There is a lack of theory-based interventions for direct support professionals (DSPs) to support a healthy lifestyle for people with moderate to profound intellectual disabilities (ID) despite their major role in this. This study aims to evaluate the preparation, implementation, and preliminary outcomes of a theory-based training and education program for DSPs to learn how to support these individuals.The program consisting of e-learning, three in-person sessions, and three assignments was implemented. The implementation process was evaluated with a mixed method design with the following components: preparation phase, implementation phase, and the outcomes. These components were measured with project notes, questionnaires, interviews, reflections, assignments, food diaries, Actigraph/Actiwatch, and an inventory of daily activities.n = 24) and DSPs (n = 32). The e-learning was completed by 81% of the DSPs, 72–88% attended the in-person sessions, and 34–47% completed the assignments. Overall, the fidelity of the program was good. DSPs would recommend the program, although they were either negative or positive about the time investment. Mutual agreement on expectations were important for the acceptability and suitability of the program. For the outcomes, the goals of the program were achieved, and the attitudes of DSPs towards a healthy lifestyle were improved after 3 months of the program . A statistically significant improvement was found for food intake of people with ID (p = 0.047); for physical activity, no statistically significant differences were determined.Regarding the preparation phase, enough potential participants met the inclusion criteria and the time to recruit the participants was 9 months. The program was implemented in four  facilities and involved individuals with moderate to profound ID (The theory-based program consisting of a training and education section for DSPs to support a healthy lifestyle for people with moderate to profound ID was feasible to implement and, despite some barriers regarding time capacity and mutual expectations, it delivered positive changes in both persons with moderate to profound ID and DSPs. Thus, the program is a promising intervention to support DSPs. People with moderate to profound intellectual disabilities (ID) often do not have a healthy lifestyle –4 with rTo support a healthy lifestyle, there are theory-based motor activity programs for people with profound intellectual and multiple disabilities , 13. HowA next step is to examine the potential of this intervention by implementing the program and evaluating this process . HoweverA theory-based program consisting of a training and education section to facilitate DSPs in promoting a healthy lifestyle for people with moderate to profound ID was implemented in four  facilities of ID care providers in the Netherlands. A mixed method design was used to evaluate the implementation phase. This implementation process was operationalised and evaluated with the following components: recruitment, reach, context, dose delivered, dose received, fidelity , recruitA  facility where people with moderate to profound ID (≥18 years) receive support.In this study people with moderate to profound ID are defined as individuals who need support in several domains, for example in language, motor skills, sensory, and in activities for daily living , 27. TheReadiness for implementation of the  facility by checking the fit of the goal of the program in consultation with the facility.Availability of one trainer to support the program.Time capacity of the team for participating in the research study by receiving approval from the manager for the indicated time investment. .The participants of four residential facilities and/or day activity centres from four different ID care providers were recruited within a consortium of eight ID care providers across the Netherlands. The inclusion criteria for the  facilities were as follows:The contact persons of the ID care providers assisted in the recruitment of the teams working at the selected  facilities by informing in person and distributing information flyers. If the team was interested in participating, the researchers contacted the team to discuss participation. If the recruited team had the capacity to participate, the DSPs, people with ID, and legal representatives were informed and asked for consent for the study.The Discovering Health-promoting Assets in Settings for people with Intellectual Disabilities (DIHASID) tool was used to gain insight in the implementation context . The DIHE-learning to increase knowledge and awareness of physical activity and healthy nutrition for people with moderate to profound ID.Social/Professional Role and Identity.Skills .Social Influences and Environmental Context and Resources.Three in-person group sessions of 2 h with the following themes:A theory-based program for DSPs to learn how to support physical activity and healthy nutrition for people with moderate to profound ID was implemented . The proThe e-learning could be performed individually or with colleagues; the in-person sessions were performed within the team of DSPs at the  facility where they work. Between and after the last in-person group session, practical assignments  were carried out within the team of DSPs.The program was in operation from April 2019 to July 2019. The training was performed by two trainers: one trainer from the Hanze University of Applied Sciences  and one trainer of each ID care provider (e.g. a behaviour scientist). Prior to the beginning of the program, the trainers received an instruction manual including PowerPoint presentations in order to prepare for the in-person sessions. A common meeting with the trainers was held to coordinate the sessions and to clarify uncertainties. After each session, there was brief contact with the trainers and with the first author about the process of the program. The e-learning was implemented in collaboration with the technical staff of the involved care providers. Before and during the program, there was consultation with the managers regarding the implementation  and contact persons of the involved ID care providers in order to improve the implementation phase.To measure the implementation components, the definitions and underlying questions of Linnan and Steckler  and the In the implementation phase, the dose delivered, dose received, and fidelity were captured with project notes, questionnaires, reflections, and assignments. The acceptability/suitability of the program was measured with reflections, questionnaires, and interviews. The last parts of the implementation phase, the factors during implementation, and the evaluation of the data collection process were measured with project notes. During the implementation phase of the program, the first author was present at one in-person session of the program with each of the four participating teams in order to observe whether the sessions were carried out as intended.For the preliminary outcomes, the changes after the program for DSPs were measured in terms of goal achievement, actual application in practice, and attitude of DSPs towards nutrition and physical activity. These data were aggregated from questionnaires, interviews, and assignments. Goal achievement was measured with a questionnaire for DSPs 1 week after the last program session. The actual application of healthy lifestyle support in daily practice was measured during the program with practical assignments for DSPs and 3 months after the program with interviews with them. Managers were also surveyed about the actual application of the program in daily practice. The attitude was defined as the thoughts and feelings of DSPs regarding a healthy lifestyle . The attn = 17) as a sufficient representation on the following topics: recommendation of the program, connection to support needs, actual implementation in daily practice, and other interventions during the program.In addition, changes in the level of physical activity and the amount of food intake of the participating people with ID were measured. Physical activity was measured with the Actigraph wGT3X BT for walking respondents [To evaluate the program, individual telephone interviews were held with half of the participating DSPs  facilities and the outcome variables for DSPs  and people with ID , a one-way ANOVA was performed.Two trained master students of Inclusive and Special Needs Education supported analysing the interview data with a conventional content analysis  and the The results are described in the order of the implementation process . DSPs also spent time to inform and obtain informed consent of the people with ID. The inclusion criteria could be met for this study, although difficulties were faced, for example, if people with mild ID lived or worked together with people with moderate to profound ID, and thus the target group did not completely match. In addition, the required time investment of the DSPs for the program and for the data collection was a challenge for the  facilities.n = 32), people with moderate to profound ID (n = 24), managers/coordinator of the participating  facilities (n = 4), and the trainers of the program (n = 6). In total, 32 DSPs out of 41 DSPs from the four  facilities participated in the study. The distribution of DSPs over the four  facilities was as follows: 4, 16, 7, and 5 DSPs. Reasons for not doing so were: lack of presence at the  facility at the time of the implementation due to attendance in another department of the ID care provider, not willing to commit to the time investment, or too recently hired. The characteristics of the DSPs and the people with moderate to profound ID supported by the participating teams are described in Table Participants in this study were DSPs n = 3, people During the program, there were changes in the context that were not provoked by the implementation of the program. These changes were with regard to staff: decrease in staff at one  facility (number 1) and additional education for two DSPs at one  facility in order to become physical activity consultants (number 2). With regard to a healthy lifestyle, the following changes were made: decrease in budget for food at one  facility (number 2), increasing offer of physical activity at one  facility (number 4), and health related activities at two  facilities (numbers 