scholarly journals P074 Crohn’s disease clinical data standards: Adoption and implementation to promote data sharing and reuse

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S177-S177
Author(s):  
J Owen
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Data ◽  
Development Process ◽  
Disease Classification ◽  
Data Standards ◽  
Adoption And Implementation ◽  
Standards Adoption ◽  
Standards Development ◽  
Education Courses

Abstract Background Creation and adoption of clinical data standards will transform incompatible and disparate data into universal and illuminating information, facilitating discoveries that could have invaluable impact on Crohn’s Disease clinical research. Implementation of CDISC standards deliver on the promise of FAIR data through consistent organization and analysis that allow all researchers to leverage information from studies globally. Methods With support from The Leona M. and Harry B. Helmsley Charitable Trust and following the CDISC consensus-based standards development process, a team of Crohn’s disease and standards development experts was created to develop clinical data standards for Crohn’s disease.The CDISC standards development process consists of five stages: Results Free and publicly available data standards are anticipated to be available in May 2021 in the following areas: - Questionnaires, Ratings and Scales (including standard symptom measures, patient/investigator reported outcomes, and socio-economic measures) - Prior and Baseline, and On-Study Treatments (including response to prior treatment) - Disease Classification (location and phenotypic descriptions of the disease)- Endoscopy Assessments - Cross Section Imaging Assessments (including CT, MRI and Ultrasound) - Histopathology of Biopsy Samples - Biomarkers of Interest for Crohn’s Disease Conclusion Widespread promotion of the standards for researchers to adopt and implement is of highest importance. CDISC provides complementary education courses and implementation information to assist in adoption for academic teams new to CDISC standards. Widespread adoption of the standards will bring clarity to Crohn’s Disease data and will enable the accessibility, interoperability, and reusability of data (FAIR).

scholarly journals P108 The importance of developing consensus-driven clinical data standards for Crohn’s disease to amplify data

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S189-S190
Author(s):  
J Owen ◽  
R Baker
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Data ◽  
Development Process ◽  
Inclusive Development ◽  
Full Potential ◽  
Data Standards ◽  
The Usa ◽  
Standards Development ◽  
Research Organisations

Abstract Background When CDISC standards are applied, data is collected, organised and analysed in a clear and consistent manner so that all researchers can leverage and share information from individuals and studies around the world. Required by the USA Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organisations, CDISC standards enable the accessibility, interoperability, and reusability of data. Adopting CDISC standards is an invaluable investment that leads to more meaningful, more efficient research for your organisation and the entire global research community. Methods With support from The Leona M. and Harry B. Helmsley Charitable Trust and following the CDISC consensus-based standards development process, a team of Crohn’s disease and standards development experts was created to develop clinical data standards for Crohn’s disease. The CDISC standards development process consists of five stages: Results The project scoping stage completed in July 2019. The scoping team, consisting of Crohn’s disease clinical SMEs, identified the following topics that would most benefit from development of clinical data standards and to move into the concept modelling and standards development phases of the project: Package 1 Package 2 Endoscopy assessments The first package of data standards for Crohn’s disease will be available for Public Review in July 2020 and is anticipated to be published in Q1 2021 for use by researchers and industry. The second package of data standards will be available for Public Review in Q3 2020 with publication in Q2 2021. Conclusion CDISC’s vision is to encourage the global adoption of standards to leverage and realise the full potential of data and produce faster, more efficient research, paving the way for more breakthroughs in Crohn’s disease treatments, therapies and cures. ECCO attendees and the Crohn’s disease community are encouraged to participate in CDISC’s informational webinars and Public Review stages to foster all-inclusive development, approval and adoption of the data standards.

