Recruiting Adolescents With [CFS/ME] to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial, 2020, Knoop, Crawley et al

Andy

Senior Member (Voting rights)
Full title: Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial
Background: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adolescents is common and disabling. Teenagers in the United Kingdom are more likely to recover if they access specialist care, but most do not have access to a local specialist CFS/ME service. Delivering treatment remotely via the internet could improve access to treatment.

Objective: This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial).

Methods: This study is an internal pilot for the initial 12 months of a full randomized controlled trial (RCT), with integrated qualitative methods (analysis of recruitment consultations and participant and clinician interviews). Recruitment and treatment were delivered remotely from a specialist pediatric CFS/ME treatment service within a hospital in South West United Kingdom. Adolescents (aged 11-17 years) from across the United Kingdom with a diagnosis of CFS/ME and no access to local specialist treatment were referred by their general practitioner to the treatment center. Eligibility assessment and recruitment were conducted via remote methods (telephone and on the web), and participants were randomized (via a computer-automated system) to 1 of 2 web-based treatments.

The trial intervention was Fatigue in Teenagers on the InterNET in the National Health Service, a web-based modular CFS/ME-specific cognitive behavioral therapy program (designed to be used by young people and their parents or caregivers) supported by individualized clinical psychologist electronic consultations (regular, scheduled therapeutic message exchanges between participants and therapist within the platform). The comparator was Skype-delivered activity management with a CFS/ME clinician (mainly a physiotherapist or occupational therapist).

Both treatments were intended to last for up to 6 months. The primary outcomes were (1) the number of participants recruited (per out-of-area referrals received between November 1, 2016, to October 31, 2017) and the proportion providing 6-month outcome data (web-based self-report questionnaire assessing functioning) and (2) the qualitative outcomes indicating the acceptability of trial processes and treatments.

Results: A total of 89 out of 150 (59.3% of potentially eligible referrals) young people and their parents or caregivers were recruited, with 75 out of 89 (84.2%) providing 6-month outcome data. Overall, web-based treatment was acceptable; however, participants and clinicians described both the advantages and disadvantages of remote methods. No serious adverse events were reported.

Conclusions: Recruiting young people (and their parents or caregivers) into an RCT of web-based treatment via remote methods is feasible and acceptable. Delivering specialist treatment at home via the internet is feasible and acceptable, although some families prefer to travel across the United Kingdom for face-to-face treatment.
Open access, https://www.jmir.org/2020/8/e17768/
 
They won't give up will they
A Dutch trial of a web-based CFS/ME-specific cognitive behavioral therapy (CBT) called Fatigue in Teenagers on the InterNET (FITNET) showed promising results [5]
This study presents the findings of the initial 12-month internal pilot phase of the FITNET-NHS RCT,
Of the 150 potentially eligible patients, 50 declined to participate. The main reason was that they wanted to be seen face-to-face
I think because [child] has had absolutely no treatment at all or help really from anywhere, she saw this as an opportunity so she was going to take it whichever she was given.
[Mother 292]
AM
The qualitative interviews indicated that most participants did not feel 3 Skype calls were enough. Clinicians did not feel that the 2 treatment arms were equal and failed to match the current standard for usual care, which had increased to 6 calls per patient since the trial was designed. In response to this feedback, the AM arm was changed to allow up to 6 sessions
A limitation is the lower recruitment compared with projections. We planned to recruit 156 participants in the in-pilot phase, representing 68% of the potentially eligible patients (expected to be 229) identified from out-of-area referrals aged between 11 and 17 years (expected n=286). We recruited 89 out of 150 participants
This study builds on the promising results of the Dutch trial of the FITNET program [5] by demonstrating the potential for the UK-adaptation of the web-based CBT intervention to be used within the NHS. The full RCT is currently ongoing, with recruitment due to be completed by October 31, 2020 (with follow-up data collection to continue for 12 months beyond this). The results of the full trial will indicate whether the FITNET-NHS treatment is effective and cost-effective when compared with web-based AM, which will inform treatment recommendations going forward.

Conflicts of Interest
HK and GB received royalties for the publication of a treatment manual for CBT in CFS/ME in adults. The remaining authors have no conflicts of interest to disclose.
 
So in the first 12 months which they are calling an internal pilot, whatever that is, they recruited far fewer than they expected, and used their data to adjust the methodology.
This appears to be now rolled into the full trial, just as they did with the SMILE LP trial.
@dave30th, something to look into?
 
So in the first 12 months which they are calling an internal pilot, whatever that is, they recruited far fewer than they expected, and used their data to adjust the methodology.
This appears to be now rolled into the full trial, just as they did with the SMILE LP trial.
@dave30th, something to look into?