1 and 4), for example, receiving recommendations from a movement expert regarding physical activity, more indoor activities, a short class for people with ID about health, and a cooking activity 1 day per week for people with ID.All program components  were available, although not all DSPs completed all of the components of the program. The e-learning was completed by 26 out of the 32 DSPs. All of the three in-person sessions were attended by 18 DSPs. The remaining 14 DSPs attended one or two in-person sessions. Reasons for not participating in the in-person sessions were illness, vacation, time, or private circumstances. An overview of dose delivered and dose received is described in Table The quality of the submitted assignments (38 out of 96) was mostly positive (23 assignments); see Table n = 16), making the sessions less effective according to the reflection of the trainers. Overall, the execution of the in-person sessions in relation to theoretical methods and determinants was good  facilities in particular prepared inadequately for the in-person sessions. However, the participation during the sessions at these two  facilities was neutral to good. One  facility had different expectations (working with more clear action points) for the in-person sessions. Additionally, the group size for one  facility was large (Table n = 17) about the connection of the program to their support needs. Approximately half of them (n = 8) considered the awareness of a healthy lifestyle and communicating with each other in this context as positive. One DSP illustrates: ‘I thought it was good. We do a lot of things, but it is the awareness of just simple things, like housekeeping, that is also physical activity. Often, we take over activities of our clients which they can do by themselves’ (respondent 5:9). Beside the positive statements about the connection of the program to support needs, there were also DSPs who made neutral (n = 8) or negative (n = 7) comments. They indicated that the program was not necessary or that they expected more tips for daily practice.Almost all of the interviewed DSPs (14 out of 17) indicated that they would recommend the program to colleagues. The DSPs mentioned that their recommendation depends on the status of the team in the domain of healthy lifestyle. Comments that were more critical by some of DSPs pertained to the lack of connection with the target group and the significant time investment of the program. In addition, all of the interviewed DSPs indicated that they were positive .Overall, the DSPs’ goals of the program have been achieved for both the e-learning and the in-person sessions; see Table The change in daily practice following the program was sufficient to good for two of the four  facilities according to DSPs. For one  facility, the change was insufficient and, for one  facility, just the change in daily practice from the e-learning was insufficient. For  facility 2, the in-person sessions made statistically significantly less change on daily practice. See Table n = 16); a DSP illustrated: ‘It is in the little things. I am more aware that I let people with ID clean up themselves after dinner instead of doing that for them’ (respondent 3.33); ‘introducing more physical activities’ (n = 14); using the BCTs (n = 13); prepare or offer healthy nutrition (n = 12); and let people with ID choose themselves (n = 12). Almost all of the DSPs (n = 15) indicated nothing has changed in involving family and others in a healthy lifestyle of people with ID. Besides these comments, 11 DSPs had some neutral comments. They indicated the use of the BCTs depends on the people with ID (n = 6), and the actual application in practice is dependent on the attitude of the DSP (n = 5).The actual applications in practice mentioned by the DSPs were: ‘awareness about a healthy lifestyle’ , resulting from a mixed model analysis with random effects for DSPs; see Table p = 0.047). Table The food intake of people with ID who were supported by the participating DSPs was measured before (T0) and three months after the program (T2). A statistical difference was ascertained between T0 and T2 for food intake from the recommended nutrition guidelines . The percentages demonstrate that people with ID spend most of their time in a sedentary state. Table p = 0.844.The physical activity of people with ID who were supported by the participating DSPs was measured before (T0) and three months after the program (T2). Table p = 0.004) and for the relevance  and satisfaction  of the in-person sessions (acceptability/suitability). No statistical differences between the four participating  facilities were found for goal achievement, the attitude of DSPs, food intake, and physical activity of people with ID.For the differences in outcomes between the four participating  facilities, statistically significant variances were ascertained for the changes after the in-person sessions  facilities, the fit of the program was sufficient. The acceptability and suitability of the program were sufficient, however, the face-to-face sessions were rated more positively than the e-learning. The DSPs ranged from slightly negative to positive about the time investment, and the alignment of the mutual expectations of all stakeholders about the program was considered as important and need to be improved. Almost all of the DSPs would recommend the program. The managers were also positive about the content of the program, and the awareness of the importance of a healthy lifestyle in the teams, even though the teams still struggle with the integration of healthy lifestyle behaviour into working processes. Despite the implementation barriers, the DSPs considered the goals of the program to be achieved. The changes after the program were sufficient.During implementation, barriers were encountered: the DSPs were not always satisfied, the program was not always relevant to them, and they had different experiences about the changes in daily practice after the program. Nevertheless, there were no statistically significant differences in changes after the program between the different  facilities. This may suggest that, despite the mixed opinions of the DSPs regarding the program, it indeed has impact on their attitudes for supporting a healthy lifestyle, which was recognized in a previous implementation study . In thisThe DSPs’ attitudes towards supporting a healthy lifestyle on nutrition increased directly after the program. For both nutrition and physical activity, their attitudes significantly increased after 3 months. This is in accordance with previous research in which education was mentioned as a factor that positively influences the attitude of DSPs for supporting physical activity , 43, 44.In addition, for the changes for people with ID after the program, statistically significant improvements were found for food intake; however, for physical activity, no statistical differences were determined. Additionally, the involvement of family and others in a healthy lifestyle for people with ID needs improvement. This social network can be supportive in adapting to the needs of people with ID by focusing on their strengths and, for example, including them in decision-making .This study was executed in daily practice at four ID care providers; this is where the actual implementation of the program should occur. Although this strength of executing the study in daily practice also brought some limitations for the study, it was the reality of the workplace for the DSPs and therefore provided a realistic representation of the implementation of the program. This study shows important factors that must be taken into account when implementing programs in daily practice.The changes after the program should be interpreted with caution. The study had a relative small sample size of 32 DSPs and 24 people with ID. In addition, there were missing data in the food diaries of people with ID, and not all persons with ID wore the Actigraphs for the recommended amount of time. Therefore, these outcomes are based on a small sample. However, this is the reality of data collection in daily practice and, nevertheless, the changes after the program were promising.Although the data collection was suitable for measuring the changes after the program, the feasibility of the data collection process needs improvement regarding the time investment for DSPs. For example, filling in food diaries and wearing physical activity trackers can be components of the daily routine to facilitate the data collection process. The lack of time for implementation corresponds with findings from other implementation studies , 23.Furthermore, physical activity and food intake was measured 3 months after the last program session. This post-test was after the summer holidays, taking into account the absence of regular staff. This may be a limitation because it is questionable if there is a causality between the program and its outcomes, for example, context factors such as changes in the organization, or the different seasons can be a mediating variable. In addition, for future research, a follow-up measurement can indicate healthy lifestyle changes in the long term.For further implementation of the program, communication and alignment with all stakeholders is an important factor. By discussing mutual expectations in advance, disappointments are avoided, and it improves the relevance of the intervention in daily practice . A contaIn the evaluation of the program, for the measurements of people with ID, the residential facility where they live should be responsible for the physical activity and food intake measurements. They are with the people with ID at the beginning and end of the day so are able to check the measurements. This data collection should be incorporated into the daily routine to avoid missing data. The importance of the commitment of staff in the implementation is also addressed in a previous evaluation study .The theory-based program consisting of a training and education section for DSPs to learn how to support a healthy lifestyle for people with moderate to profound ID was feasible to implement and, despite some barriers regarding time capacity and mutual expectations, it delivered positive changes in both DSPs and persons with moderate to profound ID. Thus, the program is a promising intervention to support DSPs.


