Tag Archives: Practice guideline

Practice Guidelines: The Holdouts

I’ve spent several posts discussing the whys and hows of developing clinical practice guidelines. But no matter how well you craft them and how much buy-in you get from potential users, there will always be a few holdouts.

In my experience, these recalcitrants fall into two general groups: the “I can do it better” group and the “I don’t like cookbooks” group. Let’s examine each one and see what can be done about them.

“I can do it better”

This group is implying that their experience and expertise exceed that of the rest of us “average” trauma professionals. They believe that their experience managing an unknown number of similar cases elevates their clinical acumen above all others. In a way, they imply that anyone who disagrees with their management is wrong.

Unfortunately, in medical care, there are very few absolute rights and wrongs, just a continuum of shades of gray. No clinician has seen enough cases to figure out how to manage the edge cases and the patients whose conditions are getting close to those very gray edges. To claim that one’s own experience allows better judgment than the collective experience of hundreds or thousands of colleagues borders on narcissism.

Unfortunately, it is extremely difficult to change anyone else’s mind. We all have cognitive biases in place to protect us from having to admit we were wrong about something. Confronting someone resistant with a pile of facts and justifications will only cause them to double down in their convictions that they are right.

There is no easy solution for such cases. The most effective technique is to slowly build buy-in from all their peers, so they end up as the last man/woman out. Over time, they may slowly recognize that the care provided by their peers is working at least as well, if not better, than theirs. If it is possible to include time and work-savers in the guideline, this may also help win the outlier over.

“I don’t like cookbook medicine”

In the early days of aviation, there were occasional horrific accidents, such as forgetting to lower the landing gear before touchdown. These occurred because the pilots were essentially “flying by the seat of their pants” and randomly using a mental list of tasks as they prepared for landing. The occasional mistake was inevitable.

However, this changed once the concept of checklists was introduced. If you ever watch a cockpit video during the approach phase of a commercial aircraft landing, you will see both pilots step through complex checklists in order and receive verification of each step from each other. When was the last time you remember a commercial aircraft landing with its gear up?

Practice guidelines are essentially a checklist of inputs to be evaluated and orders to be placed. They have been developed using sound, evidence-informed reasoning, so they are the best they can be until better research becomes available. But in medicine, as in aviation, there are a few rare events or conditions that were not or could not be considered when the guidelines were developed.

Fortunately, these edge cases make up only a few percent of the cases we encounter. The “cookbook approach,” or “checklist approach” as I like to call it, actually works well most of the time.

Here’s what you should do when faced with the “cookbook” objection.

  1. Include a phrase similar to the following in every guideline you publish: “These guidelines are not a replacement for clinical judgment and may be altered by a senior clinician as appropriate.”
  2. Explain to everyone that they are welcome to vary from the guidelines when they believe it is warranted, but they must document their rationale in a progress note in the chart. Inform everyone that if the rationale is sound, it may be used to revise and improve the guideline. But if the rationale is either unsound or undocumented, the case will definitely be discussed at the next multidisciplinary trauma PI committee meeting.

 

Guidelines vs Protocols / Evidence-Based vs Evidence Informed

In my last two posts, I reviewed the importance of having practice guidelines at your trauma center and gave some pointers on how to develop them. Today I’ll give you my take on the nomenclature and the evidence they are based on.

There are lots of names given to what we have come to know as clinical practice guidelines. You’ve heard many of them. Guidelines. Pathways. Protocols. What’s the difference?

Unfortunately, there are no real and solid definitions of these terms when used for clinical care. So here is my take on them:

  • Guideline. Guidelines are general principles that guide management. These are best illustrated by the practice guidelines published annually by the Eastern Association for the Surgery of Trauma (EAST). Each EAST guideline tackles a specific clinical problem, like DVT or blunt cardiac injury. It presents a series of clinical questions regarding the topic, such as “which is better, unfractionated heparin or low molecular weight heparin.” The pertinent literature is reviewed and its overall quality is judged. Then the questions are answered and the confidence in that answer is given, based on the strength of the research (strongly recommended vs recommended vs conditionally recommended, etc.). So in reading the guideline you may see that the use of low molecular weight heparin is recommended over unfractionated heparin in certain circumstances.
  • Protocol. A protocol is a description of very specific behaviors that are followed in certain situations. The behaviors can be described either in a list format (such as that followed in some type of formal ceremony) or in a flow diagram which is best used in clinical care.
  • Pathway. In my mind, this falls somewhere between the two extremes of guideline and protocol. It is more specific than a guideline, but less so than a protocol.

