Radiation safety of current European practices of therapeutic nuclear medicine: survey results from 20 HERCA countries.

The purpose of this study was to acquire up-to-date information on nuclear medicine treatments in Europe and on the implementation of the requirements of the Basic Safety Standards Directive in HERCA Heads of the European Radiological Protection Competent Authorities (HERCAs) member states. An electronic survey was distributed to competent authorities of 32 HERCA member states. The questionnaire addressed 33 explicitly considered treatments using 13 different radionuclides, and for each treatment, a similar set of questions was included. Questions covered the use of treatments, hospitalisation of patients and radioactive waste management related to therapeutic nuclear medicine involving other radionuclides than the well-known131I. The survey also covered justification of treatments, individual treatment planning, involvement of a medical physics expert (MPE) and radiation protection instructions given to the patient at the time of release. Responses were obtained from 20 HERCA countries. All of these countries used Na[131I]I for benign thyroid diseases and thyroid ablation of adults. 223RaCl2(Xofigo®) for bone metastases,177Lu-somatostatin analogues for neuroendocrine tumours and177Lu-labelled PSMA for castration resistant prostate cancer (PC) and PC-metastases were used in 90%, 65% and 55% of countries, respectively. Only a few countries had specific criteria for hospitalisation and waste management for new therapeutic nuclear medicine. Regulatory requirements for justification of new therapeutic nuclear medicine were in place in almost all countries. Individual treatment planning was required for all therapies in 55% and for some therapies in 28% of the responding countries. Implementation of the requirement for MPEs to be closely involved in nuclear medicine practices varied to a great extend among countries. Almost all responding countries answered that some radiation protection instructions existed for patients released after treatment with radionuclides other than131I treatment, however only few countries had developed specific guidelines in the field.

Justification of CT practices across Europe: results of a survey of national competent authorities and radiology societies.

OBJECTIVES: Published literature on justification of computed tomography (CT) examinations in Europe is sparse but demonstrates consistent sub-optimal application. As part of the EU initiated CT justification project, this work set out to capture CT justification practices across Europe. METHODS: An electronic questionnaire consisting of mostly closed multiple-choice questions was distributed to national competent authorities and to presidents of European radiology societies in EU member states as well as Iceland, Norway, Switzerland, and the UK (n = 31). RESULTS: Fifty-one results were received from 30 European countries. Just 47% (n = 24) stated that advance justification of individual CT examinations is performed by a medical practitioner. Radiologists alone mostly (n = 27, 53%) perform daily justification of CT referrals although this is a shared responsibility in many countries. Imaging referral guidelines are widely available although just 13% (n = 6) consider them in daily use. Four countries (Cyprus, Ireland, Sweden, UK) reported having them embedded within clinical decision support systems. Justification of new practices with CT is mostly regulated (77%) although three countries (Belgium, Iceland and Portugal) reported not having any national system in place for generic justification. Health screening with CT was reported by seven countries as part of approved screening programmes and by eight countries outside. When performed, CT justification audits were reported to improve CT justification rates. CONCLUSIONS: CT justification practices vary across Europe with less than 50% using advance justification and a minority having clinical decision support systems in place. CT for health screening purposes is not currently widely used in Europe.

CONTEMPORARY COLLECTIVE EFFECTIVE DOSE TO THE POPULATION FROM X-RAY AND NUCLEAR MEDICINE EXAMINATIONS-CHANGES OVER LAST 10 YEARS IN FINLAND.

Contemporary collective effective doses to the population from x-ray and nuclear medicine examinations in Finland in 2018 was estimated. The estimated effective dose per caput from x-ray examinations increased from year 2008 to 2018 respectively from 0.45 mSv to 0.72 mSv and from nuclear medicine examinations from 0.03 mSv to 0.04 mSv. The proportional dose due to CT examinations of the total collective effective dose from all x-ray examinations increased from 58% in 2008 to 70% in 2018 and the dose did not change substantially in total when new conversion factors were applied. The collective effective dose from conventional plain radiography did not change substantially during the last ten years while the new (ICRP 103) tissue weighting factors were taken into use in 2018, however frequencies of examinations in total decreased. The collective effective dose from CT in nuclear medicine tripled between 2009 and 2018.

