1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
Hunting down the cause of ME/CFS & other challenging disorders - Lipkin in London
In a talk to patients in London on 3rd September, Dr. W. Ian Lipkin described the extraordinary lengths he and his team are prepared to go to in order to track down the source of an illness, with examples ranging from autism to the strange case of Kawasaki disease.
Discuss the article on the Forums.

PACE Trial and PACE Trial Protocol

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

  1. Dolphin

    Dolphin Senior Member

    Messages:
    6,824
    Likes:
    5,933
    http://www.goodmedicine.org.uk/stre...emotion-processing-chronic-fatigue-syndrome-c

    I'm not sure if this has been posted before. It's one of the few references I've seen to the step test, the results of which have so far not been published. The walking test is presumably the six-minute walking test.

     
    Valentijn likes this.
  2. Simon

    Simon

    Messages:
    1,454
    Likes:
    4,639
    Monmouth, UK
    Initially I thought this was new info from the Leeds conference, but I'm pretty sure the weak correlation of walking/step testis with WSAS is was from that Cella paper. In Table 1 it gives the correlations with the WSAS as:
    6MWT: -0.261 [which is weak]​
    Step test: 0.128 [which is trivial]​
    both results are significant (p<0.001), but that's presumably because of the huge sample size (600+)

    Would be very interesting to see how these objective measures correlated with the self-rated physical function scores.
     
    Dolphin likes this.
  3. Dolphin

    Dolphin Senior Member

    Messages:
    6,824
    Likes:
    5,933
    Additions (this week?) to the PACE Trial manuals page:

    I happened to go back to the PACE Trial manuals page and noticed Word files which I think are recent additions - indeed I was looking at this page last week and don't recall seeing them, but could be wrong on that. But they weren't in a folder I have on my PC for the official PACE Trial manuals so I presume that means they weren't there at the start.


    * parts I think are new
     
  4. Dolphin

    Dolphin Senior Member

    Messages:
    6,824
    Likes:
    5,933
    user9876

    I came across this note to myself to try to get this paper. As I know you are interested in scales, I thought I'd post it. However I hope you weren't the original source!

    3 "mild" criticisms of the SF-36 PF scale:





    IIRC, Ware was involved in designing the SF36 so he may be biased.
     
    user9876 likes this.
  5. Dolphin

    Dolphin Senior Member

    Messages:
    6,824
    Likes:
    5,933
    I don't think that this point has been made before:

    (I've copied it from this post: http://forums.phoenixrising.me/inde...ronic-fatigue-sabes-figura.22388/#post-341565 )

    This is from this paper:

    Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care.

    The most interesting thing in this paper to me doesn't in fact really relate to this trial specifically, but more to trials in general that use the Chalder fatigue scale, particularly when they use a threshold to signify significant or important changes. For example, the PACE Trial claimed 2 points would be sufficient for a clinically useful difference with large percentages in all groups (incl. the SMC no therapy group) achieving this.

    This paper says:

    Here's the relevant part of their letter (reference 10):

     
    Esther12 and Simon like this.
  6. Graham

    Graham Senior Moment

    Messages:
    839
    Likes:
    2,153
    Sussex, UK
    Thanks Dolphin. I haven't seen that before.

    The results from our survey suggest that, in practice, a change of one point in the bimodal scale is equivalent to two points in the Likert scale.
     
  7. Tom Kindlon

    Tom Kindlon Senior Member

    Messages:
    254
    Likes:
    786
    [​IMG]
    From Tate Mitchell:
    Refs for 6MWT graph-

    PACE 6MWT results before and after treatment- APT 314m>334m, CBT

    333m>354m, GET 312m>379m, SMC 326m>348m

    Kadikar, 1997- Recommended for lung transplant= 400m
    Lipkin, 1986- Class III heart failure= 402m, Class II heart failure= 558m, healthy controls= 683m

    Steffen, 2002- Ages 60-69= 572m, ages 70-79= 527m, ages 80-89= 417m
    Ross, 2010- Various cardiopulmonary disorders. Mean distance for the different disease groups, comprising over 1000 patients, was 393m.
     
  8. Graham

    Graham Senior Moment

    Messages:
    839
    Likes:
    2,153
    Sussex, UK
    In the PACE race video, I said that a distance of less than 300 metres was medically grim. I didn't want to be too specific there, but in fact I read that that was a big indicator on the likelihood of living another year for patients with heart disease: less than 300 the majority died, more than 300 the majority lived (from memory, we are talking of more than three-quarters).

    In the UK, the slowest speed allowed to cross the road at crossings controlled by lights (pelican crossings with the green man) would correspond to a distance of 432 metres. OK, it doesn't take 6 minutes to cross a road, but it is an indication of how poor this speeds are.
     
