메뉴 건너뛰기




Volumn 11, Issue 3, 2008, Pages 509-521

Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials

Author keywords

Clinical trials; Cross cultural research; Health related quality of life; Patient reported outcomes; PRO questionnaires; Review; Translation issues

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CROSS-CULTURAL RESEARCH; CULTURAL FACTOR; FOOD AND DRUG ADMINISTRATION; LANGUAGE; METHODOLOGY; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; SELF REPORT;

EID: 44049102537     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2007.00292.x     Document Type: Article
Times cited : (509)

References (61)
  • 1
    • 0028772623 scopus 로고
    • Prevalence of disability and associated health conditions—United States, 1991–1992
    • CDC Prevalence of disability and associated health conditions—United States, 1991–1992 MMWR 43 1994 730 737
    • (1994) MMWR , vol.43 , pp. 730-737
    • CDC1
  • 2
    • 85119769856 scopus 로고    scopus 로고
    • CDC Chronic Disease Prevention The Burden of Chronic Diseases and Their Risk Factor—National and State Perspectives 2002 Department of Health and Human Services Atlanta, GA
    • (2002)
    • CDC Chronic Disease Prevention1
  • 3
    • 0031809631 scopus 로고    scopus 로고
    • The importance of patient empowerment in health system reform
    • L Segal The importance of patient empowerment in health system reform Health Policy 44 1998 31 44
    • (1998) Health Policy , vol.44 , pp. 31-44
    • Segal, L1
  • 4
    • 0035005467 scopus 로고    scopus 로고
    • The role of e-health and consumer health informatics for evidence-based patient choice in the 21st century
    • G Eysenbach TL Diepgen The role of e-health and consumer health informatics for evidence-based patient choice in the 21st century Clin Dermatol 19 2001 11 17
    • (2001) Clin Dermatol , vol.19 , pp. 11-17
    • Eysenbach, G1    Diepgen, TL2
  • 5
    • 0035123067 scopus 로고    scopus 로고
    • E-health: transforming the physician/patient relationship
    • MJ Ball J Lillis E-health: transforming the physician/patient relationship Int J Med Inf 61 2001 1 10
    • (2001) Int J Med Inf , vol.61 , pp. 1-10
    • Ball, MJ1    Lillis, J2
  • 6
    • 0033630073 scopus 로고    scopus 로고
    • The digital transformation of health care
    • RC Coile Jr. The digital transformation of health care Physician Exec 26 2000 8 15
    • (2000) Physician Exec , vol.26 , pp. 8-15
    • Coile, RC1
  • 7
    • 0342656981 scopus 로고    scopus 로고
    • E-health: reinventing healthcare in the information age
    • RC Coile Jr. E-health: reinventing healthcare in the information age J Healthc Manag 45 2000 206 210
    • (2000) J Healthc Manag , vol.45 , pp. 206-210
    • Coile, RC1
  • 8
    • 34447541034 scopus 로고    scopus 로고
    • Concept of health-related quality of life and of patient-reported outcomes
    • D Patrick Concept of health-related quality of life and of patient-reported outcomes O Chassany C Caulin Health-Related Quality of Life and Patient-Reported Outcomes: Scientific and Useful Criteria 2002 Springer Paris
    • (2002)
    • Patrick, D1
  • 9
    • 85119740519 scopus 로고    scopus 로고
    • 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 2006 EMEA London
    • (2006)
  • 10
    • 85119772825 scopus 로고    scopus 로고
    • Draft Guidance for Industry Patient-Reported Outcomes Measures: Use in Medical Product Development to Support Labeling Claims. 2006D-0044 2006 FDA Federal Register Rockville, MD
    • (2006)
    • Draft Guidance for Industry1
  • 11
    • 84888173353 scopus 로고    scopus 로고
    • 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
    • O Chassany P Sagnier P Marquis 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 36 2001 209 238
    • (2001) DIA J , vol.36 , pp. 209-238
    • Chassany, O1    Sagnier, P2    Marquis, P3    for the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group4
  • 12
    • 0027729428 scopus 로고
    • Developing and evaluating cross-cultural instruments from minimum requirements to optimal models
