Objective To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis.Design Multicentre single blind non-inferiority randomised controlled trial.Setting Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre.Participants Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg.Interventions Continuation or cessation of ECS 12 months after deep venous thrombosis.Main outcome measures The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym).Results 518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups.Conclusion Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial.Trial registration Netherlands Trial Register NTR1442.
We investigated the prevalence and determinants of nasopharyngeal carriage of Neisseria meningitidis in 3200 healthy children aged 1-19 years. The incidence of meningococcal carriage was, on average, 1.5%. Peak incidences were seen at age 1 year and after age 15 years. The independent determinants of meningococcal carriage included age, regular visits to youth clubs (odds ratio [OR], 2.2) and discotheques (OR, 4.3), and pneumococcal carriage (OR, 4.1).
Background In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level. Objective We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment. Methods We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both. Results Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference −0.50, 95% CI −0.86 to −0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference −0.73, 95% CI −1.18 to −0.28; P=.002). Conclusions Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1995).
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