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Rapid Responses: Rapid Responses published:
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The Radiologist's role in radiation protection
- Charles R Hardingham (5 March 2004)
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an impractical solution
- Bob Bury (9 March 2004)
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Sustainability of radiologists
- Guillaume Gorincour, Sebastien Tassy (10 March 2004)
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Who obtains consent and how long do they have?
- Mark D Lewars (10 March 2004)
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Who obtains consent and how long do they have?
- John Nottingham (10 March 2004)
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Sustainability of medical imaging: X ray risk is understated
- Lynn Howard Ehrle (11 March 2004)
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Sustainability of medical imaging
- Fred Wickham (12 March 2004)
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Equilibrium vs. abuse: for a practical solution
- Prof. Dr. Giovanni Comandé Esq. (14 March 2004)
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Interventional radiology involves substantial risks to patients
- Chris Sharp (15 March 2004)
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Fundamental constitutional rights and medical profession.
- Simona Cacace (16 March 2004)
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Specific needs in developing countries
- Madan M Rehani, Pedro Ortiz-Lopez (18 March 2004)
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The patient’s perspective or the society’s perspective?
- Giuseppe Turchetti (21 March 2004)
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Patient exposure demands international attention
- Pedro Ortiz-Lopez, M. Rehani, F. Mettler, A. D. Wrixon (25 March 2004)
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Sustainability of medical imaging : the cost of environmental pollution
- Franca Carini (30 March 2004)
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Evidence based radiological protection: rule of the game in the near future
- Bruno M.G. Krug, Bruno Krug and Thierry Vander Borght (5 April 2004)
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Charles R Hardingham, Consultant Radiologist Imaging Dept, Milton Keynes General Hospital, Standing Way, Milton Keynes MK6 5LD
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Dr Picano raises the very important issue of the adverse effects of medical ionising radiation, and proposes ways that this can be addressed. Anything which raises the awareness of radiation safety is welcome, but as a practising radiologist who also lectures on a radiation safety training course I would like to point out some inaccuracies and comment on his proposals from a radiologist's point of view. It is stated that under the Euratom law, the 'need for an examination should be justified before a patient is referred to a radiologist or nuclear medicine physician'. This interpretation is inaccurate, certainly in the UK, as it denies the radiologist any role in justifying the examination. The law (IRMER is the UK implementation of Euratom) does state that ionising radiation exposures must be justified, but the referrer is not solely or even principally responsible for this. The law defines roles of practicioner and operator, typically but not necessarily the radiologist and radiographer, who are central to the process of justification. For example, if a GP or hospital consultant requests a chest x-ray, they are the referrer, the radiographer who performs the examination is the operator, and the practicioner might be a local radiology consultant. The allocation of these roles depends on local protocols and can vary. For example, as a cardiologist, Dr Picano may well be the referrer, practicioner and operator all at the same time when he performs a coronary angiogram on a patient he has seen in clinic, but it is not as referrer but as practicioner and operator that he justifies the exposure. In the majority of UK practice, imaging department staff are responsible for justification, not referrers. This would remain the case even if the referrers had a qualification called a radiology prescribing license. In my view, the strength of this system is that referrers are obliged to have a dialogue with imagers (radiologists and radiographers), and the patient is protected from excess radiation exposure by the imagers. Dr Picano suggests a formal training programme for referrers. In the UK we already have formal training for health professionals who request xray imaging tests (plain films, CT and radionuclide imaging). This is now incorporated into medical school training for doctors, and for other health professionals, courses are available. It used to be called 'POPUMET' but has been expanded, and we now call it a radiation safety training course. As well as the appropriate training, the attitudes of both referrer and imager are important. It is very difficult for imaging staff to play their part in dose reduction if the referrers are not open to discussion. Referrers who 'order' a scan rather than 'request' one make no secret of their poor attitude. To me, 'prescribing' a scan sounds just as bad as ordering one. Dr Picano's radiological driving license has the advantage that it can be taken away from referrers (assuming the radiologist is judge and jury!). However, I think the patient is best served by a good relationship between referrers and imagers, leading to constructive dialogue. If a referrer makes an unjustifiable request, the imager is legally obliged to refuse, but can help build the working relationship by taking on some responsibility for the patient's welfare and suggesting a more appropriate investigation. If the imager responds by docking points from the referrer's license, this becomes personal against the referrer and does not help the patient. The idea of obtaining informed consent before performing any ionising radiation examination is impractical. In my department we perform about 15,000 examinations per year, per consultant. Not all are for ionising radiation but even so we would have to obtain consent 50 times per day just for the exams I report. If we limit consent to high dose CT exams this would still add a considerable burden. In summary I share Dr Picano's concerns about medical radiation exposure but do not think that more training and regulation for referrers is the answer, especially if the role of radiology staff in justification is reduced. I think the key is increased awareness by referrers, maintaining the advisory and protection role of radiologists and radiographers, and fostering good working relationships. Yours sincerely C.R.Hardingham BA BSc MRCP FRCR
Competing interests: Consultant Radiologist |
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Bob Bury, Consultant Radiologist Leeds General Infirmary LS1 3EX