    • M Bullinger R Anderson D Cella N Aaronson Developing and evaluating cross-cultural instruments from minimum requirements to optimal models Qual Life Res 2 1993 451 459
    • (1993) Qual Life Res , vol.2 , pp. 451-459
    • Bullinger, M1    Anderson, R2    Cella, D3    Aaronson, N4
  • 13
    • 0001242887 scopus 로고    scopus 로고
    • Language and translation issues
    • C Acquadro B Jambon D Ellis P Marquis Language and translation issues B Spilker Quality of Life and Pharmacoeconomics in Clinical Trials 2nd ed. 1996 Lippincott-Raven Publishers Philadelphia, PA
    • (1996)
    • Acquadro, C1    Jambon, B2    Ellis, D3    Marquis, P4
  • 14
    • 0001773365 scopus 로고
    • Translation of health status instruments
    • N Sartorius W Kuyken Translation of health status instruments J Orley W Kuyken Quality of Life Assesment: International Perspectives 1994 Springer Verlag Berlin Heidelberg
    • (1994)
    • Sartorius, N1    Kuyken, W2
  • 15
    • 0023938295 scopus 로고
    • Developing instruments for cross-cultural psychiatric research
    • JA Flaherty FM Gaviria D Pathak Developing instruments for cross-cultural psychiatric research J Nerv Ment Dis 176 1988 257 263
    • (1988) J Nerv Ment Dis , vol.176 , pp. 257-263
    • Flaherty, JA1    Gaviria, FM2    Pathak, D3
  • 16
    • 0030744340 scopus 로고    scopus 로고
    • Equivalence and the translation and adaptation of health-related quality of life questionnaires
    • M Herdman J Fox-Rushby X Badia Equivalence and the translation and adaptation of health-related quality of life questionnaires Qual Life Res 6 1997 237 247
    • (1997) Qual Life Res , vol.6 , pp. 237-247
    • Herdman, M1    Fox-Rushby, J2    Badia, X3
  • 17
    • 0031957008 scopus 로고    scopus 로고
    • A model of equivalence in the cultural adaptation of HRQL instruments: the universalist approach
    • M Herdman J Fox-Rushby X Badia A model of equivalence in the cultural adaptation of HRQL instruments: the universalist approach Qual Life Res 7 1998 323 335
    • (1998) Qual Life Res , vol.7 , pp. 323-335
    • Herdman, M1    Fox-Rushby, J2    Badia, X3
  • 18
    • 84970331544 scopus 로고
    • Measurement in cross-cultural psychology. A review and comparison of strategies
    • CH Hui HC Triandis Measurement in cross-cultural psychology. A review and comparison of strategies J Cross Cult Psychol 16 1985 131 152
    • (1985) J Cross Cult Psychol , vol.16 , pp. 131-152
    • Hui, CH1    Triandis, HC2
  • 19
    • 0034268666 scopus 로고    scopus 로고
    • Health-Related Quality of Life assessments in diverse population groups in the United States
    • AL Stewart A Napoles-Springer Health-Related Quality of Life assessments in diverse population groups in the United States Med Care 38 2000 102 124
    • (2000) Med Care , vol.38 , pp. 102-124
    • Stewart, AL1    Napoles-Springer, A2
  • 20
    • 85119739740 scopus 로고    scopus 로고
    • The Information Resources Centre of Mapi Research Institute
    • MP Emery The Information Resources Centre of Mapi Research Institute Quality of Life Newsletter 23 1999 9
    • (1999) Quality of Life Newsletter , vol.23 , pp. 9
    • Emery, MP1
  • 21
    • 0034671451 scopus 로고    scopus 로고
    • Guidelines for the process of cross-cultural adaptation of self-report measures
    • DE Beaton C Bombardier F Guillemin MB Ferraz Guidelines for the process of cross-cultural adaptation of self-report measures Spine 25 2000 3186 3191
    • (2000) Spine , vol.25 , pp. 3186-3191
    • Beaton, DE1    Bombardier, C2    Guillemin, F3    Ferraz, MB4
  • 22
    • 0027731119 scopus 로고
    • Cross-cultural adaptation of Health-Related Quality of Life measures: literature review and proposed guidelines
    • F Guillemin C Bombardier D Beaton Cross-cultural adaptation of Health-Related Quality of Life measures: literature review and proposed guidelines J Clin Epidemiol 46 1993 1417 1432
    • (1993) J Clin Epidemiol , vol.46 , pp. 1417-1432
