Phase II study of dichloroacetate, an inhibitor of pyruvate dehydrogenase, in combination with chemoradiotherapy for unresected, locally advanced head and neck squamous cell carcinoma.

Chemoradiotherapy (CRT) for locally-advanced head and neck squamous cell carcinoma (LA-HSNCC) yields 5-year survival rates near 50% despite causing significant toxicity. Dichloroacetate (DCA), a pyruvate dehydrogenase kinase metabolic inhibitor, reduces tumor lactate production and has been used in cancer therapy previously. The safety of adding this agent to CRT is unknown. Our randomized, placebo-controlled, double-blind phase II study added DCA to cisplatin-based CRT in patients with LA-HNSCC. The primary endpoint was safety by adverse events (AEs). Secondary endpoints compared efficacy via 3-month end-of-treatment response, 5-year progression-free and overall survival. Translational research evaluated pharmacodynamics of serum metabolite response. 45 participants (21 DCA, 24 Placebo) were enrolled from May 2011-April 2014. Higher rates of all-grade drug related fevers (43% vs 8%, p = 0.01) and decreased platelet count (67% vs 33%, p = 0.02) were seen in DCA versus placebo. However, there were no significant differences in grade 3/4 AE rates. Treatment compliance to DCA/placebo, radiation therapy, and cisplatin showed no significant difference between groups. While end-of-treatment complete response rates were significantly higher in the DCA group compared to placebo (71.4% vs 37.5%, p = 0.0362), survival outcomes were not significantly different between groups. Treatment to baseline metabolites demonstrated a significant drop in pyruvate (0.47, p < 0.005) and lactate (0.61, p < 0.005) in the DCA group. Adding DCA to cisplatin-based CRT appears safe with no detrimental effect on survival and expected metabolite changes compared to placebo. This supports further investigation into combining metabolic agents to CRT. Trial registration number: NCT01386632, Date of Registration: July 1, 2011.

Racial/Ethnic Variation in Emergency Department Care for Children With Asthma.

OBJECTIVE: To assess the variation between racial/ethnic groups in emergency department (ED) treatment of asthma for pediatric patients. METHODS: This study was a cross-sectional analysis of pediatric (2-18 years) asthma visits among 6 EDs in the Upper Midwest between June 2011 and May 2012. We used mixed-effects logistic regression to assess the odds of receiving steroids, radiology tests, and returning to the ED within 30 days. We conducted a subanalysis of asthma visits where patients received at least 1 albuterol treatment in the ED. RESULTS: The sample included 2909 asthma visits by 1755 patients who were discharged home from the ED. After adjusting for demographics, insurance type, and triage score, African American (adjusted odds ratio [aOR], 1.78; 95% confidence interval [CI], 1.40-2.26) and Hispanic (aOR, 1.64; 95% CI, 1.22-2.22) patients had higher odds of receiving steroids compared with whites. African Americans (aOR, 0.58; 95% CI, 0.46-0.74) also had lower odds of radiological testing compared with whites. Asians had the lowest odds of 30-day ED revisits (aOR, 0.26; 95% CI, 0.08-0.84), with no other significant differences detected between racial/ethnic groups. Subgroup analyses of asthma patients who received albuterol revealed similar results, with American Indians showing lower odds of radiological testing as well (aOR, 0.47; 95% CI, 0.22-1.01). CONCLUSIONS: In this study, children from racial/ethnic minority groups had higher odds of steroid administration and lower odds of radiological testing compared with white children. The underlying reasons for these differences are likely multifactorial, including varying levels of disease severity, health literacy, and access to care.

Leaving the emergency department without complete care: disparities in American Indian children.

