The king's foot of patient-reported outcomes: Current practices and new developments for the measurement of change

Quality of Life Research

Volumn 20, Issue 8, 2011, Pages 1159-1167

  Swartz, Richard J ^a   Schwartz, Carolyn ^b,c   Basch, Ethan ^d   Cai, Li ^e   Fairclough, Diane L ^f   McLeod, Lori ^g   Mendoza, Tito R ^h   Rapkin, Bruce ⁱ  

^a RICE UNIVERSITY   (United States)

^b DeltaQuest Foundation Inc   (United States)

^c TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF COLORADO   (United States)

^g RTI HEALTH SOLUTIONS   (United States)

^h UNIVERSITY OF TEXAS   (United States)

ⁱ ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

Author keywords

Longitudinal studies; Outcome assessment (Health Care); Psychometrics; Quality of life; Response shift; Statistical models

Indexed keywords

ARTICLE; HEALTH STATUS; HUMAN; INTERDISCIPLINARY COMMUNICATION; METHODOLOGY; OUTCOME ASSESSMENT; PSYCHOMETRY; QUALITY OF LIFE; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME;

HEALTH STATUS; HUMANS; INTERDISCIPLINARY COMMUNICATION; OUTCOME ASSESSMENT (HEALTH CARE); PSYCHOMETRICS; QUALITY OF LIFE; SICKNESS IMPACT PROFILE; TREATMENT OUTCOME;

EID: 80053933801     PISSN: 09629343     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11136-011-9863-1     Document Type: Article

References (63)

