This probably requires clarification.
Thank you for your comment. We
have deleted this phrase.
|
Caudwell LymeCo
|
7
|
146-
147
|
SUGGESTED AMENDMENT
Delete "There is controversy over the existence of 'chronic Lyme disease' or 'post-
treatment Lyme disease syndrome'."
REASON
There is no longer controversy over the existence of these conditions, but rather,
controversy over what these terms mean.
This is because
a) they are eccentric terms that don't use standard medical terminology, and
b) because there are, regrettably, still many doctors who have failed to keep up to date
with newer research and still believe the old assumption that Borrelia is easy to cure with a
short course of antibiotics.
EVIDENCE
There are around 700 peer-reviewed research papers documenting cases of refractory
Lyme disease, which are conveniently gathered together by Dr. Richard Bransfield, author
of what are currently the only operational Lyme disease treatment guidelines in America
(ILADS guidelines)
http://www.ilads.org/ilads_news/2015/list-of-700-articles-citing-chronic-infection-
associated-with-tick-borne-disease-compiled-by-dr-robert-bransfield/
|
Thank you for your comment. We
have made edits to this section and
removed the speech marks and
changed ‘controversy’ to ‘uncertainty’.
|
Caudwell LymeCo
|
7
|
152
|
SUGGESTED AMENDMENT
Delete "Public health England estimates that between 2000 and 3000 people develop it
each year in the UK..."
REASON
This "estimate" by Public health England is actually a guess rather than an estimate. In a
freedom of Information request, I asked their methodology and they had none.
(the FOI response is online at
https://www.whatdotheyknow.com/request/313568/response/773785/attach/html/2/551%2
0FOI%20Lyme%20testing%20reply.pdf.html
please refer to item 11.)
EVIDENCE
On behalf of the Caudwell LymeCo charity I have conducted a survey of close to 500 UK
patients, diagnosed the RIPL and in a few selected foreign labs, and extrapolated the
results to formulate an estimate which comes to around 45,000 new Lyme disease cases
per year in the UK. I plan to publish this research online, explaining my input data and
methodology.
|
Thank you for your comment. The
figures provided by Public Health
England are an estimate only. We
note that the actual number of
infections might be much higher
context and further acknowledge that
the true incidence in England remains
unknown. We would encourage you to
publish your evidence to inform the
debate.
|
Caudwell LymeCo
|
7
|
158-
159
|
SUGGESTED AMENDMENT
It would be useful to add to this the fact that only 10% of patients actually have any idea of
when a tick bit them.
REASON
The majority of tick bites are by nymphs, which are no larger than a poppy seed and
patients are unaware of their presence and unable to say how long they have been
attached.
EVIDENCE
I am not aware of any objective, laboratory-based research into the relationship between
the duration of tick attachment and the probability of Lyme disease infection in humans,
which is the only way to assess this without relying merely on the subjective accounts of
patients.
|
Thank you for your comment. We note
that not all patients are aware of
having been bitten by a tick. This is
captured in an earlier part of the
context section. We do not feel that an
exact figure should be included in the
scope as we are unaware of any
evidence to support this.
|
Caudwell LymeCo
|
8
|
167
|
SUGGESTED AMENDMENT
Delete "People with positive tests are treated"
REASON
This is not true in many cases.
EVIDENCE
In a Caudwell LymeCo patient survey of roughly 500 UK patients, we asked patients how
many weeks of antibiotics they had been given on the NHS after their positive Lyme
disease blood test, and 52% of them responded 0.
Very few of them were given the full duration of antibiotics currently recommended by PHE
treatment guidelines.
|
Thank you for your comment. This
sentence has now been changed to
address your comment.
|
Caudwell LymeCo
|
8
|
167
-
168
|
SUGGESTED AMENDMENT
"If the test is negative but symptoms persist, repeat samples are sent 3-4 weeks later."
REASON
In reality, this very rarely happens.
EVIDENCE
The typical patients' experience with their GP in Britain is that, after one negative or even
equivocal test, they are told they do NOT have Lyme disease and their doctor refuses to
contemplate a second test.
|
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 repeat testing;
however the aim of this section is to
summarise the PHE guidance and not
comment on its implementation. The
guideline will examine available
evidence and make recommendations
in this area if there is evidence to
support this.
|
Caudwell LymeCo
|
DQ1
|
|
PLEASE COMMENT ON
1) Is the time period of ‘< than 6 months since tick bite or first symptoms or signs’ an
acceptable interpretation for ‘early Lyme borreliosis’?