This cross-sectional study aimed to determine the earthquake preparedness levels and related factors of the faculty members working at a university located in a province in a first-degree earthquake zone in Turkey.The total number of faculty members at the university is 457, including 314 assistant professors, 63 associate professors, and 80 full professors. The study group included 177 (38.7%) of 457 faculty members. The dependent variable of the study is the attitudes of the faculty members towards earthquake preparedness. The independent variables were age, gender, marital sta-tus, having children, living with or without children, duration of residency in Karabuk. In addition, these were also included as variables, respectively, type of housing, property ownership, work experience, exposure to natural disasters in the past, and the awareness that Karabuk is a first-degree risk earthquake zone. The data were collected using a descriptive questionnaire and Mulilis-Lippa Earthquake Preparedness Scale. Data were analyzed using chi-square tests and binary logistic regression model and SPSS 20.0 software. There was only one (0.6%) faculty member who stated that he meets all of the preparatory criteria of the Mulilis-Lippa Earthquake Preparedness Scale. The probability of low materials preparedness score increased by 2.31 (95% CI 1.1-4.7) and 4.53 (95% CI 1.4-14.4) when the faculty members were renters and working as faculty members for 15 years and over, respectively. Being a renter also increased the probability of common knowledge and skill score by 1.95 (95% CI 1.0-3.8).This study showed that earthquake preparedness levels among the faculty members are insuffi-cient and suggests that motivation of the faculty members’ motivation to be appropriately pre-pared for future earthquake case should be increased. The country’s infrastructure, population, economy, and social structure can be seriously damaged, especially if the earthquake is severe and the preparedness measures for the earthquake are insufficient. In recent years, the effects of disasters, including earthquakes, are felt more intensely than in the past due to features such as increasing population density, industrialization, and urbanization.1 Nearly 90% of the earthquake fatalities occur in developing countries. More than 80% of the deaths caused by earthquakes in the last century have appeared in nine countries, including Turkey, Armenia, Chile, China, Guatemala, Iran, Italy, Japan, and Peru.1 Moreover, many people are injured because of earthquakes and ended up homeless.2 The lack of awareness and preparedness, poor engineering design and construction practices, and corrupt practices in the construction sector in developing countries are considered serious drawbacks.3 Located in the Alpine-Himalayan orogenic belt, Turkey is one of the world’s most active regions concerning earthquakes. The vast majority (98%) of the population lives under an earthquake risk in Turkey. Additionally, 98% of the leading industrial establishments are in earthquake zones, while 73% are located at active fault zones. Furthermore, 95% of dams are in active earthquake zones.4 Two hundred and twenty-three major earthquakes occurred between 1900 and 2009 in Turkey during which, 86 thousand people have lost their lives, while the authorities have identified destroyed or profoundly damaged housing affecting approximately 549 thousand people.5 On August 17, 1999, a 7.6 on the Richter Scale earthquake had struck the Marmara region of Turkey, resulting in 17,118 human deaths.More than a million earthquakes occur globally; as a consequence, more than one million people have lost their lives due to earthquake incursions only in the last 20 years.6 For instance, fires related injuries caused by broken gas lines can be prevented by learning how to close a gas line. Similarly, securing heavy furnishings such as a bookcase to the walls prevents extensive injuries. Materials such as first aid supplies, canned food, and bottled water can increase the chances of survival after an earthquake. 7 At an individual or institutional level, there are severe deficiencies in Turkey about taking measures against disasters, reducing the potential damages, and planning for readiness to disasters.11 In a study conducted in Antalya by Dedeoglu, it was reported that, among 198 people, only 1 (0.5%) has an earthquake home emergency kit and only 21% of the participants have received first aid training. Furthermore, over half of the participants (58%) adopted an attitude against surviving an earthquake which is ones’ fate is sealed.8 Similarly, in other developing countries, the level of preparation of individuals is low. A study involving 2,686 people in China revealed that less than 5% of the participants were classified decently prepared,12 while in the USA, the level of disaster preparedness of individuals is higher. In a study conducted by the US Federal Emergency Management Agency (FEMA), it was reported that 57% and 45% of the individuals have an emergency kit in their home and workplace, respectively, whereas 34% of them own the related equipment in their car.13 Attitudes and behaviors of individuals to disaster preparedness may vary depending on the region and the characteristics of the community in which they live. Studies indicate that factors such as age,15 gender,12 education level,16 property ownership,15 previous exposure to a disaster,18 household income level,18 occupation,18 confidence in government efforts, number of dependents in a household,17 social assurance,19 higher levels of knowledge about emergency, positive attitudes towards emergency preparedness,12 race, type of housing15 are associated with the disaster preparedness attitudes and behaviors of individuals. Earthquake preparedness is crucial for the elimination of the damages attributed to earthquakes. Taking personal precautions allows human lives sustaining by reducing death and injuries that may arise after an intense earthquake episode.This study aims to determine the earthquake preparedness of faculty members who work in a university located in the first-degree earthquake zone in Turkey and the associated factors.The cross-sectional study was conducted at Karabuk University. A total of 457 faculty members are employed at the university. According to their profession, there are 314 assistant professors, 50 associate professors, and 80 full professors. Therefore, the sample size was determined as 209 with a % 50 prevalence, 5% margin of error, and 95% confidence interval using Epiinfo Statcalc 7.2. Thirty-two faculty members refused to participate in the study. Thus, the final study group comprised 177 (84.7%) faculty members in total. The dependent variable is the level of earthquake preparedness. Independent variables were age, gender, marital status, having children, living with or without children, duration of residency in Karabuk, type of housing, property ownership, work experience, awareness of Karabuk’s being in a first-degree seismic zone, and exposure to a natural disaster in the past. 20 The MLEPS has been translated and adapted into Turkish by Sakiroglu in 2005. In the Turkish version, a section was added to measure the perceived usefulness of each preparation item .21 In this study, Cronbach’s alpha was found 0.75 for the earthquake preparedness behaviors, 0.89 for the perceived difficulty, and 0.94 for the perceived usefulness.The data were collected from the faculty members through face-to-face interviews from March to June 2018. Two forms were used as data collection tools. The first one was a form that included 12 questions and questioned the descriptive characteristics of faculty members, while the second one was the Revised and Translated Mullis-Lippa Earthquake Preparedness Scale (MLEPS), which includes 28 items. The MLEPS developed by Mulilis and Lippa aims to measure individuals’ earthquake preparedness behaviors and the perceived difficulty of becoming prepared for earthquakes.The MLEPS questions the earthquake preparedness behaviors of the individuals in three categories: 1) material preparedness, 2) planning, and 3) knowledge and skill. Material preparedness contains the relevant precautions like keeping the materials and equipment at home continuously, which may be helpful in case of a disaster, such as food, water, fire extinguisher, first aid kit, and raising the household’s awareness about fixing the tall furniture to the walls, and familiarity with the electricity, gas and water networks. Planning activities determine a safe place where the household can meet outside or inside the house. Knowledge and skill refer to the practices of individuals to participate in meetings to establish disaster preparedness, obtain first aid training, and improve knowledge and skills by reading written material. Individuals are asked to report whether they are prepared, unprepared, or unsure concerning the preparedness behavior described in each item. Individuals also can choose one of very much, a little, and not at all responses for the degree of difficulty and usefulness of fulfilling each preparatory criterion. The data were summarized as percentages. A detailed analysis was made with the findings from the part of the earthquake preparedness behaviors of the individuals of the scale. The answers given to the MLEPS earthquake preparedness questions were rated as prepared= 1, unprepared, and unsure= 0 to assess the relationship between dependent and independent variables. The points that the study group received from three preparedness categories of the scale were classified as low  and high  by taking the breakpoints of the median values. The chi-squared test was used to assess the factors associated with the earthquake preparedness behaviors of faculty members. The variables with a value of p<0.05 in the chi-squared test analysis were included in the binary logistic regression model. The variables in the binary logistic regression analysis were considered statistically significant at p<0.05. The data analysis was performed using SPSS 20.0 software.1) Material Preparednessa) Material supply: According to the faculty members’ statements, 45.8% of them had been equipped with an operating flashlight; 29.0% of them had a complete first-aid kit; 23.0% of them were aware of an emergency telephone number list; 19.9% of them had stored canned food; 34.3% of them prepared bottled water; 10.7% of them owned an operating transistor radio, and 18.3% of them prepared an operating fire extinguisher in case of an emergency. There was only one (0.6%) faculty member who fulfilled all the preparations for material supply, while 115 (65.0%) of them prepared at least one, and 61 (34.5%) members did not have any of them. The percentage of the faculty members who believe that supply is not difficult is: a) 84.7% for flashlight, b) 72.9% for radio, c) 68.9% for first aid kit, d) 77.4% for bottled water, e) 63.8% for canned food, f) 60.5% for a fire extinguisher, and g) 81.9% for emergency telephone numbers list. The majority of the faculty members reported that it is helpful to prepare these materials .b) Precautions for the electric switch, gas, and water valves: Ninety-three percent (93%) of the faculty members know the place of the water valve in their house, while 94.4% of them is aware of the gas/natural gas valve and 97.7% of them knows the electrical power switch. Furthermore, 95.4% of the faculty members know how to turn off the water valve, 94.3% of them know how to turn off the gas/natural gas valve, and 97.7% of them how to turn off the electric power. More than 90% of the faculty members claimed that it is not difficult to fulfill these preparatory measures, and almost all of them stated that these preliminary measures practical c) Fixation: Seventy-nine percent (79%) of the faculty members reported that they fixed their water heaters or combi boilers, 38.3% of them secured the heavy objects, setting them to the walls, 28.8% of them fixed the cupboards, and 24.9% of them fastened the tall furniture to the walls. While 25 (14.1%) of the faculty members reported that they fixed all of the heavy objects in their home, 31 (17.5%) of them had not secured any entity. The percentage of faculty members who think that fixation is complex was higher compared to other preparatory measures. However, almost all of them reported that these measures are useful .2) PlanningConsidering preventive measure plans, 16 (9.0%) faculty members have determined a meeting place with their family members. In comparison, 40 (22.9%) faculty members have identified a safe place to shelter during the earthquake the home after an earthquake occurs. Approximately 80% of the faculty members believe that these measures are not complicated, and 96% of them believe these are useful to apply for .3) Knowledge and SkillsSixty-one percent (61.4%) of the faculty members reported that they read tutorials about earthquake preparedness, 47.7% of them have received first aid training, 80.2% of them have earthquake insurance, and 29.4% of them stated that the experts checked