Table 2.
Risk of Bias (RoB) analysis of the clinical trials on hydroxyapatite from Table 1
Bias domain and signalling question |
Paszynska et al. 202136 |
Grocholewicz et al. 202037 |
Badiee et al. 201938 |
Schlagenhauf et al. 201939 |
Kani et al. 198940 |
RANDOMIZATION | |||||
Was the allocation sequence random? |
Y |
Y |
Y |
Y |
Y |
Was the allocation sequence concealed until the participants were assigned to the intervention? |
PY |
PY |
NI |
PY |
N |
Did the baseline difference suggest a problem with the randomization process? |
N |
PN |
NI |
N |
PY |
Risk of bias judgementa |
+ |
+ |
? |
+ |
- |
DEVIATIONS FROM INTENDED INTERVENTIONS | |||||
Were participants aware of the assigned intervention? |
N |
Y |
N |
N |
PN |
Were people delivering interventions aware of the participants' assigned intervention? |
N |
Y |
PN |
N |
Y |
If yes, were there deviations from the intended intervention that arose because of trial context? |
|
N |
|
|
Y |
If yes, were these deviations likely to have affected the outcome? |
|
|
|
|
|
If yes, were these deviations balanced between the groups? |
|
|
|
|
N |
Was an appropriate analysis used to estimate the effect of assignment to intervention? |
|
|
|
|
|
If no, was there potential for substantial impact on the result? |
Y |
Y |
Y |
Y |
PN |
Risk of bias judgement |
+ |
? |
+ |
+ |
- |
MISSING OUTCOME DATA | |||||
Were data for this outcome for all or nearly all participants randomized? |
Y |
Y |
PY |
Y |
N |
If no, is there evidence that the result was not biased by missing outcome data? |
|
|
|
|
NI |
If no, could the absence of outcome data depend on its true value? |
|
|
|
|
NI |
Risk of bias judgement |
+ |
+ |
+ |
+ |
- |
MEASUREMENT OF THE OUTCOME | |||||
Was the method of measuring the outcome appropriate? |
Y |
Y |
Y |
Y |
Y |
Could measurement of the outcome have differed between intervention groups? |
N |
N |
N |
N |
PN |
If no, were outcome assessors aware of the intervention received by the study participants? |
N |
Y |
|
N |
Y |
If yes, could assessment of the outcome have been influenced by the knowledge of if the intervention was received? |
|
|
|
|
|
If yes, is it likely that this occurred? |
|
N |
|
|
PN |
Risk of bias judgement |
+ |
+ |
+ |
+ |
? |
SELECTION OF THE REPORTED RESULT | |||||
Were the data that produced the results analysed in accordance to the prespecified analysis plan that was finalized before unblinded outcome data were available for analysis? |
Y |
NI |
NI |
Y |
NI |
Is the numerical result being assessed likely to have been selected, on the basis of the results, from: | |||||
a) multiple eligible outcome measurements? |
N |
N |
N |
N |
NI |
b) multiple eligible analyses of the data? |
N |
N |
N |
N |
NI |
Risk of bias judgement |
+ |
+ |
+ |
+ |
- |
OVERALL BIAS |
+ |
+ |
+ |
+ |
- |
aRisk of bias judgement was based on RoB2 by Sterne et al.31
Y: yes; N: no; PY: probably yes; PN: probably no; NI: not indicated; Low risk: + ; questionable risk: ? ; high risk: -.