Neurourology and Urodynamics

LUTS Patient Reported Outcomes Tool: LinguisticValidation in 10 European Languages

Barbara A. Brandt,1* Colpan Angun,1y Karin S. Coyne,2z Sameepa Doshi,3§

Tamara Bavendam,3k and Zoe S. Kopp3#

1Corporate Translations, Inc., East Hartford, Connecticut2Center for Health Outcomes, United BioSource Corporation, Bethesda, Maryland

3Pfizer Inc., New York, New York

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 reflected 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 difficult to understand and to paraphrase each sentence duringa standardized cognitive debriefing interview. Linguistic validation teams (original translators, back translator, projectmanager, interviewer, and survey research expert) conducted a qualitative analysis of the cognitive debriefing findings.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 difficulties with comprehension were identi-fied 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-specific linguisticand cultural nuances. Neurourol. Urodynam. � 2012 Wiley Periodicals, Inc.

Key words: lower urinary tract symptoms; overactive bladder; patient-reported questionnaire; validation

INTRODUCTION

Lower urinary tract symptoms (LUTS) have been classifiedas 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

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

the International Consultation on Incontinence Questionnairefor Male LUTS (ICIQ-MLUTS) and the ICIQ-Bristol Female LUTSquestionnaire (ICIQ-BFLUTS),7–9 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,

focus groups, and cognitive debriefing sessions) as well as evi-dence of the performance of the instrument in the intendedpatient population.12,13

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 first 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

Christopher Chapple led the peer-review process as the Associate Editor responsi-ble for the paper.Conflict of interest: Barbara A Brandt and Colpan Angun are employees ofCorporate Translations who were paid consultants to Pfizer in connection withthe development of this manuscript. Editorial assistance was provided by NancySheridan and Colin Mitchell of Complete Healthcare Communications, Inc., andwas funded by Pfizer Inc.yLinguistic Validation Project Manager.zSenior Research Leader Center for Health Outcomes.§

Clinical Outsourcing Manager.kMedical Director.#Director, WW Outcomes Research.Grant sponsor: Pfizer 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

(wileyonlinelibrary.com).

DOI 10.1002/nau.22265

� 2012 Wiley Periodicals, Inc.

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.

METHODS

Participants

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.

Linguistic Validation

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 MultinationalTrials—Recommendations 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

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 debriefinginterviews 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).

Bilingual interviewers (English and target language) weretrained to conduct cognitive debriefing interviews as specifiedin the Cognitive Debriefing Manual for Health OutcomesMeasures. Cognitive debriefing is a standardized interviewconducted by a trained interviewer following a subject’s re-view and completion of a health outcome instrument. Inter-viewers who conducted cognitive debriefing, the first step indetermining whether an instrument accurately evaluates itsintended measure, were trained in the study procedures andevaluated as they conducted practice interviews.

Study Procedures

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 weredifficult to understand. Comprehension rates (defined as totalpercentage of subjects who were able to successfully para-phrase the items within this instrument) were captured ondebriefing 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-ficult to understand or any questions that were difficult to an-swer?’’ Participants reported what they circled and were thenasked to explain why any circled words were difficult 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 cognitivedebriefing interview was recorded on a data collection form(Appendix B).

Face Validation Assessment

Harmonization

ReviewTranslation team amends translationafter each review stage, if necessary

Cognitive Debriefing

Original Instrument

Translator 1 Translator 2

Consensus Harmonized Translation

Approved Harmonized Translation

Linguistically Validated Translation

Back Translation

Project Manager Review

Survey Research Expert Review

Client Subsidiary Review

Interviewer debriefs 5-25 diverse subjects

Translation Team, Interviewer, Project Manager,Survey Research Expert analyze results

and make recommendations

Translation team amends translation if necessarybased on debriefing results and analysis

Fig. 1. Overview of process of a typical linguistic LUTS evaluation. Used

with permission from Corporate Translations, Inc.

