Effectiveness of collaborative stepped care for anxiety disorders in primary care: a pragmatic cluster randomised controlled trial.

BACKGROUND: Collaborative stepped care (CSC) may be an appropriate model to provide evidence-based treatment for anxiety disorders in primary care. METHODS: In a cluster randomised controlled trial, the effectiveness of CSC compared to care as usual (CAU) for adults with panic disorder (PD) or generalised anxiety disorder (GAD) in primary care was evaluated. Thirty-one psychiatric nurses who provided their services to 43 primary care practices in the Netherlands were randomised to deliver CSC (16 psychiatric nurses, 23 practices) or CAU (15 psychiatric nurses, 20 practices). CSC was provided by the psychiatric nurses (care managers) in collaboration with the general practitioner and a consultant psychiatrist. The intervention consisted of 3 steps, namely guided self-help, cognitive behavioural therapy and antidepressants. Anxiety symptoms were measured with the Beck Anxiety Inventory (BAI) at baseline and after 3, 6, 9 and 12 months. RESULTS: We recruited 180 patients with a DSM-IV diagnosis of PD or GAD, of whom 114 received CSC and 66 received usual primary care. On the BAI, CSC was superior to CAU [difference in gain scores from baseline to 3 months: -5.11, 95% confidence interval (CI) -8.28 to -1.94; 6 months: -4.65, 95% CI -7.93 to -1.38; 9 months: -5.67, 95% CI -8.97 to -2.36; 12 months: -6.84, 95% CI -10.13 to -3.55]. CONCLUSIONS: CSC, with guided self-help as a first step, was more effective than CAU for primary care patients with PD or GAD.

Collaborative care for sick-listed workers with major depressive disorder: a randomised controlled trial from the Netherlands Depression Initiative aimed at return to work and depressive symptoms.

OBJECTIVES: Major depressive disorder (MDD) is associated with absenteeism. In this study, the effectiveness of collaborative care, with a focus on return to work (RTW), was evaluated in its effect on depressive symptoms and the duration until RTW in sick-listed workers with MDD in the occupational health setting. METHODS: In this randomised controlled trial, 126 sick-listed workers with MDD were randomised to usual care (N=61) or collaborative care (N=65). Collaborative care was applied by the occupational physician care manager, supported by a web-based tracking system and a consultant psychiatrist. Primary outcome measure was time to response. Secondary outcome measures were time to remission, depressive symptoms as continuous measure and the duration until full RTW. RESULTS: Collaborative care participants had a shorter time to response, with a difference of 2.8 months. However, no difference was found on time to remission or depressive symptoms as continuous measure. With a mean of 190 days in the collaborative care group, and 210 days in the usual care group, the groups did not differ significantly from each other in the duration until full RTW. Adherence to the collaborative care intervention was low. CONCLUSIONS: These results do not justify a widespread implementation of collaborative care in occupational healthcare, as it was operationalised in this study. However, since the study might have been underpowered for RTW and because treatment integrity was low, further research, with larger sample sizes, is needed to develop the best fitting (collaborative care) model for addressing RTW in depressed sick-listed workers. TRIAL REGISTRATION: : ISRCTN78462860.

Screening high-risk patients and assisting in diagnosing anxiety in primary care: the Patient Health Questionnaire evaluated.

BACKGROUND: Questionnaires may help in detecting and diagnosing anxiety disorders in primary care. However, since utility of these questionnaires in target populations is rarely studied, the Patient Health Questionnaire anxiety modules (PHQ) were evaluated for use as: a) a screener in high-risk patients, and/or b) a case finder for general practitioners (GPs) to assist in diagnosing anxiety disorders. METHODS: A cross-sectional analysis was performed in 43 primary care practices in the Netherlands. The added value of the PHQ was assessed in two samples: 1) 170 patients at risk of anxiety disorders (or developing them) according to their electronic medical records (high-risk sample); 2) 141 patients identified as a possible 'anxiety case' by a GP (GP-identified sample). All patients completed the PHQ and were interviewed using the Mini International Neuropsychiatric interview to classify DSM-IV anxiety disorders. Psychometric properties were calculated, and a logistic regression analysis was performed to assess the diagnostic value of the PHQ. RESULTS: Using only the screening questions of the PHQ, the area under the curve was 83% in the high-risk sample. In GP-identified patients the official algorithm showed the best characteristics with an area under the curve of 77%. Positive screening questions significantly increased the odds of an anxiety disorder diagnosis in high-risk patients (odds ratio = 23.4; 95% confidence interval 6.9 to 78.8) as did a positive algorithm in GP-identified patients (odds ratio = 13.9; 95% confidence interval 3.8 to 50.6). CONCLUSIONS: The PHQ screening questions can be used to screen for anxiety disorders in high-risk primary care patients. In GP-identified patients, the benefit of the PHQ is less evident.

