• 1
    CDC. Prevalence of disability and associated health conditions—United States, 1991–1992. MMWR 1994;43:7307.
  • 2
    CDC Chronic Disease Prevention. The Burden of Chronic Diseases and Their Risk Factor—National and State Perspectives. Atlanta, GA: Department of Health and Human Services, 2002.
  • 3
    Segal L. The importance of patient empowerment in health system reform. Health Policy 1998;44:3144.
  • 4
    Eysenbach G, Diepgen TL. The role of e-health and consumer health informatics for evidence-based patient choice in the 21st century. Clin Dermatol 2001;19:1117.
  • 5
    Ball MJ, Lillis J. E-health: transforming the physician/patient relationship. Int J Med Inf 2001;61:110.
  • 6
    Coile RC Jr. The digital transformation of health care. Physician Exec 2000;26:815.
  • 7
    Coile RC Jr. E-health: reinventing healthcare in the information age. J Healthc Manag 2000;45:20610.
  • 8
    Patrick D. Concept of health-related quality of life and of patient-reported outcomes. In: ChassanyO, CaulinC, eds. Health-Related Quality of Life and Patient-Reported Outcomes: Scientific and Useful Criteria. Paris: Springer, 2002.
  • 9
    EMEA/CHMP/EWP/139391/2004. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. London: EMEA, 2006.
  • 10
    Draft Guidance for Industry. Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. Docket 2006D-0044, Rockville, MD: FDA Federal Register, 2006.
  • 11
    Chassany O, Sagnier P, Marquis P, et al., for the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group. Patient-reported outcomes: the example of Health-Related Quality of Life – a European guidance document for the improved integration of Health-Related Quality of Life assessment in the drug approval process. DIA J 2001;36:20938.
  • 12
    Bullinger M, Anderson R, Cella D, Aaronson N. Developing and evaluating cross-cultural instruments from minimum requirements to optimal models. Qual Life Res 1993;2:4519.
  • 13
    Acquadro C, Jambon B, Ellis D, Marquis P. Language and translation issues. In: SpilkerB, ed. Quality of Life and Pharmacoeconomics in Clinical Trials (2nd ed.). Philadelphia, PA: Lippincott-Raven Publishers, 1996.
  • 14
    Sartorius N, Kuyken W. Translation of health status instruments. In: OrleyJ, KuykenW, eds. Quality of Life Assesment: International Perspectives. Berlin Heidelberg: Springer Verlag, 1994.
  • 15
    Flaherty JA, Gaviria FM, Pathak D, et al. Developing instruments for cross-cultural psychiatric research. J Nerv Ment Dis 1988;176:25763.
  • 16
    Herdman M, Fox-Rushby J, Badia X. Equivalence and the translation and adaptation of health-related quality of life questionnaires. Qual Life Res 1997;6:23747.
  • 17
    Herdman M, Fox-Rushby J, Badia X. A model of equivalence in the cultural adaptation of HRQL instruments: the universalist approach. Qual Life Res 1998;7:32335.
  • 18
    Hui CH, Triandis HC. Measurement in cross-cultural psychology. A review and comparison of strategies. J Cross Cult Psychol 1985;16:13152.
  • 19
    Stewart AL, Napoles-Springer A. Health-Related Quality of Life assessments in diverse population groups in the United States. Med Care 2000;38:10224.
  • 20
    Emery MP. The Information Resources Centre of Mapi Research Institute. Quality of Life Newsletter 1999;23:9.
  • 21
    Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 2000;25:318691.
  • 22
    Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of Health-Related Quality of Life measures: literature review and proposed guidelines. J Clin Epidemiol 1993;46:141732.
  • 23
    Cull A, Sprangers M, Bjordal K, on behalf of the EORTC Quality of Life Group. EORTC Quality of Life Group translation procedure. Brussels: EORTC Publications, 2002.
  • 24
    The EuroQol Group. Draft guidelines for cultural adaptations of EQ-5D. Rotterdam: EuroQuol Group, 2000.
  • 25
    European Group for Health Measurement and Quality of Life Assessment. Cross-cultural adaptation of health measures. Health Policy 1991;19:3344.
  • 26
    Hunt SM. Cross-cultural issues in the use of socio-medical indicators. Health Policy 1986;6:14958.
  • 27
    Bonomi AE, Cella DF, Hahn EA, et al. Multilingual translations of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res 1996;5:30920.
  • 28
    Bullinger M, Alonso A, Apolone G, et al. Translating health status questionnaires and evaluating their quality: the IQOLA approach. J Clin Epidemiol 1998;51:91323.
  • 29
    Ware JE, Keller SD, Gandek B, et al. Evaluating Translations of Health Status Questionnaires. Methods from the IQOLA Project. Int J Technol Assess Health Care 1995;11:52551.
  • 30
    The Johns Hopkins University. Guidelines for Translation of the Sickness Impact Profile. Baltimore, MD: The Johns Hopkins University, January 1996.
  • 31
    Acquadro C, Conway K, Giroudet C, Mear I. Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments. Lyon: Mapi Research Institute, 2004.
