When, as a patient, you had treatment for Lyme disease, what was the outcome of that treatment? Did you completely recover and return to your normal health or did you still feel unwell in some way?
As a GP, when you read the result of a trial of treatment for Lyme disease and it says “there were no treatment failures”, do you think that treatment must be good and your patient who has had that treatment must therefore be cured?
Who defines “cured”? Well, the patient, surely! Ah, well, it isn’t necessarily like that.
In most clinical trials, to see what treatment works best, the people running the trial record the outcomes that they think matter. If they are doctors they are likely to record things they can measure and see – facial palsy, swollen joints, EM rash, reflexes. They do not always consider what matters to the patient for whom pain and poor sleep may be severely affecting their life.
So your facial palsy has resolved, your reflexes are normal and you have no neurological deficits – you can go back to work and carry on with your life.
A lot of studies involve small groups of patients, but they are deemed not to have enough “statistical significance” and they each record slightly different outcomes, so the data cannot be pooled, and we need larger numbers to be more certain about what is happening to patients following treatment.
What do we do about this? LDA is funding a project to define a Core Outcome Set (COS) that we hope will be used in the future by all trials and studies. We shall be seeking the opinions of patients and carers, as well as health professionals, on what you all think are the most important core outcomes that every study should record. This was one of the NICE recommendations for research.
If you might like to participate in the international survey that will take place, register on the Lyme COS website and you will be notified when the surveys go live.
This is an international project and is led by scientific researchers un-tainted by the Lyme disease controversies. They are specialists in helping to define Core Outcome Sets: they have worked with many diseases and conditions and they know what they are doing! This is important, as if we are to make Lyme disease research more useful, this Core Outcome Set needs to be used by the whole international community of researchers. They may not use it if they are not involved, and they will only become involved in the surveys if they can trust the project team to do a good, professional job. It goes without saying that the experience of those who have conducted many studies and trials over the years is of vital importance in getting this COS right.
Health professionals and patients, guided by the researchers, can make sense of this complex task.
For some explanations and videos, see the Comet Initiative website.