Background: Because of the growing value attributed to informed consent, competence assessment has become an important task for physicians and researchers, particularly when treatment and research involve persons who may be cognitively impaired, such as those with Alzheimer's dementia.
Methods: We developed and validated a 12-item questionnaire to assess the understanding of information about clinical trials by research subjects (score 0 to 24). The 12 questions were selected from a larger pool of 16 through internal consistency validity testing.