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Background. Appropriateness of antibiotic treatment of urinary tract infection (UTI) is important. The aim of this study was to develop a set of valid, reliable, and applicable indicators to assess the quality of antibiotic use in the treatment of hospitalized patients with complicated UTI. Methods. A multidisciplinary panel of 13 experts reviewed and prioritized recommendations extracted from a recently developed evidence-based national guideline for the treatment of complicated UTI. The content validity was assessed in 2 consecutive rounds with an in-between discussion meeting. Next, we tested the feasibility, interobserver reliability, opportunity for improvement, and case-mix stability of the potential indicators for a data set of 341 inpatients and outpatients with complicated UTIs who were treated at the urology or internal medicine departments at 4 hospitals. Results. The panel selected and prioritized 13 indicators. Four and 9 indicators were performed satisfactorily in the urology and internal medicine departments, as follows: performance of urine culture, prescription of treatment in accordance with guidelines, tailoring of treatment on the basis of culture results, and a switch to oral treatment when possible in the urology and internal medicine departments; and selective use of fluoroquinolones, administration of treatment for at least 10 days, prescription of treatment for men in accordance with guidelines, replacement of catheters in patients with UTI, and adaptation of the dosage on the basis of renal function in the internal medicine department. Conclusion. A systemic evidence- and consensus-based approach was used to develop a set of valid quality indicators. Tests of the applicability of these indicators in practice in different settings is essential before they are used in quality-improvement strategies.

Methods In this prospective study we included patients at the ICU treated with erythromycin in a dose of 200 mg bd. Electrocardiogram was registered before, 15 minutes and 24 hours after start of erythromycin.

The value of intensive combination therapy in early rheumatoid arthritis is unproven. In a multicentre, double-blind, randomised trial (COBRA), we compared the combination of sulphasalazine (2 g/day), methotrexate (7·5 mg/week), and prednisolone (initially 60 mg/day, tapered in 6 weekly steps to 7·5 mg/day) with sulphasalazine alone. 155 patients with early rheumatoid arthritis (median duration 4 months) were randomly assigned combined treatment (76) or sulphasalazine alone (79). Prednisolone and methotrexate were tapered and stopped after 28 and 40 weeks, respectively. The main outcomes were the pooled index (a weighted change score of five disease activity measures) and the Sharp/Van der Heijde radiographic damage score in hands and feet. Independent health-care professionals assessed the main outcomes without knowledge of treatment allocation. At week 28, the mean pooled index was 1–4 (95% CI 1·2–1·6) in the combined treatment group and 0·8 (0·6–1·0) in the sulphasalazine group (p<0·0001). At this time, 55 (72%) and 39 (49%) patients, respectively, were improved according to American College of Rheumatology criteria. The clinical difference between the groups decreased and was no longer significant after prednisolone was stopped, and there were no further changes after methotrexate was stopped. At 28 weeks, the radiographic damage score had increased by a median of 1 (range 0–28) in the combined-therapy group and 4 (0–44) in the sulphasalazine group (p<0·0001). The increases at week 56 (2 [0–43] vs6 [0–54], p=0·004), and at week 80 (4 [0–80] vs 12 [0–72], p=0·01) were also significant. Further analysis suggests that combined therapy immediately suppressed damage progression, whereas sulphasalazine did so less effectively and with a lag of 6 to 12 months. There were fewer withdrawals in the combined therapy than the sulphasalazine group (6 [8%] vs 23 [29%]), and they occurred later. This combined-therapy regimen offers additional disease control over and above that of sulphasalazine alone that persists for up to a year after corticosteroids are stopped. Although confirmatory studies and long-term follow-up are needed, this approach may prove useful in the treatment of early rheumatoid arthritis.

Abstract Objective: To investigate the effectiveness of aspirin and coumarin in preventing thromboembolism in patients with non-rheumatic atrial fibrillation in general practice. Design: Randomised controlled trial. Participants: 729 patients aged ≥60 years with atrial fibrillation, recruited in general practice, who had no established indication for coumarin. Mean age was 75 years and mean follow up 2.7 years. Setting: Primary care in the Netherlands. Interventions: Patients eligible for standard intensity coumarin (international normalised ratio 2.5-3.5) were randomly assigned to standard anticoagulation, very low intensity coumarin (international normalised ratio 1.1-1.6), or aspirin (150 mg/day) (stratum 1). Patients ineligible for standard anticoagulation were randomly assigned to low anticoagulation or aspirin (stratum 2). Main outcome measures: Stroke, systemic embolism, major haemorrhage, and vascular death. Results: 108 primary events occurred (annual event rate 5.5%), including 13 major haemorrhages (0.7% a year). The hazard ratio was 0.91 (0.61 to 1.36) for low anticoagulation versus aspirin and 0.78 (0.34 to 1.81) for standard anticoagulation versus aspirin. Non-vascular death was less common in the low anticoagulation group than in the aspirin group (0.41, 0.20 to 0.82). There was no significant difference between the treatment groups in bleeding incidence. High systolic and low diastolic blood pressure and age were independent prognostic factors. Conclusion: In a general practice population (without established indications for coumarin) neither low nor standard intensity anticoagulation is better than aspirin in preventing primary outcome events. Aspirin may therefore be the first choice in patients with atrial fibrillation in general practice. Key messages Studies have shown that patients with non-rheumatic atrial fibrillation may benefit from anticoagulation This study in a general practice population found no benefit of standard or low dose anticoagulation on risk of stroke, systemic embolism, major haemorrhage, or vascular death when compared with aspirin Hypertension and age were prognostic factors for event occurrence Aspirin is the treatment of choice for preventing thromboembolism in primary care patients at low risk

