Companies advertising Computerised Tomography (CT) scans as an “MOT” for people who have no relevant symptoms but who are anxious to keep one step ahead of possible illnesses, will see the service they provide become clarified in law.
The Department of Health announced the move, as it accepted all nine of the recommendations that the Committee on Medical Aspects of Radiation in the Environment (COMARE) made to it following a study of the services and a wide consultation on them.
COMARE looked at the claims these companies make and the safety of their procedures. The Committee recommended that some scans should cease altogether, others should be provided only under clinical protocols agreed by the professions and that providers should relate properly to NHS programmes.
Following this, the Department will be formally seeking the Royal College of Radiologists and the Royal College of Physicians to prepare guidance for practitioners based on the balance of risk and benefit involved in the CT scanning procedures concerned.
The advice of COMARE rests upon a fundamental principle that the benefit to the patient must always outweigh the risks to radiation exposure involved.
“MOT” style CT scans are offered directly to the public and can be up to 400 times more powerful than a chest x-ray. They are not usually mediated by the patient’s GP and the concern is this balance of risk is currently overlooked.
The move will mean self-referred CT scans will be defined as an “Individual Health Assessment”. It will not ban or prohibit any scan but will mean they are clearly brought within the regulatory regime and distinguished from diagnostic scans.
Welcoming the publication Public Health minister Gillian Merron said
“I am grateful to COMARE for their work in this important area.
“Any scan a patient undergoes should balance the clinical benefits against the risks of the radiation involved. I welcome the decision to define more closely the considerations that should govern CT scanning in cases of individual health assessments.”
“I look forward to working with the Royal Colleges of Radiologists and Physicians to develop practitioner guidance.”
Notes to editors
§ The Committee on Medical Aspects of Radiation and the Environment (COMARE) is an independent expert advisory committee with members chosen for their medical and scientific expertise and recruited from Universities, Research and Medical Institutes.
§ Their recommendations were made in 2007 and this was followed by a departmental consultation which closed in September 2008
§ The legislation which will be amended are the Ionising Radiation (Medical Exposure) regulations 2000 (IRMER)
§ CT stands for Computed Tomography. CT scanning images are used to identify and diagnose disease or health problems. CT Scanners use x-rays to take detailed images of cross sections of the body called ‘slices’. The scanners can have different numbers of detectors. Generally the greater the number of detectors, the increased amount of data that is acquired leading to more detailed images of the body. The images are stored in a computer and are interpreted by a radiologist.
§ COMARE’S recommendations are below
Medical exposures using ionising radiation and the equipment used to undertake these exposures are controlled by a number of regulations, including the Ionising Radiation (Medical Exposure) Regulations 2000 and Ionising Radiations Regulations 1993. These regulations apply to exposures undertaken both in the NHS and in the commercial sector. Commercial CT services themselves, however, are not subject to additional regulation as they do not involve interventions or treatment. COMARE recommend that the Department of Health should review this situation and consider regulating these services against agreed standards. Any regulation should address and provide guidelines on appropriate referral processes, justification and optimisation of CT scans.
It should also require that providers of CT services should submit agreed datasets to the regulator regarding the rate of reported findings.
The information supplied to asymptomatic clients attending commercial CT services is inconsistent and incomplete. COMARE recommend that all such services should provide comprehensive information regarding eligibility criteria and the dose and risk of the initial CT scan. The rates of false negative and false positive findings associated with CT scanning of asymptomatic individuals should be independently audited and explained. In particular, the range of further investigations that may be required to confirm initial findings and the risks associated with subsequent scans if recommended, should be discussed. The provision of these investigations will need to be clarified. An outline of this information should be made available to individuals before they present for scanning, as part of websites, advertising literature, etc
Any medical intervention will be most effective when part of a locally agreed and coordinated clinical care pathway that is under the supervision of a multidisciplinary team. COMARE recommend that commercial CT services should have well-developed, robust and confidential mechanisms for integrating the results of their examinations into an established care pathway, including the availability of scans and data relating to any individual scanned in formats consistent with NHS information technology programmes. This intended transfer of medical data must be discussed with and agreed by patients prior to medical exposures taking place.
Any individual with symptoms relevant to conditions likely to be identifiable by CT scanning, should be entered into an appropriate care pathway as soon as possible. The customary process is for this to be initiated by a referral from a general practitioner (GP). Therefore commercial CT services, which may not be able to provide a full range of diagnostic capabilities, should in most circumstances refer personally initiating symptomatic individuals back to their GP without delay. This will, of course, not apply where a patient has been referred for a CT scan by their GP or a relevant NHS hospital-based medical specialist who is responsible for the individual’s care.
There is a regulatory requirement that all medical exposures using ionising radiation should be referred, justified and optimised. Referral and justification must be carried out by registered healthcare professionals. Justification of any medical exposure should be based on the scientific evidence available. There is little evidence that demonstrates, for whole body CT scanning, the benefit outweighs the detriment. COMARE recommend therefore that services offering whole body CT scanning of asymptomatic individuals should stop doing so immediately. Where scans are offered for a number of discrete anatomical regions within a single scanning procedure, the advertising should clearly state which regions are examined and for which conditions the scan is optimised. In CT scanning it is not possible to optimise exposure parameters for scans of the whole of the body.
Investigation of a number of clinical conditions can be better undertaken using modalities other than CT. COMARE recommend that where there is evidence that CT is not the modality of choice for diagnostic purposes, then it should not be made available for the assessment of asymptomatic individuals. In particular, CT scanning primarily for spinal conditions, osteoporosis and body fat assessment should cease, since there are more appropriate methods available and which have lower radiological risk consequences. If analysis of data available from a scan intended for other purposes provides clinically useful and reliable information on, for example, osteoporosis, it would be permissible to include these data in the results.
Current evidence suggests that there is no benefit to be derived from CT scanning of the lung in asymptomatic individuals. Further research is required in this area but, until this is available, CT scanning of the asymptomatic individual cannot be justified for the lung and should not be made available.
CT scanning to determine coronary artery calcification is valuable for predicting cardiovascular risk in asymptomatic individuals. Further studies with multi-detector CT are expected to have similar results. COMARE recommend that CT scanning should only be undertaken on individuals with intermediate risk identified by a comprehensive cardiovascular Framingham risk score assessment, unless the referral is by a cardiac specialist. Research will be required to determine the feasibility and efficacy of a combined coronary artery calcification score/conventional risk score approach in reducing coronary heart disease events in this population. It is recommended that scans should not be performed routinely more frequently than once every three years
CT colonography has the potential to detect small lesions in asymptomatic individuals, although the finding of a suspicious lesion on CT colonography would require a conventional colonoscopy for histological diagnosis or treatment. Despite this, CT colonography may find a place in routine diagnostic and screening practice. COMARE recommend that screening for colorectal cancer outside of the NHS screening programmes should only be undertaken in individuals in the appropriate age group, and not, therefore, under the age of 50 years, unless they have been referred by an appropriate medical specialist. In keeping with the NHS screening programmes, scans should not be performed routinely more frequently than once every two or three years. Individuals at high risk of developing colorectal cancer (eg with familial adenomatous polyposis, or those with a family history of colorectal cancer) should be assessed in a specialist unit that includes access to medical genetics, and specialist services in surgery, histopathology, and oncology. Screening of high-risk individuals by CT colonography should only be performed as part of a multidisciplinary care package with input from an appropriate specialist unit.
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