scholarly journals Estimating the Inter- and Intra-Rater Reliability for NASH Fibrosis Staging in the Presence of Bridge Ordinal Ratings with Hierarchical Bridge Category Models

2021 ◽  
Author(s):  
Joshua Levy ◽  
Carly Bobak ◽  
Nasim Azizgolshani ◽  
Xiaoying Liu ◽  
Bing Ren ◽  
...  

The public health burden of non-alcoholic steatohepatitis (NASH), a liver condition characterized by excessive lipid accumulation and subsequent tissue inflammation and fibrosis, has burgeoned with the spread of western lifestyle habits. Progression of fibrosis into cirrhosis is assessed using histological staging scales (e.g., NASH Clinical Research Network (NASH CRN)). These scales are used to monitor disease progression as well as to evaluate the effectiveness of therapies. However, clinical drug trials for NASH are typically underpowered due to lower than expected inter-/intra-rater reliability, which impacts measurements at screening, baseline, and endpoint. Bridge ratings represent a phenomenon where pathologists assign two adjacent stages simultaneously during assessment and may further complicate these analyses when ad hoc procedures are applied. Statistical techniques, dubbed Bridge Category Models, have been developed to account for bridge ratings, but not for the scenario where multiple pathologists assess biopsies across time points. Here, we develop hierarchical Bayesian extensions for these statistical methods to account for repeat observations and use these methods to assess the impact of bridge ratings on the inter-/intra-rater reliability of the NASH CRN staging scale. We also report on how pathologists may differ in their assignment of bridge ratings to highlight different staging practices. Our findings suggest that Bridge Category Models can capture additional fibrosis staging heterogeneity with greater precision, which translates to potentially higher reliability estimates in contrast to the information lost through ad hoc approaches.

2019 ◽  
Author(s):  
Liran Chen ◽  
Huafang Chen

Abstract Background: The China food and drug administration (CFDA) issued the Announcement of Self-examination and Inspection of Clinical Drug Trial Data on July 22, 2015. Great changes have taken place since the launch of the most stringent drug registration self-examination and inspection in history; the cost of clinical trials is one of the important changes. Methods: The paper compares the changes in the cost of clinical drug trials on both the number and the structure of the trials 3 years before and 3 years after self-examination and inspection were initiated by the CFDA,analyzes the impact on the cost of the clinical research coordinator ( CRC ), the labor service of researchers, audit companies, institutional drug management and quality control on the quality improvement of clinical drug trials. Conclusions: According to the article, the emergence and increase in most clinical trial costs are conducive to the quality enhancement of clinical drug trials,However, the emergence and continued increase of CRC costs can improve the quality of clinical drug trials in some ways and hinder it in others..To improve the quality of clinical trials, China must regulate the booming site management organization ( SMO ) market and actively formulate industry standards and qualification certifications for CRCs.


2020 ◽  
Vol 6 (1) ◽  
pp. e000700
Author(s):  
Pierre Fremont ◽  
Kathryn Schneider ◽  
Anne Laroche ◽  
Carolyn Emery ◽  
Keith Yeates

ObjectivesA massive open online course (MOOC) has the potential to help address the public health burden of concussion across all levels of sport and leisure activities. The main objectives of this study were to document the volume of participation and to estimate the impact of a MOOC on concussion protocol implementation.MethodsBetween April 2016 and October 2018, four editions of a French-language MOOC on concussion were presented. Each of the six modules contains a section presenting the main learning content and a section proposing a reflective process to support the implementation of a concussion protocol in the participant’s environment. The proportion of registrants who achieved successful completion of the course was the main outcome. Surveys were also used to document the types of participants and their intent to implement or update a protocol.ResultsThirty per cent of 8368 registrants successfully completed the course. Of the 3061 participants who completed a survey about their background, 58.8% were healthcare professionals, 16.3% were sport or school stakeholders, and 10.1% were parents or persons who sustained a concussion. Of the 1471 participants who completed a survey about their intent to implement or update a concussion protocol in their environment, 39.4% answered positively.ConclusionThis study describes the first use of a MOOC to address the issue of concussion. The experience of a French-language MOOC shows promising results supporting the use of this innovative educational strategy as part of the solution to the public health issue of concussion.


