Treponema pallidum. Considering the high rates of syphilis in pregnancy and congenital syphilis reported in Brazil in the past, and their serious consequences, this study described the epidemiological and clinical profile of pregnant women with a confirmed diagnosis of syphilis in Campo Grande, in the state of Mato Grosso do Sul, Brazil, from 2011 to 2017.  Syphilis is a sexually transmitted infection caused by Sistema de Informação de Agravos de Notificação .This is a descriptive study, based on syphilis notifications among pregnant women reported to the Over the study period, 2,056 confirmed cases of syphilis in pregnancy were reported, resulting in a crude cumulative incidence of 144.76 cases per 1,000 live-born babies. The incidence increased from 9.97 cases per 1,000 live-born babies in 2011 to 36.10 cases per 1,000 live-born babies in 2017. It was more prevalent in women who were young, of mixed race, with low educational attainment. Over one third of women were diagnosed in the first trimester of pregnancy; therefore, they were at risk of reinfection if they or their sexual partners were inadequately treated. Furthermore, syphilis was not well classified according to its clinical stage, which led to inappropriate treatments. Despite efforts to reduce the incidence of syphilis, syphilis during pregnancy remains a public health problem, reflecting possible inadequacies in antenatal care, especially in vulnerable populations. It is important to include sexual partners in syphilis treatment during pregnancy to prevent reinfection. Treponema pallidum, which has cutaneous and systemic manifestations. Treponemal and non-treponemal tests are used in diagnosis, and benzathine penicillin is the standard treatment. There are four stages of infection: primary, secondary, tertiary, and latent. The required dose and duration of antibiotic treatment depends on the stage: the more advanced the stage, the greater the required dose,Syphilis is an infectious disease caused by According to the World Health Organization, syphilis affects more than 12 million people worldwide, with 2 million pregnant women infected annuallyPlan of Action for the Prevention and Control of HIV and Sexually Transmitted Infections (2016-2021) was released, and prevention measures, including increased access to diagnosis and early treatment of HIV infection and other sexually transmitted infections (STIs), were expanded to reduce their incidence by 2021Congenital syphilis is a disease of public health importance because it can cause early and late complications in infants, including premature birth, low birth weights, skin lesions, periostitis or osteitis, anemia, and seizuresThe persistently high incidence of syphilis is a major public health problem in Brazil, with serious consequencesThis study aimed to estimate the incidence of syphilis in pregnancy as well as congenital syphilis, and to describe the epidemiological and clinical-obstetric features of the reported and confirmed cases of syphilis in pregnant women in Campo Grande, Mato Grosso do Sul State, Brazil.Sistema de Informação de Agravos de Notificação  in Campo Grande, from 2011 to 2017. All data were provided by the Municipal Secretary of Public Health of Campo Grande.We conducted a descriptive and retrospective study based on syphilis cases in pregnant women and congenital syphilis reports from the All cases of syphilis in pregnant women in Campo Grande that were confirmed using treponemal and/or non-treponemal tests, who also did not have a previous treatment record, were included. Cases reported outside the study period, cases of syphilis in pregnant women living in other municipalities or in rural and peri-urban areas, and women who were seropositive from a previous infection were excluded.The data included age, racial origin, marital status, level of education, the trimester of diagnosis, clinical data on diagnosis and treatment of the pregnant women ; it also included data on treatments received by sexual partners , and infants born to women with syphilis during pregnancy.Analyses were performed using Statistical Package for Social Sciences version 22 .The study protocol was approved by the Universidade Federal de Mato Grosso do Sul Research Ethics Committee , which granted a waiver of the requirement for consent, and the study was conducted in accordance with the principals of the Declaration of Helsinki.During the study period, 2,255 cases of syphilis in pregnant women were notified and recorded in SINAN. After applying the exclusion criteria, 2,056 cases were included in the analysis. The highest syphilis frequency in 2017 was almost 4 times higher than that in 2011, and the crude incidence cumulative per year continuously increased .The incidence was highest in women in the 20-29 years age group, followed by those in the 10-19 years age group . More thOf the women with information on the clinical stage at the time of diagnosis, the majority were in the tertiary or latent phase, and the majority of infections were confirmed by treponemal tests .In order to consider a pregnant woman as having been adequately treated in this study, treatment should be terminated within 30 days before delivery, should occur concurrently with the sexual partner's treatment, and the dose of benzathine penicillin should be appropriate for the clinical phaseThe largest shortcoming in the management of syphilis among women in the study was the diagnosis and treatment of the sexual partners of women reported with syphilis during pregnancy. Diagnostic tests and treatment were not performed in almost half of the partners. Therefore, their treatment could be considered inadequate as well as the lack of contact with the pregnant woman and partners who did not attend the health unit when requested .A total of 907 cases of congenital syphilis were reported among the 2,056 women reported with syphilis during pregnancy in Campo Grande from 2011 to 2017. Thus, 44.1% of women with syphilis diagnosed during pregnancy had an unfavorable outcome with serious consequences for their babies, such as miscarriages, stillbirths, prematurity, and other clinical manifestations,During the study period, there was a continuous and marked increase in the incidence of syphilis diagnosed during pregnancy. Considering the introduction of mandatory notifications of gestational syphilis in Brazil in 2005, this continuous increase may result in improvements in the reporting system due to better human resource capacities, a pregnant women’s increased access to prenatal consultations as a result of the implementation of Family Health Strategy teams, and increased epidemiological surveillance. Such actions are aimed at improving women’s health during antenatal care in order to achieve a reduction in gestational and congenital syphilis,,Furthermore, there was a relatively high number of cases of syphilis diagnosed in pregnant adolescents. This is a cause of concern for health services because women reach reproductive age during adolescence. In addition, the number of cases of syphilis diagnosed in pregnant adolescents increased over the study period. In this study, adolescents accounted for 25.9% of the total number of cases of syphilis diagnosed during pregnancy. In other studies of syphilis among pregnant women conducted in Brazil between 2010 and 2014, adolescents accounted for less than 20% of cases of syphilis diagnosed during pregnancy,Studies have shown that people of mixed race and a lower level of education have a higher incidence of STIs. This has been attributed to a lack of information about prevention and treatment, and a high incidence of unprotected sex among women in these demographic groupsThe determinants of syphilis and congenital syphilis are not only related to the quality of antenatal care offered to women, but are rooted in the social, economic, cultural, and behavioral factors that women experience. During pregnancy, early diagnosis is critical in order to reduce the risk of vertical transmission. This is because in the early stages of infection there is a higher number of circulating spirochetes and a higher risk of transmission to the fetus¹.,In terms of the clinical stages seen in this study, the majority of the women were in the tertiary or latent phase. This differs from the frequencies reported in other studies, where most cases were in the primary phaseTreponemal tests were used increasingly. Although confirmation of the diagnosis using treponemal tests is important, ideally treponemal tests should be performed together with a non-treponemal test. This makes it possible to correctly classify the clinical phase of the disease so that the appropriate dose and duration of treatment can be administeredMost of the women in this study received inadequate treatment. This is a concern because a lack of adequate treatment increases the risk of vertical transmission. Although the proportion of women who received adequate treatment was low (48.9%), it was higher than the proportion reported in other municipalities, as evidenced by Teixeira et al.Given that some pregnant women may not adhere to treatment, there is a need to improve the quality of care through tools such as the continuing education of professionals. This could be achieved by promoting programs such as the Permanent Education in Health, a program designed by the Ministry of Health that provides education to health professionals in their workplace, and aims to provide meaningful learning in order to transform professional practices in daily work,--The low proportion of pregnant women in this study whose sexual partners were tested and treated for syphilis should not be attributed to the pregnant women alone, as men’s health-seeking behavior may have led them to resist treatment. Many men report feelings of fear, shame, carelessness, lack of time to seek care, and a lack of support by the health service system-We found a high incidence of congenital syphilis among the infants of women diagnosed with syphilis during pregnancy. Congenital syphilis is the leading cause of neonatal death and congenital malformation. The high incidence rate of congenital syphilis indicates a failure of the healthcare system, especially in primary care where there is the possibility of interventionThe recent increase in the syphilis diagnosed during pregnancy indicates that despite the high coverage, antenatal care is insufficient to prevent, diagnose, and treat this infection adequately. The inadequate treatment of pregnant women and their partners highlights the vulnerability of these women, mainly because syphilis is an STI. The majority of these women were in the first and second trimesters of pregnancy at the time of diagnosis, and thus had a high risk of reinfection due to inappropriate treatment, for themselves or their sexual partners. A limitation of this study is the amount of missing data in the disease notification forms. This highlights the need to improve the quality of reporting and case investigation. It also should be pointed out that it is possible that more male partners were treated than the number reflected in our data, but the deficiencies in the reporting methods could have led to them not being linked to their pregnant women partners. This study is likely to inspire research on syphilis during pregnancy, especially with respect to strategies to strengthen primary care. This will make it possible to achieve the goals related to the prevention of syphilis and a creating a better quality of life for pregnant women who are affected, as well as for their children.There is need for continual improvement of the reporting system; and staff training should be carried out consistently in primary care. In addition, receptivity toward care and the formation of bonds between health professionals and primary care users is essential for successful care provision.Finally, our results showed that social, economic, and cultural vulnerability influenced the occurrence of syphilis in different demographic groups of pregnant women, despite risk-reduction strategies on the part of the health services. The groups most affected by syphilis were the groups neglected based on their economic and social situations.