In clinical care, specifics are important. Without specificity, there is still much opportunity for variation in care, which defeats the purpose. The EAST guideline described above paints some broad strokes about clinical care, but there are huge gaps between the questions answered that need answers to provide actual patient care.

So although we (and I) tend to call these documents clinical practice guidelines, they are really clinical care protocols. They should be written in such a way that care can be provided in an “if this, then that” manner. If any kind of hedging language is used, like the word “consider”, the document is only a guideline. And this fact becomes extremely important when your trauma PI program tries to monitor for compliance. It is immediately obvious when someone deviates from the protocol, while a savvy clinician can always claim that they “considered” the desired course of action before they chose their own way using a guideline.

Now, what about evidence-based guidelines? Isn’t that what we all strive for? First of all, they’re not guidelines, remember. They are protocols. And second, there is no area of medicine where the research is so detailed that you know what to do down to specific blood draw times, vital sign monitoring, or operative techniques. There is still plenty of room for debate even in something as simple as chest tube removal. Water seal or not? How long until you get a followup x-ray? The possibilities never end.

So it’s basically impossible to develop anything that is completely evidence-based. We always have to take the best evidence and supplement it with clinical experience and judgement. The latter is what we use to fill in all the blanks in guidelines. I’ve seen too many trauma centers delay writing up their protocols because they are waiting for a better paper to be published on this or that. Good luck! It’s not coming any time soon!

Bottom line: Hopefully, I’ve convinced you that we’ve got the nomenclature all wrong. What we really want are evidence-informed protocols, not evidence-based guidelines!

How To Craft A Clinical Practice Guideline

All US trauma centers verified by the American College of Surgeons are required to have clinical practice guidelines (CPG). Trauma centers around the world generally have them, but may not be required to by their designating authority. But don’t confuse a policy about clinical management, say for head injury, with a real CPG. Policies are generally broad statements about how you (are supposed to) do things, whereas a CPG is a specific set of rules you use when managing a specific patient problem.

  1. Look around; don’t reinvent the wheel! This is the first mistake nearly every center makes. It seems like most want to spend hours and hours combing through the literature, trying to synthesize it and come up with a CPG from scratch. Guess what? Hundreds of other centers have already done this! And many have posted theirs online for all to see and learn from. Take advantage of their generosity. Look at several. Find the one that comes closest to meeting your needs. Then “borrow” it.
  2. Review the newest literature. Any existing CPG should have been created using the most up to date literature at the time. But that could have been several years ago. Look for anything new (and significant) that may require a few tweaks to the existing CPG.
  3. Create your draft, customizing it to your hospital. Doing things exactly the same as another center doesn’t always make sense, and it may not be possible. Tweak the protocols to match your resources and local standards of care. But don’t stray too far off of what the literature tells you is right.
  4. Make sure it is actionable. It should not be a literature summary, or a bunch of wishy-washy statements saying you could do this or consider doing that. Your CPG should spell out exactly what to do and when. (see examples below)
  5. Create a concise flow diagram. The fewer boxes the better. This needs to be easy to follow and simple to understand. It must fit on one page!
  6. Get buy-in from all services involved. Don’t try to implement your CPG by fiat. Use your draft as a launching pad. Let everyone who will be involved with it have their say, and be prepared to make some minor modifications to get buy-in from as many people as possible.
  7. Educate everybody! Start a campaign to explain the rationale and details of your CPG to everyone: physicians, nurses, techs, etc. Give educational presentations. You don’t want the eventual implementation to surprise anyone. Your colleagues don’t like surprises and will be less likely to follow along.
  8. Roll it out. Create processes and a timeline to roll it out. Give everyone several months to get used to it.
  9. Now monitor it! It makes no sense to implement something that no one follows. Create a monitoring system using your PI program. Include it in your reports or dashboards so providers can see how they are doing. And if you really want participation, let providers see how they are doing compared to their colleagues. Everyone wants to be the top dog.