the control of the earthquake resistance of their houses. In this category, the most difficult precautionary measure for the faculty members was to have the officials check the resistance of their homes .The percentage of scores that was lower than the median value (9) for the material preparedness category of the MLEPS was higher among younger faculty members compared to older ones (p=0.034), singles than married ones (p=0.034), renters than homeowners (p=0.002), as well as faculty members with ≤15 years of work experience compared to ones with ≥16 years (p=0.001) .No significant relationship was found between the planning category scores of the faculty members and the independent variables (p>0.05) .The median value for the knowledge and skill scores was found 4. The knowledge and skill score was lower for the renters compared to the homeowners (p=0.010). In addition, the score of this category was lower for the faculty members who had no children compared to those who had children (p= 0.006) .This study, carried out in the first-degree earthquake zone with a high level of risk at a university in Turkey, provides remarkable findings regarding the earthquake preparedness of faculty members. The study group would be expected to have a high level of earthquake preparedness because of their high education and income level. However, the current study showed that the faculty members did not implement many simple measures, so their earthquake preparations were insufficient.16 However, although there were possibilities to reach these sorts of information, it had been shown that they were weak to take action. Their levels of preparedness were low, especially in terms of supplying necessary materials and fixation and planning parts of MLEPS. Only one faculty member (0.6%) had fulfilled all preparation criteria needed for surviving when an earthquake occurs. In a study conducted at a university in Turkey with 207 faculty members using the MLEPS scale, similar to the findings in the present study, the level of fulfilling the criteria for earthquake preparedness was deficient. In that study, the preparation level of the materials that can be used immediately after the earthquake was reported as 53% for flashlight, 46% for bottled water, 44% for first aid kit, 34% for canned food, 21% for a fire extinguisher. Also, the study was informed that less than 40% of faculty members fixed heavy objects in their homes.22 According to the study conducted by FEMA, 57% of the individuals prepared all the materials in their homes needed in case of a disaster; the percentages of the prepared materials by the individuals were 74% for canned food, 71% for bottled water, 42% for flashlight, 39% for first aid kit.13 In another study conducted with 1002 participants in Hong Kong, 57% of individuals prepared food and water, 49% of them had first aid kits, and 11.5% had fire extinguishers in their houses. The same study showed that approximately one-fourth of the individuals (26%) had first aid training.23 Moreover, in a study conducted with engineering students in Lebanon, serious inadequacies in earthquake preparation have been reported. In particular, 88% of the students felt insecure against a possible earthquake, 7% of them secured heavy furniture, 3% of them determined a safe place to shelter in the house during an earthquake, 15% of them prepared a flashlight with extra batteries, 11% of them had radio with extra batteries, 23% of them have a complete first-aid kit, 19% of them prepared bottled water and canned food has been reported.24According to the study, many faculty members stated that fulfilling earthquake preparedness measures is not challenging and that these measures are helpful. Approximately two-thirds of the faculty members said they read the materials about earthquake preparation or watched the media’s related news. About half of the study group received first aid training. These findings can be explained by the fact that the study group has the highest education level and more skills and opportunities to reach the information. It has been reported that formal education is an essential factor that positively affects disaster preparedness.26 These findings indicate that renters were not as motivated as the homeowners in terms of taking responsibility; they preferred to avoid this kind of concern. However, there are some studies that earthquake preparedness is not related to property ownership.19In this study, a renter increased the probability of low score by 2.31 and 1.95 times for materials preparedness and knowledge and skill, respectively. The percentage of the faculty members who had made their house controlled by the experts was 48.1% among the homeowners, while only 14.4% among the renters. In addition, the renters were less tending to fasten their tall furniture to the walls. Many studies have shown that property ownership affects the readiness of the disaster in positive ways.In this study, the work experience as a faculty member was another critical determinant of earthquake preparedness. Fifteen years or less of work experience increased the low material preparedness score’s probability of 4.53 times. This finding can be explained by further developing self-responsibility feelings, cognitive abilities, and information sources when the work experience increases.This study, which was performed with a group of the highest level of education in a region with an increased risk of earthquakes in Turkey, shows that the faculty members’ level of fulfillment of the preparatory criteria for the earthquake was insufficient. Having a long working duration as a faculty member and homeownership affected the level of earthquake preparedness of them positively. Faculty members have an important position to increase the sensitivity of university students and the whole community regarding disaster preparedness. Hence, the motivation of faculty members to prepare for the earthquake should be strengthened. However, this study provides only the data obtained from the faculty members and does not give information about the level of earthquake preparedness of the general population. Therefore, to understand the capacity and motivation of earthquake preparedness of different social classes in Turkey and determine the best strategies for improving disaster preparedness, further studies are required.AcknowledgementsWe would like to thank Zerrin Yilmaz for her support in the data collection stage of the study. We also thank all of the faculty members for their participation in the study.


Results identified seven dietary purchase patterns that we named: Fruity; Meat alternatives; Carnivores; Hydrators; Afternoon tea; Beer and wine lovers; and Sweet tooth. On average the daily energy intake of loyalty card holders -who may buy as an individual or for a household- is less than the adult reference intake, but this varies according to dietary purchase pattern. In general loyalty card holders meet the recommended salt intake, do not purchase enough carbohydrates, and purchase too much fat and protein, but not enough fibre. The dietary purchase pattern containing the highest amount of fibre  is bought by the least deprived customers and the pattern with lowest fibre by the most deprived. In conclusion, supermarket sales data offer significant potential for understanding population dietary patterns.Poor diet is a leading cause of death in the United Kingdom (UK) and around the world. Methods to collect quality dietary information at scale for population research are time consuming, expensive and biased. Novel data sources offer potential to overcome these challenges and better understand population dietary patterns. In this research we will use 12 months of supermarket sales transaction data, from 2016, for primary shoppers residing in the Yorkshire and Humber region of the UK ( Poor diet is responsible for 90,000 deaths per year in the United Kingdom (UK) alone, equating to 1 in 7 of all deaths  and poorDiet is measured based on consumption of food and drinks, typically self-reported through a food diary or food frequency questionnaire which capture typical diet behaviours. However, these methods present limitations around error and bias in reporting . When tiAn alternative to recording consumption is to capture food and drink purchases. Here there is an assumption that food and drinks purchased are later consumed. Purchase records or sales data could provide a better reflection of household dietary patterns; however, they are unlikely to be sensitive enough to reflect individual behaviour, except where people live alone. The Family Food Unit of the Living Costs and Food Survey (LCFS) captures household expenditure from purchase records, so the principle of using purchase rather than consumption records is established . AdditioThere is increasing appetite around the world to use sales data direct from supermarket loyalty card schemes or transaction records . These dAccess to supermarket transaction data for academic research is challenging due to the commercial sensitivity of such data. In most cases this means that research is prohibited, but where partnerships and research have emerged, transaction data are aggregated in order to reduce disclosure of information which may provide a competitive advantage to other supermarkets. Alternatively, data are only provided for a particular sample of customers, a specific region or specific age group. In some cases, the retailer chooses to keep their identity secret. In spite of these challenges, the use of sales data in nutrition research offers substantial opportunity to transform our understanding of population dietary behaviour.The aim of this paper is to use sales data from a loyalty card scheme to identify dietary purchase patterns and their associated nutrient profiles and how these vary according to sociodemographic characteristics. We hypothesise that distinct dietary purchasing patterns will be identified from the typical purchasing behaviours of different demographic groups.Participants in this research were 311,972 unique Nectar loyalty card holders that reside in the Yorkshire and Humber region of the United Kingdom. All transactions for the whole of 2016 were included in this research. Participants were identified as “primary” shoppers, where we have estimated that they complete the majority of their shop with Sainsbury’s supermarket. Two conditions were set to identify these shoppers. Firstly, they needed to have shopped with the retailer on a least 10 occasions during 2016. This rule removes those loyalty card holders who just made occasional purchases, e.g., when on vacation or at Christmas. The second condition was that they must purchase from a variety of food groups. Each item purchased is categorised into one of 15 groups. Eleven were derived from the Living Cost and Food Survey (LCFS) categories: Carbohydrate Products; Meat and Fish; Dairy; Fats; Fruit; Salad/Vegetables; Potatoes; Sweets: Other; Non-alcoholic drinks; Alcoholic drinks and a further four generated by the research team: Ready Meals; Baby Food; Cakes and Biscuits; Crisps and Nuts. Only loyalty card holders that purchased from at least seven of these 15 categories, or purchased ready meals and from three other categories, are included in the cohort. This excludes more casual shoppers, e.g., those who habitually only purchase a meal per deal  or top-up a main shop made elsewhere with occasional purchases of bread, milk or snacks from the retailer. The sample of loyalty card customers is therefore designed to include only those who regularly do their main shop with the retailer.In addition to transaction records, we received information on the gender of the loyalty card holder and their age band. We also received a neighbourhood geographic identifier, an output area , to facilitate linkage to area characteristics including 2015 Index of Multiple Deprivation (IMD) ranked deciles  and the The transaction data provided included records that linked sales to the loyalty card via a hashed ID to maintain anonymity of customers. Information on product sales provided include: the stock keeping unit (SKU) code that identifies the product; the number of these items that were purchased; the price paid for the items; and, where the item was sold by weight, its weight in g.n = 305,616. For consistency we additionally removed customers spending in the bottom 2.04% of spends leaving a final sample for analysis of 299,260 loyalty card holders.During our sampling time frame from the 1 January to 31 December 2016 the retailer carried just over 25,000 products, as identified by their SKU, and in total they sold over 334 million items to our sample of loyalty card holders. Following initial inspection, we identified unusual purchasing patterns at the extremes of loyalty card spending, therefore we removed these outliers, based on information from the 2016 edition of the Family Food Survey (FFS), for the Yorkshire and the Humber region  in orderNutrient composition data were linked to our sales data at product level. These were “back of packet” values