1. Brief History of Measurement Systems with a Chart of the Modernized Metric System. (1974). In N. B. O. Standards (Ed.), Washington, DC: Government Printing Office.
2. Swartz, R. J., Basch, E., Cai, L., Fairclough, D. L., McLeod, L. D., Mendoza, T. R., Rapkin, B., Schwartz, C. E., & The SAMSI Psychometric Program Longitudinal Assessment of Patient-Reported Outcomes Working Group. (2010). The king's foot of patient-reported outcomes: Current practices and new developments for the measurement of change. from http://www.bepress.com/ mdandersonbiostat/paper60.
3. Lord, F. M., & Novick, M. R. (1968). Statistical theories of mental test scores. Reading, Mass.: Addison-Wesley Pub. Co.
4. de Boeck, P., & Wilson, M. (2004). Explanatory item response models: A generalized linear and nonlinear approach. New York: Springer.
5. McDonald, R. P. (1999). Test theory: A unified treatment. Mahwah, N.J.: L. Erlbaum Associates.
6. LI Cronbach L Furby 1970 How we should measure "change"-or should we? Psychological Bulletin 74 1 68 80 10.1037/h0029382
7. Lord, F. M. (1980). Applications of item response theory to practical testing problems. Hillsdale, NJ: Lawrence Erlbaum.
8. van der Linden, W. J., & Hambleton, R. K. (Eds.). (1997). Handbook of modern item response theory. New York: Springer.
9. Embretson, S. E., & Reise, S. P. (2000). Item response theory for psychologists. Mahwah, N.J.: L. Erlbaum Associates.
10. GR Norman KW Wyrwich DL Patrick 2007 The mathematical relationship among different forms of responsiveness coefficients Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation 16 5 815 822 1:STN:280:DC%2BD2s3jvFWltg%3D%3D (Pubitemid 46650889)
11. Fayers, P. M., & Hays, R. D. (2005). Assessing quality of life in clinical trials: Methods and practice (2nd ed.). Oxford: Oxford University Press.
12. DE Beaton C Bombardier JN Katz JG Wright 2001 A taxonomy for responsiveness Journal of Clinical Epidemilology 54 12 1204 1217 10.1016/S0895-4356(01)00407-3 1:STN:280:DC%2BD38%2FgtlCrsw%3D%3D (Pubitemid 34002973)
13. J Cohen 1992 A power primer Psychological Bulletin 112 1 155 159 19565683 10.1037/0033-2909.112.1.155 1:STN:280:DC%2BD1MvlsV2mug%3D%3D
14. US Department of Health and Human Services. (2006). Food and drug administration. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims draft guidance.
15. HC de Vet CB Terwee RW Ostelo H Beckerman DL Knol LM Bouter 2006 Minimal changes in health status questionnaires: Distinction between minimally detectable change and minimally important change Health and Quality of Life Outcomes 4 54 16925807 10.1186/1477-7525-4-54 (Pubitemid 44501757)
16. EF Juniper GH Guyatt A Willan LE Griffith 1994 Determining a minimal important change in a disease-specific quality of life questionnaire Journal of Clinical Epidemiology 47 1 81 87 8283197 10.1016/0895-4356(94)90036-1 1:STN:280:DyaK2c7htVyjsA%3D%3D (Pubitemid 24034293)
17. GR Norman J Sloan KW Wyrwich 2003 Interpretation of changes in health-related quality-of-life Medical Care 4 582 592
18. KW Wyrwich WM Tierney FD Wolinsky 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 10529027 10.1016/S0895-4356(99)00071-2 1:STN:280:DyaK1Mvls1aqtw%3D%3D (Pubitemid 29385600)
19. GH Guyatt EF Juniper SD Walter LE Griffith RS Goldstein 1998 Interpreting treatment effects in randomised trials British Medical Journal 316 690 693 9522799 1:STN:280:DyaK1c7otlensQ%3D%3D (Pubitemid 28121037)
20. GR Norman FG Sridhar GH Guyatt SD Walter 2001 Relation of distribution- and anchor-based approaches in interpretation of changes in health related quality of life Medical Care 29 1039 1047 10.1097/00005650-200110000-00002 (Pubitemid 33691379)
21. D Revicki RD Hays D Cella J Sloan 2008 Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes Journal of Clinical Epidemiology 61 2 102 109 18177782 10.1016/j.jclinepi.2007.03.012
22. J Sloan D Cella RD Hays 2005 Clinical significance of patient-reported questionnaire data: Another step towards consensus Journal of Clinical Epidemiology 58 1217 1219 16291464 10.1016/j.jclinepi.2005.07.009 (Pubitemid 41608536)
23. Raudenbush, S. W., & Byrk, A. S. (2002). Heirarchical linear models: Applications and data analysis methods (2nd ed.). Thousand Oaks, CA: Sage.
24. Reise, S. P., & Duan, N. (2003). Multilevel modeling: Methodological advances, issues, and applications. Mahwah, N.J.; London: Lawrence Erlbaum Associates.
25. Demidenko, E. (2004). Mixed models: Theory and applications. Hoboken, NJ: Wiley.
26. Skrondal, A., & Rabe-Hesketh, S. (2004). Generalized latent variable modeling multilevel, longitudinal, and structural equation models. Boca Raton: Chapman & Hall/CRC.
27. Bollen, K. A., & Curran, P. J. (2006). Latent curve models: A structural equation approach. Hoboken, NJ: Wiley.
28. Bollen, K. A. (1989). Structural equations with latent variables. New York: Wiley.
29. Hedeker, D. R., & Gibbons, R. D. (2006). Longitudinal data analysis. Hoboken, NJ: Wiley.
30. Muller, K. E., & Stewart, P. W. (2006). Linear model theory: Univariate, multivariate, and mixed models. Hoboken, NJ: Wiley.
31. Little, R. J., & Rubin, D. B. (2002). Statistical analysis with missing data (2nd ed.). New York, NY: Wiley.
32. RC MacCallum C Kim WB Marlarkey JK Kiecolt-Glaser 1997 Studying multivariate change using multilevel models and latent curve models Multivariate Behavioral Research 32 215 253 10.1207/s15327906mbr3203-1 (Pubitemid 127337149)
33. DJ Bauer 2003 Estimating multilevel linear models as structural equation models Journal of Educational and Behavioral Statistics 28 135 167 10.3102/10769986028002135 (Pubitemid 37306396)
34. Ahmed, S., & Schwartz, C. E. (2009, in press). Quality of life assessments and response shift. In A. Steptoe (Ed.), Handbook of behavioral medicine: Methods and applications. New York, NY: Springer Science.