In my next post, I’ll pontificate a bit about guidelines vs protocols, and the difference between evidence-based vs evidence-informed.

Why Create Practice Guidelines?

Practice guidelines are everywhere. More and more organizations have developed processes to create high quality ones. But why should we care? Do they improve what we already do?

Here are my reasons for using practice guidelines:

  • They provide a consistent way of approaching a clinical issue. Everybody working with the patient knows how things will be done, so they don’t have to remember the nuances that particular doctors or providers like.
  • They (hopefully) use the best and most valid scientific data to address the care issue, thus giving trauma professionals the opportunity to provide the best care we know of.
  • They decrease errors and complications by narrowing the number of choices available to providers.
  • They decrease waste for the same reason. For example, drawing blood every 6 hours vs daily for solid organ injuries can add up to three unneeded tests every day.
  • They provide our trainees with one good way to deal with the clinical issue. This is important when they move on to independent practice, and sometimes when taking standardized tests (boards).

Bottom line: If 10 trauma professionals deal with a given clinical problem 10 different ways, then none of them are doing it right! Develop a guideline that all of them can live with, based on current literature (if any). That way they can all be right for once, and our patients will reap the benefits.

In my next post, I’ll describe how to craft a good practice guideline.

Death Knell For The IVC Filter

IVC filter insertion has been one of the available tools for preventing pulmonary embolism for decades—or so we thought. Its popularity has swung back and forth over the years and has been in the waning stage for quite some time now. This pendulum-like motion offers an opportunity to study effectiveness when coupled with some of the large datasets that are now available to us.

IVC filters have been used in two ways: prophylactically in patients at high risk for pulmonary embolism (PE) who cannot be anticoagulated for some reason and therapeutically once a patient has already suffered one. Over the years, guidelines have changed and have frequently been in conflict. Currently, the American College of Chest Physicians does not recommend IVC filters in trauma patients, and the Eastern Association for the Surgery of Trauma just released a new practice guideline for them.

A previous study from Boston University reviewed its own experience retrospectively over a 9-year period. This cohort study looked at patients with and without filters, matching them for age, sex, race, and injury severity. The authors specifically looked at mortality and used four study periods during the 9-year interval.

Here are the factoids:

  • Over 18,000 patients were admitted during the study period, resulting in 451 with an IVC filter inserted and 1343 matched controls
  • The patients were followed for an average of 4 years after hospitalization
  • Mortality was identical between patients with filters vs the matched controls

dvt-study

  • There was still no difference in mortality, even if the patients with the filter had DVT or PE present when it was inserted
  • Only 8% ever had their “removable” filter removed (!)

And now, there is a paper in press from the Eastern Association for the Surgery of Trauma with their newest practice guideline on IVC filters. They examined the literature on patients with or at risk for venous thromboembolism (VTE) and sought to determine whether IVC filters should be used prophylactically or therapeutically in these situations. They reviewed twenty-one studies, most of which were of the usual low quality.  They drew the following conclusions:

  • IVC filters should not be placed routinely for prophylaxis in patients without DVT who cannot receive chemoprophylaxis.
  • EAST conditionally recommends that IVC filters not be placed in patients with DVT who cannot receive prophylaxis. This recommendation was conditional due to the very poor quality of the few papers available to answer this question.

Bottom line: It looks like the end is near for the IVC filter. However, I can still foresee a few situations where there might be some utility. Consider the case where a patient has DVT, cannot be anticoagulated, and is showering emboli to the lungs. Otherwise, it appears that this device is on its last legs!

References:

  1. Association Between Inferior Vena Cava Filter Insertion
    in Trauma Patients and In-Hospital and Overall Mortality. JAMA Surg, online ahead of print, September 28, 2016.
  2. Role of Vena Cava Filter in the Prophylaxis and Treatment of Venous Thromboembolism in Injured Adult Patients: A  Systematic Review, Meta-Analysis, and Practice Management Guideline from the Eastern Association for the Surgery of Trauma. Journal of Trauma and Acute Care Surgery, Publish Ahead of Print DOI: 10.1097/TA.0000000000004289, 2024.