Fatigue Intervention by Nurses Evaluation - The FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]

Background: Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP). Methods and design: This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral

Physical activity as a treatment for depression: the TREAD randomised trial protocol

Published version. Copyright © 2010 BioMed CentralBackground: Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service. The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care. Methods/design: The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments. Discussion: The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression. Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers

A comparison of the Work and Social Adjustment Scale (WSAS) across different patient populations using Rasch analysis and exploratory factor analysis

Introduction The Work and Social Adjustment Scale (WSAS) is designed to measure patients' perceived functional impairment associated with a health problem. There is a paucity of studies that explore the stability of the item hierarchy in the WSAS across different disease populations. This study investigated the unidimensional structure of the WSAS across different disease populations. Methods Secondary data analysis was conducted on pooled patient data (HIV, breast cancer, and inflammatory conditions) to create a new dataset (n = 554). The data were analysed using Rasch analysis and exploratory factor analysis. Results Exploratory factor analysis and principle component analysis of the WSAS showed a good fit as a unidimensional scale, person and item separation indices were &gt; 2 suggesting that the WSAS is sensitive enough to distinguish between participants of varying levels of ability. Some differential item functioning was seen by diagnosis and by sex for items 1 and 5 of the WSAS. Conclusions Overall, a one dimensional structure was identified for the WSAS. However, a small number of differential item functioning (DIF) was identified, suggesting that scores from the WSAS cannot be compared across groups.</p

Review of systematic reviews of non-pharmacological interventions to improve quality of life in cancer survivors.

Over two million people in the UK are living with and beyond cancer. A third report diminished quality of life. A review of published systematic reviews to identify effective non-pharmacological interventions to improve the quality of life of cancer survivors. Databases searched until May 2017 included PubMed, Cochrane Central, EMBASE, MEDLINE, Web of Science, the Cumulative Index to Nursing and Allied Health Literature, and PsycINFO. Published systematic reviews of randomised trials of non-pharmacological interventions for people living with and beyond cancer were included; included reviews targeted patients aged over 18. All participants had already received a cancer diagnosis. Interventions located in any healthcare setting, home or online were included. Reviews of alternative therapies or those non-English reports were excluded. Two researchers independently assessed titles, abstracts and the full text of papers, and independently extracted the data. The primary outcome of interest was any measure of global (overall) quality of life. Quality assessment assessing methdological quality of systematic reviews (AMSTAR) and narrative synthesis, evaluating effectiveness of non-pharmacological interventions and their components. Of 14 430 unique titles, 21 were included in the review of reviews. There was little overlap in the primary papers across these reviews. Thirteen reviews covered mixed tumour groups, seven focused on breast cancer and one focused on prostate cancer. Face-to-face interventions were often combined with online, telephone and paper-based reading materials. Interventions included physical, psychological or behavioural, multidimensional rehabilitation and online approaches. Yoga specifically, physical exercise more generally, cognitive behavioural therapy (CBT) and mindfulness-based stress reduction (MBSR) programmes showed benefit in terms of quality of life. Exercise-based interventions were effective in the short (less than 3-8 months) and long term. CBT and MBSR also showed benefits, especially in the short term. The evidence for multidisciplinary, online and educational interventions was equivocal. [Abstract copyright: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Heterogeneity in chronic fatigue syndrome – empirically defined subgroups from the PACE trial

Background: Chronic fatigue syndrome is likely to be a heterogeneous condition. Previous studies have empirically defined subgroups using combinations of clinical and biological variables. We aimed to explore the heterogeneity of chronic fatigue syndrome. Methods: We used baseline data from the PACE trial, which included 640 participants with chronic fatigue syndrome. Variable reduction, using a combination of clinical knowledge and principal component analyses, produced a final dataset of 26 variables for 541 patients. Latent class analysis was then used to empirically define subgroups. Results: The most statistically significant and clinically recognisable model comprised five subgroups. The largest, “core” subgroup (33% of participants), had relatively low scores across all domains and good self-efficacy. A further three subgroups were defined by: the presence of mood disorders (21%); the presence of features of other functional somatic syndromes (such as fibromyalgia or irritable bowel syndrome) (21%); or by many symptoms – a group which combined features of both of the above (14%). The smallest “avoidant-inactive” subgroup was characterised by physical inactivity, belief that symptoms were entirely physical in nature, and fear that they indicated harm (11%). Differences in the severity of fatigue and disability provided some discriminative validation of the subgroups. Conclusions: In addition to providing further evidence for the heterogeneity of chronic fatigue syndrome, the subgroups identified may aid future research into the important aetiological factors of specific subtypes of CFS and the development of more personalised treatment approaches

