The Educare intervention: Outcomes at age 3.

The effectiveness of Educare, a center-based early education program, in improving child outcomes at age 3 was evaluated in a randomized clinical trial. Educare programs serve children from birth to age 5 and are designed to reduce the achievement gap between children from low-income families and their more advantaged peers. This study began following 239 children from low-income families who were randomly assigned as infants (<19 months) to Educare or a business-as-usual control group. At age 3, assessments of the skills of 202 children remaining in the study revealed significant differences in favor of children in the treatment group on auditory language skills, early math skills, and parent-reported problem behaviors. Effect sizes were in the modest range, although not as strong as the previously reported age 2 findings. No effects were found for observations of parent-child interactions, observer-rated child behaviors, or parent-rated social competence. For English-language skills, children who were dual language learners (DLLs) benefitted more from treatment than non-DLLs. Analyses of outcomes by child care type, regardless of treatment group assignment, showed that children in Educare had better language, math, and behavioral scores than children in less formal care, whereas children in other center-based care only had higher language scores than children in less formal care. Differences in outcomes between Educare and other center-based care were not significant.

Child and Parenting Outcomes After 1 Year of Educare.

Educare is a birth to age 5 early education program designed to reduce the achievement gap between children from low-income families and their more economically advantaged peers through high-quality center-based programming and strong school-family partnerships. This study randomly assigned 239 children (< 19 months) from low-income families to Educare or a business-as-usual control group. Assessments tracked children 1 year after randomization. Results revealed significant differences favoring treatment group children on auditory and expressive language skills, parent-reported problem behaviors, and positive parent-child interactions. Effect sizes were in the modest to medium range. No effects were evident for observer-rated child behaviors or parent-rated social competence. The overall results add to the evidence that intervening early can set low-income children on more positive developmental courses.

Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

BACKGROUND: PRO-CTCAE is a library of items that measure cancer treatment-related symptomatic adverse events (NCI Contracts: HHSN261201000043C and HHSN 261201000063C). The objective of this study is to examine the equivalence and acceptability of the three data collection modes (Web-enabled touchscreen tablet computer, Interactive voice response system [IVRS], and paper) available within the US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system. METHODS: Participants (n = 112; median age 56.5; 24 % high school or less) receiving treatment for cancer at seven US sites completed 28 PRO-CTCAE items (scoring range 0-4) by three modes (order randomized) at a single study visit. Subjects completed one page (approx. 15 items) of the EORTC QLQ-C30 between each mode as a distractor. Item scores by mode were compared using intraclass correlation coefficients (ICC); differences in scores within the 3-mode crossover design were evaluated with mixed-effects models. Difficulties with each mode experienced by participants were also assessed. RESULTS: 103 (92 %) completed questionnaires by all three modes. The median ICC comparing tablet vs IVRS was 0.78 (range 0.55-0.90); tablet vs paper: 0.81 (0.62-0.96); IVRS vs paper: 0.78 (0.60-0.91); 89 % of ICCs were ≥0.70. Item-level mean differences by mode were small (medians [ranges] for tablet vs. IVRS = -0.04 [-0.16-0.22]; tablet vs paper = -0.02 [-0.11-0.14]; IVRS vs paper = 0.02 [-0.07-0.19]), and 57/81 (70 %) items had bootstrapped 95 % CI around the effect sizes within +/-0.20. The median time to complete the questionnaire by tablet was 3.4 min; IVRS: 5.8; paper: 4.0. The proportion of participants by mode who reported "no problems" responding to the questionnaire was 86 % tablet, 72 % IVRS, and 98 % paper. CONCLUSIONS: Mode equivalence of items was moderate to high, and comparable to test-retest reliability (median ICC = 0.80). Each mode was acceptable to a majority of respondents. Although the study was powered to detect moderate or larger discrepancies between modes, the observed ICCs and very small mean differences between modes provide evidence to support study designs that are responsive to patient or investigator preference for mode of administration, and justify comparison of results and pooled analyses across studies that employ different PRO-CTCAE modes of administration. TRIAL REGISTRATION: NCT Clinicaltrials.gov identifier: NCT02158637.

Applying Lean Six Sigma to Improve Depression Screening and Follow-Up in Oncology Clinics.

ABSTRACT: Depression is a common and serious illness that impairs the health of individuals and societies globally. It is associated with a significant economic burden, with productivity losses exceeding $40 billion dollars annually in the United States (U.S.) alone. This project focused on the use of a systematic, data-driven approach to improve the screening rate for depression in an academic, metropolitan cancer center located in North Texas. A multidisciplinary team collaboratively applied Lean Six Sigma education, methods, and tools within oncology and psychiatry clinics to address the increased risk of depression among oncology patients. Improving the standardization of screening and follow-up processes, resulted in a 44% sustained increase in the depression screening and follow-up performance rate. This improvement was verified to be statistically significant through the use of control charts toward the end of the project.

Children's classroom engagement and school readiness gains in prekindergarten.

