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

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SNT Gatchaman

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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)
 
The low attrition rate of participants in the present study could have been due to the superior ability of the online format for engaging participants who were not able to attend in-person sessions, in part due to the impairment of their fatigue. Other possible reasons are the emphasis at the beginning of the study about the importance of actively participating in the intervention, the weekly questionnaires, regular check-ups with a therapist to verify patient follow-through, the high flexibility of the online format, and the convenience sampling procedure applied, since recruitment was performed in the hospital where the research team was integrated.
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Besides that, the research team is strongly of the view that the following key aspects played a vital role in the effective implementation of the FaW program. First, the program benefitted from the involvement of a multidisciplinary team comprising rheumatologists, psychologists, and physiotherapists. In this regard, it is important to note that the FIBROWALK program was designed to be implemented by a psychologist and by a physiotherapist. Second, a strong emphasis was placed on fostering active engagement with the program’s content and encouraging regular practice. This emphasis was established early in the intervention and reinforced through timely reminders when needed. Lastly, continuous monitoring of participant progress enabled prompt communication and support for individuals who failed to report adherence and at-home practices. All these factors, putatively contributed to the program’s success in delivering positive outcomes.
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"All these factors, putatively contributed to the program’s success in delivering reporting positive outcomes."
 
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.
 
Another one misusing the Cochrane review, PACE etc to justify exercise.
Nonpharmacological interventions such as pain neuroscience education (PNE; Amer-Cuenca et al., 2020; Louw et al., 2016), therapeutic exercise (Larun et al., 2021), CBT (White et al., 2011), and mindfulness training (Greeson & Chin, 2019; Lakhan & Schofield, 2013; Pauzano-Slamm, 2004; Surawy et al., 1999), have shown promising evidence in reducing CFS/ME severity.
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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.
 
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?
 
Another bizarre 'study' said:
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
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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"
Neither the participants nor the clinician conducting the program (author Mayte Serrat) could be blinded within the study format. However, author Mayte Serrat was not involved in any stage of the patient assessment process and the researcher responsible for the outcome measures was unaware of the treatment allocation.
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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.
 
rvallee said:
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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Yep. Very poor reflection on the standards of peer-review in this area.
 
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%).
 
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?
...when examining the outcomes of CFS/ME participants without comorbid FM, the results showed that this subsample experienced a significant decrease in all clinical symptoms too, except for some specific aspects related to fatigue (intensity of fatigue, difficulties in concentrating, reduced motivation, reduced activity).
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