LymeNet Europe

The 2006 IDSA Lyme guidelines have been withdrawn from the National Guidelines Clearinghouse in the U.S. The NGC must have removed them either late in December or very early in January, as their policy is that guideline summaries are removed at the end of a calendar year. These guidelines no longer comply with the NGC Inclusion Criteria. While there are a number of other guidelines listed when you type in Lyme in the search box (a total of 14 listings appear including the 2014 ILADS guidelines). The old IDSA Lyme guidelines (2006) can no longer be directly accessed on the Clearinghouse. They are now located on the archive pages of guidelines that have been "WITHDRAWN" (although a link exists on the withdrawn listing to the pubmed version).

So, what is NGC and what is the Inclusion Criteria?

https://www.guideline.gov/about/index.aspx

About

NGC is an initiative of the Agency for Healthcare Research and Quality (AHRQ) External Web Site Policy, U.S. Department of Health and Human Services. NGC was originally created by AHRQ in partnership with the American Medical Association and the American Association of Health Plans (now America's Health Insurance Plans [AHIP]).

The NGC mission is to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, purchasers, and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.

https://www.guideline.gov/about/inclusion-criteria.aspx

Inclusion Criteria
Effective June 1, 2014, NGC uses the 2011 definition of clinical practice guideline developed by the Institute of Medicine (IOM).1

Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.
2013 (Revised) Criteria for Inclusion of Clinical Practice Guidelines in NGC
Effective June 1, 2014: In order for NGC to accept a submitted clinical practice guideline, the guideline must meet all the criteria below. In addition to the guideline, developers must provide NGC with documentation of the underlying systematic review*.

The full description of the inclusion criteria is available at the above link.

https://www.guideline.gov/about/Determi ... InNGC.aspx

Determining Extent Adherence to the IOM Standards in NGC
The following information describes the Institute of Medicine (IOM) standards for trustworthy guidelines and the National Guideline Clearinghouse's (NGC's) planned activities related to the standards.

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IOM Recommendation for NGC: Indicating Extent Adherence
The 2011 IOM report on trustworthy guidelines included the following recommendation:

"The Agency for Healthcare Research and Quality should…require the National Guideline Clearinghouse (NGC) to provide a clear indication of the extent to which clinical practice guidelines (CPGs) submitted adhere to the standards for trustworthiness."2

The Agency for Healthcare Research and Quality (AHRQ) is currently exploring options to determine whether and how best to meet the above recommendation. If any changes to NGC result from this exploration, they will be phased in over the next several years, and AHRQ will provide opportunities to engage stakeholders, including the NGC/NQMC Editorial Board, guideline developers, and NGC users in that effort.

NGC's Steps and Timeline
The first step has already taken place, namely the revision of NGC's Inclusion Criteria to meet the IOM's updated definition of CPGs.

"Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options."2

The revised inclusion criteria were posted to the NGC Web site in June 2013 and became effective in June 2014. Guidelines submitted after June 1, 2014, must meet the 2013 (revised) inclusion criteria to be accepted into NGC.

Will NGC have guidelines that meet two different sets of criteria (i.e., 1997 criteria versus 2013 [revised] criteria)?

How long will guidelines accepted under the old criteria remain in NGC?

https://www.guideline.gov/faq.aspx

Guidelines submitted and accepted for inclusion under the 1997 criteria will remain on the NGC site until they are revised by the developer, withdrawn by the developer, or withdrawn by NGC because they are no longer considered current (i.e., when they are ≥5 years old). As a result, there could be guidelines on NGC that were accepted under the 1997 criteria through 2019. However, it should be noted that guidelines included under the 1997 criteria could also meet the standards of the 2013 (revised) criteria.

Why are many guidelines removed from NGC at the end of the year, and how do I know whether they are going to be updated?

