Skip to main content
Log in

Responsiveness of the Quality of Life in Epilepsy Inventory (QOLIE-89) in an Antiepileptic Drug Trial

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

This study examined relationships among responsiveness indices for health-related quality of life (HRQOL) measures administered to adults with epilepsy enrolled in an antiepileptic drug trial. The Quality of Life in Epilepsy (QOLIE)-89 was completed at baseline and at a 28-week follow-up. Six responsiveness indices (effect size (ES), standardized response mean (SRM), responsiveness statistic, paired t-test, area under receiver operating characteristic curve or ROC, F-statistic) were calculated for each of the 16 QOLIE-89 scales, using two different external criteria for clinically significant change: (1) attainment of freedom from seizures with altered awareness, and (2) a two-category improvement between baseline and follow-up in a self-rating of the subject's overall condition. Spearman correlations among the six responsiveness indices for the 16 QOLIE-89 scales tended to be moderate to large (Spearman's ρ = 0.53–1.00; p's > 0.05 for 29 out of the 30 correlations). Rankings of the 16 scales across the two external criteria for change were similar for the responsiveness statistic (Spearman's ρ = 0.62; p > 0.05), but dissimilar for the other responsiveness indices (all p > 0.05). Both ES and SRM were well predicted by the other indices, except for ROC, using regression modeling. In conclusion, results using different responsiveness indices are comparable for a given external criterion. However, only the responsiveness statistic yielded robust results across two different external criteria. Responsiveness of this HRQOL measure can be reported in terms of previously established benchmarks for ESs, which can be predicted from other indices.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Hays RD, Hadorn D. Responsiveness to change: An aspect of validity, not a separate dimension. Qual Life Res 1992; 1: 73–75.

    Google Scholar 

  2. Smith MY, Feldman J, Kelly P, DeHovitz JA, Chirgwin K, Minkoff H. Health-related quality of life of HIV-infected women: Evidence for the reliability, validity, and responsiveness of the Medical Outcomes Study Short-Form 20. Qual Life Res 1996; 5(1): 47–55.

    Google Scholar 

  3. Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: Validity, responsiveness and reliability of EuroQol (EQ-5D). J. Rheumatol 1997; 36(5): 551–559.

    Google Scholar 

  4. Murawski MM, Miederhoff PA. On the generalizability of statistical expressions of health related quality of life instrument responsiveness: A data synthesis. Qual Life Res 1998; 7: 11–22.

    Google Scholar 

  5. Stokler MR, Osoba D, Goodwin P, Corey P, Tannock IF. Responsiveness to change in health-related quality of life in a randomized clinical trial: Acomparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer. J Clin Epidemiol 1998; 51(2): 137–145.

    Google Scholar 

  6. Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 1999; 52: 861–873.

    Google Scholar 

  7. Wiebe S, Eliasziw M, Matijevic S. Changes in quality of life in epilepsy: How large must they be to be real? Epilepsia 2001; 42: 113–118.

    Google Scholar 

  8. Cramer JA, Arrigo C, Van Hammee T, Bromfield EB. Comparison between the QOLIE-31 and derived QOLIE-10 in a clinical trial of levetiracetam. Epilepsy Res 2000; 41: 29–38.

    Google Scholar 

  9. Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989; 27: S178–S189.

    Google Scholar 

  10. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care 1990; 28: 632–642.

    Google Scholar 

  11. Guyatt G, Walter S, Norman G. Measuring change over time: Assessing the usefulness of evaluative instruments. J Chron Dis 1987; 40(2): 171–178.

    Google Scholar 

  12. Liang MH, Larson MG, Cullen KE, Schwartz JA. Comparative measurement efficiency and sensitivity of five health status instruments for arthritis research. Arthrit Rheumatol 1985; 28: 545–547.

    Google Scholar 

  13. Deyo RA, Centor RM. Assessing the responsiveness of functional scales to clinical change: An analogy to diagnostic test performance. J Chronic Dis 1986; 39: 897–906.

    Google Scholar 

  14. Meenan RF, Anderson JJ, Kazis LE, et al. Outcome assessment in clinical trials. Evidence for the sensitivity of a health status measure. Arthritis Rheum 1984; 27: 1344–1352.

    Google Scholar 

  15. Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. London: Academic Press, 1988, pp. 18–25.

    Google Scholar 

  16. Cohen J. A power primer. Psychol Bull 1992; 112: 155–159.

    Google Scholar 

  17. Edwards K, Schiess M, Vickrey B, et al. Rational polytherapy with Sabril (vigabatrin) vs. carbamazepine or phenytoin monotherapy in the management of patients with complex partial seizures. Epilepsia 1998; 39(Suppl 6): 190.

    Google Scholar 

  18. Vickrey BG, Perrine KR, Hays RD, et al. Scoring Manual for the Quality of Life in Epilepsy Inventory (QOLIE)-89. Santa Monica, California, RAND, 1993.

    Google Scholar 

  19. Devinsky O, Vickrey BG, Cramer J, et al. Development of the quality of life in epilepsy inventory. Epilepsia 1995; 36: 1089–104.

    Google Scholar 

  20. Hays RD, Anderson RT, Revicki D. Assessing reliability and validity of measurement in clinical trials. In Staquet MJ, Hays RD, Fayers PM (eds), Quality of Life Assessment in Clinical Trials: Methods and Practice, Oxford, England: Oxford University Press, 1998; 169–182.

    Google Scholar 

  21. Birbeck GL, Kim S, Hays RD, Vickrey BG. Quality of life measures in epilepsy: How well can they detect change over time? Neurology 2000; 54: 1822–1827.

    Google Scholar 

  22. Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol 1995; 48: 1369–1378.

    Google Scholar 

  23. Wright JG, Young NL. Acomparison of different indices of responsiveness. J Clin Epidemiol 1997; 50: 239–246.

    Google Scholar 

  24. Deyo RA, Patrick D. Barriers to the use of health status measures in clinical investigation. Med Care 1989; 27: S254–S268.

    Google Scholar 

  25. Barber BL, Santanello NC, Epstein RS. Impact of the global on patient perceivable change in an asthma specific QOL questionnaire. Qual Life Res 1996; 5: 117–122.

    Google Scholar 

  26. Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR, and the Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures. Mayo Clinic Proc 2002; 77: 371–383.

    Google Scholar 

  27. Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res 1993; 2: 221–226.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kim, S., Hays, R.D., Birbeck, G.L. et al. Responsiveness of the Quality of Life in Epilepsy Inventory (QOLIE-89) in an Antiepileptic Drug Trial. Qual Life Res 12, 147–155 (2003). https://doi.org/10.1023/A:1022209105926

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/A:1022209105926

Navigation