The effect of adding intermediate measures on the efficiency of treatment effect estimation is considered for a second-order polynomial treatment effect, equidistant time-points, different covariance structures and two optimality criteria, assuming either a fixed sample size or a fixed budget. The benefit of adding intermediate measures (at the expense of subjects) depends strongly on the assumed covariance structure and is hardly affected by the two used optimality criteria (Ds or c). For a fixed sample size, the increase in efficiency by adding intermediate measures is large for a compound symmetric structure and small for a first-order auto-regressive structure. For a first-order auto-regressive structure with measurement error, the results depend on the covariance parameter values. For a fixed budget and linear cost function, the design with only three measures per subject is often highly efficient. If the structure resembles compound symmetry and the cost per subject is eight or more times larger than the cost per repeated measure, however, more than three measures are required to obtain highly efficient treatment effect estimators. If the covariance structure is unknown, the optimal design based on a first-order auto-regressive structure with measurement error is preferable in terms of robustness against misspecification of the covariance structure. Given a design with three repeated measures and a second-order polynomial treatment effect, equidistant time-points are either optimal (Ds- ) or highly efficient (c-optimality criterion). The results are illustrated by a practical example.

It is well known that the properties of mixtures may be very different from those of the pure constituent components, due to the unlike forces. Even for mixtures composed of simple molecules, this behavior can be rather complicated at high pressures, where the system may exhibit gas–gas equilibrium, a critical double point and density inversions. A few mixtures such as He–H2 and He–N2 are discussed. It is demonstrated that Raman spectroscopy is an important tool not only for obtaining knowledge about the dynamical behavior of mixtures but also for determining phase equilibria at high pressures. The frequency shift, the linewidth, and the line shape provide information about the solubility, the state of aggregation, and other conditions of the system. Recently, a new type of compound has been found, the so-called van der Waals compound. The results obtained in simple mixtures, such as Ne–N2 and Xe–N2, are compared with the results of molecular dynamics (MD) simulations of hard sphere mixtures. It is pointed out that energy, and not a geometrical effect (or entropy), is the driving force for compound formation.

Adaptive biased urn randomization, applied in, e.g., a clinical trial, has certain attractive properties. If stratified randomization is desired, a good balance between group sizes can be guaranteed, even in (very) small strata. Yet treatment assignment may be kept unpredictable, which is necessary to avoid selection bias if blinding is impossible. In the present paper a more flexible urn model is described. The investigator may choose assignment probabilities that strongly depend on the degree of imbalance when the groups are still small, but with a tendency toward complete randomization when the groups become large. It is also possible to keep the difference in group size below a chosen maximum, which is useful if population characteristics may change during the course of a trial. The new urn model includes random permutations and complete randomization as special cases. An extension of the model allows the promotion of unequal group sizes. Some attention is paid to a randomized version of the minimization method.

Objective: To develop a self-report measure for assessment of the stage of change in patients with osteoarthritis, in order to identify patients who would benefit from a self-management programme. Methods: According to the ‘stages of change’ model a questionnaire was developed with three groups of items corresponding to the precontemplation stage (Pre), the contemplation (Cont) and the action (Act) stage. Internal consistency and factor structure of this questionnaire were investigated by assessing Cronbach's alphas and by performing factor analysis. Subjects and setting: The questionnaire was offered to 273 patients who entered a randomized clinical trial on self-management in a general health care setting. Results: Factor analysis revealed that most items corresponded to the a priori described groups, while some items were not loading on the presumed factor. In each subgroup some items were deleted, resulting in a 15-item questionnaire. After this item reduction Cronbach's alphas were 0.72 (Pre), 0.76 (Cont) and 0.79 (Act) and all factor loadings were satisfactory (above 0.35). Classification revealed some differences between parts of the total group, for example in the proportion of patients in the preparation stage (recruited by general practitioner 33.6%; advertisement 49.2%). Conclusions: The Stages of Change Questionnaire in Osteoarthritis, a 15-item questionnaire to assess the ‘stage of change’ of a patient with osteoarthritis showed good internal consistency and adequate factor structure. These findings warrant further studies on validity and applicability in a clinical context.