Care For Chronic Fatigue Syndrome Research Articles

New NICE guideline on chronic fatigue syndrome: more ideology than science?

The National Institute for Health and Care Excellence (NICE) in the UK published a new chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) guideline in October, 2021. 1 National Institute for Health and Care ExcellenceMyalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. NICE guideline [NG206]. https://www.nice.org.uk/guidance/ng206Date: Oct 29, 2021 Date accessed: January 13, 2022 Google Scholar The previous NICE 2007 guideline recommended cognitive behavioural therapy (CBT) and graded exercise therapy (GET) for people with mild or moderate CFS/ME based on evidence from randomised trials. 2 Baker R Shaw EJ Diagnosis and management of chronic fatigue syndrome or myalgic encephalomyelitis (or encephalopathy): summary of NICE guidance. BMJ. 2007; 335: 446-448 Crossref PubMed Scopus (79) Google Scholar Since then, more randomised trials and systematic reviews have provided additional evidence supporting these recommendations. 3 Price JR Mitchell E Tidy E Hunot V Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database Syst Rev. 2008; 3CD001027 Google Scholar , 4 Larun L Brurberg KG Odgaard-Jensen J Price JR Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2019; 10CD003200 PubMed Google Scholar , 5 Castell BD Kazantzis N Moss-Morris R Cognitive behavioral therapy and graded exercise for chronic fatigue syndrome: a meta-analysis. Clin Psychol Sci Pract. 2011; 18: 311-324 Crossref Scopus (133) Google Scholar , 6 White PD Goldsmith KA Johnson AL et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011; 377: 823-836 Summary Full Text Full Text PDF PubMed Scopus (622) Google Scholar , 7 Nijhof SL Bleijenberg G Uiterwaal CS et al. Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial. Lancet. 2012; 379: 1412-1418 Summary Full Text Full Text PDF PubMed Scopus (153) Google Scholar , 8 Gotaas ME Stiles TC Bjørngaard JH Borchgrevink PC Fors EA Cognitive behavioral therapy improves physical function and fatigue in mild and moderate chronic fatigue syndrome: a consecutive randomized controlled trial of standard and short interventions. Front Psychiatry. 2021; 12580924 Crossref PubMed Scopus (6) Google Scholar No new or more effective interventions have been identified. Although we applaud guideline efforts, it is remarkable that recommendations in the 2021 NICE guideline differ substantially from the previous one, and do not include CBT and GET as means to treat CFS/ME. The new guideline presents strengthened evidence, but a major shift in interpretation. How could this happen?

Expression of Concern: Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis.

Expression of Concern: Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis.

What makes a difference in chronic fatigue syndrome?

A substantial subgroup of patients with chronic fatigue syndrome (CFS) profits from behavioural interventions. 1 Knoop H Bleijenberg G Gielissen MFM Van der Meer JWM White PD Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome?. Psychother Psychosom. 2007; 76: 171-176 Crossref PubMed Scopus (118) Google Scholar , 2 White PD Goldsmith K Johnson AL Chalder T Sharpe M Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013; 43: 2227-2235 Crossref PubMed Scopus (86) Google Scholar , 3 White PD Goldsmith KA Johnson AL et al. for the PACE trial management groupComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011; 377: 823-836 Summary Full Text Full Text PDF PubMed Scopus (627) Google Scholar A minority fully recovers after these interventions, but most do not, 1 Knoop H Bleijenberg G Gielissen MFM Van der Meer JWM White PD Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome?. Psychother Psychosom. 2007; 76: 171-176 Crossref PubMed Scopus (118) Google Scholar , 2 White PD Goldsmith K Johnson AL Chalder T Sharpe M Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013; 43: 2227-2235 Crossref PubMed Scopus (86) Google Scholar and quite a few patients do not profit at all. 3 White PD Goldsmith KA Johnson AL et al. for the PACE trial management groupComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011; 377: 823-836 Summary Full Text Full Text PDF PubMed Scopus (627) Google Scholar Therefore, outcome has substantial room for further improvement. Mediation analysis of intervention studies can help to identify the variables that bring on a reduction in chronic fatigue syndrome symptoms. With this knowledge, interventions could be improved and more patients could fully benefit from treatment. Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trialOur main finding was that fear avoidance beliefs were the strongest mediator for both CBT and GET. Changes in both beliefs and behaviour mediated the effects of both CBT and GET, but more so for GET. The results support a treatment model in which both beliefs and behaviour play a part in perpetuating fatigue and disability in chronic fatigue syndrome. Full-Text PDF

