Translation and socio-linguistic adaptation of the Maltese version of the decision regret scale

Translation and socio-linguistic adaptation of the Maltese version of the decision regret scale

Authors

Keywords:

decision regret, patient-reported outcome measures, content validity, cross-cultural adaptation, non-communicable diseases, Maltese version

Abstract

Background and aim: Decision regret (DR) is critical in patient-centred care, especially among individuals with chronic diseases who face complex healthcare decisions. Despite growing interest in DR as a measurable construct, no validated instrument exists in the Maltese language. This study aimed to translate the 5-item Decision Regret Scale (DRS) into Maltese and to evaluate its content validity, following a structured methodological approach.

Methods: The study adopted a two-phase methodological design. In Phase One, the DRS was translated into Maltese using a collaborative and iterative model, as described by Douglas and Craig, which involved forward translation, synthesis, expert adjudication, and back-translation. Phase Two evaluated both quantitative and qualitative content validity. A panel of eight experts assessed the relevance and clarity of each item using the Content Validity Ratio (CVR), Item- and Scale-level Content Validity Indexes (I-CVI and S-CVI). Qualitative feedback was also collected to explore face validity and semantic nuances.

Results: All items demonstrated acceptable CVR, I-CVI, and S-CVI values after two rounds of expert review. Items 3 and 5 required further discussion due to initial concerns about semantic overlap, resulting in the revision of item 3. Additionally, minor changes were introduced to enhance conceptual clarity. Final indices confirmed the content validity of all five items.

Conclusions: The Maltese version of the DRS was found to be culturally appropriate, linguistically accurate, and content-valid. Further psychometric studies are recommended to assess construct validity, reliability, and responsiveness in clinical populations.

Author Biography

Rosario Caruso, Department of Biomedical Sciences for Health, University of Milan, Milan, Italy

Associate Professor of Nursing Science, Department of Biomedical Sciences for Health, University of Milan.

References

1. Nugent R. Preventing and managing chronic diseases. BMJ. 2019 Jan 31;364:l459. doi: 10.1136/bmj.l459.

2. Verweel L, Newman A, Michaelchuk W, Packham T, Goldstein R, Brooks D. The effect of digital interventions on related health literacy and skills for individuals living with chronic diseases: A systematic review and meta-analysis. Int J Med Inform. 2023 Sep;177:105114. doi: 10.1016/j.ijmedinf.2023.105114.

3. Wang Y, Wang J. Modelling and prediction of global non-communicable diseases. BMC Public Health. 2020 Jun 1;20(1):822. doi: 10.1186/s12889-020-08890-4.

4. NCD Countdown 2030 collaborators. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. Lancet. 2018 Sep 22;392(10152):1072-88. doi: 10.1016/S0140-6736(18)31992-5.

5. Rajashekhar M, Joshi M, Mundra A, et al. Community-based health promotion interventions to reduce risk factors of non-communicable diseases among adolescent and young adults in low- and middle-income countries: A systematic review and meta-analysis. Public Health. 2025 Jun;243:105714. doi: 10.1016/j.puhe.2025.03.026.

6. Dumcheva A, Nevalainen J, Laatikainen T, Nuorti P. How likely are Eastern European and central Asian countries to achieve global NCD targets: multi-country analysis. BMC Public Health. 2024 Oct 5;24(1):2714. doi: 10.1186/s12889-024-20186-5.

7. GBD 2021 Causes of Death Collaborators. Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet (London, England). 2024 May 18;403(10440): 2100–32. doi: 10.1016/S0140-6736(24)00367-2.

8. NCD Countdown 2030 collaborators. NCD Countdown 2030: efficient pathways and strategic investments to accelerate progress towards the Sustainable Development Goal target 3.4 in low-income and middle-income countries. Lancet. 2022 Mar 26;399(10331):1266-78. doi: 10.1016/S0140-6736(21)02347-3.

9. Hacker K. The Burden of Chronic Disease. Mayo Clin Proc Innov Qual Outcomes. 2024 Jan 20;8(1):112-119. doi: 10.1016/j.mayocpiqo.2023.08.005. Erratum in: Mayo Clin Proc Innov Qual Outcomes. 2024 Dec 13;9(1):100588. doi: 10.1016/j.mayocpiqo.2024.11.005.

10. Schneiderman N. Psychosocial, Behavioral, and Biological Aspects of Chronic Diseases. Current Directions in Psychological Science. Sage Journals 2004 Dec;13(6): 247–51. doi:10.1111/j.0963-7214.2004.00318.x.

11. Budreviciute A, Damiati S, Sabir DK, et al. Management and Prevention Strategies for Non-communicable Diseases (NCDs) and Their Risk Factors. Front Public Health. 2020 Nov 26;8:574111. doi: 10.3389/fpubh.2020.574111.

12. OECD. State of Health in the EU: Country Health Profiles. OECD; 2023. doi:10.1787/25227041. https://www.oecd.org/en/publications/state-of-health-in-the-eu_25227041.html [Accessed 17th May 2025].

