The development, assessment, and selection of questionnaires.

Patient-reported outcome measurement has become accepted as an important component of comprehensive outcomes research. Researchers wishing to use a patient-reported measure must either develop their own questionnaire (called an instrument in the research literature) or choose from the myriad of instruments previously reported. This article summarizes how previously developed instruments are best assessed using a systematic process and we propose a system of quality assessment so that clinicians and researchers can determine whether there exists an appropriately developed and validated instrument that matches their particular needs. These quality assessment criteria may also be useful to guide new instrument development and refinement. We welcome debate over the appropriateness of these criteria as this will lead to the evolution of better quality assessment criteria and in turn better assessment of patient-reported outcomes.