Developing and testing a case-management intervention to support the return to work of health care workers with common mental health disorders.

BACKGROUND: To assess the feasibility and acceptability of conducting a trial of the clinical effectiveness and cost-effectiveness of a new case-management intervention to facilitate the return to work of health care workers, on sick leave, having a common mental disorder (CMD). METHODS: A mixed methods feasibility study. RESULTS: Systematic review examined 40 articles and 2 guidelines. Forty-nine National Health Service Occupational Health (OH) providers completed a usual care survey. We trained six OH nurses as case managers and established six recruitment sites. Forty-two out of 1938 staff on sick leave with a CMD were screened for eligibility, and 24 participants were recruited. Out of them, 94% were female. Eleven participants received the intervention and 13 received usual care. Engagement with most intervention components was excellent. Return-to-work self-efficacy improved more in the intervention group than in the usual care group. Qualitative feedback showed the intervention was acceptable. CONCLUSIONS: The intervention was acceptable, feasible and low cost to deliver, but it was not considered feasible to recommend a large-scale effectiveness trial unless an effective method could be devised to improve the early OH referral of staff sick with CMD. Alternatively, the intervention could be trialled as a new stand-alone OH intervention initiated at the time of usual OH referral.

A pilot study of an integrated mental health, social and medical model for diabetes care in an inner-city setting: Three Dimensions for Diabetes (3DFD).

AIMS: We examined the effectiveness of a service innovation, Three Dimensions for Diabetes (3DFD), that consisted of a referral to an integrated mental health, social care and diabetes treatment model, compared with usual care in improving biomedical and health economic outcomes. METHODS: Using a non-randomized control design, the 3DFD model was offered in two inner-city boroughs in London, UK, where diabetes health professionals could refer adult residents with diabetes, suboptimal glycaemic control [HbA1c ≥ 75 mmol/mol (≥ 9.0%)] and mental health and/or social problems. In the usual care group, there was no referral pathway and anonymized data on individuals with HbA1c ≥ 75 mmol/mol (≥ 9.0%) were collected from primary care records. Change in HbA1c from baseline to 12 months was the primary outcome, and change in healthcare costs and biomedical variables were secondary outcomes. RESULTS: 3DFD participants had worse glycaemic control and higher healthcare costs than control participants at baseline. 3DFD participants had greater improvement in glycaemic control compared with control participants [-14 mmol/mol (-1.3%) vs. -6 mmol/mol (-0.6%) respectively, P < 0.001], adjusted for confounding. Total follow-up healthcare costs remained higher in the 3DFD group compared with the control group (mean difference £1715, 95% confidence intervals 591 to 2811), adjusted for confounding. The incremental cost-effectiveness ratio was £398 per mmol/mol unit decrease in HbA1c , indicating the 3DFD intervention was more effective and costed more than usual care. CONCLUSIONS: A biomedical, psychological and social criteria-based referral system for identifying and managing high-cost and high-risk individuals with poor glycaemic control can lead to improved health in all three dimensions.

A behaviour change package to prevent hand dermatitis in nurses working in the National Health Service: results of a cluster randomized controlled trial.

