Skip to main content
main-content
Top

Tip

Swipe om te navigeren naar een ander artikel

Gepubliceerd in: Quality of Life Research 3/2013

01-04-2013

Methods for interpreting change over time in patient-reported outcome measures

Auteurs: K. W. Wyrwich, J. M. Norquist, W. R. Lenderking, S. Acaster, the Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL)

Gepubliceerd in: Quality of Life Research | Uitgave 3/2013

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

Interpretation guidelines are needed for patient-reported outcome (PRO) measures’ change scores to evaluate efficacy of an intervention and to communicate PRO results to regulators, patients, physicians, and providers. The 2009 Food and Drug Administration (FDA) Guidance for Industry Patient-Reported Outcomes (PRO) Measures: Use in Medical Product Development to Support Labeling Claims (hereafter referred to as the final FDA PRO Guidance) provides some recommendations for the interpretation of change in PRO scores as evidence of treatment efficacy.

Methods

This article reviews the evolution of the methods and the terminology used to describe and aid in the communication of meaningful PRO change score thresholds.

Results

Anchor- and distribution-based methods have played important roles, and the FDA has recently stressed the importance of cross-sectional patient global assessments of concept as anchor-based methods for estimation of the responder definition, which describes an individual-level treatment benefit. The final FDA PRO Guidance proposes the cumulative distribution function (CDF) of responses as a useful method to depict the effect of treatments across the study population.