BACKGROUND: Children who leave the emergency department (ED) without complete evaluation or care (LWCET) have poorer outcomes in general. Previous studies have found that American Indian (AI) children have higher rates of LWCET than other racial or ethnic groups. Therefore, this study aims to examine LWCET in AI children by exploring differences by ED location and utilization patterns. METHODS: This is a retrospective cohort study of five EDs in the upper Midwest between June 2011 and May 2012. We included all visits by children aged 0-17 who identified as African American (AA), AI or White. Logistic regression was used to determine differences in LWCET by race and ED location controlling for other possible confounding factors including sex, age, insurance type, triage level, distance from ED, timing of visit, and ED activity level. RESULTS: LWCET occurred in 1.73% of 68,461 visits made by 47,228 children. The multivariate model revealed that AIs were more likely to LWCET compared to White children (Odds Ratio (OR) = 1.62, 95% Confidence Interval (CI) = 1.30-2.03). There was no significant difference in LWCET between AA and White children. Other factors significantly associated with LWCET included triage level, distance from the ED, timing of visit, and ED activity level. CONCLUSION: Our results show that AI children have higher rates of LWCET compared to White children; this association is different from other racial minority groups. There are likely complex factors affecting LWCET in AI children throughout the upper Midwest, which necessitates further exploration.

Emergency Department Utilization by Native American Children.

OBJECTIVES: The aims of this study were to determine differences in emergency department (ED) use by Native American (NA) children in rural and urban settings and identify factors associated with frequent ED visits. METHODS: This cross-sectional, cohort study examined visits to 6 EDs: 2 rural, 2 midsize urban, and 2 large urban EDs from June 2011 to May 2012. Univariate and multiple regression analyses were conducted. Frequent ED visitors had more than 4 visits in the study period. RESULTS: We studied 8294 NA visits (5275 patients) and 44,503 white visits (33,945 patients). Rural EDs had a higher proportion of NA patients, those below 200% of the income poverty level, and those who traveled more than 10 miles from their residence to attend the ED (all P < 0.05) compared with midsize and urban EDs. Native American patients had a high proportion of mental health diagnoses compared with whites (4.9% vs 1.9%, P < 0.001). Frequent ED visitors had greater odds of NA race, age younger than 1 year, public insurance, female sex, residence within less than 5 miles from the ED, and chronic disease. CONCLUSIONS: Native American children seem to have greater challenges compared with whites obtaining care in rural areas. Native American children were more likely to be frequent ED visitors, despite having to travel farther from their residence to the ED. Native American children visiting rural and midsize urban EDs had a much higher prevalence of mental health problems than whites. Additional efforts to provide both medical and mental health services to rural NA are urgently needed.

The Role of Socioeconomic Status in Individuals that Leave Against Medical Advice.

INTRODUCTION: Individuals leaving against medical advice (AMA) are at risk for adverse health outcomes including a 40 percent increased mortality rate a year after self-discharge. Additionally, leaving AMA may dramatically increase medical costs due to failure to complete treatment resulting in higher risk of readmission with additional co-morbidities. METHODS: Retrospective study of inpatients utilizing the Healthcare Cost and Utilization Project (HCUP) 2012 National Inpatient Sample (NIS) database. Primary outcome of interest was discharge type (AMA versus non-AMA) examined against primary payer type, patient and hospital characteristics. Analysis performed on the weighted discharges using Proc Surverylogistic. Statistical significance set at p less than 0.05. All analysis was performed in SAS version 9.4 (SAS Institute). RESULTS: After adjustment for possible cofounders and socioeconomic factors, there were increased odds of leaving against medical advice in those that lacked insurance (ORadj = 4.16, p less than 0.001) or had Medicare (ORadj = 2.10, p less than 0.001) or Medicaid (ORadj = 2.94, p less than 0.001). Compared to individuals in the lower income brackets, groups with higher incomes had a 20-30 percent decrease in leaving AMA. However, in comparison to white individuals, black (ORadj = 1.023, p = 0.2688) and Native Americans (ORadj = 0.994, p=0.9322) were not at an increased risk of leaving AMA. Hispanic (ORadj = 0.665, p less than 0.001) and the Asian/Pacific Islander (ORadj = 0.56, p less than 0.001) groups had decreased odds of leaving AMA. CONCLUSION: Groups at risk for leaving AMA were individuals lacking insurance, having public insurance, and those within the 0-25th percentile in income. Although ethnicity does play a factor in leaving against medical advice, our data indicates that the gap is not as extreme as previously stated. Additional work needs to be done to help health care providers set targeted preventative measures to address those at increased risk for leaving AMA in order to provide a higher standard of care for the patient.

