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Title: An instrument for methodological quality assessment of single-subject finite element analysis used in computational orthopaedics
Authors: Wong, DWC 
Chen, TLW 
Peng, Y 
Lam, W.K
Wang, Y 
Ni, M
Niu, W
Zhang, M 
Issue Date: 2021
Source: Medicine in novel technology and devices, In Press, Journal Pre-proof, Available online 5 March 2021, 100067, p. 1-26, https://doi.org/10.1016/j.medntd.2021.100067
Abstract: The methodological quality of subject-specific finite element analysis papers depends on the rigor of the study design and detailed description of key elements, while assessment instruments are often confined to clinical trials or quasi-experiments. This study aims to present an instrument for methodological quality assessment of single-subject finite element analysis used in computational orthopaedics (MQSSFE). Based upon existing instruments and relevant review papers, a pilot version was developed consisting of 37 items with 6 domains, including study design and presentation of findings, subject recruitment, model reconstruction and configuration, boundary and loading conditions (simulation), model verification and validation, and model assumption and validity. We interviewed four experts in the field to assess the face validity and refined the instrument. The instrument was tested for interrater reliability among two assessors on nine finite element study papers. Also, the criterion validity was evaluated by comparing the similarity of the MQSSFE and the modified Down and Black instrument. The intraclass correlation coefficient was 0.965, while the MQSSFE was significantly moderately correlated with the modified Down and Black instruments (r = 0.61). We believed that MQSSFE was adequately appropriate, reliable, and valid for assessing the methodological quality for finite element studies used in computational orthopaedics. The instrument could facilitate quality assessment in the systematic reviews of finite element models and checklists for fidelity.
Keywords: Finite element model
Simulation
Validation and verification
Mesh convergence
Uncertainty analysis
Publisher: Elservier
Journal: Medicine in novel technology and devices 
EISSN: 2590-0935
DOI: 10.1016/j.medntd.2021.100067
Rights: © 2021 The Author(s). Published by Elsevier B.
Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) (https://creativecommons.org/licenses/by-nc-nd/4.0/)
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
The following publication Wai-Chi Wong D, Lin-Wei Chen T, Peng Y, Lam W-K, Wang Y, Ni M, NiuW, Zhang M, An Instrument for Methodological Quality Assessment of Single-Subject Finite ElementAnalysis Used in Computational Orthopaedics, Medicine in Novel Technology and Devices is available at https://dx.doi.org/10.1016/j.medntd.2021.100067.
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