Skip to main content
Erschienen in: Quality of Life Research 1/2016

01.01.2016

Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method

verfasst von: David Thissen, Yang Liu, Brooke Magnus, Hally Quinn, Debbie S. Gipson, Carlton Dampier, I-Chan Huang, Pamela S. Hinds, David T. Selewski, Bryce B. Reeve, Heather E. Gross, Darren A. DeWalt

Erschienen in: Quality of Life Research | Ausgabe 1/2016

Einloggen, um Zugang zu erhalten

Abstract

Objective

To assess minimally important differences (MIDs) for several pediatric self-report item banks from the National Institutes of Health Patient-Reported Outcomes Measurement Information System® (PROMIS®).

Methods

We presented vignettes comprising sets of two completed PROMIS questionnaires and asked judges to declare whether the individual completing those questionnaires had an important change or not. We enrolled judges (including adolescents, parents, and clinicians) who responded to 24 vignettes (six for each domain of depression, pain interference, fatigue, and mobility). We used item response theory to model responses to the vignettes across different judges and estimated MID as the point at which 50 % of the judges would declare an important change.

Results

We enrolled 246 judges (78 adolescents, 85 parents, and 83 clinicians). The MID estimated with clinician data was about 2 points on the PROMIS T-score scale, and the MID estimated with adolescent and parent data was about 3 points on that same scale.

