Table 2. CONSORT extension checklist of ten recommendations when reporting harms in randomized controlled trials (n = 18).
Author (Year) | 1 | 2 | 3 | 4 | 5 | 6 | 7* | 8** | 9 | 10 |
---|---|---|---|---|---|---|---|---|---|---|
Brismee et al (2007)17 | X | X | X | |||||||
Hall et al (2011)16 | X | |||||||||
Li et al (2004)33 | X | |||||||||
Li et al (2004)32 | X | X | X | |||||||
Ni et al (2010)30 | X | X | X | X | ||||||
Shen et al (2010)45, 67 | X | X | X | X | X | X | X | |||
Taylor et al (2012)53 | X | X | X | |||||||
Tsang et al (2007)46, 47 | X | X | X | X | X | |||||
Tsang et al (2010)48 | X | X | X | X | X | |||||
Wang et al (2009)54 | X | X | X | |||||||
Wang et al (2010)31 | X | X | X | X | X | |||||
Wayne et al (2012)49 | X | X | X | |||||||
Wolf et al (2003)55 | X | X | X | |||||||
Wolfson et al (1996)19 | X | X | X | |||||||
Yeh et al (2004)50 | X | X | X | X | ||||||
Yeh et al (2010)51 | X | X | X | X | X | |||||
Yeh et al (2011)52 | X | X | X | X | X | |||||
Yeung et al (2012)18 | X | X | X | X | X |
We considered study to have addressed recommendation 7 if the denominator for harms could be easily inferred from the CONSORT flow diagram or other text describing 'what follow up-time counts towards overall exposure'
We considered study to have addressed recommendation 8 if adverse events were further categorized per arm by type, grade, OR seriousness (where we included relatedness to the intervention as a type). If there were no events in the control arm, this needed to be stated.