Standardizing digital biobanks: integrating imaging, genomic, and clinical data for precision medicine.

Advancements in data acquisition and computational methods are generating a large amount of heterogeneous biomedical data from diagnostic domains such as clinical imaging, pathology, and next-generation sequencing (NGS), which help characterize individual differences in patients. However, this information needs to be available and suitable to promote and support scientific research and technological development, supporting the effective adoption of the precision medicine approach in clinical practice. Digital biobanks can catalyze this process, facilitating the sharing of curated and standardized imaging data, clinical, pathological and molecular data, crucial to enable the development of a comprehensive and personalized data-driven diagnostic approach in disease management and fostering the development of computational predictive models. This work aims to frame this perspective, first by evaluating the state of standardization of individual diagnostic domains and then by identifying challenges and proposing a possible solution towards an integrative approach that can guarantee the suitability of information that can be shared through a digital biobank. Our analysis of the state of the art shows the presence and use of reference standards in biobanks and, generally, digital repositories for each specific domain. Despite this, standardization to guarantee the integration and reproducibility of the numerical descriptors generated by each domain, e.g. radiomic, pathomic and -omic features, is still an open challenge. Based on specific use cases and scenarios, an integration model, based on the JSON format, is proposed that can help address this problem. Ultimately, this work shows how, with specific standardization and promotion efforts, the digital biobank model can become an enabling technology for the comprehensive study of diseases and the effective development of data-driven technologies at the service of precision medicine.

ESR Essentials: response assessment criteria in oncologic imaging-practice recommendations by the European Society of Oncologic Imaging.

Assessing the response to oncological treatments is paramount for determining the prognosis and defining the best treatment for each patient. Several biomarkers, including imaging, can be used, but standardization is fundamental for consistency and reliability. Tumor response evaluation criteria have been defined by international groups for application in pharmaceutical clinical trials evaluating new drugs or therapeutic strategies. RECIST 1.1 criteria are exclusively based on unidimensional lesion measurements; changes in tumor size are used as surrogate imaging biomarkers to correlate with patient outcomes. However, increased tumor size does not always reflect tumor progression. The introduction of immunotherapy has led to the development of new criteria (iRECIST, Level of Evidence (LoE) Ib) that consider the possibility that an increase in disease burden is secondary to the immune response instead of progression, with the new concept of Unconfirmed Progressive Disease (a first progression event which must be confirmed on follow-up). Specific criteria were devised for HCC (mRECIST, LoE IV), which measure only enhancing HCC portions to account for changes after local therapy. For GIST treated with imatinib, criteria were developed to account for the possible increase in size reflecting a response rather than a progression by assessing both tumor size and density on CT (Choi, LoE II). This article provides concise and relevant practice recommendations aimed at general radiologists to help choose and apply the most appropriate criteria for assessing response to treatment in different oncologic scenarios. Though these criteria were developed for clinical trials, they may be applied in clinical practice as a guide for day-to-day interpretation. KEY POINTS: Response evaluation criteria, designed for use in clinical trials, might serve as a surrogate biomarker for overall survival. RECIST 1.1 defines measurable and non-measurable disease among which target lesions and non-target lesions are selected at baseline as reference for follow-ups. Some therapies and/or cancers require the use of different criteria, such as iRECIST, mRECIST, and Choi criteria.

Perceptions of radiologists on structured reporting for cancer imaging-a survey by the European Society of Oncologic Imaging (ESOI).

