Table 2.

Methodological and Reporting Quality Assessment of the Included Trials

Factors	Trials at Risk of Bias (n=117), No. (%)
Inadequate allocation sequence concealmenta	63 (54)
No blinding of patientsb	76 (65)
Early stop	9 (8)
Not using intention‐to‐treat analysisc	29 (25)
Absence of protocold	31 (26)
Without explicit statement about status of LTFU	43 (36)

LTFU indicates loss to follow‐up.

^aAllocation concealment defined as to the person enrolling participants does not know in advance which treatment the next person will get which usually involves the use of computer algorithms. It seeks to prevent selection bias by protecting the assignment sequence until allocation, and can always be successfully implemented. ¹³⁶ It is considered to be adequate according to the definition reported by Jüni et al.3

^bBlinding defined as to the withholding information about the assigned interventions from people involved in the trial who may potentially be influenced by this knowledge; blinding is performed to prevent performance and ascertainment bias by protecting the sequence after allocation and cannot always be implemented. ¹³⁶ , ¹³⁷ It is considered to be adequate only if clearly indicated.

^cIntention to treat analysis defined as an analysis that included all randomized participants in the analysis who are all retained in the group to which they were allocated. ³ , ¹³⁶

^dConsider as absence if the protocol is not published before or is included as appendix beside the main report.