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Outcomes & predictors of response from an optimised, multi-disciplinary intervention for CF states

Cheshire

Senior Member
Messages
1,129
Consecutive eligible patients (n=264) who met diagnostic criteria for chronic fatigue syndrome (CFS) or post-cancer fatigue (PCF) were evaluated with self-report measures of fatigue, functional capacity, and mood disturbance, at baseline, end-treatment (12-weeks), and follow-up (24-weeks). A semi-structured
interview recording the same parameters was conducted pre- and post-treatment by an independent clinician. Primary outcome (fatigue) was analysed by repeated measures ANOVA and predictors of response was analysed by logistic regression

The intervention produced sustained improvements in symptom severity and functional capacity. A substantial minority of patients (35%) gained significant improvement, with male gender and higher pain scores at baseline predicting non-response. A small minority of patients (3%) worsened.

Conclusions:
The manualised protocol of integrated CBT and GET was successfully implemented confirming the generally positive findings of clinical trials. Assessment and treatment protocols are available for dissemination to allow standardised management. The beneficial effects described here provide the basis for ongoing studies to further optimise the intervention and better identify those most likely to respond

Andrew Lloyd participated
Some of the people involved are from the "Fatigue Clinic, Lifestyle Clinic"

No objective measures (Absurd, even from a psychiatrist perspective: Who would accept a clinical trial for anorexia nervosa without any measurment of weight gain and be satisfied with answers to questionnaires saying the patients feel they have gained weight?)

No control group (from what I get)


http://sci-hub.cc/10.1111/imj.13251
 
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NL93

Senior Member
Messages
155
Location
The Netherlands
No control group in an illness that has the tendency to naturally improve over time? Lol

I think I am going to do a study on people with the flu, where patients have to touch their left foot with their right hand for an hour a day, while singing the national anthem. Then after 2 weeks I am going to ask if they feel a little better and will then conclude this is a helpfull treatment. :D
 

trishrhymes

Senior Member
Messages
2,158
I think I am going to do a study on people with the flu, where patients have to touch their left foot with their right hand for an hour a day, while singing the national anthem. Then after 2 weeks I am going to ask if they feel a little better and will then conclude this is a helpfull treatment. :D

:rofl::rofl::rofl::rofl:

Thank you!
 

A.B.

Senior Member
Messages
3,780
Of 389 patients who attended the Clinic, 264 (68%) met eligibility criteria for inclusion. The reasons for non-inclusion (n=125, 32%; see Figure 2) included lack of a specialist-confirmed diagnosis, alternative diagnoses (n=20; 16%); and fatigue scores below threshold. The ‘complete data’ (CD) analysis group comprised 168 patients (64%).

The patients were predominantly female (177 of 264; 67%), and most had been diagnosed with CFS (93% of ITT group and 93% of CD group). The patients had been suffering from chronic fatigue for a mean (M) of 4.9 years, with a substantial minority receiving Sickness Benefits or a Disability Support Pension (n=104; 39%)(Table 2). Patients with CFS reported significantly greater fatigue at baseline (M=8.4, SD=2.7) compared to those with PCF (M=6.6, SD=2.3; t (262) = -2.9, p<0.01), had a longer sickness duration (M=5.0 years, SD =3.6 versus M=3.1, SD=3.4; t (261) = -2.201, p<0.05) and were younger (M=36 years, SD=13.3, versus M=48, SD=11.3; t(22) = 4.5, p<0.01).


Treatment outcomes
Fatigue and physical function
The severity of self-reported fatigue improved significantly between baseline and end-treatment 12 weeks (M diff = -1.82, 95% CI: -2.23 - 1.4, p<0.001, and between baseline and follow-up 24 weeks (M diff = -1.42, 95% CI: -1.84 - -1.00, p<0.001) (Figure 3). This improvement was generally sustained, albeit with some deterioration from end-treatment to follow-up (M diff = 0.39, 95% CI: 0.04 - 0.74, p<0.05). There were consistent improvements in physical function (SF-36) between baseline and end-treatment (M diff = 2.35, 95% CI: 0.18 - 4.53, p<0.05), and end-treatment to follow up (M diff = 2.26, 95% CI: 0.18 - 4.33, p<0.05). These results translate to an effect size of d = 0.60. The findings were similar in the CD group. A subgroup analysis of participants with a diagnosis of CFS alone was conducted which showed no difference in the primary outcome (F (2, 243) = 51.09, p<0.001).

I'm not quite sure what this means but it sounds bad.
 

A.B.

Senior Member
Messages
3,780
In the GET arm

Daily step counts were recorded via pedometry for monitoring and feedback to ensure patients were maintaining agreed levels of activity.

There is no discussion or data on daily step counts in the paper.

This could have been something that adds credibility to a study design that cannot distinguish between biased responses and actual improvement. :whistle:
 
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Sidereal

Senior Member
Messages
4,856
Please elaborate.

What they meant to say here is that when they analysed only the CFS group (excluding the cancer fatigue patients) they found the same result as for the whole group. They awkwardly used "no difference in primary outcome" which unless you look at the result of the ANOVA in bracket could be interpreted as no difference, as in, no change from pre to post. But it was highly statistically significant at p<0.001.

A subgroup analysis of participants with a diagnosis of CFS alone was conducted which showed no difference in the primary outcome (F (2, 243) = 51.09, p<0.001).
 

