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Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1777 (Published 23 April 2010) Cite this as: BMJ 2010;340:c1777

Fatigue scale

Following Bart Stouten’s suggestion that scoring the Chalder fatigue
scale(1) 0123 might more reliably demonstrate the effects of pragmatic
rehabilitation, we recalculated our fatigue scale scores. Calculated this
way, the reduction in fatigue seen at post treatment (20 weeks) in
patients allocated to pragmatic rehabilitation (PR), when compared to
those allocated to general practitioner treatment as usual (GPTAU)(2), is
maintained at one year follow up (70 weeks), our primary outcome point.

Supportive listening (SL) is still ineffective when compared with GPTAU
(Table 1 and Figure 1). Effect estimates [95% confidence intervals] for 20
week comparisons are: PR versus GPTAU -3.84 [-6.17, -1.52], SE 1.18,
P=0.001; SL versus GPTAU +0.30 [-1.73, +2.33], SE 1.03, P=0.772. Effect
estimates [95% confidence intervals] for 70 week comparisons are: PR
versus GPTAU -2.55 [-4.99,-0.11], SE 1.24, P=0.040; SL versus GPTAU +0.36
[-1.90, 2.63], SE 1.15, P=0.752.

We agree with Sam Carter and other correspondents that the fatigue scale
suffers from a ceiling effect, but this is more of a problem at baseline
(before treatment started) than at the follow up assessments. With the
fatigue scale re-scored 0123, we are able to demonstrate a clinically
modest, but statistically significant effect of PR compared with GPTAU at
both outcome points. Given the chronicity of CFS/ME in our sample, we
believe that this on average small improvement in fatigue is important to
these individuals.

Tom Kindlon points out that we have not analysed all the outcomes which we
measured(3). We reported our primary outcomes and the related secondary
clinical outcome data which we thought would be of interest in judging the
clinical effectiveness of our intervention. We did not report the step
test as an outcome due to a significant amount of missing data. Further
papers will examine exercise capacity and illness beliefs as potential
mediators of the effects of pragmatic rehabilitation. We will also be
reporting on predictors or moderators of treatment response; among the
variables we will examine will be criteria fulfilled (CDC, London ME),
ambulatory status and co-morbidities. Other papers will examine economic
outcomes and barriers to delivering these treatments. All papers will use
the acronym FINE and have the same ISRCT number, so can be linked to the
BMJ paper.

References

1. Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D,
et al. Development of a fatigue scale. Journal of Psychosomatic Research
1993;37(2):147-153.

2. Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S,
et al. Nurse led, home based self help treatment for patients in primary
care with chronic fatigue syndrome: randomised controlled trial. British
Medical Journal;340.

3. Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK,
et al. Fatigue Intervention by Nurses Evaluation - The FINE Trial. A
randomised controlled trial of nurse led self-help treatment for patients
in primary care with chronic fatigue syndrome: study protocol.
[ISRCTN74156610]. Bmc Medicine 2006;4.

Competing interests:
None declared

Table 1

Figure 1 Mean scores on the Chalder et al fatigue scale, scored 0123, at baseline(week 0), after treatment (week 20), and at one year follow-up (week 70) for patients allocated to the three treatment arms. *Significant difference between PR and GPTAU. GPTAU, general practitioner treatment as usual; PR, pragmatic rehabilitation; SL, supportive listening.

Competing interests: No competing interests

27 May 2010
Alison J Wearden
Reader in Psychology
Christopher Dowrick, Carolyn Chew-Graham, Richard P Bentall, Richard K Morriss, Sarah Peters, Lisa Riste, Gerry Richardson, Karina Lovell, and Graham Dunn.
University of Manchester
University of Manchester, M13 9PL
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