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Linguistic validation teams who evaluated the debriefingresults 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 debriefing as(1) Conceptual—relative to the original English, (2) Linguis-tic—relative to the words used to translate the English con-cept, or (3) Stylistic—relative to the subject’s preference fordifferent wording. If dictated by comprehension difficulty, 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 difficul-ties were addressed, final forward and back translations werecreated.

The LUTS Tool evaluates the frequency and bother of 18LUTS. 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.

RESULTS

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 difficulties, and suggested changesfor improved readability and understanding, as needed. Partic-ipants (n ¼ 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 inTable II. The equivalence of the concepts in the translationswith the original English questionnaires was confirmed. 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

the translation team to not require changes. A summary ofthe few comprehension difficulties 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 specific question was identified as diffi-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 flow of urine dividedin two streams or spraying of your urine stream?’’ for greaterconceptual clarity.As a result of the information communicated by partici-

pants during cognitive debriefing phone interviews, changeswere made to 9 of the 10 translations (Table IV). Most changeswere made to improve conceptual clarity based on country-specific linguistic and cultural nuances. For example, for theDutch language translation, in the question ‘‘During a typicalday in the past week, how many times did you urinate duringwaking hours?’’ the term ‘‘typical’’ was replaced by ‘‘average.’’For the French language version, three changes were made toimprove conceptual clarity, including replacement of theword ‘‘delay’’ in the question ‘‘During the past week, how of-ten have you had a delay before you start to urinate?’’ with adifferent term for ‘‘delay’’ (from delai to decalage). Frequently,certain terms were replaced with more common terms specificto the target country. For example, in the Norwegian languageversion, for the question ‘‘During the past week, how often

TABLE I. Demographic Characteristics of the Participants by Target Language�

Language (n) Country� Age range (years) Gender (males/females) Education range (years)

Danish (8) Denmark 60–79 4:4 7–15

Dutch (16) Belgium, Netherlands 31–85 8:8 6–16

Finnish (8) Finland 21–77 4:4 13–24

French (32) Belgium, France, Luxembourg, Switzerland 25–86 16:16 5–19

German (16) Germany, Switzerland 27–78 8:8 9–18

Greek (8) Greece 32–87 4:4 4–16

Icelandic (8) Iceland 23–70 4:4 14–18

Italian (8) Italy 40–74 4:4 5–17

Norwegian (8) Norway 20–76 4:4 7–16

Spanish (8) Spain 18–55 4:4 9–18

�n ¼ 8 for each language/country combination.

TABLE II. Item Comprehension Rate by Language

Language Comprehension ratea (%)

Danish 98.1

Dutch 97.8

Finnish 99.0

French 98.5

German 98.7

Greek 100

Icelandic 98.8

Italian 93.8

Norwegian 98.3

Spanish 99.5

Overall 98.5

aTotal percentage of successfully paraphrased items in the LUTS Tool.

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TABLE III. Comprehension Difficulties by LUTS Tool Item�

Item Category

Incorrectly

paraphrased

Itemcomprehension

rate (%)

Total Title 22 83.7

Participant ID: Administrative 15 88.9

Initials: Administrative 3 97.8

Date: Administrative 1 99.3

This questionnaire asks about urinary symptoms you may have experienced in the past week. Instructions 1 99.3

If ‘‘rarely’’ or more, Response option 8 94.1

Somewhat Response option 2 98.5

2. During a typical day in the past week, how many times did you urinate during waking hours? Question 6 95.6

3. During a typical night in the past week, how many times did you wake up because you

needed to urinate?

Question 1 99.3

4. During the past week, how often have you had the feeling your bladder was not empty after

urinating?

Question 1 99.3

5. During the past week, how often have you had a trickle or dribble at the end of your urine

flow?

