2011. Patrick DL et al. – Patient-reported outcomes (In: Cochrane Handbook for Systematic Reviews of Interventions)


Patrick DL, Guyatt GH,  Acquadro C. Chapter 17: Patient-reported outcomes. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011.

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Key points

  • 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.