COLLABORATIVE DEVELOPMENT OF CROHN’S DISEASE CLINICAL DATA STANDARDS BY STANDARDS DEVELOPMENT AND CROHN’S DISEASE EXPERTS TO FOSTER DATA REVIEW, SHARING, AND REUSE

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S12-S12
Author(s):  
John Owen, Rebecca Baker
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Research ◽  
Clinical Data ◽  
The United States ◽  
Data Standards ◽  
Regulatory Review ◽  
Time To Market ◽  
Internal Review ◽  
Standards Development

Abstract Background The ability to access expansive collections of well-curated biological, clinical, and behavioral data will propel scientific progress and enable the discoveries needed to improve treatments for human disease. Development and adoption of standards transform incompatible and disparate data into universal and illuminating information, facilitating discoveries that could have invaluable impact on Crohn’s disease clinical research. When standards are applied, data is collected, organized, and analyzed in a clear and consistent manner, allowing all researchers to leverage information from studies around the world. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. CDISC standards addresses each step of the clinical research process to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market. Methods With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC formed a team of standards development and Crohn’s disease experts to follow our consensus-based, clinical data standards process, which consists of six stages: Scoping – Identification of development topics Concept Modeling – Deep dive understanding of topics Standards Development – Development of standards content Internal Review – Targeted review Public Review – User community review Publication – Freely available on the CDISC website Results The project Standards Development and Internal Review stages completed in September 2020, resulting in the following topics available for the Public Review stage. - Questionnaires, Ratings and Scales (including standard symptom measures, patient/investigator reported outcomes, and socio-economic measures) - Prior and Baseline, and On-Study Treatments (including response to prior treatment) - Disease Staging (location and phenotypic descriptions of the disease) - Endoscopy Assessments - Cross-section Imaging Assessments (including CT, MRI and Ultrasound) - Histopathology of Biopsy Samples - Biomarkers of Interest for Crohn’s Disease Conclusion To make the greatest impact on Crohn’s disease research, widespread promotion of the availability of the standards for researchers to adopt and implement to their data is of highest importance. CDISC provides complementary education courses and implementation information to assist in this adoption. Widespread adoption of the standards will bring clarity to Crohn’s disease data and will enable the accessibility, interoperability, and reusability of data, driving operational efficiencies, expediting regulatory review, and reducing time to market.

Long-term Disease Behavior and Surgical Intervention Analysis in Hospitalized Patients with Crohn's Disease in China: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Xiaoyin Bai ◽  
Huimin Zhang ◽  
Gechong Ruan ◽  
Hong Lv ◽  
Yue Li ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Large Scale ◽  
Hospitalized Patients ◽  
Disease Classification ◽  
Real World Data ◽  
Disease Behavior ◽  
Initial Classification

Abstract Background There is lack of real-world data for disease behavior and surgery of Crohn’s disease (CD) from large-scale Chinese cohorts. Methods Hospitalized patients diagnosed with CD in our center were consecutively included from January 2000 to December 2018. Disease behavior progression was defined as the initial classification of B1 to the progression to B2 or B3. Clinical characteristics including demographics, disease classification and activity, medical therapy, development of cancers, and death were collected. Results Overall, 504 patients were included. Two hundred and thirty one (45.8%) patients were initially classified as B1; 30 (13.0%), 71 (30.7%), and 95 (41.1%) of them had disease progression at the 1-year follow-up, 5-year follow-up, and overall, respectively. Patients without location transition before behavior transition were less likely to experience behavior progression. However, patients without previous exposure to a corticosteroid, immunomodulator, or biological agent had a greater chance of experiencing behavior progression. When the long-term prognosis was evaluated, 211 (41.9%) patients underwent at least one CD-related surgery; 108 (21.4%) and 120 (23.8%) of these patients underwent surgery before and after their diagnosis, respectively. An initial classification as B1, no behavior transition, no surgery prior to diagnosis, and previous corticosteroid exposure during follow-up were associated with a lower risk of undergoing surgery. Conclusions This study depicts the clinical features and factors associated with behavior progression and surgery among hospitalized CD patients in a Chinese center. Behavior progression is associated with a higher probability of CD-related surgery, and strengthened therapies are necessary for them in the early phase.