Complex Adaptive Systems (CAS) is an interdisciplinary and dynamic modelling approach for the study of today’s global challenges. It is used for the explanation, description, and prediction of behaviours of system components and the system at large. To understand and assess the quality of research in which CAS models are designed and used, a thorough understanding of the meanings of ‘validity’ from social science research methodology and ‘validation’ from simulation modelling is needed. In this paper, we first describe the modelling process. Then, we analyse the concepts ‘validity’ and ‘validation’ as used in a set of research methodology textbooks and a set of modelling textbooks. We present one single map that integrates validity as characteristic of the model input, the modelling process, model validation, and the validity of the model built. The map is illustrated by means of one example. The terminology proposed in the map allows to describe and distinguish between the validity of primary research used for input in the model, how the quality of the modelling depends on structural and behavioural validation, and, how the assessment of the validity of the model is informed by these types of validation plus research with independent data. Many of today’s global issues such as climate change, food security and social injustice, call for joint input of researchers from different scientific disciplines. The complexity of these issues has promoted the development of interdisciplinary research and complexity approaches, or as Fattore and Grassi , p. 1551Interdisciplinary research is  behaviours , from the conceptual model to model code (the programming step), and, from the code back to the conceptual model (the code verification step). The fourth step is running the model, the fifth step the model validation  framework  consists of two distinct parts. The first one is the joint design of the different distinguished modules of the study (Tobi and Kampen The execution (phase 3) generally starts with running the model and doing the planned analyses. In sensitivity analysis the effects of changes and uncertainties in model parameters on the model output are investigated  involves, where appropriate, a synthesis of different research modules, and reporting. Different publications may address different modules and although the leading authors may differ, all publications require interdisciplinary input.Since the system-level behaviour of CAS originates from interactions within the system, studying the within-system processes is essential for theory building and understanding CASs. Consequently, we focus on the most commonly used modelling approaches for representing these processes: system dynamics models Phelan  and agenThis section provides details on how the inventory of validity and validation terminology and its synthesis with the adapted modelling cycle were made Fig. .The small convenience sample of textbooks n = 11) was based on hands-on availability, while ensuring different focusses and takes on social research methodology  and discriminant validity (B1) respectively. The degree to which the scores on an instrument predict future characteristics reflects its predictive validity . Face and content validation do not call upon statistics, nor on hypotheses about relations between measures. Kumar (p. 272) describes the process of face validation as linking the individual items in a research instrument with the aim of the research. Other textbooks provide similar descriptions . Content validity relates to the extent the instrument covers the full scope of the concept it measures . In summary, we opt for measurement validity as the label for the ability of an instrument to measure what it is designed to measure, which encompasses construct, convergent, discriminant, predictive, concurrent, face, and, content validity.The textbooks used ‘internal validity’ differently between and within textbooks. We regard internal validity as an attribute of the research’s conclusions, relating to claims about  relations between variables . This implies that internal validity is determined by the quality of the study design.Other keywords referring to the generalizability of research results were ecological validity, external validity, and, transferability. We will understand external validity as the ability to draw inferences from the sample to the population of interest , which implies that external validity is determined by the sampling design of the research. Ecological validity is understood as the generalizability of research findings to other populations and other, naturally occurring, settings . This implies that ecological validity is influenced by many aspects of research design. Transferability, used in the context of qualitative research, parallels generalizability as “the degree to which an individual can expect the results of a particular study to apply in a new situation or with new people” . Concluding, generalizability consists of external and ecological validity.Attributes such as trustworthiness  and authenticity relate to particular qualitative research traditions in which the concept validity is considered inappropriate and replaced by other quality criteria . Statistical validity was defined as the appropriateness of research methods used and the presence of sufficient statistical power (B3 and B6). In our view, trustworthiness and statistical validity fully overlap with the validities discussed above. The keyword validation referred to the evaluation of professional development programmes (B6).In summary, this analysis yielded three general classes of validity: measurement validity relating to the data obtained, internal validity relating to claims on  relationships, and generalizability of research results.Out of the 43 identified keywords related to validity and validation, 18 were present in at least one of the modelling textbooks. Most keywords were consistent between both system dynamics textbooks, but the two ABM textbooks used different terminology. The only term that appeared in all four textbooks was sensitivity analysis, and the meaning was consistent between the four textbooks (B8–B11 in Table Both system dynamics textbooks (B8 and B9) distinguished consistently between behavioural validity, and structural validity. Behavioural validity refers to “how well the model output aligns with the observed real-world behaviour” (B9 p. 125). Structural validity refers to the model inputs, components and their relationships. Structural validity is based on “comparison with knowledge about the real-world system structure” (B9 p. 124). Several aspects of structural validity were distinguished in both system dynamics textbooks, each corresponding to different tests: boundary adequacy tests, dimensional consistency tests, extreme condition tests, structure confirmation tests, and parameter confirmation tests. Boundary adequacy tests assess whether all the relevant system components are represented in the model (B9 p. 125). Dimensional consistency tests verify the consistency of dimensions of model equations (B9 p. 125). Extreme condition tests investigate the plausibility of the model behaviour at extreme parameter conditions (B9 p. 125), whereas structure and parameter verification tests evaluate the model structure and parameter values against knowledge of the real-world system (B9 p. 125–6). For each of these tests, Bala et al. (p. 216) refer to verification tests rather than confirmation tests, but the meaning is the same as in Duggan (B9).Duggan (B9) distinguished between validation for correlational models and for causal-descriptive models. Correlational models are black-box models that are solely aimed at predicting or reproducing data from the real-world system. Duggan  considers behavioural validation to be important for black-box models, but structural validation to be irrelevant. Causal-descriptive models, in addition to predicting or reproducing data from the real-world system, aim to give a good representation of the underlying processes. Thus, for causal-descriptive models Duggan considered both behavioural and structural validation to be important.The ABM textbooks  discussed how the process of validation depends on the level of abstractness of the model. Models of specific systems can generate specific predictions to be used in validation. In contrast, output of abstract models cannot be matched directly to a specific system.The methodology textbooks distinguished many different kinds of validity, with little consensus. Threats to different kinds of validity could be found, only implicitly informing the process of validity assessment. In contrast, modelling textbooks mentioned validation as process only, without explicating the attribute being investigated by means of that process. The one keyword with a similar meaning in both methodology and modelling textbooks is “sensitivity analysis”. Sensitivity analysis appeared in one methodology textbook as “method of estimating the robustness of the conclusions of the study or its assumptions” .Concluding, taking Hox’s suggestion  to interIn this synthesis we present the `map of validity and validation in CAS modelling’ Fig. . ValiditThe three classes of validity of primary studies inform model development in different ways see Fig. . The meaIn general, internally valid studies are needed to inform the theoretical framework, the kind of relationships  in the model design, and the design of sensitivity analyses. Generalizability of primary studies determines whether results obtained in a different setting or in a small selection of system components may be considered informative for building the theoretical framework and the model.Structural validation assesses the design of the model. Each of the four tests in Fig. Execution of the behavioural validation is part of the execution phase, and the outcomes of this validation also relate to the technical design phase. Extreme conditions tests may reveal problems in the technical design related to either the conceptual model, or the coding. Sensitivity analysis helps assess choices made in the technical design by verifying to what extent different components of the model influence the model output and resulting conclusions. Furthermore, the outcomes of sensitivity analysis will reveal whether the sensitivity analyses planned in the technical design were sufficient in relation to the aims of the modellers, or whether additional analysis is needed.The outcomes of structural and behavioural validations rely on the quality of the conceptual and the technical design, and may lead to changes in the conceptual design, the technical design and the analyses planned, hence the double-headed arrow between the second and third layer in Fig. Finally, the results of model validation inform on the validity of the model. Here, we distinguish between measurement validity, internal validity and generalizability.Measurement validity of models is about whether the model yields data that represent the real-world system in a way suitable for the research question. This is influenced by the quality of the primary studies, the theoretical framework and the quality of the coding. It is furthermore determined by the rigorousness of both the structural and behavioural validation; and how the researchers use the validation procedures’ outcomes. The assessment of the measurement validity of the model can take on many different forms, including expert judgement.The internal validity of the model is about the quality of the conclusions on relationships between and across system components over time, as drawn from the model. The internal validity of the model is limited by the quality of the primary studies, the theoretical framework, and the