Paul McCrone

An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial

BACKGROUND Breathlessness is a common and distressing symptom, which increases in many diseases as they progress and is difficult to manage. We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness. METHODS In this single-blind randomised trial, we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London. We randomly allocated (1:1) patients to receive either a breathlessness support service or usual care. Randomisation was computer generated centrally by the independent Clinical Trials Unit in a 1:1 ratio, by minimisation to balance four potential confounders: cancer versus non-cancer, breathlessness severity, presence of an informal caregiver, and ethnicity. The breathlessness support service was a short-term, single point of access service integrating palliative care, respiratory medicine, physiotherapy, and occupational therapy. Research interviewers were masked as to which patients were in the treatment group. Our primary outcome was patient-reported breathlessness mastery, a quality of life domain in the Chronic Respiratory Disease Questionnaire, at 6 weeks. All analyses were by intention to treat. Survival was a safety endpoint. This trial is registered with ClinicalTrials.gov, number NCT01165034. FINDINGS Between Oct 22, 2010 and Sept 28, 2012, 105 consenting patients were randomly assigned (53 to breathlessness support service and 52 to usual care). 83 of 105 (78%) patients completed the assessment at week 6. Mastery in the breathlessness support service group improved compared with the control (mean difference 0·58, 95% CI 0·01-1·15, p=0·048; effect size 0·44). Sensitivity analysis found similar results. Survival rate from randomisation to 6 months was better in the breathlessness support service group than in the control group (50 of 53 [94%] vs 39 of 52 [75%]) and in overall survival (generalised Wilcoxon 3·90, p=0·048). Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer. INTERPRETATION The breathlessness support service improved breathlessness mastery. Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer. The improvement in survival requires further investigation. FUNDING UK National Institute for Health Research (NIHR) and Cicely Saunders International.

Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology

This revision of the 2005 British Association for Psychopharmacology guidelines for the evidence-based pharmacological treatment of anxiety disorders provides an update on key steps in diagnosis and clinical management, including recognition, acute treatment, longer-term treatment, combination treatment, and further approaches for patients who have not responded to first-line interventions. A consensus meeting involving international experts in anxiety disorders reviewed the main subject areas and considered the strength of supporting evidence and its clinical implications. The guidelines are based on available evidence, were constructed after extensive feedback from participants, and are presented as recommendations to aid clinical decision-making in primary, secondary and tertiary medical care. They may also serve as a source of information for patients, their carers, and medicines management and formulary committees.

Adjuvant occupational therapy for work-related major depression works : randomized trial including economic evaluation

BACKGROUND Major depression has far-reaching consequences for work functioning and absenteeism. In most cases depression is treated by medication and clinical management. The addition of occupational therapy (OT) might improve outcome. We determined the cost-effectiveness of the addition of OT to treatment as usual (TAU). METHOD Sixty-two adults with major depression and a mean absenteeism of 242 days were randomized to TAU (out-patient psychiatric treatment) or TAU+OT [6 months, including (i) diagnostic phase with occupational history and work reintegration plan, and (ii) therapeutic phase with individual sessions and group sessions]. Main outcome domains were depression, work resumption, work stress and costs. Assessments were at baseline and at 3, 6, 12 and 42 months. RESULTS The addition of OT to TAU: (i) did not improve depression outcome, (ii) resulted in a reduction in work-loss days during the first 18 months, (iii) did not increase work stress, and (iv) had a 75.5% probability of being more cost-effective than TAU alone. CONCLUSION Addition of OT to good clinical practice does not improve depression outcome, improves productivity without increasing work stress and is superior to TAU in terms of cost-effectiveness.

Mental disorders among Somali refugees: developing culturally appropriate measures and assessing socio-cultural risk factors.

