Translation and Adaptation of The DC-TMD 2014 - 03 - 209060

Translation and Adaptation of the DC/TMD Protocol
Prepared by:
Richard Ohrbach, DDS, PhD
University at Buffalo, NY, US
For the Committee for Translations and Protocols

International RDC-TMD Consortium Network
Revised March 20, 2014
The “Guidelines for Establishing Cultural Equivalency of Instruments”, Ohrbach et al,1 (available
on the Consortium website) specifies in detail the recommended steps and procedures for
adapting an instrument to another language. This document provides additional information and
translation guidance specific to the DC/TMD protocol.
Contents
A. Components for translation......................................................................................2

B. General Notes on the Translation Process..............................................................5
C. Examiner Commands.............................................................................................5
D. Examination Recording Form.................................................................................7
E. Diagnostic Decision Trees and Diagnostic Criteria.................................................8
F. DC/TMD Symptom Questionnaire and TMD Pain Screener....................................8
G. Demographics......................................................................................................... 9
H. Axis II Instruments................................................................................................10
I. The PHQ Family of Instruments.............................................................................11
J. Psychometric Issues.............................................................................................12
K. Filename conventions and submission of Logs for review.....................................17
L. Authorship of a translation......................................................................................19
M. References........................................................................................................... 19
N. Updates to this document......................................................................................20
Translation and Adaptation of the DC/TMD Protocol Page 2 of 21
A. Components for translation
A completed DC/TMD translation will consist of the following components:

Component Source
Title page of the translated Translation template on Consortium website

instrument
Contents page Translation template on Consortium website
Examination Commands. Translation teams will, in general, choose one of these options:
 A1 (Complete Examiner Specifications) and A2 (Examination-Related Pain Interview), or
 B (Required Examination Commands),
A1. Complete Section 5

Examiner Commands Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Clinical Examination Protocol
Ohrbach R, Gonzalez Y, List T, Michelotti A, Schiffman E
Instrument Version: June 02, 2013
A2. Examination- Section 6

Related Pain Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Interview Clinical Examination Protocol
B. Required Section 8
Examination Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Commands Clinical Examination Protocol
Examination Form Section 9

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
[translation not required; Clinical Examination Protocol
if not translated, then Ohrbach R, Gonzalez Y, List T, Michelotti A, Schiffman E
English version will be part
Form Version: May 12, 2013
of the final document]
Diagnostic Decision Trees, Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical
as based on published and Research Applications: Recommendations of the International
criteria RDC/TMD Consortium Network* and Orofacial Pain Special Interest
Group**
[translation not required; Schiffman E, Ohrbach R, et al, Journal of Orofacial Pain, 2013
if not translated, then
Figure Version: June 8, 2013
Diagnostic Criteria Table, Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical
as based on published and Research Applications: Recommendations of the International
criteria RDC/TMD Consortium Network* and Orofacial Pain Special Interest
Group**
[translation not required; Schiffman E, Ohrbach R, et al, Journal of Orofacial Pain, 2013
if not translated, then
Table Version: June 8, 2013
Component Source
DC/TMD Symptom Impact Study Research Group
Questionnaire
TMD Pain Screener Gonzalez YM, Schiffman E, Gordon G, Seago B, Truelove EL, Slade G,
Ohrbach R. Development of a brief and effective temporomandibular
disorder pain screening questionnaire: reliability and validity. JADA
142:1183-1191, 2011.
Form Version: October 11, 2013
DC/TMD Demographics Impact Study Research Group

Pain Drawing Impact Study Research Group

Graded Chronic Pain Von Korff M. Assessment of chronic pain in epidemiological and health
Scale Version 2.0 services research: empirical bases and new directions. In: Turk DC,
Melzack R, editors. Handbook of Pain Assessment, Third Edition. New
York: Guilford Press. 2011. pp 455 – 473.
Jaw Functional Limitations Ohrbach R, Larsson P, and List T. The Jaw Functional Limitation Scale:
Scale (8-item and 20-item Development, reliability, and validity of 8-item and 20-item versions.
versions) J.Orofacial Pain 22:219-230, 2008.
PHQ-4 Kroenke K, Spitzer RL, Williams JB, and Löwe B. An ultra-brief screening
scale for anxiety and depression: the PHQ-4. Psychosomatics 50 (6):613-
621, 2009.
A text-revision of this instrument is posted at http://www.phqscreeners.com/
and incorporated into the final instrument for the Consortium.
PHQ-9 Kroenke K, Spitzer RL, and Williams JB. The PHQ-9: validity of a brief
depression severity measure. Journal of General Internal Medicine 16
(9):606-613, 2001.
Component Source
GAD-7 Spitzer RL, Kroenke K, Williams JB, and Löwe B. A brief measure for
assessing generalized anxiety disorder: the GAD-7. Arch.Intern.Med. 166
(10):1092-1097, 2006.
PHQ-15 Kroenke K, Spitzer RL, and Williams JB. The PHQ-15: validity of a new
measure for evaluating the severity of somatic symptoms. Psychosom.Med.
64 (2):258-266, 2002.
Oral Behaviors Checklist Ohrbach R, Markiewicz MR, and McCall WD Jr. Waking-state oral
parafunctional behaviors: specificity and validity as assessed by
electromyography. European Journal of Oral Sciences 116:438-444, 2008.
Ohrbach R et al. Oral Behaviors Checklist: Development and validation.
Forthcoming.
B. General Notes on the Translation Process

