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Translation and psychometric validation of the traditional Chinese version of patient-reported outcomes measurement information system Pediatric-25 Profile version 2.0 (PROMIS-25) in Chinese Children with Cancer in Hong Kong

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Abstract

Purpose

To translate and cross-cultural validate the PROMIS Pediatric-25 Profile 2.0 (PROMIS-25) into traditional Chinese, and to investigate its psychometric properties in children with cancer in Hong Kong.

Methods

The Functional Assessment of Chronic Illness Therapy translation methodology was adopted in this study. Three panel members evaluated the semantic equivalence and content validity. The psychometric properties were tested with 103 children with cancer (10–18 years). Internal consistency and structural validity were examined by Cronbach’s alpha and Rasch analysis. Convergent and divergent validity were assessed by correlating it with traditional Chinese pediatric quality of life inventory™ 4.0 domains (traditional Chinese PedsQL™ 4.0), traditional Chinese Health Questionnaire-9 (C-PHQ-9), and the numeric pain rating scale (NPRS).

Results

The semantic equivalence score and content validity index were both 100%. All domains indicated good internal consistency (α = 0.83–0.88) and unidimensionality (variance explained > 55.5% and 1st contrast eigenvalues < 2.0). All items showed good item fit (0.6–1.4). For convergent validity, the traditional Chinese PROMIS-25 domains demonstrated moderate-to-large correlations with traditional Chinese PedsQL™ 4.0 domains (r ≥  ± 0.69), C-PHQ-9 Item-4 and total score (r = 0.75–0.80), except NPRS (r = 0.44). For divergent validity, traditional Chinese PROMIS-25 had low correlations with traditional Chinese PedsQL™ 4.0 domains (r <  ± 0.21), C-PHQ-9 item-4 (r = 0.3), and NPRS (r =  − 0.12). The traditional Chinese PROMIS-25 fatigue domain was weakly correlated with NPRS (r = 0.39).

Conclusion

The traditional Chinese PROMIS-25 is semantically and conceptually like the original PROMIS-25 with satisfactory internal consistency, structural validity, and construct validity.

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Data Availability

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References

  1. Steliarova-Foucher, E., Colombet, M., Ries, L. A., Moreno, F., Dolya, A., Bray, F., et al. (2017). International incidence of childhood cancer, 2001–10: A population-based registry study. The Lancet Oncology, 18(6), 719–731.

    PubMed  PubMed Central  Google Scholar 

  2. Hospital Authority. Top Five Cancers by Age. Hong Kong Cancer Registry. URL: http://www3.ha.org.hk/cancereg/default.asp. Accessed Mar 8 2020.

  3. McCabe, M. (2009). Fatigue in children with long-term conditions: An evolutionary concept analysis. Journal of Advanced Nursing, 65(8), 1735–1745. https://doi.org/10.1111/j.1365-2648.2009.05046.x.

    Article  PubMed  Google Scholar 

  4. Hudson, M. M., Mertens, A. C., Yasui, Y., Hobbie, W., Chen, H., Gurney, J. G., et al. (2003). Health status of adult long-term survivors of childhood cancer: A report from the Childhood Cancer Survivor Study. JAMA, 290(12), 1583–1592. https://doi.org/10.1001/jama.290.12.1583.

    Article  CAS  PubMed  Google Scholar 

  5. U.S. Food & Drug Administration. Patient-reported outcome measures: use in medical product development to support labelling claims. URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. Accessed Mar 25 2021.

  6. Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. J. P. R. O. M. (2018). The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Related Outcome Measures, 9, 353.

    PubMed  PubMed Central  Google Scholar 

  7. Au, H.-J., Ringash, J., Brundage, M., Palmer, M., Richardson, H., Meyer, R. M. J. E. R. O. P., et al. (2010). Added value of health-related quality of life measurement in cancer clinical trials: The experience of the NCIC CTG. Expert Review of Pharmacoeconomics & Outcomes Research, 10(2), 119–128.

    Google Scholar 

  8. Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., et al. (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. Lancet Oncology, 17(11), e510–e514.

    PubMed  Google Scholar 

  9. DeWalt, D. A., Rothrock, N., Yount, S., & Stone, A. A. (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45(5 Suppl 1), S12.

    PubMed  PubMed Central  Google Scholar 

  10. Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of Life Research, 19(4), 595–607. https://doi.org/10.1007/s11136-010-9619-3.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Lai, J. S., Stucky, B. D., Thissen, D., Varni, J. W., DeWitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS((R)) pediatric fatigue item banks. Quality of Life Research, 22(9), 2417–2427. https://doi.org/10.1007/s11136-013-0357-1.

