Computer Methods and Programs in Biomedicine 216 (2022) 106675

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Computer Methods and Programs in Biomedicine

journal homepage: www.elsevier.com/locate/cmpb

Reporting guidelines for in-silico studies using finite element analysis

in medicine (RIFEM)
Vijay Prakash Mathur a, Mohammad Atif a,∗, Isha Duggal b, Nitesh Tewari a, Ritu Duggal b,
Anoop Chawla c
a
Pedodontics and Preventive Dentistry, Centre for Dental Education and Research, All India Institute of Medical Sciences, 6th Floor, New Delhi 110029, India
b
Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi 110029, India
c
Department of Mechanical Engineering, Indian Institute of Technology, New Delhi 110016, India

a r t i c l e i n f o a b s t r a c t

Article history: Background: To the best of our knowledge, there are no reporting guidelines for design, conduct and re-
Received 19 May 2021 porting of Finite Element studies in health sciences. We intend to propose specific and detailed guidelines
Revised 8 January 2022
for reporting these studies.
Accepted 30 January 2022
Method: After recognizing the need to have uniform guidelines for reporting of finite element analysis
in medicine and dentistry, a group of 5 researchers working on FEA as their research area met in the
Keywords: summer of 2020 and drafted the methodology for the development of such guidelines. Each researcher
In-silico studies individually made a list of major headings required for reporting these studies and met again in Septem-
Finite element analysis ber 2020 to finalize the domains. Subsequently, sub headings and details were charted. The draft list of
Reporting checklist
items for reporting the guidelines were presented to a larger team of 15 experts and some changes were
Research guidelines
further made based on their inputs.
Quality assessment
Results: The guidelines entail seven major domains and their sub-domains, including parameters for
model structure, segmentation, mesh structure, force application and model validation, etc. This checklist
aims to improvise the reporting and consistency of FEA studies.
Conclusion: We hope that the usage and adoption of these guidelines by the scientific community would
result in more thoughtful and uniform documentation. Also, the confidence in the results would be
enhanced through model reproducibility, reusability and accountability. The proposed guidelines were
named as ‘Reporting of in-silico studies using finite element analysis in medicine’ and the term ‘RIFEM’
was used as acronym.
© 2022 Elsevier B.V. All rights reserved.

1. Introduction However, apart from these techniques, numerical approaches are

available that provide an approximated solution to a specified an-
In recent years, the fields of bioengineering and biotechnology alytical problem. The word in-silico was first used by Pedro Mira-
have witnessed tremendous advancement. A guidance document of montes to characterise biological experiments done entirely using
the Federal Drug Administration (FDA), USA apprised that “Com- a computer in 1989 in a workshop and later presented this in his
putational modelling and simulation studies, together with bench, PhD dissertation [3].
nonclinical in vivo, and clinical studies, can be used to evaluate The Finite element method (FEM) represents a computer-based
the safety and effectiveness of medical devices” [1]. Various exper- engineering resource involving the simulation of a real mechani-
imental as well as analytical methods are available for the study cal environment with infinite elements, into a virtual one with fi-
of anatomical structures and alloplastic structures. While experi- nite elements. The individual finite elements can be visualized as
mental methods may suffer from limitations when confronted with small pieces of a structure in which a field quantity is allowed
complex geometries or different material systems, analytical tech- to have only a simple spatial variation [4]. The elements of the
niques may be used for special cases where complex structures can structure are connected at points called nodes. This arrangement
be reduced down to a simplified problem allowing for solution [2]. of elements simulating a structure is called as mesh. Numerically,
the mesh is represented by a system of algebraic equations to be
solved for unknowns at nodes. The overall field quantity over the
∗
Corresponding author. entire structure is approximated element by element, in piecewise
E-mail address: [email protected] (M. Atif). fashion (Fig. 1) [5]. Material characteristics can be applied to the

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

Fig. 1. Figure to denote the mesh with nodes and elements.

Fig. 2. Figure describing the segmentation of the finite element model.

mesh to simulate the object response against any external stimu- while studying a homologous sample [7]. It possibly can simulate
lus (like force, pressure, thermal change, magnetic field power, and the oral environment in vitro and the displacement of oral struc-
other physical factors). The resultant displacement in the form of tures can be visualized graphically. The point of application, mag-
directional vector and the stresses generated can be identified and nitude and direction of a force may easily be altered to simulate
quantified through numerical analysis. Middleton et al. [6] stated the clinical situation. The reproducibility does not affect the phys-
that the data obtained from this analysis is more accurate than ical properties of the involved material and the study can be re-
any of the other experimental methods currently in use [6]. Thus, peated as many times as the operator wishes [8]. Thus, FEM is
it has been reported as a valid tool to predict the distribution of deemed as a powerful tool for solving various structural biome-
loads between the different structures at both the whole body and chanical problems.
single organ level by static and/or dynamic analysis [1]. This article is written with the purpose of disseminating knowl-
FEM is highly advantageous in research as it is a non-invasive edge by proposing specific and detailed guidelines for reporting of
technique allowing for complete control over the variables in use in-silico studies. This endeavor would assist in improving the qual-

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

Fig. 3. Figure describing the direction, magnitude and point of application of load.

