Browsing by Subject "Multicenter studies"

Now showing 1 - 3 of 3
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    Design and implementation of multicenter pediatric and congenital studies with cardiovascular magnetic resonance: Big data in smaller bodies
    (Elsevier, 2024) DiLorenzo, Michael P.; Lee, Simon; Rathod, Rahul H.; Raimondi, Francesca; Farooqi, Kanwal M.; Jain, Supriya S.; Samyn, Margaret M.; Johnson, Tiffanie R.; Olivieri, Laura J.; Fogel, Mark A.; Lai, Wyman W.; Renella, Pierangelo; Powell, Andrew J.; Buddhe, Sujatha; Stafford, Caitlin; Johnson, Jason N.; Helbing, Willem A.; Pushparajah, Kuberan; Voges, Inga; Muthurangu, Vivek; Miles, Kimberley G.; Greil, Gerald; McMahon, Colin J.; Slesnick, Timothy C.; Fonseca, Brian M.; Morris, Shaine A.; Soslow, Jonathan H.; Grosse-Wortmann, Lars; Beroukhim, Rebecca S.; Grotenhuis, Heynric B.; Pediatrics, School of Medicine
    Cardiovascular magnetic resonance (CMR) has become the reference standard for quantitative and qualitative assessment of ventricular function, blood flow, and myocardial tissue characterization. There is a preponderance of large CMR studies and registries in adults; However, similarly powered studies are lacking for the pediatric and congenital heart disease (PCHD) population. To date, most CMR studies in children are limited to small single or multicenter studies, thereby limiting the conclusions that can be drawn. Within the PCHD CMR community, a collaborative effort has been successfully employed to recognize knowledge gaps with the aim to embolden the development and initiation of high-quality, large-scale multicenter research. In this publication, we highlight the underlying challenges and provide a practical guide toward the development of larger, multicenter initiatives focusing on PCHD populations, which can serve as a model for future multicenter efforts.
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    Establishing a framework for privacy-preserving record linkage among electronic health record and administrative claims databases within PCORnet®, the National Patient-Centered Clinical Research Network
    (BMC, 2022-10-31) Kiernan, Daniel; Carton, Thomas; Toh, Sengwee; Phua, Jasmin; Zirkle, Maryan; Louzao, Darcy; Haynes, Kevin; Weiner, Mark; Angulo, Francisco; Bailey, Charles; Bian, Jiang; Fort, Daniel; Grannis, Shaun; Krishnamurthy, Ashok Kumar; Nair, Vinit; Rivera, Pedro; Silverstein, Jonathan; Marsolo, Keith; Medicine, School of Medicine
    Objective: The aim of this study was to determine whether a secure, privacy-preserving record linkage (PPRL) methodology can be implemented in a scalable manner for use in a large national clinical research network. Results: We established the governance and technical capacity to support the use of PPRL across the National Patient-Centered Clinical Research Network (PCORnet®). As a pilot, four sites used the Datavant software to transform patient personally identifiable information (PII) into de-identified tokens. We queried the sites for patients with a clinical encounter in 2018 or 2019 and matched their tokens to determine whether overlap existed. We described patient overlap among the sites and generated a "deduplicated" table of patient demographic characteristics. Overlapping patients were found in 3 of the 6 site-pairs. Following deduplication, the total patient count was 3,108,515 (0.11% reduction), with the largest reduction in count for patients with an "Other/Missing" value for Sex; from 198 to 163 (17.6% reduction). The PPRL solution successfully links patients across data sources using distributed queries without directly accessing patient PII. The overlap queries and analysis performed in this pilot is being replicated across the full network to provide additional insight into patient linkages among a distributed research network.
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    Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial
    (Elsevier, 2023) Martin, Samantha L.; Allman, Phillip H.; Dugoff, Lorraine; Sibai, Baha; Lynch, Stephanie; Ferrara, Jennifer; Aagaard, Kjersti; Zornes, Christina; Wilson, Jennifer L.; Gibson, Marie; Adams, Molly; Longo, Sherri A.; Staples, Amy; Saade, George; Beche, Imene; Carter, Ebony B.; Owens, Michelle Y.; Simhan, Hyagriv; Frey, Heather A.; Khan, Shama; Palatnik, Anna; August, Phyllis; Irby, Les'Shon; Lee, Tiffany; Lee, Christine; Schum, Paula; Chan-Akeley, Rosalyn; Duhon, Catera; Rincon, Monica; Gibson, Kelly; Wiegand, Samantha; Eastham, Donna; Oparil, Suzanne; Szychowski, Jeff M.; Tita, Alan; Chronic Hypertension and Pregnancy Consortium; Obstetrics and Gynecology, School of Medicine
    Background: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. Objective: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. Study design: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. Results: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. Conclusion: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.