NICE Guidelines – What’s Next?

In 2015, LDUK registered as stakeholders in the process. Representatives from LDUK attended a stakeholder meeting in February 2016 and submitted our comments on the draft scope.

NICE completes five steps before new guidelines are published. The Lyme disease guidelines are currently at step 3. The details of the steps can be found here. The guidelines are expected to be completed by April 2018, with a draft version due to stakeholders at the end of September 2017, therefore we thought it was a good time to summarise what the NICE guidelines are and what we think we may be able to expect from them.

What are the NICE guidelines?

NICE guidelines were created to end the ‘postcode lottery’ of NHS care in the UK. They are designed to help doctors, who may not specialise or have significant experience in treating a particular condition, to find trustworthy and evidence based instructions on how to help and treat patients. Once a disease is chosen for guidelines creation NICE appoints a Guideline Development Group, which reviews the available evidence to document what treatment path patients should be offered on the NHS.

How do they decide what goes into the guidelines?

The Guideline Development Group is composed of medical professionals and lay members. They have the role of assessing all existing evidence and preparing guidelines which take into account the best medical outcome, balanced with the cost of comparable options.

However, they are also expected to set the bar high in terms of what makes it into the guidelines to ensure patients are protected from unsafe treatment.

The committee formulate a series of questions which need to be answered to compose the entire guidelines, and specify the search terms which should be able to find all relevant papers. Analysts employed by NICE gather all relevant papers from medical databases, and then rate every research paper for risk of bias and for precision (in reporting of the experiment and results) according to objective criteria which are detailed here. Each paper is ranked according to the list of criteria, and the overall ranking is taken into consideration by the committee when deciding how much weight each paper should be given. Research which ranks too low is excluded from analysis by the committee. This is one reason why certain tests or treatments that have not been reviewed by scientific studies do not make it into the NICE guidelines. The experience of individual doctors who have been practicing a certain treatment is not seen by NICE as sufficiently objective evidence for that treatment to be part of the guidelines.

What can we hope for?

Whilst we know patients would like to see ILADS doctors and alternative practitioners influencing the guidelines with their hands-on experience, we do not know of any examples where this has happened with NICE guidelines for any other medical condition, therefore we think Lyme disease is unlikely to be treated any differently. Such approaches tend to be the preserve of research and private medicine, for patients who choose therapies beyond the NICE guidelines.

We have reviewed all of the scientific studies we could find related to Lyme disease, diagnosis, transmission and treatment. Whilst we recognise that we are not researchers or medical professionals and that we do not have access to all of the papers that the NICE committee have, we have attempted to summarise what we believe can be proved and therefore we feel should make it to the guidelines.

The first thing to say is that there is a concerning lack of quality research. The most obvious thing our review has shown is that there is a desperate need for quality, UK based research.

We would also hope that it would be recognised that:

  • An Erythema Migrans rash is diagnostic of Lyme and treatment should start immediately.
  • There is no test currently available in the UK which can discount the possibility of Lyme disease, therefore diagnosis should be on a clinical basis, only supported by, not limited by testing, and patients informed of the limitations of testing.
  • Lyme disease is a serious condition and left untreated or insufficiently treated can lead to ongoing symptoms, therefore it is critical patients receive sufficient early treatment and awareness improved both with the public and medical professionals.
  • There is evidence to demonstrate that Lyme disease is transmitted through the bite of an infected tick or congenitally from mother to baby, which should inform diagnosis. However, as ticks are small and bites normally painless a patient not recalling being bitten should not be taken to suggest Lyme disease is not possible.
  • Whilst there is a lack of evidence for what treatment protocols should look like for Lyme disease patients, there is evidence to demonstrate persistence. In the absence of sufficient research, the decision on the length of antibiotic treatment ought to be left up to each individual doctor. We would hope for high quality conversations to take place between Lyme disease patients and the right specialists. Whilst the NICE guidelines are unlikely to force doctors to prescribe long duration treatment, they should open the door to make it possible on a case by case basis.
  • Finally, we would hope that the findings from the three government reviews are incorporated into the guidelines ensuring that regardless of doctors preconceptions patients are always treated with respect and empathy and we see an end to patients reporting experiences such as these reported by our members.