Friday, December 18, 2015

Lunesta for Insomnia in Patients with Rheumatoid Arthritis: Treatment Scores

Evidence-based medicine is difficult. Mathematically it is nearly impossible. You may need to organize and process 10,000+ pieces of information to come up with a list of treatments for a disease and review the science behind those treatments. In medicine, each statistic has variables, and each variable has more variables, so the complexity quickly escalates out of control.

Complex problems can be solved by breaking them down into steps. Let's review treating insomnia in patients with rheumatoid arthritis. I am doing personalized medicine, by creating a very specific diagnosis:

I am looking at patients suffering from insomnia, who have rheumatoid arthritis, who do not have fibromyalgia, do not have juvenile rheumatoid arthritis, do not have sleep apnea, and do not have untreated restless leg syndrome.

I will look at Lunesta (eszopicline) as a 3 mg dose for treating insomnia in this situation. As can be seen below, I put the main statistic, the improvement in the Insomnia Severity Index compared to placebo, on the left. It is 16. I put the secondary statistics on the right. Sometimes they are positive and we put them in the green zone. Sometimes they are negative side effects and we put them in the red zone.

The Treatment Score begins at 16 per the Treatment Score Calculator™ above. However, we need to make adjustments for the secondary statistics on the right. We need to try to figure out what the medical literature says the "net treatment benefit" was for the patients who were studied to create the Treatment Score.

Currently, digesting these numbers is the "art of medicine." This is because there is almost always missing data. For example, one side effect of Lunesta (eszopicline) is an unpleasant taste. It occurred in 27% of the patients taking Lunesta (eszopicline), but in none of the patients taking placebo. Where is the mathematical formula for converting the side effect of unpleasant taste into units on the Insomnia Severity Index? Such a formula does not seem to exist. However, in the future we need to collect such data. We need to survey the patients for starters.

Some side effects already have conversion formulas. For example, the Global Burden of Disease project has converted many side effects into "disability adjusted life years" or "quality adjusted life years." Getting all the side effects converted to values that can be mathematically subtracted from the main statistic (or main outcome measure) will be an important part of the future of medicine.

Let's do an adjustment and come up with a working Treatment Score. The positive side benefits on the right of the Treatment Score Calculator™ are mostly built in to the Insomnia Severity Index. So I am not going to raise the Treatment Score. Since I don't have all the mathematical "conversion rates" I need for the side effects, we have to make some estimations based on what we think we know. For example, 1 patient (1.3%) dropped out of the study because of the unpleasant taste. The other side effects may be temporary and may not be highly significant compared to the benefits. And, there are some other benefits (that I did not list in this example), because patients reported mixed improvements in their rheumatoid arthritis pain and other arthritis symptoms because of getting better sleep. In the end I have decided on a Treatment Score of 15. (In the future this decision will hopefully be done all by math.)

Where do we get the hard numbers? They come from the medical literature. For example the number 16 comes from the following medical study.

We call this a STAR™ Block of information. STAR™ means Statistic and a Reference.

Treatment Scores is an early prototype system. You can see that in the future everything can be improved. More and more automation can be done. Statistical methodology can be improved and validated. Quantification of treatments will change everything: education, research, reimbursement, and distribution.

The main point is that we can begin to quantify treatments better than we do now. Currently, the medical world essentially quantifies what the medical literature says about treatments into 1) It probably works 2) It probably doesn't work, or 3) We can't tell. In the future we need to do better. What if you have cancer? Don't you want to know if the patients treated in the past got a 1% net treatment benefit from chemotherapy or a 90% net treatment benefit from chemotherapy? (See the disclaimers below.)

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DISCLAIMERS: You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for educational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of or Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

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