Evaluation of a training intervention to improve cancer care in Zimbabwe: Strategies to Improve Kaposi Sarcoma Outcomes (SIKO), a prospective community-based stepped-wedge cluster randomized trial.

INTRODUCTION: Most Zimbabweans access medical care through tiered health systems. In 2013, HIV care was decentralized to primary care clinics; while oncology care remained centralized. Most persons in Zimbabwe with Kaposi sarcoma (KS) are diagnosed late in their disease, and the prognosis is poor. Little is known about whether educational interventions could improve KS outcomes in these settings. METHODS: Interventions to improve KS detection and management were evaluated at eight Zimbabwe primary care sites (four rural/four urban) that provided HIV care. Interventions included a standardized KS clinical evaluation tool, palliative care integration, standardized treatment and improved consultative services. Interventions were implemented between February 2013 and January 2016 using a randomized stepped-wedge cluster design. Sites were monitored for KS diagnosis rates and KS outcomes, including early diagnosis (T0 vs. T1 tumour stage), participant retention and mortality. Analyses controlled for within-clinic correlations. RESULTS: A total of 1102 persons with suspected KS (96% HIV positive) were enrolled: 47% incident (new diagnosis), 20% prevalent (previous diagnosis) and 33% determined as not KS. Early (T0) diagnosis increased post-intervention, though not significant statistically (adjusted odds ratio [aOR] = 1.48 [95% confidence interval (95% CI): 0.66-3.79], p = 0.37). New KS diagnosis rates increased 103% (95% CI: 11-273%), p = 0.02) post-intervention; although paired with an increased odds of incorrectly diagnosing KS (aOR = 2.08 [95% CI: 0.33-3.24], p = 0.001). Post-intervention, non-significant decreases in 90-day return rates (adjusted hazard ratio [aHR] = 0.69 [95% CI: 0.38-1.45], p = 0.21) and survival (aHR = 1.36 [95% CI: 0.85-2.20], p = 0.20) were estimated. CONCLUSIONS: KS training interventions at urban and rural Zimbabwe decentralized primary care clinics significantly increased overall and incorrect KS diagnosis rates, but not early KS diagnosis rates, 90-day return rates or survival.

Association between maternal acculturation and health beliefs related to oral health of Latino children.

BACKGROUND: This report is presenting the association of maternal acculturation, measured by preferred language, and oral health-related psychosocial measures in an urban Latino population. METHODS: A cross-sectional survey was conducted with 100 mother-child dyads from the Dental Center at the Children's Hospital Colorado, the University of Colorado. A portion of Basic Research Factors Questionnaire capturing information about parental dental knowledge, attitudes, behavior and psychosocial measures was used to collect data from the participating mothers. Descriptive statistics were calculated for demographics and psychosocial measures by acculturation. A univariate linear regression model was performed for each measure by preferred language for primary analysis followed by adjusted model adjusting for parent's education. RESULTS: The mean age of the children was 3.99 years (SD = 1.11), and that of the mother was 29.54 years (SD = 9.62). Dental caries, measured as dmfs, was significantly higher in children of Spanish-speaking mothers compared to children of English-speaking mothers. English-speaking mothers had higher mean scores of oral health knowledge, oral health behaviors, knowledge on dental utilization, self-efficacy, and Oral Health Locus of Control as compared to Spanish-speaking mothers. Univariate analysis demonstrated significant association for preference for Spanish language with knowledge on dental utilization, maternal self-efficacy, perceived susceptibility and perceived barriers. The effect of language was attenuated, but significant, for each of these variables after adjusting for parent's education. CONCLUSION: This study reported that higher acculturation measured by a preference for the English language had a positive association with oral health outcomes in children. Spanish-speaking mothers perceived that their children were less susceptible to caries. Additionally, they perceived barriers in visiting the dentist for preventive visits.

Predictive value of presuperior cavopulmonary anastomosis cardiac catheterization at increased altitude.

