A Cluster-Randomised Trial Evaluating an Intervention for Patients with Stress-Related Mental Disorders and Sick Leave in Primary Care

Objective: Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%–18%. In developed countries, mental health problems are one of the main grounds for receiving disability benefits. In up to 90% of cases the cause is stress-related, and health-care utilisation is mainly restricted to primary care. The aim of this study was to assess the effectiveness of our Minimal Intervention for Stress-related mental disorders with Sick leave (MISS) in primary care, which is intended to reduce sick leave and prevent chronicity of symptoms. Design: Cluster-randomised controlled educational trial. Setting: Primary health-care practices in the Amsterdam area, The Netherlands. Participants: A total of 433 patients (MISS n ¼ 227, usual care [UC] n ¼ 206) with sick leave and self-reported elevated level of distress. Interventions: Forty-six primary care physicians were randomised to either receive training in the MISS or to provide UC. Eligible patients were screened by mail. Outcome Measures: The primary outcome measure was duration of sick leave until lasting full return to work. The secondary outcomes were levels of self-reported distress, depression, anxiety, and somatisation. Results: No superior effect of the MISS was found on duration of sick leave (hazard ratio 1.06, 95% confidence interval 0.87–1.29) nor on severity of self-reported symptoms. Conclusions: We found no evidence that the MISS is more effective than UC in our study sample of distressed patients. Continuing research should focus on the potential beneficial effects of the MISS; we need to investigate which elements of the intervention might be useful and which elements should be adjusted to make the MISS effective

Low back pain in general practice: cost-effectiveness of a minimal psychosocial intervention versus usual care

An intervention that can prevent low back pain (LBP) becoming chronic, may not only prevent great discomfort for patients, but also save substantial costs for the society. Psychosocial factors appear to be of importance in the transition of acute to chronic LBP. The aim of this study was to compare the cost-effectiveness of an intervention aimed at psychosocial factors to usual care in patients with (sub)acute LBP. The study design was an economic evaluation alongside a cluster-randomized controlled trial, conducted from a societal perspective with a follow-up of 1 year. Sixty general practitioners in 41 general practices recruited 314 patients with non-specific LBP of less than 12 weeks’ duration. General practitioners in the minimal intervention strategy (MIS) group explored and discussed psychosocial prognostic factors. Usual care (UC) was not protocolized. Clinical outcomes were functional disability (Roland–Morris Disability Questionnaire), perceived recovery and health-related quality of life (EuroQol). Cost data consisted of direct and indirect costs and were measured by patient cost diaries and general practitioner registration forms. Complete cost data were available for 80% of the patients. Differences in clinical outcomes between both the groups were small and not statistically significant. Differences in cost data were in favor of MIS. However, the complete case analysis and the sensitivity analyses with imputed cost data were inconsistent with regard to the statistical significance of this difference in cost data. This study presents conflicting points of view regarding the cost-effectiveness of MIS. We conclude that (Dutch) general practitioners, as yet, should not replace their usual care by this new intervention

Conducting research in individual patients: lessons learnt from two series of N-of-1 trials

BACKGROUND: Double-blind randomised N-of-1 trials (N-of-1 trials) may help with decisions concerning treatment when there is doubt regarding the effectiveness and suitability of medication for individual patients. The patient is his or her own control, and receives the experimental and the control treatment during several periods of time in random order. Reports of N-of-1 trials are still relatively scarce, and the research methodology is not as firmly established as that of RCTs. Recently, we have conducted two series of N-of-1 trials in general practice. Before, during, and after data-collection, difficulties regarding outcome assessment, analysis of the results, the withdrawal of patients, and the follow-up had to be dealt with. These difficulties are described and our solutions are discussed. DISCUSSION: To prevent or anticipate difficulties in N-of-1 trials, we argue that that it is important to individualise the outcome measures, and to carefully consider the objective, type of randomisation and the analysis. It is recommended to use the same dosages and dosage forms that the patient used before the trial, to start the trial with a run-in period, to formulate both general and individualised decision rules regarding the efficacy of treatment, to adjust treatment policies immediately after the trial, and to provide adequate instructions and support if treatment is adjusted. SUMMARY: Because of the specific characteristics of N-of-1 trials it is difficult to formulate general 'how to do it' guidelines for designing N-of-1 trials. However, when the design of each N-of-1 trial is tailored to the specific characteristics of each individual patient and the underlying medical problem, most difficulties in N-of-1 trials can be prevented or overcome. In this way, N-of-1 trials may be of help when deciding on drug treatment for individual patients