OBJECTIVES: To assess radiologists' current use of, and opinions on, structured reporting (SR) in oncologic imaging, and to provide recommendations for a structured report template. MATERIALS AND METHODS: An online survey with 28 questions was sent to European Society of Oncologic Imaging (ESOI) members. The questionnaire had four main parts: (1) participant information, e.g., country, workplace, experience, and current SR use; (2) SR design, e.g., numbers of sections and fields, and template use; (3) clinical impact of SR, e.g., on report quality and length, workload, and communication with clinicians; and (4) preferences for an oncology-focused structured CT report. Data analysis comprised descriptive statistics, chi-square tests, and Spearman correlation coefficients. RESULTS: A total of 200 radiologists from 51 countries completed the survey: 57.0% currently utilized SR (57%), with a lower proportion within than outside of Europe (51.0 vs. 72.7%; p = 0.006). Among SR users, the majority observed markedly increased report quality (62.3%) and easier comparison to previous exams (53.5%), a slightly lower error rate (50.9%), and fewer calls/emails by clinicians (78.9%) due to SR. The perceived impact of SR on communication with clinicians (i.e., frequency of calls/emails) differed with radiologists' experience (p < 0.001), and experience also showed low but significant correlations with communication with clinicians (r = - 0.27, p = 0.003), report quality (r = 0.19, p = 0.043), and error rate (r = - 0.22, p = 0.016). Template use also affected the perceived impact of SR on report quality (p = 0.036). CONCLUSION: Radiologists regard SR in oncologic imaging favorably, with perceived positive effects on report quality, error rate, comparison of serial exams, and communication with clinicians. CLINICAL RELEVANCE STATEMENT: Radiologists believe that structured reporting in oncologic imaging improves report quality, decreases the error rate, and enables better communication with clinicians. Implementation of structured reporting in Europe is currently below the international level and needs society endorsement. KEY POINTS: • The majority of oncologic imaging specialists (57% overall; 51% in Europe) use structured reporting in clinical practice. • The vast majority of oncologic imaging specialists use templates (92.1%), which are typically cancer-specific (76.2%). • Structured reporting is perceived to markedly improve report quality, communication with clinicians, and comparison to prior scans.

Type 2 diabetes albuminuric and non-albuminuric phenotypes have different morphological and functional ultrasound features of diabetic kidney disease.

AIMS: Whether different diabetic kidney disease (DKD) phenotypes recognise differences in morphological and vascular properties of the kidney is still unexplored. We evaluated the potential role of kidney ultrasonography in differentiating DKD phenotypes in subjects with type 2 diabetes. MATERIALS AND METHODS: This is a cross-sectional, single-centre study. Total (TRV) and parenchymal renal volumes (PRV) were calculated by applying the ellipsoid formula for conventional (2D) ultrasonography and with manual segmentation for 3D ultrasonography, and then adjusted for body surface area (aTRV, aPRV). Renal resistive index (RI) was contextually determined. DKD phenotypes have been defined based on increased urinary albumin-to-creatinine ratio (ACR >30 mg/g) and/or reduced eGFR (<60 ml/min/1.73 m2 ). Recruitment was planned to have groups of the same size. RESULTS: Among 256 subjects, 26.2% had No-DKD, 24.6% increased albuminuria only (Alb+ ), 24.2% non-albuminuric DKD (Alb- DKD), and 25.0% albuminuric DKD (Alb+ DKD). Compared to No-DKD, RI was significantly higher in all DKD phenotypes, being the highest in Alb+ DKD, and with a significant trend of RI > 0.70 to increase across phenotypes. In comparison with No-DKD, both 2D and 3D volumes were increased in Alb+ and significantly reduced in Alb- DKD as well as in Alb+ DKD, with significantly lower volumes in Alb- DKD as compared to Alb+ DKD at the same reduced levels of eGFR. In adjusted regressions, compared to No-DKD, RI was associated with Alb+ ; both RI and aPRV3D were associated with Alb+ DKD; only aPRV3D with Alb- DKD. Compared to No-DKD, Receiver Operating Characteristic curve analyses, designed taking into account conventional risk factors, showed that US parameters did not ameliorate the characterisation of Alb+ and Alb+ DKD, while aPRV3D significantly improved the phenotyping of Alb- DKD. CONCLUSIONS: As a novel information, we reported that, in type 2 diabetes, the emerging normoalbuminuric DKD phenotype showed reduced TRVs and PRVs even when compared, at similarly reduced eGFR levels, with Alb+ DKD opening. In perspective, these findings suggest a possible role of imaging for better discrimination of DKD phenotypes in clinical practice.

Dark papillary muscles sign: a novel prognostic marker for cardiac magnetic resonance.

