Conducting a National RT-QI Project - Challenges and Opportunities.

Over the past decade, there has been an increased interest in defining and monitoring quality indicators (QI) in the field of oncology including the field of radiation oncology. The comprehensive gathering and analysis of QIs on a multicentric scale offer valuable insights into identifying gaps in clinical practice and fostering continuous improvement. This article delineates the evolution and results of the Belgian national project dedicated to radiotherapy-specific QIs while also exploring the challenges and opportunities inherent in implementing such a multi-centric initiative.

Structure and Processes of Existing Practice in Radiotherapy Peer Review: A Systematic Review of the Literature.

Peer review in radiotherapy is an essential step in clinical quality assurance to avoid planning-related errors that can impact on patient safety and treatment outcomes. Despite recommendations that radiotherapy centres should include peer review in their regular quality assurance pathway, adoption of the practice has not been universal, and to date there have been no formal guidelines set out to standardise the process. We undertook a systematic review of the literature to determine existing practice in radiotherapy peer review internationally, with respect to meeting structure and processes, in order to define a standardised framework. A PubMed and Web of Science search identified 17 articles detailing peer review practice. The results revealed significant variation in peer review processes between institutions, and a lack of consensus on documentation and reporting. Variations in the grading of outcomes of peer review were also noted. Taking into account the results of this review, a framework for standardising the process and outcome documentation for peer review has been developed. This can be utilised by radiotherapy centres introducing or updating peer review practice, and can facilitate meaningful evaluation of the clinical impact of peer review in the future.

Comparison of Bayesian network and support vector machine models for two-year survival prediction in lung cancer patients treated with radiotherapy.

PURPOSE: Classic statistical and machine learning models such as support vector machines (SVMs) can be used to predict cancer outcome, but often only perform well if all the input variables are known, which is unlikely in the medical domain. Bayesian network (BN) models have a natural ability to reason under uncertainty and might handle missing data better. In this study, the authors hypothesize that a BN model can predict two-year survival in non-small cell lung cancer (NSCLC) patients as accurately as SVM, but will predict survival more accurately when data are missing. METHODS: A BN and SVM model were trained on 322 inoperable NSCLC patients treated with radiotherapy from Maastricht and validated in three independent data sets of 35, 47, and 33 patients from Ghent, Leuven, and Toronto. Missing variables occurred in the data set with only 37, 28, and 24 patients having a complete data set. RESULTS: The BN model structure and parameter learning identified gross tumor volume size, performance status, and number of positive lymph nodes on a PET as prognostic factors for two-year survival. When validated in the full validation set of Ghent, Leuven, and Toronto, the BN model had an AUC of 0.77, 0.72, and 0.70, respectively. A SVM model based on the same variables had an overall worse performance (AUC 0.71, 0.68, and 0.69) especially in the Ghent set, which had the highest percentage of missing the important GTV size data. When only patients with complete data sets were considered, the BN and SVM model performed more alike. CONCLUSIONS: Within the limitations of this study, the hypothesis is supported that BN models are better at handling missing data than SVM models and are therefore more suitable for the medical domain. Future works have to focus on improving the BN performance by including more patients, more variables, and more diversity.

[A survey of Belgian practice for non-malignant diseases]. / Une enquête de l'utilisation en Belgique de la radiothérapie pour des affections bénignes, non-tumorales.

Two prior surveys were carried out in 1995 and 1999 to evaluate the use of radiotherapy in the treatment of non-malignant disease. In 2016, the same questionnaire was used and sent to the 24 centers of the country: 22 responded. A major decrease was observed in the number of patients treated: 360 in 2016 in contrast to 954 in 1999 and 1113 in 1995. The most frequent indications remain the prevention of heterotopic bone formation, keloids or gynecomastia. A new indication was observed: trigeminal nevralgia treated with radiosurgery. Two frequent indications in the past disappeared: the prevention of coronary restenosis and the macular degeneration. A great agreement was observed regarding the possible indications for radiotherapy but also to avoid it for inflammatory pathologies.

