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Philosophy

Guidelines vs Protocols / Evidence-Based vs Evidence Informed

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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!

Guidelines

How To Craft A Clinical Practice Guideline

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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.

Guidelines

Why Create Practice Guidelines?

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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.

How to

How To: The Serial Abdominal Exam

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How often have you seen this in an admitting history and physical exam note? “Admit for observation; serial abdominal exams.” We say it so often it almost doesn’t mean anything. And during your training, did anyone really teach you how to do it? For most trauma professionals, I believe the answer is no.

Yet the serial abdominal exam is a key part of the management of many clinical issues, for both trauma patients as well as those with acute care surgical problems.

Here are the key points:

  • Establish a baseline. As an examiner, you need to be able to determine if your patient is getting worse. So you need to do an initial exam as a basis for comparisons.
  • Pay attention to analgesics. Make sure you know what was given last, and when. You do not need to withhold pain medications. They will reduce pain, but not eliminate it. You just need enough information to determine if the exam is getting worse with the same amount of medication on board.
  • Perform regular exams. It’s one thing to write down that serial exams will be done, but someone actually has to do them. How often? Consider how quickly your patient’s status could change, given the clinical possibilities you have in mind. In general, every 4 hours should be sufficient. Every shift is not. And be thorough!
  • Document, document, document. A new progress note should be written, dated and timed, every time you see your patient. Leave a detailed description of how the patient looks, vital signs, pertinent labs, and of course, exact details of the physical exam.
  • Practice good handoffs. Yes, we understand that you won’t be able to see the patient shift after shift. So when it’s time to handoff, bring the person relieving you and do the exam with them. You can describe the pertinent history, the exam to date, the analgesic history, and allow them to establish a baseline that matches yours. And of course, make sure they can contact you if there are any questions.
Complications

What Does A Retained Surgical Sponge Look Like?

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Surgeons and surgical residents rarely see these. And because it’s so uncommon, they frequently don’t recognize the telltale findings on radiographic studies. The TSA runs into the same problem in screening passengers for weapons and other hazards at airports. But it’s the bane of any surgeon’s existence. And it’s a major reason why OR personnel take such great pains to account for everything in the room. It is a catastrophe, and always a preventable one, when some piece of equipment goes missing and ends up left inside a patient.

A number of methods have been developed to try to eliminate this problem. They include careful counts, having someone record anytime anything is placed inside, x-rays, and most recently, RFID tags.

After counting, x-ray is the most common way to try to find missing objects. One would think that these foreign bodies would be easy to see. Metallic instruments are rather easy to spot. But many trauma professionals, even those who work in the OR, have never seen what a positive image of a sponge actually looks like. So here they are. You should never miss one on an xray now.

Surgeons typically use two types of sponges in the OR: Ray-Tec sponges and standard lap pads. Ray-Tecs look like a 4×8 piece of gauze with a mysterious blue string woven throughout it. The string is the only part that shows up on x-ray, and it is very thin and somewhat hard to see. Here are some Ray-Tec sponges outside the body:

And here’s one that was left inside. Note the little squiggle in the left lower quadrant and how easy it is to overlook.

On the other hand, a laparotomy pad is a 4×4 folded cloth pad that unfolds into a larger pad. It has a blue radiopaque tag sewn in the corner, extending along one edge of the pad. Here’s what they look like outside the body:

And here’s one inside a patient. Note the irregular object in the right upper quadrant. Many times the tag is scrunched up and doesn’t look like one.

Bottom line: It’s important for anyone who works in the OR on any body part to be familiar with the appearance of these tags on x-rays. Since it’s generally impossible to get accurate counts before or after a trauma procedure, always image the involved body cavity looking for these telltale signs before closing the patient.

Note: These images  were taken from the internet. Patients were not treated at Regions Hospital.