Observations on the LP trial for children with CFS

“Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial”

(Crawley EM, Gaunt DM, Garfield K, et al. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial [published correction appears in Arch Dis Child. 2019 Jul 11;:] [published correction appears in Arch Dis Child. 2019 Jul 11;:]. Arch Dis Child. 2018;103(2):155–164. doi:10.1136/archdischild-2017-313375)

The authors of the LP trial state that with the SF-36 Physical Function subscale (SF-36PF) “Higher score=fewer symptoms, better function.” This is incorrect.

The SF-36PF provides no information about the number of symptoms that a participant has. A participant with one symptom, e.g., severe chronic pain, could have an SF-36PF score of zero, equivalent to being ‘limited a lot’ for all 10 items in the questionnaire. Whereas a person with multiple symptoms could score 100, showing that they are not limited at all in carrying out any of the activities.

As this misrepresentation of the properties of the SF-36PF is obviously made-up, it is reasonable to question whether the authors intended to exaggerate the importance of their primary outcome measure, which is further suggested by the chart which they published for the measure. Figure 1 shows how the SF-36PF primary outcome measure data was represented in the LP paper, and figure 2 shows the same data in a full scale (0 to 100) chart, which does not exaggerate the small difference between the LP group and the Specialist Medical Care (SMC) control group.

Figure 1. SF-36PF data as illustrated in the LP trial

LPSF36pfChart

Figure 2. SF-36PF data from Figure 1 in a full scale chart

LPSF36pfChartFullScale

There was a 14 point difference between the mean SF-36PF outcomes of the LP group and control group which is potentially interesting. The LP group had an average outcome rating of 86, yet the mean school attendance for this group was only 4 days out of 5. While this was one day more than the control group, missing 20% of schooling one year after being given the LP is very poor. It is also notable that an average SF-36PF rating of 86 is disturbingly low for a group of formerly healthy young people (see Table 1 for an example of the questionnaire which produces a rating of 85). For example, an SF-36PF rating of 85 could represent:

  • “limited a lot” in “Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports”,
  • AND “limited a little” in “Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf”.
  • And an SF-36PF rating of 80, could correspond with both of the above PLUS: “limited a little” in “Walking more than one mile”.

Although these are unexpected limitations for young people, a rating of 80 or 85 does not allow for any limitations at all with any of the other activities listed, which includes being able to walk several blocks (approximately half a mile or 770 metres), climbing several flights of stairs and lifting and carrying groceries.

Which raises the question: if the average LP group participant was “not limited at all” in any of the SF-36PF lighter activities – why was their average school attendance only 4 days out of 5?

Table 1. SF-36 Physical Function subscale. Example illustrating a score of 85.

Table1

A possible explanation for this contradiction, would be that the mental-conditioning that the young people underwent, programmed them to say and to believe, that they are healthier and more able-bodied than they actually are. It might not be difficult to produce this effect because to a degree, it seems to occur naturally. For example, Dr David Bell wrote an article on the ‘Prognosis of ME/CFS’, which discussed his and his colleague’s studies of patients who became ill in their youth. On the 25 year follow-up of patients, Bell observed: “All studies employed the Rand-36 (SF-36), a questionnaire is [sic] common use. The first question of this instrument is ’how would you rate your health?’ Many of the patients rated their health as ‘good’, while the rest of the questionnaire demonstrated how poorly they were actually functioning.” Dr Bell concluded his essay: “Forty year old adults who had an acute onset during their teenage years have the activity of seventy year old adults. Until there is a reliable biomarker for the severity of ME/CFS, we will be unable to accurately define the prognosis.”1

The LP group mean Chalder Fatigue Questionnaire (CFQ) rating at outcome was 12.3 as shown in Figure 2. This shows that on average, only one or two fatigue items were a problem ‘more than usual’. Table 2 illustrates a CFQ producing a rating of 13.

The average LP participant reported only one or two (out of 11) CFQ factors as being, ‘worse than usual’, and indicated no limitations at all in carrying out light physical activities with the SF-36PF, yet the group were STILL missing 20% of school attendance.

