Not Reassuring – the response to the formal complaint about the Long Covid paediatric study, CLoCK.
Part Two - The CLoCK Files, the crisis in paediatric Long Covid
Finally, Long Covid Advocacy received a response (view here) from UCL, and only under some pressure, on the 27 March, after 8 months of waiting since sending the Formal Complaint for the CLoCK study. (view here) We are grateful that leading Drs in the Long Covid & ME community agreed to co-sign; Dr Binita Kane, Dr Asad Khan, Dr Brian Holloway, Dr Clare Rayner, Dr Kelly Fearnley, Dr Ben Marsh, Dr Ian Barros D'Sa, Dr Claire Taylor, Dr Deepti Gurdasani & Ms Claire Hastie.
In September 2021, CLoCK Principal Investigator, Sir Terence Stephenson, stated he was “reassured” about Long Covid in children in a BBC article. This came at a time where a series of minimising articles were published with glanceable headlines about Covid to encourage a ‘back to normal’ society and for children to be back in school (with still no protections). Did I feel reassured that 2-14% of the nation’s children had long term symptoms from Covid? No. The headline should have been very very different – one of a call to action, of concern and to ensure that children’s health was protected by ventilation, air filtration, testing and masks. At no point were clinically vulnerable children and families mentioned. Yet we see in the article the sociological bones of the CLoCK study and how the narrative and spin of lockdown, health anxiety and previous mental issues were the ‘real’ bogeymen for children.
Do we feel reassured by the response to the formal complaint Long Covid Advocacy made about the CLoCK study?
“We would like to reassure you that the CLoCk research project is not a clinical study, nor does it draw in any way on psychosocial research into ME/CFS.”
No – is the short answer.
Image credit: ‘Wait for me’ Rosie Pidgeon. @art_byrosie
Here is a point-by-point evaluation of the unresolved issues in the response:
Ethical breaches in recruitment and data collection: Informed consent; Deception; Fishing and Data Protection
1.“Study information sheet and questionnaire as a referral form and that this needed to be completed in order to access the referral and treatment” UCL Response
Here we raised the issue of CYP having to compulsorily fill in the CLoCK study questionnaire to access care and referral at a Long Covid Clinic. This point has still not been addressed. The compulsory nature of this is still concerning especially due to the serious issues about the competence of the questionnaire and its psychosocial agenda.
This still doesn’t answer or acknowledge the trauma of parents having to be told that their child had to fill in a questionnaire for referral that asked if they stole, did what they were told, if they were liked, did they lie, were they anxious, fearful or were they lonely? These questions could only be asked if the researchers are fishing for a behavioural model. It is clear from the answer below that the questionnaire is still being given out.
The quality and suitability of the questionnaire is still questionable. It mixes mental health and physical health questions in a subjective outcome questionnaire which leds to expectation and confirmation bias that falsely assumes causation, leading to a flawed methodology. This is a repeat of the problems found in the NICE ME/CFS Evidence review that led to all behavioural studies being graded as low or very low and deemed invalid and led to a replication crisis (No More Mr NICE Guy... - The Science Bit, n.d.)
2. “Research team, having spoken with their clinical collaborators, have clarified that the questionnaire was used in the clinics as a tool for assessing symptoms of Long Covid” UCL Response
The problem here was that it was unclear if CYP were being enrolled in the CLoCK study without informed consent as they were having to fill in the CLoCK study questionnaire in a clinical setting. Parents reported their concerns about this to Long Covid Advocacy. UCL reassured us this wasn’t the case and the references to CLoCK have been removed so a clean questionnaire is given.
It has now been made clear on the CLoCK website that the research project is separate from clinical services. Which was very different to the original sharing statement on the questionnaire. Yet why then is the questionnaire still being given in clinical services? Is this entirely separate? CLocK is still exerting significant cultural influence on clinical services through a behavioural orientated questionnaire.
Due to the ethical history of some of the research team is the word of the research team enough? We have researchers from the PACE scandal involved, Crawley and Chalder. Crawley has 11 papers with unresolved ethical corrections (see Tuller). Do the questionnaires need to be checked objectively and at primary source that parental consent has been given and they are not from forced compliance?
3. “had been put into the control group despite having a Long Covid diagnosis. The research team have clarified that as soon as a request was made to withdraw the participant from the study, this was acted upon.” UCL Response
We had been made aware of a CYP who had been assigned the control group even though she had a Long Covid diagnosis and that this had been raised in the CLoCK questionnaire with no action. This raises the question that if one child has been put in the control group due to a negative test but has self-reported Long Covid and/or a Long Covid diagnosis other incidents are inevitable. This means an invalid study as the control group is contaminated.
