Charles Shepherd

Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR): a pilot randomised control trial of the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation service

BACKGROUND There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI. OBJECTIVE The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI. DESIGN A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation. SETTING Primary care and secondary care mental health services in England. PARTICIPANTS Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking. INTERVENTIONS A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care. MAIN OUTCOME MEASURES The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation. RESULTS The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis. CONCLUSIONS It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness. TRIAL REGISTRATION Current Controlled Trials ISRCTN79497236. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

Illness behaviour in the chronic fatigue syndrome and multiple sclerosis. Disentangling common characteristics is not so easy.

EDITOR,--Over the past few years I have seen a growing number of patients with the chronic fatigue syndrome who have been told by psychiatrists and psychologists that abnormal illness behaviour and psychosocial factors are the main factors perpetuating their disability. Few patients have accepted or believed this explanation; neither have I. The ME Association now has evidence that the fashionable theory …

Exploring the feasibility of establishing a disease-specific post-mortem tissue bank in the UK: a case study in ME/CFS

Background Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a condition, the aetiology of which remains controversial, and there is still no consensus on its nature and determination. It has rarely been studied in post-mortem examinations, despite increasing evidence of abnormalities from neuroimaging studies. Aim To ascertain the feasibility of developing a national post-mortem ME/CFS tissue bank in the UK, to enhance studies on aetiology and pathogenesis, including cell and tissue abnormalities associated with the condition. Methods The case study was carried out combining qualitative methods, ie, key informant interviews, focus group discussions with people with ME/CFS, and a workshop with experts in ME/CFS or in tissue banking. Results and conclusions The study results suggest that the establishment of the post-mortem ME/CFS tissue bank is both desirable and feasible, and would be acceptable to the possible tissue donors, provided that some issues were explicitly addressed.

Severely affected, severely neglected

Santhouse and colleagues make several conclusions and observations that are over-simplistic, premature, or inaccurate.1 Firstly, the media did use Lynn Gilderdale’s case to highlight the existence of severe chronic fatigue syndrome (CFS) and the desperate need for biomedical research into the underlying cause. But the coverage did not imply that CFS is a “commonly fatal” condition, and …

Magnesium and chronic fatigue syndrome

Magnesium might have a beneficial effect on chronic fatigue syndrome (CFS).

Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial)

Study question How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression? Methods This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme (“Beating the Blues”) or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months. Study answer and limitations Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. What this study adds Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care. Funding, competing interests, data sharing Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management group Trial registration Current Controlled Trials ISRCTN91947481.

Shark cartilage in the water: Effective legislation is already in place but is not being properly used.

Waxman has identified the need for effective legislation to protect vulnerable cancer patients from unproven and/or harmful cancer remedies.1 The UK 1939 Cancer Act in section …

GPs' attitudes to a self diagnosis of myalgic encephalomyelitis. Evidence supports presence of encephalitis.

EDITOR,—Although the precise pathoaetiology of myalgic encephalomyelitis remains the subject of debate, Shonagh Scott and colleagues are incorrect in asserting that “no evidence exists” of encephalitis. Buchwald et al carried out a large cohort study in which neurological symptoms, results of magnetic resonance imaging, and lymphocyte phenotyping suggested that the patients were experiencing “a chronic, immunologically mediated inflammatory process of the central nervous system.”2 More recently, Schwartz et …

Patients with a self diagnosis of myalgic encephalomyelitis.

EDITOR,--S J Hurel and colleagues should have checked their facts more thoroughly before making such a generalised attack on the content of literature produced by the two support groups for patients with myalgic encephalomyelitis (ME).1 The ME Association does not believe that candida albicans is involved in the pathogenesis of the condition. Our booklet Guidelines for the Care of Patients states that “no reliable scientific evidence …

Description of ME revised in disability handbook

pain is of no value in localising the site of the lesion.2 We advocate consultation with a senior doctor and consideration of early computed tomography for patients with a good history of neck rotation at the time of impact. This increases the chance of bony injury,2 particularly between the occiput and C2, which is often poorly visualised in plain films. Computed tomography should also be considered in those with a fixed abnormal neck position, particularly if pain does not seem to be the restricting factor, and those with definite neurological signs and symptoms, even if their presentation is delayed.