Observer variability in RECIST-based tumour burden measurements: a meta-analysis

Abstract

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

Methods: 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.

Results: 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 from -19.2% (95% CI, -23.7% to -14.9%) to 19.5% (95% CI, 15.2% to 23.9%) between observers, and -9.8% (95% CI, -19.0% to -0.3%) to 13.1% (95% CI, 3.6% to 22.6%) for a single observer. Pooled 95% LOA of RMD in calculating the interval change of tumour burden with a single lesion ranged from -31.3% (95% CI, -46.0% to -16.5%) to 30.3% (95% CI, 15.3% to 44.8%) between observers. Studies on calculating the interval change of tumour burden for a single observer or with multiple lesions were lacking.

Conclusion: Interobserver RMD in measuring single tumour burden and calculating its interval change may exceed the 20% cut-off for progression. Variability decreased when tumour burden was measured by a single observer or assessed by the sum of multiple lesions.

Keywords: Measurement; Meta-analysis; Observer variation; Response Evaluation Criteria in Solid Tumours; Tumour burden.