Insomnia Part II - Using Treatment Scores

It all started with a question from a friend: "Does drinking cherry juice work for insomnia?" I never recommend treatments (consult with your own physician for that), however, I do review the medical literature to see what the science of medicine says. I also have no prejudice against Eastern medical treatments, herbal treatments, natural treatments, or any other alternative medical treatment. I just want to see the studies and see the data.

At TreatmentScores.com we do medical review articles differently. Instead of leaving the treatment effect as a difficult statistic that few people understand, or leaving the treatment effect buried deep inside the article where it's difficult to find, we put the treatment effect front and center and describe it, or summarize it, in a new way as the treatment score.

After studying the medical literature for a while, I realized that the diagnosis I wanted to quantify was insomnia, elderly patients, with at least two weeks of follow-up. Trying to quantify the science of medicine behind medical treatments is actually an organizational nightmare. First you have to figure out the diagnosis. Then you have to figure out the outcome measure that is most important for the patient, and, just to complicate things, the best outcome measure may be different depending on the patient, so you may have to do several reviews using several different outcome measures. One patient may have trouble falling asleep at night. Another patient may have trouble staying asleep at night. Those are two significantly different outcome measures.

Many diseases have had symptom scores created for them to try to take into account many symptoms, and also so that there is standard that can be used to do studies. For insomnia there are at least five different symptom scores that need to be considered.

Insomnia Severity Index (ISI)
Pittsburgh Insomnia Rating Scale (PIRS)
Visual Analogue Scale
The Questionnaire Score
Leeds sleep evaluation questionnaire

The development of symptom scores is an area in which patients should have a lot of influence, yet they sometimes have zero involvement. This is definitely an area for patient generated research in the future. These symptom scores can be biased, and can be designed to make certain treatments look better than other treatments. Do you know the people behind these symptom scores? Do you know their motivations? We can and should make all this transparent.

I decided to use the Insomnia Severity Index as my main outcome measure to see how many treatments I could quantify with it. Using the Treatment Scores Analyzer(TM) at TreatmentScores.com my diagnosis of insomnia now has the details listed below.

My treatment list will begin with one treatment, tart cherry juice, and I hope to expand it to more treatments over time. I have found clinical studies about a tart cherry juice in the medical literature. Tart cherry juice reportedly raises melatonin levels and is also an anti-inflammatory. One study used a tart cherry juice blend produced by CherryPharm, Inc. in Geneva, New York (I have nothing to do with the company). The fact that a company may be involved raises some issues, and they will be discussed later. For the moment my treatment list consists of only one treatment:

The best study I have found is this one: "Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study," which I have put inside a STAR™ Block (STAR™ = Statistic and a Reference). Note the treatment effect statistic of 8.09% on the right.

The Insomnia Severity Index
How was this statistic calculated? The Insomnia Severity Index goes from 0 to 28. According to the Insomnia Severity Index a score from 0 to 7 means no clinically significant insomnia.

This creates a bit of a problem for interpreting this study. If the score improves, what is the denominator? Is it going to be 28 or 21? Because of the way the Insomnia Severity Index is designed, I'm going to use 21 as the denominator, which may make the treatment effect seem better than it really is.

The 15 patients had a baseline Insomnia Severity Index of 15.5. In the placebo treated group the insomnia Severity Index Score dropped to 14.9. And doing the math, we get 15.5 - 14.9 = 0.6.

When the same patients were given the tart cherry juice their Insomnia Severity Index (ISI) dropped to 13.2. So the tart cherry juice reduced the ISI from 14.9 to 13.2, which is a difference of 1.7 compared to placebo.

Taking that difference of 1.7 and putting it over the denominator of 21 gives an improvement of 8.09% in the Insomnia Severity Index. The 8.09 goes into our Treatment Score Calculator™ as below.

Because of the potential side effect of night-time urination, or nocturia, I subtracted the 0.07, (which is a somewhat random estimation because there is no hard data), and gave tart cherry juice a SOM® Treatment Score of 8, which is a Treatment Grade of "E." As far as the nocturia goes, the study tried to mitigate that side effect by giving the tart cherry juice to patients twice a day, with the second dose being at least 2 hours prior to bedtime. So the treatment score and the corresponding treatment grade are:

Is this the statistically correct way to look at this situation? I think the Cohen's d statistic used in the study is misleading as it says the treatment effect is medium to high. For me, the "net treatment benefit to the patient" as the SOM® Treatment Score, is the more accurate, and understandable, way to report the treatment effect.

