References
- Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nat. Rev. Drug Discovery7, 13–14 (2008).
- Two R, Verjee-Lorenz A, Clayson D, Dalal M, Grotzinger K, Younossi ZM. A methodology for successfully producing global translations of patient reported outcome measures for use in multiple countries. Value Health13(1), 128–131 (2009).
- Kuliś D, Arnott M, Greimel E, Bottomley A, Koller M. Trends in translation requests and arising issues regarding cultural adaptation. Expert Rev. of Pharmacoeconomics Outcomes Res.11(3), 307–314 (2011).
- Tavares MG, Pizzichini MM, Steidle LJ et al. The Asthma Control Scoring System: translation and cross-cultural adaptation for use in Brazil. J. Bras. Pneumol.36(6), 683–692 (2010).
- Koller, M. [Contributions of social psychology to the analysis and solution of problems in the German health care system. The example of practice guidelines]. Zeitschrift für Sozialpsychologie36, 47–60 (2005).
- Delbecq AL, Van de Ven AH, Gustafson DH. Group Techniques for Program Planning. Scott, Foresman and Company, IL, USA (1975).
- Moscovici S. Toward a theory of conversion behavior. In: Advances in Experimental Social Psychology. Berkowitz L (Ed.). New York: Academic Press, NY, USA (1980).
- Steiner ID. Group Processes and Productivity. Academic Press, NY, USA (1972).
- Cull A, Sprangers M, Bjordal K, Aaronson N. EORTC Quality of Life Study Group Translation Procedure (Second Edition). EORTC, Brussels, Belgium (1998).
- Bonomi AE, Cella DF, Hahn EA et al. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual. Life Res.5, 309–320 (1996).
- Beaton DE, Bombardier C, Guillemin F, Bosi Ferraz M. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine25(24), 3186–3191 (2000).
- Guillemin F, Bombardier C, Beaton DE. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J. Clin. Epidemiol.46(12), 1417–1432 (1993).
- Szecket N, Medin G, Furlong WJ, Feeny DH, Barr RD, Depauw S. Preliminary translation and cultural adaptation of health utilities index questionnaires for application in Argentina. Int. J. Cancer12, 119–124 (1999).
- 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 Health8(2), 94–104 (2005).
- Bullinger M, Alonso J, Apolone G et al. Translating health status questionnaires and evaluating their quality: the IQOLA project approach. J. Clin. Epidemiol.51(11), 913–923 (1998).
- Acquadro C, Conway K, Giroudet C, Mear I. Linguistic Validation Manual for Patient-Reported Outcomes (PRO) Instruments. Mapi Research Institute, Lyon, France (2004).
- Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual. Life Res.11, 193–205 (2002).
- Sartorius N, Kuyken W. Translation of health status instruments. In: Quality of Life Assessment: International Perspectives. Orley J, Kuyken W (Eds). Springer Berlin Heidelberg, Berlin, Germany (1994).
- Hambleton RK, Patsula L. Increasing the validity of adapted tests: myths to be avoided and guidelines for improving test adaptation practices J. Appl. Test. Technol.1, 1–30 (1999).
- EuroQol Group. Translation Guidelines for the EQ-5D Developed by the EuroQol Group. EuroQol Group, Rotterdam, The Netherlands (2003).
- Eremenco SL, Cella D, Arnold BJ. A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Eval. Health Prof.28(2), 212–232 (2005).
- Dewolf L, Koller M, Velikova G, Johnson C, Scott N, Bottomley A. EORTC Quality of Life Group Translation Procedure (Third Edition). EORTC, Brussels, Belgium (2009).
- Barofsky I. Quality. Its Definition and Measurement as Applied to the Medically Ill. Springer, NY, USA (2012).
Websites
- FDA & US Department of Health and Human Services. Guidance for Industry. Patient-reported outcome measures: use in medical product development to support labelling claims (2009). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf
- EMEA. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products (2005). www.emea.europa.eu/pdfs/human/ewp/13939104en.pdf
- Gawlicki M. Procedures for linguistic validation of health status questionnaires. http://corptransinc.com/images/sidebar_pdfs/Procedures_for_the_LV.pdf
- Health Outcome Group. Questionnaire Translation and Linguistic Validation Outcomes Group. www.healthoutcomesgroup.com/translation.html
- Merkus MP, Dekker FW. KDQOL™: Translations. www.gim.med.ucla.edu/kdqol/page8.html