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HRA registered CFS studiesthat could be of interest

Discussion in 'PsychoSocial ME/CFS Research' started by Esther12, Nov 1, 2017.

  1. Esther12

    Esther12 Senior Member (Voting Rights)

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    I can be bad at finding stuff, but I was just looking through the HRA website and found reference to a few old CFS studies that I've not see published results for. I'm posting them here, along with a few others that were interesting to me, in case it would be of interest to anyone else... or someone else might be able to tell me I've missed on obvious publication? Maybe I should have given a couple of these their own threads? Not sure.

    Edit: Dolphin found this one here: http://psycnet.apa.org/doiLanding?doi=10.1037/hea0000341

    http://www.hra.nhs.uk/news/research...ct-of-fatigue-and-anxiety-provocation-in-cfs/


    Edit: Dolphin pointed out that the following is discussed here, and some results are available: https://www.s4me.info/index.php?thr...-in-people-with-cfs-me-a-diagnostic-accuracy-
    http://www.hra.nhs.uk/news/research...cfsme-examining-the-accuracy-of-a-new-method/

    Some further info on the above here: http://bedfordintegrativehealth.co....-clinic-summary-of-new-research-project-2013/

    http://www.hra.nhs.uk/news/research...ss-in-patients-with-chronic-fatigue-syndrome/

    continued in next post...
     
    Last edited: Nov 1, 2017
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  2. Esther12

    Esther12 Senior Member (Voting Rights)

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    A couple of more recent Crawley ones:

    http://www.hra.nhs.uk/news/research-summaries/investigating-outcome-in-children-with-cfsme/

    It looks like stuff is happening with MAGENTA, where the feasibility study is being folded in to the full trial. Someone was just explaining concerns they had about what SMILE did with this. HRA entry:

    The newly updated MAGENTA ISRCTN entry: http://www.isrctn.com/ISRCTN23962803

    And now there's this newly approved [non-Crawley] study:

    http://www.hra.nhs.uk/news/research...al-intervention-for-chronic-fatigue-syndrome/

    Looks like the above is funded by the BABCP, using subjective self-report outcomes and is not randomised, with maybe some sort of waiting list control group:

    https://www.isrctn.com/ISRCTN16045700

    Seems odd for the BABCP to be funding something like this.
     
    Last edited: Nov 1, 2017
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  3. Esther12

    Esther12 Senior Member (Voting Rights)

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  4. Dolphin

    Dolphin Senior Member (Voting Rights)

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    Health Psychol. 2016 Sep;35(9):979-86. doi: 10.1037/hea0000341. Epub 2016 May 16.
    Emotional suppression in chronic fatigue syndrome: Experimental study.
    Rimes KA1, Ashcroft J1, Bryan L1, Chalder T1.
    Author information

    Abstract
    OBJECTIVE:
    Emotional processing differences in chronic fatigue syndrome (CFS) have been reported but have rarely been investigated experimentally. This study used self-report, observer ratings, and electrodermal responses to test hypotheses about emotion suppression and autonomic reactivity.

    METHODS:
    Eighty adults with CFS and 80 healthy controls (HC) watched a distressing film clip. Half of each group were instructed to suppress their emotions and half were told to express their feelings as they wished. Their reactions were filmed and rated by independent observers. Electrodermal activity (skin conductance response) was used as a measure of sympathetic nervous system arousal.

    RESULTS:
    CFS participants reported higher anxiety and sadness than the HC, both before and after the film. However, observers rated the CFS group as having lower emotional expression than HC in both emotional suppression and expression choice conditions. Beliefs about the unacceptability of negative emotions were associated with greater self-reported suppression. Electrodermal responses were greater in the CFS group than HC participants. Higher skin conductance responses were associated with larger posttask increases in fatigue in the CFS participants but not in the HC.

    CONCLUSIONS:
    CFS participants had lower observer-rated emotional expression than HC, despite greater distress and higher autonomic arousal. This may have implications for their ability to access social support at times of stress. As the degree of autonomic arousal was associated with short-term increases in fatigue in the CFS participants, this requires further investigation as a contributory factor for this condition. (PsycINFO Database Record

    (c) 2016 APA, all rights reserved).

