Thread by @mecfsskeptic

1) The results of the FITNET-NHS trial have just been published, the biggest randomized trial for children and adolescents with ME/CFS.

Here’s a brief overview of its main results.
mecfsskeptic.com/fitnet-nhs-a-s…

2) 314 participants were randomized to receive either FITNET (online cognitive behavioral therapy) or Activity Management. Both interventions were delivered remotely and lasted 6 months.

3) Unfortunately, participants nor therapists could be blinded, and all the outcomes used were subjective questionnaires. The combination creates a high risk of bias.

4) It is likely that expectations and symptom reporting were biased in favour of the intervention being tested. FITNET-NHS participants also received 4x more consultations than the control group.

But let us nonetheless have look…

5) The primary outcome was physical functioning measured at 6 months with the SF-36 subscale. FITNET outperformed the control group, but the difference was 8.2 points (95% CI: 2.7 to 13.6), lower than the minimally clinically important difference (MCID) of 10 points.

6) I think it is misleading for the authors to not mention that the primary outcome difference was not clinically significant in their abstract or summaries. The MCID was determined by the same research group and used in the sample size calculation.

7) In addition, at the 12 month follow-up the control group had largely caught up and the difference was only 4.4 points (95% CI: −1.7 to 10.5).

So, for the primary outcome, there does not seem to be a clinically useful effect of receiving FITNET-NHS.

8) Most of the secondary outcomes such as fatigue, pain, or general improvement, showed no significant difference between the groups either. The main exception is self-reported school attendance which was approximately 12% higher in the FITNET-NHS group.

9) The difference in quality of life (QALY) was very close to zero at each of the assessments. Quality of life was not improved by FITNET-NHS.

10) The authors also assessed cost-effectiveness although most healthcare costs were self-reported by parents. On average, FITNET-NHS was £1000 more expensive than the control intervention and it did not result in NHS savings elsewhere during the 12 month study period.

11) In none of the statistical analyses was FITNET-NHS cost-effective. The authors write that FITNET-NHS “is expensive and is unlikely to be good value for money.”

12) Those are the main results but there are some other notable things about the trial…

13) The control group, activity mangement, is described as pacing but it looks more like graded activity with statements such as “Participants were encouraged to increase activity until they were able to do up to 8 hours of cognitive and physical activity a day.”

14) So, the trial compared one graded activity program with another. There was no third arm that tested a different approach.

15) About 25% in both groups had evidence of worsening condition during the 12 month study period. 61 participants in the FITNET-NHS withdrew from treatment compared to 12 in the control group.

16) 28 participants in the FITNET-NHS reported on one or more adverse events or serious adverse events compared to 18 in the Activity Management group.

17) Another notable figure: only 37.5% of the FITNET-NHS group completed 80% or more of expected modules/sessions (compared to 78% in the Activity Management group).

18) The authors also did sensitivity analyses to test if some subgroups did better or worse than others. The effect for physical functioning, for example, was similar for patients who met the new NICE criteria for ME/CFS.

19) There was also no strong evidence that the effect of the intervention was due to treatment of comorbid anxiety and depression.

The researchers originally planned to include 734 participants to test this more thoroughly but experienced problems with recruitment.

20) The authors also did interviews with participants, parents and therapists. These mostly describe the intervention as useful but also ‘pushy’ , ‘strict’, ‘regimented’ and hard at first.

21) Some of the statements highlight problematic aspects of the intervention with children being pushed to recover and a chapter for parents on “stop asking your child how they are”.

22) One therapist noted: “The platform can say in black and white and I think in capitals in some places, if you don’t get your sleep sorted you’re not going to get better, in places where it is really quite like if you don’t do this you’re staying ill..."

23) The idea of FITNET came from the Netherlands. It was developed at the Children's hospital in Utrecht.

Nijhof and colleagues’ trial of FITNET was published in the Lancet and reported spectacular results: 85% no longer had severe fatigue
thelancet.com/journals/lance…

24) The Long-term follow-up results, however, showed a different picture. The control group had caught up and there was no longer a significant difference between the two groups.
pubmed.ncbi.nlm.nih.gov/23669515/

25) With the new data from FITNET-NHS , it appears that FITNET is not (cost-)effective, especially considering that subjective improvements may be due to bias.

Full summary at our blog 👇

mecfsskeptic.com/fitnet-nhs-a-s…