Justification of CT for Individual Health Assessment of Asymptomatic Persons: A World Health Organization Consultation.

An international expert consultation was convened by the World Health Organization (WHO). The purpose of the meeting was to review the use of CT in examining asymptomatic people. This is often referred to as individual health assessment (IHA). IHA was identified as a global phenomenon unenthusiastically tolerated, and not actively promoted, structured, or regulated in most countries. This paper identifies the state of the art for IHA and some considerations in relation to its justification, in different regions of the world. The outcomes reached include the following: questions around terminology and culture of IHA practice; review of IHA in some countries, regions, and international bodies; dilemmas for participants in IHA; risk communication, education, and training for professions and public; the desirability of guidelines and clinical audit; social, ethical, public health, and resource considerations; and a framework for IHA and regulatory considerations. Three subcategories of examination for asymptomatic individuals were identified: formal screening programs; examinations for which the evidence base or risk profile is incomplete; and opportunistic examinations with little or no evidence or risk profile to suggest they have any merit. The latter challenges the justification principle of radiation protection. In addition, the issue of the costs, direct and indirect, associated with false positives and/or equivocal/incidental findings were highlighted. These and other considerations make it difficult to view some IHA as a bona fide medical activity. To allow it to be viewed as such requires that it be conducted within a robust clinical governance framework that includes regulatory dimensions.

Introduction

The United Nations’ World Health Organization (WHO) fosters a Global Initiative on Radiation Safety in Health Care Settings with a view to promoting safety and quality in the medical uses of radiation [1]. This demands policies that recognize its many health benefits while minimizing the related risks. The safety requirements for medical exposure are clearly articulated in the new International and European Basic Safety Standards (BSS) and supporting documents. They include, among other requirements, justification of procedures and optimization of protection and safety, including requirements for imaging asymptomatic individuals 2, 3, 4.

CT is among the more successful and widely deployed of the newer medical imaging techniques [5]. The spectrum of its applications in health care has expanded and this was accompanied by an increased contribution to the population radiation burden, with associated probable risks 6, 7, 8. The increase in dose and risk is regarded as worthwhile in medicine when there is a real need for the procedure and it yields a benefit that compensates for the risk. In addition to the use of CT in patients with signs and/or symptoms, it is also deployed for imaging asymptomatic people for what is referred to as individual health assessment (IHA), even when there is little or no evidence that it is worthwhile. This occurs, with CT, in some instances of coronary artery calcium scoring; in investigation of coronary artery plaques; in detection of cancers of the lung, colon, and abdominal cavity; in whole-body CT surveys; and in many other areas. These practices are over and above the normal medical usage that would apply to symptomatic persons. They are also outside approved screening programs 2, 3, 9, 10.

Initial concerns about IHA often arise from an unfavorable balance in benefit/risk trade-off associated with exposure to ionizing radiation 11, 12. However, many of these problems also apply to imaging with non–ionizing radiation modalities such as ultrasound (US) and MRI. More general medical, social, resource, and governance considerations arise with most forms of IHA. In addition, the public can be persuaded, in a laissez-faire IHA imaging market, that IHA is key to early diagnosis. This is simplistic and misleading, and masks many confounding factors and risks.

WHO convened an international expert consultation in Munich, Germany (October 2014), to address the use of CT for IHA in asymptomatic persons. The consultation reviewed the current status of IHA practice, including the terminology used, justification, and its social, ethics, resources, public health, and regulatory dimensions, as well as other pertinent matters. An international workshop in Seoul, Korea, in September 2016 will further address these concerns and help identify the framework and policy options for IHA in future.

The objective of this paper is to provide an overview of the consultation, including the reported summary of the state of the art for IHA in different regions of the world, and a summary of the consensus that emerged from the discussions. It provides a useful platform for the further work envisaged. Those participating in the meeting, from a wide range of professional and geographic backgrounds, are listed in Appendix 1.

State of the Art

In this section, the state of the art for IHA in various parts of the world is summarized, based on the contributions of participants and on a review of the existing literature. This, though suspected, was not previously documented other than in the most fragmentary way. This section summarizes:

Terminology and culture of IHA practice,

Perspectives from national/international bodies,

Practice in countries and regions,

Public health, resource, and other considerations,

Dilemmas for various participants in IHA, and

Regulatory considerations.