per 100 g or per 100 mL and included: Energy ; Carbohydrates; Protein; Fats; Saturated fats; Salt; Sugar and Fibre. These nutrient composition data were obtained from the supermarket own brand databases and from the commercial brandbank database for branded products. Where products still had missing nutritional information, we sourced these from the McCance and Widdowson food tables , or by sNutrient composition for the sales were calculated using values per 100 g (or mL) and product weight. Product weight data was sourced from the retailer or mined from the product description in our transaction files. We used the nutrient information for foods as sold, rather than as eaten, as we could not estimate cooking methods or waste. We did not account also for edible portions of food. It was not possible to generate weight data for 0.05% of total items sold in 2016.Each product was assigned one of the 82 detailed categories that include the LCFS sub-categories, in addition to researcher generated categories: Savoury snacks; Ready Meals; Baby Food; Meat Alternatives; Dairy Alternatives. We were unable to categorise 0.1% of items sold.k-means clustering was used to identify dietary patterns in the sales data. Loyalty card holders are represented by the distribution of their purchase volume (weight in grams) in the 82 categories that include food, non-alcoholic and alcoholic beverages. Provided with a number of classes to find, k-means attempts to group together loyalty card holders with similar patterns of purchasing. For k groups, the method begins with k starting points defined by a random composition amongst the 82 categories. Each loyalty card holder is then allocated to the starting point that they are most similar to, and the mean composition across the 82 categories in each of the k groups is calculated. These calculated means then replace the initial k starting points, and each loyalty card holder is re-allocated to which of these updated k points they are most similar to. This iterative process of re-allocation and calculation is repeated until no loyalty card holder changes their group membership between iterations, or a maximum number of iterations are reached. When this process has finished the k-means solution provides the typical composition for each of the k groups and the group that each loyalty card holder belongs to. Whilst this process is largely automatic, an important requirement is that the number of groups, k, is known. Typically, this is not the case and some judgement is required to decide on a suitable value for k. The “quality” of a solution given a value of k can be accessed via a within group sum of squares (WSS). This quantity is a measure of how similar loyalty card holders within a group are, a lower value signifying that the loyalty card holders are more similar to each other. By design, as the number of groups increases this value will not decrease, meaning that, as k increases, the quality of the solution will not deteriorate, so that looking for a measure of maximum quality  will not be possible. Instead, what is adopted in practice is to identify when this improvement in quality (reduction in WSS) as k increases becomes negligible or constant. This is best done using a scree plot, with the value of k along the x axis and the value of WSS for k on the y axis. The value of k where this plot develops an “elbow” indicates negligible improvement and is chosen as the value for k. Another consideration with k-means is that the method works best when the ranges of the values within the categories  are similar  and not skewed (k-means looks to form “circular” groupings rather than elongated ones). This is achieved here by range standardising each category, so that the values lie within a range from 0.0 to 1.0, and applying the inverse arc-sin square-root transformation to reduce skewness.Once a value of k is determined then each loyalty card holder is assigned to a group and, to help identify the nature of the group, the (untransformed) mean volume purchased in each category for members of that grouping can be calculated. For example, in one group the average purchase of meat amongst its members may be much lower than the overall sample, or in another group purchase of ready meals may be higher.The dietary patterns identified by the k-means will be further described, according to their nutrient composition, by the demographic characteristics of the loyalty card holders associated with each pattern and by the typical area characteristics of the loyalty card holders. The nutrient composition will provide an estimated daily consumption of the eight back-of-pack nutrients, calculated by dividing the average total nutrient for each dietary pattern by 366 (as 2016 was a leap year). Adult reference intake will be provided in the results for comparison . Tests fDue to the commercial nature of the data used in this research, it is not possible for data to be published alongside the manuscript.This research was reviewed by the University of Leeds ethics committee reference: AREA 18-050.Our sample of 299,260 loyalty card holders includes large numbers in each demographic group. However, women A, those Using the scree plot A and chaFeatures of the seven dietary patterns are presented in Dietary patterns are ordered by their approximate healthfulness, using amount of fibre as a proxy for healthfulness. The same type of social patterning is observed in We present a novel analysis of large and complex supermarket transaction data that identifies dietary patterns purchased in the UK. We believe this to be the first work of its kind using such detailed food transactions with associated nutritional information. We were able to generate data driven dietary patterns for ~300,000 loyalty card holders across one region of the UK and profile these by average daily nutrient intake. While the sample was biased towards certain demographic characteristics, data were available for large numbers of loyalty card holders in each sub-group.Our sample only included shoppers that we believe do the majority of their food shopping at Sainsbury’s supermarket. We were interested in capturing an indicator of habitual intake, akin to a diet diary or food frequency questionnaire, rather than looking at occasional shoppers, or those who only buy in limited food groups. Our method for identifying these customers used both a frequency metric and an indicator of variety, based on national survey categories. Whilst we set a threshold of at least 10 shops with the retailer, in reality our cohort of loyalty carders shopped more frequently, with a median of 53 shopping occasions throughout the year. Subgroup analysis (not reported here) showed that loyalty card holders shopping at least biweekly had slightly higher daily energy purchases, at 1887 kcal/day compared to the whole cohort at 1757 kcal/day.Our data include food and beverage purchases, including alcohol. Two of the dietary patterns: “Beer and wine lovers” and “Sweet tooth” were driven by alcohol sales, of different types. These two patterns were associated with the two lowest daily calorie intakes, suggesting perhaps that while these shoppers met the criteria for purchasing regularly from a range of different food groups, their main priority during their shop with this retailer was for alcohol purchases. Characteristics of the loyalty card holders purchasing each of these patterns were quite different, with the “Sweet tooth” pattern more commonly containing customers living in a neighbourhood characterised by the OAC geodemographic classification as Hard-pressed living. The “Beer and wine lovers” dietary pattern is distributed across OAC groups in a similar way to the total cohort of loyalty card holders, with no noticeable over or under-representation.All but the “Carnivores” pattern contain less than adult reference intake for energy , but all except the “Sweet tooth” and “Beer and wine lovers” contain more calories than the mean adult woman’s intake in 2016 reported by the NDNS of 1632 kcal . It is kThe “Fruity” pattern is interesting, with seven of the top ten purchased items being types of fruit. This pattern is most popular among Rural residents and in Suburbanite neighbourhoods, which are typically quite affluent. It contains the highest daily fibre intake, but this is still way below the daily recommended intake. Fibre does not form part of the adult reference intake guidance, nor is it mandated to appear on the back-of-pack of food products . In 2015Conversely, in the case of salt, where recommendations to reduce salt intake have been around for much longer, only the “Carnivores” pattern exceeds the daily recommended salt intake, and this is by 1 g at an average of 7 g/day. This is suggestive that the highly publicised guidance and product reformulations—with voluntary targets introduced in 2005 and the most recent legislation brought in in 2015—are largely successful at helping consumers achieve targets . ConsideThe most striking strengths of this research are the large sample size and the objectively measured sales records for dietary intake. The work presented here highlights the potential scope of sales data for identifying dietary purchase patterns. The transaction data are comprehensively matched to detailed nutrient composition data at the product level, providing a powerful dataset to investigate nutritional patterns and trends. These types of data would enable comprehensive modelling of proposed nutritional policies, such as the planned legislation expected to be announced in summer 2021 to restrict price and location promotions of high fat, sugar and salt products . It has These linked sales and nutrient data, with demographic characteristics, additionally make a bold step towards digitising the food system. While they may only represent part of the consumer facing retail environment, this could be the starting point for combination with other sources of retail data from the food supply chain .However, this is matched by some notable limitations. These data are only from one supermarket, which as the results demonstrate is used by people residing in areas across all deciles of deprivation, but over-represented in the least deprived areas. The loyalty card holders are predominantly women, which is the same observation found by Nevalainen, Erkkola  in FinlaIn our loyalty card data, we do not know whether the loyalty card holder is shopping for themselves, or for a family. This significantly limits the conclusions that can be drawn from our results and the reason why we only present descriptive statistics. Average daily nutrient intakes were calculated as if the loyalty card holder were living alone, but we can see from the contents of the patterns that some customers are likely to be buying for a family. With this in mind, the nutrient profiles presented in Another limitation is that we do not know whether the loyalty card holder does all of their shopping at Sainsbury’s, nor whether they use their loyalty card each time. They may forget their card, or do “top-up” shops from another retailer. Data driven dietary patterns are beneficial as they identify patterns relative to the data subjects’ behaviour, rather than trying to score them against a pre-existing dietary pattern. Being data driven, using detailed food categories, they are more difficult to compare to patterns observed in other studies, generated from subjects with different consumption or purchasing behaviours. That said, there are common themes in our patterns seen in many other studies, for example: presence of a carnivore pattern, a sweet tooth/snacking pattern and a meat alternative, or vegetarian pattern ,33. Our We hope that this study is the first of many that make use of supermarket sales data to generate insight into food purchasing behaviours around the world. In order to translate food purchase behaviours to dietary consumption, evaluation of transaction records as a source of dietary assessment is required .It is important to better understand the bias in these data, with respect to demographic characteristics of the shoppers, household composition and how much shopping is carried out at this retailer using a loyalty card. Incorporating an indication of out of home purchases to sales data would facilitate understanding of total dietary intake. Comparison with established dietary patterns or frameworks, such as the Eatwell Guide , nutrienLinkage of dietary purchase patterns to health records, with explicit consent, to better understand diet disease relationships could be paradigm shift in prevention and management of non-communicable disease. Sales data recorded by supermarket loyalty cards, linked with nutrient composition records and demographic characteristics, offer potential to understand food purchases at a scale not seen before, which unlocks the potential for more robust analysis to inform diet related policy. Further work is required to better understand the biases within these data and to extend data providers to include representation from other retailers and the out of home sector.


