期刊论文详细信息
Health and Quality of Life Outcomes
Linguistic validation of translation of the self-assessment goal achievement (saga) questionnaire from English
Jeffrey Trocio5  Agneta Bergqvist3  Christopher J Evans4  Çolpan Angün2  Barbara A Brandt2  Sameepa Doshi1  Elisabeth Piault4 
[1] Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA;Corporate Translations, Inc, East Hartford, CT 06108, USA;Pfizer PIO, VetenskapsvΣgen 10, SE-19190, Sollentuna, Sweden;MAPI Values, 133 Portland St, Boston, MA 02114, USA;Pfizer, Inc, 235 East 42nd Street 235/9/42, New York, NY 10017, USA
关键词: Patient-reported questionnaire;    Goal achievement;    Overactive bladder;    Lower urinary tract symptoms;    Validation;    SAGA;   
Others  :  825730
DOI  :  10.1186/1477-7525-10-40
 received in 2011-11-02, accepted in 2012-04-23,  发布年份 2012
PDF
【 摘 要 】

Background

A linguistic validation of the Self-Assessment Goal Achievement (SAGA) questionnaire was conducted for 12 European languages, documenting that each translation adequately captures the concepts of the original English-language version of the questionnaire and is readily understood by subjects in the target population.

Methods

Native-speaking residents of the target countries who reported urinary problems/lower urinary tract problems were asked to review a translation of the SAGA questionnaire, which was harmonized among 12 languages: Danish, Dutch, English (UK), Finnish, French, German, Greek, Icelandic, Italian, Norwegian, Spanish, and Swedish. During a cognitive debriefing interview, participants were asked to identify any words that were difficult to understand and explain in their own words the meaning of each sentence in the questionnaire. The qualitative analysis was conducted by local linguistic validation teams (original translators, back translator, project manager, interviewer, and survey research expert).

Results

Translations of the SAGA questionnaire from English to 12 European languages were well understood by the participants with an overall comprehension rate across language of 98.9%. In addition, the translations retained the original meaning of the SAGA items and instructions. Comprehension difficulties were identified, and after review by the translation team, minor changes were made to 7 of the 12 translations to improve clarity and comprehension.

Conclusions

Conceptual, semantic, and cultural equivalence of each translation of the SAGA questionnaire was achieved thus confirming linguistic validation.

【 授权许可】

   
2012 Piault et al; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20140713073018566.pdf 267KB PDF download
Figure 1. 61KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P: Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006, 50:1306-1315.
  • [2]Benner JS, Nichol MB, Rovner ES, Jumadilova Z, Alvir J, Hussein M, Fanning K, Trocio JN, Brubaker L: Patient-reported reasons for discontinuing overactive bladder medication. BJU international 2009, in press.
  • [3]Brubaker L, Kopp Z, Piault E, Trocio J, Evans C, Fitzgerald K, A W: Development of a Self-Assessment Goal Achievement (SAGA) Questionnaire in urinary disorders. In International Continence Society. Rotterdam, The Netherlands; 2007.
  • [4]Fianu-Jonasson A, Brubaker L, Kelleher C, Khullar V, Bitoun CE, Weinstein D, Andersson AS, Piault-Louis E: Understanding Swedish patients' expectations for treatment of their urinary symptoms. In Nordic Urogynecological Association. Reykjavik, Iceland; 2009.
  • [5]Brubaker L, Woodson K, Beach J, Piault E, Wennberg C, Yeh Y, Bavendam T, Kopp Z, Kelleher C, Khullar V, Trocio J: Self-Assessment Goal Achievement Questionnaire: Baseline results of a pilot study in U.S. subjects with lower urinary tract symptoms or overactive bladder. In Society of Urologic Nurses and Associates. Chicago, IL; 2009.
  • [6]Cheung SW, Aranda D, Driscoll CL, Parsa AT: Mapping clinical outcomes expectations to treatment decisions: an application to vestibular schwannoma management. Otol Neurotol 2010, 31:284-293.
  • [7]Gonzalez Saenz de Tejada M, Escobar A, Herrera C, Garcia L, Aizpuru F, Sarasqueta C: Patient expectations and health-related quality of life outcomes following total joint replacement. Value Health 2010, 13:447-454.
  • [8]Kopp Z, Brubaker L, Piault E, Trocio JN, Evans C, Fitzgerald K, A W: Development of a self-assessment goal attainment (SAGA) questionnaire in overactive bladder. In International Continence Society. Rotterdam, Netherlands; 2007.
  • [9]Khullar V, Kelleher CJ, Ebel Bitoun C, Arumi D, Whelan L, L C: Utilization of the Self-Assessment Goal Achievement Questionnaire to Evaluate the Importance of Treatment Goals in Subjects With Overactive Bladder Symptoms. ICS/IUGA; Toronto, Canada; 2010. Edited by August 23-27
  • [10]Chassany O, Sagnier P, Marquis P, Fulleton S, Aaronson N: Patient reported outcomes and regulatory issues: the example of health-related quality of life - a European guidance document for the improved integration of HRQL assessment in the drug regulatory process. Drug Inform J 2002, 36:209-238.
  • [11]Acquadro C, Conway K, Hareendran A: Aaronson NftERIaQoLAEG: Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health 2007, 11:509-521.
  • [12]Wild D, Eremenco S, Mear I, Martin M, Houchin C, Gawlicki M, Hareendran A, Wiklund I, Chong LY, von Maltzahn R, et al.: Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report. Value Health 2009, 12:430-440.
  • [13]Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P: Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health 2005, 8:94-104.
  • [14]U.S. Department of Health and Human Services: Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Final Guidance. 2009. Book Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Final Guidance. 2009 2009. (Editor ed.^eds.). City
  • [15]Brubaker L, Kopp Z, Piault E, Trocio J, Evans C, Fitzgerald K, Wong A: Development of a Self-Assessment Goal Achievement (SAGA) questionnaire in urinary disorders. In International Continence Society. Rotterdam, The Netherlands; 2007.
  • [16]Brubaker L, Khullar V, Piault E, Evans CJ, Bavendam T, Beach J, Yeh Y, Kopp ZS, Kelleher CJ, Trocio J: Goal attainment scaling in patients with lower urinary tract symptoms: development and pilot testing of the Self-Assessment Goal Achievement (SAGA) questionnaire. Int Urogynecol J Pelvic Floor Dysfunct 2011.
  • [17]McCormick MC, Workman-Daniels K, Brooks-Gunn J, Peckham GJ: When you're only a phone call away: a comparison of the information in telephone and face-to-face interviews. J Dev Behav Pediatr 1993, 14(4):250-255.
  • [18]Pettigrew LE, Wilson JT, Teasdale GM: Reliability of ratings on the Glasgow Outcome Scales from in-person and telephone structured interviews. J Head Trauma Rehabil 2003, 18(3):252-258.
  • [19]McKown S, Abraham L, Coyne K, Gawlicki M, Piault E, Vats V: Linguistic validation of the N-QOL (ICIQ), OAB-q (ICIQ), PPBC, OAB-S and ICIQ-MLUTSsex questionnaires in 16 languages. Int J Clin Pract 2010, 64:1643-1652.
  • [20]Kiresuk T, Sherman R: Goal attainment scaling: a general method of evaluating comprehensive community mental health programs. Community Ment Health J 1968, 4:443-453.
  文献评价指标  
  下载次数:6次 浏览次数:9次