1. While most extant translated versions of the RDC/TMD available on the website
for the International RDC/TMD Consortium Network (www.rdc-
tmdinternational.org) were created with only one forward translator, two forward
translators will be required for the DC/TMD data collection instruments in order to
improve overall translation quality. The two forward translators must work
independently with respect to the eventual goal of cultural adaptation of each
instrument.
2. The minimal sections of the DC/TMD protocol which must be translated include
all components in the above table except for the diagnostic decision trees and
the examination recording form.
3. The other components of the DC/TMD protocol (i.e., remainder of the
examination specifications, diagnostic decision trees, examination recording
forms, scoring rules for Axis I and Axis II components, and summary diagnosis
forms) may be translated, depending on time, interest, and needs of the
developer of the translated version; whether those parts are translated may
depend on English fluency of clinicians who will be using the DC/TMD protocol.
As noted in the table, above, the decision trees and the examination form do not
require translation, as only professional staff use those instruments. If use of
those instruments in the target language is desired, forward translation only can
be sufficient.
4. For the final document containing the translated version of the DC/TMD, two face
pages should be constructed; the first face page will be in the target language
(i.e., non-English), and the second face page will be in English. The face pages
identify the lead developer/translator as well as all collaborators. Collaborators
include forward translators, back-translator, project coordinator, and reviewer.
See example face page for the DC/TMD (as based on Italian) posted on the
Consortium web site (www.rdc-tmdinternational.org).
C. Examiner Commands
The language used by the examiner during the examination is a set of operationalized
commands that must be translated just as carefully as a self-report instrument;
otherwise, the exact behavioural context for subject response during the examination
may not be consistent with the intent of the command and may result in non-
comparability of data with that obtained in other languages. The DC/TMD examination
protocol is intended to be used in both clinical and research settings. In both settings,
the nature of the verbal command to a patient or research subject will determine the
observed responses and hence data that lead (or not) to a diagnosis. The stated
sensitivity and specificity of the common TMDs within the DC/TMD are based on data
collected according to reliable methods; consequently, failure to use the appropriate
commands (in English, or correctly translated to another language) will result in false
positive and false negative diagnoses. Consequently, translators must be very careful
in the translation process to produce examination commands that have the same
meaning (which includes the same cultural equivalence) as expressed in the English
examination commands. Examiners must then be equally careful to use the culturally
equivalent commands when actually conducting the DC/TMD examination.
Nothing in these instructions about rigorous examination commands that carry the same
meaning and clarity in all languages should be construed to imply that investigators are
not free to add other items to the core protocol, if they wish to empirically test
hypotheses about the examination protocol or particular types of findings; again, the
emphasis here pertains to adding items. The DC/TMD items, on the other hand must
be administered in their current format. Adding an item that is a modification of a
standard DC/TMD item is acceptable.
The present set of commands have been extensively field-tested for examiner reliability
in several languages (English, Swedish, German, Danish) and have been trial
translated into several languages (Dutch, German, Spanish, Swedish) in order to
provide assurance that the English language version forms a sufficient and clear base
for further translation.
For example, for pain-free opening, the command (in English) could be stated as any of
the following versions: “Open as wide as you can, without any pain”, or it might be
“Open as wide as possible without pain” or it might be “Open maximally without pain”.
While each of these versions in English means approximately the same thing and while
each can be translated reasonably accurately to another language, only one
construction, the version “Open as wide as you can, without any pain” has been shown
to translate well to the conversational forms in other languages and consistent with the
intention of the source item as implemented with native English-language speaking
individuals. Another example is to “close your teeth completely together”; in one
language (at least), the phrase “completely together”, if translated literally, means to the
speaker of that language that the teeth should be clenched tightly together, which is not
at all a requirement for the valid performance of the particular examination command;
hence, the phrase, “…but not clenching” was added as a reminder to the translator that
the intent in bringing the teeth completely together is a spatial one, not one that involves
any extra force. If other translators find problems with the current wording, they are
invited to contact the first author of this document for further review. One intent of the
present document is to provide, over time, an FAQ that describes problems
encountered by translators of different languages, and to archive the method of
resolving the particular problems.
The bias of the research group that refined the verbal examination commands in
English is that verbal language used during the examination should be as simple and
direct as possible (i.e., make it as clear as you can) in order to foster common-sense
understanding on the part of the patient. The form of the language for the verbal
examination commands should therefore be regarded as our attempt to provide as clear
a statement as possible regarding what the essential operations are in the performance
of each examination procedure. We also recognize, however, that the final performance
of a command rests upon shared understanding on the part of the patient, and that that
understanding often emerges as much from non-verbal communication or ancillary
commands which examiners instinctively provide as it does from the formal verbal
command. After capturing the essential intent of a command, common-sense usage
should be foremost for the translator and user. Translators would do well to remember
that verbal language and written language often differ, and for the examiner commands,
the requirements and sensibilities of verbal language should prevail.
The translator should consult Parts 2 and 3 of the “Diagnostic Criteria for
Temporomandibular Disorders (DC/TMD) Clinical Examination Protocol” for elaboration
regarding any particular command in the Complete Specifications (Part 5) that is
unclear with regard to the meaning in the source language.
The translator has a choice of two approaches for the translation of the examination
commands and procedures:
 To translate only the Required commands (Section 8 of the DC/TMD Examination
Protocol) and just the verbal component of the Examination Pain interview
(Section 6 of the Protocol); under this approach, everything else that an examiner
would say during an examination will be up to the examiner to create based on
the intent of the procedure as described in the Complete Specifications of the
Examiner Protocol; or
 To translate the Complete Examiner Specifications (Section 5 of the Protocol)
and complete Examination Pain Interview (Section 6 of the Protocol); together,
these two documents fully operationalize all aspects of the examination
procedure.
From our field studies of this protocol, the complete set of specifications provides the
comprehensive structure for an examiner to efficiently complete the examination.
Which version a translator develops is up to that individual and will often be determined
by the setting. For example, translated versions that will be used in university training
environments will likely be based on the complete specifications; however, whether the
additional verbal text and examiner procedures are translated will often depend on
English fluency among the users of the specifications. It is entirely sensible to insert the
translated required commands into the otherwise English language version of the
specifications. In contrast, a version used in a primary clinical setting may productively
be based only on the required commands. In both instances, however, the examination
pain interview must be translated. The verbal component of the Examination Pain
Interview is included in the Log B of the Required Commands; the same material
accompanied by the explanation also exists as a separate Log B when the complete
specifications are translated.
D. Examination Recording Form

