Quality-of-life measurement in surgical randomized controlled trials.

Quality-of-life measurement in controlled clinical trials assessing medical treatment has increased drammatically over the past decades. Although the experience with quality-of-life measurement in surgical clinical trials has been more recent, it has demonstrated the important role of these measures in determining the best treatment options as well as in clinical decisions. Two types of instruments are available to measure quality of life: generic instruments, and specific instruments. Both follow a rigorous scientific methodology that includes both a development and a validation phase. In the validation phase, instruments are assessed for their reproducibility, responsiveness, and validity. Ad hoc instruments, on the other hand, follow no such methodology and results can be open to interpretation. This review demonstrates that quality-of-life measurement in surgical clinical trials is both possible and clinically important. More study investigators will consider measuring quality of life using well-validated instruments when designing future surgical randomized controlled trials.