Current Problems in Cancer
Volume 29, Issue 6 , Pages 306-316 , November 2005

Incorporating Clinical Significance into a Study

  • Celia Kamath, PhD
    • ,
  • Amylou Dueck, PhD

      Affiliations

    • Corresponding Author InformationAddress correspondence to Dr. Jeff A. Sloan, Mayo Clinic, Section of Biostatistics, Department of Health Science Research, 200 First St. S.W., Rochester, MN 55905, USA

References 

  1. Cohen J . In: Statistical Power Analysis for the Behavioral Sciences . (ed 2). Hillsdale, NJ: Lawrence Erlbaum Associates; 1998;
  2. Norman GR , Sloan JA , Wyrwich KW . Interpretation of changes in health-related quality of life (the remarkable universality of half a standard deviation) . Med Care . 2003;41(5):582–592
  3. Jaeschke R , Singer J , Guyatt GH . Measurement of health status. Ascertaining the minimal clinically important difference . Control Clin Trials . 1989;10(4):407–415
  4. Crosby RD , Kolotkin RL , Williams GR . Defining clinically meaningful change in health-related quality of life . J Clin Epidemiol . 2003;56:397–407
  5. Guyatt GH , Osoba D , Wu AW , Wyrwich KW , Norman GR  Clinical Significance Consensus Meeting Group . Methods to explain the clinical significance of health status measures . Mayo Clin Proc . 2002;77:371–383
  6. Testa MA . Interpretation of quality-of-life outcomes issues that affect magnitude and meaning . Med Care . 2000;38:II166–II174
  7. Frost MH , Bonomi AE , Ferrans CE , Wong GY , Hays RD  Clinical Significance Consensus Meeting Group . Patient, clinician, and population perspectives on determining the clinical significance of quality-of-life scores . Mayo Clin Proc . 2002;77:488–494
  8. van Walraven CM , Mahon JL , Moher D , Bohm C , Laupacis A . Surveying physicians to determine the minimal important difference (implications for sample-size calculation) . J Clin Epidemiol . 1999;52:717–723
  9. Lydick E , Epstein RS . Interpretation of quality of life changes . Qual Life Res . 1993;2:221–226
  10. Juniper EF , Guyatt GH , Willan A . Determining a minimal important change in a disease-specific quality of life questionnaire . J Clin Epidemiol . 1994;47:81–87
  11. Juniper EF . The value and quality of life in Asthma . Eur Resp J . 1997;7:333–337
  12. Juniper EF , Guyatt GH , Feeny DH . Measuring quality of life in childhood asthma . Qual Life Res . 1996;5:35–46
  13. Ware JE , Brook RH , Davies-Avery A , Williams KN , Stewart AL , Rogers WH , et al.   Conceptualization and measurement of health for adults in the health insurance study (Vol 1, model of health and methodology) . Rand Corporation . 1980; R-1987/1-HEW
  14. Testa M , Lenderking WR . Interpreting pharmacoeconcomic and quality-of-life clinical trial data for use in therpeutics . Pharmacoeconomics . 1992;2:107
  15. Testa M , Simonson DC . Assessment of quality-of-life outcomes . N Engl J Med . 1996;28:835–840
  16. Llewellyn-Thomas HA , Williams JI , Levy L . Using a trade-off techniques to assess patients’ treatment preferences for benign prostatic hyperplasia . Med Decis Making . 1996;16:262–272
  17. Jacobson NS , Truax P . Clinical significance (a statistical approach to defining meaningful change in psychotherapy research) . J Consult Clin Psychol . 1991;59:12–19
  18. Stucki G , Liang MH , Fossel AH . Relative responsiveness of condition specific and health status measures in degenerative lumbar spinal stenosis . J Clin Epidemiol . 1995;48:1369–1378
  19. Deyo RA , Inui TS . Toward clinical application of health status measures (sensitivity of scales to clinically important changes) . Health Serv Res . 1984;19:278–289
  20. Mossey JM , Shapiro E . Self-rated health (a predictor of mortaility among the elderly) . Am J Public Health . 1982;72:800–808
  21. Kolotkin RL , Crosby RD , Williams GR . Integrating anchor-based and distribution-based methods to determine clinically meaningful change in obesity-specific quality of life . Qual Life Res . 2002;11:670
