With increasing numbers of people living with dementia relying on family to care for them at home, there is an urgent need for practical and evidence-based programs to support carers in maintaining their mental health and well-being. The objective of this study was to evaluate the acceptability and feasibility of a modified STrAtegies for RelaTives (START) program delivered online (START-online).A mixed-methods non-blinded evaluation of START-online (using Zoom as videoconferencing platform) for acceptability and feasibility  and quantitative evaluation. This occurred at the National Ageing Research Institute, in metropolitan Victoria, Australia.Twenty-nine eligible carers were referred, 20 (70%) consented to the study. Of these, 16 (80%) completed all 8 sessions, 2 completed only 3 sessions, and 2 withdrew. Carers’ qualitative feedback indicated that the therapist interaction was valued, content and online delivery of the program was acceptable. Feedback was mixed on the appropriate stage of caring.START-online was feasible and acceptable for carers, including those living outside of metropolitan areas who might otherwise be unable to access face-to-face programs. With the recent COVID-19 pandemic necessitating social distancing to avoid infection, interventions such as this one have increasing relevance in the provision of flexible services.The online version contains supplementary material available at 10.1186/s40814-022-00999-0. Only minimal testing was conducted in rural and remote settings.There remain some uncertainties regarding access to the required technology outside of metropolitan centres.What uncertainties existed regarding the feasibility?The START-online program was found to be acceptable to carers.n = 16/20) of recruited carers completed the program.80% , there is a corresponding increase in the number of informal carers required to support them to stay at home . InformaThe STrAtegies for RelaTives (START) program is a pragmatic, manual-based individual therapy program consisting of eight sessions over 8 months, aimed to provide improved coping strategies for carers of people with dementia, administered by psychology graduates without clinical qualifications . A blinded randomised-controlled trial (RCT) showed it to be a clinically and cost-effective program that improved total depressive and anxiety symptoms in carers of PLWD and quality of life, delivered face-to-face in the UK . These rThe primary aim of this study was to evaluate the acceptability and feasibility of the START-online program for carers in Australia in preparation for a future RCT. A mixed-methods unblinded before-and-after study design was conducted, drawing on Bowen’s approach to designing feasibility studies . A seconThe study was conducted at the National Ageing Research Institute (NARI), Victoria, Australia from March 2017 to August 2018.Carers were recruited from multiple sources including metropolitan and regional memory clinics, carer service providers, and support groups. To be eligible to participate in START-online, carers were aged 18 years or over, caring for a PLWD for at least 6 months, have a desktop computer, tablet or smartphone and able to communicate in English. Web cameras and dongles (mobile internet data) were provided if needed. While the availability of using an online platform meant that carers from metropolitan and regional Victoria could be involved in this study, recruitment was not specifically focused on carers living outside metropolitan cities.We developed START-online by adapting the START program for delivery in Australia using online videoconferencing. The START-online sessions were weekly and covered: education about dementia, behavioural and psychological symptoms of dementia (BPSD), and carer stress; discussion and problem-solving of challenging situations encountered by carers; planning for the future; and relaxation techniques Table . A projeEthics approval for the project was granted by Melbourne Health Human Research Ethics Committee (HREC/16/MH/133). Written informed consent was obtained from participants prior to commencing the program. Following consent, participants provided baseline data and were given the START-online manual. “Zoom”  was used as it was free for participants and easy to use. Project staff assisted with set-up of Zoom, and provided an explanation on its use either in-person or by telephone.START-online was delivered over eight 1-h weekly sessions by psychology graduates (4 years of tertiary study), who received training and weekly supervision by a registered clinical psychologist. In addition to weekly sessions, carers were encouraged to complete between-session tasks, including noting unhelpful thoughts and practicing relaxation techniques. The manual also included help sheets from Alzheimer’s Australia  and information on using Zoom. In order to review the consistency of the sessions and adherence to the protocol, a fidelity assessment was specifically developed for each session for the project Table  was condUpon conclusion of the program, carers completed outcome measures, an evaluation survey either in-person or over the phone with project staff, and were invited to participate in the evaluation focus groups. Invitations for the focus groups were sent via email, followed by two reminders and a follow-up telephone call. This resulted in eight carers participating in three focus groups also conducted via Zoom.A semi-structured focus group topic guide was developed by the research team based on program evaluation principles  with a fOutcome measures for the carers included the (i) Hospital Anxiety and Depression scale (HADS)  which meThe focus groups were audio recorded and transcribed verbatim. All data was exported for coding into QSR NVivo 12 qualitative data management software . Thematic analysis  was used for frequencies and descriptive statistics with non-parametric tests, such as Wilcoxon signed rank tests, used to compare pre- and post-intervention measures.n = 18 started, and n = 16 (80%) completed all eight sessions  to complete the program. While sessions were allocated on a weekly basis, these occurred when it suited the carer. A session was considered “delayed” when > 14 days had passed since the previous session. Delays occurred due to illness, caring responsibilities and work commitments.Fifty people were initially referred and forty-one were screened for eligibility. Twenty carers were enrolled, n = 12, 60%), were not in paid employment , were spouses of the person living with dementia , nominated English as their first language  and had completed secondary school . Their median age was 67.5 years . The carers nominated a median of 82 h per week caring . The majority were recruited from carer support groups (30%), community health services (20%), care providers (15%) and social media (15%). Most lived in metropolitan Melbourne , n = 3 (15%) lived in regional Victoria and n = 2 (10%) lived in regional centres interstate.The majority of carers who commenced the program were women , vascular dementia  and frontotemporal dementia . The median time since diagnosis was 3 years . In terms of dementia stage using the CDR, the majority of were rated as mild  or moderate  stages. Overall, their QOL-AD score was rated as fair-good and did not change over time.For the PLWD, the most common diagnoses were Alzheimer’s disease (n = 18) completed the survey. The responses (Table n = 14 (78%) agreement. Only n = 13 (72%) of participants regarded online access to be as good as in-person while n = 16 (89%) said that overall they were satisfied with the program. The questions relating to the benefit of the program to them as carers were less enthusiastically endorsed. Only n = 12 (67%) felt that START met their support needs. N = 12 (67%) felt it was suitable for the stage of dementia that the person they cared for was at. Nevertheless, overall n = 17 (94%) said they would recommend the program to other carers.All participants who started the program  and one carer participated in a one-to-one telephone interview.Four key themes emerged from the qualitative analysis: overall experience of the program (acceptability); experience of using Zoom (feasibility); perception of START-online in relation to the timing in their carer journey (demand); and carer needs met and not met by START-online program (acceptability and effectiveness).“I mean, I really loved the program, I liked just sort of knowing that there would be someone there every week.., so I found with the START program that was my one, I had to commit. Because you know, I had committed to somebody else, so I’m going to show up and set that one hour aside.” Participant 009, female caring for her mother“…the interaction with your therapist…they were very understanding. They weren’t abrupt, they weren’t misunderstanding. They were just pretty caring in the sense that they were easy to adapt to work with..” Participant 011, male caring for his wifeAll focus group participants enjoyed the program, and reported several benefits, but two also reported dissatisfaction with the content and structured approach. The importance of the interaction with the therapist, having a regular commitment with the therapist, and being able to discuss problems with a therapist who was empathetic and without judgement were reported by all carers.“…I think the main value was…two things, actually. Confirmation in part, of things that I was already doing or thinking, solutions that I was thinking up, so she was giving me confidence, perhaps, um and seemed interested in my thoughts on solving problems, and secondly .. she came up with some ideas which I hadn’t thought of! And I could add them to my repertoire, I think we had quite good discussions about how to approach certain problems.” Participant 022, female caring for her husband“ not only did I have the person, but it motivated me to try to do my part…because I can’t expect everything to come from the tutor (therapist).” Participant 016, female caring for her motherSome carers reported learning new strategies to help them in their caring role, and felt that the program empowered, motivated or reassured them. Carers described the perceived effectiveness of the intervention and discussed the use and intention to continue to use strategies learnt from the program.“So overall it was good but not dramatic”. Participant 012, male caring for his wife“It was a valuable opportunity but it missed the mark…the person delivering it tried hard..we weren’t able to come up with any ideas” Participant 007, male caring for his parentsHowever, two carers felt less positive about the program.“And whilst the relaxation was fantastic, it was literally the last sometimes maybe 2 minutes, sometimes 5 minutes… felt like it should have been a bit more of a main focus.” Participant 009, female caring for her motherMost carers in the focus group also reported aspects of the program that could be improved or described sections and content of the program that they wanted more focus on did not find relevant or useful for them. This highlighted the need for a more individualised approach.“Part of me, and our sessions often went over, and I think a reason for that is there was almost too much structure in the book.” Participant 003, male caring for his wifeI think it was becoming onerous and sometimes tiresome, like eight weeks didn’t come soon enough sometimes…some of the questions were repetitive.” Participant 019, male caring for his parent“Like say we get to a session where we’re addressing something and I’m already quite versed in that particular topic, really, I just want to be able to talk.” Participant 003, male caring for his wife“…there was a lot of repetition of what is dementia and having a run on a day centre giving lectures on dementia,… preaching to the converted.” Participant 021, female caring for her husbandSeveral carers discussed the burden, or perceived amount of effort required to participate in the program, in terms of having to go through the material in the manual, or sessions being too structured.