Emergency Department Utilization for Mental Health in American Indian Children.

OBJECTIVES: To examine emergency department (ED) visits for mental health concerns by American Indian children in a multicenter cohort. To analyze demographic and clinical factors, the types of mental health concerns, and repeat mental health visits. STUDY DESIGN: Cross-sectional study of children 5-18 years old who visited 1 of 6 EDs in the Upper Midwest from June 2011 to May 2012 and self-identified as white or American Indian. Mental health visits were identified by primary diagnosis and reasons for visit and were categorized into diagnostic groups. We explored racial differences in ED visits for mental health, diagnostic groups, and repeat mental health visits. Analysis involved χ(2) tests, Cochran-Mantel-Haenszel tests, and regression models including age, triage, timing, and insurance, and their interactions with race. RESULTS: We identified 26 004 visits of which 1545 (5.4%) were for a mental health concern. The proportion of visits for mental health differed by race and age. American Indian children had lower odds of a mental health visit for 5-10 year olds (OR, 0.40; 95% CI, 0.26-0.60), but higher odds for 11-17 year olds (OR, 1.62; 95% CI, 1.34-1.95). In the older age group, American Indian children were seen primarily for depression and trauma- and stressor-related disorders, whereas white children were seen primarily for depression and disruptive, impulse control, and conduct disorders. Repeat visits were not different by race. CONCLUSIONS: Differences were noted in mental health visits between American Indian and white children and were influenced by age. These findings warrant further investigation into care-seeking patterns and treatment for mental health in American Indian children.

The Role of Bias by Emergency Department Providers in Care for American Indian Children.

BACKGROUND: American Indian children have high rates of emergency department (ED) use and face potential discrimination in health care settings. OBJECTIVE: Our goal was to assess both implicit and explicit racial bias and examine their relationship with clinical care. RESEARCH DESIGN: We performed a cross-sectional survey of care providers at 5 hospitals in the Upper Midwest. Questions included American Indian stereotypes (explicit attitudes), clinical vignettes, and the Implicit Association Test. Two Implicit Association Tests were created to assess implicit bias toward the child or the parent/caregiver. Differences were assessed using linear and logistic regression models with a random effect for study site. RESULTS: A total of 154 care providers completed the survey. Agreement with negative American Indian stereotypes was 22%-32%. Overall, 84% of providers had an implicit preference for non-Hispanic white adults or children. Older providers (50 y and above) had lower implicit bias than those middle aged (30-49 y) (P=0.01). American Indian children were seen as increasingly challenging (P=0.04) and parents/caregivers less compliant (P=0.002) as the proportion of American Indian children seen in the ED increased. Responses to the vignettes were not related to implicit or explicit bias. CONCLUSIONS: The majority of ED care providers had an implicit preference for non-Hispanic white children or adults compared with those who were American Indian. Provider agreement with negative American Indian stereotypes differed by practice and respondents' characteristics. These findings require additional study to determine how these implicit and explicit biases influence health care or outcomes disparities.

Racial Differences in Pediatric Emergency Department Triage Scores.

