Curb on zero-hour care worker contracts and ‘call clipping’

Posted on 04/06/2018 by wames

Welsh Government announcement, 2 April 2018: New requirements to ensure care workers are treated fairly come into force

New requirements to ensure care staff who look after people in their own homes are treated fairly and people receiving care experience the best possible services come into force today, the Welsh Government has confirmed.

The new requirements are part of the Welsh Government’s wider efforts to support the delivery of high quality social care which is focused on the individual and the personal outcomes they want to achieve.

The new regulations support good employment practices by addressing the use of zero-hours contracts. From today, providers are required to give domiciliary care workers a choice of contract after a three month period of employment.

The regulations also place requirements on these providers to ensure that time allocated for travel and care is clearly and transparently set out, so that care time and therefore the quality and continuity of care is not eroded by the need to travel between visits.

Social Care Minister, Huw Irranca-Davies said:

“The new regulations coming into force today are designed to support continued improvement in the care sector in Wales. They offer staff in the social care sector a fairer deal and help to safeguard the quality of care and support which people receive in their own homes.

“There is a very clear link between the use of zero-hours contracts and a reduced quality of care, due to issues around the continuity of care and communication between workers and those they support. These measures will ensure workers are offered a choice of contractual arrangements.

“Requiring providers to distinguish clearly between travel time and care time when arranging services, will also improve the experience of people needing care. Doing so will help tackle ‘call-clipping’, ensuring people’s care and support time is not eroded by travel time between visits.

“The registration of domiciliary care workers will provide the public with confidence that care workers have the appropriate skills and qualifications to do their jobs in a professional, compassionate manner.

“I’m pleased the Welsh Government has been able to act to ensure people receiving care experience the best possible care, and to ensure fairness for social care staff across Wales.”

 The Welsh Government has also opened Social Care Wales’ workforce register to include domiciliary care workers, as part of its ongoing commitment to professionalise the workforce. This will ensure care workers receive the recognition and support they deserve from the Welsh Government, Care Inspectorate Wales, and their employers.

These requirements are part of a package of measures put in place by the Welsh Government and partners to raise the profile and status of the workforce, so that social care is recognised as an attractive and valued career.

The regulations flow from the Regulation and Inspection of Social Care (Wales) Act 2016, which sets the new legal framework for the regulation and inspection of social care services and reforms the regulation of the social care workforce in Wales.

Domiciliary support is at the very heart of the system, and domiciliary care workers play a vital role in supporting people to maintain their independence and live at home. There are estimated to be approximately 19,500 domiciliary care workers in Wales, delivering around 260,000 hours of care a week to 23,000 people.

BBC news report: Curb on zero-hour care worker contracts and ‘call clipping’

Caring in the home – Wales in figures:

  • 336 care providers
  • 18,000 workers
  • 80% of workers are female
  • 43,000 service users
  • 75% care to elderly people
  • 13.1m domiciliary care hrs a year
    Manchester Metropolitan University, 2016
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Forward ME group writes to the Science Media Centre

Posted on 04/06/2018 by wames

ME Research UK blog post, 5 April 2018: Forward-ME Group Letter – Science Media Group

Forward-ME Group Letter

Forward-ME Group Chair, The Countess of Mar, has written on behalf of the members of the Group to the Chief Executive of the Science Media Centre asking for the SMC “to retract and replace your factsheet on CFS/ME, published on 21 March 2018”.

The letter continues that the factsheet, entitled “CFS/ME – The illness and the controversy” “……. includes numerous inaccuracies and distortions; it denigrates patients and some doctors; it fails to reflect the numerous peer reviewed papers, published since the release of some of the raw data from the trial following legal action, which demonstrate serious defects in the PACE trial, and it fails to take into account the extensive research from the USA published since 2014. This will all have been available to you.”

The full text of the letter is as follows –

“Re: Science Media Centre Factsheet – CFS/ME – The illness and the controversy.

On behalf of Forward-ME I write to ask you to retract and replace your factsheet on CFS/ME, published on 21 March 2018, following the publication of a paper by Dr Carolyn Wilshire of the University of Wellington, New Zealand, which found that the findings of the Principal Investigators of the PACE trial were ‘not robust’ and showed ‘no long-term benefits’.

