The clinical decisions of emergency department triage nurses need to be of the highest accuracy. However, studies have found repeatedly that these nurses over- or underestimate the severity of patient health conditions. This has major consequences for patient safety and patient flow management. Workplace distractors such as noise and task interruptions have been pointed to as factors that might explain this inaccuracy. The use of a serious game reproducing the work environment during triage affords the opportunity to explore the impact of these distractors on nurse emergency triage accuracy, in a safe setting.A pilot study with a factorial design will be carried out to test the acceptability and feasibility of a serious game developed specifically to simulate the triage process in emergency departments and to explore the primary effects of distractors on nurse emergency triage accuracy. Eighty emergency nurses will be randomized into four groups: three groups exposed to different distractors  and one control group. All nurses will have to complete 20 clinical vignettes within 2 h. For each vignette, a gold standard assessment will be determined by experts. Pre-tests will be conducted with clinicians and certified emergency nurses to evaluate the appeal of the serious game.Study results will inform the design of large-scale investigations and will help identify teaching, training, and research areas that require further development. Patient safety is a key concern amid continuous efforts to improve the effectiveness and efficiency of health systems . DefinedDecision-making is a frequently performed process in emergency departments, especially in the course of triage, when nurses sort patients by care priority based on a process that aims for the best allocation of human and physical resources. It remains a human-driven process and as such is prone to error. Errors in clinical decisions can have serious consequences for patient safety , 8. UndeTo support nurses during the ED triage process and reduce errors, various scales have been developed since the early 1990s. Today, most of the existing triage scales cover four or five emergency levels –18. FollIn their systematic review, Farrohknia et al.  found thOn a recurring basis, researchers who have examined the clinical decision-making of emergency nurses have generally used one of two approaches: retrospective reviews or nurse-assessed written clinical vignettes. Both methodologies have their shortcomings. For example, written vignettes present limited cues to make accurate decisions and retrospective reviews must cope with missing data , 35. To Nowadays, SG appear to be a solution for exploring clinical decision-making in the context of simulation , 38. SG The use of SG that reproduce an immersive ED environment and triage tasks allows assessing the impact of distractors on triage accuracy and represents an innovation in the field of triage quality improvement. Against this background, we are planning a pilot study to examine the preliminary effects of distractors on nurse emergency triage accuracy using an SG that we are developing specifically to simulate an ED environment. The study will have three main objectives: (1) develop the SG, (2) assess the feasibility and acceptability of our study design and the SG , 44, andThe theoretical framework chosen for the study is an adapted version of the Systems Engineering Initiative for Patient Safety (SEIPS) model . It is aSpecifically, tools and technology refer to the elements that persons use to perform their tasks, such as a computerized care file, an electronic blood pressure monitor, and a telephone. ED studies have shown that technological breakdowns  can cause task interruptions , 49. As The person component represents the core variable of the work system and refers not only to all the members of a team, which can include physicians, nurses, and other care providers, but also to the patients themselves and their families. In our study, the focus will be on nurses performing the task of emergency triage. For this component, Carayon et al.  recommenThe tasks component refers to the tasks to be performed by the person. In our study, the task corresponds to triage activities. Carayon et al.  proposedThe environment component refers to the physical environment. It is characterized by various elements, including noise, lighting, air quality, and workstation design. Among these elements, ED studies have identified noise as a factor that limits interaction between care provider and patient and as a potential distractor and stressor , 34, 55.The organization component refers to management style and time management, available resources, social relationships, and rules and procedures in place . Nurse tThough the SEIPS model focuses on the work system dimension, it also allows examining the dimensions of process and outcomes. The process dimension informs on the reasoning used by nurses to arrive at clinical decisions . Within This pilot study has a double purpose. First, we wish to evaluate the acceptability and the feasibility of both our study design and the SG we developed to simulate the triage activity in an ED and reproduce an immersive work environment complete with distractors. Second, the study will also assess the preliminary effects of distractors (noise and task interruptions) on the triage accuracy of emergency nurses in the French-speaking part of Switzerland.What is the acceptability level of our study design and the SG?What is the feasibility level of our study design and the SG?The questions asked in connection with the evaluation of preliminary effects are the following:The questions asked in connection with the evaluation of preliminary effects are the following:What are the individual and combined effects of distractors on ED nurse triage accuracy?Primary question:2.How are nurse sociodemographic variables and personal characteristics related to triage accuracy?3.What is the relationship between nurse-perceived confidence and triage accuracy?Secondary questions:We propose the following hypotheses informed by the SEIPS theoretical model : (1) ourIn order to evidence the effects of noise and task interruptions on nurse triage accuracy, we will carry out a 2 × 2 factorial randomized controlled trial . A factoThis factorial design will allow us to create four groups: one control group and three experimental groups . While triaging the clinical vignettes, nurses in the control group will not be exposed to distractors. Nurses in experimental groups will be exposed to noise (group A), task interruptions (group B), or both noise and task interruptions (group C). Nurses will be block-randomized across the four groups by a computer program. The groups will be of equal size or as similar as possible in this regard.The study design comprises repeated measures. We will collect sociodemographic and personal data from participants before they begin evaluating the clinical vignettes. Then, during the evaluation of each clinical vignette, the following data will be gathered systematically: (1) emergency level assigned, (2) level of perceived confidence in emergency level assignment, and (3) duration of each clinical vignette evaluation. Upon completing the evaluation of the 20 clinical vignettes, the participants will be asked to complete a questionnaire on the acceptability of the SG.This multi-site study will be carried out in EDs where the SETS® is used. This is the case in 20 private and public care facilities in the five cantons of the French-speaking part of Switzerland . The population will consist of nurses who perform triage in these facilities. This corresponds to an accessible population of 454 nurses. The eligibility criteria will be similar to those used in previous studies of triage accuracy , 35, 68.This sample size allows the inclusion of, at least, few nurses from each hospital providing an overview of all the emergency units of the hospitals in French-speaking Switzerland. Therefore, we can assume that our sample provides a sufficient heterogeneity to test acceptability and feasibility of our protocol. Moreover, assuming an accurate triage rate of 0.85 for the control group, a decline of 0.1 in the experimental groups, and an intraclass correlation  of no more than 0.03, we estimated through simulations that each group would need to comprise at least 20 participants to obtain a power of at least 0.80 in order to answer the primary research question. Consequently, we will aim to form a convenience sample of at least 80 nurses, and we will cease recruitment once this target is reached.The study will follow a two-step procedure. The first step will be to develop the SG. This will be done by a multidisciplinary team comprising IT engineers and designers who will handle the technical elements of the SG and healthcare professionals who will create realistic content, that is, the clinical vignettes, the distractors, and the visual appearance of each on-screen element. The second step will be to recruit participants in the EDs and deliver the SG.SGTRI and to describe the tasks to be performed by the game developers, the clinical partners, and the research team. Second, the design session will cover all the elements required to recreate the ED triage environment, such as the graphic interface, clinical vignettes, adjunctive distractions, and triage tasks. The SGTRI will be designed on and operated from an open-source platform called Wegas . To develop SGTRI and allow it to evolve, the research team will use a logical graphic interface that may include audio-visual elements adaptable to needs and scenarios. This graphic interface will consist of a virtual 2D waiting room that will be the stage for different animated clips where patients may arrive by ambulance or by foot and other healthcare workers  may be present. A triage workstation will be recreated from 2D plans based on the ED triage observations of a designer on the research team. This triage station will be equipped with all the devices used by nurses under the circumstances .First, a pre-design session will be held to define the different steps in the construction of the SG called The clinical vignettes will be developed in conjunction with an emergency clinical specialist nurse, an emergency medicine professor (the initiator of SETS® development), and a certified emergency nurse. All these experts have numerous years of experience in the emergency field and with the triage process. A series of 20 interactive clinical vignettes will be created based on a retrospective review of real cases in an emergency department. The clinical vignettes will be constructed following the three quality guidelines proposed by Evans et al. : (1) eacIn each experimental group , 10 interruptions and/or noises will be introduced in different clinical vignettes. The distribution of task interruptions  will follow a predetermined sequence generated by the researchers. The SG will leave the nurse participants the choice of responding or not to some task interruptions  but will require them to respond to others . The noise will correspond to the