  • 32
    Mear I. Difficulties of international clinical trials: cultural adaptation of quality of life questionnaires. In: ChassanyO, CaulinC, eds. Health-Related Quality of Life and Patient-Reported Outcomes: Scientific and Useful Criteria. Paris: Springer, 2002.
  • 33
    Mathias SD, Fifer S, Patrick DL. Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach. Qual Life Res 1994;3:40312.
  • 34
    Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality of life instruments: attributes and review. Qual Life Res 2002;11:193205.
  • 35
    Rahman A, Iqbal Z, Waheed W, Hussain N. Translation and cultural adaptation of health questionnaires. J Pak Med Assoc 2003;53:1427.
  • 36
    Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology 2004;126(Suppl. 1):S1248.
  • 37
    Spielberger CD, Sharma S. Cross-cultural measurement of anxiety. In: SpielbergerCD, Diaz-GuerreroR, eds. Cross-Cultural Anxiety. Washington: Hemisphere Pub, 1976.
  • 38
    Swaine-Verdier A, Doward LC, Hagell P, et al. Adapting quality of life instruments. Value Health 2004;7(Suppl. 1):S2730.
  • 39
    Skevington SM. Advancing cross-cultural research on quality of life: observations drawn from the WHOQOL development. Qual Life Res 2002; 11:13544.
  • 40
    Anderson RT, Aaronson NK, Wilkin D. Critical review of the international assessments of health-related quality of life. Qual Life Res 1993;2:36995.
  • 41
    Anderson RT, Aaronson NK, Bullinger M, McBee WL. A review of the progress towards developing health related quality of life instruments for international clinical studies and outcomes research. Pharmacoeconomics 1996;10:33655.
  • 42
    Berzon R, Shumaker S. Evaluating health-related quality of life measures for cross-national research. DIA J 1994;28:637.
  • 43
    Bowden A, Fox-Rushby JA. A systematic and critical review of the process of translation and adaptation of generic health-related quality of life measures in Africa, Asia, Eastern Europe, the Middle East, South America. Soc Sci Med 2003;57:1289306.
  • 44
    Brislin RW. Backtranslation for cross-cultural research. J Cross Cult psychol 1970;1:185216.
  • 45
    Brislin RW. Questionnaire wording and translation. In: LonnerWJ, ThorndikeRM, eds. Cultural Research Methods. New York: John Wiley, 1973.
  • 46
    Brislin RW. The wording and translation of research instruments. In: LonnerWJ, BerryJW, eds. Field Methods in Cross-Cultural Methods. Beverly Hills, CA: Sage, 1986.
  • 47
    Bullinger M, Power MJ, Aaronson NK, et al. Creating and evaluating cross-cultural instruments. In: SpilkerB, ed. Quality of Life and Pharmacoeconomics in Clinical Trials (2nd ed.). Philadelphia, PA: Lippincott-Raven Publishers, 1996.
  • 48
    Falcao Dda M, Ciconelli RM, Ferraz MB. Translation and cultural adaptation of quality of life questionnaires: an evaluation of methodology. J Rheumatol 2003;30:37985.
  • 49
    Guyatt GH. The philosophy of health-related quality of life translation. Qual Life Res 1993;2:4615.
  • 50
    Hunt SM, Bhopal R. Self report in clinical and epidemiological studies with non-English speakers: the challenge of language and culture. J Epidemiol Community Health 2004;58:61822.
  • 51
    Lenderking WR. Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research. Value Health 2005;8:923.
  • 52
    Leplège A, Verdier A. The adaptation of health status measures: methodological aspects of the translation procedure. In: ShumakerSA, BerzonR, eds. The International Assessment of Health-Related Quality of Life: Theory, Translation, Measurement & Analysis. New York: Rapid Communications Oxford, 1995.
  • 53
    Maneesriwongul W, Dixon JK. Instrument translation process: a methods review. J Adv Nurs 2004;48:17586.
  • 54
    McKenna SP, Doward LC. The translation and cultural adaptation of patient-reported outcome measures. Value Health 2005;8:8991.
  • 55
    Perneger TV, Leplège A, Etter JF. Cross-cultural adaptation of a psychometric instrument: two methods compared. J Clin Epidemiol 1999;5:103746.
  • 56
    Schmidt S, Bullinger M. Current issues in cross-cultural quality of life instrument development. Arch Phys Med Rehabil 2003;84(Suppl. 2):S2934.
  • 57
    Wild D, Grove A, Martin M, et al. 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;8:94104.
  • 58
    McKenna SP. A new theoretical approach to the measurement of quality of life. Drug Inf J 1994;28:1318.
  • 59
    McKenna SP, Doward LC. The needs-based approach to quality of life assessment. Value Health 2004; 7(Suppl. 1):S13.
  • 60
    Angoff WH. Perspectives on differential item functioning methodology. In: HollandPW, WainerH, eds. Differential Item Functioning. Hillsdale, NJ: Lawrence Erlbaum, 1993.
  • 61
    Acquadro C, Joyce D, Lapalus L, Patrick DL. Cochrane Quality of Life Methods Group. Cochrane Methods Group Newsletter 2002;6:245.