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

[Bob]

I'm not sure NICE should necessarily have an agenda. However, there is a strong and influential CBT/GET-type lobby in the UK who earn a living, etc. from these treatments. Also, unfortunately I'm not sure there are many competing treatments at the moment that have the sort of evidence (at least two positive RCTs) NICE are looking for.

What is the second positive RCT that you are referring to, Dolphin? (Assuming that PACE is the first.)

 

[Dolphin]

What is the second positive RCT that you are referring to, Dolphin? (Assuming that PACE is the first.)

The NICE guidelines last time used this systematic review as the basis - it lists the RCTs, including those which were seen as positive, etc:

Chambers D, Bagnall AM, Hempel S, Forbes C. Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. Review.
Free at: http://jrsm.rsmjournals.com/content/99/10/506.full.pdf

 

[Bob]

The NICE guidelines last time used this systematic review as the basis - it lists the RCTs, including those which were seen as positive, etc:

Chambers D, Bagnall AM, Hempel S, Forbes C. Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. Review.
Free at: http://jrsm.rsmjournals.com/content/99/10/506.full.pdf

Thanks Dolphin.
I think there may also have been a number (or at least a couple that I seem to have read, but I haven't been keeping track of them) of review papers over the past couple of years or so, that have framed CBT/GET in a negative light. I haven't followed them closely, but I imagine you might have done.
Do you think there might be enough evidence, as per those reviews, and papers like the 'harms' paper, that might provide the right kind of evidence to present to NICE next time?
I'm not saying that they'll change their minds, but do you think we've got enough of the right kind of evidence to give the psychiatric lobby a good run for their money?
Just interested in your thoughts, off the top of your head, based on any research you've been following.

 

[Dolphin]

Thanks Dolphin.
I think there may also have been a number (or at least a couple that I seem to have read, but I haven't been keeping track of them) of review papers over the past couple of years or so, that have framed CBT/GET in a negative light. I haven't followed them closely, but I imagine you might have done.
Do you think there might be enough evidence, as per those reviews, and papers like the 'harms' paper, that might provide the right kind of evidence to present to NICE next time?
I'm not saying that they'll change their minds, but do you think we've got enough of the right kind of evidence to give the psychiatric lobby a good run for their money?
Just interested in your thoughts, off the top of your head, based on any research you've been following.

Well, off the top of my head, I think if one looks at objective measures* like the 6-minute walking test, with no difference for CBT and only a small improvement for GET, and then combine it with the evidence about potential harms, I think one has quite a good case against these treatments. However, things like the SF-36 "physical functioning" scale tends to be seen as actually measuring physical functioning, and there are more results for that than for the 6MWT, which I don't think has been used in other CBT or GET studies (off the top of my head) (or not many anyway).

However, a problem is that I don't think other treatments can easily be pushed for.
I think patients should have tried to stay away from NICE in the ME/CFS area. So many patients seem to push for things, focusing on possible good outcomes, rather than thinking negative outcomes are also possible and weighing things up. It's a bit like how so many people can be wont to recommend exercise for M.E. patients.

But I think it's probably worth the fight: one might win some battles, put doubt in people's mind about the so-called evidence and then by the next time around, one might be in a stronger position: then there could be a drug on the table with sufficient effidence and it'd be CBT/GET vs the drug.

* I know it may not be perfect test. But it seems reasonable to call it an objective measure. A blood test reading could be described as an objective measure, but that doesn't mean that there can't be confounders that affect its interpretation.

 

[Dolphin]

http://psychologyatmanchester.edubl...wearden-by-as-level-work-experience-students/

Interview with Prof Alison Wearden by AS-Level Work Experience students…

[..]

What moment from your career has made you proudest?

Speaking about my career as a psychologist, I suppose the thing I did that I’m most proud of is I ran a large treatment trial of pragmatic rehabilitation treatment for patients with chronic fatigue syndrome, which is a quiet controversial condition and it’s poorly understood and it’s been quite difficult to treat. We successfully carried that trial out and found a treatment that improved patients’ fatigue, so that’s probably the thing that I’m most proud of.

A reminder of the FINE Trial's abstract:

CONCLUSIONS:
For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up.

The primary outcome point was at one year follow-up.

 

[Esther12]

Unblinded trial that relies on subjective self-report measures and found 'treatment' failed to lead to an improvement at their primary outcome point.. while the editorial dwells on the less rigorous but more successful earlier trial...

Reminded me of this blog from James Coyne:

The big picture.

Invited commentaries represent one form of privileged access publishing by which articles come to be found in prestigious, high impact journals with no or only minimal peer-reviewed. When they are listed on PubMed or other electronic bibliographic resources, there are typically no indications that commentaries evaded peer review, nor is there usually any indication provided in article itself. One has to learn to be skeptical and to look for evidence, like gratuitous inaccurate citations.