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It is difficult to argue with Dr Picano's premise that it would be a good thing if the doctors who referred patients for examinations using ionising radiation had a clearer idea of the risks involved. However, Dr Hardingham is right to point out that his suggested solution of a 'driving license' is completely impractical, and is based on a misunderstanding of the current patient protection legislation. The licensing system he proposes would be bureaucratic and impossible to administer. It is also unnecessary. The legislation makes it quite clear that the referrer's responsibility is to provide the practitioner with sufficient information to decide whether the examination is justified. Wherever possible, that practitioner should be the radiologist (or nuclear medicine physician) responsible for performing and reporting the examination, who will hopefully have the requisite knowledge of the radiation hazard and will be able to make an informed judgement. And if the licensing would be an administrative nightmare, then obtaining written consent for every exposure would bring radiology departments shuddering to a halt. The concept of counselling all the anxious patients referred for a chest X-ray and confused and alarmed by the information that they are about to receive an exposure of 0.02mSv which may, or may not, cause cancer in 30 years time hardly bears thinking about. There may be a case for this with some of the higher dose procedures, but even here, we would need to give it careful thought. Simply stating the absolute level of risk (which we don't actually know with any degree of accuracy) without any attempt to put it into the context of the patient's illness and the benefits to be expected, would be unfair on them, and it would be impossible to do this adequately for more than a small minority. And if that makes me paternalistic, then I can live with that. Competing interests: Consultant radiologist with a special interest in radiation protection |
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Guillaume Gorincour, MD Department of Pediatric Radiology, La Timone children Hospital, 13005 Marseille, France, Sebastien Tassy
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In the years to come, rarer and rarer will obviously be the diagnoses made without the use of medical imaging. And this obviously is problematic, namely concerning radiation exposure, and particularly in pediatric investigations. Thus, the recent major literature (1-3) led us to answer this article (1) with 2 mainstream ideas. First and foremost, knowledge of radiation protection is defintitely mandatory. Since about ten years, french radiologists are strongly encouraged to pass, during their training, a diploma of radiation protection applied to medical imaging ; this “advice” will undoubtedly turn into an entire part of the normal radiological residency. General practitioners and clinician specialists should also be included, to some extent, in that educational program. If an informed consent is indeed needed to protect patients’ right for autonomy as well as physicians’ responsibity, a radiological “driving licence with penalty points” may definitely be a palliative option. We do think that one solution might be to re-consider the radiologists like any other specialist consultants. Facing a given clinical presentation, the clinical physician would refer the patient to the radiologist, without “dictating” the type of study to be done. The radiologist would advise the patient and his physician, following his own experience and the state of the art, on the best radiological management (with advantages and drawbacks) of this precise and unique clinical situation. They would decide altogether, namely if the radiation exposure is worthwile. Second, we would like to dwell upon pediatric practice, as the higher radio-sensitivity of children is well reminded herein. Those reports confirm that pediatric radiology departments must strictly surround the use of multi-detector CT-scans (4) and that manufacturers must definitely provide specific low-dose parameters for pediatric investigations. This also confirms that ultrasound and magnetic resonance imaging are likely to represent the very future of pediatric imaging. Scientific research must be encouraged to work in a way of low irradiation bone imaging, for which conventional X-ray is still inevitable. It is medically unbearable, though unfortunately daily observed, that “in some hospitals patients are now more likely to get a total body scan than a thorough history and careful physical examination“. We might be partial of course, but we do think that radiologists have a pivotal role to play in the improvement of this situation, for a more collaborative work and the subsequent better care to the patients. (1) Picano E. Sustainibility of medical imaging. BMJ 2004 ; 328 : 578 -580 (2) Hall P, Adami HO, Trichopoulos D, Pedersen NL, Lagiou P, Ekbom A, et al. Effect of low doses of ionising radiation in infancy on cognitive function in adulthood: Swedish population based cohort study. BMJ 2004 ; 328 : 19-23 (3) Berrington de González A, Darby S. Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries. Lancet 2004 ; 363 : 345-351 (4) Boone JM, Geraghty EM, Seibert JA, Wootton-Gorges SL. Dose reduction in pediatric CT: a rational approach. Radiology 2003 ; 228 : 352 -60 Competing interests: None declared |
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Mark D Lewars, Radiologist and Director of Breast Screening Southend Breast Unit, The Nightingale Centre, Southend Hospital NHS Trust, Prittlewell Chase, SS0 0R
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The BMJ have, once again, offered legitimacy to a hairbrained scheme from an ill-informed source. By publishing Picano's paper, they have allowed dissemination of the concept of written and fully informed consent to Radiological examinations. This ranks with the publicity of the ideas of Peter Gotzche on the premise for breast screening being falsely instigated because of faulty statistics, the dominant source being his own publications! Let us for a moment reflect on the repercussions of the suggestion that each and every irradiating examination should be performed only after obtaining informed consent. Allow a bit of instant sophistication in the form of prepared information sheets and consent forms, and some experience on behalf of the individual obtaining consent, then consider the factor of time. It will probably take the consenter fifteen seconds to lay hands on the documents, and a further fifteen seconds to introduce the written information and suggest that the patient reads it. Add a further half minute to receive the forms back and check that they are filled-in correctly, then to check that the name, signature and date are correct. Add another half minute to field average questions, and another half minute to file the paperwork. That's two minutes for the completely uncomplicated, intelligent (probably experienced) patient who has no