Effectiveness of an Online Multicomponent Program FATIGUEWALK for Chronic Fatigue Syndrome: A Randomized Controlled Trial, 2023, Serrat et al.

Discussion in 'Psychosomatic research - ME/CFS and Long Covid' started by SNT Gatchaman, Dec 22, 2023.

  1. SNT Gatchaman

    SNT Gatchaman Senior Member (Voting Rights) Staff Member

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    Effectiveness of an Online Multicomponent Program FATIGUEWALK for Chronic Fatigue Syndrome: A Randomized Controlled Trial
    Mayte Serrat, Jaime Navarrete, Sònia Ferrés, William Auer, Ramon Sanmartín-Sentañes, Rubén Nieto, Randy Neblett, Xavier Borràs, Juan V. Luciano, and Albert Feliu-Soler

    Objectives
    This study aimed to evaluate the effectiveness of an online multicomponent intervention called FATIGUEWALK (FaW) compared to treatment as usual (TAU) in patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME).

    Methods
    FaW included pain neuroscience education, therapeutic exercise, cognitive restructuring, and mindfulness training. A total of 428 patients with CFS/ME were randomized into two study arms: online FaW plus TAU versus TAU alone. A single-blinded randomized controlled trial was conducted. Validated patient-reported outcome measures of fatigue, pain, anxiety, depression, and physical function were collected at baseline and posttreatment, following the FaW intervention, which lasted 12 weeks.

    Results
    Statistically significant improvements (with small-to-moderate effect sizes) were observed in online FaW versus TAU alone with respect to multidimensional aspects of fatigue (Cohen’s d ranging from 0.25 to 0.73) and most secondary outcomes (pain and fatigue intensity, depressive and anxious symptomatology, functional impairment, kinesiophobia, physical functioning). The absolute risk reduction in FaW versus TAU was 19%, 95% confidence interval (CI) [12.19, 25.80] with number needed to treat = 6, 95% CI [3.9, 8.2]. Overall, similar clinical improvements were observed in sensitivity analyses including a subgroup of patients without comorbidity with fibromyalgia (n = 70).

    Conclusions
    This is the first study to assess the short-term effectiveness of an online multicomponent intervention added to TAU, compared to TAU alone, for the management of CFS/ME. Further trials, including active control groups with an equivalent treatment dose, and assessing the long-term effectiveness of the online FaW, are warranted.

    Link | PDF (Health Psychology)
     
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  2. SNT Gatchaman

    SNT Gatchaman Senior Member (Voting Rights) Staff Member

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    "All these factors, putatively contributed to the program’s success in delivering reporting positive outcomes."
     
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  3. NelliePledge

    NelliePledge Moderator Staff Member

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    Reinventing the pace wheel

    walking but apparently yet again no step counting

    no long term follow up beyond the 12 week programme apparently

    The remote format means participants would find it a lot easier to go under the radar if not fully adhering to the program.
     
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  4. Trish

    Trish Moderator Staff Member

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    Another one misusing the Cochrane review, PACE etc to justify exercise.
     
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  5. Trish

    Trish Moderator Staff Member

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    Looking at the outcome data, the between group differences for most outcomes were statistically significant but surely can't be regarded as clinically significant.

    For example, on SF-36 physical functioning, the whole treatment group only moved up on average from 37.45 to 42.92
    And in the subgroup with ME/CFS without FM, they moved up from 44.21 to 46.97, all figures with standard deviations over 20.
    The control groups stayed the same or got worse on this scale.

    These are statistically significant, but can't possible be called clinically significant, since a move of 5 points only requires one activity to be assessed by the patient as a bit difficult rather than very difficult, or from a bit difficult to not difficult. It's really a single point on a 20 point scale, magnified by the scoring system.

    Similarly the other data looks very unimpressive when you look at the details. Easily persuadable by all that cognitive restructuring and positive thinking stuff they have been drilled with for 12 weeks.

    There's no indication of how much exercise or what increments were involved.
     
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  6. Creekside

    Creekside Senior Member (Voting Rights)

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    I've done a lot of walking before and during ME, less during some periods, and more during others. I noticed no reduction of symptoms from walking. A reduction of symptoms, for whatever reason, did result in more walking. Could their results simply be subjects walking more when they felt better?
     
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  7. shak8

    shak8 Senior Member (Voting Rights)

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  8. rvallee

    rvallee Senior Member (Voting Rights)

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    Well, no, it isn't. In fact there are dozens like this. It's basically the current paradigm, for all intents and purposes, as found in textbooks, presentations and fancy websites. There are people who have been making it their primary income to do this stuff for many years now. So it's old and tested, but also new and full of potential.

    Basically, it's like a program that goes like this:

    while(true) {
    print("More research is needed");​
    }

    "Blinding"
    Blinded data analysis is nice and all but everyone else was not just aware but actively participating in the process. Single-blinded is that patients are blinded to the intervention they are receiving, not possible here. Double-blinded is that clinicians involved in the intervention are also blinded, also not possible here. Independent data analysis is, in my opinion, expected as a basic requirement, so it's actually concerning that it's citing this as equivalent to blinding, suggesting that it's probably standard practice for researchers actively participating in their studies to do their own data analysis.

    This is basically like claiming a chain of custody because the last person who handled the evidence was told there was a chain of evidence beforehand and it hasn't left their sight since.

    And wow they actually called the paper a randomized controlled trial, even though it isn't even properly randomized since they have a selection process with a number of criteria, despite recognizing in the abstract that it isn't controlled. And this passed peer review, because peer review in evidence-based medicine is a sick joke.
     
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  9. rvallee

    rvallee Senior Member (Voting Rights)

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    And oddly, citing PACE for CBT, but not for GET. Even though GET is the main takeaway for PACE, and the main evidence for the Cochrane review. Literally all made-up.
     
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  10. Sean

    Sean Moderator Staff Member

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    Yep. Very poor reflection on the standards of peer-review in this area.
     
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  11. ME/CFS Skeptic

    ME/CFS Skeptic Senior Member (Voting Rights)

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    Noticed some inconsistencies for this paper compared to the trial registration:
    Study Details | Effectiveness of VIRTUAL SFCAMINA STUDY | ClinicalTrials.gov

    The registration said that they would use "the Fukuda and Holmes classification criteria for Fatigue Syndrome Chronicle" as inclusion criteria. The paper refers to the ICC (carruthers et al. 2011) without any explanation that a change might have taken place.

    The study registration happend on 2020-10-13, after the recruitment had already started. The latest trial registration says that the Study Start (the actual date on which the first participant was enrolled in a clinical study) was in 2020-04-21. An older version of the trial registration said 2020-09-21 and the trial publication also says September 2020. All these dates are before the trial registration in Oktober 2020.

    Also notable that the authors managed to recruit 428 patients from 1 clinical center in less than a year. The paper notes: "strict selection criteria could not be established due to pressures in daily clinical practice (i.e., most patients were admitted)." Only 32 out of 460 patients declined to participate and the dropout rate was remarkably low (around 7%).
     
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  12. Evergreen

    Evergreen Senior Member (Voting Rights)

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    Fluge et al.'s placebo group went from 32.5 to 38.4 on the SF36 physical function subscale in 3 months.
    The PACE trial's specialist medical care group went from 39.2 to 46.6 in 3 months.

    So no, I won't be hotfooting it to FATIGUEWALK any time soon.

    It looks more like the controls were miffed than the treatment groups were treated.

    All clinical symptoms...except the disabling ones?
     
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