    • Guillemin, F1    Bombardier, C2    Beaton, D3
  • 24
    • 85119727178 scopus 로고    scopus 로고
    • The EuroQol Group Draft guidelines for cultural adaptations of EQ-5D 2000 EuroQuol Group Rotterdam
    • (2000)
    • The EuroQol Group1
  • 26
    • 0022494293 scopus 로고
    • Cross-cultural issues in the use of socio-medical indicators
    • SM Hunt Cross-cultural issues in the use of socio-medical indicators Health Policy 6 1986 149 158
    • (1986) Health Policy , vol.6 , pp. 149-158
    • Hunt, SM1
  • 27
    • 8944243553 scopus 로고    scopus 로고
    • Multilingual translations of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system
    • AE Bonomi DF Cella EA Hahn Multilingual translations of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system Qual Life Res 5 1996 309 320
    • (1996) Qual Life Res , vol.5 , pp. 309-320
    • Bonomi, AE1    Cella, DF2    Hahn, EA3
  • 28
    • 0032211585 scopus 로고    scopus 로고
    • Translating health status questionnaires and evaluating their quality: the IQOLA approach
    • M Bullinger A Alonso G Apolone Translating health status questionnaires and evaluating their quality: the IQOLA approach J Clin Epidemiol 51 1998 913 923
    • (1998) J Clin Epidemiol , vol.51 , pp. 913-923
    • Bullinger, M1    Alonso, A2    Apolone, G3
  • 29
    • 0029159747 scopus 로고
    • Evaluating Translations of Health Status Questionnaires. Methods from the IQOLA Project
    • JE Ware SD Keller B Gandek Evaluating Translations of Health Status Questionnaires. Methods from the IQOLA Project Int J Technol Assess Health Care 11 1995 525 551
    • (1995) Int J Technol Assess Health Care , vol.11 , pp. 525-551
    • Ware, JE1    Keller, SD2    Gandek, B3
  • 30
    • 85119780013 scopus 로고    scopus 로고
    • The Johns Hopkins University Guidelines for Translation of the Sickness Impact Profile 1996-01 The Johns Hopkins University Baltimore, MD
    • (1996)
    • The Johns Hopkins University1
  • 31
    • 85119746641 scopus 로고    scopus 로고
    • C Acquadro K Conway C Giroudet I Mear Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments 2004 Mapi Research Institute Lyon
    • (2004)
    • Acquadro, C1    Conway, K2    Giroudet, C3    Mear, I4
  • 32
    • 4243183182 scopus 로고    scopus 로고
    • Difficulties of international clinical trials: cultural adaptation of quality of life questionnaires
    • I Mear Difficulties of international clinical trials: cultural adaptation of quality of life questionnaires O Chassany C Caulin Health-Related Quality of Life and Patient-Reported Outcomes: Scientific and Useful Criteria 2002 Springer Paris
    • (2002)
    • Mear, I1
  • 33
    • 0028578020 scopus 로고
    • Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach
    • SD Mathias S Fifer DL Patrick Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach Qual Life Res 3 1994 403 412
    • (1994) Qual Life Res , vol.3 , pp. 403-412
    • Mathias, SD1    Fifer, S2    Patrick, DL3
  • 35
    • 0038680496 scopus 로고    scopus 로고
    • Translation and cultural adaptation of health questionnaires
    • A Rahman Z Iqbal W Waheed N Hussain Translation and cultural adaptation of health questionnaires J Pak Med Assoc 53 2003 142 147
    • (2003) J Pak Med Assoc , vol.53 , pp. 142-147
    • Rahman, A1    Iqbal, Z2    Waheed, W3    Hussain, N4
  • 36
    • 0346101530 scopus 로고    scopus 로고
    • Translation and validation of study instruments for cross-cultural research
    • AD Sperber Translation and validation of study instruments for cross-cultural research Gastroenterology 126 Suppl. 1 2004 S124 S128
    • (2004) Gastroenterology , vol.126 , Issue.Suppl. 1 , pp. S124-S128
    • Sperber, AD1
  • 37
    • 0001935406 scopus 로고
    • Cross-cultural measurement of anxiety
    • CD Spielberger S Sharma Cross-cultural measurement of anxiety CD Spielberger R Diaz-Guerrero Cross-Cultural Anxiety 1976 Hemisphere Pub Washington
    • (1976)
    • Spielberger, CD1    Sharma, S2
  • 38
    • 6344253013 scopus 로고    scopus 로고
    • Adapting quality of life instruments
    • A Swaine-Verdier LC Doward P Hagell Adapting quality of life instruments Value Health 7 Suppl. 1 2004 S27 S30
    • (2004) Value Health , vol.7 , Issue.Suppl. 1 , pp. S27-S30
    • Swaine-Verdier, A1    Doward, LC2    Hagell, P3
  • 39
    • 0036236559 scopus 로고    scopus 로고
    • Advancing cross-cultural research on quality of life: observations drawn from the WHOQOL development
    • SM Skevington Advancing cross-cultural research on quality of life: observations drawn from the WHOQOL development Qual Life Res 11 2002 135 144
    • (2002) Qual Life Res , vol.11 , pp. 135-144
    • Skevington, SM1
  • 40
    • 0027745905 scopus 로고
    • Critical review of the international assessments of health-related quality of life
    • RT Anderson NK Aaronson D Wilkin Critical review of the international assessments of health-related quality of life Qual Life Res 2 1993 369 395
    • (1993) Qual Life Res , vol.2 , pp. 369-395
    • Anderson, RT1    Aaronson, NK2    Wilkin, D3
  • 41
    • 0029788659 scopus 로고    scopus 로고
    • A review of the progress towards developing health related quality of life instruments for international clinical studies and outcomes research
    • RT Anderson NK Aaronson M Bullinger WL McBee A review of the progress towards developing health related quality of life instruments for international clinical studies and outcomes research Pharmacoeconomics 10 1996 336 355
    • (1996) Pharmacoeconomics , vol.10 , pp. 336-355
    • Anderson, RT1    Aaronson, NK2    Bullinger, M3    McBee, WL4
  • 42
    • 0028106299 scopus 로고
    • Evaluating health-related quality of life measures for cross-national research
    • R Berzon S Shumaker Evaluating health-related quality of life measures for cross-national research DIA J 28 1994 63 67
    • (1994) DIA J , vol.28 , pp. 63-67
    • Berzon, R1    Shumaker, S2
  • 43
    • 0041667813 scopus 로고    scopus 로고
    • 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
    • A Bowden JA Fox-Rushby 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 57 2003 1289 1306
    • (2003) Soc Sci Med , vol.57 , pp. 1289-1306
    • Bowden, A1    Fox-Rushby, JA2
  • 44
    • 84965932242 scopus 로고
    • Backtranslation for cross-cultural research
    • RW Brislin Backtranslation for cross-cultural research J Cross Cult psychol 1 1970 185 216
    • (1970) J Cross Cult psychol , vol.1 , pp. 185-216
    • Brislin, RW1
  • 45
    • 0009736701 scopus 로고
    • Questionnaire wording and translation
    • RW Brislin Questionnaire wording and translation WJ Lonner RM Thorndike Cultural Research Methods 1973 John Wiley New York
    • (1973)
    • Brislin, RW1
  • 46
    • 38149131000 scopus 로고
    • The wording and translation of research instruments
    • RW Brislin The wording and translation of research instruments WJ Lonner JW Berry Field Methods in Cross-Cultural Methods 1986 Sage Beverly Hills, CA
    • (1986)
    • Brislin, RW1
  • 47
    • 0000655310 scopus 로고    scopus 로고
    • Creating and evaluating cross-cultural instruments
    • M Bullinger MJ Power NK Aaronson Creating and evaluating cross-cultural instruments B Spilker Quality of Life and Pharmacoeconomics in Clinical Trials 2nd ed. 1996 Lippincott-Raven Publishers Philadelphia, PA
    • (1996)
    • Bullinger, M1    Power, MJ2    Aaronson, NK3
  • 48
    • 0037311121 scopus 로고    scopus 로고
    • Translation and cultural adaptation of quality of life questionnaires: an evaluation of methodology
    • M Falcao Dda RM Ciconelli MB Ferraz Translation and cultural adaptation of quality of life questionnaires: an evaluation of methodology J Rheumatol 30 2003 379 385
    • (2003) J Rheumatol , vol.30 , pp. 379-385
    • Falcao Dda, M1    Ciconelli, RM2    Ferraz, MB3
  • 49
    • 0027769756 scopus 로고
    • The philosophy of health-related quality of life translation
    • GH Guyatt The philosophy of health-related quality of life translation Qual Life Res 2 1993 461 465