Sidereal

Senior Member
Messages
4,856
The activity pacing component was based on the ‘envelope’ theory of CFS 15 which suggests the disorder is associated with a limited energy supply, with exacerbations of fatigue triggered by ‘excessive’ activity resulting in prolonged inactive periods. The activity pacing intervention encouraged patients to avoid exacerbations by planning daily and weekly schedules of activities and rest breaks, and segmenting tasks into short time blocks. In contrast to adaptive pacing of the PACE trial, the activity pacing was used as a precursor to GET. The GET component was based on the notion of central sensitization to physiological signals and hence desensitization (i.e. carefully graduated exposure to the triggering stimuli – exercise) to reduce the exaggerated (brain-derived) symptom of fatigue.16 Accordingly, the GET intervention established an initial achievable level of structured regular exercise (e.g. walking), in addition to activities of daily living

How does the authors' disease model account for patients who are unable to carry out activities of daily living without help from carers or those who are unable to even carry them out with help? How does the brain get sensitised to experiencing fatigue from activities like taking a shower every day, washing your hair, brushing your teeth, preparing a meal? Would the brain not get desensitised to the fatigue sensations by doing these ADLs daily just as the brain would allegedly get desensitised to gradually increasing regular exercise? In my experience, this does not happen, there is an activity ceiling even for ADLs and the body/brain NEVER gets used to doing these activities and they never become less "fatiguing" over time.

Clearly the authors have a pretty select sample here of patients who are able to achieve a level of structured regular exercise in addition to activities of daily living.
 

Cheshire

Senior Member
Messages
1,129
How does the authors' disease model account for patients who are unable to carry out activities of daily living without help from carers or those who are unable to even carry them out with help? How does the brain get sensitised to experiencing fatigue from activities like taking a shower every day, washing your hair, brushing your teeth, preparing a meal? Would the brain not get desensitised to the fatigue sensations by doing these ADLs daily just as the brain would allegedly get desensitised to gradually increasing regular exercise? In my experience, this does not happen, there is an activity ceiling even for ADLs and the body/brain NEVER gets used to doing these activities and they never become less "fatiguing" over time.

Because it has to be disensitised through the use of CBT and graded exercice therapy, which are lead by great professionals.
How dare you expect doing better on your own than with these experts, silly you?
 
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Messages
78
Location
Melbourne, Australia
Lloyd has been working on positioning himself in a post-PACE world for some time.

This just came out:
http://www.australiandoctor.com.au/...in-three-cfs-patients-improve-in-aussie-trial

Full text:

"More than one-third of patients with chronic fatigue syndrome improve when they undergo a program combining graded exercise and CBT, an Australian ‘real-world’ study shows.

The study included patients with CFS who followed personalised programs, including five one-hour consults with an exercise physiologist and 6-8 sessions with a clinical psychologist at the University of NSW's Lifestyle clinic in Sydney.

Of the 264 participants whose illness had lasted for an average of five years, 35% had a reduction in fatigue after the program, with their ‘capacity to walk more than 2km’ improving significantly.

Mood scores also improved, and this was associated with the patients’ enhanced social functioning, said the authors, led by Professor Andrew Lloyd from the University of NSW.

Improvement at 12-week follow-up was generally sustained at 24-week follow-up.

The patients least likely to benefit from the intervention were men and people with chronic pain.

“Uncontrolled pain can get in the way of this overall management program and it needs to be dealt with separately,” Professor Lloyd told Australian Doctor.

The approach aims to put together interventions such as graded exercise therapy and CBT, which have proved to be helpful in treating the condition, he said.

“In terms of what they can do in a day, the key limitation is this phenomenon that’s imposed by the disorder, where people do a certain amount physically — and sometimes it’s not very much — and, in Australian parlance, they’re then buggered for a long period of time," Professor Lloyd said.

“The same kind of thing happens with cognitive demand. Patients try and do something on the computer for an hour, and after that the brain’s fuzzy and stays bad for hours or days."

The UNSW team first looked at ‘pacing’ – finding the thresholds that lead to post-exertional exacerbation, and encouraging people to work up to, but not over, them.

They then introduced graded exercise therapy and CBT.

The Australian trial is being billed as the first real-world study of patients undergoing similar interventions as those shown to be effective in a controversial UK randomised controlled study (PACE).

The NSW results support the UK findings, but with somewhat lower effectiveness, the authors wrote in the Internal Medicine Journal.

This could be because the Australian intervention was only for 12 weeks, whereas PACE covered a year, the authors said.

Although the program was currently delivered by clinical psychologists and exercise physiologists, it could be delivered by other practitioners, including GPs, said Professor Lloyd.

The team is trialling an online manual explaining how to conduct the treatment, which could help other centres adopt the approach.

He said the UNSW method was worth trying, particularly as treatment of CFS was “a therapeutic desert”."
 

Sean

Senior Member
Messages
7,378
Oh boy, it's whack-a-mole- with this stuff, isn't it. Always one more to deal with. :grumpy:

The NSW results support the UK findings, but with somewhat lower effectiveness, the authors wrote in the Internal Medicine Journal.
Given PACE has no effectiveness (and it doesn't), then you ain't got much of a claim.

This could be because the Australian intervention was only for 12 weeks, whereas PACE covered a year, the authors said.
See previous comment.
 
Messages
32
No, they just phrased it badly.

Are you sure? The ones that have a difference are listed (diff ##) in the brackets, and you can have a confidence value for a negative/nil result.

NB I haven't read the study yet - need to sit up and open my laptop and that's not an option right now
 

Sidereal

Senior Member
Messages
4,856
Are you sure? The ones that have a difference are listed (diff ##) in the brackets, and you can have a confidence value for a negative/nil result.

NB I haven't read the study yet - need to sit up and open my laptop and that's not an option right now

Yes, I'm sure.