Advertisement

Quality of Life Research

, Volume 25, Issue 6, pp 1585–1596 | Cite as

Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation

  • Poyu Chen
  • Keh-Chung Lin
  • Rong-Jiuan Liing
  • Ching-Yi WuEmail author
  • Chia-Ling Chen
  • Ku-Chou Chang
Article

Abstract

Purpose

To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke.

Methods

The EQ-5D-5L, along with four criterion measures—the Medical Research Council scales for muscle strength, the Fugl–Meyer assessment, the functional independence measure, and the Stroke Impact Scale—was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported.

Results

Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %).

Conclusions

The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

Keywords

Stroke Quality of life Rehabilitation Validity MCID EQ-5D-5L 

Abbreviations

ES

Effect size

FIM

Functional independence measure

FMA

Fugl–Meyer assessment

HRQoL

Health-related quality of life

MCID

Minimal clinically important difference

MMSE

Mini-Mental State Examination

MRC

Medical Research Council scales for muscle strength

SIS

Stroke Impact Scale

SRM

Standardized response mean

UE

Upper extremity

VAS

Visual analog scale

Notes

Acknowledgments

This study was supported in part by the National Health Research Institutes, NHRI-EX104-10403PI (K.C.L), the Ministry of Science and Technology, 102-2628-B-182-005-MY3 (C.Y.W), and 103-2314-B-182-004-MY3 (C.Y.W), 104-2314-B-002-019-MY3 (K.C.L), Healthy Ageing Research Center at Chang Gung University, EMRPD1E1711 (C.Y.W), and Chang Gung Memorial Hospital, CMRPD1B0332 (C.Y.W), CMRPD1C0403 (C.Y.W) in Taiwan.

Compliance with ethical standards

Conflict of interest

No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

Informed consent

The institutional review board at each participating site approved the study, and all participants signed a consent form before entry into the study.

