Flaws of Nijmegen Research-1

[Guest guest]

Flaws of Nijmegen Research-1

Below the excellent Letter by Tom P Kindlon:

*Actometer readings would have provided more

objective data*

to:

*Efficacy of Cognitive Behavioral Therapy for

Adolescents With Chronic Fatigue Syndrome:

Long-term Follow-up of a Randomized, Controlled

Trial*

(Pediatrics 2008; 121: e619-e625

Hans Knoop, Gijs Bleijenberg et al.)

You will find the abstract of this Nijmegen study.

The full pdf article is attached for private members,

but can also be found at: http://bit.ly/lI7j6

Slowly but surely it becomes clear that the so-called

biopsychosocial CFS School is in a state of

bankruptcy.

13 January 2004 I wrote about Nijmegen:

*They use the same tactics (1): " .....manipulation -

distortion - deliberately portraying things differently

from what is known - falsifying facts - invention -

misquotation - suppression - illegitimate

interpretation - political re-modelling - exploiting

public ignorance and intimidation....... "

But the box of tricks will not work anymore.

The comedown of Dr. Reeves (who slowly

moved towards the psychiatric CFS School) during

the last CDC Stakeholders Meeting was the first big

bang.

From the uncountable scientific proofs, that

ME/ICD-CFS is a severe, invalidating disease and

that CBT and GET make these patients worse, only

one conclusion is possible:

The biopsychosocial CFS School will soon

be dead certain.

(1) The Mental Health Movement-Persecution of

Patients? -Prof. M Hooper et al:

http://www.meactionuk.org.uk/SELECT_CTTEE_FINAL_VERSION.htm

~jan van roijen

``````

http://pediatrics.aappublications.org/cgi/eletters/121/3/e619

Actometer readings

would have provided

more objective data

1 April 2009

This is an interesting study. However, the issue of

the use of appropriate outcome measures is an

important one in the area of Chronic Fatigue

Syndrome (CFS) research. Problems have been

reported with the use of self-report outcome

measures.

An earlier Nijmegen team incl. Gijs Bleijenberg

(one of the co- authors) investigated this area[1]:

" It is not clear whether subjective accounts of

physical activity level adequately reflect the actual

level of physical activity.

Therefore the primary aims of the present study

were to assess actual activity level in patients with

CFS to validate claims of lower levels of physical

activity and to validate the reported relationship

between fatigue and activity level that was found on

self- report questionnaires.

In addition, we evaluated whether physical activity

level adequately can be assessed by self-report

measures.

An Accelerometer was used as a reference for actual

level of physical activity. " . The authors reported on

the correlations on 7 outcome measures in relation

to the actometer readings: " none of the self-report

questionnaires had strong correlations with the

Actometer.

Thus, self-report questionnaires are no perfect

parallel tests for the Actometer. "

The authors pointed out that

" the subjective instruments do not measure actual

behaviour. Responses on these instruments appear

to be an expression of the patients' views about

activity and may be biased by cognitions concerning

illness and disability. "

This was re-iterated in another paper from a

different Nijmegen team involving Gijs

Bleijenberg[2]:

" In earlier studies of our research group, actual

motor activity has been recorded with an ankle-worn

motion-sensing device (actometer) in conjunction

with self-report measures of physical activity.

The data of these studies suggest that self-report

measures of activity reflect the patients' view about

their physical activity and may have been biased by

cognitions concerning illness and disability. "

It is thus disappointing that in this current study

actometers were not either not reported or not

used following the intervention. The authors do

report that they had used actometers before the

intervention:

" In the original trial, 2 treatment protocols were

used: 1 for patients with a passive physical activity

pattern and 1 for relatively active patients. The

physical activity pattern of the adolescent patient

with CFS was measured with an actometer, a

motion-sensing device attached to the ankle. "

A recent uncontrolled study[3] highlights the

problems that can occur with self-report

measures following CBT for CFS. It involved

testing a form Cognitive Behavior Therapy (CBT)

for CFS which included encouraging patients to go

for longer walks.

It found that on the SF-36 Physical Functioning

(PF) scale, patients improved from a

pre-treatment mean (SD) of 49.44 (25.19) to

58.18 (26.48) post-treatment, equivalent to a

Cohen's d value of 0.35. On the Fatigue Severity

Scale (FSS), the improvement as measured by the

cohen's d value was even great (0.78) from an

initial pre- treatment mean (SD) of 5.93 (0.93) to

a 5.20 (0.95) post-treatment.

However on actigraphy there was actually a

numerical decrease from a pre-treatment mean

(SD) of 224696.90 (158389.64) to 203916.67

(122585.92) post-treatment (cohen's d: -0.13).

So just because patients report lower fatigue and

better scores on the SF-36 PF scale, it does not

mean they are doing more, which is what GET and

CBT based on GET claim to bring about.

These results seem particularly pertinent given

two of the three primary outcome measures in

this study are the SF-36 PF scale and a fatigue

scale.

Being able to work full-time probably involves a

reasonable test of somebody's functioning.

However the usefulness of CBT to bring about

improvement in hours worked is far from clear.

For example, another Dutch study of CBT

reported a recovery rate of 37%[4]. It used the

following definition for recovery: " Patients were

defined as being CSI at post treatment if they had

a reliable change index > 1.96 on the CIS fatigue

severity subscale, a fatigue severity score <= 35

and a Rand-36 physical functioning score > = 65 " .

However, the improvement with regards to hours

worked was much smaller. Before the

intervention, participants worked an average of

9.4 hours (standard deviation: 13.5); after the

intervention, they worked 11.4 hours (standard

deviation: 14.7), a non- significant change.

The median number of contracted hours before

the intervention was 10 hours; after it was 7

hours. In the discussion section, the authors point

that fewer participants had a paid job following

the intervention than before.

Attendance at school is probably not as good a

measure of functioning as hours worked.

Education systems do not generally base

assessments of a child's performance on the

number of days they attend! Instead, they use

measures such as outcomes in examinations.

Charities for ME and CFS can encourage some

children that some sort of education at home may

be more beneficial for both their health and also

their education[5] than attendance at school.

CBT can encourage school attendance but by

itself, attendance at school should not necessarily

be seen as successful result in itself if, for

example, the children are not learning that much

or are under-performing relative to their

ability[6].

However if, as the authors may do, one believes

that full attendance at school is a good measure of

activity and functioning, it would have been good

if the paper had presented data on the number

and/or percentage of participants who had

" clinically significant improvement " on all three of

the outcome measures.

As I pointed out earlier, following CBT, CFS

patients who report lower fatigue and/or better

physical functioning may not actually be doing

more. Similarly, participants could be attending

work or school full-time but still have ongoing

problems with fatigue.

It is slightly disappointing that we did not see

some data:

" Data on the type of activities of patients at the

time of the follow-up assessment were not available

for all of the patients. Some patients only indicated

on the questionnaires that they did not study and

did not work. We decided not to impute these

missing values, because more detailed information

about their activities were lacking.

This could have introduced a bias when determining

the long- term effects of CBT on work and/or school

attendance. An example of such a bias would be

that these patients are less active and function at a

lower level than the patients who indicated that

they worked or attended school, which, in turn,

might have led to an overestimation of the effect of

CBT. "

Should we assume from this that the percentage

with full school/work attendance following CBT is

not 29/42 but 29/50 (58%), the same number as

at the final assessment following CBT? Data for 50

participants at follow -up was available for fatigue

severity and physical functioning.

One further point to raise is the thresholds for

" clinically significant improvement " . For

CIS-fatigue, it was a " reliable change index of

>1.96 and a score of <35.7 " .

Another CBT study in the area co-written by the

two of the authors (Knoop & Bleijenberg)[7]

referred to a " normal group of 53 healthy adults

with a mean age of 37.1 (SD 11.5) " who had " a

mean score on the CIS-fatigue of 17.3 (SD

10.1). " [8].

The threshold in the current study of 35.7 is 1.82

standard deviations above that mean of 17.3. It

should also be remembered that the minimum

score on the CIS-fatigue scale is 8 so that 17.3 is

only 0.92 standard deviations above that.

Somebody with a fatigue score in the 30s for

example still has significant fatigue.

The same study[7] by two of the authors said

that " healthy adults without a chronic condition "

had " a mean score of 93.1 (SD 11.7) " on the

SF-36 physical functioning subscale. The maximum

one can score is 100. Compare that with the

threshold of 75 that is sufficient to be seen as

having a " clinically significant improvement " on

that scale in the current study.

References

[1] Vercoulen JH, Bazelmans E, Swanink CM, Fennis

JF, Galama JM, Jongen PJ, Hommes O, Van der Meer

JW, Bleijenberg G. Physical activity in chronic fatigue

syndrome: assessment and its role in fatigue. J

Psychiatr Res. 1997 Nov-Dec;31(6):661-73.

[2] van der Werf SP, Prins JB, Vercoulen JH, van der

Meer JW, Bleijenberg G. Identifying physical activity

patterns in chronic fatigue syndrome using

actigraphic assessment. J Psychosom Res. 2000

Nov;49(5):373 -9.

[3] Friedberg F, Sohl S. Cognitive-behavior therapy in

chronic fatigue syndrome: is improvement related to

increased physical activity? J Clin Psychol. 2009 Feb

11.

[4] Scheeres K, Wensing M, Bleijenberg G, Severens

JL. Implementing cognitive behavior therapy for

chronic fatigue syndrome in mental health care: a

costs and outcomes analysis. BMC Health Serv Res.

2008 Aug 13;8:175.

[5] The Young ME Sufferers Trust

http://www.tymestrust.org [Last accessed: 31st

March, 2009]

[6] Van Hoof ELS, De Becker PJ, Lapp C, De Meirleir

KL. How do adolescents with chronic fatigue

syndrome perceive their social environment? A

quantitative study. IACFS/ME Spring Bulletin 2009

[7] Knoop H, Bleijenberg G, Gielissen MF, van der

Meer JW, White PD. Is a full recovery possible after

cognitive behavioural therapy for chronic fatigue

syndrome? Psychother Psychosom. 2007;76(3):171-6.

[8] son NK, Muller M, Cohen PD, Essink-Bot ML,

Fekkes M, Sanderman R, Sprangers MA, te Velde A,

Verrips E: Translation, validation, and norming of the

Dutch language version of the SF-36 Health Survey in

community and chronic disease population. J Clin

Epidemiol 1998; 51: 1055- 1068.

Tom P Kindlon,

Information Officer (voluntary position)

Irish ME/CFS Association

Send letter to journal:

Re: Actometer readings would have provided

more objective data

E-mail Tom P Kindlon

tomkindlon@...

Conflict of Interest:

None declared

