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 in Health - Tập 12 - Trang 430-440 - 2009
Diane Wild1, Sonya Eremenco2, Isabelle Mear3, Mona Martin4, Caroline Houchin1, Mary Gawlicki5, Asha Hareendran6, Ingela Wiklund7, Lee Yee Chong8, Robyn von Maltzahn1, Lawrence Cohen9, Elizabeth Molsen10
1Oxford Outcomes Ltd, Oxford, UK
2United BioSource Corporation, Bethesda, MD, USA
3Mapi Research Institute, Lyon, France
4Health Research Associates, Inc., Mountlake Terrace, WA, USA
5Corporate Translations, Inc., Harford, CT, USA
6Global Outcomes Research, Pfizer Ltd, Sandwich, UK
7Global Health Outcomes, GlaxoSmithKline, Middlesex, UK
8Formerly at AHP Research Ltd, Middlesex, UK
9Washington State University, Spokane, WA, USA
10International Society for Pharmacoeconomics & Outcomes Research (ISPOR), Lawrenceville, NJ, USA

Tài liệu tham khảo

Wild, 2005, ISPOR principles of good practice: the cross-cultural adaptation process for patient reported, Value Health, 8, 94, 10.1111/j.1524-4733.2005.04054.x Acquadro, 2008, Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials, Value Health, 11, 509, 10.1111/j.1524-4733.2007.00292.x Eremenco, 2005, A comprehensive method for the translation and cross-cultural validation of health status questionnaires, Eval Health Prof, 28, 212, 10.1177/0163278705275342 Bonomi, 1996, Multilingual translation of the functional assessment of cancer therapy (FACT) quality of life measurement system, Qual Life Res, 5, 309, 10.1007/BF00433915 Cella, 1998, Spanish language translation and initial validation of the functional assessment of cancer therapy quality-of-life instrument, Med Care, 36, 1407, 10.1097/00005650-199809000-00012 Koller, 2007, Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach, Eur J Cancer, 43, 1810, 10.1016/j.ejca.2007.05.029 Hunt, 1991, Cross-cultural adaptation of health measures. European Group for Health Management and Quality of Life Assessment, Health Policy, 19, 33, 10.1016/0168-8510(91)90072-6 Thumboo, 2002, The equivalence of English and Chinese SF-36 versions in bilingual Singapore Chinese, Qual Life Res, 11, 495, 10.1023/A:1015680029998 Rungtusanatham, 2008, Pooling data across transparently different groups of key informants: measurement equivalence and survey research, Decis Sci, 39, 115, 10.1111/j.1540-5915.2008.00184.x Mark, 2005, Testing measurement equivalence in a patient satisfaction instrument, West J Nurs Res, 27, 772, 10.1177/0193945905276336 Luo, 2003, Do English and Chinese EQ-5D versions demonstrate measurement equivalence? An exploratory study, Health Qual Life Outcomes, 1, 7, 10.1186/1477-7525-1-7 Maneesriwongul, 2004, Instrument translation process: a methods review, J Adv Nurs, 48, 175, 10.1111/j.1365-2648.2004.03185.x Horn, 1992, A practical and theoretical guide to measurement invariance in aging research, Exp Aging Res, 1, 117, 10.1080/03610739208253916 Mullen, 1995, Diagnosing measurement equivalence in cross-national research, J Int Bus Stud, 26, 573, 10.1057/palgrave.jibs.8490187 Davies S, Little IS, Ross R. Ensuring the measurement equivalence and appropriate use of personality assessments across cultures. Paper presented at the Annual Meeting of the Society for Industrial-Organizational Psychology, May 2006, Dallas. Scott Lennox, 1995, Reliability and validity of French, German, Italian, Dutch, and UK English translations of the Medical Outcomes Study HIV Health Survey, Med Care Stahl, 2003, Health-related quality of life in asthma studies. Can we combine data from different countries?, Pulm Pharmaco Ther, 16, 53, 10.1016/S1094-5539(02)00171-2 Smith, 1991, Psychometric equivalence of a translated circadian rhythm questionnaire: implications for between- and within- population assessments, J Applied Psycho, 76, 628, 10.1037/0021-9010.76.5.628 Wee, 2007, Factor Structure of the Singapore English version of the KINDL Children Quality of Life Questionnaire, Health Qual Life Outcomes, 10.1186/1477-7525-5-4 Timmerman, 1996, Structural comparison of a translated dental attitude questionnaire: a factor analytic study, Community Dent Oral Epidemiol, 24, 236, 10.1111/j.1600-0528.1996.tb00851.x Poirier, 2004, A factor analysis of the Strauss and Carpenter revised outcome criteria scale: a validation of the French translation, J Nerv Ment Dis, 192, 864, 10.1097/01.nmd.0000146880.91895.50 Vandenberg, 2000, A review and synthesis of the measurement invariance literature: suggestions, practices, and recommendations for organizational research, Organ Res Methods, 4, 10.1177/109442810031002 Scott, 2006, Comparing translations of the EORTC QLQ-C30 using differential item functioning, Qual Life Res, 1103, 10.1007/s11136-006-0040-x Pagano, 2005, Ethnic differential item functioning in the assessment of quality of life in cancer patients, Health Qual Life Outcomes, 3, 60, 10.1186/1477-7525-3-60 Harvey, 2002, Cross-national cognitive assessment in schizophrenia clinical trials: a feasibility study, Schizophr Res, 59, 243, 10.1016/S0920-9964(02)00153-6 Patrick, 2007, Patient-reported outcomes to support medical product labelling claims: FDA perspective, Value Health, 10, S125, 10.1111/j.1524-4733.2007.00275.x Lenderking, 2005, Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research, Value Health, 8, 92, 10.1111/j.1524-4733.2005.08201.x