The 10 CONSORT-harms recommendations9
| Recommendation | Description |
|---|---|
| 1 | If the study collected data on harms and benefits, the title and abstract should so state |
| 2 | If the trial addresses harms as well as benefits, the introduction should so state |
| 3 | List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected vs unexpected events, reference to standardised and validated definitions, and description of new definitions) |
| 4 | Clarify how harms-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harms-related monitoring and stopping rules, if pertinent) |
| 5 | Describe plans for presenting and analysing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures and any statistical analyses) |
| 6 | Describe for each arm the participant withdrawals that are due to harms and the experience with the allocated treatment |
| 7 | Provide the denominators for analyses on harms. |
| 8 | Present the absolute risk of each adverse event (specifying type, grade, and seriousness per arm), and present appropriate metrics for recurrent events, continuous variables and scale variables, whenever pertinent. |
| 9 | Describe any subgroup analyses and exploratory analyses for harms |
| 10 | Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalisability and other sources of information on harms |