What I need to do next is review the treatment scores for Ambien, Restoril, melatonin, and other treatments for insomnia. What do the statistics say about the treatment effect of each?

Wouldn't it be nice if the net treatment benefit to the patient was always clearly spelled out for you as the SOM® Treatment Score?

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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 SOM® 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 TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened in the past they do not predict the future.

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Copyright © 2015 Treatment Scores, Inc.

Evidence-Based Medicine for Insomnia using Treatment Scores: Figuring out the Diagnosis

Evidence-based medicine is not easy. Let's review the medical literature (using TreatmentScores.com) for treatments for insomnia. Our first obstacle is organization. We are going to have to look at insomnia six different ways.

There are at least five different symptom scales for insomnia. They are the Insomnia Questionnaire Score, the Insomnia Severity Index, the Leeds Sleep Evaluation Questionnaire, the Pittsburgh Insomnia Rating Scale, and the Visual Analog Scale.

We will have to look at insomnia with each of these symptom scales as the main outcome measure, and we will also look at insomnia trying to combine all the outcome measures. This project has already turned into an organizational nightmare, but TreatmentScores.com makes it more doable than ever before.

In fact, let's look at just one potential treatment to get started. Someone who suffers from insomnia asked me about cherry juice for insomnia. They had read about treating insomnia with cherry juice in a magazine.

One of the great things about TreatmentScores.com is that it doesn't matter whether it's Eastern medicine, Western medicine, herbal medicine, or any other type of alternative medicine. What matters is if a study (or studies) and statistics exist.

However, I have run into my second big obstacle. I have to find the statistics. Statistics that should be available to me in seconds are not available to me. They will be available to me in seconds in the future when TreatmentScores.com goes from an alpha website to a beta website, which will take some time. For now, I have to download and read some studies. Meanwhile, stay tuned for part 2 on insomnia.

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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 SOM® 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 TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened in the past they do not predict the future.

Copyright
Copyright © 2015 Treatment Scores, Inc.

Putting a Graphical User Interface on Evidence-Based Medicine

Have you been watching the diet wars? People have strong opinions about low-fat, high-fat, carbohydrates, sugar, protein, gluten, genetic influence, and every diet out there.

I want to see the numbers. I want to see exactly what people are thinking when they make a claim. However, typically when I read an article there are very few numbers, but lots of opinion. How can we reverse that? How does one figure out who is using the best statistics and the best evidence-based medicine? (There are some great evidence-based medicine experts who are writing excellent articles.)

What we need to do is put a graphical user interface (GUI) on the evidence-based medicine process. That's what we are doing at TreatmentScores.com, and that's what we are writing about here at TreatmentScoresBlog.com.

Remember the early days of the computer when only those who could do machine programming could use a computer? Then, Apple and Windows (or maybe someone else) put on a graphical user interface and suddenly everyone could use a computer?

At TreatmentScores.com we are putting a graphical User Interface (GUI) over the evidence-based medicine process, and are going to make it so simple and convenient that doctors, nurses, and all patients around the world can do it as an educational experience. We already have a minimum viable product - in the form of an alpha website.

Our Treatment Score Analyzer™ will eventually allow shared decision-making and evidence-based medicine to be combined.

The Treatment Score Analyzer™ has four parts:

1. Diagnosis Tool™
2. Treatment Organizer™
3. Treatment Score Calculator™
4. STAR™ Blocks

Stay tuned by subscribing to this blog with your email address in the box at the top right, or bookmark this URL so you can come back often.

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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 SOM® 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 TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened in the past they do not predict the future.

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Finding the Evidence Behind Treatments

SOM® Treatment Scores

Every day I find myself wondering about the details of our treatment options for patients. Most conditions have an array of options for patients. These are in addition to the home remedies and Eastern medicine alternatives which patients are inquiring about and are beginning to be trialed in the literature. One of the toughest decisions we make with the patient and their family is: Which treatment has the best evidence behind it for a particular disease?

