Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design.

Ablative doses of stereotactic body radiotherapy (SBRT) may improve pancreatic cancer outcomes but may carry greater potential for gastrointestinal toxicity. Rucosopasem, an investigational selective dismutase mimetic that converts superoxide to hydrogen peroxide, can potentially increase tumor control of SBRT without compromising safety. GRECO-2 is a phase II, multicenter, randomized, double-blind, placebo-controlled trial of rucosopasem in combination with SBRT in locally advanced or borderline resectable pancreatic cancer. Patients will be randomized to rucosopasem 100 mg or placebo via intravenous infusion over 15 min, before each SBRT fraction (5 × 10 Gy). The primary end point is overall survival. Secondary end points include progression-free survival, locoregional control, time to metastasis, surgical resection rate, best overall response, in-field local response and acute and long-term toxicity.

The use of high doses of radiation delivered directly to tumors (stereotactic body radiation therapy [SBRT]) may improve survival compared with lower doses of radiation in patients with pancreatic cancer, but it may increase side effects. Rucosopasem, an investigational new drug being developed, can potentially improve the ability of SBRT to treat tumors without decreasing safety. In a previous study, median overall survival was improved when patients were treated with SBRT plus avasopasem, a drug that works the same way as rucosopasem. GRECO-2 is a clinical trial of rucosopasem used in combination with SBRT for treatment of localized pancreatic cancer. Patients will be randomly selected to receive either rucosopasem 100 mg or placebo via intravenous infusion over 15 min, before each SBRT treatment. The main result being studied is overall survival. Additional results include amount of time before tumors start to grow, how often patients get tumors surgically removed, best overall response and long-term safety. Clinical Trial Registration: NCT04698915 (ClinicalTrials.gov).

Evaluating hop extract concentrations found in commercial beer to inhibit Streptococcus mutans biofilm formation.

AIMS: The purpose of this study was to compare the effect of hop extracts with diverse ß-acid concentrations on Streptococcus mutans biofilm formation. METHODS AND RESULTS: Ten different hop extracts, with α-acid concentrations similar to those found in commercial beer products and ß-acid concentrations ranging from 2.6 to 8.1%, were added to distilled water to make standardized concentrations. S. mutans isolates were treated with hop extract dilutions varying from 1:2 to 1:256. The minimum inhibitory, minimum bactericidal and minimum biofilm inhibitory concentrations were determined and the optical density was evaluated. Live/dead staining confirmed the bactericidal effects. Biofilm formation of several strains of S. mutans was significantly inhibited by hop extract dilutions of 1:2, 1:4, 1:8, 1:16 and 1:32. Strong negative correlations were observed between α- and ß-acid concentrations of the hop extracts and S. mutans total growth and biofilm formation. CONCLUSIONS: The use of hop extracts prepared similarly to commercial beer decreased S. mutans biofilm formation. SIGNIFICANCE AND IMPACT OF THE STUDY: The inclusion of hops in the commercial beer products may provide beneficial health effects. Further studies are warranted to determine an effect in vivo on the development of dental caries.

A multicenter performance evaluation of the new Elecsys Vitamin D total III assay versus reference isotope dilution liquid chromatography tandem mass spectrometry and commercially available comparators.

BACKGROUND: Vitamin D deficiency/insufficiency and toxicity are worldwide issues; thus, accurate diagnostic assays are required to measure vitamin D. We evaluated the performance of the new Elecsys® Vitamin D total III assay (Roche Diagnostics International Ltd). METHODS: Repeatability and intermediate precision of the Elecsys Vitamin D total III assay (cobas e 601 analyzer) were evaluated at three sites using five human serum pools (HSPs) and two PreciControls (five-day model, one reagent lot [CLSI-EP05-A3]) and compared against prespecified acceptance criteria. A serum verification panel, with reference isotope dilution liquid chromatography tandem mass spectrometry (ID-LC-MS/MS) values, was used for comparator assay/concordance studies at two sites, assessed using unweighted Deming regression. Testing of serum vs. plasma on the Elecsys assay was conducted at one site using samples from healthy adults; assessed using Passing-Bablok regression. RESULTS: Repeatability (HSP1 [16.8-18.4 ng/ml], SD 0.87-1.07; HSP5 [94.5-98.0 ng/ml], CV 1.58%-2.76%) and intermediate precision (HSP1, SD 1.14-1.77; HSP5, CV 2.00%-4.13%) met acceptance criteria across sites. Agreement was observed between the Elecsys assay and (i) the ID-LC-MS/MS verification panel (slope, 0.936-1.01; Pearson's r, 0.960-0.986) and (ii) comparator assays (slope, 0.921-1.15; Pearson's r, 0.958-0.982). The Elecsys assay correctly assigned the highest combined percentage of samples to deficient (100%) and insufficient (89.5%) vitamin D categories vs. comparator assays and demonstrated comparable performance in serum and plasma (y = 0.103 + 0.984x). CONCLUSIONS: The Elecsys Vitamin D total III assay demonstrated good analytical performance and compared favorably with other assays, supporting its use in clinical practice.