BACKGROUND: Racial disparities are frequently reported in emergency department (ED) care. OBJECTIVES: To examine racial differences in triage scores of pediatric ED patients. We hypothesized that racial differences existed but could be explained after adjusting for sociodemographic and clinical factors. METHODS: We examined all visits to two urban, pediatric EDs between August 2009 and March 2010. Demographic and clinical data were electronically extracted from the medical record. We used logistic regression to analyze racial differences in triage scores, controlling for possible covariates. RESULTS: There were 54,505 ED visits during the study period, with 7216 (13.2%) resulting in hospital admission. White patients accounted for 36.4% of visits, African Americans 28.5%, Hispanics 18.0%, Asians 4.1%, and American Indians 1.8%. After adjusting for potential confounders, African American (adjusted odds ratio [aOR] 1.89, 95% confidence interval [CI] 1.69-2.12), Hispanic (aOR 1.77, 95% CI 1.55-2.02), and American Indian (aOR 2.57, 95% CI 1.80-3.66) patients received lower-acuity triage scores than Whites. In three out of four subgroup analyses based on presenting complaints (breathing difficulty, abdominal pain, fever), African Americans and Hispanics had higher odds of receiving low-acuity triage scores. No racial differences were detected for patients with presenting complaints of laceration/head injury/arm injury. However, among patients admitted to the hospital, African Americans (aOR 1.47, 95% CI 1.13-1.90) and Hispanics (aOR 1.71, CI 1.22-2.39) received lower-acuity triage scores than Whites. CONCLUSION: After adjusting for available sociodemographic and clinical covariates, African American, Hispanic, and American Indian patients received lower-acuity triage scores than Whites.

Patient and Physician Perceptions of Genetic Testing in Primary Care.

INTRODUCTION: The convergence of biomedical informatics and translational genomics is changing the way we practice. Primary care will play a pivotal role in this transformation. We therefore sought to assess general knowledge about genetic testing among outpatient internal medicine providers, and the patients that they serve across a five state region in the Midwest. METHODS: One thousand take-home paper surveys were created and distributed to internal medicine patients at 13 Midwestern clinics. Sixty-two electronic surveys were also created and distributed to internal medicine providers at these same clinics. Questions assessed knowledge, interest, and comfort with genetic testing as well as the role of genetic counselors. Differences in response based on physician characteristics were compared using a Chi-squared analysis. RESULTS: In general, patients cared for in internal medicine clinics expressed an understanding of both content (75 percent) and rationale (81 percent) for genetic testing. Patients are open to hearing about genetic risks that could affect their health (88 percent) even if their visit was scheduled for a different reason. In these same clinics, providers expressed a strong understanding of the purpose of genetic testing (88 percent). However, providers were not confident in responding to questions about the impact of genetic testing on disease susceptibility (25 percent). Providers were more confident answering questions about genetic variability in drug response (46 percent). In general, outpatient internal medicine providers feel comfortable referring patients to genetic counselors to assess disease risk (88 percent) and they believe genetic testing is relevant to their practice (75 percent). CONCLUSIONS: In our Midwestern sample, we found that both patients and providers express interest in learning more about genetic testing in the context of primary care. Patient and physician responses indicate a role for genetic counselors in helping our patients understand and interpret genetic test results.

Establishing survey validity and reliability for American Indians through "think aloud" and test-retest methods.

The purpose of this study was to use a mixed-methods approach to determine the validity and reliability of measurements used within an alcohol-exposed pregnancy prevention program for American Indian women. To develop validity, content experts provided input into the survey measures, and a "think aloud" methodology was conducted with 23 American Indian women. After revising the measurements based on this input, a test-retest was conducted with 79 American Indian women who were randomized to complete either the original measurements or the new, modified measurements. The test-retest revealed that some of the questions performed better for the modified version, whereas others appeared to be more reliable for the original version. The mixed-methods approach was a useful methodology for gathering feedback on survey measurements from American Indian participants and in indicating specific survey questions that needed to be modified for this population.

Epigenetics in pediatrics.

Epigenetic mechanisms are external modifications of DNA that cause changes in gene function and are involved in many diseases. Specific examples of pediatric diseases with a known or suspected epigenetic component include Beckwith-Wiedemann syndrome, childhood leukemia, allergies, asthma, fetal alcohol spectrum disorders, childhood obesity, and type 2 diabetes mellitus. Currently, epigenetically active treatments are being used to treat childhood leukemia. Potential epigenetically active treatments and preventive regimens are under study for other diseases. Pediatricians need to be aware of the epigenetic basis of disease to help inform clinical decision making in the future.

