Investigating the effectiveness ... of FITNET-NHS compared to Activity Management to treat paediatric CFS/ME, 2018, Crawley et al. Protocol

I saw this only now.

In addition to all already pointed to in the previous comments I found the part about "possible benefits and risks of participating" very strange.

What are possible benefits and risks of participating?
Children who take part in this study will be offered treatment delivered by specialist CFS/ME therapists in both groups.
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If FITNET-NHS is effective, it may reduce NHS and wider costs to society, improve school attendance and quality of life, and change attitudes about paediatric CFS/ME being “untreatable” to being “treatable”.
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(And if FITNET-NHS is not effective?)

Also the supposed risks seem to tell more about the study design, underlying hypotheses and diagnostic criteria than about risks for the particpants...
There is a small risk that the study may recruit children that do not have CFS/ME but instead have other disorders that present with fatigue. To avoid this we have put in place rigorous tests to ensure that other causes of fatigue are diagnosed and referred for appropriate treatment. If children are recruited with fatigue and other disorders, the treatment approaches offered are sufficiently generic approaches to fatigue, they are likely to benefit to some extent.
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(Edited to add first quote.)
 
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Andy said:
Still recruiting, https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=7400&location=&distance=
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...and still updating...

Editorial Notes
01/07/2019: The following changes were made:
1. The plain English summary was updated.
2. The contact details were updated.
3. The link to the participant information sheet was added.
4. The overall trial end date was updated from 30/10/2021 to 30/04/2022.
5. The target number of participants was updated from 734 to 314.
6. The recruitment end date was updated from 30/04/2020 to 31/10/2020.
7. The intention to publish date was updated from 30/10/2022 to 30/04/2023.
8. The sponsor contact details were updated.
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09/07/2018: The following changes have been made:
1. The interventions have been changed.
2. The plain English summary has been changed.
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04/09/2017: Ethics approval information added.
Interventions and Plain English summary have been updated.
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http://www.isrctn.com/ISRCTN18020851
 
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Interesting, so they have cut the number of participants to less than half, and extended by six months. They must be having a lot of trouble recruiting and/or retaining participants. I wonder if they have given back half the funding.
 
Sly Saint said:
stop criteria? more circles?
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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.
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published protocol, 22 Feb 2018, Trials volume 19, Article number: 136 (2018),
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
 
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Given that recruitment seems to have fallen off a cliff compared to original protocol do we know when " pilot" became study and if the only way participant numbers stack up is via a rollover mechanism ?
 
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
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So they halved their target recruitment and gave themselves extra time in order to not be below target? [I've not checked those facts, just posting quickly off what was reported in this thread re recruitment]
 
Esther12 said:
So they halved their target recruitment and gave themselves extra time in order to not be below target? [I've not checked those facts, just posting quickly off what was reported in this thread re recruitment]
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It took me quite a while to find the location where all versions of the protocol are collected:

https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109#/

Edit: A summary of all changes to the protocol can be found here, pp. 36-42
https://njl-admin.nihr.ac.uk/document/download/2029706


Protocol version 06/2019
https://njl-admin.nihr.ac.uk/document/download/2029706
p. 19 f:

4.8 RECRUITMENT RECOVERY PLAN – revised sample size (added May, 2019)
In late 2018, it became clear that the recruitment rate would not allow us to achieve our secondary aims of testing the effectiveness and cost-effectiveness in children with CFS/ME and co-morbid mood disorders assuming the prevalence of co-morbid mood disorders was 30%.

