Inflammatory Neuropathy Consortium base (INCbase)

Michael, Milou R.; Wieske, Luuk|||0000-0002-2522-4081; Allen, J.A.|||0000-0001-8753-2680; Lunn, Michael P.|||0000-0003-3174-6027; Doppler, Kathrin; Tan, Cheng-Yin; Koike, Haruki; Markvardsen, Lars K.; Kapoor, Mahima; Hsieh, Sung-Tsang; Nobile-Orazio, Eduardo|||0000-0003-2624-8138; Jacobs, Bart C.|||0000-0002-8985-2458; Rajabally, Yusuf Ali|||0000-0002-7170-8343; Basta, Ivana; Ripellino, Paolo; Querol, Luis|||0000-0002-4289-8264; Eftimov, Filip|||0000-0002-0146-0776; Castro, D.; Vytopil, M.; Gable, K.; Stino, A.M.; Pasnoor, M.; Hoke, A.; Lai, K.L.; Ro, L.S.; Sung, J.Y.; Lascano, A.; Nagy, S.; Hundsberger, T.; Humm, A.; Theaudin, M.; Llauradó, Arnau|||0000-0002-4655-6157; Martinez-Hernandez, E.; Moris, G.; Sevilla, T.; Pascual, I.J.; Gutiérrez-Gutiérrez, Gerardo

Inflammatory Neuropathy Consortium base (INCbase)

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...

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Autores:	Michael, Milou R., Wieske, Luuk\|\|\|0000-0002-2522-4081, Allen, J.A.\|\|\|0000-0001-8753-2680, Lunn, Michael P.\|\|\|0000-0003-3174-6027, Doppler, Kathrin, Tan, Cheng-Yin, Koike, Haruki, Markvardsen, Lars K., Kapoor, Mahima, Hsieh, Sung-Tsang, Nobile-Orazio, Eduardo\|\|\|0000-0003-2624-8138, Jacobs, Bart C.\|\|\|0000-0002-8985-2458, Rajabally, Yusuf Ali\|\|\|0000-0002-7170-8343, Basta, Ivana, Ripellino, Paolo, Querol, Luis\|\|\|0000-0002-4289-8264, Eftimov, Filip\|\|\|0000-0002-0146-0776, Castro, D., Vytopil, M., Gable, K., Stino, A.M., Pasnoor, M., Hoke, A., Lai, K.L., Ro, L.S., Sung, J.Y., Lascano, A., Nagy, S., Hundsberger, T., Humm, A., Theaudin, M., Llauradó, Arnau\|\|\|0000-0002-4655-6157, Martinez-Hernandez, E., Moris, G., Sevilla, T., Pascual, I.J., Gutiérrez-Gutiérrez, Gerardo
Formato:	artículo
Fecha de publicación:	2024
País:	España
Recursos:	Universitat Autònoma de Barcelona
Repositorio:	Dipòsit Digital de Documents de la UAB
Idioma:	inglés
OAI Identifier:	oai:ddd.uab.cat:309319
Acesso em linha:	https://ddd.uab.cat/record/309319 https://dx.doi.org/urn:doi:10.1186/s12883-024-03903-w
Access Level:	acceso abierto
Palavra-chave:	Biomarkers Chronic inflammatory demyelinating polyneuropathy Clinimetrics Diagnosis Outcome Prediction model Prognosis Treatment