35. Sprangers, M. A., & Schwartz, C. E. (1999). Integrating response shift into health-related quality of life research: a theoretical model. Social Science & Medicine (1982), 48(11), 1507-1515. (Pubitemid 29254110)
36. BD Rapkin CE Schwartz 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 15023229 10.1186/1477-7525-2-14 (Pubitemid 39115369)
37. KW Wyrwich VM Tardino 2006 Understanding global transition assessments Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation 15 6 995 1004 (Pubitemid 44221453)
38. SP Reise NG Waller 2009 Item response theory and clinical measurement Annual Review of Clinical Psychology 5 25 46 10.1146/annurev.clinpsy.032408. 153553
39. SF Garcia D Cella SB Clauser KE Flynn T Lad JS Lai BB Reeve AW Smith AA Stone K Weinfurt 2007 Standardizing patient-reported outcomes assessment in cancer clinical trials: a patient-reported outcomes measurement information system initiative.[erratum appears in J Clin Oncol. 2008 Feb 20;26(6):1018 Note: Lad, Thomas [added]] Journal of Clinical Oncology 25 32 5106 5112 17991929 10.1200/JCO.2007.12.2341 (Pubitemid 350232291)
40. M Rose JB Bjorner J Becker JF Fries JE Ware 2008 Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS) Journal of Clinical Epidemiology 61 1 17 33 18083459 10.1016/j.jclinepi.2006.06.025 1:STN:280:DC%2BD2sjks1Cjuw%3D%3D (Pubitemid 350236703)
41. D Thissen BB Reeve JB Bjorner CH Chang 2007 Methodological issues for building item banks and computerized adaptive scales Quality of Life Research 16 Suppl 1 109 119 17294284 10.1007/s11136-007-9169-5 (Pubitemid 47036913)
42. DL Fairclough H Thijs IC Huang HW Finnern AW Wu 2008 Handling missing quality of life data in HIV clinical trials: What is practical? Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation 17 1 61 73
43. JW Hogan J Roy C Korkontzelou 2004 Handling drop-out in longitudinal studies Statistics in Medicine 23 9 1455 1497 15116353 10.1002/sim.1728 (Pubitemid 38594149)
44. B Michiels G Molenberghs L Bijnens T Vangeneugden H Thijs 2002 Selection models and pattern-mixture models to analyse longitudinal quality of life data subject to drop-out Statistics in Medicine 21 8 1023 1041 11933032 10.1002/sim.1064 (Pubitemid 34285489)
45. FJ Oort 2005 Using structural equation modeling to detect response shifts and true change Quality of Life Research 14 3 587 598 16022054 10.1007/s11136-004-0830-y (Pubitemid 40576848)
46. MO Edelen BB Reeve MO Edelen BB Reeve 2007 Applying item response theory (IRT) modeling to questionnaire development, evaluation, and refinement Quality of Life Research 16 Suppl 1 5 18 17375372 10.1007/s11136-007-9198-0 (Pubitemid 47036924)
47. Edwards, M. C., & Edelen, M. O. (2009). Special topics in item response theory. In R. E. Millsap & A. Maydeu-Olivares (Eds.), Handbook of quantitative methods in psychology (pp. 178-198). New York, NY: Sage.
48. J Tisak W Meredith 1989 Exploratory longitudinal factor analysis in multiple populations Psychometrika 54 261 281 10.1007/BF02294520
49. Hill, C. D. (2006). Two models for longitudinal item response data. Unpublished doctoral dissertation, University of North Carolina-Chapel Hill.
50. J te Marvelde CAW Glas G Landeghem J van Damme 2006 Application of multidimensional item response theory models to longitudinal data Educational and Psychological Measurement 66 1 5 34 10.1177/0013164405282490 (Pubitemid 43189657)
51. L Cai 2010 A Two-Tier Full-Information Item Factor Analysis Model with Applications Psychometrika 75 4 581 612 10.1007/s11336-010-9178-0
52. S Schilling RD Bock 2005 High-dimensional maximum marginal likelihood item factor analysis by adaptive quadrature Psychometrika 70 533 555 (Pubitemid 41771193)
53. AA Béguin CAW Glas 2001 MCMC estimation and some model-fit analysis of multidimensional IRT models Psychometrika 66 541 561 10.1007/BF02296195
54. L Cai 2010 High-dimensional Exploratory Item Factor Analysis by a Metropolis-Hastings Robbins-Monro Algorithm Psychometrika 75 1 33 57 10.1007/s11336-009-9136-x
55. L Cai 2010 Metropolis-Hastings Robbins-Monro Algorithm for Confirmatory Item Factor Analysis Journal of Educational and Behavioral Statistics 35 307 335 10.3102/1076998609353115
56. G Harding NK Leidy D Meddis L Kleinman S Wagner C O'Brien 2009 Interpreting clinical trial results of patient-perceived onset of effect in asthma: Methods and results of a Delphi panel Current Medical Research and Opinion 25 6 1563 1571 19445651 10.1185/03007990902914403
57. D Turner HJ Schünemann LE Griffith DE Beaton AM Griffiths JN Critch GH Guyatt 2009 Using the entire cohort in the receiver operating characteristic analysis maximizes precision of the minimal important difference Journal of Clinical Epidemiology 62 4 374 379 19013766 10.1016/j.jclinepi.2008.07.009
58. McLeod, L. D., Nelson, L., & Lewis, C. (July 1, 2009). Personal Communication.
59. Y Li B Rapkin 2009 Classification and regression tree uncovered hierarchy of psychosocial determinants underlying quality-of-life response shift in HIV/AIDS Journal of Clinical Epidemiology 62 11 1138 1147 19595576 10.1016/j.jclinepi.2009.03.021
60. CE Schwartz BD Rapkin 2004 Reconsidering the psychometrics of quality of life assessment in light of response shift and appraisal Health and Quality of Life Outcomes 2 16 15038830 10.1186/1477-7525-2-16 (Pubitemid 39112015)
61. Stone, A. A., Turkkan, J. S., Bachrach, C. A., Jobe, J. B., Kurtzman, H. S., & Cain, V. S. (Eds.). (2000). The science of self-report: Implications for research and practice. Mahwah, NJ: Lawrence Erlbaum.
62. EF Bloem FJ van Zuuren MA Koeneman BD Rapkin MRM Visser CCE Koning MAG Sprangers 2008 Clarifying quality of life assessment: Do theoretical models capture the underlying cognitive processes? Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation 17 8 1093 1102
63. F Rijmen F Tuerlinckx P De Boeck P Kuppens 2003 A nonlinear mixed model framework for item response theory Psychological Methods 8 2 185 205 12924814 10.1037/1082-989X.8.2.185 (Pubitemid 37189472)