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Strategies and pitfalls in quality of life research.

QOL research is an important element of outcomes research and can provide an important adjunct to clinical trials in hepatology. The principles of QOL research are similar to all outcomes research methods. Pitfalls in QOL research include poor study design, choosing the wrong instrument, and inadequate interpretation of design. These pitfalls can be avoided with a well-thought-out strategy including a well-designed hypothesis to test, a validated instrument, careful data collection and analysis, and collaboration with biostatisticians and experts in health-utility research when necessary. QOL research is best suited to questions where survival differences between the two groups studied are modest or to balance economic outcomes, but it can be a useful part of virtually any clinical question.