Abstract

A recent article in JAMA reports the extension of the Consolidated Standards of Reporting Trials (CONSORT) Patient-Reported Outcome (PRO) group on recommendations for what should be included when reporting the results of PROs in randomized controlled trials (RCTs) as primary or secondary outcomes. Five CONSORT PRO checklist items are recommended as follows:

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  that PROS be identified as a primary or secondary outcome in the abstract;
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  that a description of the hypothesis of PROs and relevant domains be provided (i.e., if a multidimensional PRO tool has been used);
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  that evidence of the PRO instrument’s validity and reliability be provided or cited;
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  that statistical approaches for dealing with missing data be explicitly stated; and
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  that PRO-specific limitation of study findings and generalizability of results to other populations and clinical practice be discussed.

PRO extension was deemed unnecessary for many CONSORT checklist items.