Table 5.
Comparison of 15 harms criteria (CONSORT-harms extension used as a benchmark)
| Trial ID | |||||||
|---|---|---|---|---|---|---|---|
| Criteria | Description of item | NM16189 | M37013 | M37002 | M37047 | BM15421 | |
| Methods criteria | 1 | List addressed adverse events (AEs) with definitions. | CSR | CSR | CSR | CSR | CSR |
| 2 | Mode of collecting harms data. | BOTH b | BOTH b | BOTH b | CSR | BOTH a | |
| 3 | Timing and time frame of surveillance for adverse events. | BOTH b | Pub | CSR | NR | BOTH a | |
| 4 | Attribution methods. | CSR | NR | CSR | NR | NR | |
| 5 | Intensity of ascertainment. | CSR | BOTH b | CSR | CSR | CSR | |
| 6 | Harms related monitoring. | CSR | BOTH b | CSR | CSR | CSR | |
| 7 | Coding of AEs. | CSR | CSR | BOTH a | CSR | CSR | |
| 8 | Handling of recurrent events. | NR | CSR | NR | CSR | NR | |
| 9 | Timing issues. | CSR | CSR | CSR | NR | CSR | |
| 10 | Plans to perform any statistical analyses and inferences. | CSR | BOTH a | BOTH a | BOTH a | BOTH a | |
| Total items satisfied for methods criteria in clinical study report (CSR) (% of total 10 items assessed) | 9 (90) | 8 (80) | 9 (90) | 7 (70) | 8 (80) | ||
| Total items satisfied for methods criteria in publication (% of total ten items assessed) | 2 (20) | 5 (50) | 3 (30) | 1 (10) | 3 (30) | ||
| Results criteria | 11 | Withdrawals and discontinuations. | BOTH a | BOTH a | BOTH a | BOTH a | CSR |
| 12 | Denominators for analyses on harms. | BOTH b | BOTH b | BOTH a | CSR | BOTH b | |
| 13 | Specifying AE type. | BOTH a | BOTH a | BOTH a | BOTH a | BOTH a | |
| 14 | Grading or scaling used. | NR | BOTH a | BOTH a | BOTH a | BOTH a | |
| 15 | Seriousness per arm. | BOTH a | BOTH a | BOTH a | BOTH a | BOTH a | |
| Total items satisfied for results criteria in the CSR (% of total five items assessed) | 4 (80) | 5 (100) | 5 (100) | 5 (100) | 5 (100) | ||
| Total items satisfied for results criteria in the publication (% of total five items assessed) | 4 (80) | 5 (100) | 5 (100) | 4 (80) | 4 (80) | ||
| Total items satisfied in CSR (% of total 15 items assessed) | 13 (87) | 13 (87) | 14 (93) | 12 (80) | 13 (87) | ||
| Total items satisfied in publication (% of total 15 items assessed) | 6 (40) | 10 (67) | 8 (53) | 5 (33) | 7 (47) | ||
Footnote:
BOTH ‘reported in CSR and the corresponding journal publication’, CSR ‘only reported within the CSR’, Pub ‘only reported in journal publication’, NR ‘neither reported in the CSR or journals publication’. Completeness of data where agreement (BOTH) is made coded as: a ‘More complete in CSR’; b ‘Similar quality for both documents’; - ‘less complete in the CSR’