Imaging referral guidelines
Imaging referral guidelines have been in place for many years in Europe. The intention of the guidelines is to help the referrer, rather than the radiologist, and to provide an indication of practice. In the USA, appropriateness criteria have been developed, which might be considered as standards against which a proposed radiological investigation can be assessed. Both approaches are valid and tend to use the same evidence base in their generation but reflect different approaches to responsibility for justification. It is worth noting that in the European BSSD, requirements for referral guidelines are intended for referrers and included in the article addressing procedures and not that for justification.
In the UK, and subsequently in France, referral guidelines were originally intended to help the referrer make the best use of the imaging department [16, 17]. This imperative remains but the emphasis has subtly changed in the UK and in other countries where referral guidelines have been produced. Notwithstanding, the value of imaging referral guidelines as part of the justification process has been shown in a number of studies [18, 19] and the importance of availability and use has been investigated by the European Commission and the ESR [20, 21]. In an ESR internal survey (2011), it was shown that although guidelines were existing and accessible, they were not widely used in the following states: Belgium, France, Germany, Hungary, Ireland, Italy, The Netherlands, Spain and Switzerland.
For imaging referral guidelines to be effective, they need to be up to date, consistent with local clinical and radiological practice, available and easily accessible at the point of care and used. Consistent use of guidelines requires their integration into normal workflow without which they will become an afterthought. Numerous publications have demonstrated this and initiatives making available stand-alone guidelines have to be repeated and reinforced if use is to be maintained. Other studies suggest poor utilisation or inconsistency between guidelines and practice could be explained because the published guidelines did not meet these requirements. A study in Sweden in 2009  showed large discrepancies between CT referrals and performed examinations and available guidelines (the EC produced RP No 118) , but this might have been expected as these guidelines reflected practice from the mid-1990s and pre-dated the availability and capability of multi-detector CT.
The perceived relevance of guidelines is also influenced by their intrinsic limitations. Guidelines are population based and may not be considered appropriate for individual patient’s presentations. Reliance on consensus rather than robust published evidence and lack of transparency reinforces different views and approaches. Failure by the radiology community to include the views of other specialties when generating guidelines has often resulted in inconsistencies between physician developed protocols and radiologist produced imaging guidelines. Early pre-authorisation systems developed in the USA resulted in decreased numbers of procedures undertaken, rather than more appropriate imaging taking place, and this was viewed as a major drawback. Nevertheless, experience in Israel of use of the American College of Radiologists’ appropriateness criteria and RCR referral guidelines have shown an efficiency impact on the justification process .
Finally, acceptance of imaging guidelines will be affected by the importance given to them by health policy makers and regional or national Ministries of Health. The necessity for referral guidelines, as required by the Euratom BSSD and resulting national regulations, may not be fully appreciated by those responsible for health provision and provision and use of imaging guidelines may not be considered a priority.
Computerised decision support (CDS) systems
To address some of these issues, in recent years more comprehensive CDS systems have been developed, integrating imaging referral guidelines into electronic requesting systems. The greatest experience of the benefit of these comes from the USA where the use of CDS was initially expected to become mandatory by 2020, and where a number of studies have shown an increase in the appropriate use of imaging within the context of an overall reduction of the number of examinations performed. In Europe, the ESR’s iGuide shows considerable promise and it is generally accepted that this approach will be productive. Although evidence demonstrating this is limited currently, the experience in Croatia is encouraging .
These early successes all highlight the need for a supportive environment, and this support is essential from health policy makers at national and local level, both for initial introduction and on-going change management. Education of referring physicians and integration into healthcare pathways and workflow are also required. Shared experience of early adopters will be essential to promote more general uptake of integrated CDS across all radiology services and if this experience relates to European models of healthcare delivery then it is likely to be quicker. The introduction may follow the same pathway as the introduction and adoption of picture archiving and communication systems (PACS) in the 1990s, and of course PACS is now ubiquitous and its value is accepted. A key factor for CDS, as with PACS, will be availability and ease of use at the point of care by referring physicians.
