Trial By Error: Stupid Studies

By David Tuller, DrPH

Boy, it’s hard to keep up with all the stupid studies coming out! But that’s no reason not to take a look at a couple of them.

(In both cases, I’m just making a few comments. Much more could be said about each of these studies. You can read more about them on the Science for ME forum here and here.)

**********

In December, Frontiers in Psychology published a paper about a four-day “mindfulness-based cognitive behavioral intervention program for CFS/ME” being offered in Norway. The authors of the study, two mental health professionals from Bergen, have tested what seems to be a ratatouille of group therapy, exercise, life-coaching, meditation, stress management, writing exercises and positive thinking—something similar, perhaps, to the Lightning Process, although I don’t know if participants are required to stand inside circles on the ground.

The study will likely be cited, in Norway and elsewhere, as evidence that this four-day program could be effective in reducing fatigue and improving physical function in people with CFS/ME, as the investigators call the illness. Yet the findings are pretty much useless in terms of providing actionable information for developing health policy or clinical recommendations, for a number of reasons.

First, this isn’t a trial. It is an observational study of 305 patients who have gone through a four-day experience. That’s it. There is no control group against which to measure the reports of success among these participants. It is possible that a program of many hours of playing Monopoly in an elevator while listening to Adele singing “Rolling in the Deep” over and over could have produced the same effect. We just don’t know.

Second, patients were recruited according to the Oxford criteria—six months of disabling, unexplained fatigue. In other words, the sample was likely a mish-mash of people with fatigue for all sorts of reasons. Moreover, not even half the participants were disabled enough to meet the PACE thresholds for trial entry on both the subjective fatigue and physical function scales. So it’s hard to know what illness many of the participants had, if any. (As in PACE, participants were re-assessed after recruitment to see if they also met the 1994 Fukuda criteria from the US Centers for Disease Control and Prevention.)

Third, all the outcomes were subjective. So, you know, it’s hard to tell what any of these outcomes mean. The intervention was apparently effective at training people to provide somewhat better responses on questionnaires.

The authors acknowledge some limitations but claim success anyhow. They report that, per their results, the program “might be highly beneficial” and that 80% of the participants demonstrated “statistically significant clinical changes,” which were sustained after a year. Unfortunately, the claim that the changes were sustained at the one-year point does not seem to take into account the fact that only 219 of the 305 study participants provided follow-up data.

That’s a sharp drop-off. Did the 86 who failed to provide follow-up data get worse? Who knows?

**********

Someone keeps funding research by Trudie Chalder. This is hard to understand. Her most recent nonsense is a study called “Perfectionism and beliefs about emotions in adolescents with chronic fatigue syndrome and their parents: a preliminary investigation in a case control study nested within a cohort.” It was just published in the journal Psychological Health.

The study posits that “psychological processes,” including “perfectionism” and “beliefs about emotion,” are risk factors for the prolonged symptoms associated with CFS. It also posits that these attitudes are transmitted to children through parental influence. In other words, if the parents exhibit high levels of perfectionism, so will the kids—and that creates an environment in which CFS can presumably thrive.

Well, the study findings contradicted the researchers’ expectations. They found no evidence for a link between personality traits and CFS. In other words, kids with CFS showed no differences in perfectionism and beliefs about emotion than peers with asthma and healthy controls. Moreover, when the kids with CFS were followed up, perfectionism and beliefs about emotions did not account for variances in fatigue and physical function.

“In this preliminary study, we did not find evidence for the hypothesis that adolescents with CFS would report higher levels of perfectionism and unhelpful beliefs about emotions than adolescents with asthma or healthy adolescents,” write Professor Chalder and her colleagues.

Nonetheless, the study goes out of its way to argue that the absence of evidence does not disprove the existence of such a link, given the study design. This is undoubtedly true. Yet the tortured logic on display comes across as wishful thinking, even desperation. The investigators argue that the experience of illness itself could have forced patients to drop the perfectionist traits they possessed before getting ill.

Here’s what they write: “With this cross-sectional study, which recruited adolescents with CFS post-diagnosis, it is not possible to conclude that perfectionism does not pose a vulnerability factor to developing CFS…It is possible that people are forced to modify their perfectionism as a result of disabling CFS symptoms or that they choose to do so.”

In other words—don’t pay attention to our findings!

That their predominant tendency is to ignore or overlook their own main findings is clear from their conclusion, as expressed in their abstract. The conclusion focuses on a different, not surprising, and relatively minor finding—that children’s personality traits might reflect those of their parents.

Here’s what they write: “Parental perfectionism and emotion regulation style may contribute to perfectionism in adolescents with CFS. Parental representations could contribute to fatigue maintenance.”