References

  1. 1.
    Go, A. S., Mozaffarian, D., Roger, V. L., Benjamin, E. J., Berry, J. D., Borden, W. B., et al. (2013). Heart disease and stroke statistics—2013 update: A report from the American Heart Association. Circulation, 127(1), e6–e245. doi: 10.1161/CIR.0b013e31828124ad.CrossRefPubMedGoogle Scholar
  2. 2.
    Lai, S. M., Perera, S., Duncan, P. W., & Bode, R. (2003). Physical and social functioning after stroke: Comparison of the Stroke Impact Scale and Short Form-36. Stroke, 34(2), 488–493.CrossRefPubMedGoogle Scholar
  3. 3.
    Golomb, B. A., Vickrey, B. G., & Hays, R. D. (2001). A review of health-related quality-of-life measures in stroke. Pharmacoeconomics, 19(2), 155–185.CrossRefPubMedGoogle Scholar
  4. 4.
    Schipper, H., Clinch, J. J., & Olweny, C. L. M. (1996). Quality of life studies: Definitions and conceptual issues. In B. Spilker (Ed.), Quality of life and pharmacoeconomics in clinical trials (pp. 11–23). Philadelphia, PA: Lippincott-Raven Publishers.Google Scholar
  5. 5.
    Carod-Artal, F. J., & Egido, J. A. (2009). Quality of life after stroke: The importance of a good recovery. Cerebrovascular Diseases, 27(Suppl 1), 204–214. doi: 10.1159/000200461.CrossRefPubMedGoogle Scholar
  6. 6.
    Pickard, A. S., Johnson, J. A., & Feeny, D. H. (2005). Responsiveness of generic health-related quality of life measures in stroke. Quality of Life Research, 14(1), 207–219.CrossRefPubMedGoogle Scholar
  7. 7.
    Gray, L. J., Sprigg, N., Bath, P. M., Boysen, G., De Deyn, P. P., Leys, D., et al. (2007). Sex differences in quality of life in stroke survivors: Data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST). Stroke, 38(11), 2960–2964. doi: 10.1161/STROKEAHA.107.488304.CrossRefPubMedGoogle Scholar
  8. 8.
    Alguren, B., Fridlund, B., Cieza, A., Sunnerhagen, K. S., & Christensson, L. (2012). Factors associated with health-related quality of life after stroke: A 1-year prospective cohort study. Neurorehabilitation and Neural Repair, 26(3), 266–274. doi: 10.1177/1545968311414204.CrossRefPubMedGoogle Scholar
  9. 9.
    Lin, K. C., Fu, T., Wu, C. Y., & Hsieh, C. J. (2011). Assessing the stroke-specific quality of life for outcome measurement in stroke rehabilitation: Minimal detectable change and clinically important difference. Health and Quality of Life Outcomes, 9, 5. doi: 10.1186/1477-7525-9-5.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Brazier, J., Jones, N., & Kind, P. (1993). Testing the validity of the Euroqol and comparing it with the SF-36 health survey questionnaire. Quality of Life Research, 2, 169–180.CrossRefPubMedGoogle Scholar
  11. 11.
    Harrison, M. J., Lunt, M., Verstappen, S. M., Watson, K. D., Bansback, N. J., & Symmons, D. P. (2010). Exploring the validity of estimating EQ-5D and SF-6D utility values from the health assessment questionnaire in patients with inflammatory arthritis. Health and Quality of Life Outcomes, 8, 21. doi: 10.1186/1477-7525-8-21.CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Linde, L., Sorensen, J., Ostergaard, M., Horslev-Petersen, K., & Hetland, M. L. (2008). Health-related quality of life: Validity, reliability, and responsiveness of SF-36, 15D, EQ-5D RAQoL, and HAQ in patients with rheumatoid arthritis. Journal of Rheumatology, 35(8), 1528–1537.PubMedGoogle Scholar
  13. 13.
    Obradovic, M., Lal, A., & Liedgens, H. (2013). Validity and responsiveness of EuroQol-5 dimension (EQ-5D) versus Short Form-6 dimension (SF-6D) questionnaire in chronic pain. Health and Quality of Life Outcomes, 11, 110. doi: 10.1186/1477-7525-11-110.CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Dorman, P., Slattery, J., Farrell, B., Dennis, M., & Sandercock, P. (1998). Qualitative comparison of the reliability of health status assessments with the EuroQol and SF-36 questionnaires after stroke. United Kingdom Collaborators in the International Stroke Trial. Stroke, 29(1), 63–68.CrossRefPubMedGoogle Scholar
  15. 15.
    Dorman, P. J., Dennis, M., & Sandercock, P. (1999). How do scores on the EuroQol relate to scores on the SF-36 after stroke? Stroke, 30(10), 2146–2151.CrossRefPubMedGoogle Scholar
  16. 16.
    Dorman, P. J., Slattery, J., Farrell, B., Dennis, M. S., & Sandercock, P. A. (1997). A randomised comparison of the EuroQol and Short Form-36 after stroke. United Kingdom collaborators in the International Stroke Trial. BMJ, 315(7106), 461.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Dorman, P. J., Waddell, F., Slattery, J., Dennis, M., & Sandercock, P. (1997). Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke, 28(10), 1876–1882.CrossRefPubMedGoogle Scholar
  18. 18.
    Hunger, M., Sabariego, C., Stollenwerk, B., Cieza, A., & Leidl, R. (2012). Validity, reliability and responsiveness of the EQ-5D in German stroke patients undergoing rehabilitation. Quality of Life Research, 21(7), 1205–1216. doi: 10.1007/s11136-011-0024-3.CrossRefPubMedGoogle Scholar
  19. 19.