Fig. 4. Figure describing the stress and strain distribution obtained after analysis.

ity of published studies and in evaluating others’ studies conducted model and analysis were missing. We concluded that the inconsis-
using finite element method [9]. Hence, it may be used by jour- tencies could possibly be due to lack of a standard reporting tool/
nal editors and reviewers for peer-review and by professionals (en- guidelines for the use of FEM in medical sciences or due to inad-
gaged in biomedical and clinical translational fields) in the interest equate standards of FE model development. Thus, our team came
of precise and correct reporting of the relevant research. up with the idea to develop and propose reporting guidelines for
FEM studies in medicine. This could help both the researchers in
1.1. Inception of the idea to develop the guidelines developing and reporting the models and the scientific community
in improving the research quality.
While screening several articles on trauma to other parts of
body, stress distribution due to various implant designs in or- 2. Methodology for development of the reporting guidelines
thopaedics, spine biomechanics, implantable medical devices and
materials, we found large variations in reporting methods. Addi- A meeting of a group of 5 researchers working on FEM as
tionally, some of the very vital details related to a finite element their research area was organised in the summer of 2020 and

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

Fig. 5. Figure describing the displacement obtained after analysis.

the methodology for the development of Reporting guidelines was ticles in the search engines. If the basic information such as use
planned. Each researcher of this group worked individually to of 2D or 3D finite element model, dynamic or static and linear or
make a list of major domains or headings required and met again non-linear analysis can be obtained from the title, the reader will
in September 2020. A senior expert from the field of mechanical be able to decide if the article is of his interest or not by merely
engineering was involved at this stage to finalize the technical do- reading the title visible in most of the scientific databases.
mains under which further details could be enlisted. After the ma- (Eg.1) “Assessment of heat generation and risk of thermal
jor domains were finalized, sub headings and details were charted necrosis during bone burring by means of three-dimensional dy-
by two groups of 3 members each and work was divided. In the namic elastoplastic finite element modelling”.
subsequent meetings in October and November 2020, both teams (Reference: Chen YC, Hsiao CK, Tu YK, Tsai YJ, Hsiao AC, Lu
proposed the draft items to be included in the guidelines under CW, Yang CY. Assessment of heat generation and risk of thermal
respective headings (mentioned in Appendix). By the end of De- necrosis during bone burring by means of three-dimensional dy-
cember 2020, a comprehensive list of domains and sub domains namic elastoplastic finite element modelling. Med Eng Phys. 2020
with description of the items was compiled. Subsequently, another Jul;81:1-12.)
meeting was hosted with a larger group comprising of 15 experts (Eg.2) “Comparison of the linear finite element prediction of de-
like editors, methodologists, mechanical engineers with in-depth formation and strain of human cancellous bone to 3D digital vol-
knowledge of FEM as well as physician-scientists with previous ex- ume correlation measurements”.
perience with FEM studies in medicine/ dentistry. The draft list and (Reference: Zauel R, Yeni YN, Bay BK, Dong XN, Fyhrie DP. Com-
its details were presented to the larger group and based on their parison of the linear finite element prediction of deformation and
inputs, some changes were further incorporated. The outcome of strain of human cancellous bone to 3D digital volume correlation
this meeting was a compilation of guidelines with sufficient infor- measurements. J Biomech Eng. 2006 Feb;128(1):1-6.)
mation under each sub heading. The final set of recommendations
have been proposed in this article. 3.2. Domain 2: Abstract: Structured summary of study objectives,
finite element modelling methods, results, conclusion and clinical
3. Results and discussion relevance with clear description of endpoints

Total of 7 domains and their subdomains have been described Abstract can be read in the journal without accessing the full
with justification in the text below and the summary table is given article. Therefore, many readers interpret the results by reading the
at the end of this section. abstract only and applying it in their clinical practise [10]. A struc-
tured abstract quickly conveys necessary information with high
3.1. Domain 1: Title: Identification as 2D/3D, dynamic/static and quality as compared to non-structured abstract [11]. Therefore, we
linear/non-linear with research objective/research phenomenon recommend that the abstract is covered under the headings- Study
background/objective, Methods, Results, Conclusion and/or Clinical
Since many of the FEM studies are published outside the med- relevance. The abstract should clearly indicate the objectives of the
ical science electronic databases, a complete title will help in find- study, what was done in methods and what was found in results.
ing the article more easily through open databases such as Google The methodology section should cover the details of segmentation,
scholar. As the keyword search can also be done by using filters development, meshing and the analysis of finite element mod-
such as title and abstract, it will augment the visibility of the ar- els used. A simplified inference of the result may not sufficiently

