How many doctors do you see on a regular basis? Many of us probably go to the doctor for an annual physical. We also see specialists regularly as well. But what about an eye doctor? When was the last time you had an eye exam?

If you haven’t seen an eye care professional in the few years, perhaps you should put it on your “to do” list. Not only is a comprehensive eye exam essential to catch eye problems early, but it is also a good way to get a glimpse of your overall health. An eye doctor can look into your eyes and see the signs of chronic diseases. It’s not just about making sure you can see. It’s how you see and how you want to keep seeing.

How often should you have an eye exam?

Acknowledging that your eyes truly are a window to your overall health, adults should get a thorough eye exam every 1-2 years. During a routine exam, eye care professionals don’t just check to see if glasses or contact lenses are needed. They also check for eye diseases. 

And, they are often the first ones to spot a number of other chronic diseases, including

  • high blood pressure,
  • high cholesterol,
  • diabetes,
  • autoimmune disease
  • some types of thyroid disease
  • and even certain cancers.

A regular eye exam is especially important if you’re considered at risk for eye and vision problems.

At-risk people are usually those with diabetes and high blood pressure, or who have a family history of eye disease like glaucoma or macular degeneration. But you might be surprised to know that “at-risk” also includes contact lens wearers and people whose jobs are highly demanding visually. If you stare at a computer screen all day, you may also be considered at risk so you’ll want to be sure to get a thorough eye exam every year.

How do you know if you have an eye issue?

So how do you know if you’re experiencing an eye issue? You may not. Many eye diseases have no symptoms until the disease process is well advanced. Typically, vision issues manifest with blurred vision while driving or reading.

You may also find yourself squinting at the television, feeling visual fatigue by the end of the day, or getting frequent headaches. If it’s been more than 1-2 years since your last visit to your eye doctor, it’s possible your prescription may be out of date.

Are online eye exams good enough?

You may come across websites or smartphone apps that offer online eye exams. These services are definitely tempting. You can get your eyes checked from the comfort of your home instead of making an appointment with your eye care professional. However, you shouldn’t rely on an online test to give you a complete picture of your eye health. Here’s why:

  • An online exam can only show what vision correction you may need. In fact, the American Optometric Association has warned against online exams specifically because they aren’t thorough enough. For example, your phone or computer can’t do an eye pressure test to check for glaucoma, which means key indicators of potential health problems could be missed.

A comprehensive eye exam should include several different tests—many of which, today, have to be done face-to-face with the proper equipment.

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-Do You Know the 3 Main Causes of Blindness in the U.S.?
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What type of tests are included in comprehensive eye exams?

In addition to the routine eye pressure test, a comprehensive eye exam should include several different tests—many of which must be done face-to-face with the appropriate equipment. These include a slit lamp exam, which uses a unique microscope to review the structures of your eye. It often also includes pupil dilation, which can help detect conditions like retinal detachment, age-related macular degeneration (AMD), and glaucoma.

During your comprehensive exam, your doctor will also review your medical history to identify any risk factors for eye disease. He or she will then determine the appropriate tests for you. For instance, glaucoma, a group of eye diseases where damage to the optic nerve can cause blindness, is hereditary. So if you have a family member with glaucoma, chances are good your doctor will test you for it as well. If fact, many eye doctors include this test in all routine eye examinations.

Patients living with diabetes may develop retinopathy, a complication of diabetes that is a result of leakage from blood vessels. It can cause blindness. Diabetics may also be at higher risk of developing cataracts, a gradual clouding of the eye’s lens.

Older individuals may be at risk of experiencing AMD, an eye disease that causes damage to the macula, which is a tiny spot near the center of the eye that is responsible for seeing objects straight ahead.

During your exam, your eye doctor may test you for one or more of the following:

  • vision sharpness
  • color-blindness
  • eye movement
  • depth perception
  • a peripheral vision test

All of these tests are helpful in diagnosing potential vision issues and determining the best method to address them. Based on your results, your doctor might also suggest additional testing.

What should I know about children’s eye exams?

While you’re making your eye exam appointment, don’t forget about your kids. The American Academy of Ophthalmology and the American Association for Pediatric Ophthalmology and Strabismus recommend that children receive at least 3 eye exams by age 6:

  • As a newborn
  • Between 6 and 12 months of age
  • About 3-3/12 years old

These exams can be done by an ophthalmologist or by other doctors with proper training.

Children’s eyes should also be screened for visual acuity at the time they enter school. because problems with visions can affect learning. After that, they should be examined every 1 to 2 years, depending on whether they need vision correction.

What are reasons for having a comprehensive eye exam in childhood?

Triggers for a comprehensive eye exam include the following: 

  • Failing or unable to perform a vision screening.
  • A school nurse or a pediatrician or family physician refers the child
  • The child has certain medical conditions that have a high risk for eye problems, such as
  • A family history of certain hereditary eye conditions, such as
    • strabismus
    • amblyopia
    • congenital cataracts 
    • congenital glaucoma 
    • retinoblastoma
  • The child has a learning disability, developmental delay, neuropsychological condition, or behavioral issue.
A child should also have a comprehensive eye examination if they have certain symptoms or behaviors, such as
  • Avoiding or disliking reading
  • Short attention span
  • Difficulty throwing or catching a ball, copying from a chalkboard, or tying their shoes
  • Pulling a book in close to their face or sitting too close to a TV
  • Lots of blinking or eye rubbing

Another reason to ensure your kids get regular eye exams is that nearly 80% of a child’s learning happens visually. Too often, a child who can’t see well is misdiagnosed with a totally unrelated behavioral problem like ADHD when they may only need a pair of glasses.

What should I tell my eye doctor during an eye exam?

Just like any other doctor’s appointment, an eye exam should include a robust dialogue with your doctor. It should include any current or past visual symptoms. There should be full transparency about the amount of time you spend staring at screens and tablets. It should also include a discussion of whether you follow guidelines for the proper use and cleaning of contact lenses and whether or not you sleep with your contact lenses in.

Sharing your lifestyle and habits with your eye doctor will allow him or her to provide guidance on optimal eye health for you. Some questions you may want to ask your eye doctor include:

  • Does my vision seem stable?
  • Are prescription sunglasses a good option for me?
  • How do I address tired eyes?
  • What kind of eye drops do you recommend, if any?

If it’s been a while since you or your kids had an eye exam, don’t put it off any longer. Make an appointment with an eye care professional today to help ensure good vision for life.

Related content: Do You Know the 3 Main Causes of Blindness in the U.S.?

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This article was first published on 8/26/2016. It was reviewed and updated on 5/24/20 for republication.

According to the World Health Organization (WHO), cardiovascular disease, specifically ischemic heart disease, is one of the leading causes of death worldwide. Cardiovascular diseases result in an estimated 17.9 million deaths each year. This is about 31% of all deaths worldwide (1). Medical researchers are continually working on ways to reduce those numbers, including the development of new technologies to combat premature deaths from cardiovascular diseases. This article will focus, in particular, on the value of induced pluripotent stem cells (iPSCs) in cardiac research.

What are induced pluripotent stem cells?

iPSCs are a type of pluripotent stem cell. These are master cells that can differentiate into any cell or tissue the body needs. They are generated directly from somatic cells through ectopic expression of various transcription factors, such as

  • Oct4,
  • Sox2,
  • Klf4, and
  • c-Myc (OSKM) (2)

They’ve become key tools to model biological processes, particularly in cell types that are difficult to access from living donors. Many research laboratories are working to enhance reprogramming efficiency by testing different cocktails of transcription factors.

IPSCs are important in some areas of medical research

iPSCs have become essential in a number of different research fields, including cardiac research.

They are a valuable and advantageous technologic development for two main reasons:

  1. iPSCs can differentiate into any specific cells needed
  2. They come from a human patient’s adult cells (2).

iPSCs vs. embryonic stem cells

Most people have heard of embryonic stem cells, which are one variation of pluripotent cells. Like iPSCs, they can be used to replace or restore tissues that have been damaged. 

The problem is that embryonic stem cells are only found in preimplantation stage embryos (3). Whereas iPSCs are adult cells that have been genetically modified to work like embryonic stem cells. Thus, the term, induced pluripotent stem cells.

The development of iPSCs was helpful because embryos are not needed. This reduces the controversy surrounding the creation and use of stem cells. Further, iPSCs from human donors are also more compatible with patients than animal iPSCs, making them even closer to their embryonic cousins.

The Japanese inventor of iPSCs, Professor Shinya Yamanaka earned a Nobel Prize in 2012 “for the discovery that mature cells can be reprogrammed to become pluripotent.” (4) The  Prize was awarded to Dr. Yamanaka because of the significant medical and research implications this technology holds.

What can iPSCs do? The answer is a lot

iPSCs hold a lot of promise for transplantation medicine. Further, they are highly useful in drug development and modeling of diseases. 

  • Transplantation medicine

iPSCs may become important in transplantation medicine because the tissues developed from them are a nearly identical match to the cell donors. This can potentially reduce the chances of rejection by the immune system (5).

In the future, and with enough research, it is highly possible that researchers may be able to perfect the iPSC technology so that it can efficiently reprogram cells and repair damaged tissues throughout the body.

iPSCs forgo the need for embryos and can be made to match specific patients. This makes them extremely useful in both research and medicine.

Every individual with damaged or diseased tissues could have their own pluripotent stem cells created to replace or repair them. Of course, more research is needed before that becomes a reality. To date, the use of iPSCs in therapeutic transplants has been very limited.

Related Content: Why a Liver Donation May One Day Save My Life

  • Cardiac research

One of the most significant areas where iPSCs are currently being used is in cardiac research. With appropriate nutrients and inducers, iPSC can be programmed to differentiate into any cell type of the body, including cardiomyocyte. This heart-specific cell can then serve as a great model for therapeutic drug screening or assay development.

Another notable application of iPSCs in cardiac research is optical mapping technology. Optical mapping technology employs high-speed cameras and fluorescence microscopy to examines the etiology and therapy of cardiac arrhythmias in a patient-like environment. This is typically done by looking into electrical properties of multicellular cardiac preparations., e.g. action potential or calcium transient, at high spatiotemporal resolution (6).

Optical mapping technology can correctly record or acquire data from iPSCs. iPSCs are also useful in mimicking a patient’s cardiomyocytes with their specific behaviors, resulting in more reliable and quality data of cardiac diseases.

Why iPSCs are so useful in cardiac research?

iPSCs are vital tools in cardiac research for the following reasons:

  • The ability for patient personalization
  • Their successful use in drug therapies
  • The capacity for modeling inheritable cardiac diseases (8).

iPSCs are patient-specific because they are 100% genetically identical with their donors. This genomic make-up allows researchers to study patients’ pathology further and develop therapeutic agents for treating their cardiac diseases.

Induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs), help researchers predict the cardiotoxicity of drugs like with widely used chemotherapy reagents (10). Predictions like this were close to impossible before iPSC technology entered the research game.

iPSC’s ability to model diseases

iPSCs really come into play with their ability to model diseases. Because iPSCs are genetic matches to their living donors, they are uniquely useful for the study of genetic cardiac diseases like monogenic disorders. iPSCs help researchers understand how disease genotypes at the genetic level manifest as phenotypes at the cellular level (5).