The factsheet includes numerous inaccuracies and distortions; it denigrates patients and some doctors; it fails to reflect the numerous peer reviewed papers, published since the release of some of the raw data from the trial following legal action, which demonstrate serious defects in the PACE trial, and it fails to take into account the extensive research from the USA published since 2014. This will all have been available to you.

The factsheet states: “CFS/ME is highly controversial with longstanding disagreements between the mainstream medical community and campaigners about its cause and treatment”. It also states that “amongst the mainstream medical research community, CFS/ME and NICE recommend management that is not especially controversial.”

These claims are patently inaccurate. The mainstream medical community in the USA concluded that the “campaigners” have actually been correct about the nature of the condition, stating that “ME/CFS is a serious, chronic, complex systemic disease” (Academy of Medicine), that it is not a primary psychological disease in aetiology” (National Institutes of Health). They state that guidance for managing ME/CFS should include a “declaration that the disease is not the result of fear-based avoidance of activity”, and a clear indication that the disease is not a psychiatric or somatoform disorder” (Chronic Fatigue Syndrome Advisory Committee of the Department of Health and Human Services). There certainly is controversy and disagreement at this time, but that disagreement is not between professionals and “campaigners”. It is between professionals in the UK and professionals elsewhere.

The factsheet claims that: “After sustained pressure from activists the CDC has removed mention of CBT and GET from its website”. This, too, is patently inaccurate and even a cursory investigation of the facts would make that clear. The CDC changed its recommendations at the urging of the Academy of Medicine, the National Institutes of Health, the Department of Health and Human Services, and the Agency for Healthcare Quality and Research, all of whom emphatically agree that the CDC’s former recommendations – that is, the current NICE recommendations – lack evidence based support.

The author of the factsheet states that existing evidence in favour of CBT and GET is “cited by the scientific community”, as if there are no reputable members of the scientific community, and no reputable health policy authorities who disagree. They go on to state that “those who disagree …. cite review articles and reanalyses of trial data published in low impact factor journals such as The Journal of Health Psychology and Fatigue: Biomedicine, Health and Behaviour”.

It is concerning that a reputable resource like the Science Media Centre would publish such a grossly inaccurate claim, one that can be so readily overturned. Those who disagree with the evidence for CBT and GET cite the extensive investigations of the US governmental health authorities. In particular they cite the Agency for Healthcare and Research Quality Publication No. 15-E001-EF, “Diagnosis and Treatment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome”. That document is readily available online and a quick investigation will reveal that it offers a very long and detailed list of unscientific practices and biases in the research that claims to support CBT and GET. There are a great many such reports by US governmental health organisations. It is unacceptable for the Science Media Centre to write as if these investigations did not take place; as if these documents do not exist – and it is unacceptable not to note that, by comparison, the professional reputations of these organisations far outstrip those of the PACE trial researchers.

The reality is that at this time there are no US governmental health authorities who agree that the PACE trial is “good quality”. It is absurd for any “Factsheet” on ME/CFS to overlook this fact.

Your Trustees’ Report for the year ended 31 March 2016 gives among the SMC objectives its overall goal to help to achieve the aim of the House of Lords Science and Technology Committee which sought to renew public trust in science “by working to promote more balanced, accurate and rational coverage of the important science, health and environment stories that appear in the media.” In the case of the promotion of the science relating to CFS/ME the Science Media Centre have singularly failed in its objectives over many years.

If you are not prepared to retract this factsheet I regret that we have no option but to report our concerns to the Charity Commission.

I look forward to hearing from you shortly.

Yours sincerely

Countess of Mar, Chairman – Forward-ME

Copy to: Professor Jonathan Baker, Chair of Trustees. ”

By way of background information, the Science Media Centre (a registered charity) has as its stated mission “To provide, for the benefit of the public and policymakers, accurate and evidence-based information about science and engineering through the media, particularly on controversial and headline news stories when most confusion and misinformation occurs.”

It states that it provides “journalists with what they need in the timeframe they need it, from interviews with leading experts to timely press briefings on topical issues. We provide journalists with information about science and its related disciplines, making it easier for them to get access to the best evidence and expertise. Given our focus on science in the headlines, the SMC works mainly with science and news journalists in the UK’s national news outlets.” The Centre sends out quotes from experts, statistical analyses of scientific studies and Factsheets, in addition to running regular press briefings on the latest hot topic.