13. Ministry For Health and Active Ageing. A National Health Systems Strategy for Malta 2023 - 2033. 2024 [Accessed 17th May 2025]. p. 1–83. https://health.gov.mt/wp-content/uploads/2024/09/A_National_Health_Systems_Strategy_for_Malta_2023_2033_September_2024.pdf [Accessed 17th May 2025].

14. Agius R, Pace NP, Fava S. Characterisation of body size phenotypes in a middle-aged Maltese population. J Nutr Sci. 2021 Sep 24;10:e81. doi: 10.1017/jns.2021.74.

15. Mifsud JL, Galea J. Cardiovascular Risk Factors Among First-Degree Relatives of Patients with Premature Cardiovascular Disease in Malta. Baseline Findings from the CRISO Project. Vasc Health Risk Manag. 2024 Apr 9;20:167-76. doi: 10.2147/VHRM.S449672.

16. Mainz J, Kristensen S, Roe D. The power of the patient's voice in the modern health care system. Int J Qual Health Care. 2022 Mar 30;34(34 Suppl 1):ii1-ii2. doi: 10.1093/intqhc/mzac001.

17. Dang-Vu G, Rein L, Szabo A, Venkatesan T. Low patient engagement is associated with reduced health-related quality of life in adults with cyclic vomiting syndrome. Scand J Gastroenterol. 2022 Sep;57(9):1030-35. doi: 10.1080/00365521.2022.2064724.

18. Veenendaal HV, Chernova G, Bouman CM, Etten-Jamaludin FSV, Dieren SV, Ubbink DT. Shared decision-making and the duration of medical consultations: A systematic review and meta-analysis. Patient Educ Couns. 2023 Feb;107:107561. doi: 10.1016/j.pec.2022.11.003.

19. Selby LV, Aquina CT, Pawlik TM. When a Patient Regrets Having Undergone a Carefully and Jointly Considered Treatment Plan, How Should Her Physician Respond? AMA J Ethics. 2020 May 1;22(5):E352-57. doi: 10.1001/amajethics.2020.352.

20. Korkidakis A, Martinez S, Sabbagh R, et al. Decision-making in women who considered planned oocyte cryopreservation: decision satisfaction or regret? Reprod Biomed Online. 2025 Feb;50(2):103944. doi: 10.1016/j.rbmo.2024.103944.

21. Liu J, Hunter S, Zhu J, Lee RL, Chan SW. Decision regret regarding treatments among women with early-stage breast cancer: a systematic review protocol. BMJ Open. 2022 Mar 17;12(3):e058425. doi: 10.1136/bmjopen-2021-058425.

22. Pearson H H, Bryan G, Kayum C, Gibson F, Darlington AS. Parent values and preferences underpinning treatment decision-making in poor-prognosis childhood cancer: a scoping review. BMC Pediatr. 2022 Oct 14;22(1):595. doi: 10.1186/s12887-022-03635-1.

23. Brera AS, Arrigoni C, Magon A, et al. Mapping the literature on decision regret in patients with non-communicable diseases (NCDs): a scoping review protocol. BMJ Open. 2023 Jul 18;13(7):e072703. doi: 10.1136/bmjopen-2023-072703.

24. Brera AS, Arrigoni C, Magon A, et al. A scoping review of decision regret in non-communicable diseases: The emerging roles of patient-clinician communication, psychological aspects, and medical outcomes. Patient Educ Couns. 2025 Jan;130:108478. doi: 10.1016/j.pec.2024.108478.

25. Wu CJ, Yeh TP, Chu G, Ho YF. Effectiveness of computerised decision aids for patients with chronic diseases in shared decision-making: A systematic review and meta-analysis. J Clin Nurs. 2024 Jul;33(7):2732-54. doi: 10.1111/jocn.17095.

26. Tews AM, Hinz A, Magnus V, et al. Decision regret in patients with head-and-neck cancer undergoing radiotherapy. Clin Transl Radiat Oncol. 2025 Jun 27;54:101005. doi: 10.1016/j.ctro.2025.101005.

27. Chehade M, Mccarthy MM, Squires A. Patient-related decisional regret: An evolutionary concept analysis. J Clin Nurs. 2024 Nov;33(11):4484-4503. doi: 10.1111/jocn.17217.

28. Brehaut JC, O'Connor AM, Wood TJ, et al. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

29. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8.

30. Caruso R, Arrigoni C, Groppelli K, et al. Italian version of Dyspnoea-12: cultural-linguistic validation, quantitative and qualitative content validity study. Acta Biomed. 2018 Jan 16;88(4):426-34. doi: 10.23750/abm.v88i4.6341.

31. Clark JA, Wray N, Brody B, Ashton C, Giesler B, Watkins H. Dimensions of quality of life expressed by men treated for metastatic prostate cancer. Soc Sci Med. 1997 Oct;45(8):1299-309. doi: 10.1016/s0277-9536(97)00058-0.

32. Clark JA, Wray NP, Ashton CM. Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer. J Clin Oncol. 2001 Jan 1;19(1):72-80. doi: 10.1200/JCO.2001.19.1.72.

