LUTS patient reported outcomes tool: Linguistic validation in 10 European languages

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<ul><li><p>Neurourology and Urodynamics</p><p>LUTS Patient Reported Outcomes Tool: LinguisticValidation in 10 European Languages</p><p>Barbara A. Brandt,1* Colpan Angun,1y Karin S. Coyne,2z Sameepa Doshi,3</p><p>Tamara Bavendam,3k and Zoe S. Kopp3#1Corporate Translations, Inc., East Hartford, Connecticut</p><p>2Center for Health Outcomes, United BioSource Corporation, Bethesda, Maryland3Pzer Inc., New York, New York</p><p>Aim: To linguistically validate the translation of the Lower Urinary Tract Symptoms (LUTS) Tool from English to 10European languages and assess whether the translations adequately reected the concepts in the original version andif urological terms and the individual items were readily understood.Methods: Residents of the target countries whospoke the native language and had LUTS were asked to evaluate a harmonized translation of the LUTS Tool, whichwas developed in 10 languages: Danish (Denmark), Dutch (Belgium, Netherlands), Finnish (Finland), French(Belgium, France, Luxembourg, and Switzerland), German (Germany, Switzerland), Greek (Greece), Icelandic(Iceland), Italian (Italy), Norwegian (Norway), and Spanish (Spain). After reviewing the language-appropriate version,participants were asked to explain why any words were difcult to understand and to paraphrase each sentence duringa standardized cognitive debrieng interview. Linguistic validation teams (original translators, back translator, projectmanager, interviewer, and survey research expert) conducted a qualitative analysis of the cognitive debrieng ndings.Results: The terminology and concepts in the English-language version of the LUTS Tool were adequately capturedin all language translations. The overall item comprehension rate, across languages, was 98.5%. Terms related tostorage, voiding, and post-micturition LUTS were comprehensible. Minor difculties with comprehension were identi-ed in 9 of 10 translations, and those changes were made to improve clarity. Conclusions: Individuals with LUTSfrom 10 countries understood the individual items captured in translated versions of the LUTS Tool. The overall com-prehension rate was high. Most changes were made to improve conceptual clarity based on country-specic linguisticand cultural nuances. Neurourol. Urodynam. 2012 Wiley Periodicals, Inc.</p><p>Key words: lower urinary tract symptoms; overactive bladder; patient-reported questionnaire; validation</p><p>INTRODUCTION</p><p>Lower urinary tract symptoms (LUTS) have been classiedas storage (e.g., daytime frequency, nocturia, urgency, and uri-nary incontinence), voiding (e.g., slow stream, intermittency,splitting/spraying of urine stream, hesitancy, straining, andterminal trickle/dribble), and post-micturition (e.g., feeling ofincomplete emptying and post-void dribble) symptoms.1 LUTSare very common; in 2008 it was estimated that 45.2% of peo-ple worldwide (4.3 billion people) have at least one LUTS.2 Theprevalence of each of the three categories of LUTS increaseswith age.3,4 LUTS can be correlated with symptom syndromessuggestive of compromised lower urinary tract functioning,including overactive bladder syndrome and bladder outletobstruction, if infection and other pathology have been ruledout.1</p><p>In epidemiology and clinical studies, a number of differentinstruments have been used for assessing patient-reportedLUTS and monitoring the response to treatment, including theInternational Prostate Symptom Score [IPSS; equivalent to theAmerican Urological Association Symptom Index (AUA-SI)],5,6</p><p>the International Consultation on Incontinence Questionnairefor Male LUTS (ICIQ-MLUTS) and the ICIQ-Bristol Female LUTSquestionnaire (ICIQ-BFLUTS),79 and the Danish ProstaticSymptom Score (DAN-PSS).10,11 However, these instrumentswere developed before regulatory agencies recommended thatthe development of patient-reported outcome (PRO) measuresinclude documented evidence of patient input on the conceptsand items to be included in the instrument. That input maycome through qualitative research methods (e.g., interviews,</p><p>focus groups, and cognitive debrieng sessions) as well as evi-dence of the performance of the instrument in the intendedpatient population.12,13</p><p>A new LUTS instrument was developed using qualitativeresearch methods, to provide patient input, for comprehensiveassessment of both male and female LUTS (Appendix A). Thequalitative research, using focus groups, was conducted intwo phases: a rst phase wherein patients described theirsymptoms and a second phase during which patients per-spectives regarding treatment outcomes were captured. Basedon the results of patient input, the LUTS Tool was developed</p><p>Christopher Chapple led the peer-review process as the Associate Editor responsi-ble for the paper.Conict of interest: Barbara A Brandt and Colpan Angun are employees ofCorporate Translations who were paid consultants to Pzer in connection withthe development of this manuscript. Editorial assistance was provided by NancySheridan and Colin Mitchell of Complete Healthcare Communications, Inc., andwas funded by Pzer Inc.yLinguistic Validation Project Manager.zSenior Research Leader Center for Health Outcomes.