Delayed diagnosis of Lyme disease is a huge problem. How can we fix it?
Melissa Wright is the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData.
She spoke at the recent Tick-borne Disease Diagnostics online event sponsored by Invisible International. Melissa used information from MyLymeData to illustrate the impact of diagnostic delays in the Lyme community.
She pointed to three top reasons why Lyme patients may get misdiagnosed: 1. Lyme is not recognized as a possibility in their area, 2. Many patients do not present with a classic erythema migrans rash, and 3. the diagnostic testing for Lyme is flawed.
View her presentation here:
Here’s the text of her remarks:
Hello everyone, my name is Melissa Wright and I am the Director of Patient Engagement & Outreach for LymeDisease.org and Project Manager of MyLymeData. I am happy to be with you today for the Tick-borne Disease Diagnostics Innovation Incubator, and have the opportunity to talk with you about the impact of diagnostic delays in the Lyme community.
Founded over 30 years ago, LymeDisease.org, is one of the oldest Lyme disease organizations in the nation. It is the largest and most trusted communications network for Lyme patients. Our mission is to harness the power of tens of thousands of patients to improve patient care and accelerate the pace of Lyme disease research. We do this through providing tools like our symptom checker, physician directory, and the MyLymeData patient registry and research platform with over 15,000 patients enrolled.
Today I’ll briefly discuss diagnostic issues with data from MyLymeData, the current testing and what we’re doing to push the needle
Using a diagram first developed by the Institute of Medicine (now the National Academy of Medicine) in its report “Improving Diagnosis in Health Care,” which identified different points along the path to diagnosis where things can go wrong and diagnosis can be delayed or missed. It has been modified to reflect the diagnostic issues we encounter in Lyme disease. For example:
- Lyme is not identified as a possibility in (name your state)
- Many patients do not present with a classic EM rash
- And the diagnostic testing is flawed
Which leads to a large majority of patients being misdiagnosed.
In MyLymeData we found that 70% of those with late or chronic Lyme disease experienced years of diagnostic delays even though 45% had presented with early symptoms. It had taken the majority, 3 or more years to be diagnosed after seeing 5 or more doctors with 72% being misdiagnosed and likely unnecessarily treated for another disease.
So why the delay? In Lyme disease we know early diagnosis can be a ticket to recovery. 70-80% do become well. Unfortunately, a diagnosis of early Lyme disease is not so straight forward. A lot of the symptoms are not specific for Lyme disease and do occur in other illnesses. So, there’s a big emphasis on whether the patient has distinguishing factors.
– Was the patient exposed to an area where there are ticks that carry the disease? (Remember, no Lyme in name your state)
– Did the patient have a distinctive round rash that could have been caused by the bite of a tick. (only 34% of patients report having a rash)
– And were any blood tests positive? (flawed testing, with 37% receiving a false negative)
In regard to testing, we know during the first four to six weeks of Lyme infection, standard Lyme disease tests are unreliable because most people have not yet developed the antibody response that the test measures, and even later in Lyme the two-tiered testing is highly insensitive.
The chart (Stricker, Johnson 2010) illustrates the studies examining the testing. As you can see, the mean sensitivity for Lyme testing is 46%. This means 108 of every 200 cases is missed in Lyme compared to that of the highly sensitive testing for HIV/AIDS, which has a mean sensitivity of 99.5%, where only 1 in every 200 cases is missed.
Simply put, the likelihood of Lyme disease being diagnosed from a positive lab test is the equivalent of getting a heads or tails in a coin toss. This ultimately means many patients go undiagnosed.
Now everyone knows the saying there is power in numbers, but despite Lyme disease having 475,000 cases annually little has been done to advance Lyme testing or research.
According to research by Goswami, the number of clinical studies for Lyme disease trails behind leprosy–which has an incidence of less than 200 cases per year. So, Lyme disease should be thought of as a research disadvantaged disease that faces the same challenges that rare diseases face.
Patients are the most underutilized resource in medical research, and we are striving to bridge that gap.
The research cycle illustrated is derived from Groft’s work with rare diseases. His model suggests forming a patient registry that links with a biorepository—we are collaborating with the Lyme Disease Biobank here.
The registry helps to develop a research hypothesis—here we have published three peer-reviewed publications to better characterize the disease, assess patient reported outcomes, and analyze treatment effects among patient subgroups. The registry can then be used to help recruit patients. We have worked on recruiting for two clinical studies.
A team research approach will allow rapid knowledge generation to accelerate the pace of research–-leading to improved diagnostics, treatment and care.
Thank you for your time, I appreciate the opportunity to speak with you all today and I want to close by encouraging anyone not yet participating in MyLymeData to enroll.