British Association of Dermatologists 1
Caudwell LymeCo 1
disease patients via social media and found that a third of them had at least one other tick- 1
Department of Health 14
Healthcare Infection Society (HIS) 14
Lyme Disease Action 14
Lyme Disease UK 28
Lyme Research UK 43
NHS England 54
NHS Highland 54
Royal College of Genera Practitioner s (RCGP) 58
Royal College of Nursing 60
Royal College of Paediatrics and Child Health 60
The British Society for Antimicrobi al chemothera py (BSAC) 60
VIRAS Vector- borne Infection, Research – Analysis - Strategy 60
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Comments
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Developer’s response
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Stakeholder
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no.
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no.
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Please insert each new comment in a new row
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Please respond to each comment
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British Association of Dermatologists
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The British Association of Dermatologists has no comments to make on this consultation.
We would request that you kindly keep us updated on developments, as an interested
party.
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Thank you for your comment. Updates
on the progress of the guideline
development and the guideline
documents will be published on the
NICE website in due course. You can
find this information by following this
link:
https://www.nice.org.uk/guidance/inde
velopment/gid-ng10007
As a registered stakeholder for this
guideline, you will be alerted to key
steps in this guideline’s development.
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Caudwell LymeCo
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2
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50
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SUGGESTED AMENDMENT
Delete "Managing other tick-borne infections" from the section "Areas that will not be
covered"
Insert "Managing other tick-borne infections" into the section "Key areas that will be
covered" (page 2 below line 49)
REASON
Ticks carry many infections. Caudwell LymeCo has conducted a survey of UK Lyme
disease patients via social media and found that a third of them had at least one other tick-
borne infection in addition to Lyme disease. The necessity of assessing suspected Lyme
disease patients for additional tick borne infections is mentioned in the current guidelines
issued by PHE.
I think it is important for this information to remain in the new NICE guidelines, and in fact
be updated and explained in more detail.
Based on anecdotal evidence from patients, it seems that a lot of them are not assessed
for tick-borne co-infections at all.
A lot of the tick-borne infections other than Lyme disease have symptoms very similar to
Lyme. It may be that some patients who seem not to respond well to Lyme treatment
actually have other overlooked infections as well.
EVIDENCE
Neglecting to tackle co-infections is the commonest cause of Lyme disease treatment
failure, according to many of the doctors in the USA and Europe who focus on treating
Lyme disease patients.
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Thank you for your comment. The
focus of this guideline is the diagnosis
and management of Lyme
Disease.We will bring your comments
on the issue of co-infection to the
guideline committee’s attention to
ensure that this issue is appropriately
addressed as part of our evidence
reviews or in our sections where we
link the consideration of the evidence
to the recommendations made as
appropriate. We will not however
address the specific management of
any co-infection and as such have
made no change to the scope.
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Caudwell LymeCo
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3
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54
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SUGGESTED AMENDMENT
Remove “Transmission” of the disease between people" from the section "Areas that will not be covered".
Insert "Transmission of the disease between people" into the section "Key areas that will
be covered" (page 2 below line 49)
REASON
Pregnant women can transmit Lyme disease to their unborn children and this is a fact
which all pregnant women with Lyme disease, and their doctors, most definitely need to
know.
Currently the CDC in America issues an information leaflet warning pregnant women with
Lyme disease that their unborn children could catch and be harmed by Lyme disease in
utero. Similar information for patients and their practitioners should form part of the NICE
guidelines to inform doctors and patients in the UK.
In fact I think a case could be made for warning all pregnant women about this risk, in the
same way they are made aware of the risks of varicella, rubella and toxoplasmosis during
pregnancy.
There is also some preliminary research suggesting that Lyme disease may be sexually
transmitted, transmitted via blood transfusions and transmitted through breastfeeding.
Some of the evidence regarding these potential risks is recent, and the NICE guidelines
committee may be the first guidelines committee to evaluate it properly.
EVIDENCE
More than 46 separate cases of congenital Lyme disease in human babies have been
documented in peer-reviewed research, in various regions of the world and produced in a
range of prestigious institutions.
The CDC patient information leaflet on Lyme in pregnancy can be viewed online here:
http://www.cdc.gov/lyme/resources/toolkit/factsheets/10_508_Lyme%20disease_Pregnant
Woman_FACTSheet.pdf
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Thank you for your comment. We
have discussed your comment in detail and reviewed the decision to
exclude other ways of transmission.
Person-to-person transmission is now
included as a key question in the
scope. The review question and
protocol will be developed by the
Guideline Committee.
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Caudwell LymeCo
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3
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55
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SUGGESTED AMENDMENT
Delete "preventing Lyme disease" from the section "Areas that will not be covered" and
insert it into the section "Key areas that will be covered" (page 2 below line 49)
REASON
A lot of patients with Lyme disease in the UK realise, with hindsight, that they exposed
themselves to risks which they could have avoided. We patients do our best to warn other
people, and I am confident I can speak for most patients in saying we would very much like
GPs to become a part of the effort to improve the level of public knowledge on this subject.
