Outcome discrepancies between prespecified (protocol) and reported outcomes (initial submission) from trials submitted to The BMJ
| Trials accepted by The BMJ (n=21 trials) | Trials rejected by The BMJ (n=21 trials) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Discrepancy type | Discrepancy type | ||||||||||||
| Article ID | Registration type | Total number of outcomes prespecified* | Prespecified outcomes not reported† | New outcomes introduced‡ | Total number of outcomes reported§ | Change in level of importance of an outcome¶ | Article ID | Registration type | Total number of outcomes prespecified* | Prespecified outcomes not reported† | New outcomes introduced‡ | Total number of outcomes reported§ | Change in level of importance of an outcome¶ |
| A1 | Prospective | 15 | 2 | 0 | 13 | 0 | R1 | Prospective | 4 | 0 | 2 | 6 | 0 |
| A3 | Prospective | 11 | 8 | 1 | 4 | 0 | R4 | Prospective | 20 | 4 | 1 | 17 | 0 |
| A4 | Prospective | 21 | 2 | 6 | 25 | (−1) | R6 | Prospective | 15 | 4 | 0 | 11 | 0 |
| A5 | Prospective | 23 | 16 | 2 | 9 | 0 | R8 | Prospective | 20 | 2 | 2 | 20 | 0 |
| A6 | Prospective | 12 | 5 | 4 | 11 | (−1) | R10 | Prospective | 22 | 0 | 2 | 24 | 0 |
| A7 | Prospective | 10 | 0 | 0 | 10 | 0 | R11 | Prospective | 30 | 19 | 3 | 14 | 0 |
| A8 | Prospective | 14 | 0 | 2 | 16 | 0 | R16 | Prospective | 5 | 1 | 0 | 4 | 0 |
| A9 | Prospective | 25 | 8 | 2 | 19 | 0 | R19 | Prospective | 11 | 5 | 11 | 17 | 0 |
| A10 | Prospective | 22 | 3 | 5 | 24 | 0 | R20 | Prospective | 15 | 0 | 1 | 16 | 0 |
| A11 | Prospective | 5 | 2 | 2 | 5 | 0 | R21 | Prospective | 3 | 0 | 0 | 3 | 0 |
| A12 | Prospective | 10 | 1 | 0 | 9 | 0 | R2 | Retrospective | 20 | 1 | 0 | 19 | 0 |
| A13 | Prospective | 3 | 0 | 0 | 3 | 0 | R3 | Retrospective | 22 | 0 | 0 | 22 | 0 |
| A14 | Prospective | 5 | 0 | 0 | 5 | 0 | R7 | Retrospective | 29 | 4 | 6 | 31 | 0 |
| A15 | Prospective | 29 | 3 | 0 | 26 | 0 | R9 | Retrospective | 15 | 7 | 0 | 8 | 0 |
| A16 | Prospective | 8 | 0 | 0 | 8 | 0 | R12 | Retrospective | 12 | 0 | 8 | 20 | 0 |
| A17 | Prospective | 22 | 0 | 2 | 24 | 0 | R13 | Retrospective | 16 | 8 | 0 | 8 | 0 |
| A19 | Prospective | 13 | 2 | 0 | 11 | 0 | R14 | Retrospective | 6 | 0 | 2 | 8 | 0 |
| A20 | Prospective | 41 | 24 | 1 | 18 | (−1) | R15 | Retrospective | 18 | 1 | 0 | 17 | 0 |
| A21 | Prospective | 21 | 1 | 0 | 20 | 0 | R17 | Retrospective | 18 | 2 | 7 | 23 | 0 |
| A18 | Retrospective | 7 | 6 | 2 | 3 | 0 | R18 | Retrospective | 15 | 2 | 0 | 13 | 0 |
| A2 | Unclear | 16 | 6 | 2 | 12 | 0 | R5 | Unclear | 19 | 3 | 0 | 16 | 0 |
| Total | 333 | 89 | 31 | 275 | (−3) | Total | 335 | 63 | 45 | 317 | 0 | ||
| Prespecified but not reported (accept BMJ): 27% (89/333) Reported but not prespecified (accept BMJ): 11% (31/275) | Prespecified but not reported (reject BMJ): 19% (63/335) Reported but not prespecified (reject BMJ): 14% (45/317) | ||||||||||||
*Prespecified: total number of outcomes listed in trial protocol.
†Outcomes mentioned in protocol but not reported in the initial article submission.
‡Outcomes not prespecified in protocol but reported in the initial article submission.
§Reported: total number of outcomes reported in initial submission. If only an outcome domain was specified in the protocol, all outcomes reported within this domain were counted.
¶Minus (−), number of prespecified protocol outcomes downgraded from primary to secondary outcomes in initial trial report submission; Plus (+), number of prespecified or protocol outcomes upgraded from secondary to primary in the initial trial report submission.