“Oh, I was lucky, the Zoom worked perfectly well, I'm being a bit … slow to develop my computer skills, I found that part perfectly alright.” Participant 005, female caring for her mother“It didn’t start too well, if I remember we had communication problems with Zoom, but, completed it all.” Participant 022, female caring for her husbandThe use of the web-based delivery and interface was explored. Six carers reported positive experiences with the use of the videoconferencing, with all of those surveyed agreeing that being available online was a good way to access the program.“I can work a computer, and it takes less time. I don’t have to spend half an hour or an hour going into places and coming back again. Would cut down at least an hour and a half at least of my time..” Participant 016, female caring for her husband“Well, I did not have to go into town to attend an appointment. I can do it any time. I guess it was safe for both parties,. So from the point of convenience and safety I think and…. Transport needs as well time saving.. it was good.” Participant 019, male caring for his parentMost carers felt the convenience of being able to participate from their own home and saving on travel time made it an accessible program.“I suppose starting with the technology.. I found that fairly awkward ..it was quite disturbing to watch the screen. It was flickering and uh, shaking, and we tried many things to improve it, but without success. So, that side of it wasn't so good.” Participant 007, male caring for his parentsHowever, two carers discussed having technical difficulties.“Yeah I think if you were just starting out with caring, it would be a great resource to use. Because there are all sorts of traps that you fall into when you're just starting out.. This could short-circuit a lot of those sorts of traps.” Participant 007, male caring for his parents“Quite a lot of it is not terribly relevant, is it, once you’re that far down the track?” Participant 004, female caring for her motherSome participants felt that the START-online program would have been most appropriate for carers close to the time of the PLWD receiving the dementia diagnosis as well as the start of their caring journey.“I wouldn’t know, for anybody else’s story and how they’re handling the situation, … I asked for help because I feel like her personality’s changed a little bit.., ..I couldn’t comment on when anyone else would you know, best need that help, it’s just individual.” Participant 013, female caring for her motherParticipants in the focus groups also acknowledged that it was difficult to identify an ideal time to undertake START-online because caring situations and carer needs varied widely.rent rates over time..” Participant 003, male caring for his wife“…maybe a health advisor or health professional is in a better position to know when you might be needing it or something, rather than trying to target a particular period after onset when you think the program should be introduced, because people’s conditions obviously change at diffeOne suggestion was for carers to be screened to determine whether START-online was likely to be beneficial for their situation.“It’s more of having that lifeline, like you just become so isolated, you realise that my mum has two carers a day, she has people she does art with at night, I’m sending someone in that teaches her tech lessons, her world has as much support as could be put in place as possible, and then I’ll think, I’ve not seen anyone for a month.. , I am way more isolated than the actual care recipient. So in that sense I feel that’s why it’s really important, in fact I think it’s critical, carers have to have access to ongoing support based on, depending on what their needs are.” Participant 009, female caring for her mother“It needs the discussion and the reassurances that every carer wants all the time, I’m guessing, needs a human touch and support as well.” Participant 012, male caring for his wife“I think it would be really good if there was some sort of option to keep that going. To have some sort of ongoing contact, maybe just on a needs basis, you know, you could sort of send a message to him or her, and say, um, look I'm really struggling with this, could we have a short Zoom session on that or you know, something like that…. it was delivered over the eight weeks and then it was finished.” Participant 007, male caring for his parentsCarers discussed the isolation they often felt as well as not having the time to look after their own care needs because they prioritised the PLWD needs. Although the START-online program offered some support and strategies for carers, as mentioned above, several carers felt a more individualised approach would be preferable. Participants also expressed that the short-term nature of the program did not fully meet their needs and that they might want to access ongoing support throughout the carer journey.“Flexible times because I'm sure others are just as busy as I am. Could it be an ongoing support for carers?” Participant 005, female caring for her mother“Greater emphasis on carers getting the support they need.” Participant 007, male caring for his parents“Offer advocacy. More fluid approach to counselling and less constrained by manual… This could be done at baseline assessment to understand where carer's knowledge and use of services is to tailor the recommendations and strategies to them.” Participant 009, female caring for her mother.Similar comments were made in response to the question "How could we make START-online better?”Table This study aimed to investigate the acceptability and feasibility of an adaptation of the UK START program to carers in Australia delivered online via Zoom platform. START-online was found to be acceptable, with a high completion rate generally positive feedback about its structure and content—which was standardised and could be delivered consistently by supervised psychology graduates, with limited clinical training. The mode of delivery was also acceptable, with most carers indicating overall positive experiences with Zoom, with some appreciating the practicality of not having to travel, despite some technical difficulties. This suggests that further implementation is feasible. The survey results suggest that carers felt START-online was generalisable and needed, with 97% saying they would recommend the program to other carers. The role of the therapist in delivering START-online was considered important by carers, rather than as an “app” or a web-based program. However, improved screening for inclusion is required, as START-online may be more appropriate for those in the early stages for caring, which might negatively affect feasibility and implementation. In terms of the methodology and quantitative measures used, these appeared feasible, as all carers who finished START-online completed all the measures.Most participants were positive about their experience with START-online, with comments about it “being a lifeline” and therapists being caring. There were also some consistent suggestions for how it could be improved. The program was adapted to better suit carers living in Australia, including modification of the language  and information regarding services, This may have meant that it “lost” some aspects as it as in the same language (English). For example, one carer thought relaxation should come earlier in the program and did not appear to know the program was designed for them to use relaxation between sessions and participants were given the recordings to facilitate this.Some focus group participants suggested that START-online would have been more relevant to them at the early stages of dementia. Sixty-seven percent of those surveyed reported that START-online was at the appropriate stage; however, it is not known which stage this was for the carers who endorsed this response—hence, it remains unclear which stage of caring START-online would be best for. This is unlike the original UK START where most of the carers included were at the early stage of caring. START-online could be offered as a series of modules, rather than an 8-session package, with carers given a choice about the modules that they take, which might enhance acceptability.This study demonstrated that most participants could use the online platform, Zoom, although some had technical difficulties. Although using an online platform meant that both metropolitan and regional carers were potential participants, only 25% of our recruited carers lived outside a metropolitan area. This was primarily due to limited familiarity with Zoom at the time of recruitment (2017–2018) and the need for project staff to assist setting up the software for the participants face-to face. Accordingly, we had to restrict the geographical reach to areas where it was feasible for our project staff to travel. However, people are now more familiar with online platforms due to the COVID-19 pandemic, there is increased potential for reach into rural and remote areas. Regardless of location, participants in this study described START-online as appealing due to the flexibility of access, ease of use, and limited travel required. Having a therapist was deemed particularly valued and moving forwards, the option of having Zoom or face-to-face START, might also improve acceptability. The therapists’ perspectives on this program based in New South Wales are currently under review, by Walter et al. (2022).START-online showed limited differences in quantitative measures, though it was not sufficiently powered to do so. Specifically, there were no reductions in total depression and anxiety. In the UK START study there were reductions, but the control group worsened. In our group of carers, following the end of START-online, there was decreased dysfunctional coping and reduced potentially abusive behaviour. There were significant reductions in potentially abusive behaviour also found in the UK START study in both intervention and control groups , and theSTART-online was, as is the nature of feasibility studies, not designed to be powered for efficacy. In addition, only 8 of the carers who completed the program participated in the focus groups, limiting the generalisability of the qualitative results, as we did not interview the carers who did not complete the program and hence do know what they thought of the program and the detailed reasons why they did not finish it.The COVID-19 pandemic, which occurred after this project concluded, has amplified the need for online delivery of services and support for carers. Given the need to provide accessible and effective treatments for socially isolated carers of people living with dementia, particularly in the post-pandemic era, further examination of the START-online program is warranted. A RCT, with a sufficiently powered sample size using a modified START-online program, including adjustments to make it more acceptable to carers, is needed to determine effectiveness. Further research might also involve carers of people with younger-onset dementia, as they might find the flexible approach of START-online relevant and beneficial.While this pilot study was limited by a small sample and heterogeneity in the disease stage of the PLWD, the findings suggest that START-online was acceptable to, and may improve coping for carers, including those living outside of metropolitan cities who might otherwise be unable to access face-to-face programs. With the recent COVID-19 pandemic necessitating social distancing to avoid infection, interventions such as this one have increasing relevance in the provision of flexible services.Additional file 1.Additional file 2.Additional file 3.


