Multidisciplinary rehabilitation treatment is not effective for ME/CFS: A review of the FatiGo trial, 2018, Vink & Vink-Niese

[Andy]

Abstract
The FatiGo trial concluded that multidisciplinary rehabilitation treatment is more effective for chronic fatigue syndrome/myalgic encephalomyelitis in the long term than cognitive behaviour therapy and that multidisciplinary rehabilitation treatment is more cost-effective for fatigue and cognitive behaviour therapy for quality of life.

However, FatiGo suffered from a number of serious methodological flaws. Moreover, it ignored the results of the activity metre, its only objective outcome. This jeopardizes the validity of FatiGo. Its analysis shows that there was no statistically significant difference between multidisciplinary rehabilitation treatment and cognitive behaviour therapy and neither are (cost-)effective. FatiGo’s claims of efficacy of multidisciplinary rehabilitation treatment and cognitive behaviour therapy for chronic fatigue syndrome/myalgic encephalomyelitis are misleading and not justified by their results.

Open access at http://journals.sagepub.com/doi/10.1177/2055102918792648

 

[Esther12]

I was just thinking about this trial, so this paper should be a helpful reminder of it. Marked for tomorrow.

 

[Snow Leopard]

Who the fuck calls a trial "Fatigo" anyway? Clearly they don't like patients much.

 

[Trish]

I've just read the paper. It is excellent.

Shows the FatiGo trial had all the same types of flaws as PACE. I hope if NICE uses FatiGo as part of its evidence, the people making the decisions read and understand this paper.

Huge thanks to the authors.

 

[Mark Vink]

Thread merged.

Just published in Health Psychology Open, review of the FatiGo trial (Vos-Vromans), one of the 13 pieces of evidence NICE will review.


Mark Vink, Alexandra Vink-Niese,
First Published August 6, 2018 Review Article

Abstract
The FatiGo trial concluded that multidisciplinary rehabilitation treatment is more effective for chronic fatigue syndrome/myalgic encephalomyelitis in the long term than cognitive behaviour therapy and that multidisciplinary rehabilitation treatment is more cost-effective for fatigue and cognitive behaviour therapy for quality of life. However, FatiGo suffered from a number of serious methodological flaws. Moreover, it ignored the results of the activity metre, its only objective outcome. This jeopardizes the validity of FatiGo. Its analysis shows that there was no statistically significant difference between multidisciplinary rehabilitation treatment and cognitive behaviour therapy and neither are (cost-)effective. FatiGo’s claims of efficacy of multidisciplinary rehabilitation treatment and cognitive behaviour therapy for chronic fatigue syndrome/myalgic encephalomyelitis are misleading and not justified by their results.


http://journals.sagepub.com/doi/10.1177/2055102918792648

 

[Tilly]

I've just read the paper. It is excellent.

Shows the FatiGo trial had all the same types of flaws as PACE. I hope if NICE uses FatiGo as part of its evidence, the people making the decisions read and understand this paper.

Huge thanks to the authors.

The person sitting on the panel to help the laypeople to understand research and the process is Professor Tony Kendrick. Most on the panel seem to be mental health researchers and providers. Nigel Beasly is an ENT, is a clinical lead in cancer Nottingham Uni Hospital and deals with clinical outcomes.

 

[Tilly]

Thread merged.

Just published in Health Psychology Open, review of the FatiGo trial (Vos-Vromans), one of the 13 pieces of evidence NICE will review.


Mark Vink, Alexandra Vink-Niese,
First Published August 6, 2018 Review Article

Abstract
The FatiGo trial concluded that multidisciplinary rehabilitation treatment is more effective for chronic fatigue syndrome/myalgic encephalomyelitis in the long term than cognitive behaviour therapy and that multidisciplinary rehabilitation treatment is more cost-effective for fatigue and cognitive behaviour therapy for quality of life. However, FatiGo suffered from a number of serious methodological flaws. Moreover, it ignored the results of the activity metre, its only objective outcome. This jeopardizes the validity of FatiGo. Its analysis shows that there was no statistically significant difference between multidisciplinary rehabilitation treatment and cognitive behaviour therapy and neither are (cost-)effective. FatiGo’s claims of efficacy of multidisciplinary rehabilitation treatment and cognitive behaviour therapy for chronic fatigue syndrome/myalgic encephalomyelitis are misleading and not justified by their results.


http://journals.sagepub.com/doi/10.1177/2055102918792648

Why are they only reviewing 13 pieces of evidence? and how do we know which ones they are reviewing? Fluff a Duck how come they announce it this way ? In need of serious amounts of coffee

 

[Esther12]

Why are they only reviewing 13 pieces of evidence? and how do we know which ones they are reviewing? Fluff a Duck how come they announce it this way ? In need of serious amounts of coffee

That sounds a bit unlikely to me. The only reference given in that sentence was to this, which does not support the point: http://journals.sagepub.com/doi/10.1177/2055102918792648

 

[ukxmrv]

The reference given for that quote was Appendix B of the recent NICE surveillance report

"Of the approximately 300 pieces of evidence highlighted to NICE by stakeholders during the consultation, the following 13 met criteria to be included in the surveillance review. Any potential impact on the guideline of the evidence is also noted."

and they marked it "as unclear"

"Unclear – Multidisciplinary rehabilitation treatment (i.e. gradual reactivation, pacing, mindfulness, body awareness therapy, normalising sleep-wake rhythm and social reintegration combined with CBT) was more costeffective than CBT when using fatigue as primary outcome variable. Using QALY as the primary outcome, CBT was more cost-effective"


https://www.nice.org.uk/guidance/cg...ed-to-nice-during-consultation-pdf-4602203535

 

[Esther12]

The reference given for that quote was Appendix B of the recent NICE surveillance report

"Of the approximately 300 pieces of evidence highlighted to NICE by stakeholders during the consultation, the following 13 met criteria to be included in the surveillance review. Any potential impact on the guideline of the evidence is also noted."