soundscape  of triage stations. The research team will modulate the noise exposure condition by varying the form, length of exposure, and intensity of the ambient noise . The intensity of the noise exposure will range from 35 (A) to 85 dB (A), the maximum level at which no auditory protection is required . To immeSGTRI is designed, a pre-test will be planned with eight clinical emergency experts. The aim of the pre-test will be to assess all the processes to correctly implement the SG during the recruitment phase.Lastly, triage nurse activities will be identified and designed to correspond as much as possible to real-life tasks. These will be the most common tasks performed by nurses at triage, such as taking the patient’s clinical history through a list of predetermined questions , measuring vital signs , recording patient clinical values, and transcribing the emergency level and chief health complaint. Once the First, the aims of the research will be presented at the annual meeting of ED SETS® users. Second, all the care facilities with an emergency unit in the five cantons of the French-speaking part of Switzerland  will be contacted to validate their interest in participating in the study. Third, nurses interested in participating in the study will receive an information and consent form. The definitive list of participants will be drawn up after consent forms are signed. Nurses will be block-randomized across the four groups just before starting the SG by order of arrival for the test. Each participant will then be assigned an identification number when they start the SG. Fourth, the study data will be collected directly in each ED by the research team. During the session, the research team will be on site to ensure nurse participants are correctly assigned and to ensure fidelity of SG session delivery.SG delivery will comprise four stages. First, participants will receive a 30-min research project information and training session led by a member of the research team. Second, the participants will run through a training session composed of two clinical vignettes that will not be included in the analyses. During this session, the participants will familiarize themselves with the equipment  provided by the members of the research team. Third, once the training session is completed, each nurse will be able to start their SG session when ready. The nurses will have 2 h to complete the 20 clinical vignettes. This corresponds to the average number of patients triaged at an ED over 2 h. To establish a controlled set for the SG, participants will be isolated in a meeting room previously prepared by the head nurses in each participating emergency unit. Members of the research team will be on site to provide technical support, if needed, and to document any technical problem that might occur during the SG. Fourth, once the 2 h has elapsed, each participant will stop the game session even if not all 20 vignettes have been evaluated. All the data collected during the SG session will be automatically recorded, and they will be saved on a secured server located in Switzerland. After their 2-h SG session, the participants will return to their workplace.Sociodemographic data, both personal  and professional , will be collected through a questionnaire developed on the basis of elements gathered in previous studies of triage accuracy , 35, 72.The clinical decision-making of the nurse participants will be judged on the emergency level that they assign based on the SETS® criteria. Following their clinical reasoning, nurses assign patients an emergency level from 1 to 4. The scale has been the focus of various independent studies , 73 wherNurse level of confidence in their clinical decision-making will be measured using a visual analogue scale from 0 to 100 . This scThe feasibility of the SG will be assessed on the basis of criteria drawn from Sidani and Braden  and FeelThe acceptability of the SG will be measured using a French version of the self-administered AttrakDiff 2 inventory  initiallN = 80) will be the analysis units for the descriptive analyses, and the assigned triage scale scores will be the analysis units for the correlational analyses and some descriptive analyses (number of nurses multiplied by number of vignettes—expected N: 80 × 20 = 1600). The following data analysis plan will be carried out to answer the research questions: First, the collected data will be verified . Second, the data on the nurses  will be analyzed via descriptive statistics, both univariate  and bivariate . Third, triage accuracy will be measured by the level of agreement between the answers given by the nurses and the gold standard established by the experts. For each nurse, the scores assigned to each clinical vignette will be compared against the gold standard. The results of the comparison will be a three-level multinomial variable: accurate triage (nurse score same as gold standard), overtriage (score higher than gold standard), and undertriage (score lower than gold standard). Over- and undertriage frequencies will be used to describe the triage accuracy of the four groups, that is, the control group and the three experimental groups: noise (A), task interruptions (B), and noise and task interruptions (C). Fourth, to examine the individual and combined effects of the distractors on the triage accuracy of the nurse participants, the groups will be compared against one another using a random-intercept multinomial regression model. For all the analyses, the statistical significance level will be p ≤ 0.05. All the data will be analyzed using the R statistical software [The nurse participants . The time that the nurses spend evaluating the clinical vignettes with the SG will count as work hours.Triage is considered a dynamic and complex nursing activity that requires a high level of concentration in a work environment marked by frequent task interruptions, an unpredictable workload, and a noisy physical layout . These tToday’s technological advances have made it possible to create tools such as SG to optimize the learning and evaluation processes in many different fields. The most salient success stories so far have perhaps been in medicine and aviation. SG, such as the one that we are developing and studying, are tools that hold tremendous promise not only to help us better understand triage accuracy and the impact of distractors but also to help us benchmark the triage process and improve its quality. They may also be used in education and ED training as a complement to written scenarios and in-person simulations.In experimental investigations, SG allow collecting a wide array of precise measurements, maintaining full control of simulated events, modulating parameters with rigor, measuring performances in detail, and controlling trigger events better . SG, as SGTRI might not be representative of the layout of triage desks. These limitations are the consequences of both technical limitations and deliberate choices to focus our SG on a few but well defined and structured elements: patient evaluations and the influence of external distractors on the triage process.Our research project has various limitations, some linked to the general use of SG and others specific to SGTRI. The general elements have to do essentially with the use of human-machine interaction to simulate human-human interaction. For example, the current status of SG technology requires that some forms of interaction, such as verbal exchanges, be reduced or even eliminated completely in favor of other forms of interaction, such as written exchanges. Moreover, SG limit sensorial interactions to sight and hearing, whereas the real triage process involves all of the senses. As for the limitations specific to SGTRI, our SG presents a series of static situations that do not evolve over time and reduces the complexity of triage by removing elements, such as patient flow management and the re-evaluation of complex cases. Furthermore, distractors and environmental configurations can vary widely across ED, and SGTRI also presents a number of strengths. First, it offers a flexible instrument that can be easily tailored to numerous research projects, whether on the effects of distractors or other subjects, such as the effects of tiredness or the impact of nurse sociodemographic and professional characteristics on triage. Second, in education, it offers an efficient means of easily and quickly updating the knowledge of triage nurses. Unlike other training approaches, SG can provide a very large number of nurses with individualized and flexible training that can be adapted to their needs and requirements by, for example, modulating or controlling the level of difficulty or the amount of time to spend on each training session. Although the use of technology-enhanced simulation to train ED healthcare professionals is an innovative solution, authors underscore the importance of applying a rigorous methodology and outcome measures when using technology in the simulation field [on field . Numerouon field –85 have


Much of what we know about the meaning and experience of pain has been facilitated through qualitative research. However, qualitative inquiry continues to be underrepresented in the pain literature relative to quantitative approaches. In this Commentary and Introduction to the Special Issue on Qualitative Research and Pain, we present a collection of high-quality, cutting-edge qualitative studies in pain that highlight theoretical and methodological advancements in the field. The articles included in this Special Issue feature a range of designs , methods of data collection , and populations . Throughout this Commentary we also address three common controversies regarding the quality of qualitative research and the stance we took on them for the Issue. These primarily deal with the procedure-related issues of sample size, generalizability, and saturation. We discuss how a more substantive-centered approach to evaluation—that is, an approach that considers the methodological and theoretical significance of the work—is crucial for advancing qualitative research in pain. Canadian Journal of Pain Special Issue on Qualitative Research and Pain. As qualitative researchers in the field, we undertook the Special Issue to highlight the contributions that qualitative methods can offer to pain research. Much of what we know about the meaning and experience of pain, including understanding the experience of providers,1 has been facilitated through qualitative research conducted over several decades. Through the robust examination of personal narratives, institutional processes, and lived experiences, qualitative research has advanced our understanding in areas such as the multidimensional experience of living with pain,2–5 barriers to evidence-based pain care,6–8 and approaches to pain education10 in populations across the life span. Despite the strengths of qualitative research and its contributions to the study of pain, qualitative inquiry continues to be underrepresented in the pain literature relative to quantitative approaches.We are delighted to present the 14 However, we wish to briefly address our position on key issues to facilitate the development and publication of high-quality qualitative research in pain. Of note, we aim to discuss qualitative research within its own paradigm, epistemologies, and ontologies.In this Commentary, we take the opportunity to address common biases and misconceptions of qualitative research and to highlight the approach we took for the Special Issue. A complete list of misconceptions, and a full explanation of why we believe they are problematic, is beyond the scope of this Commentary, and these have been discussed elsewhere.Qualitative research is an umbrella term to describe approaches to data collection and analysis that rely on largely language- and/or arts-based data. Language-based data is often conceptualized as transcripts of semistructured interviews between an interviewer and interviewee; however, it can take other forms, such as the compilation of historical documents, written story completion, or comments posted by users on social media. An innovative use of language-based data in qualitative pain research is demonstrated, in this Special Issue, by Toye et al.,15 who analyzed comments posted in response to a YouTube video on chronic pain. Two of the multiple approaches to arts-based qualitative research are also illustrated in the present Special Issue. For instance, Woodgate et al.16 explored the meaning of pain for youth with anxiety by analyzing photos they took of objects and people, and O’Keefe-McCarthy et al.17 investigated individuals’ journeys recognizing pain as a symptom of cardiovascular disease by interpreting participants’ thematic poetry and visual art. Language- and arts-based data can be used in unison to provide a comprehensive description of various phenomena.18 ethnography,19 phenomenology,21 and qualitative description,22 as well as newer designs such as arts-based approaches.23 Each of these approaches have evolved over time, have many variations, and emerge from their own historical context, epistemological position, and methodological techniques. The guiding qualitative methodology (distinct from the methods such as focus groups or interviews) should be identified in every study because this sets the groundwork for congruence across all other aspects of the design, including the analytic approach. Partially due to this complexity, there is much debate in the field of qualitative research surrounding what constitutes “good” qualitative research  and how to evaluate the “goodness” of qualitative studies.25Qualitative research is not a homogeneous category. There are various methodological approaches to qualitative research, including long-standing traditions such as grounded theory,11 refer to as substantive-centered criteria relating to methodology and theory. In line with emerging best practices,24 we believe that procedural criteria  should be used to guide one’s understanding of the substantive criteria , not as a sole indicator of the quality of the work. For this reason, we describe three common misconceptions regarding the quality of qualitative research, which primarily deal with procedure-related issues: sample size, generalizability, and saturation. We discuss how a more substantive-centered approach to evaluation is crucial for advancing qualitative research in pain.Historically, approaches to the evaluation of research quality, derived from positivist research paradigms, often focused on procedural-centered criteria that relate to methods rather than to what Eakin and Mykhalovksi26 We argue that small sample sizes are not a weakness of qualitative research but rather a core characteristic of many qualitative methodologies, given that the data are intended to provide rich and deep exploration rather than broad surveys of phenomena. As illustrated in the Special Issue, Dagg et al.27 show how small samples can be a strength by facilitating an in-depth idiographic approach to understanding the experience of pain that may not be accessible by the adoption of a more nomothetic approach. Dagg et al.27 explored the experiences of ten parents managing their children’s postoperative pain after discharge home from the hospital. Using an interpretive phenomenological analytic design, the authors provided rich, in-depth descriptions of the logistical, emotional, and relational challenges faced by parents providing postoperative pain care at home that provides important insights for both clinicians and researchers designing interventions. Sole judgment on the quality of a qualitative study based on the procedure-related criterion of sample size disregards the substantive contribution that a study may provide.One of the most widely cited criticisms of qualitative research is the relatively small sample sizes associated with these approaches.28Sample size in turn is related to the issue of generalizability, long held to be a marker of impact and usability in research studies. This is perhaps the strongest criticism that has been leveled against qualitative research: that its findings are not representative of the population from which the study sample was derived. Qualitative researchers rely on the concept of transferability rather than generalizability to describe how their findings can generate theoretical or conceptual insights that can be applied more broadly and is considered by many a key criterion of rigor.29 Using a qualitative descriptive methodology, Dale et al.28 interviewed recently discharged patients about their procedural oral pain experiences while mechanically ventilated in the intensive care unit (ICU). Using an object elicitation approach, the authors found that patients recalled significant pain and distress related to oral care in the ICU but that, because of ventilation, were unable to self-report this pain. Participants described that their attempts to communicate their pain  were often misinterpreted as agitation or uncooperative behavior. These data provide conceptual insight regarding the oral pain experienced by patients in the ICU and highlight troublesome gaps in ICU clinicians’ pain knowledge. The findings from this study are transferrable to the growing literature on the development of pain education frameworks in various disciplines such as medicine, nursing, and dentistry.30–32We illustrate the point of transferability of qualitative findings using two articles in the Special Issue.29 explored the lived experience of chronic pain in immigrant Indian-Canadian women using a phenomenological design. The authors found that immigrant Indian-Canadian women’s experiences of pain are influenced by several unique sociocultural factors , which in turn impact pain expression, openness to treatment, and the consequences of pain on the family. The implications of this study are transferable to numerous other populations and settings, demonstrating the importance of considering the cultural values and norms of patients with chronic pain.Similarly, Mustafa et al.saturation and its meaning remain contentious in the qualitative literature.33 Indeed, saturation is a central component of certain qualitative approaches ; however, it is unhelpful, unachievable, and in direct opposition to the particular epistemology associated with certain designs and methods, including phenomenology26 and reflexive thematic analysis.34 By example, Tabeefar et al.35 used thematic saturation as a construct to guide sampling adequacy in their study of community pharmacists’ experiences with chronic pain, which was guided by the principles of grounded theory. Conversely, and in line with phenomenological inquiry, the studies by Dagg et al.,27 Mustafa et al.,29 and Woodgate et al.16 focused on obtaining rich personal accounts and describing the similarities and differences in experiences across participants. A one-size-fits-all approach to evaluating qualitative studies, as is often done by non-qualitative experts, disregards the core epistemological and ontological underpinnings of the various qualitative designs.Finally, the term We argue that the misapplication of procedure-related evaluation criteria  to qualitative studies by nonqualitative experts, and even some who may be familiar with qualitative approaches, has led to inaccurate appraisals about the rigor and significance of qualitative research, and thus, exclusion of high-quality qualitative studies from top pain journals. In order to generate and retain high-quality qualitative research in pain, we must offer enhanced training opportunities for those interested in engaging with these methods. We must also increase the number of journal reviewers and editors who are competent and knowledgeable in substantive issues related to qualitative methods to ensure that high-quality qualitative research is not turned away from medical journals and that misunderstandings about qualitative research do not continue to be perpetuated. To this end, we conceived of the present Special Issue as a way of highlighting novel and innovative qualitative research that is being conducted in the field of pain.Canadian Journal of Pain Special Issue on Qualitative Research and Pain. This high level of interest demonstrates the strong appetite for qualitative research in pain as well as the large number of qualitative studies being conducted. Due to the volume of submissions, we were only able to accept the highest quality manuscripts, which we defined as involving both a strong substantive approach  and that demonstrated high rigor according to appropriate standards such as congruence.We received a tremendous response to the call for manuscripts for the 35 phenomenology,29 qualitative description,28 and arts-based approaches.17 The collection of studies also demonstrates the array of methods of data collection possible in qualitative research, including both traditional  and novel  methods. Finally, the Special Issue articles illustrate the capacity of qualitative research to capture the meaning and experience of pain in diverse populations, including children with anxiety,16 critically ill patients,28 pharmacists working with individuals with chronic pain,35 immigrant women,29 parents of children who have undergone surgery,27 individuals with heart disease,17 and those with various forms of chronic pain.15This carefully curated collection includes high-quality, cutting-edge empirical qualitative studies in pain that highlight theoretical and methodological advancements in the field. The studies included in this Special Issue employ a range of qualitative methodologies, including grounded theory,We hope that this Special Issue offers an introduction to the diversity and importance of qualitative findings to our collective understandings of pain. The articles in the Special Issue are a sampling of the many qualitative methodologies that can be applied to pain research. Some methodologies  are not represented but are also valuable for the investigation of pain. We strongly encourage researchers interested in understanding the experiences, meaning, or organization of pain to seek out the vast array of high-quality qualitative research available.


Food fortification is designed to improve the nutritional profile of diets. The purpose of this research was to estimate the potential nutrient contribution of fortified maize flour, oil, rice, salt, and wheat flour in 153 countries, using the national intake (or availability) of the food and the nutrient levels required for fortification. This was done under two scenarios—maximum, where 100% of the food is assumed to be industrially processed and fortified, and realistic, where the maximum value is adjusted based on the percent of the food that is industrially processed and fortified. Under the maximum scenario, the median Estimated Average Requirements (EARs) met ranged from 22–75% for 14 nutrients , and 338% for iodine. In the realistic scenario, the median EARs met were 181% for iodine and <35% for the other nutrients. In both scenarios, the median Tolerable Upper Intake Levels (ULs) met were <55% for all nutrients. Under the realistic scenario, no country exceeded 100% of the UL for any nutrient. Current fortification practices of the five foods of interest have the global potential to contribute up to 15 nutrients to the diets of people, with minimal risk of exceeding ULs. Vitamin and mineral deficiencies are a global public health problem . BecauseIron, vitamin A and iodine deficiencies are the most common, according to the World Health Organization . GeneralThe immediate cause of micronutrient deficiencies is “insufficient intake [of micronutrients] or sufficient intakes combined with impaired absorption due to infection, disease, or inflammation” . Food foFood fortification improves health outcomes and functional outcomes, as demonstrated in randomized controlled trials and evaluations of large-scale implementation in many countries. For example, fortification of salt with iodine  improves iodine status, thyroid function, child cognitive development, and congenital hypothyroidism . FortifiEstimating the potential dietary contribution of fortified foods is helpful in the planning and monitoring stages of national fortification programs . In the The Global Fortification Data Exchange (GFDx) is a website that visualizes diverse fortification data on maize flour, oil, rice, salt, and wheat flour, for up to 196 countries . AccordiThe goal of this study was to estimate the potential micronutrient contribution of fortified maize flour, oil, rice, salt, and wheat flour to the diet in countries with fortification requirements specified in standards. The analysis did not consider the naturally occurring nutrients in these foods.Methodological details are provided in a thesis project report . A summaThe data used in this analysis are publicly available country-level data and do not provide information about specific individuals or groups. This study was deemed exempt from ethics review by the Institutional Review Boards at The Johns Hopkins University in April 2019 and Emory University in May 2019.This is an ecological study using data from the Global Fortification Data Exchange (GFDx) from the 153 countries that specified nutrient levels to be added to maize flour, oil, rice, salt, or wheat flour, through mandatory or voluntary fortification, as of 7 December 2020 . These fThe following country- and food-specific data were drawn from the GFDx for the five foods of interest —(1) fortThe sources of the information varied. Fortification nutrient levels were extracted from the latest national standard. In those cases where two or more fortification compounds are included in standards for the same nutrient , the first compound in the GFDx database was selected. Daily food intake was extracted from published research for salt ; daily fDietary reference intakes used in the analysis were as follows—Estimated Average Requirement (EAR) or a proxy and the Tolerable Upper Intake Level (UL) for non-pregnant, non-lactating adult females 19–50 years of age .The EAR is the “nutrient intake value that is estimated to meet the requirements of half of healthy individuals in a group” . It is tThe UL is “the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population” ; it refeThe potential nutrient contribution was calculated for two scenarios for each country. The first was the maximum potential nutrient contribution  scenario—how much each nutrient could potentially contribute to diet if 100% of the food in the country was industrially processed and 100% was fortified according to fortification requirements (in standards). The second was a more realistic scenario that took into account, when available, the percentage of foods available in countries that are actually industrially processed and that are actually fortified.For the first scenario, potential nutrient contribution (in mg/capita/day) was calculated by multiplying the fortification nutrient level (in mg/kg) by the daily food intake or availability (in grams/capita/day) and dividing by 1000 g . For theThe potential nutrient contribution of each micronutrient achieved through food fortification in the two scenarios was compared to nutrient-specific EAR and UL levels, to generate the percentage of the EAR and UL potentially met for each country. The number of countries that met <50%, 50–150%, or >150% of the EARs was calculated.The analyses suffer from limitations. First, the analyses only consider the nutrients added through fortification of maize flour, oil, rice, salt, and wheat flour. They do not consider the nutrient contribution of other foods in the diet including other fortified foods, supplements, or nutrients that are naturally found in the unfortified versions of the aforementioned five foods. Accordingly, the contribution of fortified maize flour, oil, rice, salt, and wheat flour to meeting nutrient gaps in the diet could not be estimated. Second, the intake or availability estimates for each food were based on one number per country . These values were not calculated from surveys of hundreds or thousands of people, which would then allow for the calculation of the variability around mean or median intake. Ideally, the comparison of the potential fortification nutrient contribution to EARs and ULs is completed with such survey data that permits the calculation of the proportion of individuals with intakes below the EAR and above the UL. Such calculations could not be completed with the data presented in this study. The presentation of the median EARs and ULs met was to help with interpretation of the nutrient contribution values.Using Microsoft Excel, descriptive analyses were performed on the potential nutrient contribution under both scenarios separately for all nutrients and for all foods combined.n = 137), followed by wheat flour (n = 93). Among the nutrients, most countries have fortification requirements for iodine, followed by iron. The food-specific nutrients in fortification standards are noted in On 7 December 2020, the fortification requirements from national standards for maize flour, oil, rice, salt, or wheat flour, for 153 countries were accessed from the GFDx . Most coUnder the maximum scenario, where 100% of the food is assumed to be industrially processed and 100% is assumed to be fortified according to national requirements, the median contribution of maize flour, oil, rice, salt, and wheat flour (combined) ranged from a low of 0.001 mg/c/d for vitamin B12 to a high of 204 mg/c/d for calcium . When thThe number of countries meeting the nutrient-specific EARs was further broken down in As expected, under the realistic scenario where the percentage of the food that is industrially processed and fortified is known for a country (and is often less than 100%), the median contribution of fortified maize flour, oil, rice, salt, and wheat flour (combined) was lower for all nutrients than in the maximum scenario . The medFor most countries under the realistic scenario, the combination of up to five fortified foods could potentially contribute less than 50% of EARs for all nutrients, except iodine . More thIf fortified to country requirements, maize flour, oil, rice, salt, and wheat flour (combined) can contribute up to 15 nutrients to the diet. Together, these fortified foods can contribute to reductions in vitamin and mineral deficiencies, without exposing the population to unduly high nutrient levels. The potential for nutrient contribution is greater when a higher proportion of the food is both industrially processed and actually fortified. In other words, country-level industry structure and compliance are decisive in determining whether the potential nutrient contribution from national fortification requirements is optimized. This analysis focused on the nutrients potentially contributed through the fortification of several foods. However, it excluded the contribution of nutrients from the rest of the diet .In practice, most countries were estimated to meet 50% or less of EARs for 14 nutrients. If there are other micronutrient interventions in these countries, this might be an adequate amount to help reduce the nutrient gap between requirements and intake. For iodine, most countries’ fortification requirements could contribute more than 150% of the EAR. Given that the EAR is the amount needed to meet the nutritional needs of 50% of the population , 150% ofThere is a growing concern for the potential of nutrient interventions, especially when delivered simultaneously with other interventions in the same population, to contribute excessive nutrient levels . The curIn practice, a benefit–risk assessment is needed of the potential benefits and harms of fortification. Verhagen et al.  completeSeveral other studies assessed the nutrient contribution of fortified food alone; they focus on single countries , multiplFieldler et al. converted food income and expenditure data from 10,000 households into apparent consumption by individuals for Bangladesh . They esFriesen et al. converted food purchases from 1000 households each in Uganda and Tanzania to apparent intakes for individuals using nationally representative surveys . Like thThe proportion of EARs potentially contributed by fortification varied between the Friesen study and current analysis . Iron coWhile the UL calculations were different between the current analysis and the study by Friesen et al., the conclusions were the same—there is a low risk of exceeding ULs for iron, vitamin A, and iodine . In the The closest research effort in geographic scope was by Smith et al. . These rTo summarize, there were several methodological advantages and disadvantages of the current study. The advantages were the large number of countries in the analysis. Among countries with mandatory or voluntary fortification legislation, the fortification requirements are known for the majority of them (GFDx 2020). The majority of countries with fortification requirements for maize flour (100%), oil (84%), rice (100%), salt (94%), and wheat flour (94%) were included in the analysis. The proxy for food intake used for each country stems from a uniform methodology implemented by FAO in all countries. Two factors that could reduce the potential nutrient contribution of fortified foods were assessed, when available, in the realistic scenario. The analysis considered fortification’s contributions to EARs and ULs.The disadvantages included the use of one data point per country on food intake. Without distributions of intakes, further insights cannot be gleaned from calculating the proportion of individuals likely to benefit or at risk for harm from food fortification . While aIf in the maximum scenario the potential nutrient contribution of any fortified food alone or in combination with others is substantially greater or lower than goals set for the country’s fortification program, then consider if the nutrient levels in standards might need to be changed.If the potential nutrient contribution is substantially different between the maximum and realistic scenarios, then discuss strategies for addressing any factors that are affecting program implementation. For example, how can compliance be improved if the percent of food that is fortified is not as high as it should be? If the percent of food that is industrially processed is low, discuss whether current fortification of this food is benefiting any subpopulations and whether other food vehicle options should be assessed to increase the reach of fortified foods.If the potential nutrient contribution in the maximum or realistic scenarios exceeds 100% of the UL, then consider if the nutrient levels in standards might need to be changed.If the potential nutrient contribution was not calculated for the realistic scenario, then seek information from industry partners and government regulatory authorities on the percent of food that is industrially processed and the percent of food that is fortified, respectively.Given the limitations of this analysis in only presenting the contribution of nutrients added through fortification, seek or convene studies that estimate the totality of the diet. In that context, is fortification performing as planned? Does the fortification program need to be adjusted?How might country decision makers use the information in the current analysis? Decision makers might want to convene with private, public, and civic sector stakeholders to discuss the results presented here as well as other program-performance data for any of the following situations:This investigation used diverse data from most countries with fortification requirements for maize flour, oil, rice, salt, and wheat flour, to estimate their potential nutrient contribution. Current fortification practices for these foods have the potential to contribute up to 15 nutrients to the diet—some contribute a small proportion of nutrient requirements and others a greater percentage of requirements. In so doing, the fortified foods support country efforts to reduce and control micronutrient deficiencies with a food-based intervention. At the same time, there is little risk of these fortified foods, as designed and implemented, to contribute excess nutrients to the diet. Nevertheless, continuous monitoring of the nutrient contribution of fortified foods is warranted to ensure that effective and safe amounts of nutrients are delivered through fortification.


Genetically edited food utilizes new techniques that may decrease all of the risks associated with genetically modified food, or “GMO” food. Safety and labeling regulations for genetically edited food are still new, and it is challenging for the consumer to differentiate it from conventional food. Although genetically edited food has the potential for reducing the risks associated with the gene introduction process, consumer perceptions toward it are still unclear. The research has compared the regulations governing GMO food and genetically edited food in Japan, Europe, and the United States. We found that the genetically edited food regulations in Japan are the most science-based, in the meaning that genetically edited food products are allowed to be sold without any safety evaluation. Based on the difference among regions, we further studied the potential acceptance level for such products among Japanese consumers, where regulation seemed science-based as policy. To understand the factors that may affect the adoption of genetically edited food among youth in Japan, we utilized the structural equation modeling (SEM) method with 180 surveys of Japanese university students to measure six factors: Knowledge, Attitude Towards Technology, Perceived Benefits, Perceived Risks, Trust, and Willingness to Purchase. The survey was conducted twice with an intervention in the middle to measure the effect of science communication, and we found significant differences when comparing the two datasets. The results of this survey indicate the importance of increasing knowledge and the positive role of science communication in increasing the adoption and trust of biotechnology products, such as genetically edited food. The world has witnessed a massive population growth, especially in the past 70 years. The world population has grown from 2.5 billion inhabitants in the year 1950 to nearly 7.7 billion in the year 2019, which means that the world population has tripled in less than a century . The expGenetically modified crops have been cultivated in the United States on a large scale since 1996, and the GMO crops cultivation area has exceeded 70 million hectares in 2015, putting the United States on the top of the countries that cultivate the genetically modified crops . NeverthAlthough the GMO method is considered safe by scientific communities, consumers tend to have some concerns about it. Scientists have thus developed another methodology, which is a gene editing method that allows them to genetically edit crops without the use of any transgenes in a very accurate way. This process is considered scientifically safer, more cost-efficient, and quicker than the GMO method. However, there is a lack of knowledge about gene editing technology in food among average consumers as well as a lack of research about how consumers will perceive this type of new gene editing technology in food, especially that the regulatory process for it, is still ongoing .This research study highlights the differences between the gene modification and gene editing technologies in food in terms of characteristics and regulations that govern them, especially in the markets of Japan, Europe, and the United States. The research also aims to investigate how the regulations affect innovation in this field. Based on the science-based regulation policy in Japan, the level of understanding and acceptance of gene editing technology for food among youth living in Japan was studied. In the study, we sought to uncover the general perception toward gene editing technology, and we also tried to identify the main factors that affect the acceptance of gene-edited food products. The research also intended to discover the role of knowledge and science communication in changing consumer perceptions toward gene editing food and highlight the importance of science communication in raising awareness for similar cases.As mentioned in the introduction, there is no unified definition for genetically modified food. However, there are several definitions that define GMOs, such as the definition crafted by the World Health Organization (WHO)—it has defined GMO food as the food produced from or using genetically modified organisms. The WHO has also defined GMOs as organisms in which genetic materials (DNA) have been altered in a way that does not occur naturally . The U.SIn general, genetically modified food is food that contains genetically modified organisms (GMOs). In other words, the DNA of the organisms to be used as food has been altered or modified using biotechnology or without the natural recombination methodologies. This methodology is also often referred to as "DNA recombination" or "genetic engineering." Genetic modification technology allows for transferring a selected gene from one organism to another or between species that are not related.Bacillus thuringiensis corn or Bt-corn. It has been modified to produce specific proteins, which can act against insects or pests. Due to its unique characteristics, Bt-corn requires fewer pesticides, and it has a high level of herbicide resistance. Bt-corn is now widely used in the U.S. and has an 83% adoption rate [The main reason behind developing GMO food is to provide food with a higher level of nutrition as well as a higher resistance to bacteria and herbicides. One of the most famous examples of GMO food is ion rate .The use of GMOs in food has resulted in a high level of controversy. Thus far, a majority of the scientific community has agreed that there is no proven evidence of significant risks to humans from consuming GMO food. A study published by “Critical Reviews in Biotechnology” in 2014 has shown that the researchers have reviewed all of the safety reports and scientific papers published regarding GMO food safety from 2002 to 2011; there is a scientific consensus based on this study that consumption of genetically engineered or genetically modified food is common worldwide and there is no sign of a hazard associated with this consumption . MoreoveGenetic editing is considered one of the relatively new technologies for genome engineering. It is fundamentally different from genetic modification, in which gene editing precisely edits genes in a particular genome. The gene modification method usually inserts a foreign gene into the genome randomly in order to change the characteristics of the organism. However, gene editing inserts the edited gene into specific locations in the genome, which controls the outcome of the overall process. Different types of genome editors have been used in the past few years, but CRISPR-Cas9 is considered the most accurate technology. Currently, there are extensive research efforts toward utilizing gene editing technology, namely CRISPR, for food and agriculture. It has the potential to create very high value for farmers, as well as consumers, by eliminating any risk that might be associated with GMO food.CRISPR is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats. Scientists utilize this technology as molecular scissors to target a specific gene in the genome to be edited with a very high level of accuracy. The operation starts when the scientists recognize a specific gene in the genome that is responsible for a certain function in need of editing. Scientists create a guide RNA (short for ribonucleic acid), which simulates the DNA sequence that needs to be edited, as well as the Cas9 enzyme, which cuts the specific sequence at a targeted location. Specific functions can be added or edited after the cut, and after the change, the cell can be repaired using its enzymes. After the guide RNA and Cas9 enzyme are removed, the DNA editing process is considered complete, and the changes are implemented, similar to traditional breeding processes in the organism.Since genome editing technology is considered scientifically safer than genome modification technology, regulatory authorities in Japan consider the food created by genome editing technology to be similar to the food created by conventional breeding. However, an online survey study conducted by the University of Tokyo, involving over 38,000 participants, showed that 43% of respondents expressed unwillingness to consume agricultural products created by genome editing technology. Only 9.3% of the respondents expressed a clear willingness to purchase and consume genetically edited food.Viruses argued that there is a large gap between farmers and consumers regarding the acceptance of genetically modified food [The implementation of novel technologies, such as bioengineering in the food industry, has continued to increase food industry productivity, reduce food prices, as well as enhance the nutritional values of food . To idenied food . The artied food .The food supplies around the world today are massively affected by the technology in this field. However, based on several studies that looked at the diffusion of technology in the food industry, it was found that new technologies are often perceived with uncertainty and anxiety concerning the level of safety standards used . SeveralOne of the main sources of communication that plays an essential role in providing information about new technologies, such as bioengineered food, is the media. Media coverage of food technologies has a strong impact on how consumers perceive those technologies, as well as consumer attitudes and behaviors toward genetically edited food products . SeveralTherefore, and based on the articles discussed above, we have concluded that the general public tends to have concerns about genetically engineered food products. Further, we have concluded that knowledge and education play an important part in increasing the adoption rate of genetically modified food products. Regulations for defining and labeling genetically modified food are considered well developed compared to the regulations that govern genetically edited food, due to the history of GMO food commercialization that has occurred since 1994 . RegulatThis section provides a summary of the regulations that govern genetically modified food in comparison with the ones that govern genetically edited food across three regions: Japan, Europe, and the United States.In terms of genetically modified food labeling, the regulations differ by region. However, they can mainly be categorized as mandatory labeling or voluntary labeling. In the voluntary cases, authorities give the manufacturer the option to label the genetically modified food product, unless it has significant differences from the conventional one in composition or allergenic potential, at which point, the labeling becomes mandatory. Mandatory labeling can be further divided into two main categories, pan-labeling, and designated product labeling. In the pan-labeling category, the products must be labeled if they contain genetically modified materials that exceed a certain threshold level defined by the regulatory authority, or if the product has significant differences from the conventional one. For designated product labeling, specific products identified as genetically modified, or in certain categories, must be marked as such.In terms of genetically edited food, the regulations are still in the development stage, where each country is developing suitable regulations domestically, as there are no global regulations in this regard . HoweverIn terms of genetically modified food products, designated Japanese authorities have confirmed that any crops or processed food that contain certain genetically modified materials must be labeled. Regulations for processed food products specify that if one of the top three ingredients in terms of product weight ratio contains genetically modified material, or if the genetically modified ingredients comprise more than five percent of the total weight ratio of the product, it must be labeled as a genetically modified product. However, in cases of genetically modified materials that cannot be detected in oil or sauce products, mandatory labeling is not required.As we discussed in the introduction, genetically edited food is fundamentally different from genetically modified food in terms of methodology. Therefore, the Japanese Ministry of Health, Labour, and Welfare (MHLW) began to discuss how to regulate the food created by genome editing technology in September 2018. On March 27, 2019, the MHLW released its policy related to genetically edited food product regulations after studying 691 comments received from the public on the subject. The MHLW’s specialized committee proposed that any food created by genome editing technology that contains transgenes has to go through the same safety review as specified in current regulations for genetically modified food. If the food does not contain any transgenes, it will not be handled the same as the food created by DNA recombination technology . The entThe regulations that govern genetically modified food are considered the strictest regulations globally in terms of labeling because, in Europe, all genetically modified food products must be labeled as per the decision of the European Commission in 1998. The regulations and policies governing genetically modified food were updated in November 2003 to include genetically modified food products with undetectable genetically modified DNA. The regulations also stated that conventional food products containing 0.9% or more genetically modified material must have genetically modified identification labels.On July 25, 2018, the European Union Court of Justice issued press release number 111/18, which stated that genetically edited food would be considered a subset of genetically modified food, since it is still created by a gene alteration methodology. Subsequently, all food created by gene editing technology would need to go through all of the rules and regulations that govern genetically modified food in terms of labeling and safety inspection. This court ruling was in contrast to Japanese regulations that completely differentiate between genetically edited food and genetically modified food .European research labs and biotechnology experts have considered this ruling as a setback for the innovation in the food technologies in Europe. They expect it to be a hindrance to scientific development in the region since many other countries around the world are willing to apply gene editing technology to help solve economic challenges related to food and agriculture.The regulation of genetically edited food in the United States is still in the development phase. However, several drafts and official meetings have been conducted in this regard. On January 11, 2017, the FDA issued a draft with the title “Genome Editing in New Plant Varieties Used for Food,” which was intended to be an essential guideline for regulation and gain the public opinion about the process . The FDARegulations for genetically modified food differ fundamentally between Japan, Europe, and the U.S. The Japanese and European systems follow mandatory regulations, whereas the U.S. follows voluntary regulations, as explained above. Regulations for genetically modified food labeling tend to be stricter in the European Union since all products that contain genetically modified food ingredients must be labeled, even if the GMOs are undetectable in the end product. In addition, regulations for genetically edited food products follow the same system as genetically modified food in Europe, which has created a dilemma for genetically edited food labs in the region since the decision hinders innovation in the field of genetically edited food. Furthermore, the European decision to consider genetically edited food products as genetically modified food has created another problem for the food safety laboratory and inspection units, since inspectors are now required to test if the food contains genetically edited substances; however, scientists continue to struggle to find an accurate test because genetically edited food can be easily mistaken for food created by conventional breeding methods . Table 1Based on the aforementioned analysis, we believe that the system in Japan opens the doors for more innovation in genetically edited food products. The gene editing field is an innovative approach to solve several challenges related to food safety and security, and it is fundamentally different from the gene modification approach.Japan has several challenges in terms of agriculture, and genetically edited food may be a significant step toward solutions to tackle those challenges. The regulations governing genetically edited food in Japan are quite attractive for biotech companies to innovate in this field. The regulations in Japan allow companies to develop their products without any additional inspections compared to genetically modified food. However, the question remains if Japanese consumers are willing to consume genetically edited food products since they are a new type of product that also has the word “genetics” in their name. We have reviewed several scientific articles that show that consumers have associated the term with several health concerns. Therefore, this paper is trying to examine further how consumers will perceive genetically edited food in Japan and determine the factors that may enhance their level of willingness to purchase these products in the future. We believe that if we can identify those factors, it will help us understand consumer purchasing behavior and how we can implement a plan to enhance interest. These actions will give Japanese biotech companies and gene editing food researchers more incentive to innovate in this field by providing evidence of acceptance of this type of product among the public.The structural equation modeling (SEM) approach was utilized to measure the factors influencing the adoption rate of genetically edited food among youth in Japan. The factors subject to the study were as follows: Knowledge, Attitude Towards Technology, Perceived Benefits, Perceived Risks, Trust, and Willingness to Purchase. Every factor was measured by several questions, as stated in The survey was designed to be conducted twice to measure the effect of science communication on enhancing the knowledge and adoption of genetically edited food. The process of the survey was to provide the questions digitally in an education session where the respondents answer the first survey. After the first survey, the respondents viewed a short presentation for five minutes that provided more knowledge about the genome editing technology. The respondents answered the same survey one more time to measure the difference in results before and after the intervention. The survey also measured several demographic factors, such as gender, nationality, hometown, and living status. To ensure validity and construct reliability of the research tool, the survey was conducted twice for continuous updates regarding clarity and question relevance.The five-minute presentation, which was used as an intervention between the first and second surveys, provided brief information about the difference between natural and refined food as well as the main differences between organic food, non-GMO food, genetically modified food, and genetically edited food. The presentation also introduced the purpose of GMO food and the example of Bt-corn, which is widely used in the U.S. The presentation also showed how the scientific community and governments had deemed GMO food safe to consume; however, there are still increasing consumer concerns about GMO food as well as other risks from organic food or non-GMO food. Participants learned how genetically edited food differs from genetically modified food given that gene editing technology does not utilize any transgenes in the process and provides a more accurate, timely, and cost-efficient alternative for genetically modified food as introduced by scientific communities around the world. At the end of the presentation, the cases of the American company that introduced zero trans-fat soybean cooking oil, as well as the Japanese universities who developed gene-edited fish containing 20% more meat than average, were briefly introduced as examples of the impact of gene editing technology in food as shown in Since the central aspect of this study is to explore the acceptance of gene editing technology for food among youth in Japan, the survey was conducted at Ritsumeikan University in Osaka, Japan. The survey was conducted on December 24, 2019, and attended by nearly 250 students with an average age of 20 years. The students’ educational backgrounds were in economics and business, which was intentional, to avoid respondents with science or biology backgrounds, to represent the general population, who do not have any previous scientific experience concerning genetically edited food or genetically modified food. The respondents participated in the survey voluntarily and without any financial incentive to avoid any data collection bias. A group of 216 respondents answered the first survey, and then attended the short presentation about genome editing technology, and 207 respondents retook the survey. After filtering the date and matching the ID numbers of the respondents for the first and second surveys, we received 180 completed responses.The statistical survey results for the 180 completed samples show that 47% of respondents were female, while 53% were male. The majority of respondents were Japanese nationals (92%), while 6% were Korean nationals, and 2% were Chinese nationals. However, all of the respondents were residents of Japan. Moreover, 72% of respondents had an urban hometown, whereas 28% had a rural hometown. The majority of respondents said that they live with their family (71%), but 27% selected living alone, and 2% specified living with friends, as shown in There is a lack of research articles discussing the acceptance of genetically edited food using the SEM method due to the uniqueness of the genetically edited food approach and the fact that it is not commercialized on a broader level. Therefore, this research has utilized public attitudes toward biotechnology, identified by Pardo , as wellIn general, knowledge about a particular subject has a high impact on the attitude towards it. Although the public has a low level of understanding of genetically edited food, knowledge about biotechnology and its impact on modern society has increased dramatically due to advances in communication technologies and science communication in general. Gaskell has argued that knowledge plays an essential role in terms of perceived risk, following a study showing that limited knowledge regarding genetically modified food can increase the level of risk perception . TherefoHypothesis 1.Knowledge has a direct effect on Trust.Hypothesis 2.Knowledge has a direct effect on Perceived Benefits.Hypothesis 3.Knowledge has a direct effect on Perceived Risks.For this factor, we studied the level of knowledge that the respondents had in terms of genetically modified food and genetically edited food, as well as if they could differentiate between them. In addition, we determined if the respondents knew the potential for utilizing gene editing technology in food, animals, and human health, as well as their willingness to develop further knowledge about this technology.Several scientific articles have argued that if a consumer trusts a certain technology, the general new technology adoption rate for the same consumer may increase ,47,48. IHypothesis 4.Attitude Towards Technology has a direct effect on Knowledge.Hypothesis 5.Attitude Towards Technology has a direct effect on Trust.Mossialos has argued that there is a knowledge gap in the area of genetics alteration, which is caused by the low efficiency of benefits and risks communication due to widespread sources discussing this matter and scientific uncertainty .A study by Moon and Balasubramanian has shown that consumers in the United States and the United Kingdom consider the primary information source about genetics technology to be the government. Thus, trust in the government and scientists is considered an essential part of shaping public trust in genetics technology . AnotherIn this construct, we aimed to study the effect of having higher trust in the information sources or the key players in the gene editing field on adopting genetically edited food. Therefore, our hypothesis was as follows:Hypothesis 6.Trust has a direct effect on Willingness to Purchase genetically edited products.In this factor, we studied the level of trust that the respondents had toward the scientists working in the biotech industry, academic members, government information regarding genetically edited food, and companies utilizing gene editing technology, as well as in the sources providing information about gene editing technology. Several previous studies have indicated that engagement with biotechnological products is positively correlated with perceived benefits ,54,55. THypothesis 7.Perceived benefits have a direct effect on Willingness to Purchase genetically edited products.In this factor, we investigated the level of consumer perceived benefits toward genetically edited food products by assessing several factors, such as the benefits to human health, benefits for animal health and comfort, positive effects on the local economy and agriculture, and the impact of solving hunger issues in developing