Manuscript Title: Reliability and validity of the Arabic translation of the Fonseca

Anamnestic Index for Temporomandibular Disorders.

Running Title: Psychometric properties of the Arabic FAI

Article Category: Original article

Authors: XXX XXX1, XXX XXX2, and Adrian Ujin Yap3-5

1
Department of XXX
2
Department of XX
3
Department of Dentistry, Ng Teng Fong General Hospital, National University
Health System, Singapore
4
Faculty of Dentistry, National University of Singapore, Singapore
5
Duke-NUS Medical School, Singapore
6
National Dental Research Institute Singapore, National Dental Centre Singapore

Correspondence:
Name: XXX XXX
Tel.: XXX
Email: XXX
Address: XXX
SUMMARY

Objectives: The aim of this study was to develop the Arabic version of the Fonseca

anamnestic index (FAI-A) for Temporomandibular Disorders (TMDs) and to

determine its psychometric properties.

Methods: The FAI-A was derived by forward/backward translation and cross-cultural

adaption of the English FAI following international guidelines. Psychometric

assessment of the FAI-A was performed with a sample of 308 subjects seeking

orthodontics treatment. Reliability was established via internal consistency and test-

retest techniques whereas validity was verified by construct and convergent validity.

The later were carried out using factor analysis and correlation between FAI

subscale scores and global ratings of oral health respectively.

Results: Cronbach’s alpha value (internal reliability) for the FAI-A was 0.770 and the

intraclass correlation coefficient (ICC) value (test–retest reliability) was 0.996. For

construct validity, factor analysis revealed that three factors (i.e. XX, XX, and XX), all

with factor loadings above 0.45, accounted for 68.5% of the variance. An eigenvalue

>1.0 was used for extraction of the factors/dimensions which was followed by oblimin

rotation. For convergent validity, the FAI-A was significantly correlated to global oral

health ratings (rs=XXX).

Conclusions: As the FAI-A has good reliability and validity, it may be useful for

screening TMDs in the Arab world.

Key words: Temporomandibular disorders, Translation, Reliability, Validity,

Screening
Introduction

Temporomandibular disorders (TMDs) is a collective term that defines a number of

clinical problems involving the temporomandibular joints (TMJs), masticatory

musculature and/or their associated structures resulting in pain and disability [1]. It

represents the second most common TMD is the second most common

musculoskeletal condition; after chronic low back pain, and its annual cost in the

USA, has doubled in the last decade to $4 billion [2]. The signs and symptoms of

TMDs are multidisciplinary and include psychosocialcomponent: headache, neck

pain and physical or functional problems such as deviated and/or limited mouth

opening masticatory muscle and/or TMJ pain, joint noises [3]. A recent systematic

review reported a wide range of TMD prevalence between 21.1 and 73.3% in

patients seeking orthodontic treatment. There is a slight female predilection and the

percentage of males and females presenting with TMD varied from 10.6% to 68.1%

and 21.2% to 72.4% respectively [4]. Similarly, the prevalence of TMDs in the

general population was variable and varied from 20% to 50% [5-7]. The reported

reasons behind this variation in prevalence may be attributed to race and ethnicity,

sampling design differences; as well as the TMD screening instrument and

diagnostic criteria employed. The wide range in the reported prevalence reflects the

main problem regarding the diagnosis of this condition; especially in screening

surveys [8].

Screening for TMDs in specific populations is a challenge for both researchers and

clinicians due to methodological and logistic restrictions, and several TMD

assessment tools have been proposed in the literature [9]. However, there is

currently still no universally accepted and established TMD screener (methodological

and logistic limitations). The research diagnostic criteria for pain screener in TMDs
(RDC/TMDs) [10, 11], was introduced to address the lack of standardized diagnostic

criteria for defining clinical TMD subtypes and had been used in many clinical and

epidemiological studies. The diagnostic criteria for TMDs (DC/TMDs) was

subsequently developed to reach a very high sensitivity and specificity of the

RDC/TMDs [9].The DC/TMD includes a valid and reliable screening questionnaire

and diagnostic algorithms for the most common pain-related TMDs. With all the

advantages, the RDC/TMD and DC/TMD are still cumbersome tools for assessment.