We therefore: consulted with the TSC (28/11/2018), DSMC (10/10/2018 & by email report on 11/03/2019) and TMG (18/10/2018) and reviewed the trial with the funders (HTA) (10 th July 2018).
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The primary aim for the full FITNET-NHS trial is the effectiveness of FITNET-NHS in children with CFS/ME (see objective 3, page 10). The trial was powered on a secondary outcome to test the effectiveness and cost effectiveness in children with CFS/ME and co-morbid mood disorders (see objective 4, page 10). This meant that to achieve 80% power to detect a 0.4SD difference at 5% significance, assuming 30% of children had a co-morbid mood disorder, we needed to randomise 734 children. This then provided 97% power at 1% significance to detect 0.35SD difference on the primary outcome (see paragraph 4.7.1)

In September 2018, we calculated the required sample size for the primary aim of effectiveness in children with CFS/ME as follows:

Data on 266 children will give us 90% power at 5% significance to detect a 0.4SD difference on the SF36-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. Hence our new recruitment target, which is now focussed on the primary analysis, is 314 children in total, 157 in each treatment group.
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We considered the issue of co-morbid disorders.

On 02/10/2018, we investigated the rate of co-morbid mood disorders in FITNET-NHS participants. This was higher than our original estimates as the rate of co-morbid mood disorders was 40% (compared to 30% in our original estimates) meaning that the number of participants required to answer the secondary aim of efficacy in this group was 106 (53 in each treatment group).

After consultation with the HTA, TSC and DSMC, the decision was made by the TMG, on the 30 th of January 2019 to adjust the recruitment targets and extend the recruitment time by 6 months so that FITNET-NHS will be able to achieve the primary aim of testing the effectiveness and cost-effectiveness of FITNET-NHS compared to Activity Management. We will therefore recruit 314 children and recruitment will finish on 31 October 2020. Follow up will finish on 31 October 2021.
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We are following standard procedure for updating HTA, Research Ethics Committee and trial registration (ISRCTN) regarding these changes.

For transparency, we have detailed changes to the flow chart, revised sample size calculation and recruitment targets below. HTA approval for revised recruitment target and the contract variation to include the 6-months extension to the project timeline was received on 24/04/2019 further subjected to ratification by the Department of Health and Social Care.
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"This was higher than our original estimates as the rate of co-morbid mood disorders was 40%"

It is perhaps worth considering that some of the questionnaires used to quantify mood disorders in both adult and paediatric populations might cause their prevalence to be overestimated in ME patient cohorts. For example, the paediatric RCADS scale includes at least five questions that will likely be scored highly by ME patients regardless of the status of their mood: q11 ("I have trouble sleeping"); q19 ("I have no energy for things"); q21 ("I am tired a lot"); q25 ("I cannot think clearly"), and, for those with orthostatic tachycardia, q24 ("When I have a problem, my heart beats really fast").

Similar questions exist on the adult BDI-II: q15 (loss of energy); q16 (changes in sleeping pattern); q19 (concentration difficulty); q20 (tiredness or fatigue).
 
glimpsesofme said:
"This was higher than our original estimates as the rate of co-morbid mood disorders was 40%"

It is perhaps worth considering that some of the questionnaires used to quantify mood disorders in both adult and paediatric populations might cause their prevalence to be overestimated in ME patient cohorts. For example, the paediatric RCADS scale includes at least five questions that will likely be scored highly by ME patients regardless of the status of their mood: q11 ("I have trouble sleeping"); q19 ("I have no energy for things"); q21 ("I am tired a lot"); q25 ("I cannot think clearly"), and, for those with orthostatic tachycardia, q24 ("When I have a problem, my heart beats really fast").

Similar questions exist on the adult BDI-II: q15 (loss of energy); q16 (changes in sleeping pattern); q19 (concentration difficulty); q20 (tiredness or fatigue).
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So similar issues to HADS ?
How is the RCADS scale scored ?
 
Esther12 said:
So they halved their target recruitment and gave themselves extra time in order to not be below target? [I've not checked those facts, just posting quickly off what was reported in this thread re recruitment]
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I would have thought this was very dodgy. They should have done power calculations for the initial ethics approval to size the trial so cutting in half suggests that they either got these wrong or they are running a trial which may risk not having sufficient participants to give a meaningful result.
 
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