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Quality of Life Research

, Volume 27, Issue 11, pp 2897–2908 | Cite as

Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness

  • Amaia Bilbao
  • Lidia García-Pérez
  • Juan Carlos Arenaza
  • Isidoro García
  • Gloria Ariza-Cardiel
  • Elisa Trujillo-Martín
  • Maria João Forjaz
  • Jesús Martín-Fernández
Article

Abstract

Purpose

To study the psychometric properties, including reliability, validity and responsiveness, of the Spanish EQ-5D-5L questionnaire for patients with hip or knee osteoarthritis (OA).

Methods

We included 758 patients with hip or knee OA who completed the EQ-5D-5L and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, of whom 644 also did 6 months later. The EQ-5D-5L contains five questions from which a utility index is derived. The WOMAC covers three dimensions: pain, stiffness and physical function. Floor and ceiling effects were calculated. Reliability was assessed using Cronbach’s alpha. Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L and WOMAC. We examined known-groups validity by comparing the EQ-5D-5L between subgroups defined by WOMAC scores using ANOVA or the Kruskal–Wallis test. Effect sizes were calculated to assess responsiveness, and minimal clinically important difference (MCID) was estimated.

Results

The EQ-5D-5L showed minimal floor and ceiling effects (< 3%). Cronbach’s alpha was 0.86. The EQ-5D-5L index was strongly correlated with WOMAC pain and function scores (− 0.688 and − 0.782). Patients with higher WOMAC scores had significantly (p < 0.0001) lower EQ-5D-5L index. The 20.19% had hip or knee replacement during the follow-up. Effect sizes were small among non-surgical patients, but > 0.80 among “improved” surgical patients, being the MCID for improvement 0.32 points.

Conclusions

The results support the reliability, validity and responsiveness of the EQ-5D-5L, overcoming the limitations of the EQ-5D-3L in these patients. Therefore, the EQ-5D-5L could be very useful as an outcome measure, at least in patients with hip or knee OA.

Keywords

EQ-5D-5L Osteoarthritis Utility index Psychometric properties Minimal clinically important difference 

Notes

Acknowledgements

We are grateful to colleagues in the participating hospitals and primary care centres for their support and to all patients for their collaboration. We acknowledge the help provided by the Biostatistics Research Group (Biostit), supported by the Department of Education, Linguistics Policy and Culture of the Basque Government (Ref: IT620-13). We also acknowledge the editorial assistance provided by Ideas Need Communicating Language Services, through the translation and edition service of the Basque Foundation for Health Innovation and Research (BIOEF).

Funding

This study was supported in part by grants from the Carlos III Health Institute (PI13/00560, PI13/00518 and PI13/00648) and the European Regional Development Fund.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study received the approval of the following Ethics Committees for Clinical Research: ECCR of Euskadi (PI2014050), Hospital Fundación Jiménez Díaz (PIC 80/2013_HRJC), Hospital Universitario de Fuenlabrada (APR 14–27), Hospital Universitario Fundación Alcorcón (14/19), Hospital Universitario de Canarias (2014–109) and Hospital Universitario Nuestra Señora de Candelaria (PI-09/15).