Recent increases in the number of patients with non-alcoholic steatohepatitis (NASH) warrant the identification of biomarkers for early detection of hepatocellular carcinoma (HCC) associated with NASH (NASH-HCC). IgM-free apoptosis inhibitor of macrophage (AIM), which generally associates with IgM in blood and exerts its biological function by dissociation from IgM, may serve as an effective biomarker for NASH-HCC. Here, we established a fully automatic and high-throughput electrochemiluminescence immunoassay (ECLIA) to measure IgM-free AIM and investigated its efficacy in diagnosing NASH-HCC and viral HCC.IgM-free AIM levels were measured in 212 serum samples from patients with, or without, HCC related to NASH, hepatitis B virus, and hepatitis C virus, using ECLIA. We also developed an ECLIA for measuring both IgM-free and IgM-bound AIM and investigated the existing form of AIM in blood by size-exclusion chromatography.IgM-free AIM levels were significantly higher in the HCC group than in the non-HCC group, regardless of the associated pathogenesis. Moreover, the area under the receiver operating curve for IgM-free AIM was greater than that for conventional HCC biomarkers, alpha-fetoprotein or des-γ-carboxy prothrombin, regardless of the cancer stage. ECLIA counts of IgM-free AIM derived from samples fractionated by size-exclusion chromatography were significantly higher in patients with NASH-HCC than in healthy volunteers and in patients with non-alcoholic fatty liver and NASH.Serum IgM-free AIM may represent a universal HCC diagnostic marker superior to alpha-fetoprotein or des-γ-carboxy prothrombin. Our newly established ECLIA could contribute to further clinical studies on AIM and in vitro HCC diagnosis.The online version contains supplementary material available at 10.1007/s12328-021-01567-4. Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in many countries and is closely associated with metabolic syndrome –4. NAFLDAlpha-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) are widely recognized HCC biomarkers. For early HCC detection, surveillance comprising a combination of abdominal ultrasonography with multiple biomarkers is recommended in patients with chronic liver disease, particularly in those with cirrhosis derived from advanced fibrosis. However, recent studies have shown that 1/4 to 1/3 of patients with NASH develop HCC without cirrhosis , 10. FurAIM, a secretory glycoprotein produced by macrophages, suppresses macrophage apoptosis . AIM comTo use AIM as a tumor marker, it is necessary to establish a method capable of specifically measuring activated IgM-free AIM without interference from IgM-bound AIM in blood. Although an enzyme-linked immunosorbent assay (ELISA) was used for IgM-free AIM , 19, a hIn total, 212 patients with liver disease, 117 without malignancy, and 95 with HCC who visited Saiseikai Suita Hospital from January 2010 to July 2017 were included in the study , yielding specimens of at least 2.0 cm in length. The specimens were fixed in formalin, embedded in paraffin, and subjected to hematoxylin–eosin, Masson’s trichrome, and Perl’s iron staining. Histological assessment was performed by an expert hepatologist. Patients with NAFLD were classified into four types according to Matteoni’s classification : type 1,XL column  at a flow rate of 1.0 mL/min with 50 mM phosphate-buffered saline (pH 7.4). The fractionated samples were collected in 500 µL aliquots.Size-exclusion chromatography of serum samples was conducted using a Prominence high-performance liquid chromatograph (HPLC)  with a G3000SWTo obtain anti-AIM monoclonal antibodies, BALB/c mice were immunized three times using full-length recombinant AIM with an adjuvant. Then, mouse spleen cells and myeloma cells were fused as previously described . AntibodAnti-AIM antibody No. 12 or 11 was mixed with magnetic beads with epoxy groups and incubated at 25 °C for 24–72 h to coat the beads with antibodies. The beads were then washed and blocked with Tris buffer (pH 7.8) containing 0.1% BSA at 25 °C for 24 h. Finally, the beads were washed with blocking buffer and stored at 4 °C. Ruthenium (Ru)-labeled anti-AIM antibody No. 8 or 11 was prepared as follows. First, Ru with N-hydroxysuccinimide residue  was added to the anti-AIM antibody No. 8 or 11 solution and incubated at 25 °C for 30 min. Then, 2 M glycine solution was added and incubated for 20 min to stop the reaction. Ru-labeled anti-AIM antibody No. 8 or 11 was subjected to gel filtration column chromatography  to remove unlabeled Ru.IgM-free AIM, IgM-bound AIM, and IgM were measured using the ECLIA on a Picolumi III automatic analyzer . Briefly, for measuring IgM-free AIM, 5 µL serum sample was diluted with 100 µL reaction buffer containing mouse IgG (200 µg/mL); the diluted sample was then incubated with 25 µL magnetic beads coated with anti-AIM antibody No. 12 at 30 °C for 8 min (first reaction). When the HPLC fractionated sample was measured, 100 µL undiluted fraction was used. After the first reaction, the beads were washed, and 100 µL Ru-labeled anti-AIM antibody No. 11 was added and the mixture was incubated at 30 °C for 8 min (second reaction).The beads were then washed to remove the unreacted Ru-labeled antibody to form an electrode along with the electrolyte solution; the photons emitted from ruthenium by the electrochemical reaction were measured using a photomultiplier. The concentration of IgM-free AIM (µg/mL) was calculated based on the calibration curve from the photon count of the AIM standard concentrations . The AIM standard was obtained by affinity purification from the supernatant of HEK293 cells expressing full-length recombinant AIM, using a Sepharose column immobilized with the anti-AIM antibody No. 12. The purified recombinant AIM was freeze-dried and weighed, and the concentration of each standard was determined based on the weight of the freeze-dried sample. When measuring both IgM-free AIM and IgM-bound AIM, magnetic beads coated with both anti-AIM antibody No. 11 and Ru-labeled anti-AIM antibody No. 8 were used for ECLIA as described above. To measure IgM, magnetic beads coated with commercially available anti-IgM monoclonal antibody  and the same antibody labeled with Ru were used for ECLIA.2 + (1 − specificity)2] or the maximal value for [sensitivity + specificity − 1] [ROC curves were obtained by calculating the sensitivity and specificity of the assay at every possible cut-off point and plotting sensitivity against [1-specificity] in SPSS for Windows Version 24 . The area under the ROC curve (AUROC) was calculated to determine the diagnostic accuracy of the assay. Appropriate cut-off points were examined for balancing the sensitivity and specificity of the ROC curve, and the optimal cut-off point was identified as that yielding the minimal value for [(1 − sensitivity)ity − 1] .p < 0.05.Statistical analysis was performed using IBM SPSS Statistics Version 24 for Windows. All values are expressed as the mean ± standard deviation. Differences in mean values between groups were assessed using the Mann–Whitney U-test, whereas correlations between parameters were evaluated using Pearson’s correlation coefficient. For all analyses, statistical significance was set at To evaluate the analytical performance of ECLIA, size-exclusion chromatography fractionated samples from the serum of one patient with NASH-HCC were assayed by the ECLIA using magnetic beads coated with anti-AIM antibody No. 11 and Ru-labeled anti-AIM antibody No. 8 to measure IgM-free AIM and IgM-bound AIM. Bimodal peaks of ECLIA counts were observed in fractions No. 4–6 and No. 12–13  and patients with NAFL (n = 5), NASH (n = 5), and NASH-HCC (n = 10) were fractionated by size-exclusion chromatography, and both IgM-bound AIM and IgM-free AIM were measured by ECLIA using beads coated with anti-AIM antibody No. 11 and Ru-labeled anti-AIM antibody No. 8. Furthermore, the same serum samples were directly measured for IgM-free AIM concentration by ECLIA using anti-AIM antibody No. 12 and Ru-labeled anti-AIM antibody No. 11 to investigate its correlation with the fractionated IgM-free AIM samples by size-exclusion chromatography. The sum of ECLIA counts from fraction No. 12–13 by size-exclusion chromatography of the 25 serum samples and directly measured IgM-free AIM concentration were well-correlated , indicating that ECLIA using anti-AIM antibody No. 12 and Ru-labeled anti-AIM antibody No. 11 specifically and accurately measures the IgM-free AIM concentration in serum samples.Next, 25 serum samples from healthy individuals  were serially diluted from 1:1 to 1:64 and IgM-free AIM was measured by ECLIA using beads coated with anti-AIM antibody No. 12 and Ru-labeled anti-AIM antibody No. 11. Good linearity was observed for each serum sample (Online Resource 2a and b).Next, assay repeatability was evaluated by five consecutive assays of IgM-free AIM in three serum samples, and the intra-assay coefficients of variation were 0.5–4.0%. Furthermore, assay reproducibility was evaluated by assaying three serum samples on four different days, and the inter-day assay coefficients of variation were 1.8–3.2%. Both the intra-assay and the inter-day assay coefficients of