OBJECTIVES: The prognostic role of left ventricular (LV) papillary muscle abnormalities in patients with preserved LV systolic ejection fraction (LVEF) is unknown. We sought to evaluate the prognosis role of LV papillary muscle abnormalities by CMR in patients with ventricular arrhythmias, preserved LVEF with no cardiac disease. METHODS: A total of 391 patients with > 500/24 h premature ventricular complexes and/or with non-sustained ventricular tachycardia (NSVT), preserved LVEF, and no cardiac disease were enrolled. Different features of LV papillary muscles were considered: supernumerary muscles, papillary thickness, the attachment, late gadolinium enhancement (LGE). Dark-Paps was defined as end-systolic signal hypointensity of both papillary muscles in early post-contrast cine CMR images. Mitral valve prolapse, mitral annular disjunction (MAD), and myocardial LGE were considered. RESULTS: Dark-Paps was found in 79 (20%) patients and was more frequent in females. It was associated with higher prevalence of mitral valve prolapse and MAD. During a median follow-up of 2534 days, 22 hard cardiac events occurred. At Kaplan-Meier curve analysis, patients with Dark-Paps were at higher risk of events than those without (p < 0.0001). Dark-Paps was significantly associated with hard cardiac events in all the multivariate models. Dark-Paps improved prognostic estimation when added to NSVT (p = 0.0006), to LGE (p = 0.005) and to a model including NSVT+LGE (p = 0.014). Dark-Paps allowed a significant net reclassification when added to NSVT (NRI 0.30, p = 0.03), to LGE (NRI 0.25, p = 0.04), and to NSVT + LGE (NRI 0.32, p  = 0.02). CONCLUSIONS: In LV papillary muscles, Dark-Paps is a novel prognostic marker in patients with ventricular arrhythmias and preserved ejection fraction. KEY POINTS: • Papillary muscle abnormalities are seen in patients with ventricular arrhythmias and preserved left ventricular ejection fraction. • Early post-contrast hypointensity of papillary muscles in end-systolic cine images (Dark-Paps) is a novel prognostic marker in patients with ventricular arrhythmias and preserved ejection fraction. • Dark-Paps had an additive prognostic role over late gadolinium enhancement and non-sustained ventricular tachycardia.

Attitudes and perceptions of radiologists towards online (virtual) oncologic multidisciplinary team meetings during the COVID-19 pandemic-a survey of the European Society of Oncologic Imaging (ESOI).

OBJECTIVES: To explore radiologists' opinions regarding the shift from in-person oncologic multidisciplinary team meetings (MDTMs) to online MDTMs. To assess the perceived impact of online MDTMs, and to evaluate clinical and technical aspects of online meetings. METHODS: An online questionnaire including 24 questions was e-mailed to all European Society of Oncologic Imaging (ESOI) members. Questions targeted the structure and efficacy of online MDTMs, including benefits and limitations. RESULTS: A total of 204 radiologists responded to the survey. Responses were evaluated using descriptive statistical analysis. The majority (157/204; 77%) reported a shift to online MDTMs at the start of the pandemic. For the most part, this transition had a positive effect on maintaining and improving attendance. The majority of participants reported that online MDTMs provide the same clinical standard as in-person meetings, and that interdisciplinary discussion and review of imaging data were not hindered. Seventy three of 204 (35.8%) participants favour reverting to in-person MDTs, once safe to do so, while 7/204 (3.4%) prefer a continuation of online MDTMs. The majority (124/204, 60.8%) prefer a combination of physical and online MDTMs. CONCLUSIONS: Online MDTMs are a viable alternative to in-person meetings enabling continued timely high-quality provision of care with maintained coordination between specialties. They were accepted by the majority of surveyed radiologists who also favoured their continuation after the pandemic, preferably in combination with in-person meetings. An awareness of communication issues particular to online meetings is important. Training, improved software, and availability of support are essential to overcome technical and IT difficulties reported by participants. KEY POINTS: • Majority of surveyed radiologists reported shift from in-person to online oncologic MDT meetings during the COVID-19 pandemic. • The shift to online MDTMs was feasible and generally accepted by the radiologists surveyed with the majority reporting that online MDTMs provide the same clinical standard as in-person meetings. • Most would favour the return to in-person MDTMs but would also accept the continued use of online MDTMs following the end of the current pandemic.