Anomalous Origin of the Left Coronary Artery From the Pulmonary Artery: A Retrospective Multicenter Study.

OBJECTIVES: We aimed to describe characteristics and operative outcomes from a multicenter cohort of infants who underwent repair of anomalous left coronary artery from the pulmonary artery. We also aimed to identify factors associated with major adverse cardiovascular events following anomalous left coronary artery from the pulmonary artery repair. DESIGN: Retrospective chart review. SETTING: Twenty-one tertiary-care referral centers. PATIENTS: Infants less than 365 days old who underwent anomalous left coronary artery from the pulmonary artery repair. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Major adverse cardiovascular events were defined as the occurrence of postoperative extracorporeal membrane oxygenation, cardiopulmonary resuscitation, left ventricular assist device, heart transplantation, or operative mortality. Factors independently associated with major adverse cardiovascular events were identified using multivariable logistic regression analysis. We reviewed 177 infants (< 365 d old) who underwent anomalous left coronary artery from the pulmonary artery repair between January 2009 and March 2018. Major adverse cardiovascular events occurred in 36 patients (20%). Twenty-nine patients (16%) received extracorporeal membrane oxygenation, 14 (8%) received cardiopulmonary resuscitation, four (2%) underwent left ventricular assist device placement, two (1%) underwent heart transplantation, and six (3.4%) suffered operative mortality. In multivariable analysis, preoperative inotropic support (odds ratio, 3.5; 95% CI, 1.4-8.5), cardiopulmonary bypass duration greater than 150 minutes (odds ratio, 6.9 min; 95% CI, 2.9-16.7 min), and preoperative creatinine greater than 0.3 mg/dL (odds ratio, 2.4 mg/dL; 95% CI, 1.1-5.6 mg/dL) were independently associated with major adverse cardiovascular events. In patients with preoperative left ventricular end-diastolic diameter measurements available (n = 116), left ventricular end-diastolic diameter z score greater than 6 was also independently associated with major adverse cardiovascular events (odds ratio, 7.6; 95% CI, 2.0-28.6). CONCLUSIONS: In this contemporary multicenter analysis, one in five children who underwent surgical repair of anomalous left coronary artery from the pulmonary artery experienced major adverse cardiovascular events. Preoperative characteristics such as inotropic support, creatinine, and left ventricular end-diastolic diameter z score should be considered when planning for potential postoperative complications.

Higher Monocyte Count is Associated with 30-Day Case Fatality in Intracerebral Hemorrhage.

BACKGROUND: Previous studies have suggested that elevated neutrophils, monocytes, and neutrophil-to-lymphocyte ratio (NLR) may be associated with poor outcomes in intracerebral hemorrhage (ICH). We sought to determine whether white blood cell (WBC) types were independently associated with poor outcome in ICH in a large cohort. METHODS: We performed a retrospective study of primary ICH at two academic centers. Cases were identified via ICD-9 code and verified via physician review. We included only those patients with WBC types obtained within 24 h of ICH onset. RESULTS: We identified 593 patients with primary ICH and WBC differentials in the first 24 h. Independent factors (OR, 95% CI) associated with 30-day case fatality were age > 80 (2.4 (1.4, 4.2)), p = 0.0023; NIHSS greater than median (3.9 (2.4, 6.3)), p < 0.0001; ICH volume quartiles (Q1: ref, Q2: 1.5 (0.7, 3.0), Q3: 3.2 (1.6, 6.6), Q4: 11.9 (5.3, 26.4)), p < 0.0001; non-lobar location (3.3 (1.9, 5.9)), p ≤ 0.0001; IVH (2.3 (1.4, 3.6)), p = 0.0005, monocytes greater than median (1.6 (1.0, 2.4)), p = 0.0457, and anticoagulant use (3.2 (1.8, 5.6)), p < 0.0001. Elevated NLR was not associated with higher case fatality. CONCLUSIONS: We found that elevated monocytes were independently associated with 30-day case fatality. Future studies will investigate whether there are subgroups of ICH patients, including those with particular blood or imaging biomarkers, in which WBC types might help predict poor outcome and provide targets for intervention.

