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Search Results

Showing 1 - 4 of 4 results.

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    Study Title/Investigator
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    1.
    Comparative Effectiveness of Anti-TNF in Combination with Low Dose Methotrexate vs Anti-TNF Monotherapy in Pediatrics Crohn's Disease (COMBINE), United States, 2015-2022 (ICPSR 38680)
    Kappelman, Michael D.
    The COMBINE study was a longitudinal examination of pediatric Crohn's Disease (CD) patients in the United States with data collected from 2015-2022. This study was a randomized, double blind, placebo controlled pragmatic trial to compare low dose oral methotrexate versus a placebo in children with Crohn's disease initiating anti-TNF (tumor necrosis factor) therapy with Infliximab or Adalimumab. Eligible participants were randomized with a 1:1 allocation and followed for a minimum of 12 months and maximum of 36 months in the context of routine clinical care. The primary outcome was a composite of indicators of treatment failure and/or toxicity. Secondary outcomes included patient reported outcomes of pain interference and fatigue. Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that affects approximately 600,000 Americans with estimated direct costs of $3.6 billion annually. Typical symptoms (e.g., abdominal pain, bloody diarrhea) result in substantial morbidity, including hospitalization and surgery, missed work and school, and diminished quality of life. The primary treatment goals for all CD patients are to induce remission by eradicating intestinal inflammation and related symptoms and maintain remission by preventing disease flares and progression. Additional treatment goals for pediatric CD include restoring physical and emotional development.
    2024-05-14
    2.
    Integrating Data to Reduce Violence, Milwaukee, WI, 2015-2016 (ICPSR 36591)
    Hernandez-Meier, Jennifer; Hargarten, Stephen
    These data are part of NACJD's Fast Track Release and are distributed as they were received from the data depositor. The files have been zipped by NACJD for release, but not checked or processed except for the removal of direct identifiers. Users should refer to the accompanying readme file for a brief description of the files available with this collection and consult the investigator(s) if further information is needed. The study investigated the feasibility of implementing the Cardiff Model. The Cardiff Model is a unique violence surveillance system and intervention that involves data sharing and violence prevention planning between law enforcement and the medical field. Anonymized data on assaults from emergency and police departments (EDs; PDs) are combined to detail assault incidents and "hotspots." Data are discussed by a multidisciplinary consortium, which develops and implements a data-informed violence prevention action plan that includes behavioral, environmental, and policy changes to impact violence. Model actions led to decreases in injurious assaults and this model is now statutory in the United Kingdom. The Cardiff Model has never been translated to the U.S. and would require an investigation within our health care system and in different geographical and population contexts. This study investigated the feasibility of essential Cardiff Model Components in order to refine study procedures and situate this community to request further funds for full model implementation. As part of this study, researchers collected a number of feasibility measures from ED and study staff to evaluate the feasibility of translating included model components. Geospatial and statistical analyses investigated the added benefit of the combined ED, PD and Emergency Medical Services (EMS) data. The study contains 1 SPSS data files (CHW Data_1.1.15 to 7.31.16.sav (n=748; 14 variables)), 1 STATA data file (nurse survey data.dta (n=43; 26 variables)), a text document (Nurse Survey_Qualitative data.txt), and 1 excel file (CHW Incidents_Block level data only.xlsx).
    2018-03-16
    3.
    Quality of Communication in Pediatric Oncology (QCOM), Massachusetts, Tennessee, and Missouri, 2018-2020 (ICPSR 38457)
    Sisk, Bryan A.
    For parents of pediatric oncology patients, high-quality communication supports peace of mind, hopefulness, trust in physicians, and feeling validated. In order to improve communication and understand how it functions between caregivers, patients, and clinicians, the research team interviewed 80 parents of children with cancer from three different academic centers, with interviews focusing on experiences with communication with medical team staff. They recruited participants across sites, child age at diagnosis, and time points (during treatment, post-treatment or survivorship, and bereavement). Interviews followed semi-structured interview guides and were analyzed using content analysis with consensus and individual coding.
    2022-06-29
    4.
    Raw data for meta-analysis of discriminative validity of caregiver, youth, and teacher report for pediatric bipolar disorder -- all English publications through End of 2014 (ICPSR 36245)
    Youngstrom, Eric A.
    Objective: To meta-analyze the diagnostic efficiency of checklists for discriminating pediatric bipolar disorder (PBD) from other conditions. Hypothesized moderators included (a) informant - we predicted caregiver report would produce larger effects than youth or teacher report; (b) scale content - scales that include manic symptoms should be more discriminating; and (c) sample design - samples that include healthy control cases or impose stringent exclusion criteria are likely to produce inflated effect sizes. Methods: Searches in PsycINFO, PubMed, and GoogleScholar generated 4094 hits. Inclusion criteria were (1) sufficient statistics to estimate a standardized effect size, (2) age 18 years or less, and (3) at least 10 cases (4) with diagnoses of PBD based on semi-structured diagnostic interview. Multivariate mixed regression models accounted for nesting of multiple effect sizes from different informants or scales within the same sample. Results: Data included 63 effect sizes from 8 rating scales across 27 separate samples (N=11,941 youths, 1,834 with PBD). The average effect size was g=1.05. Random effect variance components within study and between study were significant, ps<.00005. Informant, scale content, and sample design all explained significant unique variance, even after controlling for design and reporting quality. Discussion: Checklists have clinical utility for assessing PBD. Caregiver reports discriminated PBD significantly better than teacher and youth self report, although all three showed discriminative validity. Studies using "distilled" designs with healthy control comparison groups, or stringent exclusion criteria, produced significantly larger effect size estimates that could lead to inflated false positive rates if used as described in clinical practice.
    2015-08-17
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