In addition, many researchers tried to introduce a short form 3Q/TMD questionnaire;

and reported high validity and reliability rates [8, 12, 13], however it is too short and

does not cover all clinical manifestations.

The Fonseca anamnestic index (FAI) proposed by Da Fonseca and his colleagues in

1994 [14], is one of the available instruments first in Portuguese language and

translated into English. [15-19], for diagnosing and classifying TMD symptoms

according to the severity of these symptoms [14]. It was developed based on the

Helkimo modified clinical index and has been mooted as a simple, low-cost, patient-

reported TMDs assessment tool. The FAI was found to be highly correlated (r=0.95)

with Helkimo index [20]. The FAI is a 10-item multi-dimensional instrument that

assesses pain frequency, psychological distress limitations, jaw function and

parafunctional behaviors encountered in patients with TMDs [21]. The FAI was found

to be also consistent with other instruments used to screen and diagnose TMDs

including the American Association of Orofacial Pain Questionnaire and the Jaw

Symptom and Oral Habit Questionnaire [22].

It has high accuracy, sensitivity and specificity for identifying myogenous TMDs

prevalence in the community samples and allows grading its severity [14, 15, 23].

The FAI has been utilized by clinicians and researchers for clinical screening and
prevalence studies. It consists of two items or axis: axis I concerning function and

physical presentation and axis II concerning psychological presentation [17, 24-26].

In spite of the widely used English FAI and many other languages [26], it was not

translated to Arabic language due to literacy and cultural issues. For the FAI to be

employed in Arabic literate population it needs to be translated into Arabic language

and the translated instrument must be assessed for reliability and validity.

Arabic is one of the five most spoken languages in the world (spoken by more than

422 million people) and is the official language of about 25 countries including Egypt,

Iraq, Jordan, United Arab Emirates, Yemen, as Western Sahara (REF).

The objective of the present study was thus to translate and cross-culturally adapt

the FAI from the English into Arabic language and to evaluate the psychometric

properties of the Fonseca Anamnestic Index-Arabic (FAI-A). A secondary objective

was to determine the prevalence of TMD in patients seeking orthodontic treatment.

A recent study in 2017 evaluated 30 patients (15 female and 15 male) submitted to

Prosthodontics Department, College of Dentistry, Al-Mustansiriyah University clinic in

Baghdad / Iraq and reported significant female predilection and highly significant

association between myofacial pain dysfunction with the duration of using the

dentures [27]. While a previous study in Mosul/ Iraq among 450 TMD patients

admitted between 2001 and 2006 used Helkimo index; found that 51patients (11.3%)

were symptoms free, 169 patients (37.5%) reported mild symptoms and 230 patients

(51.1%) complained from severe symptoms [28]. A second previous study among

100 dental students in Mosul/ Iraq reported a high prevalence (55%) of myofacial

pain dysfunction (or TMD), and reported its association with stress [29]. Similarly,

another study examined 500 undergraduate students in Sulaymania University /Iraq

and reported while mild clinical signs, moderate clinical signs and severe clinical

signs were found in 47.4%, 14%, 2.4%, respectively [30].

Patients and Methods

Ethical approval

The study protocol was approved by the ethical committee of the Medical College in

the University of Kerbala.

Participants

The included subjects were recruited from the dental hospital at the Faculty of

Dentistry/University of Kerbala. Inclusion criteria for the study group were patients

seeking orthodontic treatment aged 18–35 year with no history of previous

orthodontic treatment. Exclusion criteria included history of neurological or

musculoskeletal disorders, history of TMJ trauma or treatment, and

immunocompromised patients. Participants who were unable to understand the FAI

questions were also excluded from the study.

The sample size was calculated based on a 95% confidence level, 5% margin of

error for 95% confidence interval, estimated population of 1500 new orthodontic

patients, and a 15% prevalence of TMDs [31]. A minimum sample size of 174

subjects was considered to be enough for the present study. Consecutive patients

from the period of June to November 2019 were invited to participate in the study. A

detailed explanation was provided to the patients before answering the FAI. The

questionnaire was completed in the waiting room in a quite environment and the

participants were free to consult the researcher assistants at any time for question.