    • (1993) Qual Life Res , vol.2 , pp. 461-465
    • Guyatt, GH1
  • 50
    • 3042628307 scopus 로고    scopus 로고
    • Self report in clinical and epidemiological studies with non-English speakers: the challenge of language and culture
    • SM Hunt R Bhopal Self report in clinical and epidemiological studies with non-English speakers: the challenge of language and culture J Epidemiol Community Health 58 2004 618 622
    • (2004) J Epidemiol Community Health , vol.58 , pp. 618-622
    • Hunt, SM1    Bhopal, R2
  • 51
    • 17144368376 scopus 로고    scopus 로고
    • Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research
    • WR Lenderking Comments on the ISPOR Task Force Report on Translation and Adaptation of Outcomes Measures: guidelines and the need for more research Value Health 8 2005 92 93
    • (2005) Value Health , vol.8 , pp. 92-93
    • Lenderking, WR1
  • 52
    • 0001796878 scopus 로고
    • The adaptation of health status measures: methodological aspects of the translation procedure
    • A Leplège A Verdier The adaptation of health status measures: methodological aspects of the translation procedure SA Shumaker R Berzon The International Assessment of Health-Related Quality of Life: Theory, Translation, Measurement & Analysis 1995 Rapid Communications Oxford New York
    • (1995)
    • Leplège, A1    Verdier, A2
  • 53
    • 4944248626 scopus 로고    scopus 로고
    • Instrument translation process: a methods review
    • W Maneesriwongul JK Dixon Instrument translation process: a methods review J Adv Nurs 48 2004 175 186
    • (2004) J Adv Nurs , vol.48 , pp. 175-186
    • Maneesriwongul, W1    Dixon, JK2
  • 54
    • 17144404139 scopus 로고    scopus 로고
    • The translation and cultural adaptation of patient-reported outcome measures
    • SP McKenna LC Doward The translation and cultural adaptation of patient-reported outcome measures Value Health 8 2005 89 91
    • (2005) Value Health , vol.8 , pp. 89-91
    • McKenna, SP1    Doward, LC2
  • 55
    • 0344980153 scopus 로고    scopus 로고
    • Cross-cultural adaptation of a psychometric instrument: two methods compared
    • TV Perneger A Leplège JF Etter Cross-cultural adaptation of a psychometric instrument: two methods compared J Clin Epidemiol 5 1999 1037 1046
    • (1999) J Clin Epidemiol , vol.5 , pp. 1037-1046
    • Perneger, TV1    Leplège, A2    Etter, JF3
  • 56
    • 0037388896 scopus 로고    scopus 로고
    • Current issues in cross-cultural quality of life instrument development
    • S Schmidt M Bullinger Current issues in cross-cultural quality of life instrument development Arch Phys Med Rehabil 84 Suppl. 2 2003 S29 S34
    • (2003) Arch Phys Med Rehabil , vol.84 , Issue.Suppl. 2 , pp. S29-S34
    • Schmidt, S1    Bullinger, M2
  • 57
    • 17144423549 scopus 로고    scopus 로고
    • 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
    • D Wild A Grove M Martin 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 8 2005 94 104
    • (2005) Value Health , vol.8 , pp. 94-104
    • Wild, D1    Grove, A2    Martin, M3
  • 58
    • 0027934984 scopus 로고
    • A new theoretical approach to the measurement of quality of life
    • SP McKenna A new theoretical approach to the measurement of quality of life Drug Inf J 28 1994 13 18
    • (1994) Drug Inf J , vol.28 , pp. 13-18
    • McKenna, SP1
  • 59
    • 6344282674 scopus 로고    scopus 로고
    • The needs-based approach to quality of life assessment
    • SP McKenna LC Doward The needs-based approach to quality of life assessment Value Health 7 Suppl. 1 2004 S1 S3
    • (2004) Value Health , vol.7 , Issue.Suppl. 1 , pp. S1-S3
    • McKenna, SP1    Doward, LC2
  • 60
    • 0002635020 scopus 로고
    • Perspectives on differential item functioning methodology
    • WH Angoff Perspectives on differential item functioning methodology PW Holland H Wainer Differential Item Functioning 1993 Lawrence Erlbaum Hillsdale, NJ
    • (1993)
    • Angoff, WH1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.