quality of coding. It may be enhanced by information obtained through behavioural validation, in particular sensitivity analysis. The internal validity of a model may be assessed through the collection of new data obtained in the real-world or in an experimental study design.Generalizability of the model relates to the usefulness of the model in different settings  than the one it was designed for. This is determined not only by the choosing the right primary studies and the theoretical framework, but also by tests of the robustness of the model results and conclusions . As behavioural validation does not relate a sample to a population, nor a particular setting with other real-life settings, we chose not to distinguish external and ecological validity.Two common purposes of interdisciplinary modelling studies are (1) gaining a better understanding of the system under study by means of description or explanation, and (2) using the model for informing policy by means of prediction. For the first aim, it is essential that the model is a good representation of the real-world system, that is that the model has measurement and internal validity. Assessment of the model’s validity should therefore focus on how the system-level behaviour of the model is explained by underlying processes. For the second aim, informing policy, additional focus is needed on the predictive validity of the model, and the generalizability of the model to different settings.Our aim with this illustration is to show how Fig. Libre et al  recognizThe authors relied on a number of primary studies, and also collected primary data themselves. In total, 44 interviews were conducted with various types of stakeholders. Measurement validity of the collected primary data was not mentioned by the authors, but they do provide information that allows some assessment. Face and content validity of model input that relied on the interviews may be assessed based on the interview guide  and all model equations (online appendix) are available. The reader may also perform parameter verification, as default values and their sources are provided, as well as the range of values used in the sensitivity analysis. Regarding structure verification, the authors justify most of the modelling choices based on the interview data. However, for the exact formulation of some model processes only little justification is provided by the authors.Behavioural validation: the authors report a sensitivity analysis in which each investigated parameter was individually varied over its maximum range. This analysis is a combination of extreme condition testing and local sensitivity analysis . Parameters excluded from this analysis were listed as well  and two types of validation from computer modelling . Interdependencies between validities and validation of the conceptual model, the model inputs, the modelling process, and, the model as research instrument were identified and illustrated. Different aspects of validity and different processes for validation were disentangled, resulting in a map with four layers Fig.  to facilIn the scientific literature, validity and validation is discussed along disciplinary lines, like economics (Fagiolo et al. Interdisciplinary CAS models rely on inputs from various sources and the quality of a model inevitably depends on the quality of these inputs. The validity of interdisciplinary models is therefore vulnerable to their inputs regardless of the disciplinary backgrounds. This emphasizes the importance of validity as we know it from research methodology to all disciplines that aim to contribute to CAS models. If the quality of these models was to be assessed purely based on validation outcomes ignoring validity of inputs this could easily lead to inappropriate model structures, assumptions and outcomes. While validity of models will always rely on inputs, our proposed map Fig.  makes thWe hope that our map will support social scientists to get more involved in CAS, after all socio-technical and socio-ecological systems refer to social agents and processes which are generally not the expertise of, say, engineers and ecologists. While we focus specifically on CAS models, we expect much of Fig. The first weakness of the present paper lies in the stereotyping necessary for general statements and in the selection of textbooks. The textbooks are by no means representative of all research methodology and modelling textbooks, but they do reflect heterogeneity in both focus and audience. We investigated both ABM and system dynamics modelling, because both techniques can help understand the behaviour of system’s components but we did not investigate big data and machine learning techniques. The inductive reasoning enabled by these is insufficient to describe and explain how the components of the system operate. As interdisciplinary research aims to understand socio-technical and socio-ecological components and interactions, it cannot rely on inductive reasoning, but needs transparent models to build and test theory. Furthermore, without describing the interactions within the complex system, it is difficult to assess the generalizability of the model which hampers the utility of black-box models for informing policy. We presented one illustration (Libre et al, We noticed that producing knowledge during the modelling process, through verification, validation or sensitivity analysis, may be seen as research through designing as we know it from the interdisciplinary field of landscape architecture (Lenzholzer et al. Concluding, this paper provided a framework that linked validity to validation in the context of interdisciplinary CAS modelling. The proposed terminology allows to describe how interdisciplinary modelling research relies on the validity of primary research used for input, how the quality of the modelling depends on structural and behavioural validation, and, how the assessment of the validity of the model is informed by these types of validation plus research with independent data. We hope that the framework will help to assess and improve the validity, and consequently, utility of models for interdisciplinary CAS research, and for informing policy advice related to CAS.


There has been a strong growth in aquatic products supported by the global seafood industry. Consumers demand information transparency to support informed decisions and to verify nutrition, food safety, and sustainable operations. Supporting these needs rests on the existence of interoperable Internet of Things (IoT) platforms for traceability that goes beyond the minimum “one up, one down” scheme required by regulators. Seafood farmers, being the source of both food and food-information, are critical to achieving the needed transparency. Traditionally, seafood farmers carry the costs of providing information, while downstream actors reap the benefits, causing limited provision of information. Now, global standards for labelling, data from IoT devices, and the reciprocity of utility from collecting data while sharing them represent great potential for farmers to generate value from traceability systems. To enable this, farmers need an IoT platform integrated with other IoT platforms in the value network. This paper presents a case study of an enterprise-level IoT platform for seafood farmers that satisfies consumers’ end-to-end traceability needs while extracting data from requests for information from downstream actors. Aquaculture currently represents 53% of the total fishery production, not taking into account non-food uses such as fishmeal and fish oil. In recent decades, there has been a significant increase in fish use as a vital source of protein in food menus . The seaWhat is lacking is a distributed approach to traceability in which each actor controls what data that is shared with other actors, while having access to data controlled by other actors in the supply chain. Since the minimum requirements are “one up, one down” and there is an asymmetry in cost and revenue for implementing traceability systems beyond the minimum, these needs are still unfulfilled ,9,10,11.To share information in a reliable and secure manner and to keep control of sensitive business information that is shared, the recent blockchain technology is promising. It supports a commonly distributed infrastructure for sharing information in a reliable and secure manner, ensuring trust among actors, as highlighted by a number of researchers including Wang et al. . Their rThe traceability of the supply chain of fishery and aquaculture allows determining dubious stock lots . A new mIn Norway, the digitalizing of information handling in the fishing industry started around the year 2000, first with the instruments positioning the fleet. Later, in 2004, the possibility to email catch data was introduced. In 2010, an electronic catch log system was implemented, which led to an electronic landing/contract note, instead of doing it manually . The digFor the seafood farmer at the source of the seafood supply chain, all traceability information requests from actors downstream will be served. This provides the seafood farmer a unique opportunity to collect information of supply chain partners all the way to the end-customer to support their customer relationship management (CRM). Large actors, such as Mowi, who implemented the standard , concludThis globally unique labeling of fish crates has the potential for retailers receiving the fish crates to look up extended information about them. This information can be given to the end-customers, which significantly promotes Norwegian fish globally. Furthermore, by providing information to retailers and customers, seafood farms can collect information from their retailers and customers. This reciprocity of extracting data from requests gives valuable information that builds up over time. It can be analyzed, and the results used to adopt both fish quality and the information that is provided to the worldwide market. Thus, the need for effective information sharing across the supply chain encourages the application of the IoT concept to enhance information flow and create business benefits by utilizing the information involved. With the IoT solution, it is possible to track fish across the supply chain, providing an enormous amount of information to the different actors in the supply chain. Fish crates need to be identified, and events captured, shared, and used. This requires globally unique identifiers following global standards and a standard platform for capturing, sharing, and using the information.Introini et al.  argue thRQ1: What technology components are needed to build an IoT platform for seafood traceability at the seafood farmer level?Value creation in the fishing industry must take into account society’s need for information, especially in consideration of food safety and the added demand for traceability . FurtherRQ2: How can the IoT Platform be used to generate value to the seafood farmer?We present a case study of an IoT platform implementation that strengthens the competitive power of the fish farmer while addressing the asymmetry in cost versus revenue that hampers traditional food supply chains. The fish farmer is the source of both fish and reliable, high-quality information related to the fish. Ensuring high-quality information is of crucial importance for food safety. Consumers ask for transparency in support of informed decisions or preferences and to verify nutrition, food safety, and sustainable operations. Supporting these needs rests on the existence of Internet of Things (IoT) platforms for traceability that goes beyond the minimum “one up, one down” scheme required by regulators. The only way to provide reliable information is by letting the source