The Experts below are selected from a list of 1419 Experts worldwide ranked by ideXlab platform
Peter D White - One of the best experts on this subject based on the ideXlab platform.
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Graded Exercise Therapy guided self-help versus specialist medical care for chronic fatigue syndrome (GETSET): a randomised controlled trial
2017Co-Authors: Lv Clark, Mario Vergara-williamson, Francesca Pesola, J.m. Thomas, M Beynon, Peter D WhiteAbstract:This paper presents independent research funded by the UK National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference number PB-PG-0610-22060). The views expressed are those of the authors and not necessarily those of the UK National Health Service (NHS), the NIHR, or the UK Department of Health. This study was also funded by the Sue Estermann Fund, a donor advised fund managed by The London Community Foundation. This study was supported by the UK Clinical Research Collaboration-registered King's Clinical Trials Unit at King's Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust, King's College London, and the NIHR Evaluation, Trials and Studies Coordinating Centre. The members of our Trial Steering Committee were Christopher Williams (Chair), a patient charity representative, Alastair Miller, Rona Moss-Morris, and a patient representative. The members of our Data Monitoring and Ethics Committee were Astrid Fletcher (Chair), Charlotte Feinmann, and Irwin Nazareth. Hiroko Akagi and Vikki McKeever scrutinised our adverse event data. The physiotherapists were Jenny McClure and Emily Tims. We thank the referring clinicians at Barts Health NHS Trust, East London NHS Foundation Trust, and Kent and Medway NHS and Social Care Partnership Trust: Julius Bourke, Maurice Clancy, Wendy Hedgecock, Elizabeth Jones, Maurice Murphy, Ewa Okon-Rocha, Areti Pavlidou, Kris Ray, and Elisabeth Wilmett.
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Response to the editorial by Dr Geraghty
Journal of health psychology, 2017Co-Authors: Peter D White, H L Baber, Mary Burgess, Lucy V Clark, J Bavinton, Michael Sharpe, Trudie Chalder, Diane L. Cox, Brian Angus, Julia C DecesareAbstract:This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, Graded Activity and Cognitive behaviour Therapy; a randomised Evaluation (PACE) trial, which we led, implemented and published. The PACE trial compared four treatments for people diagnosed with chronic fatigue syndrome. All participants in the trial received specialist medical care. The trial found that adding cognitive behaviour Therapy or Graded Exercise Therapy to specialist medical care was as safe as, and more effective than, adding adaptive pacing Therapy or specialist medical care alone. Dr Geraghty has challenged these findings. In this article, we suggest that Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial; these are corrected.
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Do more people recover from chronic fatigue syndrome with cognitive behaviour Therapy or Graded Exercise Therapy than with other treatments
Fatigue: Biomedicine Health & Behavior, 2017Co-Authors: Michael Sharpe, Kimberley Goldsmith, Anthony L Johnson, Trudie Chalder, Peter D WhiteAbstract:ABSTRACTBackground: Wilshire et al. suggest that we have overestimated the number of patients that recover from chronic fatigue syndrome (CFS) after receiving a course of either cognitive behaviour Therapy (CBT) or Graded Exercise Therapy (GET), as reported in a secondary analysis of outcome data from the Pacing, Graded Activity and Cognitive behavior Therapy; a randomized Evaluation (PACE) trial. We provide counter-arguments to this view.Purpose: To provide an alternative view to that offered by Wilshire et al.Methods: We review the two different analyses of PACE trial outcome data to estimate recovery, and compare these to other published trials and cohort studies.Results: While there is no gold standard for recovery from CFS, previous trials and cohort studies provide support for our analysis of recovery in the PACE trial. Our finding that 22% of participants recover from the current episode of CFS after either CBT or GET, compared to 8% after adaptive pacing Therapy and 7% after specialist medical car...
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Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome (GETSET): Protocol for a Randomized Controlled Trial and Interview Study.
