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Reader variability is intrinsic to radiologic oncology assessments, necessitating measures to enhance consistency and accuracy. RECIST 1.1 criteria play a crucial role in mitigating this variability by standardizing evaluations, aiming to establish an accepted "truth" confirmed by histology or patient survival. Clinical trials utilize Blind Independent Centralized Review (BICR) techniques to manage variability, employing double reads and adjudicators to address inter-observer discordance effectively. It is essential to dissect the root causes of variability in response assessments, with a specific focus on the factors influencing RECIST evaluations. We propose proactive measures for radiologists to address variability sources such as radiologist expertise, image quality, and accessibility of contextual information, which significantly impact interpretation and assessment precision. Adherence to standardization and RECIST guidelines is pivotal in diminishing variability and ensuring uniform results across studies. Variability factors, including lesion selection, new lesion appearance, and confirmation bias, can have profound implications on assessment accuracy and interpretation, underscoring the importance of identifying and addressing these factors. Delving into the causes of variability aids in enhancing the accuracy and consistency of response assessments in oncology, underscoring the role of standardized evaluation protocols and mitigating risk factors that contribute to variability. Access to contextual information is crucial. Critical relevance statement: By understanding the causes of diagnosis variability, we can enhance the accuracy and consistency of response assessments in oncology, ultimately improving patient care and clinical outcomes. Key Points: Baseline lesion selection and detection of new lesions play a major role in the occurrence of discordance. Image interpretation is influenced by contextual information, the lack of which can lead to diagnostic uncertainty. Radiologists must be trained in RECIST criteria to reduce errors and variability. [ABSTRACT FROM AUTHOR]

Objective: We studied the repeatability and the relative intra-scan variability across acquisition protocols in CT using phantom and unenhanced abdominal series. Methods: We used 17 CT scans from the Credence Cartridge Radiomics Phantom database and 20 unenhanced multi-site non-pathologic abdominal patient series for which we measured spleen and liver tissues. We performed multiple measurements in extracting 9 radiomics features. We defined a "tandem" as the measurement of a given tissue (or material) by a given radiomics. For each tandem, we assessed the proportion of the variability attributable to repetitions, acquisition protocols, material, or patient. We analyzed the distribution of the intra-scan correlation between pairs of tandems and checked the impact of correlation coefficient greater than 0.90 in comparing paired and unpaired differences. Results: The repeatability of radiomics features depends on the measured material; 56% of tandems were highly repeatable. Histogram-derived radiomics were generally less repeatable. Nearly 60% of relative radiomics measurements had a correlation coefficient higher than 0.90 allowing paired measurements to improve reliability in detecting the difference between two materials. The analysis of liver and spleen tissues showed that measurement variability was negligible with respect to other variabilities. As for phantom data, we found that gray level zone length matrix (GLZLM)–derived radiomics and gray level co-occurrence matrix (GLCM)–derived radiomics were the most correlating features. For these features, relative intra-scan measurements improved the detection of different materials or tissues. Conclusions: We identified radiomics features for which the intra-scan measurements between tissues are linearly correlated. This property represents an opportunity to improve tissue characterization and inter-site harmonization. Key Points: • The repeatability of radiomics features on CT depends on the measured material or tissue. • Some tandems of radiomics features/tissues are linearly affected by the variability of acquisition protocols on CT. • Relative intra-scan measurements are an opportunity for improving quantitative imaging on CT. [ABSTRACT FROM AUTHOR]