Question 2 98.5

7. During the past week, how often have you had a delay before you start to urinate? Question 9 93.3

8. During the past week, how often did your urine flow start and stop while you were urinating? Question 3 97.8

9. During the past week, how often did you strain to urinate or strain while you were urinating? Question 5 96.3

11. During the past week, how often have you had splitting or spraying of your urine stream? Question 20 85.2

a. Leaked urine just after you have finished urinating? Question 2 98.5

c. Leaked urine in connection with laughing, sneezing, or coughing? Question 1 99.3

g. Leaked urine for no reason? Question 3 97.8

�n ¼ 120 participants.

TABLE IV. Changes Made to Language Translations Based on Comprehension Difficulty

Language Category of Change Change

Dutch Conceptual In the header, ‘‘Participant ID:’’ was expanded to ‘‘Identification of participant.’’

Linguistic In the instructions, ‘‘. . .the box that is most appropriate.’’ was replaced by more common terms for the target country.

Stylistic The question ‘‘How much does this bother you?’’ replaced by ‘‘To what extent does this bother you?’’

Conceptual The question ‘‘During a typical day in the past week, howmany times did you urinate during waking hours?’’ was replaced

by ‘‘During an average day in the past week, howmany times did you urinate during waking hours?’’ This revision was

made throughout the questionnaire.

French Conceptual In the question ‘‘During the past week, how often have you had a delay before you start to urinate?’’ the term ‘‘delay’’ was

replaced.

Conceptual In the question ‘‘During the past week, how often did you strain to urinate or strain while you were urinating?’’ the term

‘‘strain’’ was replaced with ‘‘make an effort.’’

Conceptual In the question ‘‘During the past week, how often have you had splitting or spraying of your urine stream?’’ the phrase

‘‘. . .splitting or spraying of your urine stream. . .’’ was replaced with ‘‘. . .your urine stream divided in two or more

streams. . .’’

Icelandic Stylistic In the question ‘‘During the past week, how often have you had a sudden need to rush to urinate?’’ a prepositionwas added.

This revision was made throughout the questionnaire.

Conceptual The question ‘‘Leaked urine in connectionwith a suddenneed to rush to urinate?’’ was revised as ‘‘Leaked urine in relation to

a sudden need to hurry yourself to the toilet?’’

Norwegian Conceptual The question ‘‘During the past week, how often did you strain to urinate or during urination?’’ was revised as ‘‘During the

past week, how often did you strain to urinate or strain during urination?’’

Linguistic In the question ‘‘During the past week, how often have you had a burning feeling when you urinate?’’ the term ‘‘burning’’

was replaced by a more common term for the target country.

Stylistic The question ‘‘Leaked urine for no reason?’’ was revised as ‘‘Leaked urine for no specific reason?’’

Greek Stylistic The syntax of the question ‘‘Below are several situations in which people can leak urine. How often in the past week have

you. . .’’ was revised.

Stylistic/Conceptual In the question ‘‘Leaked urine just after you have finished urinating?’’ the term ‘‘urinating’’ was replaced with ‘‘urination.’’

Linguistic In the question ‘‘Leaked urine in connection with physical activities, such as exercising or lifting a heavy object?’’ the term

‘‘heavy’’ was replaced by a more common term for the target country.

Italian Linguistic In the title, the acronym ‘‘LUTS’’ was removed as it has no significance for the reader in Italian.

Conceptual In the header, the term ‘‘Initials’’ was replaced with ‘‘Initials of the Participant.’’

Conceptual In the question, ‘‘How often during the past week did you urinate too frequently?’’ the response option ‘‘If ‘rarely’ or more,’’

was revised as ‘‘If ‘rarely’, ‘sometimes’, ‘often’, or ‘almost always’.’’

Linguistic The term ‘‘urination’’ was replaced throughout by a more common term for the target country.

Conceptual The question ‘‘During the past week, how often have you had splitting or spraying of your urine flow?’’ was replaced with

‘‘During the past week, how often have you had a flow of urine divided in two streams or spraying of your urine stream?’’