question, makes no objection, has remembered to bring reading glasses and can write, probably the rarest bird since the buck-toothed hen! Now let us translate this perfect interlocutor into the workplace. Who will be obtaining consent? A Receptionist? No, the knowledge required to answer questions on radiation demands much more sophicticated scientific training and understanding than one should expect from an underpaid and overworked receptionist. A Radiographer, perhaps? Yes, the knowledge either is, or can be instilled there. But how many Radiographers do we have to spare? Let us not even approach the argument that the Radiologist, one of a dying breed, who should not be there all day and all night, even under the new contract, should be responsible. And how many of these practitioners does one need? For the main X- ray department in a medium-sized District General Hospital, undertaking 100,000 X-ray examinations each year, that amount to a minimum of 200,000 minutes, or 3,300 hours per year. At 35 hours weekly, allowing for cover for leave, that is around 2 wte fully trained radiographers on the staff of each hospital to fulfil this task. And where will consent be obtained? Not at the reception desk - far too public; in the X-ray or CT room perhaps? Meanwhile, work is suspended and equipment lies idle. Or do we build special rooms for the purpose in each of our vast departments? Now imagine it translated to Mobile Breast-Screening Units, where each slot is seven minutes long, allowing eight minutes for each examination in the expectation of only 70% uptake, with 40 women attending each 7 hour day. Uncomplicated consent will snatch 11 - 12 slots from each day, prolonging screening by about 20%. Imagine it in the outreach clinic; the OP Unit; the mobile CT van. I have to confess that I cannot. Now multiply the time taken to obtain each consent by two, or three or four to allow for incomprehension, obtuseness, terror and other such complications!! I do believe that we need to limit irradiation to the minumum. I also know that we have no time, with our shortage of radiologists, even to vet all requests and to read our reports before they are issued. I realise that there are highly intelligent and committed staff who believe very strongly in the need for informed consent, but I wonder why the so-called paternalistic attitude that we, highly trained, knowledgeable, experienced and (usually) communicative doctors use to judge what is best for our patients is now so despised. Along with the need to prove, as "Appraisal" and "Revalidation", that we have read the right amount of the right stuff, have performed adequately the appropriate number of examinations and can make up enough data to justify our continued slavery, it has become the command of the politician and the idealist that ours skills are frittered away on such niceties. I am looking forward so eagerly to retirement and freedom from these untrusting and critical policies. Mark Lewars MB FRCS FRCR DMRD, Consultant Radiologist, Director of the South Essex Breast Screening Service. Competing interests: Consultant Radiologist with an active role in Breast Screening |
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John Nottingham, consultant histopathologist Northampton General Hospital
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I can well understand the concerns of Dr. Lewers regarding the time needed to obtain informed consent. However the consequences of not doing so are well known to all histopathologists as a result of the failures to do so (for post mortem examinations) at Alder Hey, Bristol and elsewhere. Now we pathologists are also lumbered with poorly thought out legislation in the form of the Human Tissue Bill, the subject of a separate editorial in this issue of the BMJ. Peter Furness estimates the time required to obtain consent for the further use of human tissues for teaching and research in the NHS to be equivalent to the total staffing of several small district hospitals. I disagree on one point with Dr. Lewers and that is consent to screening. It has to be remembered that the invitation for screening comes from the doctor and is not, generally, initiated by the "patient". Under these circumstances I would contend that there is an ethical obligation to explain the consquences of being screened or otherwise. Competing interests: None declared |
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Lynn Howard Ehrle, Senior Policy Analyst, National Association for Public health Policy(pro bono) 8888 Mayflower Dr., Plymouth, Michigan, USA
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Picano[1] is to be commended for opening Pandora's radiation closet, only to find a veritable hornet's nest hidden under "curtains of fog and iron" (a Churchillian phrase), specifically, the issue of informed consent. If drug interactions must be disclosed, why should X-ray exposures be immune? The medical establishment has resisted attempts requiring primary care physicians to include radiograph examinations as part of each patient's history. Ionising radiation health effects have been measured and proven at very low dose but Picano fails to cite the relevant studies, some of which are referenced in my letter[BMJ,6 March, i.e.,Muller, Stewart, Gofman]. Of greater consequence are paediatric CT studies, the first one quantifying 500 future deaths from 600,000 CT scans[2]. Based on the NEXT survey[3], there were at least 65 million CTs in the United States. Another study of 33,700 consecutive CT examinations determined that 11 percent fell within the 0-15 age-band while over 40 percent involved multiple scans. The authors indicated CTs deliver about 67 percent of the effective dose from all radiological procedures[4]. Gofman's five books on radiation health effects have a total of 1916 citations[my count] on his reference lists, including many studies that refute the hormesis or threshold theories. Also a recent report identifies "a serious misuse of the scientific method" by the International Commission on Radiological Protection in its assessment of radiation risk[5]. References 1. Picano E. Sustainability of medical imaging. BMJ 2004;328:578-580. 2. Brenner DJ, Elliston CD, Hall EJ, Berdon WE. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR 2001;176:289-296. 3. Stern SH, Kaczmarek RV, Spelic DC, Suleiman OH. Nationwide evaluation of X-ray trends(NEXT)2000-2001 survey of patient radiation exposure from computed tomographic examinations in the United States. http://www.fda.gov/cdrh/ct/ct-next.ppt. 4. Mettler FA Jr, Wiest PW, Locken JA, Kelsey CA. CT scanning: patterns of use and dose. J Radiol Prot 2000;20:353-359. 5. Busby C(ed)with Bertell R., Schmitze-Feuerhake I, Cato MS, Yablokov A. 2003 Recommendations of the European Committee on Radiation Risk: Health Effects of Ionising Radiation Exposure at Low Doses for Radiation Protection Purposes. Aberystwyth, UK: Green Audit Press, 2003. Competing interests: None declared |
