Study protocol of European Fans in Training (EuroFIT): a four-country randomised controlled trial of a lifestyle program for men delivered in elite football clubs.

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support.

A validated methodology for patient specific computational modeling of self-expandable transcatheter aortic valve implantation.

Leakage of blood alongside the implant is a relatively frequent and life-limiting complication after transcatheter aortic valve implantation. The aim of this study is to develop and validate a workflow to simulate the implantation prior to the intervention. Based on the simulation outcome, the amount of leakage is estimated in order to evaluate the risk of a severe complication.

Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study).

Background: Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor.

Objective: This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL.

Long-Term Cost-Effectiveness and Return-on-Investment of a Mindfulness-Based Worksite Intervention: Results of a Randomized Controlled Trial.

Objectives: The aim of this study was to conduct a cost-effectiveness and return-on-investment analysis comparing a mindfulness-based worksite intervention to usual practice.

Methods: Two hundred fifty-seven governmental research institute employees were randomized to the intervention or control group. Intervention group participants received an eight-week mindfulness training, e-coaching, and supporting elements.

Induction Therapy for Kidney Transplant Recipients: Do We Still Need Anti-IL2 Receptor Monoclonal Antibodies?

Induction therapy with antilymphocyte biological agents is widely used after kidney transplantation, most commonly T lymphocyte-depleting rabbit-derived antithymocyte globulin (rATG) or an IL-2 receptor antagonist (IL2RA). Early randomized trials showed that rATG or IL2RA induction reduces early acute rejection, prompting recommendations by Kidney Disease Improving Global Outcomes that IL2RA induction be used routinely in first-line therapy after kidney transplantation, with lymphocyte-depleting induction reserved for high-risk cases. These studies, however, mainly used outdated maintenance regimens.

Economic evaluation of Internet-based problem-solving guided self-help treatment in comparison with enhanced usual care for depressed outpatients waiting for face-to-face treatment: A randomized controlled trial.

Background: Previous studies have demonstrated the effectiveness of Internet-based interventions for depression in comparison with usual care. However, evidence on the cost-effectiveness of these interventions when delivered in outpatient clinics is lacking. The aim of this study was to estimate the cost-effectiveness of an Internet-based problem-solving guided self-help intervention in comparison with enhanced usual care for outpatients on a waiting list for face-to-face treatment for major depression.

Effectiveness of blended depression treatment for adults in specialised mental healthcare: study protocol for a randomised controlled trial.

Background: Internet-based interventions are seen as an important potential strategy to improve accessibility and affordability of high quality treatments in mental healthcare. A growing number of studies have demonstrated the clinical efficacy of internet-based treatment for mood disorders, but scientific evidence for the application in routine specialised mental healthcare settings is limited. Also, little is known about the clinical and health-economic benefits of blended treatment, where online interventions are integrated with face-to-face treatment of depression in one treatment protocol.

Health-Related Quality of Life at Admission Is Associated with Postdischarge Mortality, Functional Decline, and Institutionalization in Acutely Hospitalized Older Medical Patients.

Objectives: To assess the independent association between health-related quality of life (HRQOL) at admission and mortality, functional decline, and institutionalization 3 and 12 months after admission in acutely hospitalized older adults.

Design: Post hoc analysis of data from prospective cohort study, 2006 to 2009, 12-month follow-up.

Setting: Eleven medical wards in three hospitals in the Netherlands.

Cyclooxygenase-2 Is Essential for Colorectal Anastomotic Healing.

Objective: To study the effects of COX-2 on colonic surgical wound healing.

Background: Cyclooxygenase-2 (COX-2) is a key enzyme in gastrointestinal homeostasis. COX-2 inhibitors have been associated with colonic anastomotic leakage.

Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

Background: Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often.

Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial.

Purpose: To evaluate the cost-effectiveness of manual therapy according to the Utrecht School (MTU) in comparison with physiotherapy (PT) in sub-acute and chronic non-specific neck pain patients from a societal perspective.