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

yield information needed by the reader. Information in the form can be built upon the results of any trials, observational studies
of numerical data such as the load applied, the maximum stress or in-vitro or experimental studies. Mentioning the findings of any
and strain or calculated Von mises stress as well as displacement previous experimental/ in-silico study related to the FEM study be-
should be summarized. It is also essential to mention the clinical ing reported plays a very important role in expanding the knowl-
relevance in FEM studies as some authors may have studied the edge of the readers associated with the research topic and sustain
behaviour of biological tissues but the clinical applicability of the their interest in further reading. The current evidence related to
findings may not be clearly comprehensible in the results and dis- the physical properties and mechanical behaviour of the tissues or
cussion of the abstract. An example of a sample abstract is given materials being studied should also be mentioned.
below-
(Eg.3)- 3.3.2. Sub-domain 3b: Lacunae in the current knowledge in that field
Background and objective: The traditional pedicle screw-rod in- FEM studies are meant to answer certain queries that are not
ternal fixation system has been widely used for thoracic diseases discernible from human to animal studies. They also help in deeply
in clinical practice, but its high profile increases the damage to soft understanding the biomechanical behaviour, which is beyond the
tissue, leading to long-term intractable back stiffness. The purpose scope of experimental studies. Therefore, it is important to men-
of this study is to compare biomechanical advantages between the tion the lacunae in the existing knowledge related to the field, in
new spine pedicle screw-plate internal fixation system and tradi- order to explain the need to fill the knowledge gap using in-silico
tional pedicle screw-rod internal fixation system using finite ele- studies. Using the previous study as an example, given below is a
ment analysis. sample text for mentioning the lacunae in any FEM study-
Methods: Based on computed tomography (CT), four three- (Eg.4)-
dimensional finite element models of T7–T9 were constructed. The “After the new plate was implanted into patients, however, we
downward concentrated force of 150 N and the moment of 5 Nm cannot figure out its biomechanical advantages in the human body
was applied to the models to simulate six physiological activities, as a new pedicle screw-plate internal fixation system while com-
including flexion, extension, left and right lateral bending, left and paring with the traditional pedicle screw-rod internal fixation sys-
right axial torsion. The maximum displacement, range of motion tem. As far as we know, no study has reported similar pedicle
(ROM) and maximum stress of the two models in six physiological screw-plate internal fixation system and its difference with the tra-
activities, was measured to evaluate the biomechanical advantages ditional pedicle screw-rod internal fixation system. The finite ele-
of the novel pedicle screw-plate internal fixation system. ment analysis (FEA) has been used for many years to test the per-
Results: The novel pedicle screw-plate internal fixation system formance of some fixation systems in the cervical and thoracic ver-
has a lower profile than the traditional pedicle screw-rod inter- tebrae, and it can also be used to predict fracture for the patients
nal fixation system. With regards to the stability, the maximum in many ways [,].”
displacement of the models of two internal fixation systems de- (Reference: Zhang W, Zhao J, Jiang X, et al. Thoracic ver-
creased by 56.2–91.4% under the six motion status when compar- tebra fixation with a novel screw-plate system based on
ing with the unstable model. Meanwhile, the ROM remained un- computed tomography imaging and finite element method.
changed between the two models of internal fixation systems be- Comput Methods Programs Biomed. 2020;187:104990.
sides the left lateral bending. However, there is no significant dif- doi:10.1016/j.cmpb.2019.104990).
ference in the ROM between the models of the two internal fixa-
tion systems in left lateral bending motion (P = 0.203). In terms 3.3.3. Sub-domain 3c: Rationale mentioning why in-silico study was
of the strength, the maximum stress in the model with the new chosen to answer the research question
pedicle screw-plate internal fixation system was higher than that In-vitro studies usually follow the experimental design to eval-
of model with the traditional pedicle screw-rod internal fixation uate the mechanical properties of biological tissues or medical de-
system in every motion status but left and right lateral bending vices [12,13]. These studies may not be able to answer specific
motion. questions such as stress and strain distribution in different regions
Conclusions: The novel pedicle screw-plate internal fixation of the structure, vulnerable areas of fracture under different load-
system has lower profile in orthopedics and higher strength, How- ing conditions, the displacement/deformation as well as the prop-
ever, it has no disadvantage when comparing with the traditional agation of cracks within the biological tissue or medical devices.
pedicle screw-rod internal fixation system in terms of the stability. Otherwise, it may further complicate the study design and/or ex-
In summary, we suggest that the novel spine pedicle screw-plate perimental model. Thus, the rationale to utilize FEM for the re-
system can be used as a new internal fixation and provide better search purpose should be justified based on the sub-domains and
comfort for patients. examples mentioned above.
(Reference: Zhang W, Zhao J, Jiang X, et al. Thoracic ver-
tebra fixation with a novel screw-plate system based on 3.3.4. Sub-domain 3d: Specific objective(s) of the study or hypothesis
computed tomography imaging and finite element method. The objectives of the study are pre-specified goals of the study.
Comput Methods Programs Biomed. 2020;187:104990. They should clearly address the question raised in Domains 3b and
doi:10.1016/j.cmpb.2019.104990). 3c. They must also clearly define the type of finite element model
being used or the variable condition being tested and the outcome
3.3. Domain 3: Introduction variable (stress/ strain distribution, displacement, etc.) must be de-
fined. In case of multiple objectives, both the primary and sec-
The introduction can be broadly described by covering the sci- ondary objectives must be mentioned.
entific background, lacunae in the current knowledge, rationale of
the study and specific objective(s) of the study. 3.4. Domain 4: Methodology; Development of finite element model