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Fred Wickham, Masters by Research Student Department of Physics, Kings College London, Strand, London WC2R 2LS
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12 March 2004 Editor- E. Picano; Sustainability of medical imaging; BMJ Volume 328 pages 578 – 580 The issue of radiation doses in medical imaging is undoubtedly important, but the presentation of statistics in Picano’s article is misleading, and I believe that the picture he presents of widespread complacency in the medical community on this issue is unfounded. Figure 1 of Picano’s article suggests that there was a dramatic rise in doses of radiation from medical x-ray examinations between 1987 and 1997. However, the figure is misleading because the dose shown for 1987 is for the United States, where radiation doses are relatively low, whereas the dose shown for 1997 is for Germany, where radiation doses are particularly high. In fact the annual per caput effective dose from medical radiology in Germany for 1990 – 92 was 1.9 mSv (1), which means that the dose in Germany increased by around 13 % between 1990/2 and 1997, whereas Picano’s figure suggests that between 1993 and 1997 the dose roughly doubled. The dose for the United States given in the UNSCEAR 2000 Report (1) of 0.5 mSv is almost the same as the dose quoted by Picano for 1987. The per caput annual effective dose from medical and dental x-ray examinations for the UK population for 1997/8 was 0.33 mSv (2). This is actually less than the value for 1991 of 0.35 mSv (3), although the drop is not statistically significant due to uncertainties in the figures. If figure 1 of Picano’s article is revised by adding the additional data outlined above, the revised figure does not show a dramatic increase in radiation doses from medical imaging. What it does show is a substantial difference between the doses in Germany and those in the UK and the USA. I do not profess to know about procedures for monitoring patient doses in Germany, and it may well be that these high doses can be justified, but the figures suggest that it might be useful for the German authorities to study the UK’s procedures. In the second paragraph of his article, Picano suggests that the radiation dose for Germany in 1997 is representative of the dose received by the population “in most affluent countries”. In fact radiation doses in Germany are particularly high; the dose quoted by Picano for Germany in 1997 is more than double the dose quoted for any other country in the UNSCEAR 2000 Report (1), and is more than six times larger than the dose for the UK in 1997/8 (2). I do not recognise the picture painted by Picano of widespread ignorance and complacency in the medical community about this issue. In 1988 the Royal College of Radiologists and the National Radiological Protection Board set up a joint working party to make recommendations on ways of reducing patient doses in diagnostic radiology. The recommendations of the working party were published in 1990 (4). There is evidence that these recommendations have been implemented effectively. In the National Health Service any request for an examination involving ionising radiation must be justified on clinical grounds and authorised by a suitably qualified practitioner before it is carried out. In my experience it is not uncommon for radiologists to question the clinical case for examinations. This should be seen as evidence that requests for examinations are being properly scrutinised. One only has to peruse journals such as Medical Physics, or the Proceedings of the SPIE Conferences on the Physics of Medical Imaging to appreciate the extensive research efforts that are going into the development of systems to reduce radiation doses in medical imaging without compromising the clinical usefulness of the images produced. The development of new types of x-ray detector is a good example of this. In 2002 Hart and Wall published the results of an extensive study of radiation doses received by patients from medical and dental x-ray examinations in the UK (2).This study showed a slight fall in the dose of x-rays to the UK population from medical and dental x-rays between 1991 and 1997/8, which came at a time when clinically valuable but high dose examinations such as CT and interventional radiology became much more widely available. The increase in dose from these procedures was more than offset by measures such as the increased use of ultrasound and endoscopy instead of intravenous urography and barium meal examinations, and a general fall of about 30 % in the dose per examination for common radiographic and fluoroscopic examinations. Hart and Wall concluded that “…The increasing attention given in recent years to radiation protection for conventional examinations, with the development of national patient dosimetry protocols and reference doses, has played a significant part in this substantial reduction in collective dose. Widespread local monitoring of patient doses and x-ray imaging performance and comparison with national norms have undoubtedly encouraged the adoption of dose-efficient procedures and the introduction of dose-saving features into x-ray imaging equipment…” (2) Of course there is no room for complacency, and Hart and Wall identified CT, angiography and interventional radiology as procedures in which there is a particular need to develop radiation protection and optimisation activities. Correspondence in the current issue of the BMJ 5, illustrates that the effects of radiation doses from medical procedures are the subject of lively debate. In conclusion, the evidence that Picano presents for a dramatic increase in radiation doses from medical examinations is misleading, and the picture which he presents of a medical community which is ignorant and complacent about this issue is not consistent with my experiences of the National Health Service. References. 1. United Nations Scientific Committee on the Effects of Atomic Radiation; Sources and effects of ionising radiation. Volume 1: Sources, Annex D, Medical radiation exposures. New York, United Nations (2000). 2. D. Hart, B. F. Wall; Radiation exposure of the UK population from medical and dental x-ray examinations; National Radiological Protection Board; 2002. 3. S. Hughes, M. C. O’Riordan; Radiation exposure of the UK population – 1993 review; National Radiological Protection Board; 1993. 4. Patient dose reduction in diagnostic radiology; Royal College of Radiologists and National Radiological Protection Board; 1990. 5. BMJ Volume 328 pages 582 – 581. Competing interests: None declared |
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Prof. Dr. Giovanni Comandé Esq., Full Professor of Private Comparative Law Scuola Superiore Sant'Anna , Piazza Martiri della Libertà 33 Pisa ,Italy I-56127
