Tory Majority Day 87: PACE Trial 2 – Why Wasn’t My Experience Of Attending An NHS CFSME Clinic Evaluated?

This is a follow up post from yesterdays about the PACE trial. 

It could end up being quite technical so I’ll keep it short for those of us with brain fog or who don’t come from a health care background or aren’t that interested in research full stop!

Outcome research is carried out in health care settings

In a nutshell it is a particular type of research that is carried out after a patient or patients receive treatment, in order to evaluate it to discover how effective it is.

Say, for instance, you are going to have an operation on your hand.

The operation is already supported by good clinical research – this is called clinical evidence – but it’s a new treatment and there’s an old treatment that is more routinely used.

In order to follow up whether the new operation works, researchers will do an outcome study.

They’ll design the outcome study to follow up patients that have had the operation at certain points after their surgery.

It will be done formally, with a proper research team. The research they collect will be fed back to inform the treatment providers, clinicians, patients and commissioners.

It says: “asking about whether treatment works or not, doesn’t stop when it’s rolled out in the NHS. We check further down the line too.”

Outcomes research can happen independently of any other sort of research.

It’s very good for capturing a wider view of how people have responded to treatments who did not belong to an original clinical trial like the people who were in the original PACE trial.

It widens the feedback.

Outcomes are also measured within research design

We know about this in, for instance, the research into Rituximab. 

Here the outcomes that were measured were set at certain points after the patients received Rituximab. It’s these outcomes that inform the researchers as to how effective the medical trial of Rituximab was.

The first type of outcome research can happen at any stage after a treatment programme has happened. It isn’t ‘bolted on’ to a piece of research like it is in the Rituximab trials or any other clinical trial of a drug or treatment.

Clinical trials will need outcomes measured because it’s that that helps people work out if something like a new drug works or not.

They finish when the clinical trial has finished.

Outcomes measured in research only measure the outcomes for the people involved in the trial, like the people in the PACE trial. 

Then there are patient evaluations…

Patient evaluations are collected from individuals or groups of people undergoing treatment or after they’ve finished a treatment.

You’ve probably had an evaluation form put into your hands at some stage of your life, maybe at your GP’s.  They are not as ‘formal’ as outcome research but they are important.

They are collected, then collated, then they are written up in reports and fed back into teams and services.

Clinical team Managers want to see them and pay attention to them. They provide a more informal record of things that might be coming up for patients.

Evaluations are a bit like market research.

Why are you bringing this up in context with the PACE trial? 

Well the PACE trial didn’t have to be the last time patients were asked questions by an NHS team about how effective CBT and GET is. It didn’t have to stop there, in other words.

An outcome study could have been carried out by any of the NHS clinical services across the UK who use a combination of CBT and GET in the treatment of CFSME patients.

If that was too time consuming and onerous, at the very least patients could be evaluated.

Those evaluations would have shown that there were problems with outcomes for MECFS patients undergoing GET and CBT, despite what the PACE Trial said.  

Here’s where this gets…personal…for want of a better word. 

I’ve attended an NHS CFSME service. I was a patient of theirs for a long time.

During that time I undertook various treatments, including Graded Exercise Therapy and a 8-week CFS Management Group ( CMG) run by the clinical team in the clinic.

I started the CMG with very positive intentions. I believed that the CMG would, as I’d been told by my case worker within the team, give me the tools to manage my health condition.

3 weeks into the CMG not only was I totally unconvinced of that, but the journey to the clinic and the 2.5 hours sitting in a stuffy room having to concentrate on the material being presented got to me. My symptoms started to get worse.

I missed my first session in week 4. I was really struggling but their message about attendance being crucial had hit home and I felt I had to struggle through as it was the one and only chance I had to ‘learn how to deal with ME.”

I went back for the next session, week 5, and I remember sitting there feeling the way I feel when I have post-exertional malaise.

My mind wasn’t clamping onto anything I was being told because it was being delivered in a way that simply didn’t allow for the fact that the people in the room suffer from brain fog.

