Protocolize It!

We live in the era of big data. With the introduction of electronic medical records, big data is also alive and well in medicine. Mining that data can help establish therapies that are most effective in the majority of patients. The mined data plus results from large scale prospective, randomized studies then result in recommendations and protocols that are supposed to improve patient outcomes.
A majority of physicians have historically looked at medicine as an art. Each physician had his or her way of treating ailments, often tailoring them to fit individual patients.
Medicine however is moving in a direction where the “Medicine as an Art” crowd is on the edge of extinction.
Who is right? Should the practice of medicine be based on protocols or should it be practiced as an art?

I’ll start off the discussion with two examples:
Close to a million Americans suffer from strokes each year and it’s the number 4 killer in the US.
For years, different hospitals and physicians have managed patients with strokes differently. Studies show that if patients having ischemic strokes are given intravenous tissue plasminogen activator (tPA) to bust the clot causing the stroke within 60 min of arriving at a hospital, their chances of survival go up significantly. However, a study in 2014 showed that less than 30% of ischemic stroke patients were being treated this way. On the other hand, hospitals that had established protocols to facilitate this recommendation lowered the incidence of death and disability from stroke.
Another area of concern is that of medical errors. The “To Err is Human” report sounded the alarm bell in 1999. That in part led to the institution of the Surgical Safety Checklist and the “Time Out” for all surgical procedures. A 2009 study in the NEJM showed a drop in death from errors from 1.5% to 0.8% since institution of the checklist and “Time Out”. Inpatient complications dropped form 11% to 7%.

These two examples illustrate the fact that protocols based on science and solid evidence can positively affect outcomes.
Should this then be extrapolated to all of medicine? Should every decision we make be decided by protocols culled from studies and hard data?

Which brings me to the other side of the coin.
Say a study S looks at therapy for say, Prostate Cancer, in a 1000 men. if this therapy is effective in 86% of the men and it gets adopted, what happens to the 14% who do not benefit from the therapy.? if one extrapolates that to a million subjects, that 140,000 men who do not benefit from this new therapy. A good protocol has to allow a physician to cater to this group.
Recent recommendations about two tests that affect men and women have raised the ire of patients. The first is mammography to screen for breast cancer in women and the Prostate Specific Antigen (PSA)to screen for prostate cancer in men. In both cases, based on data, the opinion was that they led to an increase in the false positive diagnosis of a cancer. In other words, patients were thought to have cancer who did not. This led to further unnecessary testing and procedures. With the PSA, it is thought that a lot of small prostate cancers could be diagnosed, which left alone would not grow to be a problem. Now imagine telling a patient:
“You have cancer but it is so small we are going to leave it alone. You will outlive it.”
Sure, in a calm and reassuring manner, a doctor can try to make a patient understand but how many will bear to live with that uncertainty. Then there is also the probability that that small cluster of cells could get bigger….So why not get them out now?
Even if these cancers are small, isn’t it the smart thing to do to diagnose them and follow them? Doesn’t that make these screening tests then necessary? Doesn’t that give the patient a choice?

The point I am trying to make is, in spite of all the data, there are these people called Patients who we are supposed to serve. They are ruled by emotion and are not always as rational as the data and evidence. Is it part of “doctoring” to do whatever is possible, besides causing harm, to reassure these patients?
So on one side are the those who preach a strict adherence to the evidence and on the other those who want to tailor things to the needs of the patient and the habits of the physician.

Into this fray drops Genomic Medicine. This is an emerging discipline that bases therapy on a patient’s genome. It is a well known fact that some drugs (e.g. Plavix) do not work in some patients because of lack of or too much of certain enzymes. Before a particular therapy is initiated, the genetic make-up of a patient is determined. It is now used extensively in psychiatry to get effective therapy.
This shows that in spite of the data or evidence, there are still individual variations.

All these arguments may not matter because of the Affordable Care Act.
The Affordable Care Act has decimated the private medical practice to the point where the majority of physicians are now employed by hospitals. The Act also rewards physicians whose practices are in line with the latest most effective therapy and management modalities. Hospital administrators are then going to compel their physicians to practice in accordance with protocol that fit the best recommendations. In that sense, the autonomy of the physician may already be a thing of the past and patients’ choice may be slowly narrowed to a few options.

All this makes me wonder what role the physician may play in medicine in the future. If every decision we make is based on a protocol, what will happen to the practice of medicine as we know it? Besides surgeons, are any other specialties even needed if all one needs is to follow a protocol? Protocols so simple that even a caveman can follow them? What are we then good for?