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

Discussion in 'Latest ME/CFS Research' started by pollycbr125, Apr 23, 2010.

  1. pollycbr125

    pollycbr125 Senior Member

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    hope this is in the right place this has just been published from the BMJ http://www.bmj.com/cgi/content/short/340/apr22_3/c1777?rss=1

    Published 23 April 2010, doi:10.1136/bmj.c1777
    Cite this as: BMJ 2010;340:c1777

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

    Alison J Wearden, reader in psychology1, Christopher Dowrick, professor of primary medical care2, Carolyn Chew-Graham, professor of primary care3, Richard P Bentall, professor of clinical psychology4, Richard K Morriss, professor of psychiatry and community mental health5, Sarah Peters, senior lecturer in psychology1, Lisa Riste, FINE trial manager1, Gerry Richardson, senior research fellow in health economics6,7, Karina Lovell, professor of mental health8, Graham Dunn, professor of biomedical statistics3, on behalf of the Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group

    1 School of Psychological Sciences, University of Manchester, Manchester, 2 School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool, 3 School of Community Based Medicine, University of Manchester, Manchester, 4 School of Psychology, University of Bangor, Adeilad Brigantia, Bangor, Gwynedd, 5 School of Community Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, 6 Centre for Health Economics, University of York, York, 7 Hull York Medical School, University of York, Heslington, York, 8 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester

    Correspondence to: A J Wearden alison.wearden@manchester.ac.uk
    Objective To evaluate the effectiveness of home delivered pragmatic rehabilitationa programme of gradually increasing activity designed collaboratively by the patient and the therapistand supportive listeningan approach based on non-directive counsellingfor patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME).
    Design Single blind, randomised, controlled trial.

    Setting 186 general practices across the north west of England between February 2005 and May 2007.

    Participants 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria.

    Interventions Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period.

    Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes.

    Results A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome.

    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. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME.

    Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.

    Wearden et al 2010
    This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.
  2. pollycbr125

    pollycbr125 Senior Member

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    theres another article published today too but i havent got full access just the abstract can anyone get the full article ? http://www.bmj.com/cgi/content/extract/340/apr22_3/c1799

    Published 23 April 2010, doi:10.1136/bmj.c1799
    Cite this as: BMJ 2010;340:c1799

    Editorials
    Pragmatic rehabilitation for chronic fatigue syndrome

    Has a short term benefit, but supportive listening does not

    The first 150 words of the full text of this article appear below.
    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 . . . [Full text of this article]

    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
  3. Min

    Min Senior Member

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    What a shameful waste of taxpayers' money that should have gone to biomedical research into M.E. as a discrete neurological illness.

    Alison J Wearden's speciality is hypochondria.
  4. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    http://www.bmj.com/cgi/content/full/340/apr22_3/c1777

    This is the FINE Trial, published, then? So might we expect PACE to publish shortly?



    FINE Trial Protocol:

    http://www.biomedcentral.com/1741-7015/4/9

    Study protocol
    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]
    AJ Wearden1 , L Riste1 , C Dowrick2 , C Chew-Graham3 , RP Bentall1 , RK Morriss4 , S Peters5 , G Dunn6 , G Richardson7 , K Lovell8 and P Powell9

    1 School of Psychological Sciences, University of Manchester, Manchester, M13 9PL, UK

    2 School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool, L69 3GB, UK

    3 Division of Primary Care, Rusholme Academic Unit, University of Manchester, Manchester, M14 5NP, UK

    4 Department of Psychiatry, Queens Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK

    5 Division of Psychiatry, University of Liverpool, Liverpool, L69 3GA, UK

    6 Division of Epidemiology and Health Sciences, University of Manchester, Manchester, M13 9PT, UK

    7 Centre for Health Economics, University of York, York, YO10 5DD, UK

    8 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, M13 9PL, UK

    9 Infectious Diseases Unit, Royal Liverpool University Hospital, Liverpool, L7 8XP UK

    author email corresponding author email

    BMC Medicine 2006, 4:9doi:10.1186/1741-7015-4-9

    The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1741-7015/4/9

    Received: 31 January 2006
    Accepted: 7 April 2006
    Published: 7 April 2006

    2006 Wearden et al; licensee BioMed Central Ltd.
    This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
  5. pollycbr125

    pollycbr125 Senior Member

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    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
  6. xanadu

    xanadu

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    COI and Refs for BMJ editorial

    In case anyone wants to follow the references.

    --------------------------------------------------------------------------------
    Competing interests: All authors have completed the Unified Competing
    Interest form at www.icmje.org/coi_disclosure.pdf (available on request from
    the corresponding author) and declare that: (1) They have no specified
    support for the submitted work; (2) RM-M has had no relationships that might
    have an interest in the submitted work in the previous three years; WH is a
    part time insurance medical officer for three companies offering income
    protection insurance and board member of one; his payments are fixed hourly
    rates and wholly unconnected to the acceptance or declinature of claims; (3)
    WH's wife is also a part time insurance medical officer for one company,
    with a similar payment scheme; and (4) AJW, first author of the FINE trial,
    has chaired a trial steering committee for a study on cognitive behavioural
    therapy for adjusting to multiple sclerosis where RM-M was the principal
    investigator. WH has no non-financial interests that may be relevant to the
    submitted work.
    Provenance and peer review: Commissioned; not externally peer reviewed.