The examination form does not require translation, as only professional staff interact
with it. However, in some settings, it is desirable to make that language consistent with
the verbal language used for data collection. An international version as well as US
version is provided; the difference is solely in the numbering of the teeth. The
RDC/TMD used the English measurement pounds for specifying palpation force; the
DC/TMD has changed to the international kilogram.
E. Diagnostic Decision Trees and Diagnostic Criteria

Decision trees and the diagnostic criteria table are not used by patients, and they
consequently do not require translation as far as reliable data collection from the patient
is concerned. However, in terms of reliable decision-making by the provider, translation
of the decision trees or diagnostic criteria table may be desirable. Because the decision
trees are graphical in nature, the translation log for this content does not readily map to
the finished product. Suggestions for how to improve this will be gratefully received.
One phrase in the decision trees and diagnostic criteria table may present some
problem to non-native speakers of English. In the DC/TMD, Tables containing the
diagnostic criteria use the phrase "The pain is not better accounted for by another pain
diagnosis" for the myalgia and arthralgia diagnoses, and "Headache not better
accounted for by another headache diagnosis" for the Headache attributed to TMD
disorder. This phrase, "...not better accounted for by ..." is standard [English language]
jargon in many diagnostic taxonomies, but it is often awkward for non-native English
speakers to translate. These phrases can be equivalently expressed in English as
““The pain condition is not better explained by another disorder” or “"The pain is not
attributed to another pain disorder". Either of these English structures appears to be an
easier form of the source language for translation to other languages.
F. DC/TMD Symptom Questionnaire and TMD Pain Screener

