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)
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.
Expanding Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank Development to the Pregnant Population [Methods Study], United States, 2017-2022 (ICPSR 39586)
Understanding patients' expectations and their experiences can help hospitals improve care. Hospitals often send surveys to patients to ask about their care. To create surveys quickly, hospitals sometimes pick questions from an item bank. An item bank is a list of survey questions available to use about a specific topic.
In this study, the research team created an item bank about childbirth care. The team used the item bank to create and carry out a survey about women's preferences and experiences with care during and after childbirth. The team looked at which questions related closely to women's overall ratings of their hospital care.
Two-Stage Meta-Regression Framework for Precision Medicine Using Data from Clinical Data Research [Methods Study], United States, 2018-2023 (ICPSR 39739)
Network meta-analysis, or NMA, is a statistical method that researchers use to combine results from many clinical trials done within a research network. A research network is a group of scientists and doctors from different places, like hospitals and research centers, who do studies together and share data. Researchers can use NMA to compare how well different treatments work for a specific health problem. But current NMA methods don't work well when comparing three or more treatments across many health outcomes.
In this study, the research team developed new NMA methods to compare three or more treatments that bring on labor to start the process of childbirth across many health outcomes using research network data.