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.
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 . 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.