Search

Background All non-sensitized Rhesus D (RhD)-negative pregnant women in Germany receive antenatal anti-D prophylaxis without knowledge of fetal RhD status. Non-invasive prenatal testing (NIPT) of cell-free fetal DNA in maternal plasma could avoid unnecessary anti-D administration. In this paper, we systematically reviewed the evidence on the benefit of NIPT for fetal RhD status in RhD-negative pregnant women. Methods We systematically searched several bibliographic databases, trial registries, and other sources (up to October 2019) for controlled intervention studies investigating NIPT for fetal RhD versus conventional anti-D prophylaxis. The focus was on the impact on fetal and maternal morbidity. We primarily considered direct evidence (from randomized controlled trials) or if unavailable, linked evidence (from diagnostic accuracy studies and from controlled intervention studies investigating the administration or withholding of anti-D prophylaxis). The results of diagnostic accuracy studies were pooled in bivariate meta-analyses. Results Neither direct evidence nor sufficient data for linked evidence were identified. Meta-analysis of data from about 60,000 participants showed high sensitivity (99.9%; 95% CI [99.5%; 100%] and specificity (99.2%; 95% CI [98.5%; 99.5%]). Conclusions NIPT for fetal RhD status is equivalent to conventional serologic testing using the newborn’s blood. Studies investigating patient-relevant outcomes are still lacking.

Background Negative pressure wound therapy (NPWT) is a widely used method of wound treatment. We performed a systematic review of randomised controlled trials (RCTs) comparing the patient-relevant benefits and harms of NPWT with standard wound therapy (SWT) in patients with wounds healing by secondary intention. Methods We searched for RCTs in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and study registries (last search: July 2018) and screened reference lists of relevant systematic reviews and health technology assessments. Manufacturers and investigators were asked to provide unpublished data. Eligible studies investigated at least one patient-relevant outcome (e.g. wound closure). We assessed publication bias and, if feasible, performed meta-analyses, grading the results into different categories (hint, indication or proof of a greater benefit or harm). Results We identified 48 eligible studies of generally low quality with evaluable data for 4315 patients and 30 eligible studies with missing data for at least 1386 patients. Due to potential publication bias (proportion of inaccessible data, 24%), we downgraded our conclusions. A meta-analysis of all wound healing data showed a significant effect in favour of NPWT (OR 1.56, 95% CI 1.15 to 2.13, p = 0.008). As further analyses of different definitions of wound closure did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. A meta-analysis of hospital stay (in days) showed a significant difference in favour of NPWT (MD − 4.78, 95% CI − 7.79 to − 1.76, p = 0.005). As further analyses of different definitions of hospital stay/readmission did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. There was neither proof (nor indication nor hint) of greater benefit or harm of NPWT for other patient-relevant outcomes such as mortality and adverse events. Conclusions In summary, low-quality data indicate a greater benefit of NPWT versus SWT for wound closure in patients with wounds healing by secondary intention. The length of hospital stay is also shortened. The data show no advantages or disadvantages of NPWT for other patient-relevant outcomes. Publication bias is an important problem in studies on NPWT, underlining that all clinical studies need to be fully reported.

The analysis of adverse events plays an important role in the benefit assessment of drugs. Consequently, results on adverse events are an integral part of reimbursement dossiers submitted by pharmaceutical companies to health policy decision-makers. Methods applied in the analysis of adverse events commonly include simple standard methods for contingency tables. However, the results produced may be misleading if observations are censored at the time of discontinuation due to treatment switching or noncompliance, resulting in unequal follow-up periods. In this paper, we present examples to show that the application of inadequate methods for the analysis of adverse events in the reimbursement dossier can lead to a downgrading of the evidence on a drug's benefit in the subsequent assessment, as greater harm from the drug cannot be excluded with sufficient certainty. Legal regulations on the benefit assessment of drugs in Germany are presented, in particular, with regard to the analysis of adverse events. Differences in safety considerations between the drug approval process and the benefit assessment are discussed. We show that the naive application of simple proportions in reimbursement dossiers frequently leads to uninterpretable results if observations are censored and the average follow-up periods differ between treatment groups. Likewise, the application of incidence rates may be misleading in the case of recurrent events and unequal follow-up periods. To allow for an appropriate benefit assessment of drugs, adequate survival time methods accounting for time dependencies and duration of follow-up are required, not only for time-to-event efficacy endpoints but also for adverse events. © 2016 The Authors. Pharmaceutical Statistics published by John Wiley & Sons Ltd.

