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

It's still totally misleading information.

 

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?

(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...

(Edited to add first quote.)

 

stop criteria? more circles?

 

Really!

 

Yes - remember with paediatric CFS being able to go to school for an hour a day counts as being severely affected...... not a clue.....

 

...and still updating...

Editorial Notes

http://www.isrctn.com/ISRCTN18020851

 

The interventions have changed - to what end?

 

pilot rolled into full trial again?
not enough coffee so could have picked this up wrongly.

 

Stop criteria

published protocol, 22 Feb 2018, Trials volume 19, Article number: 136 (2018),
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3

 

In an asymmetric power relationship define " acceptable"

 

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 ?

 

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]

 

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)

 

@dave30th, could you take a look at this?

Starting here: https://www.s4me.info/threads/inves...me-2018-crawley-et-al.2592/page-3#post-198320

 

How about doing a trial on the effectiveness and cost-effectiveness of trials on the effectiveness and cost-effectiveness of interventions in ME?

 

"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).

 

So similar issues to HADS ?
How is the RCADS scale scored ?

 

would love to see a break down of the costs to see how the money was spent.