As part of the NGC Annual Verification, many guidelines are withdrawn from the Web site at the end of every year because they no longer meet our Inclusion Criteria with respect to date. NGC's inclusion criteria specifically require that guidelines represented in our database have been developed, reviewed, or revised within the last five years. All guidelines that no longer meet this criterion are removed from the Web site at the end of each calendar year. See the Guideline Archive for a list of withdrawn or updated summaries.

https://www.guideline.gov/search/search.aspx?term=lyme

Currently when searching for Lyme disease on the NGC website 14 listings can be found. One of these is not a guideline (#10) but instead is an expert commentary about guidelines by the NGC Editorial staff. Several others seem to not be particularly related to Lyme disease, but perhaps mention it somewhere in the text. Here is the list:

1.
Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease. 2004 (revised 2014 Sep). NGC:010732
International Lyme and Associated Diseases Society - Disease Specific Society.
2.
EFNS guidelines on the diagnosis and management of European Lyme neuroborreliosis. 2010 Jan. NGC:008323
European Academy of Neurology - Medical Specialty Society.
3.
EFNS-ENS guidelines for the use of PCR technology for the diagnosis of infections of the nervous system. 2012 Oct. NGC:009365
European Academy of Neurology - Medical Specialty Society; European Neurological Society - Medical Specialty Society.
4.
Evaluation of vertigo in the adult patient 2014 May. NGC:010416
University of Texas at Austin School of Nursing, Family Nurse Practitioner Program - Academic Institution.
5.
Practice guidelines for the psychiatric evaluation of adults, third edition. 1995 (revised 2015). NGC:010779
American Psychiatric Association - Medical Specialty Society.
6.
European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society – first revision. 2006 Apr (revised 2010 Mar). NGC:007904
European Academy of Neurology - Medical Specialty Society; Peripheral Nerve Society - Disease Specific Society
7.
Late intrauterine fetal death and stillbirth. 2010 Oct. NGC:008288
Royal College of Obstetricians and Gynaecologists - Medical Specialty Society.
8.
Clinical practice guideline: Bell's palsy. 2013 Nov. NGC:010075
American Academy of Otolaryngology - Head and Neck Surgery Foundation - Medical Specialty Society
9.
Chronic fatigue syndrome/myalgic encephalomyelitis. A primer for clinical practitioners. 2012. NGC:009288
International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis - Nonprofit Organization.
10.
expert commentary A Season for Change By: NGC Editorial Staff
11.
Heart failure in adults. 1997 Oct (revised 2013 Jul). NGC:009982
Institute for Clinical Systems Improvement - Nonprofit Organization.
12.
2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. 1998 Apr (revised 2013 Jan 22). NGC:009902
American College of Cardiology Foundation - Medical Specialty Society; American Heart Association - Professional Association; Heart Rhythm Society - Professional Association.
13.
ACR Appropriateness Criteria® hearing loss and/or vertigo. 1996 (revised 2013). NGC:010159
American College of Radiology - Medical Specialty Society.
14.
Evidence-based guideline: treatment of parenchymal neurocysticercosis. Report of the Guideline Development Subcommittee of the American Academy of Neurology. 2013 Apr 9. NGC:009788
American Academy of Neurology - Medical Specialty Society.

Here is the link to "WITHDRAWN" guidelines:

https://www.guideline.gov/browse/archive.aspx?type=2

The list below identifies guidelines that have been withdrawn from the NGC Web site.
Guideline summaries are removed from the NGC Web site because the guidelines they represent no longer meet the NGC Inclusion Criteria or the guideline developer indicated that the guideline should be withdrawn. Refer to the guideline developer's Web site, where available, for more information.
NGC currently contains 3668 individual guideline summaries that have been withdrawn.

To find them on these 'withdrawn' pages click on the letter I for IDSA and these are listed as #17.

17. Infectious Diseases Society of America practice guidelines for clinical assessment, treatment and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis. NGC:005085

Interesting. Will CDC website continue to link to the invalidated IDSA guidelines and totally ignore the validated ILADS guidelines?

Re: IDSA Lyme Guidelines (2006) WITHDRAWN from NGC
Post by paulieinct » Sat 13 Feb 2016 4:48
Interesting. Will CDC website continue to link to the invalidated IDSA guidelines and totally ignore the validated ILADS guidelines?

Actually, the question is: “Will [the] CDC website continue to link to the IDSA guidelines and totally ignore the ILADS guidelines?” The answer is yes. Why wouldn’t they link to science- and evidence-based guidelines used by professional societies and I.D. practitioners in the US and Europe? No one uses the ‘guidelines’ drafted by two private practice quacks and a lawyer.

The IDSA new guidelines will be posted shortly (see below) and then will be posted on the AHRQ web site again. Though what it means to have a society’s guidelines posted by a weak and politically fearful federal agency is anyone’s guess.

While you’re waiting for the new IDSA guidelines you might want to read some of the guideline reports and reviews listed below to learn why most of the world follows science-based recommendations and why the ILADS ‘guidelines’ suck except as self-serving explanations for poor medical practices by quacks and conmen. Read the UK review of the ILADS guidelines.

IDSA Guidelines

The Infectious Diseases Society of America (IDSA), the American Academy of Neurology (AAN) and the American College of Rheumatology (ACR) are jointly developing a systematic review and guideline on treatment of Lyme disease.

The author composition is made up of representatives from IDSA, AAN, and ACR with representation from the American Academy of Family Physicians (AAFP), American Academy of Pediatrics – Committee on Infectious Diseases (AAP-COID), American Academy of Pediatrics – Section on Emergency Medicine (AAP-EM), American College of Physicians (ACP), Association of Medical Microbiology and Infectious Diseases – Canada (AMMI-CA), Child Neurology Society (CNS), Pediatric Infectious Diseases Society (PIDS), Entomological Society of America (ESA), and European Society of Clinical Microbiology and Infectious Diseases (ESCMID). We also have members representing the disciplines of cardiology, microbiology and pathology, a consumer representative and a methodologist with expertise in GRADE.

The societies are utilizing the IDSA guideline development process, which includes a conflict of interest review of the guideline’s authors. In addition, the societies will make every effort to develop the guideline in accordance with the Standards for Developing Trustworthy Clinical Practice Guidelines developed by the Institute of Medicine (IOM). As part of the final document, the societies will complete a self-assessment checklist reviewing adherence to the IOM Standards.
 
What happens next?
The guideline development panel will consider all comments received through the online data collection mechanism, within the dates of the Public Comment period. 
A summary response from the Panel to the comments received will be posted on the IDSA website following the close of the Comment Period.
After a draft of the full guideline is developed, it will also be posted on the IDSA website for a 45-day public comment period. Additional information on the timing and availability of this draft will be posted to the IDSA website later this year.

Treatment Guidelines
• The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines
• Practice Parameter: Treatment of Nervous System Lyme Disease (an Evidence-based review) : Report of the Quality Standards Subcommittee of the American Academy of Neurology
• The Laboratory Diagnosis of Lyme Borreliosis: Guidelines from the Canadian Public Health Laboratory Network
• Lyme Disease: Current State of Knowledge
• Recommendations for Diagnosis and Treatment of Lyme Borreliosis: Guidelines and Consensus from Specialist Societies and Expert Groups in Europe and North America
• EFNS Guidelines on the Diagnosis and Management of European Lyme Neuroborreliosis
• CDC Issues Cautions Regarding Testing for Lyme Disease —
• Infectious Diseases Society of America’s Recommendations on the Treatment of Lyme Disease Unanimously Approved by an Independent Review Panel
• Independent Appraisal and Review of the ILADS 2004 Evidence-based Guidelines for the Management of Lyme Disease: General Information Reported by the Health Protection Agency, UK
• The Epidemiology, Prevention, Investigation, and Treatment of Lyme Borreliosis in United Kingdom Patients: a Position Statement by the British Infection Association
• Endorsement of IDSA Guidelines on Lyme Disease by the Association of Medical Microbiology and Infectious Disease (AMMI), Canada –Link it to this page and have it open in another window
• Antibiotic Maximalism: Legislative Assaults on the Evidence-based Treatment of Lyme Disease
• Infectious Diseases Society of America’s (IDSA) Testimony to Congress on Global Challenges in Diagnosing and Managing Lyme Disease (7/17/2012)