Randomized Prospective Study Evaluating Single-Injection Paravertebral Block, Paravertebral Catheter, and Thoracic Epidural Catheter for Postoperative Regional Analgesia After Video-Assisted Thoracoscopic Surgery.

OBJECTIVE: Video-assisted thoracoscopic surgery (VATS) has improved patient outcomes; however, postoperative pain remains potentially severe. The objective of this study was to compare adjunct analgesic modalities for VATS, including paravertebral nerve blockade (PVB) and thoracic epidural anesthesia (TEA). DESIGN: Prospective, randomized trial. SETTING: Large academic hospital, single institution. PARTICIPANTS: Adult patients undergoing VATS. INTERVENTIONS: Ultrasound-guided PVB catheter, ultrasound-guided single-injection PVB, or TEA. MEASUREMENTS AND MAIN RESULTS: Postoperative visual analog scale pain scores (at rest and with knee flexion) and opioid usage were recorded. Pain scores (with movement) for the TEA group were lower than those for either PVB group at 24 hours (p ≤ 0.008) and for the PVB catheter group at 48 hours (p = 0.002). Opioid use in TEA group was lower than that for either PVB group at 24 and 48 hours (p < 0.001) and 72 hours (p < 0.05). Single-injection PVB was faster compared with PVB catheter placement (6 min v 12 min; p < 0.001) but similar to TEA (5 min). Patient satisfaction, nausea, sedation, and 6-month postsurgical pain did not differ between groups. CONCLUSIONS: TEA led to lower pain scores and opioid requirement for VATS procedures compared with PVB techniques. Single-injection PVB was faster and equally as effective as PVB catheter, and it led to similar patient satisfaction as TEA; therefore, it should be considered in patients who are not ideal candidates for TEA.

Interplay between toothbrush stiffness and dentifrice abrasivity on the development of non-carious cervical lesions.

OBJECTIVE: This study investigated the effect of toothbrush stiffness and dentifrice slurry abrasivity on the development and progression of simulated non-carious cervical lesions (NCCLs). MATERIALS AND METHODS: Human maxillary premolars were allocated to 12 groups generated by the association between toothbrushes, soft, medium, and hard stiffness, and simulated dentifrice slurries, lower, medium, and higher; deionized water (DI) served as negative control. Teeth were mounted on acrylic blocks, and their root surfaces partially covered with acrylic resin to simulate gingiva, leaving a 2-mm area apical to the cemento-enamel junction exposed to toothbrushing. Specimens were brushed with the test slurries for 35,000 and 65,000 double strokes. Impressions taken at baseline and after both brushing periods were scanned by a 3D optical profilometer. Dentin volume loss (mm3) was calculated by image subtraction. Data were analyzed using three-way ANOVA and Fisher's PLSD tests. RESULTS: All toothbrushes caused higher volume loss when associated to higher abrasive slurry, compared to medium- and lower-abrasive slurries. Medium caused more volume loss than lower-abrasive slurry, which led to more volume loss than DI. Hard and medium toothbrushes were not different when used with medium- or higher-abrasive slurries. There were no differences among toothbrushes when used with DI and lower-abrasive slurry. Overall, 35,000 brushing strokes resulted in significantly less volume loss than 65,000. CONCLUSIONS: Toothbrush stiffness was an important factor on NCCL development, especially when brushing with medium- and higher-abrasive slurries. CLINICAL RELEVANCE: Medium and hard toothbrushes associated with medium- and high-abrasive toothpastes can yield more severe NCCLs.

Outcomes of pediatric oncology and hematopoietic cell transplant patients receiving extracorporeal membrane oxygenation.

BACKGROUND/OBJECTIVES: There is controversy regarding the utilization of extracorporeal membrane oxygenation in pediatric patients with an underlying oncologic diagnosis or who have undergone hematopoietic cell transplant. We hypothesized that these patients have higher mortality, more bleeding complications, more blood product utilization, and a higher rate of new infections than the general pediatric intensive care unit population supported with extracorporeal membrane oxygenation. DESIGN/METHODS: This is a retrospective chart review at a single center quaternary care pediatric hospital including all pediatric intensive care unit extracorporeal membrane oxygenation patients from 2011 to 2016. Patients were categorized as either oncology/hematopoietic cell transplant or general pediatric intensive care unit. Patients from the cardiovascular intensive care unit or the neonatal intensive care unit were excluded. RESULTS: A total of 38 patients met inclusion criteria of which 7 were oncology/hematopoietic cell transplant patients. The oncology/hematopoietic cell transplant group had lower platelets at the start of extracorporeal membrane oxygenation (p = 0.02) but other pre-extracorporeal membrane oxygenation characteristics were similar. Extracorporeal membrane oxygenation survival was lower in the oncology/hematopoietic cell transplant group (29% vs 77%, p = 0.02). The incidence of bleeding complications and new infections did not differ. The oncology/hematopoietic cell transplant group received more platelets (median of 15.9 mL/kg/day (interquartile range 8.4, 36.6) vs 7.9 mL/kg/day (3.3, 21.9), p = 0.04) and fresh frozen plasma (14.0 mL/kg/day (3, 15.7) vs 1.8 mL/kg/day (0.5, 5.9), p = 0.04). CONCLUSION: Oncology and hematopoietic cell transplant patients had a higher mortality and received more blood products while on extracorporeal membrane oxygenation than the general pediatric intensive care unit patients despite similar pre-extracorporeal membrane oxygenation characteristics. Physicians should use caution when deciding whether or not to utilize extracorporeal membrane oxygenation in this population.

