Outcome Measures for GET

[Blueskies]

Anyone being offered a relatively new medical treatment for their condition would want to know the potential benefits and potential harms. I know for instance there is a drive at the moment by the Government to make outcomes of surgery in particular hospitals available to the public so they can make an informed choice.

You've discussed the PACE trial results as providing evidence for safe and effective treatment (although my opinion is that the benefits of GET and CBT, from the data the research team has chosen to publish, are underwhelming. I don't think the research team have reported on harms yet have they?).

Anecdotal reports of harm done by GET (which you attribute possibly to poorly trained therapists) are enough to worry anyone when the consequences could be going from moderate to severe. I'd feel pretty scared if the 'dose' I'm given of any medication could be too high or increased too rapidly and I ended up being bed bound for years on end. Surely there should be some 'red flag' safety system in place to alert those who monitor clinics that something is going seriously wrong?

Patient surveys show that some some benefit from GET, some do not and some report a worsening of their symptoms. But we don't know why.

I'd be interested to know if there are any routine outcomes measures collected at clinics, if so, what measures are used to assess efficacy/harms in a clinical setting and if any follow up data is ever collected e.g. at the end of a year, two years. And most importantly is this data accessible to patients to help them decide if the benefits outweigh potential risks and if their local clinic has a 'good track record'.

Actually in my area this query is almost immaterial as the waiting time for referral to a specialist is now standing at a year and the OT team, which apparently was 6 strong, is down to just 1 OT. But I ask for others who stand a chance of being offered GET soon after diagnosis.

[talkhealth]

The PACE trial principal investigators answer questions about graded exercise therapy and the trial

A number of people have asked questions about the PACE trial and, in particular, about whether graded exercise therapy (GET) is a safe and effective treatment. The attached information, supplied directly from the PACE trial principal investigators, briefly describes the trial and its conclusions, as well as providing a link to the trial website where more detailed information and downloads are available.

http://www.talkhealthpartnership.com/on ... L_info.php

[Laurellen]

Whose question did they answer?

We can now see that the PACE researchers have not challenged the facts being reported by critics about the way in which the results from PACE were misleadingly presented, but are just not concerned by them. It seems as if they've completely avoided the specific points that were raised, and instead, have just stated that they prefer to interpret their results in a way which supports their own prior position.

Here are examples of specific questions which were asked, and then locked without explanation:

viewtopic.php?f=494&t=4729
viewtopic.php?f=494&t=4755
viewtopic.php?f=490&t=4604&p=13187#p13187

eg: They again avoided acknowledging that they had redefined 'normal' in such a way that a patient could be classed as having got "back to normal" following treatment, even if their questionnaire scores had actually got worse!

The PACE trial researcher's claim that we do not need to worry about response bias because patients thought APT sounded more sensible prior to treatment ignores the fact that the treatments themselves involved making different claims to patients which would effect their expectations of treatments, and views of symptoms.

If the PACE researchers were really confident in their claims, then they would engage in the specific points being raised by concerned patients, rather than issuing statements and FAQ which ignore the key areas of concern. They would also allow patients access to the data on the outcomes laid out in the trial's protocol, rather than restricting the information available, so as to allow patients to make their own informed decisions about how to respond to their illness.

[Blueskies]

Thank you for the link to the posting by the PACE Trail Research Team PI's.

My query was actually about Clinic Outcomes which I thought would provide additional useful information for people who are being offered GET to help make an informed decision about benefits/risks.

Whilst the talkhealthpartnership clinic was temporarily suspended I managed to find the link to the National Outcomes Database on the BACME website http://www.bacme.info/nod/

Looking at the 2012 Data Report/Excel Spreadsheet I can see that complete data was collected at commencement of therapy from 6,838 patients from 27 centres. Follow up data was collected after 12months from 3,482 patients (51%). If I understood the figures correctly, 1,006 (15%) of those included in the original full data assessment were not classified as having ME/CFS (although I don't know what diagnostic criteria was used).The tables and graphs comparing assessment & follow up data combines the two groups I think?

I can see that data was collected on a variety of measures: SF-36 (Physical Functioning), Chalder Fatigue Score, Visual Analogue Pain Rating, Self-Efficacy ratings, HADS (anxiety and depression subscales), Clinical Global Impression (at 12months) and Epworth Sleepiness Scores.

Do the clinics hold any data on what I believe is a goal of GET i.e. being able to complete 30mins of moderate exercise on at least 5 days a week (on top of normal activity)?

I don't know if anyone has analysed the clinic data and produced a report discussing the outcomes after 12months and comparing clinical outcomes with the PACE Trial Outcomes. If you know of any such report a link would be useful.

What would help me and many others I'm sure, would be more information about who is most likely to gain significant benefit from GET & who is most likely to deteriorate. I hope the PACE Trial Team & whoever oversees NOD Clinic data will be able to look at predictive variables for outcomes e.g. ME/CFS diagnosis vs other illnesses involving fatigue, severity of illness at commencement, duration, expertise of therapist, etc etc & publish their findings in the near future.

[Blueskies]

For Information: I've been pointed in the direction of a paper by Crawley et al. (2103) which looks at clinic outcomes and concludes that fatigue, pain and disability at assessment are predictors of outcomes at 8-20 month follow up.

http://www.ncbi.nlm.nih.gov/pubmed/23538643

[Blueskies]

Whoops. Obviously unless I'm in some weird time travel scenario I mean 2013 not 2103.

[Blueskies]

I've just had a look at the Crawley paper too. If I've understood it correctly the outcome measures are for all services combined, so they could relate to 'CBT, GET, a combination of both or activity management, in group and/or individual treatment sessions of varying number and lengths'. It appears that the data collected by the clinics cannot be analysed by type of therapy offered.

Patient-level treatment data were not collected by the NOD and therefore we cannot be certain what was provided

It's a shame that the recording of data from clinics wasn't managed in a better way so that it could be determined which particular service if any led to better/worse outcomes.

I also noticed the paper didn't include the Clinical Global Impression (CGI) as an outcome measure. The median outcomes for 601 patients attending 10 clinics was '3' = A little better. I had a look at the histograms on the NOD Excel Spreadsheet & at a very approximate guess I'd say around 30% of patients reported they were 'Very much or much better' at follow up, 60% 'a little better/no change/a little worse', and 10% 'much worse of very much worse'. It would be good to know what the predicting variables for the CGI were.

I think it is really important that services should be offered to those who are most likely to benefit in a way that is meaningful to the patient. I imagine it would be more satisfying for the therapists working with patients too if better outcomes could be achieved. It's even more important to try and identify why some patients are becoming much worse or very much worse after treatment.

My own personal take on GET is that it is of benefit to those who are essentially 'well' but deconditioned and possibly fearful of exercise/activity but of little benefit and potentially very harmful to those who are 'ill'. There is plenty of biological evidence to show that people with M.E. are not essentially 'well'. The false illness belief model and the therapies based on this model are not appropriate.

[Blueskies]

I know I have managed to find answers to some of my queries about GET.

If an expert can answer the unaswered bit of my query before the clinic shuts down that would be great.

1. Do the clinics hold any data on what I believe is a goal of GET i.e. being able to complete 30mins of moderate exercise on at least 5 days a week (on top of normal activity)? If so, what % of the 834 patients who attended clinics and completed follow up achieved this goal?

Thank you once again for putting on this online clinic and to all the 'experts' for volunteering their time. Thanks especially to Dr Shepherd who has replied to an astounding amount of questions in a very helpful & informed way.