Emerging good practices for translatability assessment (TA) of patient-reported outcome (PRO) measures

被引:39
作者
Acquadro C. [1 ]
Patrick D.L. [2 ]
Eremenco S. [3 ]
Martin M.L. [4 ]
Kuliś D. [5 ]
Correia H. [6 ]
Conway K. [1 ]
机构
[1] Mapi Research Trust, 27 rue de la Villette, Lyon
[2] University of Washington, Seattle, WA
[3] Critical Path Institute, Tucson, AZ
[4] Health Research Associates, Mountlake Terrace, WA
[5] EORTC, Brussels
[6] Northwestern University Feinberg School of Medicine, Chicago, IL
关键词
Clinical outcomes assessments; Cultural adaptation; Instrument development; Linguistic validation; Patient-reported outcomes; Translatability assessment; Translation;
D O I
10.1186/s41687-018-0035-8
中图分类号
学科分类号
摘要
This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs. © The Author(s).
引用
收藏
相关论文
共 34 条
[1]  
Getz K.A., Global Clinical Trials Activity in the Details, (2007)
[2]  
Glickman S.W., McHutchison J.G., Peterson E.D., Cairns C.B., Harrington R.A., Califf R.M., Et al., Ethical and scientific implications of the globalization of clinical research, N Engl J Med, 360, pp. 816-823, (2009)
[3]  
Rehnquist J., Department of Health and Human Services, Office of Inspector General, (2001)
[4]  
Wild D., Grove A., Martin M., Eremenco S., McElroy S., Verjee-Lorenz A., ISPOR Task Force for Translation and Cultural Adaptation, et al. (2015). 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, pp. 94-104
[5]  
Wild D., Eremenco S., Mear I., Martin M., Houchin C., Gawlicki M., 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, 12, pp. 430-440, (2009)
[6]  
Bullinger M., Power M.J., Aaronson N.K., Cella D.F., Anderson R.T., Creating and evaluating cross-cultural instruments, Quality of Life and Pharmacoeconomics in Clinical Trials, pp. 659-668, (1996)
[7]  
Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims, Fed Regist, 74, 35, pp. 65132-65133, (2009)
[8]  
Acquadro C., Conway K., Hareendran A., Aaronson N.K., Literature review of methods to translate health-related quality of life (HRQL) questionnaires for use in multinational clinical trials, Value Health, 11, pp. 509-521, (2008)
[9]  
Conway K., Translatability assessment, Linguistic Validation Manual for Health Outcome Assessments, pp. 127-132, (2012)
[10]  
Conway K., Acquadro C., Patrick D.L., Usefulness of translatability assessment: Results from a retrospective study, Qual Life Res, 23, pp. 1199-1210, (2014)