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METHODS • To evaluate the linguistic validity of harmonized translations of the LupusQoL, bilingual (target language and English) interviewers cognitively debriefed subjects to assess their ability to paraphrase and understand the instructions, questions and responses within each translation. • A total of thirteen translations were debriefed as part of this research [Chinese (Taiwan), Dutch (Belgium), English (US/Canada), French (Belgium/France, Canada), Greek (Greece), Hungarian (Hungary), Italian (Italy), Portuguese (Brazil), Spanish (Argentina/Chile, Mexico, US/Canada), Swedish (Sweden)]. • A convenience sample was selected and stratified with regards to education (in order to include participants both with and without a high school degree), gender, age and geographical location within the target country. • The results of the debriefings were compared on the basis of comprehension and number of suggested changes. VOCABULARY • Systemic Lupus Erythematosus (SLE): an inflammatory connective tissue disease of unknown cause that occurs chiefly in women and that is characterized especially by fever, skin rash, and arthritis, often by acute hemolytic anemia, by small hemorrhages in the skin and mucous membranes, by inflammation of the pericardium, and in serious cases by involvement of the kidneys and central nervous system. [8] • Health-related quality of life (HRQoL): a person or group’s perceived physical and mental health over time; often used by physicians to measure the effects of chronic illness in their patients to better understand how an illness interferes with a person’s day-to-day life. [9] • Cognitive debriefing: a process by which trained bilingual interviewers debrief subjects, who have already reviewed the questionnaire being tested on their own time, via telephone to assess their ability to paraphrase the instructions, questions, and response options within the questionnaire, indicating any difficult or confusing terms to the interviewer. • Item Comprehension Rate (ICR): is determined by calculating the total percentage of subjects who were able to successfully paraphrase a given item; the formula and its components are shown in Figure 1. CONCLUSIONS The translations of the instrument in this study demonstrated a high level of overall linguistic validity. This research will facilitate inter-country comparisons of Systemic Lupus Erythematosus and the pooling of data in multi-country studies. REFERENCES 1. K McElhone, J Abbott, J Shelmerdine, Y Ahmad, I Bruce, C Gordon, K Peers, D Isenberg, A Ferenkeh-Koroma, B Griffiths, M Akil, P Maddison, LS Teh. The Development and Validation of a Disease Specific Quality of Life Measure, the LupusQoL, in Adults with Systemic Lupus Erythematous (SLE), Arthritis Care Res 2007; 57:972-979. 2. Gawlicki M. Procedures for Linguistic Validation of Health Status Questionnaires. Mansfield Center, CT: Corporate Translations, Inc. 2004. 3. Leveling language barriers (n.d.). Retrieved March 6, 2009 from, http://www.drivenbydefinition.com/htm/ linguistic_validation.htm 4. K McElhone, J Abbott, J Shelmerdine, IN Bruce, Y Ahmad, C Gordon, K Peers, D Isenberg, A Ferenkeh- Koroma, B Griffiths, M Akil, P Maddison, L-S Teh. 8th International Lupus Meeting, Shanghai, China May 2007, EULAR, Barcelona, June 2007 and American College of Rheumatology AGM, Boston, USA, November 2007. The Relationship between demographic and clinical parameters and Health-Related Quality of Life (HRQoL) in patients with Systemic Lupus Erythematosus (SLE). Lupus 2007;16 (Abstract suppl.):PO313, 199. Ann Rheum Dis 2007;66 (suppl. II):SAT0182, 484. Arthritis Rheum 2007; 56 (supply):1918, S734. 5. LupusQoL (n.d.). Retrieved March 6, 2009 from, http://www.lupusqol.com/default.htm 6. K McElhone, J Abbott, LS Teh. Review of Health Related Quality of Life (HRQoL) in patients with Systemic Lupus Erythematosus (SLE). Lupus 2006; 15:633-643. 7. Chapter on “Health-related quality of life in adults with systemic lupus erythematosus” in the Burden of Diseases Handbook, Springer, Germany. Lee-Suan Teh, Kathleen McElhone, Janice Abbott. (In Press). 