keyword
https://read.qxmd.com/read/38153801/a-pragmatic-method-to-integrate-data-from-preexisting-cohort-studies-using-the-clinical-data-interchange-standards-consortium-cdisc-study-data-tabulation-model-case-study
#1
JOURNAL ARTICLE
Keiichi Matsuzaki, Megumi Kitayama, Keiichi Yamamoto, Rei Aida, Takumi Imai, Mami Ishida, Ritsuko Katafuchi, Tetsuya Kawamura, Takashi Yokoo, Ichiei Narita, Yusuke Suzuki
BACKGROUND: In recent years, many researchers have focused on the use of legacy data, such as pooled analyses that collect and reanalyze data from multiple studies. However, the methodology for the integration of preexisting databases whose data were collected for different purposes has not been established. Previously, we developed a tool to efficiently generate Study Data Tabulation Model (SDTM) data from hypothetical clinical trial data using the Clinical Data Interchange Standards Consortium (CDISC) SDTM...
December 21, 2023: JMIR Medical Informatics
https://read.qxmd.com/read/37860355/retracted-sdtm-a-novel-topic-model-framework-for-syndrome-differentiation-in-traditional-chinese-medicine
#2
Journal Of Healthcare Engineering
[This retracts the article DOI: 10.1155/2022/6938506.].
2023: Journal of Healthcare Engineering
https://read.qxmd.com/read/37768110/a-pragmatic-method-to-integrate-data-from-pre-existing-cohort-studies-using-the-clinical-data-interchange-standards-consortium-cdisc-study-data-tabulation-model-practical-use-of-redcap2sdtm
#3
JOURNAL ARTICLE
Keiichi Matsuzaki, Megumi Kitayama, Keiichi Yamamoto, Rei Aida, Takumi Imai, Mami Ishida, Ritsuko Katafichi, Tetsuya Kawamura, Takashi Yokoo, Ichiei Narita, Yusuke Suzuki
BACKGROUND: In recent years, many researchers have focused on legacy data utilization, such as pooled analyses that collect and re-analyze data from multiple studies. However, the methodology for the integration of pre-existing databases whose data were collected for different purposes has not been established. Previously, we developed a tool to efficiently generate Study Data Tabulation Model (SDTM) data from hypothetical clinical trial data using the Clinical Data Interchange Standards Consortium (CDISC) SDTM...
September 14, 2023: JMIR Medical Informatics
https://read.qxmd.com/read/37008796/interactive-statistical-monitoring-to-optimize-review-of-potential-clinical-trial-issues-during-study-conduct
#4
JOURNAL ARTICLE
David Pau, Marie Lotz, Gaëlle Grandclaude, Romain Jegou, Alexandre Civet
BACKGROUND: Statistical monitoring involves the review of prospective study data collected in participating sites to detect intra/inter patients and sites inconsistencies. We report methods and results of statistical monitoring in a phase IV clinical trial. METHOD: PRO-MSACTIVE is a study evaluating ocrelizumab in active relapsing multiple sclerosis (RMS) patients in France. Specific statistical methods (volcano plots, mahalanobis distance, funnel plot …) have been applied to a SDTM database to detect potential issues...
June 2023: Contemporary Clinical Trials Communications
https://read.qxmd.com/read/36596723/just-say-no-to-data-listings
#5
JOURNAL ARTICLE
Mercidita Navarro, Nancy Brucken, Aiming Yang, Greg Ball
Sponsor companies often create voluminous static listings for Clinical Study Reports (CSRs) and regulatory submissions, and possibly for internal use to review participant-level data. This is likely due to the perception that they are required and/or lack of knowledge of various alternatives. However, there are other ways of viewing clinical study data that can provide an improved user experience, and are made possible by standard data structures such as the Study Data Tabulation Model (SDTM). The purpose of this paper is to explore some alternatives to providing a complete set of static listings and make a case for sponsors to begin considering these alternatives...