COMMENT
No, and "early lyme borreliosis" is not an acceptable term either because it is not useful
either for diagnosis or for treatment decisions.
Please refer to my proposed category definitions in point 8.
|
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.
|
Caudwell LymeCo
|
DQ2
|
|
PLEASE COMMENT ON
2) Is the time period of ‘> 6 months since tick bite or first symptoms or signs’ or an
acceptable interpretation for ‘late Lyme borreliosis’?
COMMENT
No, and "late Lyme borreliosis" is not an acceptable term either because it is not useful
either for diagnosis or for treatment decisions.
Please refer to my proposed category definitions in point 8.
|
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.
|
Caudwell LymeCo
|
DQ3
|
|
PLEASE COMMENT ON
3) The use of the British Infection Association1 position paper classification to determine
the range of clinical presentations that will be considered.
COMMENT
This list of symptoms and clinical manifestations is woefully inadequate. it neglects to
mention some of the commonest symptoms and focuses instead on those which, as it
states, affect around 1% of patients.
A proper list of clinical manifestations and symptomatology (with prevalences of each
symptom in the UK) needs to be developed by the committee on the basis of evidence
gathered among UK patients.
Recycled evidence from America that does not apply to UK patients will not be particularly
useful.
|
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.
|
Caudwell LymeCo
|
DQ4
|
|
PLEASE COMMENT ON
4) The inclusion of the following strains of Lyme Borreliosis for consideration as part of
our review of the evidence:
•B. burgdorferi (and the subtype B. burgdorferi sensu stricto),
•B. garinii,
•B. afzelii
COMMENT
It would obviously be ideal to test for all known strains of Borrelia Burgdorferi sensu lato
which can cause Lyme disease.
However, given that this may be impractical within the limitations of current western blot
testing, I would propose that the Borrelia Valaisiana be included as a bare minimum since
it may be the Borrelia strain involved in around 7% of Lyme disease cases in Europe.
EVIDENCE
For example, Habálek, Z.; Halouzka, J. (1997-12-01). “Distribution of Borrelia Burgdorferi
sensu lato genomic groups in Europe, a review“. European Journal of Epidemiology
|
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.
|
Caudwell LymeCo
|
DQ5
|
|
PLEASE COMMENT ON
5) The appropriate diagnostic tests for consideration
COMMENT
At the original scoping meeting, a long list of diagnostic tests was presented. There is no
logical reason or evidence at this stage that could justify excluding any of those tests from
being investigated and evaluated in terms of their sensitivity and specificity.
Whether or not they are chosen for use by the NHS, there may be patients who pay for
those tests privately. Duly evaluated, objective data on their sensitivity and specificity
should be provided to these patients' doctors in a transparent manner.
|
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.
|
Department of Health
|
|
|
Thank you for the opportunity to comment on the draft scope for the above clinical
guideline.
I wish to confirm that the Department of Health has no substantive comments to make,
regarding this consultation.
|
Thank you for your comment.
|
Healthcare Infection Society (HIS)
|
Gener
al
|
Gen
eral
|
The Healthcare Infection Society has received no comments on this consultation
|
Thank you for your comment.
|
Lyme Disease Action
|
1
|
5
|
Using a title of Lyme borreliosis, rather than Lyme disease, would bring the guidelines into
line with the rest of Europe. European Lyme borreliosis is recognised to be different from
Lyme disease in the USA, due to a greater variety of genospecies and strains of Borrelia
endemic in Europe.
|
Thank you for your comment. We
have decided to use the title Lyme
disease as it is a widely accepted term
which we feel is more accessible to
non-healthcare professionals than
Lyme borreliosis. In addition it directly
reflects the commission received from
NHS England. The guideline
committee will make the final decision
on whether to include evidence from
outside UK and Europe.
|
Lyme Disease Action
|
2
|
31
|
We feel that individual consideration should be given to immunocompromised people and
pregnant women in whom diagnosis may be more difficult and treatment may be different.
|
Thank you for your comment. The
guideline committee will review the
evidence about diagnostic test
accuracy and management strategies
in pregnant women and
immunocompromised people. It is
anticipated that these populations will
form sub-groups in each of our
evidence reviews to ensure that,
where evidence exists on these
issues, the committee are able to
make evidence-based
recommendations for the NHS. Where
no evidence is available, the
committee may be able to make
research recommendations. These
subgroups have been included in the
equality impact assessment for this
guideline.