Further developments on some of these headings emerged during the consultation and are presented later in the section on new consensus positions reached.

Terminology and Culture of IHA Practice

The prevailing health care model for radiology is one in which a patient, with symptoms or likelihood of disease, presents to a physician. When further information is needed, the patient may be referred for radiological investigation(s). The model assumes that the actions of the various professionals involved are embedded in an evidence base. The physician (eg, a general practitioner or specialist) that is initially attended by a patient is known as the referring medical practitioner, sometimes abbreviated to referrer. The professional responsible for the radiological examination is known as the radiological medical practitioner 2, 4. Some differences in use of terms arise in the international organizations 3, 13, 14. When the term practitioner is used on its own in this paper, the meaning will generally be clear from the context.

A patient is a person who is a recipient of health care [15]. In this context, a person on whom an examination is performed is the patient, as this term is commonly understood. However, an asymptomatic person presenting for a radiological procedure as part of IHA is frequently not a patient in this sense. For convenience, such persons are here referred to as the presenter. The distinction between patient and presenter is not without controversy, as noted later. For example, it may be further exacerbated if the presenter is not only symptom free, but is also in a risk-free category.

The principles of radiation protection associated with exposure of a patient for medical purposes require that exposure be justified. The recommendations of the International Commission on Radiological Protection (ICRP), the International BSS, and the European BSS all require that justification of medical exposures be predicated on the medical need of the individual involved. On balance, they all agree that any radiological procedure must result in more benefit than risk (ie, a net benefit) 2, 3, 13, 14.

Population screening involving apparently healthy, symptom-free individuals, as opposed to patients, is a significant departure from this model. In screening programs justification is based on a social or group (as opposed to individual) determination of the balance between benefit and risk in the population examined. This was an innovation in the understanding of medical justification, as it is predicated on benefit to the group as opposed to the individual. Formally recognized and accepted screening programs have a robust evidence base, in which the benefits to the community screened are set against the detriment. In addition, they have the approval of health authorities and/or professional bodies and stringent quality requirements that extend to all parts of the program 2, 3. Their intent is to identify clinically relevant risk factors or latent pathology at an early stage, where treatment can improve clinical outcome [16]. National breast screening programs are a good example. However, even formal screening programs are not without controversy, often focusing on risk–benefit balance 17, 18, 19, 20.

IHA, as discussed here, in some cases operates outside a well-developed evidence base. The examinations may be conducted on an opportunistic basis, for example arising from presenters’ anxiety or practitioners’ willingness to perform unjustified examinations. Examinations conducted under such circumstances must be clearly distinguished from approved screening programs. Presenter demand, inappropriate medical advice, a poor or absent evidence base, and absence of any relevant risk profile in the presenter’s history are features of this type of IHA [9]. However, notwithstanding all of this, procedures may sometimes be performed in good faith, when the practitioner and/or the presenter have knowledge of an asymptomatic presenter’s risk profile. These should be given due consideration, even when the evidence base is not fully developed. In this paper the terms IHA and radiological IHA refer, interchangeably, to radiological examinations conducted on asymptomatic individuals outside formal population screening programs.

Perspectives from National/International Bodies

ICRP identified a three-level approach to justification of medical exposure: (1) general, (2) generic for particular techniques, and (3) for individual patients undergoing a particular examination 13, 14. The International BSS and the European BSS both provide a robust framework for justification of medical exposures and devoted particular attention to the special case of recognized screening programs 2, 4, 21, 22, 23. This has also been reflected in the Bonn Call for Action [4]. The discourse on justification in these documents is largely benefit/risk driven. The justification process requires more considered development for application in IHA, in which additional concerns apply, including presenter autonomy and consent.

In addition, some international organizations have developed approaches that may help in establishing a framework for radiation protection in radiological IHA. For example, the Heads of European Radiological protection Competent Authorities position paper underlines the need for a clear distinction between formal screening programs and radiological IHA [9]. It notes the often weak/nonexistent evidence base for net benefit, individual or social, from IHA, and addresses a list of general requirements that must be fulfilled for justification of specific IHA activities [9].

Some national bodies also provide advice referring to concrete scenarios, which may have a more general application. For example, in the UK, reports from the Department of Health and the Committee on Medical Aspects of Radiation in the Environment present valuable perspectives on IHA 24, 25, 26. The positions developed include a recommendation that whole-body CT screening of asymptomatic individuals cease. They also provide useful and nuanced recommendations related to lung cancer, colon cancer, and coronary heart disease. In general, national bodies are not enthusiastic about IHA. At least part of the reason for this lies in the inevitably high numbers of follow-up examinations as well as the typically high rate of false positives, and the equivocal/incidental findings that arise with IHA. The resource consequences of dealing with them is also a major concern.

Other aspects of the problem, for example population dose, are treated elsewhere in general advice on CT for early detection of various cancers and cardiac diseases. While generally relevant, this is not the central issue in this paper 9, 10, 16.

Practice in Countries and Regions

Radiological IHA practice throughout the world was reviewed in presentations from many regions and countries. The presentations available are listed in Appendix 2, and can be accessed at [27]. They provide useful qualitative findings, including the following:

The practice of radiological IHA is almost universal.

It is present in developing countries and the developed world.

It exists mainly in the private sector.

It is not generally embedded in clinical care pathways.

It suffers from inadequate follow-up.

It may have limited quality assurance processes, poor records, and poor information transfer.

Associated detriments may include stress arising from false-positive or false-negative findings, and morbidity and significant harm arising from overdiagnosis/overtreatment and unduly aggressive follow-up, as well as from incidental findings. Promotion using advertising and social media can be an important part of radiological IHA. Although some authorities seek out IHA, most do not. Even where authorities find it, there is reticence about intervention, for many reasons. These include the importance of issues of personal freedom and presenter empowerment, as well as uncertainty about the effectiveness of interventions in medical practices among regulators [28].

In some regions (eg, Asia), it seems that consumers dictate what is to be done; both health authorities and radiation regulators are relatively passive. In other regions (eg, Europe), the Heads of European Radiological protection Competent Authorities surveyed its member states and reported that the practice exists (or may exist) in most, even though it is not permitted in some 10, 29. In a small number of countries, some IHA activities are banned outright. Where it is not forbidden, the framework for its regulation and/or good practice does not exist. Practice even in adjacent countries can be very different, which both creates market opportunities and distorts local practice. This can occur also in other areas, for example in health tourism. Commercial services offering CT scans to individuals for the detection of lung, cardiac, and colorectal disease are available in the United States and in some parts of Europe (eg, Germany and the United Kingdom).

It was also noted that radiological IHA is not confined to CT. Examples include much dental radiography, examinations for osteoporosis, some routine radiology, and x-ray mammography (involving asymptomatic individuals)—even in countries with approved screening programs.

Public Health, Resource, and Other Considerations

The WHO definition of health as a state of complete physical, mental, and social well-being is broad, including ethical, social, public health, and resource considerations [30]. The radiation protection system has an ethical dimension that is not explicitly stated but is currently being reviewed/further elaborated 13, 14, 31, 32, 33, 34. It is important to be aware that the system of radiological protection recommended by the ICRP is based on a mixture of scientific evidence, practical experience, and value judgments. The three ICRP principles—justification, optimization, and dose limitation—should take account of the values generally informing medical practice and ethical behavior in society. A pragmatic set of such values recently presented and explored includes (Table 1) 31, 34, 35:

Table 1

Pragmatic value set to be considered in radiation protection in individual health assessment [34]

Number	Value Set	Comments
1	Dignity and Autonomy	Of the individual
2	Nonmaleficence; Beneficence	Do no harm; do good
3	Justice	In the sense of “fairness”
4	Prudence/Precaution	As in “Precautionary Principle”
5	Honesty	Particularly in openness and transparency

Dignity and Autonomy (of the individual).

Nonmaleficence and Beneficence (do not harm and do good).

Justice (be fair).

