Effect of an exercise intervention on global cognition after transient ischemic attack or minor stroke: the MoveIT randomized controlled trial.

BACKGROUND: Patients with a transient ischemic attack (TIA) or ischemic stroke are at increased risk of developing cognitive impairment in the subacute phase. At present, the effects of exercise on cognitive functioning following a TIA or stroke are not fully known. The purpose of this trial was to investigate the effect of exercise on global cognition. METHODS: The MoveIT trial is a single-centre, observer-blinded, randomized controlled trial involving a 1-year exercise intervention consisting of a 12-week group exercise program, combined with three counselling visits to the physiotherapists over a 9-month period. The control group received standard care. The primary outcome was global cognitive functioning, assessed at one year, using the Montreal Cognitive Assessment (MoCA). Secondary outcomes included cardiorespiratory fitness, the cardiovascular profile, and attainment of secondary prevention targets, anxiety, depression and fatigue at one and two years. RESULTS: The experimental group consisted of 60 patients, while the control group consisted of 59 patients. The mean age was 64.3 years and 41% were female. No between-group differences were found on global cognitive functioning (MD, 0.7 out of 30, 95% CI, - 0.2 to 1.6) or on secondary outcome measures at 12 months. The only significant between-group difference was found for fatigue, in favour of the experimental group at 12 months (MD, 0.6 out of 63, 95% CI, 0.1 to 1.1). CONCLUSIONS: No benefit of this exercise intervention was found regarding global cognition. Future studies need to focus on optimizing rehabilitation strategies for this vulnerable group of patients. TRIAL REGISTRATION: http://www.trialregister.nl . Unique identifier: NL3721 . Date first registration: 06-03-2013.

A Privacy-Preserving Infrastructure for Analyzing Personal Health Data in a Vertically Partitioned Scenario.

It is widely anticipated that the use and analysis of health-related big data will enable further understanding and improvements in human health and wellbeing. Here, we propose an innovative infrastructure, which supports secure and privacy-preserving analysis of personal health data from multiple providers with different governance policies. Our objective is to use this infrastructure to explore the relation between Type 2 Diabetes Mellitus status and healthcare costs. Our approach involves the use of distributed machine learning to analyze vertically partitioned data from the Maastricht Study, a prospective population-based cohort study, and data from the official statistics agency of the Netherlands, Statistics Netherlands (Centraal Bureau voor de Statistiek; CBS). This project seeks an optimal solution accounting for scientific, technical, and ethical/legal challenges. We describe these challenges, our progress towards addressing them in a practical use case, and a simulation experiment.

Using the Personal Health Train for Automated and Privacy-Preserving Analytics on Vertically Partitioned Data.

Conventional data mining algorithms are unable to satisfy the current requirements on analyzing big data in some fields such as medicine, policy making, judicial, and tax records. However, applying diverse datasets from different institutes (both healthcare and non-healthcare related) can enrich information and insights. So far, analyzing this data in an automated, privacy-preserving manner does not exist to our knowledge. In this work, we propose an infrastructure, and proof-of-concept for privacy-preserving analytics on vertically partitioned data.

Doxycycline for outpatient-treated acute exacerbations of COPD: a randomised double-blind placebo-controlled trial.

