Authors: Donald L Patrick, Gordon H Guyatt and Catherine Acquadro on behalf of the Cochrane Patient Reported Outcomes Methods Group.
Patient-reported outcomes (PROs) are reports coming directly from patients about how they feel or function in relation to a health condition and its therapy without interpretation by healthcare professionals or anyone else.
PROs can relate to symptoms, signs, functional status, perceptions, or other aspects such as convenience and tolerability.
Items reflecting the concepts included in a PRO questionnaire are elicited from the target population; patient involvement in questionnaire generation is essential for content validity.
A glossary is provided on the PRO Methods Group web site (www.cochrane-pro-mg.org) for finding definitions of terms unfamiliar to authors.
PROs are not only important when more objective measures of disease outcome are not available but also to represent what is most important to patients about a condition and its treatment.
PROs can be continuous or categorical. Techniques are available to pool both kinds of measures.
Review authors may need to do background reading about PROs to ensure they understand those chosen for inclusion into trials, in particular their validity and ability to detect change.
A checklist is provided in this chapter on issues relating to PROs that authors should consider before incorporating PROs into their reviews and ‘Summary of findings’ tables.
If completed reviews fail to record PROs when they were chosen as important outcomes in the review protocol, then they should be highlighted in the review as a deficiency in the current research on efficacy of treatment.