CONSORT harms criteria reported across included reviews
| Bagul (2012)14 | Breau (2011)15 | Turner (2011)16 | Shukralla (2011)17 | Capili (2009)18 | Pitrou (2009)20 | Haidich (2009)21 | |
|---|---|---|---|---|---|---|---|
| Total no. of trials included in review | 41 | 152 | 205 | 152 | 10 | 133 | 102 |
| CONSORT Recommendation | % of trials (95% CI) that adhered to each recommendation | ||||||
| (1) Title & Abstract | 20 (9, 35) | 12 (6, 20) 1i) 12 (6, 20) 1ii) 64 (53, 74) | 21 (16, 27) | 88 (81, 92) | NR | 71 (63, 79) | 76 (67, 84) |
| (2) Introduction | 34 (20, 51) | 54 (43, 65) | 4 (2, 8) | 74 (67, 81) | NR | NR | 48 (38, 58) |
| (3) Definition of adverse events | 0 (0, 9) | 15 (8, 24) | 6 (3, 11) | 3a) 36 (29, 45) 3b) 32 (25, 40) 3c) 47 (39, 55) 3d) 16 (11, 23) 3e) 22 (15, 29) | 10 (0, 45) | 16 (10, 23) | 59 (49, 69) |
| (4) Collection of harms data | 10 (3, 23) | 4i) 22 (14, 32) 4ii) 6 (2, 13) 4iii) 0 (0, 4) | 17 (12, 22) | 4a) 57 (49, 65) 4b) 76 (69, 83) 4c) 33 (26, 42) | 20 (3, 56) | 89 (82, 94) | 81 (74, 89) |
| (5) Analysis of harms | 0 (0, 9) | 76 (66, 84) | 6 (3, 10) | 5a) 36 (28, 44) 5b) 7 (4, 13) | 20 (3, 56) | 12 (7, 19) | 44 (34, 54) |
| (6) Withdrawals | 51 (35, 67) | 35 (25, 45) | 30 (24, 37) | 6a) 71 (63, 78) 6b) 72 (65, 79) | 70 (35, 93) | 53 (44, 61) | 59 (50, 69) |
| (7) Number of patients analysed | 17 (7, 32) | 35 (25, 45) | 18 (13, 24) | 7a) 78 (72, 85) 7b) 40 (32, 48) | NR | 84 (77, 90) | 74 (64, 82) |
| (8) Results for each adverse event | 39 (24, 56) | 8i) 0 (0, 4) 8ii) 28 (19, 38) | – | 8a) 35 (28, 44) 8b) 68 (60, 76) 8c) 47 (39, 56) 8d) 19 (14, 27) | NR | 73 (65, 80) | 89 (82, 95) |
| (9) Subgroup Analysis | – | – | – | – | NR | NR | 53 (43, 63) |
| (10) Balanced discussion | 5 (1, 17) | 10i) 61 (50, 71) 10ii) 14 (7, 23) 10iii) 44 (33, 55) | – | 10a) 68 (60, 76) 10b) 61 (54, 70) 10c) 41 (34, 50) | NR | NR | 83 (76, 91) |
NR Not reported in manuscript, and no response from authors when contacted.
– Author detailed reasons for not reporting the recommendation.
1) (i) Harm, safety or similar term used in title; (ii) Harm addressed in abstract.
4) (i) When harm information was collected; (ii) Methods to attribute harm to intervention; (iii) Stopping rules.
8) (i) Effect sizes for harms; (ii) Stratified serious and minor harms.
10) (i) Interpret harm outcome; (ii) discuss generalizability; (iii) discuss current evidence.
3) (a) Definition of AE; (b) All or selected sample; (c) Treatment Emergent AE; (d) Validated instrument; (e) Validated dictionary.
4) (a) Mode of AE collection; (b) Timing of AE; (c) Details of attribution.
5) (a) Details of presentation and analysis; (b) Handling of recurrent AE.
6) (a) Early or late withdrawals; (b) Serious AEs or death.
7) (a) Provide denominators for AEs; (b) Provide definitions used for analysis set.
8) (a) Same analysis set used for efficacy and safety; (b) Results presented separately; (c) Severity and grading of AEs; (d) Provide both number of AEs and number of patients with AEs.
10) (a) Discusses prior AE data; (b) Discussion is balanced; (c) Discusses limitations.