Incidental Findings and the Need for a Revised Informed Consent Process

Transcription

1 Health Care Policy and Quality Clinical Perspective Kole and Fiester A Revised Informed Consent Process Health Care Policy and Quality Clinical Perspective Jonathan Kole 1,2 Autumn Fiester 3 Kole J, Fiester A Keywords: clinical practice, CT, ethics, incidental findings, informed consent, patient care DOI: /AJR Received April 25, 2013; accepted after revision June 19, Triple Board Program, Rhode Island Hospital/Bradley Hospital, Brown University, 593 Eddy St, Physicians Office Building, Ste 122, Providence, RI Address correspondence to J. Kole (jonathan_kole@brown.edu). 2 Department of Child and Family Psychiatry, Brown University, Providence, RI. 3 Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. AJR 2013; 201: X/13/ American Roentgen Ray Society Incidental Findings and the Need for a Revised Informed Consent Process OBJECTIVE. The current clinical practice with regard to incidental findings (IFs) is suboptimal in the domains of informed consent and patient education. We argue that a more robust informed consent process is needed to enable patients to anticipate incidentalomas and to correctly perceive the associated risks. CONCLUSION. Given that IFs are very common in high-resolution imaging, patients should be provided information about the possibility of an IF as part of radiologic informed consent. The frequency of IFs, the very high rates of false-positives among incidentalomas, the very low rates of malignancies among incidentalomas, and the potential financial and emotional costs to both patients and the health care system of monitoring IFs necessitate a thorough informed consent process. Further, because radiologists are the most knowledgeable professionals regarding the nature of IFs, they should be the specialists who conduct the informed consent discussion with patients. I ncidental findings (IFs) are a common occurrence in radiologic examinations, with an everincreasing prevalence as the frequency of diagnostic scanning intensifies. Current radiologic practice rarely includes a thorough informed consent process and has never included information about the possibility and prevalence of IFs. Given that IFs often cause patients significant distress, patients should be provided information about the possibility of an IF as part of radiologic informed consent. A more robust informed consent process that forewarns patients of the possibility of an IF and provides anticipatory guidance about potential outcomes of an IF will provide patients with a substantial clinical benefit. The frequency of IFs, the very high rates of false-positives among IFs, the very low rates of malignancies among IFs, and the potential financial and emotional costs to both patients and the health care system of IF monitoring necessitate a thorough informed consent process. Further, because radiologists are the most knowledgeable professionals regarding the nature of IFs, they should be the specialists who conduct the informed consent discussion with the patient. Case Presentation to the Emergency Department Tina is a healthy 33-year-old woman who presents to the emergency department complaining of intense abdominal pain, nausea, and a bloating sensation. The previous night, she and her husband went out to a seafood restaurant where she believes she ate bad clams. The physician examines her and detects that her pain is predominantly in the right lower quadrant of her abdomen. Although the provider suspects food poisoning, the physical examination findings are concerning for acute appendicitis. The provider informs Tina that she will need to undergo CT of her abdomen to ensure there is no appendicitis. Tina agrees to the examination with no provider mention of any risks associated with the examination or the potential for IFs. The CT study reveals no appendicitis, but the radiologist notes a 1-cm small circumscribed lesion of unknown significance in her right adrenal gland. The emergency department provider tells Tina that she has no appendicitis and is safe to go home but should follow up with her primary care provider for workup of her incidental finding in the adrenal gland. Tina is relieved about the appendicitis, but she is visibly distraught about the IF, which she 1064 AJR:201, November 2013

