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      Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy

      , 1 , 2 , 3 , 4 , 5 , the PACE trial group 4

      BMC Neurology

      BioMed Central

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          Abstract

          Background

          Chronic fatigue syndrome (CFS, also called myalgic encephalomyelitis/encephalopathy or ME) is a debilitating condition with no known cause or cure. Improvement may occur with medical care and additional therapies of pacing, cognitive behavioural therapy and graded exercise therapy. The latter two therapies have been found to be efficacious in small trials, but patient organisations' surveys have reported adverse effects. Although pacing has been advocated by patient organisations, it lacks empirical support. Specialist medical care is commonly provided but its efficacy when given alone is not established. This trial compares the efficacy of the additional therapies when added to specialist medical care against specialist medical care alone.

          Methods/Design

          600 patients, who meet operationalised diagnostic criteria for CFS, will be recruited from secondary care into a randomised trial of four treatments, stratified by current comorbid depressive episode and different CFS/ME criteria. The four treatments are standardised specialist medical care either given alone, or with adaptive pacing therapy or cognitive behaviour therapy or graded exercise therapy. Supplementary therapies will involve fourteen sessions over 23 weeks and a 'booster session' at 36 weeks. Outcome will be assessed at 12, 24, and 52 weeks after randomisation. Two primary outcomes of self-rated fatigue and physical function will assess differential effects of each treatment on these measures. Secondary outcomes include adverse events and reactions, subjective measures of symptoms, mood, sleep and function and objective measures of physical activity, fitness, cost-effectiveness and cost-utility. The primary analysis will be based on intention to treat and will use logistic regression models to compare treatments. Secondary outcomes will be analysed by repeated measures analysis of variance with a linear mixed model. All analyses will allow for stratification factors. Mediators and moderators will be explored using multiple linear and logistic regression techniques with interactive terms, with the sample split into two to allow validation of the initial models. Economic analyses will incorporate sensitivity measures.

          Discussion

          The results of the trial will provide information about the benefits and adverse effects of these treatments, their cost-effectiveness and cost-utility, the process of clinical improvement and the predictors of efficacy.

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          Most cited references 56

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          EuroQol: the current state of play.

          The EuroQol Group first met in 1987 to test the feasibility of jointly developing a standardised non-disease-specific instrument for describing and valuing health-related quality of life. From the outset the Group has been multi-country, multi-centre, and multi-disciplinary. The EuroQol instrument is intended to complement other forms of quality of life measures, and it has been purposefully developed to generate a cardinal index of health, thus giving it considerable potential for use in economic evaluation. Considerable effort has been invested by the Group in the development and valuation aspects of health status measurement. Earlier work was reported upon in 1990; this paper is a second 'corporate' effort detailing subsequent developments. The concepts underlying the EuroQol framework are explored with particular reference to the generic nature of the instrument. The valuation task is reviewed and some evidence on the methodological requirements for measurement is presented. A number of special issues of considerable interest and concern to the Group are discussed: the modelling of data, the duration of health states and the problems surrounding the state 'dead'. An outline of some of the applications of the EuroQol instrument is presented and a brief commentary on the Group's ongoing programme of work concludes the paper.
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            Short form 36 (SF36) health survey questionnaire: normative data for adults of working age.

            To gain population norms for the short form 36 health survey questionnaire (SF36) in a large community sample and to explore the questionnaire's internal consistency and validity. Postal survey by using a booklet containing the SF36 and several other items concerned with lifestyles and illness. The sample was drawn from computerised registers of the family health services authorities for Berkshire, Buckinghamshire, Northamptonshire, and Oxfordshire. 13,042 randomly selected subjects aged 18-64 years. Scores for the eight health dimensions of the SF36. The survey achieved a response rate of 72% (n = 9332). Internal consistency of the different dimensions of the questionnaire was high. Normative data broken down by age, sex, and social class were consistent with those from previous studies. The SF36 is a potentially valuable tool in medical research. The normative data provided here may further facilitate its validation and use.
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              The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms.

              Somatization is prevalent in primary care and is associated with substantial functional impairment and healthcare utilization. However, instruments for identifying and monitoring somatic symptoms are few in number and not widely used. Therefore, we examined the validity of a brief measure of the severity of somatic symptoms. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-15 comprises 15 somatic symptoms from the PHQ, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The PHQ-15 was administered to 6000 patients in eight general internal medicine and family practice clinics and seven obstetrics-gynecology clinics. Outcomes included functional status as assessed by the 20-item Short-Form General Health Survey (SF-20), self-reported sick days and clinic visits, and symptom-related difficulty. As PHQ-15 somatic symptom severity increased, there was a substantial stepwise decrement in functional status on all six SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. PHQ-15 scores of 5, 10, 15, represented cutoff points for low, medium, and high somatic symptom severity, respectively. Somatic and depressive symptom severity had differential effects on outcomes. Results were similar in the primary care and obstetrics-gynecology samples. The PHQ-15 is a brief, self-administered questionnaire that may be useful in screening for somatization and in monitoring somatic symptom severity in clinical practice and research.
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                Author and article information

                Journal
                BMC Neurol
                BMC Neurology
                BioMed Central
                1471-2377
                2007
                8 March 2007
                : 7
                : 6
                Affiliations
                [1 ]Department of Psychological Medicine, Queen Mary School of Medicine and Dentistry, St Bartholomew's Hospital, London, UK
                [2 ]Psychological Medicine and Symptoms Research Group, University of Edinburgh, Royal Edinburgh Hospital, Edinburgh, Scotland, UK
                [3 ]Academic Department of Psychological Medicine, Guy's, King's and St Thomas' School of Medicine, Weston Education Centre, London, UK
                [4 ]PACE Trial Coordinating Centre, Queen Mary School of Medicine and Dentistry, St Bartholomew's Hospital, London, UK
                [5 ]Mental Health & Neuroscience Clinical Trials Unit (MH&N CTU), Institute of Psychiatry, London, UK
                Article
                1471-2377-7-6
                10.1186/1471-2377-7-6
                2147058
                17397525
                Copyright © 2007 White et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Study Protocol

                Neurology

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