Invited commentaries come about with reviewers indicating a wish to comment on an article that seems likely to be accepted. Most typically, there is a certain cronyism in lavishing praise on articles done by colleagues doing similar work. Carlson’s commentary is less common in that it is intended to neutralize the impact of a manuscript that was apparently going to be accepted.

http://blogs.plos.org/mindthebrain/2013/11/13/2127/

this is the other article in full .......

http://www.bmj.com/cgi/content/full/340/apr22_3/c1799
Editorials
Pragmatic rehabilitation for chronic fatigue syndrome

Has a short term benefit, but supportive listening does not

Each full time general practitioner in the United Kingdom has as many as 10 patients with chronic fatigue syndrome (CFS/ME) on their list.1 Many feel they have little to offer with regard to treatment.2 Patients in turn are often left feeling misunderstood and poorly cared for.

Currently, the only evidence based treatments for this condition reviewed in the Cochrane Library and recommended by the National Institute for Health and Clinical Excellence are cognitive behavioural therapy and graded exercise therapy, with cognitive behavioural therapy in specialist care having the larger evidence base.3 4 5 A primary care trial of brief cognitive behavioural therapy for CFS/ME offered by general practitioners who had received simplified training in the subject was unsuccessful.6 Few patients with CFS/ME receive specialist services, partly as a result of limited access, but also because many feel that psychological treatments delegitimise their condition.2 Thus, a treatment that includes aspects of the successful treatments, but in a more pragmatic fashion with less emphasis on psychology, is an attractive proposition. But does it work?

The linked randomised controlled trial by Wearden and colleagues (doi:10.1136/bmj.c1777), assesses pragmatic rehabilitation for CFS/ME offered in primary care.7 The rehabilitation consists of providing patients with detailed explanations for their symptoms combined with a carefully graded exercise programme, delivered by supervised general nurses after training. Patients randomised to this treatment became significantly less fatigued and depressed, and they slept better than patients who received usual care. However, one year later no significant difference was seen between the groups.

This suggests that pragmatic rehabilitation works, but only in the short term. Why then did an earlier randomised controlled trial of pragmatic rehabilitation with a single skilled therapist show large changes in fatigue and disability at one year of follow-up?8 Wearden and colleagues explain that their patients had more comorbidity and disability than patients in the earlier trial,7 8 and indeed most other trials. Increased disability is a recognised predictor of poor outcome of cognitive behavioural therapy in this condition.9 10 This may be even more relevant for a minimal intervention from less experienced practitioners. A recent trial found that guided self instruction cognitive behavioural therapy, accompanied by minimal support from a therapist, reduced fatigue and disability in patients with less severe rather than more severe CFS/ME.10 Therefore the best approach may be stepped care, in which patients with less disability are offered minimal intervention, whereas more severely affected patients are offered intensive specialist input. Alternatively, having more sessions of pragmatic rehabilitation for longer may build on initial improvements. In Wearden and colleagues’ trial, patients received fewer sessions (eight hours in total) than most successful trials of cognitive behavioural therapy and graded exercise therapy.

A further question is whether generalists are as successful as specialists in offering behavioural interventions. A large Dutch trial showed that 16 hours of cognitive behavioural therapy delivered by a range of recently trained health professionals was effective for at least a year, although the improvements were less than those obtained for highly skilled therapists.11 The effectiveness of these treatments may be a product of therapists’ skill and the number of sessions, with less experienced therapists needing more sessions. To understand these interactions further, trials comparing short and longer term treatments with skilled and unskilled therapists are needed. These should also examine the cost effectiveness of different levels of therapeutic skill. The economic and personal burden of CFS/ME is large, yet data on cost effectiveness are scarce.

Wearden and colleagues’ trial also investigated supportive listening therapy for CFS/ME. This approach is often used by counsellors and is more accessible to general practice than cognitive behavioural therapy or exercise therapy. Importantly, this treatment was ineffective—patients receiving supportive listening had significantly more disability at the end of treatment than those receiving usual general practitioner treatment. This may be because supportive listening did not include a graded activity component. Cognitive behavioural therapy protocols without this component seem to be no more effective than usual care for CFS/ME.4 The large UK based PACE trial should soon provide answers in this regard.12 PACE compared cognitive behavioural therapy and graded exercise therapy, which focus on increasing activity, with adaptive pacing therapy, which matches activity levels to the amount of energy available to patients.

Pragmatic rehabilitation as a treatment in primary care for CFS/ME has short term benefit, but supportive listening does not. Before it can be recommended, more work is needed to determine for whom pragmatic rehabilitation works best, the optimum number of sessions needed, and the required skill of the therapists. Some of these questions may be answered by further analysis of the current trial. For instance, moderator analysis, examining interactions between patient or therapist characteristics and treatment outcome, could investigate whether less disabled patients responded better to treatment than those with greater disability. Similarly, it might be useful to study the effect of therapists’ competence on outcome. Finally, pragmatic rehabilitation has the real advantage of being an acceptable treatment. Few patients dropped out of treatment, and it may be less stigmatising for some people than cognitive behavioural therapy. This last point is crucial, and if the successful elements of pragmatic rehabilitation can be identified, it may provide an additional option to the currently limited list of possibilities.

