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Negative trials of GPs carrying out CBT type stuff for CFS - are these included in meta analyses?

Discussion in 'Latest ME/CFS Research' started by Esther12, Dec 19, 2013.

  1. Esther12

    Esther12 Senior Member

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    eg:

    Can General Practitioners Manage Chronic Fatigue Syndrome?A Controlled Trial
    Lisa Whitehead, Peter Campion

    12/2011; 10(1):55-64.
    ABSTRACT Abstract Background: Chronic Fatigue Syndrome/Myalgic En-cephalomyeltis (CFS/ME) is now recognised as a condition that results in substantial disability with a prevalence of around 0.6%. Aim: The study aimed to test the hypotheses that general practitioners could (a) diagnose and (b) treat patients with the Chronic Fatigue Syndrome (CFS). Method: All practices in two health authorities were contacted with a 35% uptake. Fifty percent of practices then entered a patient into the study. Practices were randomised to either intervention or control groups, and were encouraged to recruit patients. It was intended that the intervention practices would introduce a form of brief cognitive behavioural therapy. Control practices were invited to manage their patients as usual, which often included referral to secondary care. Results: The study suffered from both poor recruitment and high drop out. However, we were able to show that this intervention had no effect on the illness of the patients enrolled, and that patients with CFS remained highly disabled over the 12 month study period, whatever their treatment. Conclusion: The study suggests that general practitioners in this study were unable to effectively treat the condition. This accords with the Royal Colleges' report (1996), that the only evidence for effective treatment thus far has come from specialist units. The study suggests that general practitioners are unable to provide a management programme of this nature, and possibly effective treatment programmes for CFS in primary care.



    Long-term efficacy of cognitive-behavioral therapy by general practitioners for fatigue: a 4-year follow-up study.
    Stephanie S Leone, Marcus J H Huibers, Ijmert Kant, Ludovic G P M van Amelsvoort, Constant P van Schayck, Gijs Bleijenberg, J André Knottnerus

    Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.
    Journal of Psychosomatic Research (Impact Factor: 3.27). 12/2006; 61(5):601-7. DOI:10.1016/j.jpsychores.2006.04.010
    Source: PubMed
    ABSTRACT In an earlier study, we found that cognitive-behavioral therapy (CBT) delivered by general practitioners (GPs) for fatigue among employees on sick leave was not effective after 12 months. In this study we aim to assess the long-term efficacy of CBT by GPs for fatigue. It was hypothesized that the intervention could prevent deterioration as well as relapse of fatigue complaints and relapse into absenteeism in the long term.
    Patients who participated in the original randomized controlled trial were followed up 4 years later. Fatigue and absenteeism were the main outcomes.
    Fatigue and absenteeism were high in the intervention and control groups at the 4-year follow-up. There was no significant difference between the intervention group and the control group on fatigue and absenteeism. The intervention group however tended toward less-favorable outcomes as compared with the control group.
    Like that of chronic fatigue syndrome, the prognosis of less-advanced fatigue is rather poor. CBT delivered by GPs is not effective in the long term.



    To me, it seems quite possible that it's that GPs doing CBT are less able to induce response bias in patients which is causing the null results, as presumably they can receive similar training to that provided to those training to do CBT. These studies often seem to not be mentioned in assessments of the evidence for CBT for CFS.

    (I'm not sure that this thread is anything more than a note for myself).
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  2. Dolphin

    Dolphin Senior Member

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    Esther12 likes this.
  3. Mark

    Mark Acting CEO

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    Would be good to find more of these and make sure they are passed on to those who are going to be submitting evidence to the IOM panel.
  4. Esther12

    Esther12 Senior Member

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    Yeah - I partly started this thread because I'd just stumbled over two, and felt like I kept losing track of things like this. I'll try to remember to post any more I find in here too.
  5. alex3619

    alex3619 Senior Member

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    The EBM methodology generally used is to run several searches in various databases, with various search terms. PubMed would be one of those. Then they run some kind of cut-off protocol, though this probably varies in different studies. So for example only randomized controlled trials are included.