BACKGROUND: Antibiotics do not reduce mortality or short-term treatment non-response in patients receiving treatment for acute exacerbations of COPD in an outpatient setting. However, the long-term effects of antibiotics are unknown. The aim of this study was to investigate if the antibiotic doxycycline added to the oral corticosteroid prednisolone prolongs time to next exacerbation in patients with COPD receiving treatment for an exacerbation in the outpatient setting. METHODS: In this randomised double-blind placebo-controlled trial, we recruited a cohort of patients with COPD from outpatient clinics of nine teaching hospitals and three primary care centres in the Netherlands. Inclusion criteria were an age of at least 45 years, a smoking history of at least 10 pack-years, mild-to-severe COPD (Global Initiative of Chronic Obstructive Lung Disease [GOLD] stage 1-3), and at least one exacerbation during the past 3 years. Exclusion criteria were poor mastery of the Dutch language, poor cognitive functioning, known allergy to doxycycline, pregnancy, and a life expectancy of shorter than 1 month. If a participant had an exacerbation, we randomly assigned them (1:1; with permuted blocks of variable sizes [ranging from two to ten]; stratified by GOLD stage 1-2 vs 3) to a 7 day course of oral doxycycline 100 mg daily (200 mg on the first day) or placebo. Exclusion criteria for randomisation were fever, admission to hospital, and current use of antibiotics or use within the previous 3 weeks. Patients in both groups received a 10 day course of 30 mg oral prednisolone daily. Patients, investigators, and those assessing outcomes were masked to treatment assignment. The primary outcome was time to next exacerbation in all randomly allocated patients except for those incorrectly randomly allocated who did not meet the inclusion criteria or met the exclusion criteria. This trial is registered with the Netherlands Trial Register, number NTR2499. FINDINGS: Between Dec 22, 2010, and Aug 6, 2013, we randomly allocated 305 (34%) patients from the cohort of 887 patients to doxycycline (152 [50%]) or placebo (153 [50%]), excluding four (1%) patients (two [1%] from each group) who were incorrectly randomly allocated from the analysis. 257 (85%) of 301 patients had a next exacerbation (131 [87%] of 150 in the doxycycline group vs 126 [83%] of 151 in the placebo group). Median time to next exacerbation was 148 days (95% CI 95-200) in the doxycycline group compared with 161 days (118-211) in the placebo group (hazard ratio 1·01 [95% CI 0·79-1·31]; p=0·91). We did not note any significant differences between groups in the frequency of adverse events during the first 2 weeks after randomisation (47 [31%] of 150 in the doxycycline group vs 53 [35%] of 151 in the placebo group; p=0·54) or in serious adverse events during the 2 years of follow-up (42 [28%] vs 43 [29%]; p=1). INTERPRETATION: In patients with mild-to-severe COPD receiving treatment for an exacerbation in an outpatient setting, the antibiotic doxycycline added to the oral corticosteroid prednisolone did not prolong time to next exacerbation compared with prednisolone alone. These findings do not support prescription of antibiotics for COPD exacerbations in an outpatient setting. FUNDING: Netherlands Organization for Health Research and Development.

Cardiorespiratory Fitness after Transient Ischemic Attack and Minor Ischemic Stroke: Baseline Data of the MoveIT Study.

BACKGROUND: Cardiorespiratory fitness (CRF) is reduced in patients with stroke. It is unclear whether it is also reduced in patients with a transient ischemic attack (TIA) or minor stroke. We investigated the CRF in patients with a recent TIA or minor stroke and explored which determinants are associated with a lower fitness. METHODS: In 113 patients with a recent TIA or minor ischemic stroke (64 (SD = 10) years of age; 49 (IQR 27-86) days post TIA or stroke), the peak oxygen consumption (VO2peak) was determined in a symptom-limited ramp exercise test. Physical activity level, vascular risk factors, history of vascular or pulmonary disease, and stroke characteristics were recorded at inclusion and related to the VO2peak. RESULTS: Mean VO2peak was 22 mL/kg/min (SD = 6), which is the fifth percentile of age- and sex-related normative values. Increasing age and female sex were associated with a lower VO2peak (B (95% CI): per 10 years -2.57 mL/kg/min (-3.75; -1.40) and female sex -5.84 mL/kg/min (-8.06; -3.62)). Age- and sex-adjusted linear regression analyses showed that a history of cardiovascular disease and pulmonary disease was associated with a lower VO2peak. In addition, a lower level of physical activity, hypertension, smoking, and overweight were associated with a lower VO2peak. History of stroke and stroke characteristics were not related to VO2peak. CONCLUSION: The majority of patients with a recent TIA or minor ischemic stroke have a poor CRF. Our findings suggest that premorbid cardiovascular and pulmonary disease and vascular risk factors, but not TIA- or stroke-related factors, contribute to a reduced CRF.

Predictive Factors for Insufficient Weight Loss After Bariatric Surgery: Does Obstructive Sleep Apnea Influence Weight Loss?

