Archive for the ‘randomized trial’ Tag

End of Medicine As We Know It

I’m trying to zoom in on critical aspects of how the digital world will create better healthcare. George Orwell once said that the hospital is the antechamber to the tomb. That was written decades ago, and unfortunately there’s still truth to that today. It’s really sad to think that 1 in 4 hospital patients in America have a problem with medical errors or that they have problems like nosocomial, or hospital-acquired, infections and medication errors.

There’s a book that was recently published called Unaccountable, by Marty Makary, MD, a surgeon at Johns Hopkins Hospital, and it’s quite an alarmist view of this problem with lack of accountability in hospitals and in the medical profession in general. The digital world could potentially help this; we’ve seen some disappointing aspects with respect to electronic medical records, which haven’t really been shown to markedly reduce medical errors. They certainly haven’t done anything to reduce hospital-acquired infections.

What will be interesting to see in the future are things like scorecards of hospitals. You saw, in recent months, Consumer Reports’ cover article about rating hospitals. This is just the beginning of where we can go to give direct information, transparency, accountability, and data to consumers and that Consumer Reports story is just going to be amplified over time, and not just through one particular magazine.

When we give a window to the consumer using real data, they can select a physician. Consumers can go to Google Scholar and figure out who the experts are in a particular field, just as we in the medical community can when we’re trying to find a physician to refer to and we can pick anywhere in the world. This is the sort of thing that can be digitally available for consumers. We as peers can put together the information that’s necessary for the proper transparency, selection of physicians, and selection of hospitals. Hopefully, that’s one way to make improvements in the future.

One of the interesting things why trustees volunteer to serve on hospital boards is that when you talk to them, they say they volunteer to be trustees so they can get access to information on which doctor is the right doctor to go to when they have a problem and, of course, there are very few people who can serve as hospital trustees, but that’s the equivalent of where we need to go with transparency, accountably, and scorecards in the future.

Consumer-Driven healthcare is a concept that a lot of physicians are very uncomfortable with. If you go back to the Gutenberg printing press, it was only then in the Middle Ages when the Bible and all the printed information could be read by others besides the high priest. In fact, that’s an analogy of what is going to happen in medicine, because until now there has been this tremendous information asymmetry.

Essentially, all the data, information, and knowledge were in the domain of doctors and healthcare professionals, and the consumer, patient, and individual was out there without that information, not even their own data. But that’s changing very quickly.

Patients will have the capability of accessing notes from an office visit and hospital records, as well as laboratory data and DNA sequencing — and on one’s smartphone, for example, blood pressure and glucose and all the key physiologic metrics.

When each individual has access to all this critical data, there will be a real shakeup to the old way that medicine was practiced. In the past, the Internet was supposed to be empowering for consumers, but that really didn’t matter because what the consumer could get through the Internet was data about a population. Now, one can get data about oneself, and, of course, a center hub for that data-sharing will be the smartphone.

Even critical information based on one’s genomic sequencing, such as drug interactions, will have a whole different look. We’ve already learned so much about the direct-to-consumer movement from the pharmaceutical industry in which patients were directed to go to their doctors and ask them for a prescription drug. That had a very powerful impact.

But in the future, with each person potentially armed with so much data and information, the role of the doctor is a very different one: It is to provide guidance, wisdom, knowledge, and judgment and, of course, the critical aspects of compassion, empathy, and communication. That is a whole different look for the consumer-driven healthcare world of the future.

We can get rid of the randomized trial and here is a better way. How we can Schumpeter or reboot the future of healthcare by leveraging the big innovations that are occurring in the digital world, including digital medicine. But one of the things that have been missed along the way is that how we do clinical research will be radically affected as well. We have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that’s great if one can do that, but often we’re talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials, and things are changing so fast with respect to medicine and, for example, genomically guided interventions that it’s going to become increasingly difficult to justify these very large clinical trials.

For example, there was a drug trial for melanoma and the mutation of BRAF, which is the gene that is found in about 60% of people with malignant melanoma. When that trial was done, there was a placebo control, and there was a big ethical charge asking whether it is justifiable to have a body count. This was a matched drug for the biology underpinning metastatic melanoma, which is essentially a fatal condition within 1 year, and researchers were giving some individuals a placebo.