JMIR research protocols, 2016Co-Authors: Lucy V Clark, Paul Mccrone, Damien Ridge, Anna Cheshire, Mario Vergara-williamson, Francesca Pesola, Peter D WhiteAbstract:Background: Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that Graded Exercise Therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability. Objective: While guided self-help based on cognitive behavior Therapy appears helpful to patients, Guided Graded Exercise Self-help (GES) is yet to be tested. Methods: This pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step Graded Exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened. Results: The project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon. Conclusions: This study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative Therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice. Trial Registration: International Standard Randomized Controlled Trial Number (ISRTCTN): 22975026; http://www.isrctn.com/ISRCTN22975026 (Archived by WebCite at http://www.webcitation.org/6gBK00CUX) [JMIR Res Protoc 2016;5(2):e70]
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The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial.
BJPsych bulletin, 2015Co-Authors: Peter D White, Trudie Chalder, Michael SharpeAbstract:The PACE trial was a four-arm trial of specialist medical care, compared with specialist medical care with a supplementary Therapy: adaptive pacing Therapy, cognitive–behavioural Therapy or Graded Exercise Therapy, for patients with chronic fatigue syndrome. The trial found that both cognitive–behavioural and Graded Exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability. This paper describes the design, conduct and main results of the trial, along with a description of the challenges that had to be overcome in order to produce clear answers to the clinically important questions the trial posed.
Trudie Chalder - One of the best experts on this subject based on the ideXlab platform.
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The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al
BMC Psychology, 2019Co-Authors: Michael Sharpe, Kim Goldsmith, Trudie ChalderAbstract:Chronic Fatigue Syndrome (CFS) is chronic disabling illness characterized by severe disabling fatigue, typically made worse by exertion. Myalgic Encephalomyelitis (ME) is thought by some to be the same disorder (then referred to as CFS/ME) and by others to be different. There is an urgent need to find effective treatments for CFS. The UK Medical Research Council PACE trial published in 2011 compared available treatments and concluded that when added to specialist medical care, cognitive behaviour Therapy and Graded Exercise Therapy were more effective in improving both fatigue and physical function in participants with CFS, than both adaptive pacing Therapy and specialised medical care alone. In this paper, we respond to the methodological criticisms of the trial and a reanalysis of the trial data reported by Wilshire at al. We conclude that neither the criticisms nor the reanalysis offer any convincing reason to change the conclusions of the PACE trial.
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The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al.
BMC psychology, 2019Co-Authors: Michael Sharpe, Kim Goldsmith, Trudie ChalderAbstract:Chronic Fatigue Syndrome (CFS) is chronic disabling illness characterized by severe disabling fatigue, typically made worse by exertion. Myalgic Encephalomyelitis (ME) is thought by some to be the same disorder (then referred to as CFS/ME) and by others to be different. There is an urgent need to find effective treatments for CFS. The UK Medical Research Council PACE trial published in 2011 compared available treatments and concluded that when added to specialist medical care, cognitive behaviour Therapy and Graded Exercise Therapy were more effective in improving both fatigue and physical function in participants with CFS, than both adaptive pacing Therapy and specialised medical care alone. In this paper, we respond to the methodological criticisms of the trial and a reanalysis of the trial data reported by Wilshire at al. We conclude that neither the criticisms nor the reanalysis offer any convincing reason to change the conclusions of the PACE trial.
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Response to the editorial by Dr Geraghty
Journal of health psychology, 2017Co-Authors: Peter D White, H L Baber, Mary Burgess, Lucy V Clark, J Bavinton, Michael Sharpe, Trudie Chalder, Diane L. Cox, Brian Angus, Julia C DecesareAbstract:This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, Graded Activity and Cognitive behaviour Therapy; a randomised Evaluation (PACE) trial, which we led, implemented and published. The PACE trial compared four treatments for people diagnosed with chronic fatigue syndrome. All participants in the trial received specialist medical care. The trial found that adding cognitive behaviour Therapy or Graded Exercise Therapy to specialist medical care was as safe as, and more effective than, adding adaptive pacing Therapy or specialist medical care alone. Dr Geraghty has challenged these findings. In this article, we suggest that Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial; these are corrected.
