Reports by the actual PACE trial participants

[Countrygirl]

https://b1ad200d-a-62cb3a1a-s-sites.googlegroups.com/site/pacefoir/pace-trial-participants-experiences.pdf?attachauth=ANoY7cr7KqSV6wrzLdVNHbzEYMLo1stCUb6RRiFy6FXfUnIHe-imQQjqXbUQs_lO_t34lPqogYh1z6sGrsnh-58yGfOUcpRkDProQj5p_FazctL4C7uOn_uICW7IXece06x5Cw4IeeNh1GF74Q4tE7X5D7fNGcrKVOwrf8rxMNGAsGiXoRfu6zB1mxQ1KF4CQb4qp1ZFyGf_z0mDN8_vzvsJY6xRr4CQZKIkmLpMS_ZauTSndzSEF2k=&attredirects=1

FOR THE FIRST-TIER TRIBUNAL (INFORMATION RIGHTS) CASE EA/2015/0269 Due to the unsettling but unsubstantiated assumptions and allegations being made within QMUL's submissions that ME/CFS advocates wish to track down and harass or harm participants of the PACE trial, I have attempted to find out what actually happens when individuals (voluntarily) claim in public to have been PACE trial participants. To inform the tribunal, I have collated publicly posted comments from those who reported being participants of the PACE trial, and the responses that they received. QMUL’s assertions, with regard to this issue, never seem to be supported by the evidence I have collated. Instead, their claims, to the best of my knowledge, are based on no more than speculation and (in my opinion) raises the question of whether the trial investigators have allowed a degree of prejudice to colour their submissions. The publicly available evidence, that I have been able to find, shows the opposite of their claims.

I took part in the pace trials and gave up after a few months. Done more damage than good. Utterly horrendous and now I've learned to live with and understand my illness I'm baffled that they even suggested it to people who suffer with this. 2 busses to get there, an hour or 2 in the hospital and 2 busses back, it took me a week to recover. Obviously created by people who have no understanding of ME.

At the start of the trial, I had to wear an accelerometor thing for a week, presumably to measure activity levels. But at the end of the trial, this wasn't repeated. The fitness tests measured the number of steps I could do in a set amount of time, but paid no attention to the fact that I usually couldn't walk for 2 days after these assessments. The 'handbook' I was given contained an incredibly flawed model, which GET is based on, which basically goes 'felt a bit ill - led to resting too much - led to deconditioning - led to the ME/CFS symptoms'. This completely ignores the fact that the vast majority of people don't rest early on and carry on pushing themselves despite severe pain and fatigue. I would suggest that the criteria were so vague and the assessment so poor that a majority of the people who recovered using GET never had ME/CFS in the first place.

a) The therapist misled me by saying he had a 99% recovery rate. b) He could not answer basic questions as to how he measured recovery.

I took part….I collapsed on week 3….Several of us had serious relapses. And when I was reduced to lying in bed every day, in pain, unable to do a thing for myself, these researchers did not want to know, believe me. I was on my own when it came to trying to undo the damage.

d. Only the Cfs patients found long term benefit from the treatments. The trial did not differentiate between these illnesses in it's trial or it's conclusion. I believe this will leas to patients with ME rather than CFS actually being mistreated and potentially harmed by being associated with treatments only suitable for CFS patients. Tragically this will also lead to a lack of investment in research to the causes of ME and any hope of a genuine treatment.

I was referred to the Sussex ME Service and after a year on the waiting list I saw Dr Broughton, who carried out an extremely thorough consultation and confirmed the diagnosis, also ruling out depression.

He suggested that I consider taking part in the PACE trial, on the basis that I could help to contribute to meaningful research into the treatment of ME/CFS, whilst receiving a course of treatment for 12 months. I was assured that at the end of the trial period I would be offered the choice of further treatment from the selection offered under the trial. I was randomly selected for the Graded Exercise Therapy (GET), and initially I was hopeful that I could slowly increase my activity and use this as a route to recovery — I always maintained a very positive attitude.

My exercise program consisted of walking approximately 50 metres in the morning and 50 meters in the afternoon, and the plan was to slowly increase the distance over the year, aiming to be able to complete approximately 600 metres, twice a day. After a promising start I suffered my first setback, and rang for advice, and was told to continue with the daily exercise despite feeling so unwell. I was provided with a heart rate monitor at the start of the trial period and had been monitoring this daily while I walked (recording the resting heart rate beforehand, the highest recorded rate during the walk, the rate at the finish, and the time taken to return to the resting rate).

My heart rate was showing higher readings as the trial progressed and I became more and more unwell as the exercise continued daily. I was reporting back to a physiotherapist and after several months with this trend increasing she did say that they had not expected this result from the heart rate monitor — and several times asked me to re-turn the monitor as she felt these results did not bring anything useful for the trial, so she suggested we stop keeping records of the heart rate readings. I refused as I felt they were important and did not under-stand how a medical trial could possibly be impartial if the criteria were changed to ensure only expected results were recorded? I'm not an expert, but I certainly felt that my results were not being viewed impartially.

As the study continued I felt increasingly unwell and my own conclusion is that GET was harmful for me. When I received a report at the end of the trial it stated that nobody was harmed by GET, and I question the interpretation of my personal results. Also, I felt that the purpose of the trial seemed to be to get ill people to work, rather than to find ways to improve their health and wellbeing.