````````

Efficacy of Cognitive Behavioral Therapy for

Adolescents With Chronic Fatigue Syndrome:

Long-term Follow-up of a Randomized, Controlled

Trial

Hans Knoop, MSca, Maja Stulemeijer, MSca, Lieke

W. A. M. de Jong, MScb, Theo J. W. Fiselier, MD,

PhDc, Gijs Bleijenberg, PhDa

ABSTRACT

OBJECTIVES.

The purpose of this work was to assess the

long-term outcome of adolescents with chronic

fatigue syndrome who received cognitive behavioral

therapy and to determine the predictive value of

fatigue severity and physical impairments of the

adolescent and the fatigue severity of the mother at

baseline for the outcome of the treatment at

follow-up.

PATIENTS AND METHODS.

Sixty-six adolescent patients with chronic fatigue

syndrome who previously participated in a

randomized, controlled trial that showed that

cognitive behavioral therapy was more effective than

a waiting-list condition in reducing fatigue and

improving physical functioning were contacted for a

follow-up assessment. Fifty participants of the

follow-up study had received cognitive behavioral

therapy for chronic fatigue syndrome (32 formed the

cognitive behavioral therapy group in the original

trial, and 18 patients received cognitive behavioral

therapy after the waiting period). The remaining 16

patients had refused cognitive behavioral therapy

after the waiting period. The main outcome

measures were fatigue severity (Checklist Individual

Strength), physical functioning (Short-Form General

Health Survey), and school attendance.

RESULTS.

Data were complete for 61 patients at follow-up

(cognitive behavioral therapy group: 47 patients;

no-treatment group: 14 patients). The mean

follow-up time was 2.1 years. There was no

significant change in fatigue severity between

posttreatment and follow-up in the cognitive

behavioral therapy group. There was a significant

further increase in physical functioning and school

attendance (10% increase). The adolescents in the

cognitive behavioral therapy group were significantly

less fatigued and significantly less functionally

impaired and had higher school attendance at

follow-up than those in the no-treatment group.

Fatigue severity of the mother was a significant

predictor of treatment outcome.

CONCLUSIONS.

The positive effects of cognitive behavioral therapy

in adolescents with chronic fatigue syndrome are

sustained after cognitive behavioral therapy. Higher

fatigue severity of the mother predicts lower

treatment outcome in adolescent patients.