Epidemiology of childhood acute myeloid leukemia.

Although leukemia is the most common childhood cancer diagnosis, the subtype, acute myeloid leukemia (AML), is less common and fewer etiologic studies exist. This review summarizes the major risk factors for AML. We searched the literature using PubMed for articles on childhood AML and reviewed 180 articles. While few risk factors are definitive, we identified several with consistent evidence of a possible effect. Thorough analysis of genetic and epigenetic factors is missing from this literature and methodological issues are unresolved. Future studies should more closely examine causal mechanisms, improve exposure measurement, and include analysis using genetic and epigenetic factors.

Racial disparities in ordering laboratory and radiology tests for pediatric patients in the emergency department.

OBJECTIVE: The objective of this study was to examine the association of race and language on laboratory and radiological testing in the pediatric emergency department (ED). METHODS: This retrospective, case-cohort study examined laboratory and radiological testing among patients discharged home from 2 urban, pediatric EDs between March 2, 2009, and March 31, 2010. RESULTS: There were 75,254 visits among 49,164 unique patients, of whom 31.0% had laboratory and 30.5% had radiological testing. African American (adjusted odds ratio [aOR], 0.93; confidence interval [CI], 0.89-0.98; P = 0.004) and biracial racial categories (aOR, 0.91; CI, 0.86-0.98; P = 0.007) were associated with decreased odds of laboratory testing compared with non-Hispanic whites. Similarly, Native American (aOR, 0.82; CI, 0.73-0.94), African American (aOR0.81; CI, 0.72-0.81), biracial (aOR, 0.82; CI, 0.77-0.88), Hispanic (aOR.76; CI, 0.72-0.81), and "other" (aOR, 0.84; CI, 0.73-0.97) racial categories were each associated with lower odds of radiological testing compared with non-Hispanic whites. Subgroup analysis of visits with a final diagnosis of fever and upper respiratory tract infection, conditions for which there were few treatment protocols, confirmed the racial differences. Subgroup analysis in visits for head injury, for which there is an established evaluation protocol, did not find a lower odds of laboratory or radiological testing by race compared with non-Hispanic whites. CONCLUSIONS: Racial disparities in laboratory and radiological testing were present in pediatric ED visits. No racial differences were seen in the radiological and laboratory charges in the head injury subgroup, suggesting that evaluation algorithms can ameliorate racial disparities in pediatric ED care.

Parental infertility, infertility treatment and hepatoblastoma: a report from the Children's Oncology Group.

BACKGROUND: A recent study suggested a markedly increased risk of hepatoblastoma (HB) among children conceived with treatment for infertility. However, it is not clear whether this finding is confounded by the association between HB and low birthweight (LBW). METHODS: Associations between parental infertility and its treatment and HB were examined using data from a case-control study conducted through the Children's Oncology Group (COG). Telephone interviews were completed for 383 mothers of cases diagnosed with HB at US COG institutions between January 2000 and December 2008 and for 387 mothers of controls recruited through state birth registries. Logistic regression was used to examine possible associations. RESULTS: After adjusting for birthweight and other potential confounders, no significant association was found for any of the measures of parental infertility or its treatment. In HB cases conceived through assisted reproductive technology (ART), 4 of 16 also had Beckwith-Wiedemann syndrome (BWS) compared with 9 of 365 in HB cases without ART. CONCLUSIONS: Little evidence of an association between parental infertility or its treatment and HB was found. The relationship found in a previous study could be due to LBW and BWS which are risk factors for HB and also associated with parental infertility and its treatment.

Similar DNA methylation levels in specific imprinting control regions in children conceived with and without assisted reproductive technology: a cross-sectional study.

