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Among patients with spondylolisthesis and lumbar spinal stenosis, laminectomy with fusion was associated with modestly greater improvement in physical health–related quality of life than laminectomy alone but not with significantly greater reduction in disability related to back pain. The increased use of the lumbar spinal fusion procedure in the United States, along with the wide variation in practice, is attracting interest from multiple stakeholders, including patients, physicians, payers, and policymakers. In a report published in 2014, spinal fusion (465,000 hospital-based procedures in 2011) accounted for the highest aggregate hospital costs ($12.8 billion in 2011) of any surgical procedure performed in U.S. hospitals. 1 The randomized, controlled Spine Patient Outcomes Research Trial (SPORT) showed that surgery was superior to nonoperative care for the management of lumbar degenerative spondylolisthesis. 2 In SPORT, most patients in the surgical group were treated by means . . .

ObjectiveThe Neonatal Adverse Event Severity Scale (NAESS) was developed to improve scoring of neonatal adverse events (AEs) and accelerate neonatal drug development. This is the first validation study of the novel tool.Study designRetrospective validation study assessing the inter-rater reliability (IRR) of the NAESS. Reviewers used real-world AE data from a neonatal trial. Intra-class correlation (ICC) statistical analysis was performed.ResultSixty AEs were randomly assigned to twelve reviewers for a total of 240 severity scores. Generic and AE-specific NAESS tables were assessed. The ICC was 0.63 (95% confidence interval 0.51 to 0.73). Percent variation due to reviewer and residual error was 0.03 and 0.34, respectively.ConclusionIn this first study of the NAESS tool, an ICC of 0.63 indicates moderate reliability. Results highlight the need for improved data collection on neonatal AE forms, augmented training on the NAESS tool, and will inform the prospective validation studies.

BackgroundPreterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP.MethodsThe safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA.ResultsWith CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA.ConclusionsA single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.

Background Stable health insurance is often associated with better chronic disease care and outcomes. Racial/ethnic health disparities in outcomes are prevalent and may be associated with insurance instability, particularly in the context of health insurance reform. Methods We examined whether insurance instability was associated with uncontrolled blood pressure (UBP) and whether this association varied by race/ethnicity. We used a retrospective longitudinal observational cohort study of patients diagnosed with hypertension who obtained care within two health systems in Massachusetts. We measured the UBP, insurance instability, and race of 43,785 adult primary care patients, age 21–64 with visits from 1/2005–12/2013. Results We found higher rates of UBP for blacks and Hispanics at each time point over the entire 9 years. Insurance instability was associated with greater rates of UBP. Always uninsured black patients fared worst, while white and Hispanic patients with consistent public insurance fared best. Conclusions Stable insurance of any type was associated with better hypertension control than no or unstable insurance.

Purpose To test whether longitudinally measured health-related quality of life (HRQL) predicts transplant-related mortality (TRM) in pediatric hematopoietic stem cell transplant (HSCT). Methods The predictors of interest were emotional functioning, physical functioning, role functioning, and global HRQL, as rated by the parent about the child up to 6 times over 12 months of follow-up and measured by the Child Health Ratings Inventories. We used joint models, specifically shared parameter models, with time to TRM as the outcome of interest and other causes of mortality as a competing risk, via the JM software package in R. Choosing shared parameter models instead of standard survival models, such as Cox models with time-dependent covariates, enabled us to address measurement error in the HRQL trajectories and appropriately handle missing data. The nonlinear trajectories for each HRQL domain were modeled by random spline functions. The survival submodels were adjusted for baseline patient, family, and transplant characteristics. Results Hazard ratios per one-half standard deviation difference in emotional, physical, and role functioning, and global HRQL were 0.61 (95 % CI 0.46-0.81; p < 0.001), 0.70 (0.51-0.96; p = 0.03), 0.54 (0.34-0.85; p = 0.007), and 0.57 (0.41-0.79; p < 0.001), respectively. Conclusions HRQL trajectories were predictive of TRM in pediatric HSCT, even after adjusting the survival outcome for baseline characteristics.

ABSTRACT IMPACT: This work has the potential to help clinicians decide which infants exposed to in utero opioids, will need to be treated early or can be discharged home early based on their risk, thus reducing prolonged hospitalization OBJECTIVES/GOALS: To develop and validate a prediction model with inclusion of clinical and demographic risk factors to identify infants with NAS likely to need pharmacotherapy. METHODS/STUDY POPULATION: A pooled cohort of 761 infants from 5 different studies including 2 trials and 3 observational cohorts will be used to develop the model. All infants >than or equal to 37 weeks gestational age born to mothers with history of OUD will be included. Infants with congenital disorders and severe medical and surgical illnesses will be excluded. Multivariable mixed effects logistic regression modeling will be performed to predict the need for pharmacologic treatment for NAS. Candidate variables will be included based on clinical knowledge and previously published data. Model performance will be evaluated by measuring discrimination using Area Under the Curve (AUC) statistics and calibration. Model will be internally validated using boot strap validation. RESULTS/ANTICIPATED RESULTS: Pending data analysis DISCUSSION/SIGNIFICANCE OF FINDINGS: Opioid Use Disorder in pregnancy has resulted in concurrent rise in NAS incidence. NAS affects opioid exposed infants variably and accurate prediction of its severity and need for treatment remains elusive. Known clinical and demographic factors can predict the need for NAS therapy in opioid exposed infants, aiding clinical decision making.