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Balance deficits in CFS with & without FM

Posted on 04/05/2018 by wames

Research abstract:

Balance deficits in Chronic Fatigue Syndrome with and without fibromyalgia, by Jorge M Serrador, Karen S Quigley, Caixia  Zhao, Thomas Findley, Benjamin H Natelson in NeuroRehabilitation 2018;42(2):235-246

OBJECTIVE:
Chronic Fatigue Syndrome (CFS) is a disorder of unknown etiology associated with debilitating fatigue. One symptom commonly reported is disequilibrium. The goal of this study was to determine if CFS patients demonstrated verified balance deficits and if this was effected by comorbid fibromyalgia (FM).

METHODS:
Twenty-seven patients with CFS (12 with comorbid FM) and 22 age and gender matched controls performed posturography.

RESULTS:
Balance scores were significantly correlated with physical functional status in the CFS group (R2 = 0.43, P < 0.001), which was not found for mental functional status (R2 = 0.06, P > 0.5). CFS patients (regardless of FM) had significantly higher anxiety subscale of the vertigo symptom scale scores. CFS patients, regardless of FM status, demonstrated significantly lower overall composite balance scores (Controls – 78.8±1.5; CFS – 69.0±1.4, P < 0.005) even when controlling for anxiety and also had worse preference scores, indicating they relied on visual information preferentially even when visual information was incorrect. Interestingly, the CFS+FM group, not CFS only, demonstrated significantly worse vestibular scores (Controls – 70.2±2.4; CFS only – 67.9±3.8; CFS with FM – 55.4±4.6, P = 0.013).

INTERPRETATION:
The major findings are that poor balance may be associated with poorer self-reported physical health. In addition, CFS patients seemed to rely preferentially on visual inputs, regardless of whether it was correct. The finding that vestibular function may be impaired in patients with CFS+FM but not in those with CFS alone suggests that the pathophysiology of CFS+FM may differ as has been suggested by some.

Read full article

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Markers of non-coeliac wheat sensitivity in patients with ME/CFS

Posted on 04/03/2018 by wames

Research letter:

Markers of non-coeliac wheat sensitivity in patients with myalgic encephalomyelitis/ chronic fatigue syndrome, by Melanie Uhde, Alyssa C Indart, Xuechen B Yu, Sophie S Jang, Roberto De Giorgio, Peter H R Green, Umberto Volta, Suzanne D Vernon, Armin Alaedini in Gut March 2018

We recently reported in Gut that non-coeliac wheat sensitivity (NCWS) is associated with a state of systemic immune activation in conjunction with a compromised intestinal epithelium. Patients with NCWS experience GI symptoms, most commonly including abdominal pain and bloating, as well as extraintestinal symptoms, among which fatigue, headache and cognitive difficulties feature prominently.1 2 A principal component analysis of the generated data from our study, including markers of antibody reactivity to wheat gluten, intestinal cell damage and systemic innate and adaptive immune responses to microbial components, found clustering of the patients and controls into discernible groups and demonstrated the potential utility of the identified biomarkers for identifying patients with NCWS.1

Extreme fatigue, in particular one that does not improve with rest, is a hallmark of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).3 Immune system abnormalities have been found to be associated with symptoms in a substantial number of patients with ME/CFS.4 5 Furthermore, many patients complain of GI symptoms of unknown aetiology.6–8 We considered whether a subset of patients with ME/CFS may exhibit serologic markers associated with NCWS, which might explain some of the corresponding symptoms.

We screened serum samples from 131 patients with ME/CFS and 86 healthy controls (table 1), recruited as previously described,9 for the same markers as those in the above-mentioned study on NCWS.1 Questionnaires were used to assess GI symptoms within the past 6 months, including abdominal pain, bloating and nausea. Severity of individual symptoms was scored from 1 to 5 (1=absent; 2=mild; 3=moderate; 4=severe; 5=very severe), and a total score, based on the sum of individual symptom scores, was calculated for each subject.

Using the previously generated data from the original cohorts of NCWS, coeliac disease and control subjects (table 1),1 we configured a discriminant function to identify potential cases of NCWS and coeliac disease among the subjects in the ME/CFS and associated control groups. Linear discriminant analysis (Minitab 17 (Minitab) software) was used to calculate the probability of each ME/CFS and control subject belonging to any one of the three categories of NCWS, coeliac disease and healthy control. The threshold for assigning a subject to a category was arbitrarily set at a calculated probability of 0.75. Accordingly, the algorithm identified one (0.76%) patient with ME/CFS and two (2.3%) control subjects as belonging to the coeliac disease group (P=0.3). In contrast, 20 (15.3%) patients with ME/CFS and 4 (4.6%) control subjects were categorised in the NCWS group (P=0.015). There was also a significant correlation between the calculated NCWS probability and the GI symptom severity total score in patients with ME/CFS (r=0.231, P=0.011).

