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August 29, 2010

Is Informed Consent Complete?

By Cyndi Gross

Is Informed Consent helping or hurting us?


There is always a lot of focus, discussion and debate about rights. Right to work, right to live where we want, right to health care, right to sue, right to marry, birthing rights, smoking rights, privacy rights... and the list goes on and on. Most human rights issues are common sense, however some are so controversial and demand a chain of changes, that no one is willing to take them on. And worse than that, those who could benefit most from those changes, don't even know that they have choices. So no one asks for options...and no one offers them.

Let's focus on maternity care.

There's so much information out there about what's good, what's bad, what's safe and what's not. Don't you love it when complete strangers have an opinion about what is right for you and your family? With all of that information, making decisions is so overwhelming, many of us just throw up our hands and say "I'll have what she's having!" or "If it's good enough for's good enough for me!" Unfortunately, what she's having, may not be good for you... or your baby.

One of the major problems in health care today is that there is no protection. Not for patients. Not for providers. Not for insurance companies. I know, many of you are saying "But, I have protection. I have insurance" I'm not talking about that kind of protection. I'm talking about the kind of protection that is already in place and already accepted, but not being used. This kind of protection doesn't cost a dime and has the potential to save BILLIONS of dollars and hundreds of thousands of lives. It's the kind of security that protects everyone ... doctors, midwives, nurses, hospitals, outpatient surgicenters, birth centers, patients and even malpractice insurers. In maternity care, this kind of protection even has the potential to drastically improve our nations Prematurity rate which was reported as a "D" in the March of Dimes worldwide 2009 Premature Birth report. 

Ok, ok... what is it already?

The kind of protection I'm talking about is Complete Informed Consent. Not just Informed Consent...Complete Informed Consent.

What's the difference?

Informed Consent is a legal ethics code written and supported by the American Medical Association. It states:

"Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention.

In the communications process, you, as the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with your patient.

The patient's diagnosis, if known;

The nature and purpose of a proposed treatment or procedure;

The risks and benefits of a proposed treatment or procedure;

Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);

The risks and benefits of the alternative treatment or procedure

The risks and benefits of not receiving or undergoing a treatment or procedure.

In turn, your patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.
This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states."

Unfortunately, the above ethics code is not being least not completely.

Now before everyone thinks that I'm bashing the AMA, I want to say that nothing could be further from the truth. I applaud them for their efforts to provide better communication and protect their patients, members and malpractice insurers. The issue is that providers who adhere to Informed Consent , both medical and alternative providers, only provide partial information.

In other words... it's biased.

Here's what I mean. Let's take one of the most common interventions in maternity care. Induction. You could probably do your own poll and find that in your immediate circle of friends and family, the majority have had, are having or will have their labor induced for various different reasons. I won't get into when an induction is medically appropriate or when it is just elective. I just want to know how many of your friends and family know or knew all of the risks and benefits of an induction. My guess is probably few to none.

Many medical providers will inform their patients of all of the benefits of an induction and the risks of NOT having it done. On the flip side, many alternative providers will inform their patients of all of the benefits of waiting for labor to start on its own and the risks of NOT waiting. So who is right? Both of them will make great arguments about the benefits of their suggestions and the risks of not complying. However, both are biased. Informed Consent is only protective when ALL of the information is being presented without bias. How can a patient make an informed decision without having complete information of the risks and benefits of all the options out on the table?

We continually see fear of litigation on the forefront of every providers mind. A patient comes in with a problem and expects their provider to decide what course of action needs to be taken. By letting the provider choose what's best for us, it frees us of any responsibility. If things go wrong...we can and will sue them! No wonder our insurance premiums and medical malpractice costs are through the roof. Not to mention the position this puts our caregivers in. Many of them are forced to make decisions based more on litigation than the actual need of the patient. Including unnecessary testing.

So in the case of induction, what would Complete Informed Consent information contain?

Benefits to both mother and baby of an induction

Risks to both mother and baby of an induction

Benefits to both mother and baby of waiting for labor to start on its own

Risks to both mother and baby of waiting for labor to start on its own

If the patient has weighed their options and chooses the option that is not offered by her provider, it is that providers legal and ethical obligation to refer that patient to a provider who can best meet those needs. What a great way to finally encourage collaborative practices between medical and alternative models of care, which we all can agree would save money, time and would be in the best interest of the patient.

Interestingly enough, the pharmaceuticals companies follow the Complete Informed Consent guideline to a "T". In a 30 second commercial they will take 10 seconds to tell you how great their pill is and the other 20 seconds to tell you about how it might harm you or even kill you! If the consumer knows the risks and still chooses to take it, then it's much harder to be held liable. Though the drug companies sometimes get a bad rap, I gotta hand it to them for at least providing complete information about their product, allowing the consumer to have all of the pros and cons so that they can make an educated decision about whether the risks outweigh the benefits.

So while President Obama works out the health care reform and budget details, maybe he should take a look at something that is already in place, something simple...something FREE. We all have the right to be protected by Complete Informed Consent as do our caregivers and insurance companies. We all just need to ask for it.

Informed Consent is really a matter of protection... but only if it's complete.

Authors Bio:
Cyndi Gross has worked as a labor doula for 18 years and is also the founder of MyBirthTeam, an unbiased website, that matches patients with providers who meet their pregnancy and birthing needs. In addition, Cyndi helps teach an advanced labor support series called Birth Wisdom in Orange County, CA and is working toward a degree in communications.