3.3.1. Sub-domain 3a: Scientific background 3.4.1. Sub-domain 4a: Method of acquisition of image/STL file for
Introduction basically comprises of free-flowing text with the finite element model development (CT, CBCT, scanner, MRI) or
goal to build-up the stage for the study. A clear and transparent self-generated finite element model used
description of scientific background updates the readers regarding This is the first crucial step for the development of finite el-
what is known about the research topic. The scientific background ement model. The base geometrical dimensions for the develop-

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

ment of 2D model can be obtained from photographs, X-rays, sec- 3.4.6. Sub-domain 4f: Mention of total number of elements and
tional planes of computed tomography (CT), whereas 3D mod- nodes of the final finite element model as well as the shape of
els can be obtained from CT, MicroCT, CBCT or MRI images. It elements
can also be self-developed using graphic designing software like The total number and shape of elements and nodes in the fi-
AutoCAD(Autodesk, USA) and SolidWorks(SolidWorks Corporation, nal finite element model and all its substructures are important
USA). Anatomically accurate finite element models can be obtained and should be reported. Different substructures of the model may
through the DICOM based digital images when compared to self- have different shapes of elements used. The reader needs to know
developed ones. On the other hand, generic models are based on the different shape choices, and the reasons thereof. A tabulated
average dimensions reported in literature. In this case, reference form of data, as represented in example below including the total
source of the dimensions used should be cited. If the finite element number of elements and nodes in each substructure as well as the
model was developed using images of the patient, it becomes im- shape of the element in different substructures can give an easy
portant to describe the basic details of the patient, particularly the identification of essential information regarding the final finite ele-
age and any deviation in characteristics from normal population. ment model.
(Eg.5)- Table 1 can be taken as an example(Table 1)
3.4.2. Sub-domain 4b: Mention of 2D/3D FE model used (Reference: Zhang W, Zhao J, Jiang X, et al. Thoracic ver-
A 2D finite element model can be used to evaluate the outcome tebra fixation with a novel screw-plate system based on
variables in single plane whereas a 3D model gives the liberty to computed tomography imaging and finite element method.
evaluate these variables in 3-dimensional structure [14]. Therefore, Comput Methods Programs Biomed. 2020;187:104990.
it is important to mention which model was used for the study doi:10.1016/j.cmpb.2019.104990).
and its utility over the other choice. If a 2D model is chosen, there
must be a mention of under what assumptions the limitations as-
sociated with 2D finite element model are acceptable. This allows 3.4.7. Sub-domain 4g: Total number of types of finite element
the readers to decide if the finite element model suits their interest models/designs used in the study with sufficient details of each
and evaluate how reliable the data could be for clinical extrapola- type/design of finite element model
tion. The relevance and applicability of the findings of the FEM study
depend upon how closely the finite element models relate to the
3.4.3. Sub-domain 4c: Mention of the software (with/without license)
clinical scenario. The readers can interpret this if total number of
used for each step for the development of finite element model,
models used and the differences in the designs of these models are
meshing and finite element analysis along with their versions
clearly mentioned and elaborated. The difference can also be in the
separately for each step
physical properties assigned to the sub-structures in the finite ele-
Different softwares are used in different steps of finite element
ment model. Insufficient description of types of finite element mod-
model development and analysis. The stages of development in-
els leaves the readers uncertain regarding the applicability of the
clude processing of acquired images, meshing and analysis of the
findings in their clinical practise. It also affects how the results are
finite element model. Therefore, software used for each step of FEM
extrapolated to different clinical situations and the conditions in
should be mentioned. The details should also include the versions
which the results hold valid.
of the software used.

