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Pain Medicine 2013; 14: 1032–1038
Wiley Periodicals, Inc.
OPIOIDS, SUBSTANCE ABUSE &
ADDICTIONS SECTION
Original Research Article
Spanish Translation and Linguistic Validation of
the Screener and Opioid Assessment for
Patients with Pain-Revised (SOAPP-R)
Stephen F. Butler, PhD,* Kevin L. Zacharoff, MD,*
Simon H. Budman, PhD,* Robert N. Jamison, PhD,†
Ryan Black, PhD,‡ Rebecca Dawsey, BA,§ and
Adrianne Ondarza, PhD¶
Method. Each step of Spanish translation and linguistic validation of the SOAPP-R was based on the
US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research translation process.
*Inflexxion, Inc., Newton, Massachusetts;
†
Pain Management Center, Brigham and Women’s
Hospital, Chestnut Hill, Massachusetts;
‡
Center for Psychological Studies, Nova Southeastern
University, Fort Lauderdale, Florida,
Result. A linguistically validated Spanish-language
version of the SOAPP-R.
Conclusion. The Spanish SOAPP-R may be useful
as a risk assessment tool, considered along with
other clinical information, by clinicians who prescribe opioid therapy for patients whose preferred
language is Spanish.
§
TransPerfect Linguistic Validation, Atlanta, Georgia;
¶
INC Research, LLC, Austin, Texas, USA
Reprint requests to: Stephen F. Butler, PhD, Inflexxion,
Inc., Newton, MA 02464, USA. Tel: 617-332-6028;
Fax: 617-332-1820;
E-mail: [email protected]
Key Words. Abuse; Aberrant Drug-Related Behavior; Chronic Noncancer Pain; Opioids; Risk
Assessment
Introduction
Introduction. Given the increase in misuse and
abuse of prescription opioids, clinicians clearly
benefit from a standardized tool to screen patients
being considered for chronic opioid therapy. The
Screener and Opioid Assessment for Patients with
Pain-Revised (SOAPP-R) is a widely used opioid
risk assessment tool in clinical practice. As one
third of the US population experiences chronic
noncancer pain at any given time, and the Hispanic
population now accounts for about 16% of the
nation’s population, the availability of a Spanishlanguage SOAPP-R fills an important clinical need.
The misuse and abuse of prescription opioids has
emerged as an important public health issue. One in 20
persons aged 12 or older report nonmedical use of a
prescription pain medication in the past year and unintended opioid-related overdose deaths have more than
tripled since 1990 [1]. Opioids may be an important component of treatment for chronic noncancer pain, which
afflicts 116 million US adults [2]. Management of chronic
noncancer pain occurs most often in a primary care
setting [3]. Most opioid prescriptions are written by family
practitioners, internists, or dentists; clinicians who are not
pain specialists [4]. These clinicians may have neither the
time nor training to adequately manage patients who
display aberrant medication-related behavior that could
arise from long-term opioid use [5,6].
Objective. To derive a linguistically validated
Spanish-language version of the SOAPP®-R.
The clinical management of patients on opioid therapy
can be complex, involving legal and regulatory
Abstract
1032
Spanish Version of SOAPP-R
implications, clinical and psychosocial factors [7,8] as
well as risk assessment and monitoring [8]. Recommended practice guidelines from the American Pain
Society, the American Academy of Pain Medicine [9],
and the Food and Drug Administration (FDA) [10]
assume a high level of clinical skill and knowledge
regarding opioid prescribing, risk assessment, and management. With approximately one third of the US population experiencing chronic pain at any given time,
clinicians treating chronic pain patients would benefit
from use of existing tools to screen patients being considered for chronic opioid therapy. Hispanic individuals
now account for 16% of the nation’s total population
[11], and it is estimated that 78% of Hispanics in the US
report Spanish as their primary language [12]; therefore,
making available risk assessment tools in Spanish would
fill an important clinical need.
Pain management regarding opioid therapy creates particular communication challenges that may result from the
lack of time during appointments or patients’ inability to
clearly describe their issues [13,14]. A language barrier
only serves to add to such challenges. As Spanish is now
spoken in over 34 million US households [15], many
clinicians are faced with such communications challenges [16].
A number of opioid risk assessment tools have been
developed to help clinicians screen patients who may be
appropriate candidates for chronic opioid therapy, and to
help identify those who may be more likely to exhibit
aberrant drug-related behaviors [17]. The Screener and
Opioid Assessment for Patients with Pain-Revised
(SOAPP®-R) (Inflexxion, Inc., Newton, MA, USA) is one
such widely used tool. The revised tool has been extensively validated over the last decade in a number of
studies, and shows good reliability, sensitivity, and specificity in identifying patients at high risk [18,19].