Developing a regional power system to achieve a high level of integration of national systems requires sufficient development of the regional transmission grid. This is possible only with appropriate schemes for the complete cost&ndash, benefit analyses, and cost allocation of these transmission investments, which plays a critical role in the selection of the most efficient network investment and the proper assignment of their cost to the national systems. Network reinforcements affect the operation of power systems and, therefore, the externalities of power generation. This paper examines the impacts of integrating local air pollution damage from power production within the benefit assessment and cost allocation of transmission investments. The paper describes the methodology followed and illustrates its application in a real-life case study where a simplified version of a European network is considered. Within this case study, we have assessed the impact of considering the reduction in air pollution damage achieved through a particular HVDC project between France and Spain on the benefits, and benefit-driven cost allocation, computed for this project. In this case study, local pollution related benefits are a relevant fraction of the overall benefits of the considered transmission project. However, considering the local air pollution benefits of the project does not affect the net positive benefits of each country significantly, resulting in a limited change in the cost allocation of the project.

ObjectivesThe aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.DesignIn this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.SettingThis German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.Participants368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.InterventionsNPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.Primary and secondary outcome measuresPrimary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.ResultsIn the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI−4.7% – 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.ConclusionsNPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.Trial registration numbersNCT01480362and DRKS00003347.

The environmental outcome of the Electronic Toll Collection (ETC) system is an important aspect in evaluating the impacts of the ETC system, which is influenced by various factors including the vehicle type, travel speed, traffic volume, and average queue length of Manual Toll Collection (MTC) lanes. The primary objective of this paper is to develop a field data-based practical model for evaluating the effects of ETC system on the fuel efficiency and vehicle emission. First, laboratory experiments of seven types of vehicles under various scenarios for toll collection were conducted based on the Vehicle Emissions Testing System (VETS). The indicator calculation models were then established to estimate the comprehensive benefit of ETC system by comparing the test results of MTC lane and ETC lane. Finally, taking Beijing as a case study, the paper calibrated the model parameters, and estimated the monetization value of environmental benefit of the ETC system in terms of vehicle emissions reduction and fuel consumption decrease. The results shows that the applications of ETC system are expected to save fuel consumption of 4.1 million liters and reduce pollution emissions by 730.89 tons in 2013 in Beijing.

Background Most European and North American clinical practice guidelines recommend screening for asymptomatic bacteriuria (ASB) as a routine pregnancy test. Antibiotic treatment of ASB in pregnant women is supposed to reduce maternal upper urinary tract infections (upper UTIs) and preterm labour. However, most studies supporting the treatment of ASB were conducted in the 1950s to 1980s. Because of subsequent changes in treatment options for ASB and UTI, the applicability of findings from these studies has come into question. Our systematic review had three objectives: firstly, to assess the patient-relevant benefits and harms of screening for ASB versus no screening; secondly, to compare the benefits and harms of different screening strategies; and thirdly, in case no reliable evidence on the overarching screening question was identified, to determine the benefits and harms of treatment of ASB. Methods We systematically searched several bibliographic databases, trial registries, and other sources (up to 02/2016) for randomised controlled trials (RCTs) and prospective non-randomised trials. Two authors independently reviewed abstracts and full-text articles and assessed the risk of bias of the studies included. As meta-analyses were not possible, we summarised the results qualitatively. Results We did not identify any eligible studies that investigated the benefits and harms of screening for ASB versus no screening or that compared different screening strategies. We identified four RCTs comparing antibiotics with no treatment or placebo in 454 pregnant women with ASB. The results of 2 studies published in the 1960s showed a statistically significant reduction in rates of pyelonephritis (odds ratio [OR] = 0.21, 95 % confidence interval [CI] 0.07–0.59) and lower UTI (OR = 0.10, 95 % CI 0.03–0.35) in women treated with antibiotics. By contrast, event rates reported by a recent study were not statistically significantly different, neither regarding pyelonephritis (0 % vs. 2.2 %; OR = 0.37, CI 0.01–9.25, p = 0.515) nor regarding lower UTI during pregnancy (10 % vs. 18 %; Peto odds ratio [POR] = 0.53, CI 0.16–1.79, p = 0.357). Data were insufficient to determine the risk of harms. As three of the four studies were conducted several decades ago and have serious methodological shortcomings, the applicability of their findings to current health care settings is likely to be low. The recent high-quality RCT was stopped early due to a very low number of primary outcome events, a composite of preterm delivery and pyelonephritis. Therefore, the results did not show a benefit of treating ASB. Conclusions To date, no reliable evidence supports routine screening for ASB in pregnant women. Electronic supplementary material The online version of this article (doi:10.1186/s12884-016-1128-0) contains supplementary material, which is available to authorized users.

