Journal of the Korean Academy of Child and Adolescent Psychiatry : eISSN 2233-9183 / pISSN 1225-729X

Table. 4.

Table. 4.

Quality checklist for randomized controlled trial [31] (Revised Cochrane risk-of-bias tool for randomized trials [RoB 2] [32])

Sl. No Signaling questions Response options
Risk of bias arising from the randomization process
1. Was the allocation sequence random? Y/PY/PN/N/NI
2. Was the allocation sequence concealed until participants were enrolled and assigned to interventions? Y/PY/PN/N/NI
3. Did baseline differences between intervention groups suggest a problem with the randomization process? Y/PY/PN/N/NI
Risk of bias due to deviations from the intended intervention/effect of assignment/adhering to intervention
4. Were participants aware of their assigned intervention during the trial? Y/PY/PN/N/NI
5. Were carers and people delivering the interventions aware of participant's assigned intervention during the trial? Y/PY/PN/N/NI
6. Were important non-protocol interventions balanced across intervention groups NA/Y/PY/PN/N/NI
7. Were there deviations from the intended intervention that arose because of the trial context NA/Y/PY/PN/NI
8. Was an appropriate analysis used to estimate the effect of assignment/adhering to intervention? Y/PY/PN/N/NI
9. Was there potential for a substantial impact (on the result) of the failure to analyze participants in the group to which they were randomized? NA/Y/PY/PN/N/NI
Risk of bias due to missing outcome data
10. Were data for this outcome available for all, or nearly all, participants randomized? Y/PY/PN/N/NI
11. Is there evidence that the result was not biased by missing outcome data? NA/Y/PY/PN/N/NI
Risk of bias due in measurement of the outcome
12. Was the method of measuring the outcome inappropriate? Y/PY/PN/N/NI
13. Could measurement or ascertainment of the outcome have differed between intervention groups? Y/PY/PN/N/NI
14. Were outcome assessors aware of the intervention received by study participants? NA/Y/PY/PN/N/NI
15. Could assessment of the outcome have been influenced by knowledge of intervention received? NA/Y/PY/PN/N/NI
16. Is it likely that the assessment of the outcome was influenced by knowledge of intervention received? NA/Y/PY/PN/N/NI
Risk of bias in selection of the reported result
17. Were the data that produced this result analyzed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? Y/PY/PN/N/NI
18. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain? Y/PY/PN/N/NI
19. Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data? Y/PY/PN/N/NI

Y, yes; PY, probably yes; PN, probably no; N, no; NI, no information

J Korean Acad Child Adolesc Psychiatry 2022;33:2-15 https://doi.org/10.5765/jkacap.210021
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