They don't want to let me have a vacation, obviously. seems they're rushing out a lot of stuff to impact NICE
 
OK this is reaching total madness levels. They could not recruit enough participants for their trials, pretend to be doing a partial feasibility trial that will be rolled into a fully-powered trial, but are instead calling it an "internal pilot". This "treatment" modality has been tested many times already, including by Crawley herself, so the idea that they need to do a feasibility study on something that's been done many times before is genuinely insane.

So putting aside the fact that this has already been tried many times before, they could barely reach 50% of their recruitment target and still report that they met their target. Seriously at this point the people who enable, fund and oversee this are bordering on criminal misconduct themselves.

The Dutch FITNET experiment's results were published in 2012. It defined "recovery" post hoc, because of course. The results were not in the slightest bit "promising".
This study aims to assess (1) the feasibility of recruitment and retention into a trial of internet-delivered specialist treatment for adolescents with CFS/ME and (2) the acceptability of trial processes and 2 web-based treatments (to inform continuation to full trial).
So promising that years later they only feel they can just try the same feasibility study again? And fail? And still argue it warrants a full trial for which they will clearly not be able to recruit? This is completely insane, these people are out of their damn minds.

FITNET-NHS's target is 734 participants. They could not even recruit 60% of a target of 156 despite using completely invalid biased methodology. This clearly shows the full trial is unfeasible.
We planned to recruit 156 participants in the in-pilot phase, representing 68% of the potentially eligible patients (expected to be 229)
When did 734 turn into 229? The numbers are all over the damn place.
The primary outcomes for this pilot study were the number of eligible adolescents (and their parents/caregivers) recruited compared with the number referred before October 31, 2017, and the proportion of those providing 6-month web-based self-report outcome data (completion of SF-36-PFS).
So clearly it failed on its primary outcome.
Those recruited came from a wide range of locations across England. A total of 76 out of 89 patients (85.3%) provided their 6-month outcome data, and 75 out of 89 patients (84.2%) provided their 12-month outcome data. A total of 2 out of 89 patients (2.2%) actively chose to withdraw from the trial.
They actually used a fraction of a fraction. What in the actual HELL? That's not how statistics work. They can't even recruit their target for a feasibility, how is it even invalid to do analysis on incomplete data when the primary outcome is meeting the recruitment target? Again even putting aside the fact that this exact same experiment has been done multiple times before and still manages to get funding.

There is no crisis of replicability, the crisis is validity. This is invalid unresearch. Real people, real human lives are just being toyed with by mediocre ideologues and it still manages to get funding, approval and gets published despite completely misrepresenting everything. This is insane.
 
This is where critical analysis and statements from charities is needed.
It is not difficult when faced with studies this bad, but it does not seem to happen.
I would love to be proved wrong on this occasion especially.
 
I'm not sure which charities have the capacity to do this.
To me this should be an inherent part of their remit. If not challenged via bodies which purport to support and represent the patient group then the narrative simply continues and the endless loop goes on with revisionist name changes.

If after all these years they do not have persons who can dissect and explain with some authority then we have have to ask why not.

I understand that getting it into mainstream narrative is difficult but social media is a gamechanger for this - we can see this repeatedly.
Perhaps I am just being incredibly naive
 
OK this is reaching total madness levels. They could not recruit enough participants for their trials, pretend to be doing a partial feasibility trial that will be rolled into a fully-powered trial, but are instead calling it an "internal pilot". This "treatment" modality has been tested many times already, including by Crawley herself, so the idea that they need to do a feasibility study on something that's been done many times before is genuinely insane.

So putting aside the fact that this has already been tried many times before, they could barely reach 50% of their recruitment target and still report that they met their target. Seriously at this point the people who enable, fund and oversee this are bordering on criminal misconduct themselves.

The Dutch FITNET experiment's results were published in 2012. It defined "recovery" post hoc, because of course. The results were not in the slightest bit "promising".

So promising that years later they only feel they can just try the same feasibility study again? And fail? And still argue it warrants a full trial for which they will clearly not be able to recruit? This is completely insane, these people are out of their damn minds.

FITNET-NHS's target is 734 participants. They could not even recruit 60% of a target of 156 despite using completely invalid biased methodology. This clearly shows the full trial is unfeasible.

When did 734 turn into 229? The numbers are all over the damn place.

So clearly it failed on its primary outcome.

They actually used a fraction of a fraction. What in the actual HELL? That's not how statistics work. They can't even recruit their target for a feasibility, how is it even invalid to do analysis on incomplete data when the primary outcome is meeting the recruitment target? Again even putting aside the fact that this exact same experiment has been done multiple times before and still manages to get funding.