January 3, 2023: Pharmaceutical Statistics
https://read.qxmd.com/read/35836172/the-application-of-the-spot-the-difference-teaching-method-in-clinical-skills-training-for-residents
#6
JOURNAL ARTICLE
Liu Yang, Wen Li, Jian Zou, Junnan An, Bin Zeng, Yitao Zheng, Jiming Yang, Jia Ren
BACKGROUND: Clinical skill training (CST) is indispensable for first-year surgical residents. It can usually be carried out through video-based flipped learning (FL) within a web-based learning environment. However, we found that residents lack the process of reflection, blindly imitating results in losing interest and passion for learning in the traditional teaching pattern. The teaching method of "spot the difference" (SDTM), which is based on the fundamentals of the popular game of "spot the difference," is designed to improve students' participation and reflective learning during skill training...
July 14, 2022: BMC Medical Education
https://read.qxmd.com/read/35392016/a-use-case-analysis-of-clinical-data-interchange-standards-consortium-study-data-tabulation-model-in-academia-in-an-investigator-initiated-clinical-trial
#7
JOURNAL ARTICLE
Shizuko Takahara, Toshiki I Saito, Yasuhito Imai, Takahiro Kawakami, Toshinori Murayama
Submitting data compliant with the Clinical Data Interchange Standards Consortium (CDISC) standards is mandatory for new drug applications (NDAs). The standards set by CDISC are widely adopted in the pharmaceutical business world. Introduction of CDISC standards in academia can be necessary to reduce labor, resolve the shortage of data managers in academia, and gain new knowledge through standardized data accumulation. However, the introduction of CDISC standards has not progressed in communities within the academia that do not apply for NDAs...
February 2022: Nagoya Journal of Medical Science
https://read.qxmd.com/read/35028123/sdtm-a-novel-topic-model-framework-for-syndrome-differentiation-in-traditional-chinese-medicine
#8
JOURNAL ARTICLE
Jialin Ma, Xiaoqiang Gong, Zhaojun Wang, Qian Xie
Syndrome differentiation is the most basic diagnostic method in traditional Chinese medicine (TCM). The process of syndrome differentiation is difficult and challenging due to its complexity, diversity, and vagueness. Recently, artificial intelligent methods have been introduced to discover the regularities of syndrome differentiation from TCM medical records, but the existing DM algorithms failed to consider how a syndrome is generated according to TCM theories. In this paper, we propose a novel topic model framework named syndrome differentiation topic model (SDTM) to dynamically characterize the process of syndrome differentiation...
2022: Journal of Healthcare Engineering
https://read.qxmd.com/read/34952759/induction-of-th1-and-th2-in-the-protection-against-sars-cov-2-through-mucosal-delivery-of-an-adenovirus-vaccine-expressing-an-engineered-spike-protein
#9
JOURNAL ARTICLE
Nai-Hsiang Chung, Ying-Chin Chen, Shiu-Ju Yang, Yu-Ching Lin, Horng-Yunn Dou, Lily Hui-Ching Wang, Ching-Len Liao, Yen-Hung Chow
A series of recombinant human type 5 adenoviruses that express the full-length or membrane-truncated spike protein (S) of SARS-CoV-2 (AdCoV2-S or AdCoV2-SdTM, respectively) was tested the efficacy against SARS-CoV-2 via intranasal (i.n.) or subcutaneous (s.c.) immunization in a rodent model. Mucosal delivery of adenovirus (Ad) vaccines could induce anti-SARS-CoV-2 IgG and IgA in the serum and in the mucosal, respectively as indicated by vaginal wash (vw) and bronchoalveolar lavage fluid (BALF). Serum anti-SARS-CoV-2 IgG but not IgA in the vw and BALF was induced by AdCoV2-S s...