2 A Revised Informed Consent Process assumes is malignant. She wishes to ask a provider for more information, but the emergency department provider has already moved on to another room. Tina is discharged from the emergency department. The Clinical Backdrop In the case described, Tina s abdominal CT study to evaluate the appendix revealed an extraappendiceal incidental radiologic finding in her adrenal gland. It was found coincidentally and had not caused any clinically significant symptoms. Because of its masslike appearance, the IF carries the name incidentaloma. Although the likelihood an incidentaloma is a malignancy varies depending on its size, appearance, and organ of origin, most of these findings are benign. Adrenal incidentalomas are quite common: They can be found in 4% of patients, at higher likelihoods with increasing age [1]. With the increased use of imaging modalities and improved machine sensitivity, the chance of discovering incidentalomas is expected to increase. The number of CT examinations alone nearly tripled from 1996 to 2010 from 5.2% of adult patients to 14.9% undergoing this type of study [2]. Not only is the number of patients undergoing CT increasing but the number of scans per examination will likely increase with greater use of whole-body CT modalities. Currently, it is estimated that 37% of patients who undergo whole-body CT may have findings warranting further evaluation [3]. Noting the large and increasing likelihood of discovering incidentalomas, we believe that potential lesions of the adrenal gland provide a telling example. The adrenal gland masses that are most commonly labeled incidentalomas are nonfunctioning benign adrenocortical adenomas [4]; they make up, on average, 89.7% of all incidentalomas [5]. A 25-study review of 87,065 all-cause death autopsies revealed benign adrenal adenomas in 6% of patients [4]. A variety of other benign lesions, including adenomas causing subclinical Cushing syndrome, pheochromocytomas, and aldosteronomas, comprise less than one tenth of incidentalomas found [2]. Excluding adrenal metastases from other cancers, the likelihood that an adrenal incidentaloma is a primary malignant cancer is, on average, only 1.9% [2]. Given this clinical picture, endocrinologists and adrenal surgeons have developed clinical guidelines to help guide management of adrenal incidentalomas. According to their 2009 guidelines [6]: Patients with adrenal incidentalomas smaller than 4 cm and radiologic characteristics consistent with a benign adenoma need to have radiographic reevaluation at 3 to 6 months and then annually for 1 to 2 years. Hormonal evaluation should be performed at the time of diagnosis and then annually for up to 5 years. The rate of a benign adenoma or hyperplasia developing into an [adrenocortical carcinoma] is not well known, but such a change seems to be extremely rare. Should the tumor grow more than 1 cm or become hormonally active during follow-up, surgical excision should be considered. Currently, it is unclear what the recommendations should be after 5 years of follow-up for a stable, nonfunctioning adrenal mass. Although this guideline is considered the standard of care, it has critics. Some authors have voiced concern that the currently recommended frequency and duration of follow-up for masses that are highly likely to be benign is excessive in an overall risk-benefit calculation. With such a low prevalence of malignancy, the standing recommendations for evaluation of an adrenal incidentaloma are likely to generate high false-positive rates, resulting in significant financial and emotional costs to both patients and the struggling health care system [5]. Additionally, radiation exposure poses a risk as well. If a patient with an adrenal incidentaloma was followed for 5 years according to the practice guidelines, he or she would undergo six additional CT examinations. The quantifiable risk from the cumulative doses of CT radiation would be equivalent to the risk of fatal cancer from the original adrenal lesion (7/430 = 1.6%) [5]. Returning to our case, Tina is discharged knowing none of this important clinical information. Discharge From the Emergency Department Discharged from the emergency department, Tina experiences significant anxiety about the IF. She contacts her primary care physician the next day and is able to schedule an appointment to see him in 3 weeks. During this time, she continues to worry about the threat posed by this small circumscribed lesion of unknown significance. She spends hours online researching adrenal cancers and their prognoses. During her visit to her primary care doctor, she finally learns of the extremely small likelihood of cancer and is very relieved. Following the specialist guidelines, the provider orders several blood tests and a hormonal response test, which come back completely normal. Many sleepless nights after her bout of food poisoning, she begins to have an understanding of what a lesion of unknown significance actually might be. Current Informed Consent Procedures for CT Studies Informed consent is a term with two common meanings that are often confused or conflated both in the literature and in clinical practice [7]. In the one sense, informed consent refers to a process of obtaining an institutionally or legally effective authorization for a procedure, test, or therapy [7]. Informed consent in this narrow legal sense is confined to a specific therapeutic or research intervention and requires the literal authorization of the patient or research subject indicated by his or her signature. It is in this sense that