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

Volumn 58, Issue 12, 2005, Pages 1241-1251

  Yost, K J ^a   Cella, D ^a   Chawla, A ^b   Holmgren, E ^b   Eton, D T ^a   Ayanian, J Z ^c,d   West, D W ^e  

^a EVANSTON NORTHWESTERN HEALTHCARE   (United States)

^b GENENTECH INC   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e NORTHERN CALIFORNIA CANCER CENTER   (United States)

Author keywords

Clinical significance; Colorectal cancer; Health related quality of life; Minimally important difference

Indexed keywords

BEVACIZUMAB; FLUOROURACIL; FOLINIC ACID;

ADULT; AGED; ARTICLE; CANCER THERAPY; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FUNCTIONAL ASSESSMENT; HUMAN; INSTRUMENT; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MEDICAL LITERATURE; OUTCOMES RESEARCH; PHASE 2 CLINICAL TRIAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VALIDATION PROCESS; WELLBEING;

ADULT; AGED; AGED, 80 AND OVER; ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; COLORECTAL NEOPLASMS; FEMALE; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS; STATISTICS; TREATMENT OUTCOME;

EID: 27744526720     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2005.07.008     Document Type: Article

References (44)

1. American Cancer Society Colorectal Cancer Facts & Figures Special Edition 2005 2005 American Cancer Society Atlanta
2. S.D. Passik, and K.L. Kirsh The importance of quality-of-life endpoints in clinical trials to the practicing oncologist Hematol Oncol Clin North Am 14 2000 877 886
3. H.F. Treurniet, M.L. Essink-Bot, J.P. Mackenbach, and P.J. van der Maas Health-related quality of life: an indicator of quality of care? Qual Life Res 6 1997 363 369
4. J.Z. Ayanian, A.M. Zaslavsky, E. Guadagnoli, C.S. Fuchs, K.J. Yost, C.M. Creech, R.D. Cress, L.C. O'Connor, D.W. West, and W.E. Wright Patients' perceptions of quality of care for colorectal cancer by race, ethnicity, and language J Clin Oncol 23 2005 6576 6586
5. N.R. Maisey, A. Norman, M. Watson, M.J. Allen, M.E. Hill, and D. Cunningham Baseline quality of life predicts survival in patients with advanced colorectal cancer Eur J Cancer 38 2002 1351 1357
6. J. Camilleri-Brennan, and R.J. Steele Prospective analysis of quality of life and survival following mesorectal excision for rectal cancer Br J Surg 88 2001 1617 1622
7. D. Cella Measuring quality of life in palliative care Semin Oncol 22 1995 73 81
8. D. Cella Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Version 4 1997 Center on Outcomes, Research & Education (CORE), Evanston Northwestern Healthcare and Northwestern University Evanston, IL
9. W.L. Ward, W.A. Hahn, F. Mo, L. Hernandez, D.S. Tulsky, and D. Cella Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument Qual Life Res 8 1999 181 195
10. M.A. Sprangers, A. te Velde, and N.K. Aaronson European Organization for Research and Treatment of Cancer Study Group on Quality of Life. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38) Eur J Cancer 35 1999 238 247
11. G.V. Padilla, and M.M. Grant Quality of life as a cancer nursing outcome variable Adv Nurs Sci 8 1985 45 60
12. G.H. Guyatt, S. Walter, and G.R. Norman Measuring change over time: assessing the usefulness of evaluative instruments J Chron Dis 40 1987 171 178
13. L.E. Kazis, J.J. Anderson, and R.F. Meenan Effect sizes for interpreting changes in health status Med Care 27 1989 S178 S189
14. N.S. Jacobson, and P. Truax Clinical significance: a statistical approach to defining meaningful change in psychotherapy research J Consult Clin Psychol 59 1991 12 19
15. H.C. Kraemer Reporting the size of effects in research studies to facilitate assessment of practical or clinical significance Psychoneuroendocrinology 17 1992 527 536
16. E. Lydick, and R.S. Epstein Interpretation of quality of life changes Qual Life Res 2 1993 221 226
17. J. Cohen Statistical power analysis for the behavioral sciences 1988 Lawrence Erlbaum Associates Hillsdale, NJ
18. K.W. Wyrwich, N.A. Nienaber, W.M. Tierney, and F.D. Wolinsky Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life Med Care 37 1999 469 478
19. K.W. Wyrwich, W.M. Tierney, and F.D. Wolinsky Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life J Clin Epidemiol 52 1999 861 873
20. H. Beckerman, M.E. Roebroeck, G.J. Lankhorst, J.G. Becher, P.D. Bezemer, and A.L. Verbeek Smallest real difference, a link between reproducibility and responsiveness Qual Life Res 10 2001 571 578
21. R.D. Hays, and J.M. Woolley The concept of clinically meaningful difference in health-related quality-of-life research: how meaningful is it? Pharmacoeconomics 18 2000 419 423
