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  • Title: PACE Trial - Home
    Descriptive info: .. Home.. FAQ.. Trial information.. Links.. Contact Us.. Please note that the PACE trial closed to recruitment on 28 November 2008.. Latest news:.. Government support for the PACE trial (50KB PDF).. 21 September 2012 update:.. Health economics paper, including cost-effectiveness comparisons, has now been published in PLOS ONE, and is.. available for free download at this link.. 11 March 2011 update:.. Full PACE paper and web appendix now available to download free of charge, after registering with.. The Lancet.. 18 February 2011 update.. :.. Results now available at.. The Lancet.. Participants' newsletter issue 4 now available on the.. Trial information page.. 17 February 2011 update:.. PACE treatment manuals available.. The treatment manuals are available, free of charge, on the.. Trial Information page.. for downloading, so long as no changes are made to the manuals.. Any use of these manuals should acknowledge the PACE trial (www.. pacetrial.. org).. These manuals were used in the PACE trial by healthcare professionals and participants to support PACE trial treatments, which are described in the manuals.. The results regarding efficacy and safety of these treatments are not yet published, but will be reported in the main paper of the PACE trial.. These treatments should only be delivered by appropriately qualified healthcare professionals, who have received appropriate training and continued supervision in their use.. The treatments described were not designed to be stand-alone self-help approaches.. No responsibility is accepted by the authors for the application of treatments described in these manuals outside of the PACE trial.. The PACE trial team are unable to respond to queries or comments regarding the use of these manuals or the treatments described.. March 2010 update:.. Data collection for the one year follow up has now been completed.. The trial data is currently being analysed in preparation for publication of the findings.. Further information regarding publication will be posted here when available.. What is the PACE trial?.. This large-scale trial is the first in the world to test and compare the effectiveness of four of the main treatments currently available for  ...   any one time.. CFS/ME causes disability as a result of persistent, abnormal tiredness which is made worse by activity.. Other symptoms can include disturbed or unrefreshing sleep, or sleeping for longer, problems concentrating or remembering, pain in the muscles and/or joints, headaches, sore throats and tenderness in the neck.. The diagnosis of CFS/ME sometimes can be difficult because it requires that a large number of other possible causes of the symptoms, such as thyroid gland disease and severe depression, are excluded.. What are the treatments being tested?.. The four treatments are standardised specialist medical care (SSMC) alone, SSMC plus adaptive pacing therapy, SSMC plus cognitive behaviour therapy and SSMC plus graded exercise therapy.. The therapies are delivered, as appropriate, by occupational therapists, physiotherapists, clinical psychologists or by other healthcare staff with specialist training.. Standardised specialist medical care.. This is the most common treatment for CFS/ME.. Specialist doctors can give an explanation of why participants are ill and general advice about managing the illness.. They may also prescribe medicines to help with troublesome symptoms such as insomnia and pain, or advise GPs on what medicine is appropriate.. If a participant is randomised to this treatment alone, they are encouraged to use specific self-help management that make most sense to them.. Adaptive pacing therapy.. This therapy is about carefully matching activity levels to the amount of energy available.. Therapists work with participants in this treatment group to help monitor activity and symptoms, aiming to improve quality of life and create the best conditions for a natural recovery.. Cognitive behaviour therapy.. This therapy is about examining how thoughts, behaviour and CFS/ME symptoms interact with each other.. Between therapy sessions, participants in this treatment group are encouraged to try out new ways of coping with their illness.. Graded exercise therapy.. This is about gradually increasing physical activity to improve fitness and get the body used to activity again.. A therapist helps participants in this treatment group to work out a basic activity routine and slowly build up the amount of exercise as fitness increases..

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  • Title: PACE Trial - FAQ
    Descriptive info: Frequently Asked Questions.. FAQ 1: written during the progress of the trial.. FAQ 2: following publication of the main results.. (.. Lancet,.. 377,9768, 823-836, 5 March 2011)..