Objectives: Following the craze for radiomic features (RF), their lack of reliability raised the question of the generalizability of classification models. Inter-site harmonization of images therefore becomes a central issue. We compared RF harmonization processing designed to detect liver diseases in CT images. Methods: We retrospectively analyzed 76 multi-center portal CT series of non-diseased (NDL) and diseased liver (DL) patients. In each series, we positioned volumes of interest in spleen and liver, then extracted 9 RF (histogram and texture). We evaluated two RF harmonization approaches. First, in each series, we computed the Z-score of liver measurements based on those computed in the spleen. Second, we evaluated the ComBat method according to each imaging center; parameters were computed in the spleen and applied to the liver. We compared RF distributions and classification performances before/after harmonization. We classified NDL versus spleen and versus DL tissues. Results: The RF distributions were all different between liver and spleen (p < 0.05). The Z-score harmonization outperformed for the detection of liver versus spleen: AUC = 93.1% (p < 0.001). For the detection of DL versus NDL, in a case/control setting, we found no differences between the harmonizations: mean AUC = 73.6% (p = 0.49). Using the whole datasets, the performances were improved using ComBat (p = 0.05) AUC = 82.4% and degraded with Z-score AUC = 67.4% (p = 0.008). Conclusions: Data harmonization requires to first focus on data structuring to not degrade the performances of subsequent classifications. Liver tissue classification after harmonization of spleen-based RF is a promising strategy for improving the detection of DL tissue. Key Points: • Variability of acquisition parameter makes radiomics of CT features non-reproducible. • Data harmonization can help circumvent the inter-site variability of acquisition protocols. • Inter-site harmonization must be carefully implemented and requires designing consistent data sets. [ABSTRACT FROM AUTHOR]

Response Evaluation Criteria In Solid Tumors (RECIST) is still the predominant criteria base for assessing tumor burden in oncology clinical trials. Despite several improvements that followed its first publication, RECIST continues to allow readers a lot of freedom in their evaluations. Notably in the selection of tumors at baseline. This subjectivity is the source of many suboptimal evaluations. When starting a baseline analysis, radiologists cannot always identify tumor malignancy with any certainty. Also, with RECIST, some findings can be deemed equivocal by radiologists with no confirmatory ground truth to rely on. In the specific case of Blinded Independent Central Review clinical trials with double reads using RECIST, the selection of equivocal tumors can have two major consequences: inter-reader variability and modified sensitivity of the therapeutic response. Apart from the main causes leading to the selection of an equivocal lesion, due to the uncertainty of the radiological characteristics or due to the censoring of on-site evaluations, several other situations can be described more precisely. These latter involve cases where an equivocal is selected as target or non-target lesions, the management of equivocal lymph nodes and the case of few target lesions. In all cases, awareness of the impact of selecting a non-malignant lesion will lead radiologists to make selections in the most rational way. Also, in clinical trials where the primary endpoint differs between phase 2 (response-related) and phase 3 (progression-related) trials, our impact analysis will help them to devise strategies for the management of equivocal lesions. [ABSTRACT FROM AUTHOR]

Artificial intelligence algorithms are booming in medicine, and the question of biases induced or perpetuated by these tools is a very important topic. There is a greater risk of these biases in radiology, which is now the primary diagnostic tool in modern treatment. Some authors have recently proposed an analysis framework for social inequalities and the biases at risk of being introduced into future algorithms. In our paper, we comment on the different strategies for resolving these biases. We warn that there is an even greater risk in mixing the notion of equity, the definition of which is socio-political, into the design stages of these algorithms. We believe that rather than being beneficial, this could in fact harm the main purpose of these artificial intelligence tools, which is the care of the patient. [ABSTRACT FROM AUTHOR]

Objective: To assess the reliability of ADC measurements in vitro and in cervical lymph nodes of healthy volunteers.Methods: We used a GE 1.5 T MRI scanner and a first ice-water phantom according to recommendations released by the Quantitative Imaging Biomarker Alliance (QIBA) for assessing ADC against reference values. We analysed the target size effect by using a second phantom made of six inserted spheres with diameters ranging from 10 to 37 mm. Thirteen healthy volunteers were also scanned to assess the inter- and intra-observer reproducibility of volumetric ADC measurements of cervical lymph nodes.Results: On the ice-water phantom, the error in ADC measurements was less than 4.3 %. The spatial bias due to the non-linearity of gradient fields was found to be 24 % at 8 cm from the isocentre. ADC measure reliability decreased when addressing small targets due to partial volume effects (up to 12.8 %). The mean ADC value of cervical lymph nodes was 0.87.10-3 ± 0.12.10-3 mm2/s with a good intra-observer reliability. Inter-observer reproducibility featured a bias of -5.5 % due to segmentation issues.Conclusion: ADC is a potentially important imaging biomarker in oncology; however, variability issues preclude its broader adoption. Reliable use of ADC requires technical advances and systematic quality control.Key Points: • ADC is a promising quantitative imaging biomarker. • ADC has a fair inter-reader variability and good intra-reader variability. • Partial volume effect, post-processing software and non-linearity of scanners are limiting factors. • No threshold values for detecting cervical lymph node malignancy can be drawn. [ABSTRACT FROM AUTHOR]

