Journal of IiME Volume 1 Issue 2 www.investinme.org The PACE TRIALS (continued) The PACE Trial Identifier (the Funding Application to the MRC) In about April 2004 the UK ME/CFS community managed to obtain a copy of the PACE Trial Identifier, which unless one is involved in the process, is usually impossible. The Identifier contained misleading statements (“Predictors of a negative outcome with treatment include membership of a self-help group, being in receipt of a disability pension [and] focusing on physical symptoms”); vital information was totally omitted; it referred to “treatment” when it would have been more accurate to describe the proposed interventions as “management strategies”; there was to be no subgrouping, and it relied on the biased Systematic Review from the CRD at York. It stated that the results of the trial: “will allow health planners, clinicians and patients to choose treatment on the basis of both efficacy and cost (and will) define the essential aspects of effective treatment”. It acknowledged that: “There is a discrepancy between patients’ organisation reports of the safety of CBT and GET and the published evidence of minimal risk from RCTs”. It undertook to monitor for any adverse effects: “We will undertake a detailed assessment, at home if necessary, for any subject who drops out of treatment for this reason, following which they will be offered appropriate help”. “Appropriate help” was not defined. It described CBT: “CBT will be based on the illness model of fear avoidance. There are three essential elements: (a) assessment of illness beliefs and coping strategies, (b) structuring of daily activity, with a graduated return to normal activity, (c) challenging unhelpful beliefs about symptoms and activity”. It described GET: “GET will be based on the illness model of both de-conditioning and exercise avoidance. Therapy involves an individually designed aerobic exercise programme with set target heart rate and times” (3.4). The inclusion criteria were to be “the operationalised Oxford criteria for CFS. We chose these broad criteria in order to enhance recruitment. Subjects who also meet the criteria for ‘fibromyalgia’ will be included” (3.6). The Oxford (1991) criteria were formulated by the Wessely School and have been criticised for being too broad -- they specifically include those with psychiatric fatigue and they potentially capture people suffering from “fatigue” that occurs in 33 different disorders -- and for specifically excluding those with neurological disorders such as ME. The Oxford criteria have no predictive validity and have never been adopted for use outside the Wessely School. They were superseded by the US Centres for Disease Control (CDC) Fukuda criteria in 1994. The assumptions of outcome were given: “At one year we assume that 60% will improve with CBT (and) 50% with GET”. Information about the day-to-day management of the trial said: “The trial will be run by the trial co-ordinator, with the PI (Principal Investigator). He/she will liaise regularly with Invest in ME Charity Nr 1114035 staff at the Clinical Trials Unit (CTU) who will be responsible for randomisation and database design and management (overseen by the centre statistician Dr Tony Johnson), directed by Professor Simon Wesssely”. The UK ME/CFS community noted with some surprise the involvement of Dr Tony Johnson, Deputy Director of the MRC’s Statistical Unit at Cambridge, because his published views on CBT were already known. In 1998, Johnson published a major review entitled “Clinical trials in psychiatry: background and statistical perspective” (Statistical Methods in Medical Research: 1998:7:209234) in which he came to some unequivocal conclusions. Johnson noted that psychiatric studies have been beset by poor design, inadequate data and incorrect analysis, and he noted the existence of studies produced by psychiatrists that claim “inordinate enthusiasm” for certain therapies. The Oxford (1991) criteria were formulated by the Wessely School and have been criticised for being too broad -- they specifically include those with psychiatric fatigue and they potentially capture people suffering from “fatigue” that occurs in 33 different disorders -- and for specifically excluding those with neurological disorders such as ME. He stated that a major requirement in any clinical trial is to determine the nature of the disease which will be investigated; he noted: “sophisticated technological examination is important in psychiatry to eliminate organic causes of psychiatric symptomatology”, a view that Wessely School psychiatrists seem not to share. Wessely maintains that there is an attractive cost implication of CBT (“The only treatment strategies of proven efficacy are cognitive behavioural ones. We have developed a more intensive therapy; this form of therapy is acceptable to patients, safe, and more effective than either standard medical care or relaxation therapy. It has also been shown to be cost effective”. “Chronic fatigue syndrome. A practical guide to assessment and management” Sharpe M, Chalder T, Wessely S et al. Gen Hosp Psychiatry 1997:19:3:185-199) but Johnson disagreed, stating that a course of psychotherapy typically lasts for 12 weeks or longer and “a major limitation is its cost”. The involvement of Dr Tony Johnson in the PACE trial Dr Johnson’s involvement in the PACE trials merits (continued on page 51) Page 50/72
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