It is widely recognized that English-language versions of
scales should not be presented to individuals whose
primary language may be other than English [20–23]. The
objective of the work described here was to derive a
linguistically validated Spanish-language SOAPP-R. Linguistic validation is a systematic process that establishes
the reliability, conceptual equivalence, and content validity
of translations of patient-reported outcome measures
[21,22]. The rationale and methods prescribed for the
adaptation of patient-reported outcome measures are
here applied to the SOAPP-R screening tool.
Spanish-speaking translators completed the dual forward
translation independently, focusing on cultural relevance
and conceptual equivalence rather than a literal translation. A third, independent native US Spanish-speaking
linguist assessed the translations and selected the best
word, phrase, or sentence from among the previous work,
or provided an alternative. Following reconciliation, a
fourth independent linguist independently completed the
back translation of the reconciled Spanish translation into
English, providing a literal translation to reflect the forward
translation. All materials were then reviewed by a US
native, Spanish-speaking fifth linguist, followed by the
TransPerfect project manager. Discrepancies between the
back translation and the English source were addressed
to ensure conceptual equivalence.
The final translation was presented to five Spanishspeaking individuals with chronic noncancer pain
for one-on-one cognitive debriefing. Respondents were
recruited through existent respondent pools (panels),
physician recruitment, advertising, support groups, and
clinics. TransPerfect does not conduct research per se,
in terms of implementing experimental manipulation of
treatment or other interventions, thus, it is not the policy
of TransPerfect to seek instituinal review board approval
for conducting consumer acceptance of the translated
assessments. In these activities, volunteers provide
general impressions about the assessments, the clarity
of the instructions, and comprehensibility and appropriateness of each question and response option. These
volunteers provided written consent and signed a nondisclosure agreement.
Inclusion criteria included: age over 18 years, diagnosis of
chronic noncancer and nonneuropathic pain, and longterm (greater than 60 days) pain management with
opioids. During cognitive debriefing, respondents participated in individual face-to-face interviews and provided
general impressions of the instrument, clarity of the
instructions, and comprehensibility and appropriateness
of each question and response option. Interviews were
conducted by in-country professional interviewers who
are native speakers of the target language, have extensive
experience with qualitative and quantitative interviews,
and hold advanced degrees. Cognitive debriefing sessions were conducted in the respondent’s native language. Interviews discussed each item separately to
reveal any problems with wording that might have made
any of the items difficult to answer or misunderstand, or to
ask the respondent whether they would have phrased the
question in a different way.
Methods
TransPerfect Translations Inc. conducted the linguistic
validation and translation. Each step of translation and
linguistic validation is based on the US FDA and the International Society for Pharmacoeconomics and Outcomes
Research translation process (Figure 1) [21–23]. The original instrument and description of its purpose were provided to translators and linguists, important concepts
identified and defined. Two independent, native US
Results
Three females and two males reviewed and provided
feedback of the Spanish-language translation of
SOAPP-R during one-on-one, face-to-face cognitive
debriefing with each respondent. Age of the respondents
ranged from 37 to 56 years, and education level from
primary school through university (Table 1).
1033
Butler et al.
•
Assessment of the source files and definitions of concepts
•
Two independent, native-speaking linguists completed the
translation
The translation was created based on conceptual equivalence and
cultural relevance
Preparation
Forward translation
•
Translator A Translator B
•
Reconciled translation
Forward version 1
•
•
Back translation
•
•
Reconciliation of back
translation
Forward version 2
•
Cognitive debriefing
•
Final translation
•
A third native-speaking linguist reconciled the two translation
versions
Discrepancies, linguistic limitations, and cultural differences were
addressed to produce a reconciled translation
A fourth native-speaking linguist translated the reconciled
translation into English
A literal back translation was produced
A fifth linguist and the project manager compared the back
translation with the source and concepts
Discrepancies, linguistic, and cultural limitations were addressed to
produce the Forward version 2
The respondents participated in face-to-face interviews and
provided feedback on the translated material
Suggestions and responses were analyzed and necessary
changes were implemented to produce the final translation
Figure 1 Linguistic validation flow chart.
Even though respondents understood the survey items in
general, some of them felt they needed clarification with
the repetition of “how often.” While the first response
option is “never,” some respondents wondered whether it
would be best to rephrase the questions as requiring
“yes” or “no” responses. One respondent also felt uncomfortable regarding the question about sexual abuse.
Finally, the word “opioid” was unfamiliar to the respondents. The translation was revised to make this understandable to all patients; a few other minor clarifications
were also added. All cognitive debriefing responses of the
final translation were analyzed by the project team
(Table 2). The five respondents provided written recommendations and feedback on the translated instrument
using a response template. These written recommendations were translated into English before being reviewed
by the project manager, the linguistic validation department head, and the individual linguists. Respondents’
feedback allowed for linguistic decisions to be made
to improve the language used in the translated
Table 1 Cognitive debriefing respondent demographics
Respondent number
R1
R2
R3
R4
R5
Age
Gender
Educational level
38
M
High school
56
F
High school
37
F
High school
41
M
Elementary school
45
F
University
1034
Forward Translation
Item 1: Las siguientes son
algunas preguntas que se
les formulan a pacientes
que toman o a quienes se
está considerando
recetarles medicamentos
para el dolor. Responda
cada pregunta con la
mayor sinceridad posible.