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Do more people recover from chronic fatigue syndrome with cognitive behaviour Therapy or Graded Exercise Therapy than with other treatments
Fatigue: Biomedicine Health & Behavior, 2017Co-Authors: Michael Sharpe, Kimberley Goldsmith, Anthony L Johnson, Trudie Chalder, Peter D WhiteAbstract:ABSTRACTBackground: Wilshire et al. suggest that we have overestimated the number of patients that recover from chronic fatigue syndrome (CFS) after receiving a course of either cognitive behaviour Therapy (CBT) or Graded Exercise Therapy (GET), as reported in a secondary analysis of outcome data from the Pacing, Graded Activity and Cognitive behavior Therapy; a randomized Evaluation (PACE) trial. We provide counter-arguments to this view.Purpose: To provide an alternative view to that offered by Wilshire et al.Methods: We review the two different analyses of PACE trial outcome data to estimate recovery, and compare these to other published trials and cohort studies.Results: While there is no gold standard for recovery from CFS, previous trials and cohort studies provide support for our analysis of recovery in the PACE trial. Our finding that 22% of participants recover from the current episode of CFS after either CBT or GET, compared to 8% after adaptive pacing Therapy and 7% after specialist medical car...
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The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial.
BJPsych bulletin, 2015Co-Authors: Peter D White, Trudie Chalder, Michael SharpeAbstract:The PACE trial was a four-arm trial of specialist medical care, compared with specialist medical care with a supplementary Therapy: adaptive pacing Therapy, cognitive–behavioural Therapy or Graded Exercise Therapy, for patients with chronic fatigue syndrome. The trial found that both cognitive–behavioural and Graded Exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability. This paper describes the design, conduct and main results of the trial, along with a description of the challenges that had to be overcome in order to produce clear answers to the clinically important questions the trial posed.
Michael Sharpe - One of the best experts on this subject based on the ideXlab platform.
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The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al
BMC Psychology, 2019Co-Authors: Michael Sharpe, Kim Goldsmith, Trudie ChalderAbstract:Chronic Fatigue Syndrome (CFS) is chronic disabling illness characterized by severe disabling fatigue, typically made worse by exertion. Myalgic Encephalomyelitis (ME) is thought by some to be the same disorder (then referred to as CFS/ME) and by others to be different. There is an urgent need to find effective treatments for CFS. The UK Medical Research Council PACE trial published in 2011 compared available treatments and concluded that when added to specialist medical care, cognitive behaviour Therapy and Graded Exercise Therapy were more effective in improving both fatigue and physical function in participants with CFS, than both adaptive pacing Therapy and specialised medical care alone. In this paper, we respond to the methodological criticisms of the trial and a reanalysis of the trial data reported by Wilshire at al. We conclude that neither the criticisms nor the reanalysis offer any convincing reason to change the conclusions of the PACE trial.
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The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al.
BMC psychology, 2019Co-Authors: Michael Sharpe, Kim Goldsmith, Trudie ChalderAbstract:Chronic Fatigue Syndrome (CFS) is chronic disabling illness characterized by severe disabling fatigue, typically made worse by exertion. Myalgic Encephalomyelitis (ME) is thought by some to be the same disorder (then referred to as CFS/ME) and by others to be different. There is an urgent need to find effective treatments for CFS. The UK Medical Research Council PACE trial published in 2011 compared available treatments and concluded that when added to specialist medical care, cognitive behaviour Therapy and Graded Exercise Therapy were more effective in improving both fatigue and physical function in participants with CFS, than both adaptive pacing Therapy and specialised medical care alone. In this paper, we respond to the methodological criticisms of the trial and a reanalysis of the trial data reported by Wilshire at al. We conclude that neither the criticisms nor the reanalysis offer any convincing reason to change the conclusions of the PACE trial.
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Response to the editorial by Dr Geraghty
Journal of health psychology, 2017Co-Authors: Peter D White, H L Baber, Mary Burgess, Lucy V Clark, J Bavinton, Michael Sharpe, Trudie Chalder, Diane L. Cox, Brian Angus, Julia C DecesareAbstract:This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, Graded Activity and Cognitive behaviour Therapy; a randomised Evaluation (PACE) trial, which we led, implemented and published. The PACE trial compared four treatments for people diagnosed with chronic fatigue syndrome. All participants in the trial received specialist medical care. The trial found that adding cognitive behaviour Therapy or Graded Exercise Therapy to specialist medical care was as safe as, and more effective than, adding adaptive pacing Therapy or specialist medical care alone. Dr Geraghty has challenged these findings. In this article, we suggest that Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial; these are corrected.