Our results suggest that there may be a subset of patients with ME/CFS who have sensitivity to wheat and related cereals in the absence of coeliac disease, with potential relevance to some of their symptoms. ME/CFS is recognised as a condition with a spectrum of clinical phenotypes and underlying aetiologies. Characterisation of patients into subsets based on clinical and biological data is essential to gaining a better understanding of the condition and identifying useful biomarkers and therapeutic targets.

The results of this analysis provide a rationale for examining the clinical and therapeutic relevance of food sensitivity, particularly NCWS, in the context of ME/CFS in future studies.

References….

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Unrest at the Senedd – #TimeForUnrestWales

Posted on 04/02/2018 by wames

Unrest at the Senedd          #TimeForUnrestWales

On Wednesday 18th April Unrest comes to the Senedd in Cardiff Bay. This will be an opportunity to let Welsh politicians and the media know about ME and the poor state of health and social care for people with ME in Wales.

At the lunchtime event in April:

  • the first 20 minutes of the award winning documentary film Unrest will be screened
  • people with ME and carers will speak about their experience of the illness and their struggle to find care and support
    concerns will be raised about the failure of Health Boards to implement the recommendations of the Welsh Assembly Government’s 2014 Task & Finish Group Report on ME/CFS and FM
  • politicians, civil servants and the media can find out more at the Q&A
  • there will be an opportunity for AMs and others to pledge their support to work towards improving health and social care for people with ME and CFS.

The event is being sponsored by Mark Isherwood, AM for North Wales, and organised by WAMES and members of MESiG.

We will be announcing ways YOU can get involved in the #TimeForUnrestWales campaign – Watch this space!

 

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Rituximab impedes natural killer cell function in CFS/ME patients

Posted on 03/28/2018 by wames

Research abstract:

Rituximab impedes natural killer cell function in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis patients: A pilot in vitro investigation by Natalie Eaton, Hélène Cabanas, Cassandra Balinas, Anne Klein, Donald Staines and Sonya Marshall-Gradisnik in BMC Pharmacology and Toxicology 2018 19:12 [Published: 27 March 2018]

Background:

A recent in vitro pilot investigation reported Rituximab significantly reduced natural killer (NK) cell cytotoxicity in healthy donors.

Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) is a debilitating disorder of unknown etiology. A consistent finding is a significant reduction in NK cell cytotoxicity. Rituximab has been reported having questionable potential therapeutic benefits for the treatment of CFS/ME, however, the potential effects of Rituximab on NK cell cytotoxicity in CFS/ME patients are yet to be determined.

Methods:

A total of eight CFS/ME patients (48.63 ± 15.69 years) and nine non-fatigued controls (NFC) (37.56 ± 11.06 years) were included using the Fukuda case definition. Apoptotic function, lytic proteins and degranulation markers were measured on isolated NK cells using flow cytometry following overnight incubation with Rituximab at 10 μg/ml and 100 μg/ml.

Results:

There was a significant reduction in NK cell lysis between CFS/ME patients and NFC following incubation with Rituximab at 100 μg/ml at

12.5:1 and 6.25:1 effecter-target (E:T) ratios (p < 0.05). However, there was no significant difference for NFC following incubation with Rituximab at 10 μg/ml and 100 μg/ml.

There was no significant difference between CFS/ME patients and NFC for granzyme A and granzyme B prior to incubation with Rituximab and following overnight incubation with Rituximab at 10 μg/ml. There was a significant decrease in granzyme B in CFS/ME patients compared to NFC with 100 μg/ml of Rituximab prior to K562 cells stimulation (p < 0.05).

There was a significant increase in CD107a (p < 0.05) and CD107b expression (p < 0.01) in NFC after stimulation with K562 cells prior to incubation with Rituximab. There was a significant increase in CD107b expression between CFS/ME patients and NFC prior to incubation with Rituximab and without stimulation of K562 cells (p < 0.01).

