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Response Evaluation Criteria in Solid Tumours (RECIST)-based tumour burden measurements involve observer variability, the extent of which ought to be determined.

A literature search identified studies on observer variability during manual measurements of tumour burdens via computed tomography according to the RECIST guideline. The 95% limit of agreement (LOA) values of relative measurement difference (RMD) were pooled using a random-effects model.

Twelve studies were included. Pooled 95% LOAs of RMD in measuring unidimensional longest diameters of single lesions ranged from −22.1% (95% confidence interval [CI], −30.3% to −14.0%) to 25.4% (95% CI, 17.2% to 33.5%) between observers and −17.8% (95% CI, −23.6% to −11.9%) to 16.1% (95% CI, 10.1% to 21.8%) for a single observer. Pooled 95% LOAs of RMD in measuring the sum of multiple lesions ranged …