Although the potential impact of food fortification to improve the micronutrient status of populations has been demonstrated beyond a doubt, it is constrained in practice by critical gaps in program design and implementation. These are partly linked to suboptimal decision making.We aimed to demonstrate how the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision (EtD) framework for health system and public health decisions can be applied to formulate recommendations and make decisions in national food fortification programming.Following a program impact pathway, we reviewed the literature to define the key decision types and identify the corresponding decision makers necessary for designing and implementing effective food fortification programs. We then applied the GRADE EtD framework to the Nigerian fortification program to illustrate how evidence-informed assessments and conclusions can be made.1) program initiation; 2) program design; 3) program delivery; 4) program impact; and 5) program continuation. Policymakers, food processors, and  development partners are the main decision makers in a fortification program, whereas technical partners play important roles in translating evidence into contextualized recommendations. The availability and certainty of evidence for fortification programs are often low  yet decisions must still be made, underscoring the importance of using available evidence. Furthermore, when making program initiation and continuation decisions, coordination with overlapping micronutrient interventions is needed where they coexist.Fortification program decisions were classified into 5 types: This framework is a practical tool to strengthen decision-making processes in fortification programs. Using evidence in a systematic and transparent way for decision making can improve fortification program design, delivery, and ultimately health impacts. This article demonstrates how a decision-making framework for health system and public health decisions can be applied to national food fortification programs. Although the potential impact of food fortification to improve the micronutrient status of populations has been demonstrated beyond a doubt , there aThese design and implementation challenges can be partly linked to suboptimal decision making. Results from fortification coverage surveys of edible oil, wheat flour, and maize flour in 8 countries identified 2 primary issues related to low coverage . First, Although part of the problem is the limited availability of evidence to inform program decisions , a more In this article, we demonstrate how a decision-making framework for health system and public health decisions can be applied to formulate recommendations and make decisions in national large-scale food fortification programs and illustrate the process using a real-world example from Nigeria.Following the program impact pathway (PIP) for large-scale food fortification as put forth by Martorell et al. , we revi1) formulating the question; 2) making an informed assessment; and 3) drawing conclusions. In the first step, a general description of the problem and the question details are defined . In the second step, data sources are identified, specific criteria are assessed , and a judgment for each criterion is made  Evidence to Decision (EtD) framework for health system and public health decisions  based on is made . In the https://ietd.epistemonikos.org). The completed EtD framework was then reviewed and interpreted by a panel comprised of the authors and a small group of stakeholders from governmental organizations involved in Nigeria's national food fortification program in a virtual workshop, followed by email communications to provide further detail and assessments. This was not a full panel of all relevant stakeholders in Nigeria, however, because that was beyond the scope of the current work; therefore, judgments and conclusions are our own. The methods deployed in this study primarily involved a narrative review of the literature, coupled with an analysis of data extracted from published articles. As such, they did not meet the definition of research with human subjects and, consequently, were not submitted for ethical review.We applied the GRADE EtD framework to a real-world example, namely a recommendation regarding modifying the design of the large-scale food fortification program in Nigeria to reduce the risk of excessive vitamin A intakes, using the interactive EtD tool template for health system and public health decisions (1) program initiation; 2) program design; 3) program delivery; 4) program impact; and 5) program continuation  and food processors are the main decision makers in a fortification program . PolicymSupplemental File 1, the question was formulated as, “Should the design of Nigeria's large-scale food fortification program, which aims to reduce vitamin A deficiency, be modified to reduce the risk of excessive vitamin A intakes?” . The problem was defined as a goal of reducing vitamin A deficiency in Nigeria through large-scale food fortification without exceeding the tolerable upper intake level (UL) for vitamin A intake in any subgroup of the population. The option considered in the framework was to modify the design of the fortification program by updating the selection of foods to be fortified with vitamin A and/or amounts of vitamin A to be added based on recent data on population need and consumption patterns. The comparison was to continue implementation of the fortification program as currently mandated [i.e., fortification of oil; sugar; and wheat, semolina, and maize flours with vitamin A as per current national standards  and 13% of mothers and 19% of pregnant women were at risk of vitamin A deficiency (<30 µg/dL), of whom 4% and 9%, respectively, were deficient (<20 µg/dL) . UnfortuThe panel determined that the desirable effects of modifying the design of the fortification program by updating the selection of foods to fortify with vitamin A and/or amounts of vitamin A to be added are moderate, the undesirable effects are trivial, and the overall certainty of effects is very low. There were no studies comparing the option with the comparison; however, there were relevant findings from 1 cross-sectional subnational study that reported apparent vitamin A intakes from fortified foods alone based on actual consumption patterns . In thatCosts incurred by food processors related to the fortification process and by government ministries related to monitoring the compliance of fortified foods with national standards must be considered along with costs required to implement other overlapping vitamin A interventions. Cost-effectiveness studies for the Nigeria fortification program specifically have not yet been done and the cumulative costs of all ongoing vitamin A interventions are unknown. However, it is assumed that if modifying the design of the fortification program by updating the selection of foods to fortify with vitamin A in Nigeria leads to fewer foods required to be fortified, then there would likely be some cost savings for both food processors and government ministries. Conversely, if new food vehicles are added, there may be additional costs. Optimizing the set of vitamin A interventions that can be effectively implemented in Nigeria to achieve the greatest impact would likely reduce cost inefficiencies of running multiple programs with low fidelity (compliance). Based on this, the panel's judgment was that, although there may be potential for moderate savings, they do not know the resources required nor the cost-effectiveness of the option as opposed to the comparison.There is evidence from 2 cross-sectional surveys in 4 out of the 36 states of Nigeria  that the coverage of the fortifiable foods currently mandated to be fortified with vitamin A is generally lower in vulnerable households, specifically those that are at risk of poverty , have low socioeconomic status , and have low dietary diversity (women's dietary diversity score <5 out of 10 food groups the previous day) , 28. SimFortification of staple foods in Nigeria is assumed to be generally accepted by the population because it neither changes the characteristics of the food nor requires any changes to consumption patterns, but no published studies are available to confirm this. Other key stakeholders, including policymakers, food processors, and development partners, have publicly demonstrated their support for the national fortification program in its current form while recognizing the need for improvements if reductions in micronutrient deficiencies are to be realized . TherefoModifying the design of the fortification program by updating the selection of foods to fortify with vitamin A and/or amounts of vitamin A to add would require recent population data on vitamin A intakes and consumption patterns of fortifiable foods. In addition, recent data on vitamin A status would be ideal to serve as a new baseline against which to evaluate program impact in the future. These data are forthcoming as part of the 2021 National Food Consumption and Micronutrient Survey (data are expected to be available in 2022). Technical support and related funding to analyze the new data and propose specific program design changes would also be needed, which may be potential barriers in Nigeria. Once redesigned, fortification standards would need to be updated along with any necessary policy and legislative changes, which would require government buy-in and may be a possible barrier if stakeholders are not accepting of the option or processes are lengthy. Beyond that, the option would be delivered through the existing fortification program structures and thus as likely to succeed as the comparison . Based on this, the panel's judgment was that modifying the design of the fortification program to reduce the risk of excessive vitamin A intakes by updating the selection of foods and/or amounts of vitamin A is probably feasible.The panel made a conditional recommendation for modifying the design of Nigeria's fortification program to reduce the risk of excessive vitamin A intakes by updating the selection of foods to be fortified with vitamin A and/or amounts of vitamin A to be added based on recent data on population need and consumption patterns  examining the option in opposition to the comparison are neither feasible nor necessary to undertake in the context of a national population-based program for which efficacy of the intervention has already been demonstrated in such studies, as is the case for vitamin A fortification.The modifications should be based on the demonstrated vitamin A needs and consumption patterns of fortifiable foods among different subpopulation groups  following global guidance on designing fortification programs and using data that are forthcoming from the 2021 National Food Consumption and Micronutrient Survey.Implementation of this recommendation should be subject to ongoing monitoring to ensure high-quality implementation according to its design, including:compliance monitoring at import, production, and market levels with effective enforcement measures as relevant; andcoverage and consumption monitoring at household and individual levels as relevant.Monitoring of vitamin A intakes from fortified foods must be coordinated with that from other interventions that similarly aim to increase vitamin A intakes to ensure that the total vitamin A intake in the diet is considered when reviewing risks of excessive intakes.In this article, we prepared the GRADE EtD framework for health system and public health decisions for a real-world example regarding a recommendation for modifying the design of the large-scale food fortification program in Nigeria to reduce the risk of excessive vitamin A intakes. The Nigeria example demonstrated the utility of the EtD framework to help policymakers guide and strengthen fortification program decision-making processes to ensure they are systematic, structured, and transparent. In addition, it highlighted the flexibility of its use because it does not require significant resources to populate and is still effective even when evidence is lacking, given the aim is simply to document the evidence (or lack of) that was used to make judgments.Using an EtD framework alongside a PIP can help improve decision making in national food fortification programs. By defining the main fortification program decisions and mapping them to the PIP, the fortification program cycle is explicitly articulated and the end