No hay respuestas
correctas ni incorrectas.
Item 4: ¿Con qué
frecuencia se ha sentido
tan abrumado por
distintas cosas que no
puede manejarlas?
Item 1: The following
are some questions
given to patients who
are on or being
considered for
medication for their
pain. Please answer
each question as
honestly as possible.
There are no right or
wrong answers.
Item 4: How often have
you felt that things are
just too overwhelming
that you can’t handle
them?
R1, R2, R3, and R5 reported
no difficulty understanding
the item.
R1, R2, R3, and R4 were all
uncomfortable with the word,
“abrumado” (“overwhelmed”).
R1, R2, and R3 suggested
changing it to “pressured.”
R4 reported certain difficulty
understanding the item.
However, when he was
asked what it meant to him,
he gave an appropriate
response: “If I have felt
overwhelmed.”
R5 suggested deleting, “How
often.”
R1, R2, R4, and R5 reported
no difficulty understanding
the item.
R2 said that the question was
too long and that it should be
made shorter.
R4 said that the question was
too long and suggested
adding, “there are no correct
or incorrect questions.”
R3 reported difficulty
understanding the item and
was not able to rephrase it in
her own words. She added it
was too long and that it
should be synthesized.
Cognitive Debriefing
Response Analysis
Cognitive debriefing response analysis (selected items)*
Source
Table 2
After review, the following
conclusions were drawn:
All respondents understood the item.
Even though the edit suggested by
R1, R2, R3, and R4 is a subjective
one (“pressured/stressed” instead
of “overwhelmed”), it would be
good for comprehension to use a
word that is more understandable
for interviewees.
After review, the following
conclusions are drawn:
The length of the first sentence
seems to hinder comprehension.
R4’s comment about the suggested
additional text is irrelevant as that
text actually is part of the copy.
However, FT and BT are updated for
added simplicity and clarity.
Linguist Feedback
Item 4: ¿Con qué
frecuencia se ha sentido
tan presionado por
distintas cosas que no
puede manejarlas?
Item 1: Las siguientes son
algunas preguntas
hechas a pacientes.
Algunos de estos
pacientes toman
medicamentos para el
dolor, pero estamos
considerando darselos.
Responda cada pregunta
con la mayor sinceridad
possible. No hay
respuestas correctas ni
incorrectas.
Final Forward Translation
Item 4: How often have you
felt so pressured by
different things that you
can’t handle them?
Item 1: The following are
some questions made to
patients. Some of these
patients take pain
medication. Others do not
take pain medication yet,
but we are considering
giving to them. Answer
each question as honestly
as possible. There are no
right or wrong answers.
Final Back Translation
Spanish Version of SOAPP-R
1035
1036
Linguist Feedback
* Four of 24 translated and validated items.
FT = forward translation; BT = back translation.
After review, the following
conclusions were drawn:
R2’s edit is subjective.
R3’s edit is not applicable within this
context as using “relapse” would
assume that the interviewee has in
fact had an alcohol or drug
problem.
R4 and R5’s suggestion is not
implementable due to content
meaning.
Therefore, a decision is made not to
implement any revisions in the
translation.
R1, R3, R4, and R5 reported
no difficulty understanding
the item.
R2 reported she was
“confused.” However, when
asked what it meant to her,
she gave an appropriate
answer, “How often I have
been treated . . . I have been
affected by a drug problem.”
R2 suggested adding the word,
“clinically” (“clinically
treated”).
R3 reported having no difficulty
understanding but then she
said it was not clear if the
question referred to her or to
somebody else and
suggested using, “How often
have you had a relapse.”
R4 and R5 suggested taking
out “How often.”
Cognitive Debriefing
Response Analysis
Item 24: How often have Item 24: ¿Con qué
you been treated for
frecuencia ha sido tratado
an alcohol or drug
por un problema de
problem?
alcoholismo o
drogadicción?
Forward Translation
R1, R2, R3, and R5 reported
After review and taking into
no difficulty understanding
consideration that all respondents
the item.
understood the item, that R4’s edit
R4 reported difficulty
is subjective and that R5’s
understanding the item, but
suggestion is also subjective and
when he was asked what it
would imply major changes in the
meant to him, he gave an
copy for internal consistency, a
appropriate response: “That if
decision is made not to implement
those people are worried
any revisions in the translation.
because I take medication.”
R4 also suggested replacing
“medication” with “medicine.”