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To a jurist, health protection and medical malpractice raise two clear “uncontested” issues to be stressed and commented in the ongoing debate nourished by Dr. Picano’s article: 1) indeed, medical radiation exposure is a risk and sometimes an unavoidable one; 2) the conflict between a paternalistic vision of individual autonomy and efficiency is perhaps unavoidable but it should be managed. These premises jointly invite to the search for practical solutions, while avoiding both the abuse of paternalism and mere efficiency arguments. Regarding the first issue, it seems rather clear that adverse effects of medical ionising radiation are acknowledged by scientists, though not necessarily at the level reported by Dr. Picano. Within these limits, however, they are risks about which patients must be informed; in light of national legal parameters. Patient’s right to information: 1) can be expressed under different legal terms (e.g., autonomy, self -determination, freedom of choice,…) and; 2) may lead to various legal results (e.g., lack of consent for medical treatment leading to liability either in tort or in contract, lawsuits for cancer-phobia, defensive medicine, insurance premiums skyrocketing …) and; 3) may raise ethical concerns (e.g., is it proper or “more fair” to conceal information, or, to the contrary, disclose it all to patients? Should the doctor decide without consulting the patient and save time or should she follow a time-consuming procedure to increase patient’s choice). All these points cannot be disregarded by radiologists and health care institutions without further investigation, be this for economic reasons. On the second issue, it is impossible not to agree with the practical concerns raised by Bob Bury (an impractical solution), on the one hand, and by Guillaume Gorincour and Sébastien Tassy (Sustainability of radiologists), on the other hand. Still, the protection of any right is impractical in efficiency terms because it is time and money consuming. We all can agree that efficiency concerns are of extreme importance in providing health care, but efficiency cannot be more paramount than the fundamental right to health and the ability of individuals to choose the risks they want to face. Patients remain the final decision-makers for their health, unless the law expressly provides differently. Were an agreement be reached among scientists on these two issues, practical solutions could then be sorted out. For example, medical examinations and tests requiring radiations are prescribed by a medical doctor (very often the “family doctor” or “one’s” doctor). These professional could easily be in charge of providing the largest amount of information and could do so in the most appropriate manner in light of each patient’s sensibility, education, and ability to understand the consequences. Both withholding information and providing too many of it pave the way to abuse. On the contrary, practical solutions respecting both the patient and the doctor can be further explored. Competing interests: None declared |
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Chris Sharp, Medical Director WorkFit UK, St Andrew's Street South, Bury St Edmunds, Suffolk, UK, IP33 3PH
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Dr Picano's article has stimualted an interesting debate, which Drs Bury and Hardingham have put into practical focus. The former raises the case for licensing of individual clinicians to use higher dose procedures from which substantial total exposures can be delivered, usually in CT. Such procedures can be substantially above the level below which there is uncertainty of risk ~50mSv. However, imaging (fluoroscopy)is also used to guide treatment in interventional procedures, where much higher doses and consequent risks are present. It is in the practice of interventional radiology where Dr Picano's recommendations should be implemented.
Skin injury after interventional procedures has been increasingly reported. (1)(2)(3) Additionally, the "interventionist" can also suffer injury to skin and other organs, which may be a spur to action. Many, in some countries most, of these procedures are undertaken by non-radiologists. The list of non-radiologists using fluoroscopy is growing - currently cardiologists are the largest group in most developed countries. It is likely that practitioners in many specialities will eventually become interventionists. Unfortunately, non-radiologists are often not adequately trained in radiation safety and radiobiology and both patients and staff may suffer as a consequence of unnecessarily high radiation doses. In the UK, The Ionising Radiation (Medical Exposure) Regulations (IRMER)have required a more rigorous and robust approach to controlling exposure to prevent unnecessary radiation detriment. IRMER requires those involved in such procedures to be “experts in the use of radiation”. This equates to a substantial combined practical and theoretical training. Clinical governance, and the requirements of legislation, dictate that all those involved in interventional procedures adopt and maintain high standards for the protection of patients and staff. Consequently, they must be appropriately aware of the potential for and the nature of radiation injuries, know the operational parameters of their equipment, measure and record technical factors, be aware of the methods to reduce dose and undertake and refresh appropriate training. This means practitioners other than radiologists are going to require a higher level of training. This is where a major effort must be focused to obtain the best overall balance of patient benefit. As the risks of injury can be very high for some procedures and for repeated procedures e.g. angioplasty, patient consent should be obtained.(1) In the latter, the single procedure dose is usually below levels of concern, but a small number of patients can have multiple procedues and it is the total dose that matters. Such consent must be informed by the explanation of possible radiation effects. Procedures for appropriate patient follow up should be established so that that both support and a mechanism for audit is available. A downloadable teaching package is available on the International Commission on Radiological Protection's (ICRP)website (www.icrp.org). Medical professional bodies should take responsibility for the training, accreditation and ongoing competency of their members who use this imaging technology. 1. International Commission on Radiological Protection, Avoidance of radiation injuries from medical interventional procedures. ICRP Publication 85. Ann ICRP 2000; 30: 2 2. Koenig TR, Wolff D, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures: Part 1, Characteristics of radiation injury. AJR. 2001; 177: 3-11. 4. Koenig TR, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures: Part 2, Review of 73 cases and recommendations for minimising dose delivered to patient. AJR 2001; 177: 13-20. Competing interests: Consultant Occupational Physician member of Committee 3 of the International Commission On Radiological Protection (ICRP) |
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Simona Cacace, Ph.D candidate Private Comparative Law Scuola Superiore Sant'Anna, Pisa.
