Preface

This booklet has been prepared to help referring clinicians make the best use of a Department of Clinical Radiology.  The Guidelines have been designed to assimilate, evaluate, and implement the ever-increasing amount of evidence and opinion on current best practice.  The EU Council Directive 1997/43/ Euratom declared that member states will promote the establishment and use of diagnostic reference levels for radiological examinations and relevant guidance.  This booklet can be used for this purpose.

The role of the radiologist in justifying the examination remains paramount and is dependent on each clinical case.  These Guidelines must not be used by health care purchasers as a means of restricting the freedom of radiologists to investigate individual cases in the most appropriate way.

Continued use of recommendations of this kind can lead to a reduction in the number of referrals for investigation and also to a reduction in medical radiation exposure [1-4]. However, the primary objective of this booklet is to improve clinical practice. Such Guidelines work best if they are used as part of clinico-radiological dialogue and the audit process. They are intended for use by all referring practitioners. The development methodology minimises context-specificity: they should be of relevance and value throughout the European Union (EU) and, indeed, internationally.

The editorial process was undertaken by Professor Gillian Needham (Aberdeen), Professor lain McCall (Stoke-on-Trent), and Dr Mike Dean (Shrewsbury), under the auspices of the European Guideline Development Steering Group (see below), and the processes of literature searching, critical appraisal, synthesis, and grading were carried out by European and UK Special Interest Groups (SIGS) and Specialist Societies (see Appendix).  Mr. Chris Squire (RCR Clinical Audit Officer) developed the evidence-gathering template.  Mr. Barry Wall from the National Radiological Protection Board (NRPB) advised on dosimetric data and scoring.

The system-based format, first introduced in 1995, has been largely retained.  Classification of evidence levels has been translated into grades of recommendation based on the system developed by the US Department of Health and Human Services, Agency for Health Care Policy and Research [5-6].  The levels are:

[A] 

• High-quality diagnostic studies in which a new test is independently and blindly compared with a reference standard in an appropriate spectrum of patients

• Systematic review and meta-analyses of such high quality studies

• Diagnostic clinical practice guidelines/clinical decision rules validated in a test set

[B] Any of the following:

• Studies with a blind and independent comparison of the new test and reference standard in a set of nonconsecutive patients or confined to a narrow spectrum of subjects

• Studies in which the reference standard was not performed on all subjects

• Systematic reviews of such studies

• Diagnostic clinical practice guidelines/clinical decision rules not validated in a test set

[C] Any of the following: 

• Studies in which the reference standard was not objective

• Studies in which the comparison between the new test and the reference standard was not blind or independent

• Studies in which positive and negative test results were verified using different reference standards

• Studies performed in an inappropriate set of patients

• Expert opinion

The evidence gathering, synthesis, and grading processes that are so crucial to best guideline development have been undertaken by over 200 radiologists across the EU.  This truly collaborative effort, cascaded out by European and UK SIGs and societies, has been supported by Guideline development teams in London (based at the RCR) and Aberdeen (based in the Health Services Research Unit, University of Aberdeen).  Training in guideline development was delivered early on in the project.

We are grateful to the RCR and the European Commission (Directorate-General for the Environment) for jointly funding this work and hope that this booklet will prove useful.

While wide consultation across the whole of Europe and the UK (see Appendix) was undertaken in the development of this booklet, and best-evidence methodology applied, undoubtedly there will be some decisions that will not accord with local practice.  Evidence has at times been conflicting and this has required compromise and interpretation.  We would welcome referenced comments, to allow continued development of these Guidelines.

A 'gold standard' search strategy for diagnostic imaging tests has been developed as part of this project, as has work to investigate the feasibility of establishing a comprehensive register of studies.  At the time of publication, however, we continue to rely on the Guideline Development Steering Group for strategic direction and SIGs for detailed content.

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