The Patient History Questionnaire (PHQ) of the RDC/TMD has been completely revised
for the DC/TMD and is renamed Symptom Questionnaire (SQ) in order to more clearly
differentiate it from the PHQ-9 and PHQ-15, where the names pre-existed the
development of the DC/TMD.
Notable differences between the RDC/TMD PHQ and the DC/TMD SQ include: focus on
Axis I diagnostic requirements (except for the pain chronicity question), placement of all
Axis II instruments as a separate set of documents, and placement of demographic
questions in a separate document. The modular organization (i.e., separation of Axis II
and demographic instruments to their own documents) enhances flexibility in how the
DC/TMD protocol can be adapted for specific settings. For example, one setting may
wish to use only the Axis II screening instruments, while another setting will use the
complete Axis II instruments. One setting may already assess the necessary
demographic information through a mandatory clinic registration form, while another
setting may need a separate form for research.
The TMD Pain Screener was intended to be a stand-alone screener for use in a variety
of settings. Almost all of the scope of the TMD Pain Screener is included in the SQ, but
note that the identified anatomical region of interest differs pain-related filter item across
the two instruments (item 1 in TMD Pain Screener; items 1 and 3 in DC/TMD SQ). The
TMD Pain Screener, in the interest of maximizing specificity in relation to other disorders
that can produce TMD-like pain, asks about pain in the jaw or temple area, whereas the
DC/TMD SQ, in the interest of being inclusive about possible areas of TMD-like pain
and coupled with a clinical examination for confirmation, asks about pain in the jaw,
temple, ear, or front of the ear. Whether this difference in wording has substantive
consequences remains to be determined by empirical or logical means. In many
settings, the DC/TMD SQ will be the sufficient pain history collection instrument, and the
TMD Pain Screener will not be needed. In other settings, only the TMD Pain Screener
might be needed. Nevertheless, both instruments must be translated in order for the
resultant language instrument set be complete for all potential users in that language
setting.
G. Demographics
Demographic questions are often asked as part of other registration materials, and
hence they are no longer a required part of the PHQ. The user could include them with
the PHQ as the first section or as the last section. If they are included as the first
section, then the item numbering of the PHQ must be carefully controlled, as the
Diagnostic Decision Trees key from the item numbers in the PHQ for the respective
criteria by history.
Questions in the Demographic form assessing education, income, marital status, and
race/ethnic status need to be carefully revised for each national setting in order to
appropriately capture the respective information in a manner that is accurate for that
setting. A literal translation of these items will almost always be incorrect for any setting
outside the United States. In making changes to these items, the source item on the
Log B for the Demographics form should be revised accordingly.
Additional comments on each aspect of demographics follow:
(1) The types of marital status, and the relevance of each type, are often unique
in each setting. Co-habitation, for example, has different meanings in
different cultures. Whether relationships of the same sex should be explicitly
acknowledged in the way the question is asked depends on local mores and
changes across time.
(2) Race/ethnicity on the Demographics form represent the categories
considered important for national surveys in the United States, as determined
by the US Federal Government. Categories appropriate in other settings will
be determined on the basis of a wide range of considerations, including the
population local to a particular setting, to theoretically or empirically
meaningful distinctions, to national record keeping. In addition, in many
settings the ethnicity and race questions, as used in the US, may be
collapsed to a single item.
(3) Years of education seem to be based on an approximately equivalent unit
throughout the world. At an instrument level, the grouping of the years may
well differ (e.g., elementary school may be 4, 5, or 6 years). And, in some
countries, the number of years of education do not necessarily map directly to
the number of years in other countries due to strong differences in the

education programs. Consequently, significant attention in data analysis of
this variable is needed even though the raw numerals appear equivalent
across settings. The primary response format for the DC/TMD was simplified
into blocks of schooling; a translator may wish to retain the actual number of
years of education since that measurement method is less ambiguous.
Moreover, the lowest level of education in the DC/TMD demographics form is
“through high school” due to the very low prevalence in the US of education
terminated early (e.g., primary school). How the lowest level of education is
represented in a given setting should be determined according to national
statistics and prevalence rates in that setting.
(4) Income levels for each bracket should be based on national indices which
may represent quartiles. Socioeconomic status is still best measured on the
basis of both education and income; in the US, there is also a directory of job
classifications, which also permits the inclusion of job status into the
computation of SES. If there is such a directory in other countries, the
instrument developer might want to consider the inclusion of that kind of item
in the Questionnaire if SES is of significant interest.
(5) There are national statistics units which provide classifications of value for
these variables. The national statistics unit in The Netherlands has links to
similar units in many countries throughout the world; see
http://www.cbs.nl/nl/service/links/default.asp#Europa to get started. In
general, it can be recommended to use instruments which have been already
used in large national health-related surveys. National survey databases
should be consulted, if available, in making decisions regarding the levels of
importance for the demographic variables.
H. Axis II Instruments
The Axis II instruments fall into two sets: the short set for primarily screening purposes,
and the long set for more comprehensive evaluation. From a translation perspective,
the short set includes two instruments (PHQ-4, JFLS-8) that are derivative from other
instruments in the long set; consequently, translating the long set provides the full
information for constructing the instruments in the short set. As a procedural policy, only
translations that include the both short and long sets of Axis II instruments of the
DC/TMD protocol will be posted on the Consortium website; this principle is consistent
with the goal of disseminating in other languages translations of the full DC/TMD
protocol. Users will often have other instruments that they wish to add to the set of Axis
II instruments for a given setting; other instruments can of course be added, and if these
instruments exist as a source language in English, they can also be translated and
added to the instrument library on the Consortium website. While we recommend that
the long set of Axis II instruments be used, in order to maximally facilitate DC/TMD
research, we also recognize that in a given setting, a different instrument (e.g., HADS
for depression and anxiety, instead of the PHQ-9 and GAD-7) might be preferred or
even required due to various consortia agreements that often exist. As noted in the
Guidelines document 1, translation and in particular cultural equivalency of instruments