Acute Respiratory Failure in Pediatric Hematopoietic Cell Transplantation: A Multicenter Study.

OBJECTIVES: Acute respiratory failure is common in pediatric hematopoietic cell transplant recipients and has a high mortality. However, respiratory prognostic markers have not been adequately evaluated for this population. Our objectives are to assess respiratory support strategies and indices of oxygenation and ventilation in pediatric allogeneic hematopoietic cell transplant patients receiving invasive mechanical ventilation and investigate how these strategies are associated with mortality. DESIGN: Retrospective, multicenter investigation. SETTING: Twelve U.S. pediatric centers. PATIENTS: Pediatric allogeneic hematopoietic cell transplant recipients with respiratory failure. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Two-hundred twenty-two subjects were identified. PICU mortality was 60.4%. Nonsurvivors had higher peak oxygenation index (38.3 [21.3-57.6] vs 15.0 [7.0-30.7]; p < 0.0001) and oxygen saturation index (24.7 [13.8-38.7] vs 10.3 [4.6-21.6]; p < 0.0001), greater days with FIO2 greater than or equal to 0.6 (2.4 [1.0-8.5] vs 0.8 [0.3-1.6]; p < 0.0001), and more days with oxygenation index greater than 18 (1.4 [0-6.0] vs 0 [0-0.3]; p < 0.0001) and oxygen saturation index greater than 11 (2.0 [0.5-8.8] vs 0 [0-1.0]; p < 0.0001). Nonsurvivors had higher maximum peak inspiratory pressures (36.0 cm H2O [32.0-41.0 cm H2O] vs 30.0 cm H2O [27.0-35.0 cm H2O]; p < 0.0001) and more days with peak inspiratory pressure greater than 31 cm H2O (1.0 d [0-4.0 d] vs 0 d [0-1.0 d]; p < 0.0001). Tidal volume per kilogram was not different between survivors and nonsurvivors. CONCLUSIONS: In this cohort of pediatric hematopoietic cell transplant recipients with respiratory failure in the PICU, impaired oxygenation and use of elevated ventilator pressures were common and associated with increased mortality.

Advancing diabetes management in adolescents: Comparative effectiveness of mobile self-monitoring blood glucose technology and family-centered goal setting.

BACKGROUND: As adolescents gain autonomy, it remains important for parents to be involved with diabetes management to avoid deterioration in glycemic control. Technologies for self-monitoring of blood glucose (SMBG) allow for remote monitoring in real-time by parents. This research compared 3 strategies for improving SMBG and diabetes self-care in the short-term. These strategies were: (1) health information technology (HIT)-enhanced blood glucose meter that shared blood glucose data among patients, their parent, and care providers, and allowed for text messaging; (2) family-centered goal setting; and (3) a combination of (1) and (2). METHODS: One hundred twenty-eight participants enrolled; 97 adolescent-parent pairs attended clinic at 3-month intervals during the 6-month intervention. Differences between treatment groups were evaluated using analysis of variance (ANOVAs) for continuous variables and χ2 tests for frequencies. Within patient changes were evaluated using paired t tests. RESULTS: Participants in the HIT-enhanced SMBG group had no change in mean glycosylated hemoglobin (HbA1c). Participants assigned to family-centered goal setting had a non-significant decrease in HbA1c of -0.3% (P = .26) from baseline to 6 months. Participants in the combined approach had a significant decrease in HbA1c of -0.6% (P = .02) from baseline to 3 months, but the decrease of -0.4% at 6 months was non-significant (P = .51). The change in HbA1c from baseline to 3 months was greater for the combined approach than for the HIT-enhanced SMBG (P = .05) or family-centered goal setting (P = .01). CONCLUSIONS: Our data suggest that utilizing the family-centered goal setting strategy when implementing HIT-enhanced diabetes technology deserves further study.