OBJECTIVE: Infants with single ventricle physiology typically undergo cardiac catheterization prior to superior cavopulmonary anastomosis (SCPA) to assess operative suitability. Predictors of poor outcome at sea level include elevated pulmonary artery pressure (mPAP), indexed pulmonary vascular resistance (PVRi), age <3 months, significant atrioventricular valve regurgitation, among others. Increased altitude has vasoconstrictive effects on the pulmonary vasculature, which may affect pre-SCPA hemodynamics and outcomes. The goal of this study was to determine the predictive value of pre-SCPA catheterization data with regard to reaching Fontan palliation at altitude. DESIGN: A retrospective review revealed 150 patients who underwent pre-SCPA catheterization over a 10-year period. Subjects were grouped by progression to Fontan vs aborted palliation, heart transplant or death. Statistics included t-tests, logistic regression and receiver operator characteristic (ROC) curve analysis. RESULTS: Independent predictors of failure to achieve Fontan operation at increased altitude include decreased ventricular function, increased mPAP, increased PVRi, and prolonged hospitalization, after adjusting for ventricular morphology and sex. CONCLUSIONS: Our data indicate that decreased ventricular function most strongly predicts failure to reach Fontan palliation. Additionally, mPAP and PVRi play an important role in determining outcomes at increased altitude. Prolonged hospitalization is likely a marker of increased medical complexity or more problematic physiology.

Infliximab Plus Intravenous Immunoglobulin (IVIG) Versus IVIG Alone as Initial Therapy in Children With Kawasaki Disease Presenting With Coronary Artery Lesions: Is Dual Therapy More Effective?

BACKGROUND: We previously demonstrated that 80% of Kawasaki disease (KD) patients who develop coronary artery lesions (CALs) have them at diagnosis. We postulated that KD patients presenting with CALs represent a group that may benefit from more aggressive initial therapy. Infliximab has been shown to decrease inflammation in KD patients when added to standard therapy. We compared outcomes of KD patients with CALs initially treated with intravenous immunoglobulin (IVIG) alone versus IVIG plus infliximab. METHODS: Medical records of KD patients from January 2009 to July 2016 were retrospectively reviewed. CALs were defined as a left anterior descending or right coronary artery Z score ≥2.5. KD patients with CALs on initial echocardiogram treated with IVIG alone were compared with those treated with IVIG plus infliximab. Clinical characteristics were compared between groups using Wilcoxon rank-sum test, χ test and Fischer's exact tests; length of stay was analyzed using log-normal regression and need for additional therapy using logistic regression. Effect of treatment on CALs between groups was assessed using linear mixed models. RESULTS: Sixty-nine KD patients with CALs at presentation were included. Fifteen of 34 (44%) patients treated with IVIG alone required additional therapy compared with 4 of 35 (11%) patients treated with IVIG plus infliximab (P = 0.003). There were no significant differences between treatment groups for length of stay, CALs or C-reactive protein fall. CONCLUSIONS: IVIG plus infliximab as initial therapy reduces the need for additional therapy in KD patients presenting with CALs. Intensified initial therapy, consisting of infliximab plus IVIG, could be considered for this group of KD patients.

Toward standardization of care: The feeding readiness assessment after congenital cardiac surgery.

BACKGROUND: Feeding practices after neonatal and congenital heart surgery are complicated and variable, which may be associated with prolonged hospitalization length of stay (LOS). Systematic assessment of feeding skills after cardiac surgery may earlier identify those likely to have protracted feeding difficulties, which may promote standardization of care. METHODS: Neonates and infants ≤3 months old admitted for their first cardiac surgery were retrospectively identified during a 1-year period at a single center. A systematic feeding readiness assessment (FRA) was utilized to score infant feeding skills. FRA scores were assigned immediately prior to surgery and 1, 2, and 3 weeks after surgery. FRA scores were analyzed individually and in combination as predictors of gastrostomy tube (GT) placement prior to hospital discharge by logistic regression. RESULTS: Eighty-six patients met inclusion criteria and 69 patients had complete data to be included in the final model. The mean age of admit was five days and 51% were male. Forty-six percent had single ventricle physiology. Twenty-nine (42%) underwent GT placement. The model containing both immediate presurgical and 1-week postoperative FRA scores was of highest utility in predicting discharge with GT (intercept odds = 10.9, P = .0002; sensitivity 69%, specificity 93%, AUC 0.913). The false positive rate was 7.5%. CONCLUSIONS: In this analysis, systematic and standardized measurements of feeding readiness employed immediately before and one week after congenital cardiac surgery predicted need for GT placement prior to hospital discharge. The FRA score may be used to risk stratify patients based on likelihood of prolonged feeding difficulties, which may further improve standardization of care.

