scholarly journals Fundamental challenges in assessing the impact of research infrastructure

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sana Zakaria ◽  
Jonathan Grant ◽  
Jane Luff

AbstractClinical research infrastructure is one of the unsung heroes of the scientific response to the current COVID-19 pandemic. The extensive, long-term funding into research support structures, skilled people, and technology allowed the United Kingdom research response to move off the starting blocks at pace by utilizing pre-existing platforms. The increasing focus from funders on evaluating the outcomes and impact of research infrastructure investment requires both a reframing and progression of the current models in order to address the contribution of the underlying support infrastructure. The majority of current evaluation/outcome models focus on a “pipeline” approach using a methodology which follows the traditional research funding route with the addition of quantitative metrics. These models fail to embrace the complexity caused by the interplay of previous investment, the coalescing of project outputs from different funders, the underlying infrastructure investment, and the parallel development across different parts of the system. Research infrastructure is the underpinning foundation of a project-driven research system and requires long-term, sustained funding and capital investment to maintain scientific and technological expertise. Therefore, the short-term focus on quantitative metrics that are easy to collect and interpret and that can be assessed in a roughly 5-year funding cycle needs to be addressed. The significant level of investment in research infrastructure necessitates investment to develop bespoke methodologies that develop fit-for-purpose, longer-term/continual approach(es) to evaluation. Real-world research should reflect real-world evaluation and allow for the accrual of a narrative of value indicators that build a picture of the contribution of infrastructure to research outcomes. The linear approach is not fit for purpose, the research endeavour is a complex, twisted road, and the evaluation approach needs to embrace this complexity through the development of realist approaches and the rapidly evolving data ecosystem. This paper sets out methodological challenges and considers the need to develop bespoke methodological approaches to allow a richer assessment of impact, contribution, attribution, and evaluation of research infrastructure. This paper is the beginning of a conversation that invites the community to “take up the mantle” and tackle the complexity of real-world research translation and evaluation.

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.


2020 ◽  
Vol 376 (1816) ◽  
pp. 20190726 ◽  
Author(s):  
A. Bevan ◽  
E. R. Crema

This paper responds to a resurgence of interest in constructing long-term time proxies of human activity, especially but not limited to models of population change over the Pleistocene and/or Holocene. While very much agreeing with the need for this increased attention, we emphasize three important issues that can all be thought of as modifiable reporting unit problems: the impact of (i) archaeological periodization, (ii) uneven event durations and (iii) geographical nucleation-dispersal phenomena. Drawing inspiration from real-world examples from prehistoric Britain, Greece and Japan, we explore their consequences and possible mitigation via a reproducible set of tactical simulations. This article is part of the theme issue ‘Cross-disciplinary approaches to prehistoric demography’.


1984 ◽  
Vol 15 (3) ◽  
pp. 140-143
Author(s):  
Sarah S. Visser

The application of increasing price-level changes to capital investment decisions Inflation (the decreasing purchasing power of money) has become a reality with which one has to live, and for which one has to plan. As a result of the decrease in the purchasing power of money, the prices of production means are going up considerably, and more so where long-term capital projects are involved. The initial investment in respect of a capital project involves the least risk in accuracy, as it has to be known at the moment of decision-making and cannot be changed significantly until the decision has been realized. The other factors essential for decision-making and which will be realized in the future throughout the lifespan of the asset are subject to change in the value of money and it is important that the influence of this change be taken into account. The impact of price-level changes can be taken into account through the use of general or specific price-level changes. The application of this has led to the fact that only general price-level changes, or only specific price-level changes, or general and specific price-level changes can be used for the adjustment of items. The last includes the advantages of using both price-level changes. In each of these applications different methods have been developed which agree in principle, while there may be differences with regard to details of the applications.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Daniel E Forman ◽  
Jeanne Y Wei ◽  
Mark I Friedman ◽  
Keith D Dawkins ◽  
Donald S Baim

