Table 1 Summary of the CONSORT PRO extension items

Structured summary of trial design, methods, results, and conclusions

The PRO should be identified in the abstract as a primary or secondary outcome

Explicitly identifying PROs in the RCT abstract will facilitate indexing and identification of studies to inform clinical care and evidence synthesis.

Specific objectives or hypotheses

The PRO hypothesis should be stated and relevant domains identified, if applicable.

PRO measures may be multi-dimensional and may assess patient status at several time points during a RCT. A pre-specified hypothesis reduces the risk of multiple statistical testing and selective reporting of PROs based on statistically significant results.

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed.

Evidence of PRO Instrument validity and reliability should be provided or cited if available including the person completing the PRO and methods of data collection (paper telephone electronic other).

This information will allow readers to assess the validity, reliability and appropriateness of the PRO being used.

Statistical Methods used to compare groups for primary and secondary outcomes

Statistical approaches for dealing with missing data are explicitly stated.

Missing PRO data is a potential source of bias. A number of methods for dealing with missing data are available with different strengths and limitations which should be described to facilitate interpretation.

Trial limitations addressing sources of potential bias, imprecision, and, if relevant multiplicity of analyses

PRO-specific limitations and implications for generalizability and clinical practice should be discussed.

PRO specific limitations may influence the generalizability of results and use in clinical practice.

Generalizability (external validity, applicability) of trial findings