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.

Abstract 

Objective

We describe an integrated method for determining meaningful change in health-related quality of life (HRQOL) that combines information from anchor-based and distribution-based methods and illustrate this method using data aggregated from weight loss studies.

Study design and setting

A total of 1476 participants in weight loss studies were evaluated at baseline and at 6 months using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite). Severity of baseline impairment was determined by comparing scores with those obtained from a normative sample of 534 normal/overweight individuals. The precision of the IWQOL-Lite was evaluated using standard error of measurement corrected for regression to the mean. Weight loss was used as an anchor for evaluating changes in IWQOL-Lite scores.

Results

Change in HRQOL varied as a function of weight loss and baseline severity of HRQOL. Using this integrated method, an improvement of 7.7 to 12 points (depending on baseline severity) on IWQOL-Lite total score is considered meaningful.

Conclusion

Meaningful change in HRQOL can be determined using an integrated method that (1) combines information from anchor-based and distribution-based methods, (2) reconciles discrepancies between these two methods, and (3) adjusts for baseline severity and regression to the mean. This method may be applied to other types of HRQOL measures and conditions.

Keywords: Meaningful change, Clinically important differences, Health-related quality of life, IWQOL-Lite, Weight loss, Obesity

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 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