The Impact of Maternal Self-Efficacy and Oral Health Beliefs on Early Childhood Caries in Latino Children.

OBJECTIVES: Latino children experience one of the highest rates of early childhood caries requiring interventions based on valid conceptual frameworks. The Health Belief Model has relevance as a predictor of compliance with health recommendations based on perceptions of a health condition and behaviors to avoid the condition. The model encompasses four perceptual constructs (susceptibility, severity, benefits, barriers) and, for complex conditions, includes self-efficacy as an extended model. This study evaluated individual (self-efficacy and health beliefs) and cultural (acculturation status) level factors and the inter-relationship to determine if items assessed for the Extended Health Belief Model (EHBM) were valid measures of maternal factors. METHODS: A cross-sectional study was conducted with 100 mother-child dyads at the Dental Center of Children's Hospital Colorado, Aurora, CO, USA. Participating mothers completed a survey in English or Spanish with items from the Basic Research Factors Questionnaire encompassing sociodemographic characteristics, oral health knowledge and behavior, and psychosocial measures including the EHBM. Language preference was a proxy for maternal acculturation. Children were examined to measure decayed, missing, and filled tooth surfaces. Internal consistency reliability of each subscale was evaluated using Cronbach's alpha. Convergent validity was assessed using linear regression to evaluate the association of the EHBM subscales with oral health-related measures and language preference. RESULTS: The benefits and self-efficacy scales reflected good reliability. Maternal education was the strongest predictor of health beliefs with significant associations for barriers, benefits, and susceptibility. Perceived benefits increased with each additional year in the household. There was a significant association between maternal oral health knowledge and higher perceived benefits and increased self-efficacy, and the same was found for higher knowledge of dental utilization which was also associated with children perceived as having increased susceptibility to early childhood caries. Less acculturated participants perceived more barriers to behavioral adherence and fewer barriers as knowledge increased. As dental utilization knowledge improved for Spanish-speaking participants, they perceived greater benefits from adherent oral health behavior compared to English-speaking participants. CONCLUSION: Items assessed for the EHBM were valid as measures of maternal factors influencing children's oral health outcomes in a Latino population.

Outcomes after combined phacoemulsification and trabecular microbypass stent implantation in controlled open-angle glaucoma.

PURPOSE: To study the effect of combined phacoemulsification cataract surgery and iStent (trabecular microbypass stent) implantation on intraocular pressure (IOP) and medication use in open-angle glaucoma (OAG) patients with a low mean preoperative IOP. SETTING: University of Colorado Health Eye Center, Aurora, Colorado, USA. DESIGN: Retrospective case series. METHODS: Treatment outcomes analyzed included IOP, medication use, and corrected distance visual acuity (CDVA). Treatment success was defined as a 20% or more IOP reduction or discontinuation of at least 1 medication. RESULTS: Sixty-four eyes of 45 patients were included in the analysis. At 1 year, the mean IOP was significantly reduced from 14.7 ± 3.2 mm Hg (SD) to 13.2 ± 2.8 mm Hg (P < .01) and the mean medication use decreased from 1.81 ± 1.13 to 1.41 ± 1.48 (P = .0001). The estimated IOP reduction at 1, 3, 6, and 12 months was 3.5% (P = .23), 7.9% (P = .04), 9.7% (P = .01), and 12.2% (P = .002), respectively. Treatment success at 1 year was achieved in 76.1% of patients, and 41% of patients were medication free at 1 year. The CDVA was significantly improved from 0.4 ± 0.38 logMAR at baseline to 0.17 ± 0.35 at 1 year (P < .0001). CONCLUSIONS: Combined cataract surgery and trabecular microbypass stent implantation was statistically effective in reducing IOP and/or medication burden in OAG patients with a low preoperative IOP. During the informed surgical consent process, the physician and patient should consider the clinical benefit of modest IOP lowering and/or a decrease in medication use. FINANCIAL DISCLOSURE: Drs. Seibold, SooHoo, Pantcheva, and Kahook have received grant support from Glaukos Corp. No other author has a financial or proprietary interest in any material or method mentioned.

