Michael, Milou R. and Wieske, Luuk and Allen, Jeffrey A. and Lunn, Michael P. and Doppler, Kathrin and Tan, Cheng-Yin and Koike, Haruki and Markvardsen, Lars K. and Kapoor, Mahima and Hsieh, Sung-Tsang and Nobile-Orazio, Eduardo and Jacobs, Bart C. and Rajabally, Yusuf A. and Basta, Ivana and Ripellino, Paolo and Querol, Luis and Eftimov, Filip and Consortium, INCbase (2024) Inflammatory Neuropathy Consortium base (INCbase): a protocol of a global prospective observational cohort study for the development of a prediction model for treatment response in chronic inflammatory demyelinating polyneuropathy. BMC Neurology, 24 (1). p. 415. ISSN 1471-2377, DOI https://doi.org/10.1186/s12883-024-03903-w.
Full text not available from this repository.Abstract
BackgroundINCbase is an international, multicenter prospective observational study using a customizable web-based modular registry to study the clinical, biological and electrophysiological variation and boundaries of chronic inflammatory demyelinating polyneuropathy (CIDP). The primary objective of INCbase is to develop and validate a clinical prediction model for treatment response.MethodsAll patients meeting clinical criteria for CIDP can be included in INCbase. Collected data include demographics, clinical history, diagnostics and various domains of clinical outcomes. Data is collected at a minimum of every 6 months for two years, and more frequently at the discretion of the investigational site to allow for assessment of unexpected changes in treatment response or clinical status. Participants can be enrolled in various sub-studies designed to capture data relevant to specific groups of interest. Data is entered directly into the web-based data entry system by local investigators and/or participants. Collection and local storage of biomaterial is optional. To develop a clinical prediction model for treatment response, newly diagnosed patients with active disease warranting start of first-line treatment will be included. The study population will be split into a development and validation cohort. Univariate and multivariate logistic regression analysis will be used to identify and combine predictors at start of treatment for treatment response at six months. Model performance will be assessed through discrimination and calibration in an external validation cohort. The externally validated prediction model will be made available to researchers and clinicians on the INCbase website.DiscussionWith this study, we aim to create a clinically relevant and implementable prediction model for treatment response to first line treatments in CIDP. INCbase enrollment started in April 2021, with 29 centers across 8 countries and 303 patients participating to date. This collaborative effort between academia, patient advocacy organizations and pharmaceutical industry will deepen our understanding of how to diagnose and treat CIDP.
| Item Type: | Article |
|---|---|
| Funders: | GBS/CIDP Foundation International |
| Uncontrolled Keywords: | Chronic inflammatory demyelinating polyneuropathy; Diagnosis; Prognosis; Outcome; Clinimetrics; Treatment; Biomarkers; Prediction model |
| Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine |
| Divisions: | Faculty of Medicine |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 17 Feb 2025 04:46 |
| Last Modified: | 17 Feb 2025 04:46 |
| URI: | http://eprints.um.edu.my/id/eprint/47403 |
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