Treatment guideline development

Guidelines listed in clearinghouse Rationale treatment guidelines Highlights of guidelines Guidelines introduced at conference Topics guidelines Timetable for adoption guidelines Validation guidelines Summary guidelines

Guidelines listed in National Guideline Clearinghouse and Pubmed

Dr. Cameron has worked with a team of 17 experts in Lyme disease to develop and publish a treatment guidelines for Lyme disease. Treatment Guidelines now listed on Pubmed. Click to link to the National Guideline Clearinghouse at www.guideline.gov.

Dr. Cameron presented a POEM (Patient oriented evidence that really matters to clinicians) at the latest International Lyme meeting called "Timely treatment" to begin the process of implementation of the guidelines.

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Rationale Lyme disease treatment guidelines

Practice treatment guidelines serve as a guide for doctors for the appropriate treatment. Using the best available evidence, the International and Associated Diseases Society (ILADS) expert panel identified and develop practice recommendations for Lyme disease.

Please forward reprint requests and other inquiries to: The International and Associated Diseases Society, or via e-mail: Lymedocs@aol.com  

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Highlights Guidelines

Practice treatment guidelines serve as a guide for doctors for the appropriate treatment. Using the best available evidence, the International and Associated Diseases Society (ILADS) expert panel identified and develop practice recommendations for Lyme disease.

Please forward reprint requests and other inquiries to: The International and Associated Diseases Society, or via e-mail: Lymedocs@aol.com  

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Guidelines introduced at conference

Title presentation: Primary changes in ILADS Evidence-Based Practice Treatment Guidelines.

Cameron DJ, Gaito A, Harris N, Bach G, Bellovin S, Bock K, Bock S, Burrascano J, Dickey CE, Horowitz R, Phillips S, Merr-Sherrer L, Raxlen B, Sherr V, Smith H, Smith P, Stricker R. International Lyme and Associated Diseases Society (ILADS), Bethesda Maryland

Objective: These guidelines build upon the Infectious Diseases Society of America (IDSA) 2000 Practice Treatment Guidelines for Lyme disease to incorporate the growing body of evidence of the complexity of persistent and recurrent Lyme disease.

Limitations of IDSA guidelines: The IDSA Lyme Disease Practice Guidelines concluded there was no evidence that chronic Lyme disease existed as a separate diagnostic entity and there is no data to support prolonged and repeated treatment.

Data Sources: English-language articles published 1975 to 2002 identified through MEDLINE and bibliographies.

Major Additions in the ILADS Guidelines:

1. Laboratory testing is meant to contribute to rather than to supersede physicians' judgment.

2. Clinical judgment is necessary to identify individuals who may benefit from antibiotics to avoid preventable persistent, recurrent, and refractory Lyme disease.

3. Empiric treatment should be considered as routine treatment of patients for whom Lyme disease is a likely diagnosis.

4. The previously recommended practice of stopping antibiotics to allow for a delayed recovery is no longer recommended for patients with persistent, recurrent and refractory Lyme disease.

5. Duration of therapy should be guided by clinical response rather than any arbitrary 30-day treatment course.

6. A reasonable course would be to continue therapy to treat Lyme disease, after clinical and laboratory abnormalities are resolving and symptoms have resolved.

7. Indications for retreatment should be broadened from meningitis, heart block, and arthritis to include symptomatic presentations.

Conclusions: The ILADS Practice Treatment Guidelines revises and expand use of clinical judgment and empiric treatment.

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Topics in guidelines

ILADS’ Lyme Treatment Guidelines address 45 subjects:

ILADS defined
Chronic Lyme disease: A growing epidemic
The need for new guidelines
A problem of definitions
Competency and training
The increasing role of primary care
Highlights of guidelines
Symptomatic presentations
symptoms of Lyme disease
Increasing evidence of persistent infection
Disappointing results of symptomatic treatment
Severity of chronic Lyme disease
Atypical early presentations
New chronic Lyme disease presentations
The limitations of physical findings
Sensitivity limitations of testing
Seronegative Lyme disease
Continued importance of differential diagnosis
Clinical judgment
Testing for coinfection
Prompt use of antibiotics
Choosing an antibiotic
Oral antibiotic options
Intravenous antibiotic options
Intramuscular antibiotic options
Combination antibiotic treatment
Sequential treatment
Dosage
Duration of therapy
Empiric treatment
Persistent Lyme disease
Recurrent Lyme disease
Refractory Lyme disease
Treatment failure
Symptomatic treatment
Fibromyalgia
Decision to stop antibiotics
Alternative antibiotics
Therapy for coinfection
Ongoing development of treatment guidelines
Validation of guidelines
Comparative studies
Grading system for evidence-based guidelines
Comparison of key IDSA and ILADS guidelines
Criteria for evidence-based guidelines.