Prudence (keep in mind possible long-term risks of actions), and

Honesty (share knowledge with those concerned truthfully).

The ethics values in Table 1 are socially sensitive and necessary for radiological IHA, if it is to function in accord with contemporary social, philosophical, and medical thinking. The values must be nuanced in their application, as their varying requirements will inevitably conflict with each other and with existing practices. For example, dignity and autonomy are essential for justification, and give rise to a requirement for implicit or explicit consent. In addition, they come into conflict with nonmaleficence (ie, do no harm). The precautionary principle implies looking at the potential for serious harm before it happens, even where the evidence base is incomplete. It has been adopted in the environmental and climate change fields at the highest levels 36, 37.

WHO places a high value on identification of the right patient, for the right examination, at the right dose. An important part of this is considering the cost of examinations and how they can be best deployed in the health care system [38]. If IHA is to be part of the health care system—and many feel it should be—it must take account of this context. This will require some adjustment to how it functions now. Present reimbursement models might be adjusted to encourage necessary changes, as further discussed below.

IHA leads to false positives and incidental/equivocal findings. The consequences of dealing with these in terms of resources can be significant 18, 19, 20, 39. This, and its management, is further discussed later in the paper.

Dilemmas for Practitioners, Referrers, and Presenters

Although both the European BSS and International BSS address radiological examination of asymptomatic persons, a good framework for the practice of IHA remains to be developed. Thus dilemmas inevitably arise for those involved (ie, referring medical practitioners, radiological medical practitioners, and presenters). Some practitioners are conflicted when confronted with inappropriate referrals and/or unreferred presenters. Professional vested interests and fear of litigation can add to the problems of all practitioners.

The motivations of presenters may be complex and include both personal and cultural/public health influences. Government initiatives promoting the idea that individuals look after their own health will have a powerful impact in some countries. In addition, cultural approaches that encourage individuals to look after their family’s health, and specifically the health and well-being of elderly parents, are important drivers.

Fear of future disease is often a powerful influence for presenters and can undermine the justification process when a practitioner is confronted with it. This may occur when, for example, the presenter has been exposed to well-publicized but not necessarily proven risk factors. Likewise, the desire to be able to confirm good health can be a significant motivator in both presenters and practitioners. Advertising can play on fear, exaggerating benefits/convenience, and failing to mention associated risks. It may move patients away from simpler, more effective approaches to their health. In practice, the path to successful early detection of disease is far from simple. In addition, apparent enhanced survival for those participating in screening programs can be overstated, if due allowance is not made for the impact of confounding factors, such as lead time bias in early detection 39, 40.

Imaging using ionizing radiation is open to the dilemmas surrounding dose and risk. CT scanners are center stage in this area, being responsible for substantial increases in individual and population exposures, with corresponding increases in the estimated risks 5, 6, 26, 41. These concerns are recognized and possible contributions to future cancer risks are acknowledged [42]. In this context, prudence and precaution must be exercised. This, however, must be balanced against known or suspected risk factors for disease in those presenting for IHA. The situation is further complicated by the promise of CT systems delivering overall effective doses in the mSv or sub-mSv range. However, even with these improvements, target organ doses from newer systems will, in some cases, continue to be high. In addition, it is probable that the installed base of higher-dose equipment may remain in place for many years to come.

Regulatory Considerations

Regulation of radiological IHA is particularly challenging. At least some variants of IHA challenge the ICRP principle of justification and its application at levels 2 and 3. In addition, there are unresolved issues with individual autonomy and major resource questions. To address these, it is essential to develop a robust framework, some of which must be regulatory.

Significant differences in both regulation and practice throughout the world make it difficult to determine how best to proceed. The international bodies expect clear documented justification as well as guidelines from professional bodies and/or competent authorities, if IHA exposures are to be regarded as medical 2, 3, 43. Notwithstanding, a great range of practices exist throughout the world and even within one region. For example, in Germany, radiological IHA is not regarded as part of health care and is not allowed within the scope of the German X-Ray Ordinance. Yet the legal base for this is intensively discussed. With respect to the revision of both the International and the European BSS, the German Radiation Protection Commission has produced requirements for justification of radiological IHA. The discussions continue and will become even more important with the transposition of the European BSS into national legislation.