BACKGROUND: While a possible link between assisted reproductive technology (ART) and rare imprinting disorders has been found, it is not clear if this is indicative of subtler disruptions of epigenetic mechanisms. Results from previous studies have been mixed, but some methylation differences have been observed. METHODS: Children conceived through ART and children conceived spontaneously were recruited for this cross-sectional study. Information about reproductive history, demographic factors, birth characteristics, and infertility treatment was obtained from maternal interview and medical records. Peripheral blood lymphocytes and buccal cell samples were collected from participating children. Methylation analysis was performed on five loci using pyrosequencing. Statistical analysis of methylation differences was performed using linear regression with generalized estimating equations. Results are reported as differences with 95% confidence intervals (CI). RESULTS: A total of 67 ART children and 31 spontaneously conceived (SC) children participated. No significant difference in methylation in lymphocyte samples was observed between groups for any loci. Possible differences were found in buccal cell samples for IGF2 DMR0 (Difference: 2.07; 95% confidence interval (CI): -0.28, 4.42; p = 0.08) and IGF2R (Difference: -2.79; 95% CI: -5.74, 0.16; p = 0.06). Subgroup analysis indicated potential lower methylation in those whose parents used ART for unexplained infertility. CONCLUSIONS: Observed differences in methylation between the ART and SC groups were small for all loci in the two sample types examined and no statistical differences were observed. It is still unclear whether or not small differences observed in several studies represent a real difference between groups and if this difference is biologically meaningful. Larger studies with long term follow-up are needed to fully answer these questions.

Birth order and risk of childhood cancer: a pooled analysis from five US States.

The causes of childhood cancers are largely unknown. Birth order has been used as a proxy for prenatal and postnatal exposures, such as frequency of infections and in utero hormone exposures. We investigated the association between birth order and childhood cancers in a pooled case-control dataset. The subjects were drawn from population-based registries of cancers and births in California, Minnesota, New York, Texas and Washington. We included 17,672 cases <15 years of age who were diagnosed from 1980 to 2004 and 57,966 randomly selected controls born 1970-2004, excluding children with Down syndrome. We calculated odds ratios and 95% confidence intervals using logistic regression, adjusted for sex, birth year, maternal race, maternal age, multiple birth, gestational age and birth weight. Overall, we found an inverse relationship between childhood cancer risk and birth order. For children in the fourth or higher birth order category compared to first-born children, the adjusted OR was 0.87 (95% CI: 0.81, 0.93) for all cancers combined. When we examined risks by cancer type, a decreasing risk with increasing birth order was seen in the central nervous system tumors, neuroblastoma, bilateral retinoblastoma, Wilms tumor and rhabdomyosarcoma. We observed increased risks with increasing birth order for acute myeloid leukemia but a slight decrease in risk for acute lymphoid leukemia. These risk estimates were based on a very large sample size, which allowed us to examine rare cancer types with greater statistical power than in most previous studies, however the biologic mechanisms remain to be elucidated.

Effects of a Decentralized Nursing Model on Patient Outcomes in Two Rural Community Hospitals.

AIM: To assess hypothesized effects of decentralized nursing models on adult inpatient outcomes, patient medical records and satisfaction surveys were analyzed from two rural community hospitals that transitioned from centralized to decentralized nursing unit designs in 2015. BACKGROUND: The objective to place nurses closer to patients precipitates broad use of decentralized nursing unit designs over models with centralized nurse stations. Decentralized models have been hypothesized to improve patient outcomes, but few studies have empirically measured effects. METHODS: A cross-sectional, pre-post study used regression and interrupted time series models of adult inpatient data. Encounter-level patient records and survey responses across both sites were analyzed for a change in length of stay (LOS) and patient satisfaction from the preperiod (centralized) to the postperiod (decentralized). RESULTS: LOS decreased in the postperiod compared to the preperiod at one site, and there was no change in LOS at the other. Patient satisfaction mostly improved at both hospitals in the decentralized model; however, most upward trends started prior to the move, with no change postmove. Patient satisfaction significantly improved regarding quietness at night and overall hospital rating at one hospital and decreased regarding receiving help as soon as wanted at the other hospital. These changes occurred at the time of the move but may not be solely attributable to the decentralized nursing model. CONCLUSIONS: Overall, the results were mixed. One hospital experienced positive changes while the other did not, suggesting factors apart from nursing unit design are important to assess.