countries.A study by Bredahl has suggested that there is a connection between perceived risks and attitudes toward genetically modified food. The study has further determined that consumer acceptance of genetically modified food tends to be very low because the perceived risks are higher than the perceived benefits, putting further emphasis on measuring the difference between perceived benefits and risks to measure attitudes toward genetically modified products . TherefoHypothesis 8.Perceived risks have a direct effect on Willingness to Purchase genetically edited products.In this study, we examined several factors that influence consumers’ willingness to purchase genetically edited food products. We have tested how the consumers’ willingness to purchase genetically edited food products are directly affected by the trust in the genetically edited food industry stakeholders (H6), the benefits of genetically edited food perceived by consumers (H7), and the risks of genetically edited food perceived by consumers (H8). In this construct, we are also exploring different attribute factors that may encourage the consumer to purchase genetically edited food products, such as having the products at lower prices compared to the conventional ones, or containing more nutrients than the conventional ones.For SEM analysis, IBM SPSS Amos (v. 26) software was used to analyze the theoretical model responses for the first and second surveys as well as to test the hypotheses stated in the previous section. The SEM method was used since it can detect measurement errors as well as estimate the path coefficient of the proposed model in a visualized way. The SEM method has had a substantial impact on research related to social studies or studies that measure different factor effects .Exploratory factor analysis (EFA) was conducted after the intervention to validate the reliability and validity of the constructs. For this purpose, we utilized IBM SPSS Statistics (v. 26) software with factor analysis functionality. To ensure the highest level of compatibility with IBM Amos, we employed the method of maximum likelihood for factor extraction since it is the same method utilized by Amos with a fixed number of five factors to be extracted and maximum iterations for convergence at 25. The analysis was conducted using Promax rotation with the Kaiser normalization method to identify the correlated factors. To ensure a high level of factor effects, we automatically suppressed small coefficients with an absolute value below 0.3. After conducting multiple rounds of EFA, several variables were deselected from the analysis, especially the ones that had a loading of less than 0.3 or were loaded in two different factors in the analysis, including KN7, TR3, TR6, TR7, WTP7, ATT3, ATT4, ATT5, and ATT7, to ensure a higher model fit. The finalized exploratory factor analysis contains 33 items instead of the 42 items from the original questionnaire, as shown in We measured the Kaiser-Meyer-Olkain (KMO) value using SPSS to measure the sampling adequacy, and it was found to be 0.904. Since the resulting KMO value was between 0.9 and 1, the analysis is considered “marvelous,” according to Kaiser, which reflects the highest level of sample adequacy . All iteThe analysis covered the internal reliability for all of the constructs as well as external reliability by covering Cronbach’s alpha for all items tested. Cronbach’s alpha was confirmed to be sufficient for all constructs since it exceeded the recommended value of 0.7 . TherefoSince the model met all of the fitness, reliability, and validity requirements using both datasets of responses from before and after the intervention, path analysis for the model was conducted. The model tested the effect of knowledge on perceived benefits, trust, and perceived risks, the effect of attitude towards technology on knowledge and trust, and the effect on willingness to purchase resulting from perceived benefits, trust, and perceived risks. All of the hypotheses have been confirmed and accepted after measuring the P-values of all paths in the model of the survey after the intervention. All P-values were accepted with statistical significance below a value of 0.05. However, in the survey before the intervention, the paths of Attitude Towards Technology to Knowledge and Knowledge to Trust had P-values of 0.647 and 0.091, respectively, so we failed to accept these hypotheses as shown in The model passed statistical significance requirements by having a P-value less than 0.05 for all of the second survey. However, it failed in two paths on the first survey, namely Attitude Towards Technology to Knowledge and Knowledge to Trust. We found that all of the paths hold positive values for coefficients except the path of Perceived Risks to the Willingness to Purchase, which holds a negative coefficient and is compatible with the majority of studies conducted in this field given that perceived risks negatively affect willingness to purchase. The study also highlights the effect of knowledge and the differences in coefficients before and after the intervention. Before the intervention, the paths between Knowledge to Trust, Perceived Benefits, and Perceived Risks held the values of 0.11, 0.56, and 0.30, respectively. In path analysis of the second survey, we noticed that the values of the paths increased to 0.38, 0.77, and 0.36, respectively, which illustrates the effect of the Knowledge construct on Trust, Perceived Benefits, and Perceived Risks as shown in To further verify the results, at the end of both surveys, we asked the respondents one direct question about whether they were willing to purchase genetically edited food. The answer options were presented as yes or no. We found a change in the final opinions of respondents; in the first survey, only 24% showed interest in purchasing genetically edited food products, but after the second survey, the number significantly increased to 41%. This result illustrates how science communication and increasing the knowledge of consumers through technology can increase their willingness to purchase, as shown in To further verify the statistical significance of the results mentioned above, a chi-square test was performed using SPSS. The asymptotic significance has been calculated to be less than 0.001, which indicates a high level of statistical significance for the differences shown in In this study, we are tackling three main themes, namely; the regulations comparison, genetically edited food knowledge, and the structural equation modeling analysis for identifying the factors that can affect the willingness to purchase the genetically edited food products. The study has three main limitations, which will require further research work to tackle them.The first limitation in the regulatory comparison part. It is clear that the framework and regulations for genetically edited food are still in the development stage in several areas around the world, and it is not yet solid or well established in comparison with the genetically modified food regulations. The comparison in Europe and the United States are in the development stage, and we encourage future research work to compare the final version of the regulations that govern genetically edited food once released or approved.The second limitation is represented in the literature review for the willingness to adopt genetically edited food or the factors that can influence it. Considering that this topic is quite new, and there is limited knowledge of the genetically edited food products among consumers, the number of literature that tackles this part is considered to be very limited in comparison with the genetically modified food. Therefore, most of the literature that we have reviewed were mainly tackling consumer perception of genetically modified food. Therefore, we highly encourage more researchers to conduct more surveys and experiments to measure consumer perception of genetically edited food in the future.The third and main concern while conducting this study is that the survey was distributed among Ritsumeikan University students in Japan who happened to be in the same age bracket, as well as from similar social backgrounds. Therefore, the results of this survey should not be interpreted as a reflection for Japan nationwide due to the tight demographic and geographic proximity of the survey respondents. Thus, we highly recommend further research efforts to validate the results by applying this model to samples of different ages and from different cities and/or social backgrounds to verify the degree to which this model represents the overall population of youth in Japan.Although we believe that the study has several limitations, the study can be considered as a start for more researches in this field. We are planning to conduct more related and complementary studies in the future, and we highly welcome the collaboration with more researchers interested in the field for future and more inclusive studies.Biotechnology is one of the most advanced scientific fields with constant innovation that can lead to impressive results. However, the field is also highly regulated due to its critical nature. The regulations are often associated with being anti-innovative by scientists in this field. In the genetically edited food field, regulations around the world are still immature and ambiguous, especially in terms of labeling. Therefore, we consider this paper as a start for comparing regulation approaches around the world, and we aim to conduct more comparisons once there are concrete regulations set by authorities in different countries.Genetically edited food is considered a new term. Thus, it is expected that the general population will have a lack of understanding of the differences between genetically modified food and genetically edited food. Therefore, we have created an intervention featuring a short educational presentation that highlights the aforementioned differences. We have observed significant changes in the results before and after the intervention, which indicates the impactful role that science communication plays in this regard. As a result, we highly encourage more researchers to investigate the role of science communication in increasing the adoption of biotechnological products and also collaborate to create easy-to-understand materials for the general public using basic terms. The responsibility and importance of science communication are not less critical than scientific achievements. Therefore, we advise that more researchers adopt this approach to help the public to understand scientific achievements and the innovation behind them, since current media sources may not accurately and effectively communicate these topics to a wider audience.Based on this study’s results, we advise considering science communication is the main factor that can affect willingness to purchase and the success of genetically edited food products in the market. Based on the survey data, we have also noticed that consumers trust the information and regulations of governments. Therefore, we advise governments to investigate further the feasibility of establishing online portals that provide education about genetically edited food in simple terms for general consumers. We also advise universities and research labs to investigate the possibility of creating a joint communication platform that delivers the latest results of research on the benefits or risks of genetically edited food products to the public. Other potential outreach approaches include developing cooking shows and YouTube videos, which can briefly introduce genetically edited food products and utilize them in an educational cooking session. Researchers in food-related technologies can also introduce the concept of genetically edited food to researchers in different fields via gathering opportunities such as Science Café, which is organized by the Japan Society for Bioscience, Biotechnology and Agro-chemistry, or any other similar events that aim to increase awareness of different scientific concepts.Based on current regulations in which Japan shows a direction of being science-based, we believe that Japan would be an attractive place for biotech companies to expand in the genetically edited food field. Therefore, we advise investigating further the efficiency of establishing investment schemes and incentives that attract leading biotech companies and innovative international start-ups to move their operations to Japan in order to gain a higher share of the Japanese market, as well as add to Japan’s domestic economy and further develop Japan into a hub of innovation in food technology-related fields.


