Based on the final KQ s specified above, we generated a list of inclusion and exclusion criteria (Table 3). We included prospective and cross-sectional observational studies of health outcomes, trials of materials developed for low-health-literacy populations, and trials of interventions that compared materials designed to be “easier to read or understand” with standard materials. We limited studies to those with outcomes related to health and use and costs of health services. Because this is an update to our original report, we limited our searches to studies that would not have been considered during the earlier review (., those more recently.