ARTICLE: Informed consent in radiology

[John Jacobus <crispy_bird@YAHOO.COM>]

The following appeared at

http://www.auntminnie.com/default.asp?Sec=sup&Sub=imc&Pag=dis&ItemId=61259

While it is geared for radiologists, I think issues

about the need to inform patients about radiation

exposures is relevant.



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Imaging and informed consent: What radiologists need

to know to protect themselves

4/2/04



"Everything that can be invented has already been

invented," said Charles Duell, director of the U.S.

Patent Office in 1899.



Sure, we laugh at him now. In radiology, a new

invention emerges every day. But keeping up with the

latest technologies is a very unfunny burden that

befalls every doctor. Why? Physicians have a legal

responsibility to inform their patients of all their

diagnostic and treatment options. When they do not,

they can be sued for violating the "reasonable patient

rule" of their duty to obtain informed consent.



Patient rule rules



What is the patient rule? In short, it requires a

physician to disclose all relevant facts, risks, and

alternatives that a reasonable patient needs to know

in order to make a decision to undergo the recommended

treatment. It.s the law in most states.



The modern standard of informed consent was defined

decades ago by case law. Salgo v. Leland Stanford Jr.

Univ. Bd. of Trustees (154 Cal. App. 2d 560, 317 P.2d

170 [1957]), a case involving translumbar aortography

that resulted in spinal cord injury, established a

doctor's duty to disclose the nature, purpose, risks,

and alternatives of a procedure.



Canterbury v. Spence (464 F.2d 772 [DC Cir. 1972])

rejected the old doctor-knows-best standard of

physician rule in favor of the reasonable patient

rule, or the " materiality of riskv standard, when a

patient was rendered paraplegic by a surgeon who

considered it counterproductive to disclose the risk

of paralysis.



Venerable case law notwithstanding, radiologists have

been slow to get with the program. According to the

American Journal of Roentgenology, 12% of medical

malpractice lawsuits involve radiologic procedures or

radiologists (October 1995, Vol. 165:4, pp. 781-788).

In addition, 41% of U.S. radiologists are sued at

least once (AJR, November 1993, Vol. 161:5, p. 931).



Many malpractice cases have a basis in patient rule

violations, which become more complicated with every

new medical advance. Are your bases covered? Here.s

what you should know.



Discuss benefits, but don.t downplay risks



Negatives associated with a physician.s

recommendations -- the dangers of radiation, contrast

media, or MRI magnets, for example -- are among the

subjects that should be discussed with patients. 



Radiation. Experts differ on how much to discuss

radiation with patients. They do agree that patients

are rarely informed of annual dose tolerances, or how

much radiation is emitted from any given modality.



"Most centers don.t adequately warn patients about the

risks of radiation," said Dr. James Ehrlich, president

of the Society for Responsible Preventive Imaging. One

example is noninvasive coronary angiograms. 

"Multislice CT spirals have an effective radiation

dose to the female breast equivalent to 19 mammograms.

It.s about three times the dose they would get in a

cath lab," noted Ehrlich, who is also the medical

director of Colorado Heart and Body Imaging in Denver.



"If your 12-year-old is getting a bunch of CT scans,

you as the parent might worry about the kid.s

radiation, and it is important to have some knowledge

of it," said Dr. Peter Mueller, division head of

abdominal imaging and interventional radiology at

Massachusetts General Hospital in Boston. However, he

added, " if we have to talk to every patient or parent

about how many rads they.re going to get, we.re going

to drive people nuts." 



Some experts say cumulative volume is the real issue,

now that the government has officially declared

radiation a carcinogen. The U.S. Department of Health

and Human Services says 66% of physicians perform

extra radiological tests just to protect themselves

from lawsuits. The Congressional Office of Technology

Assessment estimated that for minor injuries in

patients aged 5-24, 53,049 extraneous skull x-rays are

performed annually; 59,415 cervical spine x-rays; and

115,646 head CT scans.



According to research cited in the British Medical

Journal, as many as a third of radiological exams are

inappropriate. Baseless exams have vast potential for

litigation on grounds of informed consent. If a

patient believes he got cancer as a byproduct of you

covering your assets, he.ll see you in court.



Contrast agents. This is another area frequently

subjected to trivialization. Catheter angiography has

been around for so long that the use of contrast isn.t

considered particularly dangerous. However, when the

rare reaction does occur, it can be extremely serious.



Pauscher v. Iowa Methodist Medical Center (408 N.W.2d

355, 358 [Iowa 1987]) was a case brought against a

hospital for wrongful death. The hospital insisted

that it was unnecessary to inform a patient that

intravenous pyelogram (IVP) tests result in death for

only one in 100,000 people. When the patient died from

the test, her family sued and won.



And in Smith v. Shannon (100 Wn.2d 26, 666 P.2d 351

[Washington 1983]), the plaintiff suffered phlebitis

and other complications following an exam using

Renografin-60, an ionic x-ray contrast agent, and sued

the radiologist for not revealing 10 risks associated

with it that were listed in the Physicians. Desk

Reference.



Today all modalities are being used with contrast for

at least some applications. New products are

introduced constantly, including non-ionic agents,

non-blood-product agents, and improved radioactive

agents. It.s more important than ever to keep up, and

to be able to explain the pros and cons to patients.

Is contrast-enhanced ultrasound staggeringly more

detailed than unenhanced ultrasound? Is PET/CT the

greatest cancer sniffer ever? Is noninvasive MR

angiography really as vivid as catheter angiography?

Well, yes. But if the smallest chance exists that any

contrast agent being proposed may cause a grave

adverse reaction, the patient has a legal right to

know that, too.



