By Gary M. Votour
If you are a patient facing surgery during a major, life-threatening illness,
or you are a surgeon proposing surgery for that patient,
you MUST read this before giving or seeking informed consent.
Near the end of 2005, my wife Lyn and I were at one of the largest surgical hospitals in the country, waiting to give her informed consent for surgery to remove the second vertebra (C2) from her neck. Lyn had a congenital form of bone cancer, Chordoma. The cancer had been found in a routine X-Ray following a car accident almost a year before and we had been to a half dozen local oncologists and orthopedists before we were sent to a large cancer hospital and then referred to the surgical hospital. Traditional treatments for bone cancer like radiation or chemotherapy had been ruled out long before as too risky or ineffective.
Doctors had told us that with Chordoma, there were only two outcomes if untreated. The first was that the cancer would travel to her head, causing fatal bone spurs to grow into her brain. The alternative was that the weakened vertebrae would simply break apart. If that happened, the spinal cord would be severed, and her brain would lose control of her heart and lungs. She would literally have dropped dead, or had her brain crushed by bone tumors from within.
After months of misdiagnosis and false leads, the doctors at the surgical hospital had finally done a biopsy of the cancer and identified it as Chordoma. This is a very rare type of cancer that only affects hundreds of people each year in the United States. Not only is it difficult to diagnose, but the small number of patients affected by it means very few doctors have experience treating it. The average life expectancy is only 5 to 10 years without treatment, and for Lyn that treatment was a C2 Chordectomy. This entailed the surgical removal of the second vertebrae in her neck, intact, through the back of her throat and its’ replacement with titanium hardware. (About Chordoma, 2008)
Lyn was very fearful of losing her mind if the cancer reached her brain, and had decided to take the surgical route. The confidence of the doctors, especially the surgeon who would be performing the surgery, led her to decide this was her only chance to live a longer life.
Yet I sit here, alone since 2008, missing her. You see the surgeries did not go well. Following the second phase of Lyn’s C2 Chordectomy an ischemic stroke deprived almost a third of her brain of the blood it needed to survive. It left her mostly paralyzed and in permanent pain. The woman who walked into the hospital with me at her side… my wife of almost thirty years… rode home in ambulances six months later. most of which we spent in the Intensive Care Unit (ICU) together. She was unable to walk or eat, with a whisper of a voice, and had a tube in her stomach for feeding, a permanent catheter for urinating, and a bag attached to her stomach where her colon had been removed due to complications during recovery. She cried in her sleep for the next three years, while I sat next to her. I was unable to do anything but manage her care in our home, which had become the ICU we thought we had escaped from. Eventually the results of that stroke, not the cancer, ended her life with her decision to stop eating and drinking. I sat by her side as she took her last breaths.
After almost 30 years together, I was left alone with a massive emotional hole in my heart that will never fully heal. For a long time, I focused on surviving the greatest emotional suffering most could ever even imagine, the loss of my wife. I waited for the intense pain of what we had gone through together to abate. Eventually I realized that my heart would always hurt from the loss I felt, and I learned I could live with that pain. I decided to instead focus on giving our experience a greater meaning. I returned to school, earned a Master’s degree in health care administration and became a Patient Care Advocate. From great adversity often come great advocates.
I try very hard not to second guess the decisions we made then to have the surgery, but I have had the most difficulty coming to terms with one lingering question… were we given the information we needed to truly allow Lyn to give informed consent? In order to answer that question, one needs a clear understanding of what informed consent is and the value it provides. I hope that by explaining this answer to patients who are facing similar choices, I can save them or someone they know from making a wrong choice. I also hope to show their doctors how to ensure truly informed consent is given.
I also write this with doctors in mind… if you are a doctor, I hope I can instill in you the desire to examine how you pursue consent from your patients. Although what I am about to say may make some of them uncomfortable, my goal is to help them to live well with the ethical ramifications of the pursuit of consent by ensuring that consent, when given, is truly an informed decision.
So let us start at the beginning. What is informed consent?