variation obtained indicated good precision.Finally, the effect of interfering substances was examined by spiking the serum samples with Interference Check A Plus and RF Plus  and measuring the IgM-free AIM using ECLIA. No change in the IgM-free AIM level was observed in serum samples spiked with bilirubin F and C up to 25 mg/dL, hemoglobin up to 500 mg/dL, chyle up to 3,000 FTU, and rheumatoid factor (RF) up to 500 IU/mL (Online Resource 3), indicating that the assay was not affected by interfering substances.p < 0.001; Fig. n = 117) and all HCC groups (n = 95), the optimal cut-off of serum IgM-free AIM for predicting HCC was estimated to be 1.6 µg/mL as it showed the maximal diagnostic accuracy. Using this cut-off point, the sensitivity, specificity, and accuracy of IgM-free AIM were determined and compared with those of AFP and DCP, which were set to 20 ng/mL and 40 mAU/mL, respectively. The accuracy of IgM-free AIM for HCC detection related to NASH, HBV, and HCV was 87.1%, 60.9%, and 83.3%, respectively, and that in all the patients was 79.7%, indicating that IgM-free AIM has a higher clinical accuracy than AFP or DCP  or DCP . Furthermore, due to its higher positivity rate, IgM-free AIM alone can be a more sensitive marker for HCC than AFP or DCP alone, respectively . In addition, we compared the positivity rate in the combination of IgM-free AIM and AFP or DCP with that in the combination of AFP and DCP. The positivity rates in the combination of IgM-free AIM and AFP, and that of IgM-free AIM and DCP were 74.7% and 77.9%, respectively, indicating that the positivity rates of IgM-free AIM in combination with AFP or DCP are higher than those in the combination of AFP and DCP . It is notable that IgM-free AIM alone showed a higher sensitivity than the combination of AFP and DCP.To evaluate the diagnostic value of IgM-free AIM, sera from the non-HCC (chronic hepatitis and cirrhosis) patient group and the HCC patient group including all cancer stages related to NASH, HCV, and HBV were measured with ECLIA using the anti-AIM antibody No. 12 and No. 11. The IgM-free AIM value was significantly higher in the HCC patient group than in the non-HCC patient group . On the other hand, there was no difference in IgM-free AIM levels between patients with different cancer stages (Online Resource 10), and no correlation was seen between IgM-free AIM and age regardless of the presence of HCC and non-HCC (Online Resource 11), indicating that the stage of cancer and the age are independent of IgM-free AIM level.n = 5) and patients with NAFL (n = 5), NASH (n = 5), and NASH-HCC (n = 10) were fractionated in the same manner and assayed for IgM-bound AIM, IgM-free AIM, and IgM by ECLIA. The IgM-free AIM counts and IgM-free/IgM-bound AIM count ratios were significantly higher in the NASH-HCC group than in the other groups , whereas IgM-free-AIM did not  and fractions No. 12–13 (IgM-free AIM) from all patients (Online Resource 12). Interestingly, the peaks of fractions No. 4–6 (IgM-bound AIM) from healthy volunteers and patients with NAFL and NASH were higher than the peaks of fractions No. 12–13 (IgM-free AIM), whereas the peaks of fractions No. 12–13 (IgM-free AIM) from patients with NASH-HCC were higher than the peaks of fractions No. 4–6 (IgM-bound AIM). Subsequently, 25 serum samples from healthy volunteers Supplementary file2 (DOCX 33 kb)Below is the link to the electronic supplementary material.


Innovation and out-of-the-box thinking are important drivers for clinical and translational science. The complexity of large health care systems and academic bureaucracy can make rapid and novel changes challenging. The often-used analogy of the challenges in quickly turning an ocean liner comes to mind. As the need to increase the speed for development of new diagnostic and therapeutic tools, to better implement such advances, to engage and reach the full spectrum of the population, and to train and educate the next generation is paramount, the question becomes how to best support these developments. One could argue that, in a broad sense, the launch of the CTSA initiative in 2005 was done to stimulate innovation in all of these areas on a national scale. Other NIH initiatives, such as the Centers for Accelerated Innovation (CAI) program at NHLBI represent large-scale top-down efforts in this direction. To ensure sustainable development and adoption of new concepts and technologies, academic health centers, often leveraging the CTSA initiative, have focused on building capacity locally including provision of tools such as training, project teams, and regulatory guidance as key factors. There are now vibrant bottom-up efforts at many such academic health centers to grow an academic culture that values entrepreneurship and innovation. The sharing of such experiences can help in accelerating successful approaches.In the present JCTS thematic issue on Entrepreneurship and Innovation, a number of institutions and programs present their approaches and findings. The issue includes five reports from institutions on efforts at the local level . There are three reports from the NHLBI CAI program, two from sites  and one presenting evaluation of the CAI and the NIH Research Evaluation and Commercialization Hubs (REACH) programs. In addition, one paper describes the launch of the NCATS I-Corps program at 10 CTSA institutions and one paper from 4 CTSA centers detail efforts to develop a regulatory guidance program, the Regulatory Guidance for Academic Research of Drugs and Devices (REGARDD). Together, these papers illustrate the broad-based efforts throughout the nation to build capacity and to meet needs to reinvigorate the health care system. Undoubtedly, many more such efforts are ongoing at many places.Some of the common threads in the papers are efforts to build expertise in product development and commercialization. As private industry has retreated to some extent from the early phases of translating discovery into marketable products, academic centers have started to fill this void. Many institutions are creating innovation centers where medical, engineering, and business faculty and trainees can come together and exchange ideas, as described in the reports from Massachusetts and Colorado. In many places, such an initiative also opens the door for company presence. Input from industry stakeholders is characteristic of several programs, such as the NHLBI CAI and I-Corps@NCATS programs. Success of such initiatives will require a culture of academic entrepreneurship – with an increased availability of well-trained faculty and investigators to navigate early phases of the multi-stage process of product development. Health systems and front-line clinic workers have much to add in assessing real-value propositions and the fit of proposed innovations to real-world needs. Many of the papers are focused on such capacity building – examples include the REGARDD program that presents efforts to reduce gaps in regulatory support, the I-Corps@NCATS program, modeled after the long-standing NSF program that encourages aspiring entrepreneurs to reach out to their potential customers, and the University of Michigan study that details efforts to implement training and funding mechanisms. An interesting feature of the latter was the involvement of patients and family members. Boots-on-the-ground experiential training and feedback seem more effective than didactic presentations alone. Funding, while critical, alone is insufficient, and both project-specific consultation and project development teams often play a critical catalytic role.Working with existing university resources, such as Technology Transfer offices and Regulatory support programs, helps to accelerate efforts in these areas. The Boston report provides an example where the program was in part co-located with the institutional technology transfer office, facilitating expeditious interactions. The experiences detailed in these reports illustrate that while such existing offices and resources are important, there is a remaining need where CTSA and similar programs have important roles. In their role as an honest broker, institutional connector and change agent effector, these programs serve in a catalytic role that institutions can successfully leverage. Many of the papers in the issue illustrate such examples that bring us back to the original vision of CTSAs as engines of innovation and culture change. In developing and fostering a cadre of faculty with an entrepreneurial focus, there is also a need to critically review existing academic benchmarks for promotions and advancement. Contributions in the entrepreneurial area are likely to require benchmarks that go beyond publications, grants, and more traditional assessment tools. Such adjustments are under way at many places which is a welcome development.We are pleased to present this thematic issue of JCTS which provides a synopsis of efforts to grow an institutional academic entrepreneurship culture. The examples illustrate the value of partnerships and multidisciplinary teams, and they underscore one of the important roles of the CTSA initiative. We encourage others to document and share their experiences as well.