BACKGROUND: Important endpoints of bariatric surgery are weight loss and improvement of comorbidities, of which obstructive sleep apnea (OSA) is the highest accompanying comorbidity (70%). This study aimed to evaluate the influence of OSA on weight loss after bariatric surgery and to provide predictive factors for insufficient weight loss (defined as ≤50% excess weight loss (EWL)) at 1 year follow-up. METHODS: All consecutive patients, who underwent primary laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy between 2006 and 2014 were retrospectively reviewed. Patients with data on preoperative apnea-hypopnea index (AHI) and pre- and postoperative body mass index (BMI) were included. After surgery, the percentage excess weight loss (%EWL) and BMI changes were compared between preoperatively diagnosed OSA-, subdivided in mild, moderate, and severe OSA, and non-OSA patients. Multivariable logistic regression analysis evaluated predictive factors for ≤50% EWL. RESULTS: A total of 816 patients, 522 (64%) with and 294 (36%) without OSA, were included. After 1 year, OSA patients achieved less %EWL than non-OSA patients (65.5 SD 20.7 versus 70.3 SD 21.0; p < 0.01). The lowest %EWL was seen in severe OSA patients (61.7 SD 20.2). However, when adjusted for waist circumference, BMI, and age, no effect of OSA was seen on %EWL or changes in BMI. Although AHI, gender, age, BMI, type of surgery, and type II diabetes were predictive factors for ≤50% EWL (area under the curve 0.778), the AHI as variable was of little importance. CONCLUSIONS: The presence of OSA does not individually impair weight loss after bariatric surgery.

Acceptance and long-term compliance of nCPAP in obstructive sleep apnea.

In a retrospective cohort study, we evaluated whether improvements in nasal continuous positive airway pressure (nCPAP) technology, particularly the introduction of automatic adjustment of the nCPAP pressure (auto-CPAP), have led to better acceptance and (long-term) compliance in patients with obstructive sleep apnea syndrome (OSAS) as compared to earlier reported data. Questionnaires were sent to 256 patients, who were referred to our clinic for an overnight polysomnography from January 1997 to July 2005 and received nCPAP therapy for OSAS. Of the 256 patients, 24 patients were unavailable for follow-up. Of the remaining 232 patients, 58 patients (25%) had discontinued therapy, while 174 patients (75%) were still using nCPAP after 2 months to 8 years of follow-up. One Hundred and thirty eight (79%) of these 174 patients used nCPAP for at least 4 h/night during >or= 5 nights/week, 82,1% of the conventional nCPAP (fixed pressure CPAP) group (n = 78) and 77,1% of the auto-CPAP group (n = 96). Therefore, including the 58 failures, only 59.5% of patients can be seen as compliant. There were no statistical differences between the fixed pressure CPAP and auto-CPAP users, and between the compliant and non-compliant users according to age, BMI, AHI and Epworth sleepiness scale (ESS). Auto-CPAP patients used significantly more cm H2O. The long-term compliance of nCPAP therapy has have increased only slightly since the introduction of the fixed pressure CPAP 25 years ago, in spite of many efforts to improve it. It seems that a plateau has been reached and that it is unrealistic to aim at a substantially higher compliance rate.

Effectiveness of discontinuing antibiotic treatment after three days versus eight days in mild to moderate-severe community acquired pneumonia: randomised, double blind study.

OBJECTIVE: To compare the effectiveness of discontinuing treatment with amoxicillin after three days or eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment. DESIGN: Randomised, double blind, placebo controlled non-inferiority trial. SETTING: Nine secondary and tertiary care hospitals in the Netherlands. PARTICIPANTS: Adults with mild to moderate-severe community acquired pneumonia (pneumonia severity index score < or = 110). INTERVENTIONS: Patients who had substantially improved after three days' treatment with intravenous amoxicillin were randomly assigned to oral amoxicillin (n = 63) or placebo (n = 56) three times daily for five days. MAIN OUTCOME MEASURES: The primary outcome measure was the clinical success rate at day 10. Secondary outcome measures were the clinical success rate at day 28, symptom resolution, radiological success rates at days 10 and 28, and adverse events. RESULTS: Baseline characteristics were comparable, with the exception of symptom severity, which was worse in the three day treatment group. In the three day and eight day treatment groups the clinical success rate at day 10 was 93% for both (difference 0.1%, 95% confidence interval--9% to 10%) and at day 28 was 90% compared with 88% (difference 2.0%,--9% to 15%). Both groups had similar resolution of symptoms. Radiological success rates were 86% compared with 83% at day 10 (difference 3%,--10% to 16%) and 86% compared with 79% at day 28 (difference 6%,--7% to 20%). Six patients (11%) in the placebo group and 13 patients (21%) in the active treatment group reported adverse events (P = 0.1). CONCLUSIONS: Discontinuing amoxicillin treatment after three days is not inferior to discontinuing it after eight days in adults admitted to hospital with mild to moderate-severe community acquired pneumonia who substantially improved after an initial three days' treatment.