More Diabetes Answers

Why is NOT being an "early adopter" uncomfortable but might be a good thing?

You have probably seen lots of adverts on TV for new drugs to help improve your sex life, lower your cholesterol, allow you to eat salty, spicy, food without heartburn, and generally make your life better.  The adverts often show everyone looking happy and have actors dressed as earnest, sincere doctors in white coats advising you in reassuring tones that you should, "Ask you doctor about fill-in-the-blank." Then at the very end of the advert in an incomprehensibly fast rush a different voice blurts out all the fine print (including side effects, or the fact that a new fat-lowering drug actually hasn't been shown to prevent heart attacks and strokes and might in fact increase your risk of stomach bleeding... check out the website at www.lovaza.com ) 

What's a person to do when the main message is that more is better and than anything new is most likely a huge scientific advance forward and therefore a good thing.

But often it takes years before we really know if a new therapy will actually improve real health outcomes that matter to people.  There have been many examples of drugs that seemed like they were doing good but ended up causing more harm than good.  Back in the 1970s and 1980s there was a big push to give people drugs to stop the heart developing irregular rythmns after a heart attack.  Seemed like a no-brainer.  If you've just had a heart attack you wouldn't want your heart to suddenly go into irregular rythmns.  And these drugs (like encainide and flecainide) did work to make the electrical tracings of the heart (the ECGs or EKGs) look better.  But unfortunately when researchers looked at the outcomes in patients who received the new "miracle" drugs more of them died than patients who did not receive the drug.  Sometimes a drug that helped lower blood pressure (like short-acting nifedipine) can actually increase the risk of heart attacks or stroke.  Sometimes pain killers (like Vioxx) that appear to be better because they cause less risk of stomach bleeding can actually cause an increase in heart attacks.

As I have talked about in other blog postings the story with the thiazolidinediones is another example of a class of drugs that looked promising but may be causing more harm than good.  We won't know for sure for another few years.

I work for a health care organization (Group Health in Washington State) that holds itself to a very high standard.  Before we add any drug to our formulary so that our patients can get it we try to wait until there are long-term studies that show clearly that the drug is beneficial.  When those studies are published we move very fast to contact all of our patients who might benefit and offer them the drug.  But it also means that when a new drug is being hyped up by the drug companies but before we truly know if it will be beneficial we do NOT add it to our formulary.  For patients (and some of our doctors) who buy-in to the hype I often have to deal with some unhappy and angry phonecalls.  It often feels uncomfortable to be cautious and conservative.  We take a lot of heat for not being out front with "cutting edge" drugs. 

But despite the discomfort of fielding angry phone calls in the early years of new drugs, I take comfort in this.  We never had Vioxx on our formulary at Group Health.  We never had Rezulin or Avandia or Actos on our formulary either.  I don't know how many hundreds of patients are alive today because of our cautious approach because they did not get heart attacks or die as a result of taking these drugs but it does probably run into the hundreds at least.

Again, let me be clear:  I have nothing against the company who makes Lovaza and I don't know whether it will turn out to cause more good than harm.  I hope it will.  But none of will know that until larger long-term trials are done.  We do know that it causes significant side effects.  Once we know for sure that the benefits outweigh the risk we will jump on it and prescribe it widely.  But not until then.

The power of groups: why one plus one is wa-a-a-ay more than two!

I spent the morning with one of my favorite colleagues, Dr. Jeff Gelgisser.  Jeff is a family practice doctor in Redmond, Washington who looks after a lot of people who have diabetes. 

A few years ago Jeff went through his list of diabetic patients and found a dozen or more who didn't come in very often and who had blood glucose levels and blood pressure levels that were too high and who weren't getting their eyes and feet screened as often as they should. 

 

When he called them up he found:

• Some of these people just preferred to ignore their diabetes. 
• Others just didn't like the way they were treated when they came in to the clinic. 
• Some felt lonely and isolated as if no-one understood how hard it was for them to deal with diabetes along with everything else in their lives. 

They had stopped coming in because they knew that the doctor or nurse who saw them would lecture them about how "bad" they were at looking after themselves.

Jeff then did a rather brave thing.  He invited them to come in as a group and vent their frustrations to him and his staff.  He encouraged them to share ideas with each other and he took the time to explain things to them that they were frustrated about and didn't understand. 

 

And something magic started happening.  Many people in the group changed from feeling hopeless and angry to feeling motivated to change things about how they were living their lives.  They shared positive ideas with each other.  They set new goals for themselves. 

 

They wanted to keep meeting.  They celebrated each other's successes and supported and comforted each other when new difficulties arose. Most all of those people now have lower blood glucose and blood pressure levels, are eating healthier, exercising more, are taking their medicines better and feel much better about their overall lives.

 

Jeff and his team have held group meetings like this for several years now.  Once a year they ask me to join them to answer questions about new research findings in diabetes or anything else that is on their minds.  I am honored to attend.  I always leave feeling more positive and optimistic about my life, too.

There are lots of different types of "group visits" for people with diabetes and other chronic illnesses.  One very successful and popular program was started by Dr. Kate Lorig and colleagues at Stanford. 

It is called "Living Well with Chronic Conditions"

 

You can search for that phrase on the Internet to see if there is a group near where you live. Another great resource for learning how to set up and organize group visits is at www.improvingchroniccare.org.

How NOT using a cool new treatment improved our approach to wound care

Several years ago a drug company approached me to try to convince me to start using a new kind of "growth factor paste" to help speed up how fast wounds or ulcers on the feet and legs of diabetic patients would heal.  They gave me the results of of a randomized controlled trial in which half the patients were given the real "growth factor paste" and the other half were given paste with no active ingredients in it.  The growth factor paste was expensive and had some unpleasant side effects in some patients but on average wounds treated with the paste healed several days faster.  The result was statistically significant (so was unlikely to be caused by random chance) but the improvement was only healing a few days faster over a several week period so I wasn't sure if it was worth the extra cost and risk of the side effects.  Before deciding whether or not to recommend adding the new growth factor paste I got together with my colleagues.  We picked out forty or fifty patients with lower leg ulcers in our clinics to see how fast we were healing them ourselves.

