Soon Ho Yoon1, Kyung Won Kim2, Jin Mo Goo3, Dong-Wan Kim4, Seokyung Hahn5. 1. Department of Radiology, Seoul National University College of Medicine, Seoul, South Korea; Institute of Radiation Medicine, Seoul National University Medical Research Center, Seoul, South Korea. 2. Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. 3. Department of Radiology, Seoul National University College of Medicine, Seoul, South Korea; Institute of Radiation Medicine, Seoul National University Medical Research Center, Seoul, South Korea; Cancer Research Institute, Seoul National University, South Korea. 4. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea. 5. Department of Medicine, Seoul National University College of Medicine, Seoul, South Korea. Electronic address: hahns@snu.ac.kr.
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.
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.
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