DC/TMD Axis I for Children
Condition: Temporomandibular Disorder; Children, Only; Pain Disorder; Joint Disorder, Temporomandibular
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      The aim of the present investigation was to perform the content and construct validation of
      the diagnostic criteria for TMD (DC/TMD) Axis I, for children 7 to 11 years old. A Delphi
      process was used to perfom the content validity of the DC/TMD Axis I. 189 7-11 years old
      children were assessed with the adapted instrument. Confirmatory factor analysis (CFA) was
      used to investigate construct validity of the DC/TMD for children. A baseline one-factor
      model was compared against a two-factor (Model 2) and a seven-factor (Model 3) models based
      on the original DC/TMD. Root-mean-squared error of approximation (RMSEA), comparative fit
      index (CFI), chi-square, change in chi-square and Cronbach's Alpha were used to analyze the
      data. All analysis were performed in STATA© version 13.0.
    

Detailed description: 
      This research was evaluated and approved by the ethics committee of Universidad CES (File 94,
      Project Code 584). Subjects signed a written assent and their parents signed written informed
      consent to participate in the study.

      Design: This was a prospective study to perform the content and construct validation of the
      DC/TMD Axis I for 7-11 year old children.

      Population and sample

      The target population of the study was children between 7 and 11 years of age of both
      genders, that were recruited in the specialized orofacial pain clinic at Universidad CES. The
      sample was recruited by convenience from February to November 2017, after having ready the
      Delphi process (June 2015-May 2016) and the adaptation of the instrument for children (June
      2016- December 2016).

      According to Colombian laws and policies for research, participants were evaluated by a
      psychologist, using a standardized instrument (CES-ERIL), to assure that their reasoning and
      comprehension abilities, were enough to understand the questions in the instrument.

      Examiner calibration to the original DC/TMD Axis I

      The investigator who carried out the clinical assessment of participants was first calibrated
      on the use of the original Spanish translation of the DC/TMD Axis I on adults. The
      calibration process was performed by three members of INfORM and strictly followed the
      protocol
      (https://ubwp.buffalo.edu/rdc-tmdinternational/wp-content/uploads/sites/58/2017/01/DCTMD-Trai
      ning-and-Calibration-160401.pdf).

      The primary statistic for assessing performance (i.e., case classification) was Kappa.
      Comparisons of interest included pair-wise between the clinical examiner (Suarez N) and the
      Reference Standard Examiner (Restrepo C, who is a calibrated member of INfORM) and an overall
      Kappa for all examinations (Kappa=0.82).

      Content validity

      The original DC/TMD axis I9 was applied to 25 children, who were accompanied by their
      parents. The children were different from children participating in the study. The exam was
      performed in the presence of the children´s parents, who confirmed the answers to the
      symptoms questionnaires. Appreciations from the examiners, children and their parents were
      recorded, regarding the understanding of the questions in the symptoms questionnaire and the
      language used to give instructions and ask about pain in the clinical exam.

      Clinical information and results from the exploratory study were available to the performers
      of the adapted DC/TMD Axis I for children, as a basis for the construction of the new
      instrument.

      The content validity of the DC/TMD was performed through a Delphi process described below.

      Delphi process

      Delphi technique was described by one of its originators as 'a method of eliciting and
      refining group judgments' and its purpose is to find consensus of experts around a certain
      situation or research. The Delphi method in this investigation was performed following the
      process of a previous investigations in TMD.

      The subjects of the Delphi study were 3 parents of children with TMD (whose children were
      evaluated with the original DC/TMD Axis I in the exploratory study), 2 parents of children
      without TMD (whose children were evaluated with the original DC/TMD in the exploratory
      study), one pediatrician expert in neurodevelopment; two psychologists, one that works with
      children with TMD at clinics of Universidad CES and another expert in psychometrics; one
      physical therapist, two general dental practitioners, two pediatric dentists and one
      maxillofacial surgeon who were presently involved in TMD patient care and were associated
      with the Pain clinic at Universidad CES. The group was called in this investigation as
      "panelists".