Fonseca Anamnestic Index (FAI)

Da Fonseca and his colleagues [14] had been proposed a questionnaire consists of

10 questions in 1992 that allow the answers by “Yes”, “Sometimes” and “No”, with
scores of 10, 5 and zero, respectively. According to the summation of the points, the

examinees classifies in the following TMD categories: Absent (0 to 15 points), Mild

(20 to 40 points), Moderate (45 to 60 points) and Severe (70 to 100 points).

The results then analyzed using the frequency distribution of the questionnaire

answers according to the FAI.

Translation and cross-cultural adaptation

The FAI was translated into Arabic using the forward–backward process proposed

by Guillemin et al. [32]. The process included several major steps:

1. Two independent translators first translated the FAI from English to Arabic.

2. Then, the two independent versions were back-translated from Arabic to

English by a professional English teacher and two bilingual dental specialists,

none of whom know the original questionnaire.

3. The translated and back-translated versions was compared and discussed by

an expert panel consisting of two dental specialists with extensive knowledge

of FAI assessment who fluent in both English and Arabic. A preliminary Arabic

FAI version then produced.

4. The preliminary Arabic FAI was pilot tested on a convenience sample of 20

participants.

5. After the test, any emerging problems were discussed and corrections made.

The Arabic version was considered final when there were no substantial

differences.

Statistical analysis

Reliability

Two types of reliability were adopted to assess the reliability of the FAI. Internal

consistency was evaluated by calculating Cronbach’s alpha, and test–retest

reliability was determined via intra-class correlation coefficients (ICC), using data

from 30 participants selected randomly from all the participants who completed FAI

again after a 2-week interval. Cronbach’s alpha of 0.70 or greater is considered

acceptable for comparisons between groups [33].

Validity

Validity was assessed as construct and convergent validity. Construct validity was

determined using the exploratory factor analysis (EFA), specifically Principle Factor

Analysis (PFA). However, a Bartlett’s test of sphericity coefficient needs to be

conducted first to ensure sufficient sample size. Next, Kaiser–Meyer–Olkin (KMO)

test must be conducted to determine whether there are sufficient significant

correlation among the investigated items to carry out this analysis [34], here, factor

loadings greater than 0.40 was considered significant. Additionally, Factor Analysis

(FA) was used for data reduction and structure detection. In the first, the aim is to

remove redundant variables, while in the second is to examine the latent

relationships between the variables.

Finally, convergent validity was tested through investigating the correlation between

FAI subscale scores or components and the following global question: “In general,

do you have a pain in TMJ or difficulty in jaw functions?” The correlation values are

considered to indicate poor correlation when <0.20, to indicate fair correlation when

021–0.40, to signify good correlation when 0.41–0.60, to indicate moderate to high

correlation (0.61–0.80), and to indicate excellent? correlation when >0.81 [35].

Statistical analyses were conducted by SPSS 23.0 (SPSS, Chicago, IL, USA).

Results

Sample characteristics
A total of 330 patients were invited to participate in the study and 308 consented to

take part in the study. All the FAI-A questions were completed fully. The sample was

composed by 186 female and 122 male patients varying in age from 18 to 35 years,

with a mean age of 25.9 ± 4.8 years. Among the patients, 141 (46.1%) had no TMD;

118 (38.8%) had mild TMD; 36 (11.8%) had moderate TMD and 10 (3.3%) had

severe TMD. Table 1 presents the characteristics of patients.

Reliability testing

To assess the validity of any measurement; it is essential to check the reliability of

that measurement as reliability is a pre-request for any validity or in another word; no

measurement is valid unless it is reliable. The internal reliability of the total FAI-A

questions was acceptable, as Cronbach's alphas was 0.770, which indicates a good

level of internal consistency, this indicates that we can proceed to check validity of

these items.