Chest pain, depression and anxiety in coronary heart disease: Consequence or cause? A prospective clinical study in primary care.

OBJECTIVE: To examine if chest pain increases the risk of depression and anxiety, or, on the other hand, depression and anxiety increase the risk of chest pain onset in patients with coronary heart disease (CHD). DESIGN: Prospective clinical study. SETTING: 16 general practices in the Greater London Primary Care Research Network. PARTICIPANTS: 803 participants with a confirmed diagnosis of CHD at baseline on the Quality and Outcomes Framework (QOF) CHD registers. MAIN OUTCOME MEASURES: Rose Angina Questionnaire, HADS depression and anxiety subscales and PHQ-9 were assessed at seven time points, each 6 months apart. Multi-Level Analysis (MLA) and Structural Equation Modelling (SEM) were applied. RESULTS: Chest pain predicts both more severe anxiety and depression symptoms at all time points until 30 months after baseline. However, although anxiety predicted chest pain in the short term with a strong association, this association did not last after 18 months. Depression had only a small, negative association with chest pain. CONCLUSIONS: In persons with CHD, chest pain increases the risk of both anxiety and depression to a great extent. However, anxiety and depression have only limited effects on the risk for chest pain. This evidence suggests that anxiety and depression tend to be consequences rather than causes of cardiac chest pain. Intervention studies that support persons with CHD by providing this information should be devised and evaluated, thus deconstructing potentially catastrophic cognitions and strengthening emotional coping.

Collaborative stepped care for anxiety disorders in primary care: aims and design of a randomized controlled trial.

BACKGROUND: Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual. METHODS/DESIGN: The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC) or care as usual (CAU). In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1) guided self-help, 2) cognitive behavioral therapy and 3) antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI). Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. DISCUSSION: It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options for GAD and PD in the primary care setting. Results will become available in 2011. TRIAL REGISTRATION: NTR1071.

Practical guidelines for economic evaluations alongside equivalence trials.

An effective treatment already exists for many diseases. In these cases the effectiveness of a new treatment may be established by showing that the new treatment is as effective as (i.e., equivalent to) or at least as effective as (i.e., noninferior to) the old treatment. For an economic evaluation accompanying a clinical equivalence or noninferiority trial it is important to decide before the start of the study on the appropriate research question. In many cases the objective of the economic evaluation will be to show equivalence or noninferiority of the cost-effectiveness of the treatments. This has major implications for the design and analysis of the economic evaluation. In this article we propose methods for the analysis of economic equivalence and noninferiority studies that are similar to the methods applied to clinical equivalence and noninferiority trials. Furthermore, cost-effectiveness planes prove to be a valuable tool in the interpretation of the results in an economic equivalence or noninferiority trial. The concepts described in the article are illustrated using the results from an economic noninferiority trial.

Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: a randomized equivalence trial.

BACKGROUND: Minor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mild-major depression. We compared the effectiveness of usual primary care treatment, with or without antidepressants, in minor and mild-major depression. METHODS: A pragmatic patient-randomized equivalence trial with 52 weeks follow-up was conducted in The Netherlands. In total, 59 primary care physicians (PCPs) recruited and treated 181 adult patients with minor or mild-major depression. Patients were randomized to four consultations within 3 months of usual care plus antidepressants (UCandAD) or usual care alone (UCnoAD). The Montgomery Asberg Depression Rating Scale (MADRS) was used to assess changes in severity of depressive symptoms. The predefined equivalence margin was set at five points. Multilevel analysis was used to analyze the data. Secondary outcome measures were the Short-Form 36 (SF-36), and the Client Satisfaction Questionnaire (CSQ-8). RESULTS: Patients received on average 3.0 (SD 1.4) 15-min consultations within 3 months with (n = 85) or without paroxetine (n = 96). Equivalence of UCandAD and UCnoAD was demonstrated in the intention-to-treat analyses as well as the per-protocol analysis after 6 weeks, but not at 13, 26 and 52 weeks follow-up. No statistical differences in effectiveness between treatment groups were found in the intention-to-treat analysis. No differences in the physical and mental functioning (SF-36) were found between the treatment groups. Patients allocated to UCandAD were slightly more satisfied with their treatment at 13 weeks follow-up (but not at 52 weeks follow-up) than patients allocated to UCnoAD. Preliminary analyses suggested that subgroups such as patients with mild-major (instead of a minor) depression might benefit from antidepressant treatment. Patients who were assigned to their preferred treatment (in particular to UCnoAD) were more often compliant and had better clinical outcomes. CONCLUSION: UCandAD was as effective as UCnoAD over the first 6 weeks, but not at 13, 26, and 52 weeks. However, superiority of either treatment could not be demonstrated either. The question whether antidepressants add any clinical effect to usual care remains unresolved. We recommend future studies to look for subgroups of patients who may benefit from antidepressants. TRIAL REGISTRATION: Dutch Trial Registry ISRCN03007807.