      The panelists were invited to participate directly and personally by the investigators. By
      email, the panelists received a detailed explanation about the study and an attached excel
      sheet that contained the whole questions and items of the clinical examination contained in
      the original DC/TMD Axis I as rows. In the first round of the Delphi study, panelists were
      requested to fill in three columns with the following three questions:

      For questions contained in the DC/TMD Axis I symptoms questionnaire:

        1. How understandable do you think this question is for children 7-11 years old on an
           11-point rating scale from 0 "completely not understandable" to 10 "extremely
           understandable"?

        2. Should this question be included in an adapted DC/TMD axis I (0 - no, 1 - yes)?

        3. How confident are you with your recommendation about the inclusion of the question on a
           11-point rating scale from 0 "not confident at all" to 10 "extremely confident"?

        4. Do you have any suggestion on the language and/or number of questions the instrument
           should include? Why?

      For the items included in the DC/TMD Axis I clinical examination

        1. How important to you are the following items for TMD diagnoses in 7-11 year-old children
           on an 11-point rating scale from 0 'completely unimportant' to 10 'extremely important'?

        2. Should the item be included in a DC/TMD clinical examination (0 - no, 1 - yes)?

        3. How confident are you with your recommendation about the items to be included in the
           adapted DC/TMD Axis I for children on a 11-point rating scale from 0 'not confident at
           all' to 10 'extremely confident'? The panelists should fill in the requested information
           and sent the excel file back by email. In the second round of the Delphi process,
           panelists received medians and interquartile ranges for the "understandable" and
           "confidence" ratings of the symptoms questionnaire (question 1 and 3) and for the
           "importance" and "confidence" ratings of the DC/TMD Axis I clinical examination
           (questions 1 and 3); added as extra columns in the excel sheet. For question 2, the
           proportion of positive answers, i.e., the per cent of panelists recommending the
           inclusion both of questions in the symptoms questionnaire and of items in the DC/TMD
           Axis I clinical examination, was given. Provided with the findings from the first Delphi
           round, the panelists answered again the three questions. This process asking panelists
           to score the questions again while considering the findings from the previous round was
           continued until a priori set criterion for consensus among the panelists was reached.
           Criterion measure for a consensus, was set using Cronbach's alpha as a measure of
           "internal consistency of the panel". An alpha >90 was used to stop the consensus
           process.

      As a result of the Delphi process, an adaption of the early official Spanish translation of
      the DC/TMD Axis I was performed in order to use the instrument in 7 to 11 years-old children.
      All children answered the questions in spanish.

      In the clinical examination, pressure applied to the muscles and TMJ, the Palpeter® (BUTLER®.
      Etoy, Switzerland), was used to standardize the pressure to the muscles. To determine the
      best force to be applied to the masticatory muscles in children, different pressures were
      tested according to previous literature in children. The pressures used in the original
      DC/TMD Axis I were evaluated as well.

      Each child answered the symptoms questionnaire and was evaluated with the clinical
      examination form of the adapted DC/TMD Axis I fo 7-11 year-old children. All assessments were
      obtained by the same calibrated investigator.

      Construct validation

      It was performed a construct validity using CFA. Factors were initially defined according to
      the diagnosis tree of the original DC/TMD Axis I9 (Table 1).

      Pearson correlation coefficients among the items of the DC/TMD Axis I were obtained. Three
      fit indices were used to test the best CFA model that could represent the adapted DC/TMD Axis
      I for children: root-mean-squared error of approximation (RMSEA), comparative fit index
      (CFI), chi-square, and change in chi-square, according to the change in degrees of freedom
      between models. Good models have RMSEA values that are 0.08 or less and a CFI greater than
      0.90 is considered to be an indicator of a good fitting model. When comparing models, a lower
      chi-square value indicates a better fit, when an equal number of degrees of freedom is
      present.

      Based upon the hypothetical underlying constructs for the DC/TMD Axis I, three models were
      developed to represent the best fit for the overall data. Model 1 was a one factor model used
      as a baseline comparison against the other models. Model 2 was a two factor model with pain
      disorders and joint disorders treated as latent factors. For Model 3, each factor included in
      the diagnosis tree of the original DC/TMD Axis I for adults, was treated as latent factor,
      except for Subluxation, Disc Displacement with Reduction with Intermitent Locking and Disc
      Displacement with Reduction with Limited Opening.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 7 and 11 years of age of both genders, that were recruited in the
        specialized orofacial pain clinic at Universidad CES.