Informed Consent Part Two: Sign Here Please

In this section about informed consent, I will cover two types of forms you may end up signing. The first is one is the consent form which you may be asked to sign by a hospital during your stay and the second is the form signed before undergoing clinical research. It is important not to confuse the two, in addition to knowing what it means for you when you do sign the form.

First and foremost, a consent form is just a piece of paper, and while pieces of paper tend to carry an almost mystical authority for many people, it should be known that these forms in particular are not necessarily binding in many important respects. In most cases, forms are a way for the hospital or physician to show that information exchange took place, and the patient subsequently consented to the procedure. This gives all the more reason to make sure you have the information detailed in the first part of this series prior to signing anything when at all possible.

For consent forms themselves to have any power, they must still follow the guidelines mentioned before. The more general the information and authorization a form is, the less relevant it is. For example, signing a blanket consent form that authorizes the hospital to perform any and all procedures on your body is next to useless. Your signature does not mean that the standard of informed consent outlined by the courts no longer applies. Another thing to keep in mind is that a consent form is not a binding contract, meaning you can back out of a procedure even after you’ve signed the form. This is generally discouraged, and patients should very carefully consider their choices prior to consenting to a medical procedure, but it is still your legal right to refuse treatment at any point that it is possible to do so (it’s probably too late if you are already on the operating table and under sedation). People have a right to deny treatment, even when doing so will result in their death.

Informed Consent Forms for Research

The reason that consent forms are different for clinical research is that they are required by Federal regulations, and therefore must include certain information. The same principles apply in research as they did with any other medical procedures, and once again they are based on patient autonomy. Autonomy rests on the basic notion that persons should be treated with respect, which includes considering them capable of making decisions that impact them. If you don’t believe this, then I’ll go ahead and make the decision for you and say you should.

Medical research is obviously very important, but a large share of responsibility is left to the individual participants to safeguard their own interests against those of the researchers. One of the requirements for research to be conducted is something called clinical equipoise. This concept means that there is both sufficient reason to believe that the intervention will not induce harm, balanced by sufficient lack of evidence that there is a great benefit. After all, if you know for a fact that something will attain a certain goal, research would be unnecessary. For this reason, be sure to understand, at minimum, the intent, likely outcome, and risks of any trial or experimental procedure you undergo. This involves reading the informed consent form carefully, and discussing anything that is unclear to you with the researcher. Taken directly from “The Rights of Patients”, here is a list of things you should find and understand on a consent form when participating in research.

• A statement that the study involves research, an explanation of its purposes and the expected duration of the subject's participation, and a description of the procedures to be followed, identifying which are experimental;
• A description of reasonably forseeable risks or discomforts to the subject;
• A description of any reasonably expected benefits to the subject or to others;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
• For research involving more than minimal risk, an explanation about any compensation or medical treatments available if injury occurs;
• An explanation of whom to contact for answers to questions about the research and research subject's rights, and whom to contact in the event of a research-related injury;
• A statement that participation is voluntary and that refusal to participate will involve no penalty or loss of benefits; and that the subject may discontinue at any time without penalty or loss of benefits to which the subject is otherwise entitled.1

And again, here are some external sources for your consideration.

Example of a hospital consent form (note how broad it is)

Example of a research consent form

Guide to Informed Consent from the National Cancer Institute.

1. Annas,George, "The Rights of Patients" p209-210

Lifetime Insurance Caps

The Caring for Carcinoid Foundation encourages all carcinoid and related neuroendocrine tumor patients to join NORD (National Organization of Rare Disorders) in its fight to end lifetime insurance caps as soon as possible. Many patients must seek out costly therapeutic alternatives in order to receive the best care available. Furthermore, this issue is particularly relevant to patients with carcinoid and related neuroendocrine tumors as they may require chronic care and high-cost drug therapies. Therefore, CFCF supports NORD in rejecting lifetime insurance caps in insurance markets.

What is a lifetime insurance cap?

A lifetime insurance cap is a method used by health insurance companies to limit the total amount that will be paid out. In that way they are similar to deductibles and co-payments, except instead of asking for money out-of-pocket from insurers, they are limiting, or setting a cap, on the amount that people with health insurance will receive for their health care. As the name implies, this cap on payouts is for the entire life of the individual who is insured, the only way to get a reset is to find a new insurance plan. Finding a new insurance plan can become difficult to impossible in many instances where that insurance cap has been used up.