It may or may not be the case that perfectionism in parents contributes to perfectionism in their offspring. But given that the study found no link between perfectionism and CFS in adolescents, any connection between the “emotion regulation style” of parent and child would seem to be irrelevant to the matter at hand. I suppose it is possible that such “parental representations” could “contribute to fatigue maintenance.” But it is unclear why the authors are advancing this claim as their concluding point when the study provides little apparent evidence to support it.

Does anyone actually peer review this stuff?

{ 21 comments… add one }
  • Fiona M 6 March 2019, 11:50 pm

    “Did the 86 who failed to provide follow-up data get worse?”

    Maybe they just didn’t bother because they knew they’d been ‘sold’ a bunch of crap

  • Clyde 7 March 2019, 2:41 am

    Of course they peer review it.
    That rubber stamp wears out so frequently they have the supplier on speed dial

  • Couch Turnip 7 March 2019, 2:52 am

    With respect to the Chalder study, it appears that UK taxpayers may be funding this rubbish. Chalder didn’t work alone on it, and there’s another study by the same research group along similar lines, funded by the same NIHR Biomedical Research Centre. It’s entitled
    “Does fatigue and distress in a clinical cohort of adolescents with chronic fatigue syndrome correlate with fatigue and distress in their parents?”

    We can ridicule such ‘stupid’ studies and wonder how on earth they got through peer review, but is this also a scandalous misuse of taxpayers money?

  • Anni 7 March 2019, 3:09 am

    The Chalder study found that fathers of CFS kids had less perfectionist tendancies , so the blame is assigned to mothers.
    This feeds into a paradigm re FII and safeguarding that is being strengthened currently which is disturbing.
    Check out the recent Bath professional seminar on safeguarding and children with CFS.
    I expect there will be a rush of such drivel to be part of the NICE evidence base.

  • Emily 7 March 2019, 3:12 am

    The second study reminds me of how mothers used to be blamed for causing autism. It is shameful how parents of children with ME are blamed for the illness when they do so much to support and look after their children.

  • Alicia Butcher Ehrhardt 7 March 2019, 3:30 am

    That first study sounds like it had a bunch of people who had been tired for a while. Those always get better with some time off, some rest, and some attention. I’m glad they’re better, but it isn’t about ME/CFS.

  • Justin Reilly 7 March 2019, 5:38 am

    I did not have access to the full Trudie Chalder study, but yes, it struck me that in the abstract, the conclusion in was just about the opposite of the results. Great question if anyone actually peer reviews this stuff. thank you, David.

  • Peter Trewhitt 7 March 2019, 5:56 am

    What is it about ME that attracts such terrible research?

    There is the issue that the Oxford criteria, though in much of the word these have been relegated to the dustbin of scientific irrelevance, it does allow this small coterie of researchers to hang on to their focus on people with mild fatigue who may or may not have ME. What would these researchers do when confronted with someone with severe ME who is bedbound in a silent darkened room, tube fed and unable to meet even the most basic of their own care needs; someone who is unable to even engage in a conversation beyond a few words?

    I suspect an examination of the personality traits of these researchers mould be more productive, and result in a significantly more cost effective approach to ME.

  • Couch Turnip 7 March 2019, 6:45 am

    Perhaps a complaint should be made to the NIHR Biomedical Research Centre or maybe to Professor Chris Whitty, (Chief Scientific Adviser to the Department of Health and Social with responsibility for the NIHR), that a study funded by the Research Centre resulted in a conclusion being published that appears to bear little or no relation to the results. I know that the authors of this study indicate that their views cannot be deemed to be those of the NIHR, but shouldn’t the NIHR take some action if research that is paid for out of the public purse is not reported accurately?

  • Laura Whittington 7 March 2019, 7:19 am

    Thank you David. It appears that Trudie Chalder et al pay as little attention to the facts of their study as they pay to the facts presented to them by the families of children with ME. In addition I think Couch Turnip’s suggestion is an excellent one.

  • Samuel Eglington 7 March 2019, 8:06 am

    I realise that it is difficult to take these studies seriously. However as Couch Turnip has pointed out the Chalder study wasn’t funded by just someone but by the British taxpayer via the principal state institution for medical research.

    As a British patient I would appreciate it if you could add this actually quite important fact to the article itself.

  • AB 7 March 2019, 10:09 am

    Do we have a circle of peer reviewers and authors all producing poor quality research but with the same prejudices and agendas?

    Medical journals could have sets of preferred peer reviewers all operating in a vacuum and commenting on the work of colleagues, colleagues of colleagues and friend of colleagues.