R5 suggested rephrasing the
item as a yes/no question.
Continued
Item 12: How often have Item 12: ¿Con qué
others expressed
frecuencia otras personas
concern over your use
se han mostrado
of medication?
preocupadas por el uso
que usted hace de la
medicación?
Source
Table 2
Item 24: ¿Con qué
frecuencia ha sido
tratado por un problema
de alcoholismo o
drogadicción?
Item 12: ¿Con qué
frecuencia otras
personas se han
mostrado preocupadas
por el uso que usted
hace de la medicación?
Final Forward Translation
Item 24: How often have
you been treated for a
problem of alcoholism or
drug addiction?
Item 12: How often have
other people shown
concern over your use of
the medication?
Final Back Translation
Butler et al.
Spanish Version of SOAPP-R
instrument, thereby enhancing conceptual equivalence to
the English-language source instrument. The team analyzed all responses and determined the need for any
further changes to the translations.
Discussion
This article reports on an effort to systematically create a
linguistically validated, US Spanish-language version of
the SOAPP-R, a screener for risk potential for chronic
pain patients on or being considered for long-term
opioid therapy. We believe this represents a step toward
addressing a gap in the treatment of pain for an underserved, but significant portion of the US population. To
our knowledge, there are no other screening tools to
assess risk of opioid misuse available in Spanish.
patients impact the sensitivity and specificity of the
Spanish version of the SOAPP-R. Thus, although we
would anticipate that scoring of the Spanish version
would be similar to the English, that is, that higher
scores would reflect greater risk for aberrant opioid
medication-related behaviors, clinicians should interpret
scores cautiously.
To date, there are no self-report measures of opioid risk
assessment that can be administered to those individuals
who primarily, or only, read and speak Spanish. This translation is the first step toward resolving this deficit. We
believe that administration of the Spanish SOAPP-R would
offer more information for the clinician to help determine
risk of medication misuse, and would be preferable to a
provider attempting to translate the English SOAPP-R.
This initial translation meets a practical need, but we are
aware of limitations. The linguistic validation process
described here represents a first step toward validating
the Spanish version of the SOAPP-R. As the SOAPP-R is
a well-validated assessment of potential for aberrant
medication-related behaviors—a critical component of the
patient selection process for long-term opioid treatment
[24,25], this Spanish-language version should be
preferable to no language-appropriate risk evaluation for
opioid therapy. Unfortunately, we failed to collect complete
information from the chronic pain patients such as their
exact diagnosis, current treatment, types of clinics, geographic location, and pain duration. Future studies should
help to investigate the role that specific demographic information play in using a Spanish version of the SOAPP-R.
This study also included only a limited number of pain
patients, and that feedback from more subjects would
have strengthened the results. Our goal is to expand
this study to include larger numbers of Spanishspeaking individuals.
Conclusion
This linguistic validated Spanish-language SOAPP-R is
therefore offered as a practical, heuristic tool that, along
with other clinical information, may have immediate practical value and should also serve as a step toward
empirical validation on a Spanish-speaking, chronic noncancer pain population. We did not conduct an empirical
test of the predictive validity of the measure. Thus, it may
not capture critical cultural differences among those who
speak Spanish with respect to the experience of issues
associated with pain or substance use. Such a study
would be required to demonstrate that the psychometric
properties of the Spanish SOAPP-R are comparable to
the English version [18]. While providing an empirical
validation is most desirable, it is generally recognized
that a well-conducted linguistic validation is an appropriate method for adapting a patient measure [21–23]. We
intend to expand this work to a larger investigation
with different Hispanic groups to test the psychometric
properties of the Spanish SOAPP-R and to establish
the validity, reliability, sensitivity, and specificity of this
tool. It remains an empirical question as to whether
subtle linguistic or cultural differences between Englishspeaking and Spanish-speaking chronic noncancer pain
The authors would like to acknowledge Srila Sen, MA for
her work on an earlier draft of this article. This study was
funded in part by INC Research. The views expressed in
this article are those of the authors and do not necessarily
represent the views of INC Research. The authors had
sole editorial rights over the article.
We have presented a linguistically validated Spanish
version of the SOAPP-R screening tool for aberrant
medication-related behaviors in chronic noncancer pain
patients being considered for long-term opioid analgesic
therapy. We have carefully implemented modern principles
for linguistic validation to produce a useful tool for use with
Spanish-speaking patients. As with the English version,
clinicians should not rely on SOAPP-R scores alone for
making clinical decisions, but rather use this information
as part of a comprehensive evaluation of a particular
patient for long-term opioid therapy. For Spanishspeaking patients, clinicians should also use a Spanishlanguage patient–provider opioid agreement. The Spanish
SOAPP-R can be downloaded for individual, clinical use
from http://www.PainEDU.org.
Acknowledgments
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