Each year, SIR’s Guidelines and Statements division produces multiple high-quality documents designed to ensure patient safety, enhanced the delivery of care and improve practice paradigms.
These documents are compiled by volunteer members, SIR staff, and even other societies. In recent years, SIR has expanded the quantity and type of documents provided. Luke Wilkins, MD, FSIR, the councilor of the Guidelines and Statements division, discusses the various document types, how they’re developed and how they can best inform IR therapies and practices.
The Guidelines and Statements Division recently worked with SIR’s Renal and Genitourinary Clinical Specialty Council to create a practice guidance document for the creation of a percutaneous arteriovenous fistulae program. Can you tell us why authors developed a Practice Guidance Document, rather than a clinical practice guideline?
Luke Wilkins, MD, FSIR
Luke Wilkins, MD, FSIR: The traditional guidelines and statements papers that we think of are clinical practice guidelines (CPGs), position statements, and reporting standards documents. However, IR has a very fast pace of innovation, and so sometimes we have regularly performed procedures that do not have a standard methodology applied to them that would fit within a clinical practice guideline. This is because some of the recommendations that you make in a CPG are supported by data-driven studies that rely on randomized controlled trials and meta-analyses of multiple randomized controlled trials. But because we are such a technologically-driven specialty, sometimes innovation outpaces our ability to have randomized trials.
However, our members still need guidance on the best practices for different types of procedures. This is where a practice guidance document comes in (PGD). These are ideal for procedures that we regularly perform, which have good evidence to support them, but not the robust evidence needed for a CPG. There is a real need for a document that can help members know when to do what, what to look for, and which patient population will most benefit from the therapies that we are providing.
Types of documents developed
The PGD encompasses a lot of different aspects, not just clinically, but also guidance on billing or patient acquisition. Why did the authors choose to include this?
Dr. Wilkins: One of the selling points of our PGDs is that they have some elements of flexibility built into them where they can be a document that provides guidance, soup to nuts. It can answer what clinical information you need, Imaging recommendations pre-procedure and how to perform the procedure. But it can also include billing guidance, advice on program building and marketing the procedure to your colleagues. PGDs can also be tailored as more of an educational document to focus on the pathophysiology of the disease process that you are treating.
We aim to identify the areas that would be most beneficial to our members and we try and speak to that. So, the PGD is really helping our members tailor their practice and enhance what they’re already doing for the patient population.
What’s the difference between an expert consensus statement and a practice guidance document?
Dr. Wilkins: An expert consensus statement is similar to a practice guidance document in that a group of experts provide their opinions on a given treatment or a given disease state and how IR may be able to play a role. An expert consensus document is a way to say, “Hey, we're a bunch of experts, this is how we feel about the topic, and this is what we think should happen with this particular procedure.” Whereas a PGD is supposed to say, “Hey, if you have patients that have this, this is what you can do for them. Also, this is how you do it, how you talk to people about it and here is the evidence of support.”
What does the development process look like for documents?
Dr. Wilkins: It differs depending on the type of document. A position statement is our society communicating how we feel about a specific procedure or disease state. It’s essentially saying that in disease X we feel that procedure Y would most benefit this patient population, and here’s why.
Reporting standards documents are more applicable for if you will be doing research on a certain disease process or treatment technique, as that document provides the data points that we recommend you acquire and report, because we feel they will be the most beneficial.
CPGs involve a complete systematic review and grade of that literature. This is a very methodological process that is standardized through the medical research community. The process requires us to look at the quality of the research being done, assess it for bias and determine if the existing data supports a given topic. Then we use that clinical data to make recommendations.
With a PGD, we do a full literature review so that we can make recommendations based on literature, but we also have a panel of experts who make their own recommendations based on Delphi consensus.
Why does it take so long to develop guidelines?
Dr. Wilkins: Depending on the document type, the process and development timelines can differ. Developing clinical practice guidelines takes the longest, because it requires a complete, systematic review of the literature based on PICO questions developed by a panel. PICO questions focus on the patient, intervention, comparator and outcome, so we write the questions based on whatever the clinical problem is that we are trying to investigate. Then, a complete literature search is done based on those keywords. All those documents are then reviewed by the writing panel, and then they are given to dedicated methodologists who look through all the literature and determine the grade of its quality and ability to answer the specific PICO questions.
Only then is all that graded literature reviewed by the writing panel to help make recommendations and assess the strengths of those recommendations in terms of quality of evidence. The entirety of the process takes between 12-18 months. So, it’s quite a lengthy process.
With PGDs, we aim for completion within six months. That’s another benefit of this document type—they don’t have to be graded by methodologists, so we are able to produce them faster.
Is there anything you would like members to understand better about the different types of documents or their processes?
Dr. Wilkins: A lot goes into making a robust, trustworthy document that holds up over time. It requires immense behind the scenes work from our panel members and volunteers, as well as SIR staff like Kaeli Vandertulip, MBA, MS, AHIP, Jamie Collins, MSN, BSN, RN, and Liza D’Onofrio, MBA, CRA, RT(N)(ARRT), CNMT. In addition, we have illustrator Andre Uflacker, MD, who helps bring our recommendations to life.
Despite the work required, we've been able to really ramp up our production. Currently, we are on pace to have up to five documents completed before SIR 2026, and will have two CPGs coming out next year. All of this is done with the hope of getting more resources to our members, so we can support and provide value to their practices.
What should members do if they have an idea for a document topic?
Dr. Wilkins: I want them to know that I am always available. If they have an idea for a document, please reach out to guidelines@sirweb.org. The Guidelines and Statements Oversight Committee are always evaluating new ideas for documents and reassessing how we can provide value for the members.
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