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.

Surgery is more cost-effective than splinting for carpal tunnel syndrome in the Netherlands: results of an economic evaluation alongside a randomized controlled trial.

BACKGROUND: Carpal tunnel syndrome (CTS) is a common disorder, often treated with surgery or wrist splinting. The objective of this economic evaluation alongside a randomized trial was to evaluate the cost-effectiveness of splinting and surgery for patients with CTS. METHODS: Patients at 13 neurological outpatient clinics with clinically and electrophysiologically confirmed idiopathic CTS were randomly allocated to splinting (n = 89) or surgery (n = 87). Clinical outcome measures included number of nights waking up due to symptoms, general improvement, severity of the main complaint, paraesthesia at night and during the day, and utility. The economic evaluation was performed from a societal perspective and involved all relevant costs. RESULTS: There were no differences in costs. The mean total costs per patient were in the surgery group EURO 2,126 compared to EURO 2,111 in the splint group. After 12 months, the success rate in the surgery group (92%) was significantly higher than in the splint group (72%). The acceptability curve showed that at a relatively low ceiling ratio of EURO 2,500 per patient there is a 90% probability that surgery is cost-effective. CONCLUSION: In the Netherlands, surgery is more cost-effective compared with splinting, and recommended as the preferred method of treatment for patients with CTS.

Administering the MADRS by telephone or face-to-face: a validity study.

BACKGROUND: The Montgomery Asberg Depression Rating Scale (MADRS) is a frequently used observer-rated depression scale. In the present study, a telephonic rating was compared with a face-to-face rating in 66 primary care patients with minor or mild-major depression. The aim of the present study was to assess the validity of the administration by telephone. Additional objective was to study the validity of the first item, 'apparent sadness', the only item purely based on observation. METHODS: The present study was a validity study. During an in-person interview at the patient's home a trained interviewer administered the MADRS. A few days later the MADRS was administered again, but now by telephone and by a : Mean total score on the in-person administration was 24.0 (SD = 11.1), and on the telephone administration 23.5 (SD = 10.4). The ICC for the full scale was 0.65. Homogeneity analysis showed that the observation item 'apparent sadness' fitted well into the scale. CONCLUSION: The full MADRS, including the observation item 'apparent sadness', can be administered reliably by telephone.

Effectiveness and cost-effectiveness of early screening and treatment of malnourished patients.

BACKGROUND: About 25-40% of hospital patients are malnourished. With current clinical practices, only 50% of malnourished patients are identified by the medical and nursing staff. OBJECTIVE: The objective of this study was to report the cost and effectiveness of early recognition and treatment of malnourished hospital patients with the use of the Short Nutritional Assessment Questionnaire (SNAQ). DESIGN: The intervention group consisted of 297 patients who were admitted to 2 mixed medical and surgical wards and who received both malnutrition screening at admission and standardized nutritional care. The control group consisted of a comparable group of 291 patients who received the usual hospital clinical care. Outcome measures were weight change, use of supplemental drinks, use of tube feeding, use of parenteral nutrition and in-between meals, number of consultations by the hospital dietitian, and length of hospital stay. RESULTS: The recognition of malnutrition improved from 50% to 80% with the use of the SNAQ malnutrition screening tool during admission to the hospital. The standardized nutritional care protocol added approximately 600 kcal and 12 g protein to the daily intake of malnourished patients. Early screening and treatment of malnourished patients reduced the length of hospital stay in malnourished patients with low handgrip strength (ie, frail patients). To shorten the mean length of hospital stay by 1 d for all malnourished patients, a mean investment of 76 euros (91 US dollars) in nutritional screening and treatment was needed. The incremental costs were comparably low in the whole group and in the subgroup of malnourished patients with low handgrip strength. CONCLUSIONS: Screening with the SNAQ and early standardized nutritional care improves the recognition of malnourished patients and provides the opportunity to start treatment at an early stage of hospitalization. The additional costs of early nutritional care are low, especially in frail malnourished patients.