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The problem of informed consent divides the doctor and the jurist: 1) on the one hand, the frenetic rhythms of the medical profession and the daily relationship with the patient and his family are marked by an insurmountable asymmetry of competence and information and by a corollary difficulty of communication; 2) on the other hand, the jurist accuses the doctor of paternalism and omnipotence mania and denounces the frequent violation of fundamental, constitutionnaly protected rights, such as self-determination and individual autonomy. Doctors cannot claim to always know patient’s best interest, whom has, to the contrary, the ability to decide about his health, life, death and even risk exposure. Obtaining the patient’s consent, preceded still by appropriate information, requires often precious time for the efficiency of a medical facility. It’s a matter of relevance of individual constitutional rights, that cannot be sacrificed in the name of requirements of practicalness or rapidity. At least, the special gravity of detrimental consequences of medical radiation exposure would justify a specific information, even though the verification of these risks was considered exceptional. A balance between constitutional rights and efficiency of medical facilities cannot be done. Still an attempt to convey some information without collapsing the system should be experimented. Competing interests: None declared |
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Madan M Rehani, Radiation Safety Specialist International Atomic Energy Agency, Vienna, PO Box-100, Austria A-1400, Pedro Ortiz-Lopez
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The paper by Dr. Picano raises the issue of the need to increase the awareness of both doctors and patients to avoid inappropriate radiological examinations. The reason is the putative detrimental effects of ionizing radiation. In this context, we wish to draw attention to the situation in developing countries, particularly on three issues a) the large numbers of dark room based conventional fluoroscopy machines still in use, b) the rampant use of old technology in x ray cassettes and c) the clear need for more radiological imaging with the consequence that the global collective dose will continue to rise. Most developed countries have switched to image intensified fluoroscopy in the 1980’s as this gives much lower doses to patients. Indeed, a Euratom Directive concerned with protection of the patient states, “In the case of fluoroscopy, examinations without an image intensifier or equivalent techniques are not justified and shall therefore be prohibited” (1). The International Atomic Energy Agency (IAEA) for its part has also encouraged States in which direct fluoroscopy units are still being used to develop a strategy for their replacement with units with image intensifiers (2). As far as the second issue is concerned, we note that replacement of the screens in x-ray cassettes (e.g. calcium tungstate) by the newer rare earth screens would reduce the patient exposure by a half or more (3). On the third issue, we note that the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) divides the countries into four levels of health care, level I to IV, depending upon number of physicians per unit of population (4). It estimates that about 80% of the global collective radiation dose from medical x rays arises from examinations conducted in level I countries – those with the highest number of physicians per unit of population - which together constitute only a quarter of the world population. That means that developing countries are likely to need many more of imaging investigations to meet the health care requirements if they are to reach the standards of level I countries. Even if the pattern of examinations changes e.g. chest photofluroscopy disappears, urography, pelvic and lower abdomen examinations are likely to reduce, high dose procedures such as CT and interventional procedures are bound to increase. We note that the BMJ has local editions in 20 countries and a very wide readership base in developing countries. It will, in our view, provide an important service in highlighting the above issues. (1) Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, and repealing Directive 84/466/Euratom. Official Journal of the European Communities L 180 1997 Jul 9: 0022-7. (2) International Atomic Energy Agency, Radiological Protection for Medical Exposure to Ioninsing Radiation: Safety Guide: Safety Standards Series No. RS-G-1.5; 2002 (3) Radiological Protection of Patients in Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy, International Atomic Energy Agency STI/PUB/1113, 2001 (4) United Nations Scientific Committee on the Sources and Effects of Ionising Radiation. Report on the effects of atomic radiation to the general assembly, 2000. Medical radiation exposures. New York: UN, 2001 Competing interests: None declared |
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Giuseppe Turchetti, Associate Professor of Health Economics and Management Scuola Superiore Sant’Anna, Piazza Martiri della Libertà, 33 PISA, Italy, I-56127
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In my perspective, as an economist, the propositions raised by Dr. Picano’s article and the interesting comments offered by the following debate could be read as follows: a) We all agree that we have to be concerned by the relevant radiation emission; b) We all agree that radiation emission could result in detrimental health effects on the patient and on the society and that the incremental risk presents the bill in the medium/long term period (therefore, it is often underestimated, as the causal links are less evident); c) Therefore, we all agree that more detailed and shared analyses on the real adverse effects - in the short, medium and long term - of medical ionising radiation are necessary; d) We all could agree that a considerable number of examinations are not necessary nor scientifically justified and that they are performed because of defensive behaviour by the physician, because is the patient who pretends them, etc. Radiologists should not be upset by that, as overprescription is common to all clinical branches as thousands of evidences clearly show; e) We all should promote a more complete, deep and articulated technology assessment and cost-effectiveness analysis of radiological procedures in order to evaluate incremental benefits and incremental costs (in terms of higher risks and higher economic costs) associated to these procedures; f) We all should agree that these studies should be used in the definition of protocols and guidelines in order to