Methods: An economic evaluation was conducted alongside a 52-week randomized controlled trial, in which 90 patients were randomized to the MTU group and 91 to the PT group. Clinical outcomes included perceived recovery (yes/no), functional status (continuous and yes/no), and quality-adjusted life-years (QALYs).

International consensus statement regarding the use of animal models for research on anastomoses in the lower gastrointestinal tract.

Purpose: This project aimed to reach consensus on the most appropriate animal models and outcome measures in research on anastomoses in the lower gastrointestinal tract (GIT). The physiology of anastomotic healing remains an important research topic in gastrointestinal surgery. Recent results from experimental studies are limited with regard to comparability and clinical translation.

Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial.

Objectives: To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery. Previously, it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients.

Design: A preplanned substudy of a previous prospective, randomized, open-label, single-centre study, comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer.

Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study).

Transcatheter aortic valve implantation (TAVI) has become the standard of care for many patients with symptomatic severe aortic stenosis who are at increased risk of morbidity and mortality during surgical aortic valve replacement. However, there is still no general consensus regarding the use of general anesthesia (GA) versus local anesthesia with sedation (non-GA) during the TAVI procedure. Using propensity score-matching analysis, we analyzed the characteristics and outcomes of patients who underwent TAVI with either GA (n = 245) or non-GA (n = 245) in the fully monitored, international, CoreValve ADVANCE Study.

Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve.

Aims: Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI.

Methods And Results: Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule.

Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study).

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions.

Colorectal anastomotic healing: why the biological processes that lead to anastomotic leakage should be revealed prior to conducting intervention studies.

Background: Anastomotic leakage (AL) remains the most dreaded complication after colorectal surgery and causes high morbidity and mortality. The pathophysiology of AL remains unclear, despite numerous studies that have been conducted on animals and humans, probably due to the undetermined healing process of colorectal anastomoses. Increasing basic knowledge on this healing process may shed more light on causal factors of AL, and additionally reduce the quantity and accelerate the quality of experimental studies.

Validation of transcatheter aortic valve implantation risk scores in relation to early and mid-term survival: a single-centre study.

Objectives: The aim of this study was to validate recently proposed risk scores for the prediction of mortality up to 1 year after transcatheter aortic valve implantation (TAVI), using a self-expandable valve (CoreValve).

Methods: In this single-centre study, 225 consecutive patients with severe symptomatic aortic valve stenosis, who underwent TAVI between December 2007 and January 2015, were included. Conventional surgical risk scores (logistic EuroSCORE, EuroSCORE II and STS score) were calculated as well as newly proposed TAVI risk scores (TAVI2-SCORe, STT Score and OBSERVANT score).

Eastern South African hydroclimate over the past 270,000 years.

Processes that control the hydrological balance in eastern South Africa on orbital to millennial timescales remain poorly understood because proxy records documenting its variability at high resolution are scarce. In this work, we present a detailed 270,000 year-long record of terrestrial climate variability in the KwaZulu-Natal province based on elemental ratios of Fe/K from the southwest Indian Ocean, derived from X-ray fluorescence core scanning. Eastern South African climate variability on these time scales reflects both the long-term effect of regional insolation changes driven by orbital precession and the effects associated with high-latitude abrupt climate forcing over the past two glacial-interglacial cycles, including millennial-scale events not previously identified.

Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial.

Objectives: To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care.

Design: Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial.

Setting: Primary care (35 practices) in two regions in the Netherlands.

Are patients ready for communication with radiologists? Results of the R2P2 survey.

Background: Patient empowerment requires that patients have enough information to make decisions concerning their own health. If patients are to discuss imaging results with radiologists, they have to know who these medical professionals are and what they do.

Purpose: To examine whether patients understand the role of radiologists, and if particular subgroups are better informed than other ones.