Journal of Clinical Epidemiology
Volume 57, Issue 11 , Pages 1153-1160 , November 2004

An integrated method to determine meaningful changes in health-related quality of life

  • Ross D. Crosby

      Affiliations

    • Neuropsychiatric Research Institute, 700 First Avenue South, Fargo, North Dakota, 58107, USA
    • University of North Dakota School of Medicine and Health Sciences, 1919 Elm St North, Fargo, North Dakota, 58102, USA
    • Corresponding Author InformationCorresponding author. Neuropsychiatric Research Institute, 700 First Avenue South Fargo, ND 58107. Tel.: 701-293-1335; fax: 701-293-3226.
  • ,
  • Ronette L. Kolotkin

      Affiliations

    • Obesity and Quality of Life Consulting, 1400 Norwood Ave, Durham, North Carolina, 27707, USA
    • Department of Community and Family Medicine, Duke University Medical Center, PO Box 2914, Durham, North Carolina, 27710, USA
  • ,
  • G. Rhys Williams

      Affiliations

    • Department of Community and Family Medicine, Duke University Medical Center, PO Box 2914, Durham, North Carolina, 27710, USA

,Accepted 14 April 2004.

References 

  1. Kolotkin RL, Meter K, Williams GR. Quality of life and obesity. Obes Res. 2001;2:219–229
  2. Kushner RF, Foster G. Obesity and quality of life. Nutrition. 2000;16:947–952
  3. Fontaine KR, Barofsky I. Obesity and health-related quality of life. Obes Res. 2001;2:173–182
  4. Sullivan M, Karlsson J, Sjostrom L, Taft C. Why quality of life measures should be used in the treatment of patients with obesity. In:  Bjorntorp P editors. International textbook of obesity. New York: John Wiley & Sons; 2001;p. 485–510
  5. Sullivan HM, Karlsson J, Sjostrom L, Backman L, Bengtsson C, Bouchard C, et al. Swedish obese subjects (SOS): an intervention study of obesity. Baseline evaluation of health and psychosocial functioning in the first 1743 subjects examined. Int J Obes. 1993;1743:503–512
  6. Kawachi L. Physical and psychological consequences of weight gain. J Clin Psychol. 1999;60(Suppl 21):5–9
  7. de Zwaan M, Mitchell JE, Howell M, Monson N, Swan-Kremeier L, Roerig JL, et al. Two measures of health related quality of life in morbid obesity. Obes Res. 2002;10:1143–1151
  8. Rippe JM, Price JM, Hess SA, Kline G, DeMers KA, Damitz S, et al. Improved psychological well-being, quality of life, and health practices in moderately overweight women participating in a 12-week structured weight loss program. Obes Res. 1998;6:208–218
  9. Fine JT, Colditz GA, Coakley EH, Moseley G, Manson JE, Willett WC, et al. A prospective study of weight change and health-related quality of life in women. JAMA. 1999;282:2136–2142
  10. Fontaine KR, Barofsky I, Andersen RE, Bartlett SJ, Wiersema L, Cheskin LJ, et al. Impact of weight loss on health-related quality of life. Qual Life Res. 1999;8:275–277
  11. Kolotkin RL, Crosby RD, Williams GR, Hartley GG, Nicol S. The relationship between health-related quality of life and weight loss. Obes Res. 2001;9:564–571
  12. Jacobson NS, Follette WC, Revenstorf D. Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance. Behav Ther. 1984;15:336–352
  13. Barlow DH. On the relation of clinical research to clinical practices: current issue, new directions. J Consult Clin Psychol. 1981;49:147–155
  14. Yeaton WH, Sechrest L. Critical dimensions in the choice and maintenance of successful treatments: strength, integrity, and effectiveness. J Consult Clin Psychol. 1981;49:156–167
  15. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–19
  16. Jaeschke R, Singer J, Guyatt GH. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–415
  17. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395–397
  18. Lydick F, Epstein RS. Interpretation of quality of life changes. Qual Life Res. 1993;2:221–226
  19. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease specific quality of life questionnaire. J Clin Epidemiol. 1994;47:81–87
  20. Kazis LE, Anderson JJ, Meenan RS. Effect sizes for interpreting changes in health status. Med Care. 1989;27(Suppl 3):S178–S189
  21. Wyrwich K, Nienaber N, Tierney W, Wolinsky F. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999;52:861–873
  22. Cella D, Eton DT, Fairchough DL, Bonomi P, Heyes AE, Silberman C, et al. What is clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. J Clin Epidemiol. 2002;55:285–295
  23. McHorney CA. Generic health measurement: past accomplishments and a measurement paradigm for the 21st century. Ann Intern Med. 1997;127:743–750