Long QT syndrome, a condition that affects the repolarization of a patient’s heart after a heartbeat, is a notable example of iPSC-based disease modeling (7). This syndrome has been successfully modeled using iPSCs and is an excellent model for other promising target diseases (7).

Long QT syndrome is not the only disease that has been modeled by iPSCs. Other cardiac diseases like Barth syndrome-associated cardiomyopathy and drug-induced kidney glomerular injuries have been modeled as well (8).

Key takeaways about iPSCS in cardiac research

  • iPSCs can be used to create excellent models for cardiac research (e.g., cardiomyocytes) allowing researchers to learn more about the etiology of disorders and how to treat them.
  • Because they come directly from living human donors, they are 100% genetically compatible with the donor.
  • In many instances, iPSCs replace the need for embryonic stem cells, thus avoiding the controversy associated with the use of embryos for research.
     
  • Many cardiac disorders are genetic, including arrhythmias, coronary artery disease, and cardiomyopathy (9). Researchers use iPSCs to test for cardiotoxicity of drugs to help combat the devastating effects of these inheritable cardiac diseases. The aim is to identify drugs that are most likely to work but have only minimal side effects.
  • iPSCs can work well with optical mapping technology to pinpoint the exact indices of the heart that are diseased. This allows the creation of a personalized therapeutic strategy for the condition. iPSCs can also model the cardiac disorder a patient is suffering from so that researchers can learn more about the disease and ways to treat it.

The bottom line

The advent of iPSC technology has created a wealth of new opportunities and applications in cardiovascular research and treatments. In the near future, researchers hope that iPSC-derived therapies will be an option for thousands, if not millions of patients worldwide.

More from this author:  The Promising Future of Nanomedicine and Nanoparticles


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References:

  1. Cardiovascular diseases (CVDs) Fact sheet. Available at: https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1. Accessed May 4, 2020.
  2. Takahashi, K. & Yamanaka, S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126, 663–676 (2006).
  3. Regenerative Medicine. Department of Health and Human Services. August 2006. Chapter 1.
  4. The Nobel Prize in Physiology or Medicine 2012. NobelPrize.org. Nobel Media AB 2020. Mon. 4 May 2020. https://www.nobelprize.org/prizes/medicine/2012/summary Accessed May 4, 2020
  5. Huang, C., Liu, C., Ting, C. et al. Human iPSC banking: barriers and opportunities. J Biomed Sci 26, 87 (2019). 1186/s12929-019-0578-x
  6. Attin M, Clusin WT. Basic concepts of optical mapping techniques in cardiac electrophysiology. Biol Res Nurs. 2009;11(2):195‐207. doi:10.1177/1099800409338516
  7. Ilanit Itzhaki, Leonid Maizels, Irit Huber, Limor Zwi-Dantsis, Oren Caspi, Aaron Winterstern, Oren Feldman, Amira Gepstein, Gil Arbel, Haim Hammerman, Monther Boulos, Lior Gepstein. Modelling the long QT syndrome with induced pluripotent stem cells. Nature. 2011 Mar 10; 471(7337): 225–229. 2011 Jan 16. doi: 10.1038/nature09747
  8. Low L. A. and Tagle D. A. (2017). Tissue chips – innovative tools for drug development and disease modeling. Lab. Chip 17, 3026-3036. 10.1039/C7LC00462A
  9. Kathiresan S, Srivastava D. Genetics of human cardiovascular disease. Cell. 2012;148(6):1242‐1257. doi:10.1016/j.cell.2012.03.001
  10. Kim JJ. Applications of iPSCs in Cancer Research. Biomark Insights. 2015;10(Suppl 1):125‐131. Published 2015 Jul 29. doi:10.4137/BMI.S20065

When severe substance use disorder or addiction strikes, it often has devastating consequences to individuals, families, and communities across our nation. The recent to attention the opioid epidemic raises the question: why do some people struggle with addiction and some do not?

It is human nature to try to figure out the root cause of the crisis. Unfortunately, the search to find what causes addiction may lead to blaming one source over another. This adds to its stereotype and myth.

What causes addiction?

As a clinician who works with individuals and families who are making the transition from active addiction toward a pathway of wellness and recovery, I am often asked what causes addiction.

Most individuals and family members who are seeking to understand why this is happening to them, and those they love, are earnest and desperate to find answers. Many of them are coping with the loss of sons, daughters, fathers, and mothers who have died from the disease of addiction.

Others are in a state of manic fear as they reach out for help in their difficulty and suffering before the disease takes their own life or that of a loved one. Although there are no easy answers to these questions, being able to discuss the complexities of the disease is helpful in alleviating blame, frustration, and fear.

There are many parties, in the recovery and mental health field, who point to specific biological, psychological, and social factors contributing to someone developing and suffering from addiction.

Addiction is a chronic brain disease, that is clear.1 However, like most diseases, the formation of the disease of addiction is complicated and complex. In my mind, addiction is best explained by the biopsychosocial model.

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The biopsychosocial model 

Before we discuss its application to addiction, a working knowledge of the components of the biopsychosocial model is important. Created by George Engel and John Romano in the 1970’s to help physicians understand the holistic nature of disease formation, the biopsychosocial model compelled clinicians to consider the biological, psychological, and social “dimensions” of illnesses.2

The biological components of illnesses are incredibly important to understand. However, an over-focus on biology can promote seeing patients as objects instead of within the multiple social contexts and internal psychological factors impacting diseases.

The more “subjective” elements of a person’s life, the psychological and social, are incredibly important to be considered and can be studied and measured. This study can encompass disease prevention, disease formation, and the healing and recovery from disease.2

  • Biological factors

Within the model, the “biological” considers the genetics of an individual. This includes the vulnerability or susceptibility an individual has to different illnesses and disease processes due to genetic factors.

Beyond this, the biological includes our gender, brain functioning, and the general functioning of the body. An example of functioning impacting general health includes someone with a physical disability, someone who experiences chronic pain, or both.

  • Psychological

The “psychological” part of the biopsychosocial model encompasses thoughts, emotions, and behaviors. When stress is present in the environment, the psychological dimension informs how people experience, feel, manage and deal with that stress. 

Understanding how we cope with the stress in our life is essential in considering the prevention of diseases, disease formation, and healing. Psychological factors that are important to consider in the model also include identity and self-esteem as well as attitudes, memories, and beliefs.

More Information on Addiction:
Vaping Could Put Youth at Risk for Complications of COVID-19

  • Social factors

Social factors also contribute to disease prevention, formation, and healing. Components include elements such as,

        • socioeconomic status
        • religion
        • family peer groups
        • social support
        • other relationships
        • traditions
        • culture

All are included in understanding the whole person. For example, experiencing trauma within our social environment can impact both our psychological and biological well being and vice-versa.

The biopsychosocial model of addiction

To answer the question(s) about the origins of the brain disease of addiction and what causes it, we, as professionals within the field, must be able to explain the complicated factors associated with disease.

Foremost, biological factors including genetic predisposition play a role in all diseases including addiction. For whatever reasons, not of our choosing, we are born with our genetic makeup and must deal with both the strengths and weaknesses of what is passed down to us through our genetic line.

What this means is that some people have a stronger genetic “pull” to suffer from addiction than others. Some people may not have any susceptibility at all. In individuals who have less of a genetic pull, psychological and social factors may interact to provide the context where the disease of addiction manifests.

Comparing addiction to diabetes

The best parallel I have found to help those who suffer and those who love them is a comparison between addiction and diabetes. Some diabetics, mostly Type I Diabetics, have a strong genetic susceptibility. Some will develop diabetes early in life. 

Others, mostly Type II Diabetics, may have less of a genetic pull and often manifest the disease later in life. Factors that contribute to the onset of this type of diabetes include psychological and social factors such as stress, diet, exercise, etc.

Although different, both Type I and Type II diabetics must deal with the ramifications of having the disease of diabetes.

The influence of psychological factors on addiction

In addition to the biological, psychological factors influence disease formation. This is seen in the connection between the prevalence of mental health disorders and addiction.

The National Institute on Drug Abuse reports:

“Many people who are addicted to drugs are also diagnosed with other mental disorders and vice versa. For example, compared with the general population, people addicted to drugs are roughly twice as likely to suffer from mood and anxiety disorders, with the reverse also true.”2

Thus, the psychological factors leading to depression and anxiety disorders impact the creation of the disease of addiction and vice versa.

How one internally manages and copes with the stressors of life certainly impacts anxiety and depression symptoms. Often these symptoms pre-date the initial use and subsequent suffering from addiction. In fact, alcohol and drug use may begin as a powerful and readily available coping mechanism to deal with fear, stress, crises of identity, and low self-esteem.

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Social dimensions can be protective

Social dimensions can serve as protective factors of disease formation as well as contribute to addiction manifesting. Additionally, social factors are incredibly important in the healing and recovery for those who suffer from addiction.

In my clinical experience, pain derived from social factors is the most common element distinguishing between those who suffer from addiction and those who are pursuing a recovery journey. The source of the pain can come from a variety of social contexts (e.g., family, peers, community, culture, etc.).

Trauma, in all its forms, is experienced by most people who suffer from addiction. Social factors should never be used to blame families for the disease of addiction. I am, however, pointing out that social factors do play a role in the context of disease formation. More importantly, social factors, including healthy family interaction and social support, are critical in recovery from addiction.

The bottom line

In conclusion, it is important to note that no one factor is the “cause” of addiction. There are multiple culprits and, as stated earlier, all are complex and complicated. The culprits are biological, psychological, and social in nature.

The “cure” for those who suffer must be equivalent in complexity and holistic to tackle all three dimensions. Recovery and healing from addiction must consider the biological, psychological, and social.  Anything less will continue to result in poor outcomes and more suffering.

Additional stories by this author: 
Why pornography is so powerfully addictive
Why we should stop random drug testing
Methadone and suboxone for heroin recovery

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References
  1. Kimball, T.G. Addiction is a Chronic Disease Not a Character Flaw 
  2. Borrell-Carrió, F., Suchman, A. L., & Epstein, R. M. (2004). The Biopsychosocial Model 25 Years Later: Principles, Practice, and Scientific Inquiry. Annals of Family Medicine, 2(6), 576–582. httpss://doi.org/10.1370/afm.245
  3. National Institute on Drug Abuse 
 

First published March 26, 2018, the post was reviewed and updated for republication.

A blood test is an important step toward making almost any medical diagnosis. This is true whether there is concern that a patient may have diabetes, kidney disease, heart failure or many other conditions.

Most of the time, these blood tests deliver a single piece of information. They provide one clue about a potential health risk. Additional blood tests and specialized tests, such as ultrasound, X-rays or stress testing, are needed to get to the working diagnosis.

What if instead of needing different blood tests for each suspected health issue, health care providers could use one blood test to deliver a hundred or more different predictors for a large number of common diseases? In other words, what if a single blood test based on measuring thousands of proteins could provide an accurate, detailed portrait of a person’s current health and future disease risks?