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Do more people recover from chronic fatigue syndrome with cognitive behaviour Therapy or Graded Exercise Therapy than with other treatments
Fatigue: Biomedicine Health & Behavior, 2017Co-Authors: Michael Sharpe, Kimberley Goldsmith, Anthony L Johnson, Trudie Chalder, Peter D WhiteAbstract:ABSTRACTBackground: Wilshire et al. suggest that we have overestimated the number of patients that recover from chronic fatigue syndrome (CFS) after receiving a course of either cognitive behaviour Therapy (CBT) or Graded Exercise Therapy (GET), as reported in a secondary analysis of outcome data from the Pacing, Graded Activity and Cognitive behavior Therapy; a randomized Evaluation (PACE) trial. We provide counter-arguments to this view.Purpose: To provide an alternative view to that offered by Wilshire et al.Methods: We review the two different analyses of PACE trial outcome data to estimate recovery, and compare these to other published trials and cohort studies.Results: While there is no gold standard for recovery from CFS, previous trials and cohort studies provide support for our analysis of recovery in the PACE trial. Our finding that 22% of participants recover from the current episode of CFS after either CBT or GET, compared to 8% after adaptive pacing Therapy and 7% after specialist medical car...
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The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial.
BJPsych bulletin, 2015Co-Authors: Peter D White, Trudie Chalder, Michael SharpeAbstract:The PACE trial was a four-arm trial of specialist medical care, compared with specialist medical care with a supplementary Therapy: adaptive pacing Therapy, cognitive–behavioural Therapy or Graded Exercise Therapy, for patients with chronic fatigue syndrome. The trial found that both cognitive–behavioural and Graded Exercise therapies were more effective than either of the other two treatments in reducing fatigue and improving physical disability. This paper describes the design, conduct and main results of the trial, along with a description of the challenges that had to be overcome in order to produce clear answers to the clinically important questions the trial posed.
Rebecca Walwyn - One of the best experts on this subject based on the ideXlab platform.
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comparison of adaptive pacing Therapy cognitive behaviour Therapy Graded Exercise Therapy and specialist medical care for chronic fatigue syndrome pace a randomised trial
The Lancet, 2011Co-Authors: Peter D White, Anthony L Johnson, Laura Potts, Rebecca Walwyn, Julia C Decesare, H L Baber, Mary Burgess, Lucy V Clark, Kimberley Goldsmith, J BavintonAbstract:Background Trial fi ndings show cognitive behaviour Therapy (CBT) and Graded Exercise Therapy (GET) can be eff ective treatments for chronic fatigue syndrome, but patients’ organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess eff ectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing Therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The fi nal analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not diff er for APT (0·7 [–0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not diff er for APT (3·4 [–1·6 to 8·4] points lower; p=0·18). C ompared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group.
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Comparison of adaptive pacing Therapy, cognitive behaviour Therapy, Graded Exercise Therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
Lancet (London England), 2011Co-Authors: Peter D White, Anthony L Johnson, Laura Potts, Rebecca Walwyn, Julia C Decesare, H L Baber, Mary Burgess, Lucy V Clark, Kimberley Goldsmith, Diane L. CoxAbstract:Background Trial fi ndings show cognitive behaviour Therapy (CBT) and Graded Exercise Therapy (GET) can be eff ective treatments for chronic fatigue syndrome, but patients’ organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess eff ectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing Therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The fi nal analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not diff er for APT (0·7 [–0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not diff er for APT (3·4 [–1·6 to 8·4] points lower; p=0·18). C ompared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p
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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 th
BMC Neurology, 2007Co-Authors: Peter D White, Julia C Decesare, Michael Sharpe, Trudie Chalder, Rebecca WalwynAbstract: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. 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. 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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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
BMC Neurology, 2007Co-Authors: Peter D White, Julia C Decesare, Trudie Chalder, Michael C Sharpe, Rebecca WalwynAbstract: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.
