Table 1.
Summary of the CONSORT PRO extension items
| CONSORT 2010 statement | PRO extension | Brief rationale for extension |
|---|---|---|
| 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 |
Authors are referred to the CONSORT PRO Extension paper for further explanation and the full list of items [11]. The CONSORT PRO extension should be used in conjunction with the CONSORT checklist and relevant extensions as appropriate for the study design.