The fast penetration of nanoproducts on the market under conditions of significant uncertainty of their environmental properties and risks to humans creates a need for companies to assess sustainability of their products. Evaluation of the potential benefits and risks to build a coherent story for communication with clients, authorities, consumers, and other stakeholders is getting to be increasingly important, but SMEs often lack the knowledge and expertise to assess risks and communicate them appropriately. This paper introduces LICARA nanoSCAN, a modular web based tool that supports SMEs in assessing benefits and risks associated with new or existing nanoproducts. This tool is unique because it is scanning both the benefits and risks over the nanoproducts life cycle in comparison to a reference product with a similar functionality in order to enable the development of sustainable and competitive nanoproducts. SMEs can use data and expert judgment to answer mainly qualitative and semi-quantitative questions as a part of tool application. Risks to public, workers and consumers are assessed, while the benefits are evaluated for economic, environmental and societal opportunities associated with the product use. The tool provides an easy way to visualize results as well as to identify gaps, missing data and associated uncertainties. The LICARA nanoSCAN has been positively evaluated by several companies and was tested in a number of case studies. The tool helps to develop a consistent and comprehensive argument on the weaknesses and strengths of a nanoproduct that may be valuable for the communication with authorities, clients and among stakeholders in the value chain. LICARA nanoSCAN identifies areas for more detailed assessments, product design improvement or application of risk mitigation measures. Keywords: Risk assessment, Benefit assessment, Nanoproducts, Decision-making tool, Sustainable nanotechnology, Life Cycle Assessment

Maintenance and system evolution activities have a significant role in the information system (IS) life cycle. It has been estimated that approximately 80% of the total IT expenses are allocated for maintenance activities [20]. According to Lehman’s first law, maintenance is necessary, because software needs to be continuously improved or it will get out of date and cannot respond to the requirements of its environment [19]. Despite the importance of IS evolution investments, there is a gap between the IT related costs and company profitability [27]. Brynjolfssen [10] described this as a productivity paradox: information technology utilization has increased since the 70’s but simultaneously productivity has slowed down. The work effort of maintenance is generally proportional to the life time of a system. Therefore, it is more dominant in legacy information systems [7]. Besides being old, a legacy system is typically large at size and contains vital information for the user organization, uses out-of-date technology, and is laborious to maintain [3] [4]. There are three strategies to deal with a legacy system: 1) maintaining and using the system as it is, 2) developing or purchasing a new system to replace it, or 3) radically improve, i.e. modernize, the legacy system in order to meet the new business needs [4] [25, p 8-10]. IT investments can be roughly classified in two categories, acquisition projects and development projects [24]. In the context of IS evolution, acquisition project includes purchasing off-the-self software in order to replace the existing legacy system. Development investment refers to a project that aims at developing new or modernizing the existing system. Therefore, replacement can be either an

Geological information can play a key role in addressing challenges of sustainable development such as land degradation and groundwater protection, and contribute to improved decision-making processes. In this paper we: (a) provide a review of previous research on the economic value of geological information and other earth observations as well as related products, services and infrastructure; and (b) identify important lessons from this work as well as methodological challenges that require increased attention in future research. The review of prior research shows significant economic benefits attached to the generation of this type of public information. The value of geological information has typically been measured in terms of avoided costs. Still, it is difficult to compare results across studies since they differ in scope and make alternative assumptions concerning which sectors to cover. Furthermore, previous research is not uniform in their treatment of potential (rather than only existing) users, and employ varying conceptions of avoided costs. The paper concludes that future research should devote more attention to the public and experience good characteristics of this type of information, thus highlighting the preconditions for information adoption as well as addressing the role of potential users. A number of specific methodological challenges also deserve further scrutiny in future research, such as the use of discount rates and benefit-transfer approaches. We also provide some thoughts on how to proceed with such research.