Withholding antibiotic treatment in pneumonia patients with dementia: a quantitative observational study.

BACKGROUND: Pneumonia is a life-threatening disease in nursing home patients with dementia. Physicians and families face choices about whether to withhold antibiotics when patients are expected to die soon or when treatment may be burdensome. However, little information exists on what factors influence this complex decision-making process. OBJECTIVE: To identify factors associated with decisions on whether to withhold curative antibiotic treatment in patients with dementia who have pneumonia. METHODS: We performed an observational cohort study with 3-month monitoring for cure and death. Patients with pneumonia (N = 706) were enrolled in nursing home units for patients with dementia from all over the Netherlands (61 nursing homes). Characteristics of patients, physicians, and facilities were related to the outcome of withholding antibiotic treatment. RESULTS: In 23% of the patients, antibiotic treatment was withheld. The other patients received antibiotics with palliative (8%) or curative (69%) intent. Compared with the patients who received antibiotics with curative intent, patients in whom antibiotic treatment was withheld had more severe dementia, had more severe pneumonia, had lower food and fluid intake, and were more often dehydrated. In addition, withholding antibiotics occurred more often in the summer and in patients with an initial episode of pneumonia. Characteristics of facilities and physicians were unrelated to the decision. However, considerable variation occurred in how patient age, aspiration, and history of pneumonia were related to decision making by individual physicians. CONCLUSIONS: In the Netherlands, antibiotic treatment is commonly withheld in pneumonia patients with severe dementia who are especially frail. Understanding the circumstances in which this occurs can illuminate the international discussion of appropriate dementia care.

Secondary traumatization in partners and parents of Dutch peacekeeping soldiers.

This study examines secondary traumatization among 708 partners and 332 parents of Dutch peacekeepers (i.e., personnel who participated in military actions implemented by international organizations such as the United Nations). Partners or parents of peacekeepers with 4 levels of posttraumatic stress symptoms were compared on posttraumatic stress, health problems, the quality of the marital relationship, and social support. In comparison with partners of peacekeepers without posttraumatic stress disorder (PTSD) symptoms, partners of peacekeepers with PTSD symptoms reported more sleeping and somatic problems, reported more negative social support, and judged the marital relationship as less favorable. No significant differences were found for parents. Thus, peacekeepers' stress reactions were related to various problems of their partners. A systemic approach to the treatment of persons with PTSD appears appropriate.

The confidence in diabetes self-care scale: psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and US patients with type 1 diabetes.

OBJECTIVE: To examine psychometric properties of the Confidence in Diabetes Self-Care (CIDS) scale, a newly developed instrument assessing diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: Reliability and validity of the CIDS scale were evaluated in Dutch (n = 151) and U.S. (n = 190) outpatients with type 1 diabetes. In addition to the CIDS scale, assessment included HbA(1c), emotional distress, fear of hypoglycemia, self-esteem, anxiety, depression, and self-care behavior. The Dutch sample completed additional measures on perceived burden and importance of self-care. Test-retest reliability was established in a second Dutch sample (n = 62). RESULTS: Internal consistency (Cronbach's alpha = 0.86 for Dutch patients and 0.90 U.S. patients) and test-retest reliability (Spearman's r = 0.85, P < 0.0001) of the CIDS scale were high. Exploratory factor analysis showed one strong general factor. Spearman's correlations between the CIDS scale and other measures were moderate and in the expected directions, and high HbA(1c) levels were associated with low CIDS scores in the U.S. sample only. Low CIDS scores were positively associated with self-care but not with glycemic control in the original samples. CIDS scores in the U.S. and Dutch samples did not show any statistically significant differences. U.S. men had higher CIDS scores than U.S. women. CONCLUSIONS: The CIDS scale is a reliable and valid measure of diabetes-specific self-efficacy for use in patients with type 1 diabetes. High psychometric similarity allows for cross-cultural comparisons.

Cytokine producing CD8+ T cells are correlated to MRI features of tissue destruction in MS.

