Table 5. Novel methods for assessing CONSORT PRO extension items 2a/P2b and P20/21/22, grouped by combined PRO and clinical papers, or linked primary and supplemental papers (n = 67).
| CONSORT PRO item | Combined clinical and PRO paper (n = 36) | Linked clinical and PRO papers (n = 15 pairs) | |
|---|---|---|---|
| 1° | 2° | ||
| N (%) | N (%) | N (%) | |
| Rationale/hypothesis (2a/P2b)* | |||
| • Detailed | 11 (31) | 2 (14) | 73) |
| • General | 10 (28) | 3 (20) | (27) |
| • Absent | 15 (41) | 10 (66) | 0 |
| Interpretation of findings (P20/21/22)† | |||
| • Detailed | 6 (17) | 1 (7) | (20) |
| • General | 2 (64) | 4 (27) | 80) |
| • Absent | 7 (19) | 10 (66) | 0 |
* Detailed rationale/hypothesis: specifying a PRO domain or hypothesized effect; general rationale/hypothesis: any other description; absent: no rationale. See methods for more details
† Interpretation was considered “detailed” where authors discussed the direction of change (e.g. increased/decreased/no change) of a specific PRO domain (e.g. physical function) in relation to the direction of change of a specific clinical outcome (e.g. survival). All other discussions, where present, were considered “partial” interpretations. Where no appropriate text was identified, interpretation was considered “absent”. See methods for more details