Efficacy of combined cataract extraction and endoscopic cyclophotocoagulation for the reduction of intraocular pressure and medication burden.

AIM: To report on the efficacy of combined endoscopic cyclophotocoagulation (ECP) and phacoemulsification cataract extraction (PCE) with intraocular lens placement for reduction of intraocular pressure (IOP) and medication burden in glaucoma. METHODS: A retrospective case review of 91 eyes (73 patients) with glaucoma and cataract that underwent combined PCE/ECP surgery was performed. Baseline demographic and ocular characteristics were recorded, as well as intraocular pressure, number of glaucoma medications, and visual acuity postoperatively with 12-month follow-up. Treatment failure was defined as less than 20% reduction in IOP from baseline on two consecutive visits (at 1, 3, 6, or 12mo postoperatively), IOP ≥21 mm Hg or ≤5 mm Hg on two consecutive visits, or additional glaucoma surgery performed within 12mo after PCE/ECP. RESULTS: Overall, mean medicated IOP was reduced from 16.65 mm Hg at baseline to 13.38 mm Hg at 12mo (P<0.0001). Mean number of glaucoma medications was reduced from 1.88 medications at baseline to 1.48 medications at 12mo (P=0.0003). At 3mo postoperatively, the success rate was 73.6% (95%CI: 63.3, 81.5), 57.1% at 6mo (95% CI: 46.3, 66.6), and 49.7% at 12mo (95%CI: 38.9, 59.6). Patient demographic characteristics were not associated with treatment success. The only ocular characteristic associated with treatment success was a higher baseline IOP. CONCLUSION: Combined PCE/ECP surgery is an effective surgical option for the reduction of IOP and medication burden in glaucoma patients. Patients with higher baseline IOP levels are most likely to benefit from this procedure.

Feasibility and Safety of Using a Fused Echocardiography/Fluoroscopy Imaging System in Patients with Congenital Heart Disease.

BACKGROUND: Fused real-time three-dimensional transesophageal echocardiography and fluoroscopy has been used in adult patients during percutaneous mitral valve and aortic valve procedures. The use of fused echocardiographic/x-ray fluoroscopic imaging (FEX) in pediatric patients undergoing congenital heart disease catheterization has not been evaluated for feasibility and safety. The aims of this study were to assess the feasibility and safety of FEX for interventional guidance and to perform a comparison of atrial septal defect (ASD) device closure using this technology with traditional guidance methods. METHODS: Prospective evaluation of FEX in congenital cardiac interventions was conducted. A subset of patients with ASD closures were compared with patients with historical ASD closures with and without FEX. The interventionalist and echocardiographer rated the anatomic quality of the fusion imaging as (1) excellent, (2) good, or (3) poor. In addition, the utility of FEX procedural guidance was graded as (1) superior, (2) no added benefit, or (3) inferior to that of standard guidance by fluoroscopy and transesophageal echocardiography. RESULTS: FEX was successfully used in 26 procedures on 25 patients with congenital heart disease from January 2013 to February 2015. The median age was 9 years (range, 3-26 years), and the median weight was 29 kg (range, 16-77 kg). Twenty-six procedures were performed, including ASD closure, Fontan fenestration closure, and transcatheter valve placement in the tricuspid valve position. There was reduced fluoroscopy time and radiation dose in patients with ASDs who underwent imaging using this new technology (P < .001 and P < .03, respectively). There were no statistically significant differences in procedural times between the two groups. Anatomic definition was rated as excellent in 20 of 26 procedures, with the remaining six rated was good. Twenty-one of 26 procedures were graded as superior (81%), and five of 26 (19%) were graded as providing no added benefit. There were no complications in any of the procedures. CONCLUSIONS: In this early experience, FEX is feasible and safe in patients undergoing congenital heart disease catheterization and provides useful guidance in the majority of interventional procedures. There were relative reductions in fluoroscopy time and radiation dose with the use of FEX for ASD closure.