Modification and Assessment of the Bedside Pediatric Early Warning Score in the Pediatric Allogeneic Hematopoietic Cell Transplant Population.

OBJECTIVES: To determine the validity of the Bedside Pediatric Early Warning Score system in the hematopoietic cell transplant population, and to determine if the addition of weight gain further strengthens the association with need for PICU admission. DESIGN: Retrospective cohort study of pediatric allogeneic hematopoietic cell transplant patients from 2009 to 2016. Daily Pediatric Early Warning Score and weights were collected during hospitalization. Logistic regression was used to identify associations between maximum Pediatric Early Warning Score or Pediatric Early Warning Score plus weight gain and the need for PICU intervention. The primary outcome was need for PICU intervention; secondary outcomes included mortality and intubation. SETTING: A large quaternary free-standing children's hospital. PATIENTS: One-hundred two pediatric allogeneic hematopoietic cell transplant recipients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of the 102 hematopoietic cell transplant patients included in the study, 29 were admitted to the PICU. The median peak Pediatric Early Warning Score was 11 (interquartile range, 8-13) in the PICU admission cohort, compared with 4 (interquartile range, 3-5) in the cohort without a PICU admission (p < 0.0001). Pediatric Early Warning Score greater than or equal to 8 had a sensitivity of 76% and a specificity of 90%. The area under the receiver operating characteristics curve was 0.83. There was a high negative predictive value at this Pediatric Early Warning Score of 90%. When Pediatric Early Warning Score greater than or equal to 8 and weight gain greater than or equal to 7% were compared together, the area under the receiver operating characteristic curve increased to 0.88. CONCLUSIONS: In this study, a Pediatric Early Warning Score greater than or equal to 8 was associated with PICU admission, having a moderately high sensitivity and high specificity. This study adds to literature supporting Pediatric Early Warning Score monitoring for hematopoietic cell transplant patients. Combining weight gain with Pediatric Early Warning Score improved the discriminative ability of the model to predict the need for critical care, suggesting that incorporation of weight gain into Pediatric Early Warning Score may be beneficial for monitoring of hematopoietic cell transplant patients.

Analysis of Patient Characteristics and Risk Factors for Thrombosis After Surgery for Congenital Heart Disease.

OBJECTIVES: Thrombosis is a cause of morbidity in 4-15% of children who undergo pediatric cardiac surgery. Data on how to prevent this complication are sorely needed. We aimed to identify risk factors for thrombosis following pediatric cardiac surgery and determine if use of low molecular weight heparin prophylaxis is associated with a reduction in thrombosis risk. DESIGN: Retrospective cohort study. SETTING: Tertiary pediatric cardiovascular ICU. PATIENTS: Patients who underwent cardiac surgery between June 2014 and December 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Data from patients with venous or arterial thrombosis confirmed by radiologic studies were matched two-to-one to controls based on age, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category, and gender. Thrombosis was detected in 33 patients (6.2%): 25 patients (76%) had venous thromboses, five patients (15%) had arterial thromboses, and three patients (9%) had both. Median time to thrombosis detection was 13 days (25-75%; 7-31 d). On multivariate analysis, which included adjustment for postoperative disease severity, fresh frozen plasma exposure was independently associated with thrombosis (odds ratio, 3.7; 95% CI, 1.4-9.4). Twenty-eight patients (85%) had central venous catheter-related thromboses. Low molecular weight heparin prophylaxis use in this subset of patients was not statistically different from controls (50% vs 45%, respectively; p = 0.47). On multivariable analysis, fresh frozen plasma exposure was also independently associated with central venous catheter-related thrombosis (odds ratio, 3.6; 95% CI, 1.2-10.6). CONCLUSIONS: The occurrence of thrombosis after pediatric cardiac surgery at our institution was 6.2%, similar to what has been reported in other studies, despite frequent use of low molecular weight heparin. Further study is needed to determine the role of low molecular weight heparin for thromboprophylaxis and the relationship between fresh frozen plasma and thrombosis risk in children who undergo cardiac surgery.

Multicenter Validation of the Vasoactive-Ventilation-Renal Score as a Predictor of Prolonged Mechanical Ventilation After Neonatal Cardiac Surgery.

