Recent research funded UK Government - does it address NICE findings?

Hi guys now that the long awaited revision of the NICE guidance on ME/CFS is nearing completion (18th August) I thought I'd create a thread to identify studies which have been funded by the Government in the UK. Specifically do they address the draft NICE evidence review findings i.e. that the majority of studies previously funded studies were "low or very low quality"? On the face of it, there are two primary issues with the previous studies i.e.

• they were unblinded or inadequately blinded
• they used subjective outcome indicators (questionnaires) rather than objective outcome indicators (actimetry/actigraphy - fit bit type devices*).

Lets say a study is funded next month which is unblinded and uses subjective outcome indicators (questionnaires), rather than objective outcome indicators (actimetry/actigraphy*) - what can we do? The obvious thing is to ask MPs to ask a Parliamentary Question i.e. of the Minister** which funds the body which made the grant allocation. E.g.

• "Recently grant awarding body X funded study Y - study fails to address the concerns in the NICE review - what steps has the Minister taken to ensure that public money is not used to fund "low and very low quality" research?"
• "Does Minister accept concerns that research is "low and very low quality"? What is he doing to address this?"

There may be occasions when it may be helpful to ask freedom of information requests e.g. if the evaluation criteria, for a publicly funded study, are not available via the funding bodies website.

Basically the idea is to make a nuisance of ourselves and thereby force the Department of Health and Social Care to stop funding "low or very low quality" research.

*[EDIT - reference added] "Fluge and Mella used "Sensewear armband"
https://clinicaltrials.gov/ct2/show/NCT02229942

**I gather that National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI) have funded research into ME/CFS [response to Parliamentary Question - UIN 24368]. so they are obvious targets
Department of Health and Social Care fund NIHR and I think UKRI.

 

for starters, I would like to question the continuation of the FITNET-NHS trial

http://www.bristol.ac.uk/academic-child-health/research/research/cfsme/fitnet-nhs/

https://www.hra.nhs.uk/planning-and...-is-fitnet-nhs-for-children-and-young-adults/

 

Might need some help with this @Sly Saint ! E.g. was there a decision to provide additional funding and if so the was it after the draft NICE Guidelines were published (November 2020)?

EDIT - Noticed this "The study is funded by the NIHR HTA. Recruitment was complete in November 2020. Participants are followed up for 12 months." So I assume the decision to fund pre-dates the publication of the draft NICE Guidelines and the associated evidence review.
http://www.bristol.ac.uk/academic-child-health/research/research/cfsme/fitnet-nhs/

So could they pull the funding or e.g. modify the study so that the evidence derived from the study is not "low/very low quality"?

 

Can anyone find the full study protocol - I'm interested in the outcome indicators; noticed a mention of the dreaded "SF-36-PFS questionnaire"
https://www.hra.nhs.uk/planning-and...-is-fitnet-nhs-for-children-and-young-adults/

Noticed this review of actimetry (electronic activity monitoring) versus questionnaires*
"Conclusion
The findings suggest that the measurement method may have a significant impact on the observed levels of physical activity. Self-report measures of physical activity were both higher and lower than directly measured levels of physical activity, which poses a problem for both reliance on self-report measures and for attempts to correct for self-report – direct measure differences. This review reveals the need for valid, accurate and reliable measures of physical activity in evaluating current and changing physical activity levels, physical activity interventions, and the relationships between physical activity and health outcomes."
https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-5-56

 

Could you add actimetry i.e. objective measurement of physical activity to this study (I assume the study has commenced)
http://www.bristol.ac.uk/academic-child-health/research/research/cfsme/fitnet-nhs/

Issue is that, since it relies on questionnaires to assess outcome then, it will presumably be "low or very low quality" as per NICE findings re similar studies.

Thanks in advance.

@Jonathan Edwards @Snow Leopard @Sly Saint

 

Their ongoing interest in the Lightning Process is of great concern

https://www.bristol.ac.uk/academic-child-health/research/research/cfsme/lightning-process/

 

https://www.s4me.info/threads/fitnet-nhs-esther-crawley-5th-protocol-out-now.8053/

 

Thank @Sly Saint here's an extract from the study protocol
"4.11.3 Primary outcome
Our primary outcome will be disability measured using the Physical Function Scale (SF-36-PFS) measured 6 months after randomisation."
https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/#/ - Protocol 23 Jul 2019

Next question is how far on are they with the study and when is it likely to be completed? Anyone know how to find that out?

Noticed the cost of the study is "Cost: £1,026,403.00" [https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/#/] Nice little earner for a few academic salaries and a few questionnaires.

NIHR website has some information:
"Start Date: May 2016
End Date: May 2022"
[https://fundingawards.nihr.ac.uk/award/14/192/109]

So it may be nearing completion - has the raw data collection been completed (questionnaires completed!). Anyone know how to find out?

Possibly one way to challenge this is to pose a Parliamentary Question along these lines:
"For all studies of CBT and GET to date, NICE graded all the evidence accumulated as either “VERY LOW” or “LOW” one ongoing study has received £1 million in funding from NIHR and yet we know that the evidence it will provide will be “VERY LOW” or “LOW”. What steps is the Minister taking to address NICEs concerns and to prevent more £millions of public money being wasted on “VERY LOW” or “LOW” quality research?
OR
Minister's Department funds NIHR. Recent NICE review found the studies to date were “VERY LOW” or “LOW” quality research i.e. research which cannot be used as a basis for NICE Guidance to assist Doctors and other healthcare professionals. There is one ongoing £1 million study which is similarly flawed. What steps is the Minister taking to address this waste of public money?

Need an MP who is willing to help, as well.

 

I think it's due to run until next year but they are looking at/using the data as they go along.
It might help to read the whole of that thread as there are a lot of issues with the trial even before you take the new guidelines into consideration.

eta: "funding until 30 April 2022"
https://www.s4me.info/threads/fitnet-nhs-esther-crawley-5th-protocol-out-now.8053/page-3#post-349914

 

If you check out the NIHR funding awards you'll see that this study* was awarded £150K [https://fundingawards.nihr.ac.uk/award/NIHR200509]. Start date was "February 2020" but I haven't found the award date. Any idea how to find the award date?

There's a brief thread on this award here**


*Measuring Health in Children with CFS/ME: Refinement, application and evaluation of new PROM (PEACH) in routine practice.

**https://www.s4me.info/threads/in-pr...each-in-routine-practice-crawley-et-al.20930/