Table 2. The Chalder Fatigue Questionnaire (CFQ). Example showing a score of 13

Table2

Figure 2. LP trial Chalder Fatigue Questionnaire data, baseline to outcome.

CFQLP

A possible explanation for these contradictory outcomes, is that the LP made no actual difference to the participant’s fatigue and physical functioning – which as a group average was improving anyway, as evidenced by improvements in the control group. But what the LP might have done, is influence the way that the participants perceived and subjectively rated their physical limitations and fatigue. The evidence suggests that this occurred, because youngsters reporting an average SF-36PF rating of 85 and CFQ of 12 should not be missing any more school than fully fit children.

An alternative or additional explanation, could be that a small proportion of 10% to 20% of participants were suffering from depression or an anxiety disorder caused by the stress of their illness. Stress is a common consequence of chronic illness.2 So it is possible that a small proportion of participants got some benefit if the LP happened to help with these issues. This could easily result in the data of a few participants skewing the results and creating the appearance of a treatment-effect, despite the LP having no effect whatsoever on the actual causes of CFS. Had the researchers reported the trial in more detail and included some defined thresholds, even if only for post-hoc analysis, the data might have shown whether this actually occurred.

In my opinion, the LP rather cleverly exploits two phenomena – either of which could confound any serious evaluation of the effectiveness of a therapy. Firstly, the LP exploits ‘client deference’,3 a phenomenon which can prevent clients from raising concerns that they might have about their therapy or therapist, by depriving them of ‘agency’ or autonomy. It is a phenomenon which can subjugate the client’s will to that of a therapist. Secondly, the LP puts the entire responsibility for the success or failure of the therapy on to the client, thereby exploiting a ‘self-serving bias’ when the client comes to rate their progress, because the client is effectively rating their own effort and commitment to getting better.4 The simple and scientific way to prevent these phenomena from confounding the research would have been to include objective measures of physical function such as the Six Minute Walk Test.5

Finally, I cannot help wondering if some of the researchers got hypnotised during the trial. The published findings are selective and exaggerated and the interpretations suggest a lack of critical and objective analysis. The paper states that: “there was good evidence that SMC+LP was more cost-effective than SMC alone”. This round-about claim that the LP is an effective treatment for CFS is not supported even by the published data. ‘Good evidence’ that the LP was effective would be participants attending ALL their schooling and being able to do the same sports that healthy kids enjoy. These objective outcomes would show that the LP accurately and effectively addressed the underlying cause(s) of participants’ CFS. But the evidence shows that the LP got nowhere near these results. Instead, the evidence shows that the average LP participant still had substantial physical limitations, they were often absent from school and were only marginally and subjectively better than an average control participant. Furthermore, the evidence suggests that some of the LP participants acquired a distorted and over-optimistic perception of their health and physical abilities which influenced how they rated subjective measures.

Peter Kemp
September 2019

REFERENCES

  1. Bell D. Prognosis of ME/CFS. The Open Medicine Foundation. Aug 1 2016. Online. Available at: https://www.omf.ngo/2016/08/01/prognosis-of-mecfs/. Accessed February 25 2017.
  2. The Burden of Stress in America. Robert Wood Johnson Foundation and Harvard School of Public Health. July 2014. Online. Available at: https://cdn1.sph.harvard.edu/wp-content/uploads/sites/21/2014/07/Burden-of-Stress-Report-July-7-2014.pdf. Accessed Sept 16, 2019.
  3. Rennie, D. Clients’ Deference in Psychotherapy. Journal of Counseling Psychology. 1994, Vol. 41, No. 4, 427-437.
  4. Self-Serving Bias. Wikipedia. Online. Available at: https://en.wikipedia.org/wiki/Self-serving_bias. Accessed Sept 16, 2019.
  5. Ulrich S, Hildenbrand FF, Treder U, et al. Reference values for the 6-minute walk test in healthy children and adolescents in Switzerland. BMC Pulm Med. 2013;13:49. Published 2013 Aug 5. doi:10.1186/1471-2466-13-49. Available online at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3750631/
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The lightning process, coercion and placebo.