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Mahon, J. L., Bourne, R. B., Rorabeck, C. H., Feeny, D. H., Stitt, L., & Webster-Bogaert, S. (2002). Health-related quality of life and mobility of patients awaiting elective total hip arthroplasty: A prospective study. CMAJ, 167, 1115–1121.PubMedPubMedCentralGoogle Scholar
  2. 2.
    Núñez, M., Lozano, L., Núñez, E., Segur, J. M., Sastre, S., Macule, F., et al. (2009). Total knee replacement and health-related quality of life: Factors influencing long-term outcomes. Arthritis and Rheumatism, 61, 1062–1069.CrossRefGoogle Scholar
  3. 3.
    Cushnaghan, J., Coggon, D., Reading, I., Croft, P., Byng, P., Cox, K., et al. (2007). Long-term outcome following total hip arthroplasty: A controlled longitudinal study. Arthritis and Rheumatism, 57, 1375–1380.CrossRefGoogle Scholar
  4. 4.
    Rat, A. C., Guillemin, F., Osnowycz, G., Delagoutte, J. P., Cuny, C., Mainard, D., et al. (2010). Total hip or knee replacement for osteoarthritis: Mid- and long-term quality of life. Arthritis Care & Research, 62, 54–62.CrossRefGoogle Scholar
  5. 5.
    Quintana, J. M., Escobar, A., Arostegui, I., Bilbao, A., Armendariz, P., Lafuente, I., et al. (2008). Prevalence of symptoms of knee or hip joints in older adults from the general population. Aging Clinical and Experimental Research, 20, 329–336.CrossRefGoogle Scholar
  6. 6.
    Kaufman, S. (2001). The emerging role of health-related quality of life: Data in clinical research, part 2. Clinical Research, 1, 38–43.Google Scholar
  7. 7.
    Guyatt, G. H., Veldhuyzen van Zanten, S. J., Feeny, D. H., & Patrick, D. L. (1989). Measuring quality of life in clinical trials: A taxonomy and review. CMAJ, 140, 1441–1448.PubMedPubMedCentralGoogle Scholar
  8. 8.
    Brazier, J., Ratcliffe, J., Salomon, J. A., & Tsuchiya, A. (2007). Measuring and valuing health benefits for economic evaluation. New York: Oxford University Press.Google Scholar
  9. 9.
    Brooks, R. (1996). EuroQol: The current state of play. Health Policy, 37, 53–72.CrossRefGoogle Scholar
  10. 10.
    Dolan, P. (1997). Modeling valuations for EuroQol health states. Medical Care, 35, 1095–1108.CrossRefGoogle Scholar
  11. 11.
    Drummond, M. F., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. L. (2005). Methods for the economic evaluation of health care programmes. New York: Oxford University Press.Google Scholar
  12. 12.
    EuroQoL Group. (1990). EuroQol—A new facility for the measurement of health-related quality of life. Health Policy, 16, 199–208.CrossRefGoogle Scholar
  13. 13.
    Brazier, J., Roberts, J., Tsuchiya, A., & Busschbach, J. (2004). A comparison of the EQ-5D and SF-6D across seven patient groups. Health Economics, 13, 873–884.CrossRefGoogle Scholar
  14. 14.
    Conner-Spady, B. L., Marshall, D. A., Bohm, E., Dunbar, M. J., Loucks, L., Al, K. A., et al. (2015). Reliability and validity of the EQ-5D-5L compared to the EQ-5D-3L in patients with osteoarthritis referred for hip and knee replacement. Quality of Life Research, 24, 1775–1784.CrossRefGoogle Scholar
  15. 15.
    Janssen, M. F., Pickard, A. S., Golicki, D., Gudex, C., Niewada, M., Scalone, L., et al. (2013). Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: A multi-country study. Quality of Life Research, 22, 1717–1727.CrossRefGoogle Scholar
  16. 16.
    Johnson, J. A., & Pickard, A. S. (2000). Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta, Canada. Medical Care, 38, 115–121.CrossRefGoogle Scholar
  17. 17.
    Sullivan, P. W., Lawrence, W. F., & Ghushchyan, V. (2005). A national catalog of preference-based scores for chronic conditions in the United States. Medical Care, 43, 736–749.CrossRefGoogle Scholar
