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It is important to include the fact that ticks can be found in a variety of environments
including urban parks (Jennett et al, 2013). Anecdotal evidence in the patient community
also demonstrates that people have been bitten in urban gardens.
References:
1. Jennett, AL, Smith, FD & Wall, R, 2013, ‘Tick infestation risk for dogs in a peri-urban
park’. Parasites and Vectors, vol 6.
http://www.bristol.ac.uk/biology/people/richard-l-wall/pub/32548259
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Thank you for your comment. We do
not consider that the text in the scope
needs changing because it does not
specify urban or rural environments.
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164
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Anecdotal evidence from patients suggests that many doctors fail to recognise the EM
rash. Many people with EM rash appear to be diagnosed with cellulitis, a bite allergy or
ringworm instead and therefore the window for early treatment is frequently missed.
This study highlights this issue by stating ‘this lesion may go unrecognized, or be mistaken
for an “insect bite” or an “allergic rash.” Mini-erythema migrans are less likely to be
diagnosed’ (Perronne, 2014).
References:
1. Perronne C (2014) Lyme and associated tick-borne diseases: global challenges in the
context of a public health threat. Front. Cell. Infect. Microbiol. 4:74. doi:
10.3389/fcimb.2014.00074
http://journal.frontiersin.org/article/10.3389/fcimb.2014.00074/full
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Thank you for your comment. The
‘current practice’ section is a standard
section in NICE guideline scopes and
aims to describe current standard
practice (in this case the PHE
guidance) rather than level of uptake
of guidance. We acknowledge the
concerns about rash recognition;
however the aim of this section is to
summarise the PHE guidance and not
comment on its implementation. We
have added text about lack of
recognition of rash to section 3.1
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When there is currently no test available to distinguish past infection from ongoing infection
or new infection, the evidence and tests that the term ‘relapse’ is based on, should be
reviewed.
Additionally, anecdotal evidence exists to suggest that patients who still have a positive
test following ‘standard’ treatment for Lyme disease are told it is likely to be a false
positive, even when clinical signs would suggest an ongoing infection.
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Thank you for your comment. Testing
will be addressed by an evidence
review (as outlined in section 1.5).
The review question and protocol will
be developed by the guideline
committee, based on the scope.
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Lyme Disease UK
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Gener
al
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Gen
eral
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Lyme Disease UK is a patient support network with nearly 4000 members and bears
witness daily to thousands of patients who are suffering on an inhumane scale. Many have
been ridiculed by medical professionals in various disciplines, dismissed, belittled,
neglected and left with increasingly frightening and painful symptoms for which no help or
guidance is offered. Many people have lost their jobs, their homes, their life savings and
their relationships and are now living in isolation and poverty. Others are left with no other
option but to fundraise or in order to seek private Lyme disease and co-infection treatment
(often overseas) or fund it themselves in an attempt to reverse the decline in their health
and save their lives. The NHS guidance currently in use is failing these patients.
The general overview is that EM rashes are frequently being ignored by GPs and that
people aren’t being asked about potential tick exposure. Furthermore, it often appears that
people are not being offered Lyme disease testing despite presenting with numerous
symptoms consistent with the disease. Some people even report hostility from doctors if
they request a test and many are told that Lyme disease is either very rare or that it does
not exist in this country and that they should not be researching the disease online. There
have been accounts of patients, who were previously told that their Lyme disease tests
were negative, discovering that they were in fact positive when they requested a copy of
the laboratory report, sometimes months or years later. It also appears that people are all
too readily being turned away or misdiagnosed with CFS, fibromyalgia and mental health
issues without tick-borne infections even being considered. As Cameron et al point out in
the ILADS guidelines, a survey involving Lyme disease patients, conducted by Johnson et
al, reveals that ‘71.6% rated their health as fair or poor. This rate is higher than that seen in
other chronic diseases including congestive heart failure, fibromyalgia, post- stroke and
post-myocardial infarction status, diabetes and multiple sclerosis’.
It is important to note from shared patient experience that many people who have sought
ongoing private treatment for Lyme disease are seeing improvements in their health after
being essentially abandoned by the NHS.
References:
1. Cameron DJ, Johnson LB, Maloney EL. Evidence assessments and guideline
recommendations in Lyme disease: the clinical management of known tick bites, erythema
migrans rashes and persistent disease. Expert Rev Anti Infect Ther. 2014 Sep;12(9):1103-
35. doi: 10.1586/14787210.2014.940900
http://www.tandfonline.com/doi/full/10.1586/14787210.2014.940900
2. Johnson L, Wilcox S, Mankoff J, Stricker RB. Severity of chronic Lyme disease
compared to other chronic conditions: a quality of life survey. Peer J 2014;2:e322
https://peerj.com/articles/322/
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Thank you for your comment which
supports the need for developing a
NICE guideline in this topic area. We
hope that this guideline will provide
clarity for NHS healthcare providers
and patients linked to the diagnosis
and management of Lyme disease
based on the best available evidence.