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  • Title: PACE Trial - Trial information
    Descriptive info: 21 September 2012 update: Health economics paper, including cost-effectiveness comparisons, has now been published in PLOS ONE, and is.. 11 March 2011 update: Full PACE paper and web appendix now available to download free of charge, after registering with.. 18 February 2011 update: Participants' newsletter issue 4 now available.. (see below).. 17 February 2011 update: PACE treatment manuals available.. Treatment manuals.. (all PDFs): The treatment manuals are available free of charge for down-loading, so long  ...   manual.. Appendix to (3).. CBT participant manual.. NB copyright.. Constable and Robinson.. Appendix to (4).. GET treatment manual.. GET participant manual.. SSMC treatment manual.. To see the information on the trial given to potential participants, please.. click here.. (PDF, 42 KB).. Patient Clinic Leaflet.. (PDF, 30 KB).. Participants' newsletters.. (all PDFs):.. June 2006.. (330 KB).. March 2007.. (345K).. December 2008.. (400 KB).. February 2011.. (60 KB).. On-line trial protocol published on BioMed Central.. http://www.. biomedcentral.. com/1471-2377/7/6..

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  • Title: PACE Trial - Links
    Descriptive info: Participating centres.. Barts.. King s College.. Edinburgh.. Oxford.. Royal Free.. Bristol.. Affiliated research.. The FINE trial.. Funders.. MRC.. Department of Health.. UK Department for Work and Pensions.. Chief Scientist Office of the Scottish Government Health Directorates.. 11 March 2011 update..

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  • Title: PACE Trial - Contact Us
    Descriptive info: pace@qmul.. ac.. uk..

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  • Title: PACE Trial - FAQ
    Descriptive info: Why are these four particular treatments included in the trial?.. Standardised specialist medical care (SSMC) is a standardised version of the usual treatment to which CFS/ME patients are referred by their GPs in the UK.. Typically, patients attend a hospital clinic where specialist doctors can offer advice and medicines to relieve some of the symptoms.. Patients are often then referred on for supplementary therapies and the three most likely to be available are: cognitive behaviour therapy (CBT), administered by a cognitive behaviour therapist, often a psychologist; graded exercise therapy (GET), usually administered by a physiotherapist; and pacing therapy, usually administered by an occupational therapist.. What are the four treatments?.. Adaptive pacing therapy (APT) is a version of pacing, a therapy that has been found to be helpful in chronic pain disorders.. It is based on the theory that people with CFS/ME have a fixed amount of available energy to which they must adapt.. The approach is popular with CFS/ME patient organisations but, to date, little research has been done to judge its effectiveness.. CBT is a form of psychotherapy in which patients are encouraged to examine how their thoughts, beliefs and behaviour interact.. They do this by first establishing a baseline of both physical and mental activities, and then gradually increasing it, noting problems or symptoms as they arise for discussion with their therapist.. For patients with CFS/ME, CBT can offer help in finding new ways of coping with the illness.. GET is about gradually increasing physical activity, first through establishing a basic routine, centred on a preferred activity such as walking, and then gradually increasing the amount of exercise and activity, allowing patients to do more and feel better.. CBT and GET have both been found to be beneficial to patients in small trials, but subsequent surveys of members of patient organisation have suggested that CBT and especially GET may make some patients worse.. The PACE trial will compare the relative effectiveness of the three supplementary therapies when added to SSMC against  ...   ensure the trial can recruit enough people to give meaningful results.. Assessing participants using International and London criteria once they've been enrolled into the trial may shed light on whether different groups of people respond differently to different treatments.. The ultimate aim is to rigorously evaluate all the treatments on offer so that patients and doctors can make informed choices about which treatment might best improve an individual's quality of life.. Who designed the PACE trial?.. The trial was designed by the principal researchers, all specialists who have years of experience treating people with CFS/ME.. Who oversees the trial?.. The trial is led by three Principal Investigators (Professors PD White, MC Sharpe and T Chalder), aided by a trial management group, composed of all the centre and treatment leaders and statisticians.. The study was and is also subject to a series of independent checks.. There was an independent peer review process when the researchers first applied for funding.. Approval for the trial and for any changes to it are sought from an independent research ethics committee.. There is also a Trial Steering Committee, which has an independent chair, to ensure that the scientific approach is sound and can deliver the objectives of the study.. Who is funding the PACE trial?.. The trial is funded by the Medical Research Council (MRC), the Department of Health, the Department of Work and Pensions and the Scottish Chief Scientist Office.. Is PACE the only major trial for CFS/ME being carried out in the UK?.. The MRC announced funding in May 2003 for two trials looking at the effectiveness of various treatments for CFS/ME.. The other trial is FINE, (Fatigue Intervention by Nurses Evaluation) which will test two different treatments that are particularly suited to those who are too ill to attend a specialist clinic.. The FINE research is being carried out in NW England.. The MRC has designated CFS/ME a priority research area and other scientists are being encouraged to submit research proposals.. Page top.. FAQ index.. FAQ2..

