Should we still give our asthmatic patients written individualised management plans?

The document attached has been archived with permission from the editor of the Medical Journal of Australia. An external link to the publisher’s copy is included.Andrew M Thornett, Jonathan W Newbury and Andre J Duszynsk

A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin reuptake inhibitors and lofepramine

Aim/ Principal Research Question - The main aim of the “AHEAD” study was to determine the relative cost-effectiveness of three classes of antidepressants: tricyclics (TCAs), selective serotonin reuptake inhibitors (SSRIs), and the tricyclic-related antidepressant lofepramine, as first choice treatments for depression in UK primary care. Factors of interest - This is the first randomised prospective study in UK primary care to address this question. Most previous work on this topic has relied upon modelling and/or post hoc analysis of data collected for other purposes. The only other published trial of this type was conducted in HMOs in the United States.Methods - The study was an open label, pragmatic controlled trial with three randomised arms and one preference arm. Patients were followed up for a total of 12 months. Patients were randomised to receive a tricyclic antidepressant (amitriptyline, dothiepin, or imipramine), a selective serotonin reuptake inhibitor (fluoxetine, sertraline, or paroxetine), or lofepramine. Standardised recommendations about dose and dose escalation based on the BNF were issued to GPs. Cost effectiveness was based upon an analysis of direct costs from an NHS perspective.Sample groups - The study was carried out in UK primary care: 73 practices in urban and rural areas in Hampshire, Wiltshire, Dorset, Sussex, and Surrey agreed initially to take part. Patients with a new episode of depressive illness according to GP diagnosis were recruited. A total of 388 patients were referred to the study team by 87 GPs from 55 practices. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves (CEACs) were computed. Estimates were bootstrapped with 5000 replications.Outcome measures - At baseline the Clinical Interview Schedule, Revised (CIS-R PROQSY computerised version) was administered to establish symptom profiles. Outcome measures over 12 month follow-up included the Hospital Anxiety and Depression Scale self-rating of depression (HAD-D), CIS-R, EuroQol (EQ-5D) for quality of life, Short Form (SF-36) Health Survey for generic health status, and patient and practice records of use of health and social services (UHSS). The primary effectiveness outcome was the number of depression-free weeks (HAD-D less than 8, with interpolation of intervening values), and the primary cost outcome total direct NHS costs. Quality adjusted life years (QALYs) were used as the outcome measure in a secondary analysis. Findings - 327 patients were randomised. Follow-up rates were 68% at 3 months and 52% at 1 year. Linear regression analysis revealed no significant differences between groups in number of depression-free weeks when adjusted for baseline HAD-D. A higher proportion of patients randomised to TCAs entered the preference arm than those allocated to the other choices. Switching to another class of antidepressant in the first few weeks of treatment occurred significantly more often in the lofepramine arm and less in the preference arm. There were no significant differences between arms in mean cost per depression-free week. For values placed on an additional QALY of over £5,000, treatment with SSRIs was likely to be the most cost-effective strategy. Tricyclics were the least likely to be cost-effective as first choice of antidepressant for most values of a depression free week or QALY respectively, but these differences were relatively modest.Conclusion - Given the low probability of significant differences in cost-effectiveness, it is appropriate to base the first choice between these three classes of antidepressant in primary care on doctor and patient preferences. Adopting this policy may lead to less switching of medication subsequently. Choosing lofepramine is likely to lead to a greater proportion of patients switching treatment in the first few weeks.Implications for further research - It is difficult to see how a better study of this topic could be conducted in the primary care setting. The research agenda concerning the management of depression in primary care should move on to address important questions such as the most appropriate threshold of severity at which to commence antidepressant medication, the effectiveness of strategies to improve recognition of depression and quality of management of identified patients, and the efficacy of interventions to improve persistence in treatment taking by patients

Shop stewards’ leadership, left-wing activism and collective workplace union organisation

