Translation and Adaptation of The DC-TMD 2014 - 03 - 209060
Translation and Adaptation of The DC-TMD 2014 - 03 - 209060
Prepared by:
Richard Ohrbach, DDS, PhD
University at Buffalo, NY, US
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
Component Source
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),
B. Required Section 8
Examination Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
Commands Clinical Examination Protocol
Ohrbach R, Gonzalez Y, List T, Michelotti A, Schiffman E
Instrument Version: June 02, 2013
Component Source
of the final document]
DC/TMD Symptom Impact Study Research Group
Questionnaire
Form Version: May 12, 2013
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
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.
Form Version: May 12, 2013
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.
Form Version: May 12, 2013
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.
Form Version: May 12, 2013
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.
A text-revision of this instrument is posted at http://www.phqscreeners.com/
and incorporated into the final instrument for the Consortium.
Form Version: May 12, 2013
Translation and Adaptation of the DC/TMD Protocol Page 5 of 21
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.
A text-revision of this instrument is posted at http://www.phqscreeners.com/
and incorporated into the final instrument for the Consortium.
Form Version: May 12, 2013
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.
Form Version: May 12, 2013
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.
Form Version: May 12, 2013
Translation and Adaptation of the DC/TMD Protocol Page 6 of 21
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
Translation and Adaptation of the DC/TMD Protocol Page 7 of 21
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
Translation and Adaptation of the DC/TMD Protocol Page 8 of 21
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.
RDC/TMD used the English measurement pounds for specifying palpation force; the
DC/TMD has changed to the international kilogram.
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.
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
Translation and Adaptation of the DC/TMD Protocol Page 10 of 21
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
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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
Translation and Adaptation of the DC/TMD Protocol Page 12 of 21
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.
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:
Translation and Adaptation of the DC/TMD Protocol Page 13 of 21
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.
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.
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Interpretation of this instrument is, however, complex given that there is no real
“score” that emerges.
Responsiveness. Unknown at present.
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b. For each instrument, the reviewer will return a Log E with comments to the
Translation Team Leader.
Translation and Adaptation of the DC/TMD Protocol Page 19 of 21
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.
Translation and Adaptation of the DC/TMD Protocol Page 20 of 21
ii. The names of all members of the Translation Team will be posted
on the Consortium website.
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.
M. References
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.