The FINE Trial. BMJ ARTICLE. Nurse led, home based self help treatment for patients in primary care

Dolphin

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The present study found few differential results among the non-pharmacologic interventions, although the COG condition appeared to have more positive change than the other conditions. On only three variables was one intervention clearly and significantly different from all of the other three conditions (depression and pain in joints for COG, and muscle pain for RELAX).
I wonder if CBT proponents have responded with suggestions Jason et al cannot conduct CBT properly?
Vincent Deary, a therapist from Kings College London (home of Simon Wessely and Trudie Chalder) was brought in to major sure the therapy was like what they used. As I recall, he lived over there for a while (at least person was wondering about Leonard Jason when they learned about it).
The CBT treatment regimen was developed in collaboration
with Vincent Deary, who has worked for many years
with the team that completed a successful controlled clinical
trial of CBT in CFS (Deale et al., 1997).
They also checked using fidelity ratings:
Fidelity Ratings

In order to verify the distinctiveness of the behavioral
treatments, a validation study was completed using a fidelity
rating scale developed for this study. A random sample of
audiotaped sessions were selected, and each session was
rated to the degree that the therapists exhibited behaviors and
introduced techniques that were unique to each of the four
treatment conditions. Fidelity ratings were implemented in
order to monitor the consistency of implementation of the
different treatment conditions, as specified in each treatment
manual, and to ensure that the treatment conditions were in
fact distinct. Ratings were conducted by a licensed psychologist
and a master’s level psychologist, both of whom
were familiar with CFS and who had training and experience
in cognitive behavior therapy techniques.

First, inter-rater reliabilities were computed for 34 audio
taped treatment sessions to ensure an acceptable level of
inter-rater reliability. For these sessions, median inter-rater
percent agreement for item reliability was .79, and these
were at an acceptable level (Steve Hollon, personal communication
reference, June 17, 1998).

Next, mean scores for 46 rated sessions indicated that
the four treatment conditions were significantly differentiated
by the questions tapping the corresponding categories
(see Table 2). There was some overlap between the COG
and CBT conditions, but that is because the COG condition
includes CBT cognitive issues. T-tests indicated that the
majority of the items that reflected the various cognitive–
behavioral techniques in fact discriminated between the
conditions at the p\.05 level. This suggested that the
therapists implemented the treatment conditions as specified
by the treatment manual. Further, high ratings on each
set of items were in the expected direction for each treatment
condition, when assessed by a clinical expert in
cognitive–behavior therapy. Thus, our fidelity rating scale
analyses indicated that the four treatments arms were
distinct and were implemented as specified in the corresponding
treatment manuals for each condition.
 

Dolphin

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Oh, I see, thanks. So it's basically..

Placebo effect due to nurse's expectations - present
Placebo effect due to subject's expectations - present
Placebo effect due to statistician's expectations - not present

Still seems to me enough placebo in there to explain any less than dramatic outcomes.
Or maybe:
Placebo effect due to nurse's expectations - present
Placebo effect due to subject's expectations - present
Placebo effect due to assessor's expectations - not present
Placebo effect due to statistician's expectations - present
 

biophile

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The CBT treatment regimen was developed in collaboration with Vincent Deary, who has worked for many years with the team that completed a successful controlled clinical trial of CBT in CFS (Deale et al., 1997).
Thanks.

Placebo effect due to statistician's expectations - present.
Hehe!
 

V99

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Reply from Wearden
http://www.bmj.com/cgi/eletters/340/apr22_3/c1777

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




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.
 