2013 ◽  
Vol 109 (5) ◽  
pp. 777-784 ◽  
Author(s):  
I. Lenoir-Wijnkoop ◽  
P. J. Jones ◽  
R. Uauy ◽  
L. Segal ◽  
J. Milner

Non-communicable diseases (NCD) are a major and increasing contributor to morbidity and mortality in developed and developing countries. Much of the chronic disease burden is preventable through modification of lifestyle behaviours, and increased attention is being focused on identifying and implementing effective preventative health strategies. Nutrition has been identified as a major modifiable determinant of NCD. The recent merging of health economics and nutritional sciences to form the nascent discipline of nutrition economics aims to assess the impact of diet on health and disease prevention, and to evaluate options for changing dietary choices, while incorporating an understanding of the immediate impacts and downstream consequences. In short, nutrition economics allows for generation of policy-relevant evidence, and as such the discipline is a crucial partner in achieving better population nutritional status and improvements in public health and wellness. The objective of the present paper is to summarise presentations made at a satellite symposium held during the 11th European Nutrition Conference, 28 October 2011, where the role of nutrition and its potential to reduce the public health burden through alleviating undernutrition and nutrition deficiencies, promoting better-quality diets and incorporating a role for functional foods were discussed.


2021 ◽  
Author(s):  
Joshua Levy ◽  
Carly A Bobak ◽  
Nasim Azizgolshani ◽  
Xiaoying Liu ◽  
Bing Ren ◽  
...  

Non-alcoholic steatohepatitis (NASH) is a liver disease characterized by excessive lipid accumulation and disease progression is typically assessed through inspection of a Trichrome stain for Fibrosis staging. As the public health burden of NASH worsens due to evolving lifestyle habits, pathology laboratory resources will become increasingly strained due to rising demand for specialized stains. Virtual staining processes, computational methods which can synthesize the application of chemical staining reagents, can potentially provide resource savings by obviating the need to acquire specialized stains. Virtual staining technologies are assessed by comparing virtual and real tissue stains for their realism and ability to stage. However, these assessment methods are rife with statistical mistreatment of observed phenomena that are difficult to account for. Bridge category ratings represent a phenomenon where a pathologist may assign two adjacent stages simultaneously, which may bias and/or reduce the power of research findings. Such stage assignments were frequently reported in a large-scale assessment of Virtual Trichrome technologies yet were unaccounted for since no statistical adjustment procedures existed. In this work, we provide an updated assessment of Virtual Trichrome technologies using Bridge Category Models, which account for these bridge ratings. We report that two of four pathologists tended to assign lower Fibrosis stages to virtually stained tissue while the other two pathologists assigned similar stages. These research findings differ when bridge ratings are not accounted for. While promising, these results indicate further room for algorithmic finetuning of Virtual Trichrome technologies.


2013 ◽  
Vol 1 (6) ◽  
pp. 1-138 ◽  
Author(s):  
N Chambers ◽  
G Harvey ◽  
R Mannion ◽  
J Bond ◽  
J Marshall

AbstractBackgroundThere is a need to reduce the variation in organisational performance across the NHS for which boards hold ultimate responsibility. By exploring how boards can add value, we hope that this research will benefit patients and improve service efficiency and effectiveness.ObjectivesWe know that there are knowledge gaps in relation to the composition and characteristics of effective boards in the NHS, their impact and the range of tools and techniques available for developing effective boards. This realist synthesis study, therefore, aims to add to existing knowledge by (1) providing a theoretical contribution to board governance and relating it to the NHS context, (2) offering fresh insights into effective board composition, structures, processes and behaviours in the NHS, (3) furthering an understanding of how NHS boards can affect organisational performance and (4) summarising and analysing the range of board assessment tools and development interventions available for the NHS.MethodThe study adopted a realist approach to an evidence synthesis of a diffuse literature. In line with realist review principles, we tested, honed and refined the research questions and emerging findings with a joint expert advisory and stakeholder group of 23 people. A search was conducted across relevant library and external sources including ABI/INFORM® (ProQuest, Ann Arbor, MI, USA), SciVerse® ScienceDirect® (Elsevier, Amsterdam, the Netherlands), MEDLINE, EMBASE and the Social Science Research Network, from 1968 to 2011. A total of 618 general articles, 209 health-care-related articles, 252 textbooks and 54 reports were identified.ResultsFrameworks that have developed from theory and from practice were categorised into the three elements of composition (board structure), focus (what the board does) and dynamics (the behavioural dimension), and the potential conjunction between board theories and practices was explored. We found some important distinguishing characteristics in the public, non-profit and health-care sectors. In relation to the impact of boards on organisational performance, the importance of contingency factors was highlighted and there is positive empirical support for the role of physicians on the board. Other than self-reports, we could not find any significant studies on the impact of board development on board effectiveness.LimitationsThe study is dependent on the diverse nature of the sources of evidence and the relative infancy of the realist synthesis method. The literature is fragmented, equivocal and, at times, contradictory. We believe, nevertheless, that the study offers insights in terms of developing middle-range theories for effective health-care boards.ConclusionsWe found no simple theory about how boards should operate. The use of certain models for boards may be more appropriate than others, depending on what the priority is in terms of organisation outcome. We have identified some important distinguishing characteristics in the public and non-profit sectors. On the whole, evidence lends some further support for a theory about the dynamics of an effective board in relation to high challenge, high trust and high engagement, modified in the light of our developing understanding about the linkages between different contexts and desired outcomes. We identified five areas in which board development approaches should be more focused. We suggest three main areas for further research: the composition of NHS boards, the conditions under which health-care boards are able to exert a sustained focus on clinical quality and an evaluation of the impact of board development activities on organisational performance.FundingThe National Institute for Health Research Health Services and Delivery Research programme.