    EuroQol, G. (1990). EuroQol—A new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.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 Research, 20(10), 1727–1736. doi: 10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    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(7), 1717–1727. doi: 10.1007/s11136-012-0322-4.CrossRefPubMedPubMedCentralGoogle Scholar
  22. 22.
    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(4), 845–850. doi: 10.1007/s11136-014-0834-1.CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Golicki, D., Niewada, M., Karlinska, A., Buczek, J., Kobayashi, A., Janssen, M. F., et al. (2014). Comparing responsiveness of the EQ-5D-5L, EQ-5D-3L and EQ VAS in stroke patients. Quality of Life Research, 24(6), 1555–1563. doi: 10.1007/s11136-014-0873-7.CrossRefPubMedPubMedCentralGoogle Scholar
  24. 24.
    Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102–109. doi: 10.1016/j.jclinepi.2007.03.012.CrossRefPubMedGoogle Scholar
  25. 25.
    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(5), 419–423.CrossRefPubMedGoogle Scholar
  26. 26.
    Crum, R. M., Anthony, J. C., Bassett, S. S., & Folstein, M. F. (1993). Population-based norms for the Mini-Mental State Examination by age and educational level. JAMA, 269(18), 2386–2391.CrossRefPubMedGoogle Scholar
  27. 27.
    Bohannon, R. W., & Smith, M. B. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Physical Therapy, 67(2), 206–207.PubMedGoogle Scholar
  28. 28.
    van Hout, B., Janssen, M. F., Feng, Y. S., Kohlmann, T., Busschbach, J., Golicki, D., et al. (2012). Interim scoring for the EQ-5D-5L: Mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health, 15(5), 708–715. doi: 10.1016/j.jval.2012.02.008.CrossRefPubMedGoogle Scholar
  29. 29.
    Tsuchiya, A., Ikeda, S., Ikegami, N., Nishimura, S., Sakai, I., Fukuda, T., et al. (2002). Estimating an EQ-5D population value set: The case of Japan. Health Economics, 11(4), 341–353. doi: 10.1002/hec.673.CrossRefPubMedGoogle Scholar
  30. 30.
    Council, M. R. (1976). Aids to examination of the peripheral nervous system. London: Her Majesty’s Stationary Office.Google Scholar
  31. 31.
    Swash, M., Brown, M. M., & Thakkar, C. (1995). CT muscle imaging and the clinical assessment of neuromuscular disease. Muscle and Nerve, 18(7), 708–714. doi: 10.1002/mus.880180706.CrossRefPubMedGoogle Scholar
  32. 32.
    Tzvetanov, P., & Rousseff, R. T. (2003). Median SSEP changes in hemiplegic stroke: Long-term predictive values regarding ADL recovery. NeuroRehabilitation, 18(4), 317–324.PubMedGoogle Scholar
  33. 33.
    Paternostro-Sluga, T., Grim-Stieger, M., Posch, M., Schuhfried, O., Vacariu, G., Mittermaier, C., et al. (2008). Reliability and validity of the Medical Research Council (MRC) scale and a modified scale for testing muscle strength in patients with radial palsy. Journal of Rehabilitation Medicine, 40(8), 665–671. doi: 10.2340/16501977-0235.CrossRefPubMedGoogle Scholar
  34. 34.
    Fugel-Meyer, A. R., Jaasko, L., Leyman, I., Ollson, S., & Steglind, S. (1975). The poststroke hemiplegic patient. 1. A method for evaluation of physical performance. Scandinavian Journal of Rehabilitation Medicine, 7, 13–31.Google Scholar
  35. 35.
    Platz, T., Pinkowski, C., van Wijck, F., Kim, I. H., di Bella, P., & Johnson, G. (2005). Reliability and validity of arm function assessment with standardized guidelines for the Fugl–Meyer Test, Action Research Arm Test and Box and Block Test: A multicentre study. Clinical Rehabilitation, 19(4), 404–411.CrossRefPubMedGoogle Scholar
  36. 36.
    Hsieh, Y. W., Wu, C. Y., Lin, K. C., Chang, Y. F., Chen, C. L., & Liu, J. S. (2009). Responsiveness and validity of three outcome measures of motor function after stroke rehabilitation. Stroke, 40(4), 1386–1391. doi: 10.1161/STROKEAHA.108.530584.CrossRefPubMedGoogle Scholar
  37. 37.
    Cohen, M. E., & Marino, R. J. (2000). The tools of disability outcomes research functional status measures. Archives of Physical Medicine and Rehabilitation, 81(12 Suppl 2), S21–S29.CrossRefPubMedGoogle Scholar
  38. 38.
    Granger, C. V. (1998). The emerging science of functional assessment: Our tool for outcomes analysis. Archives of Physical Medicine and Rehabilitation, 79(3), 235–240.CrossRefPubMedGoogle Scholar
  39. 39.
    Chau, N., Daler, S., Andre, J. M., & Patris, A. (1994). Inter-rater agreement of two functional independence scales: The Functional Independence Measure (FIM) and a subjective uniform continuous scale. Disability and Rehabilitation, 16(2), 63–71.CrossRefPubMedGoogle Scholar
  40. 40.
    Dodds, T. A., Martin, D. P., Stolov, W. C., & Deyo, R. A. (1993). A validation of the functional independence measurement and its performance among rehabilitation inpatients. Archives of Physical Medicine and Rehabilitation, 74(5), 531–536.CrossRefPubMedGoogle Scholar
  41. 41.