The original article can be found online at https://doi.org/10.1007/s00330-021-08154-8. B Correction to: European Radiology b https://doi.org/10.1007/s00330-021-08154-8 The original version of this article, published on 06 August 2021, unfortunately contained a mistake. [Extracted from the article]

Background: In imaging-based clinical trials, it is common practice to perform double reads for each image, discrepant interpretations can result from these two different evaluations. In this study we analyzed discrepancies that occurred between local investigators (LI) and blinded independent central review (BICR) by comparing reader-selected imaging scans and lesions. Our goal was to identify the causes of discrepant declarations of progressive disease (PD) between LI and BICR in a clinical trial., Methods: We retrospectively analyzed imaging data from a RECIST 1.1-based, multi-sites, phase II clinical trial of 179 patients with adult small cell lung cancer, treated with Cabazitaxel compared to Topotecan. Any discrepancies in the determination of PD between LI and BICR readers were reviewed by a third-party adjudicator. For each imaging time point and reader, we recorded the selected target lesions, non-target lesions, and new lesions. Odds ratios were calculated to measure the association between discrepant declarations of PD and the differences in reviewed imaging scans (e.g. same imaging modality but with different reconstruction parameters) and selected lesions. Reasons for discrepancies were analyzed., Results: The average number of target lesions found by LI and BICR was respectively 2.9 and 3.4 per patient (p < 0.05), 18.4% of these target lesions were actually non-measurable. LI and BICR performed their evaluations based on different baseline imaging scans for 59% of the patients, they selected at least one different target lesion in 85% of patients. A total of 36.7% of patients required adjudication. Reasons of adjudication included differences in 1) reporting new lesions (53.7%), 2) the measured change of the tumor burden (18.5%), and 3) the progression of non-target lesions (11.2%). The rate of discrepancy was not associated with the selection of non-measurable target lesions or with the readers' assessment of different images. Paradoxically, more discrepancies occurred when LI and BICR selected exactly the same target lesions at baseline compared to when readers selected not exactly the same lesions., Conclusions: For a large proportion of evaluations, LI and BICR did not select the same imaging scans and target lesions but with a limited impact on the rate of discrepancy. The majority of discrepancies were explained by the difference in detecting new lesions., Trial Registration: ARD12166 ( https://clinicaltrials.gov/ct2/show/NCT01500720 ).

Background: For oncological evaluations, quantitative radiology gives clinicians significant insight into patients' response to therapy. In regard to the Response Evaluation Criteria in Solid Tumours (RECIST), the classification of disease evolution partly consists in applying thresholds to the measurement of the relative change of tumour. In the case of tumour volumetry, response thresholds have not yet been established. This study proposes and validates a model for calculating thresholds for the detection of minimal tumour change when using the volume of pulmonary lesions on CT as imaging biomarker., Methods: Our work is based on the reliability analysis of tumour volume measurements documented by the Quantitative Imaging Biomarker Alliance. Statistics of measurements were entered into a multi-parametric mathematical model of the relative changes derived from the Geary-Hinkley transformation. The consistency of the model was tested by comparing modelled thresholds against Monte Carlo simulations of tumour volume measurements with additive random error. The model has been validated by repeating measurements on real patient follow ups., Results: For unchanged tumour volume, relying on a normal distribution of error, the agreement between model and simulations featured a type I error of 5.25%. Thus, we established that a threshold of 35% of volume reduction corresponds to a partial response (PR) and a 55% volume increase corresponds to progressive disease (PD). Changes between -35 and +55% are categorized as stable disease (SD). Tested on real clinical data, 97.1% [95.7; 98.0] of assessments fall into the range of variability predicted by our model of confidence interval., Conclusions: Our study indicates that the Geary Hinkley model, using published statistics, is appropriate to predict response thresholds for the volume of pulmonary lesions on CT.