BACKGROUND: Occupational hand dermatitis poses a serious risk for nurses. OBJECTIVES: To evaluate the clinical and cost-effectiveness of a complex intervention in reducing the prevalence of hand dermatitis in nurses METHODS: This was a cluster randomized controlled trial conducted at 35 hospital trusts, health boards or universities in the UK. Participants were (i) first-year student nurses with a history of atopic conditions or (ii) intensive care unit (ICU) nurses. Participants at intervention sites received access to a behavioural change programme plus moisturizing creams. Participants at control sites received usual care. The primary outcome was the change of prevalent dermatitis at follow-up (adjusted for baseline dermatitis) in the intervention vs. the control group. Randomization was blinded to everyone bar the trials unit to ensure allocation concealment. The trial was registered on the ISRCTN registry: ISRCTN53303171. RESULTS: Fourteen sites were allocated to the intervention arm and 21 to the control arm. In total 2040 (69·5%) nurses consented to participate and were included in the intention-to-treat analysis. The baseline questionnaire was completed by 1727 (84·7%) participants. Overall, 789 (91·6%) ICU nurses and 938 (84·0%) student nurses returned completed questionnaires. Of these, 994 (57·6%) had photographs taken at baseline and follow-up (12-15 months). When adjusted for baseline prevalence of dermatitis and follow-up interval, the odds ratios (95% confidence intervals) for hand dermatitis at follow-up in the intervention group relative to the controls were 0·72 (0·33-1·55) and 0·62 (0·35-1·10) for student and ICU nurses, respectively. No harms were reported. CONCLUSIONS: There was insufficient evidence to conclude whether our intervention was effective in reducing hand dermatitis in our populations. Linked Comment: Brans. Br J Dermatol 2020; 183:411-412.

An observational study to compare the utilisation of computed tomography colonography with optical colonoscopy as the first diagnostic imaging tool in patients with suspected colorectal cancer.

AIM: To evaluate the clinical and cost implications of using computed tomography colonography (CTC) compared to optical colonoscopy (OC) as the initial colonic investigation in patients with low-to-intermediate risk of colorectal cancer (CRC). MATERIALS AND METHODS: A non-randomised, prospective single-centre study recruited 180 participants to compare the cost implications of two clinical pathways used in the diagnosis of low-to-intermediate risk of CRC that differ in the initial diagnostic test, either CTC or OC. Costs were compared using generalised linear models (GLM) and combined with quality-adjusted life years (QALYs, based on the EQ-5D-5L) to estimate cost-effectiveness at 6 months post-recruitment. Secondary outcomes assessed access to care and patient satisfaction. RESULTS: Mean (SD, n) cost at 6 months post-recruitment per participant was £991 (£316, n=105) for the OC group and £645 (£607, n=68) for the CTC group, leading to an estimated cost difference of -£370 (95% CI: -£554, -£185, p<0.001). Assuming a £20,000 willingness-to-pay per QALY threshold, there was a 91.4% probability of CTC being cost-effective at month 6. The utilisation of CTC led to improved access to care, with a shorter mean time from referral from primary care to results (6.3 days difference, p=0.005). No differences in patient satisfaction were detected between both groups. CONCLUSION: The utilisation of CTC as the first-line investigation for patients with low-to-intermediate risk of CRC has the potential to release OC capacity, of pivotal importance for patients more likely to benefit from an invasive diagnostic approach.

Hospital admissions for non-communicable disease in the UK military and associations with alcohol use and mental health: a data linkage study.

BACKGROUND: Since the recent conflicts in Iraq and Afghanistan, the short-term focus of military healthcare research has been on the consequences of deployment for mental health and on those wounded or injured in combat. Now that these conflicts have ended for the UK Armed Forces, it is important to consider the longer term physical and mental health consequences, and just as importantly, the links between these. The aims of this study were to determine the most common physical conditions requiring a hospital admission in UK military personnel and whether they were more common in personnel with a mental health condition, smokers, and/or those misusing alcohol compared to those without. METHODS: Data linkage of a prospective UK military cohort study to electronic admitted patient care records for England, Wales and Scotland. Nine thousand nine hundred ninety military personnel completed phase 2 of a military cohort study (56% response rate, data collected from 2007 to 2009), with analyses restricted to 86% of whom provided consent for linkage to healthcare records (n = 8602). Ninety percent were male and the mean age at phase 2 was 36 years. The outcome was physical non communicable diseases (NCDs) requiring a hospital admission which occurred after phase 2 of the cohort when the mental health, smoking and alcohol use exposure variables had been assessed until the end of March 2014. RESULTS: The most common NCDs requiring a hospital admission were gastrointestinal disorders 5.62% (95% Confidence Intervals (CI) 5.04, 6.19) and joint disorders 5.60% (95% CI 5.02, 6.18). Number of NCDs requiring a hospital admission was significantly higher in those with a common mental disorder (Hazard ratio (HR) 1.40 (95% CI 1.16-1.68), post-traumatic stress disorder (HR 1.78 (95% CI 1.32-2.40)) and in current smokers (HR 1.35 (95% CI 1.12-1.64) compared to those without the disorder, and non-smokers, respectively. CONCLUSIONS: Military personnel with a mental health problem are more likely to have an inpatient hospital admission for NCDs compared to those without, evidencing the clear links between physical and mental health in this population.