On the other hand, the UK amended its medical exposure advice and regulations to include IHA. The Committee on Medical Aspects of Radiation in the Environment and the Department of Health provide guidance, as noted previously 24, 26. In Holland IHA for asymptomatic individuals is not allowed, and this is enforced. However, many feel this simply exports the problem for presenters, who avail themselves of IHA in neighboring states with a different regulatory framework or more tolerant practice. In Israel, national insurance covers CT for IHA, provided it is “justified” in a written referral. In Korea, it is not regulated, but there is a view that it should be embedded in the health care system. Finally, it is important to bear in mind that IHA problems are not only, or even mainly, radiation protection concerns, although the radiation regulatory framework may be helpful in addressing them [27].

Consensus of Participants on New Positions

The consultation not only identified the state of the art with respect to radiological IHA, but it went on to develop a consensus on the ways to approach IHA in a more considered fashion in the future. These developments include a refinement in the terminology, and are set out under the following headings:

Terminology,

Risk communication and dialogue for presenters and professionals,

Guidelines and clinical audit,

Social, ethics, public health, and resource considerations,

Education and training of professionals and public,

Future framework and regulatory considerations.

Terminology

Two developments in terminology were made. First, with respect to the term presenter: he/she may be regarded as a patient, a client, a customer, or a healthy individual by different professional groups. The presenter may regard him/herself as a healthy individual and/or a paying consumer who, in the event of positive findings, can become a patient. Obviously, imposing the status of patient on healthy individuals is a serious matter and not to be done lightly. These concerns must be further explored, and in doing so it is possible that significant differences may emerge between presenters on the one hand and health professionals on the other. In particular, some presenters may be resistant to medicalization of what they view as service provision on a commercial basis. Additional nuanced terminology and/or a revised understanding in this area may be needed.

Second, the spectrum of practices involving radiological imaging procedures for asymptomatic people extends from formal approved population screening programs to the more extreme forms of IHA (Table 2). Table 2 presents three identifiable types of activity. These are:

Table 2

Three forms of practice involving radiological imaging of asymptomatic individuals

	Formal Screening Program	IHA(A)	IHA(B)
Participants	Populations	Presenters/Patients	Presenters
Who pays?	Public health care services	Presenter, insurer, or employer	Presenter or employer
Service provider	Health care system	Usually practice or hospital	Usually private practice or private hospital
Referral by	Health care system	Presenter’s employer, physician, or other health care professional, self-referral, self-presentation	Presenter, self-referral (conflicts of interest may exist), self-presentation, other referrers or practitioners
Recognizable features	National approval and/or approval by professional bodies; population-based rather than individual justification; demanding governance framework, and quality assurance program along the whole screening chain	At least partial evidence base; risk profile considerations; evolving research findings; individual justification; additional requirements concerning justification and quality assurance; possibly a register	No framework∗

Note: IHA = individual health assessment.

For acceptability as a medical practice, framework or similar essential.

Approved evidence-based formal population screening programs;

IHA(A), in which some evidence base is available that might justify examinations. This type of IHA occurs in areas with an incomplete but evolving research base. IHA(A) may also be found where the presence of known risk factors becomes a consideration in established clinical pathway(s). This can be the case with, for example, subgroups of patients who have risk profiles that render them eligible for cardiac, lung, or colon procedures. Some IHA(A) procedures may evolve and become approved screening programs. The challenge is to define requirements concerning both quality assurance and the justification process in terms of available, if incomplete, evidence and knowledge of the impact of risk profile. In addition, it is probable that there will be many competing demands for approval as screening programs.

IHA(B), in which there is little or no evidence base or risk profile to indicate the examination is worth doing. The examination may be entirely opportunistic. The drive to have it performed may lie with the presenter, the referrer(s), and/or the practitioner(s) involved. In this situation, a presenter’s case may rest, partially if not completely, on balancing the value of individual autonomy against that of do no harm (Table 1). Where the drive comes from the professionals, it may be influenced by many streams of motivation and these require further consideration and analysis.