  18. 18.
    Fransen, M., & Edmonds, J. (1999). Reliability and validity of the EuroQol in patients with osteoarthritis of the knee. Rheumatology, 38, 807–813.CrossRefGoogle Scholar
  19. 19.
    Ostendorf, M., van Stel, H. F., Buskens, E., Schrijvers, A. J., Marting, L. N., Verbout, A. J., et al. (2004). Patient-reported outcome in total hip replacement. A comparison of five instruments of health status. The Journal of Bone and Joint Surgery, 86, 801–808.CrossRefGoogle Scholar
  20. 20.
    Herdman, M., Gudex, C., Lloyd, A., Janssen, M., Kind, P., Parkin, D., et al. (2011). Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of Life ResearchQuality of Life Research, 20, 1727–1736.CrossRefGoogle Scholar
  21. 21.
    Hinz, A., Kohlmann, T., Stobel-Richter, Y., Zenger, M., & Brahler, E. (2014). The quality of life questionnaire EQ-5D-5L: Psychometric properties and normative values for the general German population. Quality of Life Research, 23, 443–447.CrossRefGoogle Scholar
  22. 22.
    Kim, T. H., Jo, M. W., Lee, S. I., Kim, S. H., & Chung, S. M. (2013). Psychometric properties of the EQ-5D-5L in the general population of South Korea. Quality of Life Research, 22, 2245–2253.CrossRefGoogle Scholar
  23. 23.
    Yfantopoulos, J. N., & Chantzaras, A. E. (2016). Validation and comparison of the psychometric properties of the EQ-5D-3L and EQ-5D-5L instruments in Greece. Eur J Health Econ, 18, 519–531.CrossRefGoogle Scholar
  24. 24.
    Buchholz, I., Thielker, K., Feng, Y. S., Kupatz, P., & Kohlmann, T. (2015). Measuring changes in health over time using the EQ-5D 3L and 5L: A head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample. Quality of Life Research, 24, 829–835.CrossRefGoogle Scholar
  25. 25.
    Cheung, P. W., Wong, C. K., Samartzis, D., Luk, K. D., Lam, C. L., Cheung, K. M., et al. (2016). Psychometric validation of the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in Chinese patients with adolescent idiopathic scoliosis. Scoliosis and Spinal Disorders, 11, 19.CrossRefGoogle Scholar
  26. 26.
    Garcia-Gordillo, M., Pozo-Cruz, D., Adsuar, B., Sanchez-Martinez, J. C., F. I., & bellan-Perpinan, J. M. (2014). Validation and comparison of 15-D and EQ-5D-5L instruments in a Spanish Parkinson’s disease population sample. Quality of Life Research, 23, 1315–1326.CrossRefGoogle Scholar
  27. 27.
    Golicki, D., Niewada, M., Buczek, J., Karlinska, A., Kobayashi, A., Janssen, M. F., et al. (2015). Validity of EQ-5D-5L in stroke. Quality of Life Research, 24, 845–850.CrossRefGoogle Scholar
  28. 28.
    Golicki, D., Niewada, M., Karlinska, A., Buczek, J., Kobayashi, A., Janssen, M. F., et al. (2015). Comparing responsiveness of the EQ-5D-5L, EQ-5D-3L and EQ VAS in stroke patients. Quality of Life Research, 24, 1555–1563.CrossRefGoogle Scholar
  29. 29.
    Jia, Y. X., Cui, F. Q., Li, L., Zhang, D. L., Zhang, G. M., Wang, F. Z., et al. (2014). Comparison between the EQ-5D-5L and the EQ-5D-3L in patients with hepatitis B. Quality of Life Research, 23, 2355–2363.CrossRefGoogle Scholar
  30. 30.
    Kim, S. H., Kim, H. J., Lee, S. I., & Jo, M. W. (2012). Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L in cancer patients in Korea. Quality of Life Research, 21, 1065–1073.CrossRefGoogle Scholar
  31. 31.
    Lee, C. F., Luo, N., Ng, R., Wong, N. S., Yap, Y. S., Lo, S. K., et al. (2013). Comparison of the measurement properties between a short and generic instrument, the 5-level EuroQoL Group’s 5-dimension (EQ-5D-5L) questionnaire, and a longer and disease-specific instrument, the Functional Assessment of Cancer Therapy-Breast (FACT-B), in Asian breast cancer patients. Quality of Life Research, 22, 1745–1751.CrossRefGoogle Scholar