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Thanks, V99

I wonder if Sam Carter and Tomk have seen this yet? The results do appear to show a modest but unspectacular improvement with pragmatic rehab (approx 20% reduction in fatigue at 70 weeks versus 10% reduction for controls) but I'm not sure the figures really address the ceiling effect of the Chalder scale that Tom & Sam raised. The max score on the CF scale scored 0123 is 33 (I think), and the mean score at baseline is 29 which suggests that a signigicant number of patients are still at maximum score at the start of the experiment. This would make it impossible for their score to get worse, even if their condition were to deteriorate.
 

alex3619

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Yeah, cause those initial improvements couldn't be due to intimidation/false wellness beliefs of patients desperate to believe that they can think their way out of this nightmare:p. Once we are well, we need to start some sort of organization to prevent a repetition of this sad history. It's obscene and should never happen to another group of people in a civilized society.
Hi Bluebell, I totally agree. The history of psychiatry says this will happen again if someone doesn't fight it, because we aren't the first group, nor the second, nor the twentieth they have done this to without any hard evidence. Bye, Alex
 

Dolphin

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I have just sent in a response. I'm not sure if I was quite polite enough - we'll see. It's a delicate balance between on the one hand getting something up (a brilliant response that doesn't get up is pretty useless) and on the other making sure the point you want to make is made. People who are doctors have an advantage as they are seen as the target group so more of their stuff will likely get through I would think.
 

Dolphin

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BMJ Rapid Response

BMJ Rapid Response

Data on the level of maximal scoring (on the Chalder Fatigue Scale) would be useful
http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#236818

I thought I'd point out that two of the authors (including the corresponding author who was the Principal Investigator) should be well aware of the problems of the ceiling effect of the Chalder Fatigue scale for Chronic Fatigue Syndrome (CFS) patients as they devoted a whole paper to analysing the use of the scale in CFS patients[1].

This study looked at the scores of 136 CFS patients, who were attending an outpatient clinic, using the 14-item Chalder Fatigue Scale with Likert scoring (i.e. 0, 1, 2, 3).

It found that "scores on ... six items "tiredness," "resting more,""lacking energy," "feeling weak," "feeling sleepy or drowsy," and "starts things without difficulty but gets weaker as goes on") were highly skewed with the majority of patients reaching the maximum score." One item ("Starts things without difficulty but gets weaker as goes on") is excluded from the 11-item version of the Chalder Fatigue Scale but the other 5 items remain.

They concluded: "Near-maximal scoring on six physical fatigue scale items from the total of 14 items constituting the Chalder fatigue scale supports the validity of scoring the physical fatigue scale on a two-point scale (presence or absence) rather than the four-point Likert scoring. Most of the variance in the total fatigue scale is thus accounted for by the mental fatigue score."

To me, these results would have suggested using a different scale as, in both scenarios (i.e. whether bimodal or Likert scoring is used), patients can't be recorded as getting worse if they are already scoring maximum at the start of the trial - an important issue that should be investigated in rehabilitation trials in the CFS area given the high level of adverse reactions that have been reported by patients from rehabilitative interventions[2].

Another reason to use a different scale for the FINE trial in particular is the fact that the trial, which was performed in patients' homes, was designed to include severely affected patients who would have difficulty attending an outpatient clinic[3] - the previous analysis found high rates of maximal scoring in a group well enough to attend out- patients so maximal scoring was certainly going to be an issue in a more severely affected group.

Anyway, the authors concluded the bimodal scale was sufficient and they then designed this trial using the bimodal scoring method[3]. I'm sure many pharmacological and non-pharmacological studies could look different if investigators decided to use a different scoring method or scale at the end, if the results weren't as impressive as they'd hoped. But that is not normally how medicine works. So, while it is interesting that the researchers have shared this data, I think the data in the main paper should be seen as the main data.

I have seen many studies where authors have given the percentage who scored the maximum scores as the problem of floor and ceiling effects is a well-recognised issue. In the spirit of full disclosure, it would be good if the authors of this trial would now share that data for the bimodal scoring (the scoring method used in the published paper) and also for the Likert scoring system (0-3), now that they have presented other data using that scoring method. Dr. Bart Stouten has already pointed out the problems that exist with the bimodal scoring system for the group in this study but we do not have the exact figures[4]: "Reviewing the mean and standard deviation data in this study, I calculated that between 62 (65%) and 78 (82%) patients in the Pragmatic Rehabilitation (PR) group must have recorded the maximum score of 11 at baseline (see separate response). This indicates that a substantial proportion of participants would not have been able to record an exacerbation of fatigue following PR. Similarly, between 21 (26%) and 57 (70%) patients must have recorded the maximum score at 70 weeks."