8. Merriam-Webster Medical Dictionary (n.d.). Retrieved March 5, 2009 from, http://www2.merriam-webster. com/cgi-bin/mwmednlm?book=Medical&va=Systemic%20Lupus%20Erythematosus 9. National Center for Chronic Disease Prevention and Health Promotion: Health-Related Quality of Life (01/06/2009). Retrieved March 5, 2009 from, http://www.cdc.gov/hrqol/ Table 1: Demographic characteristics of the subjects by target language* Target language Residence (towns or cities)‡ Age (range years) Gender (male: female) Education (range years) Chinese Taiwan (4) 22-63 3:2 6-16 Dutch Belgium (5) 19-60 2:3 9-17 English US (4) Canada (3) 30-71 3:4 11-20 French Belgium (4) France (3) 28-72 3:4 11-20 French Canada (4) 31-68 2:3 6-18 Greek Greece (4) 26-71 2:3 6-17 Hungarian Hungary (5) 22-55 2:3 10-17 Italian Italy (5) 22-62 2:3 8-17 Portuguese Brazil (3) 25-62 2:3 1-18 Spanish Argentina (3) Chile (2) 21-76 3:4 4-16 Spanish Mexico (4) 20-68 3:2 6-16 Spanish US and Canada Colombia (1) Cuba (1) Dominican Republic (2) Guatemala (2) Puerto Rico (1) 28-62 4:3 11-17 Swedish Sweden (4) 22-66 2:3 8-18 * n=5 for each language, except French (Belgium/ France), Spanish (Argentina/Chile), English (US /Canada) and Spanish (US/Canada) where n=7 ‡ Country of origin for Spanish (US /Canada) Item Comprehension Rates • The overall item comprehension rate for the LupusQoL was 99.5%. • All items had a comprehension rate of greater than 91.8%, while most had 100%. • All countries had at least a 98.1% rate. • 4 changes were made to 3 of the translations [Italian (Italy), Portuguese (Portugal), Spanish (Argentina/Chile)] as a result of debriefing. • In most cases, these issues 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. Table 2: Item Comprehension Rates Language Country ICR Comprehension Issue (# of subjects) Change made (if any) Chinese Taiwan 99.3% Not Applicable (2) Dutch Belgium 100% English US/Canada 100% French Belgium/France 100% French Canada 100% Greek Greece 99.6% The hair loss I have experienced (1) Hungarian Hungary 100% Italian Italy 98.5% SLE (3) Not applicable (1) Change made from “non pertinente” to “non pertinente al mio caso”. Portuguese Brazil 98.5% SLE (2) Disturbed (1) Change made from “LES” to “Lupus Eritematoso Sistemico”. Spanish Argentina/Chile 98.1% Most of the time (1) I am unable perform everyday tasks (3) Slower (2) I avoid planning to attend (1) Change made from “debido al Lupus, soy incapaz de realizar las tareas cotidianes, como mi trabajo, cuidar a los ninos o los quechaceres domesticos tan bien como quisiera” to “debido al Lupus, soy incapaz de realizar tan bien como quisiera las tareas cotidianes, como mi trabajo, cuidar a los ninos o los quechaceres domesticos”. Change made from “mas calma” to “mas despacio”. Spanish Mexico 100% Spanish US/Canada 99.7% SLE (1) Swedish Sweden 100% Terms and phrases with comprehension rates lower than 100% across languages for the LupusQoL were as follows: • “The following questionnaire is designed to find out how SLE affects your life” was understood by 91.8% of subjects (67/73)* • “Most of the time” was understood by 98.6% of subjects (72/73) • “Because of my Lupus I am unable to perform everyday tasks such as my job, childcare, housework as well as I would like to” was understood by 95.9% of subjects (70/73) • “I have to do things at a slower pace because of my Lupus” was understood by 97.3% of subjects (71/73) • “Because of my Lupus my sleep pattern is disturbed” was understood by 98.6% of subjects (72/73) • “Because of my Lupus I avoid planning to attend events in the future” was understood by 98.6% of subjects (72/73) • “Not applicable” was understood by 95.9% of subjects (70/73)* • “Resentful” was understood by 98.6% of subjects (72/73) • “The hair loss I have experienced because of my Lupus makes me feel less attractive” was understood by 98.6% of subjects (72/73) * Comprehension difficulties were present for more than one language OBJECTIVE To create and establish the linguistic validity of thirteen translations of the Lupus Quality of Life (LupusQoL) Questionnaire. BACKGROUND Patients with Systemic Lupus Erythematosus (SLE) have shown significantly improved survival rates, causing researchers and physicians alike to become increasingly interested in patients’ health-related quality of life (HRQoL). A variety of generic HRQoL questionnaires exist to assess this measure; however, the Lupus Quality of Life Questionnaire (LupusQoL) is the only disease-specific HRQoL questionnaire. [1] Since this questionnaire was only recently developed and psychometrically validated, it has yet to be linguistically validated for use across diverse cultures and languages. LINGUISTIC VALIDATION Linguistic Validation is a process that is conducted to confirm that a Patient-Reported Outcome (PRO) questionnaire is acceptable for use in multinational clinical trials. Without this careful development of a translation and subsequent cognitive debriefing, one could not be reasonably certain that the adapted instrument is equivalent to the original and can also be clearly understood by the average individual. The Linguistic Validation process begins with a harmonized translation created by two translators working independently; after that, the harmonized translation is provided to a third translator who translates the text back into English without access to the original English. Both the harmonized translation and the English back translation are reviewed by a project manager, a survey research expert and an in-country clinician; adaptations to the translation are made as needed. Once the translation has been approved, it is debriefed among in-country native speakers of the language, with varying demographic and educational backgrounds, to check for conceptual equivalence and clarity. [2, 3] LUPUSQOL QUESTIONNAIRE Overview: • The LupusQoL is a 34-item SLE-specific health-related quality of life (HRQoL) measure, which was developed in the UK [4] for use in adults with Systemic Lupus Erythematosus (SLE). • The final version of the LupusQoL consists of eight domains: - physical health (8 items) - planning (3 items) - burden to others (3 items) - pain (3 items) - intimate relationships (2 items) - emotional health (6 items) - body image (5 items) - fatigue (4 items) Development: • To derive the items for this instrument, semi-structured interviews were informed by the literature and interviews with 10 clinicians specializing in SLE and then administered to 30 patients with SLE. • Cognitive debriefing with an additional 20 patients with SLE was conducted before the first version of the LupusQoL was devised. • Three versions of the questionnaire were evaluated in over 600 outpatients. Prior Psychometric Validation: Prior to being translated and linguistically validated by Corporate Translations, the developers of the LupusQoL performed measures in order to psychometrically validate the questionnaire; the results are as follows: • Factor analysis used to examine the construct validity of the three versions of the questionnaire. • Good internal reliability (Cronbach’s 0.88 to 0.95), good test-retest reliability (r 0.72 to 0.93), good concurrent validity with the comparable domains of the SF-36 (r 0.71 to 0.79) and good discriminant validity for different levels of disease activity, measured by the British Isles Lupus Assessment Group (BILAG) index and damage (SLICC/ACR-DI) but not for all domains. • Acceptable ceiling effects and minimal floor effects. • Limitations include the lack of males in its initial development phase. In subsequent phases, approximately 6% of patients recruited were male (representative of the SLE population in the UK.) • Currently no sensitivity to change data. [4, 5, 6, 7] Demographic Description of Subjects • A total of 73 subjects were enrolled, between 5 and 7 subjects for each of the 13 languages tested. • Overall, 40% of subjects had less than 12 years of education; years of education ranged from 1 to 20, with a mean of 12.6 years. • 45% of the subjects were male; 55% were female. • The average age of subjects was 44.2 years; the range of ages was from 19 to 76 years. Linguistic Validation of the Lupus Quality of Life (LupusQoL) Questionnaire into 13 Languages Mary C. Gawlicki, MBA; Melissa Handa, BA; Shawn McKown, MA —— Corporate Translations, Inc. —— Number of respondents Number of comprehension issues Number of items Number of correct responses Number of responses ICR = (nR * nI) - CI / (nR * nI) Figure 1