The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization

BACKGROUND: The Four-Dimensional Symptom Questionnaire (4DSQ) is a self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. The purpose of this paper is to evaluate its criterion and construct validity. METHODS: Data from 10 different primary care studies have been used. Criterion validity was assessed by comparing the 4DSQ scores with clinical diagnoses, the GPs' diagnosis of any psychosocial problem for Distress, standardised psychiatric diagnoses for Depression and Anxiety, and GPs' suspicion of somatization for Somatization. ROC analyses and logistic regression analyses were used to examine the associations. Construct validity was evaluated by investigating the inter-correlations between the scales, the factorial structure, the associations with other symptom questionnaires, and the associations with stress, personality and social functioning. The factorial structure of the 4DSQ was assessed through confirmatory factor analysis (CFA). The associations with other questionnaires were assessed with Pearson correlations and regression analyses. RESULTS: Regarding criterion validity, the Distress scale was associated with any psychosocial diagnosis (area under the ROC curve [AUC] 0.79), the Depression scale was associated with major depression (AUC = 0.83), the Anxiety scale was associated with anxiety disorder (AUC = 0.66), and the Somatization scale was associated with the GPs' suspicion of somatization (AUC = 0.65). Regarding the construct validity, the 4DSQ scales appeared to have considerable inter-correlations (r = 0.35-0.71). However, 30–40% of the variance of each scale was unique for that scale. CFA confirmed the 4-factor structure with a comparative fit index (CFI) of 0.92. The 4DSQ scales correlated with most other questionnaires measuring corresponding constructs. However, the 4DSQ Distress scale appeared to correlate with some other depression scales more than the 4DSQ Depression scale. Measures of stress (i.e. life events, psychosocial problems, and work stress) were mainly associated with Distress, while Distress, in turn, was mainly associated with psychosocial dysfunctioning, including sick leave. CONCLUSION: The 4DSQ seems to be a valid self-report questionnaire to measure distress, depression, anxiety and somatization in primary care patients. The 4DSQ Distress scale appears to measure the most general, most common, expression of psychological problems

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

Is treatment of atrial fibrillation in primary care based on thromboembolic risk assessment?

BACKGROUND: Antithrombotic treatment in atrial fibrillation should be guided by the risk of thromboembolic events. Although practice studies have shown underutilization of antithrombotics, it is not clear whether physicians make use of thromboembolic risk stratification in their treatment decisions, as recommended in current guidelines. OBJECTIVE: The aim of the present study was to assess which clinical determinants influence coumarin and aspirin prescription in patients with atrial fibrillation in primary care. METHODS: In a cross-sectional study of 15 computerized general practices covering 38 000 patients in The Netherlands, we identified patients with atrial fibrillation using several search algorithms. Determinants of antithrombotic therapy were assessed using polytomous logistic regression analysis. RESULTS: A total of 247 patients with atrial fibrillation were identified among 10 335 patients aged 55 years or over (prevalence 2.4%). Mean age was 77 years (range 55-95); 51% were male. Overall, 52% of the patients used coumarin and 27% used aspirin. About 50% of patients were also treated by a cardiologist. Referred patients were prescribed coumarin more often (63% versus 35%, P < 0.001). Prior stroke/transient ischaemic attack or systemic embolism [adjusted odds ratio (OR) 5.3, 95% confidence interval (CI) 1.1-24.8], and chronic heart failure (adjusted OR 2.1, 95% CI 0.8-5.1) were independent determinants for coumarin prescription. These associations were less strong for aspirin prescription. However, other established risk factors for future thromboembolic events, such as hypertension and diabetes mellitus, did not lead to higher prescription rates. In contrast, several factors not associated with thromboembolic events, such as chronic (versus paroxysmal) atrial fibrillation (adjusted OR 3.7, 95% CI 1.7-8.2) and longstanding (versus recent) diagnosis (adjusted OR 2.2, 95% CI 1.1-4.5), were also associated with higher coumarin prescription. CONCLUSION: These results illustrate that physicians' decisions about initiating antithrombotic therapy in atrial fibrillation are not evidence based. They are guided partly by thromboembolic risk stratification, but also by factors insignificant for thromboembolic risk

Feasibility and acceptability of a physical activity promotion programme in general practice

BACKGROUND: Physical activity promotion in general practice is advocated though not incorporated into daily practice. Several barriers must be overcome to develop a feasible and acceptable programme. OBJECTIVE: The aim of this study was to conduct a process evaluation of a physical activity promotion programme in general practice (PACE), in which patients visited their provider (GP or practice nurse) twice. METHODS: Process evaluation was conducted by means of telephone-administered, semi-structured interviews with providers and practice assistants. The main topics of the interviews were overall impression of PACE, PACE training, content and usability of the intervention materials, counselling, implementation of the intervention, and opportunities for future use. RESULTS: In the 15 participating general practices, a total of 17 providers and 12 practice assistants were interviewed. The overall impression of the PACE programme was positive. Most providers experienced the provided material and training as helpful. Some problems concerning the number of forms used and patients having difficulties completing the forms were mentioned. Most providers (70.6%) spend 10 min or more discussing PACE during the first consultation. The second consultation mostly was completed within 10 min. Patients overestimating their level of physical activity was mentioned as the main barrier in providing the counselling. PACE was evaluated as suitable for implementation in Dutch general practice, and 60% of the providers actually intended using PACE in the future. CONCLUSION: The PACE programme was evaluated as being both acceptable and feasible in a selection of Dutch general practices. Positive adaptations will be made in order to implement PACE successfully in general practice at a wider scale

Is asthma in 2-12 year-old children associated with physician-attended recurrent upper respiratory tract infections?

In a prevalence study, we evaluated whether recurrent physician-attended URTI episodes are more common in asthmatic children as compared to age- and gender-matched controls. URTI proneness, defined as > or = 5 episodes of rhinitis/pharyngitis, sinusitis, laryngitis/tracheitis or otitis media in a 24-month period, was more common in asthmatics than controls (adjusted odds ratio 2.5, 95% confidence interval: 1.1-6.1). As a consequence, antibiotic prescriptions and referrals to hospitals occurred more frequently among asthmatics than controls