    Article  PubMed  Google Scholar 

  12. Varni, J. W., Stucky, B. D., Thissen, D., Dewitt, E. M., Irwin, D. E., Lai, J. S., et al. (2010). PROMIS Pediatric Pain Interference Scale: An item response theory analysis of the pediatric pain item bank. Journal of Pain, 11(11), 1109–1119. https://doi.org/10.1016/j.jpain.2010.02.005.

    Article  Google Scholar 

  13. Dewalt, D. A., Thissen, D., Stucky, B. D., Langer, M. M., Morgan Dewitt, E., Irwin, D. E., et al. (2013). PROMIS Pediatric Peer Relationships Scale: Development of a peer relationships item bank as part of social health measurement. Health Psychology, 32(10), 1093–1103. https://doi.org/10.1037/a0032670.

    Article  PubMed  Google Scholar 

  14. DeWitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: Built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804. https://doi.org/10.1016/j.jclinepi.2010.10.012.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Lee, S., Cheung, Y., Wong, H., Leung, T., Lam, T., & Lau, Y. J. B. O. (2013). Chronic health problems and health-related quality of life in Chinese children and adolescents: a population-based study in Hong Kong. BMJ Open, 3(1), 1183.

    Google Scholar 

  16. Yeung, N. C., Lau, J. T., Yu, X.-N., Chu, Y., Shing, M. M., Leung, T. F., et al. (2013). Psychometric properties of the Chinese version of the pediatric quality of life inventory 4.0 Generic core scales among pediatric cancer patients. Cancer Nursing, 36(6), 463–473.

    PubMed  Google Scholar 

  17. Patient-reported Outcome Measurment Information System. PROMIS Pediatric and Parent Proxy Profile Instruments [Internet]. (2017). https://www.assessmentcenter.net/documents/PROMIS%20Pediatric%20Profile%20Scoring%20Manual.pdf. Accessed Jan 16 2020.

  18. Liu, Y., Yuan, C., Wang, J., Shen, N., Shen, M., & Hinds, P. S. J. C. N. (2019). Chinese version of pediatric patient-reported outcomes measurement information system short form measures: Reliability, validity, and factorial structure assessment in children with cancer in China. Cancer Nursing, 42(6), 430–438.

    PubMed  Google Scholar 

  19. Liu, Y., Hinds, P. S., Wang, J., Correia, H., Du, S., Ding, J., et al. (2013). Translation and linguistic validation of the pediatric patient-reported outcomes measurement information system measures into simplified Chinese using cognitive interviewing methodology. Cancer Nursing, 36(5), 368–376.

    PubMed  Google Scholar 

  20. Eremenco, S. L., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions, 28(2), 212–232.

    Google Scholar 

  21. Bujang, M. A., & Baharum, N. J. W. (2016). Sample size guideline for correlation analysis. World Journal of Social Science Research, 3(1), 37.

    Google Scholar 

  22. Reeve, B. B., McFatrich, M., Mack, J. W., Pinheiro, L. C., Jacobs, S. S., Baker, J. N., et al. (2020). Expanding construct validity of established and new PROMIS Pediatric measures for children and adolescents receiving cancer treatment. Pediatric Blood & Cancer, 67(4), e28160.

    Google Scholar 

  23. Chen, W.-H., Lenderking, W., Jin, Y., Wyrwich, K. W., Gelhorn, H., & Revicki, D. A. J. Q. O. L. R. (2014). Is Rasch model analysis applicable in small sample size pilot studies for assessing item characteristics? An example using PROMIS pain behavior item bank data. Quality of Life Research, 23(2), 485–493.

    PubMed  Google Scholar 

  24. Eremenco, S. L., Cella, D., & Arnold, B. J. J. E. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions, 28(2), 212–232.

    Google Scholar 

  25. Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQL 4.0: Reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care, 39(8), 800–812.

    CAS  PubMed  Google Scholar 

  26. Hao, Y., Tian, Q., Lu, Y., Chai, Y., & Rao, S. J. Q. O. L. R. (2010). Psychometric properties of the Chinese version of the Pediatric Quality of Life InventoryTM 4.0 generic core scales. Health and Quality of Life Outcomes, 19(8), 1229–1233.

    Google Scholar 

  27. Tsai, F.-J., Huang, Y.-H., Liu, H.-C., Huang, K.-Y., Huang, Y.-H., & Liu, S.-I.J.P. (2014). Patient health questionnaire for school-based depression screening among Chinese adolescents. Pediatrics, 133(2), e402–e409.