    PMID:

    27183308

    DOI:

    10.1037/hea0000341
     
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  5. Esther12

    Esther12 Senior Member (Voting Rights)

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  6. Dolphin

    Dolphin Senior Member (Voting Rights)

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    https://www.s4me.info/index.php?thr...me-a-diagnostic-accuracy-study.351/#post-5856

    http://clok.uclan.ac.uk/20386/

    CAN PHYSICAL ASSESSMENT TECHNIQUES AID DIAGNOSIS IN PEOPLE WITH CHRONIC FATIGUE SYNDROME/MYALGIC ENCEPHALOMYELITIS? A DIAGNOSTIC ACCURACY STUDY



    Hives, Lucy, Bradley, Alice, Richards, James, Sutton, Chris J, Selfe, James, Basu, Bhaskar, Maguire, Kerry, Sumner, Gail, Gaber, Tarek et al

    ABSTRACT


    Objective: To assess 5 physical signs to see whether they can assist in the screening of patients with CFS/ME, and potentially lead to quicker treatment.

    Methods: This was a diagnostic accuracy study with inter-rater agreement assessment. Participants recruited from 2 NHS hospitals, local CFS/ME support groups and the community were examined by three practitioners on the same day in a randomized order. Two Allied Health Professionals (AHPs) performed independent examinations of physical signs including; postural/mechanical disturbances of the thoracic spine, breast varicosities, tender Perrin’s Point, tender coeliac plexus and dampened cranial flow. A physician conducted a standard clinical neurological and rheumatological assessment, whilst looking for patterns of illness behaviour. Each examination lasted approximately 20 minutes.

    Results: Ninety-four participants were assessed, 52 CFS/ME patients and 42 non-CFS/ME controls, aged 18-60. Cohen’s kappa revealed agreement between the AHPs was substantial for presence of the tender coeliac plexus (κ=0.65, p<0.001) and moderate for postural/mechanical disturbance of the thoracic spine (κ=0.57, p<0.001) and Perrin’s point (κ=0.56, p<0.001). A McNemar’s test found no statistically significant bias in the diagnosis by the experienced AHP relative to actual diagnosis, (p=1.0) and a marginally non-significant bias by the newly trained AHP, p=0.052. There was however, a significant bias in the diagnosis made by the physician relative to actual diagnosis, (p<0.001), indicating poor diagnostic utility of the clinical neurological and rheumatological assessment.

    Conclusions: Using the physical signs appears to improve the accuracy of identifying people with CFS/ME and shows agreement with current diagnostic techniques, however the present study concludes that only 2 of these may be needed. Examining for physical signs is both quick and simple for the AHP and may be used as an efficient screening tool for CFS/ME. This is a small single centre study and therefore further validation in other centres and larger populations is needed.
     
  7. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research...tivity-monitors-with-young-people-with-cfsme/

    Exploring the use of activity monitors with young people with CFS/ME

    Full title Exploring the use of activity monitors with young people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)
    Research type Research study
    IRAS ID 161923
    Contact Name Joan Simons
    Contact Email joan.simons@open.ac.uk
    Sponsor organisation Milton Keynes Hospital NHS Foundation Trust
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    The purpose of this study is to pilot assess the use of activity monitors within the pathway for treating young people with Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME). The patients are currently treated using graded exercise therapy GET) which has shown to be effective and will not be the focus of this pilot. This pilot will investigate the compliance to a GET; development of positive carer support for young people following GET; and development of self-management strategies by young people with CFS/ME.
    REC Name East of Scotland Research Ethics Service REC 2
    REC Reference 15/ES/0025
    REC Opinion
    Further Information Favourable Opinion

    Date of REC Opinion 31 March 2015
     
  8. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research-summaries/psychological-factors-in-cfsme-ibs/