Spanish Linguistic The term ‘‘urinate’’ was replaced throughout by a more common term for the target country.

Note: No changes were made to the Danish translation.

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have you had a burning feeling when you urinate?’’ the term‘‘burning’’ was replaced by a more common Norwegian term(from brennende to sviende). And, in the Italian version, a sen-tence with the term ‘‘urinate’’ was replaced throughout by amore common term (from minzione to urinazione).

DISCUSSION

The development of the LUTS Tool has been particularlyvaluable for increasing our understanding of how patientswith LUTS describe their symptoms, perspectives, and expect-ations for treatment outcomes.14 It is critical that patients un-derstand their LUTS to adequately convey their symptoms tohealthcare providers; however, evidence suggests a discrepan-cy in terms used and understood by patients and health careprofessionals. An inverse relationship has been demonstratedbetween education level and symptom misrepresentation onthe AUA-SI, possibly predisposing patients with lower educa-tion to inadequate care.18,19 Indeed, a study evaluating wom-en’s understanding of LUTS demonstrated that >20% wereunsure of the definitions for the following terms: daytime fre-quency, nocturia, urgency, urge, urinary incontinence, stressurinary incontinence, and hesitancy.20 Hence, the FDArequires evidence of adequate translation for internationalPROs to ensure that the instrument retains its integrity forcapturing patients’ symptoms and their perspectives orexpectations for treatment outcomes comparable to that ofthe original version.13 In this study, the various translationsadequately captured the concepts of the original English-lan-guage version of the questionnaire and were readily under-stood by participants with LUTS, thereby establishinglinguistic validity of the LUTS Tool for 10 additional languagesand maintaining the validity of the instrument across variouscountries.

An emphasis has been placed on qualitative research to es-tablish the content validity of PRO assessment tools.13 There-fore, each iteration for the countries targeted was developed

following industry guidance for best practices regarding lan-guage validity.16,17 Telephone interviews have been shown tobe acceptable means of obtaining accurate information in oth-er disciplines21,22 and were used in this study. There was a98.5% item comprehension rate, and the changes to 9 of 10translations were minor and most often to increase claritybased on cultural nuances or country-specific terms.Multiple language iterations of the LUTS Tool should facili-

tate wide-spread utilization of the questionnaire and fostercommunication between patients and healthcare providers,which could lead to more consistent assessment and propertreatment of the symptoms that are the most bothersome toindividual patients. Further psychometric validation of theLUTS Tool, including additional content validation analyses,are currently being conducted.

CONCLUSIONS

Translations of the LUTS Tool into 10 languages adequatelycaptured the concepts of the original English-language ver-sion. In general, participants demonstrated an ability to un-derstand the concepts assessed in the LUTS Tool. The overallitem comprehension rate was 98.5%. As a result of the infor-mation communicated by patients during cognitive debriefinginterviews, changes were required and made to 9 of the 10translations. The LUTS Tool is a linguistically validated PROmeasure for assessing LUTS and treatment seeking for LUTS inboth men and women who speak 10 European languages.

ACKNOWLEDGMENTS

This study was sponsored by Pfizer. Barbara A Brandt andColpan Angun are employees of Corporate Translations whowere paid consultants to Pfizer in connection with the devel-opment of this manuscript. Editorial assistance was providedby Nancy Sheridan and Colin Mitchell of Complete HealthcareCommunications, Inc, and was funded by Pfizer Inc.

Appendix A. LUTS Tool

Item 1Circleditems 2

Paraphrasedcorrectly/conceptunderstood 3 Comments 4

LUTS Tool

Participant ID:

Initials:

Date:

This questionnaire asks about urinary symptoms you may have experienced in the past week.

For each symptom, please record how often you have experienced it in the past week by placing aU in the

most appropriate box.