That was the question that the authors of a recent Nature Medicine article1, co-led by Drs. Stephen Williams (SomaLogic, Inc.), Peter Ganz (University of California, San Francisco) and Nicholas Wareham (University of Cambridge) aimed to answer.

Why proteins are a special source of health information

The body’s proteins are particularly well suited to provide comprehensive health information. They are the instruments – the worker bees of the body – that carry out the functions of all cells.

Proteins circulating in blood reflect a person’s genetically inherited predisposition to diseases. It is encoded by the sequences of nucleotides that make up the genes in our DNA. 

Proteins also reflect the effects of one’s environment (diet, lifestyle habits, the aging process and any drugs taken to ameliorate one’s health risks). This takes place by modification of gene expression rather than alteration of the genetic code itself. 

DNA tests provide static information about our genes. By and large, that information does not change during one’s lifetime. And, it is only weakly associated with the risk of common diseases.2

On the other hand, protein levels change continuously as one’s health changes and disease risks emerge3, 4  And, the association of proteins with the risk of diseases can be strong.5

For these reasons, blood proteins have been hypothesized to provide a powerful snapshot of current health. They also offer a sneak preview of diseases not yet clinically apparent.

Technology to measure thousands of proteins in the blood

Until recently, the measurement of a large number of proteins in a complex mixture of cells and chemical substances such as blood was limited by a lack of suitable technology. The SomaLogic (Boulder, CO) technology overcomes this challenge.5, 6  

It uses modified aptamers. These are chemically modified bits of single-stranded DNA that bind to proteins with high affinity (sub-nanomolar) and excellent specificity, similar to antibodies.7  

The assay can currently measure nearly five thousand different proteins present in vastly different concentrations. And it can do it using just 0.15 milliliters of blood.

Related Content: Dried Blood Spot Testing: Innovations and Applications

The utility of proteomics: The proof-of-concept study

In the aforementioned proof-of-concept study, investigators measured the levels of 5,000 different proteins in archived blood samples from nearly 17,000 individuals participating in 5 different longitudinal health studies.1 This yielded a total of 85 million protein measurements making this the largest protein study to date.

Applying sophisticated machine learning computer approaches to this massive data set revealed protein expression patterns that correlated with 11 different measures of patients’ overall health. It also correlated with their risk of developing certain diseases in the years following the blood draw.

For example, the test could predict how much fat a person’s liver contained. Liver fat is a forerunner of liver cirrhosis, a risk factor for cardiovascular disease, and an indicator of insulin resistance.

The test also provided a measure of the overall level of physical fitness as well as a predictor of the likelihood of developing diabetes or cardiovascular disease within 5 years.

Eleven health indicators in a single blood test

The set of 11 results that this single blood test provided is listed here:

  • the presence or absence of liver fat
  • kidney function
  • the percent body fat
  • visceral fat
  • lean body mass
  • cardiopulmonary fitness
  • average daily physical activity
  • alcohol consumption
  • cigarette smoking
  • predicted diagnosis of diabetes in pre-diabetics within 10 years
  • likelihood of heart attack, stroke, heart failure or cardiovascular death within 5 years in people without known heart disease

And since the paper was published, tests for cardiovascular risk in people with known heart disease, resting energy expenditure and glucose tolerance have been added to the list.

Protein patterns can pinpoint propensity for disease

This proof-of-concept study demonstrates a new paradigm. The measurement of blood proteins can accurately deliver health information that spans numerous medical specialties. This information should be actionable for patients and their health care providers.

From all the studies conducted to date, there is evidence that protein patterns can pinpoint propensity for the following diseases:

  • coronary heart disease,
  • heart failure,
  • diabetes,
  • liver disease,
  • kidney disease,
  • dementia and
  • cancer.

This is likely just the tip of the iceberg. Ultimately, our goal is to deliver a one-stop “Liquid Health Check” for personalized detection, prevention, and treatment of many diseases.

proteomics-liquid-health-check

Graphic courtesy of the authors

Implications of Liquid Health Check for patients and health care

A single blood test based on measuring proteins at scale has potentially important implications for transforming health care. They are as follows:

1. Patient convenience and reduction in health care cost

A patient would have to make several appointments with health care providers and undergo multiple tests costing thousands of dollars to get the equivalent amount of health information that the one blood sample provides by measuring thousands of proteins at once at a reasonable cost.

2. Provision of  truly “personalized (precision) medicine” 

Proteins are “downstream” from the traditional clinical risk factors. They can, therefore inform whether or not a person’s clinical risk factors have set in motion the machinery required to cause diseases.

Unlike genetic risk factors that do not change during an individual’s lifetime, protein risk scores are responsive to modifications in their environment (e.g., diet, lifestyle behaviors, drugs and so forth).

We thus envision that protein-based risk scores (unlike genetic risk scores) would be regularly tracked over one’s lifetime to inform the following:

  • changes in health risk 
  • the need for any treatments
  • the necessity to make lifestyle changes

We believe it is important to commercialize this test so it can help patients broadly. To this end, SomaLogic has already launched the first ten SomaSignal™ tests based on the findings described in the Nature Medicine article. Discovery and development efforts are ongoing and there are already more than one hundred tests in the pipeline.

Liquid Health Check: academic and industry collaboration

Liquid Health Check represents an important collaboration between academic centers and industry. An important aspect of this collaboration is a focus on openness and transparency from which patients will ultimately benefit.

Study results are published in peer-reviewed journals, typically with detailed supplemental information.1, 5, 8  We do this so that health care professionals and pharma to be able to scrutinize and use the data and information for their own research studies.

The bottom line

Advanced technology and data analytics have made it possible to create a single blood test, the Liquid Health Check, that provides personalized, actionable information about an individual’s health and health risks. We believe that this will transform healthcare. 

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References

  1. Williams SA, Kivimaki M, Langenberg C, Hingorani AD, Casas JP, Bouchard C, Jonasson C, Sarzynski MA, Shipley MJ, Alexander L, Ash J, Bauer T, Chadwick J, Datta G, DeLisle RK, Hagar Y, Hinterberg M, Ostroff R, Weiss S, Ganz P and Wareham NJ. Plasma protein patterns as comprehensive indicators of health. Nat Med. 2019;25:1851-1857.
  2. Mosley JD, Gupta DK, Tan J, Yao J, Wells QS, Shaffer CM, Kundu S, Robinson-Cohen C, Psaty BM, Rich SS, Post WS, Guo X, Rotter JI, Roden DM, Gerszten RE and Wang TJ. Predictive Accuracy of a Polygenic Risk Score Compared With a Clinical Risk Score for Incident Coronary Heart Disease. JAMA. 2020;323:627-635.
  3. Lehallier B, Gate D, Schaum N, Nanasi T, Lee SE, Yousef H, Moran Losada P, Berdnik D, Keller A, Verghese J, Sathyan S, Franceschi C, Milman S, Barzilai N and Wyss-Coray T. Undulating changes in human plasma proteome profiles across the lifespan. Nat Med. 2019;25:1843-1850.
  4. Emilsson V, Gudnason V and Jennings LL. Predicting health and life span with the deep plasma proteome. Nat Med. 2019;25:1815-1816.
  5. Ganz P, Heidecker B, Hveem K, Jonasson C, Kato S, Segal MR, Sterling DG and Williams SA. Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients With Stable Coronary Heart Disease. JAMA. 2016;315:2532-41.
  6. Gold L, Ayers D, Bertino J, Bock C, Bock A, Brody EN, Carter J, Dalby AB, Eaton BE, Fitzwater T, Flather D, Forbes A, Foreman T, Fowler C, Gawande B, Goss M, Gunn M, Gupta S, Halladay D, Heil J, Heilig J, Hicke B, Husar G, Janjic N, Jarvis T, Jennings S, Katilius E, Keeney TR, Kim N, Koch TH, Kraemer S, Kroiss L, Le N, Levine D, Lindsey W, Lollo B, Mayfield W, Mehan M, Mehler R, Nelson SK, Nelson M, Nieuwlandt D, Nikrad M, Ochsner U, Ostroff RM, Otis M, Parker T, Pietrasiewicz S, Resnicow DI, Rohloff J, Sanders G, Sattin S, Schneider D, Singer B, Stanton M, Sterkel A, Stewart A, Stratford S, Vaught JD, Vrkljan M, Walker JJ, Watrobka M, Waugh S, Weiss A, Wilcox SK, Wolfson A, Wolk SK, Zhang C and Zichi D. Aptamer-based multiplexed proteomic technology for biomarker discovery. PLoS One. 2010;5:e15004.
  7. Rohloff JC, Gelinas AD, Jarvis TC, Ochsner UA, Schneider DJ, Gold L and Janjic N. Nucleic Acid Ligands With Protein-like Side Chains: Modified Aptamers and Their Use as Diagnostic and Therapeutic Agents. Mol Ther Nucleic Acids. 2014;3:e201.
  8. Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR and Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018;137:999-1010.

Financial Disclosures: Dr. Ganz is a member of the SomaLogic Medical Advisory board, for which he receives no remuneration of any kind. Dr. Williams is an employee of SomaLogic.

Editors note: I invited Drs. Ganz and Williams to submit this post after hearing their excellent presentation at the always excellent Precision Medicine World Conference 2020. We received no remuneration for publishing this post. 

During the first ten days of December 2019, two very different headlines highlighted news reports that seemingly had nothing in common. But in actuality, they did. They both illustrated the potential new benefits from a well-established, but previously limited, clinical laboratory technique called Dried Blood Spot Testing or DBS.

Here are the stories:

  • On December 1, World AIDS Day was commemorated. It provided an opportunity for people around the globe to unite in the fight against HIV. It reminded us to support the 36.7 million people living with the virus. And, to remember those who died from AIDS-related illness.
  • Eight days later, the World Anti-Doping Agency (WADA) issued a four-year penalty against the Russian national athletics team [1], banning them from all international sporting competitions, including the Olympics,. The ban was because of their continued participation in the years-long doping scandal.

Here’s a closer look at the role of DBS in those stories:

In October of 2019, the WADA announced a collaboration with seven Anti-Doping Organizations [2] The collaboration centered on the development and implementation of DBS for drug testing in sports in time for the 2022 Winter Olympic and Paralympic Games in Beijing, China.

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Want to read more about doping in sports? Check out this book: Doping in Sports: Winning at Any Cost? (Amazon Affiliates disclosure is in the footer.)

***

Meanwhile, UNAIDS was approaching the final stretch of their 90-90-90 initiative [3] that included three goals to accomplish by the end of 2020.

Ninety percent of all people: 

  • living with HIV should know their HIV status,
  • diagnosed with HIV should receive sustained antiretroviral therapy (ART)
  • receiving ART should have viral suppression.

DBS testing has shown promise for both HIV screening and viral load testing [4], potentially facilitating the achievement of those goals.

Advantages of DBS testing

DBS testing is a form of blood sampling that uses capillary blood obtained using a heel stick or finger prick instead of serum or plasma drawn from a vein.[5] The blood is then blotted and dried onto filter paper that is used for testing.