The prognostic value of radiomic features in liver-limited metastatic colorectal cancer patients from the TRIBE2 study.

Aims: Evaluating the prognostic role of radiomic features in liver-limited metastatic colorectal cancer treated with first-line therapy at baseline and best response among patients undergoing resection. Patients & methods: Among patients enrolled in TRIBE2 (NCT02339116), the association of clinical and radiomic data, extracted by SOPHiA-DDM™ with progression-free and overall survival (OS) in the overall population and with disease-free survival/postresection OS in those undergoing resection was investigated. Results: Among 98 patients, radiomic parameters improved the prediction accuracy of our model for OS (area under the curve: 0.83; sensitivity: 0.85; specificity: 0.73; accuracy: 0.78), but not progression-free survival. Of 46 resected patients, small-distance high gray-level emphasis was associated with shorter disease-free survival and high gray-level zone emphasis/higher kurtosis with shorter postresection OS. Conclusion: Radiomic features should be implemented as tools of outcome prediction for liver-limited metastatic colorectal cancer.

Diagnostic and prognostic role of late gadolinium enhancement in cardiomyopathies.

Late gadolinium enhancement (LGE) is the most relevant tool of cardiac magnetic resonance for tissue characterization, and it plays a pivotal role for diagnostic and prognostic assessment of cardiomyopathies. The pattern of presentation of LGE allows differential diagnosis between ischaemic and non-ischaemic heart disease with high diagnostic accuracy, and among different cardiomyopathies, specific presentation of LGE may help to make a diagnosis. Late gadolinium enhancement may be caused by conditions that significantly increase the interstitial space or, less frequently, that slow down Gd exit, like myocardial fibrosis. In chronic myocardial infarction, hypertrophic cardiomyopathies (HCM), dilated cardiomyopathy, Fabry disease, and other conditions, LGE is a marker of myocardial fibrosis, but also in patients with acute myocarditis where LGE may be also explained by the increase of interstitial space caused by interstitial oedema or by tissue infiltration of inflammatory cells. In cardiac amyloidosis, LGE represents myocardial fibrosis but the interstitial overload of amyloid proteins should also be considered as a potential cause of LGE. The identification of the pattern of presentation of LGE is also very important. In the ischaemic pattern, LGE always involves the subendocardial layer with more or less transmural extent, it is confluent, and every single scar should be located in the territory of one coronary artery. In the non-ischaemic pattern, LGE does not fulfil the previous criteria, being midwall, subepicardial, or mixed, not necessarily confluent or confined to a territory of one coronary artery. For cardiomyopathies, the exact pattern of non-ischaemic LGE is important. Quantitative analysis of LGE is required in some specific conditions as in HCM. Magnetic resonance imaging with LGE technique should be performed in every patient with suspect of cardiomyopathy. The lack of standardization of pulse sequence and mostly of quantification methods is the main limitation of LGE technique.

Explainable AI in radiology: a white paper of the Italian Society of Medical and Interventional Radiology.

The term Explainable Artificial Intelligence (xAI) groups together the scientific body of knowledge developed while searching for methods to explain the inner logic behind the AI algorithm and the model inference based on knowledge-based interpretability. The xAI is now generally recognized as a core area of AI. A variety of xAI methods currently are available to researchers; nonetheless, the comprehensive classification of the xAI methods is still lacking. In addition, there is no consensus among the researchers with regards to what an explanation exactly is and which are salient properties that must be considered to make it understandable for every end-user. The SIRM introduces an xAI-white paper, which is intended to aid Radiologists, medical practitioners, and scientists in the understanding an emerging field of xAI, the black-box problem behind the success of the AI, the xAI methods to unveil the black-box into a glass-box, the role, and responsibilities of the Radiologists for appropriate use of the AI-technology. Due to the rapidly changing and evolution of AI, a definitive conclusion or solution is far away from being defined. However, one of our greatest responsibilities is to keep up with the change in a critical manner. In fact, ignoring and discrediting the advent of AI a priori will not curb its use but could result in its application without awareness. Therefore, learning and increasing our knowledge about this very important technological change will allow us to put AI at our service and at the service of the patients in a conscious way, pushing this paradigm shift as far as it will benefit us.

