These are the methodology standards published by the Patient-Centered Outcomes Research Institute for its patient-centered outcomes research. The standards describe how patient-reported outcomes (PROs) should be used in patient-centered outcomes research.

Research Question Standard 6 is:

Measure outcomes that people representing the population of interest notice and care about.  Identify and include outcomes the population of interest notices and cares about (e.g., survival, function symptoms, health-related quality of life) and that inform an identified health decision. Define outcomes clearly, especially for complex conditions or outcomes that may not have established clinical criteria. Provide information that supports the selection of outcomes as meeting the criteria of “patient-centered” and “relevant to decision makers,” such as patient and decision-maker input from meetings, surveys, or published studies. Select outcomes based on input directly elicited from patient informants and people representative of the population of interest, either in previous studies or in the proposed research.

Patient-Centeredness Standard 3 is:

Use patient-reported outcomes when patients or people at risk of a condition are the best source of information: When patients or people at risk of a condition are the best source of information regarding outcomes of interest, then the study should employ patient-reported outcome (PRO) measures in lieu of, or in addition to, measures derived from other sources. Proposals should describe: 1) the concept(s) underlying each PRO measure (e.g., symptom or impairment) and how it is meaningful to, and noticed by, patients in the population of interest; 2) how the concept relates to the health decisions the study is designed to inform; 3) how the PRO measure was developed, including how patients were involved in the development; and 4) evidence of measurement properties including content validity, construct validity, reliability, responsiveness to change over time, and score interpretability, including meaningfulness of score changes in the population of interest with consideration of important subgroups. If these measurement properties are not known, a plan for establishing the properties must be provided. Caregiver reports may be appropriate if the patient cannot self-report the outcomes of interest. If PROs are not planned for use in the study, justification must be provided.

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