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Patient-reported outcome measures (PROMs) are intended to reflect outcomes relevant to patients. They are increasingly used for healthcare quality improvement. To produce valid measures, patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities. This potential exclusion raises concerns about whether these groups will be able to use these measures and participate in quality improvement practices.Taking PROMs for chronic obstructive pulmonary disease (COPD) as an exemplar condition, our review determined the inclusion of people with low literacy skills and learning disabilities in research developing, validating, and using 12 PROMs for COPD patients. The studies included in our review were based on those identified in two existing systematic reviews and our update of this search.People with low literacy skills and/or learning disabilities were excluded from the development of PROMs in two ways: explicitly through the participant eligibility criteria and, more commonly, implicitly through recruitment or administration methods that would require high-level reading and cognitive abilities. None of the studies mentioned efforts to include people with low literacy skills or learning disabilities.Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs. Given that implicit exclusion was most common, researchers and those who administer PROMs may not even be aware of this problem. Without effort to improve inclusion, unequal quality improvement practices may become embedded in the health system.