BackgroundThere are few mental health data for Somali people. This is due to the absence of culturally validated appropriate assessment instruments and methodological challenges. We aimed to develop a culturally appropriate instrument, and address the methodological challenges and assess some risk factors for mental disorder among Somalis in London.MethodsFollowing a comprehensive process of cultural adaptation of the MINI Neuropsychiatric Interview, we assessed ICD-10 mental disorders among 143 Somalis recruited from GP registers and community sites. Associations with demographic and economic characteristics, sampling venues, cultural and migration related risk factors are reported.ResultsA higher risk of mental disorders was found among Somalis who used Khat (OR = 10.5, 1.1–98.3) claimed asylum at entry to the UK (OR = 12.8, 2–81.4) and recruits from primary care rather than from community sites (OR = 5.9, 1.4–25.8). A lower risk of mental disorders was found amongst Somalis in employment (OR = 0.03, 0.01–0.61), and those receiving education in the UK and in Somalia (OR = 0.13, 0.02–0.92). Over a third of subjects had any mental disorder (36.4%, 28.4–44.4), mainly common mental disorders (CMD) (33.8%, 26–41.5) and post-traumatic stress disorder (PTSD) (14%, 8.8–20.8). CMD were found among 80% of those with PTSD.ConclusionPublic health interventions for Somalis should focus on CMD as well as PTSD, khat use and mental health screening for suicide risk and mental disorders on arrival.

Evaluating complex interventions in End of Life Care: the MORECare Statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews

BackgroundDespite being a core business of medicine, end of life care (EoLC) is neglected. It is hampered by research that is difficult to conduct with no common standards. We aimed to develop evidence-based guidance on the best methods for the design and conduct of research on EoLC to further knowledge in the field.MethodsThe Methods Of Researching End of life Care (MORECare) project built on the Medical Research Council guidance on the development and evaluation of complex circumstances. We conducted systematic literature reviews, transparent expert consultations (TEC) involving consensus methods of nominal group and online voting, and stakeholder workshops to identify challenges and best practice in EoLC research, including: participation recruitment, ethics, attrition, integration of mixed methods, complex outcomes and economic evaluation. We synthesised all findings to develop a guidance statement on the best methods to research EoLC.ResultsWe integrated data from three systematic reviews and five TECs with 133 online responses. We recommend research designs extending beyond randomised trials and encompassing mixed methods. Patients and families value participation in research, and consumer or patient collaboration in developing studies can resolve some ethical concerns. It is ethically desirable to offer patients and families the opportunity to participate in research. Outcome measures should be short, responsive to change and ideally used for both clinical practice and research. Attrition should be anticipated in studies and may affirm inclusion of the relevant population, but careful reporting is necessitated using a new classification. Eventual implementation requires consideration at all stages of the project.ConclusionsThe MORECare statement provides 36 best practice solutions for research evaluating services and treatments in EoLC to improve study quality and set the standard for future research. The statement may be used alongside existing statements and provides a first step in setting common, much needed standards for evaluative research in EoLC. These are relevant to those undertaking research, trainee researchers, research funders, ethical committees and editors.

Cost-effectiveness of an early intervention service for people with psychosis

BACKGROUND There is concern that delaying treatment for psychosis may have a negative impact on its long-term course. A number of countries have developed early intervention teams but there is limited evidence regarding their cost-effectiveness. AIMS To compare the costs and cost-effectiveness of an early intervention service in London with standard care. METHOD Individuals in their first episode of psychosis (or those who had previously discontinued treatment) were recruited to the study. Clinical variables and costs were measured at baseline and then at 6- and 18-month follow-up. Information on quality of life and vocational outcomes were combined with costs to assess cost-effectiveness. RESULTS A total of 144 people were randomised. Total mean costs were 11,685 pounds sterling in the early intervention group and 14,062 pounds sterling in the standard care group, with the difference not being significant (95% CI -8128 pounds sterling to 3326 pounds sterling). When costs were combined with improved vocational and quality of life outcomes it was shown that early intervention would have a very high likelihood of being cost-effective. CONCLUSIONS Early intervention did not increase costs and was highly likely to be cost-effective when compared with standard care.