|
Lyme Disease Action
|
2
|
38
|
Consideration at assessment should be given to ‘red flags’ such as severe neurological,
cardiac and ophthalmic complications requiring specialist referral, and also special groups
such as pregnancy and immunosuppression. See also comment on line 50 of the scope.
|
Thank you for your comment. We will
pass the detail of your comment
related to severe neurological, cardiac
and ophthalmic complications to the
guideline committee for their
consideration as they develop
protocols linked to the appropriate
management for different
presentations being considered
The guideline committee will review
the evidence in pregnant women and
immunocompromised people. It is
anticipated that these populations will
form sub-groups in each of our
evidence reviews to ensure that,
where evidence exists on these
issues, the committee are able to
make evidence-based
recommendations. These subgroups
have been included in the equality
impact assessment for this guideline.
|
Lyme Disease Action
|
2
|
39
|
In addition to clinical assessment mention should be made of the value of including
assessment of risk of tick exposure and tick bite in the period prior to onset of symptoms,
including assessment of travel history.
|
Thank you for your comment. This
guideline will include assessment of
risk of tick exposure and tick bite in
the period prior to onset of symptoms
as part of the topic area on
assessment (history and
examination).
|
Lyme Disease Action
|
2
|
40
|
Remove "confirmatory" as it implies this leads to a diagnosis and it may not. Perhaps “first
and second tier serology testing and the use of PCR” instead
|
Thank you for your comment. We
believe that the term ‘confirmatory’ is
a widely accepted term for second line
tests after initial testing. We do not
feel any change is necessary.
|
Lyme Disease Action
|
2
|
40
|
Suggest that item 2 is Testing (first and second tier tests) and that an additional point
“Diagnosis” is introduced. Diagnosis is the result of assessment, investigations and tests
which are building evidence to inform a diagnosis. 2nd line serology tests may yield false
positives, especially in areas where seroprevalence is high, and may give false negatives,
so it is important to separate diagnosis from testing.
|
Thank you for your comment.
The guideline will look at the role of
second-line tests as part of diagnosis
as well as assessment and
investigations.
We feel that this is adequately
captured in the “key areas that will be
covered” section and have not made
any changes.
The exact review questions to cover
the key area of ‘diagnosis’ will be
developed by the Guideline
Committee at a later stage. An
evidence review on diagnostic test
accuracy will look at the likelihood of a
test being false negative, for example.
The Guideline Committee will take this
into account and the findings from its
other evidence reviews (for example,
on assessment) when formulating
recommendations.
|
Lyme Disease Action
|
2
|
41
|
This specifies Management to be “for example” treatment using antibiotics. It is unclear
what other aspects to treatment might be covered - eg neuropathic pain relief, anti-
inflammatories, treatment for unresolved facial palsy, physiotherapy for arthritis,
pacemaker insertion etc. See our comment on section 3, Context.
|
Thank you for your comment. We
have used the example of antibiotics
as an illustrative example. The
guideline committee will consider
which other treatments of Lyme
Disease are of relevance for the
evidence review. This guideline will
not address the management of
conditions secondary to Lyme
Disease although other NICE
guidance is available in some of the
areas that you mention such as in the
management of neuropathic pain
(https://www.nice.org.uk/guidance/cg1
73).
|
Lyme Disease Action
|
2
|
48
|
The information, education and support needs of healthcare professionals requires
consideration.
|
Thank you for your comment. The
information, education and support
needs of healthcare professionals will
be considered by the guideline
committee and acknowledged as part
of the work linking evidence to
recommendations rather than as a
formal review question. It is
anticipated that the publication of the
guideline will provide helpful
information for healthcare
professionals which may then be
further developed by relevant groups.
|
Lyme Disease Action
|
2
|
50
|
Although this guideline will not cover management of other tickborne infections, it is
important to mention somewhere in the guideline that co-infections eg. Anaplasmosis, may
lead to more severe symptoms, interfere with test results and possibly also response to
treatment as a result of immune suppression. See comment on line 38 re Red Flags.