Impact of the systematic introduction of tomosynthesis on breast biopsies: 10 years of results.

Digital Breast Tomosynthesis (DBT) is a cutting-edge technology introduced in recent years as an in-depth analysis of breast cancer diagnostics. Compared with 2D Full-Field Digital Mammography, DBT has demonstrated greater sensitivity and specificity in detecting breast tumors. This work aims to quantitatively evaluate the impact of the systematic introduction of DBT in terms of Biopsy Rate and Positive Predictive Values for the number of biopsies performed (PPV-3). For this purpose, we collected 69,384 mammograms and 7894 biopsies, of which 6484 were Core Biopsies and 1410 were stereotactic Vacuum-assisted Breast Biopsies (VABBs), performed on female patients afferent to the Breast Unit of the Istituto Tumori "Giovanni Paolo II" of Bari from 2012 to 2021, thus, in the period before, during and after the systematic introduction of DBT. Linear regression analysis was then implemented to investigate how the Biopsy Rate had changed over the 10 year screening. The next step was to focus on VABBs, which were generally performed during in-depth examinations of mammogram detected lesions. Finally, three radiologists from the institute's Breast Unit underwent a comparative study to ascertain their performances in terms of breast cancer detection rates before and after the introduction of DBT. As a result, it was demonstrated that both the overall Biopsy Rate and the VABBs Biopsy Rate significantly decreased following the introduction of DBT, with the diagnosis of an equal number of tumors. Besides, no statistically significant differences were observed among the three operators evaluated. In conclusion, this work highlights how the systematic introduction of DBT has significantly impacted the breast cancer diagnostic procedure, by improving the diagnostic quality and thereby reducing needless biopsies, resulting in a consequent reduction in costs.

Structured reporting of computed tomography in the polytrauma patient assessment: a Delphi consensus proposal.

OBJECTIVES: To develop a structured reporting (SR) template for whole-body CT examinations of polytrauma patients, based on the consensus of a panel of emergency radiology experts from the Italian Society of Medical and Interventional Radiology. METHODS: A multi-round Delphi method was used to quantify inter-panelist agreement for all SR sections. Internal consistency for each section and quality analysis in terms of average inter-item correlation were evaluated by means of the Cronbach's alpha (Cα) correlation coefficient. RESULTS: The final SR form included 118 items (6 in the "Patient Clinical Data" section, 4 in the "Clinical Evaluation" section, 9 in the "Imaging Protocol" section, and 99 in the "Report" section). The experts' overall mean score and sum of scores were 4.77 (range 1-5) and 257.56 (range 206-270) in the first Delphi round, and 4.96 (range 4-5) and 208.44 (range 200-210) in the second round, respectively. In the second Delphi round, the experts' overall mean score was higher than in the first round, and standard deviation was lower (3.11 in the second round vs 19.71 in the first round), reflecting a higher expert agreement in the second round. Moreover, Cα was higher in the second round than in the first round (0.97 vs 0.87). CONCLUSIONS: Our SR template for whole-body CT examinations of polytrauma patients is based on a strong agreement among panel experts in emergency radiology and could improve communication between radiologists and the trauma team.

Bridging gaps between images and data: a systematic update on imaging biobanks.