a provider would have the patient sign an informed consent form. However, in clinical practice, there is a second meaning of informed consent that is much broader: It invokes an ethical, rather than legal, obligation of the provider to ensure the patient s or subject s substantial understanding of the intervention, including short- and long-term consequences, alternatives to the proposed intervention, risk-benefit analysis, and provider recommendations [7]. In this sense, informed consent refers to a more expansive physician-patient discussion or conversation rather than to a narrow signing of a legal document. Radiology has not always been a specialty engaged in informed consent discussions of this second type, but the field is engaging in a disciplinewide debate on precisely this question [8]. In the remainder of this article, we will be using the second, broader meaning of the term. As is standard practice, there was no discussion of the potential for IFs, adrenal or otherwise, in the clinical informed consent process in our case. Tina s experience is, unfortunately, the norm. In fact, any form of preprocedure informed consent for CT is either limited or nonexistent. A survey of 91 radiology department chairs revealed that only 73% regularly inform patients about the purpose of their nonemergent CT examinations [9]. When the risks of CT are discussed, the potential for IFs are not part of the consent process. The only risk routinely discussed before CT is the risk of allergic reaction or nephrotoxicity to the contrast material in contrastenhanced CT studies [9]. Although there has AJR:201, November

3 Kole and Fiester been highly publicized research investigating radiation dose risks of CT [10, 11], only 15% of departments reported regularly sharing this information with patients [9]. This omission is even more alarming considering that only a mere 5% of patients recognize that radiation from repeated CT examinations may increase their cancer risk [12]. We believe that this known risk of CT radiation paired with a proven lack of patient knowledge provide a compelling reasonable patient standard that providers should inform patients of this risk. Fortunately, there is growing interest within the specialty in improving ionizing radiation dose disclosure for patients before nonemergent CT [13, 14]. The only other risks noted to be even occasionally part of pre-ct informed consent discussions are risks to pregnant women [9]. With regard to the possibility and significance of potential IFs, there appear to be no discussions whatsoever before CT, either with the ordering physician or with the clinical radiology staff. Although there is clearly room for improvement in all aspects of informed consent before CT, the absence of an informed consent discussion related to IFs is striking given their frequency and potential financial, emotional, and physical costs. A Parallel: Informed Consent Protocols for Imaging Incidental Findings in Research Subjects Despite the complete absence of a discussion of and informed consent with regard to IFs in clinical practice, this omission is not found in clinical research that uses radiologic imaging. In fact, not only is a thorough informed consent regarding IFs routinely obtained before nondiagnostic imaging of research subjects, it is backed by multidisciplinary research guidelines [15, 16]. The Council for International Organizations of Medical Sciences, a nongovernmental collaborative serving the scientific interests of the international biomedical community, has thoroughly addressed this issue in their respected guidelines for the ethical conduct of research. They require that investigators provide information to subjects regarding IFs, including the risks and frequency before obtaining research consent [15]. In the United States, there is extensive legal and bioethical precedent that informed consent requires a description of all reasonably foreseeable risks and benefits, [17] which points to an ethical duty to include a discussion of IFs [18]. With broad acceptance in the research domain of the necessity of informing subjects about potential IFs, interest is shifting from questions about whether IFs should be discussed to questions about how to disclose the risks and implications of IFs [17, 19]. In light of the recognized importance of discussing potential IFs in the research context, we will argue for an extension of this practice into the clinical sphere. Arguments for Extension of Informed Consent for Clinical Imaging to Include a Discussion of the Possibility of Incidental Findings Informed consent has the dual goals of minimizing harm and maximizing autonomous choice [7]. The practice of informed consent is essential for respecting the autonomy of patients, a principle that is central to biomedical ethics. Patient autonomy is not merely about patients accessing the care they need but also about having enough information to get the care that is best for them