There is no crisis of replicability, the crisis is validity. This is invalid unresearch. Real people, real human lives are just being toyed with by mediocre ideologues and it still manages to get funding, approval and gets published despite completely misrepresenting everything. This is insane.
not like you to be so generous "mediocre" really that would be a vast improvement on the blatant fraud that these people commit in every psuedo scientific piece of trash they produce .
 
I'd have to look again. Did they actually mention any pilot study in the protocol? I can't remember that.
Here's our thread on the protocol:
FITNET-NHS Esther Crawley - 5th protocol out now

Here's the version of the protocol from February 2018
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
Methods
Seven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders.
Trial design
This is an RCT comparing FITNET-NHS with Activity Management for paediatric CFS/ME. An internal pilot study will be conducted with continuation of the trial based on achieving defined criteria. Integrated qualitative methods will be used to optimise recruitment and retention. Pilot data will be used in the effectiveness analyses unless changes to the interventions or trial design are significant.
Sample size
Full trial: we plan to randomise 734 young people in the full trial. The study will proceed to full trial assuming the stop criteria (see below) are not met. Assuming 10% attrition (withdrawal or non-provision of primary outcome data) [16, 33], data on 660 young people will be available for the primary analysis.
Outcomes and analyses of the internal pilot study
The internal pilot study will run for 12 months using integrated qualitative methods to determine feasibility of trial processes and acceptability of interventions. Defined criteria (see below) will be used to determine whether the study should proceed to full trial, in which case data from the internal pilot phase will be included in full trial analysis.
Stop criteria
The stop criteria have been agreed with the Trial Steering Committee (TSC) prior to starting recruitment. The internal pilot study will not proceed to full trial if: (1) the recruitment rate is substantially below target during the last 6 months of the internal pilot study and if the qualitative data suggests that we cannot improve recruitment by changing recruitment methods or (2) the qualitative data suggests that the interventions are not acceptable to participants.

My bolding.

And an announcement of amendment December 2019:
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3895-1

Amendment
Recruitment into the FITNET-NHS Trial began on 1 November 2016. In mid-2018, it became apparent that the recruitment rate would not allow us to achieve our original sample size target (n = 734) without a substantial extension to the recruitment period. The original sample size was selected to provide 80% power to detect a 0.4-standard deviation (SD) difference at 5% significance with 10% attrition on the primary outcome in a subgroup of participants (estimated to be 30% or n = 220) with co-morbid mood disorders of anxiety and depression. For all participants (with or without co-morbid mood disorders), the original sample size provided 97% power at 1% significance to detect a 0.35-SD difference on the primary outcome (Short Form Health Survey; Physical function Subscale (SF-36-PFS) score) at 6 months.

We reviewed the trial with the funders – National Institute for Health Research, Health Technology Assessment (NIHR HTA, on 10 July 2018) and consulted with the Trial Management Group (TMG, on 12 September 2018 and 18 October 2018), the Data Safety Monitoring Committee (DSMC, on 10 October 2018 and by email report on 11 March 2019) and the Trial Steering Committee (TSC, on 28 November 2018).

In September 2018, we calculated the required sample size for the primary outcome in all participants (with or without co-morbid mood disorders):

Data on 266 children will give us 90% power at 5% significance to detect a 0.4-SD difference on the SF-36-PFS. With attrition currently at approximately 15%, we will need to recruit 314 children. This is achievable (based on recruitment rates to date) by the end of October 2020.

This gave us a new recruitment target of 314 children in total, 157 in each treatment group
They then go on to talk about the larger proportion than expected with comorbid mood disorders, and then about getting approval from the funding body for the revised recruitment target.

So, despite being way below recruitment target, they have managed to get approval to continue with a half size trial and a time extension.

Oh, and by the way, the trial budget is over £1 million. And I haven't seen anywhere mention of cutting that budget in half for their half sized trial.
 
The internal pilot study will not proceed to full trial if: (1) the recruitment rate is substantially below target during the last 6 months of the internal pilot study and if the qualitative data suggests that we cannot improve recruitment by changing recruitment methods
That "and" is way too flexible, allows for any BS argument to be used, which of course it was. That they lowered their recruitment target by half, which they clearly will not meet after having failed to meet half of that to begin with, is proof that they cannot improve recruitment. This is as clear as it gets, no amount of interpretation over what "data suggests" can change that.
Recruitment into the FITNET-NHS Trial began on 1 November 2016. In mid-2018, it became apparent that the recruitment rate would not allow us to achieve our original sample size target (n = 734) without a substantial extension to the recruitment period
So that's it then. End of story. What is there even to discuss here? Why continue to spend money when this weird aberration of an "internal pilot", a feasibility study in all but name, has failed to meet its objectives? What is this, Mulligan research? Just keep trying until you get the results you want, change your targets, redefine your goals, cheat about everything?