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  • Title: PACE Trial - FAQ
    Descriptive info: FAQ 2: following publication of the main results.. Written 13.. 12.. 2011.. No.. Question.. Answer.. PATIENTS and their diagnoses.. 1.. What is CFS?.. Chronic Fatigue Syndrome (CFS) is an illness in which a person is disabled by severe fatigue and other symptoms, which have lasted at least six months, and for which there is no other disease to explain it.. 2.. How is CFS defined?.. There are several published definitions or criteria that can be applied to decide if a person has CFS.. We used the Oxford definition to define CFS in the PACE trial.. We also assessed participants to see if they met the International (Centers for Disease Control) definition (see question 4), to see whether the effects of treatments were different in those who met this alternative definition.. 3.. What are the Oxford criteria for CFS?.. These require that a person has had at least six months of severe fatigue, with fatigue being their main symptom, which is disabling and is usually accompanied by other symptoms.. No other medical or psychiatric explanation for the symptoms has been found.. All patients in the PACE trial met these criteria.. 4.. Why did you choose the Oxford criteria for defining CFS?.. We chose the Oxford criteria for several reasons: (a) we wanted to find out which treatments were best in those who had fatigue as their principal symptom.. Some patients, clinically diagnosed as having CFS, may have another symptom, such as pain, as their primary symptom.. (b) The Oxford criteria include a greater number of patients with CFS, by not requiring a specific number of additional symptoms, as other definitions of CFS do.. (We wanted to make sure our findings applied to the greatest number of patients.. ) (c) The Oxford definition of CFS is the most straightforward to use in clinical practice.. 5.. Do the Oxford criteria exclude patients with neurological symptoms?.. Having neurological symptoms , like memory difficulties or muscle weakness, did not exclude anyone from taking part in the trial, since these symptoms were medically recognised symptoms of CFS.. Neurological conditions, such as Parkinson s disease which might be an alternative cause for the symptoms, did exclude patients from participation, since the diagnosis would have been Parkinson s disease, not CFS.. 6.. What are the International (Center for Disease Control) criteria for CFS?.. These require that a person is suffering from fatigue, and also has at least four of eight other symptoms, these being: (1) post-exertional fatigue, (2) muscle pain, (3) joint pain, (4) headaches, (5) sore throat, (6) tender lymph nodes, (7) poor concentration and memory, and (8) sleep disturbance, with no other medical or psychiatric explanation for these symptoms.. 67% of PACE trial patients met the CDC criteria.. 7.. What is ME?.. ME or myalgic encephalomyelitis/encephalopathy refers to an illness in which severe fatigue is a symptom, which is characteristically exacerbated by minimal activity, along with other symptoms that fluctuate over time.. We assessed whether patients in the PACE trial met the London criteria for ME, which are based on the original description of the illness.. We did this to see whether the effects of treatment differed in those who met criteria for ME.. 51% of PACE trial patients met the London criteria for ME.. 8.. What is the difference between CFS and ME?.. ME is a similar or related condition to CFS.. Some regard it as the same condition; others believe it to be a distinct illness.. It may be a sub-group of CFS.. 9.. Did the trial include patients with ME?.. All patients met the Oxford criteria for CFS.. 67% also met the international (CDC) criteria for CFS, and 51% also met the London criteria for ME.. We analysed our data separately for all these groups and found that the pattern of the effects of treatments were similar in all three groups.. 10.. Why were the Canadian consensus criteria for defining ME not used?.. These criteria were designed for use in clinical practice, rather than research, and have therefore been very little used in research.. One of the important reasons for this is that they include many symptoms, some of which may not be related to ME or CFS.. The criteria are similar in some respects to the London ME criteria, which we did use in PACE; for instance both require post-exertional malaise or fatigue.. We used the London criteria for ME since they included this characteristic symptom, were based on Ramsay s original description of ME, and were simpler to apply.. 11.. Would it have made a difference if the Canadian definition for ME had been chosen?.. We cannot know for sure, but when we analysed data from those participants who met the London criteria for ME, the pattern of results was the same; both CBT and GET, combined with SMC, were the most effective treatments.. This was also the case when we analysed only data from participants who met the International (CDC) criteria for CFS, another way of defining the illness (see question 6).. 12.. Were the participants of the PACE trial representative of all patients with CFS?.. We included only participants who were able to attend hospital for the trial treatments and assessments.. However, some of the PACE trial participants were quite severely disabled and had to use mobility aids.. Participants were representative of patients who attend clinics with a diagnosis of CFS in the UK.. 13.. Are the results applicable to those worst affected?.. We do not know as we did not study housebound participants.. Results cannot be therefore be extrapolated to those who are severely affected.. 