Inter-observer variation of hippocampus delineation in hippocampal avoidance prophylactic cranial irradiation.

BACKGROUND: Hippocampal avoidance prophylactic cranial irradiation (HA-PCI) techniques have been developed to reduce radiation damage to the hippocampus. An inter-observer hippocampus delineation analysis was performed and the influence of the delineation variability on dose to the hippocampus was studied. MATERIALS AND METHODS: For five patients, seven observers delineated both hippocampi on brain MRI. The intra-class correlation (ICC) with absolute agreement and the generalized conformity index (CIgen) were computed. Median surfaces over all observers' delineations were created for each patient and regional outlining differences were analysed. HA-PCI dose plans were made from the median surfaces and we investigated whether dose constraints in the hippocampus could be met for all delineations. RESULTS: The ICC for the left and right hippocampus was 0.56 and 0.69, respectively, while the CIgen ranged from 0.55 to 0.70. The posterior and anterior-medial hippocampal regions had most variation with SDs ranging from approximately 1 to 2.5 mm. The mean dose (Dmean) constraint was met for all delineations, but for the dose received by 1% of the hippocampal volume (D1%) violations were observed. CONCLUSION: The relatively low ICC and CIgen indicate that delineation variability among observers for both left and right hippocampus was large. The posterior and anterior-medial border have the largest delineation inaccuracy. The hippocampus Dmean constraint was not violated.

Analysis of Global Radiotherapy Needs and Costs by Geographic Region and Income Level.

Recent years have seen various reviews on the lack of access to radiotherapy often based on geographic regions of the world such as Africa, Asia Pacific, Europe, Latin America and North America. Countries are often defined by their national income per capita levels based on World Bank definitions of high income, upper middle income, lower middle income and low income. Within the world regions, there are significant variations in gross national income (GNI) per capita among the different countries, and even within similar income levels, large variations exist. This report presents the actual status of radiotherapy and analyses the current needs and costs to provide full access in the different regions of the world. Actual coverage of the needs ranges from 34% in Africa to over 92% in Europe to about double the needs in North America. In line with this, proportional additional investments and operational costs are as high as more than 200% in Africa to almost none in North America. Two world regions face substantial challenges: Africa, based on the important demands to build new capacity and subsequently to maintain operational capability; and Asia Pacific, due to its high population density, translating into large absolute needs in radiotherapy treatments and resources, and hence in associated costs. With the data highlighting a large variability of GNI/capita even within similar income levels in the various world regions, it is expected that additional investment in resources and costs may be more dependent on income level of the country than on the GNI group or the geographic region of the world.

Balancing Equity and Advancement: The Role of Health Technology Assessment in Radiotherapy Resource Allocation.

Radiotherapy is an essential modality for effective cancer control, yet enormous inequalities in access in low- and middle-income countries (LMICs) have created one of the largest global technology gaps in medicine today. The Global Task Force on Radiotherapy for Cancer Control quantified this gap and showed that over half of patients worldwide do not have access to treatment. Governments, policy makers and the global health community have ignored this crisis due to the complexity of radiotherapy technology and its seemingly high upfront costs. However, understanding the cost of treatment in the context of a dramatic clinical benefit could help to demonstrate the feasibility of radiotherapy in diverse income settings. When there are scarce resources, such analysis is essential in order to set priorities and provide high-value interventions to large populations. Here we explore the current status of economic evaluation tools in LMICs and some of the barriers to their use. We describe how the concepts of health technology assessment, value-based care and investment frameworks can be applied to the global crisis of radiotherapy availability to guide appropriate capacity building and resource utilisation. The development of local expertise in these health economic tools can be a powerful level to improve cancer care in LMICs and to build universal global access to radiotherapy.

Radiotherapy access in Belgium: How far are we from evidence-based utilisation?