The origins of the concept of informed consent are found in the ethical principles of enhancing a patient’s wellbeing (do no harm) and the need for respecting a patient’s right to make decisions for themselves that are based on factual information (autonomy). This belief has its roots in a famous court case almost 100 years ago which stated “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” The value this has comes from how it is now interpreted: that every patient “should be able to participate in decisions about their medical care, weighing the risks, benefits, and alternatives of a proposed intervention to ensure that the care they receive reflects their goals, preferences, and values.” (Meisel and Schenker, 2011)
Informed consent is generally given in the form of a patient signature on a form prior to every procedure or treatment in a health care setting, from surgery to participation in clinical trials. As described by Aiken (2009), it has 8 components. The form must include the name of provider(s), the patient diagnosis, a disclosure of conflicts of interest, a description of the procedure or treatment and its purpose, a description of the potential risks, likely outcome and available alternatives and a statement of consequences of no treatment. Health care professionals have several key responsibilities when seeking informed consent. It is specifically the responsibility of the physician performing the procedure/treatment to obtain the consent, although the actual presentation of the form can be accomplished by his/her authorized agent, such as a Physician’s Assistant. Others providers (ex. nurses) can act as witness to the signature. Effort must be made to ensure that patients who speak a different language are provided with translation services. When circumstances require a third party (a spouse or other proxy holder) to give the patient’s consent, the conversation leading to that must be documented as well.
Truly informed consent requires a truthful statement of the potential risks and most likely outcomes.
What happens when we can not trust our doctors to be truthful to us, or even possibly to themselves?
In a 2009 survey of over 1900 doctors was conducted by the journal Health Affairs. They found that “approximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year.”
That means a third of the doctors surveyed would hide an error, a fifth of them felt it was all right to mislead a patient regarding the truth, and a tenth of them admitted to lying to a patient within the last year. That equates to a fair amount of uncertainty that a doctor will always be honest even if you ask them the right questions when deciding to give informed consent. (Lezzoni et al, 2012)
So… as shocking as it is to realize some doctors will admit to lying about errors,
does that mean they would be less than truthful when seeking informed consent?
Apparently it does. ABC News in 2012 ran a story called “8 Things Your Doctor’s Not Telling You”. On the list of what they will not say is “I’ll always push surgery”. They reported that many doctors will always recommend surgery as the only option, even when studies show that some surgeries do not actually improve patient outcomes at all. “You should always ask what the alternatives are to surgery, including an approach that most physicians feel uncomfortable offering: to do nothing,” stated Christopher Meyers, head of the Kegley Institute of Ethics at California State University. (Dailey, 2012)
All too often we make choices based on incorrect information. Lyn had been told the cancer would proceed a certain way, but my own research later shows that was not a certainty. Without evidence of growth, a Chordoma site can stay dormant for years. Despite multiple X-Rays, CTs and MRIs there was no evidence to indicate that her lesion had grown in the ten months since it had been discovered.
If it was me, I’d have the surgery.”
“If it was me, I’d skip the surgery and live my life to the fullest.”
Not only were there possible flaws in Lyn’s diagnosis, there was an absence of personal opinions from those recommending the surgery. Not one doctor ever said “If it was me, I’d have the surgery.” Nor did they say, “If it was me, I’d skip the surgery and live my life to the fullest.” We did not ask them that question. We assumed that because they proposed it as a solution for her, it was what they would have chosen for themselves. And today, looking back, I believe that assumption was the single greatest mistake we made.
I recently read an article written by Ken Murray, a physician at USC titled “How Doctor’s Die.” What he had to say on this subject made me think hard on what had happened to Lyn. He wrote, “Almost all medical professionals have seen what we call “futile care” being performed on people. That’s when doctors bring the cutting edge of technology to bear on a grievously ill person near the end of life. The patient will get cut open, perforated with tubes, hooked up to machines, and assaulted with drugs. All of this occurs in the Intensive Care Unit at a cost of tens of thousands of dollars a day. What it buys is misery we would not inflict on a terrorist.”
Those are strong words indeed…
“misery we would not inflict on a terrorist.”
He is correct… when futile care is brought to bear on a terminal illness, what is accomplished? Often it nothing but pain, suffering and anguish. The last few days or weeks are spent clouded with medication to relive the pain and suffering, and often that pain is from the treatment itself. If there is no cure to grasp, no solution at hand… why then do we as patients often choose futile care rather than begin to prepare for death? I used to think it was because we are tenacious beings who simply want to live no matter what the cost. I felt that every day lived, regardless of accomplishment within that day, was important. I was wrong. This is the bitter pill of health care we all will likely face someday, either for ourselves or with someone we love… and it is simple.
