Linguistic validation of translation of the self-assessment goal achievement (saga) questionnaire from English

Participants were recruited by clinical investigators through referrals. Participants had to be native-speaking residents of the target countries who reported urinary problems/lower urinary tract problems. Subject selection criteria for each language, assuming a sample of 8 participants per language, were patients with self-reported urinary problems/lower urinary tract problems, equal representation of gender, and (when possible) ≥ 2 participants with fewer than 12 years of education, ≤ 2 participants per 10-year age range and a minimum range of 30 years between the youngest and oldest subject, and ≥ 3 geographical areas in the target country.

A schematic overview of a typical linguistic validation process is illustrated in Figure 1. The methodology to conduct the linguistic validation of SAGA was based on linguistic adaptation principles detailed by the European Regulatory Issues and Quality of Life Assessment (ERIQA) Group [11] and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) [12, 13] and recommended by the US Food and Drug Administration [14].

Translations were created by linguists meeting the cultural, technical, and linguistic standards of competence through a process of forward and back translations and review by an expert in survey research and a local user, in accordance with industry standards outlined in Appendix A. A harmonized translation of the SAGA questionnaire was created in 12 languages: Danish, Dutch, English (UK), Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Spanish, and Swedish. The translations were then tested via cognitive debriefing interviews of patients with OAB residing in the target countries. Cognitive debriefing is a standardized interview conducted by a trained interviewer following a subject's review and completion of a PRO instrument. All interactions with participants were conducted in the target language only. The source language was never used in discussing the document with the subject. Bilingual interviewers (English and target language) were trained to conduct one-on-one cognitive debriefing interviews as previously described [15].

Participants were asked to review the SAGA questionnaire during a baseline interview and in the follow-up module, to return the questionnaire with any words, phrases, or sentences circled that were difficult to understand. During a subsequent debriefing telephone interview, participants were asked to paraphrase each sentence in the questionnaire and explain why any circled words were difficult to understand. Comprehension rates (defined as total percentage of subjects who were able to successfully paraphrase the items within this instrument) were captured during debriefing interviews. Interviewing was conducted using a script that was read to the participants: "As you know, we are testing a questionnaire for use in clinical studies and want to know if they can be easily understood. Did you have a chance to review the document and circle any words that you found difficult to understand or any questions that were difficult to answer?" The interviewer judged whether items were correctly paraphrased and recorded any comprehension problems or proposed changes to the wording. In keeping with regulatory guidelines and good clinical practice, cognitive debriefing information was captured on a data collection form (Appendix B).

In the subsequent qualitative analysis, linguistic validation teams, consisting of the original translators, back translator, project manager, interviewer, and survey research expert, evaluated the debriefing results. The teams categorized problems that emerged during the debriefing as: Conceptual - a function of the original English; Linguistic - a function of the words used to translate the English concept; or Stylistic - a function of the subject's preference for a different wording. When warranted, the original translators of the questionnaire created a new harmonized translation of problem words or sentences and the back translator created a new back translation for review by a survey research expert. Once all issues were resolved, final forward and back translations were created.

After creating comprehensive translations, which were approved by the translators, project manager, and survey research expert involved in its production, debriefing interviews were conducted with 144 participants with urinary/lower urinary tract problems from 16 countries: Denmark, The Netherlands, Finland, United Kingdom, Ireland, Greece, Norway, Iceland, Spain, Sweden, France, Belgium, Luxembourg, Switzerland, Italy, Germany. The participants ranged in age from 18 to 87 years and had 4 to 24 years of education (Table 1). An equal number of men and women participants in each language sample were included. The age range in the Danish population was < 30 years (60-79 y).

A breakdown of item comprehension by language is summarized in Table 2. The average item comprehension rate for each item in the SAGA questionnaire, across languages, was 98.9%. A summary of the comprehension difficulties for each SAGA item is listed in Table 3. For most difficulties, the terms were judged by the translation team to not require changes because the overall comprehension levels were relatively high and the translated terms were accurately rendered in the target languages. The various types of changes that were required are summarized in Table 4 with the majority of changes made to the questionnaire instructions. No changes were made for the Danish, Spanish, and Swedish translated versions. For the Greek, Italian, Norwegian, German, and English (Irish and UK) versions, comprehension difficulties that required changes occurred only in the instructions for the questionnaire. For example, "Finally, circle the three most important goals in the combined symptom and other personal goals sections, as shown below" was the most common statement that was incorrectly paraphrased, with an 88.1% comprehension rate. Therefore, this instruction was changed for greater conceptual clarity. Examples of other changes include: for the Dutch translation, all changes were made to the instructions, including a comma inserted after "treatment goals" for greater conceptual clarity: "Each patient is unique and has different treatment goals, depending on the symptoms experienced, lifestyle, and any other health concerns" and "Use the scale below..." was replaced by more common terms for the target countries. This revision was made throughout the questionnaire. In the French version, examples of changes made were: in the instructions, "Circle the 3 goals from the combined sections below (Symptom and Other personal goals) which are the most important for you" was revised for greater conceptual clarity; and in the item "To reach my goals I will:" the phrase "Keep record of my progress" was revised as "Keep track of my progress" for both greater conceptual clarity and cultural appropriateness. The Icelandic version had 2 changes to improve grammatical accuracy: in the item "Reduce the difficulty starting or maintaining a urinary stream" a preposition was added, and in the item "Sign your name to confirm your commitment to working towards your own better health" noun case was changed.