FITNET’s Internet-Based Cognitive Behavioural Therapy Is Ineffective and May Impede Natural Recovery

[Dolphin]

Work absence of 10% (or less) is 26 days of sick leave per year. The average number of days of sick leave in the Netherlands is 7 (in Ireland and the UK it is even lower at 4) [60]. This is a school or work attendance rate of nearly 100% (97% or higher), for the average working-age population (those aged 18–67, including the chronically ill). Yet this trial regarded an attendance rate of 90% or more at LTFU as recovery. Moreover, 6% of participants in the treatment group of the trial already had a school/work attendance of 85% or more at trial commencement [12]. Therefore, these participants would have already been considered to be nearly or fully recovered—according to 1 of the 4 recovery criteria upon entering the trial—before receiving any treatment at all.

Minor point: I think the working year is less than 260 days when you factor in holidays and bank holidays.

But I think this was generally worth highlighting i.e. 10% absence for people is a lot.

 

[Dolphin]

According to the NHS FITNET protocol, participants assigned to internet-based CBT will receive 19 sessions lasting 60 min over a six-month period while those in the activity management group “will have up to three video (e.g., Skype) appointments (one assessment and two follow up)” from an occupational therapist from the trial (after which the participant’s nominated local therapist or doctor is asked for a “review within six to eight weeks”) [61] (p. 13). Yet in evaluating a psychological treatment, it’s important that the control group offers the same frequency and intensity of contact, positive expectations, attention and support as the intervention group otherwise any difference between the two groups might be simply down to the design of the study leading to the erroneous inference of efficacy in its absence [18].

Fair point

 

[Dolphin]

Consequently, this trial, like other CBT trials is an unblinded trial by definition which relies on one subjective outcome. Yet as mentioned above, unblinded trials should use objective primary outcomes (instead or as well), to safeguard against erroneous inference of efficacy in its absence [16].

It is worth highlighting the problem of relying on subjective outcomes in a nonblinded trial.

However that could be read that there is only one outcome measure.
I think the point is is that there is only one primary outcome measure.

And there is "school attendance" which is a secondary outcome measure which is somewhat objective.

https://njl-admin.nihr.ac.uk/document/download/2010266

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. Disability is an important outcome [41] for children with CFS/ME and we have shown it is sufficiently sensitive in this patient group. We want to allow children with CFS/ME the longest possible window to return outcome data and therefore the permissible measurement window will be between 5 and 9 months after randomisation.

4.11.4 Secondary outcomes

All secondary outcomes are measured at 3, 6 and 12 months unless otherwise specified. Our secondary outcomes include:

1. SF36-PFS [42] measured at 3 and 12 months after randomisation.

2. Fatigue (Chalder scale [43] and Checklist Individual Strength (CIS) fatigue severity subscale [44])

3. School attendance (self-report school or home tuition)

4. Mood (Revised Children’s Anxiety and Depression Scale (RCADS) [45])

5. Pain visual analogue scale [46]

6. Clinical Global Impression Scale [16]

7. Quality of Life (EQ-5D-Y) [47]

8. Parental completed: Healthcare Resource Use questionnaire

9. Parental completed: Work Productivity & Activity Impairment Questionnaire General Health (WPAI:GH) [48] All these measures are important and relevant domains [41] that are used in UK services, CAMHS and/or tested in previous trials [8, 22, 23].

 

[Dolphin]

6.4. Activity Management

The protocol states that “Activity Management is used as the comparator in this study as it is recommended by the National Institute of Health & Care Excellence (NICE)” [61] (p. 5). The trial’s protocol describes activity management in the following manner: “When participants have managed the baseline for 1–2 weeks, they will be asked to increase this by 10–20% each week” “until they are able to do up to 8 hours of activity a day” [61] (pp. 13–14). Yet according to the NICE guidelines ‘activity management’ is “A way for people to manage their symptoms by learning to analyse and plan activities so that they can achieve more at home, at work and at leisure” [68] (p. 1) with “Gradually increasing activity above the baseline in agreement with the person” [65] (p. 31). This is how the NICE guidelines describes GET: “When the low-intensity exercise can be sustained for 5 days out of 7 (usually accompanied by a reduction in perceived exertion), the duration should be reviewed and increased, if appropriate, by up to 20%” [65] (p. 29). So it seems that the NHS FITNET trial isn’t using activity management but a form of GET by instructing participants to increase activity by “10–20% each week” [61] (p. 14), irrespective of symptoms.