and to protect their health care interests and values [20]. To make appropriate decisions about their care, patients must have the requisite information that is available solely from clinicians [7]. Informed consent has been achieved only when a patient has been given all of the pertinent medical information about the risks, benefits, and alternatives by the provider and has a clear understanding of those facts, implications, and future consequences of the treatment or diagnostic options. Several legal and ethical standards have been proposed to assess the adequacy of information disclosure by the provider in informed consent discussions. In the first, the professional practice standard [7], the profession s customary practice determines the pertinent information to disclose and this standard appears to favor no disclosure of potential IFs in CT studies, because this practice is the current norm. However, the fact that the professional practice standard reinforces the status quo is precisely the source of the widespread critique of this standard [12]. In contrast, the second standard called the reasonable person standard judges the adequacy of provider disclosure from the perspective of a typical patient. By this standard, if clinical information would be considered by a reasonable patient to be necessary to decide to undergo a particular procedure or treatment plan or to be properly forewarned of its risks, then the information must be disclosed [7]. The reasonable person standard has been adopted in most states. On the basis of this standard, we contend that a patient like Tina would want to know about the potential for IFs detected in CT studies and the likely clinical implications if an IF were found. Information about radiologic IFs is pertinent because there exist potential harms from their discovery and patients are currently insufficiently aware of those potential harms. As Tina s case shows, there are myriad risks associated with IFs. Even appropriate clinical laboratory workup of an IF creates the possibility of false-positives and more invasive procedures such as biopsies [5, 6]. Specifically with the high prevalence of commonly benign adrenal incidentaloma, the increased personal and societal financial costs may yield no clear mortality benefit [5]. IFs may also adversely affect a patient s employment or medical and life insurance [19]. There are psychologic harms as well. Radiologic findings can uniquely undermine an individual s ability to judge his or her own health status [21], reframing every new twinge or ache as a potential symptom of the now-revealed IF. Incidental findings and the weeks to years of follow-up can be detrimentally anxiety-producing for patients and their families [18]. In the absence of adequate clinical information, patients like Tina might imagine worst-case scenarios and fear a bad prognosis even with continued normal follow-up. This problem is exacerbated by the fact that patients generally approach radiologic examinations with a very limited understanding of their potential risks. Patients typically believe that CT is an infallible technology with miniscule risk of harm [13, 20]. Not only is it unlikely that patients will refuse to undergo scanning when it is recommended by a physician but, more importantly, it is counter-intuitive to most patients that information from a radiologic examination might not be helpful to them [20, 22]. In contrast to the prevalent view decades earlier that informed consent about radiologic examinations would create unnecessary patient anxiety [23, 24], there is now legitimate ground for some concern about ionized radiation [11]. In light of new clinical information and given the potential consequences of IFs, the need for a more rigorous and thorough informed consent process is clear. Appendix 1 shows our proposed informed consent for IFs in diagnostic imaging AJR:201, November 2013

4 A Revised Informed Consent Process Objections to the Clinical Extension of Informed Consent for Incidental Findings There are a few important objections that could be raised against our proposal to expand the informed consent procedure used for CT. First, if patients were informed not only about the minimal risks of the study but also about the possibility of IFs, one might legitimately raise the concern that patients would opt to forego CT out of fear of IFs even if the reason for the study was important to their overall health. On this objection, informed consent would not create an informed consumer of medical care but one provoked into making self-defeating decisions based on an exaggerated fear of potential risks. In response, we point to evidence that patients inherently favor both receiving radiologic studies and any and all information learned from them. For example, when asked, more than 90% of neuroradiology volunteers said they wanted to know about everything that was found in an MRI brain study [25]. Additionally, in the clinical setting, CT