IDEAS home Printed from
MyIDEAS: Log in (now much improved!) to save this paper

Sample sizes for the SF-6D preference based measure of health from the SF-36: a practical guide

Listed author(s):
  • Walters, SJ
  • Brazier, JE
Registered author(s):

    Background Health Related Quality of Life (HRQoL) measures are becoming more frequently used in clinical trials and health services research, both as primary and secondary endpoints. Investigators are now asking statisticians for advice on how to plan and analyse studies using HRQoL measures, which includes questions on sample size. Sample size requirements are critically dependent on the aims of the study, the outcome measure and its summary measure, the effect size and the method of calculating the test statistic. The SF-6D is a new single summary preference-based measure of health derived from the SF-36 suitable for use clinical trials and in the economic evaluation of health technologies. Objectives To describe and compare two methods of calculating sample sizes when using the SF-6D in comparative clinical trials and to give pragmatic guidance to researchers on what method to use. Methods We describe two main methods of sample size estimation. The parametric (t-test) method assumes the SF-6D data is continuous and normally distributed and that the effect size is the difference between two means. The non-parametric (Mann-Whitney MW) method assumes the data are continuous and not normally distributed and the effect size is defined in terms of the probability that an observation drawn at random from population Y would exceed an observation drawn at random from population X. We used bootstrap computer simulation to compare the power of the two methods for detecting a shift in location. Results This paper describes the SF-6D and retrospectively calculated parametric and nonparametric effect sizes for the SF-6D from a variety of studies that had previously used the SF-36. Computer simulation suggested that if the distribution of the SF-6D is reasonably symmetric then the t-test appears to be more powerful than the MW test at detecting differences in means. Therefore if the distribution of the SF-6D is symmetric or expected to be reasonably symmetric then parametric methods should be used for sample size calculations and analysis. If the distribution of the SF-6D is skewed then the MW test appears to be more powerful at detecting a location shift (difference in means) than the t-test. However, the differences in power (between the t and MW tests) are small and decrease as the sample size increases. Conclusions We have provided a clear description of the distribution of the SF-6D and believe that the mean is an appropriate summary measure for the SF-6D when it is to be used in clinical trials and the economic evaluation of new health technologies. Therefore pragmatically we would recommend that parametric methods be used for sample size calculation and analysis when using the SF-6D.

    If you experience problems downloading a file, check if you have the proper application to view it first. In case of further problems read the IDEAS help page. Note that these files are not on the IDEAS site. Please be patient as the files may be large.

    File URL:
    File Function: original version
    Download Restriction: no

    Paper provided by University Library of Munich, Germany in its series MPRA Paper with number 29742.

    in new window

    Date of creation: Nov 2002
    Handle: RePEc:pra:mprapa:29742
    Contact details of provider: Postal:
    Ludwigstra├če 33, D-80539 Munich, Germany

    Phone: +49-(0)89-2180-2459
    Fax: +49-(0)89-2180-992459
    Web page:

    More information through EDIRC

    References listed on IDEAS
    Please report citation or reference errors to , or , if you are the registered author of the cited work, log in to your RePEc Author Service profile, click on "citations" and make appropriate adjustments.:

    in new window

    1. Brazier, John & Roberts, Jennifer & Deverill, Mark, 2002. "The estimation of a preference-based measure of health from the SF-36," Journal of Health Economics, Elsevier, vol. 21(2), pages 271-292, March.
    2. Andrew R. Willan & Bernie J. O'Brien, 1999. "Sample size and power issues in estimating incremental cost-effectiveness ratios from clinical trials data," Health Economics, John Wiley & Sons, Ltd., vol. 8(3), pages 203-211.
    3. P. Williamson & J. L. Hutton & J. Bliss & J. Blunt & M. J. Campbell & R. Nicholson, 2000. "Statistical review by research ethics committees," Journal of the Royal Statistical Society Series A, Royal Statistical Society, vol. 163(1), pages 5-13.
    Full references (including those not matched with items on IDEAS)

    This item is not listed on Wikipedia, on a reading list or among the top items on IDEAS.

    When requesting a correction, please mention this item's handle: RePEc:pra:mprapa:29742. See general information about how to correct material in RePEc.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: (Joachim Winter)

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If references are entirely missing, you can add them using this form.

    If the full references list an item that is present in RePEc, but the system did not link to it, you can help with this form.

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your profile, as there may be some citations waiting for confirmation.

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    This information is provided to you by IDEAS at the Research Division of the Federal Reserve Bank of St. Louis using RePEc data.