14.. Why did you change entry criteria while the trial was recruiting participants?.. We made two changes.. First, we increased the threshold for physical functioning by one incremental point as we decided the original level of functioning we required for entry was too low, and also to reduce the number of otherwise eligible patients who were excluded from the trial for this reason.. The overall mean score for the physical function scale of participants was similar to those in previous trials conducted in hospital clinics.. Second, we decided to exclude only those who had already received a trial treatment in a PACE trial centre, because we found it difficult to be certain whether patients treated elsewhere (not at a PACE centre) with something like CBT or GET had received a proper course of treatment consistent with that provided in the trial.. Both these changes were approved by the independent Trial Steering Committee.. TREATMENTS.. 15.. What treatments did you test?.. All participants received specialist medical care (SMC).. One group received this alone.. The other three groups also received either adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET).. All treatments were provided on an individual patient basis.. 16.. What was SMC?.. Specialist Medical Care (SMC) consisted of seeing a doctor in a clinic that specialised in the management of CFS.. This included providing general advice about managing the illness and prescribing medicines for symptoms such sleep problems and pain, as well as encouraging self-help when SMC was provided by itself without an additional therapy.. 17.. What was APT?.. Adaptive Pacing Therapy (APT), delivered by occupational therapists, assumed that the illness cannot be changed by changing behaviour, and aimed to help the patient to use their energy wisely and to allow natural recovery, by both stabilising and balancing activities with rest, while staying within the limits imposed by the illness.. All participants also received Specialist Medical Care (SMC).. 18.. What was CBT?.. Cognitive behaviour therapy (CBT) was provided by a clinical psychologist or nurse therapist.. After stabilising the level of activity CBT aimed to help the patient to do more and feel better by testing out the best ways to cope with the illness.. This included a gradual return to activities and challenging what both patients and therapists had identified as potentially unhelpful ways of coping and thinking about the illness.. All participants also received SMC.. 19.. What was GET?.. Graded exercise  ...   the treatments in five separate ways, and found no significant differences in any of these measures among the different arms of the trial.. We concluded that all these treatments are safe so long as they are delivered by similar healthcare professionals, who are trained and supervised to deliver these treatments in a similar way to the PACE trial.. 35.. Does APT not work?.. A minority of people who received APT did improve, but no more than the proportion who received SMC by itself.. The majority of patients who received APT reported that they were satisfied with their therapy.. 36.. How is it possible that APT had the most satisfied group of patients but was the least effective therapy?.. Satisfaction with a treatment is based on lots of things, such as how helpful the person found their therapist, and does not necessarily relate to its effectiveness.. Patients can be satisfied that their therapist did their best, without the therapy itself improving symptoms and disability.. 37.. Did poor delivery of APT account for the findings?.. We know the therapists delivered APT to a high standard and that APT was delivered as planned because of:.. The high rates of patient satisfaction,.. Recorded therapy sessions were consistent with the therapy manual,.. The quality of the therapeutic relationships between patients and therapists, which were independently assessed, were as good with APT as with other therapies.. This suggests that it was the content of the therapy that was less effective, not the therapists or how it was delivered.. It seems as though the adaptive nature of APT is not as effective as the rehabilitative approach common to both CBT and GET.. 38.. How do we know that the results were not biased in any way?.. Bias means that the results were not correct because of a limitation in the methods.. There are many forms of bias:.. Bias in design and conduct of the trial:.. The trial was subject to independent scrutiny by both a Trial Steering Committee and a Data Monitoring and Ethics committee throughout, and was conducted to the highest standards.. A patient charity, Action for ME, helped to design, implement and oversee the study throughout its existence.. Outcome measurement bias:.. This might have occurred because the research assessors knew which treatment each participant had received.. However, as the participants rated the main outcomes themselves, any measurement bias would have been determined by participants themselves.. One reason may have been different expectations of treatments.. We measured expectations before treatment and the highest expectations were in those about to start APT and GET, with less expectations of improvement in those about to receive CBT.. This makes patient rating bias an unlikely explanation of the results:.. Bias in assessing safety outcomes:.. These were reported by participants themselves, and finally assessed by independent scrutineers, so this is unlikely.. Bias in the analysis:.. The statistician who analysed the main results did not know which outcome data referred to which treatment, so this is unlikely.. Whilst it is never possible to completely eliminate all bias in trials we are confident that the findings of the trial were not substantially affected by bias.. IMPLICATIONS.. 