Public Health England Porton have identified cases of Anaplasmosis, and Lyme Disease
Action has had experience of some cases via the help desk.
|
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.
|
Lyme Disease Action
|
2
|
51
|
It is not clear why CFS is specifically named as fatigue due to Lyme borreliosis does not
equate to CFS/ME. Other conditions such as multiple sclerosis, rheumatoid arthritis,
Sjogrens Syndrome, etc are not mentioned, so why CFS.
|
Thank you for your comment. The
remit of this guideline is the diagnosis
and management of Lyme
disease.The reference to the chronic
fatigue syndrome /myalgic
encephalomyelitis (or
encephalopathy) guideline has been
included to make it clear that the
guideline will not cover management
of fatigue as part of the CHF/ME. It is
provided as an example of another
NICE guideline that is available and is
not intended to be an exhaustive list.
|
Lyme Disease Action
|
3
|
68
|
This should state “What symptoms, clinical signs and history”. A person’s clinical history
and tick exposure is an important factor in acute Lyme borreliosis when symptoms plus
history might indicate immediate treatment should be started. History is also important in
late Lyme borreliosis.
|
Thank you for your comment. The
diagnosis and management of Lyme
disease will be covered in this
guideline. The Guideline Committee
will make recommendations based on
the evidence identified.
History taking is part of the draft
question on in whom Lyme disease
should be suspected and as such will
inform the relevant recommendations
made in the guideline.
|
Lyme Disease Action
|
3
|
68
|
Consideration should be given to adding development of a weighting table. This was one
of the Top 10 James Lind Alliance Uncertainties ‘What key questions (clinical and
epidemiological) should be considered to help make a diagnosis of Lyme disease in
children and adults in the UK and would a weighting table be useful?’
This was also raised as a key area of uncertainty during the American Association for the
Advancement of Science AAAS InnovationsX conference in Washington, USA 17/18
November 2015.
|
Thank you for your comment. After
reviewing the evidence, the guideline
committee will consider the most
appropriate way to present the
information. The committee can also
make a research recommendation if
this is considered appropriate.
|
Lyme Disease Action
|
3
|
69
|
Rephrase to simply “Diagnostic testing.” There is no current test which can confidently rule
out Lyme disease and no test which can confirm currently active disease.
|
Thank you for your comment. This has
now been amended to ‘Diagnostic
testing for Lyme disease’.
|
Lyme Disease Action
|
3
|
7
|
Transmission should be included in the guideline. Clinicians need to know what evidence
there is as this question will be raised in consultations.
|
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.
|
Lyme Disease Action
|
3
|
72
|
See answers to the directly posed question 3 re clinical presentations.
|
Thank you for your response to this
question. 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.
|
Lyme Disease Action
|
3
|
77
|
We do not see how someone would be considered to have late disease without symptoms
or signs.
|
Thank you for your comment.
We had intended for ‘without
symptoms or signs’ to refer to the
absence of either clinical signs or
symptoms, and not the absence of
both. For example a person could
have a clinical sign (something than
can be easily measured by someone
else, e.g. a rash) but no symptoms
(something that cannot be easily
measured by someone else, e.g.
feeling unwell or a headache) or vice
versa. This was to reflect the issue
around the difficulty of diagnosing or
ruling out Lyme disease using clinical
signs only. However, we now propose
to present the guideline committee
with the stakeholder feedback on the
issue of clinical scenarios and
presentations 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 different clinical
scenarios and presentations.
|
Lyme Disease Action
|
3
|
79
|
The phrase “full course” is subjective. Currently many clinicians appear to believe that a 10
|
Thank you for your comment. The
term ‘definitive’ has now been
removed.
|
day course is “full”. There is no “definitive” treatment (see James Lind Alliance
|
uncertainties) for anything other than perhaps early Lyme borreliosis with erythema
|
migrans and given trials in progress it is unlikely that this will change in the near future.
|
Suggest rephrase to “early or late disease where an initial course of treatment has been
|
completed but symptoms or signs have recurred.”
|
Lyme Disease Action
|
3
|
82
|
As above: there is no definitive treatment so suggest re-phrase to “…have not resolved
despite an initial course of treatment.”
|
Thank you for your comment. The
term ‘definitive’ has been removed.
|
Lyme Disease Action
|
3
|
83
|
Insert
What tests for other tick-borne infections should be considered. See comments on
lines 38 and 50.
What factors to consider if the pre-test probability is raised and the test results are
negative or equivocal. Given the limitations of current tests, it may not be possible
to make a definite diagnosis of Lyme disease, so it would be useful to give
guidance on ‘probable’ and ‘possible’ Lyme disease.
|
Thank you for your comment. The
remit of this guideline is Lyme disease
and therefore other tick-borne
infections will not be covered.