Given that the initial scores in the Pragmatic Rehabilitation (PR) group on the Likert scoring scale were 29.39 (SD: 3.46), one can clearly see that there was a large amount of maximal scoring on many or all of the 11-items in the Likert scale also.

References:

[1] Morriss RK, Wearden AJ, Mullis R. Exploring the validity of the Chalder Fatigue scale in chronic fatigue syndrome. J Psychosom Res. 1998 Nov;45(5):411-7.

[2] Kindlon T, Goudsmit EM. Graded exercise for chronic fatigue syndrome: too soon to dismiss reports of adverse reactions. J Rehabil Med. 2010 Feb;42(2):184; author reply 184-6. http://jrm.medicaljournals.se/article/full/10.2340/16501977-0493

[3] Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Dunn G, Richardson G, Lovell K, Powell P. 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 Med. 2006 Apr 7;4:9. http://www.biomedcentral.com/1741-7015/4/9

[4] Stouten B. Fatigue scale. http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235631

Competing interests: None declared
 

Dolphin

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Sometimes research is only ever presented in abstract form.

There are quite a lot of CFS papers at:
http://abstracts.bps.org.uk/

I don't have time to read them all but found this one. I'm not saying I think this is very interesting; however it is interesting to know some information about why people don't take part in CBT/GET/similar trials as one might be able to say/suggest that the people who took part aren't representative in some way:

http://abstracts.bps.org.uk/index.c...view&frmShowSelected=true&localAction=details

Conference Proceedings
Abstract Details

2008 Division of Health Psychology/European Health Psychology Society
Health
Conference Venue: Bath
Division of Health Psychology (DHP)

From: 09 Sep 2008
To: 09 Dec 2008

Wearden will begin by presenting research on why patients refuse to participate in an RCT. Understanding why patients refuse to take part may help increase uptake and generalisability.

[..]

Paper 1
The recruitment of patients with chronic fatigue syndrome to a primary care treatment trial: patients reasons for refusal

Wearden, A.; University of Manchester, UK

Background:
We examined why patients did not wish to enter a randomised controlled trial of nurse-led self-help treatment for patients with chronic fatigue syndrome (CFS) in primary care.

Methods:
Patients were screened by GPs for referral to the trial, sent study information, and then contacted after one week. Some patients volunteered reasons for declining to participate. Subsequently, these reasons were explored in semi-structured interviews with seven declining patients, which were analysed thematically.

Findings:
77/449 (17%) patients declined to participate. Reasons fell into four categories: dislike of the treatments; too ill to take part; not wanting to be randomized; conflicting demands of work, life or family. Qualitative analysis of interviews underlined the role of significant others (GPs, family members) in reaching these decisions.

Discussion:
Patients understanding of their condition, constructed in a social context, was a major determinant of their participation, but research and treatment trial issues were also important.
 

Dolphin

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Another FINE abstract, FWIW:

http://abstracts.bps.org.uk/index.c...view&frmShowSelected=true&localAction=details
Conference Proceedings
Abstract Details

2008 Division of Health Psychology/European Health Psychology Society
Health
Conference Venue: Bath
Division of Health Psychology (DHP)

From: 09 Sep 2008
To: 09 Dec 2008



Peer-Reviewed


Psychological interventions for long term conditions in primary care: the case of chronic fatigue syndrome
S. Peters
University of Manchester

C. Dowrick
University of Manchester


Background: An NHS emphasis on primary care management of chronic conditions coupled with a shortage of psychologists has led to an increasing use of nurses to deliver psychological interventions. A recent trial examining nurse-delivery of two health psychology interventions for chronic fatigue syndrome provided an opportunity to examine the challenges non-specialist nurses face in delivering psychological treatments.