Hans Knoop - One of the best experts on this subject based on the ideXlab platform.
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cognitive behavioral Therapy or Graded Exercise Therapy compared with usual care for severe fatigue in patients with advanced cancer during treatment a randomized controlled trial
Annals of Oncology, 2020Co-Authors: Hanneke Poort, Marlies E W J Peters, Winette T A Van Der Graaf, Pythia Nieuwkerk, Agnes W Van De Wouw, Gijs Bleijenberg, M Nijhuisvan Der W G Sanden, Constans A H H V M Verhagen, Hans KnoopAbstract:BACKGROUND: Cancer-related fatigue remains a prevalent and burdensome symptom experienced by patients with advanced cancer. Our aim was to assess the effects of cognitive behavioral Therapy (CBT) or Graded Exercise Therapy (GET) on fatigue in patients with advanced cancer during treatment with palliative intent. PATIENTS AND METHODS: A randomized controlled trial was conducted from 1 January 2013 to 1 September 2017. Adult patients with locally advanced or metastatic cancer who reported severe fatigue during treatment [Checklist Individual Strength, subscale fatigue severity (CIS-fatigue) ≥35] were accrued across nine centers in The Netherlands. Patients were randomly assigned to either 12 weeks of CBT or GET, or usual care (1 : 1: 1, computer-generated sequence). Primary outcome was CIS-fatigue at 14 weeks. Secondary outcomes included fatigue measured with the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30), quality of life, emotional functioning, physical functioning, and functional impairments at baseline, 14, 18, and 26 weeks. RESULTS: Among 134 participants randomized, the mean age was 63 (standard deviation 9) years and 77 (57%) were women. Common diagnoses included: breast (41%), colorectal (28%), and prostate cancer (17%). A total of 126 participants completed assessment at 14 weeks. Compared with usual care, CBT significantly reduced fatigue [difference -7.2, 97.5% confidence interval (CI) -12.7 to -1.7; P = 0.003, d = 0.7], whereas GET did not (-4.7, 97.5% CI -10.2 to 0.9; P = 0.057, d = 0.4). CBT significantly reduced EORTC-QLQ-C30 fatigue (-13.1, 95% CI -22.1 to -4.0; P = 0.005) and improved quality of life (10.2, 95% CI 2.4 to 17.9; P = 0.011) and physical functioning (7.1, 95% CI 0.5 to 13.7; P = 0.036) compared with usual care. Improvement in emotional functioning and decrease in functional impairments failed to reach significance. GET did not improve secondary outcomes compared with usual care. CONCLUSIONS: Among advanced cancer patients with severe fatigue during treatment, a CBT intervention was more effective than usual care for reducing fatigue. Following GET, patients reported lower fatigue, but results were not significant, probably due to a smaller sample size and lower adherence than anticipated. TRIAL REGISTRATION: Netherlands National Trial Register, identifier: NTR3812.
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tired a randomised controlled trial evaluating efficacy of cognitive behavior Therapy and Graded Exercise Therapy in severely fatigue patients with advanced cancer
Journal of Clinical Oncology, 2018Co-Authors: Hanneke Poort, Marlies E W J Peters, Winette T A Van Der Graaf, Pythia Nieuwkerk, Agnes W Van De Wouw, Maria Nijhuisvan Der W G Sanden, Gijs Bleijenberg, S Verhagen, Hans KnoopAbstract:183Background: Patients with advanced, metastatic cancer frequently suffer from severe fatigue. We assessed the effect of cognitive behavioral Therapy (CBT) and Graded Exercise Therapy (GET) on fat...
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Study protocol of the TIRED study: a randomised controlled trial comparing either Graded Exercise Therapy for severe fatigue or cognitive behaviour Therapy with usual care in patients with incurable cancer
BMC cancer, 2017Co-Authors: Hanneke Poort, Marlies E W J Peters, Gijs Bleijenberg, Constans A H H V M Verhagen, Martine M. Goedendorp, A. Rogier T. Donders, Maria T. E. Hopman, Maria W. G. Nijhuis-van Der Sanden, Thea Berends, Hans KnoopAbstract:Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as Graded Exercise Therapy (GET) or cognitive behaviour Therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised Exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.