Table 2 identifies characteristics of the three groups of radiological imaging procedures for asymptomatic people, including the payers, the service providers, and the referrers, and some recognizable features that characterize them. In the fullness of time, more formal recognition of IHA(A) procedures may be achieved as their evidence base evolves, particularly if it can be incorporated into guidelines.

IHA(B) is presently difficult, if not impossible, to justify, and it challenges the ICRP concept of justification at a fundamental level. It is also, for practical purposes, unregulated and unaccountable in most countries. It is thus not acceptable as a medical procedure in its present form. Depending on the level of scientific evidence, this might be altered through the definition of requirements concerning justification and quality assurance and/or the establishment of registers of IHA(B) practitioners, presenters, and outcomes. Based on these, it would be possible to improve oversight and, perhaps, yield a social dividend through contributing to understanding early incidence and progress of disease. This type of framework might change the balance of benefit and risk sufficiently to allow some IHA(B) activities be considered as bona fide medical procedures. More work is necessary to explore this approach.

Many professionals and providers use the term “screening” for all three categories in Table 2. Here we limit use of the term to formally approved screening programs to highlight the fundamental differences between them and IHA(A)/IHA(B).

Risk Communication and Benefit–Risk Dialogue With Presenters

New imaging technologies may carry significant risks for presenters. The risks and benefits must be explained together with the modifying factors and uncertainties involved. Communication must be honest, open, and transparent and may be assisted by leaflets, tables, and short videos. Presenters may already be in receipt of information from the internet, media coverage, and social media. Justice and dignity demand that promotion in advertising or social media, where permitted, must be honest; should not mislead the individual; and should, in keeping with prudence and precaution, note benefits, risks, and potential risks. As already noted, the risks include not only those from radiation, but also false positives, false negatives, and incidental and unclear findings, as well as the potential harm from overdiagnosis and overtreatment.

The information should help manage expectations. The communication should be predicated on obtaining fully informed consent, where the examination cannot be medically justified and the probability of risk is significant. This applies even in countries where consent may not be required by regulation or good practice for otherwise justifiable radiological examinations. If there is little possibility that the outcome can be of value, this should be clearly explained as part of the consent process.

Appropriateness Guidelines and Clinical Audit

Evidence-based or consensus imaging guidelines are important tools for implementing justification of medical imaging procedures for specific clinical conditions [44]. For the particular circumstances of IHA, special guidelines for practitioners, referrers, and presenters might also be considered. These should relate to risk of, rather than symptoms of, the conditions concerned. However, some of the considerations in their development and deployment will inevitably depend on whether or not IHA is viewed as a health care activity.

Successful guidelines require the involvement of general practitioners and other referrers, radiologists, nuclear medicine specialists, cardiologists, pulmonologists, oncologists, gastroenterologists, et al. Additional stakeholders will be required to represent social issues, including involvement from international organizations, public health experts, patient advocates, epidemiologists, health economists, policymakers, and consumer/community groups. Guidance on the approach to equivocal, incidental, or false-positive findings and their communication to presenters will be important.

Clinical audit is a critical adjunct to the justification process and must be part of effective radiological IHA programs. Audit should monitor the outcomes of IHA and assess their follow-up. It should also evaluate compliance with policies and with general and specific guidance addressing requirements for justification and quality assurance programs. This may include dose reference levels and/or dose constraints where they apply. More ambitious targets for audit might include input to research programs that seeks to build a socially valuable data and evidence base arising from IHA.

Social Ethics, Public Health, and Resource Considerations

Ethics and resource considerations are important, as are concerns about false positives and incidental findings and the aspiration that radiological IHA should yield a social dividend. The principles of ICRP (particularly justification and optimization) must be implemented taking due account of the values noted in Table 1. For example, the importance of Beneficence/Nonmaleficence arises immediately in IHA. This provides a transparent basis for judgment. It must be balanced against the importance of giving appropriate weight to the dignity and autonomy of the presenter, particularly if the presenter is among the worried well.