INTRODUCTION: Underutilisation of radiotherapy has been observed worldwide. To evaluate the current situation in Belgium, optimal utilisation proportions (OUPs) adopted from the European SocieTy for Radiotherapy and Oncology - Health Economics in Radiation Oncology (ESTRO-HERO) project were compared to actual utilisation proportions (AUPs) and with radiotherapy advised during the multidisciplinary cancer team (MDT) meetings. In addition, the impact of independent variables was analysed. MATERIALS AND METHODS: AUPs and advised radiotherapy were calculated overall and by cancer type for 110,810 unique cancer diagnoses in 2009-2010. Radiotherapy utilisation was derived from reimbursement data and distinguished between palliative and curative intent external beam radiotherapy (EBRT) and/or brachytherapy (BT). Sensitivity analyses regarding the influence of the follow-up period, the survival length and patient's age were performed. Advised radiotherapy was calculated based on broad treatment categories as reported at MDT meetings. RESULTS: The overall AUP of 37% (39% including BT) was lower than the OUP of 53%, but in line with advised radiotherapy (35%). Large variations by tumour type were observed: in some tumours (e.g. lung and prostate cancer) AUP was considerably lower than OUP, whereas in others there was reasonable concordance (e.g. breast and rectal cancer). Overall, 84% of treatments started within 9 months following diagnosis. Survival time influenced AUP in a cancer type-dependent way. Elderly patients received less radiotherapy. CONCLUSION: Although the actually delivered radiotherapy in Belgium aligns well to MDT advices, it is lower than the evidence-based optimum. Further analysis of potential barriers is needed for radiotherapy forecasting and planning, and in order to promote adequate access to radiotherapy.

[Valorisation of high technology radiotherapy in Europe]. / Valorisation de la radiothérapie de haute technologie en Europe.

In order to support adoption and dissemination into clinical practice of innovative treatment strategies, being almost by definition more expensive than the corresponding standard treatments, an appropriate reimbursement is a prerequisite. This article describes different possible financing systems in the context of technological advances in radiation oncology and analyses if and how the reimbursement issue has been tackled in European radiotherapy centres.

[Needs and financing of radiotherapy in France and Europe]. / Besoins et financement de la radiothérapie en France et en Europe.

Access to high-quality and safe radiotherapy is a prerequisite to assure optimal oncology care in a multidisciplinary environment. In view of supporting long-term radiotherapy planning, actual and predicted radiotherapy needs should be put in context of the nowadays' available resources. The present article reviews the existing data on radiotherapy resources and needs, along with the prevailing reimbursement systems in the different European countries, with a specific emphasis on France. It describes potential incentives of different financing systems on clinical practice and highlights how knowledge of the cost of radiotherapy treatments, by indication and technique, is essential to support correct reimbursement, hence access to radiotherapy. It is expected that such data will help national professional and scientific radiotherapy societies across Europe in their negotiations with policy makers, with the ultimate aim to make radiotherapy accessible to all cancer patients who need it, now and in the decades to come.

HERO (Health Economics in Radiation Oncology): a pan-European project on radiotherapy resources and needs.