Protocol of a two arm randomised, multi-centre, 12-month controlled trial: evaluating the impact of a Cognitive Behavioural Therapy (CBT)-based intervention Supporting UPtake and Adherence to antiretrovirals (SUPA) in adults with HIV.

BACKGROUND: Delay to start antiretroviral therapy (ART) and nonadherence compromise the health and wellbeing of people living with HIV (PLWH), raise the cost of care and increase risk of transmission to sexual partners. To date, interventions to improve adherence to ART have had limited success, perhaps because they have failed to systematically elicit and address both perceptual and practical barriers to adherence. The primary aim of this study is to determine the efficacy of the Supporting UPtake and Adherence (SUPA) intervention. METHODS: This study comprises 2 phases. Phase 1 is an observational cohort study, in which PLWH who are ART naïve and recommended to take ART by their clinician complete a questionnaire assessing their beliefs about ART over 12 months. Phase 2 is a randomised controlled trial (RCT) nested within the observational cohort study to investigate the effectiveness of the SUPA intervention on adherence to ART. PLWH at risk of nonadherence (based on their beliefs about ART) will be recruited and randomised 1:1 to the intervention (SUPA intervention + usual care) and control (usual care) arms. The SUPA intervention involves 4 tailored treatment support sessions delivered by a Research Nurse utilising a collaborative Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) approach. Sessions are tailored to individual needs and preferences based on the individual patient's perceptions and practical barriers to ART. An animation series and intervention manual have been developed to communicate a rationale for the personal necessity for ART and illustrate concerns and potential solutions. The primary outcome is adherence to ART measured using Medication Event Monitoring System (MEMS). Three hundred seventy-two patients will be sufficient to detect a 15% difference in adherence with 80% power and an alpha of 0.05. Costs will be compared between intervention and control groups. Costs will be combined with the primary outcome in cost-effectiveness analyses. Quality adjusted life-years (QALYs) will also be estimated over the follow-up period and used in the analyses. DISCUSSION: The findings will enable patients, healthcare providers and policy makers to make informed decisions about the value of the SUPA intervention. TRIAL REGISTRATION: The trial was retrospectively registered 21/02/2014, ISRCTN35514212 .

Improving patient experiences of mental health inpatient care: a randomised controlled trial.

BACKGROUND: Poorer patient views of mental health inpatient treatment predict both further admissions and, for those admitted involuntarily, longer admissions. As advocated in the UK Francis report, we investigated the hypothesis that improving staff training improves patients' views of ward care. METHOD: Cluster randomised trial with stepped wedge design in 16 acute mental health wards randomised (using the ralloc procedure in Stata) by an independent statistician in three waves to staff training. A psychologist trained ward staff on evidence-based group interventions and then supported their introduction to each ward. The main outcome was blind self-report of perceptions of care (VOICE) before or up to 2 years after staff training between November 2008 and January 2013. RESULTS: In total, 1108 inpatients took part (616 admitted involuntarily under the English Mental Health Act). On average 51.6 staff training sessions were provided per ward. Involuntary patient's perceptions of, and satisfaction with, mental health wards improved after staff training (N582, standardised effect -0·35, 95% CI -0·57 to -0·12, p = 0·002; interaction p value 0·006) but no benefit to those admitted voluntarily (N469, -0.01, 95% CI -0.23 to 0.22, p = 0.955) and no strong evidence of an overall effect (N1058, standardised effect -0.18 s.d., 95% CI -0.38 to 0.01, p = 0.062). The training costs around £10 per patient per week. Resource allocation changed towards patient perceived meaningful contacts by an average of £12 (95% CI -£76 to £98, p = 0.774). CONCLUSION: Staff training improved the perceptions of the therapeutic environment in those least likely to want an inpatient admission, those formally detained. This change might enhance future engagement with all mental health services and prevent the more costly admissions.

