Walk well:a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

Background - Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design - This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion - Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

Contains fulltext : 65628.pdf ( ) (Open Access)BACKGROUND: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. METHODS/DESIGN: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm. DISCUSSION: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. TRIAL REGISTRATION: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217

Oral abstracts of the 21st International AIDS Conference 18-22 July 2016, Durban, South Africa

The rate at which HIV-1 infected individuals progress to AIDS is highly variable and impacted by T cell immunity. CD8 T cell inhibitory molecules are up-regulated in HIV-1 infection and associate with immune dysfunction. We evaluated participants (n=122) recruited to the SPARTAC randomised clinical trial to determine whether CD8 T cell exhaustion markers PD-1, Lag-3 and Tim-3 were associated with immune activation and disease progression.Expression of PD-1, Tim-3, Lag-3 and CD38 on CD8 T cells from the closest pre-therapy time-point to seroconversion was measured by flow cytometry, and correlated with surrogate markers of HIV-1 disease (HIV-1 plasma viral load (pVL) and CD4 T cell count) and the trial endpoint (time to CD4 count <350 cells/μl or initiation of antiretroviral therapy). To explore the functional significance of these markers, co-expression of Eomes, T-bet and CD39 was assessed.Expression of PD-1 on CD8 and CD38 CD8 T cells correlated with pVL and CD4 count at baseline, and predicted time to the trial endpoint. Lag-3 expression was associated with pVL but not CD4 count. For all exhaustion markers, expression of CD38 on CD8 T cells increased the strength of associations. In Cox models, progression to the trial endpoint was most marked for PD-1/CD38 co-expressing cells, with evidence for a stronger effect within 12 weeks from confirmed diagnosis of PHI. The effect of PD-1 and Lag-3 expression on CD8 T cells retained statistical significance in Cox proportional hazards models including antiretroviral therapy and CD4 count, but not pVL as co-variants.Expression of ‘exhaustion’ or ‘immune checkpoint’ markers in early HIV-1 infection is associated with clinical progression and is impacted by immune activation and the duration of infection. New markers to identify exhausted T cells and novel interventions to reverse exhaustion may inform the development of novel immunotherapeutic approaches

Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]

Contains fulltext : 126176.pdf (publisher's version ) (Open Access)BACKGROUND: Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS/DESIGN: The TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs. DISCUSSION: The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis

Shifting from car to active transport : a systematic review of the effectiveness of interventions

Introduction A promising way to stimulate physical activity is to promote the choice for active modes of transport (walking and cycling). Over the past years, several interventions and policies have been implemented to stimulate this mode shift. However, information concerning the effectiveness of these interventions and policies is still limited. The aim of the present study was to systematically review the effectiveness of interventions designed to stimulate a shift from car use to cycling or walking and to obtain insight into the intervention tools that have been used to promote and/or implement these interventions. Methods Five databases were searched and articles published in English, Dutch, German, Danish, Norwegian and Swedish were included. Only studies that focussed on a mode shift from car use towards active transport in a general adult population, which were published in peer reviewed journals and which investigated effectiveness were included. Intervention tools used were categorized by using the model of Hoogerwerf &amp; Herweijer, as either legal, economic (subsidy, reward system, penalty), communicative (written materials, behavioural tools) and physical tools (providing bicycles, providing better bicycle facilities at work, adjustment of the environment). Results Nineteen studies met our inclusion criteria. Studies included described work-place-based interventions, architectural and urbanistic adjustments, population-wide interventions, and bicycle-renting systems. Nearly all studies (except three) showed positive effects concerning a mode shift. Most of the included studies used more than one intervention tool and the tools used differed between types of interventions. However, information about the statistical significance of these results was often lacking and the study methodologies used were not of high quality. Conclusion Nearly all studies showed results in a positive direction. However, the quality of the included studies was mostly low and intervention characteristics were poorly described

Perceived health status associated with transport choices for short distance trips

Background\u3cbr/\u3eThis study examines the association between active transport and perceived general health, perceived psychological wellbeing and a healthy body weight in the Netherlands.\u3cbr/\u3e\u3cbr/\u3eMethods\u3cbr/\u3eData were collected by an online questionnaire (N = 3663) in the Netherlands. Data collection was conducted over a period of one calendar year starting July 2012. Logistic regression analyses were used to investigate the association between choice of transport mode (bicycling vs car use and walking vs car use) and perceived general health, perceived psychological wellbeing and having a healthy weight respectively. The presented OR's may be interpreted as the likelihood of an average person in our dataset to have a better perceived health or body weight when choosing active transport (either bicycling or walking) over using the car for trips up to 7.5 km.\u3cbr/\u3e\u3cbr/\u3eResults\u3cbr/\u3eCycling was found to be significantly associated with a better perceived general health (OR = 1.35, 95%CI:1.07–1.70) and having a healthy body weight (OR = 1.52, 95%CI:1.28–1.79), but not with a better perceived psychological wellbeing (OR = 1.12, 95%CI:0.93–1.34). Walking was found to be significantly associated with having a healthy body weight (OR = 1.35, 95%CI:1.09–1.69), but not with a better perceived general (OR = 1.12, 95%CI:0.84–1.51) or psychological wellbeing (OR = 0.85, 95%CI:0.67–1.08).\u3cbr/\u3e\u3cbr/\u3eConclusion\u3cbr/\u3eOur results suggest that active transport use has been associated with a better perceived general health and a healthy body weight. However, more research is needed to be able to elucidate which factors cause this better health. No associations were observed between transport choice and perceived psychological wellbeing.\u3cbr/\u3e\u3cbr/\u3eKeywords\u3cbr/\u3eTransport choice; \u3cbr/\u3ePerceived general health; \u3cbr/\u3ePsychological wellbeing; \u3cbr/\u3eMental health; \u3cbr/\u3eCycling; \u3cbr/\u3eWalking; \u3cbr/\u3eHealthy weight\u3cbr/\u3

Perceived accessibility is an important factor in transport choice : results from the avenue project

Background\u3cbr/\u3eStimulating active transport by encouraging replacement of short-distance car trips by active transport modes such as cycling or walking has become a popular policy strategy. It has been suggested that neighbourhoods, designed to facilitate healthy behaviour, can influence a person׳s behavioural choices such as transport choice. In the present study, we investigated the association between perceived accessibility of facilities and transport choice for three different trip purposes (shopping, going to public natural spaces, and going to sports facilities) in the Netherlands.\u3cbr/\u3eMethods\u3cbr/\u3eAn online questionnaire (N=3663) was used to collect data concerning transport choice for the general Dutch population over a period of one calendar year starting July 2012. Logistic regression analyses were used to model the odds of cycling versus car use and to model the odds of walking versus car use.\u3cbr/\u3eResults\u3cbr/\u3eWhen perceived accessibility by car is high, persons were less likely to use active transport modes (OR range: 0.09–0.66) and when perceived accessibility by active transport modes is high, persons were more likely to use the bicycle (OR range: 2.18–10.43) or walk (OR range: 2.97–11.22).\u3cbr/\u3eConclusions\u3cbr/\u3eOur results showed a strong association between perceived accessibility and transport choice even after adjusting for personal and environmental characteristics. Our results suggest that perceived accessibility should be taken into account when stimulating a shift from car use to cycling or walking.\u3cbr/\u3