goal to be reached at each stage is clarified. This understanding is an important first step in strengthening decision-making processes because although fortification programs are intended to serve as medium- to long-term interventions to address micronutrient deficiencies  , in realThe Nigeria example in this article illuminates several key findings regarding fortification program decision making that are relevant across countries, as follows.The availability and certainty of evidence for population-based public health interventions, such as fortification, are often low or very low, yet decisions must still be made, underscoring the importance of using the best available evidence . For decFortification program decisions do not always occur in a linear process as shown in the PIP. Whereas at the onset of a program decisions are likely to proceed in order , evidence at delivery and impact stages may trigger the need to revisit previous program decisions downstream in the PIP. This was the case in the Nigeria example, where evidence from a study examining the potential for program impact triggered the need to consider a program design decision because it estimated a high risk of excessive vitamin A intakes if the program were implemented as currently designed, but with greater fidelity (compliance). Regular assessments of the quality of implementation and initial design assumptions (particularly as they relate to micronutrient needs and consumption patterns of fortifiable foods) are essential as part of monitoring a fortification program throughout the program life cycle . AlthougFortification decisions related to program initiation, design, and continuation should be made in coordination with those (decisions) that pertain to other complementary micronutrient deficiency control interventions where they coexist. Ideally, decisions on what set of programs should be implemented in a country should be made jointly by all stakeholders involved in micronutrient deficiency control interventions and optimized to maximize impact and cost-effectiveness while ensuring safety over time. However, currently these interventions are often initiated and implemented independently by different national and/or international stakeholders  and therThere are some limitations to this article and the use of the GRADE EtD framework for fortification program decision making. First, the example framework was populated by the authors and a small group of stakeholders but did not include a full panel of all relevant stakeholders in Nigeria ; therefore, the recommendation may not reflect all perspectives. An important next step would be to conduct a validation workshop with a wider and more diverse range of fortification stakeholders in Nigeria to review and revise the framework and recommendation. Second, the Nigeria example framework completed in this article was for a design decision, which is only 1 of the 5 main decision types relevant to food fortification programs. Future work should explore testing this framework for other fortification decision types at different stages of the PIP as well as in programs carried out in different contexts. Third, there are other factors beyond evidence that influence decision making in national programs  . AlthougThe GRADE EtD framework is a practical tool that can be used by stakeholders in national food fortification programs to facilitate and document the use of evidence to inform decisions to start, strengthen, and sustain food fortification programs. Using evidence for decision making in a systematic and transparent way can improve fortification program design, delivery, and ultimately health impacts while reducing risks associated with excess micronutrient intakes.nzac010_Supplemental_FileClick here for additional data file.


Intergenerational programs have long been identified as a way of promoting health and well-being for participants. Continuing such programs during pandemic restrictions is challenging and requires a novel approach. This community case study describes the use of co-design to create a high-level intergenerational program model, adapt it to specific community needs, and deliver it virtually with the aid of modern communication technology. Interviews conducted after the program had finished indicated that despite the challenges and limitations of the virtual environment, meaningful connections were achieved across three generations. The high-level program model may serve as a basis for other programs wanting to explore this area. The existence and benefits of non-familial intergenerational programs for children and older adults are well-established –4. EmergReported benefits for children include supporting them to develop a positive attitude to and more knowledge of aging , 9, skilQuality outcomes in intergenerational programs are achieved when implementation is theoretically sound and evidence based, and the high level of logistical, staffing and curricular work or training is addressed , 10. EviOne form of service delivery involves the co-location of pre-school children and vulnerable seniors in fully integrated shared site intergenerational programs (SSIPs) to meet the diverse needs of families without duplication of services . The SSIUsing technology as a mode for delivering health programs is also well-established with telehealth being in existence for almost 60 years . HoweverThis community case study reports on a pilot project using virtual conferencing to deliver a structured, co-designed intergenerational program with children located in an inner-city childcare center and residents of a suburban aged care facility.The Australian Government's Aging in Place policy has changed the way services are provided to its older citizens. Of the 1.3 million consumers of aged care services in 2019–2020, only one third were living in residential care  with theThe intergenerational program, which is the focus of this report, took place in Adelaide, South Australia, a city of 1.3 million, in an inner-city childcare center and a suburban aged care facility located 10 km away. This project fits in the context of South Australia's Plan For Aging Well 2020–25 , which iThe intergenerational program was the product of co-design between the aged care provider, university staff and students, childcare staff and aged care residents and had six phases: scoping, planning, co-design, pilot, evaluation, and reporting.Co-design, also referred to as participatory design , 19, is Older adults, living in residential care, and young children are both vulnerable groups. Bringing two vulnerable groups physically together can be logistically complex and was made more difficult by the COVID-19 pandemic. The safety of both groups needed to be ensured and appropriate compliance checks needed to be in place. Although the intergenerational program was originally planned for delivery face-to-face, COVID-19 restrictions throughout 2020 and much of 2021 excluded young children from visiting aged care facilities and so a virtual program was designed instead.The co-design phase was conducted between August and December 2020 and aimed to involve all stakeholders in the development of a high-level program model. It was conceived as a three-level exercise starting from broad principles and concluding with the test of actual locally responsive intergenerational activities designed in partnership with participants. In this phase, aged care residents, staff, children and their families and occupational therapy students were consulted in depth regarding their interest in an intergenerational program, their hopes and any concerns that they might have. These were incorporated into the original design with the key objectives of increasing social connectedness for both older people and young children. The project also aimed to explore and develop new opportunities for older people to actively shape services that support aging well.Following this, the key stakeholders developed a broad program model that was feasible within the restrictions but also contained flexibility and ensured the needs of both children and aged care residents were represented. The basic structure of the model consisted of re-occurring “book-ends” to start and finish each session, a warm-up and a main activity. Staff with experience working in aged care and childcare proposed basic themes such as gardening, cooking, travel, going to the beach, which served as a starting point for customization with the participants see .At the beginning of the pilot phase, two occupational therapy students took the basic structure and brought the ideas of the program to residents. The students spent time with the residents building relationships and explaining what would be involved. Of the fifteen people identified as possible participants, ten chose to participate and either they or their next of kin signed consent forms. Possible participants were identified by the aged care facility's lifestyle coordinator. Residents with behaviors of concern were excluded from the program. As this was a health promotion project, diagnoses were not recorded nor relevant. The common reason for participation was a desire to interact with children as many residents had grandchildren they did not see often. Residents also participated because they wanted to engage with other like-minded residents. Reasons given for parents enrolling their children in the program included their child not having grandparents and wanting to develop their child's connection to the wider community.via informal conversation and via play with the children. The student facilitators spent one morning a week interacting with the children, and one morning a week interacting with the residents. The interactions allowed the facilitators to develop a relationship with the children and residents, and to learn about them as individuals. Further, the interactions guided the themes and activities of the weekly sessions, as they were based on the information gained from discussions and feedback from the participants. Ultimately, the interactions ensured the weekly sessions were client-centered, and based on tailored activities, interests, and themes. Following the program design, the pilot intergenerational program was run as described below.The two occupational therapy students, in partnership with staff of all three organizations involved, spent 3 weeks adapting the broad model program to the specific needs and interests of those who enrolled in the pilot. This involved fine-tuning all the proposed activities and overcoming logistic and coordination problems, including how to best introduce participants to the technology. This included repeated interactions with the aged care residents via Zoom Cloud Meetings from their childcare center, supported by their teachers and one occupational therapy student. The aged care residents met in the facility's clubrooms which had a large drop-down screen for the projection of the Zoom connection. They were supported each week by an occupational therapy student and university supervisor, the aged care facility lifestyle coordinator and a volunteer.The final program consisted of a 45-min session held once a week for 5 weeks. Children participated Older adult participants ranged in age from 77– 94 years and the children were aged between 3–5 years. Each session followed the same pattern, starting with a welcome song (“Wheels on the bus”), themed activities, a refreshment, time to chat and then a goodbye song (“You are my sunshine”). An additional component was added to the broad model developed in the planning phase. Due to concerns regarding establishing relationships and connections being minimized on a virtual platform, a sharing component was added to the plan to assist with individual interactions, knowledge sharing and relationship development.In addition to the weekly Zoom session between the residents and children, an extra session was run with just the children a day prior to the intergenerational program. These sessions supported the children's ability to participate in the virtual sessions and were shorter but had the same theme with a different activity. The additional session allowed time to familiarize the children with the Zoom sessions and assisted with developing relationships with the children. The children sang the same “book-ends” and the facilitators discussed the weekly theme with the children and their “Grandfriends” . 