Clinical audit in European radiology: current status and recommendations for improvement endorsed by the European Society of Radiology (ESR).

Clinical audit is an important quality improvement activity and has significant benefits for patients in terms of enhanced care, safety, experience and outcomes. Clinical audit in support of radiation protection is mandated within the European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom. The European Society of Radiology (ESR) has recognised clinical audit as an area of particular importance in the delivery of safe and effective health care. The ESR, alongside other European organisations and professional bodies, has developed a range of clinical audit-related initiatives to support European radiology departments in developing a clinical audit infrastructure and fulfilling their legal obligations. However, work by the European Commission, the ESR and other agencies has demonstrated a persisting variability in clinical audit uptake and implementation across Europe and a lack of awareness of the BSSD clinical audit requirements. In recognition of these findings, the European Commission supported the QuADRANT project, led by the ESR and in partnership with ESTRO (European Association of Radiotherapy and Oncology) and EANM (European Association of Nuclear Medicine). QuADRANT was a 30-month project which completed in Summer 2022, aiming to provide an overview of the status of European clinical audit and identifying barriers and challenges to clinical audit uptake and implementation. This paper summarises the current position of European radiological clinical audit and considers the barriers and challenges that exist. Reference is made to the QuADRANT project, and a range of potential solutions are suggested to enhance radiological clinical audit across Europe.

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.

Improving justification of medical exposures using ionising radiation: considerations and approaches from the European Society of Radiology.

This discussion paper has been produced within the context of the European Society of Radiology EuroSafe Imaging initiative and considers primarily the issues and challenges associated with justification of medical exposures using ionising radiation for individual patient diagnostic imaging procedures. It addresses both regulatory requirements and practical considerations and discusses approaches that are intended to improve justification.

ESR EuroSafe Imaging and its role in promoting radiation protection - 6 years of success.

This article introduces the European Society of Radiology's EuroSafe Imaging initiative in the year of its 6th anniversary. The European and global radiation protection frameworks are outlined and the role of the EuroSafe Imaging initiative's Call for Action in successfully achieving international radiation protection goals as set out by those frameworks is detailed.

Justification of CT for Individual Health Assessment of Asymptomatic Persons: A World Health Organization Consultation.

An international expert consultation was convened by the World Health Organization (WHO). The purpose of the meeting was to review the use of CT in examining asymptomatic people. This is often referred to as individual health assessment (IHA). IHA was identified as a global phenomenon unenthusiastically tolerated, and not actively promoted, structured, or regulated in most countries. This paper identifies the state of the art for IHA and some considerations in relation to its justification, in different regions of the world. The outcomes reached include the following: questions around terminology and culture of IHA practice; review of IHA in some countries, regions, and international bodies; dilemmas for participants in IHA; risk communication, education, and training for professions and public; the desirability of guidelines and clinical audit; social, ethical, public health, and resource considerations; and a framework for IHA and regulatory considerations. Three subcategories of examination for asymptomatic individuals were identified: formal screening programs; examinations for which the evidence base or risk profile is incomplete; and opportunistic examinations with little or no evidence or risk profile to suggest they have any merit. The latter challenges the justification principle of radiation protection. In addition, the issue of the costs, direct and indirect, associated with false positives and/or equivocal/incidental findings were highlighted. These and other considerations make it difficult to view some IHA as a bona fide medical activity. To allow it to be viewed as such requires that it be conducted within a robust clinical governance framework that includes regulatory dimensions.

Clinical imaging guidelines part 4: challenges in identifying, engaging and collaborating with stakeholders.

The effective development and use of clinical imaging guidelines requires an understanding of who the stakeholders are, what their interests in the process are, and what roles they should play. If the appropriate stakeholders are not engaged in the right roles, it is unlikely that clinical imaging guidelines will be successfully developed, relied on, and actually used. Some stakeholders are obvious: for the development of clinical imaging guidelines, both imagers and those who request examinations, such as general practitioners, internists, and medical specialists, must be involved. To gain acceptance, other relevant groups are stakeholders, including medical societies, other health care professionals, insurers, health IT experts and vendors, and patients. The role of stakeholders must be dictated by their specific interest. For some, involvement in the creation of guidelines is the right role. For others, such as regulators or insurers, reviews or invitations to comment are required, and for others, such as medical educators, it is probably sufficient to provide information and create awareness. Only through a careful consideration of who the stakeholders are and what are their interests are the successful development, acceptance, and use of clinical imaging guidelines likely to occur. Future efforts must focus on collaboration, particularly among groups that create clinical imaging guidelines and those that can support their use, and on regulatory roles and mandates.

Monitoring of clinical imaging guidelines part 3: norms, standards, and regulations.

It is known that the use of imaging in clinical situations is not always optimal, leading to suboptimal health care and potential radiation risk. There may be overuse of imaging, underuse, or use of the wrong modality. The use of clinical imaging guidelines is likely to improve the use of imaging, but roadblocks exist. Some of these relate to regulatory oversight and mandates. There is wide variation by country and region in the regulatory setting, ranging from actual absence of regulatory authorities to mandated availability of clinical imaging guidelines in the European Community. Collaborative efforts to ensure that clinical imaging guidelines are at least available is a good starting point. Regulatory oversight and support are necessary to ensure the use of clinical imaging guidelines. Regulations should address 3 areas: availability, clinical utilization, and adherence to and revision of guidelines. The use of both internal and external audits, with the aim of both use of and adherence to guidelines and quality improvement, is the best tool for enhancing use. The major challenges that need to be addressed, collaboratively, to ensure the dissemination and use of clinical imaging guidelines are the development of regulations, of regulatory structures that can be effectively deployed, and of benchmarks for adherence and for utility.