of information provide this information. Experiences from several studies show that the food industry is slow at adopting electronic traceability systems beyond the minimum required by regulations .The rest of the paper is organized as follows. In This paper presents a case study investigating the use of an IoT platform for seafood traceability focusing on the seafood farmer. According to , a reseaThe interviews were exploratory in nature, except for the interviews with GS1 France, which were confirmatory interviews, and data exchange via e-mail to set up the system. The interviews were semi-structured, whereas information gathering at the seminar was implemented through unstructured interviews. During the interviews, notes were taken to avoid the loss of relevant information. The interviews took place face to face, by phone (four), and via email. The ideas and views provided by the companies were analyzed through an interpretive measure. Our interpretation was based on interviews with experts and led to the identification of the technology components needed for an IoT platform for global seafood traceability, as well as of the reciprocal information needed by fish farmers and their customers.In order to obtain data on the feasibility of the IoT platform for a seafood farmer, our case included a demonstration of components based on system design techniques for developing implementable digital solutions from standard off-the-shelf software for traceability ,35. The IoT was first suggested by the Auto-ID Center—a collaboration between multiple universities and Massachusetts Institute of Technology . Their iIn their study “The internet of things: A survey”, Atzori et al.  discuss Xu  suggestsYan et al.  proposedA structural design for a monitoring tool to support traceability in the Romanian fisheries supply chain to ensure the safety and quality of fishery products was proposed by Nicolae et al. . Cario eAn IoT-based automation system can regularly and efficiently monitor various critical parameters in fish farming, such as the water level, temperature, and dissolved oxygen . IoT tecConnecting event data with master data is implemented by globally unique identifiers serving as links to event information as well as additional rich information on the fish crates, the fish inside them, and the fish farmer’s production facilities and operations. Data include fish crate master data, fish master data, and fish farmer master data. The standardized IoT Platform functions Identify, Capture, Share, and Use ,59 are sIdentify: A fish crate is identified by a unique identifier, which can be a GS1 serial container shipment code (SSCC) or another scheme for standard identification. A label containing the identifier is attached to the fish crate. Typical label types are bar codes, RFID tags, or QR codes .Capture: Capturing can be implemented by any standard label scanner .Share: Standardized real-time tracking events are stored in a standard web-based information system such as the Electronic Product Code Information Services (EPCIS) system. Any actor can look up information on the fish crates on the IoT platform by using the globally unique identifier .Use: The GS1 Core Business Vocabulary is used to assign standard traceability event names in the business process to each event by using the “why” attribute. The traceability events “packing” and “shipping” are core events that are linked to the corresponding operations in the sales business process.A supply chain-wide IoT platform in which each actor governs his/her own enterprise-level IoT platform by global standards 1  is illusThe critical factor enabling global traceability is the unique identification of the product. For farmed seafood, the ideal unit to identify is each individual fish. However, at this granularity level, there are no mandatory rules at the international level. The mandatory identification of transportation units containing seafood was agreed upon in 2014  with an The operations in a typical farmed seafood supply chain from the fish farm to the consumer  are showWe developed the real-time event traceability part of the IoT platform to present a solution for a seafood farmer using electronic product code technologies, ONS (Object Name Service), EPCIS (EPC Information Service) server, and a web server. Three different EPCIS installations were used for testing. The software architecture consists of a web-based Graphical User Interface (GUI), business logic, and the data layer. The data layer relevant to our discussion consists of the traceability events data, any other sensor data, and the Enterprise Resource Planning (ERP) data including Customer relationship management (CRM) data as illustrated in www.fosstrak.com) EPCIS software provided by ETH Zurich. It is a well-known and much-used system based on a MySQL database and an Apache Tomcat web server used for traceability systems.The EPC event management system utilizes open-source software. Our demonstrator consisted of the Fosstrak  packaging and shipping. These events related to the completion of operations are the business processes of the seafood farmer. Upon the completion of the packaging operation of a fish crate, the crate’s label with an SSCC code is scanned, and a packing event generated. A capturing device registers the event and stores it in the EPCIS system as packaging, with values filled in for the standard event attributes What, Where, When, and Why. A fish crate is stored until it leaves the facility. At this point, the crate’s label with an SSCC code is scanned, and a shipping event is registered in the EPCIS system, with values filled in for the standard event attributes What, Where, When, and Why.A range of globally unique SSCC codes is provided by GS1 for the seafood farmer.The label on the fish crate can be any label containing the SSCC code, typically a bar code, an RFID tag, or a QR code. A standard reading device reads the label and transmits it to the EPCIS-database.The EPCIS database is a part of the webserver connected to the internet. When an actor in the supply chain scans the SSCC code by using a web-app, a lookup request is sent to the webserver of the fish farmer. The server submits the information requested. At the same time, it registers data on the customer supply chain actor in the CRM system.Standard track and trace applications can use the event data and other data accessible through the unique SSCC code. In addition, CRM data can be used for marketing purposes.A typical query is illustrated in To look up event information from the EPCIS server, we developed a web-interface for entering SSCC codes with a display of information retrieved to demonstrate the universal access to the IoT-platform via a web-interface, as shown in The IoT platform demonstrated consists of components from standard off-the-shelf software, including the ERP system containing master data and business transactions, the CRM system with customer data , and theAs the amount of on-chain data increases, it supports AI and machine learning applications. In particular, it allows us to verify information from IoT-sensors. For example, temperature, weight, and locations handled by machine learning provide a value of how accurate the sensor data are by correlating them with other information. The data also enable automation of operations between companies by the smart contract functionality of the blockchain. The blockchain is the only technology that gives all parties across the entire supply chain coherent information regarding the products in an irreversible public record. This information is collected from the IoT platform of actors being the authoritative source of the information. Seafood farmers have valuable product information, while other actors along the supply chain supplement this information with their own information about logistics and quality as the product moves through the chain . The SeaThe aquatic food supply chain is challenging to manage as these products are perishable, high-protein, exposed to environmental pollution, may contain fishery residues, and may be exposed to microbial contagion or biotoxin pollution in the farming process . ApplicaOur case study adds to the IoT components the integration with the actor’s enterprise systems, thus showing the potential value creation based on seeing the mandatory traceability events in relation to the rich set of enterprise data at the supply chain actor level.The novel algorithms and data-collection tools emerging in relation to social software are powerful value-generating mechanisms, as described by .Our case demonstrates the applicability of such an approach for actors in the seafood supply chain. This particularly applies to the seafood farmer at the source, with a rich set of information that can be requested by any external actor directly across the web based on the standardized, globally unique identifier of seafood containers. Valuable information attracts requests while allowing the actor to collect information on the requesters to be handled by the CRM system.The first point of traceability data is at the source of the product—namely, the seafood farmer. Data to minimize safety, legal compliance, and commercial risks and that have a genuine and complete packing list of the seafood associated with the unique identification of the seafood in a fish crate container have to come from the source. This is necessary to ensure that the data contain reliable information on the shipment. As our case demonstrates, labeling each fish crate with the SSCC code with a globally unique identifier that links the fish in the crate with master data on the product provides a reliable source of data for all actors in the supply chain.Gao et al.  studied The QR-code label linked to aquatic products facilitates customers in tracing and investigating historical farming process data, ensuring aquaculture data to be verifiable and traceable .The query and management of the GUI makes it possible for farmers to see charts showing fishpond-monitoring data, configure aquaculture management modes, and perform manual control if required . Gao et Yan et al.  developeCruz et al.  proposedThe blockchain infrastructure supports the interoperability of IoT platforms by providing a trusted common infrastructure for sharing data ,61. The Fisheries and aquatic products are crucial to serving food for the growing population. The request by society for information transparency in support of informed decisions, nutrition verification, food safety, and sustainable operations can only be fulfilled by the seafood farmers, who are at the source of seafood and seafood information. To overcome the farmer’s cost-only view of minimum-required “one up, one down” traceability solutions, new IoT platform solutions can provide value generation for the seafood farmers while supporting end-to-end traceability. This paper presented a case study of an enterprise-level IoT platform for seafood farmers that satisfies the end-to-end traceability needs of consumers through the reciprocity of benefits by collecting information while sharing information. The IoT platform can be integrated with value chain operators and customer-oriented applications, such as CRM and blockchain technology, to build the robust infrastructure required to serve seafood for the growing global population. Consumers can acquire information about suppliers and products while companies can use it to reduce costs and gain increased market opportunities. Government agencies can ensure governance resulting in aquatic products of high quality and safe operational conditions. As this is an emerging research area, comparing the literature and various approaches in this area can be a pointer towards a future research direction.


