Quality of life variables in surgical trials.

Clinical trials are commonly performed in surgery to assess the efficacy of one or more treatments. Many therapies result in only partial or temporary improvement, rather than cure. Others sharply affect the quality of patients' lives or of their deaths. For most interventions, it is important to document effects on quality of life as well as morbidity and mortality rates. yet, a review of the literature reveals that very few surgical trials consider quality of life variables as outcome measures. Surgical investigators in areas like cancer, inflammatory bowel disease, end stage renal disease, and cardiac disease have examined quality of life issues extensively using a variety of scales and indices. However, most studies on quality of life are hampered by poor design and inadequate methods of assessment. Failure to evaluate quality of life variables prevents the recognition and full use of potentially beneficial therapies and the rejection of potentially harmful ones.