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This agreement describes the process of treating late disseminated Lyme disease. It is intended to brief the patient signatory on the anticipated benefits and risks of that treatment, so they may give their informed consent.

If you are not a Lyme patient seeking care for this disease specifically, you do not need to sign this form.


May 3, 2026

There is considerable uncertainty regarding the diagnosis and treatment of Lyme disease. No single diagnostic and treatment program for Lyme disease is universally successful or accepted. Medical opinion is divided, and two schools of thought regarding diagnosis and treatment exist. Each of the two schools of thought is described in peer-reviewed, evidence-based treatment guidelines. Until we know more, patients must weigh the risk and benefits of treatment in consultation with their doctor. This document contains information that will help you decide whether you consent to treatment for late disseminated (post-treatment, persistent, chronic or neurological) Lyme disease. Please read this agreement carefully and contact us (Danio Group providers and appropriate staff) to ask any and all questions you need to understand it; you (the signatory patient) are responsible for understanding the risks and benefits associated with this treatment before you sign. You will receive a copy of this agreement by email after you have signed it for your records. 

Our email: info@daniogroup.com  Phone: (678) 439-6871

 

 

My Diagnosis.

The diagnosis of Lyme disease is primarily a clinical determination made by my doctor based on my exposure to ticks, my report of symptoms, and my doctors observation of signs of the disease, with diagnostic tests playing a supportive role.

 

Doctors differ in how they diagnosis Lyme disease.

Some physicians rely on narrow surveillance case criteria of the CDC for clinical diagnosis even though the CDC itself cautions against this approach. These physicians may fail to diagnose some patients who actually have Lyme Disease. For these patients, treatment will either not occur or will be delayed.

 

Other physicians use broader clinical criteria for diagnosing Lyme disease. These physicians believe that it is better to err on the side of treatment because of the serious consequences of failing to treat active Lyme Disease. These physicians sometimes use the antibiotic responsiveness of a patient to assist in their diagnosis. Since no treatment is risk-free, use of broader clinical criteria to diagnose disease could in some cases expose patients to increased treatment complications. This approach may result in a tendency to over-diagnose and over-treat Lyme disease.

 

My treatment choices.

The medical community is divided regarding the best approach for treating late disseminated Lyme disease. At this time, many physicians follow the treatment guidelines of the Infectious Diseases Society of America [IDSA] that recommend short term treatment only and view the long-term effects of Lyme disease as an autoimmune process or permanent damage that is unaffected by antibiotics.[1] Other physicians believe that the infection persists, is difficult to eradicate, often associated with co-infections or additional organisms and therefore requires long-term treatment with intravenous, intramuscular, or oral antibiotics frequently in high and/or combination doses. In fact, there have been questions as to the validity of the aforementioned IDSA guidelines, that have been published in the peer reviewed literature. [2-4] Alternative guidelines promoted by the International Lyme and Associated Diseases Society [ILADS] [5] support the concepts that diagnostic technology and criteria for the diagnosis of Lyme disease are often too insensitive. That the clinical judgement in the appropriate setting as described above, ought to provide the clinician at the point of care, with the ability to diagnose and clinically determine the activity of this infectious process. That this approach supports the concept that this complex may be difficult to treat and may require longer courses of antibiotics and protocols such as pulsing or cycling. That while doing all we can to do no harm, the perspective remains that often times quite ill patients would often benefit from these alternative approaches to the management of this most complex process. [6]

 

Potential Benefits of Treatment.

Some clinical studies support longer term treatment approaches while others do not. The experience in this office is that although most patients improve with continued treatment, some do not.

 

Risks of Treatment.

There are potential risks involved in using any treatment, just as there are in foregoing treatment entirely. Some of the problems with antibiotics may include [a] allergic reactions, that may manifest as rashes, swelling, and difficulty in breathing, [b] stomach and/or bowel upset or [c] yeast infections. Severe allergic reactions may require emergency treatments, while other problems may require suspension of treatment, or adjustment of medication. Other problems, such as adverse effects on liver, kidneys, gallbladders or other organs may occur. 

 

For Women.

Many treatment options or therapies have not been adequately tested in pregnant or lactating mothers, or may have been found to potentially harm an unborn fetus. Therefore: If I am pregnant or plan on becoming pregnant, I will communicate this to my Danio Group clinician before I begin treatment. As a care team, we will decide together to pursue or reject treatment based on a number of factors, including whether potential benefits may warrant treatment in pregnant or lactating women despite potential risks.  

Factors to Consider in My Decision.

No one knows the optimal treatment of symptoms that persist after a patient is diagnosed with Lyme disease and treated with a simple short course of antibiotic therapy. The appropriate treatment may be supportive therapy without the administration of any additional antibiotics. Or, potentially herbal/complementary supplements may be warranted. Or, the appropriate treatment might be additional antibiotic therapy, either oral or intravenous. If additional antibiotic therapy is warranted, no one knows for certain exactly how long to give the additional therapy. By taking antibiotics for longer periods of time, I place myself at greater risk of a potentially serious infection will progress [7]. No all patients respond to antibiotic therapy. There is no currently available diagnostic test that can demonstrate the eradication of the Lyme bacteria from my body [8]. Other foms of treatment designed to strengthen my immune system also may be important. Some forms of treatment are only intended to make me more comfortable by relieving my symptoms and do not address any underlying infection.

