Analyzing and advising on clinical outcome assessment measurements translation and cross-cultural adaptation_Chinese Journal of Evidence-Based Medicine

Authors：

NING Xiaoying ¹ , XU Qinyong ¹ , CHEN Yuanfang ¹ , YE Yutong ² , LIU Fengbin ³ ,  HOU Zhengkun ⁴

1. The First Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;
2. Kunshan Hospital of Integrated Traditional Chinese and Western Medicine, Suzhou 215301, P. R. China;
3. Department of Spleen and Stomach, Baiyun Branch, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;
4. Department of Spleen and Stomach Diseases, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510006, P. R. China;

Corresponding author：

HOU Zhengkun, Email: fenghou5128@126.com

Keywords：

Clinical outcome assessment; Scales; Translation; Cross-cultural adaptation; Patient-reported outcomes

DOI：

10.7507/1672-2531.202401067

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

With the transformation of modern medical models, patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes have become internationally recognized clinical outcome assessment indicators, and scales have also become important evaluation tools, among which translation and cross-cultural adaptation are one of the important sources of scales. However, at present, there are fewer guidelines for scale translation in China. At present, domestic scale translation has not yet been unified and standardized in clinical reporting. Most translation reports provide readers with incomplete information, which affects the development of scale translation, and the methodology related to the translation of clinical outcome assessment scales still focuses on patient-reported outcome scales, which creates a gap in terms of the recommendations for the rest of the types of translations, a gap which leads to inconsistencies in the translation methodology and process. In this paper, we will develop specific translation methods and processes for each of the four current types of clinical outcome assessments by combining scale translation guidelines to support a standardized approach to translation, cross-cultural adaptation, and linguistic validation for use in standardizing the process of recommending translations of patient-reported outcome scales, clinical-reported outcome scales, observer-reported outcome scales, and behavioral outcome scales.

Citation： NING Xiaoying, XU Qinyong, CHEN Yuanfang, YE Yutong, LIU Fengbin, HOU Zhengkun. Analyzing and advising on clinical outcome assessment measurements translation and cross-cultural adaptation. Chinese Journal of Evidence-Based Medicine, 2024, 24(8): 943-950. doi: 10.7507/1672-2531.202401067 Copy