Following the Francis report: investigating patient experience of mental health in-patient care.

BACKGROUND: The Francis report highlights perceptions of care that are affected by different factors including ward structures. AIMS: To assess patient and staff perceptions of psychiatric in-patient wards over time. METHOD: Patient and staff perceptions of in-patient psychiatric wards were assessed over 18 months. We also investigated whether the type of ward or service structure affected these perceptions. We included triage and routine care. The goal was to include at least 50% of eligible patients and staff. RESULTS: The most dramatic change was a significant deterioration in all experiences over the courseof the study. Systems of care or specific wards did not affect patient experience but staff were more dissatisfied in the triage system. CONCLUSIONS: This is the first report of deterioration in perceptions of the therapeutic in-patient environment that has been captured in a rigorous way. It may reflect contemporaneous experiences across the National Health Service of budget reductions and increased throughput. The ward systems we investigated did not improve patient experience and triage may have been detrimental to staff.

The economic costs of mental health-related discrimination.

OBJECTIVE: To estimate and compare the economic costs of mental health-related discrimination in the domains of health care, relationships and participation in leisure activities in England between 2011 and 2014. METHOD: A subsample of the Viewpoint survey was interviewed using the Costs of Discrimination Assessment Questionnaire in 2011 and 2014. Information on the impact of discrimination on healthcare use, help seeking from family and friends and participation in leisure activities was recorded. Pattern of contacts, costs and predictor of costs were examined. RESULTS: Our findings showed higher costs of health service use for individuals who reported experiences of discrimination in healthcare settings in 2011 compared with those who did not (mean difference £625, P-value 0.019). Individuals who reported experiences of discrimination in relationships in 2014 had higher healthcare costs than those who did not (mean difference £418, P -value 0.034). There was some evidence of a reduction in overall levels of healthcare use, leisure activities and support from families over time. Discrimination did not significantly affect help seeking from family/friends or leisure activities. CONCLUSION: There is some evidence that discrimination is related to increased healthcare costs. A prospective study is needed to better understand the consequences of these effects.

Pilot randomised trial of a brief intervention for comorbid substance misuse in psychiatric in-patient settings.

OBJECTIVE: This proof of principle study evaluated the effectiveness and feasibility of a brief motivational intervention, delivered in mental health in-patient settings, to improve engagement in treatment for drug and alcohol misuse. METHOD: A randomised controlled trial using concealed randomisation, blind, independent assessment of outcome at 3 months. Participants were 59 new adult admissions, to six acute mental health hospital units in one UK mental health service, with schizophrenia related or bipolar disorder diagnoses, users of community mental health services and also misusing alcohol and/or drugs. Participants were randomised to Brief Integrated Motivational Intervention (BIMI) with Treatment As Usual (TAU), or TAU alone. The BIMI took place over a 2-week period and encouraged participants to explore substance use and its impact on mental health. RESULTS: Fifty-nine in-patients (BIMI n = 30; TAU n = 29) were randomised, the BIMI was associated with a 63% relative odds increase in the primary outcome engagement in treatment [OR 1.63 (95% CI 1.01-2.65; P = 0.047)], at 3 months. Qualitative interviews with staff and participants indicated that the BIMI was both feasible and acceptable. CONCLUSION: Mental health hospital admissions present an opportunity for brief motivational interventions focussed on substance misuse and can lead to improvements in engagement.

Modelling the cost-effectiveness of pharmacotherapy compared with cognitive-behavioural therapy and combination therapy for the treatment of moderate to severe depression in the UK.

