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. 2021 Oct 1;55(3):148–159.

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: -.