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New paper on FINE in PLOS: "Therapist Effects and the Impact of Early Therapeutic Alliance"

worldbackwards

Senior Member
Messages
2,051
Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome
  • Lucy P. Goldsmith ,
  • Graham Dunn ,
  • Richard P. Bentall ,
  • Shôn W. Lewis ,
  • Alison J. Wearden
logo.plos.95.png


  • Published: December 14, 2015
Haven't read it. Doesn't look like they found anything. This is the conclusion:
The different therapists in the trial did not tend to form significantly different levels of alliance with clients, apart from therapist three when delivering PR compared to when delivering SL. Analysis of the outcomes did not indicate any significant therapist effects for change in physical functioning or fatigue at either 20 or 70 weeks; all therapists delivered both treatments at comparable levels of effectiveness. Furthermore, our analysis suggests that when specially trained nurse therapists delivered pragmatic rehabilitation or supportive listening at home to people with CFS/ME, the level of therapeutic alliance did not influence the effectiveness of treatment.
This stood out to me:
It is unusual, although not unknown, to find no therapist effects or effects of therapeutic alliance in trials of psychological or behavioural therapies.
According to James Coyne, data has been made available to those at PLOS, which is a start. That said, it's not like FINE can do too much damage compared to PACE.
 

Sidereal

Senior Member
Messages
4,856
Problem in the first paragraph already:

Chronic Fatigue Syndrome (CFS), also known as myalgic encephalomyelitis or encephalopathy (ME), is characterised by severe, disabling fatigue which affects both physical and mental functioning [1]. The most effective treatments for CFS are cognitive behaviour therapy (CBT) and graded exercise therapy (GET) delivered by expert therapists [2–4]. Pragmatic rehabilitation, an approach which combines elements of CBT and GET, delivered by trained general nurses was effective in improving fatigue over an 18-week treatment period but effects attenuated over one year follow up [5].

The primary outcome measure was one-year follow-up and the effect of pragmatic rehabilitation compared to control group didn't "attenuate", it was null.
 

A.B.

Senior Member
Messages
3,780
Excerpt from a Tuller article on the FINE trial:

Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?


BMJ published the FINE results in 2010. The FINE investigators found no statistically significant benefits to either pragmatic rehabilitation or supportive listening at 70 weeks. Despite these null findings one year after the end of the 18-week course of treatment, the mean scores of those in the pragmatic rehabilitative arm demonstrated at 20 weeks a “clinically modest” but statistically significant reduction in fatigue—a drop of one point (plus a little) on the 11-point fatigue scale. The slight improvement still meant that participants were much more fatigued than the initial entry threshold for disability, and any benefits were no longer statistically significant by the final assessment.

Despite the null findings at 70 weeks, the authors put a positive gloss on the results, reporting first in the abstract that fatigue was “significantly improved” at 20 weeks. Given the very modest one-point change in average fatigue scores, perhaps the FINE investigators intended to report instead that there was a “statistically significant improvement” at 20 weeks—an accurate phrase with a somewhat different meaning.

The abstract included another interesting linguistic element. While the trial protocol had designated the 70-week assessment as “the primary outcome point,” the abstract of the paper itself now stated that “the primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment.”

After redefining their primary outcome points to include the 20-week as well as the 70-week assessment, the abstract promoted the positive effects found at the earlier point as the study’s main finding. Only after communicating the initial benefits did they note that these advantages for pragmatic rehabilitation later wore off. The FINE paper cited no oversight committee approval for this expanded interpretation of the trial’s primary outcome points to include the 20-week assessment, nor did it mention the protocol’s caveat about the “misleading” nature of short-term assessments in chronic health conditions.

In fact, within the text of the paper, the investigators noted that the “pre-designated outcome point” was 70 weeks. But they did not explain why they then decided to highlight most in the abstract what was not the pre-designated but instead a post-hoc “primary” outcome point—the 20-week assessment.

A BMJ editorial that accompanied the FINE trial also accentuated the positive results at 20 weeks rather than the bad news at 70 weeks. According to the editorial’s subhead, pragmatic rehabilitation “has a short term benefit, but supportive listening does not.” The editorial did not note that this was not the pre-designated primary outcome point. The null results for that outcome point—the 70-week assessment—were not mentioned until later in the editorial.

Can anyone explain what the point of looking at the effect of therapeutic alliance is here?
 

Gijs

Senior Member
Messages
690
This contradicts the ideas of professor Blijenberg e.a. He said that only special therapists (with licence for CFS) can give CBT and GET -:) I think the Pace authors wanted that this therapy CBT can be used by any therapist because this is much better for there implementation in the daily care practice. Now every therapist can give CBT and make a lot of money with this scam.
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
This contradicts the ideas of professor Blijenberg e.a. He said that only special therapists (with licence for CFS) can give CBT and GET -:) I think the Pace authors wanted that this therapy CBT can be used by any therapist because this is much better for there implementation in the daily care practice. Now every therapist can give CBT and make a lot of money with this scam.

The various contradictions are very useful. We know from patient testimonies that UK benefits are sometimes denied if CBT isn't done "correctly" by "special therapists" (who probably have long wait lists). Who cares about consistency when there is money to be made by therapists and money to be saved by disability insurers?
 

