Abstract
In this presentation, issues that influenced the development of policies for inclusion of quality of life end points in certain Southwest Oncology Group clinical trials are reviewed. The key policies recommended by us and adopted by the Cancer Control Research Committee of the Southwest Oncology Group are as follows: (a) Begin assessment of quality of life in specific types of phase III protocols. (b) Always measure physical functioning, emotional functioning, symptoms (general and protocol specific), and global quality of life separately. (c) Include measures of social functioning and additional protocol-specific measures if resources permit. (d) Use patient-based questionnaires with psychometric properties that have been documented in published studies. In this review, we also recommend specific questionnaires. Our recommendations may prove useful for other cancer clinical trials groups and for multi-institution trials of treatment for chronic diseases.
Highlights
Introduction of Procedures To EnsureCompliance and Quality ControlSpecial procedures should be introduced to ensure compliance and quality control of the quality of life data
We developed nine policy recommendations to guide the inclusion of quality of life end points in Southwest Oncology Group trials
The single-item Uniscale is worded as follows: "Please score how you feel your life has been, affected by the state of your health during the last week." This Uniscale, which will be included in the Southwest Oncology Group quality of life assessment packet, was taken from the 31-item linear analogue self-assessment (LASA) developed by Selby and colleagues (28)
Summary
Quality of Life End Points in Cancer Clinical Trials: Review and Recommendations. In this presentation, issues that influenced the development of policies for inclusion of quality of life end points in certain Southwest Oncology Group clinical trials are reviewed. The recent review by Aaronson (22) was not available when our work began His recommendations are consistent with ours, and this underscores the agreement that is developing with respect to assessment of quality of life in clinical trials. Laupacis et al (23) reviewed a number of statistics for summarizing benefits and harm associated with medical treatment for groups of patients They described the properties of quantifiable measures such as the reciprocal of the absolute risk reduction. Another alternative to inclusion of a battery of patient-based instruments is the use of physician-based data on toxic effects to create a variable relating to time without symptoms and toxic effects (TWiST) that is amenable to survival analysis techniques (24)
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