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spelling	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 polyneuropathyMichael, Milou R.Wieske, Luuk\|\|\|0000-0002-2522-4081Allen, J.A.\|\|\|0000-0001-8753-2680Lunn, Michael P.\|\|\|0000-0003-3174-6027Doppler, KathrinTan, Cheng-YinKoike, HarukiMarkvardsen, Lars K.Kapoor, MahimaHsieh, Sung-TsangNobile-Orazio, Eduardo\|\|\|0000-0003-2624-8138Jacobs, Bart C.\|\|\|0000-0002-8985-2458Rajabally, Yusuf Ali\|\|\|0000-0002-7170-8343Basta, IvanaRipellino, PaoloQuerol, Luis\|\|\|0000-0002-4289-8264Eftimov, Filip\|\|\|0000-0002-0146-0776Castro, D.Vytopil, M.Gable, K.Stino, A.M.Pasnoor, M.Hoke, A.Lai, K.L.Ro, L.S.Sung, J.Y.Lascano, A.Nagy, S.Hundsberger, T.Humm, A.Theaudin, M.Llauradó, Arnau\|\|\|0000-0002-4655-6157Martinez-Hernandez, E.Moris, G.Sevilla, T.Pascual, I.J.Gutiérrez-Gutiérrez, GerardoBiomarkersChronic inflammatory demyelinating polyneuropathyClinimetricsDiagnosisOutcomePrediction modelPrognosisTreatmentBackground: 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.Universitat Autònoma de Barcelona 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/309319https://dx.doi.org/urn:doi:10.1186/s12883-024-03903-wreponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3093192026-06-06T12:50:31Z
dc.title.none.fl_str_mv	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
title	Inflammatory Neuropathy Consortium base (INCbase)
spellingShingle	Inflammatory Neuropathy Consortium base (INCbase) Michael, Milou R. Biomarkers Chronic inflammatory demyelinating polyneuropathy Clinimetrics Diagnosis Outcome Prediction model Prognosis Treatment
title_short	Inflammatory Neuropathy Consortium base (INCbase)
title_full	Inflammatory Neuropathy Consortium base (INCbase)
title_fullStr	Inflammatory Neuropathy Consortium base (INCbase)
title_full_unstemmed	Inflammatory Neuropathy Consortium base (INCbase)
title_sort	Inflammatory Neuropathy Consortium base (INCbase)
dc.creator.none.fl_str_mv	Michael, Milou R. Wieske, Luuk\|\|\|0000-0002-2522-4081 Allen, J.A.\|\|\|0000-0001-8753-2680 Lunn, Michael P.\|\|\|0000-0003-3174-6027 Doppler, Kathrin Tan, Cheng-Yin Koike, Haruki Markvardsen, Lars K. Kapoor, Mahima Hsieh, Sung-Tsang Nobile-Orazio, Eduardo\|\|\|0000-0003-2624-8138 Jacobs, Bart C.\|\|\|0000-0002-8985-2458 Rajabally, Yusuf Ali\|\|\|0000-0002-7170-8343 Basta, Ivana Ripellino, Paolo Querol, Luis\|\|\|0000-0002-4289-8264 Eftimov, Filip\|\|\|0000-0002-0146-0776 Castro, D. Vytopil, M. Gable, K. Stino, A.M. Pasnoor, M. Hoke, A. Lai, K.L. Ro, L.S. Sung, J.Y. Lascano, A. Nagy, S. Hundsberger, T. Humm, A. Theaudin, M. Llauradó, Arnau\|\|\|0000-0002-4655-6157 Martinez-Hernandez, E. Moris, G. Sevilla, T. Pascual, I.J. Gutiérrez-Gutiérrez, Gerardo
author	Michael, Milou R.
author_facet	Michael, Milou R. Wieske, Luuk\|\|\|0000-0002-2522-4081 Allen, J.A.\|\|\|0000-0001-8753-2680 Lunn, Michael P.\|\|\|0000-0003-3174-6027 Doppler, Kathrin Tan, Cheng-Yin Koike, Haruki Markvardsen, Lars K. Kapoor, Mahima Hsieh, Sung-Tsang Nobile-Orazio, Eduardo\|\|\|0000-0003-2624-8138 Jacobs, Bart C.\|\|\|0000-0002-8985-2458 Rajabally, Yusuf Ali\|\|\|0000-0002-7170-8343 Basta, Ivana Ripellino, Paolo Querol, Luis\|\|\|0000-0002-4289-8264 Eftimov, Filip\|\|\|0000-0002-0146-0776 Castro, D. Vytopil, M. Gable, K. Stino, A.M. Pasnoor, M. Hoke, A. Lai, K.L. Ro, L.S. Sung, J.Y. Lascano, A. Nagy, S. Hundsberger, T. Humm, A. Theaudin, M. Llauradó, Arnau\|\|\|0000-0002-4655-6157 Martinez-Hernandez, E. Moris, G. Sevilla, T. Pascual, I.J. Gutiérrez-Gutiérrez, Gerardo
author_role	author
author2	Wieske, Luuk\|\|\|0000-0002-2522-4081 Allen, J.A.\|\|\|0000-0001-8753-2680 Lunn, Michael P.\|\|\|0000-0003-3174-6027 Doppler, Kathrin Tan, Cheng-Yin Koike, Haruki Markvardsen, Lars K. Kapoor, Mahima Hsieh, Sung-Tsang Nobile-Orazio, Eduardo\|\|\|0000-0003-2624-8138 Jacobs, Bart C.\|\|\|0000-0002-8985-2458 Rajabally, Yusuf Ali\|\|\|0000-0002-7170-8343 Basta, Ivana Ripellino, Paolo Querol, Luis\|\|\|0000-0002-4289-8264 Eftimov, Filip\|\|\|0000-0002-0146-0776 Castro, D. Vytopil, M. Gable, K. Stino, A.M. Pasnoor, M. Hoke, A. Lai, K.L. Ro, L.S. Sung, J.Y. Lascano, A. Nagy, S. Hundsberger, T. Humm, A. Theaudin, M. Llauradó, Arnau\|\|\|0000-0002-4655-6157 Martinez-Hernandez, E. Moris, G. Sevilla, T. Pascual, I.J. Gutiérrez-Gutiérrez, Gerardo
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv	Biomarkers Chronic inflammatory demyelinating polyneuropathy Clinimetrics Diagnosis Outcome Prediction model Prognosis Treatment
topic	Biomarkers Chronic inflammatory demyelinating polyneuropathy Clinimetrics Diagnosis Outcome Prediction model Prognosis Treatment
description	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.
publishDate	2024
dc.date.none.fl_str_mv	2 2024-01-01 2024 2024-01-01
dc.type.none.fl_str_mv	Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv	info:eu-repo/semantics/article
format	article
dc.identifier.none.fl_str_mv	https://ddd.uab.cat/record/309319 https://dx.doi.org/urn:doi:10.1186/s12883-024-03903-w
url	https://ddd.uab.cat/record/309319 https://dx.doi.org/urn:doi:10.1186/s12883-024-03903-w
dc.language.none.fl_str_mv	Inglés eng
language_invalid_str_mv	Inglés
language	eng
dc.rights.none.fl_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv	info:eu-repo/semantics/openAccess
rights_invalid_str_mv	open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv	openAccess
dc.format.none.fl_str_mv	application/pdf
dc.source.none.fl_str_mv	reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona
instname_str	Universitat Autònoma de Barcelona
reponame_str	Dipòsit Digital de Documents de la UAB
collection	Dipòsit Digital de Documents de la UAB
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Inflammatory Neuropathy Consortium base (INCbase)

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