Our medical literature gives us guidance on this question. We have randomized controlled trials to compare treatments, and we have systematic reviews, Cochrane reviews, and meta-analyses where there is significant controversy. These studies and reviews build a strong foundation for our individualized conversations with patients. Increasingly the doctor-patient relationship is becoming more of a partnership with the physician giving advice and recommendations, but also giving patients the options and a thorough discussion about which option may or may not be appropriate for each individual patient. I find this leads to situations and attempted comparisons made from extrapolation of the literature.

Here’s an example. Take the case of a simple traumatic iritis. No other ophthalmic problems, just a simple mild iritis from blunt trauma without other traumatic sequelae. The treatment options in this scenario typically include: observation, topical steroids, or topical steroids plus pharmacological dilation. Seems relatively straight forward – until you consider the individualization of treatment for each patient. Let’s say the patient is a pilot and will not be able to function if you pharmacologically dilate her eye. What’s the literature or support for cycloplegia (giving medication to dilate the eye) in simple traumatic iritis?

What has happened to patients who have been studied in the past regarding true risks and benefits both with or without treatment? We end up extrapolating from broader literature and attempting to score each treatment for the patient’s situation. In this case the pilot and her physician may elect not to receive pharmacological dilation, or may choose a short treatment period. Now imagine the patient was known to develop high intraocular pressure with steroids, or that the patient is a child? We quickly begin to find that our literature can be somewhat difficult to apply to each and every individual situation and may require some extrapolation. Hence the Art of Medicine.

Similar scenarios play out in many disease processes in all specialties every day. Over the next few weeks I am going to take you step-by-step through a new tool, the Treatment Score Analyzer™, we now have to give a simple, inclusive, and comprehensive comparison of the literature supporting each treatment. The evidence-based scoring of treatment options will hopefully empower us to make better decisions both for and with our patients every day. See the disclaimers below.

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Evidence-Based Medicine, Treatment Scores, and the Hepatitis C Commercial on TV

Have you seen the commercial on TV for Harvoni? It's one of the seemingly hundreds of TV commercials about medicines frequently seen on TV. When I saw the Harvoni commercial I was skeptical. Was it all hype or was it for real? Hepatitis C is a bad disease and if you Google it, many celebrities have allegedly suffered from it such as: Stephen Tyler, Evel Knievel, David Crosby, and Pamela Anderson.

So, how does one do an evidence-based medicine review of the literature? First, I established the diagnosis that I wanted to review. After doing some searching on Medline I came up with: hepatitis C, chronic, genotype 1 infection.

Then, I decided on the outcome measure. The outcome measure most important to the patient, in my opinion, is a cure of hepatitis C. The medical literature uses the phrase: "sustained virologic response," which means that no virus can be detected in your body. It's more cautious than using the word cure. After all, what if the disease relapses years later?

At this point, to define things further I was willing to look at "adult patients" and "any time period" of follow-up. Although, after I while I realized that many studies used 12 weeks as their follow-up time period.

So, I collected some studies into STAR™ Blocks. STAR™ stands for a "Statistic and a Reference."

I was able to find some great randomized controlled studies. The main outcome measure was above 90% for sustained virologic response in three such studies. I finally settled on 95% as the number I would use as a weighted average of the statistics from the three studies.

This gave me a Treatment Score Calculator™ that looks like this:

I now have the main statistic on the left and the secondary statistics on the right. I still need to go through and come up with event rates for all the secondary statistics. But for right now, I think they are worth getting "cured" of chronic hepatitis C. Since they are relatively minor side effects I am only reducing the main statistic down one point to get a Treatment Score of 94 for Harvoni. This may change later with more study.

In other words, the medical literature seems to say, as I now understand it, that there is a 94% net treatment benefit when you treat Chronic hepatitis C of this type with Harvoni. That's much better than the old "gold standard" treatment with interferon.

The bottom line is that with a new statistic, the SOM® Treatment Score, we can begin to quantify the science of medicine behind treatments as part of the educational process. And we can make the entire process transparent to the patient from the diagnosis, to a list of treatments, to the Treatment Score Calculator™, and finally to the STAR™ Blocks. This system will eventually allow for shared decision-making and evidence-based medicine to be combined.

Follow Treatment Scores:

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Blog:
http://TreatmentScoresBlog.com

Website:
http://TreatmentScores.com

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 SOM® 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 TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened in the past they do not predict the future.

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Copyright © 2015 Treatment Scores, Inc.

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