Recommendations by MEDIRAD, a European project on the implication of medical low dose radiation exposure

How to enhance the protection of patients and medical professionals exposed to low doses of radiation?

What did MEDIRAD do

MEDIRAD is a European-funded project with the overall aim of enhancing the scientific basis and clinical practice of radiation protection in medicine, in particular by better understanding and evaluating the health effects of exposure to low-dose ionising radiation resulting from diagnostic and therapeutic procedures. The multidisciplinary consortium consists of 34 partners from 14 European countries, and its work focused on the three following areas:

First, improving organ dose estimation and registration to inform clinical practice, optimise doses, set recommendations and provide adequate dosimetry for clinical epidemiological studies. Second, evaluating and understanding the effects of medical exposures to radiation, focusing on two major endpoints of public health relevance: cardiovascular effects of low to moderate exposure in breast cancer patients treated with radiotherapy; and long-term cancer risk of low dose exposure from CT in children. Third, developing science-based consensus policy recommendations for the effective protection of patients and staff. 

Some of the main outputs of the MEDIRAD consortium include the development of a series of freely-available tools for the scientific and medical communities (such as online tools to determine CT dose and image quality, voxel phantoms, diagnostic reference levels for CT applications in nuclear medicine, dosimetry software packages for molecular radiotherapy), as well as prediction models and imaging biomarkers for identifying radiotherapy-treated breast cancer patients at risk of coronary events. MEDIRAD also expanded the follow-up of children undergoing CT scans, and managed to set up the first European network for iodine imaging as well as an imaging and dose biobank across partner countries. 

Going beyond the science

One of the main objectives of the MEDIRAD project was to use the research results obtained throughout the project to develop a series of recommendations that would contribute to improving radioprotection of medical workers and patients across Europe. The added value of these recommendations is that they were drafted after engaging in a substantial dialogue with international and European stakeholders, who were invited to express their needs and expectations, and to comment on the draft recommendations. 

The entire consultation process spanned almost five years during which two surveys and two webinars were conducted. It involved a stakeholder board (with ten representatives from European medical associations, radiation protection research platforms, and patient care advocates) and a wider stakeholder forum (from 86 organisations, including health professionals, patients, nuclear scientists, policy makers, competent authorities and representatives from international organisations). The stakeholder survey revealed 10 top priorities, which, together with 15 priorities identified through MEDIRAD research, were grouped into four major topics: i) consolidation of patient data repositories across Europe; ii) optimisation of radiation-based protocols for diagnostics or therapy; iii) further optimisation of radiation protection for patients and medical workers; iv) future radioprotection research in Europe. For each topic, a series of overall recommendations are given (Table 1), together with an explanation of why they are relevant, specific recommendations on how to implement them, and the audiences concerned. 

Key Messages

	These recommendations were drafted under the overarching principle of optimising the benefit/risk ratio for medical procedures based on ionising radiation.
	One of the main pillars -and challenges- of radiation protection optimisation and research is having open access to an interconnected and organised collection of image and dose data at the European level. This requires: Harmonising data collection protocols, including information on organ dose exposure and image quality parameters. Addressing heterogeneity in GDPR implementation across countries for efficient data sharing. Linking them to biobanks to maximise the utility of the information.
	Semi-automated tools that facilitate appropriate dose and image data collection without adding to clinicians’ workload need to be developed.
	Modelling of delivered doses to individual patients needs to be generalised in the clinical practice within Europe.
	Artificial intelligence and machine learning will play a major role in advancing towards personalised medicine, and is one of the key research avenues identified.
	Long-term EU-wide epidemiological studies are needed, and participation of small clinical centres in such studies should be supported.
	Interdisciplinarity (bridging medical specialities, research and patients) is of uttermost importance to harmonise practices and ensure the quality of care and follow-up of patients.
	Regular training programmes, responding to European standards and tailored to specific needs, should be provided for medical workers and medical physicists

Our recommendations

MEDIRAD was designed to have direct implications for the radiological safety of European patients undergoing medical imaging and therapy procedures involving ionising radiation, and of exposed medical professionals. For this purpose, one of the goals of MEDIRAD was to establish evidence-based consensus policy recommendations for enhancing the effective protection of patients and medical professionals, as well as for identifying further research priorities. 

The scientific basis for the following recommendation stems from the research developed in the course of the MEDIRAD project. In order to achieve a sufficient degree of consensus, MEDIRAD engaged in a substantial dialogue with relevant stakeholders in Europe and internationally. The MEDIRAD Stakeholder Forum, which underpinned this dialogue, included representatives from 86 organisations who were invited to express their views on issues to be considered as priority, and to comment on the draft formulation of MEDIRAD recommendations. 

MEDIRAD Recommendations are made publicly available under the sole authority of the MEDIRAD Consortium.

Competent international organisations, public authorities at European and national level, and organisations such as European research platforms and professional or patient associations, are invited to consider these recommendations and engage or support actions towards their implementation as they see fit, taking the opportunity of initiatives such as the SAMIRA (Strategic Agenda for Medical Ionising radiation Applications) European Action plan.

	Consolidation of patient data repositories across Europe Develop an interconnected and sustainable system of image and dose repositories at the European level Harmonise GDPR implementation in medical radiation protection research Enhance awareness regarding radiation protection research among public and patients
	Optimisation of radiation-based protocols for medical diagnostics or therapy Develop robust tools for optimisation of CT scanning and multimodality imaging Develop dosimetry-based protocols for molecular radiotherapy across Europe Deploy a EU-wide strategy to better predict and reduce secondary cardiovascular risks in breast cancer patients treated with radiotherapy Actively promote good practices aimed at reducing cardiovascular risks after breast radiotherapy Accelerate the generalised use in clinical practice of modelled total delivered doses to individual patients within Europe
	Further optimisation of radiation protection for patients and medical workers Optimise systems for quantitative imaging irrespective of camera make or model Encourage harmonisation of practices through active engagement of health professionals, researchers, health authorities and patients Optimise the use of protective equipment to improve radiation protection of medical workers in interventional settings
	Future research on medical radiation protection in Europe Conduct further research into adverse effects of ionising radiation on healthy tissues Promote a EU-wide research strategy to use AI for optimising protection in radiation oncology Develop biologically-based models to evaluate radiation-induced disease risk Conduct large-scale clinical epidemiological follow-up of patients to assess late health effects of radiation Investigate new and optimise existing medical imaging procedures to improve benefit/risk ratios and personalised approaches