Would we even do that kind of trial in the future when we now have such elegant matching of the biological defect and the specific drug intervention? A remarkable example of a trial of the future was announced in May. For this trial, the National Institutes of Health is working with Banner Alzheimer’s Institute in Arizona, the University of Antioquia in Colombia, and Genentech to have a specific mutation studied in a large extended family living in the country of Colombia in South America. There is a family of 8000 individuals who have the so-called Paisa mutation, a presenilin gene mutation, which results in every member of this family developing dementia in their 40s.

Researchers will be testing a drug that binds amyloid, a monoclonal antibody, in just [300] [1] family members. They’re not following these patients out to the point of where they get dementia. Instead, they are using surrogate markers to see whether or not the process of developing Alzheimer’s can be blocked using this drug. This is an exciting way in which we can study treatments that can potentially prevent Alzheimer’s in a very well-demarcated, very restricted population with a genetic defect, and then branch out to a much broader population of people who are at risk for Alzheimer’s. These are the types of trials of the future and, in fact, it would be great if we could get rid of the randomization and the placebo-controlled era going forward.

One of things that I’ve been trying to push is that we need a different position at the FDA. Now, we can find great efficacy, but the problem is that establishing safety often also requires thousands, or tens of thousands, of patients. That is not going to happen in the contrived clinical trial world. We need to get to the real world and into this digital world where we would have electronic surveillance of every single patient who is admitted and enrolled in a trial. Why can’t we do that? Why can’t we have conditional approval for a new drug or device or even a diagnostic test, and then monitor that very carefully. Then we can grant, if the data are supported, final approval.

I hope that we can finally get an innovative spirit, a whole new way of a conditional and then final approval in phases in the real world, rather than continuing in this contrived clinical trial environment. These are some things that can change in the rebooting or in the creative destruction, or reconstruction, of medicine going forward.

Social networking is having big impact on medicine. Social networking is changing the practice of medicine. Everybody is familiar with Facebook, which soon will have 1 billion registrants and be second only to China and India as far as a community or population. What isn’t so much appreciated by the medical community is that our patients are turning to online health social networking. These are such Websites as PatientsLikeMe, CureTogether, and many others.

Interestingly, patients with like conditions — often chronic conditions, such as multiple sclerosis, diabetes, or amyotrophic lateral sclerosis — will find patients with the same condition on these networking sites, and these virtual peers will become very much a key guidance source. This is so different from the past, when all information emanated from physicians. In fact, now many of these individuals who use social networks trust their virtual peers more than their physicians, so this is a real change that’s taken place. In addition to this, the social networking platforms, which are free, offer an opportunity we haven’t seen before.

If you combine the capability of monitoring such things as blood pressure or glucose with social networking, then you can have managed competitions with your friends, your family, or your social networking cohort, and you can start to compete for such things as who has the best blood pressure or who has the best glucose level. This, of course, is beyond competitions as simple as who has the best weight or does the most activity in terms of number of steps.

What we’re going to see going forward is the leveraging of social networking for improving healthcare. This is really taking advantage of a preexisting platform of digital infrastructure, and something that we did not anticipate would be so popular in the medical sphere. This is superimposed on Facebook, for example, which has already had individuals who at least claim that their lives were saved on the basis of pictures of themselves and their condition.

In fact, there was a young boy who was desperately ill and undiagnosed, but a Facebook friend of the mother of this boy made the diagnosis of Kawasaki disease. Historically, this is the first case in which social networking supposedly led to saving one’s life. There have been many other cases like this one that have been subsequently documented.

This is really an interesting trend, social networking. I’m really big on Twitter. My handle is @ nishanil1, and I get my most useful information in the whole biomedical research digital health arena through that mechanism. I’d encourage you to try it out or get active on it if you haven’t. Social networking is having a big impact on medicine at multiple levels.