The congenital transmission route seems to be overlooked by medical professionals as
well as the public. I believe it is essential to include information in the guidelines on how to
prevent pregnant women from passing Lyme disease on to their babies, particularly since
there are documented cases of Lyme causing miscarriages, stillbirths, and deaths in new
born babies.
EVIDENCE
Lyme disease can be transmitted congenitally. Many papers have been published
reporting evidence of this. Borrelia is also proven to remain viable under blood transfusion
conditions.
There is preliminary evidence that Borrelia could be transmitted from person to person via
blood transfusions, congenitally, breast feeding and even sexually. Whilst there is
uncertainty, I think people who are unaware of the potential risks of these kinds, need to
be protected by guidelines that embrace the possibility. I think risk assessment should
accept the growing knowledge base pointing to a broader range of possible routes to
exposure.
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Thank you for your comment. While
we understand the importance of
public awareness, this is a clinical
guideline on the diagnosis and
management of Lyme disease and it
would therefore not be appropriate to
review evidence on prevention.
However, we hope and anticipate that
the publication of this guideline will
help to raise awareness among both
health care professionals and the
public.
Pregnant women, will be included in
each of our evidence reviews as a
special subgroup and any direct
evidence for this group, if available,
will be analysed and presented
separately allowing the committee to
make specific recommendations in
this population. (This is also the case
in those people who are
immunocompromised).
Furthermore, person-to-person
transmission is now included as a key
question in the scope. The review
question and protocol will be
developed by the Guideline
Committee in due course.
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Caudwell LymeCo
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3
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69
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SUGGESTED AMENDMENT
Change "Diagnostic testing to confirm or rule out Lyme disease" to "Diagnostic testing to
help confirm Lyme disease"
REASON
I believe the majority of the current commercially produced, certified diagnostic tests for
Lyme disease state that a negative result cannot rule out Lyme disease. On this basis, it
seems Lyme disease cannot be definitively ruled out. I think this should be reflected
accurately in the scoping document.
EVIDENCE
Test kits' instructions which I have seen typically include an explanation of the currently
known causes for sero-negativity or partial sero-negativity in patients who may actually be
infected with Lyme disease.
The following explanation of the diagnostic significance of antibodies against Borrelia
species it taken from the instructions on the interpretation of test results published by
ViraMed, the manufacturer of the western blot test kit used by RIPL.
"1. IgG antibodies are produced for the first time several weeks to months after
infection and are often not detectable in early stages of infection (22). In suspicion of a
recent infection, IgM antibodies should be checked and a second sample should be
analysed later. Patients in the 2nd or 3rd stage of the disease are usually positive for IgG
antibodies.....5. An early antibiotic therapy can suppress the development of antibodies
(17)."
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Thank you for your comment. This has
now been amended to ‘Diagnostic
testing for Lyme disease’.
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Caudwell LymeCo
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3
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71-
73
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SUGGESTED AMENDMENT
Change "What is the most clinically- and cost-effective test or combination of tests for
diagnosing Lyme disease in different clinical scenarios or presentations?" to "What is the
most clinically- and cost-effective test or combination of tests for diagnosing Lyme disease,
the appropriate timing for testing, and the appropriate way to interpret test results,
in different clinical scenarios or presentations?"
REASON
It may turn out that the same test is best for all clinical scenarios or presentations, yet that
test's results may have different meanings in different clinical scenarios.
The appropriate timing of the test (in relation to believed time of exposure) and whether a
repeat test is necessary, also needs to be part of the guidance given to doctors.
EVIDENCE
Refer to the existing test kit manufacturers' instructions on interpretation of results.
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Thank you for your comment. The
review questions will be further
developed by the Guideline
Committee based on the scope of the
guideline. We will bring the detail of
your comment to the attention of the
guideline committee to inform that
development process
Recommendations will then be made
based on the best available evidence
identified.
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Caudwell LymeCo
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3
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74,
76
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SUGGESTED AMENDMENT
Delete "a tick bite" and insert "suspected time of infection"
REASON
Tick bites are not the only source of infection with Lyme disease. The infection can also be
spread by blood transfusion and congenitally.
It MAY also be spread by breast feeding, eating unpasteurised dairy products, other biting
insects or sexual contact. Since these transmission routes may also be possible, patients
who may have been infected in these ways should not be excluded from laboratory testing.
EVIDENCE
There is no proof that tick bites are the only means of spreading Lyme disease.
The recently published peer-reviewed medical papers presenting new evidence for other
means of transmission should be examined and reviewed.
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Thank you for your comments about
the use of the phrase “tick bite”. The
detailed sub questions in this section
have been removed from the final
version of the scope. Your comments
will be shared with the guideline
committee for their consideration
when the protocols for review
questions are discussed.
