Tag Archives: Practice guideline

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


  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!

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.

Best Practices For TBI Patients On Oral Anticoagulants: Part 4

In my last post, I started reviewing the anticoagulant reversal section of the Austrian consensus statement on TBI patients taking anticoagulants. Due to its length, I covered only anti-platelet agents. Today I’ll discuss their findings on reversing  Vitamin K antagonists.

Q1. Should Vitamin K antagonists (VKAs) be reversed in case of hemorrhagic TBI?

Answer: That’s simple. Yes!

Q2. Should Vitamin K be administered to reverse the effects of VKAs?

Answer: Yes, as an adjunct to other reversal agents. The usual dose is 5-10mg IV.

Adjuncts must always be used, because Vitamin K only enables the liver to produce factors II, VII, IX, and X. This is not an immediate process, and may take up to 24 hours for the INR to fall to reasonable levels. Additional treatment is needed to raise these factor levels quickly.

Q3. Should prothrombin complex concentrate (PCC) and/or plasma be used for reversal of VKAs?

Answer: Four-factor PCC is the treatment of choice, and is preferred over plasma. 

Reversal of VKAs with plasma requires administration of large volumes, and each unit is given over one to two hours. This results in a slower correction when compared to PCC, which occurs in less than 30 minutes. And many elderly patients with comorbidities cannot tolerate the colloid volume administered with multiple units of plasma. Multiple studies have shown that patients treated with PCC achieve their target INR significantly faster and have less hematoma progression than those treated with plasma.

Q4. Should recombinant activated factor VII (rFVIIa) be used for reversal of VKAs?

Answer: No.

This drug was the darling in trauma care around the turn of the century, but has since fallen into disuse. The few studies available show that there may be INR rebound and more frequent hematoma expansion compared to PCC.

Next post: Recommendations for reversal of DOACs.

Reference: Diagnostic and therapeutic approach in adult patients with traumatic brain injury receiving oral anticoagulant therapy: an Austrian interdisciplinary consensus statement. Crit Care 23:62, 2019.

Best Practices For TBI Patients On Oral Anticoagulants: Part 3

My last post covered coagulation tests for oral anticoagulants and antiplatelet agents, as well as target levels of reversal. Today, I’ll share more of the Austrian consensus paper on actual reversal of anticoagulants. I’ll also add a little commentary to some of the answers.

This is a lengthy section in the paper, so I’ll split it into antiplatelet agents today, the vitamin K antagonists tomorrow, and the direct oral anticoagulants (DOACs) after that.

Q1. Should desmopressin (DDAVP) be administered to reverse the effect of platelet inhibitors?

Answer: No recommendation. (My answer: no)

DDAVP accelerates platelet adhesion. Very few papers have looked at using DDAVP in patients with platelet inhibition, and those that did had low numbers of subjects. The only positive study showed a reduction in hematoma of only 0.5 cc (in hemorrhagic stroke patients, by the way, not trauma). This is not clinically significant. It is likely that the nonfunctional platelets do not really respond to DDAVP, so this drug is not very useful.

Q2. Should TXA be used in patients receiving platelet inhibitors?

Answer: No recommendation. (My answer: no)

There are few, if any, studies that address this. A CRASH-2 subset with TBI showed no significant difference in intracranial hematoma size after TXA. Only one very small (80 patient) study showed a decreased total hematoma after TXA administration (2cc vs 4cc). I’m not sure how clinically significant this is. CRASH-3 did not address it. Overall there is too little data to make a decision regarding this one. It’s value, if any, is very subtle.

Q3. Should platelet concentrate be administered to reverse the effect of platelet inhibitors?

Answer: No

There are no studies that have shown any clear benefit to giving units of platelets to these patients. And a meta-analysis showed no survival benefit. Giving platelets sounds like a good idea, but remember that the drug that poisoned the patient’s platelets is still circulating. It can and does poison the new platelets as well. So adding more platelets that are destined to stop functioning doesn’t seem like a good idea.

In my next post, I’ll dig into the recommendations for reversing Vitamin K antagonists (warfarin).