3.4.4. Sub-domain 4d: Mention of the details of segmentation process

(Fig. 2) 3.4.8. Sub-domain 4h: Mention of dimensions of included
The process of image segmentation includes the location of the substructures in all the finite element models
different substructures within the image and identification of the The mechanical properties of the substructures are dependent
boundaries or edges to differentiate these substructures precisely upon the physical properties assigned as well as the dimensions
from one another. The meticulous segmentation would yield re- of the included substructure. These dimensions are either deter-
sults that are very close to real life situation. Therefore, description mined from the imported digital images as mentioned in Domain
about the segmentation process as well as the method of segmen- 4a or certain assumptions based on the average dimensions of the
tation should be stated. study substructures. Detail is necessary to interpret if appropriate
dimensions were used. Assumption of acceptable dimension may
3.4.5. Sub-domain 4e: Mention of the convergence test with be considered but it should match with the characteristics of the
important details such as number of finite element models used for rest of the substructures as well as the context of the study. Thus,
convergence test (with specification of number of nodes and elements the reference from which the average dimensions of the substruc-
in each test model) and acceptable percentage of error considered for ture was used should be cited giving the readers an opportunity to
the testing cross-verify their aptness
Convergence testing is a very important step during the process
of meshing where one evaluates the minimum number of elements
and nodes necessary to give reliable results. The convergence test 3.4.9. Sub-domain 4i: Mention of properties such as elastic modulus,
enables the acquisition of a mesh that balances accuracy and ju- Poisson’s ratio, Young’s modulus etc. of the described substructure
dicious use of resources. A selected result parameter (such as the The physical properties assigned to the substructures of the fi-
number of elements in the whole finite element model or in the nite element model also play a significant role in its mechanical be-
region of interest) is plotted as a function of a measure of “mesh haviour under different loading conditions. In most studies, the dif-
density”. Therefore, if convergence test was used before finalising ferent types of finite element models being compared may be built-
the finite element model for analysis, the authors should mention up of different materials and therefore, only the assigned physical
in detail the total number of models used for convergence testing, properties of these materials may differ among the types of finite
the number and nodes in each of the models as well as the per- element models. The readers may not usually have detailed knowl-
centage of error considered acceptable for the convergence. Lack of edge about the physical properties as well as the terminologies
such information leads to incomplete description and inability to used in FEA studies. It is therefore important to describe the prop-
interpret the appropriateness of the test as well as the final model erties assigned to various substructures in clear, simple and com-
used. prehensible language along with appropriate literature references.

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

Table 1
The element number and type used in finite element models.

Model C element amounts Model D element amounts Element type

T7 208,513 211.243 C3D4

T8 227.049 231.402 C3D4
T9 389.820 344.736 C3D4
internal fixation system - - C3D4
cortical bone - - C3D4
cancellous bone - - C3D4
ligament T3D2
T7-8 nucleus pulposus 580 580 C3D6H
T7-8 annulus fibrosus 1110 1110 C3D6
T8-9 nucleus pulposus 724 724 C3D6H
T8-9 annulus fibrosus 1210 1210 C3D6

3.4.10. Sub-domain 4j: Mention of the boundary conditions/restraints 3.5. Domain 5: Results
and contact condition between the substructure interfaces (Fig. 1)
The boundary condition is of key significance in the finite el- 3.5.1. Sub-domain 5a: Range of stress and strain,
ement models. It represents simply how something is “fixed” in maximum-minimum stress and strain areas in different structures
space and time (and/or how it is forcibly displaced). In a situation supported with figures (Fig. 4)
where a model is subjected to loading without boundary condition The von Mises criterion, defined as the maximum distortion
fixed, the model tends to displace as a whole without imparting a energy criterion is the sum of all forces like compressive, tensile
real stress plot that is required from the simulation. As for defining and shear stress. However, each material responds differently in
the contact conditions, if there cannot be any movement between response to the type of forces. For example, compressive stress is
two substructures, the interface should be assigned as bonded. On more favourable to the bone than tensile stresses [15]. Therefore,
the other hand, if the two substructures are free to move, the in- a detailed description of which kind of force acts on a particular
terface between them should be assigned as non-bonded or fric- area is relevant. Another example is of a study with base metal
tionless. Similarly, if some degree of friction is expected between post and core in dental research, in which it is expected that von
them, the interface should be assigned as frictional interface and Mises stress value can be recorded more over the base metal al-
value of coefficient of friction should be mentioned. loy, post-core as compared to adjacent tooth structure owing to its
greater modulus of elasticity value, but that stress value doesn’t
3.4.11. Sub-domain 4k: Figures of mesh and FE model, direction of mean necessarily that material is going to fail there.
loading along with area of application ( 3) The results are usually presented as a colour map of the dis-
Well-illustrated figures with thorough labelling are necessary tribution of the response, in which each colour pattern represents
for easy understanding. The anatomy and the meshing pattern may a range of values. Both the maximum and minimum values in the
not be completely understandable with mere textual description in respective regions of interest should be mentioned. There should
the methodology section. Hence, figures can be a complementary be a clear representation in figures and tabular form keeping in
source to understand these details with ease. Similarly, the mag- mind the appropriate units (Mega/Giga Pascals) as well as direc-
nitude of load, area of application of load as well as direction of tion (tensile/compressive stress etc). Often other parameters are
loading need to be appropriately illustrated in the form of figures also used- for instance, fluid pressure, strain, force or kinematic
allowing the reader to understand the methodology and analysis motion. Should the researchers choose to use some other parame-
visually. ters, the same should be appropriately reported as well.