Effect of early intervention on 5-year outcome in non-affective psychosis

BACKGROUND Early specialised care may improve short-term outcome in first-episode non-affective psychosis, but it is unclear if these benefits endure. AIMS To assess the long-term effect of early intervention in psychosis. METHOD Individuals with first-episode psychosis were randomised to specialised care or care as usual (trial number: ISRCTN73679874). Outcome after 5 years was assessed by case-note review. RESULTS There were no significant differences in the admission rate (coefficient 0.096, 95% CI -0.550 to 0.742, P = 0.770) or the mean number of bed days (coefficient 6.344, 95% CI -46 to 58.7, P = 0.810). CONCLUSIONS These findings that specialist intervention did not markedly improved outcome at 5 years accord with those from a larger OPUS study. The sample size of this study was small and these results should be generalised with caution. More research is needed.

Is Short-Term Palliative Care Cost-Effective in Multiple Sclerosis? A Randomized Phase II Trial

CONTEXT Palliative care is being advocated for noncancer patients but needs evidence of effectiveness and cost-effectiveness. OBJECTIVE We evaluated the cost-effectiveness of a new palliative care service for people with multiple sclerosis (MS). METHODS We used a randomized fast-track Phase II controlled trial. Patients in South East London who were severely affected by MS were referred by clinicians to the trial. After baseline interview, patients were randomly allocated to either a multiprofessional palliative care team (PCT) immediately (fast track) or the control care group who continued best usual care for three months and then were offered the PCT. Data were collected at baseline, 6, 12, 18, and 26 weeks on use of services, patient symptoms, other outcomes, and caregiver burden. RESULTS Fifty-two patients were randomized: 25 fast track and 21 control patients completed the trial. There was a high level of disability, and mean Expanded Disability Status Scale score was 7.7 (median 8, standard deviation 1.0). At 12 weeks, caregiver burden was 4.47 points lower (95% confidence interval [CI]: 1.05-7.89) in the fast track compared to the control group. Mean service costs, including inpatient care and informal care, over the 0-12-week follow-up were pound1,789 lower for the fast-track group (bootstrapped 95% CI: - pound5,224 to pound1,902). There was a trend toward lower community costs in the fast-track group and no differences in costs to informal caregivers. CONCLUSIONS The trial suggests that short-term palliative care for people severely affected by MS and their caregivers will be cost-effective and warrants further study. The fast-track trial design could be used to assess this.

Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial

Summary Background Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care. Methods We did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16–60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013. Findings 187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference −3·75, 95% CI −7·92 to 0·42; p=0·08; IDEAS −0·95, −1·68 to −0·23; p=0·01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall symptoms (PANSS 85 [51%] in the intervention group vs 44 [51%] in the control group; p=0·89; IDEAS 75 [48%] vs 28 [35%]). We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site (−9·29, −15·41 to −3·17; p=0·003). Two patients (one in each group) died by suicide during the study, and two patients died because of complications of a road traffic accident and pre-existing cardiac disease. 18 (73%) patients (17 in the intervention group) were admitted to hospital during the course of the trial, of whom seven were admitted because of physical health problems, such as acute gastritis and vomiting, road accident, high fever, or cardiovascular disease. Interpretation The collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care, especially for reducing disability and symptoms of psychosis. Our results show that the study intervention is best implemented as an initial service in settings where services are scarce, for example in rural areas. Funding Wellcome Trust.

The economic impact of mental health stigma and discrimination: A systematic review

UNLABELLED People with mental illness face stigma and discrimination in a variety of settings which can have an economic impact. AIM The aim of this paper was to identify literature on the economic impact of mental illness stigma. METHODS A systematic review of the literature identified 30 papers from 27 studies by searching electronic databases and hand searching reference lists. RESULTS Mental illness stigma/discrimination was found to impact negatively on employment, income, public views about resource allocation and healthcare costs. CONCLUSIONS Stigma and discrimination regarding mental health problems lead to adverse economic effects for people with these conditions. Interventions that reduce stigma may therefore also be economically beneficial.