DBS offers practical, clinical, and financial advantages as compared to conventional blood testing:

DBS testing was developed in 1963 and became widely used for the first time in 1969-70 for neonatal screening for the congenital metabolic disease, phenylketonuria (PKU) [7].

Challenges related to DBS testing

DBS has been the standard of care for neonatal screening for a variety of diseases, including PKU, sickle cell, hypothyroidism, and HIV infection.

However, the utilization of DBS beyond neonatal screening was limited for many years [8] due to a variety of technical issues. First and foremost, the quantity of blood collected with each sample is small (only 2-3 drops of blood). Therefore, successful analysis is dependent on highly sensitive and reliable analytic techniques.

Other contributing factors that make consistent DBS sampling a challenge include the following:

  • cumbersome drying procedures
  • differences in blood sample viscosity
  • distribution on the filter paper
  • stability of the sample during transport and storage (especially at high temperatures and humidity)

More work than conventional blood tests

The actual work of processing and analyzing the DBS samples involves more labor than with conventional serum samples, often requiring manual processes.

The utility of DBS as a diagnostic tool is also dependent upon the cross-validation of the method with a reference plasma/serum-based assay for the same target substance. Reference intervals need to be established in order to properly interpret the results of DBS testing. This is because the values for whole blood used in DBS often differ from those derived from serum or plasma.

Taken together, these technical challenges have played a role in limiting the adoption of DBS testing despite its potential advantages. Historically, few clinical laboratories have been equipped to perform DBS testing.

Related content:
The Liquid Health Check: How Proteomics Can Transform Healthcare

Current use case: HIV viral load monitoring

The World Health Organization recommends viral load monitoring to test the efficacy of ART in HIV patients. However, although countries in sub-Saharan Africa are scaling up their efforts to monitor ART, most African countries are not able to provide monitoring for more than 50% of all affected patients. In order to provide full access to testing services, countries will need to address the “Last Mile”, or patients in the most remote areas. This use case illustrates a challenge that can potentially benefit from the use of DBS. 

In the Journal of the International AIDS Society [9], Nichols and colleagues recently reported on the incremental costs of accessing the most remote 20% of patients in Zambia. It was done by expanding the network required to transport blood samples from ART clinics to centralized laboratories.

The last mile is costly

They concluded that “providing sample transport services to the most remote clinics in low- and middle-income countries is likely to be cost-prohibitive. Other strategies are needed to reduce the cost and increase the feasibility of making viral load monitoring available to the last 10% of patients.”

They recommended evaluation of the cost of alternative testing methods, such as dried blood/plasma spot specimens, point-of-care testing or drones. Point-of-care devices show promise but still require lab facilities. Viral load monitoring using DBS still needs to be validated before being scaled up, but the first field testing of a CE marked protocol for HIV RNA testing using DBS [10] has been reported.

Technological innovations in DBS testing

The technological improvements that have made DBS testing more practical and more promising have come in both the “pre-analytical” and “analytical” phases [11] of DBS testing.

  • Pre-analytical phase

The pre-analytical phase of DBS testing includes:

        1. Blood collection from the patient 
        2. Application of the drop(s) of blood onto the filter paper 
        3. Drying
        4. Transport and storage of the DBS sample.

Each component needs to be performed correctly and consistently:

      • Sample collection – if the drop(s) of blood are too large or too small or not properly applied, the sample may not be suitable for analysis.
      • Paper thickness and density can influence the rate of adsorption and dispersion.
      • The patient’s hemoglobin can influence the distribution of biomarkers within a sample.
      • DBS samples must be allowed to dry completely before transport and storage (typically takes from 90 minutes to four hours and is influenced by room temperature, humidity, and exposure to sunlight). 

Innovative products

Innovative products, such as the HemaSpot devices [12], have simplified DBS specimen collection, transport, and processing. HemaSpot utilizes a self-contained device (12) consisting of an absorbent paper and desiccant covered with an application surface housed within a plastic cartridge.

Two to three drops of blood are absorbed by the filter paper after passing through a small opening in the application surface. The cartridge is closed immediately, preventing contamination and reducing biohazard risk.

The devices can be immediately shipped and stored at ambient temperature without additional drying. Other new devices claim accurate volume measurement of samples, enabling better quantitation of analyzed substances.

  • Analytical phase

In the analytic phase of DBS testing, the substance being measured needs to be removed from the filter paper. Originally this was done by placing the disc in a solvent or buffer [13].

In the 1990s, the ability of DBS to be used for profiling and quantification of biomolecules and synthetic drugs expanded greatly with the development and adoption of liquid chromatography [14]and mass spectrometry [15] to separate and identify molecules within a sample.

Surface sampling technology[16] has now been developed to allow for direct sampling of DBS without the need for a change to liquid form. This eliminates another source of potential inconsistency.

Several companies now manufacture robotic end-to-end hardware [17] for DBS handling: extraction, purification, concentration, and introduction into the analysis system.

Expanded indications for DBS

With current technology, DBS testing is currently used for a range of applications. These include widespread neonatal screening, drug toxicology, and sports doping screening.

DBS samples are compatible with a large number of bioanalytical methods. Zakaria and colleagues reported on 121 distinct biomarkers (biological molecules like peptides, proteins, and lipids) determined from DBS samples using mass spectrometry (11). Immunoassays can also be used to detect nucleic acids from and antibodies to viruses. These can be used to screen for such diseases as cytomegalovirus, herpes simplex virus, hepatitis A, hepatitis C, and HIV.

The 2017 WHO Guidelines [18] on hepatitis B and C testing recommended consideration of DBS testing in the following circumstances:

    • There are no facilities or expertise are available for conventional venipuncture
    • Rapid diagnostic tests are not available
    • It is being used for persons with poor venous access, such as those in drug treatment programs or prisons.

Finally, genomic testing using DBS [19] has allowed the detection of mutations responsible for fragile X syndrome, thalassemia, and some cancers.

The range of emerging DBS applications is vast

The range of emerging DBS applications [20] is vast and includes the following:

  • preclinical drug development
  • toxicokinetic (TK) and pharmacokinetic (PK) studies
  • clinical pharmacology
  • metabolic profiling
  • therapeutic drug monitoring
  • forensic toxicology
  • environmental contaminant control
  • epidemiological disease surveillance

Related Content: What You Need to Know About Hepatitis

Excitement for the potential of DBS

Further collaboration around standardization for both collection and transport as well as analysis and storage of DBS is required. But the excitement over the potential of DBS is typified by the comments of Dr. Olivier Rabin (2), WADA Senior Executive Director, Sciences and International Partnerships. When discussing the utilization of DBS testing in sports anti-doping programs, he said,

“The possible advantages of DBS are clear. It has the potential to add to the current global anti-doping program by complementing existing urine and blood testing to expand upon the program’s testing coverage and capacity to better reveal doping practices.

WADA is committed to making available new ways of protecting clean sport that reduce the inconvenience or discomfort for athletes and is easier, more effective and cheaper to carry out. In that way, it could be that DBS will be a major breakthrough in global anti-doping testing capacity.”

Summary

From screening to monitoring, DBS technology has the potential to bring convenient, cost-effective blood testing to a wide variety of clinical applications for patients in all corners of the world. Innovations in sample collection, storage, and analysis provide the opportunity to greatly broaden the adoption of DBS technology beyond the few large centers that perform DBS analysis today.

Continued standardization validation of DBS reference values for a wider variety of substances and standardization of clinical processes for collection and analysis of DBS samples (including further automation) will reduce barriers to widespread adoption.

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**Love our content? Want more stories about HIV Testing, Testing Technologies, and New Innovations?  SIGN UP FOR OUR WEEKLY NEWSLETTER HERE**

***

Additional articles on diagnostic innovations:
–Barrett’s Esophagus: New Tool Predicts the Risk of Cancer
–The Promise of Menstrual Blood Diagnostics

***

References

[1] Panja, Tariq. (2019, December 10th). Russia Banned From Olympics and Global Sports for 4 Years Over Doping. https://www.nytimes.com/2019/12/09/sports/russia-doping-ban.html

[2] WADA (2019, October 3rd). WADA leads exciting collaboration on dried-blood-spot testing. https://www.wada-ama.org/en/media/news/2019-10/wada-leads-exciting-collaboration-on-dried-blood-spot-testing

[3] UNAIDS (2014, October). 90-90-90 An ambitious treatment target to help end the AIDS epidemic. https://www.unaids.org/sites/default/files/media_asset/90-90-90_en.pdf

[4] Neogi, Ujjwal. Gupta, Soham. Rodridges, Rashmi. Nalini Sahoo, Pravat. D. Rao, Shwetha. B. Rewari, Bharat. Shastra, Suresh. De Costa, Ayesha. Shet, Anita (2012). Dried blood spot HIV-1 RNA quantification: A useful tool for viral load monitoring among HIV-infected individuals in India (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612324/).

[5] MM De Kesel, Pieter. Sadones, Nele. Capiau, Sara. E Lambert, Willy. P. Stove, Christophe (2013). Hemato-critical issues in quantitative analysis of dried blood spots: challenges and solutions (https://www.future-science.com/doi/10.4155/bio.13.156).

[6] Lehmann, Sylvain. Delaby, Constance. Vialaret, Jerome. Ducos, Jacques. Hirtz, Christohe (2013) Current and future use of “dried blood spot” analyses in clinical chemistry (https://www.degruyter.com/view/j/cclm.2013.51.issue-10/cclm-2013-0228/cclm-2013-0228.xml?f=&print).

[7] Guthrie, R. Susi, A (1963). A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants (https://www.ncbi.nlm.nih.gov/pubmed/14063511)

[8] Lehmann, Sylvain. Delaby, Constance. Vialaret, Jerome. Ducos, Jacques. Hirtz, Christohe (2013) Current and future use of “dried blood spot” analyses in clinical chemistry (https://www.degruyter.com/view/j/cclm.2013.51.issue-10/cclm-2013-0228/cclm-2013-0228.xml?f=&print).

[9] E Nichols, Brooke. J Girdwood, Sarah. Crompton, Thomas. Steward-Isherwood, Lynsey. Berrie, Leigh. Chimhamiwa, Dorman. Moyo, Crispin. Kuehnle, John. Stevens, Wendy. Rosen, Sydney (2019). Monitoring viral load for the last mile: what will it cost? (https://onlinelibrary.wiley.com/doi/full/10.1002/jia2.25337).

[10] Taleb, F. Tran Hong, T. Ho, HT. Nguyen, Thanh B. Pham Phuon, T. Viet Ta, D. Le Thi Hong, N. Ba Pham, H. Nguyen, LTH. Nguyen, HT. Tuaillon, E. Delaporte, E. Le Thi, H. Tran Thi Bich, H. Nguyen, TA. Madec, Y (2018). First field evaluation of the optimized CE marked Abbott protocol for HIV RNA testing on dried blood spot in a routine clinical setting in Vietnam (https://www.ncbi.nlm.nih.gov/pubmed/29425216).