  24. Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J, Matchar D. Determining clinically important differences in health status measures: a general approach with illustration to the Health Utilities Index Mark II. Pharmacoeconomics. 1999;15:141–155
  25. Stratford PW, Binkley JM, Riddle DL, Guyatt GH. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: Part 1. Phys Ther. 1998;78:1186–1196
  26. 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
  27. Engel SG, Crosby RD, Kolotkin RL, Hartley GG, Williams GR, Wonderlich SA, et al. The impact of weight loss and regain on obesity-specific quality of life: mirror image or differential effect?. Obes Res. 2003;11:1207–1213
  28. Speer DC. Clinically significant change: Jacobson and Truax (1991) revisited. J Consult Clin Psychol. 1992;60:402–408
  29. Hageman WJ, Arrindell WA. Establishing clinically significant change: increment of precision and distinction between individual and group level of analysis. Behav Res Ther. 1999;37:1169–1193
  30. Hsu LM. Regression toward the mean associated with measurement error and the identification of improvement and deterioration in psychotherapy. J Consult Clin Psychol. 1995;63:141–144
  31. Samsa GP, Kolotkin RL, Williams GR, Nguyen MH, Mendel CM. Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of sibutramine versus placebo. Am J Manag Care. 2001;7:875–883
  32. Raebel MA, Conner DA, Porter JA, Lanty FA, Vogel EA, Gay EC, et al. The long-term outcomes of sibutramine effectiveness on weight (LOSE Weight) study in a managed care organization: twelve-month clinical outcomes in a naturalistic clinical setting. Diabetes. 2002;51(Suppl 2):A413
  33. Anderson JW, Greenway FL, Fujioka K, Gadde KM, McKenney J, O'Neil PM. Bupropion SR enhances weight loss: a 48-week double-blind, placebo-controlled trial. Obes Res. 2002;10:633–641
  34. Heshka S, Anderson JW, Atkinson RL, Greenway F, Hill JO, Phinney SD, et al. Weight loss with self-help compared with a structured commercial program: a randomized trial. JAMA. 2003;289:1792–1798
  35. Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res. 2001;9:102–111
  36. Kolotkin RL, Crosby RD. Psychometric evaluation of the Impact of Weight on Quality of Life-Lite questionnaire (IWQOL-Lite) in a community sample. Qual Life Res. 2002;10:748–756
  37. Kolotkin RL, Crosby RD. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite): user's manual. Durham (NC): Obesity and Quality of Life Consulting; 2002;
  38. Anastasi A, Urbina S. Psychological testing. 7th edition. Upper Saddle River (NJ): Prentice Hall; 1997;
  39. Nunnally JC, Bernstein IH. Psychometric theory. 3rd edition. New York: McGraw-Hill; 1994;
  40. Edwards DW, Yarvis RM, Mueller DP, Zingale HC, Wagman WJ. Test-taking and the stability of adjustment scales: can we assess patient deterioration?. Eval Q. 1978;2:275–292
  41. Stanley JC. Reliability. In:  Thorndike RL editors. Educational measurement. 2nd edition. Washington, DC: American Council on Education; 1971;p. 356–442
  42. Food and Drug Administration Guidance for the Clinical Evaluation of Weight-Control Drugs. Available at: http://www.fda.gov/cder/guidance/obesity.pdf (accessed April 10, 2004)
  43. Vidal J. Updated review on the benefits of weight loss. Int J Obes. 2002;26(Suppl 4):S25–S28
  44. Pasanisi F, Contaldo F, deSimone G, Mancini M. Benefits of sustained moderate weight loss in obesity. Nutr Metab Cardiovasc Dis. 2001;11:401–406
  45. Cohen J. Statistical power analysis for the behavioral sciences. 2nd edition. Hillsdale (New Jersey): Lawrence Erlbaum; 1988;
  46. Hudgens SA, Yost K, Cella D, Hahn E, Peterman A. Comparing retrospective and prospective anchors for identifying minimally important differences. Qual Life Res. 2002;11:629
  47. Guyatt GH, Osaba D, Wu AW, Wyrwich KW, Norman GR. Clinical Significance Consensus Group. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77:371–383
  48. Fontaine KR, Bartlett SJ, Barofsky I. Health-related quality of life among obese persons seeking and not currently seeking treatment. Int J Eat Disord. 2000;27:101–105
  49. Kolotkin RL, Crosby RD, Williams GR. Health-related quality of life varies among obese sub-groups. Obes Res. 2002;10:748–756

 Portions of this paper were presented at the 12th European Congress on Obesity, Helsinki, Finland, May 2003.

PII: S0895-4356(04)00112-X

doi: 10.1016/j.jclinepi.2004.04.004

Journal of Clinical Epidemiology
Volume 57, Issue 11 , Pages 1153-1160 , November 2004