Conclusions

The MIDs enhance the value of PROMIS pediatric measures in clinical research studies to identify meaningful changes in health status over time.
Literatur
1.
Zurück zum Zitat Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., & Norman, G. R. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77(4), 371–383. doi:10.4065/77.4.371.PubMedCrossRef Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., & Norman, G. R. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77(4), 371–383. doi:10.​4065/​77.​4.​371.PubMedCrossRef
4.
Zurück zum Zitat Wells, G., Li, T., Maxwell, L., MacLean, R., & Tugwell, P. (2007). Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. Journal of Rheumatology, 34(2), 280–289.PubMed Wells, G., Li, T., Maxwell, L., MacLean, R., & Tugwell, P. (2007). Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. Journal of Rheumatology, 34(2), 280–289.PubMed
5.
Zurück zum Zitat Bellamy, N., Anastassiades, T. P., Buchanan, W. W., Davis, P., Lee, P., McCain, G. A., et al. (1991). Rheumatoid arthritis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs—Results of a consensus development (Delphi) exercise. Journal of Rheumatology, 18(12), 1908–1915.PubMed Bellamy, N., Anastassiades, T. P., Buchanan, W. W., Davis, P., Lee, P., McCain, G. A., et al. (1991). Rheumatoid arthritis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs—Results of a consensus development (Delphi) exercise. Journal of Rheumatology, 18(12), 1908–1915.PubMed
6.
Zurück zum Zitat Bellamy, N., Buchanan, W. W., Esdaile, J. M., Fam, A. G., Kean, W. F., Thompson, J. M., et al. (1991). Ankylosing spondylitis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs—Results of a consensus development (Delphi) exercise. Journal of Rheumatology, 18(11), 1716–1722.PubMed Bellamy, N., Buchanan, W. W., Esdaile, J. M., Fam, A. G., Kean, W. F., Thompson, J. M., et al. (1991). Ankylosing spondylitis antirheumatic drug trials. III. Setting the delta for clinical trials of antirheumatic drugs—Results of a consensus development (Delphi) exercise. Journal of Rheumatology, 18(11), 1716–1722.PubMed
7.
Zurück zum Zitat Bellamy, N., Carette, S., Ford, P. M., Kean, W. F., le Riche, N. G., Lussier, A., et al. (1992). Osteoarthritis antirheumatic drug trials. III. Setting the delta for clinical trials–results of a consensus development (Delphi) exercise. Journal of Rheumatology, 19(3), 451–457.PubMed Bellamy, N., Carette, S., Ford, P. M., Kean, W. F., le Riche, N. G., Lussier, A., et al. (1992). Osteoarthritis antirheumatic drug trials. III. Setting the delta for clinical trials–results of a consensus development (Delphi) exercise. Journal of Rheumatology, 19(3), 451–457.PubMed
8.
Zurück zum Zitat Spiegel, B. M., Younossi, Z. M., Hays, R. D., Revicki, D., Robbins, S., & Kanwal, F. (2005). Impact of hepatitis C on health related quality of life: A systematic review and quantitative assessment. Hepatology, 41(4), 790–800. doi:10.1002/hep.20659.PubMedCrossRef Spiegel, B. M., Younossi, Z. M., Hays, R. D., Revicki, D., Robbins, S., & Kanwal, F. (2005). Impact of hepatitis C on health related quality of life: A systematic review and quantitative assessment. Hepatology, 41(4), 790–800. doi:10.​1002/​hep.​20659.PubMedCrossRef
9.
Zurück zum Zitat Wyrwich, K. W., Metz, S. M., Kroenke, K., Tierney, W. M., Babu, A. N., & Wolinsky, F. D. (2007). Triangulating patient and clinician perspectives on clinically important differences in health-related quality of life among patients with heart disease. Health Services Research, 42(6 Pt 1), 2257–2274. doi:10.1111/j.1475-6773.2007.00733.x. Wyrwich, K. W., Metz, S. M., Kroenke, K., Tierney, W. M., Babu, A. N., & Wolinsky, F. D. (2007). Triangulating patient and clinician perspectives on clinically important differences in health-related quality of life among patients with heart disease. Health Services Research, 42(6 Pt 1), 2257–2274. doi:10.​1111/​j.​1475-6773.​2007.​00733.​x.
10.
Zurück zum Zitat Rai, S. K., Yazdany, J., Fortin, P. R., & Avina-Zubieta, J. A. (2015). Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Research & Therapy, 17, 143. doi:10.1186/s13075-015-0658-6.CrossRef Rai, S. K., Yazdany, J., Fortin, P. R., & Avina-Zubieta, J. A. (2015). Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Research & Therapy, 17, 143. doi:10.​1186/​s13075-015-0658-6.CrossRef
11.
Zurück zum Zitat van Walraven, C., Mahon, J. L., Moher, D., Bohm, C., & Laupacis, A. (1999). Surveying physicians to determine the minimal important difference: Implications for sample-size calculation. Journal of Clinical Epidemiology, 52(8), 717–723. doi:10.1016/S0895-4356(99)00050-5.PubMedCrossRef van Walraven, C., Mahon, J. L., Moher, D., Bohm, C., & Laupacis, A. (1999). Surveying physicians to determine the minimal important difference: Implications for sample-size calculation. Journal of Clinical Epidemiology, 52(8), 717–723. doi:10.​1016/​S0895-4356(99)00050-5.PubMedCrossRef
14.
Zurück zum Zitat Gong, G. W., Young, N. L., Dempster, H., Porepa, M., & Feldman, B. M. (2007). The Quality of My Life questionnaire: The minimal clinically important difference for pediatric rheumatology patients. Journal of Rheumatology, 34(3), 581–587.PubMed Gong, G. W., Young, N. L., Dempster, H., Porepa, M., & Feldman, B. M. (2007). The Quality of My Life questionnaire: The minimal clinically important difference for pediatric rheumatology patients. Journal of Rheumatology, 34(3), 581–587.PubMed