Specific T-cell subsets and their ability to produce cytokines have been involved in concepts of multiple sclerosis (MS) pathogenesis. Evidence to link cytokine producing T-cell subsets to magnetic resonance imaging (MRI) features of tissue destruction, however, is limited. Cytokine flow cytometry was performed in 124 patients with different subtypes of MS. In a subgroup of 69 patients, from whom longitudinal MRI was available, the ability of circulating types 1 and 2 helper T cells to produce cytokines was correlated to changes in T1 hypointense and T2 hyperintense lesion load (LL) on brain MRI during 3 years of follow-up. Significant negative correlations were found between baseline CD8(+) T-cell subsets producing IL-2, IL-4 or IL-13 and the change in T1 LL. Subgroup analyses demonstrated that in RRMS, CD8(+) T cells producing IL-2, IL-4 or IL-13, and in PPMS, CD8(+) IL-10(+) T cells correlated negatively with T1 LL. To our knowledge, this study provides the first direct immunophenotypic evidence of cytokine producing CD8(+) T cells being directly related to long-term development of MRI features of demyelination and axonal loss.

Image registration and subtraction to detect active T(2) lesions in MS: an interobserver study.

Serial MRI studies are used to analyse change in multiple sclerosis (MS) lesion volume in clinical trials. As such an evaluation is very time consuming and subject to quantification errors, one might assess only the change in number or size of lesions using subtracted images. The advantage of subtracted images is that both new and/or enlarging and resolving and/or shrinking lesions can be evaluated, resulting in a more precise volume change than a net volume change. We studied the interobserver agreement in the detection of active MS lesions using paired dual-echo T(2)-weighted spin-echo studies (3-mm slices) of 30 MS patients with a range of MS disease activity on MRI from treatment trials. Using an automatic matching algorithm based on mutual information, the follow-up scan was registered to baseline, after which subtracted images were obtained. After a training session with formulation of guidelines, six observers identified new, enlarging, resolving and shrinking lesions on subtracted images. Weighted kappa (kappa) values were calculated to assess interobserver agreement. Good agreement was found for new lesions (kappa 0.69 +/- 0.08), while moderate agreement was found for enlarging lesions (kappa 0.52 +/- 0.06). When new and enlarging lesions were combined, good agreement was found for "positive" activity (kappa 0.71 +/-0.06). The interobserver agreement was poor for resolving lesions (kappa 0.31 +/- 0.07), and moderate for shrinking lesions (kappa 0.53 +/- 0.08). In conclusion, the use of subtracted images in the visual detection of new T(2) lesions resulted in a good level of interobserver agreement for "positive" disease activity. Subtraction of registered images is a reliable, time efficient method to assess disease progression in MS.

Cognition and health-related quality of life in a well-defined subgroup of patients with partial epilepsy.

To investigate the extent and nature of the objective and subjective cognitive deficits and health-related quality of life (HRQOL) in adult outpatients with relatively well-controlled partial epilepsy without symptomatic aetiology, who were on carbamazepine (CBZ) monotherapy. Furthermore, we studied the influence of the epilepsy history and medication on various cognitive functions and the HRQOL. 56 outpatients (29 male, 27 female, mean age 41.3 years) with partial epilepsy were compared with 56 age-, gender-, and education-matched healthy controls. Patients were tested on attention, memory, speed of information processing, and executive functioning. Questionnaires aimed at measuring self-perceived cognitive functioning (CFQ) and HRQOL (SF-36) were administered. Mann Whitney-U tests were used to compare the two groups. Linear regression analysis was performed to identify the epilepsy and medication-related factors that are associated with cognitive functioning and HRQOL. Patients scored lower on measures of attention (P = 0.03), learning (P = 0.02) and speed of information processing (P = 0.00). Mental aspects of HRQOL such as fatigue were lower (P = 0.00), whereas physical functioning was unaffected. These patients also expressed reductions in mental functioning as indicated by a low self-perceived cognitive functioning (P = 0.01). Age at onset, duration of epilepsy, seizure type, seizure frequency, localisation, years on CBZ, and CBZ dosage were not related to cognitive functioning or HRQOL. Patients with partial epilepsy, even when able to maintain regular jobs, have impaired cognition and HRQOL that cannot be attributed to their epilepsy history or CBZ dosage or years of CBZ intake. Therefore, physicians should be more aware of their cognition and HRQOL, in addition to the antiepileptic drug regime.