3.4.12. Sub-domain 4l: Mention if the static or dynamic conditions

3.5.2. Sub-domain 5b: Range of displacement, maximum-minimum
were used. If dynamic, the peak load and the time duration/intervals
displacement in all dimensions in different structures supported with
of dynamic loading
figure (Fig. 5)
The mechanical behaviour of any material depends upon the
The results may also be presented as a displacement pattern
characteristics of the load applied to it. This includes static or dy-
depicting the movement of structures in the three planes under an
namic loads, the magnitude of the loading force, the direction of
external factor (force, pressure, thermal change etc). The contour
the loading force as well as the point of application of the load.
plots for displacement must also be provided along with the colour
Most of the applications of FEM in medical sciences involve dy-
pattern representing the range of values.
namic loading conditions. Therefore, if dynamic load was used, the
specifics such as the peak load, time duration and interval of dy-
namic load application should be mentioned. A small change in 3.6. Domain 6: Discussion (Analysis and interpretation of data)
any of the above-mentioned characters can change the stress/strain
distribution or displacement in the finite element model. Also, lack 3.6.1. Sub-domain 6a: Interpretations of the values as obtained on
of details could result in failure to reproduce the same conditions analysis and mentioned in results
for future studies. Interpretation of the results is a crucial step in FEM studies. It
requires integration of the knowledge of FEM, relevant mechanical
3.4.13. Sub-domain 4m: Mention of details of validation of FE model concepts and the underlying biological phenomenon in the context
using mechanical model of the study. The extrapolation of a computer-based analysis out-
If any mechanical model was used to validate the finite element come to the real-time clinical situation is a time-consuming, ardu-
model, details of the same should be mentioned in the methodol- ous task that must be done meticulously.
ogy. The method of application of force to the FE model, the po- The final results must reflect an optimal balance between the
sition of the strain gauge used or how the displacement, deforma- objectives of the study, computational accuracy and practical limi-
tion or crack propagation was examined should also be mentioned. tations of a finite element model.

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V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

Table 2
List of reporting guidelines for in-silico studies using finite element analysis in medicine (RIFEM 1.0).

Domain Item no Sub-domain

Title 1 Identification as 2D/3D, Dynamic/static and linear/nonlinear with research objective/research

phenomenon
Abstract 2 Structured summary of study objectives, methods, results, conclusion and clinical relevance
with clear description of endpoints
Introduction 3a Scientific background
3b Lacunae in the current knowledge in that field
3c Rationale mentioning why in-silico study was chosen to answer the research question
3d Specific objective/s of the study or hypothesis
Methodology
Development of FE model 4a Method of acquisition of image/STL file for finite element model development(Photographs, X
rays, CT,CBCT, scanner, MRI, etc) or self-generated finite element model used
4b Mention of 2D/3D model use
Software used 4c Mention of the software(with/without license) used for each step for the development of finite
element model, meshing and finite element analysis along with their versions separately for
each step
Segmentation process 4d Mention of the details of segmentation process
Convergence test 4e Mention of the convergence test with important details such as number of finite element
models used for convergence test(with specification of number of nodes and elements in each
test model) and acceptable percentage of error considered for the testing. Results of
convergence test including graphs/figures (if not described in methods section)
Nodes and elements 4f Mention of total number of elements and nodes of the final finite element model as well as the
shape of elements
Types/design of FE model 4g Total number of types of finite element models/designs used in the study with sufficient details
of each type/design of finite element model
Dimensions 4h Mention of dimensions of included structures in all the finite element models
Physical properties 4i Mention of properties such as elastic properties, Poisson’s ratio, Young’s modulus and material
stiffness of the described structure
4j Mention of the boundary conditions/restraints and contact condition between the structure
interfaces
Figures 4k Figures of mesh and finite element model, direction of loading along with area of application of
loading
Impact loading 4l Mention if the static or dynamic conditions were used. If dynamic, the peak load and the time
duration/intervals of dynamic loading
Mechanical validation 4m Mention of details of validation of finite element model using mechanical model
Results
Stress and strain distribution 5a Range of stress and strain, maximum-minimum stress and strain areas in different structures
supported with figures
Displacement 5b Range of displacement, maximum-minimum displacement in all dimensions in different
structures supported with figure
Discussion
Interpretation 6a Interpretations of the values as obtained on analysis and mentioned in results
Clinical relevance 6b Mention of clinical relevance/application of the findings
Limitations 6c Mention limitation in context with the finite element model, properties assigned to different
structures, and analysis
Conclusion 7 Conclusion should answer the questions raised as per the study objective

