Informed Consent


doi: 10.1097/01.COT.0000337623.59001.fb
View from the Other Side of the Stethoscope

One essential chore stands between the patient and the physician's knife or catheter: obtaining informed consent. Physicians and nurses are obligated to get each patient's John Hancock to make the permission official.

As an internist, the only interventions done in my office that required a release form were sigmoidoscopies. Informed consent served as my legal safety net by documenting that my patients were both knowledgeable and free in their decision to proceed.

With triplicate forms in hand, I carefully modulated the tone of my voice, striving to communicate the threats without scaring my patients out of signing. Obviously I'd already recommended the procedure to my prepped-and-gowned patients. Invariably I'd also shared my confidence that the benefits outweighed the risks.

If patients hesitated, I assured them I was familiar with and prepared to address potential complications. I often repeated how I'd seen the desired outcome often enough to hope for the same for them. That I never had a patient balk at the dotted line suggested a job well done. Yet in the spring of ‘93, I discovered a better way’.

I was a cancer patient facing my second recurrence and frightened beyond words. I forced myself to shift into disciplined-doctor mode, knowing that wise treatment decisions must be made dispassionately. Wishes and hopes must be shoved aside, just for the moment, while statistics reign supreme.

Taking notes helped me make sense of my telephone consultations with various experts around the country. To sum up what I'd learned, I designed a crude chart that weighed the advantages and disadvantages of my best options. (Interestingly, physicians who do this for their patients are called “admirably thorough,” while patients who do this for themselves are labeled “obsessive compulsive.”)

A week's worth of serious talks and salty tears later, my husband and I met with my local oncologist to make a final decision. We reviewed the options again and unanimously agreed I should enroll in one particular trial.

So my husband and I made arrangements. A few days later, we flew out west to meet the research team. After doing a history and physical, the same researcher from my earlier phone calls once again discussed my options, as well as the risks and benefits of the trial. Then we were ushered into a conference room to fill out the informed consent forms for the following day's treatment.

Weak and worn-out, both physically and emotionally, I experienced a bizarre disequilibrium as I entered the room. The research nurse started reading the form aloud, pointing to each potential complication. Knowing that once treated I could never go back and undo what had been done, I urged myself, “Pay attention, Wendy.” Lord knows I tried, following the tip of her finger as if it were the bouncing ball over the words to a sing-along. But the words looked and sounded like gibberish.

Nothing would have been lost had the nurse thumbed quickly through the pages to the signature line at the end, the way I now scroll down quickly to the “I accept” box whenever signing up for Internet access in a hotel. I'd let go of my objectivity the moment I left my local oncologist's office to purchase plane tickets for the trial.

With my survival instincts in full gear and the nurse's pen in my hand, I tuned out her recitation of potential complications. I could no more have refused consent than I could have made an about-face at the altar and left my wedding without saying, “I do.” For me, this mind-numbing formality simply legalized the many meaningful conversations that had led up to my commitment to the trial. And that was okay.

Wait! We're talking about my signing a legal document regarding life-and-death treatment.

Yes, but as a patient about to undergo an investigational therapy, I couldn't focus on all that could go wrong, even for a few moments. Doing so would have made it far more difficult to psych myself up for the imminent treatment. Letting go of my objectivity was more than okay; it was exactly what I needed to do.

I'm sure I'm not the only patient who zones out when presented with a consent form. So what are clinicians to do?

It makes sense that “obtaining informed consent” be included with the other pre-treatment preparations. This ensures the signed forms get into patients' charts. But this timing can create problems for patients: The mindset necessary for giving informed consent is distinctly “un-healing” for patients about to undergo treatment.

Maybe hospitals and medical practices could first present consent forms when patients are still in critical-thinking mode, such as immediately following the treatment decision. This would lend itself to careful patient review and opportunities for the health care team to address their questions. Signatures would signify thoughtful consent.

Later, when patients are eventually admitted to the clinic or hospital for treatment, they could be handed their consent forms once again. Only this time the expectation would be for patients to flip right to the signature line, where the addition of their initials would confirm they haven't changed their mind.

Clinicians know that informed consent is a process, not a piece of paper. A two-stage signing might help the consent form function as intended: to promote patients' clear understanding. Getting the “informed” part of the consent completed early, patients can approach treatment with a healing blend of optimism and hope. With the frightening facts no longer forced in front of them, patients may do better medically. For sure, they'll feel better.

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