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Translation and cultural adaptation of the CLEFT-Q into Arabic, Dutch, Hindi, Swedish, and Turkish

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European Journal of Plastic Surgery Aims and scope Submit manuscript

Abstract

Background

Treatment for cleft lip and/or palate (CL/P) involves a multidisciplinary team of experts who aim to improve ones’ appearance, health-related quality of life, and speech function. To appropriately measure outcomes in CL/P from the patient perspective, a CL/P-specific patient-reported outcome (PRO) instrument is needed. The CLEFT-Q is a self-report PRO instrument developed to evaluate treatment outcomes in patients with CL/P. The aim of this study was to translate and culturally adapt the CLEFT-Q.

Methods

The CLEFT-Q was translated and culturally adapted from English into Arabic, Dutch, Hindi, Swedish, and Turkish using guidelines set forth by the International Society for Pharmacoeconomics and Outcomes Research. For each language, two forward translations, one back translation, and cognitive debriefing interviews with patients were conducted.

Results

The field test version of the CLEFT-Q consisted of 154 items across 13 scales. Forward translations for each language revealed few items that were difficult to translate into the various languages. Comparison of each back translation to the English version identified that a change in the meaning of an item was more common in the Turkish (n = 40, 26%) and Arabic (n = 17, 11%) translations, and required re-translation. Cognitive debriefing interviews involved 41 participants from plastic surgery centers in India, Qatar, Sweden, the Netherlands, and Turkey. Participants reported few difficulties in understanding the items, instructions, and response options in each CLEFT-Q translation.

Conclusions

Semantic, idiomatic, experiential, and conceptual equivalence of the CLEFT-Q was achieved for all language versions, thus providing evidence of the CLEFT-Q’s transferability to other languages and cultures.

Level of Evidence: Not ratable

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References

  1. Rothrock NE, Kaiser KA, Cella D (2011) Developing a valid patient-reported outcome measure. Clin Pharmacol Ther 90(5):737–742

    Article  CAS  Google Scholar 

  2. Wagner AK, Gandek B, Aaronson NK, Acquadro C, Alonso J, Apolone G, Bullinger M, Bjorner J, Fukuhara S, Kaasa S, Leplège A, Sullivan M, Wood-Dauphinee S, Ware JE Jr (1998) Cross-cultural comparisons of the content of SF-36 translations across 10 countries: results from the IQOLA Project. J Clin Epidemiol 51(11):925–932

    Article  CAS  Google Scholar 

  3. US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. Retrieved from: https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf. Accessed 11 July 2018

  4. Acquadro C, Bayles A, Juniper E (2014) Translating patient-reported outcome measures: a multi-step process is essential. J Bras Pneumol 40(3):211–212

    Article  Google Scholar 

  5. Acquadro C, Conway K, Giroudet C, Mear I (2012) Linguistic validation manual for health outcome assessments (new edition). Mapi Institute, Lyon

  6. Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P (2005) 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(2):i:94–i104

    Article  Google Scholar 

  7. Tanaka SA, Mahabir RC, Jupiter DC, Menezes JM (2012) Updating the epidemiology of cleft lip with or without cleft palate. Plast Reconstr Surg 129(3):511e–518e

    Article  Google Scholar 

  8. Locker D, Jokovic A, Stephens M, Kenny D, Tompson B, Guyatt G (2002) Family impact of child oral and orofacial conditions. Community Dent Oral Epidemiol 30:438–448

    Article  Google Scholar 

  9. Sitzman TJ, Allori AC, Thorburn G (2014) Measuring outcomes in cleft lip and palate treatment. Clin Plast Surg 41(2):311–319

    Article  Google Scholar 

  10. Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M (2003) Incorporating the patient’s perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health 6(5):522–531

    Article  Google Scholar 

  11. Wong Riff KWY, Tsangaris E, Goodacre T, Forrest CR, Pusic AL, Cano SJ, Klassen AF (2017) International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome instrument for children and young adults with cleft lip and/or palate (CLEFT-Q). BMJ Open 7:e015467