Final Note:
As recently as Nov. 2015, a review of guidelines for neuroborreliosis found: “Individual guidelines with highest overall scores on guideline quality, which were also the two guidelines recommended according to AGREE II ratings were the EFNS [European Federation of Neurological Societies] and the AAN guidelines.” “Both guidelines stem from scientific societies. None of the guidelines from patient advocacy groups were rated as ‘recommended’.”

It ain't 2006 this time around.

@ Hv808ct

You wrote:

The IDSA new guidelines will be posted shortly (see below) and then will be posted on the AHRQ web site again. Though what it means to have a society’s guidelines posted by a weak and politically fearful federal agency is anyone’s guess.

By your reference to below; I presume you are referring to the following quote, which can be found in full on the IDSA website at:

http://www.idsociety.org/templates/cont ... 2212267305

The societies are utilizing the IDSA guideline development process, which includes a conflict of interest review of the guideline’s authors. In addition, the societies will make every effort to develop the guideline in accordance with the Standards for Developing Trustworthy Clinical Practice Guidelines developed by the Institute of Medicine (IOM). As part of the final document, the societies will complete a self-assessment checklist reviewing adherence to the IOM Standards.

What happens next?
The guideline development panel will consider all comments received through the online data collection mechanism, within the dates of the Public Comment period.
A summary response from the Panel to the comments received will be posted on the IDSA website following the close of the Comment Period.
After a draft of the full guideline is developed, it will also be posted on the IDSA website for a 45-day public comment period. Additional information on the timing and availability of this draft will be posted to the IDSA website later this year.

However, for some reason you must have skipped over the following information when you copied the material from the website:

From March 9 to April 24, 2015, IDSA, AAN and ACR requested input on a project plan that laid the ground work for new Lyme Disease Guidelines. The public comment period is now closed.

So, where exactly is this summary response to the public comments period?

It currently is certainly well past the close of the public comments period. In fact, it is roughly 9 months and 18 days AFTER the close of this period. I seems pretty incredulous to me that a couple who conceived a child shortly after the close of this comment period would already have given birth to a full-term baby, yet there is still no posting of this intended summary response.

Furthermore, where is the additional information on the timing and availability of this draft which was stated would be posted to the IDSA website later in 2015???

We are now one month and thirteen days into 2016. So, what does this inability to follow through and actually produce and publish these two pieces of information in a timely manner tell us about the credibility of the IDSA?

Perhaps, you could tell us what the problem is that is causing this delay and why exactly we should believe what you have written.

As to your obvious disdain with regards to the Agency for Healthcare Research and Quality (AHRQ), perhaps you could enlighten us as to this seemingly IDSA biased contempt for an organization that develops the knowledge, tools, and data needed to improve the health care system and help Americans, health care professionals, and policymakers make informed health decisions. As far as I can determine, their mandate is to achieve the goals of better care, smarter spending of health care dollars, and healthier people.

According to the Office of the Federal Register (US) website:
https://www.federalregister.gov/agencie ... nd-quality

AHRQ is the health services research arm of the U.S. Department of Health and Human Services (HHS). AHRQ is a home to research centers that specialize in major areas of health care research such as: quality improvement and patient safety, outcomes and effectiveness of care, clinical practice and technology assessment, and health care organization and delivery systems. AHRQ is also a major source of funding and technical assistance for health services research and research training at leading U.S. universities and other institutions. In addition AHRQ acts as a science partner, working with the public and private sectors to build the knowledge base for what works—and does not work—in health and health care and to translate this knowledge into everyday practice and policymaking.

http://www.ahrq.gov/cpi/about/profile/index.html

As to why anyone having developed a guideline would want to have the endorsement of NGC........
The NGC aims to provide physicians, nurses, and other health professionals, health care providers, health plans, integrated delivery systems, purchasers and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation and use.

http://www.guideline.gov/about/index.aspx

Really, does the IDSA feel that this organization is worthy of such contempt?