has a therapeutic purpose that would make it overwhelmingly compelling to the patient. However, as in all medical procedures, if some patients did forego scanning despite a full disclosure of the risks of refusing it, it would be a patient s right to do so. But this issue, then, raises a second objection: If every patient is going to agree to the CT study even after being informed about the probability of IFs and their possible significance, then what benefit is the information to the patient? There is an easy rejoinder to this objection: A patient who is properly informed about both the frequency of IFs in CT examinations and their low probability of being malignant or clinically significant is well armed to avoid the prolonged anxiety that Tina experienced. If, before undergoing scanning, Tina had been prepared for the possibility of an IF and had been provided the clinical picture that an IF warrants monitoring but is rarely a cause for concern, she would have had a context in which to receive the examination results without the paralyzing distress and fear. That understanding is an enormous clinical benefit to patients even if they would make the same choice to undergo the study or not regardless of a thorough informed consent procedure. Finally, one might object that a demand for informed consent for every CT study may prove overly burdensome to providers in a setting that already has overwhelming time pressures. This concern is a legitimate one and a potentially significant obstacle. However, if done properly, an informed consent discussion need not be time-consuming and may forestall the need for a larger investment of clinical time in addressing the needs of patients distraught over clinical findings for which they were not prepared. Who Should Conduct the Informed Consent Discussion With Patients Regarding CT? Currently, the focus of informed consent for CT, when it is given, is the risk of an allergic reaction to contrast medium. The most likely personnel to provide this information in contemporary practice are radiology technologists (57.1%), followed by the radiologists (19.8%), and then nurses [9]. We contend that, when possible, radiologists should conduct the informed consent discussions regarding CT because they have the most expertise in explaining both radiation risks and information about IFs. Parallel to recent arguments advocating direct radiologic disclosure to patients [8], radiologists have the necessary training and context to engage in these discussions. Also, even when nurses or other staff engage in informed consent discussions, it is always the physician s ethical obligation to ensure that the patient is adequately informed and has given genuine consent. Serious potential objections can be raised against this suggestion. Some might legitimately argue that it is impractical to require radiologists to obtain consent from patients for these procedures when they need to dedicate their valuable time resources to the reading of the study, not to patient interaction. Adding to this concern is the fact that radiologists are often not onsite when the patient is scanned. These concerns are important. Our first response is that the ideal may not be achievable in all settings and that there may need to be a group of professionals trained to do this important work of adequately obtaining informed consent from patients for these procedures. Perhaps nurse practitioners, for example, could fill this void as they do in so many other arenas of clinical medicine. Our second response is that until a systematic approach to altering the culture of radiologic informed consent is tried, the number of obstacles that could be surmounted will be impossible to ascertain. If informed consent about IFs came to be understood as an ethical obligation, the field would begin to work out the logistic problems in its implementation. Conclusion We have argued that the current practice of informed consent for diagnostic imaging is insufficient without a discussion of the potential discovery of IFs. For any test, patients deserve an adequate disclosure of the reasonable risks and benefits. Patients are not prepared or educated about IFs and their potential medical, financial, and psychologic costs. We call for a richer IF-inclusive radiologic informed consent to protect patient autonomy. We contend that the experience of receiving results including IFs may be greatly improved if radiologists inform patients before scanning about the common and real possibility of an IF. Although change may take time and effort, the duty to our patients autonomy will not waver, thus neither will our resolve for improvement. References 1. Bovio S, Cataldi A, Reimondo G, et al. Prevalence of adrenal incidentaloma in a contemporary computerized tomography series. J Endocrinol Invest 2006; 29: Smith-Bindman R, Miglioretti DL, Johnson E, et al. Use of diagnostic imaging studies and association radiation exposure for patients