1 The cTime was spent interacting and establishing relationships with the participants to guide the themes used within the pilot. Interactive activities were chosen based on participants' interests, while ensuring the activities enabled inclusion of everyone involved and appropriateness for both generations. Themes included “Getting to Know You, Rhythm, Gardening, Farms, and Easter,” as participants shared an interest in music and gardening, some residents had lived on farms and the children enjoyed farm animals, and Easter brought about mutual excitement among the participants. The participants' culture was considered in session planning, and the sessions provided them with the opportunity to share their culture (particularly within the Easter session), which supported knowledge sharing, learning and connection. At the conclusion of the pilot program, interviews were conducted with adult participants to involve them in the evaluation of the project and to gain an in-depth understanding of their perspectives. Six residents agreed to be interviewed and two staff members see . InterviFive key themes were identified from the interviews with participants and staff. These themes included: “connection, skilled facilitators, exploration of past and present roles, a wish for continuity, and online challenges.”Findings are evidenced by quotes in text, pseudonyms are used to differentiate between participants, and different groups are identified by abbreviations R (resident) and S (Staff).The residents spoke of the connection they were able to develop with the children, even though the connection was developed and maintained over a virtual platform.I think the painting and that sort of thing was the best part… they were participating, and we were participating”. This was also reflected through Flynn's statement “there is a purpose and activity and that's what they come for” (S).This connection was fostered through the use of shared occupation and experiences — which was reflected in the interview with Vera (R) “I shall treasure this because I can't believe the note” . In this statement Ruby was referring to a touching note from a child that expressed feelings of care and love toward her.When discussing highlights of the group three of the five residents spoke of the shared occupations where the children completed part of the task  and the resident finished the task . The children also made cards for the residents for Easter which were mentioned in the interviews “they gelled with us…they wanted to see us again…they wrote notes to us”. The residents also reflected on the level of connection with the younger people and the “genuine” nature of this connection. This sentiment was reflected by the children who embraced the title of “Grandfriends.” The use of this terminology demonstrated a “language of connecting with older people” [Roger(S)].The connection formed between the participants was emphasized by Eileen (R), “contact between [old and young] is very important in all walks of life, from when you start walking” — Peggy (R), and “I think everybody was really impressed, old and young” Eileen (R). In fact, one of the older participants referred to the “adults” (facilitators) as being separate from the main group. This observation was supported through a staff member identifying that the “third generation [the student facilitators]” were important in bridging the age gap.The sense of connection was strengthened through the self-identified grouping of the younger and older generations to the exclusion of the facilitators' (who were not part of either generation). Based on the interviews it appeared there was an “us and them” mentality with the older adults and children being “us” and the facilitators being “them”. This exclusive clique was reflected through the interviews; “A key theme that was identified was the skill of the facilitators in running the group and managing the technology, group dynamics and the children's engagement.The areas that were commended were the facilitators' use of shared activities, adapting to an online environment and supporting the children to stay engaged.I did not think we'd be able to do a group with another group at the other end, but they made it work really well” [Flynn (S)] and “whoever you are, to generate energy through a screen, to connect people, it is almost impossible to do” [Roger (S)].In particular, their ability to adapt to technology was mentioned by participants and staff, “the control she had over those children for their ages… it was amazing”  and “She had the class right under her [control]” .The residents all identified being surprised and impressed by the children's levels of engagement and the role of the facilitators in enabling this, “I thought it was very good the way it was done” (R.), this was supported by Ruby (R.) who identified that despite the need to run the group online “everything else flowed so well.”In terms of the program itself, the residents identified that the group had run well, and this was confirmed with examples of activities completed. One participant, Vera stated “Each of the residents described their interaction with the group and the children through the lens of their own experience. This often led to an unprompted exploration of roles they had previously held in their families and/or the workplace. These roles were celebrated with a sense of achievement and pride.It may have been that I have had a bit of training in that area” . Another spoke of her role as a mother “I've been with children a lot, with six of our own”  and one shared his experience as a grandfather raising his grandson. Those who had less experience with children spoke of their upbringing and exposure to older adults when they themselves were a child “I had a lot of contact with older people and that was, I don't know, just part of life” .For example, one participant reminisced on her previous experiences as a teacher and saw a relationship between this and her ability to easily engage with the children: “I wonder what memories the kids will have.” This finding portrayed the theme of hope for the future and a desire to be engaged in that future “That's why I want to stick around for a few years, because I want to see what's going to happen” .Participants were also able to be future focused, thinking about the children's future and the future of technology, and the modern world. Bob (R) shared a sense of wonderment at the children's future; “I think it should keep going” , “I did enjoy it very much actually”  “I was sorry when it finished” .All participants and staff expressed their enjoyment in the program and a wish for the program to continue, but this theme was most strongly shared by all the residents. “Some of the residents reported in the interviews that the group was still being raised for discussion in their communal dining room. Many residents also reported that the timeframe (5 weeks) went very quickly, and they were “saddened” when the program was due to end.Despite the positive outcomes and enjoyments of participants — both staff and residents expressed a desire for the program to run face to face — whilst acknowledging the merits of technology to enable it to happen during COVID-19 limitations.I think we had our reservations about it being virtual”- Flynn (S) and their hopes that it could have been run in person “We were hoping for these sessions to be face to face” – Roger (S).In particular the staff reported disappointment at the program needing to move online “It is a shame they couldn't come here- but never mind” . Residents were also surprised at the children's adaptability to the use of technology. When speaking about the use of technology, one resident discussed the children's ability to adapt to it “[that was] the way that it worked, and they accepted it” .Although the staff identified challenges with being online — the residents reported that the program ran well-despite the modifications, “This project tested an intergenerational program conducted virtually. Initially the project was anticipated to run face to face — however changes in COVID-19 restrictions forced the group into an online environment. To the best of our knowledge, this is the first study to report on the use of technology and occupation to facilitate the development of these connections.Despite concerns that this shift would limit engagement and connection, the project was a success and this outcome opens up the potential for more diverse and innovative approaches to intergenerational connection.Based on the interviews with the participants, it was evident that a bond was able to be formed between the children and older adults over the course of the project. The children readily adopted the term “grandfriends” indicating a special relationship built on pillars of friendship rather than service delivery, obligation, or family ties. The importance of friendship for older people in terms of physical, social and mental well-being is well known  and therAnalysis of the interviews suggested that this bond was enabled through the use of shared occupations and enhanced through a shared commonality: vulnerability.The use of meaningful occupation to enable engagement, participation and well-being forms the foundation of occupational therapy . SharingIntergenerational programs can facilitate connection even when conducted virtually. This innovative program demonstrated that while face to face is preferred, virtual interaction can still support a sense of belonging across generations. There was a unanimous response from residents and staff that the program should continue. It created meaning and connection and was a source of joy. More resources may be needed to deal with the technological challenges or ongoing technical advancements and the quality of the programming relies on careful attention to co-design and evaluation.This was a pilot program conducted over 5 weeks with two vulnerable populations, aged care residents and very young children. This placed constraints on what outcome measures could be used and who could be interviewed. Not all residents were able to be interviewed due to limited verbal capacity. The findings of this project cannot be generalized to all aged care facilities however, they do provide a starting point and initial evidence on which longer and more in-depth projects can be based.The raw data supporting the conclusions of this article will be made available by the authors, without unduereservation.The studies involving human participants were reviewed and approved by University of South Australia's Human Research Ethics Committee. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin.AK-B: led the ethics application, supervised delivery of program, conducted all interviews, and co-wrote the manuscript. ER: led the Child Care in Aged Care project and contributed to the manuscript. SM-R: contributed to the development of the research protocol, data analysis, and manuscript. AB: contributed conceptually to the project and contributed the manuscript. AH and HB: facilitated the program and contributed to the manuscript. KB: contributed to the development of the research protocol and data analysis. DA and BJ: contributed conceptually to the co-design and delivery of the program. CM: contributed the development of the research protocol, the co-design process, data analysis, and manuscript. All authors contributed to the article and approved the submitted version.The Child Care in Aged Care project was supported by Office for Aging Well, SA Health , through a Strategic Projects Grant. The University of South Australia provided in-kind support.ER and DA are employed by ACH Group. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Meanwhile, the average self-efficacy score was 3.35 ± 0.57 before the program and 3.90 ± 0.60 after . Further, the average handover performance competency was 1.75 ± 0.25 before the program and 2.37 ± 0.21 after . The simulation-based handover education intervention was effective in improving knowledge, self-efficacy, and performance competency of nursing students. This intervention can provide an effective method of improving nursing students’ handover skills prior to entering clinical practice.Nursing handover facilitates the continuity of nursing and ensures patient safety and quality of care. This study aimed to evaluate the effectiveness of a handover education program by assessing handover knowledge, self-efficacy, and handover performance competency. A group pretest–post-test quasi-experimental design was used. Thirty 4th-year Korean nursing students participated in a handover education program comprising a lecture and simulation training using a high-fidelity simulator. The average level of handover knowledge was 4.63 ± 1.61 before the program and 5.83 ± 0.95 after (t = −3.71,  Handover is a communication process among nurses that involves conveying patient information and is important in ensuring quality and continuity of nursing care ,2. AccurDuring handover, team members inspect patients’ treatment plans and reorganize the nursing diagnoses . HandoveThis can be accomplished with simulation-based programs, which allow students to experience the problem-solving process while gaining theoretical knowledge. It also helps them practice in a realistic setting, thereby improving their communication skills and self-efficacy . FurtherHandover is not merely the delivery of information about the assessment of a patient’s condition, but a dynamic and complex task that includes clinical judgment and evaluation of the patient’s condition . For nurThis study used a one-group pretest–post-test design to develop and implement a simulation-based handover education program and verify its effects.This study was conducted on senior students attending a nursing college in Korea, who showed interest in simulation-based handover education after listening to the objectives of the study and voluntarily agreeing to participate. Sample size was calculated using G*Power 3.1.9.2 , and theTo develop a handover education program and verify its effects, this study recruited research participants after obtaining permission from one of the colleges of nursing in Korea. Data were collected from 15 February to 2 March 2018.Handover knowledge was measured using a tool designed based on the Korean Nurses Association’s refresher training “Integrative Application of the Situation Background Assessment Recommendation (SBAR) Communication Method”  and a prSelf-efficacy was measured using a self-administered questionnaire developed by Sherer et al. , modifieHandover performance competency was measured using the Patient, Assessment, Situation, Safety concerns, Background, Action, Recommendation method (PASS-BAR) from previous research  that stuThe simulation-based handover education program comprised five steps: analysis, design, development, implementation, and evaluation based on the Analysis, Design, Development, Implementation, and Evaluation (ADDIE) model , a typicA survey on educational needs was conducted on 40 senior nursing students at S University. Nearly 72.2% of the students considered handover “very important” in nursing practice, while 19.4% said it is “important”. Further, ~55.6% responded that the program is “highly necessary”, while 33.3% responded that it is “necessary.” All the students (100%) claimed that they had no educational experience in handover. Simulation training was the most highly rated method, with 56.6% saying it was the best “method of education” to improve handover performance. Handover based on changes in the patient’s condition, as the “area most requiring” a handover program, was rated highest at 75%, while the “appropriate time for the program” was in the senior year, according to 52.8% of the students.For an enhanced sense of realism in the general ward, research was conducted in the simulation-center training room of S University in Gyeonggi. Based on the scenario, the venue was equipped with a high-fidelity simulator  as well as audio and video devices to implement a real-life scenario. The handover took place in the nurses’ station.Nursing handover was conducted for a patient with respiratory problems. This was done based on the results of analyzing participants’ educational needs, and the specific goals of the learning were divided into knowledge, skills, and attitude.To evaluate the effects of the simulation-based handover education program, handover knowledge and self-efficacy before and after the education program were evaluated by the subjects themselves through a self-administered questionnaire. Handover performance competency was evaluated by the researcher before and after the education program.Two scenarios involving patients with respiratory problems were developed using the high-fidelity simulator. Scenarios I and II were developed with reference to an actual clinical case to implement the handover situation, according to the changes in the patients’ conditions, and were used in the evaluation before and after education. The same algorithm was used to maintain a consistent level of difficulty in the scenarios. Moreover, an overview of the situation, guidelines, and debriefing plans for the students were developed, as well as an outline of the cases and a checklist for the professors.The contents of the scenarios were inspected by two nursing professors and three clinical nurses with at least 10 years of experience, to determine whether they were realistic and could be seen in a real clinical situation. There were additional requests in the verification process of Scenario I, such as administration of antihypertensive drugs (+) and findings of Computed Tomography. There was also additional advice on allergies (+) in the verification process for Scenario II, which was revised and inspected a second time before ultimately being used in the program.To identify and resolve issues before implementing the simulation-based handover education program, and to check the scenarios’ suitability and running time, supplies for preparation, and unexpected problems, a pilot test was conducted with two nursing students who did not participate in the research.The handover education program was implemented from 19 February to 2 March 2018, over 8 sessions, with 120 min of education per student. Students were divided into groups of 3–4 for 120-min sessions that consisted of 50 min of theoretical education and 70 min of simulation-based education.Theoretical education on handover included its definition and importance, practical standards and guidelines, current status, contents, and methods of handover. The importance was explained by presenting cases of inappropriate handovers, and methods were explained by the order and items involved in handover. A PowerPoint presentation was used, and an open discussion followed.The scenarios were run one by one in the simulation-based component of the program, consisting of pre-briefing and running the simulation. During the pre-briefing, the participants learned the order of the simulation, setting, supplies for preparation, and the starting conditions of the scenarios. They were then given enough time to familiarize themselves with the environment and check the location and use of supplies. The participants listened to the researcher’s explanation about the contents and beginning of the scenarios, then experienced the high-fidelity simulator. A nurse with 10 years of experience, who was trained with simulation-based education, played the doctor’s role and served as the operator. The nursing students assessed the patients according to the changes in their condition and communicated with the doctor by delivering an oral report over the phone. They then performed nursing care according to these changes, and determined and combined the contents of handover in the evaluation step of the nursing process. The receiver of the handover was an experienced nurse in the next shift. After completing the simulation, the students participated in a 40 min debriefing in 3–4 people per group. Debriefing was conducted by designing questions for the description, analysis, and application phases, as presented by Fanning and Gaba . In the Evaluation was performed the same way as the pre-evaluation to verify the effects of the simulation-based handover education program.Ethical approval was obtained from the Institutional Review Board (IRB File No: 1041078-201712-HR-243-01) prior to conducting this study. Nursing students expressing an interest in participating were informed about the study by the lead researcher, and written consent was obtained for participation.t-test.All statistical analyses were performed using SPSS version 22.0 . Descriptive statistical analysis was used to classify participants’ general characteristics. Handover knowledge, self-efficacy, and handover performance competency of participants, before and after participating in the simulation-based handover education program, were analyzed using a paired The average age of the participants was 22.17 years, and all 30 of them were female. The students required 90 h of clinical practice per subject; 25 (83.3%) participants had clinical practice experience in 4–6 subjects and 5 (16.7%) had clinical practice experience in 7 or more subjects.p = 0.001; The average level of handover knowledge was 4.63 ± 1.61 before the program and 5.83 ± 0.95 after the program, indicating a significant difference (t = −3.71, p < 0.001; The average self-efficacy rate was 3.35 ± 0.57 before the program and 3.90 ± 0.60 after the program, showing a significant difference (t = −5.65, p < 0.001; The average handover performance competency was 1.75 ± 0.25 before the program and 2.37 ± 0.21 after the program, indicating a significant difference (t = −12.08, Despite the high necessity and effectiveness of handover education for nursing students, research on improving handover performance competency has thus far not been conducted. Therefore, this study developed and verified its effectiveness using a simulation-based handover education program. It was based on a scenario similar to an actual clinical environment, to enhance their handover capability before graduation and help them more easily adapt to clinical practice.We evaluated nurses’ handover knowledge before and after a simulation-based handover education program and found a significant increase in knowledge level. This was similar to findings from Seada and Bayoumy , who surAfter comparing self-efficacy among nursing students before and after participating in the program, it was found to have significantly increased after the program. This is similar to the results of previous studies conducted with nurses that showed a significant increase in self-efficacy after implementing a communication analysis handover education program  and a coParticipants’ handover performance competency increased significantly after the program. This finding is in line with a previous study finding that clinical performance competency level increased more after simulation-based handover education than after small-group handover education for new nurses . MoreoveAlthough the type and time of handover varies according to the clinical setting and medical environment, most patient handovers are performed orally . In termThere are two limitations to this study: First, because it was conducted with students belonging to only one women’s nursing college, the findings cannot be generalized to all nursing students or student populations. Second, as this study was conducted with a single-group pre- and post-design, the effect of the interventional design was not assessed by comparing it with a control group.Patient handover is a type of indirect nursing care that requires high-level nursing competencies to make comprehensive clinical decisions. It was found that the simulation-based handover education program was effective in improving handover knowledge, self-efficacy, and handover performance competency in nursing students. Thus, this program can be used as a basis for establishing an education system to improve handover performance competency. Furthermore, by expanding the scope of application to new nurses, nurses who have not worked in clinical practice for long-term, and nursing students, handover quality and patient safety can be improved.In this study, we developed a simulation-based handover educational program for nursing students and confirmed its effectiveness. In terms of nursing practice, this program was designed to allow nurses to experience handover after patient nursing, based on clinical cases. This program is expected to be a basis for establishing a future handover-education system for improving nursing education. In terms of nursing administration, if a fourth-grade nursing student uses a simulation-based handover educational program, they can more easily adapt to the patient handover task in a clinical setting in the future. Furthermore, it is expected that nurses’ performance and job satisfaction will be improved. Finally, this program can help improve the quality of nursing handover, contributing to patient safety.