Conclusions

While CDFs serve an important role, they should not be a replacement for the careful investigation of a PRO’s relevant responder definition using anchor-based methods and providing stakeholders with a relevant threshold for the interpretation of change over time.
Literatuur
2.
go back to reference King, M. T. (2011). A point of minimal important difference (MID): A critique of terminology and methods. Expert review of pharmacoeconomics & outcomes research, 11(2), 171–184. CrossRef King, M. T. (2011). A point of minimal important difference (MID): A critique of terminology and methods. Expert review of pharmacoeconomics & outcomes research, 11(2), 171–184. CrossRef
3.
go back to reference Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133. Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133.
4.
go back to reference Burke, L. B., & Trenacosti, A. M. (2010). Interpretation of PRO trial results to support FDA labelling claims: the regulator perspective. International Society for Pharmacoecomomics and Outcomes Research 15th Annual International Meeting. Atlanta: GA. Burke, L. B., & Trenacosti, A. M. (2010). Interpretation of PRO trial results to support FDA labelling claims: the regulator perspective. International Society for Pharmacoecomomics and Outcomes Research 15th Annual International Meeting. Atlanta: GA.
5.
go back to reference Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status. Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10(4), 407–415. PubMedCrossRef Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status. Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10(4), 407–415. PubMedCrossRef
6.
go back to reference Guyatt, G. H., Berman, L. B., & Townsend, M. (1987). Long-term outcome after respiratory rehabilitation. Canadian Medical Association Journal, 137(12), 1089–1095. PubMed Guyatt, G. H., Berman, L. B., & Townsend, M. (1987). Long-term outcome after respiratory rehabilitation. Canadian Medical Association Journal, 137(12), 1089–1095. PubMed
7.
go back to reference Guyatt, G. H., Townsend, M., Nogradi, S., Pugsley, S. O., Keller, J. L., & Newhouse, M. T. (1988). Acute response to bronchodilator. An imperfect guide for bronchodilator therapy in chronic airflow limitation. Archives of Internal Medicine, 148(9), 1949–1952. PubMedCrossRef Guyatt, G. H., Townsend, M., Nogradi, S., Pugsley, S. O., Keller, J. L., & Newhouse, M. T. (1988). Acute response to bronchodilator. An imperfect guide for bronchodilator therapy in chronic airflow limitation. Archives of Internal Medicine, 148(9), 1949–1952. PubMedCrossRef
8.
go back to reference Guyatt, G. H., Sullivan, M. J., Fallen, E. L., Tihal, H., Rideout, E., Halcrow, S., et al. (1988). A controlled trial of digoxin in congestive heart failure. American Journal of Cardiology, 61(4), 371–375. PubMedCrossRef Guyatt, G. H., Sullivan, M. J., Fallen, E. L., Tihal, H., Rideout, E., Halcrow, S., et al. (1988). A controlled trial of digoxin in congestive heart failure. American Journal of Cardiology, 61(4), 371–375. PubMedCrossRef
9.
go back to reference Guyatt, G. H., Berman, L. B., Townsend, M., Pugsley, S. O., & Chambers, L. W. (1987). A measure of quality of life for clinical trials in chronic lung disease. Thorax, 42(10), 773–778. PubMedCrossRef Guyatt, G. H., Berman, L. B., Townsend, M., Pugsley, S. O., & Chambers, L. W. (1987). A measure of quality of life for clinical trials in chronic lung disease. Thorax, 42(10), 773–778. PubMedCrossRef
10.
go back to reference Guyatt, G. H., Nogradi, S., Halcrow, S., Singer, J., Sullivan, M. J., & Fallen, E. L. (1989). Development and testing of a new measure of health status for clinical trials in heart failure. Journal of General Internal Medicine, 4(2), 101–107. PubMedCrossRef Guyatt, G. H., Nogradi, S., Halcrow, S., Singer, J., Sullivan, M. J., & Fallen, E. L. (1989). Development and testing of a new measure of health status for clinical trials in heart failure. Journal of General Internal Medicine, 4(2), 101–107. PubMedCrossRef
11.
go back to reference Juniper, E. F., Guyatt, G. H., Willan, A., & Griffith, L. E. (1994). Determining a minimal important change in a disease-specific Quality of Life Questionnaire. Journal of Clinical Epidemiology, 47(1), 81–87. PubMedCrossRef Juniper, E. F., Guyatt, G. H., Willan, A., & Griffith, L. E. (1994). Determining a minimal important change in a disease-specific Quality of Life Questionnaire. Journal of Clinical Epidemiology, 47(1), 81–87. PubMedCrossRef
12.
go back to reference Sloan, J. A., Cella, D., Frost, M., Guyatt, G. H., Sprangers, M., & Symonds, T. (2002). Assessing clinical significance in measuring oncology patient quality of life: Introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proceedings, 77(4), 367–370. PubMedCrossRef Sloan, J. A., Cella, D., Frost, M., Guyatt, G. H., Sprangers, M., & Symonds, T. (2002). Assessing clinical significance in measuring oncology patient quality of life: Introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proceedings, 77(4), 367–370. PubMedCrossRef
13.