Accepting death in the face of a terminal illness is not giving up. I am not advocating that everyone with an illness that is terminal should forgo treatment… That is not what I mean. What I am talking to you about here is the situation where there is no realistic treatment that will have a positive outcome. It is fine to buy more time with treatment, but I am stating that we all need to understand what the quality of that time would be when making the decision to pursue it.
When a surgery has a high risk, we are making a choice between treatment and doing nothing. Would we give up up months spent living, spending time with our friends and family, fulfilling our dreams and goals, checking off the items on our individual ‘bucket lists’… in exchange for a year or two spent extension of life spent in pain, staring at a ceiling, watching those who love us suffer along with us? Sometimes that is the actual question we are answering when we decide to give consent to a treatment or not. Sometimes giving informed consent means asking yourself “Do I trust this doctor to cut me apart and reassemble me without error?” Those are the actual choices Lyn made when she gave her consent. I believe we do not always receive the information we need to make that informed consent… and we need to understand why.
Dr. Murray believes the reasons for this are three-fold: the patients, the doctors and system. Patients facing a life ending illness are scared of dying and overwhelmed by despair. Desperate for a different outcome, when a doctor offers them a choice of survival, no matter how slim it is, they grasp at it without thinking of the alternatives. If you are drowning and someone throws you a life preserver, do you look to see if it is tied to a boat or an anchor? It is hard to blame a dying patient for wanting to live and despair does cloud one’s judgment.
Then there are the doctors. Dr. Murray points out, even doctors “who hate to administer futile care must find a way to address the wishes of patients and families.“ He argues that because many doctors are poor communicators, they often find themselves in situations where they agree to the wishes of a patient and their family. They lack the ability to explain the downside of a particular treatment or course of action, and focus on the outcomes that end in success. It is, after all, a calling to save lives that brought most of them to their chosen occupation. Take his opinion along with the study I mentioned earlier… factor in that percentage of doctors who will lie about errors or give a rosier picture of a prognosis… and the blame shifts even more to them.
I would add that, from my personal experience, sometimes it even goes a bit further. Surgeons in large hospitals are often under extreme pressure to perform high risk procedures to gain acceptance from their peers. Even the very best surgeons are often in a competitive environment, where their fellows grant them acclaim and acceptance based upon their ability to perform complicated procedures. Being able to meet the high performance standards set by others in their own field can drive them to minimize the risks of a procedure and even overstate their own skills when seeking a patient’s informed consent. When this occurs, the patient facing a high risk surgery is not always given a clear understanding of the realistic risks of complications.
It is indeed unfortunate that Lyn’s doctors were not more like Dr. Murray. He describes his approach “…of laying out only the options that I thought were reasonable (as I would in any situation) as early in the process as possible. When patients or families brought up unreasonable choices, I would discuss the issue in layman’s terms that portrayed the downsides clearly.” Lyn’s doctors spoke in clinical terms like ‘transmandibular approach’ and stated a risk level no higher than any other surgery. We did not know that there were other, less risky approaches that could be used to gain surgical access to the tumor. In surgical reviews of this procedure, this approach is defined as “provides the most complete exposure, but it is a morbid procedure and is associated with the risk of complications.” (Celtiklioglu, 2001). The term morbid is defined from its Lation roots, where morbi means to “to die” and is generally defined in medicine as meaning “Adverse effects caused by a medical treatment such as surgery.” (Morbidity, defined. 2013)
Doctor’s need to supply a patient with a complete view of the risks of the surgeries they seek consent to perform. They need to use words that patients can fully understand when explaining procedures and risks, and have an actual discussion of the risks of any surgery, not simply a passing statement of the likelihood of complications. If any of the doctors on Lyn’s consultation team had shown us the stroke care floor at the rehab we ended up in and told her she could end up there, I am certain she would have taken those few months or maybe even years walking, talking and living instead.
Then there is the system itself. Once again, Dr. Murray sums it up. “In many ways all the parties are simply victims of a larger system that encourages excessive treatment. In some unfortunate cases, doctors use the fee-for-service model to do everything they can, no matter how pointless, to make money. More commonly, though, doctors are fearful of litigation and do whatever they’re asked, with little feedback, to avoid getting in trouble.”