that assess mood and similar constructs can be a complex undertaking.
A developer may also consider retaining the legacy instruments for depression, anxiety,
and physical symptoms, as based on the SCL90 and used in the RDC/TMD. Already
completed translations may exist of the entire SCL90-Revised (SCL90-R), perhaps also
accompanied by psychometric data with regard to reliability and validity; note that the
Revised version of the SCL90 is copy-righted, while the original SCL90 is not (and from
which the depression and non-specific physical symptoms scales in the RDC/TMD were
derived). Data for the construction of a scoring concordance table are currently being
conducted, with data collection scheduled to be completed by December 2013; a
measurement table will be released (estimate: 2014) which will allow direct comparison
of RDC/TMD Axis II legacy data with the new PHQ family instruments.
I. The PHQ Family of Instruments

The PHQ family of instruments comprises PHQ-4, PHQ-9, GAD-7, and PHQ-15. These
instruments were derived from the PRIME-MD project, which sought to improve mental
health assessment in primary care settings. The specific item content for each of these
instruments has undergone text revision since publication, and we have chosen to use
the most recent versions of each of these instruments for the Consortium Axis II
dataset. If a given setting for DC/TMD implementation needs to be compatible with the
version of the instruments initially published, then the translation developer must decide
whether to use the published wording or the text-revision. If using the published
wording, the Log B for the respective instruments will need to be modified in order to
reflect that particular wording.
The PHQ-4, PHQ-9, GAD-7, and PHQ-15 have already been extensively translated as
part of Pfizer, Inc.’s research program, and already translated versions are readily
available (http://www.phqscreeners.com/). In order to conserve resources and promote
cross-domain research, DC/TMD translation groups are therefore encouraged to use
the existing translations if the translation is acceptable. Consequently, if an existing
translation of any of these instruments is used for a given translation of the DC/TMD,
indicate in the translation Log A that an existing translation was used, provide the
citation to that version, and attach the translated instrument to Log A. That “translation”
would then be complete.
The origin of these translations archived at phqscreeners.com is, however, not clearly
stated on the website, and while many have been translated by a professional
translation group, it is not clear which ones have been, and we have found items in the
PHQ-9, for example, that were translated into another language by an unknown group
and which we disagreed with. Consequently, DC/TMD translators are encouraged to
consider the available translations of these instruments but to first critically review the
translation as well as any published supporting material for the reliability, validity, and
cultural equivalence of the translation. Should a DC/TMD translator find problems in the
existing translation of one of these instruments, we recommend the following steps:
 Use the translation available via Pfizer for “Translation 1”

 Perform an independent translation from the source Log B (“Translation 2”)
 Critically review and synthesize the two translations into a single translation
 If the differences between Translation 1 and Translation 2 are minor and of no
substantive consequence in the target language, then use the existing Pfizer-
based translation; if the differences are not minor, then note on the translation
Log C as a comment (use another color in the synthesis column) that the
translation group disagrees with the Pfizer-based version, and briefly explain
why.
 The Consortium will convey this information as well as the final Consortium
version to the individual who monitors the Pfizer translations, and we will add a
note on the Consortium website regarding the presence of differences in our
version of the translation vs that on the Pfizer website.
As an official Consortium policy, we encourage collaboration between individuals and

groups when difference perspectives emerge regarding the correctness of a translation.
However, we contacted Pfizer and they have no formal method in place for resolving
differences in translations. Pfizer states that “no permission is required to reproduce,
translate, display, or distribute them”. We have therefore adopted the above
recommendations for translations of the PHQ instruments that will be part of the
DC/TMD protocol. As always, the marketplace for science is peer-reviewed journals,
and the scientific community through that mechanism decides upon measures,
instruments, and data. If a translation developer decides to not use an existing
translation of any of these 4 instruments and instead create a new translation, the
rationale for this should be briefly stated in the Translation Log A and, if possible, to note
which items in the existing translation were considered incorrect.
J. Psychometric Issues
The DC/TMD components encompass a clinical assessment protocol that is actually
very complex in terms of the psychometric methods associated with establishing
reliability and validity in a cultural context. The types of instruments include examination
commands, single item inquiries, checklists (an aggregate of single item inquiries held
together by a common theme such as “oral behaviors”), and formal measurement
scales (e.g., Graded Chronic Pain, Depression, Anxiety). Each type of instrument has
its own standards for assessing reliability and validity. In the following section, “Stages”
refers to process stages of development as described in the document, Guidelines for
Establishing Cultural Equivalency of Instruments.
1. Clinical DC/TMD examination