make examination prescription more rational and appropriate; g) Of course we could discuss about the measures to be introduced to make the prescriptive behaviour more adherent to protocols (as radiological prescribing licence, etc..); h) We all should agree that the patient should be better informed concerning advantages and disadvantages of the examination; of course, as Prof. Comandé points out, any information procedure that we could imagine to introduce is time and money consuming, but extremely high are also costs connected to litigation procedures and costs connected to adverse effects of the examination. Nevertheless, even if we improve the prescriptive behaviour and we minimise improper examinations, the central point has still to be addressed. If we all agree that the emission of medical ionising radiation could result in detrimental health effects on the patient and on the society, in fact, the final choice about the diffuse use of these examinations is still controversial. The decisive factor is the perspective of analysis we choose to adopt. We could have at least two different situations: 1) the cost-effectiveness analysis tells us that the examination would not provide extra information to the diagnostic and therapeutic decision or that the incremental benefits are so small that the incremental disadvantages do not suggest to proceed. In this case the rational solution would be not to execute the examination and this would be the proper prescriptive behaviour. 2) the cost-effectiveness analysis tells us that the examination would provide extra relevant information to the diagnostic and therapeutic decision or that the incremental benefits are so high in respect to the incremental disadvantages. What do we do? 2a) Patient’s perspective: it would be better to proceed, as the incremental benefit is higher than the incremental disadvantage for the patient; 2b) Society’s perspective: we also have to consider the benefits and disadvantages for the society. If the adverse effects for the society are higher that the benefits, what do we do? Is it the case to increase the probability to save one patient now, increasing the risk to harm other persons in the next future? This is the real choice that we have to make once we have collected all necessary information about benefits and disadvantages connected to a medical procedure. And this is a choice that not the single patient (and then the discussion about the informed consent might be inappropriate/premature), nor the physician, nor the jurist and certainly not the economist, but the society, has to make. Competing interests: None declared |
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Pedro Ortiz-Lopez, Unit Head, Radiological Protection of Patients International Atomic Energy Agency, Vienna, PO Box-100, Austria A-1400, M. Rehani, F. Mettler, A. D. Wrixon
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The paper by Dr. Picano emphasizes that the increased awareness among both doctors and patients would help reduce the number of inappropriate examinations. We agree with this statement. In addition, we would like to draw attention to the need to optimize protection in those examinations that are necessary. Worldwide, more than 2000 million diagnostic X ray examinations and 32 million nuclear medicine procedures are carried out annually, and of about 10 million cancer patients, 40-50 % receive radiotherapy. Moreover, it can be expected that the use of radiation in medicine will increase; in overall terms the benefits for patients are enormous and far exceed the risks and large parts of the world population still lack access to these benefits. In the 2000 report of the United Nations Scientific Committee on the Effects of Atomic Radiation (1), it was stated that medical applications of ionizing radiation represented by far the largest man-made source of ionizing radiation exposure. Moreover, medical exposure to the world’s population amounts to about 150 times the occupational exposure from all uses of radiation (2). Yet far more effort has been devoted to reducing occupational exposures than exposures received by patients. According to the International Commission on Radiological Protection (ICRP), there is considerable scope for dose reduction in diagnostic radiology and simple, low-cost measures are available for reducing doses without loss of diagnostic information(3). At the same time, while new diagnostic equipment and techniques are bringing new benefits, some of the procedures involve the delivery of relatively high radiation doses to patients. In addition, a number of radiation injuries in interventional radiology and accidental exposures in radiotherapy have been reported. These facts have focused attention on the need to improve the radiological protection of patients in diagnostic and interventional radiology, nuclear medicine and radiotherapy. This matter is central to an International Action Plan on the Radiological Protection of Patients (4) that involves international organizations and professional societies. In 2001 the International Atomic Energy Agency organized the International Conference on the Radiological Protection of Patients, which was cosponsored by the World Health Organization, the Pan American Health Organization, the European Commission and the relevant Professional Bodies. As a result of this Conference the International Action Plan was formulated in 2002.- The Action Plan recognizes that “Health professionals involved in the processes of diagnosis and treatment are the critical link. Training them properly and ensuring intensive information exchange among them are, therefore, probably the most cost-effective ways of achieving patient safety.” They can make a difference by maintaining awareness of radiation doses of different types of examinations, by using appropriateness criteria to make the right choice and reduce the number of unnecessary ones, optimize protection by keeping the dose to the minimum necessary to obtain the diagnostic information or the successful intervention, and avoid or reduce the severity of radiation injuries in the high dose interventions. For this reason, the International Action Plan places the main emphasis on education and training and information exchange. It recommends the development of appropriate training material for use in training all those involved in the use of radiation in medicine, and the development of mechanisms for disseminating the material, for example, through training the trainers. Particular attention is being given to dealing with the radiation protection problems of specific audiences, such as interventional cardiologists or those involved in transitioning from conventional to digital radiology. The Action Plan strongly emphasizes the need to establish an Internet information exchange, so that the documents – training material, guidance, etc. - relevant to particular needs in radiation protection, developed by the various authoritative groups, can be readily accessible to those who need them. This is ambitious, but in the interests of patient care, it is in our view essential. (1) UNITED NATIONS SCIENTIFIC COMMITTEE ON THE EFFECTS OF ATOMIC RADIATION. 2000 Report to the General Assembly with Annexes, United Nations, New York (2) Norman Gentner, UNSCEAR, Personal communication (2004) (3) INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION, 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60. Annals of the ICRP 21 (1-3), Pergamon Press, Oxford (1991). (4) INTERNATIONAL ATOMIC ENERGY AGENCY. International Action Plan on the Radiological Protection of Patients, IAEA, Vienna, 2002. Competing interests: None declared |