3.6.2. Sub-domain 6b: Mention of clinical relevance/application of the finite element model and send across a word of caution to the
findings reader before final conclusions are drawn.
The FEM can provide information that is difficult or impossible
to obtain with experimental observations. Thus, it becomes imper- 3.7. Domain 7: Conclusion: Conclusion should answer the questions
ative to translate the outcome of the numerical analysis into clin- raised as per the study objective
ical applicability. Every study conducted using FEM must explain
how clinically relevant information may be obtained from the sim- It is important that a well-designed and well-conducted study
ulation and guide further research in the related fields. Hence, a derives conclusions congruent with the primary objective. Since
finite element model must be created to a suitable degree of ac- different readers could interpret the qualitative outcome of the
curacy in order to answer the research questions at hand with ut- study in different ways, the conclusion must always provide an un-
most certainty. ambiguous answer to the research question considered in the be-
ginning. The take-home message of the study must be clear, con-
3.6.3. Sub-domain 6c: Mention limitation in context with the finite cise and also facilitate the understanding of the reader for future
element model, properties assigned to different structures and scope of research in the respective areas.
analysis The summary of all the domains and subdomains can be seen
FEM has its limitations compared to a true tissue-based experi- in Table 2.
mental study. However, these are mainly due to the various factors
that contribute to the mechanical response and are poorly under- 4. Justification
stood. These may arise due to the inherent inability of researcher
to accurately simulate biomechanical dynamics, lack of knowledge The proposed guidelines were named as ‘Reporting of in-silico
regarding the properties of sub-structures or oversimplification of studies using finite element analysis in medicine’ and the term
the real-time conditions. All of this may affect the accuracy of the ‘RIFEM’ was used as acronym. It comprises of a checklist of es-
results. It is ideal for authors to lay down the shortcomings of their sential items that should be reported in the FEM studies used in

8
V.P. Mathur, M. Atif, I. Duggal et al. Computer Methods and Programs in Biomedicine 216 (2022) 106675

medical sciences. The primary aim of this checklist is to improvise – review & editing, Formal analysis, Supervision, Investigation,
the reporting of FEM studies as well as to enhance the consistency Methodology, Validation, Writing – original draft. Isha Duggal:
in reporting. It would also help in the peer review process wherein Conceptualization, Visualization, Writing – review & editing, Inves-
reviewers can use the checklist as a standard for critical appraisal. tigation, Methodology, Writing – original draft, Validation. Nitesh
The involvement of a small expert group in drafting the guidelines Tewari: Conceptualization, Visualization, Data curation, Formal
is acknowledged as a limitation. However, with the changing times, analysis, Writing – review & editing, Validation. Ritu Duggal: Con-
this can be overcome by engaging a larger core group. It may also ceptualization, Investigation, Formal analysis, Methodology, Valida-
require addition or editing a few items under each domain in fu- tion, Writing – review & editing. Anoop Chawla: Conceptualiza-
ture which may be referred as the next version. Hence, this set of tion, Investigation, Formal analysis, Methodology, Validation, Writ-
RIFEM is being proposed as version 1.0. ing – review & editing.

5. Conclusion Acknowledgement

The reporting guidelines for in-silico studies in medicine and We would like to acknowledge the valuable contribution of 15
dentistry are need of the time. It will serve two purposes- one for experts for their valuable contribution in refining the domains and
the people who are writing the report and follow the guidelines, it subdomains of this guidelines.; 1 Sridhar Kannan; 2 Aditi Nanda; 3
is expected that the experiment/ study shall be more explicitly ex- Amandeep Kaur; 4 Joy Kurian; 5 Anika Dawan; 6 Manoj Jaiswal; 7
plained and easy to repeat with consistent results. The other pur- Siddhantha Sharma; 8 Veena Jain; 9 Joe Cherian; 10 Rekha Gupta;
pose is that the readers will be sure of validity of the experiment 11 Shubhra Gill; 12 Divyajoti Das; 13 Nishat Sultan; 14 Amolkumar
and its results. Lokade; 15 Dheeraj Kumar Koli.