go back to reference 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. 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. PubMedCrossRef
14.
go back to reference Cella, D., Bullinger, M., Scott, C., & Barofsky, I. (2002). Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clinic Proceedings, 77(4), 384–392. PubMedCrossRef Cella, D., Bullinger, M., Scott, C., & Barofsky, I. (2002). Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clinic Proceedings, 77(4), 384–392. PubMedCrossRef
15.
go back to reference Sloan, J. A., Aaronson, N., Cappelleri, J. C., Fairclough, D. L., & Varricchio, C. (2002). Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proceedings, 77(5), 479–487. PubMed Sloan, J. A., Aaronson, N., Cappelleri, J. C., Fairclough, D. L., & Varricchio, C. (2002). Assessing the clinical significance of single items relative to summated scores. Mayo Clinic Proceedings, 77(5), 479–487. PubMed
16.
go back to reference Frost, M. H., Bonomi, A. E., Ferrans, C. E., Wong, G. Y., & Hays, R. D. (2002). Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clinic Proceedings, 77(5), 488–494. PubMed Frost, M. H., Bonomi, A. E., Ferrans, C. E., Wong, G. Y., & Hays, R. D. (2002). Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores. Mayo Clinic Proceedings, 77(5), 488–494. PubMed
17.
go back to reference Sprangers, M. A., Moinpour, C. M., Moynihan, T. J., Patrick, D. L., & Revicki, D. A. (2002). Assessing meaningful change in quality of life over time: A users’ guide for clinicians. Mayo Clinic Proceedings, 77(6), 561–571. PubMedCrossRef Sprangers, M. A., Moinpour, C. M., Moynihan, T. J., Patrick, D. L., & Revicki, D. A. (2002). Assessing meaningful change in quality of life over time: A users’ guide for clinicians. Mayo Clinic Proceedings, 77(6), 561–571. PubMedCrossRef
18.
go back to reference Symonds, T., Berzon, R., Marquis, P., & Rummans, T. A. (2002). The clinical significance of quality-of-life results: Practical considerations for specific audiences. Mayo Clinic Proceedings, 77(6), 572–583. PubMedCrossRef Symonds, T., Berzon, R., Marquis, P., & Rummans, T. A. (2002). The clinical significance of quality-of-life results: Practical considerations for specific audiences. Mayo Clinic Proceedings, 77(6), 572–583. PubMedCrossRef
19.
go back to reference Food and Drug Administration. (2006). Draft guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 71(23), 5862–5863. Food and Drug Administration. (2006). Draft guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 71(23), 5862–5863.
20.
go back to reference Hamilton, M. (1967). Development of a rating scale for primary depressive illness. The British Journal of Social and Clinical Psychology, 6(4), 278–296. PubMedCrossRef Hamilton, M. (1967). Development of a rating scale for primary depressive illness. The British Journal of Social and Clinical Psychology, 6(4), 278–296. PubMedCrossRef
21.
go back to reference Revicki, D. A., Erickson, P. A., Sloan, J. A., Dueck, A., Guess, H., & Santanello, N. C. (2007). Interpreting and reporting results based on patient-reported outcomes. Value Health, 10(Suppl 2), S116–S124. PubMedCrossRef Revicki, D. A., Erickson, P. A., Sloan, J. A., Dueck, A., Guess, H., & Santanello, N. C. (2007). Interpreting and reporting results based on patient-reported outcomes. Value Health, 10(Suppl 2), S116–S124. PubMedCrossRef
22.
go back to reference Patrick, D. L., Burke, L. B., Powers, J. H., Scott, J. A., Rock, E. P., Dawisha, S., et al. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health, 10(Suppl 2), S125–S137. PubMedCrossRef Patrick, D. L., Burke, L. B., Powers, J. H., Scott, J. A., Rock, E. P., Dawisha, S., et al. (2007). Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health, 10(Suppl 2), S125–S137. PubMedCrossRef
23.
go back to reference Lydick, E., & Epstein, R. S. (1993). Interpretation of quality of life changes. Quality of Life Research, 2(3), 221–226. PubMedCrossRef Lydick, E., & Epstein, R. S. (1993). Interpretation of quality of life changes. Quality of Life Research, 2(3), 221–226. PubMedCrossRef
24.
go back to reference 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. PubMedCrossRef 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. PubMedCrossRef
25.
go back to reference Sloan, J. A., Frost, M. H., Berzon, R., Dueck, A., Guyatt, G., Moinpour, C., et al. (2006). The clinical significance of quality of life assessments in oncology: A summary for clinicians. Supportive Care in Cancer, 14(10), 988–998. PubMedCrossRef Sloan, J. A., Frost, M. H., Berzon, R., Dueck, A., Guyatt, G., Moinpour, C., et al. (2006). The clinical significance of quality of life assessments in oncology: A summary for clinicians. Supportive Care in Cancer, 14(10), 988–998. PubMedCrossRef
26.
go back to reference Farrar, J. T., Young, J. P., Jr, LaMoreaux, L., Werth, J. L., & Poole, R. M. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 94(2), 149–158. PubMedCrossRef Farrar, J. T., Young, J. P., Jr, LaMoreaux, L., Werth, J. L., & Poole, R. M. (2001). Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain, 94(2), 149–158. PubMedCrossRef
27.
