Significance of the sample determination in assessment of radiological examinations frequencies for population doses due to medical exposures.

The radiological examination frequency, i.e. the number of examinations performed annually, is necessary for estimating the collective effective dose of the population from medical exposures with ionizing radiation. Examination frequency surveys usually collect data from a limited number of radiological facilities participating in the survey. The collected data are then extrapolated to the existing radiological facilities in a country/region. Thus, the number of facilities and the specific facilities to participate, as well as, the extrapolation method used, are significant elements when designing the survey sample and methodology for examinations frequency assessments. This work attempted to simulate the situation when examination frequency data are collected from a limited number of facilities by investigating several "virtual sample" designs and two extrapolation methods. Comparisons between the calculated - by extrapolation - and the actual examination frequency in the country were made, for several scenarios and examination type data sets. The uncertainties were estimated and discussed thoroughly. The findings of this work highlighted the need for appropriate registry of the existing facilities in a country/region, the categorization of facilities considering the medical sector pattern in the country/region, the representativity and homogeneity of the samples used for a survey, as well as, the necessity for quality control of the collected examination frequency data. The results showed that when the aforementioned conditions were fulfilled, the examination frequency could be calculated with reasonable accuracy, based on data collected from a limited number of facilities. The paper also provides suggestions and tips for the collection and analysis of examination frequency data.

Updating national diagnostic reference levels for computed tomography in Greece: Challenges on patient protection optimisation.

The escalating use of Computed Tomography (CT) imaging necessitates establishment and periodic revision of Diagnostic Reference Levels (DRLs) to ensure patient protection optimization. This paper presents the outcomes of a national survey conducted from 2019 to 2022, focusing on revising DRLs for adult CT examinations. Dosimetric data from 127 scanners in 120 medical facilities, representing 25% of the country's CT scanners, were collected, emphasizing geographic distribution and technology representation. Τhe parameters used for DRLs were the CTDIvol and the DLP of a typical acquisition of the region of interest (scan DLP). In addition to the 7 CT examination for which the DRL values were revised, establishment of DRLs for neck, cervical spine, pelvic bones-hips, coronary artery calcium (Ca) score and cardiac computed tomography angiography (CCTA) examinations was performed. Revised DRLs exhibited a 15 % average decrease in CTDIvol and a 7 % average decrease in scan DLP from the initial DRLs. This reduction of dosimetric values is relatively low compared to other national studies. The findings revealed wide variations in dosimetric values and scan lengths among scanners, emphasizing the need for standardization and optimization. Incorporation of advanced technologies like Iterative Reconstruction (IR) showcased potential for further dose reduction, yet challenges in uniform implementation persist. The study underscores the importance of ongoing optimisation efforts, particularly in the context of increased CT utilization and evolving technology. The revised DRLs have been officially adopted in Greece, emphasizing the commitment to safe and effective CT practices.

Management of pregnant or potentially pregnant patients undergoing diagnostic and interventional radiology procedures: Investigation of clinical routine practice.

It is well known that foetuses are highly sensitive to ionising radiation and special attention to justification and optimisation of radiological procedures involving a pregnant patient is required. A task to review, validate and compare different approaches to managing the pregnant patient and to estimating the associated foetal doses arising from a diagnostic or interventional radiology (DIR) procedure was designed in the framework of EURADOS working group 12. As a first step, a survey of radiation protection practice including dosimetry considerations among EURADOS members was performed using online questionnaire. Then, to evaluate the possible differences in the estimated foetal doses, a comparison of assessed dose values was made for three cases of pregnant patients that underwent different CT procedures. More than 120 professionals from 108 institutions and 17 countries that are involved in managing pregnant patients undergoing DIR procedures answered the questionnaire. Most of the respondents use national or hospital guidelines on the management of pregnant patients undergoing DIR procedures. However, the guidelines differ considerably among respondents. Comparison of foetal dose assessments performed by dosimetry experts showed the variety of methods used as well as large variability of estimated foetal doses in all three cases. Although European and International commission on radiation protection guidelines already exist, they are more than 20 years old and, in some aspects, they are obsolete. This paper shows that there is a need to revise and update these guidelines.

Establishing a priori and a posteriori predictive models to assess patients' peak skin dose in interventional cardiology. Part 2: results of the VERIDIC project.

