Rapporteurs' report: workshop on ethical issues in diagnostic radiology.

This paper presents the summary reports of the session rapporteurs at the Workshop on Ethical Issues in Diagnostic Radiology. The summaries reflect the extent to which the topics discussed are well reflected in the papers presented in this proceedings.

A preliminary study of issues and practices concerning pregnancy and ionising radiation.

A literature review in relation to irradiation of patients and staff during pregnancy was carried out. A number of publications describing procedures to be followed in the case of a pregnant patient who needs to have a radiological examination and in the case of pregnant staff who work in a department where they could be exposed to radiation were reviewed. A review of existing practices in 13 European countries was carried out by sending a questionnaire to representatives in each country. From the review, it was found that the existing practices with respect to irradiation of patients and staff during pregnancy vary enormously. There is no harmonisation on this issue at the European level. From the literature review and the review of practices, a number of ethical issues were identified and exposed and a number of conclusions were drawn.

Changing from image intensifier to flat detector technology for interventional cardiology procedures: a practical point of view.

A small-scale internal audit has been used to evaluate the impact of the use of a dynamic flat panel detector in the clinical routine in the National Interventional Cardiology Centre in Luxembourg. The parameters tested during commissioning and constancy control of an X-ray system, the introduction of new clinical protocols, the patient and the personal staff dosimetry were considered. The technical parameters tested by the hospital physicist stay the same as for the image intensifier. No innovative protocols have been adopted due to the existence of the flat panel detector. A reduction in dose was noted after the installation of a flat detector, due mostly to the continuing education of the interventional cardiologists as well as the initial calibration of the radiological system. The understanding of the X-ray system and its possibilities is vital for the optimisation of clinical procedures in patient and staff exposure.

Review of existing issues and practices with respect to irradiation of patients and staff during pregnancy.

A number of ethical issues concerning the irradiation of patients and staff during pregnancy are presented and discussed. A review of existing practices in 13 European countries was carried out, by sending a questionnaire to each country. From the review, it was found that the existing practices with respect to irradiation of patients and staff during pregnancy in various European countries vary enormously. There is no harmonisation on this issue at a European level. From the review of practices, a number of conclusions were drawn.

Review of existing issues, ethics and practices in general medical research and in radiation protection research.

A literature review was carried out in relation to general medical research and radiation protection research. A large number of documents were found concerning the subject of ethics in general medical research. For radiation protection research, the number of documents and the information available is very limited. A review of practices in 13 European countries concerning general medical research and radiation protection research was carried out by sending a questionnaire to each country. It was found that all countries reviewed were well regulated for general medical research. For research that involves ionising radiation, the UK and Ireland are by far the most regulated countries. For other countries, there does not seem to be much information available. From the literature review and the review of practices, a number of existing ethical issues were identified and exposed, and a number of conclusions were drawn.

Review of image quality standards to control digital X-ray systems.

A literature review was carried out on quality criteria for the evaluation of image quality for interventional radiology, digital subtraction angiography, computed radiography and direct digital radiography systems. Existing national and international standards were also reviewed. Recommendations for image quality standards for digital X-ray systems are proposed.

Does digital imaging decrease patient dose? A pilot study and review of the literature.

The potential for decreasing patient dose is one of the main arguments for the justification of the cost of digital imaging equipment. However, the literature review with respect to patient doses using digital imaging modalities, presents conflicting results. During this study, patients' entrance surface doses were measured for three simple radiographic examinations, in European centres equipped with a computed radiography digital system. Results showed that doses between centres varied from 30% for chest LAT to 250% for chest PA examination. With the digital image quality criteria still under discussion, and with the post-processing parameters and/or image documentations varying, any dose comparisons between conventional/digital systems, as well as dose comparisons between different centre using digital units, are difficult. Clinical trials are required in order to define reference levels associated with quality of digital image necessary to address specific clinical requirements.

Dose optimisation in computed radiography.

After the installation of computed radiography (CR) systems in three hospitals in Luxembourg a patient dose survey was carried out for three radiographic examinations, thorax, pelvis and lumbar spine. It was found that the patient doses had changed in comparison with the patient doses measured for conventional radiography in the same three hospitals. A close collaboration between the manufacturers of the X-ray installations, the CR imaging systems and the medical physicists led to the discovery that the speed class with which each radiographic examination was to be performed, had been ignored, during installation of the digital imaging systems. A number of procedures were carried out in order to calibrate and program the X-ray installations in conjunction with the CR systems. Following this optimisation procedure, a new patient dose survey was carried out for the three radiographic examinations. It was found that patient doses for the three hospitals were reduced.

Practical implementation of the medical exposure directive (97/43) in Luxembourg.

The medical exposure Directive of 1984 was updated in 1997 (EURATOM 97/43) and should be implemented into national legislation before May 2000. Need for harmonisation exists in Europe, as differences in the application of ionising radiation exist throughout European countries and social mobility of the population is increasing. The context of the justification/optimisation process as well as specific characteristics of national health legislation and Social Security legislation and their impact on radiation protection of the patient, are presented. Existing differences in the justification process throughout Europe are: (i) prescribing process of the X ray examination, training of the prescriber, (ii) auto-referral; (iii) economic situation in the member states. The optimisation process is mainly sensitive to: (i) 'culture' of radiation protection in each national medical community; (ii) training; (iii) technical and clinical audits; (iv) quality assurance.

The quality assurance and constancy checking of fluoroscopy and fluorography systems.

X ray procedures which involve fluoroscopy often give significant radiation doses to patients. A valuable radiation protection procedure is the adoption of a quality assurance programme which will ensure the continual production of optimal quality images with the minimum necessary dose to the patient. Various publications exist which provide information on quality assurance (QA) and constancy checking of fluoroscopy and fluorography systems. These publications were reviewed and tests recommended for QA and constancy checking of fluoroscopy and fluorography systems are presented. It was found that not much information exists on QA and constancy checking for digital subtraction angiography and digital fluorography systems. More research is required in this field. Information on protocols used by various countries of the European Community for QA and constancy checking of fluoroscopy and fluorography systems was gathered. From this information it is apparent that there is a need for harmonisation within Europe.