By David Tuller, DrPH
Last year, Mark Vink, a Dutch physician with ME/CFS, and Friso Vink-Niese, an independent researcher, published a review of occupational outcomes among ME/CFS patients after treatment with either graded exercise therapy (GET) and cognitive behavior therapy (CBT). The results were not pretty. When viewed specifically through the perspective of employment status, the treatments bombed.
This is not a surprise to anyone who is familiar with the sub-par research conducted by members of the GET/CBT ideological brigades. It remains hard to fathom how anyone could promote these interventions as effective based on such crap, but that’s where we are. Anyway, I have just collaborated with Dr Vink on a commentary with a straightforward title: “Graded Exercise Therapy and Cognitive Behaviour Therapy Do Not Improve Employment Outcomes in ME/CFS.”
It’s always bugged me that the PACE authors got away with their exaggerated claims of success even though they had abysmal results for their four objective outcome—including those regarding employment status and the receipt of disability-related benefits. Moreover, they dissed these objective measures as not objective after the results proved disappointing—even though they themselves had selected the indicators. So I was glad to have a chance to expound on this point in this piece.
Earlier today, I submitted it to a journal, so we’ll see how it fares in peer review. In the meantime, I’ve posted it as a pre-print here, which means I can share it. Below is the first half.
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Commentary:
Graded Exercise Therapy and Cognitive Behaviour Therapy Do Not Improve Employment Outcomes in ME/CFS.
In a 1989 article, Wessely et al. proposed a model of the onset and perpetuation of chronic fatigue syndrome, the illness often called myalgic encephalomyelitis and now frequently referred to as ME/CFS. In this model, patients’ symptoms were attributed to the effects of deconditioning following an acute illness. The symptoms were said to be exacerbated and perpetuated by patients’ persistent but unwarranted belief that they continued to suffer from a medical disease and that exertion made them worse. The proposed treatment strategy combined gradual increases in activity to reverse the presumed deconditioning with efforts to alter patients’ purportedly misguided perceptions about their ailment.
ME/CFS is associated with marked disability and long-term sickness absences; it has been estimated that the rate of unemployment among patients ranges from 35% to 69%. From the start, the promotion of behavioral and psychological interventions has been linked to concerns about employment status and whether patients should be able to receive social welfare and disability support if they have limited capacity to work. In a section on “sickness benefits” in the 1989 paper, the authors argued that decisions about social welfare benefits should be linked to patients’ willingness to undergo behavioral and psychological interventions to. “It is reasonable to expect a patient to cooperate with treatment before being labelled as chronically disabled,” noted the authors, notwithstanding the theoretical and unproven nature of their model.
This approach achieved dominance over the next couple of decades, not only in the UK but in the US and many other countries. Graded exercise therapy (GET) and an illness-specific form of cognitive behavior therapy (CBT) became the predominant and heavily researched interventions for ME/CFS and were enshrined in multiple clinical guidelines. A 2005 review of the natural history of the illness, which found that only 5% of patients fully recovered without treatment, noted “increasing evidence” for GET and CBT and therefore advised that “medical retirement should be postponed until a trial of such treatment has been given.”
Many studies have included occupational status as a demographic question; fewer have specifically examined how GET and CBT impact employment. Nonetheless, the results from the latter group are consistent and clear: The interventions do not lead to improved outcomes in occupational status. This question has taken on renewed urgency given the overlaps between ME/CFS and the phenomenon now known as long Covid, which has led to efforts to promote a similar rehabilitation paradigm for patients suffering from prolonged symptoms after coronavirus infection.
Employment outcomes in the PACE trial
After gaining momentum during the 1990s and 2000s, the GET/CBT approach was significantly reinforced with the 2011 publication in The Lancet of the first results of the PACE trial, the largest study of the two interventions for ME/CFS, with additional results published in 2012 and 2013. The study was partially funded by the U.K.’s Department for Work and Pensions (DWP). Officials at DWP presumably believed or hoped that the trial would provide robust data to support the use of these two purportedly rehabilitative strategies.