Then, follow the directions to the right of the question to determine if you need to answer the second part of

the question: ‘‘How much does this bother you?’’

1. How often during the past week did you urinate too frequently?

Never

Rarely

Sometimes

Often

Almost always

If ‘‘rarely’’ or more,

Not at all

A little bit

Somewhat

Quite a bit

(Continued)

Linguistic Validation of LUTS Outcome Tool 5

Neurourology and Urodynamics DOI 10.1002/nau

Item 1Circleditems 2

Paraphrasedcorrectly/conceptunderstood 3 Comments 4

LUTS Tool

Participant ID:

Initials:

Date:

This questionnaire asks about urinary symptoms you may have experienced in the past week.

For each symptom, please record how often you have experienced it in the past week by placing aU in the

most appropriate box.

Then, follow the directions to the right of the question to determine if you need to answer the second part of

the question: ‘‘How much does this bother you?’’

1. How often during the past week did you urinate too frequently?

Never

Rarely

Sometimes

Often

Almost always

If ‘‘rarely’’ or more,

Not at all

A little bit

Somewhat

Quite a bit

A great deal

2. During a typical day in the past week, how many times did you urinate during waking hours?

1–3 times a day

4–7 times a day

8–10 times a day

11–13 times a day

14 or more times a day

3. During a typical night in the past week, howmany times did youwake up because you needed to urinate?

None

1 time a night

2 times a night

3 times a night

4 or more times a night

If ‘‘1 time a night’’ or more,

4. During the past week, how often have you had the feeling your bladder was not empty after urinating?

5. During the past week, how often have you had a trickle or dribble at the end of your urine flow?

6. During the past week, how often have you had a sudden need to rush to urinate?

7. During the past week, how often have you had a delay before you start to urinate?

8. During the past week, how often did your urine flow start and stop while you were urinating?

9. During the past week, how often did you strain to urinate or strain while you were urinating?

10. During the past week, how often have you had a weak urine stream?

11. During the past week, how often have you had splitting or spraying of your urine stream?

12. During the pastweek, how often have you had a sudden need to rush to urinate for fear of leaking urine?

13. During the past week, how often have you had pain or discomfort in your bladder area?

14. During the past week, how often have you had a burning feeling when you urinate?

15. During the past week, how often did you leak urine?

16. Below are several situations in which people can leak urine. How often in the past week have you. . .

a. Leaked urine just after you have finished urinating?

b. Leaked urine in connection with a sudden need to rush to urinate?

c. Leaked urine in connection with laughing, sneezing, or coughing?

d. Leaked urine in connection with physical activities, such as exercising or lifting a heavy object?

e. Leaked urine when you are sleeping?

f. Leaked urine during sexual activity?

g. Leaked urine for no reason?

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Neurourology and Urodynamics DOI 10.1002/nau

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Appendix B. Sample Data Collection Form (DCF)

The sample DCFs illustrate the two steps in the collection and analysis of cognitive debriefing data, as follows:

(1) Interviewers complete and submit a DCF for each subject as specified in the Cognitive Debriefing Manual.(2) Interviewers compile DCFs into a Summary DCF and submit the Summary DCF.

The interviewer should label the Summary DCF with the language code, e.g., SW–SW Summary DCF is the label for theSwedish for Sweden Summary DCF.

At the top of the DCF, the interviewer enters the interview begin and end times. The subject’s demographics and the time tocomplete the interview (elapsed time) are entered into the boxes that correspond to the subject’s ID#. On the Summary DCF, theinterviewer enters the demographic information for all participants.

Interview Begin Time: _:_, Interview End Time _:_

Subject 1 2 3 4 5

Age (years)

Gender

Academic education (years)

City and country of residence

Elapsed time for interview

Item 1 Circled items 2 Paraphrased correctly/concept understood 3 Comments 4

Linguistic Validation of LUTS Outcome Tool 7

Neurourology and Urodynamics DOI 10.1002/nau