BACKGROUND AND OBJECTIVE: The systematic collection of medical images combined with imaging biomarkers and patient non-imaging data is the core concept of imaging biobanks, a key element for fuelling the development of modern precision medicine. Our purpose is to review the existing image repositories fulfilling the criteria for imaging biobanks. METHODS: Pubmed, Scopus and Web of Science were searched for articles published in English from January 2010 to July 2021 using a combination of the terms: "imaging" AND "biobanks" and "imaging" AND "repository". Moreover, the Community Research and Development Information Service (CORDIS) database ( https://cordis.europa.eu/projects ) was searched using the terms: "imaging" AND "biobanks", also including collections, projects, project deliverables, project publications and programmes. RESULTS: Of 9272 articles retrieved, only 54 related to biobanks containing imaging data were finally selected, of which 33 were disease-oriented (61.1%) and 21 population-based (38.9%). Most imaging biobanks were European (26/54, 48.1%), followed by American biobanks (20/54, 37.0%). Among disease-oriented biobanks, the majority were focused on neurodegenerative (9/33, 27.3%) and oncological diseases (9/33, 27.3%). The number of patients enrolled ranged from 240 to 3,370,929, and the imaging modality most frequently involved was MRI (40/54, 74.1%), followed by CT (20/54, 37.0%), PET (13/54, 24.1%), and ultrasound (12/54, 22.2%). Most biobanks (38/54, 70.4%) were accessible under request. CONCLUSIONS: Imaging biobanks can serve as a platform for collecting, sharing and analysing medical images integrated with imaging biomarkers, biological and clinical data. A relatively small proportion of current biobanks also contain images and can thus be classified as imaging biobanks. KEY POINTS: • Imaging biobanks are a powerful tool for large-scale collection and processing of medical images integrated with imaging biomarkers and patient non-imaging data. • Most imaging biobanks retrieved were European, disease-oriented and accessible under user request. • While many biobanks have been developed so far, only a relatively small proportion of them are imaging biobanks.

Post-mortem computer tomography in ten cases of death while diving: a retrospective evaluation.

INTRODUCTION: Self-contained underwater breathing apparatus (SCUBA) diving deaths have always been a challenge for forensic pathologists. Post-mortem computer tomography (PMCT) allows intracorporeal gas visualization, contributing to identify the cases in which the cause of death is arterial gas embolism (AGE). However, in the literature, it is indicated to perform the radiological examination within 24 h after death. MATERIALS AND METHODS: In this retrospective study, 32 cases of death who had undergone PMCT 24-48 h after death/corpse finding between January 2011 and March 2021 were analyzed, including ten cases of SCUBA divers who died of AGE. All cases' radiological images were reviewed to localize the intracorporeal gas distribution alongside other findings that are usually related to SCUBA diving death. A semi-quantitative evaluation was also performed. RESULTS: Most of the divers showed gas within the left heart and the arteries. In addition, the semi-quantitative evaluation revealed that the divers presented a higher mean amount of intraarterial gas compared to the fresh corpses. On the other hand, the putrefied corpses presented gas within the portal system and generalized subcutaneous emphysema with higher frequency and quantity than the divers and fresh corpses. CONCLUSION: Our cases suggested that the PMCT, even when performed 24-48 h after death, remains a valuable tool to diagnose AGE in cases of SCUBA diving deaths. In addition, with the limit of the small sample size, our data showed that at least a medium quantity of intraarterial gas, when not associated with a high amount of gas within the portal system and subcutaneous emphysema, could be considered a diagnostic criterion of AGE.

Impact of temporalis muscle thickness in elderly patients with newly diagnosed glioblastoma treated with radio or radio-chemotherapy.

BACKGROUND: There is an unmet need for new biomarkers able to predict both the outcomes of up-front therapy and the compliance of elderly patients diagnosed with glioblastoma. For this purpose, temporal muscle thickness is a promising tool to be investigated. METHODS: Data from 52 glioblastoma patients older than 65 years, treated with post-operative radio or radio-chemotherapy and referred to Pisa University Hospital, were retrieved. The thickness of temporal muscle (TMT) was divided into quartiles and correlated with overall survival (Our primary endpoint). Survival curves were calculated using Kaplan-Meier method, and log-rank test was used to evaluate the differences between curves. RESULTS: Patients in the lower quartile of TMT, with TMT thinner than 7 mm, have survived longer; both univariate and multivariate analyses showed a statistically significant correlation between TMT and overall survival (P = 0.012 and P = 0.003, respectively). CONCLUSION: Future prospective and more extensive studies focused on elderly glioblastoma patients are needed to confirm the role of TMT as prognostic value on OS and to help explaining this association.

Extracorporeal membrane oxygenation (ECMO) in COVID-19 patients: a pocket guide for radiologists.

During the coronavirus disease 19 (COVID-19) pandemic, extracorporeal membrane oxygenation (ECMO) has been proposed as a possible therapy for COVID-19 patients with acute respiratory distress syndrome. This pictorial review is intended to provide radiologists with up-to-date information regarding different types of ECMO devices, correct placement of ECMO cannulae, and imaging features of potential complications and disease evolution in COVID-19 patients treated with ECMO, which is essential for a correct interpretation of diagnostic imaging, so as to guide proper patient management.