The PACE investigators presumably hoped for that as well; key members of the team maintained strong links with disability insurance companies, advising them that GET and CBT were effective in helping patients recover. In a 2002 essay for a UNUMProvident report on trends in disability, Michael Sharpe, a lead PACE investigator, wrote that “symptoms and disability” in patients with unexplained conditions “are shaped by psychological factors,” and in particular by “patients’ beliefs and fears.” He suggested that the support of patient advocates for biological disease models could impact health outcomes among insurance claimants. Commenting on how public messaging and related “social factors” influenced the course of illness for those with unexplained conditions, Sharpe wrote:
“Relevant factors include the information patients receive about the symptoms and how to cope with them. This information may be helpful or may stress the chronicity of the illness and promote helplessness. Such unhelpful information is found in “self-help” (!) books and increasingly on the Internet (see for example www.meassociation.org.uk)…Other social factors that perpetuate illness are anger with the person or organisation the illness is attributed to, or toward the insurer for not believing them. It has been pointed out that: ‘if you have to prove you are ill you can’t get well’. Both State and private insurers pay people to remain ill.”
Despite Sharpe’s argument that receiving financial support discouraged claimants from getting better, the data from PACE did not provide evidence that GET and CBT were effective in helping ME/CFS patients in the domain of employment. With 641 participants, PACE was the largest treatment trial for ME/CFS. The investigators themselves referred to it as the “definitive” test of the two interventions [9]. In touting it as a success, they reported that 60% had improved and 22% had recovered after treatment with GET and CBT, much more than in the other groups. However, these positive findings were all from subjective, self-reported measures. When paired with unblinded treatments, as in the PACE trial, such measures are subject to an unknown amount of bias.
PACE also included an employment measure as one of four objective outcomes, along with a six-minute-walking test, a step test to assess fitness, and whether or not the participant was receiving social welfare or disability benefits. The results for all four objective measures were poor—there were no clinically significant benefits from the interventions and no meaningful differences between the groups. In terms of employment, the percentage of participants in the GET group who lost days of work due to their illness increased from 83% at baseline to 86% after treatment; in the CBT group, the percentage was 84% both before and after treatment. In all study arms, the percentage of participants receiving unemployment or disability benefits was higher after treatment.
In promoting CBT and GET as effective, the PACE authors downplayed the findings on employment as well as the other objective results. In correspondence, they challenged the reliability and even the objectivity of the post-treatment results for their own employment and benefits measures, which they themselves had identified and selected as objective outcomes. As they wrote: “Recovery from illness is a health status, not an economic one, and plenty of working people are unwell, while well people do not necessarily work. Some of our participants were either past the age of retirement or were not in paid employment when they fell ill. In addition, follow-up at 6 months after the end of therapy may be too short a period to affect either benefits or employment. We therefore disagree…that such outcomes constitute a useful component of recovery in the PACE trial.”
It is indisputable that other factors besides health status play a role in employment outcomes. Nonetheless, if the PACE trial’s reported results of significant improvement and recovery were accurate, then a measurable increase in employment and a comparable decrease in the receipt of financial support would have been expected. As has been well-documented, the investigators weakened key subjective outcome measures in ways that dramatically improved their reported results; published re-analyses of trial data have found that no one achieved “recovery” from either of the therapies, and rates of improvement were so marginal that they were likely due to bias and expectation effects. Given these findings, the similarly disappointing results for employment outcomes in PACE should not be surprising.
You can read the rest here.
Excellent, thorough and valuable analysis. Thank you both.
Economic inactivity due to ill health would appear to constitute a significant economic concern in the UK with not enough workers to fill posts -https://www.bankofengland.co.uk/speech/2022/may/michael-saunders-speech-at-the-resolution-foundation-event. Now why would that be?
Our Prime Minister’s solution seems to be to import more workers from overseas -https://www.theguardian.com/uk-news/2022/sep/24/liz-truss-plans-to-loosen-immigration-rules-to-boost-uk-economy rather than addressing the real problems that people, especially women, suffer in our healthcare system that stop them from working. Instead of allowing more workers in, (which past Conservative voters possibly aren’t going to like?), perhaps our government should be looking more seriously and closely at what has gone so badly wrong with NHS healthcare to cause so many UK citizens, especially women, to stop work? (Hint: Perhaps look at MUS, FND and the whole ‘functional’ agenda, as well as ME/CFS and Long Covid, and consider how NHS strategies and doctors’ opinions around these are impacting the lives of chronically ill patients.)