BACKGROUND: The National Institute of Health and Care Excellence (NICE) in England and Wales recommends the combination of pharmacotherapy and psychotherapy for the treatment of moderate to severe depression. However, the cost-effectiveness analysis on which these recommendations are based has not included psychotherapy as monotherapy as a potential option. For this reason, we aimed to update, augment and refine the existing economic evaluation. METHOD: We constructed a decision analytic model with a 27-month time horizon. We compared pharmacotherapy with cognitive-behavioural therapy (CBT) and combination treatment for moderate to severe depression in secondary care from a healthcare service perspective. We reviewed the literature to identify relevant evidence and, where possible, synthesized evidence from clinical trials in a meta-analysis to inform model parameters. RESULTS: The model suggested that CBT as monotherapy was most likely to be the most cost-effective treatment option above a threshold of £ 22,000 per quality-adjusted life year (QALY). It dominated combination treatment and had an incremental cost-effectiveness ratio of £ 20,039 per QALY compared with pharmacotherapy. There was significant decision uncertainty in the probabilistic and deterministic sensitivity analyses. CONCLUSIONS: Contrary to previous NICE guidance, the results indicated that even for those patients for whom pharmacotherapy is acceptable, CBT as monotherapy may be a cost-effective treatment option. However, this conclusion was based on a limited evidence base, particularly for combination treatment. In addition, this evidence cannot easily be transferred to a primary care setting.

Distress improves after mindfulness training for progressive MS: A pilot randomised trial.

BACKGROUND: Mindfulness-based interventions have been shown to effectively reduce anxiety, depression and pain in patients with chronic physical illnesses. OBJECTIVES: We assessed the potential effectiveness and cost-effectiveness of a specially adapted Skype distant-delivered mindfulness intervention, designed to reduce distress for people affected by primary and secondary progressive MS. METHODS: Forty participants were randomly assigned to the eight-week intervention (n = 19) or a waiting-list control group (n = 21). Participants completed standardised questionnaires to measure mood, impact of MS and symptom severity, quality of life and service costs at baseline, post-intervention and three-month follow-up. RESULTS: Distress scores were lower in the intervention group compared with the control group at post-intervention and follow-up (p < 0.05), effect size -0.67 post-intervention and -0.97 at follow-up. Mean scores for pain, fatigue, anxiety, depression and impact of MS were reduced for the mindfulness group compared with control group at post-therapy and follow-up; effect sizes ranged from -0.27 to -0.99 post-intervention and -0.29 to -1.12 at follow-up. There were no differences in quality-adjusted life years, but an 87.4% probability that the intervention saves on service costs and improves outcome. CONCLUSIONS: A mindfulness intervention delivered through Skype video conferences appears accessible, feasible and potentially effective and cost-effective for people with progressive MS.

Efficacy of a triage system to reduce length of hospital stay.

BACKGROUND: Attempts have been made to improve the efficiency of in-patient acute care. A novel method has been the development of a 'triage system' in which patients are assessed on admission to develop plans for discharge or transfer to an in-patient ward. AIMS: To compare a triage admission system with a traditional system. METHOD: Length of stay and readmission data for all admissions in a 1-year period between the two systems were compared using the participating trust's anonymised records. RESULTS: Despite reduced length of stay on the actual triage ward, the average length of stay was not reduced and the triage system did not lead to a greater number of readmissions. There was no significant difference in costs between the two systems. CONCLUSIONS: Based on our findings we cannot conclude that the triage system reduced length of stay, but we can conclude that it does not increase the number of readmissions as some have feared.

Impact of initial treatment outcome on long-term costs of depression: a 3-year nationwide follow-up study in Taiwan.