  22. Cella D , Bullinger M , Scott C , Barofsky I  Clinical Significance Consensus Meeting Group . Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life . Mayo Clin Proc . 2002;77:384–392
  23. Litwin MS , McGuigan KA . Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer . J Clin Onc . 1999;17:2882–2888
  24. Wyrwich KW , Metz S , Babu AN . The reliability of retrospective change assessments . Qual Life Res . 2002;11:636
  25. Mozes B , Maor Y , Shumueli A . Do we know what global ratins of health-related quality of life measure? . Qual Life Res . 1999;8:269–273
  26. Kirwan JR , Chaput de Sainttonge DM , Joyce CRB . Clinical judgment in rheumatoid arthritis. III. British rheumatologists’ judgment of “change in response to therapy.” . Ann Rheum Dis . 1984;43:686–694
  27. Cella D , Hahn EA , Dineen K . Meaningful change in cancer-specific quality of life scores (differences between improvement and worsening) . Qual Life Res . 2002;11:207–221
  28. Guyatt GH , Jaeschke R . Reassessing quality of life instruments in the evaluation of new drugs . Pharmacoeconomics . 1997;12:616–626
  29. Lydick F , Yawn BP . Clinical interpretation of health-related quality of life data . In:  Staquet MJ ,  Hays RD ,  Fayers PM editor. Quality of Life Assessment in Clinical Trials (Methods and Practice) . Oxford: Oxford University Press; 1998;p. 299–314
  30. Barber B , 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
  31. Ware J , Snow K , Kosinski M , et al.   SF-36 health survey (manual and interpretation guide) . Boston, MA: The Health Institute; 1993;
  32. Baker DW , Hays RD , Brook RH . Understanding changes in health status (is the floor phenomenon merely the last step of the staircase?) . Med Care . 1997;35:1–15
  33. Husted JA , Cook RJ , Farewll VT . Methods for assessing responsiveness (a critical review and recommendations) . J Clin Epidemiol . 2000;53:459–468
  34. Cohen J . Statistical Power Analysis for the Behavioural Sciences . London: Academic Press; 1969;
  35. Kazis L , Anderson JJ , Meenan RS . Effect sizes for interpreting changes in health status . Med Care . 1989;27(suppl 3):S178–S189
  36. Guyatt GH , Bombardier C , Tugwell PX . Measuring disease-specific quality of life in clinical trials . CMAJ . 1986;134:889–895
  37. Samsa G , Edelman D , Rothman ML . Determining clinically important differences in health status measures (a general approach with illustration to the Health Utilities Index Mark II) . Pharmacoeconomics . 1999;15:41–55
  38. Wyrwich KW , Tiemey 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
  39. Stewart AL , Greenfield S , Hays RD . Functional status and well-being of patients with chronic conditions (results from the medical outcomes study) . JAMA . 1989;262:907–913
  40. Sloan JA , Vargas-Chanes D , Kamath C , Sargent D , Novotny P , Atherton P , et al.   Detecting worms, ducks, and elephants (a simple approach for defining clinically relevant effects in quality of life measures) . J Cancer Integrative Med . 2003;1(1):41–47
  41. Sloan JA , Symonds T , Vargas-Chanes D , Fridley B . Practical guidelines for assessing the clinical significance of health-related QOL changes within clinical trials . Drug Inf J . 2003;37:23–31
  42. Pukelsheim F . The three sigma rule . Am Stat . 1994;48:88–91
  43. Angst F , Aeschlimann A , Stucki G . Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implication for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities . Arthritis Care Res . 2001;45:384–391
  44. Symonds T , Berzon R , Marquis P , Rummans TA  Clinical Significance Consensus Meeting Group . The clinical significance of quality-of-life results (practical considerations for specific audiences) . Mayo Clin Proc . 2002;77:572–583
  45. Sprangers MAG , Moinpour CM , Moynihan TJ , Patrick DL , Revicki DA  Clinical Significance Consensus Meeting Group . Assessing meaningful change in quality of life over time (a users’ guide for clinicians) . Mayo Clin Proc . 2002;77:561–571

PII: S0147-0272(05)00059-0

doi: 10.1016/j.currproblcancer.2005.09.005

Current Problems in Cancer
Volume 29, Issue 6 , Pages 306-316 , November 2005

Article Tools