Clinical Trial Update November 2009

We know many patients would like to know more about the clinical trial we are undertaking, and how this is progressing, so we have decided to write this update for everyone.

Plans for the clinical trial started at the end of 2008, and we began to implement those plans in February 2009. This year so far, we have completed Stage 1. Stage 1 is about putting the procedures in place to actually gather the data from some of the 500 patients that are with the clinic at any one time – a huge undertaking. It takes a lot of time and effort to put the procedures in place to gather data on patients’ treatment progress and success rates. Clinical trials are notoriously both labour and time intensive. Patients might gain some insight into this by understanding the level of time, finances and human resource that has been required to complete this project so far.

One of the main reasons why most clinics never get as far as we have is due to lack of funding. It is ultimately because the management team at the clinic recognises the value of reinvesting a large part of any profits into research that makes it possible for a study such as this to be happening. It should also be noted that any money raised for the clinic’s registered charity is not being used for the clinical trial, but to support additional research beyond just the clinic’s direct treatments.

The aim, quite simply, with the trial, is to assess the differences between those in treatment at the clinic and those in no treatment. We aim to look at the success rate of those in treatment solely with the nutrition and biomedical division, those solely in treatment with the psychology division, and the success rates of patients who receive treatment from both divisions simultaneously. In order to compare this to a group of patients who have not received any treatment – we have set up a voluntary control group of patients with CFS/ME who are not currently getting treatment, but have agreed to fill out questionnaires over similar time periods as the patients in treatment, so we can compare recovery/improvement rates.

Stage 1 – Putting procedures in place to gather data from patients

As there is no official blood test or biomedical marker that is accepted to assess CFS/ME patient improvement rates, we have had to stick to focusing on gathering together scientifically validated symptom analysis questionnaires for patients to fill out so we can monitor symptom progress rates. The excel CFS document that every single patient fills out when they come to the clinic is on the support site and many patients will be familiar with the questions on there. These questionnaires are all scientifically validated methods of evaluating the level of illness in CFS/ME patients. A PhD student from Goldsmith’s University helped us to compile this questionnaire.

We also added one of own questionnaires at the end of this document which we hope to develop called the Maladaptive Stress Response. We did this because generally the official psychology questionnaires are very poor at assessing CFS/ME patients in our experience. The second ME questionnaire which is a word document contains all the detail we need for clinical management and contains the patient sign-off and agreement section to be part of the trial.

All patients fill both questionnaires out whether they agreed to be part of the clinical trial or not in the sign-off section. Patients who do not want to be part of the clinical trial will be excluded from that published data, however we still track and monitor their progress for internal clinical audit procedures by having them fill out the questionnaires still. We want to be able to report results from all patients in the clinic as this is part of our internal performance management strategy.

Our original plan was that all patients are automatically sent the CFS excel doc questionnaire every three months from the date of their initial consultation to track progress rates. Any patient that drops out for any reason is also sent one final CFS excel doc to assess progress, and an online feedback form is sent to them to explain why they have left. So far we have had trouble gathering the quarterly questionnaires from patients – mainly because some patients are too ill/tired or just focused on their recovery to make the time to fill these out. We will be reassessing our strategy in this area to work out a feasible solution going forward.

Bebe Kohlap, the clinic’s Practice Manager, runs the clinical trial management excel doc which tracks all patient start dates, questionnaires sent and monitors and records if any patients drop out. It also tracks who the patient is signed up with (which side of the clinic, which treatment programme and which practitioner).

All the questionnaires for patients are saved in electronic secure online files. We are a paperless clinic so every patient has an online file where all their questionnaires and other data are kept – it can only be accessed by the admin team and practitioners. We try to get all patients where possible to fill out their forms online, but occasionally they need to hand write them so they are posted to the clinic, scanned in and uploaded to the patient files.

Stage 2 – Compiling the data which is now being collected.

So the point we are now at, is that all this data is being collected – but we need the resources in place to start compiling the information from all the online patient files containing their progress reports in the CFS questionnaires.

This data needs to be complied into reports and graphs which show:

1/ Improvement rates per practitioner over 3, 6, 9 and 12 months
2/ Improvement rates per division – over similar time scales
3. Improvement rates of patients who work on both sides of the clinic at once, over the same time scale.
4/ Success rates of different protocols within the divisions for example The 90 Day Programme versus the Telephone Treatment Programme (TTP).

We are in discussion with a PhD research expert at the moment to help us find the right software and human resources to compile this data.

While this major project is underway, we are also looking at publishing smaller case studies, and a dissertation that Niki Gratrix is completing on a smaller group of patients from the nutrition side of the clinic. These smaller studies are very useful to complete as they highlight issues that will need addressing in the larger clinical trial – such as data omission in questionnaires, what information we need to be asking to ensure any published data results are valid, patient compliance issues and so on. These smaller studies are currently being overseen by Dr Shaobo Zhou, Ph.D. M.Med, MBBS Senior Lecturer in Nutritional Science/ Program Manager at Bedfordshire University.

Overall we are pleased with the progress, as very few clinics or practitioners ever get as far as this. We still have a large task ahead of us. We know there will be problems and issues that will arise – for example how do we rule out the possible placebo effect of taking the nutritional supplements if our control group are not given placebo supplements? If a patient has not done well in treatment – how much was it because the treatment didn’t work and how much due to the fact the patient didn’t comply with instructions? So we have many issues to iron out over the coming months and years – however what we can do, is to endeavor to keep these regular progress reports in our newsletters for patients. As always, we appreciate all support and suggestions, and look forward to moving forwards with this immensely exciting and groundbreaking study.

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