    This ensures that the same people keep producing the same nonsense over and over again. They reference one another, mix at conferences, work for the same insurance companies and government agencies.

    They serve on medical research funding groups and make sure money gets funneled into their pet interests.

    A closed and protected and very powerful group producing nothing of worth at all decade after decade.

  • Ekhi 7 March 2019, 10:25 am

    Would it be a new strategy to avoid treatment or even child attendance to a MP? And thus less expenses?
    I mean, if I were a mom of a possible sick child w/ mild ME, after reading such info I would think twice about taking the kid to the health system. Indeed, there is no treatment and too many dangers for the whole family…

  • Lorraine Moss 7 March 2019, 10:53 am

    They are talking about perfectionism and anxiety. Type A personality in other words – these things along with fatigue are all indicators of adrenal dysfunction.

  • Marcie Myers 7 March 2019, 1:37 pm

    I just love how most of these studies don’t use large numbers of patients or controls, admit they’ve disproved their own hypothesis, yet continue then to give lame and inane reasons why or how it MIGHT still be true. As for the concept of perfectionism, all of us with ME have had to give up that ideal as we are simply struggling to get out of bed (mine lacks sheets right now) and get enough food to sustain us. These are, indeed, ridiculous. Grrrrr. Marcie

  • Allison Haynes May 7 March 2019, 5:35 pm

    Thank-you again David for pointing out more ‘stupid studies’.
    That is exactly the language needed, although of course they are more than stupid ; they are harmful, because some people actually believe that they have value or relevance to M.E..
    It’s unbelievable, after 35+ years of the ravages caused by M.E., that we severely ill & disabled people are still having to see this type of garbage. (Garbage studies, apparently reviewed by garbage reviewers, then published by garbage publishers, & then picked up by garbage media.)
    It’s infuriating.
    It’s ego over science & over compassion.
    It’s more evidence of corruption.
    Thank-you for giving us these articles to share, to expose this.

  • steve hawkins 7 March 2019, 9:50 pm

    “…It is possible that people are forced to modify their perfectionism as a result of disabling CFS symptoms or that they choose to do so.””
    cf: ‘Is this the right room for an argument?’ >> They might be perfectionist… in their spare time! 😉

  • Lou Corsius 8 March 2019, 4:25 am

    Their Dutch fatigue colleagues are equally good at stipulating very strange conclusions after their research has showed a null result.
    Please note that the outcomes at follow-up for patients who followed the CBT treatment with a graded activity protocol were worse than the placebo group outcomes.

    Let me just give you some citations from the recent qfs follow-up study
    (Raijmakers, PH, Keijmel, SP, Breukers, MC, Bleijenberg, G et al (2018) Long-term effect of cognitive behavioural therapy and doxycycline treatment for patients with Q fever fatigue syndrome: One-year follow-up of the Qure study Journal of Psychosomatic Research 116:62-67)

    “Due to its initial positive effect and side effects of long-term doxycycline use, CBT is still advised as therapy of choice for QFS patients. At present, it is still the only well-investigated treatment modality for QFS patients with a positive effect.”
    “Throughout this study, all patients were functionally impaired. It is conceivable that persisting functional impairment leads to a constant confrontation with limitations caused by an impaired health status which could eventually lead to an increase in fatigue severity.”
    “In addition, it can be noted that patients received a median of 9 CBT sessions in the original trial, which, although effective for fatigue severity, might be insufficient to address perceived functional impairment. As noted in the original trial, there was a trend towards a beneficial effect of CBT on functional impairment.”
    “An alternative explanation could be the recurrent negative media attention in the Netherlands for Q fever since the outbreak of 2007, frequently reminding patients of their complaints and possible unfavourable long-term outcome of QFS.”
    “Moreover, a large lawsuit, in which patients collectively sued the Dutch government for negligence during the Q fever outbreak, was still pending during the follow-up period. This encouraged patients to supply attorneys with proof of diagnosis and constantly reminded them of their often dire financial situation and perceived lack of social support.”
    “It is likely that not all relevant perpetuating factors for QFS have yet been identified and were therefore not addressed during CBT. It could be postulated that such inappropriately addressed perpetuating factors contributed to the relapse in fatigue severity at 1-year follow-up. The fact that there was a positive effect of CBT directly following CBT however speaks against this hypothesis. One could however also assume that the unknown and unaddressed perpetuatingfactors in QFS are responsible for the relapse.”

  • Julia 19 March 2019, 7:13 pm

    Of course parents of children with ME are more than averagely anxious and fatigued. Their children’s lives have been devastated by an appalling illness and they are exhausted from caring for them. This simply proves that are normal human beings.

Leave a Comment