“I weep for this devoted mother. For I, too, watched my daughter endure a living death from ME”. By Esther Rantzen. The Daily Mail.  9 December 2008.

http://www.dailymail.co.uk/femail/article-1093325/I-weep-Kay-Gilderdale-For-I-watched-daughter-endure-living-death-ME.html

“The Lightning Process is a kind of neuro-linguistic approach which trains the brain to withstand the symptoms of the illness.

“And although the process, I am told, does not work for everyone with ME, it worked for Emily, and for many other patients I have subsequently recommended should try it.”

“At last, I have discovered the secret of Emily’s 14 lost years”.  by Esther Rantzen”. The Daily Mail.  15 February 2011.

http://www.dailymail.co.uk/health/article-1356316/At-I-discovered-secret-Emilys-14-lost-years-Esther-Rantzen.html

“When Emily developed ME, she was tested for all sorts of things to make sure there was no other underlying illness.

“But at no time was she ever tested for coeliac disease.”

So the fact is that Emily did not have M.E. and she never had.  She had coeliac disease and it was not cured by the lightning process even though 3 years earlier Rantzen had claimed that her daughter was cured.  Emily was actually cured by not eating any gluten.

And that is how the lightning process ‘works’.  It is pure quackery which exploits the placebo-effect, coerces ‘patients’ into claiming that they are cured and incidentally, makes money for its ‘practitioners’.  Some people will remember Ester Rantzen from ‘That’s Life’, a TV programme which often exposed quackery, fraud and other malpractice.  But even she was taken in.  Had Emily not remained ill and continued to search for the cause of her illness, she would still be ill today with coeliac disease.

Karina Hansen 6: THE HOMECOMING

My joy at this wonderful news is tainted with bitterness that this young woman was subjected to unspeakable arrogance and cruelty

valerieeliotsmith

KarinaHansenStockPicKARINA HANSEN, “PRISONER OF DENMARK”, IS HOME AT LAST.

On Monday 17 October 2016, after three and a half years of incarceration, Karina finally returned home to her family. The arrangement was on a trial basis but in the hope and expectation that she would be finally and permanently back where she belongs.

In recent weeks, Karina’s condition had improved slightly and her parents were able to visit her on a regular basis (more detail in my previous post). As a result, meetings took place between those in charge of the Clinic at Hammel where she had been an inmate since February 2013 (see Karina’s Story below for background) and representatives of Karina’s family. An arrangement for Karina’s return home was agreed whereby her parents would take her home within the next few days and she would remain there for a trial period. If all went well…

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The PACE Trial – ‘Illegal’ Participants skew the data

Changing the Protocol to admit less severely ill patients was rather desperate.  But then concocting the outcome measure ‘Normal Range’ which meant that some participants had recovered before they started, has made a laughing-stock of the PACE Trial.  But what did it do to the data?  Actually, it is not dreadful, but then again, it is not science.  Splitting the treatment groups into ‘legal’ and ‘illegal’ participants illustrates the difference between them.  Participants are ‘legal’ if their baseline score is BELOW the threshold of ‘Normal Range’ (60).  They are ‘illegal’ if their baseline is equal to or above that score – because, well, you just can’t do that!  It’s DUMB.

CBT group SF36PF

CBT group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=20:

i.e., already ‘Normal Range’

Legal Participants Illegal Participants
Baseline Average  = 36 Baseline Average  = 62
Outcome Average = 56 Outcome Average = 75

The ‘illegal’ CBT participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
80% scored 60 or more and were ‘Normal Range’
60% scored 75 or more and were ‘Improved’ as per the Protocol
45% scored 85 or more and were ‘Recovered’ as per the Protocol

 

 

SMC group SF36PF

SMC group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=22:

i.e., already ‘Normal Range’

Baseline Average  = 34 Baseline Average  = 62
Outcome Average = 47 Outcome Average = 71

The ‘illegal’ SMC participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
82% scored 60 or more and were Normal Range
50% scored 75 or more and were ‘Improved’ as per the Protocol
23% scored 85 or more and were ‘Recovered’ as per the Protocol

Conclusion

The incredible blunder of positioning an outcome threshold BELOW the level required for participation has had an effect on the outcome.  The overall influence has been limited due to the Control Group, but in a Trial where the researchers were evidently scrabbling for a few points here and there, the influence has significance.