    Svenja and Dolphin like this.
  9. Bob

    Bob

    Messages:
    8,552
    Likes:
    11,422
    South of England
    PACE Trial - 6mwdt - new version 5.PNG Here's a similar graph, in case helpful for anyone.

    The most objective measure used in the PACE Trial to assess the effectiveness of the interventions, was the Six Minute Walking Distance Test.
    The CBT group achieved no average improvement beyond the SMC control group.
    The GET group made a modest average improvement (35.3 m) (adjusted difference from SMC) beyond the SMC control group after 52 weeks.
    The average distance that the GET group achieved, of 379m at 52 weeks, is still far from what might be considered a common healthy average distance, as shown in the graph.


    References:
    (1) The 6-min walk distance in healthy subjects: reference standards from seven countries.
    Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT).
    1 January 2010
    European Respiratory Journal 2011 Jan;37(1):150-6. Epub 2010 Jun 4.
    doi: 10.1183/09031936.00194909
    http://www.ncbi.nlm.nih.gov/pubmed/20525717
    http://erj.ersjournals.com/content/early/2010/06/04/09031936.00194909.full.pdf html
    Adults without chronic disease, aged 40 to 80 years, across seven countries = 571m

    (2) Six minute walk distance in healthy subjects aged 55–75 years
    Bernadine Camarri, Peter R. Eastwood, Nola M. Cecins, Philip J. Thompson, Sue Jenkins
    Respiratory Medicine, Volume 100, Issue 4 , Pages 658-665, April 2006
    http://www.resmedjournal.com/article/S0954-6111(05)00326-4/abstract
    Healthy subjects aged 55-75yrs = 659m

    (3) Six minute walking distance in healthy elderly subjects
    T. Troosters, R. Gosselink, M. Decramer
    Eur Respir J 1999; 14: 270±274
    http://www.ersj.org.uk/content/14/2/270.full.pdf
    Healthy elderly subjects (50-85 yrs) = 631m

    (4) Inspiratory Capacity, Dynamic Hyperinflation, Breathlessness, and Exercise Performance during the 6-Minute-Walk Test in Chronic Obstructive Pulmonary Disease
    José M. Marin, Santiago J. Carrizo, Manuel Gascon, Andres Sanchez, Begoña Gallego And Bartolomé R. Celli
    Am. J. Respir. Crit. Care Med. May 1, 2001 vol. 163 no. 6 1395-1399
    http://171.66.122.149/content/163/6/1395.full
    Patients with Chronic Obstructive Pulmonary Disorder = 439m

    (5) Six minute walking test for assessing exercise capacity in chronic heart failure
    D P Lipkin, A J Scriven, T Crake, P A Poole-Wilson
    British Medical Journal Volume 292 8 March 1986
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1339640/pdf/bmjcred00224-0015.pdf
    Patients with class III heart failure = 402m
     
  10. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,501
    Likes:
    9,627
    Amersfoort, Netherlands
    Shocking how the 6MWD didn't make it into the determination of "recovery", eh?
     
    Sean, Svenja and Bob like this.
  11. Valentijn

    Valentijn Activity Level: 3

    Messages:
    6,501
    Likes:
    9,627
    Amersfoort, Netherlands
    So Hitler wasn't joking when he said someone's 90 year old grandma could run circles around him :oops:
     
    Shell likes this.
  12. Bob

    Bob

    Messages:
    8,552
    Likes:
    11,422
    South of England
    After seeing Tate's graph, I decided to change some of the category's and research papers that I used in my graph, to enhance its consistency.
    I've also added an extra category of severe MS.
    I don't know which of my graphs is most helpful, but I thought I'd post this one, as I've done the work. I should combine the data contained in both graphs really, but it's too much work.

    PACE Trial - 6mwdt - new version a2.PNG

    References:

    (1) Six minute walking test for assessing exercise capacity in chronic heart failure
    D P Lipkin, A J Scriven, T Crake, P A Poole-Wilson
    British Medical Journal Volume 292 8 March 1986
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1339640/pdf/bmjcred00224-0015.pdf
    Healthy Controls = 683m
    Patients with class III heart failure = 402m

    (2) Six minute walk distance in healthy subjects aged 55–75 years
    Bernadine Camarri, Peter R. Eastwood, Nola M. Cecins, Philip J. Thompson, Sue Jenkins
    Respiratory Medicine, Volume 100, Issue 4 , Pages 658-665, April 2006
    http://www.resmedjournal.com/article/S0954-6111(05)00326-4/abstract
    Healthy subjects aged 55-75yrs = 659m

