I thank the ICRP for the efforts provided in drafting this important document entitled “Ethics in Radiological Protection for Medical Diagnosis and Treatment”.
Ethics and deontology are fundamental pillars of the medical profession.
As reported by Bibbolino C, Ferrante Z, Canitano S et al [1] “these two words are commonly confused and misused, although they have profoundly different meanings. The word ethics is derived from the Greek word “ethos” (behavior) and according to the encyclopedia, it is the branch of philosophy that addresses behavior with the aim of morally investigating human actions and ways of life, classifying them as right/wrong and not as permitted/prohibited by law or as politically correct/incorrect. The word deontology is derived from the Greek word “to deon” (which must be done) and “logos” (speech, word, science). It is commonly translated as “duty” and in medicine it refers to the set of rules governing the physician’s rights, duties and responsibilities towards his colleagues, the institutions and, above all, the patients. These rules are contained in a “Code of Conduct” and their primary characteristic is that they are extra-judicial; i.e. they are rules of conduct arisen spontaneously in a professional group and followed on a voluntary basis”.
The major changes undergone by the health service structure in Italy have urged an organic and logical reconsideration of the relationship between health service resources and health needs, between competences and new patterns of organization. Italian radiologist directly participates in a structure and productivity project, playing a major role in the transition from the technological, organizing and functional approach to the clinical management of the patients. These changes cannot be separated from their ethical and deontological implications. The ethical issue begins at the patient's bedside and does not end with technical quality and feasibility or with the economic aspects of the medical-radiological procedure, but continues with the assumption of a precise legal and deontological responsibility.
Italian medical community and, in particular, the radiological one, have developed a particular sensitivity to the issues of ethics and professional deontology.
On 19 October 2018 the central committee of FNOMCeO (the National Federation of Medical and Dental Councils) officially approved a document entitled “the new radiologist” [2]. This “position paper” was the outcome of the joint efforts of several physicians working in the field of radiology, members of the main scientific societies of the sector, such as SIRM (Italian Society of Radiology), Italian Society of Radiation oncologist (AIRO), Italian Society of Nuclear Medicine (AIMN), Italian Society of Neuroradiologist (AINR), the trade union SNR (Italian College of Radiologist) and some Provincial Medical Councils – with the objective of drawing up a professional profile of the radiologist today taking into account the current socio-political and technical-scientific scenarios. This document is the only one of its kind as it pays particular attention to the radiological medical act breaking it down into its individual parts and emphasizing its importance, both as regards treatment safety and accuracy of the radiological performances. The document is particularly important as it also outlines an ethical-professional profile that takes into account possible future scenarios including big data, artificial intelligence, personalized medicine and teleradiology in total agreement with what is stated in the articles 19 and 21 of the current Code of Medical Deontology (CMD), which addresses continuing medical education, permanent professional training and professional competence.
Following the position paper “the new radiologist” and the proposal rised from the Ethical committee of the Italian Society of Radiology (SIRM) a new document was published in 2020 “ethical-deontological corpus of the radiologist” [3], listing some ethical-deontological rules applicable particularly in the field of diagnostic imaging (ie. informed consent in medicine, inappropriate overtreatment, patient safety, prevention of clinical-biological risk and diagnostic appropriateness). It goes without saying that a qualified physician registered with the Italian Medical Council and specialized in diagnostic imaging (a radiologist) must:
1) comply with the ethical rules governing the professional activity of physicians and dentists registered with their respective professional Councils ;
2) take into account all the ethical principles inherent in his/her specialization, which are closely linked to the technological development, socio-economic changes and professional services automation;
3) comply with the complex regulatory and jurisprudential framework governing his/her professional activity, also in view of the use of ionizing radiation.
I agree with the general structure of the ICRP document on “Ethics in Radiological Protection for Medical Diagnosis and Treatment” and, in particular, with the following key points (comments are added point-by-point where necessary):
- pag. 7 (228-230) “Understanding and acting appropriately on the risks and harms of radiological exposure is important not only for physicians, nurses, radiographers, radiation therapists (RTTs), medical physicists, and other related professionals, but also for patients, citizens, governments, regulators, and other stakeholders”. This is a fundamental point, a worldwide culture about growing usefulness of medical exposure and of their potentially harmful effects is mandatory to avoid non-ethical radiological practices
- pag. 7 (241-245) “…there are ongoing areas in need of improvement, not the least of which concerns justification of procedures as well as honest communication about dose, benefit and risk with the patient, which can be addressed by increased awareness and more robust understanding of the underlying ethical values”.Improvement of Justification in medical exposures is the main challenging task of the next revision of system of RP. As done for optimization in draft TG108, also a graded approach to justification with levels from basic to advanced could be reasonable. The Fryback and Thornbury hierarchy proposed in drafts TG108 and TG109 (pagg. 47-48) represent an excellent example of different level of individual justification: technical efficacy (justification level 1, basic), diagnostic efficacy (justification level 2), diagnostic impact (justification level 3) and so on, trying to reach therapeutic impact, patient outcome or socio-economic benefit.