BACKGROUND: Optimizing patient exposure in interventional cardiology is key to avoid skin injuries. PURPOSE: To establish predictive models of peak skin dose (PSD) during percutaneous coronary intervention (PCI), chronic total occlusion percutaneous coronary intervention (CTO), and transcatheter aortic valve implantation (TAVI) procedures. MATERIAL AND METHODS: A total of 534 PCI, 219 CTO, and 209 TAVI were collected from 12 hospitals in eight European countries. Independent associations between PSD and clinical and technical dose determinants were examined for those procedures using multivariate statistical analysis. A priori and a posteriori predictive models were built using stepwise multiple linear regressions. A fourfold cross-validation was performed, and models' performance was evaluated using the root mean square error (RMSE), mean absolute percentage error (MAPE), coefficient of determination (R²), and linear correlation coefficient (r). RESULTS: Multivariate analysis proved technical parameters to overweight clinical complexity indices with PSD mainly affected by fluoroscopy time, tube voltage, tube current, distance to detector, and tube angulation for PCI. For CTO, these were body mass index, tube voltage, and fluoroscopy contribution. For TAVI, these parameters were sex, fluoroscopy time, tube voltage, and cine acquisitions. When benchmarking the predictive models, the correlation coefficients were r = 0.45 for the a priori model and r = 0.89 for the a posteriori model for PCI. These were 0.44 and 0.67, respectively, for the CTO a priori and a posteriori models, and 0.58 and 0.74, respectively, for the TAVI a priori and a posteriori models. CONCLUSION: A priori predictive models can help operators estimate the PSD before performing the intervention while a posteriori models are more accurate estimates and can be useful in the absence of skin dose mapping solutions.

Patient exposure dose in interventional cardiology per clinical and technical complexity levels. Part 1: results of the VERIDIC project.

BACKGROUND: Patients can be exposed to high skin doses during complex interventional cardiology (IC) procedures. PURPOSE: To identify which clinical and technical parameters affect patient exposure and peak skin dose (PSD) and to establish dose reference levels (DRL) per clinical complexity level in IC procedures. MATERIAL AND METHODS: Validation and Estimation of Radiation skin Dose in Interventional Cardiology (VERIDIC) project analyzed prospectively collected patient data from eight European countries and 12 hospitals where percutaneous coronary intervention (PCI), chronic total occlusion PCI (CTO), and transcatheter aortic valve implantation (TAVI) procedures were performed. A total of 62 clinical complexity parameters and 31 technical parameters were collected, univariate regressions were performed to identify those parameters affecting patient exposure and define DRL accordingly. RESULTS: Patient exposure as well as clinical and technical parameters were collected for a total of 534 PCI, 219 CTO, and 209 TAVI. For PCI procedures, body mass index (BMI), number of stents ≥2, and total stent length >28 mm were the most prominent clinical parameters, which increased the PSD value. For CTO, these were total stent length >57 mm, BMI, and previous anterograde or retrograde technique that failed in the same session. For TAVI, these were male sex, BMI, and number of diseased vessels. DRL values for Kerma-area product (PKA), air kerma at patient entrance reference point (Ka,r), fluoroscopy time (FT), and PSD were stratified, respectively, for 14 clinical parameters in PCI, 10 in CTO, and four in TAVI. CONCLUSION: Prior knowledge of the key factors influencing the PSD will help optimize patient radiation protection in IC.

Use of out-of-field contact shielding on patients in medical imaging: A review of current guidelines, recommendations and legislative documents.

The use of patient contact-shielding has become a topic of intensive scientific debate. While it has been common practice during the last decades, some studies have questioned the efficiency of using such shielding while others have highlighted the inconsistencies in its application. The objective of this work is to review current recommendations and legislative documents on the use of out-of-field shielding in X-ray imaging, including those from national authorities and from international and national organisations and professional bodies. The review, performed within the framework of the activities of EURADOS Working Group 12, covers available recommendations on use of contact shielding in adult, pregnant and paediatric patients in general radiography, fluoroscopy, computed tomography, mammography and dental radiology. It includes a comprehensive search of 83 documents from 32 countries and 6 international organisations over the last 39 years. In general, using shielding is recommended only under two conditions: if it does not compromise the diagnostic task and the performance of the procedure and/or if it reassures the patient and comforters that they are appropriately protected against potentially harmful effects of radiation. There are very few specific regulatory requirements to use shielding in a particular imaging modality, although they may consider use of shielding either as part of good radiological practice or as requirements for availability of protective or ancillary tools, without further specification of their use. There is a wide variety of positions among documents that recommend out-of-field shielding, those that do not recommend it and those that are not specific. Therefore, evidence-based consensus is still needed to ensure best and consistent practice.