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Franca Carini, Professor Università Cattolica del Sacro Cuore29100 Piacenza (Italy)
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As an ecologist, I read with interest the article by Picano (1). The issue of environmental sustainability of medical imaging is a key issue from the social and economic viewpoint. In a world in which resources are diminishing, those who will recognize first the need of sustainability will obtain the best results (2): this is true for nations, for industries, and for individuals. Imaging techniques seem to make no exception. Please consider also another aspect which is not mentioned in the article but which introduces a key difference on the sustainability of radiological versus nuclear medicine techniques: the exorbitant cost and ecological stress of radioactive waste disposal inherent to the use of nuclear medicine. For social, economic, medical and also security reasons the cost of radioactive waste has increased dramatically in recent years. US data describe an increase from 36 dollars/m3 to 14286 dollars/m3 in 25 years, and forecast a rise well above 35000 dollars/m3 in the near future (3). The International Atomic Agency encouraged the adoption of any effort to shrink radioactive waste production (4). Are physicians fully aware of the economic, social and ecological burdens of their acts? If not, as one might guess from some of the radiologists' rapid responses, strict auditing proposed by Picano should strongly support them in the restoration of the lost awareness. 1. Picano E : Sustainability of medical imaging. Education and debate. BMJ 2004 2. Sturm A, Wackernagel M, Muller K. The winners and losers in global competition: why eco-efficiency reinforces competitiveness: a study of 44 Nations. Zurigo, Verlag Ruegger, 2000 3. Ryan, M.T., Newcomb, W.E. The Status of Commercial Low-Level Radioactive Waste Disposal in the United States. Technology, 7: 479-489, 2000. 4. International Atomic Energy Agency. Predisposal Management of Radioactive Waste, Including Decommissioning. Safety Standards Series No. WS-R-2, IAEA, Vienna, 2003. Competing interests: None declared |
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Bruno M.G. Krug, Nuclear Medicine Physician UCL Mont-Godinne Medical Center, Nuclear Medicine Division, Av Dr G. Therasse 1, 5530 YVOIR, BELGIUM, Bruno Krug and Thierry Vander Borght
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Editor – Picano1 highlights rightly the radiation protection concern raises by the increasing use of radiological and mediconuclear investigations and procedures in daily practice. The use of procedures with a high load of radiation continues to grow steadily with an increasing long term development of iatrogenic cancer and genetic damage. As suggested by the author, the medical staff should always evaluate the medical benefice of exposure to ionizing radiation keeping in mind the potential risks. However, further information worth to be given, especially in the table reporting the estimated cancer risk and radiation dose for common imaging examinations. Concerning computed tomography, more than a factor of three in the effective doses is reported depending of the equipment and the local scanning technique2. With the increasingly used fast multi-slice spiral CT, more slices tend to be performed and more images acquired in different phases of enhancement, which results in an increased dose of radiation. Radiologists, authorities and manufacturers pay growing attention to CT radiation risks, especially in children and patients of small stature3. The potential danger of fluoroscopically guided interventions is also highly dependent on the duration of the procedure4. When requiring more than 20 min, the procedure may be responsible of patient skin injuries5. The radiologists and their staffs must take protective measures to avoid overexposing themselves. In hospital environment, it is well known that such interventional procedures carry the highest radiation risks for the patient and the personnel. Despite some misconceptions, the radiation doses imparted by most nuclear medicine studies are considerably less than that for abdominal CT. In contrast to conventional radiology, the integral dose is independent of the body sections in an examination (e.g. planar views, whole body or tomographic acquisition). New acquisition protocols have also reduced the radiation dose (e.g. brain FDG-PET dosimetry is reduced by half by acquiring in 3D-mode) and alternative techniques with less radiation burden are considered (e.g. FDG-PET instead of Gallium scan; Technetium-99m sestamibi instead of thallium scan). New medical decision trees need to be developed which better take in account the radiation exposure of patients. For instance, lung scintigraphy is certainly a better technique than spiral CT to exclude pulmonary embolism in a low prevalence population. In the same way, rate and type of imaging technique prescribed for follow-up studies should carry the lowest radiation burden for the same diagnostic information. References 1. Eugenio Picano Sustainability of medical imaging BMJ 2004;328:578-580 2. Golding SJ, Shrimpton PC Radiation dose in CT: Are we meeting the challenge? Br J Radiol 2002; 75:1-4 3. Rogers LF. Taking care of children: Check out the parameters used for helical CT. Am J Roentgenol 2001; 176:287-288-289. 4. Buls N. Evaluation of patient and staff doses during various CT fluoroscopy guided interventions. Health Phys. 2003 Aug;85(2):165-73. 5. Koenig TR, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures Am J Roentgenol 2001; 177:13-20. Competing interests: None declared |
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