A.B.

Senior Member
Messages
3,780
My guess is that this will be cited by the PACE authors to demonstrate a lack of bias in their methods, which it does not, but most will be taken in by the claim.

My thinking is more along the lines: if the effect is 0%, what's the point of trying to figure out how much of that 0% is attributable to the therapeutic alliance?

It all seems rather bizarre.
 
Messages
59
According to James Coyne, data has been made available to those at PLOS, which is a start. That said, it's not like FINE can do too much damage compared to PACE.

Does anyone (e.g. James Coyne) plan to reanalyse this specific data?

Given their claims that Rehab. is significantly more effective than listining (at least at 20weeks as they claim)?
...which seems very marginal in my (not relevant) opinion?
And challenging the "attentuation" euphemism (at 70 weeks follow-up).

I just got the bad feeling there is "slight";) exaggeration wherever we look at... which needs to be challanged.

Any plans known?
 
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13,774
The public release of this data screws so many of PACE's arguments against the release of their data.

I had thought that maybe their decision to publish like this reflected some desire to distance themselves from PACE? Had the indefensible PACE spin become an embarrassment? Reading the paper makes that seem unlikely. Pro-biopsychosocial bias to everything.

Some sleepy notes:

To their credit, they did include this:

This analysis was repeated for fatigue (0123 scoring method) and physical functioning, as shown in Table 2. The results are consistent. Patients in receipt of PR fare significantly better than patients in receipt of SL at 20 weeks, but the difference is no longer significant at the 70 week outcome. In the main trial results [4], randomisation to PR only had a significant effect on the Chalder fatigue scale at 20 weeks when the fatigue scale was scored 0011. Readers should note that the analysis reported in this paper compares two therapies, delivered by different therapists, in contrast to the main trial results [4], which compared each therapy to GP treatment as usual. Therapist effects are not significant.

Which is clearer than they often are. To me, their introduction still seems to imply PR is a valuable intervention though.

Also, are they saying PR did worse at 20 weeks with likert scoring? [edit: No they're not, I misunderstood]. In the BMJ RR where they first provided likert results they said:

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.

http://www.bmj.com/rapid-response/2011/11/02/fatigue-scale-0

Is there a contradiction there? I'm half-asleep.

They went on to mention a certain @Tom Kindlon commenting on some outcomes mentioned in the trial protocol not being released... maybe this played a role in them now releasing their data via plos?

At the end of their discussion they say:

While PR was effective in reducing fatigue in the FINE Trial, when compared with GP treatment as usual, neither PR nor SL significantly improved physical functioning, and there was little change in this outcome variable. This may reduce the likelihood of finding therapist effects or an effect of therapeutic alliance.

So it was effective in the introduction, ineffective in the results section, but effective in the discussion?

I'm so relieved I finished that - bed, here I come!
 
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13,774
Okay, I wasn't just tired, this makes no sense [yes it does, I was being thick, and misunderstood the sentence as saying PR only had a significant effect at 20 weeks when calculated 0011 rather than 0123, when they were saying it only had a significant effect at 20 weeks when scored 0011, not at 70 weeks]:

In the main trial results [4], randomisation to PR only had a significant effect on the Chalder fatigue scale at 20 weeks when the fatigue scale was scored 0011.

But then, this was the graph they provided in a RR when they released likert (0,1,2,3) results there:

finefatigue_1.jpg


http://www.bmj.com/rapid-response/2011/11/02/fatigue-scale-0

Anyone digging into the data they provided want to explain what's going on here? Maybe hard to do without TAU data?
 
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13,774
I'm suspecting you're a bit tired now. Unless one of the other eleven Esthers has gotten control :)

You mean the double post? Yeah - sure I tried to post the above about 4 times, then double posted... right now. Trying to keep up with well people on PACE has been an pleasure and a nightmare. Relieved Tuller seems to have givgen us a break from his excellent work!
 
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15,786
Anyone digging into the data they provided want to explain what's going on here? Maybe hard to do without TAU data?
It's a bit odd. The calculated values for PR and SL match up with the points on the graph. Specifically, at week 70 PR has an average Fatigue score of 23.76 while SL has 26.5.

There are a lot fewer patients at week 70, compared to week 20. SL is down to 88 out of 101 (87%), and PR is down to 76 out of 95 (80%). Maybe they couldn't get statistical significance unless they imputed or similar?
 
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Sorry Val - I was being thick, and misunderstood the sentence as saying PR only had a significant effect at 20 weeks when calculated 0011 rather than 0123, when they were saying it only had a significant effect at 20 weeks when scored 0011, not at 70 weeks. Blame it on being too tired when I first read it. Tricked myself.
 

Dolphin

Senior Member
Messages
17,567
Trying to make my way through it. A lot of papers are easier to read/less technical.
Anyone got the questions from the California Psychotherapeutic Alliance Scale (CALPAS)? I find it's easier and better to read such papers when you can see the questionnaires used.
Or has anyone found any questions from it. Often if you get a question or two, the questionnaire will show up with enough searching e.g. full questionnaires are often not given in open access papers but often turn up in student theses.

All I've found so far is the questionnaire is scored 1-7, 1 = “Not at all” to 7 = “Very much so”