Accuracy of skin dose mapping in interventional cardiology: Comparison of 10 software products following a common protocol.

PURPOSE: Online and offline software products can estimate the maximum skin dose (MSD) delivered to the patient during interventional cardiology procedures. The capabilities and accuracy of several skin dose mapping (SDM) software products were assessed on X-ray systems from the main manufacturers following a common protocol. METHODS: Skin dose was measured on four X-ray systems following a protocol composed of nine fundamental irradiation set-ups and three set-ups simulating short, clinical procedures. Dosimeters/multimeters with semiconductor-based detectors, radiochromic films and thermoluminescent dosimeters were used. Results were compared with up to eight of 10 SDM products, depending on their compatibility. RESULTS: The MSD estimates generally agreed with the measurements within ± 40% for fundamental irradiation set-ups and simulated procedures. Only three SDM products provided estimates within ± 40% for all tested configurations on at least one compatible X-ray system. No SDM product provided estimates within ± 40% for all combinations of configurations and compatible systems. The accuracy of the MSD estimate for lateral irradiations was variable and could be poor (up to 66% underestimation). Most SDM products produced maps which qualitatively represented the dimensions, the shape and the relative position of the MSD region. Some products, however, missed the MSD region when situated at the intersection of multiple fields, which is of radiation protection concern. CONCLUSIONS: It is very challenging to establish a common protocol for quality control (QC) and acceptance testing because not all information necessary for accurate MSD calculation is available or standardised in the radiation dose structured reports (RDSRs).

Medical imaging dose optimisation from ground up: expert opinion of an international summit.

As in any medical intervention, there is either a known or an anticipated benefit to the patient from undergoing a medical imaging procedure. This benefit is generally significant, as demonstrated by the manner in which medical imaging has transformed clinical medicine. At the same time, when it comes to imaging that deploys ionising radiation, there is a potential associated risk from radiation. Radiation risk has been recognised as a key liability in the practice of medical imaging, creating a motivation for radiation dose optimisation. The level of radiation dose and risk in imaging varies but is generally low. Thus, from the epidemiological perspective, this makes the estimation of the precise level of associated risk highly uncertain. However, in spite of the low magnitude and high uncertainty of this risk, its possibility cannot easily be refuted. Therefore, given the moral obligation of healthcare providers, 'first, do no harm,' there is an ethical obligation to mitigate this risk. Precisely how to achieve this goal scientifically and practically within a coherent system has been an open question. To address this need, in 2016, the International Atomic Energy Agency (IAEA) organised a summit to clarify the role of Diagnostic Reference Levels to optimise imaging dose, summarised into an initial report (Järvinen et al 2017 Journal of Medical Imaging 4 031214). Through a consensus building exercise, the summit further concluded that the imaging optimisation goal goes beyond dose alone, and should include image quality as a means to include both the benefit and the safety of the exam. The present, second report details the deliberation of the summit on imaging optimisation.

Reference levels and patient doses in interventional cardiology procedures in Greece.

OBJECTIVES: To present a national survey that was performed for the establishment of national reference levels (RLs) for interventional cardiology (IC) procedures and to estimate the effective dose (E) received by the patient during these procedures. METHODS: Data concerning the fluoroscopy time and air kerma-area product (P KA) during coronary angiography (CA), percutaneous coronary intervention (PCI), pacemaker implantation (PMI) and radiofrequency cardiac ablation (RFCA) from 26 centres were collected. Moreover, measurements concerning the performance of X-ray systems used in IC were performed in order to set system-related reference levels. P KA to E conversion factors were also calculated. RESULTS: The suggested P KA RLs for CA, PCI, PMI and RFCA are 53 Gycm(2), 129 Gycm(2), 36 Gycm(2) and 146 Gycm(2), respectively, and the estimated E to the patient from these procedures is 9.7 mSv, 26.8 mSv, 5.5 mSv and 20.4 mSv, respectively. Reference levels for the fluoroscopic dose rate and dose per frame during image acquisition at the entrance of a water phantom are 29 mGy/min and 0.23 mGy/frame, respectively. CONCLUSIONS: The suggested RLs are comparable to those suggested by other studies. Additional information concerning the complexity of the procedures and patient pathology should be collected for future reevaluation of the suggested RLs. KEY POINTS: • The radiation dose imparted during fluoroscopically guided interventional procedures can be high • Understanding of reference levels might help optimise interventional cardiological procedures • Optimisation by changing the systems' settings seems feasible in some cases • Procedure complexity and the patient's clinical problem should be taken into account.