Incidental Findings and the Need for a Revised Informed Consent Process

Kole, Jonathan; Fiester, Autumn

doi:10.2214/ajr.13.11138

Cited by 29 publications

(22 citation statements)

References 21 publications

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“…The handling of incidental findings outside the target organ is both ethically and legally sensitive. Therefore, whether the participant would like to be informed of such findings should be defined in writing during the informed consent discussion [9]. Diagnostic assessment of incidental findings was mentioned on 28 of the analyzed websites but as a fact and not as a process to be defined in a common dialog.…”

Section: Examination-specific Aspectsmentioning

confidence: 99%

Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example

Brix

Nekolla

Griebel

2019

Fortschr Röntgenstr

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Background Radiological imaging offers promising prospects for the early detection of diseases. In Germany, the legal framework for such examinations was created by the Radiation Protection Law, which entered into force on December 31, 2018. Under this law, each specific type of radiodiagnostic screening of non-communicable diseases needs an approval on a generic level (permission) by a federal statutory ordinance, defining the specific requirements and conditions. It is the aim of the present paper, (i) to present in detail the new legal situation and (ii) to assess actual service offers for the screening of asymptomatic persons using CT examinations as an example. Method In February 2019, radiology institutions in Germany illegally offering on the Internet CT examinations for the screening of lung and colon cancer or coronary artery disease were identified. For each type of examination, 50 pertinent websites were evaluated particularly regarding the general information on the offered screening examination and the concrete procedure. Results In the vast majority of cases, the information provided on the websites was inadequate and disproportionately emphasized the benefits over the risks of the screening examination. Moreover, the offers differed substantially with respect to the age and risks factors of potential participants, the frequency of examinations, the screening procedure, and the diagnostic workup. Conclusion The evaluated service offers strongly substantiate the need to define requirements and conditions regarding radiological screening examinations by statutory ordinances, in order to ensure an informed decision of potential screening participants as well as the benefit versus the risks of the procedures. Key Points: Citation Format

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Section: Examination-specific Aspectsmentioning

confidence: 99%

Early Detection of Diseases by Radiological Imaging: New Legal Situation and Evaluation of Service Offers using CT Examinations as an Example

Brix

Nekolla

Griebel

2019

Fortschr Röntgenstr

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“…A second strategy to reduce the frequency of incidentally detected lung nodules is to inform parents of the risk of this possibility as part of an informed consent process prior to performing a chest CT, as has recently been proposed [8,45]. This approach remains controversial even in adults, because the perceived risk may be much larger than the actual risk.…”

Section: Preventionmentioning

confidence: 99%

The incidental pulmonary nodule in a child

et al. 2015

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The incidental detection of small lung nodules in children is a vexing consequence of an increased reliance on CT. We present an algorithm for the management of lung nodules detected on CT in children, based on the presence or absence of symptoms, the presence or absence of elements in the clinical history that might explain these nodules, and the imaging characteristics of the nodules (such as attenuation measurements within the nodule). We provide suggestions on how to perform a thoughtfully directed and focused search for clinically occult extrathoracic disease processes (including malignant disease) that may present as an incidentally detected lung nodule on CT. This algorithm emphasizes that because of the lack of definitive information on the natural history of small solid nodules that are truly detected incidentally, their clinical management is highly dependent on the caregivers' individual risk tolerance. In addition, we present strategies to reduce the prevalence of these incidental findings, by preventing unnecessary chest CT scans or inadvertent inclusion of portions of the lungs in scans of adjacent body parts. Application of these guidelines provides pediatric radiologists with an important opportunity to practice patient-centered and evidence-based medicine.

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“…The most prominent example within radiology is the suggestion to include the discovery of incidental findings in the informed consent process (12). Although incidental findings typically refer to poorly understood hyperintense foci of signal within the abdominal organs, a 2-mm aneurysm could easily fall under this umbrella when an emergency physician orders an enhanced head computed tomography (CT), CT angiography, or magnetic resonance imaging for another reason.…”

Section: Ethical Issues Surrounding Testing and Uncertaintymentioning

confidence: 99%