The steering group and funders have failed miserably. Why even have a steering group if they allow everything and don't bother with the registered objectives? Now that the practice was normalized with PACE it's just become normal to them. Complete corruption of the very system of medicine.

And where is £1M even going towards? This is a copy-paste experiment, the substance is the same as every other identical trial. It's been done many times before, does not require any specialists or technology. Extremely poor fiscal responsibility here. This is blatant misuse of funds they were entrusted with.
 
And of course the whole trial is based on comparing two different versions of on line 'treatment', both of which involve encouraging kids to find a baseline and then increase activity, as far as I can see.. So it's a win win for the researchers and therapists. Whichever version does a bit better than the other will be declared the definitive treatment, and they will claim they have proved it works.
 
And of course the whole trial is based on comparing two different versions of on line 'treatment', both of which involve encouraging kids to find a baseline and then increase activity, as far as I can see.. So it's a win win for the researchers and therapists. Whichever version does a bit better than the other will be declared the definitive treatment, and they will claim they have proved it works.

I'm actually perplexed at offering essentially two related interventions. I don't see how you can show much difference between them. It's not likely activity management has been 'proven' to do anything.
 
I'm actually perplexed at offering essentially two related interventions. I don't see how you can show much difference between them. It's not likely activity management has been 'proven' to do anything.
just like MAGENTA
MAGENTA remains puzzling to me because the treatments are so much alike. It seems like one form of graded activity versus another that focuses on physical activity. So what exactly is being tested here: whether graded activity should focus on physical activity or not?

They also say they used a checklist of GET elements and activity management elements to check the fidelity of treatment. I would be interested in seeing that checklist, cause what exactly are the differences? The only one I notice is that GET is focused on physical activity rather than all forms of activity.

They mention that both approaches are recommended by NICE but poorly tested in adolescent ME/CFS patients. So why didn't they try to test them first?
https://www.s4me.info/threads/magen...scents-esther-crawley.4808/page-8#post-227869
 
Trial By Error: FITNET-NHS Falls Short in Recruitment Drive

Professor Esther Crawley, Bristol University’s methodologically and ethically challenged pediatrician and star researcher, has weighed in with an interim analysis of FITNET-NHS, her trial of online cognitive behavior therapy for adolescents with what she calls CFS/ME. Poor Professor Crawley! Despite her ambitious goal of enrolling a whopping 734 participants, early recruitment fell way below expectations. She is now pursuing a scaled-down, shrunken version–MINI-FITNET-NHS, perhaps?

The interim analysis–Recruiting Adolescents With Chronic Fatigue Syndrome/Myalgic Encephalomyelitis to Internet-Delivered Therapy: Internal Pilot Within a Randomized Controlled Trial—was published last week in the Journal of Medical Internet Research. As the report makes apparent, Professor Crawley’s reach far exceeded her grasp. She and her team failed to deliver on the targets outlined in their trial protocol, which formed the basis for their approvals and funding.
https://www.virology.ws/2020/08/18/trial-by-error-fitnet-nhs-falls-short-in-recruitment-drive/
 
I've decided belatetly that it might be worth exposing and highlighting who the people are who are funding these endless same old same old trials that show nothing except to conclude that 'more research is needed'.

So NIHR, health technology assessment programme is responsible for handing out money for this useless trial.

The person behind this unit is here:

Professor Andrew Farmer has been appointed as the new NIHR Health Technology Assessment (HTA) Programme Director.

Professor Farmer, an experienced General Practitioner and academic, begins his new role on 1 June 2020 and will take over from Professor Hywel Williams who will be stepping down in September after heading the programme since 2015.

So someone new is now heading this unit since June 2020 and the former person (who doled out the cash would have been Hywel Williams the previous head.

I think that the funders need to start being held accountable for this endless wasting of taxpayer resources.
 
I've decided belatetly that it might be worth exposing and highlighting who the people are who are funding these endless same old same old trials that show nothing except to conclude that 'more research is needed'.
Yep. It isn't just the researchers who carry the blame, it is the whole system that supports them. The researchers could not have got so far on their own. They needed substantial sustained material and political support and protection. And they have had it for 30 years.

I think that the funders need to start being held accountable for this endless wasting of taxpayer resources.
Not to mention patients' lives.
 
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