    Psychological Factors in CFS/ME & IBS

    Full title Psychological Factors in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis & Irritable Bowel Syndrome
    Research type Research study
    IRAS ID 171274
    Contact Name Hazel Carrick
    Contact Email hc553@bath.ac.uk
    Sponsor organisation University of Bath
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    The term Medically Unexplained Symptoms (MUSs) is used to described physical symptoms, which doctors can’t find a medical cause for. MUS can also refer to specific disorders, such as Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) and Irritable Bowel Syndrome (IBS), which will be the focus of this study. It is agreed that MUSs are best understood using the Cognitive Behavioural Therapy (CBT) model (Deary, Chalder, & Sharpe, 2007). This model looks at how there are many different factors involved in these problems, such as levels of low mood & anxiety, the nature of physical symptoms, beliefs about symptoms and behavioural responses to symptoms. More research is needed to find out how these factors impact CFS/ME & IBS. More research is also needed to find out how these factors are similar and different in CFS/ME & IBS. This study will look at these issues. Patients with CFS/ME & IBS will be asked to completed questionnaires looking at these factors. The way people answer will help us to understand the things that are shared and different in CFS/ME & IBS, so that we can develop treatments that are tailored to each condition.
    REC Name Wales REC 7
    REC Reference 15/WA/0298
    REC Opinion
    Favourable Opinion

    Date of REC Opinion 27 August 2015
     
  9. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research...for-children-with-cfsme-cognitive-interviews/

    Developing a PROM for Children with CFS/ME: Cognitive Interviews

    Full title Developing a Patient Reported Outcome Measure (PROM) for Children with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME). Cognitive Interviews with Children.
    Research type Research study
    IRAS ID 194846
    Contact Name Roxanne Parslow
    Contact Email roxanne.potgieter@bristol.ac.uk
    Sponsor organisation Royal United Hospitals Bath NHS Foundation Trust
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    This study will: Evaluate whether children understand and interpret questions in a new paediatric CFS/ME Patient Reported Outcome Measure (PROM)/ questionnaire the way that was intended. Design: Cognitive interviews Recruitment: We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 8 and 18 years old and are mild to moderately affected (not housebound). We will recruit children at assessment and follow up. Cognitive Interviews: In the cognitive interview process, patients are asked to say what they are thinking as they work through the questionnaire—to think aloud and then they will be asked open ended semi structured interview questions about how they make sense of questionnaire items. Cognitive interviews will take up to 30 minutes. Analysis: Interviews will be audio-recorded and transcribed. We will use thematic analyses in an iterative process. The results will inform the development of the PROM.
    REC Name West of Scotland REC 3
    REC Reference 16/WS/0011
    REC Opinion
    Further Information Favourable Opinion

    Date of REC Opinion 25 January 2016
     
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  10. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research...in-paediatric-chronic-fatigue-syndrome-cfsme/

    Depression in Paediatric Chronic Fatigue Syndrome (CFS/ME)

    Full title Depression in Paediatric Chronic Fatigue Syndrome (CFS/ME)
    Research type Research study
    IRAS ID 203495
    Contact Name Maria Loades
    Contact Email m.e.loades@bath.ac.uk
    Sponsor organisation University of Bristol
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME) affects approximately 1 - 2 teenagers in every 100. It interferes significantly with their day-to-day lives. For example, on average, children and young people with CFS/ME miss one year of school. We think that about 1 in 3 children and young people with CFS/ME also have depression. Those with depression seem to be more disabled, experience more pain, and don’t seem to recover as well from CFS/ME. My research aims to improve the recognition of teenagers who have both CFS/ME and depression. It will result in us knowing how to identify depression and who is most at risk of getting depression. To find out how many teenagers with CFS/ME actually have depression and how best to identify them, I will recruit teenagers with CFS/ME after their first appointment with the specialist paediatric CFS/ME service in Bath. Teenagers with CFS/ME will be interviewed to assess depression, and asked them to fill in two short questionnaires about symptoms of depression. They can choose to be interviewed by Skype or face-to-face, at home or at the hospital. I will analyse how good the questionnaires are at picking up depression in these patients so that we know which questionnaire is best to use. I will also ask the young people to complete the questionnaires again 6 months after their interview.
    REC Name South West - Frenchay Research Ethics Committee
    REC Reference 16/SW/0136
    REC Opinion
    Further Information Favourable Opinion

    Date of REC Opinion 1 July 2016
     
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  11. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research...-is-fitnet-nhs-for-children-and-young-adults/