[11]Zakaria, R. Allen, KJ. Koplin, JJ. Roche, P. Greaves, RF (2016) Advantages and Challenges of Dried Blood Spot Analysis by Mass Spectrometry Across the Total Testing Process (https://www.ncbi.nlm.nih.gov/pubmed/28149263).

[12] Spot On Sciences. Product Catalog – HemaSpot Devices (https://www.spotonsciences.com/products/).

[13] Gruner, Nico. Stambouli, Oumaima. Stefan Ross, R (2015). Dried Blood Spots – Preparing and Processing for Use in Immunoassays and in Molecular Techniques (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4397000/).

[14] Waters – The Science of What’s Possible (2020). Beginners Guide to Liquid Chromatography (https://www.waters.com/waters/en_US/HPLC—High-Performance-Liquid-Chromatography-Explained/nav.htm?locale=en_US&cid=10048919)

[15] Khan Academy (2016). Isotopes and mass spectrometry (https://www.khanacademy.org/science/chemistry/atomic-structure-and-properties/mass-spectrometry/a/isotopes-and-mass-spectrometry).

[16] R Venter, Andre. A Douglass, Kevin. T Shelley, Jacob. Hasman Jr, Gregg. Honarvar, Elahe (2013). Mechanisms of Real-Time, Proximal Sample Processing during Ambient Ionization Mass Spectrometry (https://pubs.acs.org/doi/10.1021/ac4038569#).

[17] Gaugler, Stefan. K Al-Mazrou, Maha. Y Issa, Sahar. Rykl, Jana. Grill, Matthias. Qanair, Asem. L Cebolla, Vicente (2018). Fully Automated Forensic Routine Dried Blood Spot Screening for Workplace Testing (https://academic.oup.com/jat/article-abstract/43/3/212/5112958?redirectedFrom=PDF).

[18] World Health Organization (2018). Guidelines for the care and treatment of persons diagnosed with chronic hepatitis c virus infection (https://apps.who.int/iris/bitstream/handle/10665/273174/9789241550345-eng.pdf).

[19] Lehmann, S. Delaby, C. Vialaret, J. Ducos, J. Hirtz, C (2013). Current and future use of “dried blood spot” analyses in clinical chemistry (https://www.ncbi.nlm.nih.gov/pubmed/23740687).

[20] A Demirv, Plamen (2013). Dried Blood Spots: Analysis and Applications (https://pubs.acs.org/doi/10.1021/ac303205m)


Financial disclosure: Dr. Lerman is a consultant for Spot Bioscience.

People living with chronic disease(s) benefit enormously from the pipeline of medications brought to market by hard-working clinical researchers who design and carry out clinical trials of drugs that show promise after testing in animals.

In the case of arthritis, particularly autoimmune forms like rheumatoid arthritis (RA), there are already many approved medications, including complex biologics and biosimilars that are effective. These drugs are proven to both reduce pain, reduce joint damage, and allow people to live a better quality of life.

Despite these advancements, however, it is incredibly common for people living with one or more chronic diseases to find that they need to cycle through a variety of medications to find one that works them. Sometimes, they may also become less responsive to their current regimen over time. For that reason, and others, there is an ongoing need to research and develop innovative therapies that are safe and effective.

Clinical trials need patients like you

Clinical trials are simply not possible without the participation of patients. Animal studies are not enough. This is because drugs that appear to work in animals may not work in humans. Or they may prove to have too many side effects to be acceptable for human use. There is no getting around it. Drugs have to be tested for safety and efficacy in patients. And that may mean you!

Here are five reasons why you might consider participating in a clinical trial to evaluate a drug candidate or medical device. Remember, when you do this, you are providing real-world evidence about the experience of living with chronic disease.

1. Science is not static

Without scientific research, we cannot advance our understanding of the human mind and body. And, we cannot assess the impact of our interventions on medical conditions that afflict us.

Scientists at major research institutions, government laboratories, and pharmaceutical and biotechnology companies work hard to design clinical trials that test the safety and effectiveness of medications and therapies that may someday benefit the patient population. Volunteering to participate in clinical trials in the hopes that the drug might one day benefit other people who have the same condition as you is a major contribution to our society.

2. Clinical trials may give you early access to new therapies.

Phase 1 clinical trials involve testing drugs to ensure general safety. In Phase 2 trials the aim is to determine if the drug is effective. They are usually done with a relatively small group (25-50) of subjects who have similar conditions. They may be randomized to receive different doses or routes of administration.

Phase 3 trials involve much larger numbers of people. They are used to determine if the new drug is as safe and efficacious as what is already available (the current standard treatment). Participants in Phase 3 trials all have the medical condition that the new drug is targeting. They are usually randomized to receive either the investigative drug plus the current standard treatment or the standard treatment alone. Therefore, not all participants will receive the new therapy unless the trial has a cross-over design.

Before agreeing to participate in Phase 3 clinical trials, it is important to understand that these types of trials require control groups (people who do not receive the drug being studied) in order to determine whether the drug causes benefit (or harm) to patients. So there is always a chance that you will be randomized to the control arm of the trial so that you do not actually receive the new therapeutic.

3.  Receive enhanced medical care during and after the trial.

Clinical trials are not designed by researchers alone. It is a co-partnership requiring participation by clinicians, researchers, patients and even an ethical oversight body to protect the rights of those who participate.

This oversight body reviews the structure and management of clinical trials and research involving humans in general. It is called the Institutional Review Board (IRB). The IRB requires that scientific investigators communicate directly with participants to responsibly share and transparently inform them about

  • what to expect from the trial
  • their rights as patients during the trial.

In turn, patients can then share what matters to them with researchers. This is a collaborative process.

In addition, participants must consent to enroll and share their health data with scientific investigators.  Once enrolled, patients are carefully observed, meaning you may see your doctor and healthcare team more frequently and experience benefits not available from standard, approved treatments.

Of course, there is always the possibility that you are assigned to the standard treatment group or that you may not respond to the medication being tested. You could also experience adverse reactions to the medication. In that event, your doctor would make recommendations about whether you should continue in the trial or not.

4.  It’s not just medicine, experience matters too.

Before enrolling in any clinical trial, certain conditions need to be met. These conditions may vary from trial to trial. Many times, the people who participate in clinical trials – particularly for medications – must meet very strict physical and mental health criteria so that researchers can tease out real results from a vast amount of data they collect from each and every person.

Sometimes, people living with a disease may not be eligible for clinical trials. Some of the reasons for exclusion include having:

  • Co-morbid conditions,
  • A family history that precludes participation
  • Not having enough time to fully participate in the trial
  • Being physically unable to travel to the facility for evaluation

Despite those barriers, there remain ways for patients to contribute to the advancement of science because the unique experience of people living with diseases is of immense value.

The ArthritisPower Research Registry

After obtaining consent to participate, the ArthritisPower Research Registry collects data from patients with arthritis via a free smartphone or desktop application. Participants can select from dozens of validated Patient-Reported Outcomes (PRO) that help people self-assess (measure) their experience of pain, fatigue, and other symptoms.

This data is donated to the registry that researchers can access to study the arthritis population across many different dimensions (e.g., age, specific arthritis diagnosis, men vs. women). This allows researchers to design research studies that are deployed directly in the application.

For example, recently, we asked women with arthritis about their experience, concerns, and preferences with reproductive health issues. Data stemming from that research was presented at a major medical meeting and later published in a peer-review journal, thereby increasing our understanding of arthritis.

Another example is that we designed a study to better understand how the arthritis community accessed and used marijuana for medical use and related CBD products. These results were presented at two medical meetings, which is important because it allowed us to directly communicate with an audience of physicians who need to understand how their patients are using alternative therapies. This is particularly important to assess the risks and benefits of therapies that aren’t well studied, such as marijuana and CBD. These are just two of the many studies that are available to people in this registry and others like it.

5.  Put yourself at the center of your treatment journey.

Participation in a clinical trial or a research registry is always optional. By electing to share your personal health data, you are playing a more active role in your own healthcare. You are also contributing to the advancement of our understanding of disease as a society. Participation allows you to advocate for the topics most important to you as well as the patient community.

Ask the right questions

It can take months or even years for researchers to understand the effect of a medication or device. Further, a successful clinical trial may not lead to the therapy being immediately available to you and others via prescription. This is because an additional study may be required by the FDA. There is also a lengthy process related to securing approvals to market and sell medications by the sponsoring companies.

Therefore, it is essential that you ask your health care provider important questions about what to expect from your participation.

Suggested questions might be:

      • What is the time commitment for participation?
      • Will I need the support of a family member or friend to help me manage the experience?
      • What can I expect from the treatment? Will I know if I’m on treatment versus being in the control group?
      • What are the risks or side effects I might experience?
      • Is there compensation?
      • When will the results of the trial be shared and how will I find out about them?

Unfortunately, there aren’t enough people participating in clinical trials. Some of that may be linked to concerns about:

      • The time commitment and possible costs related to participation. (Importantly, patients should never be asked to pay to be in a clinical trial. Rather, the study should cover costs and some provide compensation.)
      • Experiencing possible adverse events
      • Being selected for placebo (the control group) and seeing no benefit from participation; or, being on medication and seeing no benefit from the actual therapy, itself. Patients may not know if they are on placebo or the medication until the end of a study. This type of study design is called “blinded.”
      • Lack of support from family and friends regarding participation

An urgent and never-ending need for patient participation in clinical trials

Despite these barriers, there is an urgent and never-ending need for patients to participate in clinical trials. It is also essential that they contribute information about their lived experience with the disease (and associated treatments) to research registries.

The first place to ask for more information is from your doctor. Many doctors participate in research or can refer you to a research center for more information. It’s important to keep your health care team informed of your participation in clinical trials so that they can note it in your electronic health records and coordinate care.

All clinical trials are required to be listed at ClinicalTrials.gov, which has a search function to navigate through over 324,000 currently enrolling trials. People with arthritis who seek more information about clinical trial participation can visit www.ArthritisPower.org or www.CreakyJoints.org. People living with other chronic diseases can find a research registry at the National Institutes of Health or at the Patient-Centered Outcomes Research Institution.

Related Content:  8 Practical Tips to Delay Surgery for Arthritis

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 The author does not have any financial disclosures to report.

Imaging studies are an important part of screening and diagnosis for some cancers, lung, and breast in particular. Such studies have led to more lung and breast cancers being diagnosed at a smaller size compared to what was found prior to the advent of screening programs. One important research question that is currently being explored is whether the use of artificial intelligence to aid in diagnosis can improve the performance of radiologists alone. Let’s take a look at what we know so far.

Breast cancer screening

According to the American Cancer Society (ACS), approximately one in eight women will be diagnosed with breast cancer in their lifetime. It is the second leading cause of death from cancer in women.  

Breast cancer screening is commonly performed on patients who have no obvious signs of disease. Many of these women are not at high risk for the disease. Nor do they have a family history. 

Although many preventive health guidelines recommend screening mammograms, concerns have been raised. For example, one in five abnormal mammograms is a false positive. That means the mammogram was read as positive by a radiologist but proved not to be cancer on biopsy. 