</p><p>Clinical Outsourcing Manager.kMedical Director.#Director, WW Outcomes Research.Grant sponsor: Pzer Inc.*Correspondence to: Barbara A. Brandt, Research Analyst, Linguistic Validation,Corporate Translations, Inc., East Hartford, CT 06108.E-mail: bbrandt@corptransinc.comReceived 1 November 2011; Accepted 26 March 2012Published online in Wiley Online Library</p><p>(wileyonlinelibrary.com).</p><p>DOI 10.1002/nau.22265</p><p> 2012 Wiley Periodicals, Inc.</p></li><li><p>for assessment and treatment of LUTS. Consequently, theLUTS Tool assesses the frequency and bother of 18 LUTS.14 Theitems assessed with the LUTS Tool, which has not yetbeen clinically validated, are: incomplete emptying, urinaryfrequency, intermittency, urgency, weak stream, straining,nocturia, splitting or spraying, hesitancy, terminal dribble,urgency with a fear of leaking, urgency incontinence, stressincontinence (laughing, sneezing, and coughing/physicalactivities), leak for no reason, nocturnal enuresis, leakingduring sexual activity, post-micturition dribble. The objectiveof the current research was to linguistically validate the trans-lation of the LUTS Tool from English to 10 European languagesby determining if the translations adequately captured theconcepts of the original English-language version of theinstrument and if each item was readily understood byindividuals reporting LUTS.</p><p>METHODS</p><p>Participants</p><p>For each of the 10 languages, participants, who were nativespeakers living in the target countries, were selected to evalu-ate the translations of the LUTS Tool. Participants wererecruited through advertisements on the internet, clinicianreferrals, and in patient support groups and had self-reportedurinary problems/lower urinary tract problems. Assuming asample of eight participants per language, the following crite-ria were applied (when possible): 4 participants of eithergender, 2 participants with fewer than 12 years of academiceducation, 2 participants per 10-year age range and a mini-mum range of 30 years between the youngest and oldest sub-ject, and 3 geographical areas in each target country.Participants were at least 18 years old.</p><p>Linguistic Validation</p><p>The US Food and Drug Administration (FDA) recommendsadequate language translations of PRO instruments in consid-eration for use in countries/languages other than original-lan-guage version to ensure that the content validity and othermeasurement properties of the instrument remain adequatelycomparable among versions.15 The International Society forPharmacoeconomics and Outcomes Research MultinationalTrialsRecommendations on the Translations provides guid-ance for translating a PRO and maintaining the integrity ofthe tool. The publication, entitled Required Approaches toUsing the Same Language in Different Countries, and theApproaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation GoodResearch Practices Task Force Report,16 was developed to ex-pand on a previous publication 2005 that provided guidancefor the translation of PRO measures.17</p><p>A harmonized translation of the LUTS Tool was created in10 languages: Danish, Dutch, Finnish, French, German, Greek,Icelandic, Italian, Norwegian, and Spanish. In accordance withindustry standards, individual language versions of the LUTSTool were developed by linguists meeting the cultural, techni-cal, and linguistic standards of competence, using a reiterativeprocess of forward and back translations and review by anexpert in survey research and a local user. Cognitive debrienginterviews were conducted in the target language only (with-out ever discussing the document in the source language) todetermine if the translations were comprehended by the par-ticipants (Fig. 1).</p><p>Bilingual interviewers (English and target language) weretrained to conduct cognitive debrieng interviews as speciedin the Cognitive Debrieng Manual for Health OutcomesMeasures. Cognitive debrieng is a standardized interviewconducted by a trained interviewer following a subjects re-view and completion of a health outcome instrument. Inter-viewers who conducted cognitive debrieng, the rst step indetermining whether an instrument accurately evaluates itsintended measure, were trained in the study procedures andevaluated as they conducted practice interviews.