    FITNET-NHS: How effective is FITNET-NHS for children and young adults

    Full title Investigating the effectiveness and cost-effectiveness of using FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME) in the United Kingdom: A randomised controlled trial (FITNET-NHS)
    Research type Research study
    IRAS ID 211202
    Contact Name Esther Crawley
    Contact Email esther.crawley@bristol.ac.uk
    Sponsor organisation Research and Enterprise Development
    Eudract number
    ISRCTN number
    ISRCTN18020851
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    This large randomised controlled trial will investigate the relative clinical and cost-effectiveness of the FITNET-NHS intervention compared with Activity Management, among children with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME) who do not have a local NHS specialist CFS/ME service. The FITNET-NHS intervention delivers specialist cognitive behavioural therapy for CFS/ME via the internet. Participants and their parents work through 21 modules and have e-consultations with therapists. Activity Management is used as the comparator in this study as it is recommended by the National Institute of Health & Clinical Excellence (NICE) and is currently the best alternative for children in regions without a local specialist CFS/ME service. Activity Management will be delivered by specialist occupational therapists from Bath Specialist CFS/ME Service via video calls (e.g. Skype). Children will be referred from primary care throughout the UK to the Bath Specialist CFS/ME Service where potentially eligible children will be identified and invited to eligibility screening prior to randomisation. The first phase of the trial is an internal pilot study which will use integrated qualitative methods to examine the acceptability of the treatment arms and the feasibility of recruitment. The full study will assess whether FITNET-NHS is clinically effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS questionnaire. The trial is powered to perform a secondary subgroup analysis investigating the effectiveness of FITNET-NHS in those with co-morbid mood disorders. The full study will also assess whether FITNET-NHS is cost-effective in a cost utility analyses from NHS and social perspective. If FITNET-NHS is effective and cost effective, its provision by the NHS has the potential to deliver substantial health gains for the large number of children suffering from CFS/ME but unable to access treatment because there is no local specialist service.
    REC Name South West - Frenchay Research Ethics Committee
    REC Reference 16/SW/0268
    REC Opinion
    Further Information Favourable Opinion

    Date of REC Opinion 10 October 2016

     
  12. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research-summaries/explorer-exploring-cfsme-in-younger-children-ages-5-7/

    EXPLORER: EXPLORing CFS/ME in youngER children (ages 5-7)

    Full title Exploring chronic fatigue syndrome/myalgic encphalomyelitis in children aged 5-7 years.
    Research type Research study
    IRAS ID 210532
    Contact Name Amberly Brigden
    Contact Email amberly.brigden@bristol.ac.uk
    Sponsor organisation University of Bristol
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    Aims and objectives The overall aim is to develop an understanding of CFS/ME in children age 5-7 years. This will be done by exploring the epidemiology (demographic and clinical characteristics) and capturing the views and experiences of parents/carers and children. To carry out this work effectively it will be important to explore measures and data collection methods appropriate for this age group. Specific objectives are: • To carry out a prospective cohort study of children with CFS/ME aged 5-7 capturing baseline, 6 and 12 month follow-up data. • To carry out integrated qualitative methods to explore the child and parents/ carers experience of the illness as well as explore feasible and acceptable outcome measures and methods of data collection. Design Cohort study with integrated qualitative methods. Part 1: Cohort Study We will recruit children attending a specialist CFS/ME service in the Bath/Bristol area. Children will be eligible if they have a diagnosis of CFS/ME and are between 5- 7 years old. We will collect baseline data and 6 month and 12 month follow up data from patients, parents/ carers, schools and clinicians. Follow-up questionnaires will be completed on-line. Part 2: Integrated qualitative methods For the qualitative interviews we will exclude children who are severely affected. Interviews will take place in clinic, the patient's home or via Skype depending on patient preference. We will invite parents to participate in two interviews and children to participate in one. We anticipate each parental interview to take no longer than one hour and child interviews to take no longer than 30 minutes. We will offer families the opportunity to do a number of shorter interviews if this is preferred.
    REC Name South West - Cornwall & Plymouth Research Ethics Committee
    REC Reference 16/SW/0335
    REC Opinion
    Favourable Opinion

    Date of REC Opinion 9 December 2016
     
  13. Dolphin

    Dolphin Senior Member (Voting Rights)

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    http://www.hra.nhs.uk/news/research-summaries/mitochondrial-dna-copy-number-in-cfs/