Left Ventricular Dilatation Increases the Risk of Ventricular Arrhythmias in Patients With Reduced Systolic Function.

BACKGROUND: Reduced left ventricular (LV) ejection fraction increases the risk of ventricular arrhythmias; however, LV ejection fraction has a low sensitivity to predict ventricular arrhythmias. LV dilatation and mass may be useful to further risk-stratify for ventricular arrhythmias. METHODS AND RESULTS: Patients from the Genetic Risk of Assessment of Defibrillator Events (GRADE) study (N=930), a study of heart failure subjects with defibrillators, were assessed for appropriate implantable cardioverter-defibrillator shock and death, heart transplant, or ventricular assist device placement by LV diameter and mass. LV mass was divided into normal, mild, moderate, and severe classifications. Severe LV end-diastolic diameter had worse shock-free survival than normal and mild LV end-diastolic diameter (P=0.0002 and 0.0063, respectively; 2-year shock free, severe 74%, moderate 80%, mild 91%, normal 88%; 4-year shock free, severe 62%, moderate 69%, mild 72%, normal 81%) and freedom from death, transplant, or ventricular assist device compared with normal and moderate LV end-diastolic diameter (P<0.0001 and 0.0441, respectively; 2-year survival: severe 78%, moderate 85%, mild 82%, normal 89%; 4-year survival: severe 55%, moderate 64%, mild 63%, normal 74%). Severe LV mass had worse shock-free survival than normal and mild LV mass (P=0.0370 and 0.0280, respectively; 2-year shock free: severe 80%, moderate 81%, mild 91%, normal 87%; 4-year shock free: severe 68%, moderate 73%, mild 76%, normal 76%) but no association with death, transplant, or ventricular assist device (P=0.1319). In a multivariable Cox proportional hazards analysis adjusted for LV ejection fraction, LV end-diastolic diameter was associated with appropriate implantable cardioverter-defibrillator shocks (hazard ratio 1.22, P=0.020). LV end-diastolic diameter was associated with time to death, transplant, or ventricular assist device (hazard ratio 1.29, P=0.0009). CONCLUSIONS: LV dilatation may complement ejection fraction to predict ventricular arrhythmias. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02045043.

Dexamethasone intravitreal implant in the treatment of persistent uveitic macular edema in the absence of active inflammation.

PURPOSE: To examine the observational effectiveness of the dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc., Irvine, CA) in the treatment of noninfectious uveitic macular edema in patients with otherwise quiescent uveitis. DESIGN: Retrospective chart review. PARTICIPANTS: A total of 27 consecutive patients with persistent macular edema resistant to standard short-term therapy despite quiescent noninfectious intermediate or posterior uveitis. METHODS: Each patient was treated with a DEX 0.7 mg implant. MAIN OUTCOME MEASURES: Primary outcome measure was resolution of macular edema 1 month after injection as measured by decrease in central macular thickness (CMT). Secondary outcome was change in visual acuity 1, 2, and 3 months after injection. RESULTS: A total of 27 eyes of 27 patients were included for analysis. One eye was randomly selected for 6 of these patients who received bilateral DEX implants. There was a statistically significant reduction in mean CMT 1 month after DEX implantation (mean, 278.9 µm; range, 206-352 µm) compared with baseline (mean, 478.7 µm; range, 330-667 µm) (P < 0.0001). There was a statistically significant improvement in visual acuity at 3 months (logarithm of the minimum angle of resolution [logMAR] 0.41; 20/51) compared with baseline (logMAR 0.60; 20/80) (P = 0.0005). There were no major complications after DEX implantation. CONCLUSIONS: The DEX implant resulted in a statistically significant improvement in mean CMT and visual acuity without any serious adverse events.

The pancreas of sacrificial animals as an object of divination for the indigenous peoples on the Island of Sumba, Indonesia.

This paper describes contemporary 'intestinal' divination with the pancreas by indigenous people in Indonesia and explores the feasibility of comparing it to ancient intestinal divination. To our knowledge, divinatory use of the pancreas of sacrificial animals (chickens) has not yet been described in the literature.