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
Rattachement africain : nl, us, gb, de, my, jp, dk, au, tw, it, rs, ch, es. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
BACKGROUND: INCbase 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. METHODS: All 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. DISCUSSION: With 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.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 25/10/2024
- Éditeur
- Springer Science and Business Media LLC
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Amsterdam Neuroscience pays non établi dans la noticeStructure de recherche
-
Amsterdam University Medical Centers pays non établi dans la noticeÉtablissement de santé
-
University of Amsterdam Department of Neurology and Neurophysiology pays non établi dans la noticeUniversité ou école supérieure
-
University of Minnesota Department of Neurology pays non établi dans la noticeUniversité ou école supérieure
-
National Hospital for Neurology and Neurosurgery Centre for Neuromuscular Disease pays non établi dans la noticeÉtablissement de santé
-
University College London pays non établi dans la noticeUniversité ou école supérieure
-
Universitätsklinikum Würzburg pays non établi dans la noticeÉtablissement de santé
-
University of Malaya Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
-
Saga University pays non établi dans la noticeUniversité ou école supérieure
-
Aarhus University Hospital Department of Neurology pays non établi dans la noticeÉtablissement de santé
-
The Alfred Hospital Neurology Department pays non établi dans la noticeÉtablissement de santé
-
National Taiwan University Hospital Department of Neurology pays non établi dans la noticeÉtablissement de santé
Amsterdam Neuroscience, Amsterdam University Medical Centers et Department of Neurology and Neurophysiology — University of Amsterdam, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.