Skip to main content
Log in

Guidelines for reporting results of quality of life assessments in clinical trials

  • Research Papers
  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Clinical trials involving quality of life measurement published in the literature suffer from important weaknesses due to the lack of information on numerous topics. The psychometric properties of the instruments are often lacking as well as data on the number of patients treated and analyzed. The handling of missing data is rarely documented. In order to facilitate the reporting of trials and the evaluation of published results, this article proposes a set of general guidelines for the reporting of clinical trials which include a quality of life assessment. A checklist designed to assist authors is appended.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Sander JO, VelduyzenVan Zanten. Quality of life as outcome measures in randomized trials. An overview of three general medical journals. Control Clin Trials 1991; 12: 234S-242S.

    Google Scholar 

  2. Schumaker M, Olschewski M, Schulgen G. Assessment of quality of life in clinical trials. Stats Med 1991; 10: 1915–1930.

    Google Scholar 

  3. Gotay CC, Moore TD. Assessing quality of life in head and neck cancer. Qual Life Res 1992; 1: 5.

    Google Scholar 

  4. Hunt S. The credibility of quality of life claims in clinical trials. Second Symposium on Contributed papers in Quality of Life Evaluation. Charleston, USA. 1994.

  5. Osoba D. Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 1994; 12: 608–616.

    Google Scholar 

  6. Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA 1994; 272: 619–626.

    Google Scholar 

  7. Hopwood P, Stephens RJ, Machin D. Approaches to the analysis of quality of life data: experiences gained from a Medical Research Council Lung Cancer Working Party palliative chemotherapy trial. Qual Life Res 1994; 3: 339–352.

    Google Scholar 

  8. Coste J, Fermanian J, Venot A. Methodological and statistical problems in the construction of composite measurement scales: a survey of six medical and epidemiological journals. Stats Med 1995; 14: 331–345.

    Google Scholar 

  9. Fletcher A. Quality-of-life measurements in the evaluation of treatments: proposed guidelines. Br J Clin Pharm 1995; 39: 217–222.

    Google Scholar 

  10. Altoona DG, Gore SM, Gardner MJ, Pock S. Statistical guidelines for contributors to medical journals. Br Med J 1983; 286: 1489–1493.

    Google Scholar 

  11. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. JAMA 1993; 269: 2282–2286.

    Google Scholar 

  12. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994; 272: 1926–1931.

    Google Scholar 

  13. The Asilomar Working Group. Checklist of information for inclusion in reports of clinical trials. Ann Intern Med 1996; 124: 741–743.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Staquet, M., Berzon, R., Osoba, D. et al. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res 5, 496–502 (1996). https://doi.org/10.1007/BF00540022

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF00540022

Key words

Navigation