![]() ![]() ![]() In asthma, Yohannes and colleagues (Yohannes et al (1998) found that variability in exercise capacity contributed to only 3% of the variability in breathing problems on a patient self-report questionnaire. Self-reported outcomes often correlate poorly with physiological and other outcomes such as performance-related outcomes, clinician-reported outcomes, or biomarkers. PROs provide patients’ perspectives regarding treatment benefit and harm, directly measure treatment benefit and harm beyond survival, major morbid events and biomarkers, and are often the outcomes of most importance to patients and families. The principles also apply to systematic reviews of non-randomized studies addressing PROs (e.g. The focus is on the use of PROs in randomized trials, and what is crucial in this context when selecting PROs to include in a meta-analysis. This chapter outlines a step-by-step approach to addressing each of these elements in the systematic review process. The objectives of this chapter are to: (i) describe the category of outcomes known as PROs and their importance for healthcare decision making (ii) illustrate the key issues related to reliability, validity and responsiveness that systematic review authors should consider when including PROs and (iii) address the structure and content (domains, items) of PROs and provide guidance for combining information from different PROs. Conducting systematic reviews and meta-analyses including PROMs and interpreting their results is not straightforward, and guidance can help review authors address the challenges. PROs provide crucial information for patients and clinicians facing choices in health care. Although investigators may address patient-relevant outcomes via proxy reports or observations from caregivers, health professionals, or parents and guardians, these are not PROMs but rather clinician-reported or observer-reported outcomes (Powers et al 2017). Patient-reported outcome measures (PROMs) are instruments that are used to measure the PROs, most often self-report questionnaires. hospitalization), and survival used and reported in clinical trials and non-randomized studies (FDA 2018). stroke, myocardial infarction), burden (e.g. ![]() PROs are one of several clinical outcome assessment methods that complement biomarkers, measures of morbidity (e.g. Available from 18.1 Introduction to patient-reported outcomesġ8.1.1 What are patient-reported outcomes?Ī patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else” (FDA 2009). Cochrane Handbook for Systematic Reviews of Interventions version 6.1 (updated September 2020). In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Summary data on patient-reported outcomes (PROs) are important to ensure healthcare decision makers are informed about the outcomes most meaningful to patients.Īuthors of systematic reviews that include PROs should have a good understanding of how patient-reported outcome measures (PROMs) are developed, including the constructs they are intended to measure, their reliability, validity and responsiveness.Īuthors should pre-specify at the protocol stage a hierarchy of preferred PROMs to measure the outcomes of interest.Ĭite this chapter as: Johnston BC, Patrick DL, Devji T, Maxwell LJ, Bingham III CO, Beaton D, Boers M, Briel M, Busse JW, Carrasco-Labra A, Christensen R, da Costa BR, El Dib R, Lyddiatt A, Ostelo RW, Shea B, Singh J, Terwee CB, Williamson PR, Gagnier JJ, Tugwell P, Guyatt GH. ![]()
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