The results were striking.  Even the placebo group in the research trial (the ones who weren't getting the growth factor paste) healed much faster than most of our cases!  How could that be? Well, in the research trial all the patients were seen by expertly trained nurses who followed the same protocols when they treated patients with foot ulcers.  They did a comprehensive assessment every time.  They recorded exactly how long and broad and deep the wound was every time they saw the patient.  They cut away the dead skin around the ulcers.  They cleaned them and dressed the wounds the same way every time and they saw the patients back frequently until the ulcer was healing well.  They taught the patients how to change their wound dressings and how to look for signs that things were not going well.  Now when I looked at our own wound cases some of those good things happened some of the time but they didn't all happen every time.  Sometimes a patient would be seen but the size of the ulcer was not recorded.  Sometimes they were left to go too long before they were seen again.  They might be seen by a different person the next time who, not knowing how big the wound had been the last time, didn't know if it was improving or getting worse. different doctors and nurses in different clinics used different approaches to how they treated wounds.  No one was talking to each other or sharing their results and nothing was being tracked, so no-one could learn or improve.

So after discussing this with my colleagues we came to two conclusions.  First, there was no point in adding expensive new growth factor paste onto a chaotic system where no two wounds were being treated the same way.  Second, we needed to change the way we were treating our wounds.  We needed to look at the published medical literature and visit wound care "Centers of Excellence" to learn the best way to treat wounds.  We then needed to develop rules and expectations that used these good approaches and teach that to all of the doctors and nurses who treat patients with wounds.  Everyone would follow these rules.  Everyone would record their results and progress in the same way.  We would share results with each other.  We would learn together and keep improving.

So what happened?  Once we put this new "evidence-based wound care system" in place and trained our doctors and nurses to do it the right way every time we started healing wounds much faster than we ever had before.  We review results at every clinic every week.  We coach people to improve.  We share results with each other and change the "evidence-based protocols" whenever we find a new and better way to do something.  When that change is made everyone makes that change and this becomes the new "standard approach" for managing wounds.  The doctors and nurses are much happier with their work, now, take pride in how well they are doing, and more importantly, patients are getting their wounds healed faster and fewer of them are losing their legs.

Standard work: the boring way to innovate?

I spent yesterday morning with a very lively and passionate group of nurses who help heal ulcers and wounds.  They work all over the Puget Sound region in medical clinics and urgent care facilities helping people with diabetes and other conditions that lead them to have ulcers and wounds on their feet and legs.  When a foot ulcer is not well managed it can be disastrous.  Infection can spread through the skin and muscles into the bones of the feet, into the bloodstream and that can lead to a deadly blood borne infection called septicemia.  If a foot ulcer is not well managed the person may have to have their foot or leg amputated.  It is one of the most feared of all the complications of diabetes.  It is easy to see why these nurses are so passionate about what they do.  When their treatment works well they are saving feet, legs, and lives.

They were meeting to share ideas with each other but more important than that, to agree that they would all start treating wounds and foot ulcers the same way.  Many of them did not like that idea.  Over the years they had learned some tricks that they were sure worked for them.  Some of them were reluctant to change and do things the way someone else was doing it.  So why did they agree to change?  Because when we all looked at how well their patients were doing it wasn't nearly as good as they thought, or as good as it could be.  They used different dressings for the wounds.  Sometimes they got doctors to put the patients on antibiotics, sometimes they didn't.  They didn't all evaluate the wounds in the same way.  They didn't always write down how long, wide and deep the wound was.  So if that nurse was off for a few days and the patient came in to see someone else that person didn't know whether the wound was smaller or larger than when they were seen before.  So the new person couldn't tell if the wound was getting better or worse.  The nurses varied in how often they saw patients with wounds, and on how much of the surrounding dead skin they should cut off to allow the wound to heal better.

It turns out that many of the technical details of treating wounds have been studied in well-designed research trials.  So we know how often to see someone back, when to use antibiotics and when they are not needed.  We know the best way to cut off the dead skin, how to record treatment properly and when patients need to be referred on for more advanced treatments (like putting the patient in a hyperbaric oxygen chamber or having surgery to increase the circulation to the feet).  But over the years some of the nurses had forgotten those research results or had been told to do things a different way by doctors.  They had got sloppy with the way they wrote down their treatments.  They liked to try new and different things just to see if it would help.

But although it may seem boring to all agree to treat wounds in a standard way it is the most powerful way to improve things.  If everyone agrees to assess wounds in the same way, agrees to record the length, width and depth of the wound at every visit, and agree to how to cut of the dead skin and on how to check for infection and to see if their is enough blood going to the wound then it is much easier to compare how everyone is doing.  Once everyone is treating wounds in a standard way then it becomes much easier to improve the treatment.  If one of the nurses thinks of an improvement to the standard treatment (perhaps because she read about a new research study that proved that a new dressing speeded up the healing) then all of the nurses in all the different clinics can try the new dressing.  If they all agree that this speeds up the healing then the new dressing can become part of the NEW standard work for healing wounds.

Luckily, by the end of the day yesterday these talented and passionate nurses agreed that they could learn best from each other if they agreed to do things in the same boring standard way, then compare their results, and try to look for better ways to improve their care.  So the standard work doesn't stay standard and boring for long - it keeps improving over time so that more and more patients get their ulcers to heal faster and avoid losing their legs.