Additionally, intra-class reliability was conducted among 30 patients through

retesting after two weeks and the intra-class coefficient value was 0.996 (95%

Confidence interval 0.992-0.998), which represent an excellent reliability or

agreement of test retest results.

Validity testing

Validity was assessed as construct and convergent validity. Construct validity was

determined using the Principal Factor Analysis (PFA). The Bartlett’s test of sphericity

coefficient was highly significant (p<0.001), which means that the correlation matrix

of the participants answers on FAI-A questions differ significantly from an identity

matrix or a matrix of absent or zero correlation. The Kaiser–Meyer–Olkin (KMO)

value was 0.680, which indicates acceptable value (>0.60), which is a measure of

adequacy of the sample size.

The PFA is a dimension reduction procedure which helps in reducing the items

of participants’ answers into a smaller number of components through combining the

correlated (highest eigenvalue) items into one component. The result of PFA showed

that the ten items of FIA in this sample could be reduced into three components

(Occlusion related component, Psychological-related component and Para-function

related component) accounting for 60.5% of the total variance (table 2). The

suggested names given to these components were Occlusion related component

(Poor occlusion, Neck pain, Emotional stress and Headache or items: 1, 2, 8, 9);

Psychology-related component (Pain in TMJ, TMJ sounds, Jaw fatigue or muscle

pain or items: 7, 6, 3) and Para-function related component (Mouth opening

difficulties, Jaw movement difficulties and Teeth clenching, or items: 4, 5, 10; table

3). Here only item 10 seemed not suitable for Para-function related component and

even analysis showed this fact as its correlation coefficient was the least (0.513).

This is also clear in the scree plot where the eigenvalue of each component in the

initial solution is plotted to determine the optimal number of showed that three

components got an eigenvalue greater than one. This generally, extracts the

components on the steep slope, where the components on the shallow slope

contribute little to the solution. The last big drop was observed between the third and

fourth components, so using the first three components is the best choice (Figure 1).

In Principle Component Analysis, two main categories differentiate between a group

where the factors within a component are correlated; and a second group where no

such correlation exists (orthogonal or rotated components). The rotated component

matrix helps to determine the strength of correlation of each factor within each

component. The first component (Para-function related component) was most highly

correlated with Mouth opening difficulties, Jaw movement difficulties. The second
component (TMD risk factors) was most highly correlated with Poor occlusion. While,

in the third component (Pain related factor) was most highly correlated with Pain and

noise in TMJ on chewing (Table 5). The next step was to determine whether there is

sufficient significant correlation among items included in each component. The

internal reliability within the Psychology-related component was good (Cronbach's

alpha= 0.727), and among Para-function related component (Cronbach's alpha=

0.533), and among non-TMD specific component (Cronbach's alpha= 0.736).

Next it was found that, the FAI subscale was significantly highly correlated with the

global question. Convergent validity was tested through investigating the correlation

between FAI subscale scores and the global question (Table 6).

Further analysis to determine the simultaneous effect of the components of the main

three factors was conducted through Structural Equation Model (SEM) using IBM-

Amos software. The model showed acceptable model fit (not significant which

indicates that the model is reasonably consistent with the data). The three

components were named as pain-related factor, function-related factor and TMD risk

factors correlated to the determining items (Figure2). The regression weight for each

factor within each component showed that for TMD risk factors, the highest

regression weight was for Headache, and for Para-function related component the

highest regression weight was for jaw movement difficulties, while for the third

component (pain related Component) the highest regression weight was for

Nervousness (figure 2).

Findings suggest that the FAI-A had acceptable reliability and good validity.

Discussion
With the growing number of multinational and multicenter studies, the need to

culturally adapt health status measures for use in other than the original source

language has grown rapidly. In recent years, FAI as a screening instruments has

been widely used to evaluate prevalence and severity of temporomandibular

disorders among general population and among specific groups of patients

instruments have been conducted to evaluate prevalence and severity of

temporomandibular disorders among patients [1, 31].