1.	Walton MK, Powers JH, Hobart J, et al. Clinical outcome assessments: conceptual foundation-report of the ISPOR clinical outcomes assessment - emerging good practices for outcomes research task force. Value Health, 2015, 18(6): 741-752.
2.	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(12): 1417-1432.
3.	张琪琪, 周文哲, 林瑶瑶, 等. 简化版青光眼患者用药自我效能量表的汉化及信效度检验. 中华护理杂志, 2022, 57(15): 1914-1920.
4.	刘宁等, 刘佳, 钟竹青, 等. 2020版Basel免疫抑制药物依从性评估量表的跨文化调适及信效度检验. 护理学杂志, 2021, 36(16): 6-9.
5.	钱超, 彭幼清, 李欣琪, 等. 健康循证实践量表的汉化及文化调适研究. 护士进修杂志, 2020, 35(20): 1848-1852.
6.	张世豪, 朱亚鑫, 赖雁妮, 等. 团队发展测评量表的跨文化调适. 医学教育研究与实践, 2019, 27(2): 252-255.
7.	刘谆谆, 张兰凤, Lisa G. 癌症患者疾病获益感量表的跨文化调适. 中华护理杂志, 2015, 50(5): 561-566.
8.	Beaton DE, Bombardier C, Guillemin F, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976), 2000, 25(24): 3186-3191.
9.	方积乾. 生存质量测定方法及应用. 北京: 北京医科大学出版社, 2000.
10.	Hilton A, Skrutkowski M. Translating instruments into other languages: development and testing processes. Cancer Nurs, 2002, 25(1): 1-7.
11.	Brislin RW. Back-translation for cross-cultural research. J Cross Cult Psychol, 1970, 1(3): 185-216.
12.	Eremenco S, Pease S, Mann S, et al. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. J Patient Rep Outcomes, 2017, 2(1): 12.
13.	Mathias SD, Fifer SK, Patrick DL. Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach. Qual Life Res, 1994, 3(6): 403-412.
14.	Ware JE, Keller SD, Gandek B, et al. Evaluating translations of health status questionnaires. Methods from the IQOLA project. International quality of life assessment. Int J Technol Assess Health Care, 1995, 11(3): 525-551.
15.	Anderson RT, Aaronson NK, Bullinger M, et al. A review of the progress towards developing health-related quality-of-life instruments for international clinical studies and outcomes research. Pharmacoeconomics, 1996, 10(4): 336-355.
16.	Gandek B, Ware JE. Methods for validating and norming translations of health status questionnaires: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol, 1998, 51(11): 953-959.
17.	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(2): 94-104.
18.	Flaherty JA, Gaviria FM, Pathak D, et al. Developing instruments for cross-cultural psychiatric research. J Nerv Ment Dis, 1988, 176(5): 257-263.
19.	Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract, 2011, 17(2): 268-274.
20.	Ozturk EA, Kocer BG, Umay E, et al. Cross-cultural adaptation and psychometric evaluations of the Turkish version of Parkinson fatigue scale. Qual Life Res, 2018, 27(10): 2719-2730.
21.	Ahnfeldt-Mollerup P, Riisgaard H, Søndergaard J, et al. Cross-cultural adaptation of the medical engagement scale into Danish general practice setting. Scand J Prim Health Care, 2019, 37(2): 200-206.
22.	Silva-Neves V, Caramelo A, Alves P, et al. Translation and cross-cultural adaptation of quality of life scale in patients with onychomycosis. Int J Environ Res Public Health, 2021, 18(11): 5793.
23.	Mgbeojedo UG, Akosile CO, Ezugwu JC, et al. Cross-cultural adaptation and validation of the 15-item Geriatric Depression Scale (GDS-15) into Igbo language: a validation study. Health Qual Life Outcomes, 2022, 20(1): 22.
24.	Feghali Y, Koubaissy H, Fares Y, et al. Cross-cultural adaptation and validation of the Arabic version of the rating anxiety in dementia scale. Clin Gerontol, 2020, 43(3): 320-330.
25.	McKown S, Acquadro C, Anfray C, et al. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. J Patient Rep Outcomes, 2020, 4(1): 89.
26.	Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology, 2004, 126(1 Suppl 1): S124-S128.
27.	McKenna SP, Doward LC. The translation and cultural adaptation of patient-reported outcome measures. Value Health, 2005, 8(2): 89-91.
28.	Swaine-Verdier A, Doward LC, Hagell P, et al. Adapting quality of life instruments. Value Health, 2004, 7(Suppl 1): S27-S30.
29.	Zaragoza-Salcedo A, Oroviogoicoechea C, Saracíbar-Razquin MI, et al. The significance of exploring conceptual equivalence within the process of the cross-cultural adaptation of tools: the case of the patient's perception of feeling known by their nurses scale. J Nurs Scholarsh, 2023, 55(6): 1268-1279.
30.	Shumaker S, Berzon R. The international assessment of health-related quality of life: theory, translation, measurement and analysis. Oxford: Rapid Communication of Oxford, 1995.
31.	Wang Y, Li S, Zou X, et al. Cross-cultural adaptation and validation of the Chinese version of the loneliness scale for older adults. Geriatr Nurs, 2022, 48: 190-196.
32.	Lynn MR. Determination and quantification of content validity. Nurs Res, 1986, 35(6): 382-385.
33.	Wynd CA, Schmidt B, Schaefer MA. Two quantitative approaches for estimating content validity. West J Nurs Res, 2003, 25(5): 508-518.
34.	Borsboom D, Mellenbergh GJ, van Heerden J. The concept of validity. Psychol Rev, 2004, 111(4): 1061-1071.
35.	马文军, 潘波. 问卷的信度和效度以及如何用SAS软件分析. 中国卫生统计, 2000, (6): 45-46.
36.	Hou Z, Liu F, Tan Y, et al. Improving the reporting quality of instrument cross-cultural adaption the IRICA statement. 2021.