2021 ◽  
Vol 4 (32) ◽  
pp. 189-201
Author(s):  
Jarosław Szymański

The aim of the article/hypothesis: The impact of the pandemic on the European and global economy is unquestionable. The question is how the epidemiological situation has affected the European public procurement system. The study was limited to assessing the changes in the structure of the procedures used to award public contracts and the possible effects of a lack of dynamics in this respect. The aim of the work is to observe the effects of changes in the structure of tendering procedures and to identify other phenomena in the public procurement system, caused by the pandemic. Methodology: Taking into account the diversity of national solutions in the field of public procurement, resulting both from the legal systems and national practice, an analysis of awarded public contracts was carried out, with particular emphasis on the domestic market. The research was conducted in the direction of determining the changes in preferences of selecting non-competitive procedures, new possibilities of awarding contracts and the analysis of changes in the preferences of the non-competitive procedure on the European Union market. The tools used for the analysis included basic statistical measures and the non-parametric Mann-Whitney test. Results of the research: As a result of the analysis, it was found that there was a statistically significant increase in the share of the non-competitive procedure on the European market. The observation of individual national markets shows that in some Member States there has been a decrease or a very limited increase in the non-competitive mode. This may result from ad hoc legal changes and means that an unknown number of contracts of unknown value was awarded outside the control of the monitoring of the public procurement system.


2018 ◽  
Author(s):  
Nabeel Abdur Rehman ◽  
Henrik Salje ◽  
Moritz U G Kraemer ◽  
Lakshminarayanan Subramanian ◽  
Simon Cauchemez ◽  
...  

AbstractDengue virus causes over 96 million cases worldwide per year and is ex-panding rapidly in geographic range, especially in urban areas. Containment activities are an essential part of reducing the public health burden caused by dengue, but systematic evidence on the comparative efficacy of activities from the field is lacking. To our knowledge, the effect of containment activities on local (sub-city) scale disease dynamics has never been systematically characterized using empirical containment and case data. We combine data from a comprehensive dengue containment monitoring system with confirmed dengue case data from the local government hospitals to estimate the efficacy of seven common containment activities in two urban areas in Pakistan. We use a modified version of the time series Suspected Infected Recovered frame-work to estimate how the reproductive number, R0, of the outbreak changed in relation to deployment of each containment activity. We also estimate the spatial dependence of cases based on deployment of each containment activity. Both analyses suggest that activities aimed at the adult phase of the mosquito lifecycle have the highest efficacy, with fogging having the largest quantifiable effect in reducing cases immediately after deployment. In examining the efficacy of containment activities contemporaneously deployed in the same locations, results here can guide recommendations for future deployment of resources during dengue outbreaks in urban settings.


2019 ◽  
pp. 109-123
Author(s):  
I. E. Limonov ◽  
M. V. Nesena

The purpose of this study is to evaluate the impact of public investment programs on the socio-economic development of territories. As a case, the federal target programs for the development of regions and investment programs of the financial development institution — Vnesheconombank, designed to solve the problems of regional development are considered. The impact of the public interventions were evaluated by the “difference in differences” method using Bayesian modeling. The results of the evaluation suggest the positive impact of federal target programs on the total factor productivity of regions and on innovation; and that regional investment programs of Vnesheconombank are improving the export activity. All of the investments considered are likely to have contributed to the reduction of unemployment, but their implementation has been accompanied by an increase in social inequality.


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