Child engagement in prekindergarten classrooms was examined using 2,751 children (mean age=4.62) enrolled in public prekindergarten programs that were part of the Multi-State Study of Pre-Kindergarten and the State-Wide Early Education Programs Study. Latent class analysis was used to classify children into 4 profiles of classroom engagement: free play, individual instruction, group instruction, and scaffolded learning. Free play children exhibited smaller gains across the prekindergarten year on indicators of language/literacy and mathematics compared to other children. Individual instruction children made greater gains than other children on the Woodcock Johnson Applied Problems. Poor children in the individual instruction profile fared better than nonpoor children in that profile; in all other snapshot profiles, poor children fared worse than nonpoor children.

Measures of classroom quality in prekindergarten and children's development of academic, language, and social skills.

This study examined development of academic, language, and social skills among 4-year-olds in publicly supported prekindergarten (pre-K) programs in relation to 3 methods of measuring pre-K quality, which are as follows: (a) adherence to 9 standards of quality related to program infrastructure and design, (b) observations of the overall quality of classroom environments, and (c) observations of teachers' emotional and instructional interactions with children in classrooms. Participants were 2,439 children enrolled in 671 pre-K classrooms in 11 states. Adjusting for prior skill levels, child and family characteristics, program characteristics, and state, teachers' instructional interactions predicted academic and language skills and teachers' emotional interactions predicted teacher-reported social skills. Findings suggest that policies, program development, and professional development efforts that improve teacher-child interactions can facilitate children's school readiness.

Children enrolled in public pre-K: the relation of family life, neighborhood quality, and socioeconomic resources to early competence.

This article presents data on the family and social environments of 501 children enrolled in public sponsored pre-K in 5 states and tests the relation of these resources to child competence. Structured interviews and questionnaires provide information from parents about the family's social and economic status. Direct assessments and teacher reports provide data on children's literacy, numeracy, and behavioral problems. A majority of the children served in public pre-K lived in poverty and showed decrements in language but not in other domains. A socioeconomic resource factor consisting of parental education, household income, and material need predicted all domains of children's functioning. Children from households high in socioeconomic resources entered pre-K with more well developed language and math skill but fewer behavioral problems than their disadvantaged peers. Neighborhood quality status was related to language competence and mother's marital status to math competence. Neighborhood quality and income level may have their impact on child competence through their relation to dyadic quality and the health and the psychological well-being of the parents.

Quality improvement in the national cancer institute community cancer centers program: the quality oncology practice initiative experience.

PURPOSE: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) began in 2007; it is a network of community-based hospitals funded by the NCI. Quality of care is an NCCCP priority, with participation in the American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) playing a fundamental role in quality assessment and quality improvement (QI) projects. Using QOPI methodology, performance on quality measures was analyzed two times per year over a 3-year period to enhance our implementation of quality standards at NCCCP hospitals. METHODS: A data-sharing agreement allowed individual-practice QOPI data to be electronically sent to the NCI. Aggregated data with the other NCCCP QOPI participants were presented to the network via Webinars. The NCCCP Quality of Care Subcommittee selected areas in which to focus subsequent QI efforts, and high-performing practices shared voluntarily their QI best practices with the network. RESULTS: QOPI results were compiled semiannually between fall 2010 and fall 2013. The network concentrated on measures with a quality score of ≤ 0.75 and planned voluntary group-wide QI interventions. We identified 13 measures in which the NCCCP fell at or below the designated quality score in fall 2010. After implementing a variety of QI initiatives, the network registered improvements in all parameters except one (use of treatment summaries). CONCLUSION: Using the NCCCP as a paradigm, QOPI metrics provide a useful platform for group-wide measurement of quality performance. In addition, these measurements can be used to assess the effectiveness of QI initiatives.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.

Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual.

PURPOSE: Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials. METHODS: The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility. RESULTS: Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P = .15) or between Hispanic and non-Hispanic patients (P = .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers. CONCLUSION: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.

Early-phase clinical trials in the community: results from the national cancer institute community cancer centers program early-phase working group baseline assessment.

PURPOSE: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. METHODS: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. RESULTS: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. CONCLUSION: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

Contributions of hot and cool self-regulation to preschool disruptive behavior and academic achievement.

The construct of self-regulation can be meaningfully distinguished into hot and cool components. The current study investigated self-regulation in a sample of 926 children aged 3-5 years old. Children's performance on self-regulatory tasks was best described by two latent factors representing hot and cool regulation. When considered alone, hot and cool regulation were both significantly correlated with disruptive behavior and academic achievement. When considered together, cool regulation was uniquely associated with academic achievement, while hot regulation was uniquely associated with inattentive-overactive behaviors. Results are discussed with respect to treatment studies that directly target improvement in children's self-regulation.

Teachers' education, classroom quality, and young children's academic skills: results from seven studies of preschool programs.

In an effort to provide high-quality preschool education, policymakers are increasingly requiring public preschool teachers to have at least a Bachelor's degree, preferably in early childhood education. Seven major studies of early care and education were used to predict classroom quality and children's academic outcomes from the educational attainment and major of teachers of 4-year-olds. The findings indicate largely null or contradictory associations, indicating that policies focused solely on increasing teachers' education will not suffice for improving classroom quality or maximizing children's academic gains. Instead, raising the effectiveness of early childhood education likely will require a broad range of professional development activities and supports targeted toward teachers' interactions with children.