go back to reference Norman, G. R., Stratford, P., & Regehr, G. (1997). Methodological problems in the retrospective computation of responsiveness to change: The lesson of Cronbach. Journal of Clinical Epidemiology, 50(8), 869–879. PubMedCrossRef Norman, G. R., Stratford, P., & Regehr, G. (1997). Methodological problems in the retrospective computation of responsiveness to change: The lesson of Cronbach. Journal of Clinical Epidemiology, 50(8), 869–879. PubMedCrossRef
28.
go back to reference 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(6), 1523–1532. PubMedCrossRef 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(6), 1523–1532. PubMedCrossRef
29.
go back to reference Metz, S. M., Wyrwich, K. W., Babu, A. N., Kroenke, K., Tierney, W. M., & Wolinsky, F. D. (2007). Validity of patient-reported health-related quality of life global ratings of change using structural equation modeling. Quality of Life Research, 16(7), 1193–1202. PubMedCrossRef Metz, S. M., Wyrwich, K. W., Babu, A. N., Kroenke, K., Tierney, W. M., & Wolinsky, F. D. (2007). Validity of patient-reported health-related quality of life global ratings of change using structural equation modeling. Quality of Life Research, 16(7), 1193–1202. PubMedCrossRef
30.
go back to reference Wyrwich, K., Harnam, N., Revicki, D. A., Locklear, J. C., Svedsater, H., & Endicott, J. (2009). Assessing health-related quality of life in generalized anxiety disorder using the Quality Of Life Enjoyment and Satisfaction Questionnaire. International Clinical Psychopharmacology, 24(6), 289–295. PubMedCrossRef Wyrwich, K., Harnam, N., Revicki, D. A., Locklear, J. C., Svedsater, H., & Endicott, J. (2009). Assessing health-related quality of life in generalized anxiety disorder using the Quality Of Life Enjoyment and Satisfaction Questionnaire. International Clinical Psychopharmacology, 24(6), 289–295. PubMedCrossRef
31.
go back to reference Brozek, J. L., Guyatt, G. H., & Schunemann, H. J. (2006). How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure. Health and Quality of Life Outcomes, 4, 69. PubMedCrossRef Brozek, J. L., Guyatt, G. H., & Schunemann, H. J. (2006). How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure. Health and Quality of Life Outcomes, 4, 69. PubMedCrossRef
32.
go back to reference Kosinski, M., Zhao, S. Z., Dedhiya, S., Osterhaus, J. T., & Ware, J. E., Jr. (2000). Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis and Rheumatism, 43(7), 1478–1487. PubMedCrossRef Kosinski, M., Zhao, S. Z., Dedhiya, S., Osterhaus, J. T., & Ware, J. E., Jr. (2000). Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis and Rheumatism, 43(7), 1478–1487. PubMedCrossRef
33.
go back to reference Eton, D. T., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D. S., et al. (2004). A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. Journal of Clinical Epidemiology, 57(9), 898–910. PubMedCrossRef Eton, D. T., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D. S., et al. (2004). A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. Journal of Clinical Epidemiology, 57(9), 898–910. PubMedCrossRef
34.
go back to reference Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates. Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates.
35.
go back to reference Kazis, L. E., Anderson, J. J., & Meenan, R. F. (1989). Effect sizes for interpreting changes in health status. Medical Care, 27(3 Suppl), S178–S189. PubMedCrossRef Kazis, L. E., Anderson, J. J., & Meenan, R. F. (1989). Effect sizes for interpreting changes in health status. Medical Care, 27(3 Suppl), S178–S189. PubMedCrossRef
36.
go back to reference Norman, G. R., Wyrwich, K. W., & Patrick, D. L. (2007). The mathematical relationship among different forms of responsiveness coefficients. Quality of Life Research, 16(5), 815–822. PubMedCrossRef Norman, G. R., Wyrwich, K. W., & Patrick, D. L. (2007). The mathematical relationship among different forms of responsiveness coefficients. Quality of Life Research, 16(5), 815–822. PubMedCrossRef
37.
go back to reference Liang, M. H. (1995). Evaluating measurement responsiveness. Journal of Rheumatology, 22(6), 1191–1192. PubMed Liang, M. H. (1995). Evaluating measurement responsiveness. Journal of Rheumatology, 22(6), 1191–1192. PubMed
38.
go back to reference 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. PubMed 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. PubMed
39.
go back to reference Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric Theory. New York: McGraw-Hill. Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric Theory. New York: McGraw-Hill.
40.
go back to reference 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(9), 861–873. PubMedCrossRef 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(9), 861–873. PubMedCrossRef
41.
go back to reference Wyrwich, K. W. (2004). Minimal important difference thresholds and the standard error of measurement: Is there a connection? Journal of Biopharmaceutical Statistics, 14(1), 97–110. PubMedCrossRef Wyrwich, K. W. (2004). Minimal important difference thresholds and the standard error of measurement: Is there a connection? Journal of Biopharmaceutical Statistics, 14(1), 97–110. PubMedCrossRef