Over the span of ten years, about half of women are given a false-positive result. This usually leads to further testing, anxiety, distress, and sometimes unnecessary procedures or treatment.

The Google Health study

Experts from Google Health and its subsidiary, Alphabet’s DeepMind unit, recently worked with Northwestern University, Cancer Research UK Imperial Center, and Royal Surrey County Hospital to examine aspects of radiographic breast cancer diagnosis. In particular, they wanted to better understand the reasons for inaccuracies in the diagnosis of breast cancer. And, they wanted to determine if artificial intelligence could help. 

In order to comprehend how AI can be used to improve the results of breast imaging moving forward, it is important to have a basic understanding of how this artificial intelligence system works. This is a type of system known as “Deep Learning” which involves a three-dimensional model:

  • The first component is analyzing of imaging with nodules already confirmed as cancerous in order to obtain “training data”. 
  • The second component is training the system to detect a “region of interest” that is suspicious. 
  • Finally, the third step involves developing a cancer prediction model that would operate independently of the first two steps.

International evaluation of an AI system for breast cancer screening

The results of this research were recently published in the journal Nature in an article titled “International evaluation of an AI system for breast cancer screening.” The study compared the results of mammography readings in an artificial intelligence model to those read by radiologists. There were close to 26,000 women from the UK and over 3,000 women in the United States in the study.

The researchers found that the artificial intelligence model reduced both false positives (when patients are told they have cancer when they don’t) and false negatives (when the disease is present, but not diagnosed).

ADD_THIS_TEXT
 

Although in this early testing the AI caught cancers missed by radiologists, there were also cases in which it missed cancer that was caught by radiologists. This suggests that AI alone may not be the sole solution moving forward. 

Screening for lung cancer with low-dose chest CT 

With approximately 160,000 deaths in 2018 due to lung cancer, it is the most common cause of cancer death in the United States. The U.S Preventive Services Task Force’s (USPSTF) new guidelines for the use of low dose computed tomography has recently been updated for individuals at high risk of having lung cancer. 

Lung cancer screening using this type of computed tomography testing has been shown to reduce death by 20-40%. However, similar to breast cancer screening, one ongoing issue with the use of this screening exam has been the high rate of false positives (a result that indicates that a person has a disease when they actually do not).  Although low-dose lung CTs have helped immensely in early detection, it has been found that about one-quarter of the suspected nodules are actually not cancerous. 

To determine if this could be improved upon, doctors at Northwestern University and Stanford, teamed up with Google to determine if the same type of artificial intelligence, called Deep Learning, could help improve upon our current methods with lung cancer. 

The lung cancer screening AI study

Researchers from Google used more than 42,000 CT scans to train this artificial intelligence system to detect cancerous lung nodules on radiology imaging. The study, titled “End-to-end lung cancer screening with three-dimensional deep learning on low dose chest computed tomography” was published in Nature as well.

Over 6,000 National Lung Cancer Screening Trial cases were tested in this study. In addition, there was an independent evaluation of a set of over a thousand cases. The performance of the artificial intelligence system was compared against radiologists who had evaluated low-dose chest computed tomography scans for patients – several of which had confirmation of cancer by biopsy within a year. 

This deep-learning artificial intelligence system produced fewer false negatives (a result that indicates that a person does not have a disease when they actually do) as well as fewer false positives. When prior imaging was available, the model performed better than the radiologists (six of them) with an 11% reduction in false positives and a 5% reduction in false negatives.

What’s next in AI-assisted lung-cancer screening?

The Nature study was a retrospective study that examined past cases. This type of study design is not as strong as prospective studies with randomization. Mozziyar Etemadi, MD, Ph.D., one of the authors of the study has said that “the next step is to perform a prospective study to see if the tool, when used by a radiologist, can lead to earlier and more accurate diagnosis of cancer”.

Another caveat is that it may be some time before AI with deep learning is routinely used in hospital and free-standing radiology suites. The algorithm that is the backbone of the AI-deep learning system is very sophisticated and will undoubtedly require some painstaking work to fully integrate into hospital computer systems. Further, the variability of many cancers could make new scenarios difficult for the deep learning system to interpret if they have not been seen before. 

We also need to consider that although AI with deep learning improves some aspects of cancer screening diagnoses, it is not (yet) perfect. It may be that the best way to introduce AI into imaging analysis is to add it to the workflow of radiologists. This is because both have the potential to not catch something or make mistakes.

The bottom line

The performance of the deep learning system shows that there can be a beneficial role of artificial intelligence in cancer screening moving forward. In fact, the use of algorithms that incorporate co-morbidities and risk factors in medicine is not uncommon today. However, the use of such a sophisticated one on its own will most certainly take time. It will also require well-designed prospective studies that follow patients over time. Nonetheless, there is no denying that there will be an important role of artificial intelligence in cancer screening moving forward.     

Related Content:  Google, Big Data, and Public Health

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Study after study has shown that people fear vision loss more than they fear cancer, stroke, heart disease, and other serious health problems. But a new study shows that Americans are scared about an issue they know very little about. And what they don’t know is putting them at risk of vision loss, including blindness.

A survey[mfn]This survey was conducted online within the U.S. by The Harris Poll on behalf of the American Academy of Ophthalmology among 3,512 U.S. adults ages 18 and over between August 8 and 27, 2019. Data by race/ethnicity were weighted where necessary by gender, age, region, income, education, household size, marital status, employment, and specific eye conditions of interest to bring them into line with their actual proportions in the population. The data for each race/ethnicity group was then combined into a grand total to reflect the proportions of each race/ethnicity within the U.S. adult population. Propensity score weighting was also used to adjust for respondents’ propensity to be online.[/mfn] conducted by The Harris Poll shows that while 81% of adults say they are knowledgeable about eye/vision health, less than 1 in 5 (19%) were able to correctly identify the three main causes of blindness in the U.S., which are glaucoma, age-related macular degeneration (AMD) and diabetic eye disease.

Why does this matter? Because most people are also unaware of key facts that could protect them from vision loss, according to the survey. For example, only around one-third of adults (37%) know you do not always experience symptoms before you lose vision to eye diseases. And less than half (47%) are aware your brain can make it difficult to know if you are losing your vision by adapting to vision loss.

The brain adapts to vision loss 

Here are the facts: 

  • Many forms of glaucoma have no warning signs. The effect is so gradual you may lose most of your vision before you realize it.
  • Diabetic retinopathy may cause no symptoms or only mild vision problems, at first. Eventually, it can cause blindness.
  • AMD is first noticed as blurriness or difficulty seeing colors and fine detail. Symptoms usually appear suddenly and worsen rapidly.

Ophthalmologists, physicians who specialize in medical and surgical eye care, have more tools than ever before to diagnose these eye diseases earlier and to treat them better. But these advances cannot help patients whose disease is undiagnosed.

Further, ophthalmologists cannot adequately care for patients who are unaware of the seriousness of their disease. Far too often, ophthalmologists witness the consequences of patients entering our office too late to avoid severe vision loss.

In 2020, we want all Americans to have a clear vision when it comes to eye health. That starts with educating yourself about eye diseases.

Eye disease is a growing epidemic

The consequences of failing to increase awareness about eye health can be dire. Right now, the number of Americans affected by these potentially blinding eye diseases is expected to double within the next 30 years, due mainly to the aging of the population.[mfn]The Future of Vision: Forecasting the Prevalence and Cost of Vision Problems. Prevent Blindness. Retrieved December 3, 2019, from https://www.preventblindness.org/sites/default/files/national/documents/Future_of_Vision_final_0.pdf[/mfn] 

    • In 2010, approximately 2.7 million persons in the United States aged 40 and older had glaucoma. By 2050, this number is projected to increase to 5.5 million persons.
    • Diabetic retinopathy will increase to 13.2 million persons by 2050, up from 7.7 million in 2010.  
    • The population with AMD will double between 2010 and 2050, increasing from 2 million to 4.4 million.  

It’s important to note that vision loss affects more than the eyes. Vision loss is also associated with the following:

  • increased risk of falls and injuries
  • social isolation
  • depression
  • other psychological problems

All of these complications of vision loss can worsen other chronic illnesses.

Related Content:  
Why You Should Have Regular Eye Exams
The Aging Eye: How to Protect Your Vision

Dealing with a Rare Eye Disease in the Midst of a Pandemic

Eye disease doesn’t affect everyone equally

Another key finding from the Harris poll is that less than half (47%) of respondents were aware that vision loss and blindness does not affect all people equally. But your risk of developing an eye disease varies significantly by your age, ethnicity, family history, and whether you smoke. Here are some relevant facts:

  • African Americans are 6 to 8 times more likely to get glaucoma than white Americans.
  • Further, blindness from glaucoma is 6 to 8 times more common in African Americans than white Americans.
  • People with diabetes are 2 times more likely to get glaucoma than people without diabetes.
  • Asians are at an increased risk for the less common types of glaucoma: angle-closure glaucoma and normal-tension glaucoma.
  • AMD disproportionately affects whites. Nearly 90% of Americans with AMD are white. Black and Hispanic American populations each account for ~4% of AMD cases.
  • African Americans, Hispanics, American Indians, and Asian-Americans all have a higher risk of diabetes.
  • Some 45% of people with diabetes have some stage of diabetic eye disease.

Vision loss and blindness is not inevitable

The Harris poll also found that only around one-third of adults surveyed (37%) know that vision loss is not inevitable as you age. Many people think vision loss is just a normal part of aging but it doesn’t have to be. You can take many steps to reduce your risk of vision loss, including

    • Eat a healthy diet, including leafy greens such as spinach or kale
    • Maintain a healthy weight.
    • Know your family’s eye health history.
    • Wear sunglasses that block out 99% to 100% of UV-A and UV-B radiation (the sun’s rays).
    • Quit smoking or don’t start.
    • Get regular eye exams

Time for an exam?

Just because you can see well, doesn’t mean all is well. That’s why the American Academy of Ophthalmology recommends that healthy adults see an ophthalmologist or an eye care professional for a comprehensive, baseline eye exam by age 40 and have their eyes checked every year or two at age 65 or older. 

People who have other risk factors will need to be seen more frequently. People with diabetes should have a dilated eye exam every year. African Americans, age 40 and older, and people with a family history of glaucoma should have a dilated eye exam every 2 years.

If you are concerned about the cost of the exam, the Academy’s EyeCare America® program may be able to help. This program provides eye care through volunteer ophthalmologists for eligible seniors 65 and older and those at increased risk for eye disease. See if you’re eligible, visit www.aao.org/eyecareamerica.

Medicare provides an annual dilated eye exam for Medicare beneficiaries over 65 at high risk for glaucoma. Those eligible for this service are people with diabetes, family history of glaucoma, or African Americans over 50. To learn more, call 800-633-4227.

The bottom line

2020 is the year to get smart about eye health. For ophthalmologist-reviewed information about eye diseases and treatments, eye health news, and tools to locate an ophthalmologist, visit AAO.org/EyeSmart.