Methods: Perspectives of nurse-therapists (n=3), their supervisors (n=3) and patients (n=40) were gathered using semi-structured interviews. Exploring data from different perspectives provides triangulation, hence increased trustworthiness, of the analysis. An iterative approach was used to develop conceptual categories from the dataset.

Findings: Analyses demonstrate that nurse-patient interactions frequently challenge each party causing tension and potential conflict, regardless of therapy type. For the nurses, using psychological interventions for chronic illness was novel and required communicating in unfamiliar ways with patients.

Discussion: If primary care is to develop psychological services in this way, nurses need to be adequately trained and supported.
 

Dolphin

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Mechanisms of change in pragmatic rehabilitation for chronic fatigue syndrome

Another FINE abstract, FWIW:
Conference Proceedings
Abstract Details

2010 Division of Health Psychology Annual Conference

Conference Venue: Queen's University Belfast
Division of Health Psychology (DHP)

From: 15 Sep 2010
To: 17 Sep 2010



Individual Paper(s)


Mechanisms of change in pragmatic rehabilitation for chronic fatigue syndrome (CFS/ME).
J. ROOS
IAPT Services, 2gether NHS Foundation Trust, Gloucester

A. WEARDEN
University of Manchester School of Psychological Sciences



Background: Successful treatment for chronic fatigue syndrome (CFS/ME) may involve a process of socialisation to a model of the illness and its treatment. Previous work suggests that an enhanced sense of control and lower levels of focussing on symptoms are associated with better outcomes. We investigated whether socialisation to a physiological dysregulation model of CFS/ME was associated with improved outcome, and whether perceived control and reduced symptom focussing mediated this effect.
Method: Adults who fulfilled UK criteria for CFS/ME participated in a randomised controlled trial of pragmatic rehabilitation. Data for this study came from therapy tapes of 50 participants in the active treatment arm. Measures of socialisation to the pragmatic rehabilitation model, personal control and symptom focussing were extracted and coded from audiotapes of early and late treatment sessions. Outcomes were changes in physical functioning and fatigue between baseline and the end of treatment.
Findings: At the end of treatment, higher levels of socialisation to the treatment model were associated with improvements in fatigue, and higher perceptions of personal control over the illness were associated with improved physical functioning. However, there was no evidence that change in socialisation or change in personal control cognitions mediated change in outcome. Symptom focussing did not predict outcome.
Discussion: Our study was limited by the degree of change seen in the treatment group, but our findings suggest that further research into enhancing a sense of control over the condition may be warranted.
 

Dolphin

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(One of?) Their excuse(s) for PR's lack of efficacy

(One of?) Their excuse(s) for PR's lack of efficacy:

From: http://www.implementationscience.com/content/6/1/132
Challenges of nurse delivery of psychological interventions for long-term conditions in primary care: a qualitative exploration of the case of chronic fatigue syndrome/myalgic encephalitis.
Peters S, Wearden A, Morriss R, Dowrick CF, Lovell K, Brooks J, Cahill G, Chew-Graham C.
Implement Sci. 2011 Dec 22;6(1):132.
At times social circumstances hindered therapy considerably. In another study we found the number of social problems and level of social support to be associated with adherence to the therapy [48]. These findings might help explain the reduction in consistency and effect sizes for primary care treatments compared to those in secondary care [7]. The complexity of working in primary care led nurses to apply therapy more flexibly than might be the case within a secondary care service, a strategy that should be considered when translating secondary care interventions to primary.

48. Morriss R, Bennett C, Fleetwood D, Connell S, Bentall RP, Riste L, Wearden A: Adaptations and adherence to pragmatic rehabilitation delivered to patients with chronic fatigue syndrome by general nurses in primary care. (under submission).
 