N = 178) was characterized by low levels of trust in the government, but high levels of trust in science and one’s primary care provider. Next, was the generally low trust profile (N = 108), characterized by low levels of trust directed towards all stakeholders and institutes. The third profile (N = 79) was characterized by high levels of trust. Results are discussed in relation to the important role of trust in determining people’s response to the current pandemic and the unique features of Israeli society.This study examined the role of trust in lay people’s health behaviors related to the current pandemic. A total of 376 Israelis completed an online questionnaire during the second lockdown. A latent profile analysis was conducted to identify profiles of individuals based on their levels of trust in the various institutions and stakeholders examined in this study. A three-profile solution was deemed most appropriate. The largest profile ( First, even seven months into the outbreak of the COVIDs impact ,3,4. Secs impact . Hence, s impact ,7.Under such circumstances, this study was set to examine the role of trust in lay people’s health behaviors related to the current pandemic. Theoretically, the issue of trust has been examined both in relation to interpersonal relations and in relation to institutions . It has The present study was conducted in Israel. The Israeli government and governmental response to the pandemic have received much attention given the fact that the pandemic has occurred during a political deadlock, an unprecedented constitutional crisis, and a prime minister, facing a criminal trial, on the grounds of bribery, fraud, and breach of trust. The government’s reaction to the pandemic was portrayed as being disproportionate, both rhetorically and practically. At the same time, however, there were multiple errors of omission or commission of guidelines and policy measures, many of which, guided by political, rather than healthcare considerations . In the most extreme period of lockdown imposed during the first wave of the pandemic, the public was instructed to stay within 100 m away from home, whereas during the second wave, a 1km restriction was imposed. Between the two waves, the prime minister, who has been holding multiple media appearances throughout the pandemic has instructed the public to go back to life and have fun. Hence, although the initial response and outcomes of the pandemic management in Israel have been portrayed as successful, the second wave of the pandemic had occurred quite early and resulted in a very large number of infected individuals, relative to the size of the population. This has been accompanied by a growing political upheaval accompanied by repeated ongoing demonstrations of Israeli citizens, who have been protesting on multiple grounds from the perceived illegitimacy of the Prime Minister to the financial crises brought by the restrictive measures implemented by the government or the sense of discrimination and unfair treatment of some segments of the population. Moreover, multiple political figures, including the Prime Minister, Benjamin Netanyahu, have been repeatedly violating and breaking the exact same orders they had issued to fight the pandemic. Thus, the contribution of leaders as role models [As reported in past research, the acts (or lack of acts) taken by governments to protect their citizens have been highly associated with the level of trust in governments reported by these same citizens . ResearcIn the face of the unknown, science plays an important role in characterizing the pandemic, its lethality and spread as well as ways of coping with it . Early oThe WHO views its role as a leader on matters related to health, responsible for shaping the research agenda, synthesizing and disseminating relevant knowledge, building sustainable institutional capacity, articulating ethical and evidence-based policy options, and monitoring health status and trends . These rEarly on, it has been made clear that the “starving and highly neglected” healthcare systems worldwide will not survive a full-blown pandemic, with millions of infected and dying people. In fact, the measures enacted by governments, worldwide, have been guided by the effort to save the healthcare system, in each country, rather than by a direct effort to protect their citizens . This isThe healthcare system in Israel is considered a highly robust and trustworthy system but has suffered from extreme neglect over the years. Its hospitals are already over-crowded and fully occupied, even beyond full capacity as the ratios of nurses, physicians and hospital beds to citizens are low relative to other Organisation for Economic Co-operation and Development (OECD) countries ,22. CleaIn a sharp contrast to the general healthcare system, which is constantly failing its customers, one’s relationships with his or her individual physician might still be characterized by high levels of trust . In factThe media can be divided into new  and old or traditional . In the past two decades, there has been an ongoing shift from the reliance on the more traditional media to the new media, also known as social media. This transition to the new media is characterized by an influx of fake news and increasingly polarized societies. In the case of COVID-19, fake news is thought to be spreading at a faster pace than the pandemic itself . It has These global trends likely coincide with local events, as even prior to the pandemic, there have been high levels of skepticism towards mainstream news channels due to their reliance on sectorial and extranational news . MoreoveDuring a global crisis, characterized by high levels of uncertainty and increasing demands for behavioral change in the face of the unknown, trust plays a major role. This study examined the relationship between compliance with health behaviors and trust during the second lockdown, imposed on Israel during September–October 2021. This study adds by examining the public trust in a breadth of possible stakeholders or institutions, taking a comprehensive approach to the issue. As trust was measured across a variety of possible stakeholders and institutions, this study aimed to identify public profiles of Israeli citizens distinguished based on degree of trust. The association of these profiles of trust with COVID-19 preventive behaviors and demographic characteristics was then examined.The study was approved by the ethics committee of the PI’s university and all participants signed an informed consent. We relied on a convenience sample recruited via an online survey agency. Respondents received reimbursement for their time. Between 7th October and 15th October, when the state of Israel was under strict lockdown (1 km confinement), 376 people completed an online survey about their experiences during lockdown. Data are available upon request. Respondents were asked: “please indicate on a scale of 0 to 100, how much do you trust any of the following institutes with the management of the Corona crisis.” The following institutes were subsequently presented and ranked by respondents: the government, science, primary care physician, healthcare system, the WHO, the traditional media and the new media.COVID-19 preventive behaviors were assessed using 13 items, including: obtain COVID-19 health information, wash hands, use disinfectants, maintain good personal hygiene, wear a face mask, avoid traveling to areas infected by COVID-19, avoid public transportation, avoid sick people, avoid flights, avoid shaking hands, avoid eating out, avoid large gatherings, avoid work or school. These questions were ranked on a 1–4 scale, with 4 indicating greater frequency, with a higher overall score representing greater compliance. The reliability of overall compliance with COVID-19 preventive behaviors was Cronbach’s alpha of 0.81. Demographic variables including age, sex, and education  were gathered based on self-report.Descriptive statistics and correlations were obtained via R . Latent p-value suggests that the model provides a better fit to the data compared with a model with one less profile. Entropy scores indicate the degree to which profiles are differentiated from one another. The closer the entropy score is to 1, the better the prediction is. The outcome of the analysis is the assignment of each individual to a profile. A good fitting model has a high probability of classifying each case to only one profile.The seven trust indicators were entered into a mixture modeling procedure. Latent profile analysis provides a flexible approach to determine the number of potential profiles to model observed variables within the profiles . The modThe size of each profile also can be used to determine the overall number of profiles as very small profiles represent spurious results. To ensure the stability of the models, different sets of starting values based on the local maximum in the iteration process were specified .Once a profile solution was established based on the fit indices described above, it was examined against the descriptive characteristics of the sample as well as against the COVID-19 preventive behaviors overall score.As can be seen in Next, the three- profile solution was examined against demographic characteristics and overall compliance with COVID-19 preventive behaviors. These are reported in This study examined whether individuals can be characterized according to the level of trust they report regarding major stakeholders or institutes of potential relevance to the implementation and enforcement of the current health related COVID-19 guidelines. Our findings point to the presence of three distinct profiles of individuals, characterized based on their levels of trust in various institutes and stakeholders of relevance as well as to the importance of trust in establishing people’s compliance with current COVID-19 guidelines.The highest levels of trust were reported regarding primary care physicians and science. This is reassuring given the important role assigned to the primary care provider in guiding patients through their health regimes . People’A three-profile solution emerged as the most adequate solution to explain the variability in people’s responses regarding their level of trust in the various stakeholders and institutes examined in this study. The first profile, which was the second largest, was characterized by general low levels of trust in all stakeholders examined in this study. Individuals classified into this profile were significantly younger than those in the other two profiles. Past research has shown that younger people are disproportionally stressed, anxious and lonely during the pandemic . PossiblThe profile characterized as having general low levels of trust also was the least likely to comply with COVID-19 guidelines in this study. Hence, consistent with past research ,40, our The largest profile in this study consisted of individuals who reported very low trust in the government, comparable to those reported by the generally limited trust profile, but high levels of trust in science and one’s primary care physician at comparable levels to those reported by the high trust profile. Low levels of trust in the government can be attributed to the highly polarized and contested political discourse in the country . NonetheOf note is the fact that the sample was not distinguished regarding its religiosity. This is unexpected given the fact that most infected cases in Israel have been ultra-orthodox . Althoug