OBJECTIVES: We sought to validate the Vasoactive-Ventilation-Renal score, a novel disease severity index, as a predictor of outcome in a multicenter cohort of neonates who underwent cardiac surgery. DESIGN: Retrospective chart review. SETTING: Seven tertiary-care referral centers. PATIENTS: Neonates defined as age less than or equal to 30 days at the time of cardiac surgery. INTERVENTIONS: Ventilation index, Vasoactive-Inotrope Score, serum lactate, and Vasoactive-Ventilation-Renal score were recorded for three postoperative time points: ICU admission, 6 hours, and 12 hours. Peak values, defined as the highest of the three measurements, were also noted. Vasoactive-Ventilation-Renal was calculated as follows: ventilation index + Vasoactive-Inotrope Score + Δ creatinine (change in creatinine from baseline × 10). Primary outcome was prolonged duration of mechanical ventilation, defined as greater than 96 hours. Receiver operative characteristic curves were generated, and abilities of variables to correctly classify prolonged duration of mechanical ventilation were compared using area under the curve values. Multivariable logistic regression modeling was also performed. MEASUREMENTS AND MAIN RESULTS: We reviewed 275 neonates. Median age at surgery was 7 days (25th-75th percentile, 5-12 d), 86 (31%) had single ventricle anatomy, and 183 (67%) were classified as Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery Mortality Category 4 or 5. Prolonged duration of mechanical ventilation occurred in 89 patients (32%). At each postoperative time point, the area under the curve for prolonged duration of mechanical ventilation was significantly greater for the Vasoactive-Ventilation-Renal score as compared to the ventilation index, Vasoactive-Inotrope Score, and serum lactate, with an area under the curve for peak Vasoactive-Ventilation-Renal score of 0.82 (95% CI, 0.77-0.88). On multivariable analysis, peak Vasoactive-Ventilation-Renal score was independently associated with prolonged duration of mechanical ventilation, odds ratio (per 1 unit increase): 1.08 (95% CI, 1.04-1.12). CONCLUSIONS: In this multicenter cohort of neonates who underwent cardiac surgery, the Vasoactive-Ventilation-Renal score was a reliable predictor of postoperative outcome and outperformed more traditional measures of disease complexity and severity.

Factors associated with seeking preventive dental care: an integrative model exploration of behaviors in Mexican immigrants in Midwest America.

BACKGROUND: Mexican immigrants in the United States suffer from poor oral health. The objective of the current study was to explore the utility of applying theory-based factors associated with seeking preventive dental care in a sample of Mexican American adults. METHODS: Data were collected from a cross-sectional survey of a sample of 157 people of Mexican origin (64% female; age 34 ± 11 years) recruited primarily from church congregations and lay community organizations in Central Indiana. Using the Integrative Model of Behavioral Prediction as the guiding framework, structural equation modeling was used to test factors associated with intention to seek preventive dental care. RESULTS: Attitude towards seeking preventive dental care (estimate = 0.37; p < .0001) and self-efficacy for seeking preventive dental care (estimate = 0.68; p < .0001) were associated with intention to seek preventive dental care. The association between dental beliefs and intention to seek preventive dental care was mediated by attitude and self-efficacy (indirect effect = 0.26, p = .002), and the association between past behavior and intention to seek preventive dental care was mediated by self-efficacy (indirect effect = 0.26, p = .003). CONCLUSIONS: These findings suggest that interventions to increase preventive dental care seeking behavior among Mexican Americans should focus on changing attitudes toward seeking preventive dental care and on increasing self-efficacy to seek preventive dental care. Findings also support the use of interventions to influence dental beliefs.

Prospective Evaluation of Physical Contact with Critically Ill Child on Caregiver Spiritual Wellbeing.

OBJECTIVES: To evaluate whether a pediatric intensive care unit initiative promoting physical contact between caregiver and patient improves caregiver spiritual wellbeing. The secondary objectives were to evaluate caregiver perceptions of care before and after the initiative and to follow unplanned extubation rate as a marker of safety of the initiative. We hypothesized that caregiver spiritual wellbeing and caregiver perceptions of care would improve with implementation of our physical contact initiative known as Project ROSE (Reach Out, Soothe, and Embrace). STUDY DESIGN: Project ROSE was a practice change initiative promoting physical contact between caregiver and hospitalized child in an academic quaternary care pediatric intensive care unit. Caregivers' spiritual wellbeing and perceptions of care were surveyed at days 1 and 4, then compared pre- and postimplementation of the unit-wide initiative. Wilcoxon rank sum tests compared groups (pre- and post-Project ROSE). A total of 331 caregivers returned surveys. RESULTS: We analyzed 331 surveys (pre, n = 174/post, n = 157). Caregiver spiritual wellbeing at enrollment (day 1) was no different between groups (P = .47). Caregiver spiritual wellbeing on day 4 was greater in the postintervention group (pre 40.0 [32.0, 44.0] vs post 42.0 [37.5, 45.0] P = .03). Caregiver perceptions of care improved postintervention. There was no change in the unplanned extubation rate between groups. CONCLUSION: Project ROSE improved caregiver spiritual wellbeing and perceptions of care, was implemented safely, addresses a need in family-centered care of critically ill pediatric patients, and merits consideration for integration into practice.