Endo-epicardial asynchrony (EEA) is a new mechanism possibly maintaining atrial fibrillation. We aimed to determine the sensitivity and best recording modus to detect EEA on electrograms recorded from one atrial side using electrogram fractionation. Simultaneously obtained right atrial endo- and epicardial electrograms from 22 patients demonstrating EEA were selected. Unipolar and (converted) bipolar electrograms were analyzed for presence and characteristics of fractionation corresponding to EEA. Sensitivity of presence of EEA corresponding fractionation was high in patients (86–96%) and moderately high (65–78%) for the asynchronous surface area for unipolar and bipolar electrograms equally. In bipolar electrograms, signal-to-noise ratio of EEA corresponding fractionation decreased and additional fractionation increased for electrograms recorded at the endocardium. Sensitivity of fractionation corresponding to EEA is high for both unipolar and bipolar electrograms. Unipolar electrograms are more suited for detection of EEA due to a larger signal-to-noise ratio and less disturbance of additional fractionation.The online version contains supplementary material available at 10.1007/s12265-021-10111-1. The electrical pathophysiological mechanisms of persistent atrial fibrillation remain to this day largely unknown. Recent evidence suggests that dissociated electrical conduction between the layers of the atrial wall presenting as endo-epicardial asynchrony (EEA) in excitation is a potential significant mechanism for persistence of atrial fibrillation , 2. The N=15) and/or valvular heart disease (N=12); ten patients had a history of atrial fibrillation of whom one had persistent atrial fibrillation.Twenty-two patients from the ongoing Epic End study in the Erasmus Medical Center were selected. The Epic End study is approved by the local medical ethics committee (MEC-2015-373) and includes patients over 18 years of age undergoing cardiac surgery for coronary artery disease, heart valve disease, and/or congenital heart disease. This study complies with the Declaration of Helsinki and prior to participation all patients gave informed consent. Mean age of selected patients was 65±9 years and 15 of 22 were male. Cardiac surgery was performed for coronary artery disease  arrays in the right atrium via the incision for venous cannulation for endocardial mapping. The other array was placed on top of the epicardium for epicardial mapping. Both electrode arrays  were fixed on a steel spatula and bound together to ensure good contact and precise alignment of the two arrays. An indifferent electrode is attached to a steel wire fixed in subcutaneous tissue and a reference signal is stitched to the right atrium. Unipolar electrograms of the right atrial wall were recorded for 5–10 s during sinus rhythm and pacing at the superior, middle, and inferior right atrial free wall Fig. . In one epicardial and endocardial local activation time of ≥15ms. If unipolar asynchrony maps demonstrated EEA at ≥4 adjacent electrode sites that did not include border electrodes, the recording site was included for analysis. Border electrodes, defined as electrodes with <7 opposite local activation times, and electrodes missing the exact opposite electrogram were excluded from analysis. One electrode site corresponds to an area of 4mm2.Recorded data during sinus rhythm and pacing of all patients included in our study were analyzed for the presence of EEA see Fig. . Only pax) direction and in the vertical (y) direction. Local AT in bipolar electrograms was marked at the largest  peak. EEA and electrode inclusion was then determined as described above with the exception that bipolar electrograms at the right or left border in case of x-direction conversion and top or bottom border in case of y-direction conversion were included for analysis  deflections Fig. , or addiepicardial deflection or peak and the endocardial primary deflection or peak were compared to the direct opposite electrogram for the presence of fractionation corresponding to the primary deflection/peak. If the FT of a fractionation peak or deflection on the opposite side was ≤7 ms of the LAT, it was labeled as corresponding fractionation (to the primary deflection/ peak)  Fig. . This cuBesides analysis of fractionation corresponding to EEA, each opposite electrogram was analyzed for the presence of fractionation in addition to the EEA corresponding fractionation with a FT ≥15 ms separated from the LAT. This fractionation can be confused for EEA and does not correspond to the primary deflection on the other side and could complicate determining presence of EEA.x and (2) unipolar and bipolar-y were performed with Wilcoxon signed rank test. Statistical significance was set at p≤0.05, and post hoc test significance levels were adjusted according to Bonferroni at p≤0.025. The Mann-Whitney U test was used for comparison between patients with different recording sites and atrial rhythms. Data of which outcomes of statistical significance were similar between observers is presented in the text as the mean of the two medians and percentiles and the highest p-value is presented.Data with a normal distribution are presented as the mean ±SD and skewed data are presented as the median (p25–p75). To assess differences between unipolar and bipolar electrograms, Friedman’s test was used in case of skewed data and ANOVA repeated measures was used in case of normally distributed data. Post hoc tests between (1) unipolar and bipolar-n=14), followed by the mid-right atrial wall (n=6)  mm2, bipolar-y: 52 (32–94) mm2, p=0.78, see Table p=0.37). Amplitudes of bipolar electrograms were lower compared to unipolar electrograms for both epicardial and endocardial electrograms (p<0.001). In addition, SNR of bipolar electrograms in the y-direction was lower compared to unipolar electrograms: 32 (16–62) vs 62 (32–114) for epicardial electrograms and 13 (5–35) vs 28 (18–52) for endocardial electrograms (p≤0.001).Included EEA areas occurred during sinus rhythm in 14 patients, during an atrial extrasystole in 7 patients and during pacing at 240 bpm in one patient. Most recordings were from the superior right atrial wall  for endocardial unipolar electrograms. Bipolar epicardial electrograms showed fractionation corresponding to EEA at 64% (30–89%) of electrode sites per patient in the x-direction and 69% (24–92%) in the y-direction. Bipolar endocardial electrograms showed EEA corresponding fractionation in the x- and y-direction at respectively 78% (49–97%) and 72% (33–92%) of electrode sites. Complete absence of EEA fractionation occurred in one patient (<5%) for unipolar epicardial electrograms and in maximal two patients (<10%) for bipolar epicardial electrograms and in maximal three patients (<14%) for unipolar and bipolar endocardial electrograms  vs bipolar-y SNR: 4 (2–7), p<0.001). Examples of SNR decrease in bipolar electrograms are shown in Fig. Absolute voltage of EEA corresponding fractionation was higher on unipolar electrograms than on bipolar electrograms Table . Howeverx-direction demonstrated more additional fractionation than unipolar electrograms: 82% (52–100) vs 53% (10–86) (p=0.019) of electrograms and 2 peaks (1–3) vs 1 (0–1) deflection per electrogram (p=0.004). Figure endocardial electrograms.The presence of other fractionation that does not correspond to EEA will complicate determining the presence of EEA based on fractionation. Table x electrograms of patients with recordings at the superior right atrium demonstrated more additional deflections compared to the other atrial regions combined (2.5 (2–3) vs 0.5 (0–2), p=0.040); other results between these two patient groups were similar.In this small sample size, no differences in results were observed between the sinus rhythm and atrial extrasystole/pacing recordings. Only the endocardial bi-epicardium (p=0.04 vs p=0.12) and percentage and number of additional fractionation at the epicardium (p=0.011 vs p=0.098 and p=0.002 vs p=0.056). At the endocardium, the higher number of additional fractionation per electrogram reached significance in only one observer (p=0.023 vs p=0.027).Results of each observer are shown in Supplemental tables Previously, it was shown that most fractionation occurs due to inhomogeneous conduction patterns , 11. AlmBecause a bipolar electrogram is the product of two unipolar electrograms, several factors influence the morphology of a bipolar electrogram. For one, the distance between the two poles of a bipolar electrogram affects degree of fractionation. A computer model, which was also validated in a clinical population of atrial fibrillation patients, demonstrated that a larger interelectrode distance increases electrogram fractionation in bipolar electrograms in case of inhomogeneous activation patterns . Also, iComponents (deflections) of a unipolar fractionated electrogram relate to remote parts of dissociatively activated myocardium, e.g., after a line of conduction block or to dissociation in activation of myocardial bundles underneath the electrode , 14. A bEEA has been suggested as a pathophysiological mechanism for persistence of atrial fibrillation . Unfortuintramural asynchrony and thereby the specificity of EEA-based fractionation. Furthermore, in order to make the tool suitable for endovascular procedures, endovascular mapping would need technological advancements as well. Endovascular mapping will require high-density mapping arrays in order to detect neighboring sources of dissociated activation that can also have good wall contact as sensitivity could otherwise decrease compared to our study. If, finally, we will be able to accurately identify presence of asynchrony during arrhythmia, we will have better understanding of causes of ablation failures and possible solutions, and, in case of atrial fibrillation, could identify those patients in which the atrial myocardium had become so dissociated that any additional ablation is pointless. We are only at the start of the race and just took our first hurdle with this exploratory study.This kind of detailed marking of atrial electrograms with the fractionated deflections included will require automated software that is able to adjust marking settings to each recording accordingly and may require machine learning–based software development. Animal studies can help clarify fractionation occurrence based on Endo-epicardial mapping was mainly performed at the right atrial free wall as left atrial simultaneous endo-epicardial mapping can only be performed in very select cases. The differences between unipolar and bipolar electrograms may not apply to the thinner wall of the left atrium although an increase in sensitivity of asynchrony-based fractionation is expected at the left atrium compared to the right atrial free wall due to its thinner structure.ESM 1(DOCX 35 kb).


