Analysis of interobserver and intraobserver variability in CT tumor measurements.

Hopper, Kenneth D.; Kasales, Claudia J.; Slyke, Mark A. Van; Schwartz, Todd A.; TenHave, Thomas R.; Jozefiak, Judith A.

doi:10.2214/ajr.167.4.8819370

Cited by 166 publications

(87 citation statements)

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“…For tumors up to 1 cm in size, lesion measurement variation up to 2 mm among observers for each of the 3 orthogonal measurements was considered acceptable. 3,4 If the variation of any of the 3 diameters was greater than 2 mm, the discrepancy was resolved by consensus. The final size that was tabulated for each lesion was the single largest diameter.…”

Section: Identification Of Study Participantsmentioning

confidence: 99%

Sonographically Identified Echogenic Renal Masses Up to 1 cm in Size Are So Rarely Malignant They Can Be Safely Ignored

Itani

Pandya

Bude

2016

J of Ultrasound Medicine

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chogenic renal masses in general are more often angiomyolipomas than carcinomas. Without regard to size, the chance of carcinoma in general is high enough that echogenic masses should not be ignored, and further workup is advocated. To this end, a recent review by Farrelly et al 1 concluded that "all noncalcified echogenic renal lesions detected with ultrasound need a CT to rule out a renal cell carcinoma." Another study further recommended computed tomography (CT) ORIGINAL RESEARCHObjectives-The purpose of this study was to determine whether small echogenic renal masses up to 1 cm in size incidentally detected by sonography are rarely malignant and thus do not need further workup.Methods-We reviewed approximately 13,600 reports of all abdominal sonographic examinations performed between November 2001 and October 2007 that identified a small echogenic mass in a kidney. Patients with known malignancy of any kind, tuberous sclerosis, lesions larger than 1.0 cm, lesions with heterogeneous echogenicity, and lesions with posterior ring-down artifacts or posterior acoustic shadowing were excluded. All patients without magnetic resonance imaging or computed tomographic scans that completely characterized the lesions were excluded unless a follow-up study (sonography, magnetic resonance imaging, or contrast-enhanced computed tomography) at least 5 years later was available for comparison to prove that the lesion was benign.Results-A total of 120 lesions in 111 patients satisfied the inclusion criteria. Lesion sizes were 0 to 5 mm (n = 16) and 6 to 10 mm (n = 104). Of these, 54 lesions were characterized as definitely benign (47 angiomyolipomas and 7 other benign entities: calcifications in stones or within a cyst or calyx and cysts that were either simple on follow-up studies or complicated with hemorrhagic or proteinaceous content). For the remaining 66 lesions, follow-up results after at least 5 years were normal in 24 cases (which meant that the lesion was no longer visible), and the remaining 42 lesions were stable in size. The mean duration of follow-up for these 66 lesions was 7.4 years.Conclusions-Small echogenic renal masses up to 1 cm in size that fulfill our study criteria are so likely to be benign that they can be safely ignored.

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Section: Identification Of Study Participantsmentioning

confidence: 99%

Sonographically Identified Echogenic Renal Masses Up to 1 cm in Size Are So Rarely Malignant They Can Be Safely Ignored

Itani

Pandya

Bude

2016

J of Ultrasound Medicine

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“…Several studies have tried to quantify this variability by having radiologists perform repeat measurements on a single set of CT scans. [3][4][5][6] Separately, the process of performing a CT scan can lead to changes in the appearance of a tumor or…”

Section: Introductionmentioning

confidence: 99%

Variability of Lung Tumor Measurements on Repeat Computed Tomography Scans Taken Within 15 Minutes

Oxnard

Zhao

Sima

et al. 2011

JCO

140

102

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A B S T R A C T PurposeWe use changes in tumor measurements to assess response and progression, both in routine care and as the primary objective of clinical trials. However, the variability of computed tomography (CT) -based tumor measurement has not been comprehensively evaluated. In this study, we assess the variability of lung tumor measurement using repeat CT scans performed within 15 minutes of each other and discuss the implications of this variability in a clinical context. Patients and MethodsPatients with non-small-cell lung cancer and a target lung lesion Ն 1 cm consented to undergo two CT scans within a period of minutes. Three experienced radiologists measured the diameter of the target lesion on the two scans in a side-by-side fashion, and differences were compared. ResultsFifty-seven percent of changes exceeded 1 mm in magnitude, and 33% of changes exceeded 2 mm. Median increase and decrease in tumor measurements were ϩ4.3% and Ϫ4.2%, respectively, and ranged from 23% shrinkage to 31% growth. Measurement changes were within Ϯ 10% for 84% of measurements, whereas 3% met criteria for progression according to Response Evaluation Criteria in Solid Tumors (RECIST; Ն 20% increase). Smaller lesions had greater variability of percent measurement change (P ϭ .005). ConclusionApparent changes in tumor diameter exceeding 1 to 2 mm are common on immediate reimaging. Increases and decreases less than 10% can be a result of the inherent variability of reimaging. Caution should be exercised in interpreting the significance of small changes in lesion size in the care of individual patients and in the interpretation of clinical trial results.

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“…This has been reported in body imaging [8,9] and CNS imaging of high grade gliomas [10,11]. There are many factors influencing discordance rates among independent reviewers in the assessment of oncology clinical trial subjects.…”

Section: Introductionmentioning

confidence: 84%

Monitoring Reader Metrics in Blinded Independent Central Review of Oncology Studies

Gonen¹,

Ford²

2015

J Clin Trials

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Purpose: Blinded independent central review (BICR) is advocated by regulatory authorities as a means of minimizing bias and independently verifying endpoints based on medical imaging when the data is intended to support pivotal trials. However, discordance between reviewers at the BICR raises concern with regulators. There are few published metrics related to discordance rates at the BICR and there is currently no standard metric which can be used to monitor reviewer performance in the BICR setting. Methods:We analyzed BICR data from 29 oncology clinical trials including interpretations by 24 different radiologist reviewers of over 12,000 subject cases. Results:The average reader acceptance rate was 48% and the rejection rate was 52%. Conclusion:Based on our analysis, we propose the use of p-charts to monitor reviewer performance in oncology clinical trials employing BICR.

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Analysis of interobserver and intraobserver variability in CT tumor measurements.

Cited by 166 publications

References 0 publications

Sonographically Identified Echogenic Renal Masses Up to 1 cm in Size Are So Rarely Malignant They Can Be Safely Ignored

Sonographically Identified Echogenic Renal Masses Up to 1 cm in Size Are So Rarely Malignant They Can Be Safely Ignored

Variability of Lung Tumor Measurements on Repeat Computed Tomography Scans Taken Within 15 Minutes

Monitoring Reader Metrics in Blinded Independent Central Review of Oncology Studies

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