In recent decades, foods rich in polyphenols have received great interest from researchers, who have performed numerous studies in in vitro and animal models and clinical trials. In parallel, food industries have spent many resources in the formulation of functional foods and food supplements that could provide the consumer with an enriched source of these molecules. The consumer has certainly appreciated the expansion of the market for products of “natural” origin, as they consider them (often erroneously) safe by definition. Polyphenols, compounds from vegetable origin with no nutritional value, have long been considered “functional ingredients”, i.e., positive for human health. On the other hand, given that polyphenols are not strictly necessary for the physiological functions of the body, as in the case of vitamins and minerals, the scientific committees often raise concerns on the validity of the studies from which any recommendations for intake derive. Among the few claims allowed for polyphenols, there is that published by the EFSA (Commission Regulation (EU) 432/2012) relating to olive oil: “Olive oil polyphenols contribute to the protection of blood lipids from oxidative stress. The claim may be used only for olive oil, containing at least 5 mg of hydroxytyrosol and its derivatives  per 20 g of olive oil. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20 g of olive oil”.Among the various properties described, phenolic compounds possess the ability to neutralize free radicals; it is therefore thought that their main role may consist in counteracting oxidative stress at the cellular level, and the health claim allowed for olive oil supports it. The antioxidant effect, which is the activity in counteracting the deleterious effects of free radicals, can modulate many of the risk factors responsible for: (1) chronic degenerative diseases, such as tumor diseases, cardiovascular disorders, metabolic syndrome, and dementia; (2) degenerative physiological processes, such as aging.In more recent times, several authors have published data in support of other beneficial activities related to polyphenols : anti-inFurthermore, the metabolic processes that polyphenols undergo in the human body are not yet fully known, even taking into account that they are consumed with complex matrices (such as fruit and vegetables) or foods in combination. For example, the study by Serafini and co-workers  showed hNutrients collects new information on the role of polyphenols in human health considering the different classes of molecules, their bioavailability, the synergy between the different active components, and the different food sources. Particular interest was addressed to the metabolic syndrome, which is considered among the main causes of morbidity and mortality of populations both in industrialized areas and in developing countries. The authors have proposed both original studies and reviews of the literature data both reiterating the role of bioavailability  and identifying the components that have been most active in the diseases considered . The sources of polyphenols described include both plants already studied and appreciated for their beneficial activities  and plants or fruits less known in European culture but with promising future development .One of the few certainties lies in the numerous epidemiological studies, where the consumption of fruit and vegetables is considered critical for the positive effects of the diet on health. In confirmation of this, the Mediterranean diet is now universally known thanks to its inclusion by UNESCO in the intangible heritages of humanity. This Special Issue of


Collaborative governance and social capital can help to form a resilient community in the wake of a disaster, such as the eruptions of Mount Merapi in Indonesia. This study examines the successfulness of the handling of disasters in Indonesia, with particular focus on eruptions of Mount Merapi. Disasters foster a close relationship between the government and the community in response to the emergency. This study uses a mixed method to analyse social networks in evaluating the structure of disaster networks in Indonesia and their implications for disaster management. Data were collected via a survey of 100 respondents from 28 institutions representing, for practical purposes, each population identified by each institution  that participated in handling the Merapi eruption disaster. The findings revealed that considerable miscommunication between institutions reduced the effectiveness of disaster management so that close discussion about conflict resolution was needed to develop more mature and systematic planning. Inter-agency trust is also felt to be necessary in disaster management. Trust between agency members and other institutions strongly supports the success of systematic disaster management. Meanwhile, every institution must foster open leadership by giving individuals with precise knowledge of the situation and the condition of the disaster area a mandate to lead directly in the field. Disaster governance is carried out through the agreement of each institution formed in the Disaster Emergency Planning (Rencana Penanggulangan Kedaruratan Bencana – RPKB) guidelines. These guidelines expect the Government and the community to coordinate with each other in a structured and systematic manner in the process of disaster management. Indonesia, as an archipelago located on the equator, is prone to natural disasters. According to the National Disaster Management Agency , until mid-2018 a total of 1134 natural disasters had been recorded in Indonesia. These included tornadoes, landslides, floods, earthquakes and volcanic eruptions. Volcanic eruptions are frequent in Indonesia. This is not surprising because Indonesia has a record of 129 active volcanoes, 70 of which are considered very dangerous for the surrounding community (BNPB 2010).3. In that eruption, Mount Merapi spewed hot clouds of ejecta more than 6.5 km to the northwest and south, affecting 64 people badly and causing injuries. An eruption in 2006 destroyed the Kaliadem area, with two volunteers being killed by the hot cloud of the eruption. This eruption was marked by earthquakes and deformation of the landscape, followed by a rain of volcanic ash for 3 days in Magelang and Sleman, Central Java. The eruption of Mount Merapi in 2010 was the largest in the past 100 years. In mid-2018, Merapi began to exhibit increased activity, which continued until the end of January 2019. Merapi’s activity is still being monitored to minimise the danger it poses. Disasters require decentralised decision-making and intensive human interaction :Moreover, managers need to understand and work strategically within the institutional environment and build capacity across agency boundaries through rigorous structures and processes with the new commitment and coordination required to work towards successful cross-agency collaborative management and a good network outcome Kapucu . CrucialH12: There is a significant relationship between leadership and trust.H13: There is a significant relationship between leadership and planning.H14: There is a significant relationship between leadership and managing conflict.H15: There is a significant relationship between leadership and existing relationships.Significantly, Kapucu  noted thH16: There is a significant relationship between trust and planning.H17: There is a significant relationship between trust and managing conflict.H18: There is a significant relationship between trust and existing relationships.Meanwhile, the division of labour and different functions of the organisations in the network influence the attitude and behaviour of the members and inevitably create conflict. Thus, the interpersonal skills of the members and their relationship to the organisational integration should be explored ; this is used to test the relationship between variables. The study involved 100 respondents from 28 institutions, practically representing the entire population identified for this study. Data validity depends not only on the number and characteristics of respondents but also onthe type of questions asked. When the questions for this study were tested, the results revealed that the number of statement items contained 50 of 7 variables  and the value of Cronbach’s alpha for the analysis was 0.912. This value implies that the questionnaire used in gathering primary data is valid and reliable.Analysis of the outer model ensures that the model with its variables and indicators is worth measuring, considering that this is valid and reliable. Thus, the external model analysis measures construct validity using convergent validity and discriminant validity as indicators.As shown in R2 value of the existing relationship initial agreement and managing conflict is considered unacceptable. And that indicates that the independent variable (previous performance) cannot explain the endogenous dependent variable. However, R2 values are usually low in studies related to human behaviour and human relations with other humans because human behaviour is more difficult to predict . Therefore, even though the predictive capacity of structural models is low, important conclusions about the relationship between variables can still be derived from statistically significant predictors. As Paul  R2 is not enough by itself.As revealed in  As Paul  said, a p-value of the regression analysis.Meanwhile, the effect size (f2) of the variables is also used to assess the structural model. The effect size (f2) values of 0.02, 0.15 and 0.35 for the significant independent variables represent weak, moderate and substantial effects, respectively Chin . The efft-statistic or the t-test. Testing can be declared significant if the t-statistic value is > 1.96 and the p-values are < 0.05 During an interview the Yogyakarta Special Region Social Service explained that:‘As social workers, we work hard to collaborate more with the Subdistrict Health office and other related offices to be ready to respond more effectively during times of disaster. Managing conflicts also becomes accessible after the experience and performance of previous member institutions.’ The disaster management division of the Indonesian Red Cross (PMI) explained that:’As social workers, we work hard to collaborate more with the Subdistrict Health office and other related offices to be ready to respond more effectively during times of disaster. Managing conflicts also becomes accessible after the experience and performance of previous member institutions.’ These data show that in general, the performance of previous disaster management networks significantly affected aspects of the governance process. Therefore, if the past network performance increases the motivation of members in institutions and leadership capacity and facilitates conflicts in the network, disaster management has a higher chance of being productive and successful.The initial agreement that referred to altruism and the desire to increase office legitimacy was significantly related to leadership. To quote from an interview from the Sleman Regency Regional Disaster Management Agency:‘We, at our institution, understand the complexity and relevance of our mandate regarding disaster management. By doing that, we have created manuals and guidelines at all levels to be followed in the event of a disaster.’ As outlined by the Head of the Yogyakarta Special Region Disaster Management Agency, it was stated:‘As the primary agency in disaster evacuation and camp management, amending the procurement process during the disaster is a great help for us in mobilising our resources to provide for the basic needs of the victims. We can now explore strategies that we can adopt to improve the delivery of our mandate. Therefore, in this case, the issuance of a new policy, namely the Policy Framework For Disaster Emergency Plan, or RPKB, can motivate member institutions to utilize their potential in fulfilling their respective mandates related to the disaster.’ As revealed, members of the disaster management network have a high level of altruism so that, despite challenges, they can explore ways to improve the delivery of their mandates. Therefore, altruistic tendencies of institutions and institutions to provide better public services, as well as their desire to increase each other’s legitimacy, contribute to better disaster leadership.