scholarly journals Classifying Crohn’s disease into colon-involving versus non-colon-involving groups is a better predictor of clinical outcomes than the Montreal classification

2020 ◽  
Vol 13 ◽  
pp. 175628482096873
Author(s):  
Si-Nan Lin ◽  
Dan-Ping Zheng ◽  
Yun Qiu ◽  
Sheng-Hong Zhang ◽  
Yao He ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Abdominal Surgery ◽  
Clinical Outcomes ◽  
Protective Factor ◽  
Age Of Onset ◽  
Disease Classification ◽  
Major Abdominal Surgery ◽  
Montreal Classification

Background: A suitable disease classification is essential for individualized therapy in patients with Crohn’s disease (CD). Although a potential mechanistic classification of colon-involving and non-colon-involving disease was suggested by recent genetic and microbiota studies, the clinical implication has seldom been investigated. We aimed to explore the association of this colonic-based classification with clinical outcomes in patients with CD compared with the Montreal classification. Methods: This was a retrospective study of CD patients from a tertiary referral center. Patients were categorized into colon-involving and non-colon-involving disease, and according to the Montreal classification. Clinico-demographic data, medications, and surgeries were compared between the two classifications. The primary outcome was the need for major abdominal surgery. Results: Of 934 patients, those with colonic involvement had an earlier median (interquartile range) age of onset [23.0 (17.0–30.0) versus 26.0 (19.0–35.0) years, p = 0.001], higher frequency of perianal lesions (31.2% versus 14.5%, p < 0.001) and extraintestinal manifestations (21.8% versus 14.5%, p = 0.010), but lower frequency of stricture (B2) (16.3% versus 24.0%, p = 0.005), than those with non-colon-involving disease. Colon-involving disease was a protective factor against major abdominal surgery [hazard ratio, 0.689; 95% confidence interval (CI), 0.481–0.985; p = 0.041]. However, patients with colon-involving CD were more prone to steroids [odds ratio (OR), 1.793; 95% CI, 1.206–2.666; p = 0.004] and azathioprine/6-mercaptopurine (AZA/6-MP) treatment (OR, 1.732; 95% CI, 1.103–2.719; p = 0.017) than were patients with non-colon-involving disease. The Montreal classification was not predictive of surgery or steroids and AZA/6-MP treatment. Conclusion: This study supports the rationale for disease classification based on the involvement of colon. This new classification of CD is a better predictor of clinical outcomes than the Montreal classification.

scholarly journals Effect of fuzzy partitioning in Crohn’s disease classification: a neuro-fuzzy-based approach

2016 ◽  
Vol 55 (1) ◽  
pp. 101-115 ◽  
Author(s):  
Sk. Saddam Ahmed ◽  
Nilanjan Dey ◽  
Amira S. Ashour ◽  
Dimitra Sifaki-Pistolla ◽  
Dana Bălas-Timar ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Classification ◽  
Fuzzy Partitioning ◽  
Neuro Fuzzy

Eosinophilic colitis. Differential diagnosis. Analysis of own observation

2019 ◽  
Vol 1 (6) ◽  
pp. 20-22
Author(s):  
A. B. Krivosheev ◽  
E. V. Shidlovskaya
Keyword(s):  
Differential Diagnosis ◽  
Crohn’S Disease ◽  
Comparative Analysis ◽  
Crohn's Disease ◽  
Sigmoid Colon ◽  
Histological Examination ◽  
Clinical Data ◽  
Emergency Surgery ◽  
Intestinal Disease ◽  
Eosinophilic Colitis

The article is devoted to the description of a rare intestinal disease - eosinophilic colitis. Presented patient O., 27 years old, whose disease was diagnosed during histological examination after an emergency surgery for perforation of the sigmoid colon. The clinical data, results of laboratory, instrumental, morphological examinations are analyzed. A comparative analysis was carried out with Crohn's disease, collagen colitis.

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