Extubation Failure after Neonatal Cardiac Surgery: A Multicenter Analysis.

OBJECTIVES: To describe the epidemiology of extubation failure and identify risk factors for its occurrence in a multicenter population of neonates undergoing surgery for congenital heart disease. STUDY DESIGN: We conducted a prospective observational study of neonates ≤30 days of age who underwent cardiac surgery at 7 centers within the US in 2015. Extubation failure was defined as reintubation within 72 hours of the first planned extubation. Risk factors were identified with the use of multivariable logistic regression analysis and reported as OR with 95% CIs. Multivariable logistic regression analysis was conducted to examine the relationship between extubation failure and worse clinical outcome, defined as hospital length of stay in the upper 25% or operative mortality. RESULTS: We enrolled 283 neonates, of whom 35 (12%) failed their first extubation at a median time of 7.5 hours (range 1-70 hours). In a multivariable model, use of uncuffed endotracheal tubes (OR 4.6; 95% CI 1.8-11.6) and open sternotomy of 4 days or more (OR 4.8; 95% CI 1.3-17.1) were associated independently with extubation failure. Accordingly, extubation failure was determined to be an independent risk factor for worse clinical outcome (OR 5.1; 95% CI 2-13). CONCLUSIONS: In this multicenter cohort of neonates who underwent surgery for congenital heart disease, extubation failure occurred in 12% of cases and was associated independently with worse clinical outcome. Use of uncuffed endotracheal tubes and prolonged open sternotomy were identified as independent and potentially modifiable risk factors for the occurrence of this precarious complication.

Weight gain and supplemental O2 : Risk factors during the hematopoietic cell transplant admission in pediatric patients.

BACKGROUND: Respiratory failure in the pediatric hematopoietic cell transplant (HCT) recipient is the leading cause for admission to the intensive care unit and carries a high mortality rate. The objective of this study is to investigate the association of clinical risk factors with the development of respiratory failure in the pediatric allogeneic HCT recipient. PROCEDURES: This is a single-center, retrospective review of allogeneic pediatric HCT from 2008 to 2014. Multiple variables were examined. The primary outcome was respiratory failure. Percent weight gain was investigated at multiple time points. Bivariate and multivariate regression was used. RESULTS: Of the 87 allogeneic HCT recipients, 22 (25%) developed respiratory failure. Mortality for entire cohort was 13.8%. All who died were intubated prior to death. The group with respiratory failure had significantly higher percent weight gain increase at multiple time points: peak weight prior to discharge or intubation (P = 0.008), weight at discharge or intubation (P = .001), and weight at day 43 (median day for intubation) (P = 0.02). Odds ratio (OR) for respiratory failure increased with increasing percentage peak weight gain: 10% increase (3.1 [1.1, 9.0]), 15% increase (4.1 [1.5, 11.2]), and 20% (8.3 [2.4. 28.9]). Fifty percent of all patients required supplemental O2 . OR for respiratory failure in patients requiring more than 1 l supplemental O2 is 25.3 (6.5, 98.7). CONCLUSION: Percent weight gain and need for supplemental oxygen is highly associated with the development of respiratory failure in pediatric HCT recipients, representing predictors of acute respiratory failure in pediatric HCT. These data could be incorporated into an algorithm that should be developed, implemented, and validated in a prospective, multicenter fashion.

Low serum albumin levels prior to pediatric allogeneic HCT are associated with increased need for critical care interventions and increased 6-month mortality.

Poor nutritional status in HCT patients is a negative prognostic factor. There are no pediatric studies evaluating albumin levels prior to HCT and need for critical care interventions. We hypothesized that pediatric patients with low albumin levels, routinely measured 30 days (±10 days) prior to allogeneic HCT, have a higher risk of critical care interventions in the post-transplant period. We performed a 5-year retrospective study of pediatric patients who underwent allogeneic HCT for any indication. Patients were categorized based on albumin level. Hypoalbuminemia was defined as <3.1 g/dL. A total of 73 patients were included, with a median age of 7.4 years (IQR 3.3, 13.2). Patients with hypoalbuminemia had higher needs for critical care interventions including non-invasive ventilation (44% vs 8%, P=.01), mechanical ventilation (67% vs 17%, P<.01), and vasoactive therapy (56% vs 16%, P=.01). Patients with hypoalbuminemia also had a higher 6-month mortality (56% vs 17%, P=.02). Our data demonstrate that children undergoing allogeneic HCT with hypoalbuminemia in the pretransplant period are more likely to require critical care interventions and have higher 6-month mortality. These findings identify an at-risk population in which nutritional improvements may be instituted prior to HCT in hopes of improving outcomes.