Thanks! That was just for the surveillance review though, so I didn't think it could be that. It looks like you're right that it is the source of the '13 pieces of evidence' claim though. To me this reads as if it's claiming that the full review of the NICE guidelines will only review 13 pieces of evidence:

The British National Institute for Health and Care Excellence (NICE) has recently announced, partly in response to the problems of the PACE trial that it will be performing a full upgrade of their CFS/ME guidelines (NICE, 2017b), and it has released a document that it will review 13 pieces of evidence that were selected from approximately 300, highlighted to NICE. One of these is the FatiGo trial (NICE, 2017a) by Vos-Vromans et al. (2016a), who concluded that their trial showed that multidisciplinary rehabilitation treatment (MRT) is more effective than CBT (Vos-Vromans et al., 2016b).

 

[Dolphin]

It compared the efficacy of CBT and MRT which consisted of ‘CBT and, depending on the individual analysis, elements of body awareness therapy, gradual reactivation, pacing, mindfulness, gradual normalization of sleep/wake rhythm and social reintegration’.

 

[Dolphin]

FatiGo used two subjective primary outcomes (fatigue and health-related quality of life) and a number of subjective secondary outcomes including one objective outcome (the activity monitor also known as the actometer). Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation, that is, at the end of treatment and 26 weeks later.

 

[Tom Kindlon]

 

[Dolphin]

Patients were selected between December 2008 and January 2011. Therapy lasted 6 months. The protocol was submitted on 17 March 2011 (accepted on the 16 April 2012 and published on the 30 May 2012 (Vos-Vromans et al., 2012) even though ‘a fundamental principle in the design of randomized trials involves setting out in advance the endpoints that will be assessed in the trial, as failure to prespecify endpoints can introduce bias into a trial and creates opportunities for manipulation’ (Evans, 2007). Therefore a protocol should be published before the start of a trial and not when it (in FatiGo’s case) has (almost) finished.

 

[Dolphin]

Problems with the design of the study

FatiGo was an unblinded trial with two treatment groups without a ‘placebo’ control group that used two subjective primary outcomes. Even though, according to a systematic review of the interventions for the treatment and management of CFS by Whiting et al. (2001), one of the problems with subjective outcomes is that patients ‘may feel better able to cope with daily activities because they have reduced their expectations of what they should achieve, rather than because they have made any recovery as a result of the intervention’. Therefore more objective measures of the effect of any intervention should be used.

Also, unblinded trials should use objective primary outcomes alone or in combination with subjective ones to avoid the erroneous interference of efficacy in its absence (Edwards, 2017; Lilienfeld et al., 2014). FatiGo could have done this very easily by using their objective secondary outcome (the activity monitor) as a primary one. Why it did not do it is unclear. The risk for false-positive results was made even bigger because there was a large difference in treatment hours between the MRT (44.5) and the CBT (16) groups (Vos-Vromans et al., 2016a). This creates serious biases towards finding a positive effect for the intervention regardless of whether it is effective or not (Coyne, 2016).

 

[Dolphin]

Table 1. CIS fatigue scores

This includes means scores from 21 different cohorts (including the two in the study). This could be useful to refer to in the future.

 

[Dolphin]

FatiGo was based on the biopsychosocial model that after a viral infection, which has been cleared by the body, there is no underlying illness anymore. Instead, patients have developed the belief that they suffer from a physical illness.

 

[Dolphin]

According to a systematic review by Whiting et al. (2001), it is essential not to rely on the outcome at the end of treatment but to wait at least 6–12 months to remove the naturally-occurring fluctuation of the disease.

 

[Dolphin]

The other subjective primary outcome was the health-related quality of life scores. The scores for its physical component summary after 52 weeks (26 weeks after the end of treatment), measured by the SF-36 were 40.2 (MRT) and 36.7 (CBT) (scale 0–100; higher scores indicate a better quality of life). According to the study itself, ‘no significant differences in quality of life were found between the groups’ (Vos-Vromans et al., 2016a). A study by Farivar et al. (2007) of 7093 patients, who received medical care from an independent association of 48 physician groups in the western United States, found that their mean physical health summary score was 62.2. The above-mentioned scores therefore indicate that the physical quality of life was still poor.

It might be useful to be cautious when quoting the 62.2 figure. The PCS scores are supposed to be norm-based with a mean of 50 and standard deviation of 10 for the general population. Though in the general population some people are somewhat disabled either through age, disability or illness.

 

[Dolphin]

The activity monitor was the only objective outcome of the trial (Vos-Vromans et al., 2016a). Its results were published in a table but not discussed in the article. Not publishing or ignoring the results of outcomes measured is a form of reporting bias that jeopardizes the validity of a study (Heneghan et al., 2017).

Heneghan C, Goldacre B and Mahtani KR (2017) Why clinical trial outcomes fail to translate into benefits for patients. Trials 18(1): 122.

Nice find to have a reference to backup this point.