22. K.W. Wyrwich, and F.D. Wolinsky Identifying meaningful intra-individual change standards for health-related quality of life measures J Eval Clin Pract 6 2000 39 49
23. G.H. Guyatt, D. Osoba, A.W. Wu, K.W. Wyrwich, and G.R. Norman Clinical Significance Consensus Meeting Group. Methods to explain the clinical significance of health status measures Mayo Clin Proc 77 2002 371 383
24. J. Sloan, D. Vargas-Chanes, C. Kamath, D. Sargent, P. Novotny, P. Atherton, C. Allmer, B. Fridley, M. Frost, and C. Loprinzi Detecting worms, ducks and elephants: a simple approach for defining clinically relevant effects in quality-of-life measures J Cancer Integrative Med 1 2003 41 47
25. G.R. Norman, J.A. Sloan, and K.W. Wyrwich Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation Med Care 41 2003 582 592
26. D.E. Beaton Simple as possible? Or too simple?: possible limits to the universality of the one half standard deviation Med Care 41 2003 593 596
27. J.G. Wright Interpreting health-related quality of life scores: the simple rule of seven may not be so simple Med Care 41 2003 597 598
28. R.D. Crosby, R.L. Kolotkin, and G.R. Williams Defining clinically meaningful change in health-related quality of life J Clin Epidemiol 56 2003 395 407
29. D. Cella, D.T. Eton, D.L. Fairclough, P. Bonomi, A.E. Heyes, C. Silberman, M. Wolf, and D. Johnson What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L): results from the Eastern Cooperative Oncology Group (ECOG) Study 5592 J Clin Epidemiol 55 2002 285 295
30. D. Cella, D.T. Eton, J.S. Lai, A. Peterman, and D.E. Merkel Combining anchor and distribution based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) Anemia and Fatigue scales J Pain Symptom Manage 24 2002 547 561
31. D.L. Patrick, D.D. Gagnon, M.J. Zagari, R. Mathijs, and J. Sweetenham Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa Eur J Cancer 39 2003 335 345
32. D.T. Eton, D. Cella, K.J. Yost, S.E. Yount, A.H. Peterman, D.S. Neuberg, G.W. Sledge, and W.C. Wood A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale J Clin Epidemiol 57 2004 898 910
33. K.J. Yost, S.E. Yount, D.T. Eton, C. Silberman, A. Broughton-Heyes, and D. Cella Validation of the Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) Breast Cancer Res Treat 90 2005 295 298
34. K.J. Yost, M.V. Sorensen, E.A. Hahn, G.A. Glendenning, A. Gnanasakthy, and D. Cella Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument Value Health 8 2005 117 127
35. Tugwell P, Guyatt G. Generating measurements, especially for quality of life. In: Haynes RB, Sackett DL, Guyatt GH, Tugwell P, editors. Clinical epidemiology: how to do clinical practice research. Philadelphia: Lippincott Williams & Wilkins [forthcoming].
36. D.L. Fairclough, and D.F. Cella Functional Assessment of Cancer Therapy (FACT-G): non-response to individual questions Qual Life Res 5 1996 321 329
37. D.E. Beaton, C. Bombardier, J.N. Katz, J.G. Wright, G. Wells, M. Boers, V. Strand, and B. Shea OMERACT-MCID Working Group. Outcome Measures in Rheumatology-Minimal Clinically Important Difference. Looking for important change/differences in studies of responsiveness J Rheumatol 28 2001 400 405
38. J. Ware, K. Snow, and M. Kosinski SF-36 Health Survey: manual and interpretation guide 2000 QualityMetric Lincoln, RI
39. A.L. Potosky, L.C. Harlan, J.L. Stanford, F.D. Gilliland, A.S. Hamilton, P.C. Albertsen, J.W. Eley, J.M. Liff, D. Deapen, R.A. Stephenson, J. Legler, C.E. Ferrans, J.A. Talcott, and M.S. Litwin Prostate cancer practice patterns and quality of life: the Prostate Cancer Outcomes Study J Natl Cancer Inst 91 1999 1719 1724
40. K.W. Wyrwich, S.D. Fihn, W.M. Tierney, K. Kroenke, A.N. Babu, and F.D. Wolinsky Clinically important change in health-related quality of life for patients with chronic obstructive pulmonary disease J Gen Intern Med 18 2003 196 202
41. D. Cella, E.A. Hahn, and K. Dineen Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening Qual Life Res 11 2002 207 221
42. J. Ringash, A. Bezjak, B. O'Sullivan, and D.A. Redelmeier Interpreting differences in quality of life: the FACT-H&N in laryngeal cancer patients Qual Life Res 13 2004 725 733
43. E.F. Juniper, G.H. Guyatt, A. Willan, and L.E. Griffith Determining a minimal important change in a disease-specific quality of life questionnaire J Clin Epidemiol 47 1994 81 87
44. K. Basen-Engquist, D. Bodurka-Bevers, M.A. Fitzgerald, K. Webster, D. Cella, S. Hu, and D.M. Gershenson Reliability and validity of the functional assessment of cancer therapy-ovarian J Clin Oncol 19 2001 1809 1817