TABLE 5.
Level of PRO reporting by year (2013) of publication of the CONSORT‐PRO extension
| CONSORT‐PRO Extension Item |
RCTs before CONSORT‐PRO publication (2004‐2013) (n = 79) No (%) |
RCTs after CONSORT‐PRO publication (2014‐2019) (n = 41) No (%) |
|---|---|---|
| P1b. The PRO should be identified in the abstract as a primary or secondary outcome. | 72 (91.1) | 38 (92.7) |
| P2b. The PRO hypothesis should be stated, and relevant domains should be identified if applicable. a | 25 (31.7) | 14 (34.2) |
| P6a. Evidence of PRO instrument validity and reliability should be provided or cited if available. b | 55 (69.6) | 32 (78.0) |
| P6aa. This is the mode of administration, including the person completing the PRO and the methods of data collection (paper, telephone, electronic, and other). b , c | 15 (19.0) | 9 (22.0) |
| P12a. Statistical approaches for dealing with missing data are explicitly stated. | 17 (21.5) | 15 (36.6) |
| P20/21. PRO‐specific limitations and implications for generalizability and clinical practice should be discussed. | 26 (32.9) | 19 (46.3) |
Abbreviations: CONSORT, Consolidated Standards of Reporting Trials; PRO, patient‐reported outcome; RCT, randomized controlled trial.
This percentage was calculated on the basis of all studies (including those explicitly reporting an exploratory evaluation, for which this item would be rated as not applicable).
Items P6a and P6aa were combined in the original CONSORT‐PRO extension; however, for the purposes of this study, to better appraise the proportion of RCTs providing evidence on the validity of the PRO instrument but not further describing how this was administered to patients, this item was split into two items.
In case of studies using multiple PRO measures, we evaluated this as “yes” if at least one measure was validated.