    Article  Google Scholar 

  12. Klassen AF, Tsangaris E, Forrest CR, Wong KW, Pusic AL, Cano SJ, Syed I, Dua M, Kainth S, Johnson J, Goodacre T (2012) Quality of life of children treated for cleft lip and/or palate: a systematic review. J Plast Reconstr Aesthet Surg 65(5):547–557

    Article  Google Scholar 

  13. Wong Riff KWY, Tsangaris E, Forrest CR, Lawson J, Pusic AL, Klassen AF (2018) What matters to patients with cleft lip and/or palate: an international qualitative study informing the development of the CLEFT-Q. Cleft Palate Craniofac J 55(3):442–450

    Article  Google Scholar 

  14. Tsangaris E, Wong Riff KWY, Goodacre T, Forrest CR, Dreise M, Sykes J, de Chalain T, Harman K, O’Mahony A, Pusic AL, Thabane L, Thoma A, Klassen AF (2017) Establishing content validity of the CLEFT-Q: a new patient-reported outcome instrument for cleft lip and/or palate. Plast Reconstr Surg Glob Open 5(4):e1305

    Article  Google Scholar 

  15. Klassen A, Wong Riff K, Longmire N, Albert A, Baker S, Cano S, Chan A, Courtemanche D, Dreise M, Goldstein J, Goodacre T, Harman K, Munill M, Palomares MA, Peterson P, Pusic A, Slator R, Stiernman M, Tholpady S, Tsangaris E, Vargas F, Forrest C (2018) Psychometric findings and normative values for the CLEFT-Q based on 2,434 children and young adult patients with cleft lip and/or palate from 12 countries. CMAJ 190(15):E455–E462

    Article  Google Scholar 

  16. Bullinger M, Ravens-Sieberer U (1995) Health-related QOL assessment in children: a review of the literature. Eur Rev Appl Psychol 45:245–254

    Google Scholar 

  17. Cremeens J, Eiser C, Blades M (2006) Factors influencing agreement between child self-report and parent proxy-reports on the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™) generic core scales. Health Qual Life Outcomes 4:58

    Article  Google Scholar 

  18. Ungar WJ, Boydell K, Dell S, Feldman BM, Marshall D, Willan A, Wright JG (2012) A parent-child dyad approach to the assessment of health status and health-related quality of life in children with asthma. PharmacoEconomics 30(8):697–712

    Article  Google Scholar 

  19. Rajmil L, López AR, López-Aguilà S, Alonso J (2013) Parent–child agreement on health-related quality of life (HRQOL): a longitudinal study. Health Qual Life Outcomes 11:101

    Article  Google Scholar 

  20. Tobin GA, Begley CM (2004) Methodological rigour within a qualitative framework. J Adv Nurs 48(4):388–396

    Article  Google Scholar 

  21. Bitsch V (2005) Qualitative research: a grounded theory example and evaluation criteria. J Agribusiness 23(1):75–91

    Google Scholar 

  22. Hunt SM, Bhopal R (2004) Self-report in clinical and epidemiological studies with non-English speakers: the challenge of language and culture. J Epidemiol Community Health 58(7):618–622

    Article  Google Scholar 

  23. Tsangaris E, Wong Riff KW, Vargas F, Aguilera MP, Alarcón MM, Cazalla AA, Thabane L, Thoma A, Klassen AF (2017) Translation and cultural adaptation of the CLEFT-Q for use in Colombia, Chile, and Spain. Health Qual Life Outcomes 15(1):228

  24. Guillemin F, Bombardier C, Beaton D (1993) Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 46:1417–1432

    Article  CAS  Google Scholar 

  25. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42(2):377–381

    Article  Google Scholar 

  26. Aaronson N, Acquadro C, Alonso J, Apolone G, Bucquet D, Bullinger M, Bungay K, Fukuhara S, Gandek B, Keller S, Razavi D, Sanson-Fisher R, Sullivan M, Wood-Dauphinee S, Wagner A, Ware J (1992) International quality of life assessment (IQOLA) project. Qual Life Res 1:349–351

    Article  CAS  Google Scholar 

Download references

Acknowledgements

We would like to acknowledge the following individuals for their help with translating the CLEFT-Q, or in conducting the cognitive debriefing interviews: Nayantara Ghosh, Dudu Dilek Yavuz, Beyza Nur Ordu, Esra Yuksel, Mehmet Inceer, Sirma Saltik, Bulent Erdogan, Magnus Becker, Marie Crisp, John Soliman, Noor Hamideh, Mohamed Sarraj, Renu Parmar, Ishanee Garg, Muskaan Sachdeva, and Meenu Sharma, as well as Percy Balemans and Annette Visser from the Language Centre of the University of Groningen. We would also like to acknowledge our partners at the cleft care centers around the world for participating in data collection for the cognitive debriefing interviews.