enrolled in large integrated health care systems, JAMA 2012; 307: Furtado CD, Aguirre DA, Sirlin CB, et al. Wholebody CT screening: spectrum of findings and recommendations in 1192 patients. Radiology 2005; 237: Young WF Jr. Clinical practice: the incidentally discovered adrenal mass. N Engl J Med 2007; 356: Cawood TJ, Hunt PJ, O Shea D, Cole D, Soule S. Recommended evaluation of adrenal incidentalomas is costly, has high false-positive rates and confers a risk of fatal cancer that is similar to the risk of the adrenal lesion becoming malignant: time for a rethink? Eur J Endocrinol 2009; 161: American Association of Clinical Endocrinologists website. Zeiger MA, Thompson GB, Duh QY, et al. American Association of Clinical Endocrinologists and American Association of Endocrine Surgeons medical guidelines for the management of adrenal incidentalomas. aace.com/files/adrenal-guidelines.pdf. Published Accessed June 24, Beauchamp T, Childress J. Principles of biomedical ethics, 5th ed. New York, NY: Oxford University Press, 2001: Amber I, Fiester A. Communicating findings: a justification and framework for direct radiologic disclosure to patients. AJR 2013; 200: AJR:201, November

5 Kole and Fiester 9. Lee CI, Flaster HV, Haims AH, Monaco EP, Forman HP. Diagnostic CT scans: institutional informed consent guidelines and practices at academic medical centers. AJR 2006; 187: Smith-Bindman R, Lipson J, Marcus R, et al. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med 2009; 169: Brenner DJ, Elliston CD, Hall EJ, Berdon WE. Estimated risks of radiation-induced fatal cancer from pediatric CT. AJR 2001; 176: Busey JM, Soine LA, Yager JR, Choi E, Shuman WP. Patient knowledge and understanding of radiation from diagnostic imaging. JAMA Intern Med 2013; 173: Picano E. Informed consent and communication of risk from radiological and nuclear medicine examinations: how to escape from a communication inferno. BMJ 2004; 329: Lee CI, Haims AH, Monico EP, Brink JA, Forman HP. Diagnostic CT scans: assessment of patient, physician, and radiologist awareness of radiation dose and possible risks. Radiology 2004; 231: Council for International Organizations of Medical Sciences website. Council for International Organizations of Medical Sciences; World Health Organization. International ethical guidelines for biomedical research involving human subjects. guide2002.pdf. Published Accessed June 24, Illes J, Kirschen MP, Edwards E, et al. Incidental findings in brain imaging research: what should happen when a researcher sees a potential health problem in a brain scan from a research subject? Science 2006; 311: Wolf SM, Paradise J, Caga-anan C. The law of incidental findings in human subjects research: establishing researchers duties. J Law Med Ethics 2008; 36: Wolf SM, Lawrenz FP, Nelson CA, et al. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 2008; 36: Booth TC, Jackson A, Wardlaw JM, Taylor SA, Waldman AD. Incidental findings found in healthy volunteers during imaging performed for research: current legal and ethical implications. Br J Radiol 2010; 83: Hofmann B, Lysdahl KB. Moral principles and medical practice: the role of patient autonomy in the extensive use of radiological services. J Med Ethics 2008; 34: Gunderman RB. The medical community s changing vision of the patient: the importance of radiology. Radiology 2005; 234: Schneider C. The practice of autonomy: patients, doctors, and medical decisions. New York, NY: Oxford University Press, 1998: Alfidi RJ. Informed consent: a study of patient reaction. JAMA 1971; 216: Alfidi RJ. Controversy, alternatives, and decisions in complying with the legal doctrine of informed consent. Radiology 1975; 114: Kirschen MP, Jaworska A, Illes J. Subjects expectations in neuroimaging research. J Magn Reson Imaging 2006; 23: APPENDIX 1: Proposed Informed Consent for Incidental Findings in Diagnostic Imaging As we ve discussed, the primary purpose for this diagnostic imaging study is (e.g., to detect X, to rule out Y, to reassess Z). This study may give us information about other organs of your body near the focus point of the examination. Much of the time, your other organs will look indistinguishable from any other person s organs. Commonly, radiologists may see one or more things in your other organs that look different from what they typically see. These findings are called incidental findings. Most incidental findings are completely normal and are not harmful, whereas others may require that you undergo additional tests. If the radiologist sees an incidental finding, we will be sure to tell you everything we know about it. Do you have any questions about incidental findings? We recommend you undergo this study for the primary purpose of. Remember that study is imperfect and can provide only certain types of information about the body. Whatever we see, we will explain the information we obtain from this study. Do you have any questions before we begin? 1068 AJR:201, November 2013