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References

  1. This survey was conducted online within the U.S. by The Harris Poll on behalf of the American Academy of Ophthalmology among 3,512 U.S. adults ages 18 and over between August 8 and 27, 2019. Data by race/ethnicity were weighted where necessary by gender, age, region, income, education, household size, marital status, employment, and specific eye conditions of interest to bring them into line with their actual proportions in the population. The data for each race/ethnicity group was then combined into a grand total to reflect the proportions of each race/ethnicity within the U.S. adult population. Propensity score weighting was also used to adjust for respondents’ propensity to be online.
  2. The Future of Vision: Forecasting the Prevalence and Cost of Vision Problems. Prevent Blindness. Retrieved December 3, 2019, from https://www.preventblindness.org/sites/default/files/national/documents/Future_of_Vision_final_0.pdf

Medical marijuana, also known as marijuana for medical use (MMU) is becoming increasingly available in the United States. So far, 33 different states have legalized it allowing it to be available to patients under specific circumstances.

According to a survey conducted by CreakyJoints using our ArthritisPower Research Registry, more than half of arthritis patients (57%, n=1,059) have reported trying MMU and/or cannabidiol (CBD) products for a purpose they perceived as medical. Of those who use MMU regularly for medical reasons 62 percent reportedly use MMU at least once daily.

Why do patients with chronic pain seek medical marijuana?

The attractiveness of these products stems from the unmet treatment needs of people living with rheumatic and musculoskeletal diseases and other chronic conditions. Many of these patients are seeking non-pharmacological alternative and complementary treatments to help manage their condition and symptoms.

Here is what we know about MMU use in these types of patients:

  • Yet, we also know that of respondents who live in states where marijuana is medically legal, nearly one-third (31%) had not informed their health care provider (HCP) about their MMU use
  • In non-legal states, only (46%) had informed their HCP in non-legal states.

A quandary for physicians

This sets up a quandary for physicians. Depending on where their patients live, the MMU and CBD products that they are taking are regulated in variable ways.

Even more concerning is that physicians are without any credible, peer-reviewed guidelines that provide a standard or even suggested approach to incorporating MMU (and CBD products) into the management of arthritis.

Marijuana remains a Schedule 1 substance, meaning the federal government prohibits its study as a possible prescription or OTC medication.

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Open Dialogue

It’s important that people with arthritis and other chronic disease are at the center of their care. They need to feel empowered to ask questions about their treatment and make suggestions for future management. They also need to have reasonable access to those treatments.

ADD_THIS_TEXT
 

According to our survey, of those who consulted with a doctor about using or wanting to use MMU, 58 percent reported that their healthcare provider did not offer advice about the effectiveness or proper dosage. Nor did they consider marijuana or CBD use when making treatment changes.

Again, we can draw a direct line from the lack of clinical study to the lack of information that physicians can communicate to their patients. Given this scenario, patients are motivated to rely on anecdotes or experiment with products to determine whether MMU or CBD might make them feel better.

Physicians need to ask their patients about whether they are trying or interested in trying MMU or CBD products so that they can monitor its impact on their symptoms and/or treatment, plus incorporate it into their electronic health records. Patients need to feel confident that they can confide about their use of these adjunctive products without repercussion particularly in states where MMU is not legal.

Related Content:  How Medical Marijuana Helps Some Patients Get Better

It’s time to reschedule medical marijuana

On November 20, the House Judiciary Committee approved (24-10), the Marijuana Opportunity Reinvestment and Expungement Act of 2019 (the MORE Act). This Act would decriminalize marijuana at the federal level.

It would remove marijuana from the list of federally controlled substances. It would also allow states to set their own policies to determine access and use of marijuana. Further, it would require federal courts to expunge prior convictions for marijuana offenses.

There are other provisions that are meant to spur investment in the business of marijuana as well as substance abuse treatment. Despite approval in committee, approval in the Democratic-led House and Republican Senate is considered a longshot.

This conversation is too important to let wither on the vine.

By necessity, patients have put the cart before the horse by trying MMU and/or CBD as a supplemental and/or alternative therapy to manage the ups and downs of their chronic conditions. That’s why at CreakyJoints, we are urging the federal government to reschedule marijuana so that it can be studied in high-quality clinical trials.

Questions waiting to be answered

There are questions waiting to be answered, including:

  • What is the optimal dose for people living with arthritis and other chronic diseases?
  • What is the optimal administration method?
  • How does MMU and/or CBD interact with prescription medications for arthritis (or other chronic diseases)?
  • What is the safety profile for MMU and CBD?

The bottom line

The medical community and the federal government that regulates access to prescription medications have a responsibility to patients to better understand these products. Further, this must be done expeditiously. There is no time to waste.

What does the future of healthcare offer for chronic autoimmune and inflammatory disease?  Having just come back from the Personalized Lifestyle Medical Institute functional medicine thought leaders conference (PLMI), I was curious to find out what HLTH had in store.

Although there were no sessions specifically focused on autoimmune patients, I was inspired nevertheless, when at every meal, the people on my right and left knew someone with an autoimmune disease. It’s clear that chronic inflammatory and autoimmune diseases are slowly increasing in industry awareness.

With 6200 attendees from all over the world attended this year’s HLTH conference: Create Health’s Future. It has quickly emerged as one of the healthcare industry’s leading gatherings.

The conference featured an impressive list of speakers from many sectors, including:

  • Payers
  • Providers
  • Big Tech
  • Biotech

It also attracted researchers and companies focused on a specific area, such as the microbiome, digital therapeutics, care coordination and so much more. This wide assortment of viewpoints with a shared goal of building the future of healthcare provided a rich networking environment for participants.

I attended the conference with my autoimmune patient hat on. I was seeking a sweet spot where consumer wellness and maximizing well-being for people with chronic disease overlap. I was pleased to find some amazing innovations that will be useful for patients with immune-mediated diseases.

Autoimmune patients are frustrated with the status quo

My conversations with autoimmune patients have revealed widespread frustration with the lack of care coordination and collaboration between and among their primary providers and various specialists (Rheumatology, Gastroenterology, Immunology, etc.). This is an obvious target for better technology.

Related Content:  
Why Collaboration is So Important in Autoimmune Disease
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Another source of frustration and sub-optimal quality of life is that most autoimmune patients struggle to find appropriate, supportive physical therapy and exercise modalities and programs.

Autoimmune patients are especially likely to suffer from intolerance at exercise levels normal people are comfortable with. Therefore, chronic immuno-inflammatory patients and their providers need more customized and personalized approaches to movement as therapy.

Bridge Connector helps put data around the patient

As shown below, Bridge Connector, an integration platform as a service (iPaaS) company, enables development, execution, and governance of workflows connecting any combination of on-premise and cloud-based processes, services, applications and data within individual or across multiple organizations.

Speaking with Jason Raphael, The Chief Delivery Officer of Bridge Connector, “breaking down walls of connection while putting data around the patient. Their soon to be launched product, Destinations, is designed to enable the citizen integrator.  His descriptions left me hopeful that tech companies are finally identifying problems that are important to autoimmune patients. 

It is the first middleware without coding to create an Integration Platform as a Service.  Its customers include hospitals, post-acute facilities, behavioral health, specialty care, and new technology start-ups.

Photo from HLTH

Kaia helps chronic pain patients with home exercise and rehab

On a related note, many autoimmune patients could use better tech for home exercise and rehab. This is why Kaia’s AI home exercise coach, the Motion Coach ™  excited me. Interestingly, it started as a business-to-consumer model and has transitioned to a business-to-business model, selling to self-insured employers and health plans for chronic low back pain.

You may also enjoy: Dealing with a Rare Eye Disease in the Midst of COVID

As shown below, the Motion Coach acts similarly to a “virtual physical therapist” correcting and helping to mediate the patient’s home exercise program. An independent randomized clinical trial recently published in Nature found Kaia Health’s app-based exercise therapy for lower back pain (LBP) to be an effective treatment for patients. It could be more effective than a standard strategy of individual physiotherapy sessions paired with online education. More studies are underway to further explore these results, with even larger sample sizes.

https://www.youtube.com/watch?v=QmsVmCHsXA

There are 3 components to the program, which is a digital version of multimodal pain therapy:

    • Education-using all types of digital media
    • Relaxation- includes meditation, breathing, progressive muscle relaxation
    • Physical exercises, which can be done with the help of Motion Coach to ensure proper execution- there are no sensors, just the phone

Photo from HLTH

Beyond remote exercise coaches, exciting future technology is the creation/discovery of digital biomarkers, which could track disease progression as well as record snapshots of users’ ability to perform ADL (activities of daily living). 

I would love to see Kaia expand to include other movement therapies such as Gyrotonic, Feldenkrais, and others.

ClassPass helps promote fearless experimentation

For those who prefer in-person exercise, perhaps ClassPass is a viable option to encourage fearless experimentation. ClassPass is a monthly membership program that allows users to attend classes from multiple studios, gyms, and wellness partners.

Like other aggregated marketplaces, it offers users discounted prices, but it’s different from an offering like Groupon because it is focused on habituation, with more variety in wellness choices.

Similar to Kaia’s business model transition, according to Jennie Aberle, the Strategic Accounts Director of ClassPass “exercise has become one component of the larger growing health and wellness trend, so that 2 years ago ClassPass went B2B in corporate wellness.”  She continued, “I love fitness and wellness and love the idea that HR leaders are looking for something that works.”

With 26,000 partners in 27 countries, ClassPass makes it easy to find a class either at home or when traveling. Over the years we learned that “location, convenience, variety, and cost are key to making it easy for people to participate in a fitness class.”  We would like to see ClassPass extended to an even more diverse selection of studios as well as other studios specializing in small, personalized exercise classes.

 

Photo by HTH

After interviewing Bridge Connector, Kaia and ClassPass, I remain hopeful that the emergence of consumer wellness as a trend, will become more relevant to those who manage chronic diseases in the future.

Brief sidebar: Consumer brands and healthcare

Before closing, I must include a brief sidebar on consumer brands and healthcare. One noteworthy session at the conference was a discussion of on-demand personalized health with Lyft, Mastercard, and Bose.

At another time I would have wondered what these consumer brands were doing at a healthcare conference, but with the entrance of Google, Amazon and Berkshire Hathaway into healthcare, it is no longer surprising.

  • Lyft became the first on-demand transportation company to be designated as a covered option for eligible Medicaid beneficiaries.
  • Bose Health is focusing on hearing loss (a growth industry for aging rock ‘n’ roll Boomers). 
  • Mastercard has launched an integrated healthcare product suite. It is basically smart cards for payments, flexible spending management as well as abuse, fraud, and waste reduction.

Going Forward

Next year at HLTH, it would be great to see some sessions specifically dedicated to improving care coordination and collaboration for those with immune-mediated diseases.  Thus creating customized exercise programs for those dealing with the chronic pain and fatigue associated with these diseases.