Five devices physicians need to know about in digital revolution occurring in the practice of medicine and how this revolution can radically improve the healthcare of the future. I’d like to show you many of the devices that I think are transforming medicine today. These devices represent an exciting opportunity as we move forward in the practice of medicine.

This is 2012, obviously, and this is something that we’re going to build upon. You’re used to wireless devices that can be used for fitness and health, but these are now breaking the medical sphere. One device you may have already noticed turns your smartphone into an electrocardiogram (ECG). The ECG adaptor comes in the form of a case that fits on the back of a smartphone or in a credit card-size version. Both contain 2 sensors. With the first model, you put the smartphone into the case and then pull up the app — in this case I’m using the AliveCor app — and put 2 fingers on each of the sensors to set up a circuit for the heart rhythm. Soon you’ll see an ECG. What’s great about this is you don’t just get a cardiogram, which would be like a lead II equivalent; using the "credit card" version, you get all the V-leads across the chest as well. I have found this to be really helpful. It even helped me diagnose an anterior wall myocardial infarction in a passenger on a flight.

The second device I will enumerate is another adaptation of the smartphone, but this one is for measuring blood glucose. Obviously we do that now with finger-sticks, but the whole idea is to get away from finger-sticks. I’m wearing a sensor right now that can be worn on the arm. It also can be worn on the abdomen. What’s nice about this is that I can just turn on my phone, and every minute I get an update of my blood glucose right on the opening screen of the phone. It’s a really nice tool, because then I can look at the trends over the course of 3, 6, 12, or even 24 hours. It plays a big behavioral modification type of a role, because when you’re looking at your phone, as you would be for checking email or surfing the Web, you also are integrating what you eat and your activity with how your glucose responds. This is going to be very helpful for patients — not only those with diabetes, but also those who are at risk for diabetes, have metabolic syndrome, or are considered to be in the pre-diabetic state.

The third device I’d like to talk about is another device from the cardiovascular arena that comes in the form of an adhesive patch. It’s called the iRhythm, and I tried this out on myself. It’s really a neat device, because the results are sent by mail to the patient. You put it on your chest for 2 weeks, and then you mail it back. It’s the Netflix equivalent of a cardiovascular exam. The company then sends the patient 2 weeks’ worth of heart rhythm detection. I think it’s a far better, practical way, as compared to the Holter monitor wireless device. It’s not as time-continuous as the ECG or glucose device, but it’s in that spectrum.

I want to now explain a fourth device, which I use on my iPad. This device allows physicians the ability to monitor patients in the intensive care unit on their iPads. I use it to monitor patients at the ICU. You can use it for any ICU that allows for the electronic transmission of data. Right now, I’m monitoring 4 patients simultaneously. You can change the field to monitor up to 8 patients simultaneously. This is a great way to monitor patients in the ICU because you can do it remotely and from anywhere in the world where you have access to the Web. This is just to give you a sense of what this innovative software sensor can do to change the face of medicine.

Finally, I wanted to describe is something that I’ve become reliant upon, and that’s this high-resolution ultrasound device known as the Vscan. I use this in every patient to listen to their heart. In fact, I haven’t used a stethoscope for over 2 years to listen to a patient’s heart. What’s really striking about this is that it’s a real stethoscope. "Scope" means look into. "Steth" is the chest. And so now I carry this in my pocket, and it’s just great. I still need a stethoscope for the lungs, but for the heart this is terrific. You just pop it open, put a little gel on the tip of the probe, and get a quick, complete readout with the patient looking on as well. I’m sharing their image on the Vscan while I’m acquiring it and it only takes about a minute. It is validated of its usefulness in an Annals of Internal Medicine paper, in July 2011, [1] describing how it compares favorably to the in-hospital ultrasound echo lab-type image. This could be another very useful device in emergency departments, where the wireless loops could be sent to a cardiologist. Another application it could be used for is detecting an abdominal aortic aneurysm. Paramedics who are out in the field, or at a trauma case, could use this to wirelessly send these video loops to get input from a radiologist or expertise from any physician for interpretation.

These are just a few of the gadgets that give you a feel for the innovative, transformative, and really radical changes that will be seen going forward in medicine.

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