Accuracy of central axis dose calculations for photon external radiotherapy beams in Finland: the quality of local beam data and the use of averaged data.

PURPOSE: The accuracy of central axis dose calculation was evaluated for 48 photon beams from 28 linear accelerators at nine centres in Finland. In addition, inter-accelerator consistency of beam data was evaluated for Varian Clinac 600 CDs and 2100 CDs, and averaged data sets were generated for output factors (OFs) and percentage depth doses (PDDs). The averaged data sets obtained were used to identify potential dosimetry reasons for local errors. MATERIALS AND METHODS: Agreement between measured and calculated doses was determined at isocentre at 10 cm depth in water for nine different sized open square and rectangular fields. Averaged OFs were determined for nominal energies of 4, 6, 10, 15 and 18 MV both at d(max) and at a 10-cm depth. In order to develop a function for the OF data, OFs for square fields were parameterised through empirical model fitting. The feasibility of a simple equivalent square collimator formula was also evaluated for the presentation of OFs for rectangular fields. Averaged PDDs were determined at a 10-cm depth. RESULTS: The difference between measured and calculated doses exceeded +/-3%, +/-2% and +/-1% for 3, 6 and 35 of the investigated 48 beams, respectively. The differences were due to errors observed in both OFs and depth dose data. When the agreement between dose calculation and measurement was within +/-1%, inter-accelerator differences in OFs were within +/-1.0% at both the depth of dose maximum and at 10 cm for Clinac 600 CDs and also for 2100 CDs. Differences in PDDs were within +/-1.2%. CONCLUSIONS: The importance of quality control for beam data was demonstrated by showing significant errors in measured data. For Clinac 600 and 2100 CDs, the quality control can be accurately performed by comparing local data to averaged reference data. Robust averaged data sets were obtained for 6, 15 and 18 MV beams of Clinac 2100 CDs.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.

Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe.

PURPOSE: To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems. MATERIAL AND METHODS: The original data were collected as part of the ACCIRAD project through two online surveys. RESULTS: Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear "requirements" for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries. CONCLUSIONS: Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.

Patient safety in external beam radiotherapy - guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.

In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated "ACCIRAD", recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled "Guidelines for patient safety in external beam radiotherapy - Guidelines on risk assessment and analysis of adverse-error events and near misses". The present article describes the aims and current status of the project, including results of the surveys.

Guidelines for equipment and staffing of radiotherapy facilities in the European countries: final results of the ESTRO-HERO survey.

BACKGROUND AND PURPOSE: In planning to meet evidence based needs for radiotherapy, guidelines for the provision of capital and human resources are central if access, quality and safety are not to be compromised. A component of the ESTRO-HERO (Health Economics in Radiation Oncology) project is to document the current availability and content of guidelines for radiotherapy in Europe. MATERIALS AND METHODS: An 84 part questionnaire was distributed to the European countries through their national scientific and professional radiotherapy societies with 30 items relating to the availability of guidelines for equipment and staffing and selected operational issues. Twenty-nine countries provided full or partial evaluable responses. RESULTS: The availability of guidelines across Europe is far from uniform. The metrics used for capital and human resources are variable. There seem to have been no major changes in the availability or specifics of guidelines over the ten-year period since the QUARTS study with the exception of the recent expansion of RTT staffing models. Where comparison is possible it appears that staffing for radiation oncologists, medical physicists and particularly RTTs tend to exceed guidelines suggesting developments in clinical radiotherapy are moving faster than guideline updating. CONCLUSION: The efficient provision of safe, high quality radiotherapy services would benefit from the availability of well-structured guidelines for capital and human resources, based on agreed upon metrics, which could be linked to detailed estimates of need.

