Consent for CT Radiation? Pros and Cons

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Audrey Small
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1 Consent for CT Radiation? Pros and Cons Donald P. Frush, MD No Disclosures

2 Consent for CT Radiation? Summary: No..

3 AJR July 2012

4 Should we inform patients about radiation? Professionalism: Principles Primacy of patient welfare service, altruism Autonomy empower to make informed decisions Social justice Fair, equitable

5 Consent Consent is one of the basic principles of bioethics because it is closely linked to the principle of autonomy and because it reflects affirmation of human rights and human dignity which are the core values of democratic societies. N.C. General Statute regarding informed consent A reasonable person would have a general understanding of the procedures or treatments and of the usual and most frequent risks and hazards inherent in the proposed procedures or treatments which are recognized and followed by other health care providers engaged in the same field of practice in the same or similar communities

6 Consent: challenges Patients may not understand Clear information on risk? Cultural differences Age differences: children The United Nations Convention on the Rights of the Child (1989) asserts that children have the right to say what they think should happen when adults make decisions that affect them and to have their opinions taken into account (Art. 12), have the right to get and share information (Article 13 )

7 It should be underlined that, in general, adequate information given to the patient is the condition sine qua non for consent to be validly obtained; without adequate information, there can be no validlygiven consent. UNESCO 2008

8 Recent Support for Consent JAMA 2010

9 Pro Medical imaging uses ionizing radiation Ionizing radiation at higher levels can cause cancer Increased use (CT, nuclear medicine) Increased public, scientific, and regulatory scrutiny Increased accountability Discussions often lacking People have a right to know!

10 Lancet June 2012 First direct association of CT and cancer Increased risk of leukemia and brain tumors with childhood CT 1 add l brain tunor per 10,000 childhood brain CTs

11 September, 2012 BRCA1/2 mutations Medical imaging radiation exposure before age of 30 Increased susceptibility to breast cancer

12 Which Procedures? > Background? msv range chest radiograph (5y) abdominal radiograph (5y) pelvic radiograph (5y) voiding cystourethrography small bowel series head CT chest CT abdominal CT FDG-PET angiography natural radiation background 2-3 msv! Courtesy RAJ Nievelstein MD IPR 2010

13 What to Include? Type of examination Risks/benefits of the proposed examination Dose estimates in appropriate terms e.g. number of Chest X-rays Comparative risks (e.g. car accidents, airplane flights) Alternative examinations Risks/benefits Risks/benefits of no examination... hmmmm.

14 What do medical professionals think of this?

15 Duke/UNC Survey: 34 Emergency Medicine MDs Signed, informed consent for CT? 27 (79%) : No 6 (18%) : No opinion 1 ( 3%) : Yes, but then apologized for not understanding original question so, 0% wanted this consent

WHO Radiation Risk Communication in Paediatric Imaging Informal Survey September 20 th, 2010 Patient/Parent Advocates Radiologists Medical Physicist Communication

16 WHO Radiation Risk Communication in Paediatric Imaging Informal Survey September 20 th, 2010 Patient/Parent Advocates Radiologists Medical Physicist Communication experts/officers Family Practitioners Pediatricians Regulators Nurses Technologists Ethicists Radiation Biologists Epidemiologists Radiation oncologists Public policy experts

17 Medical Radiation Consent: (some) Challenges What is threshold to get consent? One CT? and after 100 chest xrays? For fluoro? Who tracks this? Age-, size, gender-based language? Who gets consent? Clinician? Radiologist? What do we say for risk? BIG PROBLEM!! We have data for infection, bleeding, life and limb etc Who is accountable? Institution, department, radiologist, technologist, ordering MD? If multiple scans, which scan caused the cancer? Talking someone out of study?

18 There are three ingredients to informed consent: the informee, the information, and the informer. No problem with the informee: he or she exists. The problem is with the other two. The content of the "information" is more speculation than fact, more hypothetical than realistic. So if the informer doesn't know all of the facts because the information is devoid of facts, then what is supposed to be told to the informee? Personal communication, Leonard Berlin, MD August 31, 2012

19 the risk of this CT is about the equivalent of living in Denver for one year Cosmic Radiation I live in Denver. Why am I not consented to for that? NCRP Report 160, 2009

20 Signed informed consent is ill-advised and impossible or is it?

21 Efforts should be directed towards: Cumulative radiation history: EMR Better dose estimates Evidence-based data Appropriateness criteria Interdisciplinary Decision support Educational efforts: ie health literacy The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate decisions (Goske and Bulas)

22 Patients knowing and patients deciding are very different We have a responsibility to provide information, but this information is insufficient to require them to make a decision.

23 References 1. Goske MJ, Dorothy Bulas. COMMENTARY: Improving health literacy: informed decision-making rather than informed consent for CT scans in children Pediatr Radiol. 2009; 39: Larson DB, Rader SB, Forman HP et al (2007) Informing parents about CT radiation exposure: it s OK to tell them. AJR 189: American College of Radiology (2005) Practice guideline for communication of diagnostic imaging findings. org/secondarymainmenucategories/quality_safety/guidelines/dx/ comm_diag_rad.aspx 4. Frush DP (2003) Letters to the editor: responsible use of CT. Radiology 229: Karsli T, Kalra M, Self JL et al (2009) What physicians think about the need for informed consent for cancer risk with low-dose radiation. Pediatr Radiol.

24 References 6. Baerlocher MO, Detsky AS. Discussing radiation risks associated with CT scans with patients. JAMA. 2010; 304(19): International Commission on Radiological Protection Recommendations of the International Commission on Radiological Protection (ICRP Publication 60). Oxford, England: Pergamon 8. Picano E. Informed consent and communication of risk from radiological and nuclear medicine examinations: how to escape from a communication inferno. Br Med J 2004;329: Verdun FR, Bochud F, Gudinchet F, et al. Radiation risk: what you should know to tell your patient. RadioGraphics 2008; 28: Terry PB. Informed consent in clinical medicine. Chest. 2007;131(2): Report of the International Bioethics Committee of UNESCO (IBC) ON CONSENT

Radiation Exposure 1980 to 2006

Radiation Exposure 1980 to 2006 Background 3-6 msv/yr Natural (85% 45%) Radon Cosmic Rays Air travel Living at Altitude Man-made (15% 55%) Medical Imaging** mgy Radiation Therapy cgy Radiation Whole Body