From Fable to Reality at Parkland Hospital: The Impact of Evidence-Based Design Strategies on Patient Safety, Healing, and Satisfaction in an Adult Inpatient Environment.

OBJECTIVE: This research aimed to evaluate the quantitative effects of new hospital design on adult inpatient outcomes. BACKGROUND: Tenets of evidence-based healthcare design, notably single-patient acuity-adaptable and same-handed rooms, decentralized nursing stations, onstage offstage layout, and access to nature were expected to promote patient healing and increase patient satisfaction, while decreasing adverse events. METHODS: Patient healing was operationalized through length of stay (LOS) and patient safety through three adverse events: falls, hospital-acquired infections (HAI), and medication-related events. Standard patient surveys captured patient satisfaction. Patient records from 2013 through 2017 allowed for equivalent time periods surrounding the move to the new hospital in August 2015. Stratified by hospital division where significant, pre/post comparisons utilized proportional hazards or logistic regression models as appropriate; interrupted time series analyses afforded longitudinal interpretations. RESULTS: Observed higher postmove LOS was due to previously increasing trends, not increases after the move. In surgical and trauma units, a constant increase in falls was unaffected by the move. Medication events decreased consistently over time; medication events with harm dropped significantly after the move. No change in HAI was found. Significant improvement on most relevant patient satisfaction items occurred after the move. Call button response decreased immediately after the move but subsequently improved. CONCLUSION: Results did not clearly indicate a net change in adult inpatient outcomes of healing and safety due to the hospital design. There was evidence that the new hospital improved patient satisfaction outcomes related to the environment, including comfort, noise, temperature, and aesthetics.

Infant leukemia and parental infertility or its treatment: a Children's Oncology Group report.

BACKGROUND: Little is known about the potential risk factors for infant leukemia. With its very young age at diagnosis, exposures occurring in the perinatal period are suspected. Parental infertility and infertility treatment have been studied with regard to childhood cancer in general, but rarely in individual cancer subtypes. METHODS: A case-control study of infant leukemia was conducted through the Children's Oncology Group, including cases diagnosed from January 1996 to December 2006 and controls selected through random digit dialing and birth certificate tracing. Maternal phone interviews were conducted to obtain information about infertility, infertility treatment and demographic factors. All cases as well as subgroups defined by mixed lineage leukemia (MLL) translocation status and leukemia subtype were examined. Statistical analysis was performed using multivariate logistic regression models. RESULTS: No significant associations between infertility or its treatment and combined infant leukemia were found. In subgroup analyses, there was a significant increase in the risk of MLL--leukemia for children born to women not trying to conceive compared with those trying for <1 year for all types combined [odds ratio (OR) = 1.62, 95% confidence interval (CI) = 1.01-2.59] and for acute lymphoblastic leukemia (OR = 2.50, 95% CI = 1.36-4.61). CONCLUSIONS: There were no positive associations between parental infertility or infertility treatment and infant leukemia. While this is the largest study to date, both selection and recall bias may have impacted the results. However, for infant leukemia, we can potentially rule out large increases in risk associated with parental infertility or its treatment.

Single-family room neonatal intensive care unit design: do patient outcomes actually change?

OBJECTIVE: This study examined outcomes in a single-family room neonatal intensive care unit (NICU) compared to an open bay within a public safety net hospital. STUDY DESIGN: We included 9995 NICU encounters over 5 years pre and post move for a predominantly low SES population. Outcomes were length of stay (LOS), growth, time to first oral feeding, and incidence of sepsis. Analysis included regression models, interrupted time series, and growth models. RESULTS: LOS decreased over time in preterm infants both pre and post move, but increased post move for term/post-term infants (p < 0.001). First oral feeding decreased over time in both periods. A higher incidence of sepsis was found in the post period for term/post-term infants (p = 0.01). CONCLUSION: Our analysis appropriately accounted for time trends. Few differences were observed. Changes in LOS for term/post-term infants should be further explored as well as the impact of NICU care patterns.