    For a start the study in this thread is a controlled study, not it seems a randomized controlled study. If the cut-off is high, and it usually is, this study would be excluded.

    This can distort the EBM process as many high grade studies will be below the threshold, no matter where the threshold is. Further, EBM usually includes provision for upgrading or downgrading studies depending on strength of results or issues with methodology. Arbitrary cut-offs thus eliminate studies that should be upgraded because of strength of the evidence.

    There is also a connection to Zombie Science. RCTs are expensive. The most well funded researchers usually do them. Those researchers are usually funded by government or large institutions. Those institutions often have preference in which kinds of studies they will fund. So the bias starts right at the funding level, and such studies are thus given a financial bias in where they appear in an EBM ranking. Zombie Science wins again.

    PS I almost forgot. Contrary studies are sometimes of a lower evidence grade, and these are therefore excluded.
    Last edited: Dec 19, 2013
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  6. alex3619

    alex3619 Senior Member

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    There was a great parody of an EBM study published some years ago, which I first read in The Philosophy of Evidence-Based Medicine by J. Howick, p5.

    Smith and Pell co-authored "Parachute use to prevent death and major trauma related to gravitational challenge: a systematic review of randomized controlled trials" which was in the British Medical Journal, 2003, 327, 1459-61.

    http://www.bmj.com/content/327/7429/1459

    My underlining.

    Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials

    BMJ 2003; 327 doi: http://dx.doi.org/10.1136/bmj.327.7429.1459 (Published 18 December 2003)
    Cite this as: BMJ 2003;327:1459


    Gordon C S Smith (gcss2{at}cam.ac.uk), professor1, Jill P Pell, consultant2

    1Department of Obstetrics and Gynaecology, Cambridge University, Cambridge CB2 2QQ,
    2Department of Public Health, Greater Glasgow NHS Board, Glasgow G3 8YU

    1Correspondence to: G C S Smith

    Abstract

    Objectives To determine whether parachutes are effective in preventing major trauma related to gravitational challenge.

    Design Systematic review of randomised controlled trials.

    Data sources: Medline, Web of Science, Embase, and the Cochrane Library databases; appropriate internet sites and citation lists.

    Study selection: Studies showing the effects of using a parachute during free fall.

    Main outcome measure Death or major trauma, defined as an injury severity score > 15.

    Results We were unable to identify any randomised controlled trials of parachute intervention.

    Conclusions As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials. Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.


    Footnotes

    Contributors GCSS had the original idea. JPP tried to talk him out of it. JPP did the first literature search but GCSS lost it. GCSS drafted the manuscript but JPP deleted all the best jokes. GCSS is the guarantor, and JPP says it serves him right.

    Funding None.

    Competing interests None declared.

    Ethical approval Not required
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  7. user9876

    user9876 Senior Member

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    The size of the study and the way that statistics are quoted can also be critical. Small studies where the mean is quoted are highly subject to outliers. Even larger studies are subject to issues with the distributions particularly where a proportion of the population responds and hence the mean becomes inappropriate.
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  8. alex3619

    alex3619 Senior Member

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    Size of study goes to strength of evidence, and is one of the things that can upgrade or downgrade a study. There are many factors that can do so. I hope to investigate this more in time, but its not urgent right now except as it might modify how we view studies the IOM might like to review. One that is very important is effect size. I regard Lerner's studies on antivirals show such a large effect that this would lead me to rate his studies more highly, though other methodological issues might downgrade his papers. We need to be aware of these issues when sending commentary to the IOM.

    Statistical problems with mean and average are often recognized. It is not my area of expertise, but I understand the basics of how this can distort the evidence, particularly in a highly skewed data set.

    Problems with small studies is in part why EBM often results in metastudies, where many similar studies are merged. Studies are often rejected for metastudies if they have technical or methodological problems that prevent data being merged.

    In ME and CFS I think the heterogeneity of the studies make any study not using the same definition and methods very difficult to merge quantitatively if you want results that are not nonsense. In fact I would argue much more than this, but not for now.
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  9. A.B.

    A.B. Senior Member

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    So CBT patients got worse. Maybe denying reality is not good for health, as it undermines the symptom control behavior of patients?
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