Table 2.
Items adequately reported against the quality of reporting criteria (Consolidated Standards of Reporting Trials (CONSORT) Extension for Harm).
| Recommendations of 2004 CONSORT harm extension | Quality of reporting criteria | Number of trials |
|---|---|---|
| 1. If the study collected data on harms and benefits, the title of the abstract should state so | Adverse events mentioned in the title | 0 (0%) |
| Adverse events mentioned in the abstract | 9 (56%) | |
| 2. If the trial addresses both harms and benefits, the introduction should state so | Information on adverse events mentioned in the introduction | 5 (31%) |
| 3. List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected versus unexpected events, reference to standardized and validated definitions, and description of new definitions) | 3a. If article mentioned the use of a validated instrument to report adverse event severity | 5 (31%) |
| 3b. If article mentioned definition of adverse event | 8 (50%) | |
| 4. Clarify how harm-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harm-related monitoring and stopping rules, if pertinent) | 4a. Description of how harm data were collected (e.g. diaries, phone interviews, face-to-face interviews) | 7 (44%) |
| 4b. Description of when adverse event data were collected | 9 (56%) | |
| 4c. Whether or not adverse events were attributed to trial drug (e.g. how adverse events were attributed to drugs) | 2 (13%) | |
| 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) | 5. Description of methods for presenting and/or analysing adverse events | 2 (13%) |
| 6. Describe for each arm the participant withdrawals that are due to harms and the experience with the allocated treatment | 6a. If the article reported number of withdraws caused by adverse events in each arm | 7 (44%) |
| 6b. Description of adverse events leading to withdrawals | 5(31%) | |
| 6c. Description of adverse events leading to death | 2 (13%) | |
| 7. Provide the denominators for analyses on harms | 7a. If the article provided denominators for adverse events | 10 (63%) |
| 7b. If the article provided definitions used for analysis set (intention to treat, per protocol, safety data available, unclear) | 3 (19%) | |
| 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 | 8a. Results presented separately for each arm | 13 (81%) |
| 8b. Separate reporting of severe adverse events s (grade >2 or serious adverse events) | 11 (69%) | |
| 8c. Provided both number of adverse events and number of patients with adverse events | 2 (13%) | |
| 9. Describe any subgroup analyses and exploratory analyses for harms | – | 2 (13%) |
| 10. Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalizability, and other sources of information on harms | 10a. If the discussion was balanced with regard to efficacy and adverse events | 9 (56%) |
| 10b. Limitations of the study specifically in relation to adverse events discussed | 2 (13%) |