15.
Zurück zum Zitat Kingston, N. M., Kahl, S. R., Sweeney, K. P., & Bay, L. (2001). Setting performance standards using the body of work method. In G. J. Cizek (Ed.), Setting performance standards: Concepts, methods, and perspectives (pp. 219–248). Mahwah, NJ: Lawrence Erlbaum Associates Inc. Kingston, N. M., Kahl, S. R., Sweeney, K. P., & Bay, L. (2001). Setting performance standards using the body of work method. In G. J. Cizek (Ed.), Setting performance standards: Concepts, methods, and perspectives (pp. 219–248). Mahwah, NJ: Lawrence Erlbaum Associates Inc.
16.
Zurück zum Zitat Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J. S., et al. (2014). Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment. Quality of Life Research,. doi:10.1007/s11136-014-0732-6. Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J. S., et al. (2014). Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment. Quality of Life Research,. doi:10.​1007/​s11136-014-0732-6.
17.
Zurück zum Zitat Cook, K. F., Victorson, D. E., Cella, D., Schalet, B. D., & Miller, D. (2015). Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning and sleep disturbance using standard setting with patients and providers. Quality of Life Research, 24(3), 575–589. doi:10.1007/s11136-014-0790-9.PubMedCrossRef Cook, K. F., Victorson, D. E., Cella, D., Schalet, B. D., & Miller, D. (2015). Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning and sleep disturbance using standard setting with patients and providers. Quality of Life Research, 24(3), 575–589. doi:10.​1007/​s11136-014-0790-9.PubMedCrossRef
18.
Zurück zum Zitat Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 19(4), 595–607. doi:10.1007/s11136-010-9619-3.CrossRef Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 19(4), 595–607. doi:10.​1007/​s11136-010-9619-3.CrossRef
20.
Zurück zum Zitat Lai, J. S., Stucky, B. D., Thissen, D., Varni, J. W., Dewitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS® pediatric fatigue item banks. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation,. doi:10.1007/s11136-013-0357-1. Lai, J. S., Stucky, B. D., Thissen, D., Varni, J. W., Dewitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS® pediatric fatigue item banks. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation,. doi:10.​1007/​s11136-013-0357-1.
21.
Zurück zum Zitat Dewitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item Patient-Reported Outcomes Measurement Information System pediatric physical function scales: Built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804. doi:10.1016/j.jclinepi.2010.10.012.PubMedPubMedCentralCrossRef Dewitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item Patient-Reported Outcomes Measurement Information System pediatric physical function scales: Built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804. doi:10.​1016/​j.​jclinepi.​2010.​10.​012.PubMedPubMedCentralCrossRef
22.
Zurück zum Zitat Qualtrics. (2013). Qualtrics research suite (version 37892). Provo, UT. Qualtrics. (2013). Qualtrics research suite (version 37892). Provo, UT.
23.
Zurück zum Zitat Robinson-Cimpian, J. P. (2014). Inaccurate estimation of disparities due to mischievous responders: Several suggestions to assess conclusions. Educational Researcher, 43(4), 171–185. doi:10.3102/0013189x14534297.CrossRef Robinson-Cimpian, J. P. (2014). Inaccurate estimation of disparities due to mischievous responders: Several suggestions to assess conclusions. Educational Researcher, 43(4), 171–185. doi:10.​3102/​0013189x14534297​.CrossRef
26.
Zurück zum Zitat Copay, A. G., Glassman, S. D., Subach, B. R., Berven, S., Schuler, T. C., & Carreon, L. Y. (2008). Minimum clinically important difference in lumbar spine surgery patients: A choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. The Spine Journal, 8(6), 968–974. doi:10.1016/j.spinee.2007.11.006.PubMedCrossRef Copay, A. G., Glassman, S. D., Subach, B. R., Berven, S., Schuler, T. C., & Carreon, L. Y. (2008). Minimum clinically important difference in lumbar spine surgery patients: A choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. The Spine Journal, 8(6), 968–974. doi:10.​1016/​j.​spinee.​2007.​11.​006.PubMedCrossRef
28.
Zurück zum Zitat Demyttenaere, K., Desaiah, D., Petit, C., Croenlein, J., & Brecht, S. (2009). Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Primary Care Companion to the Journal of Clinical Psychiatry, 11(1), 8–15. doi:10.4088/PCC.08m00670.PubMedPubMedCentralCrossRef Demyttenaere, K., Desaiah, D., Petit, C., Croenlein, J., & Brecht, S. (2009). Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Primary Care Companion to the Journal of Clinical Psychiatry, 11(1), 8–15. doi:10.​4088/​PCC.​08m00670.PubMedPubMedCentralCrossRef
Metadaten
Titel
Estimating minimally important difference (MID) in PROMIS pediatric measures using the scale-judgment method
verfasst von
David Thissen
Yang Liu
Brooke Magnus
Hally Quinn
Debbie S. Gipson
Carlton Dampier
I-Chan Huang
Pamela S. Hinds
David T. Selewski
Bryce B. Reeve
Heather E. Gross
Darren A. DeWalt
Publikationsdatum
01.01.2016
Verlag
Springer International Publishing
Erschienen in
Quality of Life Research / Ausgabe 1/2016
Print ISSN: 0962-9343
Elektronische ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-015-1058-8

Weitere Artikel der Ausgabe 1/2016

Quality of Life Research 1/2016 Zur Ausgabe