Stroke of Consistency: Streamlining Multicenter Protocols for Enhanced Reproducibility of Infarct Volumes in Preclinical Stroke Research.

multicenter studies as topic reference standards reproducibility of results stroke

Journal

Stroke
ISSN: 1524-4628
Titre abrégé: Stroke
Pays: United States
ID NLM: 0235266

Informations de publication

Date de publication:
Oct 2024
Historique:
medline: 24 9 2024
pubmed: 24 9 2024
entrez: 24 9 2024
Statut: ppublish

Résumé

The discrepancy between experimental research and clinical trial outcomes is a persistent challenge in preclinical studies, particularly in stroke research. A possible factor contributing to this issue is the lack of standardization across experimental stroke models, leading to poor reproducibility in multicenter studies. This study addresses this gap by aiming to enhance reproducibility and the efficacy of multicenter studies through the harmonization of protocols and training of involved personnel. We established a set of standard operating procedures for various stroke models and the Neuroscore. These standard operating procedures were implemented across multiple research centers, followed by specialized, in-person training for all participants. We measured the variability in infarct volume both before and after the implementation of these standardized protocols and training sessions. The standardization process led to a significant reduction in variability of infarct volume across different stroke models (40%-50% reduction), demonstrating the effectiveness of our harmonized protocols and training. Additionally, the implementation of the Neuroscore system across centers showed low variability and consistent results up to 28 days poststroke, underscoring its utility in chronic phase evaluations. The harmonization of protocols and surgeon training significantly reduced variability in experimental outcomes across different centers. This improvement can increase the comparability of data between research groups and enhance the statistical power of multicenter studies. Our findings also establish the Neuroscore as a reliable tool for long-term assessment in stroke research, paving the way for more consistent and impactful multicenter preclinical studies.

Sections du résumé

BACKGROUND UNASSIGNED
The discrepancy between experimental research and clinical trial outcomes is a persistent challenge in preclinical studies, particularly in stroke research. A possible factor contributing to this issue is the lack of standardization across experimental stroke models, leading to poor reproducibility in multicenter studies. This study addresses this gap by aiming to enhance reproducibility and the efficacy of multicenter studies through the harmonization of protocols and training of involved personnel.
METHODS UNASSIGNED
We established a set of standard operating procedures for various stroke models and the Neuroscore. These standard operating procedures were implemented across multiple research centers, followed by specialized, in-person training for all participants. We measured the variability in infarct volume both before and after the implementation of these standardized protocols and training sessions.
RESULTS UNASSIGNED
The standardization process led to a significant reduction in variability of infarct volume across different stroke models (40%-50% reduction), demonstrating the effectiveness of our harmonized protocols and training. Additionally, the implementation of the Neuroscore system across centers showed low variability and consistent results up to 28 days poststroke, underscoring its utility in chronic phase evaluations.
CONCLUSIONS UNASSIGNED
The harmonization of protocols and surgeon training significantly reduced variability in experimental outcomes across different centers. This improvement can increase the comparability of data between research groups and enhance the statistical power of multicenter studies. Our findings also establish the Neuroscore as a reliable tool for long-term assessment in stroke research, paving the way for more consistent and impactful multicenter preclinical studies.

Identifiants

pubmed: 39315830
doi: 10.1161/STROKEAHA.124.047232
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2522-2527

Déclaration de conflit d'intérêts

None.

Auteurs

Gemma Llovera (G)

Institute for Stroke and Dementia Research, Ludwig Maximilians University (LMU) University Hospital, LMU Munich, Germany (G.L., S. Heindl, A.R., A.L.).
Munich Cluster for Systems Neurology (SyNergy), Munich, Germany (G.L., A.L.).

Friederike Langhauser (F)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Sara Isla Cainzos (S)

Department of Neurology, University Medical Centre Hamburg-Eppendorf, Germany (S.I.C., L.K.-P., M. Gelderblom, T.M.).

Maike Hoppen (M)

Department of Neurology with Institute of Translational Neurology, University Hospital Münster, Germany (M.H., A.S.-P., J.M.).

Hanna Abberger (H)

Institute of Medical Microbiology, University Hospital Essen (H.A., W.H.), University of Duisburg-Essen, Germany.

Ayan Mohamud Yusuf (A)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Stine Mencl (S)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Steffanie Heindl (S)

Institute for Stroke and Dementia Research, Ludwig Maximilians University (LMU) University Hospital, LMU Munich, Germany (G.L., S. Heindl, A.R., A.L.).

Alessio Ricci (A)

Institute for Stroke and Dementia Research, Ludwig Maximilians University (LMU) University Hospital, LMU Munich, Germany (G.L., S. Heindl, A.R., A.L.).

Steffen Haupeltshofer (S)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Lennart Kuchenbecker-Pöls (L)

Department of Neurology, University Medical Centre Hamburg-Eppendorf, Germany (S.I.C., L.K.-P., M. Gelderblom, T.M.).

Matthias Gunzer (M)

Institute for experimental Immunology and Imaging (M. Gunzer), University of Duisburg-Essen, Germany.
Leibniz-Institut für Analytische Wissenschaften-ISAS-e.V., Dortmund, Germany (M. Gunzer).

Wiebke Hansen (W)

Institute of Medical Microbiology, University Hospital Essen (H.A., W.H.), University of Duisburg-Essen, Germany.

Dirk M Hermann (DM)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Matthias Gelderblom (M)

Department of Neurology, University Medical Centre Hamburg-Eppendorf, Germany (S.I.C., L.K.-P., M. Gelderblom, T.M.).

Antje Schmidt-Pogoda (A)

Department of Neurology with Institute of Translational Neurology, University Hospital Münster, Germany (M.H., A.S.-P., J.M.).

Jens Minnerup (J)

Department of Neurology with Institute of Translational Neurology, University Hospital Münster, Germany (M.H., A.S.-P., J.M.).

Christoph Kleinschnitz (C)

Department of Neurology and Center for Translational Neuro- and Behavioral Sciences, University Hospital Essen, Germany (F.L., A.M.Y., S.M., S. Haupeltshofer, D.M.H., C.K.).

Tim Magnus (T)

Department of Neurology, University Medical Centre Hamburg-Eppendorf, Germany (S.I.C., L.K.-P., M. Gelderblom, T.M.).

Arthur Liesz (A)

Institute for Stroke and Dementia Research, Ludwig Maximilians University (LMU) University Hospital, LMU Munich, Germany (G.L., S. Heindl, A.R., A.L.).
Munich Cluster for Systems Neurology (SyNergy), Munich, Germany (G.L., A.L.).

Classifications MeSH