 Translation. All verbal commands need to go through Stages I-IV. The
recording form (used by the examiner), if translated for data collection, should be
reviewed via trial usage. Known problematic areas include:
o Certain words cause problems, such as “Place your mouth in a comfortable

position” where in some languages “mouth” is better translated as “mandible”.
The pre-testing phase of Stage V in a small group of subjects is important and
should be done.
o The procedures “maximum unassisted opening” and “maximum assisted
opening” are also referred to, particularly in the physical therapy domain, as
“active opening” and “passive opening”, respectively. However, these terms
are not as operationally descriptive as the terms “unassisted” and “assisted”.
Users should of course use labels that are meaningful in their setting;
however, for any publication purposes, adherence to “unassisted” and
“assisted” is recommended since these are the formal labels in the DC/TMD.
o The complete examiner specifications includes a left-hand column containing
the name of the construct that is operationalized in that row of the table; this
construct label is also included in the corresponding Log B. These labels are
for reference only by users of the document; translators should adjust the
names as needed for clarity.
 Reliability. The primary psychometric methods for verbal commands are
bilingual reliability (see Guidelines document for explanation), test-retest
reliability, and inter-rater reliability. Such analyses provide evidence for the
correctness of the translated verbal commands.
 Validity. Simple face validity of the examination commands can be verified
through usage in an examination reliability study; in other words, does the
command result in the expected subject behavior or demonstration of the
phenomenon. Construct validity of the clinical examination items and diagnoses
is a very complex undertaking, and not part of the purview of this document.
 Responsiveness. Not applicable.
2. DC/TMD Symptom Questionnaire

 Translation. With only few exceptions, all of the items in this instrument
contribute to the diagnostic algorithms for the Axis I diagnoses. Readability and
adaptation of physical symptom-oriented items are important. The remainder of
the Questionnaire can be translated directly, recognizing that some words such
as “click”, “lock”, and “pain” may require special attention. Clinical symptoms
relating to mechanical jaw problems seem especially prone to problems in
translation and adaptation; this is also true in English.
 Reliability. The primary psychometric methods for individual items are
bilingual reliability (see Guidelines document for explanation) and test-retest
reliability.
 Validity. Simple face validity of the items can be verified through usage in
a semi-structured interview or open interview.
 Responsiveness. Not applicable.
3. Graded Chronic Pain Scale, Version 2.0

 Translation. The GCPS instrument published as part of the RDC/TMD contained
errors in contrast to the correct version of the Graded Chronic Pain instrument as
published (M. Von Korff, J. Ormel, F. J. Keefe, and S. F. Dworkin. Grading the
severity of chronic pain. Pain 50:133-149, 1992). The new version 2.0 includes
an additional item, and the wording of all of the questions has been revised.
Stages I-V should be performed.
 Reliability. Test-retest assessment is the primary form of analysis that can be
done, as internal reliability for this instrument is harder to interpret due to the
complex nature of all 8 of the items that comprise the Graded Chronic Pain
Scale. Internal consistency of each set of items 2-4 (characteristic pain) and
items 6-8 (interference) can readily be done; published data (R. Ohrbach, J. A.
Turner, J. J. Sherman, L. A. Mancl, E. L. Truelove, E. L. Schiffman, and S. F.
Dworkin. Research Diagnostic Criteria for Temporomandibular Disorders. IV:
Evaluation of Psychometric Properties of the Axis II Measures. J.Orofacial Pain
24:48-62, 2010) indicate excellent reliability which should serve as an
appropriate benchmark for other translations. Additionally, Rasch analysis also
yields a clearly reliable measurement scale for each of pain and interference
items, when using data collected in the US, but whether this holds true for other
countries is as yet unknown and, as such, Rasch (or other IRT) analysis for item
reliability may be premature. Moreover, the Chronic Pain Grades 1-4 are derived
from a Mokken analysis, and hence customary reliability statistics are not useful
for the instrument as a whole.
 Validity. Pain scaling across cultures (i.e., from the characteristic pain items)
clearly needs attention via data analysis. However, cultural equivalency should
not be based solely on demonstrating the equivalence of pain scores across
cultures. This may be a situation where confirmatory factor analysis is the
appropriate assessment method for validity.
 Responsiveness. Establishing responsiveness in the context of cultural
equivalency of these items is beyond these guidelines. Published data, to date,
seem to support the GCPS as a classification instrument rather than a monitoring
instrument, and consequently responsiveness may not be a critical analysis for
evaluating this instrument.
4. Depression, anxiety, and physical symptoms

 Translation. The items in these 4 instruments (PHQ-4, PHQ-9, GAD-7, PHQ-15)
index traits that clearly require the full set of Stages described in the Guidelines
document. DC/TMD translators should note the items comprising the PHQ-9 and
GAD-7 instruments require special attention in the translation process. For
example, an item referencing “feeling down” may need cultural modification. The
PHQ-4 contains 2 items from the PHQ-9 and 2 items from the GAD-7. If the
translator decides to first translate the PHQ-9 and GAD-7, and then later decides
to also use the PHQ-4, the appropriate items should be retrieved from the two
prior translations; there is no need to do a separate PHQ-4 translation in this
instance.
 Reliability. Stages I-V should be followed.