Radiotherapy continues to evolve at a rapid rate in technology and techniques, with both driving up costs in an era in which health care budgets are of increasing concern at every governmental level. Against this background, it is clear that the radiotherapy community needs to quantify the costs of state of the art practice and then to justify those costs through rigorous cost-effectiveness analyses. The European Society for Radiotherapy and Oncology-Health Economics in Radiation Oncology project is directed towards tackling this issue in the European context. The first step has been to provide a validated picture of the European radiotherapy landscape in terms of the availability of equipment, personnel and guidelines. An 84-item questionnaire was distributed to the 40 countries of the European Cancer Observatory, of which 34 provided partial or complete responses. There was a huge variation in the availability and sophistication of treatment equipment and staffing levels across Europe. The median number of MV units per million inhabitants was 5.3, but there was a seven-fold variation across the European countries. Likewise, although average staffing figures per million inhabitants were 12.8 for radiation oncologists, 7.6 for physicists, 3.5 for dosimetrists, 26.6 for radiation therapists and 14.8 for nurses, there was a 20-fold variation, even after grouping personnel with comparable duties in the radiotherapy process. Guidelines for capital and human resources were declared for most countries, but without explicitly providing metrics for developing capital and human resource inventories in many cases. Although courses delivered annually per resource item ­ be it equipment or staff ­ increase with decreasing gross national income (GNI) per capita, differences were observed in equipment and staff availability in countries with a higher GNI/n, indicating that health policy has a significant effect on the provision of services. Although more needs to be done to increase access to radiotherapy in Europe, the situation has improved considerably since the comparable RadioTherapy for Cancer: QUAnification of Infrastructure and Staffing Needs (QUARTS) study reported in 2005.

Improved management of radiotherapy departments through accurate cost data.

BACKGROUND AND PURPOSE: Escalating health care expenses urge governments towards cost containment. More accurate data on the precise costs of health care interventions are needed. We performed an aggregate cost calculation of radiation therapy departments and treatments and discussed the different cost components. MATERIALS AND METHODS: The costs of a radiotherapy department were estimated, based on accreditation norms for radiotherapy departments set forth in the Belgian legislation. RESULTS: The major cost components of radiotherapy are the cost of buildings and facilities, equipment, medical and non-medical staff, materials and overhead. They respectively represent around 3, 30, 50, 4 and 13% of the total costs, irrespective of the department size. The average cost per patient lowers with increasing department size and optimal utilization of resources. Radiotherapy treatment costs vary in a stepwise fashion: minor variations of patient load do not affect the cost picture significantly due to a small impact of variable costs. With larger increases in patient load however, additional equipment and/or staff will become necessary, resulting in additional semi-fixed costs and an important increase in costs. A sensitivity analysis of these two major cost inputs shows that a decrease in total costs of 12-13% can be obtained by assuming a 20% less than full time availability of personnel; that due to evolving seniority levels, the annual increase in wage costs is estimated to be more than 1%; that by changing the clinical life-time of buildings and equipment with unchanged interest rate, a 5% reduction of total costs and cost per patient can be calculated. More sophisticated equipment will not have a very large impact on the cost (+/-4000 BEF/patient), provided that the additional equipment is adapted to the size of the department. That the recommendations we used, based on the Belgian legislation, are not outrageous is shown by replacing them by the USA Blue book recommendations. Depending on the department size, costs in our model would then increase with 14-36%. CONCLUSION: We showed that cost information can be used to analyze the precise financial consequences of changes in routine clinical practice in radiotherapy. Comparing the cost data with the prevailing reimbursement may reveal inconsistencies and stimulate to develop improved financing systems.

A glance on quality assurance in EORTC study 22922 evaluating techniques for internal mammary and medial supraclavicular lymph node chain irradiation in breast cancer.

PURPOSE: To evaluate the irradiation techniques used for the irradiation of the internal mammary and medial supraclavicular lymph node chain (IM-MS) in the EORTC 22922 study, which evaluates its impact on survival in stage I-III breast cancer patients with axillary node invasion and/or central or medial location of the primary tumour. MATERIALS AND METHODS: The analysis was performed based on the dummy run data of the Quality Assurance Programme of the study. A standard irradiation technique was proposed within the study protocol, and the use of other treatment set-up techniques was allowed. RESULTS: By March 2000, 39 centres from 12 different countries had participated in the study; 32 of these had already fulfilled the dummy run procedure. No centres had to be excluded from the study. Seventy-eight percent of the centres are using the standard irradiation technique, 64% of these with minor variations. Twenty-two percent of the centres developed an alternative irradiation technique. The remarks to the centres using the standard set-up were most often related to the junction problem and the possible under- or overdosage in the target volumes. The remarks to the centres with alternative techniques most often concerned the possible enhanced dose to the lungs and the heart. CONCLUSION: In a multi-centre trial an easy irradiation technique applicable in a large number of centres should be provided. A quality assurance programme allows early detection of possible problems with treatment planning and delivery. The analysis of the dummy run data showed that if the recommendations of the Quality Assurance Committee are applied, both standard and alternative IM-MS irradiation techniques produce acceptable dose distributions.

Palliative radiotherapy practice within Western European countries: impact of the radiotherapy financing system?

PURPOSE: To analyze the reimbursement modalities for radiotherapy in the different Western European countries, as well as to investigate if these differences have an impact on the palliative radiotherapy practice for bone metastases. MATERIALS AND METHODS: A questionnaire was sent to 565 radiotherapy centres included in the 1997 ESTRO directory. In this questionnaire the reimbursement strategy applied in the different centres was assessed, with respect to the use of a budget (departmental or hospital budget), case payment and/or fee-for-service reimbursement. The differences were analyzed according to country and to type and size of the radiotherapy centre. RESULTS: A total of 170 centres (86% of the responders) returned the questionnaire. Most frequent is budget reimbursement: some form of budget reimbursement is found in 69% of the centres, whereas 46% of the centres are partly reimbursed through fee-for-service and 35% through case payment. The larger the department, the more frequent the reimbursement through a budget or a case payment system and the less the importance of fee-for-service reimbursement (chi(2): P=0.0012; logit: P=0.0055). Whereas private centres are almost equally reimbursed by fee-for-service financing as by budget or case payment, radiotherapy departments in university hospitals receive the largest part of their financial resources through a budget or by case payment (83%) (chi(2): P=0.002; logit: P=0.0073). A correlation between the country and the radiotherapy reimbursement system was also demonstrated (P=0.002), radiotherapy centres in Spain, the Netherlands and the United Kingdom being almost entirely reimbursed through a budget and/or case payment and centres in Germany and Switzerland mostly through a fee-for-service system. In budget and case payment financing lower total number of fractions and lower total dose (chi(2): P=0.003; logit: P=0.0120) as well as less shielding blocks (chi(2): P=0.003; logit: P=0.0066) are used. A same tendency is found for the use of isodose calculations and field set-up, but without being statistically significant (P=0.264 and P=0.061 res.). The type of the centre and the reimbursement modality influence the fractionation regimen independently (P=0.0274). This is not the case for the centre size and the reimbursement, which were found to exert correlated effects on the fractionation schedule (P=0.1042). CONCLUSION: Reimbursement systems seem to influence radiotherapy practice. One should therefore aim to develop reimbursement criteria that pursue to deliver, not only the best qualitative, but also the most cost-effective treatments to the patients.

Differences in palliative radiotherapy for bone metastases within Western European countries.

PURPOSE: To evaluate the differences in palliative radiotherapy for painful bone metastases amongst different Western European countries. MATERIALS AND METHODS: A questionnaire was sent to 565 radiotherapy centres in 19 Western European countries, based on the 1997 ESTRO directory. In this questionnaire the current local palliative radiotherapy practice for bone metastases was assessed in terms of total dose, fractionation, treatment complexity (use of shielding blocks, frequency of isodose calculations, field set-up) and type of machine used. The differences were analyzed according to the country and to the type and size of radiotherapy centre. RESULTS: A total of 205 centres (36%) returned the questionnaire, of which 198 could be further analyzed. The most frequently used antalgic fractionation schedule is 30 Gy in ten daily fractions of 3 Gy (50%), single fractions and conventional 2 Gy fractions being used in a minority of the centres (respectively, 11 and 9%). Most antalgic treatments are performed on a linear accelerator (67% of the centres uses linear accelerators) and 64% of the centres predominantly uses a two-field set-up. The majority of the centres uses shielding blocks and performs isodose calculations in less than 50% of the patients, (respectively, 88 and 81%). There is a correlation between the centre size and the palliative irradiation practice, the largest centres using more hypofractionation (chi(2): P=0.001; logit: P=0. 0003) and a less complex treatment set up as expressed by the use of isodose calculations (chi(2): P=0.027; logit: P=0.0161). There is also a tendency to use less shielding blocks (P=0.177). The same goes for university centres as compared with private centres: university centres use shorter fractionation schedules (chi(2): P=0. 008; logit: P=0.0094), less isodoses (chi(2): P=0.010; logit: P=0. 0115) and somewhat less shielding blocks (P=0.151). Amongst the analyzed countries different tendencies in fractionation (P=0.001) and treatment complexity are observed (use of isodoses: P=0.014, use of shielding blocks: P=0.001). CONCLUSION: These data suggest that beside work-load and clinical evidence, country-related factors such as tradition and habits, past teaching, the national organization of health care and reimbursement criteria may influence the local practice.