    (3) Inspiratory Capacity, Dynamic Hyperinflation, Breathlessness, and Exercise Performance during the 6-Minute-Walk Test in Chronic Obstructive Pulmonary Disease
    José M. Marin, Santiago J. Carrizo, Manuel Gascon, Andres Sanchez, Begoña Gallego And Bartolomé R. Celli
    Am. J. Respir. Crit. Care Med. May 1, 2001 vol. 163 no. 6 1395-1399
    http://171.66.122.149/content/163/6/1395.full
    Patients with Chronic Obstructive Pulmonary Disorder = 439m

    (4) Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls
    Myla D Goldman, Ruth Ann Marrie, Jeffrey A Cohen
    2008
    Multiple Sclerosis, April 2008; vol. 14, 3: pp. 383-390., first published on October 17, 2007
    DOI:10.1177/1352458507082607
    http://msj.sagepub.com/content/14/3/383.abstract
    http://pocketknowledge.tc.columbia.edu/home.php/viewfile/download/65399/The six-minute walk test.pdf
    Patients with severe MS = 389m


    Note 1:

    The most objective measure used in the PACE Trial to assess the effectiveness of the interventions, was the Six Minute Walking Distance Test.
    The CBT group achieved no average improvement beyond the SMC control group.
    The GET group made a modest average improvement (35.3 m) (adjusted difference from SMC) beyond the SMC control group after 52 weeks.
    The average distance that the GET group achieved, of 379m at 52 weeks, is still far from what might be considered a common healthy average distance, as shown in the graph.


    Note 2:

    Fewer patients/controls were studied in the categories that I've added to this graph (i.e. 'healthy controls', and 'severe MS'), so perhaps some of the data is not quite as robust as in my previous graph.
    Having said that, the top entry that I used in the previous graph was not demographically representative, because it was taken from a review of research carried out in a number of different countries, including some non-European and developing nations, and they used slightly older adults.
    But, as seen in the graphs, all the data I've used seems consistent, and perhaps the new graph might make more intuitive sense to a casual reader.
     
    Svenja, Valentijn and ukxmrv like this.
  13. Bob

    Bob

    Messages:
    8,552
    Likes:
    11,422
    South of England
    Does anyone have a helpful citation to use when stating that it's bad scientific practice not to publish trial outcomes that were outlined in a trial protocol?
     
  14. Esther12

    Esther12 Senior Member

    Messages:
    5,294
    Likes:
    5,603
    Something like this: http://www.bmj.com/content/346/bmj.f105

    There have been a few things like this recently, but I've not been saving references for them (so many things that might be useful someday, it's difficult to keep track of them all).
     
  15. Bob

    Bob

    Messages:
    8,552
    Likes:
    11,422
    South of England
    Thanks Esther. That's very helpful, and interesting. And very strongly worded!
    I'm looking for something that specifically refers to trial protocols.
    I haven't got access to the full article, so I don't know if it refers to protocols.
    Specifically, I want something that says, or implies, that it is bad practise not to publish trial protocol outcomes.
     
  16. Esther12

    Esther12 Senior Member

    Messages:
    5,294
    Likes:
    5,603
    Not sure Bob - I thought that one did, and assumed the 'registering' in the title referred to registering outcome measures, but I didn't check before posting. I think that this used to be open access, but I could probably find a copy now. I think that it was prompted by the Sense about Science campaign for protocols to be registered and results made available in the manner laid out there. Haveyou looked at any of the things related to that? It's something I've only been semi-following. There have been papers in journals about this, but I'm not certain of the references.

    [edit - here's the paper, looks like it does mention a problem with a failure to release protocol defined data, although I expect the PACE researchers would try to wiggle around this: http://www.anzctr.org.au/docs/Chalm...st be registered and published_BMJ 9Jan13.pdf ]

    I did a quick google and found this paragraph in a letter related to the campaign, so it is in the right area:

    http://www.alltrials.net/wp-content...m-clinical-trial-participants-2013-Jan-18.pdf

    These quotes could be helpful:

    http://www.alltrials.net/supporters/

    Links to a couple of things here:

    http://www.alltrials.net/blog-2/
     
  17. Esther12

    Esther12 Senior Member

    Messages:
    5,294
    Likes:
    5,603
    Another Trish Groves thing:

    http://www.pharmaphorum.com/2013/01/30/data-transparency-clinical-trials-bmj/
     
  18. Bob

    Bob

    Messages:
    8,552
    Likes:
    11,422
    South of England
    Thanks for all the info Esther. :)
     
  19. Esther12

    Esther12 Senior Member

    Messages:
    5,294
    Likes:
    5,603
    No probs. Just edited in the link to the Groves thing above as I forgot it first time. Happy reading!
     
    Bob likes this.
  20. user9876

    user9876 Senior Member

    Messages:
    771
    Likes:
    1,867
    There is also a quote from the medical research council
    http://www.alltrials.net/supporters/
    They seem to find it easy to make such statements but don't actually enforce them.
     
    Bob and Valentijn like this.

See more popular forum discussions.

Share This Page