Patient autonomy and physician paternalism will be important counterpoints in shaping the future of radiological IHA. Respect for both “patient rights” and “physician duties” are essential. Physicians have many duties, including duty of care, fiduciary duty, duty to obtain consent, and duty to disclose without being specifically questioned. Radiological medical practitioners’ duties include, in addition, an obligation to provide CT services in a regulated environment, and a duty of care in respect of the technical performance of examinations 2, 3, 45. Radiological practitioners must, ideally, make every effort to ensure the right image is obtained at the right dose for the right patient, even in IHA. Sometimes the right image may be no image, when there is no foreseeable benefit to the procedure. Many ultimately feel the value of do no harm trumps individual autonomy, as the latter can lead to unnecessary and/or inappropriate risk of probable harm.

The other values in Table 1 also have an impact. For example, prudence creates a requirement to review the risks and benefits to both the individual and society. Likewise, there are imperatives from justice, particularly in respect of a fair distribution of services. Where a practitioner has a conflict of interest related to their IHA practice, it must be disclosed to presenters [21].

More generally, justice and honesty require that the resources committed to IHA, and the consequences of conducting it, especially in respect of incidental/equivocal findings and false positives, must be reviewed. The charges involved may not arise in the clinic in which the IHA was conducted and may be diverted into the general health care system, often in the public sector. Thus, follow-up of IHA can potentially divert resources from more needy patients and add to inequality, often with little gain in real health outcomes 39, 45, 46.

It has been argued that the presenter should be liable for the real costs of an IHA investigation that initiates a diagnostic/therapeutic chain of interventions. However, a more equitable and less punitive approach may be possible if IHA providers are required to operate a bond or insurance system to provide for follow-up procedures. This would help mitigate the potential impact of IHA on public health services. Services to symptomatic patients would not be displaced or delayed because of diversion of resources to follow-up, for example, incidental or uncertain IHA findings. However, much more work on financial models of IHA is required and must include discussion of when the IHA presenter becomes a patient entitled to access the public hospital system. Registers would facilitate modeling and help mitigate some of the problems raised here.

Education/Training of Professionals/Public

Radiological IHA requires commitments to education and training, which share much with those for health professionals in general but also address its own specific requirements. The training and education must be integrated into existing undergraduate and specialist postgraduate programs (including Continuing Medical Education / Continuing Professional Development) and be required for maintenance of professional certification/accreditation. Particular attention should be given to optimization and justification, including the 3As, Awareness, Appropriateness, and clinical Audit [21]. In addition, the required technical skills, as well as the broader social, ethics, and resources issues in which the practice is necessarily embedded, are important. Likewise, incompleteness of the evidence base, where it exists, must be emphasized.

It will be exceptionally important to develop education and health promotion initiatives aimed at raising public awareness. WHO can play a critical and influential role with regard to both professional and public education [47].

Regulation, Framework, and Control

Radiological IHA explores many body systems and has a global reach. Yet it lacks a framework to ensure that it operates in the best interests of the presenters who avail themselves of it and the communities that host it. Such a framework must be developed by regulators, competent authorities (primarily health authorities, but also radiation protection authorities), policymakers, the professionals involved, and patient/presenter representatives. They must ensure that it achieves a good balance between the interests involved, for example, between a presenter’s sense of entitlement and good public health practice. If IHA is to be part of the health care system, it must operate within a framework for good clinical governance, which requires development of arrangements for regulation, compliance and good practice. It should not challenge radiation protection's justification principle, or be wasteful.

The most challenging aspect of IHA, from regulatory and good practice perspectives, is the IHA(B) subcategory, in which there is little or no evidence base to justify the activity, and in which there may be significant financial and social costs. Some feel IHA(B) should be rejected outright, and this will most probably result in more restrictive measures in future in some countries. Others held a strong view that these problems should be addressed within a medical framework and be embedded within the health care system (rather than be viewed as a nonmedical consumer activity). However, the actions required to ensure that IHA(B) examinations are regulated and compliant medical exposures are problematic for some.

