Table 4

Modified Consolidated Standards of Reporting Trials extension for Patient-Reported Outcomes (CONSORT-PRO) extension

ItemDescriptionNo description n (%)Inadequate description n (%)Adequate description n (%)
1P1b: the PRO should be identified in the abstract as a primary or secondary outcome13 (19.4)24 (35.8)30 (44.8)
2C2a: Background and rationale for PRO assessment19 (28.4)24 (35.8)24 (35.8)
3P2b: hypothesis should be stated and relevant domains identified, if applicable44 (65.7)13 (19.4)10 (14.9)
4P6a: Evidence of PRO-instrument validity and reliability should be provided or cited if available13 (19.4)3 (4.5)51 (76.1)
5P6aa: Mode of administration, including the person completing the PRO and methods of data collection16 (23.9)19 (28.4)32 (47.8)
6C7a: How sample size was determined: only if PRO was a primary study outcome23 (34.3)9 (13.4)35 (52.2)
7P12a Statistical approaches for dealing with missing data are explicitly stated50 (74.6)6 (9.0)11 (16.4)
8C13a: Results: the number of PRO outcome data at baseline and at subsequent time points should be made transparent3 (4.5)15 (22.4)49 (73.1)
9C15: Baseline table/outcomes showing PRO data when collected6 (9.0)10 (14.9)51 (76.1)
10C16a: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups, required for PRO results3 (4.5)8 (11.9)56 (83.6)
11C17a: 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 point22 (32.8)19 (28.4)26 (38.8)
12C18: Results of any other analysis and adjusted analysis distinguishing prespecified from explanatory, including PRO analysis where relevant3 (4.5)24 (35.8)40 (59.7)
13P20/21: PRO-specific limitations and implications for generalisability and clinibal practice31 (46.3)22 (32.8)14 (20.9)
14C22: PRO data should be interpreted in relation to clinical outcomes including survival data, where relevant19 (28.4)35 (52.2)13 (19.4)