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. 2024 Jul 16;74:102717. doi: 10.1016/j.eclinm.2024.102717

Table 2.

Example of integrity assessment sheet to be published alongside guidelines or publications, with integrity domains assessed (using the TRACT integrity tool), risk ratings, documented votes, final risk ratings after discussion and final allocation after author contact.

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.

a

Denotes the initials of committee members and their respective votes.

b

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).