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. 2022 Sep 9;11(3):643–666. doi: 10.1556/2006.2022.00061

Table 8.

Risk of Bias (RoB) assessment with CONSORT items

Randomized controlled trial Non-randomized controlled trial
CONSORT item Bőthe et al. (2021) Wainberg et al. (2006) Hallberg et al. (2019) Crosby and Twohig (2016) Sniewski et al. (2020) Wilson and Fischer (2018) Savard et al. (2020) Hallberg et al. (2020) Hallberg et al. (2017) Raymond et al. (2010) Hartman et al. (2012) Twohig and Crosby (2010) Kjellgren (2018) Holas et al. (2021) Levin et al. (2017) Hardy et al. (2010) Gola and Potenza (2016) Coleman et al. (2000) Kafka and Hennen (2000) Klontz et al. (2005) Efrati and Gola (2018) Orzack et al. (2006) Hall et al. (2020) Wan et al. (2000)
Title and abstract 1a 2 1 2 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1b 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0
Background and objectives 2a 2 2 2 2 2 2 2 2 2 2 2 2 1 2 2 2 1 2 2 2 2 2 1 0
2b 2 1 2 1 1 0 2 2 2 2 2 2 2 2 1 2 1 2 1 2 2 2 1 0
Trial design 3a 2 2 2 1 2 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0
3b 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Participants 4a 2 2 2 2 1 2 2 2 2 0 2 1 1 2 2 1 0 1 0 0 0 1 1 0
4b 0 2 2 1 2 1 2 2 2 2 2 1 1 2 2 0 0 1 0 2 0 0 1 2
Interventions 5 2 2 1 2 2 2 2 2 1 2 1 1 0 1 2 2 2 2 2 1 0 2 1 1
Outcomes 6a 2 2 2 2 2 2 2 2 2 2 2 1 2 1 2 2 2 1 2 2 2 2 1 1
6b 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Sample size 7a 2 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
7b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Sequence generation 8a 2 2 2 0 2 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
8b 2 2 2 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Allocation concealment mechanism 9 2 2 0 0 2 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Implementation 10 2 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Blinding 11a 2 2 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
11b 0 2 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Statistical methods 12a 2 2 2 2 0 2 0 0 0 0 2 0 0 0 0 0 0 0 2 0 0 0 0 0
12b 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Participant flow 13a 2 2 2 2 2 2 2 2 2 2 2 2 2 0 0 0 2 2 0 1 0 0 1 0
13b 2 2 2 2 2 1 2 2 2 2 2 2 2 0 0 0 2 0 0 0 0 0
Recruitment 14a 2 2 2 2 1 1 2 2 1 2 2 2 2 0 0 1 1 0 1 1 0 0 0 0
14b 2 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Baseline data 15 2 1 2 1 2 1 2 2 1 2 2 2 2 2 1 1 2 0 1 1 1 0 0 2
Numbers analysed 16 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 2 2 2 2 2 0 2 2
Outcomes and estimation 17a 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2 1 1 2 0 1
17b 0 0 1 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Ancillary analyses 18 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Harms 19 0 2 0 0 0 0 2 0 0 2 0 0 0 0 0 0 2 2 2 0 0 0 1 0
Limitations 20 2 2 2 2 2 2 2 2 2 1 1 2 2 2 2 2 1 2 2 2 2 2 0 1
Generalisability 21 2 2 2 2 2 2 2 2 2 1 1 1 1 2 2 2 1 1 1 1 1 2 1 1
Interpretation 22 2 2 2 2 2 2 2 2 2 1 1 1 2 2 3 2 2 1 2 1 2 2 1 1
Registration 23 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Protocol 24 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Funding 25 2 2 2 2 2 0 2 2 2 2 0 2 2 2 2 2 2 0 0 0 2 0 2 0
RoB Sum 61 48 46 35 43 36 36 34 30 30 29 28 27 25 25 24 24 23 23 20 18 18 15 13

Note. Bold references have been included in the quantitative synthesis. We differentiate between randomized controlled trials and non-randomized controlled trials. Within these categories, references are sorted from lowest to highest risk of bias with higher sum scores indicating lower risk of bias. A detailed description of the CONSORT items can be retrieved from Moher et al. (2012). If an item was completely reported, it was rated with a score of ‘2’, if some information was missing, it was rated with ‘1’, if no information was given at all, it was rated with a score of ‘0’. This was also the case if the item was probably not applicable to the design. By this procedure studies which did not report a certain detail of the study were equally rated as studies which neglected this detail within the study design. 1a = Randomized trial in abstract, 1b = Structured abstract, 2a = Background/rationale, 2b = Objectives/hypotheses, 3a = Description, 3b = Changes, 4a = Eligibility criteria, 4b = Settings/locations data collection, 5 = For each group, 6a = Primary/secondary outcomes, 6b = Changes, 7a = How determined, 7b = Interim analyses/stopping guidelines, 8a = Method, 8b = Type of randomization, 9 = Mechanism, 10 = Who, 11a = Who blinded, 11b = Similarity of interventions, 12a = Statistical methods, 12b = Methods for additional analyses, 13a = Numbers of participants at each stage, 13b = Losses, exclusions, reasons, 14a = Dates defining the periods, 14b = Why the trial ended or was stopped, 15 = Table with characteristics, 16 = Number of participants, 17a = For each primary and secondary outcome, 17b = For binary outcomes, 18 = Results of any other analyses performed, 19 = All important harms or unintended effects, 20 = Trial limitations, 21 = Generalizability, 22 = Consistent with results, balanced, considering other relevant evidence, 23 = Registration number and name of trial registry, 24 = Where accessible, 25 = Sources of funding, role of funders, RoB = risk of bias assessment.