Importantly, there was a significant increase in CD107b following overnight incubation with 100 μg/ml of Rituximab in NFC prior to K562 cells stimulation (p < 0.01).

Conclusion:

This study reports significant decreases in NK cell lysis and a significant increase in NK cell degranulation following Rituximab incubation in vitro in CFS/ME patients, suggesting Rituximab may be toxic for NK cells. Caution should be observed in clinical trials until further investigations in a safe and controlled in vitro setting are completed.

Griffith news blog post by Louise Durack, March 27, 2018 : Drug hoped to treat CFS causes impaired immune function, Griffith study says

… the use of Rituximab in CFS patients could incur problems with their immune cells and is not beneficial as a potential treatment. The Natural Killer (NK) cells have vital functions in fighting viruses, bacteria and tumours.

“We found that these functions were significantly impaired when exposed to Rituximab in CFS patients,” says Scientific Co-Director of NCNED, Professor Sonya Marshall-Gradisnik.

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Dutch report on CFS downgrades CBT & GET, calls for more research

Posted on 03/27/2018 by wames

The Dutch Health Council  report to their Parliament in the Hague on CFS, 19 March 2018.

Report in Dutch          Summary in Dutch        Background

Google translation of Report into English     Google translation of Summary into English 

Google translation of Background into English

The Report’s conclusions and recommendations:

  • Scientific research into ME / CFS is necessary to help patients better.
  • In the meantime it is essential that the diagnosis ME / CFS is put into practice, that the symptoms of patients are taken seriously and treated as well as possible.
  • Their functional limitations must also be fully recognized when assessing entitlements to income and other provisions.
  • The Minister of Health, Welfare and Sport gives ZonMw the assignment for a long-term and substantial research program for ME / CFS.
  • The research should mainly focus on substantiating the diagnosis, the development of the disease and the treatment of ME / CFS.
  • Those responsible for training and further training of health care providers ensure that in education and training attention is paid to the severe, chronic multisystem disease ME / CFS and to what caregivers can mean for the patients with this disease.
  • The Dutch Federation of University Medical Centers (NFU) and health insurers appoint a number of university medical centers that – in collaboration with patient representatives, other hospitals, general practitioners, rehabilitation centers, sleep centers and other health care providers in the region – open an outpatient clinic for ME / CFS. associated care networks and research groups.
  • Medical assessors in the context of occupational disability insurance, the Social Support Act, the Long-term Care Act and the Participation Act recognize that ME / CFS is a serious illness that is accompanied by substantial functional limitations and do not consider a patient’s choice not to do CBT or exercise therapy as’ not adequate recovery behavior ‘.

Cort Johnson blogs about the surprising conclusions from a country  that has long supported CBT and GET as treatments for CFS:

The Dutch Surprise: Federal Report Calls for More ME/CFS Research – Less CBT/GET

A Serious Disease 
It became clear the Committee was on a mission to convince its readers that chronic fatigue syndrome (ME/CFS) is a “serious chronic disease” which substantially limits functioning. One recommendation was that the government institute health care provider training which “highlight(s) the serious, chronic, multisystem (nature of the) disease ME/CFS.”

Prof David Tuller comments on the draft report: Trial By Error: The Dutch Review; My Trip; Bristol’s Silence

The draft stated flatly that, based on the evidence, “the committee sees no reason” for GET to be used in the Netherlands. As for CBT, the draft noted that “a small majority” of committee members believed it could be helpful for some patients. But those in this group also acknowledged that patients also reported having been harmed by the approach, and they suggested that the treatment should be pursued with care. The other committee members objected to any use of the kind of CBT designed for ME/CFS, in part given the therapy’s reliance on the theory of misguided illness beliefs. In any event, this split decision was hardly a full-throated endorsement of CBT.

ME Action blog post, 23 March 2018: Dutch Health Council Downgrades GET for ME/CFS

The report stated that patients must be free to decide whether or not to undergo Cognitive Behavioural Therapy (CBT) and/or GET, and that choosing to decline these treatments should not invalidate patients’ insurance or disability claims.

“The choice to refrain from CBT or GET should not lead to the judgment that the patient misses his chance of recovery, does not cooperate in his or her recovery or acts culpably,” the report stated.