December 17, 2021: Vaccine
https://read.qxmd.com/read/34727871/standardizing-registry-data-to-the-omop-common-data-model-experience-from-three-pulmonary-hypertension-databases
#10
JOURNAL ARTICLE
Patricia Biedermann, Rose Ong, Alexander Davydov, Alexandra Orlova, Philip Solovyev, Hong Sun, Graham Wetherill, Monika Brand, Eva-Maria Didden
BACKGROUND: The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) can be used to transform observational health data to a common format. CDM transformation allows for analysis across disparate databases for the generation of new, real-word evidence, which is especially important in rare disease where data are limited. Pulmonary hypertension (PH) is a progressive, life-threatening disease, with rare subgroups such as pulmonary arterial hypertension (PAH), for which generating real-world evidence is challenging...
November 2, 2021: BMC Medical Research Methodology
https://read.qxmd.com/read/34237784/semi-automated-conversion-of-clinical-trial-legacy-data-into-cdisc-sdtm-standards-format-using-supervised-machine-learning
#11
JOURNAL ARTICLE
Takuma Oda, Shih-Wei Chiu, Takuhiro Yamaguchi
OBJECTIVE:  This study aimed to develop a semi-automated process to convert legacy data into clinical data interchange standards consortium (CDISC) study data tabulation model (SDTM) format by combining human verification and three methods: data normalization; feature extraction by distributed representation of dataset names, variable names, and variable labels; and supervised machine learning. MATERIALS AND METHODS:  Variable labels, dataset names, variable names, and values of legacy data were used as machine learning features...
May 2021: Methods of Information in Medicine
https://read.qxmd.com/read/34154777/femoral-strength-can-be-predicted-from-2d-projections-using-a-3d-statistical-deformation-and-texture-model-with-finite-element-analysis
#12
JOURNAL ARTICLE
Lukas Steiner, Alexander Synek, Dieter H Pahr
Ultimate force of the proximal human femur can be predicted using Finite Element Analysis (FEA), but the models rely on 3D computed tomography images. Landmark-based statistical appearance models (SAM) and B-Spline transformation-based statistical deformation models (SDM) have been used to estimate 3D images from 2D projections, which facilitates model generation and reduces the radiation dose. However, there is no literature on the accuracy of SDM-based FEA models of bones with respect to experimental results...
July 2021: Medical Engineering & Physics
https://read.qxmd.com/read/34042643/comparing-sdtm-and-fhir%C3%A2-for-real-world-data-from-electronic-health-records-for-clinical-trial-submissions
#13
JOURNAL ARTICLE
Sarah Riepenhausen, Cornelia Mertens, Martin Dugas
Real world data for use in clinical trials is promising. We compared the SDTM for clinical trial data submission with FHIR® for routine documentation. After categorization of variables by relevance, clinically relevant SDTM items were mapped to FHIR®. About 30% in both were seen as clinically relevant. The majority of these SDTM items were mappable to FHIR® Observation resource.
May 27, 2021: Studies in Health Technology and Informatics
https://read.qxmd.com/read/33974947/the-evolution-of-send-at-astrazeneca
#14
COMMENT
Claire Kent, Brett Coupland, Claire Barnard, Jason Schofield, Shameen Afif-Rider
No abstract text is available yet for this article.
July 2021: Regulatory Toxicology and Pharmacology: RTP
https://read.qxmd.com/read/33839303/cdisc-compliant-clinical-trial-imaging-management-system-with-automatic-verification-and-data-transformation-focusing-on-tumor-response-assessment-data-in-clinical-trials
#15
JOURNAL ARTICLE
Amy Junghyun Lee, Kyung Won Kim, Youngbin Shin, Jiwoo Lee, Hyo Jung Park, Young Chul Cho, Yousun Ko, Yu Sub Sung, Byung Sun Yoon
OBJECTIVE: Major issues in imaging data management of tumor response assessment in clinical trials include high human errors in data input and unstandardized data structures, warranting a new breakthrough IT solution. Thus, we aim to develop a Clinical Data Interchange Standards Consortium (CDISC)-compliant clinical trial imaging management system (CTIMS) with automatic verification and transformation modules for implementing the CDISC Study Data Tabulation Model (SDTM) in the tumor response assessment dataset of clinical trials...