</p><p>Study Procedures</p><p>Interviewers sent the questionnaires to participants via e-mail, prior to the interview. Subjects then independentlyreviewed the translation and completed the questionnaire onpaper. The participants were asked to review the question-naire and to circle any words, phrases, or sentences that weredifcult to understand. Comprehension rates (dened as totalpercentage of subjects who were able to successfully para-phrase the items within this instrument) were captured ondebrieng telephone interviews that were conducted using ascript that was read to the participants: As you know, we aretesting a questionnaire for use in clinical studies and want toknow if it can be easily understood. Did you have a chance toreview the document and circle any words that you found dif-cult to understand or any questions that were difcult to an-swer? Participants reported what they circled and were thenasked to explain why any circled words were difcult to com-prehend. Participants were asked to paraphrase each sentencein the questionnaire, and the interviewer judged whetheritems were correctly paraphrased, recording any comprehen-sion problems and proposing changes to the wording. Copiesof the participants questionnaires were not collected; infor-mation captured by the interviewer during each cognitivedebrieng interview was recorded on a data collection form(Appendix B).</p><p>Face Validation Assessment</p><p>Harmonization</p><p>ReviewTranslation team amends translationafter each review stage, if necessary</p><p>Cognitive Debriefing</p><p>Original Instrument</p><p>Translator 1 Translator 2</p><p>Consensus Harmonized Translation</p><p>Approved Harmonized Translation</p><p>Linguistically Validated Translation</p><p>Back Translation</p><p>Project Manager Review</p><p>Survey Research Expert Review</p><p>Client Subsidiary Review</p><p>Interviewer debriefs 5-25 diverse subjects</p><p>Translation Team, Interviewer, Project Manager,Survey Research Expert analyze results</p><p>and make recommendations</p><p>Translation team amends translation if necessarybased on debriefing results and analysis</p><p>Fig. 1. Overview of process of a typical linguistic LUTS evaluation. Usedwith permission from Corporate Translations, Inc.</p><p>2 Brandt et al.</p><p>Neurourology and Urodynamics DOI 10.1002/nau</p></li><li><p>Linguistic validation teams who evaluated the debriengresults and performed the qualitative analysis were com-prised of the original translators, back translator, project man-ager, interviewer, and survey research expert. The teamscategorized problems that emerged during the debrieng as(1) Conceptualrelative to the original English, (2) Linguis-ticrelative to the words used to translate the English con-cept, or (3) Stylisticrelative to the subjects preference fordifferent wording. If dictated by comprehension difculty, theoriginal translators of the questionnaires developed a revisedharmonized translation of problem words or sentences andthe back-translator created a new back translation for reviewby a survey research expert. Once all comprehension difcul-ties were addressed, nal forward and back translations werecreated.The LUTS Tool evaluates the frequency and bother of 18</p><p>LUTS. All LUTS (except incontinence items) are rated on a 5-point Likert scale of frequency: Never, Rarely, Some-times, Often, and Almost always. The frequency of incon-tinence symptoms are rated with the following 5-point Likertscale: Less than once a month, A few times a month, Afew times a week, Daily, or Many times a day. For thebother scale, response options were: Not at all, A little bit,Somewhat, Quite a bit, and A great deal. LUTS subscalescores (voiding, storage, post-micturition) are computed as thesum of participant ratings to respective items within eachsubscale. Higher scores indicate greater LUTS.</p><p>RESULTS</p><p>After creating comprehensive translations of the LUTS Tool,which were approved by the translators, project manager, andsurvey research expert involved in its production, participantsindicated comprehension difculties, and suggested changesfor improved readability and understanding, as needed. Partic-ipants (n 120) were from 15 countries, ranged in age from18 to 87 years, and had between 4 and 24 years of total aca-demic education (Table I). Half of the sample was men. Op-tional criteria were not met in all cases (e.g., there was a 19-year age range between the youngest and oldest subjects inDenmark, and no subjects in Iceland or Finland had less than12 years of education).Comprehension rates by language are summarized in</p><p>Table II. The equivalence of the concepts in the translationswith the original English questionnaires was conrmed. Therewas an overall comprehension rate of 98.5%, indicating thatthe translated terms were accurately rendered in the targetlanguages. In most cases, terms (including those related tostorage, voiding, and post-micturition LUTS) were judged by</p><p>the translation team to not require changes. A summary ofthe few comprehension difculties are listed by item inTable III. Among the questions in the LUTS Tool, number 11(during the past week, how often have you had splitting orspraying of your urine stream?) was most frequently para-phrased incorrectly and had the lowest comprehension rate(85.2%). Because this specic question was identied as dif-cult to answer in France, the phrase . . .splitting or sprayingof your urine stream. . . was replaced with . . .your urinestream divided in two or more streams. . . for greater concep-tual clarity. In Italy, the question was replaced with: Duringthe past week, how often have you had a ow of urine dividedin two streams or spraying of your urine stream? for greaterconceptual clarity.As a result of the information...</p></li></ul>

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