The control group needs to be contacted to see if there are other cases of self-reported symptoms and/or Long Covid diagnosis’. This flaw will give false results and will not be in the favour of CYP. It has the ability to discredit Long Covid as connected to a Covid infection as symptoms will be seen in the control group. Relying on the unreliable, tests for Covid for a diagnosis of Long Covid, is fraught with difficulties.
This is especially important as the study;
“will assess if there are any differences between CYP who initially tested negative or positive test for covid”.
4. Insufficient public patient involvement: issues raised are being inadequately addressed from a PPIE perspective resulting in major flaws in the proposed trial.
In this section we raised the issue that serious concerns were not being listened to about the methodology of the trial by PPI. This included numerous stages - funding application, NHSEI Taskforce, DHSC Roundtable and NIHR. Yet we received essentially a description on the PPI, at no point were the methodological issues addressed – another example of the original question. We also asked why a progressive design wasn’t included that could take in and adapt to the growing evidence of Long Covid? Surely this would be sensible scientific design as ‘Lockdown anxiety’ might just might be a flawed hypothesis (irony included in this sentence). Yet another circular answer was given that the study didn’t include that.
PPI with this type of psychosocial study can be tricky and walking on a knife’s edge. On one hand it offers a direct line to the researchers to try to influence them. Yet, these researchers have had years of practice with PPI and have never moved their ideological position. The question remains does PPI have a chance of doing this or are they just really after the endorsement of the PPI charity and the access to CYP with Long Covid for recruitment? The ME community still remembers Action for ME’s involvement and enabling of Esther Crawley’s severe ME Paediatric study; the PACE trial, involvement with Simon Wessely and that they wouldn’t comment on harmful studies or sign open letters. This resulted in serious reputational damage.
5. “Long Covid and ME/CFS are clinically linked” UCL Response
This is not addressed in the response despite extensive referencing to studies that clearly show that one phenotype of Long Covid, and up to 50%, meet the criteria for ME/CFS. Why when some of these researchers have so much experience of ME/CFS do we not see a mention? The CLoCK study is designed to identify Long Covid symptoms in CYP yet we do not see any attempt to find the symptoms of PEM, MCAS, POTS, hEDS and vascular damage. Instead we see fishing for behavioural ‘abnormalities’. The questionnaire even if it doesn’t find a treatment could have been a thousand times better. How is the definition of paediatric Long Covid going to be accurate if the wheel is rigged?
6. “nor does it draw in any way on psychosocial research into ME/CFS” UCL Response
It does have psychosocial ME/CFS researchers which hasn’t been addressed. It does draw on the same psychosocial reasons for symptoms in ME/CFS which were extensively referenced in the formal complaint.
7. “The study has no direct treatment implications relating to any specific model, and the UCL research team have no plans to consider any form of randomised control trial after this project” UCL Response
Here we raised the concern that an RCT of Graded Activity Intervention was planned from the CLoCK definition and data. We know that activity for post-acute viral infections have serious capacity to cause harm and disability. Good to hear that there are no plans for any RCTs or treatment, yet we would be more reassured if a specific confirmation that this document and action has been scrapped. If they have no plans what is this?
8. “CYP may face a misdiagnosis of PRS or FII or if parents refuse or pull out of treatment or research; this may further prompt inappropriate involvement from Child Protection Services” UCL Response
Here we raised the issue that more families with a CYP with Long Covid are being involved with Child Protection services as raised by the Social Workers Practice Guide. We have seen in ME/CFS that this is more likely if the parents refuse harmful treatment for their child and up to 1 in 5 families have Child Protection called in inappropriately.
“recent reports about responses to children with long Covid-19 show how parents and children are being disbelieved and categorised as FII (Munblit et al, 2021 p. 1): “The issue of not being believed is a common one, and the fear of being considered over-anxious and/ or Munchausen’s by proxy is very difficult. (Long et al., 2022, p. 9)”
This is not addressed in the response despite serious safeguarding issues and considerable distress for families who are already dealing with lack of care and treatment for their children. The CLoCK study perpetuates psychological attribution for Long Covid symptoms which is the basis for Child Protection being called through misdiagnosis.
9. “Psychosocial aspects such as ‘Lockdown Anxiety’ and ‘abnormal thoughts’ are being inappropriately researched in CLoCK.” UCL Response
“research team’s view that both are important to study as mental health can impact physical health”
“questionnaire cannot be used to isolate mental health factors as causative”
We also have some fudging around mental health directionality and causation, both denying and insinuating. Yet this is to be expected. Psychological causation and psychosomatism is a highly toxic field and their argument just becomes more convoluted, muddied and ambiguous. It is interesting to note though that anxiety has been deliniated as one of the ‘reliable’ top 3 symptoms of paediatric Long Covid by the same team by WHO.
