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PACE Trial and PACE Trial Protocol

Discussion in 'Latest ME/CFS Research' started by Dolphin, May 12, 2010.

  1. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    Interesting thought. I am not much worse than I was when I first became ill - 18 years ago - but people of the same age without ME will on average have been deteriorating with age, so I am now probably closer to normal health than I was 18 years ago!
     
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  2. user9876

    user9876 Senior Member

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    I just saw this paper which talks about the need to manage expectations in control groups. I've ony read the abstract though. PACE seems to two or 3 different levels of expectation with CBT/GET being sold as a cure. APT being sold as a management technique which might let the body recover naturally and finally SMC being symptom management.

    http://pps.sagepub.com/content/8/4/445.full.pdf html

     
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  3. EllenGB

    EllenGB

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    PACE did not use the London criteria (any incarnation), nor other criteria for ME. We have no idea, therefore, if any participant had ME.
     
  4. Dolphin

    Dolphin Senior Member

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    Not to do with the PACE Trial, but thought I'd post it somewhere, but didn't think it deserved its own thread:

     
  5. biophile

    biophile Places I'd rather be.

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    I tried looking into this a while ago and the two versions (original vs PACE) were not quite as different as I initially expected. The overall difference seems to be clinically contextual rather than clearly mandatory. However, these differences are still potentially significant when used by PACE, because the clinical assessments used in their trial could have increased the chances of patients who would otherwise meet the London criteria on its own from being excluded.

    There are 5 major LC criteria and these are essentially identical between the two versions, except for the possibility of #3. Here, both versions state that, "Fluctuation of symptoms, usually precipitated by either physical or mental exercise.". Version 2 however adds that, "The usual precipitation by 'physical or mental exercise', should be recorded, but is not necessary to meet the criteria." Whereas version 1 states later that "it is absolutely characteristic that they tend to be exacerbated by physical or mental exertion and the association should always be sought whilst taking the history".

    Therefore, version 1 places more emphasis on the existence of post-exertional symptoms than the version 2 used by PACE, the latter which only requires "exercise-induced fatigue" or increased fatiguability compared to pre-illness.

    Furthermore, version 1 includes dozens of additional (but non-mandatory) minor symptoms and even signs which are not mentioned at all in version 2. Again, these are not mandatory, but "in the right symptomatic context they contribute to the validity of the diagnosis", something which would have been difficult to standardize for a trial.

    The interesting thing about these, and the further section on exclusions for the purposes of research, is that we get a sense of what symptoms and signs are allowed in ME according to the London criteria, whereas during the medical assessments employed in the PACE Trial, some of these same symptoms and signs may have increased the chances of being excluded from the trial. That issue however is another whole can of worms.
     
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  6. Valentijn

    Valentijn Activity Level: 3

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    Amersfoort, Netherlands
    Morocco? I thought they preferred Afghanistan :D

    Still seems like they're going very far away from anywhere where there would be any interest it.
     
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  7. biophile

    biophile Places I'd rather be.

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    Evangelism takes people all over the world!
     
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  8. user9876

    user9876 Senior Member

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    Don't forget that in PACE patients had to meet the Oxford criteria so where they also report on other criteria they are talking about the intersection between Oxford and London or Oxford and CDC. I'm not sure if that would make a difference but it could have lead to people with certain groups of symptoms being filtered.
     
  9. Dolphin

    Dolphin Senior Member

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    This is being discussed on this PR thread: http://forums.phoenixrising.me/inde...linic-for-august-is-cfs-me-fibromyalgia.24156 so perhaps best to discuss it there.

    August 19:

     
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  10. biophile

    biophile Places I'd rather be.

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    Too much of a burden for ME/CFS patients, or for the claims of CBT/GET proponents?

    actiwatch-plus.jpg

    CBT/GET proponents have been claiming, implying, or alluding, that these therapies increase physical activity levels. Actigraphy by actometers is an objective measurement of physical activity, and would help to resolve the controversy.

    The PACE Trial originally intended on using actigraphy for one-week at baseline and as a followup outcome, but the latter was dropped because supposedly, after adding on more questionnaires to the trial protocol, it would have been too much of a "burden" for participants to wear the actometer at the end of the trial. The ethics committee said something should be discarded, and according to PACE, the "most logical" measure to drop was actigraphy, rather than any of the dozen or so questionnaires, and Action for ME while collaborating with them had agreed that this decision was "sensible".