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Lyme Disease UK
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Gener
al
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Gen
eral
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All known pathogenic strains of Borrelia should be covered in the scope and not just
Borrelia afzelii, Borrelia garinii and Borrelia burgdorferi. One in five patients is thought to be
infected abroad and so could potentially be affected by different species which should also
be covered by UK testing and come under the term ‘Lyme disease’.
Borrelia valaisiana has been found in UK ticks according to the BIA position statement on
Lyme borreliosis, although it states that Borrelia valaisiana is not regarded as pathogenic.
However, in this study, Borrelia valaisiana was suspected of causing infection (Saito et al,
2007).
In this study, after culturing ‘live Borrelia bissettii-like strain from residents of North
America,’ the ‘results support the fact that B. bissettii is responsible for human Lyme
borreliosis worldwide along with B. burgdorferi s.s. The involvement of new spirochaete
species in Lyme borreliosis changes the understanding and recognition of clinical
manifestations of this disease’ (Rudenko et al, 2016).
Borrelia miyamotoi also needs to be taken into consideration and incorporated into testing
as it has been found in the UK (Hansford et al) and it is known to cause disease (Molloy et
al, 2015).
The brief for the scope should include a review of the literature on other pathogenic strains
of Borrelia, especially as there has been a number of new research papers since the BIA
position statement was issued in 2011.
References:
1. British Infection Association. The epidemiology, prevention, investigation and treatment of Lyme borreliosis in United Kingdom patients: A position statement by the British Infection Association. J Infect. 2011 May;62(5):329-38. doi: 10.1016/j.jinf.2011.03.006. http://www.aldf.com/pdf/BIA%202011statement%20on%20Lyme%20disease.pdf
2. Saito K, Ito T, Asashima N, Ohno M, Nagai R, Fujita H, Koizumi N, Takano A, Watanabe H, Kawabata H. Case report: Borrelia valaisiana infection in a Japanese man associated with traveling to foreign countries. Am J Trop Med Hyg. 2007 Dec;77(6):1124-7 http://www.ajtmh.org/content/77/6/1124.long
3. Rudenko, N et al.Isolation of live Borrelia burgdorferi sensu lato spirochaetes from patients with undefined disorders and symptoms not typical for Lyme borreliosis. Clin Microbiol Infect. 2016 Mar;22(3):267.e9-267.e15. doi: 10.1016/j.cmi.2015.11.009. http://www.ncbi.nlm.nih.gov/m/pubmed/26673735/
4. Hansford, K. M., Fonville, M., Jahfari, S., Sprong, H., & Medlock, J. M. (2014). Borrelia
miyamotoi in host-seeking Ixodes ricinus ticks in England. Epidemiology and Infection, 1–
9. doi:10.1017/S0950268814001691
http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=9595260&fileId
=S0950268814001691
5. Molloy PJ, Telford SR 3rd, Chowdri HR, Lepore TJ, Gugliotta JL, Weeks KE, Hewins
ME, Goethert HK, Berardi VP (2015). Borrelia miyamotoi Disease in the Northeastern
United States: A Case Series. Annals of Internal Medicine. doi:10.7326/M15-0333
http://annals.org/article.aspx?articleid=2301402
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Thank you for your response and
detailed comments on our questions.
We will bring the detail of your
response to the Guideline
Committee's attention. The
information will be used to inform the
Committee's decision making as they
develop the review protocols that
guide the searches for and review of
the evidence for the questions
outlined in the guideline scope.
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Transmission of Lyme borreliosis between people is not covered:
This was covered in the previous version of the Guideline scope, and we think it should
remain. There is published evidence for transmission between infected mothers and
babies in-utero (Schlesinger et al, 1985; Weber et al, 1988; MacDonald et al, 1987).
Untreated pregnant women with Lyme borreliosis have a higher incidence of adverse
outcomes of pregnancy than treated women (Lakos et al, 2010).