New opportunities to create and evaluate population-based selective prevention programs for suicidal behavior are emerging in health care settings. Standard depression severity measures recorded in electronic medical records (EMRs) can be used to identify patients at risk for suicide and suicide attempt, and promising interventions for reducing the risk of suicide attempt in at-risk populations can be adapted for web-based delivery in health care.This study aims to evaluate a pilot of a psychoeducational program, focused on developing emotion regulation techniques via a web-based dialectical behavior therapy (DBT) skills site, including four DBT skills, and supported by secure message coaching, including elements of caring messages.Patients were eligible based on the EMR-documented responses to the Patient Health Questionnaire indicating suicidal thoughts. We measured feasibility via the proportion of invitees who opened program invitations, visited the web-based consent form page, and consented; acceptability via qualitative feedback from participants about the DBT program; and engagement via the proportion of invitees who began DBT skills as well as the number of website visits for DBT skills and the degree of site engagement.A total of 60 patients were invited to participate. Overall, 93% (56/60) of the patients opened the invitation and 43% (26/60) consented to participate. DBT skills website users visited the home page on an average of 5.3 times (SD 6.0). Procedures resulted in no complaints and some participant feedback emphasizing the usefulness of DBT skills.This study supports the potential of using responses to patient health questionnaires in EMRs to identify a high-risk population and offer key elements of caring messages and DBT adapted for a low-intensity intervention. A randomized trial evaluating the effectiveness of this program is now underway . The program uses real people to teach specific coping skills, like mindfulness and paced breathing.We invite you to try Now Matters Now today. Learn more at <Link to Intervention Website>We care about you.My job is to encourage you to use the program over the next three months and to practice the skills you are learning. If you haven’t visited the program in a while, I’ll send you a message to remind you. If you have visited, I’ll check with you about what you find helpful.I’ll communicate with you through messages, and in order to message you, I will access your medical record.Sending care,TEAM NOW MATTERS NOW—Introducing the real people who use these skills and helped develop this programMINDFULNESS—A way to be present for what is most important in your lifeOPPOSITE ACTION—Living a full and healthy life, despite what negative or unhelpful emotions and thoughts are telling you to doMINDFULNESS OF CURRENT EMOTION—Observing, honoring, and moving through strong emotions without being controlled by themPACED BREATHING—A different and scientific approach to the old saying “Just Breathe”GIVE US FEEDBACK—Did you have technical problems with this program? Do you want to give us feedback about the program, good or bad?coach for 3 months. In line with the stage model of behavior therapies, the interventionist for this study was the lead intervention developer (UW) [The DBT skills intervention was supported by an interventionist or program per (UW) -53. ThisHi [First Name],I’m writing to check-in from the Now Matters Now program. Do any of the skills look interesting to you to try?Paced Breathing is a breathing technique that can calm the mind and body naturally. Some people like to use Paced Breathing when they’re feeling nervous or anxious. It can also be a helpful way to clear the mind if you’re having a difficult time falling asleep.The key to Paced Breathing is to have your exhale be longer than your inhale. It can be a good way to center yourself and makes it easier to then practice other skills.If you try it, let me know how it goes.To learn more, please click the link below:[link to Consent “form” video]Take care,We evaluated feasibility by measuring the proportion of invited patients who opened the program invitation, the proportion of patients who visited the consent page, and the proportion of patients who consented. We qualitatively evaluated acceptability by using secure message feedback that the coach received from patients invited to participate and summarized relevant themes . We evalreceive the caring message aspect of this contact), 65% (39/60) clicked the link to the consent form, and 43% (26/60) consented to participate.In total, 60 patients were invited to participate . Of thesThe coach received no complaints from those invited to participate in the program. The feedback the coach received via secure messaging mainly included descriptions of how participants had used the program, specifically their helpful experiences practicing each of the four program skills and the challenges they experienced. One participant described a helpful experience in trying mindfulness skills, which involved bringing attention and awareness to their thoughts:I did the first lesson last night—I was able to use it today when I started having negative thoughts that wouldn’t stop. I cleared my mind and started looking at the trees, buildings and other things around me and noticing the little details of things. It actually calmed me down and gave me a sense of control.Another participant described the experience of practicing paced breathing:I am doing my best to make the Paced Breathing a daily practice. I forget sometimes until I am “over the edge” and am in deep panic/terror, but I can still even then use the breathing to help get me feeling more calm.Another participant described a powerful experience using an opposite action, which involved choosing to do the opposite of ineffective emotional urges:Yesterday I began the module called “Opposite Action” and printed it out after I completed it. Doing it was empowering but also very emotional for me.Finally, a participant described a plan to use mindfulness of current emotion, which involved learning how to bring attention and awareness to the bodily sensations of emotions:I used [a DBT skill] about 5 times today when I was out walking—it keeps my emotions under control, so I don’t start crying. I’m going to try [the]“mindful emotion” thing tomorrow. I appreciate [my health care organization] offering something like this—I like having concrete tools I can use.In terms of challenges, participants described difficulties in using their skills effectively while experiencing intense emotions. For example, one participant described:One inescapable problem I have found is that once the line that gets crossed where “there is no hope” of being able to turn around the anxiety, I have little ability to do anything constructive to stop the terror from escalating ... if I am not too “far gone” the skills do help to lower the physical and mental/emotional distress.In total, 92% (24/26) of the participants that consented had visited the landing page of DBT skills. These DBT skills site users logged in on an average of 5.3 times to the home page . We examined a subsample of those consenters to look at engagement in the specific DBT modules . Among the first 20 participants enrolled, 19 (95%) read the invite. Of these 19 participants, 12 (63%) visited the website and 8 (42%) agreed to participate. Of those who consented, participant engagement in the different skills ranged from 38% (3/8) for paced breathing to 88% (7/8) for opposite action .This pilot study demonstrated the feasibility, acceptability, and engagement of a population-based intervention involving active elements of caring messages and DBT. Specifically, we demonstrated that by using an accurate method for identifying those at risk for suicide and suicide attempt—in this case, PHQ item 9—we can adapt existing interventions to be suitable for delivery on a large scale and that these models are promising for intervention delivery.The number of patients who received the initial message that involved elements of caring messages was high 56/60, 93%). This provides support for the delivery of caring messages through this type of intervention (delivered over time through secure messaging with the support of a coach or care manager). The rate of patients who actually reached the DBT skills site content  indicates a need for strategies to reduce barriers to DBT skills site participation, such as simplifying the invitation and consent process for patients. The steepest drops were between viewing the message and visiting the consent page , and between visiting the consent page and consenting to the DBT skills intervention . This research, led by four health care systems within the Mental Health Research Network, is underway to determine its effectiveness . In thatThe videos that were developed as part of this project that make up most of the DBT skills content are publicly available to both the researchers and the public as one piece of NowMattersNow.org . Survey