Explain alternative exams and procedure details



Like many clinics, yours may have a considerable

investment in the latest imaging equipment. Naturally

you.d like to recoup, and when advising your patients

about options it is understandably tempting to omit

services you don.t sell.



Omission is unlawful in most places, though, and there

are other reasons to resist the urge. Think your fancy

new MRI is just what your patient needs? Maybe not, if

he.s like the plaintiff with panic disorder in Curtis

v. RI Imaging Services II (148 Or App 607, 941 P2d 602

[Oregon 1997]). Curtis sued for psychological injuries

sustained when an imaging provider failed to explain

the claustrophobic effects of MRI scanners and never

obtained a history of Curtis.s asthma condition prior

to his exam.



Doctors who don.t own imaging equipment may still

shortchange patients by not keeping current on newer

technologies. For instance, some exams traditionally

performed using IVP, such as cardiac and urologic

procedures, can now be done with noninvasive or

minimally invasive CT techniques. Would the reasonable

patient want to know about them? You bet. 



Unfortunately, there.s usually a downside to address,

too.



"What happens in radiology a lot is that referring

physicians don.t necessarily understand all the

nuances of the procedures patients will undergo,"

Mueller said. "Most patients. concept of radiology is

getting an x-ray. When they get anything different,

it.s a little bit of a shock to them." 



Mueller cited a common example, a shoulder problem

best diagnosed by MRI with contrast. " The patient may

not have been told he.s going to get an injection. Now

the radiologist is faced with the referring doctor

wanting MR arthrography, which is much better than a

standard MR, and the patient is expecting just an MR.

He.s upset, anxious, and nervous. Then it.s the

obligation of the radiologist to explain it and

assuage the patient.s fears." 



If it ain.t broke, don.t fix it. But if it is, follow

up. 



The relatively new industry of screening services has

its own set of informed consent issues -- caveat

emptor, if you own or plan to establish a screening

center.



"In preventive imaging, the risk/benefit ratio is not

as well worked out as it is in diagnostic imaging,"

Ehrlich said, "and every imaging center has its own

vested interest. A whole lot of radiology groups have

purchased multislice CT scanners meant for diagnostic

imaging, and, as an add-on profit center, they decide

to use them for coronary scanning." 



CT is not approved for any body screening applications

by the FDA, which states: "The main risks are...benign

or incidental finding(s) leading to unneeded, possibly

invasive, follow-up tests that may present additional

risks, and the increased possibility of cancer

induction from x-ray exposure." 



"Some people want a CT body scan for the wrong reason,

like following malignancies, and are not informed that

this is not the way to go, " Ehrlich said. And on the

flip side, screening centers sometimes find

abnormalities they weren.t looking for. They become

huge liability targets if, for example, they find a

lung abnormality during a cardiac exam, or a patient

suffers a heart attack after an exam, and the

screening center never told the patient at the exam

how to follow up. 



In the majority of malpractice actions against all

radiologists, failure to diagnose or misdiagnosis are

the most frequent claims. Typical is Smith v.

Daneshjoo, (C.A. Case No. 18802 and 19088 [Ohio

2002]), in which a patient claimed a radiologist told

her not to worry about a breast tumor that turned out

to be malignant. The delayed diagnosis resulted in

radical mastectomy and cardiomyopathy that was caused

by aggressive chemotherapy, and the patient sued for

negligence. 



So if you find anything at all, say so right away and

suggest further action.



Tag, you.re it



If you think a negligence lawsuit can.t happen to you,

check your malpractice insurance premiums and think

again. The first court award for x-ray burns occurred

back in 1899, right after x-ray was introduced to

medicine. Fast forward to 2003. X-ray is still the

predominant modality in medical imaging, not to

mention the most litigated, and the median award for

medical malpractice is a sobering $1.2 million (U.S.).



For any imaging service, job one is patient-rule risk

management: explaining to your patients all the

technology options available, and informing them of

risks versus benefits. Malpractice attorneys also

recommend that you have systems in place to ensure

that the exams you.ve ordered are performed (or noted

if they.re not) and patients are told how to follow

up. Document phone conversations with patients to

avoid he-said/she-said scenarios. 



Patients who refuse treatment should sign a " refusal

of consent" form. You probably want to avoid

situations like Broek v. Park Nicollet Health Services

(Case No. C9-02-1611 [Minnesota 2003]), which involved

a man with a heart muscle disease who ignored his

doctor.s advice to have regular exams. Seven years

after his last echocardiogram, he died of cardiac

arrest while playing racquetball. His widow filed a

wrongful death suit that was eventually thrown out,

but not before everyone spent a small fortune in

attorneys. fees.



Long story short, you.ll need all the ammo you can

get. Ehrlich advised asking yourself -- and acting on

-- the following questions:



Do your doctors actually understand the

recommendations based on the findings?



Do they get the latest information from specialty

conferences?



Do they know what to do with a polyp on a virtual

colonoscopy or a lesion on a lung CT?

When they write their recommendations of how to follow

up, are they correct? 

If not, "a patient could easily put this in the closet

until two years later, when they.re coughing up

blood," Ehrlich said. "Legally, that.s a big can of

worms." 



By Sydney Schuster

AuntMinnie.com contributing writer

April 2, 2004



=====

+++++++++++++++++++

"We cannot escape danger, or the fear of danger, by crawling into bed and pulling the covers over our heads."

-- Franklin Delano Roosevelt



-- John

John Jacobus, MS

Certified Health Physicist

e-mail:  crispy_bird@yahoo.com





	

		

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