 Validity. Stages I-V should be followed. Moreover, full construct validity in a
given culture requires collection of data for assessing formal validity as is
commonly used in test development assessment. See Norman and Streiner,
Health Measurement Scales, 3rd edition, NY: Oxford University Press, 2003, for
suggested methods.
 Responsiveness. Can be tested. Contemporary methods should be used such
as those described in Norman and Streiner.
5. Jaw Functional Limitation Scale

 Translation. These items should be straight-forward. However, the items
that start with “Open wide enough to …” refer to opening the mouth, and they can
be changed to “Open the mouth wide enough to …” if needed for clarity. The
JFLS-8 is a subset of the JFLS-20, and consequently if both instruments are to
be translated, then the developer should do the complete translation for the
JFLS-20, and then adapt a final JFLS-8 instrument for administration from the
JFLS-20 translation.
 Reliability. The primary psychometric methods for the JFLS are internal
reliability for each of the component constructs, test-retest reliability of
subscores, and model fit via Rasch analysis.
 Validity. Confirmatory factor analysis should be considered.
 Responsiveness. Can be tested. Contemporary methods should be used
such as those described in Norman and Streiner.
6. Oral Behaviors Checklist

 Translation. These items should be straight-forward.
 Reliability. The primary psychometric methods are bilingual reliability (see
Guidelines document for explanation) and test-retest reliability.
 Validity. Clarification via interview of whether the selected translated term
points to the same behavior as intended in the source version is probably the
most direct, in order to map the better words for these behaviors to common-
sense understanding and labeling of the behavior.
 Responsiveness. Unknown at present.
7. Pain Drawing
 Translation. The instructions are minimal.
 Reliability. The primary psychometric method is test-retest reliability for
the individual completing the pain drawing.
 Validity. Clarification via interview of whether the reported body parts on
the pain drawing correspond to pain symptoms is probably the most direct.
Interpretation of this instrument is, however, complex given that there is no real
“score” that emerges.
 Responsiveness. Unknown at present.
K. Filename conventions and submission of Logs for review

1. Filename conventions. The Translation Team Leader will verify that the filename
for each Log follows the correct convention:
a. For single version of a log:

i. Format: Log <letter> - <instrument name> - <language>.doc
ii. Example: “Log A – Symptom Questionnaire – Greek.doc”
b. For log that has several iterations:

i. Format: Log <letter><iteration number> - <instrument name> -
<language>.doc
ii. Example: “Log D1 – Symptom Questionnaire – Greek.doc” for first
back-translation, and
iii. Example: “Log D2 – Symptom Questionnaire – Greek.doc” for

second corrected back-translation
c. For Log C, given two forward translations:

i. Format: : Log <letter> - FT<translator number> - <instrument
name> - <language>.doc
ii. Example 1: “Log C – FT1 - Symptom Questionnaire – Greek.doc”
for forward translator #1, and
iii. Example 2: “Log C – FT2 …” for forward translator #2.
d. For Log C, when a corrected forward translation is required:

i. Format: : Log <letter><iteration number> - FT<translator number> -
<instrument name> - <language>.doc
ii. Example 1: “Log C1 – FT1 - Symptom Questionnaire – Greek.doc”
for first translation by forward translator #1, and
iii. Example 2: “Log C2 – FT1 …” for second translation by forward

translator #1.
2. Logs may be submitted in either .doc or .docx format.
3. Submission of Logs for independent back-translation review.
a. For each instrument, a completed Log D will be submitted to the

independent reviewer.
b. For each instrument, the reviewer will return a Log E with comments to the
Translation Team Leader.
4. Submission of Logs for final administrative review
a. Administrative review focuses not on the content of the translation, but

rather on the adequacy of addressing any concerns in the translation as
well as completeness of the documentation itself. Examples of errors or
discrepancies that would not be acceptable are: (1) incomplete Section A
on a Log; (2) inadequate follow-through of potential cultural problem in a
translation as identified by the expert committee; (3) inadequate
representation of an expert committee; or (4) missing component on a
final instrument for patient administration. An acceptable translation Log
should readily demonstrate a complete translation process that meets the
requirements of cultural validity for a given target translation.
b. The Translation Team Leader will submit via email all logs (fully completed
Log A – Log H; header row completed for Log I) in .doc or .docx format, as
follows:
i. If the Logs are separate files, then all Logs for one instrument will
be submitted as the attachments to a single email message. For
example, the minimum translation requirement is 13 instruments,
each of which will have a set of Logs; 13 email messages would be
submitted for the minimal set of instruments to be translated.
ii. The logs may be compiled into a .zip file according to the Team
Leader preference; if so, the compiled .zip files for all instruments
can be submitted as multiple attachments to a single email
message. For example, the one email message could contain 13
.zip files, assuming that only the minimal instrument set has been
translated. Email servers may impose size limitations on outgoing
email, and consequently, the 13 (or more) .zip files may be
submitted across more than 1 email message.
c. For the full set of instruments, the Team Leader will also submit a title
page in each of English and the target language, using the title page
template posted on the website. The name of the Translation Team
Leader(s) listed on the title page should be consistent with the information
in Log A for all of the instruments.
d. The final translated instrument for patient administration, for each source
instrument, will be submitted as a separate document, in addition to the
instrument being an attachment to Log H.
e. Translation Logs not meeting the stated requirements will be returned for
correction.
f. When a DC/TMD translation is approved, the following steps will occur:
i. The name and email address of the Translation Team Leader(s), as