BACKGROUND: The impact of initial treatment outcome on long-term healthcare costs in depression remains to be determined. We aimed to identify demographic and clinical characteristics associated with initial treatment outcomes and to test whether and how these outcomes influence total healthcare costs over the subsequent 3 years. METHOD: In this secondary analysis of a large healthcare database, a national cohort of adult patients (n = 126,471) who received antidepressant treatment for depression was identified and factors associated with initial outcomes were examined. Potential predictors of total healthcare costs in the subsequent years were assessed using generalized linear modeling, with a particular focus on initial outcome status after antidepressant treatment and co-morbidities. RESULTS: Depression type and co-morbid painful physical symptoms (PPS) or mental illnesses were found to be associated with initial outcome status. Having sustained treatment-free status after initial treatment was shown to be associated with a 22-33% reduction in total healthcare costs in the second and third years (compared to those with late recontacts). Although the presence of co-morbid PPS was associated with higher healthcare costs, having certain co-morbid anxiety disorders was associated with lower costs over the 3 years. CONCLUSIONS: Initial outcome status after antidepressant treatment has a sustained impact on individuals' total healthcare costs over the following 3 years. Future efforts to improve initial treatment outcome of depression are warranted.

Randomized controlled trial of computerized cognitive behavioural therapy for depressive symptoms: effectiveness and costs of a workplace intervention.

BACKGROUND: Depression and anxiety are major causes of absence from work and underperformance in the workplace. Cognitive behavioural therapy (CBT) can be effective in treating such problems and online versions offer many practical advantages. The aim of the study was to investigate the effectiveness of a computerized CBT intervention (MoodGYM) in a workplace context. METHOD: The study was a phase III two-arm, parallel randomized controlled trial whose main outcome was total score on the Work and Social Adjustment Scale (WSAS). Depression, anxiety, psychological functioning, costs and acceptability of the online process were also measured. Most data were collected online for 637 participants at baseline, 359 at 6 weeks marking the end of the intervention and 251 participants at 12 weeks post-baseline. RESULTS: In both experimental and control groups depression scores improved over 6 weeks but attrition was high. There was no evidence for a difference in the average treatment effect of MoodGYM on the WSAS, nor for a difference in any of the secondary outcomes. CONCLUSIONS: This study found no evidence that MoodGYM was superior to informational websites in terms of psychological outcomes or service use, although improvement to subthreshold levels of depression was seen in nearly half the patients in both groups.

Economic costs and quality of life in chronic inflammatory neuropathies in southeast England.

BACKGROUND AND PURPOSE: Cost-of-illness studies and health-related quality of life (HRQoL) measurements are needed to assess the effects of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), multifocal motor neuropathy (MMN) and paraproteinaemic demyelinating neuropathy (PDN) on society. METHODS: This study was conducted in 2008 in a southeast England population of 3,557,352 people. Data on service use and treatment were collected with a client service receipt inventory and service costs were calculated by combining these data with national unit costs. The EuroQol was used to calculate utility scores, a measurement of HRQoL. RESULTS: The total annual cost-of-illness per patient was £22,085 for CIDP, £22,812 for MMN and £7566 for PDN. The annual total cost per patient was £49,430 for individuals on intravenous immunoglobulin (IVIg) and £9046 for those not on IVIg (P < 0.01). The mean (SD) utility scores were 0.62 (0.23) for CIDP, 0.63 (0.22) for PDN and 0.72 (0.14) for MMN (P = 0.52). The mean (SD) utility score for those on IVIg was 0.65 (0.16) and those not on IVIg 0.63 (0.23) (P = 0.77). CONCLUSION: The use of IVIg was the most important determinant of cost in all three diseases and the higher frequency of its use in CIDP and MMN accounted for the much greater average cost per patient in these diseases. There was no significant difference in HRQoL amongst the three diseases or between those receiving or not receiving IVIg.

Is community treatment best? a randomised trial comparing delivery of cancer treatment in the hospital, home and GP surgery.