    But what do these devices actually look like? Is a small light watch-size device really that much of a burden to wear around the ankle for one week? There are plenty of images of actometers on the internet, but it would be better to look at the ones used in the PACE Trial. The PACE Trial Identifier mentions the purchase of "12 'Actiwatch Plus' activity sensors (Cambridge Neurotechnology)". The complete PACE Trial protocol also mentions pressing the button of the "actiwatch" when going to bed and when waking up.

    I recently tried and had some difficulty finding a photo of the same "Actiwatch Plus" devices by Cambridge Neurotechnology, used in the PACE Trial, because PACE purchased the devices years ago and the product line was acquired by another company (Philips Respironics) and both them and the original company (Cambridge Neurotechnology, now "CamNtech") have a new range of updated products which may or may not be of similar appearance.

    All I could find was this with a bit of luck ( http://www.sen-instytut.pl/sleep_laboratory.html ). The text reads "devices for actigraphy (Actiwatch Plus, produced by Cambridge Neurotechnology)".

    Apparently this is what PACE claimed was too much of a "burden" for trial participants. However, as actometer data from similar studies demonstrated no such increases in physical activity levels (data which PACE may have been aware of), which challenges the way that CBT/GET has and is still being promoted to ME/CFS patients and the public in general, perhaps it was more likely that these actometers would have been more of a "burden" to the credibility of previous claims.
     
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  11. biophile

    biophile Places I'd rather be.

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    Re this: http://www.talkhealthpartnership.com/online_clinics/PACE_TRIAL_info.php

    Was too much to respond to in one day, but there was at least one false statement made in the safety paragraph:

    This contradicts their own 2011 Lancet paper, which states that:
    "There were more serious adverse events in the GET group than there were in the SMC group (p=0·0433)."

    I attempted to discuss the safety issue in more detail here:
    http://www.talkhealthpartnership.com/forum/viewtopic.php?f=451&t=4827&p=14076#p14076
     
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  12. biophile

    biophile Places I'd rather be.

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    A recent large study revealed high levels of physical inactivity in the UK, when measured by telephone survey.

    http://www.bristol.ac.uk/news/2013/9641.html

    "Overall the team found fewer than ten per cent of the adult population in England who can walk do not even walk for five minutes continuously in a four-week period and nearly 80 per cent of people do not hit government physical activity targets of moderate exercise at least 12 times in a four-week period. Forty-six per cent of adults had not walked for leisure for 30 minutes continuously, while 88 per cent had not swum and 90 per cent had not used a gym. Around 20 per cent of the population over the age of 16 do minimal levels of physical activity."

    Shopping activity was not counted as walking.

    Also note that there is a difference between activity recommendations and minimal national targets.

    In the full text ( http://www.bristol.ac.uk/cmpo/publications/papers/2013/wp311.pdf ) I also noticed this citation:

    "By an objective measure (using accelerometers) only 6 per cent of men and 4 per cent of women reach the UK’s Department of Health’s recommended levels for activity and over one quarter of the adult English population is obese and 44 per cent of men and 33 per cent of women are overweight (Department of Health, 2011)."

    [Aside: According to PACE logic, surveys are more reliable than objective accelerometer data!]

    New activity guidelines for the UK were published on the 25th July 2011:
    https://www.gov.uk/government/news/new-physical-activity-guidelines

    "Adults (19-64 years old) and older people (65+): 150mins - two and half hours - each week of moderate to vigorous intensity physical activity (and adults should aim to do some physical activity every day). Muscle strengthening activity should also be included twice a week."

    The GET therapist manual for the PACE Trial states that:
    http://www.pacetrial.org/docs/get-therapist-manual.pdf

    "Apart from improvements in CFS/ME and function, a major objective for GET is to undertake the amount of exercise recommended for full health and prevention of disease. The quantity of exercise recommended by the Chief Medical Officer (2004) is 30-45 minute sessions of moderate intensity physical activity at least five times a week."

    This above information provides useful context for the physical function UK population normative data used by PACE.

    On the recent NHS online CFS/FM/ME clinic forum, Jessica Bavinton claimed that the physical function subscale of SF-36 health survey was a measure of physical activity. However, strictly speaking it is a measure of impairment not activity.

    PACE used an absurdly low threshold for "normal" physical function i.e. 60/100 points. This is several standard deviations away from average for healthy people of middle-age. Their justification for changing it from 85 to 60 appears to be based on a schoolboy error of interpreting statistics, something which reflects rather poorly on the trial and those involved.