Why does this matter for me?

This is an issue that should matter to everyone for a number of reasons. First, rising health care costs means that fixed caps become increasingly inappropriate. From 2000 to 2008, national health care expenditures increased by 13.6% (HUS 2008), and they are projected to continue rising at high rates. A million dollar payout at the beginning of that period is therefore worth less (gets you less care) than the same amount in 2008, and increasingly less in the future.

This is a particularly critical issue for patients with rare and/or chronic diseases like carcinoid and NETs, which anybody can fall victim to. This matters because diseases that are rare and/or chronic tend to be more expensive. Rarity drives up costs because effective treatment methods such as pharmaceuticals and technologies have not been developed to the same degree as more common diseases, and what treatments there are tend to cost more. There are a number of contributing factors to this, including the necessary incentive structure for enticing drug companies to develop treatments.

Chronic conditions, especially those without a cure, cost more than acute conditions for more obvious reasons. The continuous need for care builds up and becomes very expensive over time. A 2 million dollar cap could quickly disappear in the span of a few surgeries. With a condition such as carcinoid that is both rare and chronic, it is easy for patients to burn through the lifetime cap, leaving them with no insurance to cover their necessary continuing care.

Carcinoid is a disease that is both rare and chronic, and therefore people with this condition should be particularly concerned about lifetime caps and how to reform them.

Here is some information on carcinoid and NETs:

While the age adjusted incidence (number of new cases over a given time) for neuroendocrine tumors has increased from 1973 to 2004, the estimated 29-year limited duration prevalence (number of people alive with a disease diagnosed within the last 29 years) as of January 1, 2004 was 103,312 in the United States, making carcinoid and NETs a rare condition. Data is from research done by Dr. James Yao in “One Hundred Years After “Carcinoid”: Epidemiology of and Prognostic Factors for Neuroendocrine Tumors in 35,825 Cases in the United States”.

As a result, the comparatively fewer available therapies and surgeries tend to be more expensive, for reasons previously mentioned. This increase does not include non-medical costs. An example of this may be a person who does not have anyone in close proximity that is capable of giving the best, or even decent level of care because of the rarity of their disease. As a result, they may be forced to travel great distances just to receive care, and be burdened with all the associated costs of doing so.

Finally, carcinoid, like many cancers, is chronic and deadly. There is currently no cure for carcinoid, meaning that there is no specific time period when treatment will no longer be necessary. This means that even if costs of treatment weren’t already high, the considerable time frame for treatment alone could easily leave someone with a low lifetime insurance cap with no resources after a few years.

What can I do?

Many groups are currently fighting to reform the current lifetime caps on insurance plans. The National Organization for Rare Diseases (NORD) is advocating the elimination of lifetime caps by supporting a letter being circulated by Rep. Patrick Kennedy. Your support would be tremendously helpful. I have included contact information for Representatives and Senators, in addition to a template provided by NORD, we at CFCF encourage you to call or e-mail them soon.

Call the switchboard at (202) 224-3121 and ask to be transferred to your local representative.

Find House e-mail addresses here: http://www.house.gov/

Find Senator e-mail addresses here: http://www.senate.gov/

Here is the template, feel free to modify and personalize it in any way that suits you.

Good morning/afternoon. My name is _____________________ and I am a constituent living in (city, state). I have a rare disease.

I am calling to bring to your attention a letter that Rep. Patrick Kennedy is circulating in Congress. This letter calls for the immediate abolition of lifetime insurance caps in the House health care reform bill, HR 3200.

As this bill is currently written, patients may have to wait up to nine years after reform is enacted to see those lifetime caps eliminated. People like me who have rare diseases face possible financial ruin if lifetime insurance caps are not immediately abolished. This issue is very important to me.

Will Representative (insert name of your Representative) sign on to Patrick Kennedy's letter?

Informed Consent Part One: You want to do what?