  32. 32.
    Lee, C. F., Ng, R., Luo, N., Wong, N. S., Yap, Y. S., Lo, S. K., et al. (2013). The English and Chinese versions of the five-level EuroQoL Group’s five-dimension questionnaire (EQ-5D) were valid and reliable and provided comparable scores in Asian breast cancer patients. Support Care Cancer, 21, 201–209.CrossRefGoogle Scholar
  33. 33.
    Lin, F. J., Pickard, A. S., Krishnan, J. A., Joo, M. J., Au, D. H., Carson, S. S., et al. (2014). Measuring health-related quality of life in chronic obstructive pulmonary disease: Properties of the EQ-5D-5L and PROMIS-43 short form. BMC Medical Research Methodology, 14, 78.CrossRefGoogle Scholar
  34. 34.
    Pattanaphesaj, J., & Thavorncharoensap, M. (2015). Measurement properties of the EQ-5D-5L compared to EQ-5D-3L in the Thai diabetes patients. Health and Quality of Life Outcomes, 13, 14.CrossRefGoogle Scholar
  35. 35.
    Sakthong, P., Sonsa-Ardjit, N., Sukarnjanaset, P., & Munpan, W. (2015). Psychometric properties of the EQ-5D-5L in Thai patients with chronic diseases. Quality of Life Research, 24, 3015–3022.CrossRefGoogle Scholar
  36. 36.
    Scalone, L., Ciampichini, R., Fagiuoli, S., Gardini, I., Fusco, F., Gaeta, L., et al. (2013). Comparing the performance of the standard EQ-5D 3L with the new version EQ-5D 5L in patients with chronic hepatic diseases. Quality of Life Research, 22, 1707–1716.CrossRefGoogle Scholar
  37. 37.
    Tran, B. X., Ohinmaa, A., & Nguyen, L. T. (2012). Quality of life profile and psychometric properties of the EQ-5D-5L in HIV/AIDS patients. Health Qual Life Outcomes, 10, 132.CrossRefGoogle Scholar
  38. 38.
    Yfantopoulos, J., Chantzaras, A., & Kontodimas, S. (2017). Assessment of the psychometric properties of the EQ-5D-3L and EQ-5D-5L instruments in psoriasis. Archives of Dermatological Research, 309, 357–370.CrossRefGoogle Scholar
  39. 39.
    Conner-Spady, B. L., Marshall, D. A., Bohm, E., Dunbar, M. J., & Noseworthy, T. W. (2018). Comparing the validity and responsiveness of the EQ-5D-5L to the Oxford hip and knee scores and SF-12 in osteoarthritis patients 1 year following total joint replacement. Quality of Life Research, 27(5), 1311–1322CrossRefGoogle Scholar
  40. 40.
    Ramos-Goñi, J. M., Craig, B. M., Oppe, M., Ramallo-Fariña, Y., Pinto-Prades, J. L., Luo, N., et al. (2017). Handling data quality issues to estimate the Spanish EQ-5D-5L value set using a hybrid interval regression approach. Value Health, 21(5), 596–604CrossRefGoogle Scholar
  41. 41.
    Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., Norman, G. R., & Clinical Significance Consensus Meeting Group. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77, 371–383.CrossRefGoogle Scholar
  42. 42.
    Bellamy, N., Buchanan, W. W., Goldsmith, C. H., Campbell, J., & Stitt, L. W. (1988). Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. Clinical Rheumatology, 15, 1833–1840.Google Scholar
  43. 43.
    Escobar, A., Quintana, J. M., Bilbao, A., Azkarate, J., & Guenaga, J. I. (2002). Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clinical Rheumatology, 21, 466–471.CrossRefGoogle Scholar
  44. 44.
    Escobar, A., Quintana, J. M., Bilbao, A., Arostegui, I., Lafuente, I., & Vidaurreta, I. (2007). Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage, 15, 273–280.CrossRefGoogle Scholar
  45. 45.
    Quintana, J. M., Escobar, A., Bilbao, A., Arostegui, I., Lafuente, I., & Vidaurreta, I. (2005). Responsiveness and clinically important differences for the WOMAC and SF-36 after hip joint replacement. Osteoarthritis Cartilage, 13, 1076–1083.CrossRefGoogle Scholar
  46. 46.