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Cortene – a new drug trial & disease hypothesis for ME/CFS

Posted on 03/26/2018 by wames

Cortene

In his blog, Health Rising, Cort Johnson introduces a new drug trial and hypothesis for ME/CFS.

With the help of Dr Lucinda Bateman and Dr Suzanne Vernon a small drug company, Cortene, will be conducting a small proof-of-concept trial of a new drug, at the Bateman Horne Center in the US.

Their hypothesis is that a maladaptation within the limbic system, which shapes our response to stress, may underlie ME/CFS.  Specifically that a receptor called CRF2, which triggers neurons to release serotonin, has become unusually prevalent in parts of ME/CFS patients’ brains. Cortene believes that the elevated release of serotonin – in response to even small levels of stress – in turn causes ME/CFS.

 

Read more:

The Cortene Way: New Drug to Be Trialed in Chronic Fatigue Syndrome (ME/CFS) Soon – Pt. I

Cortene II: A New Drug & A New Hypothesis For Chronic Fatigue Syndrome (ME/CFS)

The Cortene Way: New Drug to Be Trialed in Chronic Fatigue Syndrome (ME/CFS) Soon – Pt. I

Cortene – A New Drug for Chronic Fatigue Syndrome (ME/CFS) Pt III: The Clinical Trial

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Forward ME Group writes to the Times: patients are ‘not simply deconditioned’

Posted on 03/23/2018 by wames

Times online letter, 22 March 2018: TREATMENT FOR PATIENTS WITH ME

Sir, The article by Tom Whipple, (“Findings of £5m ME chronic fatigue study ‘worthless’,” Mar 22) highlights a long-standing problem.

The National Institute for Health and Care Excellence (Nice) is in the process of replacing its guideline for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but this will take time.

Patients with ME/CFS in this country continue to receive damaging treatment in the form of graded exercise therapy (GET). Despite evidence of disabling metabolic abnormalities in their muscles, patients are advised to “exercise back to fitness”. They are not simply “deconditioned” as claimed by many psychiatrists. Forced exercise above very low levels characteristically incapacitates most patients. The “exercise will make you better doctrine” applied to ME/CFS is profoundly incorrect and has no scientific evidence base.

The human cost is enormous, with many sufferers from ME/CFS rendered worse by inappropriate medical management. Even worse, such management is inflicted compulsorily on some patients, both adults and children, with their informed consent being bypassed via the use of mental health and child protection legislation.

Countess of Mar, Forward-ME; Dr William Weir, infectious disease consultant;
Dr Nigel Speight, paediatrician; Dr Charles Shepherd, ME association;
Dr Vance Spence, ME research UK; Jonathan Davies, ME research UK;
Dr Gareth Tuckwell, ME trust; Dr Paul Worthley, ME trust; Jane Colby, Tymes trust;
Helen Brownlie, 25 per cent ME group; Tanya and Christine Harrison, Brame;
William and Janice Kent, Remember; Hannah Clifton, ME trust;
Clare Ogden, Action for ME

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Rethinking the treatment of CFS – a reanalysis of the PACE trial

Posted on 03/22/2018 by wames

Research abstract:

Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT by Carolyn E. Wilshire, Tom Kindlon, Robert Courtney, Alem Matthees, David Tuller, Keith Geraghty and Bruce Levin in BMC Psychology BMC series  2018 6:6 [Published: 22 March 2018]

 

Background:

The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome.

Reports concluded that both treatments were moderately effective, each leading to recovery in over a fifth of patients. However, the reported analyses did not consistently follow the procedures set out in the published protocol, and it is unclear whether the conclusions are fully justified by the evidence.

Methods:

Here, we present results based on the original protocol-specified procedures. Data from a recent Freedom of Information request enabled us to closely approximate these procedures. We also evaluate the conclusions from the trial as a whole.

Results:

On the original protocol-specified primary outcome measure – overall improvement rates – there was a significant effect of treatment group. However, the groups receiving CBT or GET did not significantly outperform the Control group after correcting for the number of comparisons specified in the trial protocol. Also, rates of recovery were consistently low and not significantly different across treatment groups. Finally, on secondary measures, significant effects were almost entirely confined to self-report measures. These effects did not endure beyond two years.

Conclusions:

These findings raise serious concerns about the robustness of the claims made about the efficacy of CBT and GET. The modest treatment effects obtained on self-report measures in the PACE trial do not exceed what could be reasonably accounted for by participant reporting biases.

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