However, there remained a need for an Arabic version of FAI instruments to evaluate

prevalence and severity of temporomandibular disorders among patients. Foreign

instruments must be adapted before they can be used among people speaking

different languages and cultures. Therefore, we performed a cross-cultural

adaptation of the FAI to evaluate the reliability and validity of the FAI and compare it

to similar international studies. Cross-cultural adaptation is a term that addresses

both linguistic and cultural adjustment issues when translating an instrument into

another language setting [36]. The results demonstrated the linguistic and cultural

equivalence of Arabic to the English versions of FAI. Arab has a large portion in the

world population, with more than 420 million people speaking Arabic language [37].

This necessitates the development of an Arabic version of the FAI, which would have

wide clinical and research applications.

The reasons behind choosing FAI was because of its simplicity, speed and low cost

[11], even though it is not a diagnostic instrument of TMD. The FAI proposed by Da

Fonseca and his colleagues in 1994 [14], is one of the available instruments in

Portuguese language for the diagnosing and classifying TMD symptoms according to

the severity of these symptoms. These authors studied its correlation with the

Helkimo [20], modified Clinical Index and obtained a high positive correlation
(r=0.95) [14], and was also recommended by too many other studies [17, 24-26]. In a

large scale study in Brazil among 1230 patients; Compas and his colleagues

reported a median scale internal consistency of FAI questionnaire of 0.559.

Questions 1, 2, 3, 6 and 7 had greater contribution towards the total the Kuder-

Richardson coefficient-20, and the consistency of the instrument was higher when it

was composed only of these questions (0.7044) [17]. Additionally, Zhang and his

colleagues tried to determine the psychometric criteria of the FAI‐C among a sample

of 613 patients with TMDs and 57 controls and reported the internal consistency for

total FAI‐C score at 0.669, and intra‐class correlation coefficient value at 0.823 [26].

Other questionnaires such as RDC/TMD which is also used in epidemiological

studies depends on interview technique [11, 17], but is more difficult as it is long and

found to be not suitable according to the available time for data collection in the

present study.

The present study might be the first study to translate and cross-culturally adapt the

English version of the FAI into Arab population. A previous study in Saudi Arabia in

2015, used the English form of FAI to determine the prevalence of TMDs among

university students in Riyadh with an Arabic translation of the questionnaire was

provided to students who could not read English [1].

The FAI-A showed acceptable reliability and good validity in the Arab population

studied.

For internal consistency, Cronbach’s coefficient alpha to test reliability exceeded

0.75 for all items. In fact, Cronbach’s coefficient alpha in this study was higher than

Chinese version (0.67) [26], and a study among 1230 participants over the age of 18

years who were living in the city of Ribeirao Preto, Brazil (0.56) [17]. One potential

explanation for this particular finding could be that the Cronbach’s coefficient alpha is
partly affected by the type of population selected, where in the present study

conducted in patients seeking orthodontic treatment.

Additionally, intra-class reliability among 30 patients through retesting after two

weeks and the intra-class coefficient value was 0.996. A study in Brazil reported that

the intra‐class correlation coefficient (ICC) value (test‐retest reliability) was 0.823

[26].

Another important psychometric property of a questionnaire is its validity. Construct

validity refers to the extent to which scores on a particular instrument relate to other

measures in a manner that is consistent with the theoretically derived hypotheses on

the concepts being measured [38]. In present study, factor Analysis was used, which

is primarily used for data reduction or structure detection. In data reduction; the goal

is to remove redundant (highly correlated) variables from the data file, possibly with

replacing the entire data file with a smaller number of uncorrelated variables which

explain most of the variance that is observed. Here it helps to generate hypotheses

regarding causal mechanisms or to screen variables for subsequent analysis through

determining collinearity prior to performing a linear regression analysis or through the

other wide flexible available choices in FA including the seven methods of factor

extraction or the five selections of rotation or the multiple factor scores estimation

ways.

While in structure detection we aim to examine the underlying or so called latent

relationships between the variables. The principal components method of extraction

used in this study had demonstrated that the components that accounts for the

highest variation in FAI-A (65.5%) were three; namely Psychology-related

component, function-related component and Occlusion related components.

