Guidelines for reporting results of quality of life assessments in clinical trials
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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.
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Quality of Life Research
Volume 5, Issue 5 , pp 496-502
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- Online ISSN
- Kluwer Academic Publishers
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- Clinical trials
- health-related quality of life
- quality of life
- Industry Sectors
- Author Affiliations
- 1. Faculty of Medicine (DCS), Brussels Free University, Route de Lennik, 808, CP 623, B-1070, Brussels, Belgium
- 2. Bayer Pharmaceuticals, 400 Morgan Lane, 06516, West Haven, CT, USA
- 3. British Columbia Cancer Agency, 600 West 10th Avenue, V5Z 4E6, Vancouver, BC, Canada
- 4. University of British Columbia, 600 West 10th Avenue, V5Z 4E6, Vancouver, BC, Canada
- 5. MRC Cancer Trials Office, 5 Shaftesbury Road, CB2 2BW, Cambridge, UK