Personally, I found the PACE trial set me back by several years, and improvement since has been very slow. I declined the offer of a different course of treatment, as the travelling was onerous and opted instead to be returned to the Sussex service. However Dr Broughton had left the service and there was very little help forthcoming.

My GP oversaw my care, and whilst he was very kind, he did not have any specialist knowledge of ME/CFS. Since then I have undertaken a course of 6 individual sessions of Cognitive Behavioural Therapy (CBT), which served to confirm that I had a positive attitude towards my illness, with realistic expectations. However, there was nothing in the course that helped me to improve my health, so I would say it was neither helpful nor harmful.

ME mild before course, became severe after course. Symptoms very much worse after. Course not appropriate to needs. As it was part of the PACE trial, a strict agenda was adhered to with no deviations. Also, the physio was not allowed to comment on any symptoms I may have had between sessions or as a result of treatment. The course was weekly for 4 weeks, fortnightly for 10 sessions and a last one 3 months later.

 

[Countrygirl]

After reading the above document this letter written towards the end of last year to Prof Crawley, which quotes some of her previous responses, makes for very interesting reading.

http://www.bristol.ac.uk/media-libr...mation of favourable opinion 24.11.16 (1).pdf

You (EC) provided a written response to the above claims and advised that the recent re-analysis by the PACE authors of primary outcomes, as written in the original protocol were consistent with their original interpretations and that they concluded ‘In summary, these results support our initial interpretation that CBT and GET can be safely added to the SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition’. Your response stated that results from PACE and the wider world literature show that patients are more likely to improve with exercise therapy compared to either medical care alone or medical care plus pacing as given as a therapy.

Your (EC) written response stated that there was no evidence of a significant risk of serious, long lasting harm and that the best quality evidence is from systematic reviews of high quality research which would be relied upon in preference to patient surveys in evidence based medicine. Your response stated that the largest systematic review to date was the Cochrane review which looked carefully at harm and side effects in 1518 patients and concluded that no evidence suggests that exercise therapy may worsen outcomes. Your response advised the Committee that the MAGENTA trial had an independent Data Safety Monitoring Committee (DMSC) appointed by the NIHR which funded the study. The DMSC had reviewed the accumulating data relevant to Magenta which included serious adverse events and all instances of deterioration in the SF-36-physical function subscale in either treatment arm and concluded that the data did not suggest evidence of any harm in MAGENTA.

You (EC) responded that informed consent is taken very seriously. It addition to patient information leaflets all participants discuss MAGENTA with the recruiting clinician with a further lengthy conversation with the research nurse to ensure that the information provided is balanced and considered. The information sheets are also discussed at length with a patient advisory group which included children and teenagers with CFS/ME, their parents, adults who developed CFS/ME as a child and the Chief Executive officer from the largest paediatric charity: The association for young children with ME. Your letter advised that you had used GET (as recommended by NICE) in your specialist paediatric CFS/ME service for nearly a decade and after over a year of running MAGENTA and a careful review of both the qualitative data and independent review by the DMSC you were more convinced that children and teenagers were not harmed by GET when delivered by specialist trained therapists.

 

[Barry53]

Not only evidence of detriment/harm, but out of the PACE trial itself.

Also indicates that the majority of people who dropped out probably would have scored badly, if the trial had been properly run and such factors taken honestly into account.

 

[Esther12]

Interesting stuff, and great for undermining the fears QMUL were trying to generate at the tribunal, but also it's worth being a bit cautious about anecdotes of any sort on the internet. It's possible some of those people have half remembered things from years ago... eg: maybe they were doing some trial that was only similar to PACE?

 

[Barry53]

Interesting stuff, and great for undermining the fears QMUL were trying to generate at the tribunal, but also it's worth being a bit cautious about anecdotes of any sort on the internet. It's possible some of those people have half remembered things from years ago... eg: maybe they were doing some trial that was only similar to PACE?

Agreed. On the one hand such accounts would have to be properly verified. On the other hand there are major privacy issues - would be very wrong to presume that just because someone went public on social media a while back, they would necessarily wish to take anything further.

 

[RogerBlack]

I somewhat object to the line 'patients with CFS benefited, I had ME'.
As of course patients may have been diagnosed with either depending on the symptoms just based on date.
I wonder if as a participant, one can in principle request their information under FOIA.

 

[user9876]

I wonder if as a participant, one can in principle request their information under FOIA.

It would be under the DPA (Data protection act) which used to and may still have some medical exceptions. There can also be a small charge,

 

[trishrhymes]

I somewhat object to the line 'patients with CFS benefited, I had ME'.
.

I suspect the patient was simply trying to highlight the fact that some patients had chronic fatigue, but not ME - they may have been aware of other patients in their treatment group who did not have PEM, for example. In such a brief comment, we cannot expect patients to get the terminology and definitions exact. After all, the researchers were using a research definition we don't accept as valid - veering between chronic fatigue, CFS and ME to suit themselves.

 

[Barry53]

I wonder if as a participant, one can in principle request their information under FOIA.

There is also the possible scenario that such a thing might be technically/legally feasible, but might nonetheless put a participant in a stressful situation themselves - the exact personal details are not necessarily for us to know. I think that whatever might be considered, participant well-being has to be the number one priority. If however, it could be confirmed that a participant freely agreed to assist, then any of the other legitimate options should be up for grabs.