    PubMed  Google Scholar 

  28. Leung, D. Y., Mak, Y. W., Leung, S. F., Chiang, V. C., & Loke, A. Y. J. A. P. P. (2020). Measurement invariances of the PHQ-9 across gender and age groups in Chinese adolescents. Asia-Pacific Psychiatry, 123, 81. https://doi.org/10.1111/appy.12381.

    Article  Google Scholar 

  29. Ho, K. Y., Li, W. H., Lam, K. W., Chui, S. Y., & Chan, C. F. (2015). Psychometric properties of the Chinese version of the fatigue scale-adolescent. BMC Cancer, 15, 938. https://doi.org/10.1186/s12885-015-1945-y.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Lynn, M. R. (1986). Determination and quantification of content validity. Nursing Research, 35(6), 382–385.

    CAS  PubMed  Google Scholar 

  31. Polit, D. F., & Beck, C. T. (2004). Nursing research: Principles and methods. Lippincott: Williams & Wilkins.

    Google Scholar 

  32. Terwee, C. B., Bot, S. D., de Boer, M. R., van der Windt, D. A., Knol, D. L., Dekker, J., et al. (2007). Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology, 60(1), 34–42.

    PubMed  Google Scholar 

  33. De Vet, H. C., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). sMeasurement in medicine: A practical guide. Cambridge: Cambridge University Press.

    Google Scholar 

  34. Hu, L. T., & Bentler, P. M. (1999). Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling: A Multidisciplinary Journal, 6(1), 1–55.

    Google Scholar 

  35. Carmines, E. G., & Zeller, R. A. (1979). Reliability and validity assessment (Vol. 17). Thousand Oaks, CA: Sage.

    Google Scholar 

  36. Streiner, D. L., Norman, G. R., & Cairney, J. (2015). Health measurement scales: A practical guide to their development and use. Oxford: Oxford University Press.

    Google Scholar 

  37. Tsutakawa, R. K., & Johnson, J. C. (1990). The effect of uncertainty of item parameter estimation on ability estimates. Psychometrika, 55(2), 371–390.

    Google Scholar 

  38. Bond, T. G., & Fox, C. M. (2001). Applying the Rasch model: Fundamental measurement in the human sciences. East Sussex: Psychology Press.

    Google Scholar 

  39. Krumlinde-Sundholm, L., Holmefur, M., Kottorp, A., Eliasson, A. C. J. D. M., & Neurology, C. (2007). The Assisting Hand Assessment: Current evidence of validity, reliability, and responsiveness to change. Developmental Medicine & Child Neurology, 49(4), 259–264.

    Google Scholar 

  40. Linacre, J. M. (2011). A user’s guide to WINSTEPS Ministeps. Chicago: Rasch Model Computer Programs.

    Google Scholar 

  41. Mukaka, M. J. M. M. J. (2012). Statistics corner: A guide to appropriate use of correlation in medical research. Malawi Medical Journal, 24(3), 69–71.

    CAS  PubMed  PubMed Central  Google Scholar 

  42. Padilla, J.-L., & Leighton, J. P. (2017). Cognitive interviewing and think aloud methods. In B. Zumbo & A. M. Hubley (Eds.), Understanding and investigating response processes in validation research (pp. 211–228). Berlin: Springer.

    Google Scholar 

  43. OudeVoshaar, M. A., ten Klooster, P. M., Taal, E., Krishnan, E., & van Laar, M. A. J. A. R. (2012). Dutch translation and cross-cultural adaptation of the PROMIS® physical function item bank and cognitive pre-test in Dutch arthritis patients. Arthritis Research and Therapy, 14(2), 1–7.

    Google Scholar 

  44. Irwin, D. E., Varni, J. W., Yeatts, K., DeWalt, D. A. J. H., & Outcomes, Q. O. L. (2009). Cognitive interviewing methodology in the development of a pediatric item bank: A patient reported outcomes measurement information system (PROMIS) study. Health and Quality of Life Outcomes, 7(1), 3.

    PubMed  PubMed Central  Google Scholar 

  45. Rebok, G., Riley, A., Forrest, C., Starfield, B., Green, B., Robertson, J., et al. (2001). Elementary school-aged children’s reports of their health: a cognitive interviewing study. Quality of Life Research, 10(1), 59–70.

    CAS  PubMed  Google Scholar 

  46. Westmoreland, K., Reeve, B. B., Amuquandoh, A., van der Gronde, T., Manthalu, O., Correia, H., et al. (2018). Translation, psychometric validation, and baseline results of the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures to assess health-related quality of life of patients with pediatric lymphoma in Malawi. Pediatric Blood & Cancer, 65(11), e27353.

    Google Scholar 

  47. DeWitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804.

    PubMed  PubMed Central  Google Scholar 

  48. Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., DeWitt, E. M., Lai, J.-S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res, 19(4), 595–607.