Radiotherapy equipment and departments in the European countries: final results from the ESTRO-HERO survey.

BACKGROUND: Documenting the distribution of radiotherapy departments and the availability of radiotherapy equipment in the European countries is an important part of HERO - the ESTRO Health Economics in Radiation Oncology project. HERO has the overall aim to develop a knowledge base of the provision of radiotherapy in Europe and build a model for health economic evaluation of radiation treatments at the European level. The aim of the current report is to describe the distribution of radiotherapy equipment in European countries. METHODS: An 84-item questionnaire was sent out to European countries, principally through their national societies. The current report includes a detailed analysis of radiotherapy departments and equipment (questionnaire items 26-29), analyzed in relation to the annual number of treatment courses and the socio-economic status of the countries. The analysis is based on validated responses from 28 of the 40 European countries defined by the European Cancer Observatory (ECO). RESULTS: A large variation between countries was found for most parameters studied. There were 2192 linear accelerators, 96 dedicated stereotactic machines, and 77 cobalt machines reported in the 27 countries where this information was available. A total of 12 countries had at least one cobalt machine in use. There was a median of 0.5 simulator per MV unit (range 0.3-1.5) and 1.4 (range 0.4-4.4) simulators per department. Of the 874 simulators, a total of 654 (75%) were capable of 3D imaging (CT-scanner or CBCT-option). The number of MV machines (cobalt, linear accelerators, and dedicated stereotactic machines) per million inhabitants ranged from 1.4 to 9.5 (median 5.3) and the average number of MV machines per department from 0.9 to 8.2 (median 2.6). The average number of treatment courses per year per MV machine varied from 262 to 1061 (median 419). While 69% of MV units were capable of IMRT only 49% were equipped for image guidance (IGRT). There was a clear relation between socio-economic status, as measured by GNI per capita, and availability of radiotherapy equipment in the countries. In many low income countries in Southern and Central-Eastern Europe there was very limited access to radiotherapy and especially to equipment for IMRT or IGRT. CONCLUSIONS: The European average number of MV machines per million inhabitants and per department is now better in line with QUARTS recommendations from 2005, but the survey also showed a significant heterogeneity in the access to modern radiotherapy equipment in Europe. High income countries especially in Northern-Western Europe are well-served with radiotherapy resources, other countries are facing important shortages of both equipment in general and especially machines capable of delivering high precision conformal treatments (IMRT, IGRT).

How can a cost/benefit ratio be optimized for an output measurement program of external photon radiotherapy beams?

We estimated cost/benefit ratios for different quality control programs of radiation output measurements of medical linear accelerators. The cost/benefit ratios of quality control (QC) programs (a combination of output measurement time interval and measurement action levels) were defined as workload divided by achievable dose accuracy. Dose accuracy was assumed to be inversely proportional to the 99% confidence limit of shifts of total treatment doses and workload as inversely proportional to the output measurement time interval. Our previously reported method was used to estimate the distribution of shifts of total treatment doses due to changes in accelerator radiation output (Gy/MU). The confidence limits of dose shifts were estimated for different QC programs and for different levels of output measurement reproducibility. Output shifts used in the estimations had previously been observed for four linear accelerators over 5 years. We observed that the cost/benefit ratio increases remarkably when the output measurement time interval is less than 1 month. The ratio depends strongly on the action levels and reproducibility of the QC measurements. Improvement of these factors optimizes the cost/benefit ratio by a factor of several times. The most cost-effective output measurement time interval to achieve 99% confidence limits of ±2, ±2.5 or ±3% for dose shifts ranged from 0.25 month to as much as 6 months depending on the factors given above and the intended accuracy level. It is several times more cost effective to increase dose accuracy by lowering the action levels of the QC measurements and by attempting to improve their reproducibility than by simply shortening the time interval of the output measurements. Methods improving utilization and interpretation of the results of the QC measurements play a key role in further optimization of cost/benefit ratios in dosimetric QC.