1. Walton MK, Powers JH, Hobart J, et al. Clinical outcome assessments: conceptual foundation-report of the ISPOR clinical outcomes assessment - emerging good practices for outcomes research task force. Value Health, 2015, 18(6): 741-752.
2. 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(12): 1417-1432.
3. 张琪琪, 周文哲, 林瑶瑶, 等. 简化版青光眼患者用药自我效能量表的汉化及信效度检验. 中华护理杂志, 2022, 57(15): 1914-1920.
4. 刘宁等, 刘佳, 钟竹青, 等. 2020版Basel免疫抑制药物依从性评估量表的跨文化调适及信效度检验. 护理学杂志, 2021, 36(16): 6-9.
5. 钱超, 彭幼清, 李欣琪, 等. 健康循证实践量表的汉化及文化调适研究. 护士进修杂志, 2020, 35(20): 1848-1852.
6. 张世豪, 朱亚鑫, 赖雁妮, 等. 团队发展测评量表的跨文化调适. 医学教育研究与实践, 2019, 27(2): 252-255.
7. 刘谆谆, 张兰凤, Lisa G. 癌症患者疾病获益感量表的跨文化调适. 中华护理杂志, 2015, 50(5): 561-566.
8. Beaton DE, Bombardier C, Guillemin F, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976), 2000, 25(24): 3186-3191.
9. 方积乾. 生存质量测定方法及应用. 北京: 北京医科大学出版社, 2000.
10. Hilton A, Skrutkowski M. Translating instruments into other languages: development and testing processes. Cancer Nurs, 2002, 25(1): 1-7.
11. Brislin RW. Back-translation for cross-cultural research. J Cross Cult Psychol, 1970, 1(3): 185-216.
12. Eremenco S, Pease S, Mann S, et al. Patient-Reported Outcome (PRO) Consortium translation process: consensus development of updated best practices. J Patient Rep Outcomes, 2017, 2(1): 12.
13. Mathias SD, Fifer SK, Patrick DL. Rapid translation of quality of life measures for international clinical trials: avoiding errors in the minimalist approach. Qual Life Res, 1994, 3(6): 403-412.
14. Ware JE, Keller SD, Gandek B, et al. Evaluating translations of health status questionnaires. Methods from the IQOLA project. International quality of life assessment. Int J Technol Assess Health Care, 1995, 11(3): 525-551.
15. Anderson RT, Aaronson NK, Bullinger M, et al. A review of the progress towards developing health-related quality-of-life instruments for international clinical studies and outcomes research. Pharmacoeconomics, 1996, 10(4): 336-355.
16. Gandek B, Ware JE. Methods for validating and norming translations of health status questionnaires: the IQOLA Project approach. International Quality of Life Assessment. J Clin Epidemiol, 1998, 51(11): 953-959.
17. 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(2): 94-104.
18. Flaherty JA, Gaviria FM, Pathak D, et al. Developing instruments for cross-cultural psychiatric research. J Nerv Ment Dis, 1988, 176(5): 257-263.
19. Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract, 2011, 17(2): 268-274.
20. Ozturk EA, Kocer BG, Umay E, et al. Cross-cultural adaptation and psychometric evaluations of the Turkish version of Parkinson fatigue scale. Qual Life Res, 2018, 27(10): 2719-2730.
21. Ahnfeldt-Mollerup P, Riisgaard H, Søndergaard J, et al. Cross-cultural adaptation of the medical engagement scale into Danish general practice setting. Scand J Prim Health Care, 2019, 37(2): 200-206.
22. Silva-Neves V, Caramelo A, Alves P, et al. Translation and cross-cultural adaptation of quality of life scale in patients with onychomycosis. Int J Environ Res Public Health, 2021, 18(11): 5793.
23. Mgbeojedo UG, Akosile CO, Ezugwu JC, et al. Cross-cultural adaptation and validation of the 15-item Geriatric Depression Scale (GDS-15) into Igbo language: a validation study. Health Qual Life Outcomes, 2022, 20(1): 22.
24. Feghali Y, Koubaissy H, Fares Y, et al. Cross-cultural adaptation and validation of the Arabic version of the rating anxiety in dementia scale. Clin Gerontol, 2020, 43(3): 320-330.
25. McKown S, Acquadro C, Anfray C, et al. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. J Patient Rep Outcomes, 2020, 4(1): 89.
26. Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology, 2004, 126(1 Suppl 1): S124-S128.
27. McKenna SP, Doward LC. The translation and cultural adaptation of patient-reported outcome measures. Value Health, 2005, 8(2): 89-91.
28. Swaine-Verdier A, Doward LC, Hagell P, et al. Adapting quality of life instruments. Value Health, 2004, 7(Suppl 1): S27-S30.
29. Zaragoza-Salcedo A, Oroviogoicoechea C, Saracíbar-Razquin MI, et al. The significance of exploring conceptual equivalence within the process of the cross-cultural adaptation of tools: the case of the patient's perception of feeling known by their nurses scale. J Nurs Scholarsh, 2023, 55(6): 1268-1279.
30. Shumaker S, Berzon R. The international assessment of health-related quality of life: theory, translation, measurement and analysis. Oxford: Rapid Communication of Oxford, 1995.
31. Wang Y, Li S, Zou X, et al. Cross-cultural adaptation and validation of the Chinese version of the loneliness scale for older adults. Geriatr Nurs, 2022, 48: 190-196.
32. Lynn MR. Determination and quantification of content validity. Nurs Res, 1986, 35(6): 382-385.
33. Wynd CA, Schmidt B, Schaefer MA. Two quantitative approaches for estimating content validity. West J Nurs Res, 2003, 25(5): 508-518.
34. Borsboom D, Mellenbergh GJ, van Heerden J. The concept of validity. Psychol Rev, 2004, 111(4): 1061-1071.
35. 马文军, 潘波. 问卷的信度和效度以及如何用SAS软件分析. 中国卫生统计, 2000, (6): 45-46.
36. Hou Z, Liu F, Tan Y, et al. Improving the reporting quality of instrument cross-cultural adaption the IRICA statement. 2021.

Chinese Journal of Evidence-Based Medicine

Analyzing and advising on clinical outcome assessment measurements translation and cross-cultural adaptation

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content