PACE Trial CBT v. SMC

The PACE Trail Protocol states: “We propose that a clinically important difference would be between 2 and 3 times the improvement rate of SSMC.”

The chart below shows actual, individual CHANGES between baseline (start of the trial) and the 52 week Outcome for 148 participants in the CBT and SMC groups.  Added, are CHANGES in the SMC (Control Group) multiplied by 2 (blue) and 3 (green). These show the difference expected by the researchers.  If CBT had been effective, the red line would be between or above the blue and green lines at all points.

smcvcbtdifference

CBT failed in the PACE Trial – the data proves it. No torture was involved, I politely asked the data whether CBT lived-up to White et al’s expectations. It did not come close.  The only way to claim a treatment-effect from these outcomes is by denying the data.

PACE Trial Chalder Fatigue Questionnaire Data

In the charts below, each vertical blue line represents a PACE Trial participant’s BASELINE (before treatment) CFQ score.

The dark-red dot vertically aligned shows that same participant’s OUTCOME at 52 WEEKS.

A LOWER score means LESS fatigue. An effective treatment for fatigue would have the majority of red dots scoring 12 or lower.  It should also have many times more dots at this level than the Control Group (SMC).

cfq0and52smc

cfq0and52apt

cfq0and52cbt

cfq0and52get

The chart below shows the corresponding CFQ Baseline (yellow) CFQ Outcome (green) and SF36PF (red dots) for each participant in the CBT group.  There is little correlation between CFQ baseline and outcome or with the SF36PF.  The data is so random that no reliable or consistent influence could produce these results.  This is a NULL treatment-effect.

cfqbaseoutcomesf36pfoutcome

Do You Know About Action T4? The Erasure Of Disabled People From The Holocaust Narrative, And Why It Matters Today

Brilliant! From overview to detail and daily struggles to orchestrated vilification and eradication. Relevant for all disability campaigners.

Granite and Sunlight

“[£200,000] is what this person suffering from a hereditary defect costs the People’s community during his lifetime. Fellow citizen, that is your money too.”


Sioux Blair-Jordan outside the conference, from the East Anglia Daily Times.

In the midst of the most controversial Labour Conference in recent times, the speeches were pored over for things to be outraged about. The country needed to show that the Party had been taken over by ‘lefty loonies’ and, while the big names got front page headlines, other speakers became easy targets. One of these was Sioux Blair-Jordan, a Labour disability rights campaigner, who gave a powerful speech about the dehumanising narrative regarding sickness and disability emanating from the government, and the risks disabled people face if the Conservative Government follows through on their campaign pledge to dissolve the power of the European Court of Human Rights in the UK. The media and commentariat exploded with…

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Coercion of Participants in the PACE Trial

This follows on from my blogs:
The Science Media Centre and the PACE Trial – a deceptive partnership (https://wordpress.com/post/peterkempblog.wordpress.com/318) and
PACE Trial Participants – were they exploited?(https://wordpress.com/post/peterkempblog.wordpress.com/91)

One could be forgiven for wondering if M.E. patients and PACE Trial participants have any right to respect for their autonomy.  The PACE authors seem to have no such respect.  Collecting information about people then publicly misrepresenting them is not showing respect.

Reading the PACE Trial documents, from the Protocol to the Lancet publication, disregard for participant autonomy seems pervasive and could even be considered inevitable considering espoused theories of the PACE researchers.  To whit: ‘participants are so incompetent that they cannot even judge their own health or tell whether they are ill or not, if they could, then a bit of exercise and positive thinking would cure them’.  So working from this view of participants as incompetent, it is no surprise that the researchers attitude towards participants was one of condescension verging on abuse.

