From Silence to Voice*

I am a member of the Institutional Review Board (IRB) at my university. IRBs, also known as independent ethics committees (IECs) or ethical review boards (ERBs) are committees that have been formally designated to approve, monitor, and review biomedical and behavioral research involving humans in order to protect the rights and welfare of the research subjects. While I sometimes gnash my teeth at the IRB when I'm working on my own research, I enjoy being a part of the board and interacting with my colleagues.

The reality is that there is not a lot of nursing presence on the university's IRB. It is mostly physicians, a few others who are involved with the research process, and the requisite community member. Over the two years that I have been on the board, I have contributed...adequately. I do my reviews, I occasionally ask questions or contribute my thoughts to the discussion. But at the last meeting I attended, I felt that I was present as the Voice of Nursing.

Usually, an IRB meeting has the same components -- reviewing and voting on the status of newly submitted studies, continuing reviews for on-going studies, and modification reviews for studies requesting changes. Occasionally, however we have to deal with Protocol Deviations. Protocol Deviations can range, but generally only those that cause harm or have the potential to cause harm are brought to the board. Last week's meeting included a review of a study with two major protocol deviations. The study is situated in the ICU, and utilizes very aggressive diuresising (i.e. giving medications--in this case IV furosemide--that causes one to eliminate fluid). One of the dangers with diuresis is that the process also causes a loss of potassium and can increase the blood sodium levels. Both of these processes are dangerous: potassium makes muscles contract, and either too much or too little can make muscles flaccid. Seeing how the heart is a muscle, this can be very problematic, and lead to icky things like heart arrhythmias. Sodium is involved in the transmission of electrical impulses, and since that's a very important part of brain function, this too can be very dangerous. Low sodium can cause delirium, high sodium, seizures.

This study had very strict protocols for stopping diuresis and beginning electrolyte and/or fluid replacement if the values go out of range. In this case, potassium got low, sodium high, the protocol was stopped....and then the furosemide was, for some inexplicable reason, restarted. By the time the situation was remedied, the subject's potassium was 1.8 (normal is 3.5-4.5) and sodium was 159 (normal is 135-145). When we questioned the study's principal investigator (PI), he said that a resident must have ordered the furosemide restarted, and while he did not speak with the resident, he and his team went back and worked with the ICU nurses, reeducating them regarding the protocol and electrolyte values.

Part of what I was trying to tease out was where was the root of the problem: was it a hospital systems/QA problem or was it an issue with the study? What I wound up addressing in the meeting was what is common knowledge/common practice for nurses.

First of all, electrolyte balance is nursing 101. Keeping track of critical labs like potassium and sodium is as natural to a nurse as breathing. I cannot imagine an ICU nurse not understanding what was going on, and responding accordingly.

But what really got to me, was the implication in the PI's comments that nurses blindly follow orders, whether they make sense or not. ICU nurses in particular work very collaboratively with providers, and are not known for shrinking away from making independent care decisions. Furthermore, any nurse worth her salt will not carry out provider orders that they feel are unsafe--a common response to a physician insisting on something a nurse feels is unsafe is for the nurse to say "fine, if you want them to have X, then you give it to them."

After the PI left, and the board was discussing the case, I felt it was important to raise these points. Not because they had direct bearing on the case in front of us, but because, as the lone nurse in the room, I felt it important that I remind those assembled of the scope of nursing practice, and of our skills and abilities. Even though it painted that specific nurse in a poor light, it felt more important to stand up for nursing as a profession, not as mindless "handmaidens to doctors." I'm not saying that that is how most providers perceive us, but as much as the public doesn't understand what we do, I sometimes get the sense that our colleagues and co-workers don't always get it either.

*Hat Tip to Bernice Buresh and Suzanne Gordon, authors of From Silence to Voice: What Nurses Know and Must Communicate to the Public

Ethics

Things are starting to move along in dissertation land. After some small hiccups, I received IRB approval.

The only issue related to my recruitment process: my plan was to work with hospice agency staff: asking them to share my recruiting brochures with potential participants and ask if it is OK for me to contact them. The IRB decided that, while no health care information was being released, the family member would need to sign a form stating that they have given permission for their contact information to be released to me.