    Wallace, D., Duncan, P. W., & Lai, S. M. (2002). Comparison of the responsiveness of the Barthel Index and the motor component of the Functional Independence Measure in stroke: The impact of using different methods for measuring responsiveness. Journal of Clinical Epidemiology, 55(9), 922–928.CrossRefPubMedGoogle Scholar
  42. 42.
    Carod-Artal, F. J., Coral, L. F., Trizotto, D. S., & Moreira, C. M. (2008). The stroke impact scale 3.0: Evaluation of acceptability, reliability, and validity of the Brazilian version. Stroke, 39(9), 2477–2484. doi: 10.1161/STROKEAHA.107.513671.CrossRefPubMedGoogle Scholar
  43. 43.
    Lin, K. C., Fu, T., Wu, C. Y., Hsieh, Y. W., Chen, C. L., & Lee, P. C. (2010). Psychometric comparisons of the Stroke Impact Scale 3.0 and Stroke-Specific Quality of Life Scale. Quality of Life Research, 19(3), 435–443. doi: 10.1007/s11136-010-9597-5.CrossRefPubMedGoogle Scholar
  44. 44.
    De Vet, H. C., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. Cambridge: Cambridge University Press.CrossRefGoogle Scholar
  45. 45.
    Nichols-Larsen, D. S., Clark, P. C., Zeringue, A., Greenspan, A., & Blanton, S. (2005). Factors influencing stroke survivors’ quality of life during subacute recovery. Stroke, 36(7), 1480–1484. doi: 10.1161/01.STR.0000170706.13595.4f.CrossRefPubMedGoogle Scholar
  46. 46.
    Sidiras, G., Patsaki, I., Dakoutrou, M., Karatzanos, E., Gerovasili, V., Kouvarakos, A., et al. (2012). Muscle strength assessment of critically ill patients is associated with functional ability and quality of life at hospital discharge. Paper presented at the 32nd international symposium on intensive care and emergency medicine, Brussels, Belgium.Google Scholar
  47. 47.
    Abubakar, S. A., & Isezuo, S. A. (2012). Health related quality of life of stroke survivors: Experience of a stroke unit. International Journal of Biomedical Sciences, 8(3), 183–187.Google Scholar
  48. 48.
    Husted, J. A., Cook, R. J., Farewell, V. T., & Gladman, D. D. (2000). Methods for assessing responsiveness: A critical review and recommendations. Journal of Clinical Epidemiology, 53(5), 459–468.CrossRefPubMedGoogle Scholar
  49. 49.
    Wright, J. G., & Young, N. L. (1997). A comparison of different indices of responsiveness. Journal of Clinical Epidemiology, 50(3), 239–246.CrossRefPubMedGoogle Scholar
  50. 50.
    Cohen, J. (1988). Statistical power analysis for the behavior sciences. Hillsdale, NJ: Lawrence Erlbaum Associates.Google Scholar
  51. 51.
    Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41(5), 582–592. doi: 10.1097/01.MLR.0000062554.74615.4C.PubMedGoogle Scholar
  52. 52.
    Lin, K. C., Fu, T., Wu, C. Y., Wang, Y. H., Liu, J. S., Hsieh, C. J., et al. (2010). Minimal detectable change and clinically important difference of the Stroke Impact Scale in stroke patients. Neurorehabilitation and Neural Repair, 24(5), 486–492. doi: 10.1177/1545968309356295.CrossRefPubMedGoogle Scholar
  53. 53.
    Duncan, P. W., Wallace, D., Lai, S. M., Johnson, D., Embretson, S., & Laster, L. J. (1999). The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Stroke, 30(10), 2131–2140.CrossRefPubMedGoogle Scholar
  54. 54.
    Zorowitz, R. D., Smout, R. J., Gassaway, J. A., & Horn, S. D. (2005). Usage of pain medications during stroke rehabilitation: The Post-Stroke Rehabilitation Outcomes Project (PSROP). Topics in Stroke Rehabilitation, 12(4), 37–49. doi: 10.1310/C7MF-VLR0-CKDL-3C44.CrossRefPubMedGoogle Scholar
  55. 55.
    Ahlsio, B., Britton, M., Murray, V., & Theorell, T. (1984). Disablement and quality of life after stroke. Stroke, 15(5), 886–890.CrossRefPubMedGoogle Scholar
  56. 56.
    Sagberg, L. M., Jakola, A. S., & Solheim, O. (2013). Quality of life assessed with EQ-5D in patients undergoing glioma surgery: What is the responsiveness and minimal clinically important difference? Quality of Life Research, 23(5), 1427–1434. doi: 10.1007/s11136-013-0593-4.CrossRefPubMedGoogle Scholar
  57. 57.
    Pickard, A. S., Neary, M. P., & Cella, D. (2007). Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health and Quality of Life Outcomes, 5, 70.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Poyu Chen
    • 1
  • Keh-Chung Lin
    • 2
    • 3
  • Rong-Jiuan Liing
    • 1
  • Ching-Yi Wu
    • 1
    • 4
    Email author
  • Chia-Ling Chen
    • 5
    • 6
  • Ku-Chou Chang
    • 7
  1. 1.Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of MedicineChang Gung UniversityTaoyuanTaiwan
  2. 2.School of Occupational Therapy, College of MedicineNational Taiwan UniversityTaipeiTaiwan
  3. 3.Division of Occupational Therapy, Department of Physical Medicine and RehabilitationNational Taiwan University HospitalTaipeiTaiwan
  4. 4.Healthy Aging Research CenterChang Gung UniversityTaoyuanTaiwan
  5. 5.Department of Physical Medicine and RehabilitationChang Gung Memorial HospitalTaoyuanTaiwan
  6. 6.Graduate Institute of Early Intervention, College of MedicineChang Gung UniversityTaoyuanTaiwan
  7. 7.Department of NeurologyChang Gung Memorial HospitalKaohsiungTaiwan

Personalised recommendations