42.
go back to reference 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), 1–7. PubMedCrossRef 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), 1–7. PubMedCrossRef
43.
go back to reference Cella, D., Eton, D. T., Fairclough, D. L., Bonomi, P., Heyes, A. E., Silberman, C., et al. (2002). What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. Journal of Clinical Epidemiology, 55(3), 285–295. PubMedCrossRef Cella, D., Eton, D. T., Fairclough, D. L., Bonomi, P., Heyes, A. E., Silberman, C., et al. (2002). What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. Journal of Clinical Epidemiology, 55(3), 285–295. PubMedCrossRef
44.
go back to reference Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2004). An integrated method to determine meaningful changes in health-related quality of life. Journal of Clinical Epidemiology, 57(11), 1153–1160. PubMedCrossRef Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2004). An integrated method to determine meaningful changes in health-related quality of life. Journal of Clinical Epidemiology, 57(11), 1153–1160. PubMedCrossRef
45.
go back to reference Yost, K. J., Cella, D., Chawla, A., Holmgren, E., Eton, D. T., Ayanian, J. Z., et al. (2005). Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. Journal of Clinical Epidemiology, 58(12), 1241–1251. PubMedCrossRef Yost, K. J., Cella, D., Chawla, A., Holmgren, E., Eton, D. T., Ayanian, J. Z., et al. (2005). Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. Journal of Clinical Epidemiology, 58(12), 1241–1251. PubMedCrossRef
47.
go back to reference Copay, A. G., Subach, B. R., Glassman, S. D., Polly, D. W., Jr, & Schuler, T. C. (2007). Understanding the minimum clinically important difference: A review of concepts and methods. Spine Journal, 7(5), 541–546. PubMedCrossRef Copay, A. G., Subach, B. R., Glassman, S. D., Polly, D. W., Jr, & Schuler, T. C. (2007). Understanding the minimum clinically important difference: A review of concepts and methods. Spine Journal, 7(5), 541–546. PubMedCrossRef
48.
go back to reference Sprangers, M. A., & Schwartz, C. E. (1999). Integrating response shift into health-related quality of life research: A theoretical model. Social Science and Medicine, 48(11), 1507–1515. PubMedCrossRef Sprangers, M. A., & Schwartz, C. E. (1999). Integrating response shift into health-related quality of life research: A theoretical model. Social Science and Medicine, 48(11), 1507–1515. PubMedCrossRef
49.
go back to reference Rapkin, B. D., & Schwartz, C. E. (2004). Toward a theoretical model of quality-of-life appraisal: Implications of findings from studies of response shift. Health and Quality of Life Outcomes, 2, 14. PubMedCrossRef Rapkin, B. D., & Schwartz, C. E. (2004). Toward a theoretical model of quality-of-life appraisal: Implications of findings from studies of response shift. Health and Quality of Life Outcomes, 2, 14. PubMedCrossRef
50.
go back to reference Barclay-Goddard, R., Epstein, J. D., & Mayo, N. E. (2009). Response shift: A brief overview and proposed research priorities. Quality of Life Research, 18(3), 335–346. PubMedCrossRef Barclay-Goddard, R., Epstein, J. D., & Mayo, N. E. (2009). Response shift: A brief overview and proposed research priorities. Quality of Life Research, 18(3), 335–346. PubMedCrossRef
51.
go back to reference Sprangers, M. A., & Aaronson, N. K. (1992). The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease: A review. Journal of Clinical Epidemiology, 45(7), 743–760. PubMedCrossRef Sprangers, M. A., & Aaronson, N. K. (1992). The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease: A review. Journal of Clinical Epidemiology, 45(7), 743–760. PubMedCrossRef
52.
go back to reference von Essen, L. (2004). Proxy ratings of patient quality of life–factors related to patient-proxy agreement. Acta Oncologica, 43(3), 229–234. CrossRef von Essen, L. (2004). Proxy ratings of patient quality of life–factors related to patient-proxy agreement. Acta Oncologica, 43(3), 229–234. CrossRef
53.
go back to reference van der Linden, F. A., Kragt, J. J., van Bon, M., Klein, M., Thompson, A. J., van der Ploeg, H. M., et al. (2008). Longitudinal proxy measurements in multiple sclerosis: Patient-proxy agreement on the impact of MS on daily life over a period of two years. BMC Neurol, 8, 2. PubMedCrossRef van der Linden, F. A., Kragt, J. J., van Bon, M., Klein, M., Thompson, A. J., van der Ploeg, H. M., et al. (2008). Longitudinal proxy measurements in multiple sclerosis: Patient-proxy agreement on the impact of MS on daily life over a period of two years. BMC Neurol, 8, 2. PubMedCrossRef
Metagegevens
Titel
Methods for interpreting change over time in patient-reported outcome measures
Auteurs
K. W. Wyrwich
J. M. Norquist
W. R. Lenderking
S. Acaster
the Industry Advisory Committee of International Society for Quality of Life Research (ISOQOL)
Publicatiedatum
01-04-2013
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 3/2013
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-012-0175-x