Reliability and validity of the assessment of depression in general practice: the Short Depression Interview (SDI).

General practitioners (GPs) are recommended to use DSM-IV criteria to diagnose major depression in daily clinical practice. This implies the assessment of nine depressive symptoms and four additional criteria. A short structured interview has been developed to assess these symptoms and criteria, and a study was carried out to investigate the reliability and validity with which GPs can assess these symptoms and criteria and the DSM-IV diagnosis of major depression. In 14 general practices, 52 patients with symptoms of distress and depression were interviewed twice by their GP, with an interval of one to four days. Furthermore, the patients filled out three depression questionnaires. The reproducibility of eight symptoms and three additional criteria was moderate to good (kappa >0.40). The reproducibility of the depressive symptom count, that is necessary to arrive at a diagnosis of major depression, was such that in 75 percent of the patients the test-retest difference did not exceed one symptom. The reproducibility of the diagnosis of major depression was good (kappa 0.63). The validity of the diagnosis of major depression assessed by the GPs, as compared to results of the self-report depression questionnaires, was satisfactory (r 0.35-0.61). Diagnosing major depression in patients with depressive symptomatology just above or below the threshold of major depression warrants a certain amount of caution in general practice.

Cost effectiveness and cost utility of acetylcysteine versus dimethyl sulfoxide for reflex sympathetic dystrophy.

OBJECTIVE: To determine the cost effectiveness and cost utility of acetylcysteine versus dimethyl sulfoxide (DMSO) for patients with reflex sympathetic dystrophy (RSD), from a societal viewpoint. DESIGN: An economic evaluation was conducted alongside a double-dummy, double-blind, randomised, controlled trial. Patients were followed for 1 year. The primary outcome measure was the Impairment-level Sum Score (ISS). Utilities were determined by the EuroQOL instrument (EQ-5D). Both cost-effectiveness and cost-utility analyses were performed. Differences in mean direct, indirect and total costs were estimated. Corresponding 95% confidence intervals were calculated by bootstrapping techniques. RESULTS: Both groups (DMSO, n = 64; acetylcysteine, n = 67) showed relevant improvement; no differences in effects were found. Only the total direct costs were significantly lower in the DMSO group for the period of 0-52 weeks. The incremental cost-effectiveness ratios showed that, in general, DMSO generated fewer costs and more effects compared with acetylcysteine. Post-hoc subgroup analyses on cost effectiveness suggested that patients with warm RSD could be best treated with DMSO and patients with cold RSD with acetylcysteine. These results were based on small subsamples. CONCLUSION: In general, DMSO is the preferred treatment for patients with RSD.

Cost effectiveness of interventions for lateral epicondylitis: results from a randomised controlled trial in primary care.

OBJECTIVE: Lateral epicondylitis is a common complaint, with an annual incidence between 1% and 3% in the general population. The Dutch College of General Practitioners in The Netherlands has issued guidelines that recommend a wait-and-see policy. However, these guidelines are not evidence based. DESIGN AND SETTING: This paper presents the results of an economic evaluation in conjunction with a randomised controlled trial to evaluate the effects of three interventions in primary care for patients with lateral epicondylitis. PATIENTS AND INTERVENTIONS: Patients with pain at the lateral side of the elbow were randomised to one of three interventions: a wait-and-see policy, corticosteroid injections or physiotherapy. MAIN OUTCOME MEASURES AND RESULTS: Clinical outcomes included general improvement, pain during the day, elbow disability and QOL. The economic evaluation was conducted from a societal perspective. Direct and indirect costs (in 1999 values) were measured by means of cost diaries over a period of 12 months. Differences in mean costs between groups were evaluated by applying non-parametric bootstrap techniques. The mean total costs per patient for corticosteroid injections were euro430, compared with euro631 for the wait-and-see policy and euro921 for physiotherapy. After 12 months, the success rate in the physiotherapy group (91%) was significantly higher than in the injection group (69%), but only slightly higher than in the wait-and-see group (83%). The differences in costs and effects showed no dominance for any of the three groups. The incremental cost-utility ratios were (approximately): euro7000 per utility gain for the wait-and-see policy versus corticosteroid injections; euro12000 per utility gain for physiotherapy versus corticosteroid injections, and euro34500 for physiotherapy versus the wait-and-see policy. CONCLUSIONS: The results of this economic evaluation provided no reason to update or amend the Dutch guidelines for GPs, which recommend a wait-and-see policy for patients with lateral epicondylitis.