Table 2 Details of signaling questions in each domain of risk of bias assessment for 10 randomized controlled trials.
Domains | Signaling questions | Reponses of RCTs | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Refai 2011 | Kilic 2016 | Fouda 2018 | Mustafa 2018 | Louw 2018 | Mahmoud 2018 | Saadat 2018 | Arafat 2019 | Zarate 2020 | Hassanien 2020 | ||
Bias arising from the randomization process | 1.1 Was the allocation sequence random? | NI | NI | PY | NI | Y | NI | NI | NI | Y | NI |
1.2 Was the allocation sequence concealed until participants were recruited and assigned to interventions? | NI | NI | Y | NI | Y | NI | NI | NI | Y | NI | |
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | NI | N | NI | N | PY | NI | NI | NI | PN | NI | |
RoB judegement | SOME | SOME | LOW | SOME | SOME | SOME | SOME | SOME | LOW | SOME | |
Bias due to deviations from intended interventions | 2.1 Were participants aware of their assigned intervention during the trial? | N | PN | PN | PN | PN | PY | PN | PY | N | PY |
2.2. Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | N | PN | PN | PN | PN | PY | PN | PY | N | PY | |
2.3. If Y/PY/NI to 2.1 or 2.2: Were there deviations from the intended intervention that arose because of the trial context? | NA | NA | NA | NA | NA | NI | NA | NI | NA | NI | |
2.4 If Y/PY to 2.3: Were these deviations likely to have affected the outcome? | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
2.5. If Y/PY/NI to 2.4: Were these deviations from intended intervention balanced between groups? | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention? | PY | PN | PY | N | Y | NI | PY | PY | PY | PY | |
2.7 If N/PN/NI to 2.6: Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized? | NA | PY | NA | PY | NA | NI | NA | NA | NA | NA | |
RoB judegement | LOW | HIGH | LOW | HIGH | LOW | HIGH | LOW | SOME | LOW | SOME | |
Bias due to missing outcome data Bias in measurement of the outcome | 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | Y | N | PY | N | Y | NI | PY | PY | Y | PY |
3.2 If N/PN/NI to 3.1: Is there evidence that the result was not biased by missing outcome data? | NA | PN | NA | PN | NA | PN | NA | NA | NA | NA | |
3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | NA | NI | NA | NI | NA | NI | NA | NA | NA | NA | |
3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | PN | NA | PN | NA | PN | NA | NA | NA | NA | |
RoB judegement | LOW | SOME | LOW | SOME | LOW | SOME | LOW | LOW | LOW | LOW | |
4.1 Was the method of measuring the outcome inappropriate? | PN | PN | PN | PN | PN | PN | PN | PN | PN | PN | |
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | PN | PN | PN | PN | PN | PN | PN | PN | PN | PN | |
4.3 If N/PN/NI to 4.1 and 4.2: Were outcome assessors aware of the intervention received by study participants? | PN | NI | NI | NI | PN | NI | NI | NI | N | NI | |
4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | NA | PY | PY | PY | NA | PY | PY | PY | NA | PY | |
4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | PN | PN | PN | NA | PN | PN | PN | NA | PN | |
RoB judegement | LOW | SOME | SOME | SOME | LOW | SOME | SOME | SOME | LOW | SOME | |
Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | NI | NI | NI | NI | PY | NI | NI | NI | NI | NI |
For 5.2 and 5.3 Is the numerical result being assessed likely to have been selected, on the basis of the results, from… | |||||||||||
5.2. … multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain? | PN | PN | PY | PN | PN | PN | PN | PN | PN | PN | |
5.3 … multiple eligible analyses of the data? | PN | PN | PN | PN | PN | PN | PN | PN | PN | PN | |
RoB judegement | SOME | SOME | HIGH | SOME | LOW | SOME | SOME | SOME | SOME | SOME | |
Overall bias | SOME | HIGH | HIGH | HIGH | SOME | HIGH | SOME | SOME | SOME | SOME | |