    Wyrwich, K. W., Tierney, W. M., & Wolinsky, F. D. (1999). Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. Journal of Clinical Epidemiology, 52, 861–873.CrossRefGoogle Scholar
  47. 47.
    Cronbach, L. J. (1951). Coefficient alpha and the internal structure of test. Psychometrika, 16, 297–334.CrossRefGoogle Scholar
  48. 48.
    Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory (3rd ed.). New York: McGraw-Hill.Google Scholar
  49. 49.
    Cohen, J. (1988). Statistical power analysis for the behavioural sciences. New York: Academic Press.Google Scholar
  50. 50.
    Guillemin, F., Bombardier, C., & Beaton, D. (1993). Cross-cultural adaptation of health-related quality of life measures: Literature review and proposed guidelines. Journal of Clinical Epidemiology, 46, 1417–1432.CrossRefGoogle Scholar
  51. 51.
    Cohen, J. (1992). A power primer. Psychological Bulletin, 112, 155–159.CrossRefGoogle Scholar
  52. 52.
    Hays, R. D., & Woolley, J. M. (2000). The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics, 18, 419–423.CrossRefGoogle Scholar
  53. 53.
    Schmitt, J. S., & Di Fabio, R. P. (2004). Reliable change and minimum important difference (MID) proportions facilitated group responsiveness comparisons using individual threshold criteria. Journal of Clinical Epidemiology, 57, 1008–1018.CrossRefGoogle Scholar
  54. 54.
    Wyrwich, K. W., Tierney, W. M., & Wolinsky, F. D. (2002). Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Quality of Life Research, 11, 1–7.CrossRefGoogle Scholar
  55. 55.
    de Boer, M. R., de Vet, H. C., Terwee, C. B., Moll, A. C., Volker-Dieben, H. J., & van Rens, G. H. (2005). Changes to the subscales of two vision-related quality of life questionnaires are proposed. Journal of Clinical Epidemiology, 58, 1260–1268.CrossRefGoogle Scholar
  56. 56.
    Brazier, J. E., Harper, R., Munro, J., Walters, S. J., & Snaith, M. L. (1999). Generic and condition-specific outcome measures for people with osteoarthritis of the knee. Rheumatology, 38, 870–877.CrossRefGoogle Scholar
  57. 57.
    Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of Life Research, 14, 1523–1532.CrossRefGoogle Scholar
  58. 58.
    Terwee, C. B., Dekker, F. W., Mourits, M. P., Gerding, M. N., Baldeschi, L., Kalmann, R., et al. (2001). Interpretation and validity of changes in scores on the Graves’ ophthalmopathy quality of life questionnaire (GO-QOL) after different treatments. Clinical Endocrinology (Oxford), 54, 391–398.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  • Amaia Bilbao
    • 1
    • 2
  • Lidia García-Pérez
    • 2
    • 3
  • Juan Carlos Arenaza
    • 2
    • 4
  • Isidoro García
    • 5
  • Gloria Ariza-Cardiel
    • 2
    • 6
  • Elisa Trujillo-Martín
    • 7
  • Maria João Forjaz
    • 2
    • 8
  • Jesús Martín-Fernández
    • 2
    • 9
    • 10
  1. 1.Research UnitBasurto University Hospital (Osakidetza)BilbaoSpain
  2. 2.Health Service Research Network on Chronic Diseases (REDISSEC)BilbaoSpain
  3. 3.Canary Foundation for Health Research (FUNCANIS)La LagunaSpain
  4. 4.Traumatology and Orthopedic Surgery ServiceBasurto University Hospital (Osakidetza)BilbaoSpain
  5. 5.Traumatology and Orthopedic Surgery ServiceGaldakao-Usansolo Hospital (Osakidetza)GaldakaoSpain
  6. 6.Multiprofessional Teaching Unit of Primary and Community Care, Primary Healthcare ManagementMadrid Health ServiceMadridSpain
  7. 7.Rheumatology ServiceUniversity Hospital of the Canary IslandsTenerifeSpain
  8. 8.Carlos III Health InstituteNational School of Public HealthMadridSpain
  9. 9.Villamanta Clinic, Navalcarnero Health CentreMadrid Health ServiceMadridSpain
  10. 10.Health Sciences FacultyRey Juan Carlos UniversityMadridSpain

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