Therefore treatment of pregnant women should be included in the scope. The appropriate
treatment for pregnant women should be reviewed. What constitutes appropriate antibiotic
treatment in pregnant patients has yet to be determined. The U.S. Centres for Disease
Control and Prevention (2016a) state "Lyme disease acquired during pregnancy may lead
to infection of the placenta and possible stillbirth; however, no negative effects on the fetus
have been found when the mother receives appropriate antibiotic treatment." Surviving
babies born to untreated mothers may be infected and if so may need treatment, which
should also be covered in the scope.
There is also some evidence suggesting that sexual transmission may be possible
(Middelveen et al, 2015 in review). The evidence for sexual transmission is limited and
inconclusive (Stricker et al, 2015) but we suggest adopting a precautionary principle and
that clinicians should inform sexually active, infected patients of the potential risks, whilst
acknowledging the knowledge in this area is uncertain.
Many patients are concerned about donating or receiving blood that may be contaminated
with Lyme borreliosis, and we believe that this issue should be addressed. At least one
study shows B. miyamotoi's ability to survive standard blood storage (Thorp et al, 2006).
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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.
Pregnant women, will be included in
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).
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55
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Preventing Lyme borreliosis is not covered:
Does this only refer to ways to prevent tick bites? We think that prophylactic treatment
with antibiotics after a tick bite should be considered.
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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.
Preventing Lyme disease as outlined
in the scope refers to the prevention of
tick bites and prevention of Lyme
disease in the absence of a tick bite.
Prophylactic treatment with antibiotics
after a tick bite will be considered.
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56
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“Economic aspects”:
We hope that you will include the potential costs of misdiagnosis and inadequate antibiotic
treatment leading to chronic long-term disease in your economic analysis.
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Thank you for your comment. The
details of the economic analyses that
may be performed for this guideline
will be decided in collaboration with
the Guideline Committee and will
depend on the availability of data. We
will take your suggestion in to
consideration when developing our
economic analysis.
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"2.2 Starting treatment?":
When Lyme borreliosis is suspected, treatment should start immediately and be based on
symptoms, since rapid treatment is important to help prevent long-term problems.
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Thank you for your comment. The
Guideline Committee will formulate
recommendations on the timing of
treatment based on the evidence
identified through evidence reviews.
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Lyme Research UK
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79,
82,
90,
93
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“Definitive treatment”:
be given more powerful intravenous antibiotics. A milder term such as the “recommended
antibiotic treatment” would be more suitable here.
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Thank you for your comment. The
term ‘definitive’ has been removed.
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96
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The NICE guideline should give guidance to the testing laboratories that in
communications to clinicians and patients they should:
a/ Report clearly the results of the test in the manner described by test kit manufacturers.
b/ Inform clinicians of the test limitations and the kit manufacturers' statements that a
negative result does not indicate absence of Lyme borreliosis.
c/ The laboratories should not reinterpret the test results in a manner not supported by
the test kit manufacturers.
d/ The laboratories should confine themselves to reporting the test results and should not
give clinical advice on specific cases without seeing the patient, and definitely not with
the very basic data sent by clinicians.
e/ Provide clear dates for taking samples and testing samples to ensure specimens are
‘fresh’ as defined by the manufacturer.
f/ Patients should have access to their full laboratory results if they request them.
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Thank you for your comment. This is a
clinical guideline for the NHS. While
the points you have raised are very
important, we would not usually go
into this level of detail from a particular
evidence review for this guideline. The
committee may choose to comment
on reporting issues as part of the
planned diagnostic test accuracy
review.
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“Incubation period”:
The use of the phrase "incubation period" in the context of human infection with Borrelia is
not valid. The pathogen is infectious immediately. Symptoms develop as the pathogen
multiplies and disseminates.
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Thank you for your comment. We use
the phrase ‘the incubation period’ to
refer to the time between infection and
the onset of symptoms.
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You write "... in approximately two thirds of people this is followed by a circular, target-like
rash centred on the bite, known as erythema migrans":
We have not found the source of this estimate of two thirds and think it may actually be
lower. There are difficulties in getting representative patient samples which include all
types of patients. We hope that that you will look into this. This estimate can of course only
be based on patients diagnosed with Lyme borreliosis. Undiagnosed patients, of whom
there may be many, are less likely to have had an erythema migrans aiding diagnosis.
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Thank you for your comment. We
have changed the wording in the
scope to read: “ …..in some people
this is followed by …..” to reflect the
uncertainty about the true proportion
of people.
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141,
144
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You write “Lyme disease is frequently self-limiting and resolves spontaneously” and “If
Lyme disease does not resolve spontaneously, ...”:
This implies that it often resolves without any antibiotic treatment. We do not know of any
evidence for this, so think that the statements should not be made.
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Thank you for your comment however
we do not feel any change is required
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