Part I: Benefit and Risk
By Jim Huizenga, M.D. and Chief Clinical Officer of Appriss Health
Series Introduction – Appriss Health has long held that chronic pain and addiction (substance use disorder) are separate medical conditions and that each deserve a unique clinical approach. We have spent years developing clinical decision support tools and in doing so have obtained the feedback from countless medical professionals, including many pain providers. Through those providers we have also heard (directly and indirectly) from many chronic pain patients as well.
To continue this conversation, over a long series of blog posts, we will explore our approach to benefit/risk assessment, data presentation, and clinical support…and how they relate to our goal of creating a usable and balanced, clinical viewpoint that protects access to care while highlighting areas of risk that clinicians and patients should be aware of.
Let’s start with a basic tenet: Opioids are risky.
One need look no further than the escalating opioid death toll (42,249 in 2016, CDC) to understand this one basic fact. Then again, life in general is a risky endeavor and most of us are exposed to many significant (and a few insignificant) risks every day of our lives:
- 2016 automobile accident fatalities: 40,200 (NSC)
- 2016 gun related fatalities: 38,000 (CDC)
- 2016 drowning fatalities: 3,536 (CDC)
- 2016 flying fatalities: 412 (NTSB)
Let’s look at the other side as well: Opioids are beneficial.
In fact, in the right clinical situation, they can be almost miraculous in their ability to treat pain. One of my most unforgettable patient encounters involved the simple application of appropriate pain medication to a patient with terminal cancer. Eliminating her pain gave both her and her doting husband relief, and although the cancer would take her life, it was the pain that was stealing their remaining time together.
In general, we all deal with risk and benefit every day of our lives, usually with informal benefit/risk assessments. Should I save a few minutes and jaywalk in this quiet, sleepy town where I haven’t seen a car drive by in the last three minutes? Vs. should I do the same in New York City at rush hour? Benefit/risk assessments can also be detailed and extensive as evidenced by any formal assessment done by the FDA.
I recently attended a six-hour FDA session devoted to the chronic pain community and listened carefully to many accounts of how chronic pain has impacted so many. These types of patient histories and descriptions were not at all new to me, as I’ve heard many similar accounts as an emergency physician over the last couple of decades, myself. As always, I found many of the patient accounts to be heart-wrenching and thought provoking. The recording is available here.
So what is the benefit/risk assessment for opioids for chronic pain?
It turns out that is not a simple question to answer. Opioid risk can be quantified and assessed on numerous fronts ranging from risk of death, to risk of overdose, to risk of dependence and addiction. The news cycle has been dominated by (appropriately so) these measurements of risk.
When it comes to benefit we have subjective and objective measures, but in general, we must be able to reliably measure the impact of chronic pain and then use before and after measurements to imply benefit (or lack thereof). There are several tools available for this purpose, including the Brief Pain Inventory (BPI), Chronic Pain Grade (CPG), SF-36, and others, including the “PEG” scale.
“PEG” stands for Pain, Enjoyment, and General activity. The PEG scale quantifies the impact of pain on a person’s life and is applied by ranking pain intensity, interference with enjoyment of life, and interference with general activity – rated on a scale of zero to 10. A bed-ridden person with very severe chronic pain may have a 10 out of 10 in each of the three categories with a resultant PEG scale of 30. A person with chronic low back pain who is still able to work and maybe go fishing once in a while may score a 5 or 10 or 15. The CDC has recommended the PEG scale as one possible measurement of pain and function and included in their guidelines that a 30% reduction is clinically meaningful.
Let’s apply the PEG scale and the CDC recommendations to a patient, Chris, who suffers from chronic pain. Chris reported a baseline PEG scale of 24 before beginning treatment with opioids. Now on a stable opioid dose for the past six months, Chris reports a new baseline PEG scale of 12, a 50% (clinically significant) improvement.
So… What is the benefit/risk assessment for Chris? The patient definitely has benefit…and there is certainly non-zero risk associated with the use of opioids.
Does the benefit/risk assessment justify or validate the use of opioids for Chris’ chronic pain?
Can anyone besides Chris answer this question?
We need to dig deeper into risk to even begin to answer these last few questions. We will do this in the coming weeks.
To read more on this series: