Donald P. Frush, MD

No Disclosures

Consent for CT Radiation? Pros and Cons

Consent for CT Radiation? Summary:

No…..

AJR July 2012

Professionalism: Principles

• Primacy of patient welfare – service, altruism

• Autonomy – empower to make informed decisions

• Social justice –Fair, equitable

“Should we inform patients about radiation?”

“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…”

Consent

• 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…)”

Consent: challenges

UNESCO 2008

“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 validly-

given consent.

Recent Support for Consent JAMA 2010

• 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!

Pro

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”

September, 2012

• BRCA1/2 mutations • Medical imaging

radiation exposure before age of 30

• Increased susceptibility to breast cancer

mSv range • chest radiograph (5y) 0.007 0.003-0.014 • abdominal radiograph (5y) 0.044 0.020-0.070 • pelvic radiograph (5y) 0.027 0.008-0.055 • voiding cystourethrography 0.33 0.12-3.2 • small bowel series 1.9 1.17-6.47 • head CT 2.1 1.9-11 • chest CT 2.6 0.55-28 • abdominal CT 5.5 1-13 • FDG-PET 10 7.8-15.3 • angiography 11 .. -20 natural radiation background 2-3 mSv!

Courtesy RAJ Nievelstein MD IPR 2010

Which Procedures? > Background?

• 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.

What to Include?

What do medical professionals think of this?

2-2-11 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 20th, 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

• 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?

Medical Radiation Consent: (some) Challenges

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

Cosmic Radiation

NCRP Report 160, 2009

“…the risk of this CT is about the

equivalent of living in

Denver for one year…”

“I live in Denver. Why

am I not consented to

for that?”

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

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)

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.

1. Goske MJ, Dorothy Bulas. COMMENTARY: Improving health literacy: informed decision-making rather than informed consent for CT scans in children Pediatr Radiol. 2009; 39:901–903

2. Larson DB, Rader SB, Forman HP et al (2007) Informing parents about CT radiation exposure: it’s OK to tell them. AJR 189:271–275

3. American College of Radiology (2005) Practice guideline for communication of diagnostic imaging findings. http://www.acr. org/SecondaryMainMenuCategories/quality_safety/guidelines/dx/ comm_diag_rad.aspx

4. Frush DP (2003) Letters to the editor: responsible use of CT. Radiology 229:289–291

5. 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.

References

6. Baerlocher MO, Detsky AS. Discussing radiation risks associated with CT scans with patients. JAMA. 2010; 304(19): 2170-2171

7. International Commission on Radiological Protection. 1990 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: 849–85

9. Verdun FR, Bochud F, Gudinchet F, et al. Radiation risk: what you should know to tell your patient. RadioGraphics 2008; 28: 1807–1816

10. Terry PB. Informed consent in clinical medicine. Chest. 2007;131(2):563-568

11. 2008 Report of the International Bioethics Committee of UNESCO (IBC) ON CONSENT

References