Person-to-person transmission is now
included as a key question in the
scope. The review question and
protocol will be developed by the
Guideline Committee in due course.
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Caudwell LymeCo
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3
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74-
82
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SUGGESTED AMENDMENT
Delete all the suggested categories. New categories need to be defined AFTER examining
the explanations of how to interpret the test results of each of the test kit manufacturers.
Just as an example, the test currently used by RIPL MIGHT divide patients into the
following clinical scenarios in order to interpret their test results:
1.Suspicion of a recent infection
2.Patients 2-3 weeks after onset of the disease
3.Patients given early antibiotic therapy
4.Patients infected for a longer period of time
5.Patients on certain medication or immunoglobulin therapy
6.Patients who may have Treponema, Leptospira or other bacteria with flagella, acute
EBV infection, autoimmune diseases, MS, ALS, Influenza or Syphilis.
REASON
The categories into which patients needs to be divided to interpret the results of their tests
will be dictated by the manufacturers of those tests. They do not interpret results based on
whether the patient has been infected for more or for less than 6 months, for example. An
examination of the documentation provided with each test kit should form part of the work
of the committee to define these categories meaningfully.
EVIDENCE
The above example of possible categories for interpretation of results was taken from the instructions published by ViraMed, the manufacturer of the western blot test kit used by RIPL
1. IgG antibodies are produced for the first time several weeks to months after infection and are often not detectable in early stages of infection (22). In suspicion of a recent infection, IgM antibodies should be checked and a second sample should be analysed later. Patients in the 2nd or 3rd stage of the disease are usually positive for IgG antibodies. Antibody titers decrease gradually during convalescence (22).
2. IgM antibodies usually appear 2-3 weeks after onset of the disease for the first time (22). Antibody titers often decline several weeks to months after convalescence. But they may also persist up to several years (7,11,20).
3. IgA antibodies are detectable at an early stage of Borreliosis in many patients, in some cases earlier than IgM antibodies.
4. The immune response and consequently the band pattern differs from patient to patient. As a general rule: The number of antibody types and therefore the number of specific bands is increasing with progression of the disease (1).
5. An early antibiotic therapy can suppress the development of antibodies (17).
6. Medication and immunoglobulin therapy can cause unspecific antibody reactions (24).
7. Cross reactivities to Borrelia antigens are described for infections with Treponema,
Leptospira and other bacteria with flagella (2,15,22). An acute EBV infection can cause a
polyclonal stimulation of Borrelia antibodies (22). If IgM antibodies against OspC or p41
are detected without clinical symptoms for borreliosis an EBV infection needs to be tested
for. Cross reactivities in cases of autoimmune diseases, MS, ALS, Influenza and Syphilis
are described as well.
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Thank you for your comment on the
issue of the classification of Lyme
disease as described in the
consultation version of the scope. We
have invited stakeholders to provide
comment on this in a specific question
at consultation to ensure that we
collected the widest views on this
issue. We now propose to present the
guideline committee with the
stakeholder feedback on this issue to
allow them to determine the best
approach for the guideline to take. As
such, we have removed detail linked
to the definitions of early and late
Lyme disease from the final scope.
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Caudwell LymeCo
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4
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85 -
94
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SUGGESTED AMENDMENT
Remove all categories as listed.
A new list of patient categories and clinical scenarios needs to be composed by the
committee.
Firstly patients need to be divided into specific categories. I would suggest:
1. Active Borrelia infection with symptoms. These are sometimes divided into acute cases,
and disseminated or "Late Lyme" cases. The usual cut-off point for 'acute' seems to be
about 6 weeks and it is widely stated that treatment outcomes are very successful in this
acute or early stage of infection, but I think the committee should check if this really is
based on evidence. The patient experience is that standard treatment often fails at this
stage but doctors seem not to consider this at all.
2. Latent Lyme disease, i.e. bacteriologically positive but no symptoms - This category may
or may not be considered the same as category 3. This is an area where there is a lack of
understanding of the patient experience – where symptoms can develop many months
after being infected. It is recognised that Lyme disease can be symptom free but doctors
do not seem aware that symptoms may develop later. Repeat testing, monitoring of
symptoms, etc is something guidelines should address.
3. Lyme disease in remission, i.e. no symptoms but bacterial infection is still present - The
experience of many patients is that they may achieve this state for periods of months or
even years, with or sometimes without antibiotic treatment, but any form of stress or an
insult to the immune system will trigger a return of symptoms. Many patients alternate
between category 1 and category 3 for the rest of their lives after being infected with Lyme
disease.
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Thank you for your comment on the
issue of the classification of Lyme
disease as described in the
consultation version of the scope. We
have invited stakeholders to provide
comment on this in a specific question
at consultation to ensure that we
collected the widest views on this
issue. We now propose to present the
guideline committee with the
stakeholder feedback on this issue to
allow them to determine the best
approach for the guideline to take. As
such, we have removed the detail
linked to the definitions of Lyme
disease from the final scope.
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