Funding References

This research did not receive any specific grant from fund- [1] M. Cicciù, Bioengineering methods of analysis and medical devices: a cur-
rent trends and state of the art, Materials 13 (3) (2020) 797, doi:10.3390/
ing agencies in the public, commercial, or not-for-profit sectors.; ma13030797.
No funding was received to assist with the preparation of this [2] D.L. Romanyk, B. Vafaeian, O. Addison, S. Adeeb, The use of finite element anal-
manuscript.; No funding was received for conducting this study.; ysis in dentistry and orthodontics: critical points for model development and
interpreting results, Semin Orthod. 26 (3) (2020) 162–173, doi:10.1053/j.sodo.
No funds, grants, or other support was received 2020.06.014.
[3] P. Miramontes, Un Modelo de Autómata Celular para la Evolución de los Áci-
Availability of data dos Nucleicos [A Cellular Automaton Model for the Evolution of Nucleic Acids],
UNAM, 1992.
[4] G.P. Nikishkov, in: Introduction to the Finite Element Method, University of
Not applicable. Aizu, 2004, pp. 1–70.
[5] R.D. Cook, Concepts and Applications of Finite Element Analysis, John Wiley &
Code availability Sons, 2007.
[6] J. Middleton, M. Jones, A. Wilson, The role of the periodontal ligament in
bone modeling: the initial development of a time-dependent finite element
Not applicable. model, Am. J. Orthod. Dentofac. Orthop. 109 (2) (1999) 155–162, doi:10.1016/
s0889- 5406(96)70176- 2.
Ethical approval [7] L. Knop, L.G. Gandini, R.L. Shintcovsk, M.R. Gandini, Scientific use of the finite
element method in orthodontics, Dent. Press J. Orthod. 20 (2) (2015) 119–125,
doi:10.1590/2176- 9451.20.2.119- 125.sar.
Not applicable. [8] S. Trivedi, Finite element analysis: a boon to dentistry, J. Oral Biol. Cranio-fac.
Res. 4 (2014) 200–203, doi:10.1016/j.jobcr.2014.11.008.
Declaration of Competing Interest [9] A. Erdemir, T.M. Guess, J. Halloran, S.C. Tadepalli, T.M. Morrison, Considerations
for reporting finite element analysis studies in biomechanics, J. Biomech. 45 (4)
(2012) 625–633, doi:10.1016/j.jbiomech.2011.11.038.
The authors have no relevant financial or non-financial interests [10] PLoS Medicine Editors, The impact of open access upon public health, PLoS
to disclose.; The authors have no conflicts of interest to declare Med. 3 (5) (2006) e252, doi:10.1371/journal.pmed.0030252.
[11] S. Sharma, J.E. Harrison, Structured abstracts: do they improve the quality of
that are relevant to the content of this article.; All authors certify
information in abstracts? Am. J. Orthod. Dentofac. Orthop. 130 (4) (2006) 523–
that they have no affiliations with or involvement in any organiza- 530, doi:10.1016/j.ajodo.2005.10.023.
tion or entity with any financial interest or non-financial interest [12] R. Akhtar, M.J. Sherratt, J.K. Cruickshank, B. Derby, Characterizing the elas-
in the subject matter or materials discussed in this manuscript.; tic properties of tissues, Mater. Today 14 (3) (2011) 96–105, doi:10.1016/
S1369-7021(11)70059-1.
The authors have no financial or proprietary interests in any mate- [13] Y. Wang, J. Hahn, Y. Zhang, Mechanical properties of arterial elastin with water
rial discussed in this article. loss, J. Biomech. Eng. 140 (4) (2018) 041012, doi:10.1115/1.4038887.
[14] A. Boccaccio, A. Ballini, C. Pappalettere, D. Tullo, S. Cantore, A. Desiate, Finite
element method (FEM), mechanobiology and biomimetic scaffolds in bone tis-
CRediT authorship contribution statement
sue engineering, Int. J. Biol. Sci. 7 (1) (2011) 112, doi:10.7150/ijbs.7.112.
[15] J. Prasad, A. Goyal, An invertible mathematical model of cortical bone’s adap-
Vijay Prakash Mathur: Conceptualization, Visualization, Data tation to mechanical loading, Sci. Rep. 9 (1) (2019) 5890 Apr 10.
curation, Formal analysis, Writing – review & editing, Valida-
tion. Mohammad Atif: Conceptualization, Visualization, Writing