Although percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is widely used for treating elderly patients (pts), there are limited data regarding PCI outcomes in this high-risk patient population. To determine the impact of age on long-term safety and efficacy following implantation of the TAXUS Express 2 paclitaxel-eluting stent, we analyzed the TAXUS and ARRIVE studies. The 2,797 pts in TAXUS I, II SR, IV and V randomized trials and 7,492 pts in ARRIVE 1 and 2 “real world” registries were divided into three groups based on age: <60, 60 –70 and >70 years. Safety and efficacy outcomes were compared among these age groups. Results: While the 5-year death rate increased with age in the TAXUS trials, the rates of target lesion revascularization (TLR) and myocardial infarction (MI) were comparable, and the rate of stent thrombosis (ST) decreased with age. Moreover, the bare metal stent pts >70 (not shown) had similar rates of death and MI and a higher rate of TLR and ST than the corresponding TAXUS cohort. In “real world” higher risk ARRIVE pts, the 2-year death rate and cardiac death rate also increased with age while the rates of TLR, MI, and ST actually decreased with age. Elderly pts (age >70) treated with the TAXUS Express 2 stent had higher long-term death rates, but comparable TLR and MI rates and reduced ST rates compared to their younger counterparts. Collectively, these results indicate that despite the high-risk clinical and angiographic characteristics commonly observed in elderly pts, this patient population derives similar safety and efficacy from TAXUS stent treatment and such treatment should not be withheld on the basis of age alone when clinically and anatomically appropriate.


2021 ◽  
Vol 11 (1) ◽  
pp. 165-175
Author(s):  
Bakir Hameed Jasoum ◽  
Noaman Mundher Younus ◽  
Fouad Farhan Hussein

Foreign direct investment is of paramount importance at the international level, especially in developing countries, as many studies have shown its effective impact and its essential role in the medium and long term in advancing economic growth by stimulating GDP rates, providing employment opportunities, providing expertise and advanced technology. What prompted most Arab countries, including Algeria, to exert efforts in order to provide an appropriate investment environment to attract direct investment through a set of economic reforms, guarantees and facilities, and their conclusion of multiple bilateral agreements to encourage and protect the foreign investor.The research aims to know the extent of the impact of foreign direct investment on economic growth in Algeria for the period (2000-2017) by using standard analysis tools to identify the nature of the relationship between foreign direct investment and economic growth.The research also found that the gross domestic product has a positive relationship with foreign direct investment, that is, when foreign direct investment increases by one unit, this will inevitably lead to an increase in economic growth by (6.43). The research also recommends the necessity of adopting economic structural reform policies in line with the reality The Algerian economy, and working to develop and develop the financial markets through their size and tools, with an emphasis on the issue of legislation and laws that guarantee the regulation of capital investment flows.


2021 ◽  
pp. 1-15
Author(s):  
Gregory Falco ◽  
Eric Rosenbach

The question “Why is cyber risk an issue?” pinpoints the leadership challenge that cyber risk poses. The chapter begins with a WannaCry case study that demonstrates how cyberattacks can impact every aspect of organizations given the pervasive nature of digital systems. The chapter describes how leadership must address cyber risk by analyzing the organization’s unique threats, its vulnerabilities, and the impact an attack can have on the organization. It describes how mitigation measures minimize cyber vulnerabilities and maximize an organization’s ability to respond to cyberattacks. It emphasizes that leadership must strategically manage cyber risk through carefully selected mitigations. This chapter introduces how an Embedded Endurance cyber risk strategy offers a systems-level approach to mitigating cyber risk by addressing interdependent components of the organization’s risk and preparing for the inevitability of cyber threats over the long term, and details real-world Embedded Endurance cyber risk strategy experiences.


Subject Shortcomings in Brazilian infrastructure. Significance The quality of Brazil’s infrastructure is a key business complaint. Infrastructure is viewed as central to boosting the country’s long-term competitiveness, as well as a potential motor of recovery from the economic crisis. However, infrastructure investment remains low. This is due in part to the budgetary restrictions faced by the government, but also to the impact of corruption scandals on leading construction companies. Impacts Better roads, railways and ports will be central to boosting Brazil's exports, notably of primary commodities. Poor infrastructure will continue to affect both business and the daily life of ordinary citizens, particularly in remote regions. The execution of infrastructure investments could produce positive and long-lasting effects on the overall economy.