Author information

Authors and Affiliations

  1. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, L8S 4K1, Canada

    Elena Tsangaris & Lehana Thabane

  2. Division of Plastic and Reconstructive Surgery, Hospital for Sick Children, University of Toronto, Toronto, Ontario, M5G 1X8, Canada

    Karen W. Y. Wong Riff & Bhoomika Piplani

  3. Department of Plastic Surgery, University of Groningen, Groningen, The Netherlands

    Marieke Dreise

  4. Department of Plastic Surgery, Lund University, 21228, Malamö, Sweden

    Mia Stiernman

  5. School of Rehabilitation Science, McMaster University, Hamilton, Ontario, L8S 1C7, Canada

    Manraj Nirmal Kaur

  6. Division of Plastic Reconstructive and Aesthetic Surgery, Suleyman Demirel University, Isparta, Turkey

    Asim Aydin

  7. Department of Maxillofacial Surgery, Hamad Medical corporation, Doha, PO Box 3050, Qatar

    Ghassan Naser Moh’d Kharashgah

  8. Division Plastic and Craniofacial Surgery, Sidra Medical and Research Center, Doha, PO Box 26999, Qatar

    Mitchell A. Stotland

  9. Division of Plastic Surgery, McMaster University, Hamilton, Ontario, L8P 3A9, Canada

    Achilleas Thoma

  10. Department of Pediatrics, McMaster University, Hamilton, Ontario, L8S 4K1, Canada

    Anne F. Klassen

Authors
  1. Elena Tsangaris
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  2. Karen W. Y. Wong Riff
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  3. Marieke Dreise
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  4. Mia Stiernman
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  5. Manraj Nirmal Kaur
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  6. Bhoomika Piplani
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  7. Asim Aydin
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  8. Ghassan Naser Moh’d Kharashgah
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  9. Mitchell A. Stotland
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  10. Lehana Thabane
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  11. Achilleas Thoma
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  12. Anne F. Klassen
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Corresponding author

Correspondence to Anne F. Klassen.

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Funding

The research described in this paper was supported by a grant from the Canadian Institute of Health Research.

Conflict of interest

Elena Tsangaris, Karen W.Y. Wong Riff, Marieke Dreise, Mia Stiernman, Manraj Nirmal Kaur, Bhoomika Piplani, Asim Aydin, Ghassan Naser Moh’d Kharashgah, Mitchell A. Stotland, Lehana Thabane, Achilleas Thoma, and Anne F. Klassen declare that they have no conflict of interest.

Ethical approval

The study was conducted in accordance with policies for ethical conduct in research involving humans, and was approved by the Hamilton Integrated Research Ethics Board (HiREB) and the Research Ethics Board of each of the following participating hospitals: Hamad Medical Corporation in Doha, Qatar; University of Groningen in the Netherlands; G.S. Memorial Plastic Surgery Hospital and Trauma Centre in Varanasi, India; Skåne University Hospital in Malamö, Sweden; and Suleyman Demirel University School of Medicine Research Hospital in Isparta, Turkey. All participants and/or their legal guardians provided written informed consent or assent for participation according to each center’s policy.

Informed consent

All participants and/or their legal guardians provided written informed consent or assent for participation according to each center’s policy.

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Tsangaris, E., Wong Riff, K.W.Y., Dreise, M. et al. Translation and cultural adaptation of the CLEFT-Q into Arabic, Dutch, Hindi, Swedish, and Turkish. Eur J Plast Surg 41, 643–652 (2018). https://doi.org/10.1007/s00238-018-1445-9

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  • DOI: https://doi.org/10.1007/s00238-018-1445-9

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