BACKGROUND: Care closer to home is being explored as a means of improving patient experience as well as efficiency in terms of cost savings. Evidence that community cancer services improve care quality and/or generate cost savings is currently limited. A randomised study was undertaken to compare delivery of cancer treatment in the hospital with two different community settings. METHODS: Ninety-seven patients being offered outpatient-based cancer treatment were randomised to treatment delivered in a hospital day unit, at the patient's home or in local general practice (GP) surgeries. The primary outcome was patient-perceived benefits, using the emotional function domain of the EORTC quality of life (QOL) QLQC30 questionnaire evaluated after 12 weeks. Secondary outcomes included additional QOL measures, patient satisfaction, safety and health economics. RESULTS: There was no statistically significant QOL difference between treatment in the combined community locations relative to hospital (difference of -7.2, 95% confidence interval: -19·5 to +5·2, P=0.25). There was a significant difference between the two community locations in favour of home (+15·2, 1·3 to 29·1, P=0.033). Hospital anxiety and depression scale scores were consistent with the primary outcome measure. There was no evidence that community treatment compromised patient safety and no significant difference between treatment arms in terms of overall costs or Quality Adjusted Life Year. Seventy-eight percent of patients expressed satisfaction with their treatment whatever their location, whereas 57% of patients preferred future treatment to continue at the hospital, 81% at GP surgeries and 90% at home. Although initial pre-trial interviews revealed concerns among health-care professionals and some patients regarding community treatment, opinions were largely more favourable in post-trial interviews. INTERPRETATION: Patient QOL favours delivering cancer treatment in the home rather than GP surgeries. Nevertheless, both community settings were acceptable to and preferred by patients compared with hospital, were safe, with no detrimental impact on overall health-care costs.

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

BACKGROUND: Trial 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. 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 final 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 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. INTERPRETATION: CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition. FUNDING: UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.

The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial.

BACKGROUND: To evaluate the effectiveness of graded exercise therapy (GET), counselling (COUNS) and usual care plus a cognitive behaviour therapy (CBT) booklet (BUC) for people presenting with chronic fatigue in primary care. METHOD: A randomized controlled trial in general practice. The main outcome measure was the change in the Chalder fatigue score between baseline and 6 months. Secondary outcomes included a measure of global outcome, including anxiety and depression, functional impairment and satisfaction. RESULTS: The reduction in mean Chalder fatigue score at 6 months was 8.1 [95% confidence interval (CI) 6.6-10.4] for BUC, 10.1 (95% CI 7.5-12.6) for GET and 8.6 (95% CI 6.5-10.8) for COUNS. There were no significant differences in change scores between the three groups at the 6- or 12-month assessment. Dissatisfaction with care was high. In relation to the BUC group, the odds of dissatisfaction at the 12-month assessment were less for the GET [odds ratio (OR) 0.11, 95% CI 0.02-0.54, p=0.01] and COUNS groups (OR 0.13, 95% CI 0.03-0.53, p=0.004). CONCLUSIONS: Our evidence suggests that fatigue presented to general practitioners (GPs) tends to remit over 6 months to a greater extent than found previously. Compared to BUC, those treated with graded exercise or counselling therapies were not significantly better with respect to the primary fatigue outcome, although they were less dissatisfied at 1 year. This evidence is generalizable nationally and internationally. We suggest that GPs ask patients to return at 6 months if their fatigue does not remit, when therapy options can be discussed further.

Chronic pain through COVID.

Objectives: To identify good practice in the community management of chronic pain, and to understand the perspective of a group of healthcare service users towards the management of chronic pain using technology during the COVID-19 pandemic. Methods: Forty-five people, recruited via social media and Pain Association Scotland, participated in three focus groups hosted over Zoom. Focus groups were conducted using semi-structured questions to guide the conversation. Data were analysed using Ritchie / Spencer's Framework Analysis. Results: The participants shared observations of their experiences of remotely supported chronic pain services and insights into the potential for future chronic pain care provision. Experiences were in the majority positive with some describing their rapid engagement with technology during the COVID pandemic. Conclusion: Results suggest there is strong potential for telehealth to complement and support existing provision of pain management services.