39.. Will the results have an effect on policy?.. The 2007 NICE guidelines recommend both CBT and GET.. The PACE trial results were reviewed by NICE in 2011, and it was concluded that there was currently no need to change this advice.. 40.. Why did NICE recommend the treatments before now?.. More evidence was available to support the effectiveness of CBT and GET than for other treatments.. However that evidence was limited to small trials, and the recommendation remained controversial.. PACE is a large scale clinical trial (with 641 participants), which has provided definitive evidence of effectiveness and safety.. 41.. Does the effectiveness of CBT indicate that CFS is a psychological condition?.. The effectiveness of cognitive behaviour therapy (CBT) as a treatment for CFS does not make assumptions about the nature of the illness.. Pigeon-holing CFS as either physical or psychological is not helpful as many if not all illnesses have elements of both.. CBT is used widely to manage many medical conditions such as arthritis, heart disease and chronic pain.. There is also evidence that CBT can have an effect on the body.. For instance it has been recently found to reduce repeat heart attacks in people who have had a first attack.. This is because CBT helps to change behaviour, which in turn changes the functioning of the body.. 42.. How have you found a treatment to be useful when we do not know the cause of CFS?.. There are very many examples in medicine where a treatment is developed for an illness before the cause of the illness is known.. For example: quinine treating malaria, or digitalis (from the foxglove) helping heart failure.. Treatments sometimes help in reversing the factors that keep someone unwell rather than addressing original causes.. Digitalis is an example of that.. CFS and ME are extremely debilitating and therefore there is a real need for treatment now.. We are open minded about what research into the condition s causes will reveal; in the meantime the PACE trial shows that CBT and GET can make a difference to patients lives today.. 43.. Do the treatments give value for money?.. Our health economic analysis will be reported in a separate paper.. It is important to think about the costs of these treatments to the National Health Service as well as the costs of the illness to patients families and society in general due to the costs of caring for patients, and some patients inability to work.. 44.. If patients continued treatments for longer would they continue to get better?.. The PACE trial was designed to measure benefits of five months of therapeutic treatment.. We cannot predict the effects of continued treatment from this study.. 45.. Do the effects of these treatments last?.. We will have followed up participants long-term (for 2.. 5 years) and therefore will be able to make a better assessment of whether the positive effects shown in the trial are long-lasting.. Previous studies have shown that the effects of both CBT and GET do last.. 46.. Some patients didn t improve: was it worth it?.. Since approximately 6 out of 10 patients improved after either cognitive behavioural or graded exercise therapies, the results of this study are encouraging.. But, as with many treatments in most areas of medicine, there will be patients who do not respond to treatment.. This underscores the need for continued research into this area.. 47.. What would you say to participants who didn t get better?.. After participation in the trial, if patients did not improve, they were offered further or alternative treatments; we hope this would happen in clinical practice.. 48.. Are the CBT and GET widely available on the NHS?.. NICE currently recommends these treatments, but their availability varies across the UK.. We hope that the results of this trial will inform practice throughout the UK and abroad.. 49.. Who funded the PACE trial?.. Large trials like this are expensive and it is common for funding to be shared between different public sector bodies including charities with an interest in finding the best treatments for a debilitating condition.. The PACE trial was primarily funded by the Medical Research Council as well as the Department of Health for England, The Scottish Chief Scientist Office and the Department for Work and Pensions.. CFS and ME are a priority research area for the MRC.. The MRC s decision to fund this trial was based on detailed peer review of the grant application, including the fact that there was a lack of high quality evidence to inform treatment, and in particular on the need to evaluate treatments that were already in use and for which there was insufficiently strong evidence from randomised controlled trials to support their effectiveness.. Main results available for free download, once registered with the Lancet at no charge:.. 377,9768, 823-836, 5 March 2011.. FAQ1..

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