Enid

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I hope this is Fiona Godlee of the BMJ (as she was this am trying to tell all of the impending disaster in much needed changes in UK NHS - and not getting much shrift either).
 

Dolphin

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I imagine in the "real world" if counselling was going to be made available, it would be given by qualified counsellors.
I'm not an expert on counselling but I believe counsellors have to go through counselling themselves and generally would be better qualified than this group.
One gets an eye how much out of their depth they are from:

http://www.implementationscience.com/content/6/1/132
Challenges of nurse delivery of psychological interventions for long-term
conditions in primary care: a qualitative exploration of the case of chronic
fatigue syndrome/myalgic encephalitis.
Peters S, Wearden A, Morriss R, Dowrick CF, Lovell K, Brooks J, Cahill G,
Chew-Graham C.
Implement Sci. 2011 Dec 22;6(1):132.
 

Dolphin

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Main paper was "declined by the Lancet"

Main paper was "declined by the Lancet"

Wearden, A.J., Dowrick, C., Chew-Graham, C., Bentall, R.P., Morriss, R.K., Peters, S., Riste, L., Richardson, G., Lovell K., & Dunn, G. (the FINE Trial Writing group on behalf of the FINE Trial group). A randomised controlled trial of a nurse-led home-based self-help treatment for patients in primary care with chronic fatigue syndrome the FINE Trial. (Declined by the Lancet, in preparation for the British Medical Journal.).

From: http://www.fine-trial.net/downloads/Publications from FINE trial 121009.doc
 

Dolphin

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Wearden, A.J., Riste, L., & Bentall, R.P. Performance on a timed step test in chronic fatigue syndrome patients: the role of illness beliefs and behaviors In preparation for Journal of Psychosomatic Research.

Wearden, A., Riste, L., Bentall, R., for FINE Trial Group - Performance on a timed step test by patients with chronic fatigue syndrome.* The role of illness beliefs. August 30th 2008. 18th International Congress of Behavioural Medicine, Tokyo. (Presentation invited by symposium organiser, Dr Rona Moss-Morris, as part of symposium on medically unexplained conditions.)

http://www.fine-trial.net/downloads/Publications from FINE trial 121009.doc
------
In the BMJ, in reply to a letter asking about this outcome measure, they said:
"We did not report the step test as an outcome because of a large amount of missing data."
I'm guessing the above papers may be on baseline levels (am not sure) but it is interesting they don't publish any data. I'm guessing if the data suited them, they would publish it. The total number of patients in this trial (n=296) was relatively large (for a CFS paper anyway) so there should still be a reasonable number who did the test (unless something odd happened).
 

Enid

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Dolphin whatever all the above comes to they are beating about the bush until the pathiogies are recognised and understood. Yes a kind hand as one's abilities severely deteriorate is rare but very much appreciated. So sorry SW et al not one of yours - very much wiser and much iller. Tell me (as my Neurologist at worst admitted "I don't understand yet"). Tell me on on that basis only I will accept.
 

Vitalic

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First time I've heard of this term pragmatic rehabilitation, are there any commentaries on this paper and how it fits in with the PACE trial etc.? I'm struggling to see the significance as any biopsychosocial advocate would simply point to the PACE trial as evidence of efficacy and put this down to "social circumstances" or some other exuse.
 

currer

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The BMJ have refused to publish anything on the Fluge and Mella rituximab trial though. The reason they gave was that ithe rituximab trial was too small to be of interest to their journal.
So why publish this rubbish?
 

Dolphin

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The BMJ have refused to publish anything on the Fluge and Mella rituximab trial though. The reason they gave was that ithe rituximab trial was too small to be of interest to their journal.
So why publish this rubbish?
This paper gives one theory:
Goudsmit, E and Stouten, B. Chronic fatigue syndrome: editorial bias in the British Medical Journal. Journal of Chronic Fatigue Syndrome, 2004, 12, 4, 47-59.
http://freespace.virgin.net/david.axford/JCFS.pdf