All of this leads me to one inevitable conclusion, the one and only answer to the question that plagues me still. Lyn didn’t say no to the surgery because she had truly no idea what could happen.
Back we go to that day a little over six years ago when they explained to Lyn what the surgery entailed while seeking her informed consent. Using clinical terms like ‘transmandibular approach’, barely discussing the elevated risks, and never once discussing the alternatives, Lyn was not told whether they would have the surgery themselves if faced with this diagnosis. I know we did not ask, but we did not know enough to be able to. They did know the risks and the high likelihood of failure and complications, and had an ethical obligation to tell Lyn what they knew. But they did not do so.
I just wish I could accept it. I can understand now why Lyn made this choice, but that’s only because in hindsight I have knowledge that comes from study and wisdom that comes from experience. All I can do now is help others not to make the same mistakes, and if they do help them improve their outcome. As patients we are evolving into far more educated consumers. As more educated consumers, we are demanding transparency and the truth that comes along with it.
I am not alone in this belief. David Mayer, a doctor who speaks about the growing need for transparency, sums up this need quite succinctly. He writes, “[Our patients] want Transparency in outcomes. …They want Transparency in shared decision-making. Informed consent doesn’t cut it anymore. More and more patients want their caregivers to fully understand their values, preferences, needs and goals before any discussions on care options, risks, benefits and alternatives begin. They want information on the hospital and their physician’s experience related to the procedure they will undergo–more succinctly–how many similar procedures have we performed, and how well have we done? They want to know our infection and complication rates. And more and more patients also want to understand the costs related to different treatment options. … It is my opinion these new patient demands for transparency have been long overdue, are badly needed, and will help move us to a more cost-effective, higher quality, lower risk patient care model. It will be a new and better health care system, but history has taught us change will not come easily or quickly.”
He also instructs doctors on how to better reach out to their patients. “…When you enter a patient’s room, instead of standing at the foot or side of the bed (as I had done for so many years) pull up a chair, sit down and have a true conversation with them. Research has shown that patients perceive caregivers who did this to have spent twice as much time in the room with them, versus a comparison group of physicians, who actually spent the same amount of time with the patient, but stood at the foot of the bed while talking to them.”
Sit next to us, and explain it to us
as if was you lying in this bed.
Tell us if you would have this surgery or treatment yourself whether we ask the question or not.
Remember we are desperate to survive our
illnesses and injuries and may not think to ask.
Above all else, tell us the truth.
About Chordoma. (2012). The Chordoma Foundation. http://www.chordomafoundation.org/chordoma/
Aiken, T. (2009). Legal and Ethical Issues in Health Occupations. St. Louis: Saunders Elsevier.
Celtiklioglu, Feridun. (2001). A new case of a branchial cyst of the parapharyngeal space. Ear, Nose and Throat Journal. June 1, 2001 http://www.thefreelibrary.com/A+new+case+of+a+branchial+cyst+of+the+parapharyngeal+space-a076877194
Dailey, Kate, 20120. “8 Things Your Doctor’s Not Telling You”. ABC News, April 20, 2012 http://abcnews.go.com/Health/Wellness/things-doctors-telling/story?id=16175754
Lezzoni, L., Rao, S., DesRoches, C, Vogeli, C and Campbell, G. (2012). Survey shows that at least some physicians are not always open or honest with patients. Health Affairs. February 2012, vol. 31 no. 2 pp.383-391. http://content.healthaffairs.org/content/31/2/383.abstract
Mayer, D. 2013. Sitting Down with Patients. Educate the Young. March 18, 2013. http://educatetheyoung.wordpress.com/category/patient-advocacy /
Meisel, A. and Schenker,Y. (2011). Informed Consent in Clinical Care: Practical Considerations in the Effort to Achieve Ethical Goals. Journal of the American Medical Association. AMA. 2011;305(11):1130-1131.
Morbidity, defined. A Wiki based open content dictionary. June 7, 2013.
Murray, K. (2011). How Doctors Die: It’s Not Like the Rest of Us, But It Should Be. California HealhCare Foundation, Zocalo Public Square. http://zocalopublicsquare.org/thepublicsquare/2011/11/30/how-doctors-die/read/nexus/