    Suppose in reality about 92% of the working age population without chronic illness are scoring at or above 85/100 points in physical function and the median (middle score) is 100/100 or the maximum score. The majority of the UK population are also physically inactive, even though at least half are scoring 100% in physical function. Scoring 85 is obviously no guarantee that a PACE Trial participant was physically active or came anywhere near achieving the GET goal.
     
  13. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    If fewer than ten per cent of the adult population in England who can walk do not even walk for five minutes continuously in a four-week period, that means that at least 90% do walk for five minutes continuously! I have to assume that this is an example of very poor grammar (which one should not find on a university website) and means that fewer than 10% do walk for less than 5 mins continuously. Ah yes - the full text says "About 8 per cent of the adult population that can walk do not even walk for five minutes continuously in a four-week period."

    But it appears that the research data were gathered via survey. It would be interesting to see results from similar research questions using objective measures.

    And shopping is not walking? What about housework, DIY or gardening? Catching buses and trains commonly involves at least 5 minutes continuous walking. I can't think of anyone I know who does not walk for at least 5 minutes continuously in a four-week period.

    I recall recently seeing something to the effect that housework is now considered to be exercise or activity.
     
  14. biophile

    biophile Places I'd rather be.

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    @ MeSci. I do not yet know exactly what was counted or not, but it looks like gardening was counted.
    I lazily lifted the shopping comment from a news article:
    http://www.theguardian.com/society/2013/aug/10/uk-exercise-levels-low-targets-fitness

    "The study found that nearly 80% of the population fails to hit key national government targets – performing moderate exercise for 30 minutes at least 12 times a month. It found that just over 8% of adults who could walk had not – with the exception of shopping – walked continuously for five minutes within the previous four weeks, while 46% had not walked for leisure for 30 minutes continuously over the same period. Almost nine out of 10 had not swum and a similar proportion had not used a gym."

    I agree the results would underestimate the level of physical activity. The researchers mention the possibility.
    Here is some more extracts from the full text ( http://www.bristol.ac.uk/cmpo/publications/papers/2013/wp311.pdf ):

    "Second, the data set identifies around 300 separate physical activities so we can focus our study on the most common physical activities and can undertake separate analyses for physical activities that differ in their direct cost, allowing us to go some way in separating out a price effect from an income effect."

    "The survey covers a wide range of recreational activities (including gardening) but does not ask explicitly about occupational physical activity or housework. An analysis of 14,018 adults in England found the contributions of occupational physical activity to meeting government physical activity targets to be socially patterned (Allender et al., 2008). When occupational physical activity was included, men in manual jobs were more likely to meet government targets than those in nonmanual jobs. Similar patterns were observed for women. This omission means that our data may lead us to under-estimate the amount of physical activity and possibly also over-estimate the SEP gradient in total physical activity. However, within the large set of common physical activities that we examine this bias should not be present. Further, to partially circumvent this problem we include analysis of a very marginal level of the most common physical activity (whether the individual has walked for five continuous minutes in the last four weeks)."

    For many ME and CFS patients, any physical activity at all is significant, and 5 minutes of continuous walking may be actively avoided where possible on purpose to prevent adverse effects.
     
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  15. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    True, of course. I also think that having ME/CFS makes sufferers more aware than most of how much exertion is involved in basic everyday activities, as we tend to struggle with them.

    I have to express considerable scepticism about the validity of government targets, bearing in mind the rubbish they give us about food, and the constant shifting of guidelines about alcohol, for example.

    I doubt whether a particularly high percentage of the population is as sedentary as this report suggests. If the concern is obesity, exercise is by and large irrelevant anyway. There is plenty of research that has found no significant link between the two.

    I like this bit from your 2nd link:

    No! Men in manual jobs are more active? Who would have guessed that? :lol: Having just watched builders battling through a heatwave doing some work for me, I sort of guessed that that was the case!
     
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  16. Dolphin

    Dolphin Senior Member

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    (I'd love to be able to exercise). Anyway, just thought I'd post this:


     
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  17. MeSci

    MeSci ME/CFS since 1995; activity level 6

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    I note that that one of the researchers comments on the issue that immediately sprang to my mind:

    In the UK at least, the poorer you are the shorter your life, on average.
     
  18. Dolphin

    Dolphin Senior Member

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    Yes, it may not be well controlled in that way.
     
  19. Dolphin

    Dolphin Senior Member

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    Just to point there's a new PACE Trial paper out (but it's not open access):

    Probably best to keep most/all discussions on it to this thread: http://forums.phoenixrising.me/inde...eatments-in-the-pace-trial.24886/#post-380652
     
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  20. Dolphin

    Dolphin Senior Member

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