33. Zeelenberg M, Beattie J. Consequences of Regret Aversion 2: Additional Evidence for Effects of Feedback on Decision Making. Organizational Behavior and Human Decision Processes. 1997 Oct 20;72(1): 63–78. doi:10.1006/obhd.1997.2730.

34. Creyer EH, Ross WT. The Development and Use of a Regret Experience Measure to Examine the Effects of Outcome Feedback on Regret and Subsequent Choice. Marketing Letters. 1999;10(4): 379–92. doi: 10.1023/A:1008166305455

35. Tsiros M, Mittal V. Regret: A Model of Its Antecedents and Consequences in Consumer Decision Making. Journal of Consumer Research. 2000 Feb;26(4): 401–17. doi: 10.1086/209571.

36. Inman JJ, Zeelenberg M. Regret in Repeat Purchase versus Switching Decisions: The Attenuating Role of Decision Justifiability. Journal of Consumer Research. 2002 Feb;29(1): 116–28. doi:10.1086/339925.

37. Horst SJ. Critical Synthesis Package: Decision Regret Scale. MedEdPORTAL. 2015 Jul 21;11:10147. doi:10.15766/mep_2374-8265.10147

38. Douglas SP, Craig CS. Collaborative and Iterative Translation: An Alternative Approach to Back Translation. Journal of International Marketing. 2007;15(1): 30–43. https://doi.org/10.1509/jimk.15.1.030.

39. Spoto A, Nucci M, Prunetti E, Vicovaro M. Improving content validity evaluation of assessment instruments through formal content validity analysis. Psychol Methods. 2025 Apr;30(2):203-22. doi: 10.1037/met0000545.

40. Almanasreh E, Moles RJ, Chen TF. A practical approach to the assessment and quantification of content validity. In: Desselle SP, García-Cárdenas V, Anderson C, Aslani P, Chen AMH, Chen TF, editors. Contemporary Research Methods in Pharmacy and Health Services. London: Academic Press; 2022. p. 583–599. doi:10.1016/B978-0-323-91888-6.00013-2.

41. Ivziku D, Caruso R, Lommi M, et al. Cultural Adaptation and Psychometric Properties of the Trust Me Scale-Italian Version: A Validation Study. Healthcare (Basel). 2023 Apr 11;11(8):1086. doi: 10.3390/healthcare11081086.

42. Brera AS, Arrigoni C, Belloni S, et al. Decision Regret and Vaccine Hesitancy among Nursing Students and Registered Nurses in Italy: Insights from Structural Equation Modeling. Vaccines (Basel). 2024 Sep 14;12(9):1054. doi: 10.3390/vaccines12091054.

43. Content Validity Ratio. In: The SAGE Encyclopedia of Educational Research, Measurement, and Evaluation. 2455 Teller Road, Thousand Oaks, California 91320: SAGE Publications, Inc.; 2018. doi:10.4135/9781506326139.n151. [Accessed 17th May 2025].

44. Cuschieri S, Pallari E, Hatziyianni A, Sigurvinsdottir R, Sigfusdottir ID, Sigurðardóttir ÁK. Mortality comparisons of COVID-19 with all-cause and non-communicable diseases in Cyprus, Iceland and Malta: lessons learned and forward planning. Public Health. 2022 Jan;202:52-7. doi: 10.1016/j.puhe.2021.03.025.

45. GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability (YLDs), disability-adjusted life-years (DALYs), and healthy life expectancy (HALE) for 371 diseases and injuries in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2133-61. doi: 10.1016/S0140-6736(24)00757-8.

46. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-22. doi: 10.1016/S0140-6736(20)30925-9. Erratum in: Lancet. 2020 Nov 14;396(10262):1562. doi: 10.1016/S0140-6736(20)32226-1.

47. Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. 2018 May;27(5):1159-70. doi: 10.1007/s11136-018-1829-0.

48. Baroni I, Paglione G, De Angeli G, et al. A COSMIN systematic review of instruments for evaluating health-related quality of life in people with Hereditary Angioedema. Health Qual Life Outcomes. 2025 Feb 13;23(1):12. doi: 10.1186/s12955-025-02342-6.

49. Roebianto A, Savitri I, Aulia Syaiful I, Suciyana Sriyanto A, Mubarokah L. Content validity: Definition and procedure of content validation in psychological research. Testing, Psychometrics, Methodology in Applied Psychology. 2023 March;30(1): 5–18. doi:10.4473/TPM30.1.1.

50. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010 Jul;63(7):737-45. doi: 10.1016/j.jclinepi.2010.02.006.

51. Chiarotto A, Ostelo RW, Boers M, Terwee CB. A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain. J Clin Epidemiol. 2018 Mar;95:73-93. doi: 10.1016/j.jclinepi.2017.11.005.

Downloads

Published

28-10-2025

Issue

Section

HEALTH PROFESSIONS

How to Cite

1.
Brera AS, Mifsud JL, Trapani J, et al. Translation and socio-linguistic adaptation of the Maltese version of the decision regret scale. Acta Biomed. 2025;96(5):17213. doi:10.23750/abm.v96i5.17213