Functional Stroke Symptoms: A Narrative Review and Conceptual Model

Stroke services have been reconfigured in recent years to facilitate early intervention. Throughout stroke settings, some patients present with functional symptoms that cannot be attributed to a structural cause. Emphasis on fast diagnosis and treatment means that a proportion of patients entering the care pathway present with functional symptoms that mimic stroke or have functional symptoms in addition to vascular stroke. There is limited understanding of mechanisms underlying functional stroke symptoms, how the treatment of such patients should be managed, and no referral pathway or treatment. Predisposing factors vary between individuals, and symptoms are heterogeneous: onset can be acute or insidious, and duration can be short-lived or chronic in the context of new or recurrent illness cognitions and behaviors. This article proposes a conceptual model of functional symptoms identified in stroke services and some hypotheses based on a narrative review of the functional neurological disorder literature. Predisposing factors may include illness experiences, stressors, and chronic autonomic nervous system arousal. Following the onset of distressing symptoms, perpetuating factors may include implicit cognitive processes, classical and operant conditioning, illness beliefs, and behavioral responses, which could form the basis of treatment targets. The proposed model will inform the development of theory-based interventions as well as a functional stroke care pathway

Illness-Related Cognition, Distress and Adjustment in Functional Stroke Symptoms, Vascular Stroke, and Chronic Fatigue Syndrome

Background: High rates of psychological distress are reported in functional conditions and vascular stroke, but there is limited understanding of how patients with functional neurological symptoms in stroke settings respond to symptoms. Aims: This study compared patients with functional stroke symptoms to those with vascular stroke and chronic fatigue syndrome (CFS). Methods: A prospective cohort of 56 patients with functional stroke symptoms were age-gender matched to patients with vascular stroke and CFS. Analysis of variance compared groups on cognitive and behavioral responses to symptoms, psychological distress, and functioning. Sensitivity analyses controlled for known confounders. The proportions of clinical anxiety and depression were compared between groups. Results: The functional stroke symptom group had a higher proportion of clinical anxiety cases than the CFS group, and a higher proportion of clinical depression cases than the vascular stroke group. Patients with functional stroke symptoms reported the highest rate of “damage beliefs” and “all-or-nothing” behaviors and greater symptom focusing and resting behavior than patients with vascular stroke. Limitations: Larger cohorts and a longitudinal design would strengthen study findings. Conclusion: Compared to patients with vascular stroke or CFS, patients with functional stroke symptoms show a somewhat distinct profile of illness-related beliefs and behaviors, as well as higher rates of clinical anxiety. Understanding such group differences provides some insights into aetiology and cognitive-behavioral responses. Appropriate support and referral should be available to patients with functional stroke symptoms to address distress and reduce the likelihood of severe impairment

Complementary and alternative healthcare use by participants in the PACE trial of treatments for chronic fatigue syndrome

BackgroundChronic Fatigue Syndrome sCFS) is characterised by persistent fatigue, disability and a range of other symptoms. The PACE trial was randomised to compare four non-pharmacological treatments for patients with CFS in secondary care clinics. The aims of this sub study were to describe the use of complementary and alternative medicine (CAM) in the trial sample and to test whether CAM use correlated with an improved outcome.MethodCAM use was recorded at baseline and 52 weeks. Logistic and multiple regression models explored relationships between CAM use and both patient characteristics and trial outcomes.ResultsAt baseline, 450/640 (70%) of participants used any sort of CAM; 199/640 (31%) participants were seeing a CAM practitioner and 410/640 (64%) were taking a CAM medication. At 52 weeks, those using any CAM fell to 379/589 (64%). Independent predictors of CAM use at baseline were female gender, local ME group membership, prior duration of CFS and treatment preference. At 52 weeks, the associated variables were being female, local ME group membership, and not being randomised to the preferred trial arm. There were no significant associations between any CAM use and fatigue at either baseline or 52 weeks. CAM use at baseline was associated with a mean (CI) difference of 4.10 (1.28, 6.91; p = 0.024) increased SF36 physical function score at 52 weeks, which did not reach the threshold for a clinically important difference.ConclusionCAM use is common in patients with CFS. It was not associated with any clinically important trial outcomes

An attention and interpretation bias for illness-specific information in chronic fatigue syndrome

Background: Studies have shown that specific cognitions and behaviours play a role in maintaining chronic fatigue syndrome (CFS). However, little research has investigated illness-specific cognitive processing in CFS. This study investigated whether CFS participants had an attentional bias for CFS-related stimuli and a tendency to interpret ambiguous information in a somatic way. It also determined whether cognitive processing biases were associated with co-morbidity, attentional control or self-reported unhelpful cognitions and behaviours. Method: A total of 52 CFS and 51 healthy participants completed self-report measures of symptoms, disability, mood, cognitions and behaviours. Participants also completed three experimental tasks, two designed specifically to tap into CFS salient cognitions: (i) visual-probe task measuring attentional bias to illness (somatic symptoms and disability) v. neutral words; (ii) interpretive bias task measuring positive v. somatic interpretations of ambiguous information; and (iii) the Attention Network Test measuring general attentional control. Results: Compared with controls, CFS participants showed a significant attentional bias for fatigue-related words and were significantly more likely to interpret ambiguous information in a somatic way, controlling for depression and anxiety. CFS participants had significantly poorer attentional control than healthy individuals. Attention and interpretation biases were associated with fear/avoidance beliefs. Somatic interpretations were also associated with all-or-nothing behaviour and catastrophizing. Conclusions: People with CFS have illness-specific biases which may play a part in maintaining symptoms by reinforcing unhelpful illness beliefs and behaviours. Enhancing adaptive processing, such as positive interpretation biases and more flexible attention allocation, may provide beneficial intervention targets.</p