Background Pediatric health-related quality of life (HRQL) measures explore multiple domains of HRQL. To ease administration, burden, and implementation, we created a 7-item unidimensional global HRQL scale for children. This paper evaluates the psychometric properties of the global HRQL scale in children undergoing hematopoietic stem cell transplant (HSCT) and describes the trajectory of global HRQL scores over the 12-month course following HSCT. Methods As part of two longitudinal HSCT studies, HRQL was collected on 312 parent–child dyads using the Child Health Ratings Inventories. Parents of children aged 5–18 completed the pediatric global HRQL scale about their child and 117 adolescents completed the scale themselves. Psychometric properties were compared across both raters. Two repeated measures models were built to describe trajectories of (1) global HRQL for all children based on parent proxy report and (2) global HRQL for adolescents based on adolescent self-report and parent proxy report. Results Internal consistency reliability was high for parent proxy report and adolescent self-report (Cronbach’s alpha 0.9, 0.8, respectively). Unidimensionality was verified using principal components analysis. Both models indicated decreased global HRQL in the presence of early complications related to HSCT and Model 1 further indicated decreased HRQL in the presence of later complications. Model 2 showed that parent proxies reported lower global HRQL scores than adolescent self-report. Conclusions This study has demonstrated the unidimensionality and strong psychometric properties of a 7-item global HRQL scale in a sample of children undergoing HSCT. Despite its brevity, scale scores vary in clinically meaningful ways. Future applications of this scale are encouraged.

To describe health behaviors of cancer survivors by cancer diagnosis and to compare them to people without a personal or family cancer history. Cross-sectional secondary data analysis. A national, list-assisted telephone survey using random-digit dialing of U.S. adults about use of cancer-related information and cancer beliefs. 619 cancer survivors and 2,141 participants without a history of cancer from the original 6,369 Health Information National Trends Survey (HINTS) respondents. Using the National Cancer Institute's 2003 HINTS, further analyses were conducted. Cancer history, current smoking, fruit and vegetable consumption, physical activity, and body mass index (BMI). When controlling for demographic variables, no differences were found in self-reported health behaviors between survivors and those without cancer: 22.5% of survivors and 18.4% of those without cancer were current smokers, 18% of survivors and 14.9% of those without cancer consumed at least five fruits or vegetables per day, 45.3% of survivors and 53% of those without cancer were physically active at least weekly, and 58% of survivors and 54.9% of those without cancer were overweight or obese (i.e., BMI > 25). Only 7.4% of survivors and 6.4% of participants without cancer reported positively on all three health behaviors and had a healthy or normal weight. Survivors did not have different health behaviors when compared to participants without a history of cancer. Neither group met the American Cancer Society or Healthy People 2010 objectives for these behaviors. Adoption of healthy lifestyle behaviors should be addressed in cancer survivors. Cancer survivors need to be assessed for current smoking, dietary habits, physical activity, and weight. Information and resources should be made available, if needed, to promote the adoption of healthy lifestyle behaviors.

Purpose Parents of children undergoing hematopoietic stem cell transplantation (HSCT) may face emotional distress while managing intense treatments with uncertain outcomes. We evaluated a brief parental emotional functioning (PREMO) screener from a health-related quality of life instrument to identify parental emotional distress, as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID). Methods As part of a longitudinal pediatric HSCT study, parents (N= 165) completed the Child Health Ratings Inventories, which contain the 7-item PREMO screener. Some parents (n = 117) also completed SCID modules for Anxiety, Mood, and Adjustment disorders at baseline and/or 12 months. A composite outcome was created for threshold or subthreshold levels of any of these disorders. Receiver operating characteristic (ROC) analysis assessed how the PREMO screener predicted emotional distress as measured by the SCID. A prediction model was then built. Results Fifty-two percent of parents completing the SCID had an Axis I disorder at baseline, while 41 % had an Axis I disorder at 12 months. The area under the ROC curve was 0.75 for the PREMO screener and 0.81 for the prediction model. Conclusions The PREMO screener may identify parents with, or at risk for, emotional distress and facilitate further evaluation and intervention.

Concerns about overtreatment of clinically indolent prostate cancer (PrCa) have led to recommendations that men who are diagnosed with low‐risk PrCa be managed by active surveillance (AS) rather than immediate definitive treatment. However the risk of underestimating the aggressiveness of a patient's PrCa can be a significant source of anxiety and a barrier to patient acceptance of AS. The uncertainty is particularly keen for African American (AA) men who are about 1.7 times more likely to be diagnosed with PrCa than European American (EA) men and about 2.4 times more likely to die of this disease. The AA population, as many other populations in the Americas, is genetically heterogeneous with varying degrees of admixture from West Africans (WAs), Europeans, and Native Americans (NAs). Recommendations for PrCa screening and management rarely consider potential differences in risk within the AA population. We compared WA genetic ancestry in AA men undergoing standard prostate biopsy who were diagnosed with no cancer, low‐grade PrCa (Gleason Sum 6), or higher grade PrCa (Gleason Sum 7‐10). We found that WA genetic ancestry was significantly higher in men who were diagnosed with PrCa on biopsy, compared to men who were cancer‐negative, and highest in men who were diagnosed with higher grade PrCa (Gleason Sum 7‐10). Incorporating WA ancestry into the guidelines for making decisions about when to obtain a biopsy and whether to choose AS may allow AA men to personalize their approach to PrCa screening and management. African American men are at higher risk for prostate cancer but public health recommendations rarely consider potential differences in risk within the African American population. We found that in self‐identified African Americans, West African genetic ancestry was significantly higher in men who were diagnosed with PrCa on biopsy, compared to men who were cancer negative, and highest in men who were diagnosed with higher grade PrCa (Gleason Sum 7‐10). Incorporating West African ancestry into prostate cancer clinical guidelines may allow African American men to personalize their approach to screening and management.