Modified Consolidated Standards of Reporting Trials extension for Patient-Reported Outcomes (CONSORT-PRO) extension
| Item | Description | No description n (%) | Inadequate description n (%) | Adequate description n (%) |
| 1 | P1b: the PRO should be identified in the abstract as a primary or secondary outcome | 13 (19.4) | 24 (35.8) | 30 (44.8) |
| 2 | C2a: Background and rationale for PRO assessment | 19 (28.4) | 24 (35.8) | 24 (35.8) |
| 3 | P2b: hypothesis should be stated and relevant domains identified, if applicable | 44 (65.7) | 13 (19.4) | 10 (14.9) |
| 4 | P6a: Evidence of PRO-instrument validity and reliability should be provided or cited if available | 13 (19.4) | 3 (4.5) | 51 (76.1) |
| 5 | P6aa: Mode of administration, including the person completing the PRO and methods of data collection | 16 (23.9) | 19 (28.4) | 32 (47.8) |
| 6 | C7a: How sample size was determined: only if PRO was a primary study outcome | 23 (34.3) | 9 (13.4) | 35 (52.2) |
| 7 | P12a Statistical approaches for dealing with missing data are explicitly stated | 50 (74.6) | 6 (9.0) | 11 (16.4) |
| 8 | C13a: Results: the number of PRO outcome data at baseline and at subsequent time points should be made transparent | 3 (4.5) | 15 (22.4) | 49 (73.1) |
| 9 | C15: Baseline table/outcomes showing PRO data when collected | 6 (9.0) | 10 (14.9) | 51 (76.1) |
| 10 | C16a: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups, required for PRO results | 3 (4.5) | 8 (11.9) | 56 (83.6) |
| 11 | C17a: For each primary and secondary outcome, results for each group, the estimated effect size and its precision measure (such as 95% CI). For multidimensional PRO results from each domain and time point | 22 (32.8) | 19 (28.4) | 26 (38.8) |
| 12 | C18: Results of any other analysis and adjusted analysis distinguishing prespecified from explanatory, including PRO analysis where relevant | 3 (4.5) | 24 (35.8) | 40 (59.7) |
| 13 | P20/21: PRO-specific limitations and implications for generalisability and clinibal practice | 31 (46.3) | 22 (32.8) | 14 (20.9) |
| 14 | C22: PRO data should be interpreted in relation to clinical outcomes including survival data, where relevant | 19 (28.4) | 35 (52.2) | 13 (19.4) |