May 2021: Journal of Biomedical Informatics
https://read.qxmd.com/read/30741184/development-of-data-validation-rules-for-therapeutic-area-standard-data-elements-in-four-mental-health-domains-to-improve-the-quality-of-fda-submissions
#16
JOURNAL ARTICLE
Maryam Garza, Emel Seker, Meredith Zozus
Data standards are now required for many submissions to the United States Food and Drug Administration (FDA). The required standard for submission of clinical data is the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Tabulation Model (SDTM). Currently, 45 business rules and 115 associated validation rules exist for SDTM data. However, such rules have not yet been developed for therapeutic area data standards developed under the last reauthorization of the Prescription Drug User Fee Act (PDUFA V)...
2019: Studies in Health Technology and Informatics
https://read.qxmd.com/read/30256906/presenting-and-sharing-clinical-data-using-the-etriks-standards-master-tree-for-transmart
#17
JOURNAL ARTICLE
Adriano Barbosa-Silva, Dorina Bratfalean, Wei Gu, Venkata Satagopam, Paul Houston, Lauren B Becnel, Serge Eifes, Fabien Richard, Andreas Tielmann, Sascha Herzinger, Kavita Rege, Rudi Balling, Paul Peeters, Reinhard Schneider
Motivation: Standardization and semantic alignment have been considered one of the major challenges for data integration in clinical research. The inclusion of the CDISC SDTM clinical data standard into the tranSMART i2b2 via a guiding master ontology tree positively impacts and supports the efficacy of data sharing, visualization and exploration across datasets. Results: We present here a schema for the organization of SDTM variables into the tranSMART i2b2 tree along with a script and test dataset to exemplify the mapping strategy...
September 26, 2018: Bioinformatics
https://read.qxmd.com/read/29211742/fear-of-falling-and-postural-reactivity-in-patients-with-glaucoma
#18
JOURNAL ARTICLE
Fábio B Daga, Alberto Diniz-Filho, Erwin R Boer, Carolina P B Gracitelli, Ricardo Y Abe, Felipe A Medeiros
PURPOSE: To investigate the relationship between postural metrics obtained by dynamic visual stimulation in a virtual reality environment and the presence of fear of falling in glaucoma patients. METHODS: This cross-sectional study included 35 glaucoma patients and 26 controls that underwent evaluation of postural balance by a force platform during presentation of static and dynamic visual stimuli with head-mounted goggles (Oculus Rift). In dynamic condition, a peripheral translational stimulus was used to induce vection and assess postural reactivity...
2017: PloS One
https://read.qxmd.com/read/28487263/a-pragmatic-method-for-transforming-clinical-research-data-from-the-research-electronic-data-capture-redcap-to-clinical-data-interchange-standards-consortium-cdisc-study-data-tabulation-model-sdtm-development-and-evaluation-of-redcap2sdtm
#19
JOURNAL ARTICLE
Keiichi Yamamoto, Keiko Ota, Ippei Akiya, Ayumi Shintani
The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format...
June 2017: Journal of Biomedical Informatics
https://read.qxmd.com/read/28053065/data-standardization-pharmaceutical-drug-development-and-the-3rs
#20
JOURNAL ARTICLE
Laura Kaufman, Katrina Gore, Joyce Chandler Zandee
Despite the efforts, cost, and extensive use of animals for nonclinical research, only a small number of studies have methodically compared findings from animal toxicology studies to those from human clinical trials. Impediments to understanding the translation of nonclinical safety have included the lack of easy access to data and the need for extensive data curation given the diverse terminologies, formats, and data platforms in use. SEND and SDTM study data standards, developed by CDISC and about to become mandated by FDA, can address this and other drug development issues by facilitating access to data in ways that are not currently feasible...
December 2016: ILAR Journal
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