Last Thursday, I had my first meeting with hospice staff. It was the RN staff meeting, and three nurses signed up to work with me. Two stated that they had people in mind. Exciting!

This afternoon, I receive a call from D., one of the nurses. She tells me that she has talked with a family member who is willing to talk to me. I ask D. if she got the release signed.

D: No, I didn't see her in person, we just talked on the phone.

Me: Oh, when will you see her next?

D: I won't be out to see the patient again until next Thursday and she may or may not be there.

Thoughts race through my mind: what would it hurt to take the information? Who would know? It won't affect the validity of the data...

And of course, I say the only thing that I can say. I ask if D. will call the family member back and give her my contact info. D states she can't do it now as it is the end of the day. I assure her that I do not want to make more work for her, and any chance she gets in the next few days would be great.

We do so much based on trust: trust that what we say is the truth, that what we say we will do is what we do, and what we say we will not do, we don't do. Our patients trust us to be honest, but compassionate, to not abandon or exploit.

As researchers, most of the time, things are not so life and death, but the value of our work rests in the integrity of our words and actions.

Deactivating ICDs

Here's an ethical question for you:

When is it appropriate to deactivate an ICD (implanted cardioverter-defibrilator)? To give some background: an ICD is a device that is surgically placed in the chest of a person who are at risk of sudden cardiac death due to ventricular fibrillation. Unlike a pacemaker, which uses electrical impulses to control the heart rate, the ICD "shocks" the heart when detecting an abnormal rhythm--just like the paddles used externally. From what I hear and read, the shock is a pretty nasty thing, and can cause pain, anxiety and a loss of consciousness. The issue here, is that when someone is close to death, their heart rhythm can go wacky, resulting in repeated shocks being delivered by the ICD. Turning off an ICD is not a simple matter: it is a process that requires specific skills and equipment. Theoretically, one can deactivate (temporarily) an ICD with the use of a magnet, but it is a stopgap measure--it needs to be taped to the patient's chest to keep it deactivated, and, I've read that sometimes the magnets don't work.

We currently have a patient, end-stage cancer, who also has an ICD. It has been discussed with him at least twice, and he has declined to have his ICD turned off. The problem, is that the other day, he got up unassisted (he's pretty weak) and was shocked by his ICD, causing him to blackout. Since then he has been anxious and afraid to sleep: afraid that he'll be shocked in his sleep. On Friday night, I managed to reduce his anxiety by providing him with an anti-anxiolytic and pain medicine. When I was back on Sunday afternoon, and heard in report that he was again, not sleeping and anxious, I decided to go down and talk over his options. Options seemed pretty limited: continuing to provide support and comfort via medication, conversation and presence, and, as far as I could see, also included offering to tape that big ol' donut shaped magnet onto him. The issues with the latter are multiple:

1. He is confused, and I'm not sure about his decision-making ability
2. He is fairly withdrawn, and when I attempt to talk with him he pretty much shuts me out
3. What are the ethics here? How confused is without capacity to make appropriate decisions? What are the ethics of doing a stop-gap measure that may, or may not work?

Luckily, I did not have to face this question head-on: the patient did sleep most of my shift, and I knew that the next day was Monday, when more services (including the most awesome social worker and the patient's provider) were available to discuss and revisit the matter. I did leave a note, as requested by the physician indicating his distress and concern. I know the folks I work with--they will continue to talk with the patient about the issue.

But what if he had been more awake and I less busy with another patient who was needing one-on-one care monitoring for delirium? What about the next time we have a patient in this situation? What if he/she clearly does not have decisional capacity, and, like is so often the case, has family members who disagree on the appropriate course?

This problem is not going to go away. Rather, it is most likely to come up more often as time wears on.

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I did a quick lit search and found that:

1. Deactivating ICDs is in general considered ethical if it is the patient's desire, or the desire of the patient's surrogate.
2. The most discussed aspect of deactivating ICDs in the articles I read was the lack of discussion about this issue with patients before it becomes critical with a decision needed now (as in the patient is unconscious, dying and receiving repeated shocks). Sounds like so many of the end-of-life discussions that should, and don't happen (or happen too late).
3. Christian Sinclair over at Pallimed has contributed to articles in health care journals about this subject at least twice. And in a bit of synchronicity, Pallimed has a new post up about heart failure and implantable devices.