‘Leadership in disaster management is well-defined but not always easy due to various issues that need to be addressed by the main institution, the government. Fortunately, leadership in disaster management can maintain the active participation of members over time, which assists us in becoming familiar with the mandates of other institutions that somehow easily help them whenever our agents have the means to do it.’ There are several challenges in building an effective disaster response. The respondents stressed that the leadership of the Regional Disaster Management Agency could have facilitated various problems that occur during a disaster. For instance, there are general issues regarding the validity and reliability of information shared during disasters. Those issues cause doubts and miscommunication between agencies, which are discussed and solved in regular meetings before, during and after disasters to update and share true and real-time information with all stakeholders. The part of volunteers and community organisations articulates shares that:‘Sharing information through regular government meetings, especially in times of disasters, or sending e-mails where possible and using handheld radios, help us in communicating the information needed to produce the right actions when we are given our responsibilities.’ With this, competency as well as dependency between and amongst agents is increased. Meanwhile, the Indonesian Red Cross shares that:‘We know that communication is very important in various aspects of our lives, but this cannot be managed perfectly during disasters when all lines of communication are cut off. Interruption in communication often arises; what we do is establish a command center where all messages are sent, and, most importantly, the feedback system is monitored to ensure that member agencies get accurate information.’ The strong relationship between trust and planning shows that each member shares the dependencies and competencies in institutions of the disaster management network, which leads to efficient network planning. According to the statement given by the Heads of each village affected:‘We always believe that all member agencies are doing their best to fulfill their respective mandates, as we do. And when we are allowed to voice our concerns and thoughts during the meeting of all stakeholders in planning, we get to discuss and finally understand each other. As a result, I think we have made a better disaster management plan. Also, reliable exchange of information between agencies facilitates the planning activities of all the stakeholders included in the disaster network.’ Generally, the data show that the trust between members of disaster management networks in terms of competency and dependency among member institutions exceeds the complexity and challenges inherent in disaster management planning.The significant relationship between managing conflict and planning reveals the importance of effective mechanisms in managing conflict towards more efficient disaster and emergency planning. As discussed before, conflict and disagreement cannot be avoided in any collaborative arrangement. Volunteers in the impacted area of the Merapi earthquake said:‘During disasters, many individuals of their respective institutions want to be at the peak of response and rescue operations. However, when they face any bureaucratic procedures, they tend to take off and leave operations. As a result, misunderstandings arise between stakeholders.’ Disaster management always creates an atmosphere of misunderstanding between the government and non-government agencies. As stated:‘Misconceptions in Disaster Management are usually caused by different interpretations of mandates or simple miscommunication between partner institutions. To solve them, discussions are held until all problems and problems are resolved. Occasionally, closed meetings are held to discuss and resolve conflicts.’ On the same note, representatives from community organisations described the conflict as being resolved professionally. The representatives from community organisations said to bear in mind that ‘whenever there is a difference, we discuss it among ourselves for a perfect solution. Usually, disagreements are discussed by groups such as shelter, health, water and sanitation’.According to the volunteer representatives, everything was resolved properly, and it provided benefits in terms of decision-making and disaster management planning. As they said, ‘All stakeholders in disaster management ensure that conflicts are resolved before the actual meeting. As a result, consensus is reached’. Therefore, the network’s capacity to resolve conflicts because of coordination failure creates strong bonds and facilitates the disaster management network planning process.The findings revealed that the previous performance of the network is crucially associated with the initial agreement, leadership and managing conflict, which validates the theory of Bryson et al. . That seMoreover, the findings indicated that as leadership is significantly associated with the motivations in the initial agreement, leadership expands trust in the governance process. Generally, trust refers to a person’s confidence in the reliability of another person concerning certain outcomes, whilst the shared confidence held by the members of an organisation is called inter-organisational trust (Rashid & Edmondson Significantly, the data show that trust in terms of dependability and competence is associated substantially with collaborative planning. The finding suggests that leadership enhances the reliability and expertise of the network, and trust enriches the planning process and output. These findings do not fully agree with the conclusions of Lester and Krejci . Those fThe outputs of collaborative governance show that cross-sector collaboration has a very direct influence on the management of Mount Merapi disaster, especially in the provision of mandates and information sharing. Meanwhile, the main problem during disaster management is the lack of available resources and the absence of reliable information. In addition, the less centralised nature of the disaster response network interferes with the governance process. The mandated network structure strengthens the capacity of key institutions to direct disaster response operations in the region. Kapucu  asserts Given these findings, this study enriches the current understanding of cross-sector collaboration, which Bryson et al.  referredThis study further reinforces the findings of Chang Seng  that a sPejuang Sigap Bencana, who is committed to serving the public. Such an ambassador should adapt to changing operating conditions and ensure that the heads of institutions attend collaborative activities (Rai & Khawas Practically, this research implies that at the national and regional levels, where many organisations are part of the network, centralised decision-making is needed and disaster operations must be decentralised Kapucu . However


Nutritional Warning Labels (NWLs) inform consumers about processed foods that exceed critical nutrient levels activating the risk perception in consumers. However, this information is limited. The objective was to identify the dimensions of risk perception and to study their associations with avoidance of buying processed foods with warning labels. A survey was applied to 807 decision-makers who choose what to eat at home. The four dimensions of risk perception  were identified through exploratory factor analysis. Through a multiple regression model, we determined the dimensions of risk perception and sociodemographic variables that affect the intention to avoid buying processed foods with NWLs. The results show that the performance risk, physical risk, and psychological risk positively affect the intention of avoiding processed foods with NWLs. In addition, the female gender considers NWLs to purchase foods. Nevertheless, the high frequency of consumption and belonging to a lower-income socioeconomic group are barriers to the use of NWLs. In conclusion, NWLs help people to choose processed food that does not impact negatively their food expectations, as well as their mental and physical health. However, health authorities must invest in nutrition education. Specifically, in groups who pay less attention to NWLs. Such groups include people with high daily consumption of processed foods, males, and low-income socioeconomic groups. The non-communicable diseases (NCDs) associated with obesity still are a challenge around the world . One of In recent years, the presence of front-of-package labels as a nutrition label (FOP) on food has proliferated, either due to regulatory conditions in each country or due to marketing strategies. Different studies have analyzed the importance of FOP in the decision-making power of consumers. These studies showed that FOP in processed foods may alter the perception, evaluation, and dietary choices of individuals ,8,9,10, From a theoretical perspective, the NWL has convincing abilities based on the persuasive communication theories and principles of social and behavioral sciences . In thatThe concept of perceived risk refers to individual perceptions of uncertainty and the possible negative consequences of a specific event or behavior. The magnitude of the risk perception is determined by the probability of the risk occurring and its potential loss . This loPerformance risk refers to the fact that a product does not meet consumer expectations in terms of taste, nutrition, and/or price-quality ratio . For exaBased on the previous background, the aims of this study are to identify the dimensions of risk perception and to study their associations with avoidance of buying processed foods with warning labels. We have hypothesized that the dimensions of performance risk, financial risk, physical risk, psychological risk, women in charge of food at home and people with high and middle socioeconomic status, would be associated with the avoidance buying processed foods with warning labels. These results will contribute to evidence about the effectiveness of NWLs, given that they activate risk perception in consumers, helping them to discriminate between healthy and less-healthy processed foods.The study design was descriptive and cross-sectional, and was conducted in the city of Talca, Maule Region, Chile. The sample was obtained through convenience sampling and a questionnaire was applied to 807 decision-makers in charge of buying processed food for their home, who were of legal age (>18 years old). The survey data were collected through interviews conducted in public places near banks, stores, and supermarkets. The interviews were carried out from July to November 2018. Before data collection, the questionnaire was previously validated through a preliminary test of 10% of the sample, approaching the participants with the same method used in the final questionnaire. The problems detected were corrected for the final version of the questionnaire and the interview procedure. All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of Universidad Católica del Maule (Acta N° 85/2017).The questionnaire was divided into three sections. The first section compiled general information about the consumption of processed foods and included the frequency of daily consumption and place of purchase of processed foods. The second section included the risk perception scale adapted from previous studies ,38. ThisThe statistical analysis included two phases; the first included the descriptive statistics of the consumption of processed foods, sociodemographic variables, and the physiological variable of BMI. The second phase included multivariate models and was carried out in two stages. The first stage consisted of identifying the four dimensions of risk perception through an exploratory factor analysis of principal components with varimax rotation. Through this same technique, the intention to avoid buying processed foods with NWLs (IAB) was identified as a dimension. Once each of the dimensions had been identified, the second stage was carried out, in which a series of linear regressions were applied that increasingly added to the control variables to evaluate the estimated parameters. In this way, it was possible to quantify the relationship between the dependent variable (IAB) and the set of independent variables, which covered the four dimensions of risk perception  and sociodemographic and physiological elements. In the first regression, the dimensions of risk were controlled (stage 1). In the subsequent regressions (stage 