Cite this as: BMJ 2010;340:c1799

Rona Moss-Morris, professor of health psychology1, William Hamilton, consultant senior lecturer2

1 School of Psychology, University of Southampton, Southampton SO17 1BJ , 2 Primary Health Care, University of Bristol, Bristol BS8 2AA

remm@soton.ac.uk
Research, doi:10.1136/bmj.c1777

 

[Esther12]

This seperate Coyne blog contained a bit kind of relevant to FINE:

For their primary analysis, the investigators compared the intervention and control group and overall level of depressive symptoms. There were no significant differences. That would usually rule out continuing onto subgroup analyses examining the different time points. However, the investigators went on to look at depressive symptoms at each of the three post-assessment time points, and found a small difference at the first assessment that did not persist. This provided the basis for their bragging rights for having found a small, rather no effect, which is emphasized in their abstract and discussion.

http://blogs.plos.org/mindthebrain/...ogy-in-the-schools-the-uk-resilience-project/

Generally, I'm always keen to get as much data out as possible, but the way in which the FINE trial has been presented as a positive result in other contexts does show the danger of "continuing onto subgroup analyses".

Not sure what I think about that, and not a strong enough point to probably ever be worth bring up, but I thought that it could still be of interest.

The blog was about a positive psychology program teaching school children resilience (yuck - fortunately I expect most teenagers would instinctively rip the piss).

This from the comments is relevent to all manner of trials for psychosocial interventions:

donald klein says:
December 2, 2013 at 9:03 am
A major problem is called reactivity of measurement. The therapy teaches you to avoid all words signifying dispirited wimp. The evaluations use this vocabulary”Do you????” Ans. “What me, (I know that is systematically discouraged)”.
consonant with small effects ,decreasing in time.
Poses an interesting methodological quandary.

Don Klein

Rating: 0 (from 0 votes)
Reply

James Coyne PhD says:
December 2, 2013 at 5:42 pm
I very much agree. Particularly bright students can figure out the point of these lessons and tendencies to want to please the instructors can take over.

 

[Tom Kindlon]

For what it's worth: Somebody who was in the FINE Trial who responded to the (UK) ME Association survey:
http://www.meassociation.org.uk/2015/05/23959/

#905: ME moderate before course, became severe after course. Symptoms were very much worse after. Course not appropriate to needs. Part only attended.

“I felt the psychologist did her best to help me and was prepared to be flexible.

I would like to comment on the FINE trial. It was a mixture of 3 therapies and also included sleep advice. As a model it could be quite helpful but I found the ideas of faulty belief systems and assumption that you weren't as active as possible really offensive at times.

There was a fixed view of what ME was and it was definitely NOT a physical illness. I have a scientific background and it became obvious to me that the sessions were already looking for reasons in your life would explain why their approach hadn’t worked but that it was still the right model.”

 

[Tom Kindlon]

Oops, I didn't mean to post this here as it is not to do with the FINE Trial. I posted it here: http://forums.phoenixrising.me/inde...ry-treatments-for-me.37782/page-6#post-652380 along with a lot of other extracts from the ME Association survey.

CBT
Page 117-118

#917: ME moderate before course, became severe after course. Symptoms were very much worse after. Course not appropriate to needs.

“It was clear that the course leaders considered we were mentally ill and had "abnormal illness beliefs". The course encouraged us to IGNORE and PLAY DOWN distressing physical symptoms, particularly pain and exhaustion, and they kept stressing that what we were experiencing was normal aches and pains and tiredness.

The course leaders took pains to come across as friendly and nice but frequently made inappropriate remarks. The course encouraged me to push beyond my boundaries and I got significantly worse following the course. I then immediately stopped CBT/GET.

The CBT had no effect at all as I realised that the intention of it was to try and make me believe I was not ill. That, together with the fact that I realised at that point that I would get no medical help whatsoever from the NHS, made me more depressed and anxious than I had been before the course! The course led to a significant worsening of the illness.”

 

[Tom Kindlon]

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.

Did anyone store their reply, either from here or from the BMJ site: http://www.bmj.com/rapid-response/2011/11/02/fatigue-scale-0

The BMJ updated their website and the table isn't there (same thing happened with the Phoenix Rising site). A quick Google search for

"Following Bart Stouten’s suggestion that scoring the Chalder fatigue"

suggested it isn't on the web elsewhere.

If you want, e-mail me the info at: tomkindlon @ gmail dot com . It may be useful for something I'm working on. Thanks.

 

[Dolphin]

New David Tuller article today:
"Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?"

http://www.virology.ws/2015/11/09/t...-sister-trial-been-disappeared-and-forgotten/

Phoenix Rising thread on it:
http://forums.phoenixrising.me/inde...rial”-been-“disappeared”-and-forgotten.41104/

 

[Dolphin]

A participant in the FINE Trial explains why she wanted to withdraw (not new I think)

http://www.investinme.org/Article-015A FINE Trials-Alice.htm