- pag. 10 (357-358) “Individual patient radiation dose and risk – as we understand them – have not been disclosed to patients as a routine practice; this must change so that these data become no different from all other patient health information”. I partially agree on this point. Usually in interventional procedures or “high-dose” proocedures (CT, PET-CT- nuclear medicine) benefits and risks of medical exposure are disclosed with patients and their caregivers. The problem exists on low-dose procedures, such as conventional x-ray. The huge number of examinations and often excessive workloads make it impossible for a single radiologist to adequately inform all patients. Anyway adequate information on benefits/risks of medical exposure is a legal and ethical requirement. It must be considered that according to the LNT theory even the smallest dose of radiation exposes patients to a (“negligible”) risk of developing a neoplasm. If the task group considers it useful, a case study could be added as an example of 'good practice' describing a scenario of proper communication of benefits and risk of ionizing radiation in low-dose diagnostic imaging (digital imaging) and interventional radiology. In particular it could be useful to underline the importance of shared decision making and of an adequate time for communication with patients, in line with ICRP Publication 139 and Italian law (“The time of communication between medical practitioner and patient constitutes care time” as reported in article 1, paragraph 8 of Italian Legislative decree 219/2017) [5].
- pag. 21 (711-717) “(69) The health care provider must take into account not only the well-being of individual patients (according to beneficence, Section 2.3.1) but the effects of health care on others including other patients and the general public, to ensure the efficiency and even sustainability of the health care system. …. Efficiency and sustainability are promoted by avoiding the overuse of imaging and addressing the ever-growing costs of overuse of technological improvements outside of the context where they provide clinical benefit” I totally agree with this concept, this is a crucial point. In according to WMA Declaration of Geneva medical practitioner and radiologists, who assumes the clinical responsibility of the procedures, should consider first of all the health and well-being of the patient, but in a limited/non-infinite resource system efficiency and sustainability must be considered. Some potential effects of “productivity” are growing waiting lists, longer reporting times, overdiagnosis and overtreatment, overexposure (cumulative dose) of patients. These are central ethical issues in centered patient healthcare.
- pag. 29 (1067-1075) “(116) Shared decision-making for diagnostic and therapeutic procedures is often a key element in radiological protection in the clinical context (IAEA, 2011; Malone et al., 2012). Consent for diagnostic procedures is sometimes considered "implicit," but there is little evidence that patients can be assumed to have prior knowledge of the risks of different diagnostic procedures (Ribeiro et al., 2020). There is discussion in radiology about the appropriate manner of achieving transparent understanding of benefit/risk for diagnostic exams (Picano, 2004; Brink et al., 2012; Semelka et al., 2012). There is growing awareness that ethics and law support improving transparency by communication and education ((IAEA/WHO, 2014; Doudenkova and Belisle Pipon, 2016). Transparency of communication and education are other two fundamental points to improve ethical radiological practices. There is a worldwide growing culture about communication of benefits and risks of medical exposure and transparency about potential harmful effects of ionizing radiation. In my personal opinion education and training in radiation protection between health professionals are not equally proportional and a lot of work about this task should be done in the next future, especially in undergraduate and postgraduate courses.
- pag. 80 (2887-2890) “(305) Key Message 26: Everyone in the diverse groups of relevant stakeholders is responsible for assuring strong radiological protection and ethical values in health care. Each target group needs to be empowered and educated to ensure that patients are imaged and treated correctly”.I agree that is essential to strengthen education and training in radiological protection and its ethical aspects. In this regard the link between “code of ethics” of the different healthcare professionals involved in medical exposures and radiological protection ethical is particularly important.
- pagg. 80-81 (2913-2914) “(308) Key Message 27: Although it may be of value to integrate the ethics teaching into everyday practical education, it is necessary to provide specific, practical teaching on ethics” …. (2936-2943) “(311) The clinical value of the use of radiation technologies in medicine are clear; however, inappropriate or unskilled use of such radiation technologies or failure to provide appropriate equipment and/or education may increase risk and result in harm for patients and/or workers. 2939 Examples of inappropriate or unskilled use include inappropriate imaging requests, failure to optimise an imaging protocol or a calibration for a patient, use of suboptimal equipment or techniques or applying pressure to image or treat patients too quickly resulting in a failure to complete the full range of checks prior to exposure or to understand why they are necessary.(NPR, 2009; New York Times, 2010; Tamarat and Benderitter, 2019). This practical approach to aspects of radiation protection ethics is fundamental. Medical practitioners/radiologists who have the clinical responsibility of the procedure, and all the healthcare professionals that are part of the optimization team (radiologists/radiation oncologists, medical physicists, radiographers), as defined by TG 108, must keep in mind that overexposure or underexposure are medical errors. They should be considered errors such as overdose and underdose of antibiotics .
REFERENCES
[1] Working hypothesis for the drafting of ethical-deontological regulations in radiodiagnostics and interventional radiology. Corrado Bibbolino, Zairo Ferrante, Stefano Canitano, Roberta Chersevani. Journal of Radiological Review 2020 May-June; 7(3):165-72 (DOI: 10.23736/S2723-9284.20.00013-2)
[2] “the new radiologist” (Italian text), approved by the central committee of FNOMCeO (the National Federation of Medical and Dental Councils) on the 19 october 2018.
https://areasoci.sirm.org/download/4186
[3] Documento SIRM CORPUS ETICO-DEONTOLOGICO DEL MEDICO RADIOLOGO. Corrado Bibbolino, Zairo Ferrante, Stefano Canitano, Roberta Chersevani (2020)
https://sirm.org/wp-content/uploads/2021/04/313-Documento-SIRM-2020.-Corpus-etico-deontologico.pdf
[4] The Radiological Medical Act. Radiol med (2008) 113:319–328 (DOI 10. 1007/s11547-008-0266-5)
https://areasoci.sirm.org/download/186
[5] Legislative decree 219/2017. “Rules on informed consent and advance treatment provisions”. GU General Series n.12 of 16-01-2018
https://www.gazzettaufficiale.it/eli/id/2018/1/16/18G00006/sg