    References

    1.. Gallagher A, Thomas J, Hamilton W, White P. The incidence of fatigue
    symptoms and diagnoses presenting in UK primary care from 1990 to 2001. J R
    Soc Med 2004;97:571-5.[Abstract/Free Full Text]
    2.. Raine R, Carter, S., Sensky T, Black N. General practitioners'
    perceptions of chronic fatigue syndrome and beliefs about its management,
    compared to irritable bowel syndrome: a qualitative study. BMJ
    2004;328:1354-7.[Abstract/Free Full Text]
    3.. National Institute for Health and Clinical Excellence. Chronic fatigue
    syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and
    management. 2007. http://guidance.nice.org.uk/CG53.
    4.. Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for
    chronic fatigue syndrome in adults. Cochrane Database Syst Rev
    2008;(3):CD001027.
    5.. Larun L, McGuire H, Edmonds M, Odgaard-Jensen J, Price JR. Exercise
    therapy for chronic fatigue syndrome. Cochrane Database Syst Rev
    2004;(3):CD003200.
    6.. Whitehead L, Campion P. Can general practitioners manage chronic
    fatigue syndrome? A controlled trial. J Chronic Fatigue Syndr
    2002;10:55-63.[CrossRef]
    7.. 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. BMJ
    2010;340:c1777.[Abstract/Free Full Text]
    8.. Powell P, Bentall RP, Nye FJ, Edwards KHT. Randomised controlled trial
    of patient education to encourage graded exercise in chronic fatigue
    syndrome. BMJ 2001;322:387-90.[Abstract/Free Full Text]
    9.. Prins JB, Bazelmans E, van der Werf, SP, van der Meer, JWM Bleijenberg
    G. Cognitive behaviour therapy for chronic fatigue syndrome: predictors of
    treatment outcome. In: Sivik T, Byrne D, Lipsitt DR, Christodoulou GN,
    Dienstfrey H, eds. Pscho-neuro-endocrino-immunology: a common language for
    the whole human body. Elsevier 2002:131-5.
    10.. Knoop H, van der Meer, JWM., Bleijenberg, G. Guided self-instructions
    for people with chronic fatigue syndrome: randomised controlled trial. Br J
    Psychiatry 2008;193:340-1.[Abstract/Free Full Text]
    11.. Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens
    JL, et al. Cognitive behaviour therapy for chronic fatigue syndrome: a
    multicentre randomised controlled trial. Lancet
    2001;357:841-7.[CrossRef][Web of Science][Medline]
    12.. White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R. Protocol for
    the PACE trial: a randomised controlled trial of adaptive pacing, cognitive
    behaviour therapy, and graded exercise as supplements to standardised
    specialist medical care versus standardised specialist medical care alone
    for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or
    encephalopathy. BMC Neurol 2007;7:6.[CrossRef][Medline]
  7. fred

    fred The game is afoot

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    It would make the timing very prudent, wouldn't it?

    Get FINE and PACE published and out of the way before XMRV gets too strong a foothold, otherwise they will look like a laughing stock.
  8. V99

    V99 *****

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    The will end up looking bad if they publish before or after.

    Before - we didn't know.
    After - how could we have known.

    Either way, why do the results show positive results for CBT/ GET. (Just an educated guess)

    Selective about how they measure outcomes, and who they choose to test?
  9. fred

    fred The game is afoot

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    I'm not sure if they could publish 'post XMRV', even given a 'how could have we have known?' defence. It would be like going to press with "nurse-led self-help doesn't do anything for AIDS".

    And if they don't publish at all, they'll be asked what they've spent the money on.

    At least publishing 'pre XMRV', as you say, they can go for the 'we didn't know' defence, supplemented by the 'we were only trying to something to help' line.

    The whole thing is a crock.

    It's just an opinion, but I think we should be firing off more complaints to the BMJ about these two articles. They really do need to dump their support of puerile and archaic psychobabble and get with current biomedical thinking.
  10. julius

    julius Watchoo lookin' at?

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    Oxford Criteria + patient self reporting (presumably, not really clear from the paper though)
  11. Gerwyn

    Gerwyn Guest

    The study is underpowered and the confidence intervals are rediculous.It takes years to train as an effective counsellor not months. They could not even get a positive result using Oxford the therapists must have been unbelievably bad!
  12. V99

    V99 *****

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    Fred
    sorry I should have said I meant the CBT and GET arms of the PACE trail. How will it look saying these things are worth bothering with. If XMRV continues the way I think it will, they will look like fools if they publish now and liars if they publish later. I do get your point though. I suppose before is an attempt to save face.

    As for this study - who in the tiny mind thought it was worth spending precious funds on such clap trap.
  13. Dolphin

    Dolphin Senior Member

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    Last time I saw, the cost of this was 1.3-1.4m (somewhere between those values). 1.3m = US$2m.
  14. Min

    Min Senior Member

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    The charity Action for ME actually gave this rubbish and the nonsensical PACE trail their public support



    (PACE trail - in which the psychiatrists, Chalder, White, Sharpe etc overseen by Wessely, who developed the useless and potentially dangerous NHS treatments for whatever they chose to mean by their own invented term 'chronic fatigue syndrome' evaluate their own treatments - how could this possibly be unbiased? Are they at all likely to try the treatments on patients who actually have neurological M.E. and to declare that they don't work?)
  15. fred

    fred The game is afoot

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    I'm getting punch drunk with the stupidity of all this.
  16. Bob

    Bob

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    Are these actually the results of the FINE trial? Surely it couldn't die such a quiet death?
    Call me cynical, but I imagine that they might be quietly publishing all of their negative results separately before they publish all of their positive results with great fanfare at a later date without any mention of any negative results. I thought the study was set up so it couldn't fail.
  17. Gerwyn

    Gerwyn Guest

    the shame Fred that it is not stupidity it is quite deliberte
  18. fred

    fred The game is afoot

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    I know. Deliberate stupidity.:Retro mad:
  19. V99

    V99 *****

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    I agree, must be more to come
  20. ukxmrv

    ukxmrv Senior Member

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