Other Articles by this author:
Millions with Autoimmune Disease Need a Better Solution
How Movement Therapy Can Help You Overcome Chronic Pain

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After 40 years as a practicing physician, I have concluded that the burden of treating chronic diseases has grown so enormous that more pills and procedures will never be enough to cure the ills of my patients. Over those years, I also came to realize that we as physicians are failing to take sufficient advantage of one of our most powerful available tools: the ability of our patients to practice self-care.

Consider the most recent data from the Centers for Disease Control and Prevention.

  • Six of every ten adults in America suffer from a chronic illness.
  • Four out of ten have two or more chronic conditions

Clearly, we can never expect to stem this rising tide of disease unless we can design medical practices to promote serious behavior change. We also need to cultivate, as never before, the power of patients to take care of themselves.

Determinants of health

We have long known that some 80 percent of health is determined by factors outside of the doctor’s office. These behaviors include activities such as,

  • not smoking
  • moderating alcohol use
  • consuming healthy food
  • engaging in regular exercise
  • managing stress

These are all vital components of chronic disease self-management. Improving these behaviors empowers patients to become responsible stewards of their own health and yields tangible improvement in outcomes. 

Robust evidence from numerous disciplines confirms that practices such as therapeutic yoga, massage, mind-body practices, nutritional counseling, journaling, and others can enrich patients’ physical, emotional, and spiritual functioning. Yet self-care remains the subject of numerous myths and misperceptions among patients.

I believe that physicians can play a crucial role in expanding their patients’ understanding and enabling them to make important lifestyle changes to significantly improve their health.

What a new survey tells us about chronic illness self-care

Earlier this year, Samueli Integrative Health Programs commissioned two nationwide surveys by the Harris Poll. These polls involved more than 1,000 patients as well as more than 300 family medicine and internal medicine physicians.

ADD_THIS_TEXT
 

The goal was to try to better understand how America’s doctors and their patients view and discuss self-care in their personal lives and in their conversations with each other. This is an important first step for thinking about systemic change.

Our surveys yielded new insights about a critical communications gap between doctors and their patients when it comes to taking the time and the initiative to engage in conversations about self-care that can improve health and even save lives. Among our key findings:

  • Seven in 10 physicians said they believe their patients would benefit from discussing self-care with them
  • Yet 75 percent of patients said they haven’t discussed any self-care with their doctors.
  • Almost half of physicians (46%) believe that their patients would not be interested in discussing it
  • But a strong majority of patients (72%) say they actually would like to have such discussions.
  • Most respondents (73% of consumers, 92% of physicians) consider adequate sleep to be a vital part of self-care
  • But only 40 percent of physicians discuss sleep habits with their patients during office visits.

Additional findings

Majorities of patients said they wish they could talk more to their doctors about non-medical factors that are important in their lives. They also want to discuss their life goals.

Our findings showed a sharp disconnect between patients who said they seek more help and physicians who may believe that they are already helping. For example:

  • 81 percent of physicians said they refer their patients to mental health professionals,
  • But only 18 percent of patients said they received such referrals
  • 78 percent of physicians said they refer patients to a dietician or nutritionist
  • Yet only 19% of patients report such referrals.

Patients and physicians are shying away from more self-care discussions for a variety of reasons.

Time and money are cited as the primary roadblocks:

  • 44 percent of consumers believe self-care is only possible for people with “enough” time
  • 35 percent believe it requires “enough” money
  • More than one in four (28%) also said they feel guilty about taking the time to indulge in self-care

Chronic Illness self-care misconceptions

There are some central misconceptions about self-care including the following:

  • Many patients see it as a costly indulgence, equating it with things like buying luxury skin-care products or treating themselves to a shopping spree.
  • During stressful times, people often treat themselves with unhealthy behaviors, like drinking alcohol or bingeing on a tub of ice cream.

But self-care is really about finding healthier ways to nourish your body, mind, and spirit.

Majorities of patients reported awareness of the importance of getting enough sleep (66%), eating healthy foods (62%), taking care of their mental health (60%), and exercising (59%).

Doctors can play an important role by emphasizing these behaviors and suggesting other simple options such as journaling, reading, meditating, going on a walk, chatting with a friend, or playing with a pet. These are all effective ways to decrease stress and increase well-being at little or no cost.

What about complementary and alternative medicine? 

It might surprise some physicians to learn that our poll found strong support for Complementary and Alternative Medicine (CAM) practices such as yoga, meditation, acupuncture, massage, chiropractic, biofeedback, and other options.

  • Sixty-one percent of consumers said they have seen or used CAM practitioners and techniques in the last two years
  • 69 percent said they wished their physicians offered these options in their practice.
  • People who use CAM reported that they typically spend $100 a month on these practices.

It’s interesting to note that doctors themselves appear to feel defeatist about their own self-care:

  • 81% of physicians say it’s very important personally for them to practice self-care
  • But only 57% report doing so often
  • More than three-quarters (78%) said they don’t have enough time for it themselves.
  • A majority of physicians (56%) said the demands of their job prevent them from practicing self-care
  • 20% said they don’t practice it because they struggle to change their own bad habits.
  • Nearly one-quarter of physicians cite burnout as preventing them from focusing on self-care.

The tangible benefits of engaging in chronic illness self-care conversations

In my own practice, I have seen the tangible benefits of engaging in personal, patient-centered conversations that extend beyond conventional medicine. I offer my patients an Integrative Health & Wellness Visit. And, I do what I call a HOPE Note.

This is an interview with patients that focuses on what matters to them in their life. We also discuss how they can improve their personal determinants of health.This interaction creates a collaborative approach that enables me and the patient to become true partners.

Self-care that includes addressing the physical, emotional, spiritual, and social realms has enabled my patients to maintain or improve their health and well-being. It also helps them prevent or cope with chronic illness. Promoting self-care becomes the cornerstone of integrative health and good medicine.

The bottom line

Our survey showed us that patients have a strong desire for their physicians to be involved in more aspects of their health beyond prescriptions, test results, and diagnoses. They want a fuller partnership and relationship where they can discuss their health and well-being in other, deeper ways that impact them. As physicians, it’s important that we listen to these desires and adjust how we are treating our patients.

Related content:

Reshaping Patient Engagement in a Multicultural World

Data-Driven Self-Care Will Transform Chronic Disease Management

The final rule that would allow Part B Medicare Advantage health plans to implement step therapy and other drug-limiting programs was announced by the Center for Medicare & Medicaid Services (CMS) on May 16, 2019. You can read about it this press release entitled “CMS empowers patients with more choices and takes action to lower drug price.” This rule is part of the Trump Administration’s plan to lower drug prices by introducing more negotiation and competition.

The problem is that these “fail first” programs will adversely affect people with arthritis and other chronic illnesses. Here’s why.

What are Part B medications?

Part B medications are treatments that need to be administered in a provider’s office or in a hospital setting. Patients with rheumatoid arthritis and other autoimmune diseases, as well as many other chronic disorders, are often forced to use medications covered under Medicare Part B. This is because of the complexity and progression of their disease on other types of treatments.

It should be clear, therefore, that policies like this have the effect of targeting people with chronic diseases.

The initial proposed rule described in the press release (above) had many patient organizations worried, including the Global Healthy Living Foundation (GHLF). However, the final rule appears to have taken public comments into consideration.

It implements a number of safeguards that patient groups can support. This is because these new components of the regulation seem to ensure that these programs are put in place with the patient at the center of all discussions.

Let’s dive into some of the ways in which these safeguards may accomplish that.

Don’t fail first, succeed first

Step therapy, or “fail-first”, protocols are a one-size-fits-all cost-saving practice that requires patients to try and fail on one or more prescription drugs before accessing the more costly prescription drug their doctor has prescribed. Sometimes the drug trial may last for as long as 130 days.

This drug trial must take place before coverage is provided for the medication originally chosen by the patient’s health care provider. Sometimes physicians endorse fail-first for medical reasons, but when it is used solely to save the system money, it can be misused.

Using step therapy, insurance companies save money by starting patients on older, less expensive medications first. This delays or sometimes even overrides a treatment plan created by a doctor and patient. These medically unnecessary practices undermine physicians’ ability to effectively treat patients. They also lower the quality of care. This can cause setbacks and disease progression in some cases.

Change in Step Therapy Protocols

Many of us in the patient community were concerned that the decision to allow these policies into Medicare Advantage plans would disrupt the coverage of some of the most vulnerable patients in our community. However, in an effort to alleviate these concerns in the final ruling, CMS determined that step therapy protocols can only apply to when patients begin a new medication. In other words, beneficiaries who are actively taking a Part B drug are exempt from going through the step therapy requirement.

Stabilization – No Sudden Changes

This addressed one of our major concerns by ensuring that patients who are currently stable on their medications are not subjected to a sudden change in treatment. Patients who are stabilized on their drugs need to be left alone.

It can take a long time to find the right drug or drugs to combat serious autoimmune diseases, so the successful patient needs to be protected. Destabilizing a patient doesn’t save money, it costs money. We prefer to see patients succeed first, not fail first. This change in the CMS’ final rule seems to do that.

Put the Patient First

Another important issue is that despite claims from some insurers, there is no evidence that savings from these drug limiting programs are passed on to the patients. CMS optimistically expects health plans will put the patient first. And, they expect that savings will be passed on to them. However, this doesn’t generally happen.

Insurers are in business to make money. Without providing any specific form of policing, there is no way to ensure that these health plans are following through on these expectations.

Monitor and Enforce Regulations?

Prior to the final rule coming out, CMS attempted to address this concern by stating that Medicare Advantage plans are subject to penalties if they do not spend at least 85% of their revenue on healthcare services and quality improvement activities.

While we would have liked to see instructions that more explicitly state that this 85% directly benefits patients, we appreciate that CMS is attempting to address these concerns in a general manner.

However, we still believe that monitoring health plans and proper enforcement of these regulations is key. Luckily, this can be done semi-automatically if the insurer’s existing software is able to track prescriptions.

Related Content:  Will the Medicare Donut Hole Continue to Shrink?

One Size Doesn’t Fit All

We understand the administration’s attempt to lower drug prices for Medicare patients. We also appreciate their attempt to ease some of the concerns of the patient community between the initial rule and the final rule.

However, we do not believe that inserting the one-size-fits-all model of step therapy into Part B Medicare Advantage plans is the way to do it. Particularly because easy tweaks can save money and ensure healthy seniors.

Without further tweaks to the system, the elderly patient community faces potentially dangerous delays in access to treatment. Of course, they are the beneficiaries that can ill afford these types of setbacks.

Since its creation, one of the best features of Medicare Part B, even the privately managed Medicare Advantage plans, has been that patients are able to access their treatments without delay. Seniors can’t live with delays.

Patient-Focused Decisions

GHLF believes a patient’s healthcare provider should have the ultimate authority to make treatment decisions. But ‘fail-first’ stands in the way of patients receiving the right medication at the right time. It may be too late to completely eliminate the practice in the private health care market. However, our organization and others that represent patients and providers will continue to fight for sensible patient-focused decisions. We will continue to advocate for an easier appeal process that allows patients to access the treatment outlined by their provider before any damage occurs.

We invite chronic disease patients concerned about the CMS policy to learn more at www.50statenetwork.org.


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