Whilst we do not feel that any change
to the wording of the scope is
required, we will bring the detail of
your second point to the committee’s
attention as part of their consideration
of evidence and classification of any
management recommendations.
|
Lyme Disease Action
|
3
|
83
|
Is antibiotics intended to be an example of treatment or the only type of treatment to be
considered? Consideration should be given to management for arthritis, neurological pain,
facial palsy and endocrine, auto-immune, cardiac and ophthalmic sequelae. Some of this
might depend on whether this guideline is concerned with Lyme Borreliosis (ie active
infection) or with Lyme disease in its potentially wider context.
|
Thank you for your comment. The
remit of this guideline is the diagnosis
and management of Lyme disease.
Antibiotic treatment is the only
established treatment for Lyme
disease. We acknowledge that where
complications of Lyme disease occur
referral for specialist NHS opinion may
be desirable if the evidence supports
this. The Guideline Committee will
consider clinical scenarios where
there is a need for specialist referral
for management of complications.
This guideline will not however,
consider in detail the management of
these complications.
|
Lyme Disease Action
|
3
|
84
|
See answers to the directly posed question 3 re clinical presentations.
|
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.
|
Lyme Disease Action
|
4
|
104
|
Insert an additional outcome “Continuation of symptoms or signs”. It may seem a question
of semantics, but evidence showing a reduction of clinical symptoms may be viewed as
evidence that a treatment is “successful” whereas evidence showing a continuation of
symptoms should be viewed as indicating a potentially unsuccessful intervention.
|
Thank you for your comment. For the
purpose of the scope, we believe this
is covered under the outcomes
‘reduction of symptoms’ and ‘cure’.
The guideline committee will agree the
key outcomes for each review and will
use their expertise to determine
whether the results of relevant studies
are significant.
|
Lyme Disease Action
|
4
|
90
|
replace the phrase “a full course of definitive treatment” with “initial treatment
|
Thank you for your comment. The
term ‘definitive’ has now been
removed.
|
Lyme Disease Action
|
4
|
93
|
replace the phrase “a full course of definitive treatment” with “initial treatment”
|
Thank you for your comment. The
term ‘definitive’ has now been
removed. No further edits have been
made.
|
Lyme Disease Action
|
4
|
96
|
The information needs of other healthcare providers requires consideration. A significant
barrier to diagnosis and to effective, safe care is currently the lack of experience amongst
UK clinicians.
Lyme borreliosis can cause many complications and a patient may be seen by a
rheumatologist, endocrinologist, neurologist, gynaecologist, physiotherapist, psychiatrist,
psychologist, cardiologist and immunologist. These clinicians may not recognise the
possibility of Lyme disease and have no quality, experienced resource to consult.
The information and education needs of infectious diseases consultants also needs
consideration. Lyme Disease Action has received many comments indicating that some do
not believe Lyme borreliosis can be contracted “in their area”, that negative serology
means that Lyme borreliosis cannot be present and that Lyme borreliosis cannot relapse.
This despite Public Health England’s referral pathway for GPs which counters each of
those statements. Whatever other recommendations are made during the course of this
guideline development, the context section of the NICE guideline must attempt to address
these issues in case this is the only resource that any clinician refers to.
|
Thank you for your comment. The
information, education and support
needs of healthcare professionals
may be considered by the guideline
committee as part of its reviews of
evidence in the scope areas and
acknowledged when linking evidence
to recommendations. It is also
anticipated that the publication of the
guideline will provide helpful
information for healthcare
professionals and this may then be
subsequently taken forward by
appropriate providers as a resource
for professionals.
The NICE guideline context section
will be drafted in light of the
recommendations made in due
course.
|
Lyme Disease Action
|
4
|
97
|
A key issue with the potential to improve outcomes is the provision of a network of regional
centres of expertise. These require access to specialist diagnostic facilities a multi-
disciplinary approach with a variety of healthcare professionals (nurses, physiotherapists
occupational therapy etc) to meet the potential complex needs of patients with Lyme
disease. This was supported by the Minister, Lord Prior, in a debate in the House of Lords
in October 2015.
|
Thank you for your comment. The
point you have raised concerns
service delivery, which is unfortunately
outside the remit of this clinical
guideline.
