Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires.
Looking hard for genuinely objective outcome measures...
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Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires.
Looking hard for genuinely objective outcome measures...
I believe the full paper is available for the moment at http://press.thelancet.com/FITNET.pdf
And the protocol is here:
http://www.biomedcentral.com/content/pdf/1471-2377-11-23.pdf
School attendance is not too bad an objective measure. There is of course a problem that kids with mild ME could be encouraged to use all their energy going to school rather than doing other activities hence an increase in school attendance does not necessarily corrospond to an increase in activity.
School presence Last two weeks school presence expressed in attended hours/obliged hours * 100%[3]
Table 1 Inclusion and exclusion criteria
Inclusion criteria
(1) The participant has given written informed consent
(2) CFS diagnosis according to the CDC criteria [1]
(3) Adolescent between 12-18 years old at inclusion
(4) Fatigue severity subscale (CIS-20) score ?40 (healthy
populations mean plus two SD) [19]
(5) Physical functioning (Child Health Questionnaire) score <85
(healthy populations mean minus two SD) and/or school
participation ?85% (healthy populations mean minus two SD) in
last two weeks [20]
Exclusion criteria
(1) Inadequate control of Dutch language by child or parent
(2) No availability of computer hardware and internet connection
(3) Suicide risk as assessed on the Childrens Depression Inventory
(CDI) [21]
(4) Cognitive retardation (when indicated an IQ-test will be
conducted; IQ <85 will be excluded)
(5) Score greater than or equal to 44 (healthy populations mean
plus two SD) on the State-Trait Anxiety Inventory for Children
(STAIC) [23]
(6) Score greater than or equal to 16 (healthy populations mean
minus two SD) on the Childrens Depression Inventory (CDI) [21]
I only had a quack (edit - genuine typo, 'quick') glance - but it looked like they talked of using actometers. That would be great if it got us some real data on how these different groups were responding to treatment.
Apologies for citing Wessely, but... at least compared to adults, most children recover from CFS anyway.
"Of 26 studies identified, four studied fatigue in children, and found that 54-94% of children recovered over the periods of follow-up. Another five studies operationally defined chronic fatigue syndrome in adults and found that < 10% of subjects return to pre-morbid levels of functioning, and the majority remain significantly impaired."
The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review
http://qjmed.oxfordjournals.org/content/90/3/223.full.pdf+html
If half to almost all children recover within several years anyway, it's plausible that FITNET could accelerate the recovery period to within 1 year. If over 90% of adults usually don't recover, I wouldn't expect the same effect size.
Nb they didn't use SF-36, but the CHQ scale. I'm not familiar with the scoring system, but they did say the 85% threshold was based on mean-2SD of a healthy population, which would be the equivlaent of about 75 for SF-36, I think.<85% PF? Many of these patients may be mildly affected at best. Note that after both 'treatments'
, PF was similar across both groups (~85%).
Physical activity was measured by the Child Health Questionnaire (CHQ-CF87 subscale physical functioning):
...
This is broadly similar to the SF-36 Physical Functioning sub-scale, though it merges walking/stairclimbing, and has the extra questions in italics. This is all I could find on scoring: "Response options also vary from 4-6 levels for the scales"
I wonder if they simply wanted to turn up (or say they turned up) for those two weeks so they can be seen as compliant? Remember that children are much more erm, susceptible to suggestion than adults.
Fatigue In Teenagers on the interNET - The FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol: "(d) Physical performance as measured with the actometer. This is a motion-sensing device worn at the ankle that registers and quantifies physical activity. The actometer is worn day and night during a period of twelve consecutive days [27]."
Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial: "Physical functioning was measured with the subscale physical functioning of the CHQ-CF87 (0100%). This assessment method is reported to be reliable and has been validated with a good internal consistency (Cronbachs ?=086)."
The PACE trial started with actometers in the design, but finished without them. Every study with actometers that I have read showed either no improvement in functional capacity or a decline in functional capacity.
This study dropped actometers from their protocol too. I wonder why?
Bye, Alex
Measurement of School attendanceSchool attendance records would have been very easy to obtain and analyse. There was a school mentor involved in the FITNET programme as well so I don't know what roll they have taken. I think the question remains as to is this about shifting the focus of what energy some kids have or did there function really improve.
... I also feel that they are ignoring a large amount of phycological literature around bias in surveys and ways of asking questions. My initial thought was that school attendance is a good proxy for activity but when thinking about it this is only the case where there are suitable proxies for other activity otherwise you may just see an effect of squeezing effort where energy usage is shifted from one activity to another.
Really the only way to judge is to look at overall activity patterns. Accelorometers are quite cheap and small these days - many people even have them within their phones so I don't see that activity level monitoring should be hughly expensive. I've heard about recent break throughs using nano technology to make very cheap small and accurate accelorometers (and chemical sensors)
School attendance was
measured as the proportion of classes attended, expressed
as a percentage of the normal school schedule. It was
recorded daily on a 24 h timetable of the self-observation
list 12 days before testing.29 On the day of testing, the past
2 weeks of school attendance were validated with a
general questionnaire and checked with the parents.
During FITNET treatment, the therapist and school
mentor were in contact about the school plan and
attendance when needed.
Measurement of School attendance
Do you know of any specific references re survey bias? I know there's a lot of literature but never managed to find a particular killer paper; all the stuff I saw was tangential.
That would be interesting, but what I was really hoping for was something that looked at possible bias where trial participants had a strong relationship with a therapist, and might be, subconsciously or otherwise, boosting their score a little. I've not seen anything like that to date.I'd need to search for the reference but I was reading one paper recently on the use of a particular questionnaire the review included the point that different responses are obtained when the questionnaire is adminstered by telephone compared to 'on site'. Perhaps there is a similar distance effect here?
"Analysis at other cutoff points for recovery (1 SD) did not change our findings with respect to treatment effects (appendix)."
That would be interesting, but what I was really hoping for was something that looked at possible bias where trial participants had a strong relationship with a therapist, and might be, subconsciously or otherwise, boosting their score a little. I've not seen anything like that to date.
When I read the discharge report back to my GP my psychologist had reported some useful progress. Which is probably what I told him rather than appear ungrateful.
Well, that is interesting - good work. Did they cite any evidence for their use of mean-2SD?Using a stricter (& better) definition of recovery (Appendix 1) causes drop from 63% to 36%!