In the present study, the PFA was used to determine the construct validity. The PFA

extracted three components named (Function, Pain and TMD risk factors). Function

component included: Opening difficulty; ‘Difficulty in moving the jaw’ and ‘Teeth

clenching’ and Pain component included: ‘Poor occlusion’; ‘Frequent Headaches’

and ‘Neck pain’. While, Pain component included the remaining four questions:

‘Noise in TMJ on Chewing’; ‘Pain in TMJ’; ‘Feel tired on chewing’ and ‘Emotional

stress’. The internal reliability within the Function component was Cronbach's alpha=

0.727, among Pain component Cronbach's alpha= 0.533, and among Occlusion

related component Cronbach's alpha= 0.736. That is means there was acceptable

reliability within these three components. To the best of our knowledge, the current

study is the first to clarify the factor structure of the FAI. This clarification was not

confirmed in the original version of the FAI or in other relevant studies.

Conclusion:

The translation of the English FAI‐C questionnaire into Arabic language and its

cross‐cultural adaptation in accordance to the international guidelines was tried.

Psychometric evaluation of the FAI‐C was carried out on a sample of 613 patients

with TMDs and 57 controls. Reliability of the FAI‐C was determined by means of

internal consistency and test-retest methods while validity was ascertained by

criterion‐related validity. Criterion validity was examined via Cohen's kappa,

sensitivity and specificity when compared with DC/TMD Axis I diagnose

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 Table 1: Characteristics of patients (n = 308)

Variables Values

Age (year; mean ± SD) 25.9 ± 4.8

Gender (frequency; percentage)

Male 122 (39.6%)

Female 186 (60.4%)

Fonseca’s classification N (%)

No TMD 141 (46.1%)

Mild TMD 118 (38.8%)

Moderate TMD 36 (11.8%)

Severe TMD 10 (3.3%)

Table 2: The distribution of Eigenvalue of FIA components in Principal Factor

Analysis showing the total variance explained through extraction method

Extraction Sums of
Initial Eigenvalues
Item Squared Loadings

sequ Percent Cumulativ Percent Cumulat

Component
ence age e age ive
Total Total
Varianc Percentag Variance Percent

e e age

1. Opening difficulty 3.386 33.859 33.859 3.386 33.859 33.859

2. Jaw movement 1.469 14.690 48.548 1.469 14.690 48.548

difficulty

3. Jaw fatigue or 1.195 11.951 60.500 1.195 11.951 60.500

muscle pain

4. Frequent .974 9.742 70.241

 Headaches

5. Neck pain .831 8.307 78.548

6. TMJ pain .700 7.002 85.550

7. TMJ sounds .535 5.355 90.905

8. Teeth clenching .374 3.738 94.643

9. Poor occlusion .322 3.218 97.861

10. Emotional stress .214 2.139 100.000

Figure 1: Scree plot of FAI component by Eigenvalue of FAI components in

extraction method through Principal Factor Analysis

Table 3: Varimax-rotated factor loadings of the FIA items in each of the three

components

Sequ Component

ence Variable 1 2 3

7 Noise TMJ Chewing 0.843

6 TMJ pain 0.827

3 Feel tired chewing 0.682

Opening difficulty 0.856

1

2 Jaw movement difficulty 0.818

Teeth clenching 0.601

8

9 Poor occlusion 0.747

4 Frequent Headaches 0.628

Neck pain 0.594

5

Emotional stress 0.513

10

Table 6: Correlation between Fonseca Anamnestic Index-Arabic subscale scores

and the global question

Index Pearson Significance

Correlation

Opening difficulty 0.284 <0.001

Jaw movement difficulty 0.341 <0.001

Feel tired chewing 0.263 <0.001

Frequent Headaches 0.209 <0.001

Neck pain 0.207 <0.001

TMJ pain 0.704 <0.001

Noise TMJ Chewing 0.612 <0.001

Teeth clenching 0.304 <0.001

Poor occlusion 0.291 <0.001

Figure 2: Structural Equation Model of the components of the main three factors

showing the regression weight for each factor within each component