|
Lyme Disease Action
|
4
|
97
|
A key issue to improve knowledge and outcomes and reduce ineffective care would be
research to include follow up of patients after treatment. Consideration should therefore be
given to follow up as a specific key issue, rather than just including it under treatment when
symptoms or signs have not resolved. This could include consideration of diverse points
such as removal of temporary pacemakers, and consideration of treatment for incompletely
resolved facial palsy, in addition to consideration of further antibiotic treatment in case of
relapse.
|
Thank you for your comment. Follow
up of patients after treatment is an
important part of the management of a
condition and this has been identified
as a specific outcome. We
acknowledge a specific key issue
around the management of Lyme
disease when symptoms or signs
have not resolved. We will bring the
detail of your comment to the
committee for their consideration
when developing protocols. The
committee is able to make research
recommendations where evidence is
lacking or inconclusive.
|
Lyme Disease Action
|
5
|
111
|
NICE guidance on treatment of neuropathic pain CG173 is relevant.
|
Thank you for your comment. This
section only details NICE guidance
whose recommendations support
overarching principles of patient
management rather than
recommendations for specific
symptom management. . As such
CG173 is not included here in line with
the NICE template.
|
Lyme Disease Action
|
6
|
130
|
If this context statement is to be used in the final guideline, it is imperative that it is clear
and correct. This may be the only resource consulted by a busy clinician.
|
Thank you for your comment. The
purpose of the context section in the
scope is to set the scene in terms of
epidemiology, nature of the condition
and current practice. It is not intended
to be included as part of the narrative
of the published guideline. The scope
is usually included as an appendix to
the full published guideline.
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Lyme Disease Action
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6
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132
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It is not just B burgdorferi. Not enough is known about B miyamotoi infections, but this, and
infections caused by other as yet unidentified genospecies, should not be excluded. See
comment on Q4.
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Thank you for your comment. The
context section of the scope is
intended to give a short overview of
what is currently known. As such, it
cannot outline all areas that are
potentially being researched. Lyme
disease itself is currently only linked to
Borrelia burgdorferi-group. The
management of co-infections is
outside the scope of the guideline.
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Lyme Disease Action
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6
|
134
|
Where is the evidence (evidence, not personal opinion quoted in a paper) that Lyme
disease can be asymptomatic? This trivialises the disease and has no place in a guideline
dealing with symptomatic infection.
|
Thank you for your comment. We
have amended the text in the scope to
distinguish between asymptomatic
infection and Lyme disease as a
symptomatic infection.
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Lyme Disease Action
|
6
|
135
|
There is evidence of longer incubation periods tan one month (eg Logar et al 2004).
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Thank you for your comment. It is
widely accepted that the incubation
period ranges from a few days to
about a month. However, the course
of a disease is different for each
individual and some people might
experience a much longer incubation
period. People who experience the
onset of symptoms after more than
one month from the time of infection
will be included in the relevant
reviews.
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Lyme Disease Action
|
7
|
137
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erythema migrans may not be centred on the bite and there may be multiple erythema
migrans. People have been refused initial treatment because the rash was elsewhere and
therefore “could not” be erythema migrans.
|
Thank you for your comment. We
have changed the wording in the
scope to read: “...in some people this
is followed by a circular, target-like
rash centred on the bite, known as
erythema migrans…” to reflect the
uncertainty about the proportion of
people affected in this way.
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Lyme Disease Action
|
7
|
141
|
Where is the evidence that Lyme disease is frequently selflimiting? It can resolve without
treatment, but frequently? A statement like this is unsafe and runs the risk of encouraging
a clinician to delay treatment.
|
Thank you for your comment. We
believe our current wording is
sufficient to describe the disease
trajectory.
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Lyme Disease Action
|
7
|
142
|
Suggest replace “risk of later symptoms” with “risk of chronic infection”.
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Thank you for your comment. We
have chosen to maintain the wording
linked to later symptoms as this does
not rely on definition of chronic
infection.
|
Lyme Disease Action
|
7
|
143
|
Remove the phrase “post infectious Lyme disease” as this implies infection has been
eliminated and we do not currently have the means to know this, as there is no reliable
biomarker for disease activity and no test of cure.
|
Thank you for your comment. We
have deleted this phrase.
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Lyme Disease Action
|
7
|
145
|
Add “frank arthritis” because this is what the pathology shows in late Lyme borreliosis.
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Thank you for your comment. This
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