Structured reporting of computed tomography in the staging of colon cancer: a Delphi consensus proposal.

BACKGROUND: Structured reporting (SR) in radiology is becoming increasingly necessary and has been recognized recently by major scientific societies. This study aims to build structured CT-based reports in colon cancer during the staging phase in order to improve communication between the radiologist, members of multidisciplinary teams and patients. MATERIALS AND METHODS: A panel of expert radiologists, members of the Italian Society of Medical and Interventional Radiology, was established. A modified Delphi process was used to develop the SR and to assess a level of agreement for all report sections. Cronbach's alpha (Cα) correlation coefficient was used to assess internal consistency for each section and to measure quality analysis according to the average inter-item correlation. RESULTS: The final SR version was built by including n = 18 items in the "Patient Clinical Data" section, n = 7 items in the "Clinical Evaluation" section, n = 9 items in the "Imaging Protocol" section and n = 29 items in the "Report" section. Overall, 63 items were included in the final version of the SR. Both in the first and second round, all sections received a higher than good rating: a mean value of 4.6 and range 3.6-4.9 in the first round; a mean value of 5.0 and range 4.9-5 in the second round. In the first round, Cronbach's alpha (Cα) correlation coefficient was a questionable 0.61. In the first round, the overall mean score of the experts and the sum of scores for the structured report were 4.6 (range 1-5) and 1111 (mean value 74.07, STD 4.85), respectively. In the second round, Cronbach's alpha (Cα) correlation coefficient was an acceptable 0.70. In the second round, the overall mean score of the experts and the sum of score for structured report were 4.9 (range 4-5) and 1108 (mean value 79.14, STD 1.83), respectively. The overall mean score obtained by the experts in the second round was higher than the overall mean score of the first round, with a lower standard deviation value to underline greater agreement among the experts for the structured report reached in this round. CONCLUSIONS: A wide implementation of SR is of critical importance in order to offer referring physicians and patients optimum quality of service and to provide researchers with the best quality data in the context of big data exploitation of available clinical data. Implementation is a complex procedure, requiring mature technology to successfully address the multiple challenges of user-friendliness, organization and interoperability.

Structured reporting of x-ray mammography in the first diagnosis of breast cancer: a Delphi consensus proposal.

BACKGROUND: Radiology is an essential tool in the management of a patient. The aim of this manuscript was to build structured report (SR) Mammography based in Breast Cancer. METHODS: A working team of 16 experts (group A) was composed to create a SR for Mammography Breast Cancer. A further working group of 4 experts (group B), blinded to the activities of the group A, was composed to assess the quality and clinical usefulness of the SR final draft. Modified Delphi process was used to assess level of agreement for all report sections. Cronbach's alpha (Cα) correlation coefficient was used to assess internal consistency and to measure quality analysis according to the average inter-item correlation. RESULTS: The final SR version was built by including n = 2 items in Personal Data, n = 4 items in Setting, n = 2 items in Comparison with previous breast examination, n = 19 items in Anamnesis and clinical context; n = 10 items in Technique; n = 1 item in Radiation dose; n = 5 items Parenchymal pattern; n = 28 items in Description of the finding; n = 12 items in Diagnostic categories and Report and n = 1 item in Conclusions. The overall mean score of the experts and the sum of score for structured report were 4.9 and 807 in the second round. The Cronbach's alpha (Cα) correlation coefficient was 0.82 in the second round. About the quality evaluation, the overall mean score of the experts was 3.3. The Cronbach's alpha (Cα) correlation coefficient was 0.90. CONCLUSIONS: Structured reporting improves the quality, clarity and reproducibility of reports across departments, cities, countries and internationally and will assist patient management and improve breast health care and facilitate research.

A multiparametric approach to improve the prediction of response to immunotherapy in patients with metastatic NSCLC.