Cancer patients will be faced with an incredible range of choices, very few of them minor. In making these decisions, it is almost impossible to underestimate the importance of informed consent, also called informed choice. Informed consent is the advent of the view that patients have a right to take part in the decision making process where their care is involved. While the internet age may make this seem obvious, there are still many who can recall the bygone days of doctor paternalism.

The most widely recognized instances of informed choice may be the consent forms signed at the beginning of clinical trials and experiments (both medical and social). Some hospitals also have their patients sign consent forms at various times (more on this in the next section). It is important to know that while the former category of forms is important, they are by no means the extent to which informed care, which is a right conferred by common law and basic ethical principles, extends.

Informed consent is described by George Annas in “The Rights of Patients” as “…before a patient is asked to choose to undergo any treatment or procedure that has risks, the patient must be provided with information…presented in language the patient can understand.”1

This last part requires two people, you being one of them. While a doctor can’t give you a long explanation involving medical jargon and expect his duty of informed consent to be fulfilled, it is up to you to let the doctor know when you don’t understand something. This is without a doubt one of those times where feeling foolish should be your lowest priority; it’s better to feel a little foolish now than to wake up on the operating table with your right leg amputated (this is obviously an extreme example). Here is a list of questions you should be positive you can answer before consenting to a serious medical procedure:

• What is the exact purpose of this procedure, and how will that purpose be fulfilled?
• What exactly can I expect to gain by undergoing this procedure?
• What risks are associated with this procedure?
• What alternatives do I have? Furthermore, what happens if I don’t do anything?
• How likely is it that this will work?
• Any other information you feel is pertinent.2

Medical decisions as a cancer patient are more important than decisions most other people will face in their lifetime, which is why careful and reasoned consideration is so important. Think of purchasing a home: your real estate agent is often an invaluable part of the process, and you will likely acknowledge that he or she is much more knowledgeable about the homes you are considering and real estate in general. At the end of the day, however, you are the one who will be forced to live there and make the payments, and it is prudent to make an informed and carefully considered decision. This analogy is not meant in any way to demean or downplay the role that doctors play in your care, clearly a real estate agent is not a physician. Nevertheless, I believe considering it will be helpful in keeping the immensity of your numerous options in mind. A few final considerations:

• A useful list of questions to ask your doctor: http://www.oncologychannel.com/questions.shtml
• Ask for numbers, not just words. You may have a very different opinion of what it means for something to be ‘rare’ or ‘probable’ than your doctor does.
• Try to communicate effectively to your physician what your specific aims and goals are, in addition to what you value. It is easier for your physician to make ‘good’ recommendations if the two of you are in sync. I’ll be discussing the doctor-patient relationship in a future post.

And lastly, some additional resources for your consideration:

American Cancer Society on Informed Consent

University of Washington School of Medicine on Informed Consent



1 Annas, George, "The Rights of Patients" p 116
2 Annas, George, "The Rights of Patients" p 116

Introduction

Your Rights: A Guide to Self-Advocacy

It is easy to feel disempowered following the diagnosis of a serious illness, particularly a rare cancer such as carcinoid. While such reactions are natural, it is important to remember that many things are still in your control. This is important for many reasons, your health not being the least among them. Helplessness is related to depression, which has been shown to have a relation to adverse health effects (see "Post-infarction depression and incomplete recovery 6 months after acute myocardial infarction"), so simply the act of taking a proactive role in your care may reap benefits for your health.

Being a cancer patient does not mean that you give up the rights you had before being diagnosed, and in fact those rights may become more important as you encounter new settings, including ones specific to health care you may not have considered before. Over a series of posts, I will cover a broad range of topics detailing ways in which you can proactively make decisions regarding your care and treatment, because the key is to remember that it is your body. In addition, I will touch upon advocating beyond your own personal care to policy considerations which you, as both a patient and a citizen, have a right to participate in.

I will be drawing upon a large number of sources for these entries, certainly not the least of which will be “The Rights of Patients” by George Annas. It has been referred to as “the Bible of patient rights” and I highly recommend anyone who believes they may need to seek health care one day to read it.

Please direct any questions or comments to Daniel.joo@caringforcarcinoid.org. Please consider anything in these posts that are not backed up by some clear fact (such as a court case or statute) to be a matter of opinion. I also encourage you to use them as a starting point to do your own research (feel free to share that as well).