2), the variables gender  and socioeconomic group  were added as dummy variables; while the frequency of consumption of processed foods (CFPF) was added as a continuous variable, since it is measured as the average of processed food eaten per day. The sociodemographic and physiological variables in Most of the decision-makers in charge of buying food for their home were women with an average age corresponded of 37 years. Regarding the physiological characteristics, an average weight of 71 kg was found, with an average height of 1.64 m and an average BMI of 26.04, which indicated overweight in the sample. More than half of the respondents declared living in a home consisting of three to four members. The low socioeconomic status (SEG1) represents 52.17% of the sample. In this group, the head of household maximum education level was secondary; their jobs were not specialized and their incomes lower than US$1050; middle socioeconomic status (SEG2) made up 42.38% of the sample. In this group, the head of household education level was university and they worked as professionals. Monthly income ranged between US$1051–US$3700; and only 5.45% of the respondents belonged to the high-income group (SEG3), which include professionals with postgraduate and top executives. The income is higher than US$3700.Most interviewees (close to 90%) purchased processed foods at the supermarket. The second most selected option was neighborhood stores with 8.8% of preferences. In relation to frequency of consumption, the number of serves eaten of processed food per day for each interviewee were on average 2.67 unities see .To identify the dimensions of risk perception and the IAB dimension, two exploratory factor analyses were performed see . The firOnce the factor model was determined, we calculated the correlations of the evaluated factors. To identify the determinants of the intention to avoid buying processed foods with NWLs (IAB), a multiple linear regression model was carried out see . CollineSociodemographic and physiological variables were added in the second model, maintaining the set of risk factors. Of these variables, gender, frequency of consumption of processed foods, and the socioeconomic group were able to explain the consumers’ intentions regarding processed foods with NWLs. The other variables that did not have a significant explanatory effect  were discarded from the analysis. Regarding the factors that determined the model, performance risk continued to contribute positively with the highest weight, with an estimated beta coefficient of 0.194 points, therefore presenting an increase compared to the initial model. Regarding physical risk, the results showed a positive association with the dependent variable, with an estimated beta coefficient of 0.156 points, presenting a decrease compared to the initial model. Regarding psychological risk, this continued to be a significant factor, with an estimated beta coefficient of 0.135 points. Consequently, it was found that performance, physical, and psychological risk factors were the ones that contributed to increasing the IAB in consumers. Regarding the sociodemographic determinants, it was observed that when the food decision-maker was a woman, the IAB increased by 0.389 points. Conversely, belonging to a low-income socioeconomic group had a negative effect on the IAB, indicating that low-income people are less likely to avoid purchasing processed foods with NWLs. The frequency of consumption of processed foods also negatively affected the IAB by 0.073 points, which implies that the higher the frequency of consumption of processed foods, the more difficult it is to avoid consuming foods with NWLs. On the other hand, the R-square statistic of the second model increased the explanatory capacity, which reached 0.222. These statistics indicate than more than 20% of buyers’ consumption decision is explained by the variation in risk factors and the sociodemographic variables and frequency of consumption.This study used the theoretical model of risk perception, previously validated in other food topics . As postOf the four dimensions of risk perception, only three of them were associated with the intention to avoid purchasing processed foods with NWLs. Performance risk was the most significant predictor of the intention to avoid eating processed foods with NWLs. It means that the presence of NWLs reduces the consumer’s perceptions of processed foods meeting their expectations. This finding is in line with previous studies, in which the authors showed that activation of performance risk is due to the lack of fulfillment of expectations, given that the analyzed foods present low nutritional contribution, low price-quality ratio, or flavors or textures that are not what the consumer expects ,41. As aThe second significant predictor for avoiding consumption of processed foods with NWLs was a physical risk. In this context, if the NWLs indicate a high content of critical nutrients such as sodium, sugars, saturated fats, and/or calories, people will consider that this food may be harmful to their health and that of others, so they will try to avoid it. This finding is in line with a previous study about the sodium NWL, in which the authors concluded that the inclusion of sodium warnings can discourage the choice of products with high content of this nutrient . TherefoThe third significant predictor was a psychological risk. The product with NWLs can generate some degree of dissatisfaction or disappointment in the consumer for not making a good decision about food. This disagreement can psychologically affect consumer self-esteem, both in men and women . TherefoFurthermore, and unsurprisingly, women try to avoid processed foods with NWLs. This finding is in line with previous research showing that women are more aware of paying attention to credibility attributes such as NWLs ,45. BesiFurthermore, our findings show that the lowest-income socioeconomic group is the one that least avoids the purchase of food with NWLs, becoming a risk group that can develop NCDs over time. This fact makes it necessary to intervene in this group through public policies. Previous studies have shown that this socioeconomic group also presents barriers to a healthy diet, which are represented by the low income it perceives, the need to satisfy hunger, the low level of schooling, and obesity ,48.The results of this study provide evidence that an NWL is a credibility attribute that corrects information asymmetries between food-producing companies and consumers. The credibility of NWLs “wake up” the risk perception of the consumers. In that sense, it is necessary to highlight that NWLs are mandatory  to help consumers clearly distinguish between healthy and unhealthy products. Recent studies have shown that foods with a big number of NWLs will provide less satisfaction to consumers, from the view of the classical economic theory; it can generate less demand for the product ,49. TherAmong the limitations presented by this study is the use of a non-probability type sampling, which makes the results not generalizable, as the sample is not representative of the socioeconomic situation in Chile. However, the study was carried out with the decision-makers who choose what to eat at home and who influence the eating habits of the family members. Another limitation of this research is that the study contains correlational  data; therefore, the direction of causality cannot be established. Another limiting element of this study is that it did not consider product categories. For this reason, it is suggested to carry out further research for differentiated products, specifically by the number and type of NWL, to identify which dimensions of risk perception are more relevant in specific foods that exceed the levels of critical nutrients and have great demand in the market. In addition, we considered that future studies should develop specific items for social risk dimension to supplement the scale presented in this research.Results from this research contribute to evidence about the effectiveness of warning labels, given that they partly activate different dimensions of the risk perception in consumers, helping them discriminate between healthy and less-healthy processed foods. This NWL allows people to discriminate between products that can affect their food expectations as well as their mental and physical health. Therefore, it is important that food-producing companies must transform their production processes to achieve foods that comply with these types of standards, and that generate less adverse effects on the population. Additionally, health authorities must make a real effort to provide nutritional education to those groups that place less importance on warning labels. Such groups include people´s high daily consumption of processed foods, the group of males and low-income socioeconomic groups. In this way, consumers will be able to make informed choices about the types of processed foods that they consume.


Objectives: To analyse the market shares of biosimilars in Slovakia and to calculate the potential cost-savings from the use of biosimilars in Slovakia based on two different data sources.Methods: National reimbursement lists from the Czech Republic, Hungary, Poland and Slovakia were used for analyzing the availability of biosimilars with public funding. In addition, the reimbursement dossiers of biosimilars, the justifications of reimbursement decisions by the Slovak Ministry of Health, and final reimbursement decrees, which are published on the webpage of the Slovak Ministry of Health, were utilized for this study. Reimbursement decisions regarding biosimilars by the Slovak Ministry of Health from 2006 to August 2019 were considered and the detailed utilization of biosimilars in 2018 was analyzed based on data from the State Institute for Drug Control. The study was validated based on data from the Slovak National Health Information Center.Results: Fifty four biosimilars were approved by the European Medicines Agency (EMA) in August 2019. Of the total group of licensed biosimilars on the market, 29 biosimilars (54%) were available in the Czech Republic, 28 biosimilars (52%) were available in Poland, and 27 biosimilars (50%) were available in Hungary and 24 biosimilars (44%) were available in Slovakia. Our analysis, based on the data provided by distributors of medicinal products to the State Institute for Drug Control, revealed that the health fund in Slovakia could have saved 35 to 50 million euros per year if biosimilars with marketing authorisations had been available on the Slovak market. The calculations assumed a 25–35% price decrease against the original biological medical products, and that there would be no increase in the utilization of biosimilars in Slovakia.Conclusions: To achieve significant improvement in patient access to biosimilars in Slovakia, a top-down approach establishing targets and quotas for the procurement of biosimilars should be applied. According to the European Medicines Agency (EMA), biological medicines consist of active components from biological sources such as living cells or organisms and most biologicals are produced by biotechnology, usually using sophisticated cell systems and recombinant DNA technology . MarketiA biosimilar medicine is greatly similar to another biological medicine, known as a “reference medicine” . MarketiKurki  concludeHowever, Markus  emphasizOn the other hand, other systematic reviews found that switching patients from chronic biologic therapy to a biosimilar alternative was not associated with an increased risk of adverse reactions or loss of efficacy , 11.Cook  stressedResults from a recently published systematic review demonstrate that physicians in Europe and the U.S. do not primarily support the use of biosimilar medicinal products as safe and effective pharmacotherapies for patients already getting reference biological treatment .The outcomes of a study performed by the European Society for Medical Oncology (ESMO) on biosimilar understanding among oncologists emphasized the need for education and worldwide alignment .However, physicians in the European Crohn's and Colitis Organization (ECCO) have stated that switching from the reference biological medicinal product to a biosimilar for patients with inflammatory bowel disease is acceptable .In Norway, physicians envisaged first-line use of biosimilar medicines for biologic naïve patients with inflammatory bowel disease  and in DAccording to Moorkens  