| Title: |
Harmonization of sensorimotor deficit assessment in a registered multicentre pre-clinical randomized controlled trial using two models of ischemic stroke |
| Authors: |
Valente, Alessia; Mariani, Jacopo; Seminara, Serena; Tettamanti, Mauro; Pignataro, Giuseppe; Perego, Carlo; Sironi, Luigi; Pedata, Felicita; Amantea, Diana; Bacigaluppi, Marco; Vinciguerra, Antonio; Diamanti, Susanna; Viganò, Martina; Santangelo, Francesco; Zoia, Chiara Paola; Rodriguez-Menendez, Virginia; Castiglioni, Laura; Rzemieniec, Joanna; Dettori, Ilaria; Bulli, Irene; Coppi, Elisabetta; Di Santo, Chiara; Cuomo, Ornella; Gullotta, Giorgia Serena; Butti, Erica; Bagetta, Giacinto; Martino, Gianvito; De Simoni, Maria-Grazia; Ferrarese, Carlo; Fumagalli, Stefano; Beretta, Simone |
| Source: |
Journal of Cerebral Blood Flow & Metabolism ; volume 43, issue 7, page 1077-1088 ; ISSN 0271-678X 1559-7016 |
| Publisher Information: |
SAGE Publications |
| Publication Year: |
2023 |
| Description: |
Multicentre preclinical randomized controlled trials (pRCTs) are a valuable tool to improve experimental stroke research, but are challenging and therefore underused. A common challenge regards the standardization of procedures across centres. We here present the harmonization phase for the quantification of sensorimotor deficits by composite neuroscore, which was the primary outcome of two multicentre pRCTs assessing remote ischemic conditioning in rodent models of ischemic stroke. Ischemic stroke was induced by middle cerebral artery occlusion for 30, 45 or 60 min in mice and 50, 75 or 100 min in rats, allowing sufficient variability. Eleven animals per species were video recorded during neurobehavioural tasks and evaluated with neuroscore by eight independent raters, remotely and blindly. We aimed at reaching an intraclass correlation coefficient (ICC) ≥0.60 as satisfactory interrater agreement. After a first remote training we obtained ICC = 0.50 for mice and ICC = 0.49 for rats. Errors were identified in animal handling and test execution. After a second remote training, we reached the target interrater agreement for mice (ICC = 0.64) and rats (ICC = 0.69). In conclusion, a multi-step, online harmonization phase proved to be feasible, easy to implement and highly effective to align each centre’s behavioral evaluations before project’s interventional phase. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1177/0271678x231159958 |
| DOI: |
10.1177/0271678X231159958 |
| Availability: |
https://doi.org/10.1177/0271678x231159958; https://journals.sagepub.com/doi/pdf/10.1177/0271678X231159958; https://journals.sagepub.com/doi/full-xml/10.1177/0271678X231159958 |
| Rights: |
https://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.17C85443 |
| Database: |
BASE |