Just one instance of this disrespect occurred in a Participant Newsletter and is neatly analysed by Hooper and Williams in Magical Medicine.  The dubious tactic of employing participants as recruitment officers for the Trial, is not only coercive of the participants, but also risks skewing the data of what was supposed to be a scientific experiment.  The PACE researchers stopped short of offering a set of steak-knives for each new recruit introduced, or a skiing holiday for the one that got the most new participants, but the principal is not dissimilar.

 From Magical Medicine, How to make a disease disappear, by Professor Malcolm Hooper (http://www.meactionuk.org.uk/magical-medicine.pdf):

The PACE Participants’ Newsletter (Issue 2, March 2007) was openly soliciting for more participants: “If you know of any friends or family who suffer from CFS/ME and who might be eligible and interested in taking part in the study and live close enough to one of these centres, please suggest they approach their GP for a referral to a PACE centre”. The problems with using existing participants to recruit new participants are obvious.

First, the existing participant might no longer feel inclined to report negative effects and might exaggerate any positive effects because (i) they may feel they have become part of the PACE research team and thus feel a loyalty that could influence how they report their experience and (ii) participants who recruit others are asking them to join in their own experience and thus they assume a burden of responsibility, as a result of which they may be less likely to report ‘it was awful’ or ‘ it did not help’.  This could render their own subjective data invalid.  Furthermore, if a participant knows s/he has persuaded someone else to join the trial, the recruiting participant might no longer feel s/he had the right to drop out or withdraw consent at any time of their choice.

Secondly, a participant who was recruited by a friend or family might also feel similar obligations of loyalty to their friend or family member, so their own data might also be unreliable.

Thirdly, only participants who are enjoying or benefiting from their participation are likely to have recruited others, with the result that a potential participant is exposed to a positive viewpoint that might not adequately reflect the risks and burdens of participation, as well as arousing fears that they are missing out on something helpful.  This could be viewed as making unjustifiable claims about the therapies on trial (which could be in breach of the GMC’s Guidelines for Good Medical Practice (section 61) that states: “You must not make unjustifiable claims about the quality or outcomes of your services in any information you provide to patients.  It must not…exploit patients’ vulnerability or lack of medical knowledge”).

Fourthly, participants who do not recruit anyone might be influenced by the suggestion that they should recruit and may feel guilty if they are unable to recruit more participants, with the result that they may compensate by being ‘better’ (ie. more positive and less critical) participants.  This could affect they way they report their experience and thus invalidate their data.

Other institutions concerned with research integrity require approval for all methods of advertisement prior to use and they consider “advertising or soliciting for study participants to be the start of the informed consent process…Advertisements must be reviewed and approved…When advertising is to be used, the information contained in the advertisement and the mode of its communication (must be reviewed) to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favourable outcome” (http://orip.syr.edu/sop/sop036.php ).

The tactics used for recruitment to the PACE trial seem to indicate the difficulties encountered by the Investigators, a fact that is believed by many people ought to have raised concern with the various ethics bodies.

It is believed that the difficulty in recruitment may have resulted in coercion of sick people.

The Light of Day

Must read for all PACE Trial watchers

spoonseekerdotcom

After long opposition (and substantial expense) from the trial investigators and Queen Mary University of London, data from the £5m publicly funded PACE Trial, which studied graded exercise (GET) and CBT therapies for ME/CFS, has finally been released under the Freedom of Information Act. ME patients Alem Matthees, Tom Kindlon and Carly Maryhew, with the support of two prominent US statisticians, have reanalysed the data according to the original trial protocol and illustrated that the recovery results were exaggerated by a factor of four due to unexplained protocol changes. The revised results were in fact statistically insignificant. This means that , in spite of what the investigators claimed, the trial provided no proof that GET and CBT help people with ME/CFS to recover.

Though those who have studied the trial have long suspected that the results as originally presented were grossly misleading, it is still a “gosh- wow” moment…

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