Swedish The introduction of biosimilars may create competition for biological medicinal products, possibly resulting in reduced prices, and altered market dynamics in disease areas .Because of its high development costs, the biosimilar medicinal product can only be introduced on the pharmaceutical market with a limited discount compared to the reference medicine . AlthougHidden volume constraints to biologicals implemented by payers to facilitate the financial sustainability of health care systems may increase the European inequity in patient access to treatment .Kaló  argued tKaló  pointed Policymakers in healthcare systems should take action to increase the use of biosimilar medicines, partly by handling concerns related to their efficacy and safety raised by different stakeholders , 25.The Slovak Ministry of Health , 27 statThe situation with availability of biosimilars was compared among V4 countries. The Visegrád Group, or V4, is considered as a cultural and political alliance of the Czech Republic, Hungary, Poland, and Slovak Republic.Kuenzel  highlighThe implementation of policy practices that maximize the social benefits of biosimilars for patients in Slovakia should be approved. This paper is aimed at examining the lost opportunities for savings due to the restrained availability of biosimilars in the Slovak healthcare system.The publicly available EMA website  was searThe analysis covered the following elements: (a) the reimbursement status of biosimilars in the Czech Republic, Hungary, Poland, and Slovakia, (b) a comparative study of the market shares of biosimilars in Slovakia and (c) a calculation of potential cost-savings that could be achieved through the use of biosimilars in Slovakia based on two different data sources.The reimbursement status of biosimilars in the Visegrád Group was analyzed based on the national reimbursement lists of medicinal products, which was valid in the countries for August 2019 –33. If aCoverage decisions regarding biosimilar medicinal products made by the Slovak Ministry of Health from 2006 to August 2019 were studied more deeply and the consumption of biosimilars in 2018 was analyzed.We assumed a 25–35% price decrease  against Pursuant to updated legislation for 2019  the firsBased on the 5th level of the Anatomical Therapeutic Chemical Classification System (ATC5), financial expenditures of the Slovak health insurance funds for reference medicines with biosimilar alternatives approved by the EMA which were not present in the Slovak reimbursement list in 2018 were analyzed and the potential cost-savings expected from the use of the biosimilars in the case of their availability on the Slovak reimbursement list was calculated. We estimated saving potential based on a 25–35% decrease in financial expenditures of Slovak health insurance funds for the ATC5 of reference medicines with those EMA-approved biosimilar alternatives, which were not on the Slovak reimbursement list in 2018. We estimated no additional saving potential for reference biological medicines with EMA-approved biosimilar alternatives, which were on the Slovak reimbursement list in 2018 because in those ATC5, cost-savings had already been achieved. Additionally, we calculated no potential cost-savings for the subcutaneous formulation of Trastuzumab and Rituximab, without biosimilar alternatives approved by the EMA. However, we incorporated potential cost-savings for the intravenous formulation of Trastuzumab and Rituximab with biosimilar alternatives already approved by the EMA.Data from distributors of medicinal products, which are required to deliver sales data to the State Institute for Drug Control, were used for this study . This daThe overview presented in Sales data from wholesalers provided to the State Institute for Drug Control, were used for analyzing the opportunity cost. The results summarized in Data from payers provided to the National Health Information Center were used for validation purposes. The results summarized in Inotai  argued tThe high launch prices of original medicines, including biologics, may necessitate confidential price discounts, using managed entry agreements or, sub-optimally, the implementation of transparent or hidden access restrictions in order to ensure their financial sustainability .The objective of biosimilar medicine policy, provided that patients have full access to the relevant original biologic products prior to the expiration of their patent, is usually defined as reducing health expenditures without compromising health outcomes . MulcahyIn 2017 and 2018, the EMA authorized biosimilar medicines with the following six active substances with patent expiry: adalimumab bevacizumab, trastuzumab, rituximab, insulin lispro, and teriparatide. Between July 2018 and July 2019, medicines containing the active substances adalimumab, trastuzumab, rituximab, etanercept, and teriparatide were added to the categorization lists in Slovakia. Despite this, of the molecules available in at least one V4 country, biosimilar drugs containing the active substances somatotropin, enoxaparin, and insulin lispro are still absent in Slovakia.Looking back, over the period up to 2012, four biosimilar drugs were added to the reimbursement list in Slovakia, one of which was later removed at the request of the marketing authorization holder. Two more medicines were added in 2013, one in 2014 and three in 2015. No new biosimilar drugs were added to the reimbursement list in 2016, 2017, or the first half of 2018. These figures presented in However, since the second half of 2018 up to May 2019, a fundamental change occurred, as during this period, the Ministry of Health decided to add 15 additional biosimilar drugs to the reimbursement list. The change was partially related to the expiry of the patent protection of several reference medicines, but also to the reduction of the initial compulsory price discount for the first biosimilar product entering the market . Longitudinal analyses of biosimilar drug shares by molecule in the Slovak market show that there was a sharp increase in the filgrastim and erythropoietin molecules after their entry to the market in 2009–10, followed by a slowdown in growth and a plateau at high utilization levels. Insulin glargine, infliximab, and follitropin alpha molecules, where biosimilar drugs came to the market later, gradually increased in share. Biosimilar drugs with rituximab and trastuzumab did not enter the market until the end of 2018; therefore, their penetration rates are still low .Kaló  emphasizKawalec  and MoorIn Slovakia, on the other hand, international price referencing significantly reduces drug list prices. The European reference price of a medical product is defined in Slovakia by Act No. 363/2011 Art. 2(f) as “the average of the three lowest prices from among the officially determined prices of the medicinal product in other Member States” . Most EUIt is therefore important for buyers to set appropriate price reduction rules. From an economic point of view, price regulation is needed unless fair competition generates a market price. This applies to monopolistic suppliers, oligopolies, or price cartels. However, if there are several competitors on the market and the authorities reduce the risk of a cartel, such price regulation is not needed. In the case of original reference biologic medicines and the gradual launch of first biosimilars, price regulation  is necessary. However, if several competing medicines are available on the market, price regulation may have a limited impact . In the countries examined by Kawalec  and MoorSignificant initial mandatory price reductions  in combination with strict conditions for international price referencing may discourage biosimilar drug manufacturers from entering the market in Slovakia. This may extend the monopoly position of some original biopharmaceuticals, reduce price competition, and ultimately limit the cost saving potential of biosimilars in Slovakia.Countries need to implement a longer-term biosimilar strategy. The following policy practices should be implemented to maximize the social benefits of biosimilars [adapted from Inotai ]:□ Administrative tools and policy measures should be implemented to incentivize the use of more affordable biosimilars;□ The pricing and reimbursement processes for biosimilars should be expedited to facilitate their prompt market entry;□ Amendments to clinical guidelines recommending the extended use of biosimilars should be implemented if justified by health benefits, such as providing patients with improved or earlier access to biological therapy;□ Off-patent biologics (including biosimilars) should be set as the preferred first-line biological therapy for treatment-naive patients; other, still patent-protected biologic medicines with no or limited added benefit should be used only in subsequent treatment lines;□ After the expiration of a patent, patients should be switched, under medical supervision, from the original biologic medicine to the more affordable biosimilar alternative;□ There should be no separate reimbursement categories for biosimilars and original biologics with the same active compound or slightly modified formulations , unless the modified formulation has significant and proven added benefits to patients or healthcare systems ;□ In addition to being informed about scientific evidence on biosimilars, physicians should be guided on how to appropriately educate their patients regarding these medicines; and□ Information exchange platforms on good practices related to biosimilars between EU Member States should be established.The current perception and knowledge among physicians in the Slovak Republic regarding biosimilars in comparison with original biologics is unknown. The lack of information in this field represents a limitation of our research, which will be mitigated by the publication of the results of ongoing studies. The first assumption, concerning a 25–35% price decrease against that of reference products, represents one of the limitations of our study, because some higher price decreases could be offered in the case of stronger market competition in particular groups of biosimilars. The second assumption, concerning no increase in the consumption of analyzed biosimilar medicines in Slovakia, represents a limitation of our study, as well. There is a possibility for an increase in the consumption of the analyzed biosimilars in comparison with the reference biological medicines in Slovakia and therefore the potential cost-savings would be lower. On the other hand, the role of biosimilars is not only about cost-saving potential but improving patient access to needed biological pharmacotherapy and ultimately to improve health status of the society.The timeline can also be considered as a limitation of this analysis. The Slovak Ministry of Health required that the first biosimilar entering the reimbursement list had to offer a 20% initial price reduction in comparison with the price of the reference biological medicine between 2013 and 2018 and there were no requirements for price reductions for the biosimilars added to the Slovak reimbursement list for the same ATC group. From 2018, the first biosimilar entering the reimbursement list had to offer a 30% initial price reduction compared with the price of the reference drug and there are price reduction requirements for the second and the third biosimilars . The timIt needs to be stated that the generalization of our results is limited. However, while we discussed the issues of Slovakia, we believe that even other countries with low availability of biosimilars can benefit from this research. The aim of biosimilar policies can be determined differently in countries with significant resource limitations, where access to high-cost biologics is restricted , 24, 43.Despite recent changes in the Slovak legislation, the availability and penetration of biosimilars in the Slovak pharmaceutical market remains limited. This prevents buyers from exploiting the full cost-saving potential of biosimilars. Policies aimed at maximizing the social benefits of biosimilars in Slovakia should be implemented.All datasets generated for this study are included in the article/supplementary material.TT, PG, ZK, MW, PK, and AI conceived the conception, design of the study, and contributed in acquisition of data. TT prepared the draft of the manuscript. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer MM declared a past co-authorship with the authors to the handling Editor.