based on the title page, will be posted on the Consortium website
as the contact individual(s).
ii. The names of all members of the Translation Team will be posted
on the Consortium website.
iii. The title pages and each administrative instrument will be

aggregated into a .zip file and posted on the Consortium website for
public download.
iv. The Log files will be aggregated into a composite .pdf file and
posted on the Consortium website for member-only access.
L. Authorship of a translation
Authorship of a translation should be decided in the same way as for a publication. The
title page of the translated instrument set includes the authors’ names. Two primary
categories are used: translators and collaborators. In this context, a “translator” refers
to anyone making a major contribution to the final product; this could be a coordinator
who does not actually translate but manages the full project, or it could refer only to
those who actually do forward translation (the most restrictive approach).
“Collaborators” refers to everyone else involved in the project who makes substantive
contributions but not as extensive as that of the “translators”. A third category could
also be used: “acknowledgments”, such as for the expert panel members.
Recognizing contributions should be distinguished from a purchased service (such as a

back-translator hired through an agency). Consequently, individuals simply hired to
forward or backward translate but who do not contribute to the scientific quality of the
translation are often not included as authors. Translation team leaders will make the
final decisions regarding how credit is listed on the title page, and the listing can be as
inclusive as needed. As with publications, the web page for the translation will list the
email address of the translation team leader (and co-leader, as determined by the team)
for inquiries.
M. References
1. Ohrbach R, Jezewski MA, Bjorner JB et al. Guidelines for Establishing Cultural

Equivalency of Instruments. 2013.
N. Updates to this document
2014 Mar 20
 Clarification regarding translation of the examiner specifications; see pages 2
and 7.
 Added information regarding authorship (new section L).
2014 Feb 23
 Clarification that both TMD Pain Screener and DC/TMD Symptom Questionnaire
(SQ) must be translated as part of the DC/TMD instrument set.
2014 Jan 04
 The order of the list of instruments to be translated and the contents listing was
reversed.
 New section K for filenaming conventions and document submission was added.

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Translation and Adaptation of the DC/TMD Protocol

For the Committee for Translations and Protocols

A. Components for translation......................................................................................2

A. Components for translation

A completed DC/TMD translation will consist of the following components:

Title page of the translated Translation template on Consortium website

Contents page Translation template on Consortium website

A1. Complete Section 5

A2. Examination- Section 6

Examination Form Section 9

DC/TMD Demographics Impact Study Research Group

Pain Drawing Impact Study Research Group

B. General Notes on the Translation Process

D. Examination Recording Form

E. Diagnostic Decision Trees and Diagnostic Criteria

F. DC/TMD Symptom Questionnaire and TMD Pain Screener

the number of years in other countries due to strong differences in the

Guidelines document 1, translation and in particular cultural equivalency of instruments

I. The PHQ Family of Instruments

 Use the translation available via Pfizer for “Translation 1”

As an official Consortium policy, we encourage collaboration between individuals and

1. Clinical DC/TMD examination

o Certain words cause problems, such as “Place your mouth in a comfortable

2. DC/TMD Symptom Questionnaire

3. Graded Chronic Pain Scale, Version 2.0

4. Depression, anxiety, and physical symptoms

 Reliability. Stages I-V should be followed.

5. Jaw Functional Limitation Scale

6. Oral Behaviors Checklist

K. Filename conventions and submission of Logs for review

a. For single version of a log:

ii. Example: “Log A – Symptom Questionnaire – Greek.doc”

b. For log that has several iterations:

iii. Example: “Log D2 – Symptom Questionnaire – Greek.doc” for

c. For Log C, given two forward translations:

iii. Example 2: “Log C – FT2 …” for forward translator #2.

d. For Log C, when a corrected forward translation is required:

iii. Example 2: “Log C2 – FT1 …” for second translation by forward

2. Logs may be submitted in either .doc or .docx format.

3. Submission of Logs for independent back-translation review.

a. For each instrument, a completed Log D will be submitted to the

4. Submission of Logs for final administrative review

a. Administrative review focuses not on the content of the translation, but

f. When a DC/TMD translation is approved, the following steps will occur:

i. The name and email address of the Translation Team Leader(s), as

iii. The title pages and each administrative instrument will be

Recognizing contributions should be distinguished from a purchased service (such as a

1. Ohrbach R, Jezewski MA, Bjorner JB et al. Guidelines for Establishing Cultural

N. Updates to this document

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