Pneumothorax is one complication of transbronchial biopsy (TBB) using endobronchial ultrasonography with a guide sheath (EBUS-GS-TBB). We sought to clarify the risk factors for pneumothorax after EBUS-GS-TBB under fluoroscopic guidance.We retrospectively reviewed data from 916 patients who underwent EBUS-GS-TBB at Fujita Health University Hospital. We evaluated the following risk factors for pneumothorax after EBUS-GS-TBB: patient characteristics ; lesion data ; final diagnosis; years of bronchoscopist experience; and guide sheath size. Univariate and multivariate logistic regression analyses were performed.P = 0.001) and lesions in lung segments with a sagittal orientation on fluoroscopy  were significant risk factors for EBUS-GS-TBB-related pneumothorax.Among the 916 patients, 30 (3.28%) presented with pneumothorax. With a univariate analysis, factors that independently predisposed to pneumothorax included lesions containing GGOs, lesions in sagittal lung segments on fluoroscopy, lesions that were not visible on fluoroscopy, and infectious lesions. A univariate analysis also showed that lesions in the right upper lobe or left upper division, as well as malignant lesions, were less likely to lead to pneumothorax. Age, underlying pulmonary disease, CT bronchus sign, EBUS findings, bronchoscopist experience, and guide sheath size did not influence the incidence of pneumothorax. A multivariate analysis revealed that only lesions containing GGOs (odds ratio [OR] 6.47; 95% confidence interval [CI] 2.13–19.6, EBUS-GS-TBB of lesions containing GGOs or lesions located in sagittal lung segments on fluoroscopy correlate with a higher pneumothorax risk. Since chest computed tomography (CT) screening for lung cancer has become a standard of care in routine clinical practice, there is an increasing need to diagnose small peripheral pulmonary lesions . TransbrThis study was a single-center retrospective review. The medical records of patients who underwent EBUS-GS-TBB for peripheral solitary lung lesions between August 2013 and March 2017 at Fujita Health University Hospital were examined. Peripheral pulmonary lesions were defined as lesions surrounded by lung parenchyma without direct visualization by bronchoscopy. Patients who underwent biopsy for ≥ 2 separate lesions were excluded. We investigated the incidence of pneumothorax after EBUS-GS-TBB, sequential therapy for pneumothorax, and resulting outcomes. We also reviewed the following data of all patients: age; sex; smoking status; lung complications ; steroid use; thin-section CT images of target lesions  within 1 month prior to the procedure. Each bronchoscopist evaluated the CT images and identified the bronchus and target lesion . The resIn total, 25 bronchoscopists performed EBUS-GS-TBB in the study period. The number of years of clinical experience ranged from 2 to 30 years . We routinely perform bronchoscopy with the involvement of at least three bronchoscopists . Five-hundred twenty-seven procedures (57.7%) were performed by bronchoscopists with fewer than five years of experience in bronchoscopy.EBUS-GS was performed using an endoscopic ultrasound system  with a 20-MHz radial-type ultrasound probe  according to the standard Kurimoto method  upright position) and the patient did not exhibit significant dyspnea, clinical observation was often selected; however, in some cases, chest drainage and prolonged hospitalization were used. Oxygen supplementation was administered based on the attending clinician’s judgment.To determine the risk factors for pneumothorax after EBUS-GS-TBB, we investigated the clinical factors related to pneumothorax after bronchoscopy, including age (> 75 years), sex, pulmonary comorbidities (severe emphysema and pulmonary fibrosis), lesion location, fluoroscopic view (not visible), lesion size (long diameter of < 20 mm), GGNs (CTR of > 0.5), CT bronchus sign (CT bronchus sign B or C), pleural contact/indentation, EBUS findings (other than “within”), bronchoscopists’ clinical experience, guide sheath size, and final diagnosis . Associations between the variables of interest and the incidence of pneumothorax after EBUS-GS-TBB were first examined by univariate logistic regression and presented as odds ratios (ORs) and 95% confidence intervals (CIs). Next, multivariate logistic regression for pneumothorax was performed using all variables that were used for the univariate analysis. A backward variable selection procedure was employed to obtain the final model. We presented mutually adjusted ORs and 95% CIs for pneumothorax after EBUS-GS-TBB for the final model. We also conducted stratified analyses according to lesion location; that is, lung segments in the sagittal direction, which are difficult to recognize under fluoroscopic guidance, or other subsegments. All statistical analyses were performed using JMP version 15.2 statistical software .2 < 90%) when pneumothorax occurred. All patients recovered without any surgical intervention or pleurodesis. None of the patients experienced pneumothorax recurrence. Patients’ characteristics are shown in Table During the study period, 921 patients underwent EBUS-GS-TBB. Five patients were excluded from the study because they underwent biopsy of ≥ 2 lesions in different lung lobes. Thus, 916 patients were included in the study. Thirty patients (3.28%) developed pneumothorax after EBUS-GS-TBB, which was resolved in 22 patients by observation. Eight patients required chest drainage, and four patients developed respiratory failure (SpOTable P = 0.001) and lesions located in sagittal lung segments  were significantly associated with EBUS-GS-TBB-related pneumothorax .Fluoroscopic recognition of target lesions depends on the imaging performance of the fluoroscopic system. For example, fluoroscopy with a C-arm or cone-beam CT could offer more recognizable images, even at lung segments in the sagittal direction. Thus, we further investigated whether the risk factors for EBUS-GS-TBB-related pneumothorax changed when lesion location was excluded from the analysis. A multivariate analysis of patients whose lesions were located in sagittal lung subsegments (n = 214) and patients whose lesions were present in other subsegments (n = 702) revealed that only GGNs were significant risk factors for EBUS-GS-TBB-related pneumothorax in both groups (OR 6.43, 95% CI 1.89–21.89, The present study demonstrates that the risk factors for EBUS-GS-TBB-related pneumothorax are GGOs in target lesions and lesions located at lung subsegments in a sagittal direction.GGO-dominant lesions were difficult to detect using fluoroscopy , 15. EBUPneumothorax during TBB is caused by injury of the visceral pleura by biopsy forceps or bronchial brushes . The tipOur study also showed that EBUS-GS-TBB for lesions in the upper lobe or upper division of the left upper lobe is unlikely to be accompanied by pneumothorax. With real-time fluoroscopic guidance, movement of lesions by breathing was less pronounced in the upper lung field compared with the lower lung field. Thus, lesions in the upper lobe and upper division may be easier to recognize during bronchoscopy under fluoroscopic guidance, which is beneficial for avoiding iatrogenic pneumothorax.Huang et al. reported predictive risk factors for pneumothorax after EBUS-guided TBB . They inA recent study showed that even with newly developed robotic bronchoscopy, 3.7% of patients are complicated with pneumothorax . This reOne limitation of our study is that it is a single-center study with a retrospective design. Bronchoscopy procedures, including biopsy, sedation, and fluoroscopy, vary between institutes. Thus, multi-institutional prospective studies are warranted in the future. Nevertheless, we believe our study reveals solid risk factors for pneumothorax after EBUS-GS-TBB, since these risk factors were determined from a large number of patients.Our study shows that with EBUS-GS-TBB, we should be aware of the risk of pneumothorax when lesions are located in sagittal lung segments on fluoroscopy, because the positional relationship between biopsy forceps and the pleura is difficult to recognize, even under EBUS guidance. The risk of pneumothorax should also be considered when lesions present as GGOs, which are difficult to identify, even in combination with fluoroscopy and EBUS.