODS: Children 10-18 years old who had laboratory-defined dyslipidemia were identified from the Integrated Healthcare Information Services (IHCIS) database 2003-2006. For comparison purposes, the corresponding prevalence among the US children of same age was estimated from the NHANES 1999-2004 data. RESULTS: Among the 273 064 children with at least one laboratory lipid value in the IHCIS database, 22.9% (n = 62 451) had laboratory-defined dyslipidemia. This prevalence was the same as the NHANES estimate (23.9%, 95%CI: 21.6-26.3). Elevated triglyceride (TG) was the most common type of dyslipidemia, detected among 13.2% of the IHCIS children and 14.2% of the US children, followed by elevated total cholesterol (TC), 7.7 and 9.6%, respectively. Among IHCIS dyslipidemic children, older teenage boys had higher rates than younger boys for high-density lipoprotein cholesterol (HDL-C) abnormality, but lower rates for elevated TC and low-density lipoprotein cholesterol (LDL-C). These age-related trends were also seen among NHANES dyslipidemic children. CONCLUSIONS: Analyses of a population-based claims database revealed the same prevalence of pediatric dyslipidemia as that among the US children assessed in the NHANES data. Among dyslipidemic children in the claims database, the occurrence of specific dyslipidemias appeared to vary by age and gender, a trend that was also seen among the dyslipidemic children in the US.

Epidemiology of bloodstream infections in burn-injured patients: a review of the national burn repository.

Bloodstream infections (BSIs) are a major cause of morbidity and mortality in thermally injured patients. However, these infections have not been well defined in this patient population. Therefore, the authors performed a retrospective case-control study to characterize the epidemiology, microbiology, and outcomes of burn-associated BSIs. A retrospective review of all patients in the National Burn Repository (NBR) between the years 1981 and 2007 was performed. All cases that had infection listed under complications were included in this study. For each case, two randomly selected patients from the same time period served as controls. Patient demographic data, extent of %TBSA, and type of infection were extracted. Primary end point was mortality. Secondary endpoints were hospital length of stay (LOS), intensive care unit LOS, total ventilator days, and hospital charges. Further analysis of the data involved case-matching patients by TBSA deciles, adjustment for the effects of TBSA and other potential confounders, and a sensitivity analysis of the effects of including or excluding sites that might have failed to consistently capture BSI information. A total of 11,793 patients (3931 cases and 7862 control) were included in the study. Of cultures revealing a Gram-positive organism, Staphylococcus aureus (32%) was the most common. From samples where isolation of a Gram-negative species occurred, Pseudomonas aeruginosa (35%) was more prominent. Infected patients were older (40.9 vs 32.8, P < .05) and had higher %TBSA (22.2 vs 7.9, P < .05). BSI was associated with significantly higher mortality (21.9% vs 3.09%), hospital LOS (47.4 vs 8.8 days) intensive care unit LOS (30.8 vs 2.6 days), ventilator days (29.2 vs 1.4 days), and hospital charge ($339,909.91 vs $33,272.43); P < .001 for all values. On evaluation of case-matched controls, mortality was higher for patients with BSI only <50% TBSA strata. Conclusions were unaffected by adjustment for TBSA and other possible confounders and was not influenced by possible failure of some sites to consistently capture BSI information. Development of BSI in hospitalized burn patients is associated with significant increases in morbidity, mortality, and resource utilization.

The Ghrelin agonist TZP-101 for management of postoperative ileus after partial colectomy: a randomized, dose-ranging, placebo-controlled clinical trial.

PURPOSE: Ghrelin agonist TZP-101 is a potent prokinetic. This phase 2b study evaluated TZP-101 safety and efficacy in postoperative ileus management. METHODS: Adults undergoing open partial colectomy were adaptively randomized to receive 20, 40, 80, 160, 320, 480 or 600 microg/kg TZP-101 (n = 168) or the placebo (n = 68) by 30-minute IV infusion within 1 hour of surgical closure and then daily for up to 7 days. The primary efficacy end point was the time to first bowel movement. Secondary end points included the percentage of patients with return of gastrointestinal function within 72 hours, and the time to readiness for discharge. RESULTS: TZP-101 accelerated the time to first bowel movement in all groups, with Cox proportional hazard ratios of 1.57 (P = .056) for the low-efficacious dose (80 microg/kg) and 1.67 (P = .03) for the most efficacious dose (480 microg/kg). Using Kaplan-Meier analysis, the median time to first bowel movement was reduced in all TZP-101 groups by 10 to 22 hours vs. the placebo. A greater number of patients who received TZP-101 achieved recovery (P

A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms.

BACKGROUND: This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. METHODS: Sixty-one adults were enrolled (age 36.5 +/- 12.6 years; height 165.1 +/- 9.2 cm; weight 75.4 +/- 17.3 kg) and randomized to either Digestive Advantage Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. RESULTS: Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. CONCLUSION: In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00881322.