Table 3.

GRADE assessment of the quality of the evidence and the strength of the recommendations.

Certainty assessment							№ of patients		Effect		Certainty		Importance
№ of studies	Study design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	[Intervención]	[Comparación]	Relative (95% CI)	Absolute (95% CI)
iHOT 6 months
4	Randomised trials	Seriousa	Not serious	Seriousb	Not serious	None	294	295	NA	MD 3.98 higher (0.19 higher to 7.77 higher)	⨁⨁◯◯ low	Important
iHOT 12 months
5	Randomised trials	Seriousa	Not serious	Seriousb	Seriousc	None	295	299	NA	MD 10.65 higher (6.54 higher to 14.76 higher)	⨁◯◯◯ very low	Critical
HOS ADL 6 months
3	Randomised trials	Seriousa	Not serious	Seriousb	Not serious	None	124	121	NA	MD 5.19 higher (0.77 higher to 9.61 higher)	⨁⨁◯◯ Low	Important
HOS ADL 12 months
5	Randomised trials	Seriousa	Not serious	Seriousb	Seriousc	None	120	118	NA	MD 8.09 higher (3.11 higher to 13.07 higher)	⨁◯◯◯ very low	Critical
Infection rate
4	Randomised trials	Seriousa	Not serious	Not serious	Not serious	None	6/404 (1.5%)	0/410 (0.0%)	OR 4.14 (0.87 to 19.59)	0 fewer per 1000 (from 0 to 0 fewer)	⨁⨁⨁◯ moderate	Important
Osteoarthritis rate
2	Randomised trials	Not serious	Not serious	Seriousb	Not serious	None	8/444 (1.8%)	1/449 (0.2%)	OR 6.18 (1.06 to 36.00)	11 more per 1000 (from 0 fewer to 72 more)	⨁⨁⨁◯ moderate	Critical

CI confidence interval, MD mean difference, OR odds ratio, NA not applicable.

^aThere were several risk of bias items with high risk of bias among the studies included in this outcome.

^bThe examined patients are similar but not identical.

^cComparing the lower and upper limit of the confidence interval, there were demonstrated clinical differences.