A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan

BackgroundThe publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency. Recently, Finfer and Bellomo have suggested the publication of statistical analysis plans (SAPs).The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE (Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation) trial, a treatment trial for chronic fatigue syndrome. It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers, where multiple care-providers are present for each patient in some but not all arms of the trial.ResultsThe trial design, objectives and data collection are reported. Considerations relating to blinding, samples, adherence to the protocol, stratification, centre and other clustering effects, missing data, multiplicity and compliance are described. Descriptive, interim and final analyses of the primary and secondary outcomes are then outlined.ConclusionsThis SAP maximises transparency, providing a record of all planned analyses, and it may be a resource for those who are developing SAPs, acting as an illustrative example for teaching and methodological research. It is not the sum of the statistical analysis sections of the principal papers, being completed well before individual papers were drafted.Trial registrationISRCTN54285094 assigned 22 May 2003; First participant was randomised on 18 March 2005.

Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis

BackgroundThe PACE trial compared the effectiveness of adding adaptive pacing therapy (APT), cognitive behaviour therapy (CBT), or graded exercise therapy (GET), to specialist medical care (SMC) for patients with chronic fatigue syndrome. This paper reports the relative cost-effectiveness of these treatments in terms of quality adjusted life years (QALYs) and improvements in fatigue and physical function.MethodsResource use was measured and costs calculated. Healthcare and societal costs (healthcare plus lost production and unpaid informal care) were combined with QALYs gained, and changes in fatigue and disability; incremental cost-effectiveness ratios (ICERs) were computed.ResultsSMC patients had significantly lower healthcare costs than those receiving APT, CBT and GET. If society is willing to value a QALY at £30,000 there is a 62.7% likelihood that CBT is the most cost-effective therapy, a 26.8% likelihood that GET is most cost effective, 2.6% that APT is most cost-effective and 7.9% that SMC alone is most cost-effective. Compared to SMC alone, the incremental healthcare cost per QALY was £18,374 for CBT, £23,615 for GET and £55,235 for APT. From a societal perspective CBT has a 59.5% likelihood of being the most cost-effective, GET 34.8%, APT 0.2% and SMC alone 5.5%. CBT and GET dominated SMC, while APT had a cost per QALY of £127,047. ICERs using reductions in fatigue and disability as outcomes largely mirrored these findings.ConclusionsComparing the four treatments using a health care perspective, CBT had the greatest probability of being the most cost-effective followed by GET. APT had a lower probability of being the most cost-effective option than SMC alone. The relative cost-effectiveness was even greater from a societal perspective as additional cost savings due to reduced need for informal care were likely.

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial

Can a care pathway help streamline the care process for patients with chronic fatigue syndrome?

In this paper, the authors show how the implementation of a care pathway can streamline the care for chronic fatigue syndrome (CFS). The methodology of seven phases is used as a guide to develop, implement and evaluate the CFS care pathway. Some patients have already completed the care pathway. With the help of these case studies, a few strengths and weaknesses of the care process can be formulated. The development and implementation of the care pathway result in a structured process. Patients are diagnosed and treated based on an evidence-based method. The care path also leads to an enhancement of the interdisciplinary cooperation. Nevertheless, the criteria for inclusion and exclusion of patients are taken into account insufficiently. Moreover, family doctors should be involved more often. In the future, it is also important to pay more attention to the role of the family members during the treatment. The entire steering group now needs to engage in a discussion about the test pathway and then subsequently put it to use in daily practice. Additional challenges for the steering group include the objective evaluation and the continuous follow-up of the care pathway.

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial

SummaryBackgroundTrial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective 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 effectiveness and safety of all four treatments.MethodsIn 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 final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094.FindingsWe 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 differ 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 differ for APT (3·4 [−1·6 to 8·4] points lower; p=0·18). Compared 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.InterpretationCBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.FundingUK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.

Effectiveness of stepped care for chronic fatigue syndrome: A randomized noninferiority trial.

In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period. A total of 171 CFS patients were randomly allocated to stepped care or care as usual. Patients in both conditions were assessed 3 times: at baseline, after guided self-instruction or the waiting period, and after CBT. The primary outcome variables were fatigue severity (Checklist Individual Strength) and disabilities (Sickness Impact Profile and Medical Outcomes Survey Short Form-36). An intention to treat analysis showed that stepped care (N = 84) for CFS is noninferior to care as usual (N = 85). Both conditions were equivalent in reducing fatigue severity, reducing disabilities, and increasing physical functioning. The treatment results of both conditions were in accordance with those of previous randomized controlled trials testing the effectiveness of CBT for CFS. The total therapist time needed to treat a patient was significantly less in the stepped care condition. Stepped care is as effective as CBT and is more time efficient for the therapist.