Original Research Article Spanish Translation and Linguistic Validation of the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)

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1 bs_bs_banner Pain Medicine 2013; 14: 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 *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, 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: ; Fax: ; sfbutler@inflexxion.com Abstract 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. Objective. To derive a linguistically validated Spanish-language version of the SOAPP -R. 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. 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. Key Words. Abuse; Aberrant Drug-Related Behavior; Chronic Noncancer Pain; Opioids; Risk Assessment Introduction 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]. The clinical management of patients on opioid therapy can be complex, involving legal and regulatory 1032

2 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. 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 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. 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

3 Butler et al. Preparation Assessment of the source files and definitions of concepts Forward translation Translator A Translator B Reconciled translation Forward version 1 Back translation Two independent, native-speaking linguists completed the translation The translation was created based on conceptual equivalence and cultural relevance 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 Reconciliation of back translation Forward version 2 Cognitive debriefing Final translation 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 M F F M F Educational level High school High school High school Elementary school University 1034

4 Spanish Version of SOAPP-R Table 2 Cognitive debriefing response analysis (selected items)* Source Forward Translation Cognitive Debriefing Response Analysis Linguist Feedback Final Forward Translation Final Back Translation 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? 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? R1, R2, R4, and R5 reported 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. R1, R2, R3, and R5 reported 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 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. 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. After review, the following conclusions were drawn: All respondents understood 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. 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. Item 4: Con qué frecuencia se ha sentido tan presionado por distintas cosas que no puede manejarlas? 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. Item 4: How often have you felt so pressured by different things that you can t handle them? 1035

5 Butler et al. Table 2 Continued Source Forward Translation Item 12: How often have others expressed concern over your use of medication? Item 12: Con qué frecuencia otras personas se han mostrado preocupadas por el uso que usted hace de la medicación? Item 24: How often have you been treated for an alcohol or drug problem? Item 24: Con qué frecuencia ha sido tratado por un problema de alcoholismo o drogadicción? * Four of 24 translated and validated items. FT = forward translation; BT = back translation. Cognitive Debriefing Response Analysis Linguist Feedback Final Forward Translation Final Back Translation R1, R2, R3, and R5 reported R4 reported difficulty understanding the item, but when he was asked what it meant to him, he gave an appropriate response: That if those people are worried because I take medication. R4 also suggested replacing medication with medicine. R5 suggested rephrasing the item as a yes/no question. R1, R3, R4, and R5 reported 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. After review and taking into consideration that all respondents understood the item, that R4 s edit is subjective and that R5 s suggestion is also subjective and would imply major changes in the copy for internal consistency, a decision is made not to implement any revisions in the 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. Item 12: Con qué frecuencia otras personas se han mostrado preocupadas por el uso que usted hace de la medicación? Item 24: Con qué frecuencia ha sido tratado por un problema de alcoholismo o drogadicción? Item 12: How often have other people shown concern over your use of the medication? Item 24: How often have you been treated for a problem of alcoholism or drug addiction? 1036

6 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. 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. 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 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. Conclusion 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 Acknowledgments 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. References 1 Centers for Disease Control and Prevention. Prescription painkiller overdoses in the US. Vital Signs Available at: PainkillerOverdoses/?s_cid=vitalsigns-098-bb (accessed December 8, 2011). 2 Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; Reid CM, Engles-Horton LL, Weber MB, et al. Use of opioid medications for chronic noncancer pain syndromes in primary care. J Gen Intern Med 2002; 17:

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