Pediatric Acute Respiratory Distress Syndrome in Pediatric Allogeneic Hematopoietic Stem Cell Transplants: A Multicenter Study.

OBJECTIVE: Immunodeficiency is both a preexisting condition and a risk factor for mortality in pediatric acute respiratory distress syndrome. We describe a series of pediatric allogeneic hematopoietic stem cell transplant patients with pediatric acute respiratory distress syndrome based on the recent Pediatric Acute Lung Injury Consensus Conference guidelines with the objective to better define survival of this population. DESIGN: Secondary analysis of a retrospective database. SETTING: Twelve U.S. pediatric centers. PATIENTS: Pediatric allogeneic hematopoietic stem cell transplant recipients requiring mechanical ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: During the first week of mechanical ventilation, patients were categorized as: no pediatric acute respiratory distress syndrome or mild, moderate, or severe pediatric acute respiratory distress syndrome based on oxygenation index or oxygen saturation index. Univariable logistic regression evaluated the association between pediatric acute respiratory distress syndrome and PICU mortality. A total of 91.5% of the 211 patients met criteria for pediatric acute respiratory distress syndrome using the Pediatric Acute Lung Injury Consensus Conference definition: 61.1% were severe, 27.5% moderate, and 11.4% mild. Overall survival was 39.3%. Survival decreased with worsening pediatric acute respiratory distress syndrome: no pediatric acute respiratory distress syndrome 66.7%, mild 63.6%, odds ratio = 1.1 (95% CI, 0.3-4.2; p = 0.84), moderate 52.8%, odds ratio = 1.8 (95% CI, 0.6-5.5; p = 0.31), and severe 24.6%, odds ratio = 6.1 (95% CI, 2.1-17.8; p < 0.001). Nonsurvivors were more likely to have multiple consecutive days at moderate and severe pediatric acute respiratory distress syndrome (p < 0.001). Moderate and severe patients had longer PICU length of stay (p = 0.01) and longer mechanical ventilation course (p = 0.02) when compared with those with mild or no pediatric acute respiratory distress syndrome. Nonsurvivors had a higher median maximum oxygenation index than survivors at 28.6 (interquartile range, 15.5-49.9) versus 15.0 (interquartile range, 8.4-29.6) (p < 0.0001). CONCLUSION: In this multicenter cohort, the majority of pediatric allogeneic hematopoietic stem cell transplant patients with respiratory failure met oxygenation criteria for pediatric acute respiratory distress syndrome based on the Pediatric Acute Lung Injury Consensus Conference definition within the first week of invasive mechanical ventilation. Length of invasive mechanical ventilation, length of PICU stay, and mortality increased as the severity of pediatric acute respiratory distress syndrome worsened.

Potential Impact of Amantadine on Aggression in Chronic Traumatic Brain Injury.

OBJECTIVE: To assess the effects of amantadine on anger and aggression among individuals with a chronic traumatic brain injury (TBI). METHODS: A cohort of 118 persons with chronic TBI (>6 months postinjury) and moderate-severe aggression selected from a larger cohort of 168 participants enrolled in a parallel-group, randomized, double-blind, placebo-controlled trial of amantadine 100 mg twice daily (n = 82) versus placebo (n = 86) for treatment of irritability were studied. Anger and aggression were measured at treatment days 0, 28, and 60 using observer-rated and participant-rated State-Trait Anger Expression Inventory-2 (STAXI-2) and Neuropsychiatric Inventory-Agitation/Aggression domain (NPI-A) Most Problematic and Distress scores. RESULTS: Participant-rated day 60 NPI-A Most Problematic (adjusted P = .0118) and NPI-A Distress (adjusted P = .0118) were statistically significant between the 2 groups, but STAXI-2 differences were not significant after adjustment for multiple comparisons. Substantial improvements were noted in both amantadine and placebo groups (70% vs 56% improving at least 3 points on day 60 Observer NPI-A; P = .11). CONCLUSION: Amantadine 100 mg twice daily in this population with chronic TBI appears to be beneficial in decreasing aggression from the perspective of the individual with TBI. No beneficial impact on anger was found. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00779324; http://www.clinicaltrials.gov/ct2/show/NCT00779324?term=irritability&rank=6.