12. Practice Guidelines: Procedure Context for Product Development

Issue 12.

Any time that you can spend with a physician or with the surgical team - watching their procedures and seeing their decision processes for individual patients - is time well spent. You will learn about the context of the products being used and how decisions and selections are made. In a way, you are like a football scout watching a team to understand and predict how they will respond in a game situation. More time observing equates to a better understanding of the thinking process and a better prediction of the choices that will be made.

Suppose however, that you were given the playbook? Would it be worth your time to read? In other words, what if there were a document that described the decision process and recommended choices for some specific, complex situations that the majority of your customers would turn to in their practice? If that playbook were authored by some of the most respected people in the field, and furthermore, also had the authority of a society that nearly all of your customers held membership in?

In medicine, that document is a clinical practice guideline.

What is a clinical practice guideline?

A Clinical Practice Guideline is many things. It is a structured literature review focused on the questions of treatment for a specific group of patients with a limited number of conditions. It is an evidence-based treatment recommendation that seeks to help physicians select treatments proven to have positive outcomes on patient health while limiting costs. It is a tool to grade the strength of evidence support for any of several potentially competing therapies in a given condition, and thus support the decision process. It has the authority of a well-respected clinical society or other body and is typically authored by a panel of highly accomplished physicians, public health experts, and other medical experts.

Here are a handful of examples:

• The North American Spine Society (NASS) Guideline on Diagnosis and Treatment of Low Back Pain
• The American Academy of Orthopaedic Surgeons Evidence-Based Practice Guideline on Management of Osteoarthritis of the Knee (Non-Arthroplasty)
• The American College of Cardiology/American Heart Association Guideline for the Management of Patients With Chronic Coronary Disease
• They can also be very narrowly focused: AO Spine Guideline for the Use of Osteobiologics (AOGO) in Anterior Cervical Discectomy and Fusion for Spinal Degenerative Cases

In each case, the authors consider treatment benefits, with evidence quality assessments, for potential treatments that could be applied to the patient. Some include detailed care pathways in flow chart form (example in the figure below). Many do not. They may identify useful diagnostics that help with clinical decisions, as well as others to avoid that are costly but are not supported by evidence. Some may suggest external consults with practitioners in outside disciplines at key points in the patient's care. They may describe which order in which to offer treatments (First Line, Second Line, etc.).

[From Figure 1 in Chou et al- Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society | Annals of Internal Medicine (acpjournals.org)]

[See also How to Interpret and Use a Clinical Practice Guideline or Recommendation JAMA. 2021;326(15):1516-1523. doi:10.1001/jama.2021.15319]

Why Would You Want to Read a Clinical Practice Guideline?

A practice guideline will tell you much about the context of your product's use:

• What diagnostic tests the patient has undergone when they reach a point of receiving your therapy
• What other treatments must have failed before your therapy could be a candidate
• What existing process, procedure, decision tree or other structure your therapy must fit into in order to easily fit into the clinical practice. If you require the physician to do something new in their workflow there must be a compelling reason and even then, your adoption will suffer. Better, if possible, to make it very much like something they are already doing.
• What are the current competing treatments and how effective they have proven to be. This gives you targets for clinical efficacy studies, and health economic evidence.
• What portion of patients that your customer will see for the condition might be a candidate for your treatment. This is market segmentation and provides key information about your addressable market.

Example - Postoperative Pain Management

Suppose that it is 2016 and you are working on a device for pain management that is used during the operation by a surgeon. The specific technology doesn't really matter - it could be a locally-delivered analgesic, or an ablation technology, or a short-term indwelling delivery system - the example would be the same. You hope to apply it to, say, minimizing pain that a patient experiences following knee joint replacement surgery.

You come across a 2016 clinical practice guideline on the management of post-operative pain, prepared jointly by the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists which defines recommended procedures, paths and treatments. This document covers pain from many operative procedures and goes well beyond knee arthroplasty, but it is authoritative there also. As with practice recommendations in other areas of medical practice, these have been selected based upon clinical studies reported in the medical literature. The recommendations have been shown to control pain adequately, manage costs of care, and - one of the recent critical issues in pain management- limit opioid exposure. Approaches include pain medicines, local and topical treatments, regional anesthesiology, neuraxial methods, and non-pharmacologic therapies including TENS and cognitive methods (Table 3 of the linked article). Multi-modal approaches (using several of these in combination) are recommended, and validated methods for measuring pain (frequently an issue for pain diagnosis and treatment as nowhere else in medicine) are discussed and recommended.

Does this matter? You really won't be directly using traditional pain drugs in your therapy. Is it really worthwhile to read this whole long paper?

The answer is an emphatic "YES." Let me now list just a portion of the reasons:

1. The described approaches have been adopted by three of the largest professional bodies for practitioners of anesthesiology and pain control. Their entire memberships will be made aware of the existence of this guideline.
2. Hospitals and anesthesia departments throughout the USA and beyond will be adopting these guidelines, or will tweak them to provide similar variants adapted to the hospital.
3. The Guideline touches on the types of therapies that a patient undergoing a knee replacement might receive - and therefore which practitioners might be providing them. Which treatments are applied by the operating surgeon? The anesthesiologist? A psychiatrist? A regional anesthesiologist? When does the patient leave the care of the treating surgeon for a referral-- and when does he or she return?
4. Eminent authors will be regularly speaking about the approaches and impacts - and will be encouraging their colleagues to adopt it.
5. The opioid epidemic will force this work into a public policy spotlight.
6. This is likely to include therapies that will become standards of care in your field, and which your new therapy would be judged against.
7. The cited references will be a gold mine of information about investigators to approach for your trials, performance that you must improve on, standard metrics that others use in assessing outcomes, etc.
8. The society membership roster could be mined to identify surgeons in multidisciplinary practices that have pain management colleagues in their practice. Such practices are likely to think more deeply about the issue of post-surgical pain for their patients than others and might make good early market candidates or KOL's.

And so on. A few minutes' thought would likely add several additional items to the list.

For reasons included here, many of your potential customers will be working a version of the practice guideline into their practice. The guideline can provide to you many insights about

• What your target customers are already doing
• What techniques you might supplant if you can prove a better result
• What you would need to prove to replace those current techniques (read the citations!)
• Who can be your advocate, and who will oppose you from the care team. Who will lose treatment business from your efforts and who will enhance their income.
• A rough idea of the current costs, and what level of savings would motivate a hospital to adopt your therapy based upon your health economic evidence.
• What unmet needs they still have
• Which surgeons (as opposed to anesthesiologists) are deeply involved in pain management for their patients.

With a few discussions with the some of the authors as well as other practitioners, this document may guide you to your value proposition. A close analysis could even form the foundation of your whole business plan. Not bad for a boring clinical practice document, right?

So the next time you are trying to understand the game, get a copy of the playbook. A Practice Guideline is an outstanding place to start your journey.

Todd Boyce | [email protected]

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(c) 2024 Todd M Boyce. Images created by me with DALL-E3, or excerpted from a cited reference.