Table 3.
Quality Assessment according to Methodological Quality Assessment of Single-Subject Finite Element Analysis Used in Computational Orthopaedics (MQSSFE).
| Question | Chang et al. 2012 [27] | Shen et al. 2014 [28] | Dastenaei et al. 2015 [29] | Pouyafar et al. 2021 [30] | |
|---|---|---|---|---|---|
| Study Design and Presentation of Findings | |||||
| 1 | Was the hypothesis/aim/objective of the study clearly described? | Yes | Yes | Yes | Yes |
| 2 | Were all analyses planned at the outset of study? Answer NO for unplanned analysis/sub-analysis, unable to determine. |
Yes | Yes | Yes | Yes |
| 3 | If data dredging (establish objectives, hypothesis and endpoint parameters without scientific reason) was used, was the spectrum of the data justified by any concepts? Answer YES if no data dredging, NO if unable to determine |
Yes | Yes | Yes | Yes |
| 4 | Were ALL the outcome measures and parameters (including all data reduction methods or derived parameters) clearly described and defined in the Objectives or Methods section? Answer NO if they are only defined in results or discussion |
Yes | Yes | No | No |
| 5 | Were the time points or period for ALL the outcome measures clearly described? Answer YES if not applicable |
Yes | No | No | Yes |
| 6 | Were the main outcome measures appropriate to describe the targeted conditions? Answer NO if unable to determine |
Yes | Yes | Yes | Yes |
| 7 | Were the key findings described clearly? | Yes | Yes | Yes | Yes |
| 8 | Were ALL the contour plots that were used for comparison presented with the same colour scale? | Yes | Yes | Yes | Yes |
| Subject Recruitment | |||||
| 9 | Were the characteristics of the model subject clearly described? | Yes—implants with features invented by researchers | Yes—specific implant available for purchase | Yes—specific implant available for purchase | Yes—specific implant available for purchase |
| 10 | Were the principal confounders of the model subject clearly described? (Age, sex, or body weight, and height) | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features |
| 11 | Was the model subject participated in the study representative of the population with the targeted clinical conditions or demographic features? (e.g., answer NO if simulating a pathology by modifying a normal subject model; or scaling an adult model to a child model) | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features |
| 12 | Were the targeted intervention or clinical condition clearly described? (with details in the severity, class, design/dimensions of implants, or details in surgical surgery) | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features | Yes—standard artificial bone features |
| Model Reconstruction and Configuration | |||||
| 13 | Was the model reconstruction modality for the body parts and ALL other items, such as implants, clearly described (e.g., MRI, 3D-scanning, CAD)? | Yes | Yes | Yes | Yes |
| 14 | Were ALL important technical specifications (e.g., resolution) for the reconstruction modality clearly described? | Yes | Yes | Yes | Yes |
| 15 | Was the posture or position of the body parts controlled during the acquisition process (e.g., MRI, CT) of the model reconstruction? | Yes/No | Yes | Yes | Yes |
| 16 | Were the model reconstruction methods for ALL components clearly described including those requiring additional procedures (e.g., connecting points for drawing ligaments from MRI)? | Yes/No | Yes | Yes | Yes |
| 17 | Were the orientation or relative position among the components of the model assembly (where appropriate) clearly described? Answer YES if not applicable |
Yes | Yes | Yes | Yes |
| 18 | Was the type of mesh for ALL components, including the order of magnitude of the elements, clearly described? | No | No | No | Yes |
| 19 | Were the material properties for ALL components clearly described and justified? (e.g., with reference) | Yes | Yes | No | Yes |
| 20 | Were ALL the contact or interaction behaviours in the model clearly described and justified? | Yes/No | Yes/No | No | No |
| Boundary and Loading Condition (Simulation) | |||||
| 21 | Were the boundary and loading conditions clearly described? | Yes | Yes | Yes | Yes |
| 22 | Was the boundary and loading condition sufficiently simulating the common activity/scenario of the conditions? (e.g., if the research or inference is targeted to ambulation or daily activities, simulations of balanced standing or pre-set compressive load are insufficient) | Yes | Yes | Yes | Yes |
| 23 | Was the model driven by the boundary condition acquired from the same model subject? | Yes | Yes | Yes | Yes |
| 24 | Was loading condition on the scenario sufficiently and appropriately considered in the simulation? (e.g., muscle force, boundary force, inertia force) | Yes | Yes | Yes | Yes |
| 25 | Was the loading condition acquired from the same model subject? | Yes | Yes | Yes | Yes |
| 26 | Were the software (e.g., Abaqus, Ansys), type of analysis (e.g., quasi-static, dynamic), AND solver (e.g., standard, explicit) clearly described? (solver can be regarded as clearly described if it is obvious to the type of analysis) | Yes | Yes | Yes | Yes |
| Model Verification and Validation | |||||
| 27 | Were the methods of mesh convergence or other verification tests conducted and clearly described? | No | Yes | No | Yes |
| 28 | Were the model verification conducted and results presented clearly; and that the model was justified acceptable? | No | Yes | No | No—just mentioned about carrying them out |
| 29 | Were direct model validation (with experiment) conducted and described clearly? Answer YES if the authors had direct model validation previously with reference. |
No | Yes | No | Yes |
| 30 | Were the model validation conducted and results presented clearly; and that the model was justified acceptable? | No | Yes | No | Yes |
| 31 | Were the model prediction or validation findings compared to relevant studies? | No | Yes | Yes | No |
| Model Assumption and Validity | |||||
| 32 | Were the model assumptions or simplifications on model reconstruction/configuration AND material properties discussed? | No | Yes | No | Yes |
| 33 | Were the model assumptions or simplifications on the boundary and loading conditions discussed? | Yes/No | Yes | Yes/No | Yes |
| 34 | Were the limitations of model validation discussed? (e.g., differences in case scenario; differences between validation metric and primary outcome) | Yes | No | No | No |
| 35 | Was the limitation on external validity, single-subject, and subject-specific design discussed? | No | Yes | No | Yes |
| 36 | Were there any attempts to improve or discuss internal validity (such as mesh convergence test), uncertainty and variability in the study? | No | Yes | Yes | Yes |
| 37 | Was there any discussion, highlights or content on the implications or translation potential of the research findings? Answer NO if there are only bold claims without making use of the result findings or key concepts |
No | Yes | No | Yes |
| Sum: | 26 | 34.5 | 23.5 | 33 | |