On the other hand, the basis for medical justification of both IHA(A) and national screening programs involves developments in the application of this principle to allow collective, as well as individual, benefits to be reckoned in the medical justification process. The fact that such developments have occurred is helpful in considering IHA(B), especially given the ethical, social, and public health issues involved 3, 34. A successful framework for radiological IHA must also balance enforcement tools such as legislation, directives, recommendations, guidelines, and protocols. Although radiation may not be radiological IHA’s main source of detriment, radiation regulators must consider it and they may, perhaps fortuitously, find themselves in a position to lead on moving it toward good practice.

The regulation and practice framework associated with formal screening programs is robust, well developed, and widely accepted in the professional communities. Among the public this consensus is also widespread, but pockets of distrust remain to be convinced. The international organizations like WHO, the International Atomic Energy Agency, the European Commission, and other regional organizations will play a critical role in facilitating consensus building and in securing the attention of governments and professions. A significant evidence base is developing for some well-defined subpopulations that may be at risk (eg, with cardiac, lung, and colon diseases). IHA(A), with these groups, does not fundamentally challenge the concept of justification, though some developments in its application may be warranted. IHA(B), on the other hand, fundamentally challenges the ICRP principle. Any approach to its development, including options based on social or ethical concerns, will have to address this challenge. If it is to be developed within medicine, a framework is required that will allow an evidence base to emerge. Collection and regular review of records, their incorporation into local/national medical record systems, and the establishment of registers of practitioners and presenters would advance this.

What is necessary for good radiological IHA, if such can be achieved? A robust, well-defined framework for good governance is essential. This must include levels of process control, oversight, and input from professional organizations as good as, or better than, those prevailing in mammography screening. Staffing, facilities, technical equipment, protocols for quality assurance, informed consent, performance of examinations, interpretation of scans, confidentiality, record keeping, clinical audit, and acceptability guidelines would all have to be at least as demanding as those deployed in health care or approved screening settings. Registers could function as regulatory tools but, through generation of useful data, could begin to rebalance the evidence deficit. Ultimately, the solution(s) identified must create a working framework for the many concerns raised in this paper.

Take-Home Points

New definitions differentiating screening programs from individual health assessment (IHA) are developed.

Substantial heterogeneity exists in health care approaches to and regulation of IHA.

Large social/financial cost and individual risk burden arises from aggressive follow-up of IHA.

Some IHA challenges the radiation protection principle of justification.

It is desirable that IHA yield a social benefit.

Consensus existed on the need to develop a regulatory and operational framework.

Stop talking about saving lives—we only postpone death.

Name(Alphabetical Order)	City and Country
Gunnar Brix	Neuherberg, GERMANY
Lilian Corra	Buenos Aires, ARGENTINA
Sandor Demeter	Winnipeg, CANADA
Steve Ebdon-Jackson	Chilton, UK
Eva Godske Friberg	Østerås, NORWAY
Gloria Soto Giordani	Santiago, CHILE
Jürgen Griebel	Neuherberg, GERMANY
Bernd Grosche	Neuherberg, GERMANY
Priyank Gupta	Dubai, UNITED ARAB EMIRATES
Azza Hammou	Tunis, TUNISIA
Iona Heath	London, UK
Bruce Hillman	Charlottesville, USA
Tsuneo Ishiguchi	Aichi, JAPAN
Seung Eun Jung	Seoul, SOUTH KOREA
Michael Kawooya	Kampala, UGANDA
Lawrence Lau	Melbourne, AUSTRALIA
Osnat Luxenburg	Jerusalem, ISRAEL
Jim Malone	Dublin, IRELAND
Irfan Mamoun	Jeddah, SAUDI ARABIA
Giles Maskell	Truro, UK
Miriam Mikhail	Geneva, SWITZERLAND
Elke Nekolla	Neuherberg, GERMANY
Stephanie Newell	Sydney, AUSTRALIA
Narayan Pendse	New Delhi, INDIA
Maria del Rosario Pérez	Geneva, SWITZERLAND
Eugenio Picano	Pisa, ITALY
Mathias Prokop	Nijmegen, THE NETHERLANDS
Katrine Åhlström Riklund	Umeå, SWEDEN
Asadur Tchekmedyian	Montevideo, URUGUAY
Peter Vock	Bern, SWITZERLAND
Liang Wang	Wuhan, CHINA