It didn't seem to be the case as long as the 2006 Lyme Guidelines were featured (and thereby endorsed) on the NGC website, which after all seeks to ensure that Clinical Practice Guidelines can be counted on to be up-to-date and trustworthy.

As to what you mean by, "The IDSA new guidelines will be posted shortly (see below) and then will be posted on the AHRQ web site again."

Given the inability to produce and publish the summary response to the public comments period in a reasonable time period......... Just how many years away from seeing the new guidelines are we?

It sounds to me like all is not well in the IDSA guidelines process. Given that they have brazenly and openly flouted the IOM mandated procedures, including refusing to appoint an actual Lyme patient on the committee, it is likely that the whole process has collapsed under the weight of its own incompetence. How delightful that would be. A loss, of course, for an arrogant few, but a huge win for the WORLD. Even if they do come up with some drivel, how could they be validated in the absence of conformity to IOM mandates?

The question is who really enforces this? Is anyone actually reading all these guidelines to see if they conform? There are a heck of a lot of guidelines.

dlf wrote:
So, where exactly is this summary response to the public comments period?

It currently is certainly well past the close of the public comments period. In fact, it is roughly 9 months and 18 days AFTER the close of this period. I seems pretty incredulous to me that a couple who conceived a child shortly after the close of this comment period would already have given birth to a full-term baby, yet there is still no posting of this intended summary response.

Furthermore, where is the additional information on the timing and availability of this draft which was stated would be posted to the IDSA website later in 2015???

So is there an actual requirement by the IOM to publish a summary/summary response of the public comments?

There is no enforcement of IOM recommendations. They are supposed to work by shame, which isn't very effective among powerful medical academics.

The default assumption, which hv808ct and certainly Henry are always ducking behind, is that guideline authors are the cream of the crop of medical experts in a field, and that it is outrageous to suggest that they are often just power-hungry guys who have mastered the techniques of spinning their reputations and influence. COIs don't matter because MDs (except for the quacks and mavericks who diverge from mainstream consensus or decrees) are so smart and virtuous that they would never let self-interest trump good science or good patient care. And the need for a patient rep (just one?) on a guideline panel is an idealistic notion that would just gum up the process. Patients are seen to be uniformly stupider and less informed than any doctor, let alone an academic expert.

Among educated people, there is a sadder-but-wiser minority, like us, who know better. But how can medicine be reformed? You can't legislate morality. Or even logic, or common sense. So I predict that the IDSA will remain free to propagate its nonsensical LD model, and the majority of doctors and the public will follow along like baby ducks. Including the AAN, etc.

I'm still wondering if medical schools (and maybe grad schools too) somehow select for spineless conformists, or if they create them. There are good arguments on either side. I feel lucky to have survived the process as able to question authority as I am. (Not to say I have any less illusions than average, over all. As the second Zen boddhisatva vow says, "Delusions are inexhaustible. I vow to end them all." )

As for non-MDs, including scientists, I think we just don't want to lose our faith in both medicine and the scientific process, which we've been taught to believe is "self-correcting." We all want to think that in the vast majority of cases, we can trust the medical establishment to help us when we get sick, without our having to watch them like hawks to keep them from making us worse instead of better. (Preferably hawks with a lot of education, investigative skill, and money of our own.)

Clearly some folks at the IOM have recognized there is a problem with the naive default view. But the IOM has no teeth. It's just a commentator.

I do like to see problems recognized, even if they can't be fixed.