BACKGROUND: It is still unclear how to combine biomarkers to identify patients who will truly benefit from anti-PD-1 agents in NSCLC. This study investigates exosomal mRNA expression of PD-L1 and IFN-γ, PD-L1 polymorphisms, tumor mutational load (TML) in circulating cell-free DNA (cfDNA) and radiomic features as possible predictive markers of response to nivolumab and pembrolizumab in metastatic NSCLC patients. METHODS: Patients were enrolled and blood (12 ml) was collected at baseline before receiving anti-PD-1 therapy. Exosome-derived mRNA and cfDNA were extracted to analyse PD-L1 and IFN-γ expression and tumor mutational load (TML) by digital droplet PCR (ddPCR) and next-generation sequencing (NGS), respectively. The PD-L1 single nucleotide polymorphisms (SNPs) c.-14-368 T > C and c.*395G > C, were analysed on genomic DNA by Real-Time PCR. A radiomic analysis was performed on the QUIBIM Precision® V3.0 platform. RESULTS: Thirty-eight patients were enrolled. High baseline IFN-γ was independently associated with shorter median PFS (5.6 months vs. not reached p = 0.0057), and levels of PD-L1 showed an increase at 3 months vs. baseline in patients who progressed (p = 0.01). PD-L1 baseline levels showed significant direct and inverse relationships with radiomic features. Radiomic features also inversely correlated with PD-L1 expression in tumor tissue. In subjects receiving nivolumab, median PFS was shorter in carriers of c.*395GG vs. c.*395GC/CC genotype (2.3 months vs. not reached, p = 0.041). Lastly, responders had higher non-synonymous mutations and more links between co-occurring genetic somatic mutations and ARID1A alterations as well. CONCLUSIONS: A combined multiparametric approach may provide a better understanding of the molecular determinants of response to immunotherapy.

RSNA International Trends: A Global Perspective on the COVID-19 Pandemic and Radiology in Late 2020.

The coronavirus disease 2019 pandemic has challenged and changed health care systems around the world. There has been a heterogeneity of disease burden, health care resources, and nonimaging testing availability, both geographically and over time. In parallel, there has been a continued increase in understanding how the disease affects patients, effectiveness of therapeutic options, and factors that modulate transmission risk. In this report, radiology experts in representative countries from around the world share insights gained from local experience. These insights provide a guidepost to help address management challenges as cases continue to rise in many parts of the world and suggest modifications in workflow that are likely to continue after this pandemic subsides.

Incorporating dose-volume histogram parameters of swallowing organs at risk in a videofluoroscopy-based predictive model of radiation-induced dysphagia after head and neck cancer intensity-modulated radiation therapy.

PURPOSE: To develop a videofluoroscopy-based predictive model of radiation-induced dysphagia (RID) by incorporating DVH parameters of swallowing organs at risk (SWOARs) in a machine learning analysis. METHODS: Videofluoroscopy (VF) was performed to assess the penetration-aspiration score (P/A) at baseline and at 6 and 12 months after RT. An RID predictive model was developed using dose to nine SWOARs and P/A-VF data at 6 and 12 months after treatment. A total of 72 dosimetric features for each patient were extracted from DVH and analyzed with linear support vector machine classification (SVC), logistic regression classification (LRC), and random forest classification (RFC). RESULTS: 38 patients were evaluable. The relevance of SWOARs DVH features emerged both at 6 months (AUC 0.82 with SVC; 0.80 with LRC; and 0.83 with RFC) and at 12 months (AUC 0.85 with SVC; 0.82 with LRC; and 0.94 with RFC). The SWOARs and the corresponding features with the highest relevance at 6 months resulted as the base of tongue (V65 and Dmean), the superior (Dmean) and medium constrictor muscle (V45, V55; V65; Dmp; Dmean; Dmax and Dmin), and the parotid glands (Dmean and Dmp). On the contrary, the features with the highest relevance at 12 months were the medium (V55; Dmin and Dmean) and inferior constrictor muscles (V55, V65 Dmin and Dmax), the glottis (V55 and Dmax), the cricopharyngeal muscle (Dmax), and the cervical esophagus (Dmax). CONCLUSION: We trained and cross-validated an RID predictive model with high discriminative ability at both 6 and 12 months after RT. We expect to improve the predictive power of this model by enlarging the number of training datasets.