I crashed for weeks and didn’t return. I wrote to the team about why I wasn’t returning and at that point I was told something by my friend with CFSME, CB. 

She told me that everyone in the CMG who completed all 8 sessions filled out an evaluation form.

She said that the team told her it was only the people at the CMG who attended all sessions and finished the CMG who were being evaluated. 

Now CB doesn’t come from the same professional background as I do, so she didn’t understand my reaction, which was to say: “What the f**k??”

I explained why. It’s important to evaluate ALL patients that have experienced a treatment, whether they complied with the treatment (that means attended, followed advice and finished the treatment programme) or not.

By excluding CFSME patients like me, who weren’t able to continue with the CMG because attending it made me iller, it automatically skews the results,  as any researcher will tell you.

Then I got a letter from my case worker. The letter said: “She was unable to continue to attend the CMG because she attributed attending the group to an increase in her symptoms.”

WTAF. I didn’t ‘attribute’ the increase in my symptoms to attending the CMG, the CMG was the only thing I was capable of doing at the time, I was so ill. My entire week was affected by going to it. There was no travel apart from public transport, I’d feel crap while I was there, of course, but afterwards I’d collapse for days.

Any post-exertional malaise and brain fog I felt and the subsequent crash I experienced after attending was down to one thing only – attending the C.M.G.

Why wasn’t I evaluated? 

At no point during the time I was a patient at the NHS CFSME clinic was I handed an evaluation form. Not even after I did Graded Exercise Therapy. To remind anyone reading, I stopped GET when I had an injury. I told the physiotherapist of this, and was asked why having an injury would stop me from doing exercise?

My experience of increasing symptoms through attending the CMT will never be formally captured, neither will the experiences of the other people who didn’t complete it either.

CB told me that only half of the CMG who started the group finished it. So in one cohort, that’s a 50% compliance rate. That’s also only 50% of the people who were evaluated. Accepting that some of that 50% won’t have returned a form, that’s not a high number of evaluations as a percentage of patients who started the CMG.

The interaction with the physiotherapist who suggested that I could continue exercising and didn’t ask the extent of my leg injury before giving me that advice, will also never be fed back.

I think this is blatant gerrymandering of patient evaluations in order to capture the opinions of those most capable of attending an 8 week CMG.

The evaluations will capture those that are likely to be higher functioning MECFS patients. This is called research bias.

When this data is fed back to the clinical managers, were the managers aware that people are being selected based on criteria that automatically show a bias?

If so, what does that say about the clinical managers’ interest in hearing views from the broader patient group or the team in hearing things that did not necessarily support their treatments?

Why isn’t everyone being evaluated? 

The answer? Because I suspect it was like those capable of continuing through the PACE trial. If you were able to comply with the treatment there, you were probably self-selected into a higher functioning ME CFS cohort. That also skews results and shows bias.

I think that if everyone who attended the CFSME service was evaluated for their opinion and experience, it would be like chopping down a tree at it’s roots. It would have toppled over.

Then the NHS would have to admit that the only treatment they can offer MECFS patients has serious concerns attached to it regarding the the research that underpinned it and therefore patient safety.

My post yesterday was opinionated about how much having MECFS has changed my previously positive view of the NHS for the worse. I’m not kidding. Even if I was well enough, I’d never return to working in the NHS, so unsupported I’d feel being a working health care professional with MECFS.

Not being evaluated because I didn’t complete the C.M.G. is one of the cuts in the tree trunk where my professional respect also used to be.

Good news …

In April this year, Healthwatch Trafford launched a patient survey  which asks people with CFS ME to say how they experience services in the area.

This is a VERY GOOD IDEA! If I was on Facebook right now I’d click ‘like.’

To every other NHS CFSME service – it’s time for you to do the same.

ALL PATIENTS WITHIN NHS CFS ME SERVICES SHOULD BE ROUTINELY EVALUATED

Then we’d have a much faster, honest and wide ranging feedback that would successfully underpin the criticisms of the PACE trial.

© Lindy 2015

Addendum: this post was edited to remove all the errors that having Brain Fog caused when it was first written. 5/11/15. 15:30pm.