Fair point. The term "Activity management" doesn't get the essence of the treatment across.

 

[Dolphin]

Moss-Morris et al. reported that in 40% of patients their health deteriorated as a consequence of exercise [74].

74. Moss-Morris, R.; Sharon, C.; Tobin, R.; Baldi, J.C. A randomized controlled graded exercise trial for chronic
fatigue syndrome: Outcomes and mechanisms of change. J. Health Psychol. 2005, 10, 245–259. [CrossRef]

I can't see any results in this study which shows that claim. I could be missing something of course.

 

[Dolphin]

The NHS FITNET trial authors are using their ‘boom and bust’ theory of CFS to blame any deterioration on the disease, and not on the adverse effects of their own treatment. This was disproved by Van der Werf et al. (co-authored by an investigator also involved in both the Dutch and the UK NHS FITNET trial) [77] and in a systemic review by Evering et al. [78]. Using or re-analysing actometer readings, both found no significant differences during the day or in the day-to-day fluctuations in activity patterns between controls and CFS patients.

Good point

 

[Dolphin]

Although it may not be clear from the abstract, this paper has over two pages discussing the FITNET NHS study.

 

[Sean]

But I think this was generally worth highlighting i.e. 10% absence for people is a lot.

10% is still high. No employer would be able to tolerate that rate in their workforce.

 

[Valentijn]

And there is "school attendance" which is a secondary outcome measure which is somewhat objective.

Not really, since they're relying on self-report, and there may be pressure to report an improvement where there is none.

 

[AndyPR]

The MEA has a Facebook post on this paper - https://www.facebook.com/meassociation/posts/1490285491029104

In the comments, a parent has put

We signed up for this my 13 year old daughter was put in the Skype group after 2 calls they decided she was too severe and removed her from the trial even though we filled in all the paperwork and explained everything. Then they started chafing for us to complete questionnaires even though she was no longer part of the trial. It was all very confusing and absolutely no help in aiding her recovery in any way.

 

[docsimsim]

This is a comment from the parent of a 13 year old who was accepted to take part in the current NHS FITNET trial but was removed after 2 sessions 'for being too ill'! So yes it's business as usual:

"We signed up for this my 13 year old daughter was put in the Skype group after 2 calls they decided she was too severe and removed her from the trial even though we filled in all the paperwork and explained everything. Then they started chafing for us to complete questionnaires even though she was no longer part of the trial. It was all very confusing and absolutely no help in aiding her recovery in any way".

 

[anni66]

This is a comment from the parent of a 13 year old who was accepted to take part in the current NHS FITNET trial but was removed after 2 sessions 'for being too ill'! So yes it's business as usual:

"We signed up for this my 13 year old daughter was put in the Skype group after 2 calls they decided she was too severe and removed her from the trial even though we filled in all the paperwork and explained everything. Then they started chafing for us to complete questionnaires even though she was no longer part of the trial. It was all very confusing and absolutely no help in aiding her recovery in any way".

Why repeat a study that found no long term differences in the first place?

 

[docsimsim]

Why repeat a study that found no long term differences in the first place?

Coz there's money in it? £1m big ones

 

[Valentijn]

"We signed up for this my 13 year old daughter was put in the Skype group after 2 calls they decided she was too severe and removed her from the trial even though we filled in all the paperwork and explained everything. Then they started chafing for us to complete questionnaires even though she was no longer part of the trial. It was all very confusing and absolutely no help in aiding her recovery in any way".

This is very odd. If she met the entrance requirements, then her health status during the trial shouldn't impact her enrollment in it. It sounds like they are trying to classify her as a dropout, even though they're the ones who have removed her, since researchers generally want as much info as they can get from dropouts at the time that they stop the treatment.