We see two highly concerning papers referenced by CLoCK Concern for Covid-19 cough, fever and impact on mental health. What about risk of Somatic Symptom Disorder? (Willis & Chalder, 2021), and Reduced social distancing early in the COVID-19 pandemic is associated with antisocial behaviours in an online United States sample (O’Connell et al., 2021), both examples of trying to see abnormal thoughts and behaviours causing Long Covid.
The fallacy of Lockdown anxiety is still not addressed in the response even though CYP are still developing Long Covid when Lockdown is not present. Again, we just receive padding describing the questionnaire.
“We hope this allays your concerns regarding the above points”.
Image credit: ‘I am Still Here’ by Rosie Pidgeon. @art_byrosie
Conclusion
So, are our concerns allayed, are we reassured? No – due to the reasons given above. It is baffling that serious concerns regarding the safeguarding of children can be literally ignored. It feels like there is a serious institutional problem regarding the complaints process. We see this in the recent issues in OFSTED and the myriad complaints and outcries about exercise studies in Long Covid and ME/CFS which are ignored. You can complain but they will be marking their own homework. Even the HRA is led by Sir Terence Stephenson so what hope is there at objectivity? You can write a fully referenced letter and report widely held concerns from parents, organisations and even the children involved, and the computer says No. The need to protect careers and the institution comes first – it feels like a “too big to fail” policy is in place. Yet even Lehman Brothers fell eventually.
If this response was held to academic standards, it would receive a big fail, nil points, because it fails to do what is drilled into most students – answer the question. Most of the response is just descriptive padding that aims to reassure but avoids the actual issues. There has been no actual investigation – only the researchers who the complaint was made against were asked. No actual checking of primary sources occurred which needs to happen to ensure an objective response.
It is clear that a repeat of the mistakes made in ME/CFS research and the Cognitive Behavioural Model and Biopsychosocial model is happening. The cultural and political influence of CLoCK is profound. The not reassuring WHO clinical definition of paediatric Long Covid was led by CLoCK researchers Stephenson and Shafran. The consequences of this looks likely to restrict access to care and will not improve or benefit paediatric outcomes. This definition needs a positive covid test (argghhhh - because testing is so widespread, accepted and equitable now, not) and only defines as ‘reliable’ 3 symptoms fatigue (not PEM), loss of smell and yes our old friend anxiety. All other symptoms are minimised & misrepresented:
“Symptoms described thus far in children and adolescents are non-specific and can occur with other childhood infections and illnesses. Due to the lack of empirical evidence, a broad list of potential post COVID-19 condition symptoms affecting different organ systems should be considered until more data are available.”
Regardless of the reassurance and all the words, we have to look at the cold outcome - and that is children with Long Covid have been labelled as anxious. Anxiety in the modern age is the rebranded hysteria and the stage is now set for psychosomatic medicine.
CLoCk is also deeply embedded in Paediatric Long Covid Clinics due the questionnaire being ubiquitous and other studies refer to it as foundational and refuse to counter or apply critical thinking. So, this means we are in serious trouble as the attempt to establish a psychosocial model into research, policy and treatment is well under way. So much so that it is questionable that the web is too well established to break.
But the paradigm is shifting with ME/CFS (slowly and with a very long way to go still) so it must be possible with Long Covid. But this should never have happened in the first place. But for the CYP actually affected by Long Covid we need to try, as they deserve better. We must do all we can not to lay to waste another generation of children as what happened to children with ME/CFS. The advice we would give for any parent whose child is part of the CLoCK study would be to avoid, avoid, avoid.
Actions
We call for these actions:
For the questionnaire to be removed as an access form for Long Covid Clinics or for at least the compulsory nature be withdrawn.
For the CLoCk study to be stopped and any funding left be redirected to biological investigations & medical treatment in CYP with Long Covid.
For any reference to lockdown to be removed
For the CYP and families be contacted directly to check they were not made to fill in the questionnaire under threat of no referral.
For the control group to be contacted and checked that there are no Long Covid diagnoses or self-reported Long Covid
An independent investigation at a primary source level
A ReCOVer fast-tracked treatment based study
Prevention to stop endless reinfection – monitoring, filtration & ventilation legislation for schools. See call for a Ventilation Bill by Long Covid Support
Parent choice for Covid vaccination for CYP