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

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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.

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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

References

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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. 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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    PubMed  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  19. EuroQol, G. (1990). EuroQol—A new facility for the measurement of health-related quality of life. Health Policy, 16(3), 199–208.

    Article  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  27. Bohannon, R. W., & Smith, M. B. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Physical Therapy, 67(2), 206–207.

    CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  30. Council, M. R. (1976). Aids to examination of the peripheral nervous system. London: Her Majesty’s Stationary Office.

    Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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. 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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  44. De Vet, H. C., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). Measurement in medicine. Cambridge: Cambridge University Press.

    Book  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

  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.

    CAS  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  49. Wright, J. G., & Young, N. L. (1997). A comparison of different indices of responsiveness. Journal of Clinical Epidemiology, 50(3), 239–246.

    Article  CAS  PubMed  Google Scholar 

  50. Cohen, J. (1988). Statistical power analysis for the behavior sciences. Hillsdale, NJ: Lawrence Erlbaum Associates.

    Google Scholar 

  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.

    PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  55. Ahlsio, B., Britton, M., Murray, V., & Theorell, T. (1984). Disablement and quality of life after stroke. Stroke, 15(5), 886–890.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  PubMed Central  Google Scholar 

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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.

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    Authors and Affiliations

    1. Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, 259 Wenhua 1st Road, Taoyuan, Taiwan

      Poyu Chen, Rong-Jiuan Liing & Ching-Yi Wu

    2. School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan

      Keh-Chung Lin

    3. Division of Occupational Therapy, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan

      Keh-Chung Lin

    4. Healthy Aging Research Center, Chang Gung University, Taoyuan, Taiwan

      Ching-Yi Wu

    5. Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Taoyuan, Taiwan

      Chia-Ling Chen

    6. Graduate Institute of Early Intervention, College of Medicine, Chang Gung University, Taoyuan, Taiwan

      Chia-Ling Chen

    7. Department of Neurology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

      Ku-Chou Chang

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    Chen, P., Lin, KC., Liing, RJ. et al. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation. Qual Life Res 25, 1585–1596 (2016). https://doi.org/10.1007/s11136-015-1196-z

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