Education and training
Education and training of healthcare professionals provides the knowledge and competence required to undertake their activities and this will vary for those involved in the justification process for radiological imaging. All staff involved in radiology and nuclear medicine imaging should have sufficient training to understand their roles and responsibilities, if any, as outlined in the national regulation derived from the BSSD.
Those specialising in radiology and nuclear medicine will be expected to keep up to date with developments in radiation protection as well as advances in clinical and therapeutical knowledge and the application of new techniques in their field. In addition, consideration of the benefits of non-ionising radiation imaging modalities must be regularly updated and shared with other non-imaging physicians. Medically qualified imaging specialists will be adequately trained to be referrers and practitioners in their own specialty.
Specialists in other fields (e.g., orthopaedists, interventional cardiologists etc.) may have sufficient medical and radiation protection training to undertake justification for a limited scope of practice.
Patient assessment is an essential part of all doctors’ activities so they should not require additional training to be referrers. Most family doctors and many hospital doctors, however, are unlikely to have up to date knowledge of imaging or radiation protection and they should not take on the role and responsibilities of the practitioner, without undergoing considerable further training, including detailed radiation protection training. Nevertheless, some knowledge is helpful for all clinical staff who act as referrers for imaging, to support their interaction with patients. For example, a family doctor should be able to provide limited information about the preparation for different imaging procedures and the relative risks of each and be able to put this into perspective when considering and discussing the patient’s potential condition. Guidance is available to support this.
Evidence of the value of CDS and its impact on justification can be produced by clinical audit which is itself a requirement of the BSSD. Guidance on clinical audit has been produced by the European Commission  and will be subject to further study by the Commission. The ESR has developed a practical audit tool - Esperanto  - and there is a long history of clinical audit in radiology in both UK and Finland [28,29,30]. Up to now, audits of appropriate justification have required manual processes which are time consuming. Comprehensive CDS systems offer the option of real-time review of individual cases, patterns of referrals and subsequent justification of examinations, and may influence requesting practice by offering feedback to referrers. This should make review of practice much easier and quicker, including the resetting of standards and inform subsequent data collection exercises for imaging referral guideline generation.
Clearly, the generation, availability, use and audit of the role of imaging referral guidelines in justification are inextricably linked. CDS could change significantly the willingness to undertake audit, the frequency that this is done and consequently raise the profile importance of awareness and appropriateness with referrers. Recently, the European commission launched a tender on audit of CT justification , showing the actuality of this topic.
Inspection of clinical practice by a regulatory body is unusual in medicine but the BSSD requires this for medical exposures. In practice the focus is on processes rather than individual actions and this applies to the justification process.
Inspectors will assess compliance with local procedures and regulatory requirements for justification. Specific elements of the process will include assessing whether an institution’s policies and procedures are for purpose, identification of the referrer and practitioner, the competence of individuals to act in these capacities (i.e., education and training records), verification that clinical data was provided to support the justification of a specific imaging procedure and that the procedure was justified prior to the exposure taking place.
In some cases, the education and training of the inspector may be sufficient to discuss or challenge justification of procedures for individual patients. This remains unusual in Europe.
In 2015, as part of its activities to demonstrate compliance with regulations, HERCA’s Working Group on Medical Applications (HERCA WGMA) instigated an inspector workshop on justification in radiology and in 2016/2017 organised a coordinated European Action Week on the inspection of justification involving 148 inspections in 17 countries . The results showed significant variation across Europe and a need for increased awareness of the importance of justification.
While inspection is a useful tool, aimed at demonstrating compliance with regulatory requirements rather than enforcement, it has limited impact on day-to-day practice unless the importance of justification is recognised by professionals and professional bodies. HERCA WGMA is continuing to work with professional bodies and will launch other initiatives in the future.