    PubMed  PubMed Central  Google Scholar 

  49. Lai, J.-S., Stucky, B. D., Thissen, D., Varni, J. W., DeWitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS® pediatric fatigue item banks. Quality of Life Research, 22(9), 2417–2427.

    PubMed  Google Scholar 

  50. DeWalt, D. A., Thissen, D., Stucky, B. D., Langer, M. M., Morgan DeWitt, E., Irwin, D. E., et al. (2013). PROMIS pediatric peer relationships scale: development of a peer relationships item bank as part of social health measurement. Health Psychology, 32(10), 1093.

    PubMed  Google Scholar 

  51. Varni, J. W., Stucky, B. D., Thissen, D., DeWitt, E. M., Irwin, D. E., Lai, J.-S., et al. (2010). PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. Pain, 11(11), 1109–1119.

    Google Scholar 

  52. Kashikar-Zuck, S., Zafar, M., Barnett, K. A., Aylward, B. S., Strotman, D., Slater, S. K., et al. (2013). Quality of life and emotional functioning in youth with chronic migraine and juvenile fibromyalgia. The Clinical Journal of Pain, 29(12), 1066–1072.

    PubMed  Google Scholar 

  53. Løvaas, M. E. S., Sund, A. M., Patras, J., Martinsen, K., Hjemdal, O., Neumer, S.-P., et al. (2018). Emotion regulation and its relation to symptoms of anxiety and depression in children aged 8–12 years: Does parental gender play a differentiating role? BMC Psychology, 6(1), 42.

    Google Scholar 

  54. Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606–613.

    CAS  PubMed  PubMed Central  Google Scholar 

  55. Choi, S., Podrabsky, T., McKinney, N., Schalet, B., Cook, K., & Cella, D. J. C., IL: Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University. (2012). PROSetta Stone® analysis report: A Rosetta Stone for patient reported outcomes.

  56. Richardson, L. P., McCauley, E., Grossman, D. C., McCarty, C. A., Richards, J., Russo, J. E., et al. (2010). Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics, 126(6), 1117.

    PubMed  PubMed Central  Google Scholar 

  57. Hinz, A., Mehnert, A., Kocalevent, R.-D., Brähler, E., Forkmann, T., Singer, S., et al. (2016). Assessment of depression severity with the PHQ-9 in cancer patients and in the general population. BMC Psychiatry, 16(1), 22.

    PubMed  PubMed Central  Google Scholar 

  58. Hinds, P. S., Hockenberry-Eaton, M., Gilger, E., Kline, N., Burleson, C., Bottomley, S., et al. (1999). Comparing patient, parent, and staff descriptions of fatigue in pediatric oncology patients. Cancer Nursing, 22(4), 277–289.

    CAS  PubMed  Google Scholar 

  59. Kashikar-Zuck, S., Carle, A., Barnett, K., Goldschneider, K. R., Sherry, D. D., Mara, C. A., et al. (2016). Longitudinal evaluation of patient reported outcomes measurement information systems (PROMIS) measures in pediatric chronic pain. Pain, 157(2), 339.

    PubMed  PubMed Central  Google Scholar 

  60. Devine, K. A., Willard, V. W., Hocking, M. C., Stapleton, J. L., Rotter, D., Bukowski, W. M., et al. (2018). PROMIS peer relationships short form: How well does self-report correlate with data from peers? Journal of Pediatric Psychology, 43(9), 1059–1067.

    PubMed  PubMed Central  Google Scholar 

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Authors and Affiliations

  1. Allied Health Department (Physiotherapy), Hong Kong Children’s Hospital, HKSAR, China

    Stephen W. W. Chan

  2. Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HKSAR, China

    Stephen W. W. Chan, C. W. Chien, Arnold Y. L. Wong & Marco Y. C. Pang

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  2. C. W. Chien
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  3. Arnold Y. L. Wong
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  4. Marco Y. C. Pang
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Contributions

SWWC: All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed. SWWC: The first draft of the manuscript was written. AYLW: reviewed and edited. All authors edited subsequent versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Arnold Y. L. Wong.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee. The study was approved by the Review Board of Kowloon Central Cluster, Hospital Authority (Ref: KC/KE-18–0170/ER4).

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Chan, S.W.W., Chien, C.W., Wong, A.Y.L. et al. Translation and psychometric validation of the traditional Chinese version of patient-reported outcomes measurement information system Pediatric-25 Profile version 2.0 (PROMIS-25) in Chinese Children with Cancer in Hong Kong. Qual Life Res 30, 1779–1791 (2021). https://doi.org/10.1007/s11136-021-02759-8

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