 

Adapted from Cameron DJ, Gaito A, Harris N, Bach G, Bellovin S, Bock S, Burrascano J, Dickey C, Horowitz R, Phillips S, Meer-Sheerer L, Raxlen B, Sherr V, Smith H, Smith P, Stricker R. Evidence-based guidelines for the management of Lyme disease. Expert Rev. Anti-infect. Ther. 2(1), 2004.

To order a copy of these guidelines visit the www.ILADS.org.

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Timetable for development guidelines

2001	Practice treatment Guideline proposed by the International Lyme and Associated Diseases Society (ILADS).
2001	The experts from the ILADS board proposed to prepare guidelines consisting of experts in primary care, rheumatology, immunology, hematology, preventive medicine, preventive medicine, and psychiatry.
2002	MEDLINE, other databases, references of articles, and the collective experience of board members in treating thousands of Lyme disease patients were reviewed.
2002	The board reviews drafts of the guidelines.
2003	The board adopts the final draft of the guidelines.
2003	The guidelines are sent out for external peer review.
2004	The guidelines are in press in the Expert Review of Anti-infective Therapy. Ther. 2(1), Suppl. (2004) Future Drugs Ltd.
2004	The guidelines were disseminated through ILADS. The first printing was sold out. The second printing is made available.
2004	The guidelines are adopted by CALDA and Lyme Disease Association (national).
2004	The guidelines are published in the summer 2004 issue of LymeTimes
2004	The guidelines were validated with a POEM - timely treatment - Patient Oriented Medicine that Matters.
2004	The guidelines are expected to appear in the National Guideline Clearinghouse by the end of October 2004.
Future	The guidelines will be reviewed and recommendations update accordingly.

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Guidelines validation

Cameron DJ, Glushanok G, McCoy K. Mt. Kisco, New York, USA, board member, International Lyme and Associated Diseases Society (ILADS)

Background: Both ILADS and the IDSA have developed practice guidelines for the management of Lyme disease, yet little data exist regarding their validation.

Objectives: To examine the validity of ILADS Practice Treatment Guidelines for the diagnosis and treatment of Lyme disease on clinical success, relapse rate, and success of retreatment.

Design: Observational study.

Setting: A single center, prospective, surveillance database.

Participants: From 2575 patients in whom Lyme disease was identified during 1997-2001; 100 were examined that were confirmed with at least 5 bands on a IgG Western blot.

Results: Seventy-five percent of the patients who entered the surveillance database were successfully treated the first time. Only 20 patients remained well on long term follow-up, the others developing recurrent Lyme disease during prospective follow-up. Of the 20 patients who were not successfully treated initially, 10 (50%) were successfully retreated. Of the 70 patients with a relapse of symptoms, 70% were successfully retreated. There was no evidence of serious adverse events utilizing ILADS practice guidelines.

Conclusion: Implementation of ILADS practice treatment guidelines for diagnosis and treatment of Lyme disease were shown to be effective. Centers that treat large numbers of patients symptomatically should formally evaluate the value of their own programs. This may also allow comparison of results of practice treatment guidelines that use more antibiotics with those that do not.

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Summary guidelines

A short summary of ILADS’ recommendations include:

Treatment for symptomatic presentations
Treatment should not be withheld based on laboratory testing
Early use of antibiotics
Longer courses of antibiotics treatment
Repeat antibiotics for recurrence

A more indept summary is being drafted.

Adapted from Cameron DJ, Gaito A, Harris N, Bach G, Bellovin S, Bock S, Burrascano J, Dickey C, Horowitz R, Phillips S, Meer-Sheerer L, Raxlen B, Sherr V, Smith H, Smith P, Stricker R. Evidence-based guidelines for the management of Lyme disease. Expert Rev. Anti-infect. Ther. 2(1), 2004.

To order a copy of these guidelines visit www.ILADS.org.

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