The time course of development of late side effects after irradiation of the prostate with multiple fractions per day.

BACKGROUND AND PURPOSE: A group of patients with prostate cancer was irradiated in the early 1980s with a TID schedule, resulting in a very high frequency of side effects. The time course of development of severe late complications was evaluated. MATERIALS AND METHODS: We retrospectively reviewed the records of 91 patients with prostate cancer, irradiated on a linear accelerator or a cobalt unit between 1980 and 1983. They received a split-course irradiation with multiple fractions per day (MFD) up to a nominal dose of 60 Gy. The rate of development of severe late urological and gastrointestinal complications, grade 3 or more according to the RTOG scoring system, was analysed. RESULTS: The 5-year actuarial incidence of urological complications was 51%. After a lag time of a few months, patients develop "first events' at a nearly constant rate of 10% for 5 years after treatment. Subsequent events ("all events') seem to continue to appear even after 5 years. The actuarial incidence at 5 years of gastrointestinal complications was 14%, with no new events developing later than 3 years after treatment. CONCLUSIONS: The irradiation schedule used resulted in an unacceptable high incidence of late side effects, probably due to incomplete repair between fractions. MFD fractions to the pelvis should be avoided, unless sufficient time in between fractions can be allowed. Moreover, the fact that after this treatment schedule with very pronounced biological effects, new severe complications continued to develop up to 5 years after therapy, indicates that sufficiently long follow-up time has to be respected when investigating new radiation techniques for pelvic tumours.

Does sucralfate reduce the acute side-effects in head and neck cancer treated with radiotherapy? A double-blind randomized trial.

BACKGROUND AND PURPOSE: We evaluated sucralfate, well-known in the treatment of gastric ulcers, in relation to its possible reduction of radiation-induced acute complications in the treatment of head and neck cancers. MATERIALS AND METHODS: One hundred two patients were randomized in a double-blind placebo-controlled prospective setting. All patients were treated to a minimum dose of 55 Gy in 5 weeks. Oral intake of sucralfate was started at the beginning of radiotherapy and continued during the whole treatment at a dose of 1 g six times a day. All patients were scored according to a scoring system developed in our department. Weight was checked once a week. RESULTS: Comparing the time course of the mean scores for subjective intolerance, mucositis, dysphagia, dermatitis and nausea, no statistically significant differences between the two treatment arms (sucralfate, n = 38; placebo, n = 45) were observed. The mean weight loss in the sucralfate arm was 1.6 +/- 3.4 kg while it was 1.3 +/- 2.0 kg in the placebo arm. Apart from gastrointestinal upset, the administration of sucralfate did not cause any side-effects. CONCLUSION: This trial produced no clinical evidence indicating that the oral intake of sucralfate reduces the acute radiation-induced side-effects. Therefore, we do not recommend the prophylactic use of sucralfate in patients with head and neck cancer treated by radiotherapy.