This is why I think economists, especially UK economists, need to wake up and listen to David Tuller:
The Bermingham et al paper, published in 2010, provided an estimate that somatizing patients of working age cost the NHS around £3 billion. It was also estimated that these somatizing patients cost the wider UK economy around £14.5 billion. The paper suggested more patients being directed into psychological therapies (such as the IAPT programme in which CBT is the main therapy used) to both save the NHS money and presumably boost the economy. The assumption appeared to be that psychological therapies such as CBT work and help to keep people in employment or get them back to work. (The paper’s estimate for the cost of sick days was £5.235 billion.) But this paper was published before the PACE Trial’s results were out and, from what David reports here, the PACE Trial found no improvement in employment rates in either the CBT or GET groups. So, assuming that management of ME/CFS might have been used as a model for other ‘medically unexplained symptoms’ -https://www.sciencedirect.com/science/article/abs/pii/S0163834397803155?via%3Dihub, if CBT can’t help ME patients with respect to employment then maybe it won’t help reduce those UK employment (sick day) costs of over £5billion that apparently result from somatization? And it might actually pay for the UK Government to invest in better medical care for these patients and good biomedical research to elucidate diseases/conditions and find biomedical treatments for them, rather than risk losses to the economy of over £5billion (sick days) or £14.5 billion (when Quality of Life costs are also included)? It seems to me that in trying to shave around £3billion off the NHS budget, UK governments (past and present) may have bitten off their noses to spite their faces because they may risk much greater losses to the economy by not treating these supposedly somatizing patients adequately. And, in the UK, that’s where we seem to be right now. Chronically ill UK patients, especially women, appear to have voted with their feet, whole bodies even, and walked, crawled or bum-shuffled out of employment and into economic inactivity, quite likely because the NHS refuses to address their debilitating physical health problems, preferring to divert them to cheap psychological care.
To be fair to Bermingham et al, their paper seems to suggest that evidence in the form of a comprehensive cost-offset study would be needed for policy and decision making. I’m not aware of any such study having been completed since and yet I strongly suspect that important policy and strategy decisions have been made based on Bermingham et al’s rough estimate. (For example, the paper was referenced in the 2017 JCPMH’s Guidance for Commissioners of Services for People with Medically Unexplained Symptoms -https://www.slideshare.net/jcpmh/guidance-for-commissioners-of-services-for-people-with-medically-unexplained-symptoms.) If such a comprehensive study has been done, and I’ve missed it, then CBT proponents don’t appear to be referencing it in recent papers. It looks to me like UK women (not forgetting that men are suffering this too in lesser numbers) with chronic health problems are being badly let down and discriminated against on a huge scale – forced out of the workplace and into economic inactivity (living off their savings or reliant on their partners, families etc) – because of a poor evidence-base combined with insufficient scrutiny of the economic case.
CT–thanks for linking this issue to the estimated social costs of. ME/CFS as enumerated in Bermingham et al and to the promotion of programs like IAPT. The unwarranted conviction that these interventions improve employment outcomes is obviously likely a driving factor in any number of contexts.
If, as for ME, CBT doesn’t work to improve employment rates in chronically ill people in general, then the CBT approach surely deprives many people of the ability and opportunity to work and contribute to society. If being a woman is a risk factor for medically unexplained symptoms, as the JCPMH’s guidance on MUS states it is, and CBT doesn’t work with respect to employment for MUS sufferers (like it seems it doesn’t for those with ME, a supposed example of MUS), then being a woman would also be a risk factor for chronically ill people being denied the right healthcare support to enable them to earn a living – support that in the UK is rightfully theirs.
Whether it’s ME, Long Covid or undiagnosed lupus, POTS or endometriosis, if CBT doesn’t work to improve employment rates then countless people, (especially but not exclusively women), are presumably being discriminated against by the UK’s healthcare system and pushed into economic inactivity, aren’t they? And without either a correct diagnosis or effective treatment/management plan, workplace adjustments can’t easily be made to help people stay in work. I’d argue that ceasing investigations too early and imposing a MUS label consigns people to an added struggle in the workplace because they have no valid/legitimate reason for the problems they are encountering there. The economic harm so caused to their income and career prospects may well outweigh any potential iatrogenic harm of further investigations – risks that could easily be explained to the patient at each stage of investigation.
Just to add to “The economic harm so caused to their income and career prospects may well outweigh any potential iatrogenic harm of further investigations – risks that could easily be explained to the patient at each stage of investigation.”
Isn’t this exactly what the biopsychosocial model of medicine should be about? – Weighing up the adverse ‘social’ and ‘psychological’ effects of not investigating and not treating effectively – loss of employment, income, prospects and quality of life – against the potential biological risks of over-investigation?
Or in (UK) economic terms – weighing up the economic risk of providing an ineffective treatment to MUS sufferers (£5.235 billion in sick days, £14.5 billion to the economy overall) against the cost of investigating NHS patients more thoroughly than at present (upwards of £3billion)?
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