2020 ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li

Abstract Background: Coronary chronic total occlusions (CTOs) are correlated with increased risk of adverse clinical outcomes. The optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world.Methods: A total of 592 consecutive patients with CTO in Beijing Friendship Hospital from June 2017 to December 2019 were enrolled, 29 patients were excluded due to Coronary artery bypass grafting (CABG). After exclusion, 563 patients were divided into the no-revascularized group (CTO-NR group, n=263) and successful revascularized group (CTO-R group, n=300). The primary endpoint was cardiac death; Secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke.Results: Percent of Diabetes mellitus (53.2% vs 39.7), Chronic kidney disease (8.7% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease(96.2% vs 90%) and left main coronary artery disease (25.1% vs 13.7%) was significantly higher in the CTO-NR group than in success PCI group (all P<0.05). Moreover, the CTO-NR group has lower EF (0.58±0.11 vs 0.61±0.1, p=0.001) and FS (0.31±0.07 vs 0.33±0.07, p=0.002). At a median follow-up of 12 months, CTO revascularization was superior to CTO no-revascularization in terms of cardiac death (adjusted hazard ratio [HR]: 0.27, 95% conference interval [CI] 0.11-0.64). The superiority of CTO revascularization was consistent for MACCE (HR: 0.55, 95% CI 0.35-0.79). At multivariable Cox hazards regression analysis, CTO revascularization remains one of the independent predictors of lower risk of cardiac death and MACCE.Conclusions: Successful revascularization by PCI may bring more clinical benefits. The presence of LVEF<0.5 and LM-disease was associated with an incidence of cardiac death; CTO revascularization was a protected predictor of cardiac death.


2020 ◽  
Author(s):  
Xuhe Gong ◽  
Li Zhou ◽  
Xiaosong Ding ◽  
Hui Chen ◽  
Hongwei Li

Abstract Backgroud: Chronic total occlusions (CTOs) are an important and increasingly recognized subgroup of coronary lesions; the optimal treatment strategy for CTO has not been well established. We sought to examine the impact of CTO percutaneous coronary intervention (PCI) on long-term clinical outcome in the real world.Methods: A total of 592 consecutive patients with CTO in Beijing Friendship Hospital from June 2017 to December 2019 were enrolled. 29 patients were excluded due to Coronary artery bypass grafting (CABG), 301 patients were revascularized by PCI (CTO-R group) and 262 were not revascularized (CTO-NR group). The primary endpoint was cardiac death; Secondary endpoint was major adverse cardiac and cerebrovascular events (MACCE), a composite of all-cause death, cardiac death, recurrent myocardial infarction, target lesion revascularization, re-hospitalization, heart failure, and stroke. Results: Percent of Diabetes mellitus (53.4% vs 39.5), Chronic kidney disease (8.8% vs 3.7%), CABG history (7.6% vs 1%), three vessel disease(96.2% vs 90%) and LM disease(25.2% vs 13.6%) was significantly higher in the CTO-NR group than in success PCI group (all P<0.05). Moreover, the CTO-NR group has lower EF (0.58±0.11 vs 0.61±0.1, p=0.002) and FS (0.32±0.07 vs 0.33±0.07, p=0.003). At a median follow-up of 12 months, CTO-R was superior to CTO-NR in terms of cardiac death (adjusted hazard ratio [HR]: 0.32, 95% conference interval [CI] 0.11-0.94). The superiority of CTO-R was consistent for MACCE (HR: 0.57, 95% CI 0.37-0.87). At multivariable Cox hazards regression analysis, CTO-R remains one of the independent predictors of lower risk of cardiac death and MACCE.Conclusions: Successful revascularization by PCI offered CTO patients more clinical benefits. The presence of LVEF<0.5 and LM-disease was associated with an incidence of cardiac death; CTO revascularised was a protected predictor of cardiac death.


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