Table 2.
Author, year | Governance |
Author group |
Plausibility of intervention |
Timeframe |
Drop outs |
Baseline characteristics |
Outcomes |
Total (3a.)b | Initial risk rating (3b.)b | Voting record (4b.)b | Final risk rating (4b./4c.)b | Final study allocation (after author contact) (6a.)b | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Absent or retrospective registration | Discrepant registration | Absent or vague ethics | Low # or ratio of authors | Retraction watch base (2a./2b.)b | Large # RCTs | Implausible intervention | Illogical methods | Fast recruitment | Fast follow-up | No LTFU | Ideal numbers | No or few (<5) BL data | Implausible data | Perfectly balanced | Larger effect size than other RCTs | Conflicting outcomes | ||||||
Author, 2010 | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Retracted- Exclude | Unanimous ×6 | Retracted | Excluded |
Author, 2009 | Yes | No | No | Yes | No | No | No | Yes | No | No | No | Yes | No | Yes | No | Yes | No | 6 | High | Unanimous ×6 | High | Not Included |
Author, 2018 | Yes | No | No | Yes | No | No | No | No | No | Yes | Yes | No | Yes | No | No | No | No | 5 | Moderate | ×2 mod (BM, MF); ×4 high (HT, AM, JT, MC)a | High | Awaiting Classification |
Author, 2009 | No | No | No | Yes | No | Yes | No | Yes | No | No | Yes | No | Yes | Yes | No | No | No | 6 | High | Unanimous ×6 | High | Not Included |
Author, 2013 | Yes | No | No | Yes | No | No | No | No | No | No | Yes | No | No | Yes | No | No | No | 4 | Moderate | Unanimous ×6 | Moderate | Awaiting Classification |
Author, 2005 | No | No | No | No | Yes | Yes | No | No | No | No | Yes | No | No | No | No | No | No | 3 | Low | ×4 low (AM, HT, JT, MC), ×2 mod (BM, MF)a | Low | Included |
Author, 2019 | Yes | No | No | Yes | No | No | No | No | No | No | Yes | No | No | Yes | No | No | No | 4 | Moderate | ×4 low (AM, HT, JT, MC), ×2 mod (BM, MF)a | Low | Included |
All scoring tables with votes and final decisions should be documented for transparency and published in technical reports or supplemental material.
Denotes the initials of committee members and their respective votes.
Refers to the checklist item for this part of the Research Integrity in Guidelines and evIDence synthesis (RIGID) framework (Table 3). BL, baseline; LTFU, lost to follow up; mod, moderate; TRACT, Trustworthiness in Randomized Controlled Trials tool; RCTs, randomized controlled trials. Descriptions of the domains for the tool shown here can be found in Mol et al.24 and in the Supplemental Material (Appendix 2).