    Mitochondrial DNA copy number in CFS

    Full title Mitochondrial DNA copy number in the blood of those with Chronic Fatigue Syndrome (CFS), with a focus on circulating mtDNA
    Research type Research study
    IRAS ID 221364
    Contact Name Joanna Elson
    Contact Email j.l.elson@ncl.ac.uk
    Sponsor organisation Newcastle Hospitals NHS Foundation Trust
    Eudract number
    ISRCTN number
    Clinicaltrials.gov identifier
    Additional reference number fields
    Research summary
    Chronic Fatigue Syndrome (CFS) is a prevalent debilitating condition affecting ~250,000 people in the UK. The fatigue is not alleviated by sleep or rest having a substantial impact on the lives of patients, leaving some bed-bound and in chronic pain. Mitochondria are the “powerhouse” of the cell, the organelle (sub-unit) producing a chemical called ATP that drives cellular functions. Uniquely among the organelles of our cells, mitochondria have their own chromosome, called mitochondrial DNA (mtDNA). MtDNA codes for 13 proteins essential for the cell to produce energy. MtDNA is present in hundreds or thousands of copies within a cell. This mtDNA “copy number” is variable by cell type and between individuals. Mitochondrial patients frequently have mutations of mtDNA. A recent study conducted at Newcastle University by members of the fatigue group in collaboration with the mitochondrial group found that mitochondrial patients suffer from severe fatigue, comparable in 30% of case with CFS patients. Thus, there is growing interest in the role of mitochondria in fatigue, and in CFS. However, a mtDNA sequencing study of 300 CFS patients did reveal any clinically proven mtDNA mutations. Therefore, sequencing mtDNA in CFS patients is unlikely to reveal clinically proven mutations, which would change their diagnosis or could be transmitted to their offspring. However, some studies suggest that mtDNA population variants and changes in mtDNA copy number are associated with different outcomes in complex disease such as diabetes or Parkinson’s, while not causing the disease. Although this work is still a matter of scientific investigation. We would like to conduct analysis on the blood of CFS patients to determine if at a cohort level there are differences in the mtDNA between the patient cohort and controls. Our hope would be that we could elucidate mechanisms of disease, or be able to provide better prognostic information.
    REC Name South Central - Oxford C Research Ethics Committee
    REC Reference 17/SC/0147
    REC Opinion
    Further Information Favourable Opinion

    Date of REC Opinion 8 June 2017
     
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  14. Dolphin

    Dolphin Senior Member (Voting Rights)

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  15. Sean

    Sean Senior Member (Voting Rights)

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    Maybe, at least in part, because patients have learned the hard way that showing external signs of emotion, even if proportional and appropriate to the situation, is all too easily and commonly interpreted as evidence of psychopathology.

    Heads they win, tails we lose.

    Who would have thought that using physical signs to diagnose a physical disease was the way to go?

    Once again, make one tiny little change to the wording to better reflect the reality, and you get a very different result:
     
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  16. Valentijn

    Valentijn Moderator Staff Member

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    Unforutantely the Perrin study seemed a bit quackish in that regards. More akin to diagnosing based on posture than standing blood pressure, heart rate, or CPET, basically.
     
  17. Sean

    Sean Senior Member (Voting Rights)

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    Yeah, I am not defending it.
     
  18. chrisb

    chrisb Senior Member (Voting Rights)

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    Will "What is Perrin's Point?" become as famous a medical question as "What's the bleeding time?"?
     
  19. ladycatlover

    ladycatlover Senior Member (Voting Rights)

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    Well they are being busy little bees aren't they? Love the couples psychotherapy idea - get patients' partners to take over the majority of the therapy! :banghead: And the one about using activity monitors on kids... Creepy :eek:

    Smacks a bit of big brother don't you think? Or maybe You will comply. :borg:

    :sick::sick::sick::sick::sick:
     
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  20. Esther12

    Esther12 Senior Member (Voting Rights)

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    I ended up looking at the twitter feed of Rickards, and he seems like exactly the sort of Wessely fan you'd expect: https://twitter.com/hughrickards/with_replies

    I wonder what result he'll want from his study?

    http://www.hra.nhs.uk/news/research...ss-in-patients-with-chronic-fatigue-syndrome/
     
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