Table 3.

GRADE Assessment for Reported Outcomes

			Certainty Assessment
Outcome	Pooled Incidence (95% CI)	No. of Cohort Studies	Type of Evidence	Quality	Consistency	Directness	Effect Size	Overall Quality	Certainty
Radiographic response	80% (58%-96%)	6	+2	–1	–1	0	+1	+1	Very low
Clinical response	57% (43%-71%)	4	+2	–2	+1	–1	+2	+2	Low
Serious adverse event	8% (2%-17%)	7	+2	–1	+1	0	+1	+3	Moderate
Progression	51% (28%-74%)	6	+2	–2	–1	0	+2	+1	Very low

Abbreviation: GRADE, Grading of Recommendations, Assessment, Development and Evaluations.

Overall quality score is determined based on the sum of included domains. Type of evidence is based on design of included studies (range, +2 to +4). Study quality reflects blinding and allocation, follow-up and withdrawals, sparsity of data, and methodological concerns (range, –3 to 0). Consistency is graded based on heterogeneity of included population and study end points with respect to one another (range, –1 to +1). Directness is graded based on generalizability of included results (range, –2 to 0). Effect size is graded based on the overlap of 95% CI estimates within 10% of either 0% or 100% incidence (range, 0 to 2). The overall quality of results for each outcome can be considered high (≥ 4 points), moderate (3 points), low (2 points), or very low (≤ 1 point).