Providing an account of the dynamic interrelationship between shop steward leadership and membership interaction, Ralph Darlington focuses particular attention on the much-neglected crucial role that left-wing political activists can play in shaping the nature of collective workplace relations

Considering Usual Medical Care in Clinical Trial Design

Liza Dawson and colleagues discuss the scientific and ethical issues associated with choosing clinical trial designs when there is no consensus on what constitutes usual care

The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>In patients with type 2 diabetes, the risk for cardiovascular disease is substantial. To achieve a more favourable risk profile, lifestyle changes on diet, physical activity and smoking status are needed. This will involve changes in behaviour, which is difficult to achieve. Cognitive behavioural therapies focussing on self-management have been shown to be effective. We have developed an intervention combining techniques of Motivational Interviewing (MI) and Problem Solving Treatment (PST). The aim of our study is to investigate if adding a combined behavioural intervention to managed care, is effective in achieving changes in lifestyle and cardiovascular risk profile.</p> <p>Methods</p> <p>Patients with type 2 diabetes will be selected from general practices (n = 13), who are participating in a managed diabetes care system. Patients will be randomised into an intervention group receiving cognitive behaviour therapy (CBT) in addition to managed care, and a control group that will receive managed care only. The CBT consists of three to six individual sessions of 30 minutes to increase the patient's motivation, by using principles of MI, and ability to change their lifestyle, by using PST. The first session will start with a risk assessment of diabetes complications that will be used to focus the intervention.</p> <p>The primary outcome measure is the difference between intervention and control group in change in cardiovascular risk score. For this purpose blood pressure, HbA_1c, total and HDL-cholesterol and smoking status will be assessed. Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating behaviour, smoking status, depression and determinants of behaviour change. Differences between changes in the two groups will be analysed according to the intention-to-treat principle, with 95% confidence intervals. The power calculation is based on the risk for cardiovascular disease and we calculated that 97 patients should be included in every group.</p> <p>Discussion</p> <p>Cognitive behavioural therapy may improve self-management and thus strengthen managed diabetes care. This should result in changes in lifestyle and cardiovascular risk profile. In addition, we also expect an improvement of quality of life and patient satisfaction.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN12666286</p

Depression care management for late-life depression in China primary care: Protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>As a major public health issue in China and worldwide, late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Like other chronic diseases in elders such as hypertension and diabetes, depression is a chronic disease that the new National Health Policy of China indicates should be managed in primary care settings. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management (DCM) intervention, and examine its effectiveness on the depressive symptoms of older patients in Chinese primary care settings.</p> <p>Methods/Design</p> <p>The trial is a multi-site, primary clinic based randomized controlled trial design in Hangzhou, China. Sixteen primary care clinics will be enrolled in and randomly assigned to deliver either DCM or care as usual (CAU) (8 clinics each) to 320 patients (aged ≥ 60 years) with major depression (20/clinic; n = 160 in each treatment condition). In the DCM arm, primary care physicians (PCPs) will prescribe 16 weeks of antidepressant medication according to the treatment guideline protocol. Care managers monitor the progress of treatment and side effects, educate patients/family, and facilitate communication between providers; psychiatrists will provide weekly group psychiatric consultation and CM supervision. Patients in both DCM and CAU arms will be assessed by clinical research coordinators at baseline, 4, 8, 12, 18, and 24 months. Depressive symptoms, functional status, treatment stigma and clients' satisfaction will be used to assess patients' outcomes; and clinic practices, attitudes/knowledge, and satisfaction will be providers' outcomes.</p> <p>Discussion</p> <p>This will be the first trial of the effectiveness of a collaborative care intervention aiming to the management of late-life depression in China primary care. If effective, its finding will have relevance to policy makers who wish to scale up DCM treatments for late-life depression in national wide primary care across China.</p> <p>Study Registration</p> <p>The DCM project is registered through the National Institutes of Health sponsored by clinical trials registry and has been assigned the identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01287494">NCT01287494</a></p