My decision about continued treatment may depend on a number of factors that may be important to me. Some of these factors include (a) the severity of my illness and degree to which it impairs my quality of life, (b) whether I have co-infections, which can complicate treatment, (c) my ability to tolerate antibiotic treatment and the risk of major and minor side effects associated with the treatment, (d) whether I have been responsive to antibiotics in the past, (e) whether I relapse o my illness progresses when I stop taking antibiotics, and (f) my willingness to accept the risk that left untreated a bacterial infection potentially may get worse.

For example, if my illness is severe, significantly affects the quality of my life, and I have been responsive to antibiotic treatment, I may wish to continue my treatment. However, if I am unresponsive to antibiotics, I may wish to terminate treatment. I will ask my doctor if I need any more information to make this decision and am aware that I have the right to obtain a second opinion at any time if I think this would be helpful.

Once I have signed this agreement, I agree to all of the terms and conditions contained herein and the agreement will be in full force and effect. By signing, I declare under penalty of perjury that all information (identifying or otherwise) I have given in this agreement is true and correct. The invalidity or unenforceability of any clause or provision in this Agreement shall not have an impact or affect on the enforceability of validity of any other clause. Any unenforceable or invalid clause shall be regarded as removed from this Agreement to the extent of its unenforceability and invalidity. Therefore, this Agreement shall be interpreted and enforced as if it did not contain the said clause to the extent of its unenforceability and invalidity.  

References

1.Wormser, GP Dattwyler DJ, Shapiro E, Halperin A, Steere A, Klempner MS, Krause PJ, Bakken JS, Strie F, Stanek G, Bockenstedt L, Fish D,Dumler JS, and Nadelman RB. The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006; 41 (1 November): 1089.

Available at: http://www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_Care/PDF_Library/Lyme%20Disease.pdf

2.Khan AR, Khan S, Zimmerman V. Baddour LM and Tleyeh IM. Quality and Strength of Evidence of the Infectious Diseases Society of America Clinical Practice Guidelines CID (15 November) 2010: 51

3.Deresinski S. Guiding Clinical Care through Evidence Free Zones. CID (15 November) 2010:51 1157-1159

4.Johnson L and Stricker RB The Infectious Disease Society of America Lyme Guidelines: A Precautionary Tale about development of clinical practice guidelines Philosophy, Ethics and Humanities in Medicine 2010, 5:9 doi:10. 1186/1747-5341-5-9

5.The International Lyme and Associated Diseases Society, ILADS Evidence-based Guidelines for the Management of Lyme disease. Expert rev. Anti-infect Ther. 2004; 2(1):S1-S13. Available at www.ilads.org

6.Shor S. Retrospective Analysis of a Cohort of Internationally Case Defined Chronic Fatigue Syndrome Patients in a Lyme Endemic area. Bulletin of the IACFS

7.Virginia Govenor McDonnells Task Force On Lyme disease 2010-2011, position paper published June 30, 2011

8.Cameron DJ. Consequences of Treatment Delay in Lyme disease. Journal of Evaluation in Clinical Practice. 13 (2007) 470-472

 

Adaptation from JJ Burrascano Jr., MD

 

By selecting a treatment strategy for managing persistent Lyme Disease, I understand the benefits and risks of this proposed course of treatment and of the alternatives to it, including the risks and benefits of foregoing treatment altogether. My questions have all been answered in terms I understand, and I have had ample opportunity to carefully think through my treatment decision(s).




First Patient's Name
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Choosing My Treatment Approach

I realize that the choice of treatment approach to use in treating my condition is mine to make in consultation with my physician and/or other clinical provider at Danio Group. After weighing the risks and benefits of the treatment approaches, I have decided:

(Choose one)*
To treat my Lyme disease and/or symptoms through a treatment approach that relies heavily on clinical judgement and may use antibiotics until my clinical symptoms resolve. I recognize that his treatment approach does not conform to IDSA guidelines and that insurance companies may not cover the cost of some of my treatment.
Only to treat my Lyme disease and/or symptoms with antibiotics for thirty days, even I still have those symptoms.
Not to pursue antibiotic therapy.

You can visit this website to review the IDSA's recommended treatment of Lyme Disease: https://www.idsociety.org/practice-guideline/lyme-disease/

Parent(s) or court-appointed legal guardian(s) must sign for any participating minor (those under 18 years of age or mentally incapacitated adult-age applicants) and agree that they and the minor are subject to all the terms of this document, as set forth above.


By signing below the Parent or Court-Appointed Legal Guardian agrees that they are also subject to all the terms of this document, as set forth above.
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Electronic Signature Consent*
 By checking here, you are consenting to the use of your electronic signature in lieu of an original signature on paper. You have the right to request that you sign a paper copy instead. By checking here, you are waiving that right. After consent, you may, upon written request to us, obtain a paper copy of an electronic record. No fee will be charged for such copy and no special hardware or software is required to view it. Your agreement to use an electronic signature with us for any documents will continue until such time as you notify us in writing that you no longer wish to use an electronic signature. There is no penalty for withdrawing your consent. You should always make sure that we have a current email address in order to contact you regarding any changes, if necessary.


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