Validation of two age dependent D-dimer cut-off values for exclusion of deep vein thrombosis in suspected elderly patients in primary care: retrospective, cross sectional, diagnostic analysis

Objective To determine whether the use of age adapted D-dimer cut-off values can be translated to primary care patients who are suspected of deep vein thrombosis

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial):design and rationale of a nationwide stepped-wedge cluster-randomized trial

Background: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. Methods: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide daily multilevel advice on the management of patients after pancreatic resection (i.e. indication for abdominal imaging, antibiotic treatment, percutaneous drainage and removal of abdominal drains). The algorithm is designed to aid early detection and minimally invasive step-up management of postoperative pancreatic fistula. Outcomes of current practice will be compared with outcomes after implementation of the algorithm. The primary outcome is a composite of major complications (i.e. post-pancreatectomy bleeding, new-onset organ failure and death) and will be measured in a sample size of at least 1600 patients undergoing pancreatic resection. Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization and costs analysis. Follow up will be up to 90 days after pancreatic resection. Discussion: It is hypothesized that a structured nationwide implementation of a dedicated algorithm for early detection and minimally invasive step-up management of postoperative pancreatic fistula will reduce the risk of major complications and death after pancreatic resection, as compared to current practice. Trial registration: Netherlands Trial Register: NL 6671. Registered on 16 December 2017

The Introduction of Bioptic Driving in the Netherlands

Background: In many US states, people with moderately reduced visual acuity (eg, 20/50–20/200) can legally drive with the aid of a small, spectacle-mounted (“bioptic”) telescope.We conducted a demonstration project to assess the viability of implementing bioptic driving in the Netherlands. In this article, we describe the framework of the project from conception through to realization of our primary objective—the introduction of bioptic driving as a legal option for visually impaired people in the Netherlands. Methods: The project was based on bioptic driving programs in the United States, which were adapted to fit into current driving training and assessment practices in the Netherlands. The project convened a consortium of organizations including the Netherlands Bureau of Driving Skills Certificates, service organizations for the visually impaired, and research departments at universities investigating driving and vision. All organizations were educated about bioptic driving and participating professionals were trained in their specific aspects of the project. Media publicity led to significant interest and helped recruitment that enabled the screening and selection of potential participants. Outcomes: The project demonstrated that people with moderately reduced visual acuity can be trained to achieve an adequate level of proficient and safe driving (as assessed by the local official driving licensing professionals) when using a bioptic telescope for the road conditions in the Netherlands. Based on the successful project outcomes, a request was made to the minister to allow bioptic driving in the Netherlands. This request has been accepted; the legal procedures for implementation are in process

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

BACKGROUND: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. METHODS: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide da

Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

Validation of the Oudega diagnostic decision rule for diagnosing deep vein thrombosis in frail older out-of-hospital patients

Objective. We aimed to validate the Oudega diagnostic decision rule-which was developed and validated among younger aged primary care patients-to rule-out deep vein thrombosis (DVT) in frail older outpatients. Methods. In older patients (>60 years, either community dwelling or residing in nursing homes) with clinically suspected DVT, physicians recorded the score on the Oudega rule and d-dimer test. DVT was confirmed with a composite reference standard including ultrasonography examination and 3-month follow-up. The proportion of patients with a very low probability of DVT according to the Oudega rule (efficiency), and the proportion of patients with symptomatic venous thromboembolism during 3 months follow-up within this 'very low risk' group (failure rate) was calculated. Results. DVT occurred in 164 (47%) of the 348 study participants (mean age 81 years, 85% residing in nursing homes). The probability of DVT was very low in 69 patients (Oudega score {Eth}3 points plus a normal d-dimer test; efficiency 20%) of whom four had non-fatal DVT (failure rate 5.8%; 2.3-14%). With a simple revised version of the Oudega rule for older suspected patients, 43 patients had a low risk of DVT (12% of the total population) of whom only one had DVT (failure rate 2.3%; 0.4-12%). Conclusions. In older suspected patients, application of the original Oudega rule to exclude DVT resulted in a higher failure rate as compared to previous studies. A revised and simplified Oudega strategy specifically developed for elderly suspected patients resulted in a lower failure rate though at the expense of a lower efficiency

Is It Our Duty To Hunt for Pathogenic Mutations?

Should professionals systematically screen whole-genome sequencing (WGS) data to check for life-threatening mutations? Alternatively, should genome analysis focus on the primary reason for testing – that is, aiming to achieve precision medicine? We present an ethical review of the arguments and compare the act of searching for mutations with disclosing mutations that are discovered incidentally

Exploring land use trends in Europe: A comparison of forecasting approaches and results

Over the past years several studies have explored future land use trends for Europe. This paper presents a comparison of six land use studies for Europe that explore land use changes until 2020/2030. We compared these studies with respect to qualitative as well as quantitative aspects. The qualitative analysis shows that many studies focus on agricultural land uses and therefore draw on detailed agricultural models, while only few include urban developments. The purpose of about half of the studies is to provide land use outlooks, while the other half used scenarios to test the behaviour of scientific models or show their potential applicability. For the quantitative comparison we considered the results of their reference and alternative scenarios. This comparison shows that there is a large difference between the projected results provided by the different outlooks. We even found that alternative scenario outcomes within a single outlook study are more similar than the results of reference scenarios between outlook studies. To a large extent this can be traced back to the differences in initial data sources, data pre-processing and model assumptions. To exclude the impact of differences in initial data, also relative changes were computed. Results from this analysis show a large range of values, which indicates a large uncertainty in the results of land use outlooks. We suggest using all results as the plausibility space for future land use changes. Many studies have kept the values of drivers within a rather limited range, while in reality larger shocks may well be possible