Conversion from conventional ventilation to INTELLiVENT-ASV resulted in a lower intensity of ventilation. These findings may favor the use of INTELLiVENT-ASV in COVID-19 ARDS patients, but future studies remain needed to see if the reduction in the intensity of ventilation translates into clinical benefits.Driving pressure (ΔP) and mechanical power (MP) are associated with outcomes in critically ill patients, irrespective of the presence of Acute Respiratory Distress Syndrome (ARDS). INTELLiVENT-ASV, a fully automated ventilatory mode, controls the settings that affect ΔP and MP. This study compared the intensity of ventilation (ΔP and MP) with INTELLiVENT-ASV versus conventional ventilation in a cohort of COVID-19 ARDS patients in two intensive care units in the Netherlands. The coprimary endpoints were ΔP and MP before and after converting from conventional ventilation to INTELLiVENT-ASV. Compared to conventional ventilation, INTELLiVENT-ASV delivered ventilation with a lower ΔP and less MP. With conventional ventilation, ΔP was 13 cmH T) and, as such, represents the strain applied to the lung with each breath during mechanical ventilation [T and ΔP, but also respiratory rate (RR) [Limiting the intensity of ventilation could improve outcomes in patients with acute respiratory distress syndrome (ARDS) ,2,3. Thitilation . The sectilation ,7. The late (RR) ,9.It can be very challenging, if not practically impossible, to keep the intensity of ventilation low at all times. INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated, closed-loop ventilatory mode that automatically controls gas exchange at the lowest work of breathing  and at tIt is uncertain whether INTELLiVENT-ASV affects the intensity of ventilation in COVID-19 patients with ARDS. The aim of this substudy of the ‘PRactice of VENTilation in COVID-19’ (PRoVENT–COVID) study  was to cwww.clinicaltrials.gov (accessed on 15 April 2020); trial identification number NCT04346342). The need for informed consent was waived because of the observational nature of this study and because the decision to use conventional ventilation, or INTELLiVENT-ASV, was left to the discretion of attending physicians and nurses and in accordance with the local guideline for ventilation in the 2 ICUs. Before and after the conversion to INTELLiVENT-ASV, fairly identical target ranges for end-tidal carbon dioxide (etCO2) and peripheral oxygen saturation (SpO2) were used. We targeted normocapnia and normoxemia with both ventilation modes in all patients. Pressure limits were left unchanged. Additional details on ventilator settings are depicted in This was a retrospective 2-center substudy within a large national observational study undertaken during the first wave of the COVID-19 pandemic in the Netherlands. The substudy was conducted at the Intensive Care Unit (ICU) of the Reinier de Graaf Hoss alignmentpital in Delft and the ICU of the Amsterdam University Medical Centers, ‘location AMC’ in Amsterdam, the Netherlands. The study protocol (number W20_157#20.171) was approved on 7 April 2020 by the Institutional Review Board of the AMC (chairperson Prof. Dr. J.A. Swinkels), Amsterdam, and was prepublished , and thePatients aged 18 years or older with COVID-19 confirmed with RT-PCR for SARS-CoV-2 and ARDS according to the Berlin definition  were eliThe severity of illness, medication and vital signs were obtained at baseline. Ventilation variables and parameters were collected at 4 consecutive timepoints: at 2 and 1 h before and at 1 and 2 h after conversion from conventional ventilation to INTELLiVENT-ASV. Thus, we had a maximum of 4 timepoints at which ΔP and MP could be calculated. ΔP was calculated as plateau pressure (Pplat) minus positive end-expiratory pressure (PEEP). MP was calculated as :MP  or mean (±SD) for continuous variables. Proportions were compared using the chi-squared test or Fisher exact test as required by variable distribution, and continuous variables were compared using the Wilcoxon Rank Sum Test or the Wilcoxon signed-rank test as appropriate. Effects are presented with a 95% confidence interval (95% CI).A mixed-effects generalized linear model with a Gaussian distribution was used, wherein ventilation mode was used as a fixed effect and patients as a random effect, to account for repeated measurements.T, PEEP, Pmax, RR and other ventilator parameters with INTELLiVENT-ASV versus conventional ventilation, cumulative distribution plots were constructed. Medians were compared using the Wilcoxon signed-rank test. In addition, the relation between VT and ΔP at the 4 timepoints was visualized in plots using least square method regression analysis. Scatterplots and line graphs were also used to show how individual changes in VT related to changes in ΔP.To compare ΔP, MP, VWe performed 2 post hoc analyses. In the first post hoc analysis, MP was calculated using another equation than the one proposed above as :MP (J/miRS) and was calculated as:In the second post hoc analysis, MP was normalized for respiratory system compliance  and R version 3.6.3 .There were no missing data. A Between 1 March and 1 June 2020, 144 patients were screened for eligibility . A totalDemographic data, including preceding medication, the severity of disease and comorbidities, are presented in 2O, the median MP was 21.5 (IQR 14.6 to 32.1) and 24.8 (IQR 19.4 to 31) J/min. 1 and 2 h after the conversion, the median ΔP was 11 (IQR 9 to 14) and 10 (IQR 8 to 14) cmH2O (mean difference –2 cmH2O (95% CI –2.5 to –1.2 cm H2O); p < 0.001) and the median MP was 18.8 (IQR 12.2 to 22) and 17.5 (IQR 12.2 to 21.1) J/min (mean difference of –7.7 J/min (95% CI –8.8 to –5.8 J/min); p < 0.001)  and 13 (IQR 10 to 17) cmH< 0.001) .T, but most patients maintained a VT of < 8 mL/kg PBW. Before conversion to INTELLiVENT-ASV, 7 of 51 patients (14%) received ventilation with a VT > 8 mL/kg PBW. At 1 and 2 h after conversion, 10 (19%) and 8 patients (16%) received ventilation with a VT of > 8 mL/kg PBW. With INTELLiVENT-ASV, when VT increased, ΔP decreased. In addition, when ΔP was high with conventional ventilation, VT decreased with INTELLiVENT-ASV  a reduction in ΔP and 2) a reduction in MP. Limiting ΔP and MP have been proposed as targets that may result in better outcomes in patients with ARDS  a reduct, and autThis study has strengths and limitations. First, this study was performed in ICUs with physicians and nurses with extensive experience in the use of lung-protective ventilation and also the use of INTELLiVENT-ASV. The first can be seen as a strength, as this means that we compared ‘best practice’ in lung-protective ventilation during conventional ventilation with fully automated ventilation. However, the second could be seen as a limitation, as this may reduce the generalizability of the findings. Of note, adequate input into the ventilator by the caregivers remains necessary for the optimal use of INTELLiVENT-ASV, and the quality of input increases with experience. Other strengths are that we strictly followed a predefined analysis plan, and we had no missing data. One limitation is that we did not use a cross-over, cross-back approach, which means that part of the findings may be explained by natural changes in respiratory physiology. For example, the changes in ΔP and MP over the hours we observed in the patients could also have been caused by an improvement in the clinical condition, independent of the way ventilation was applied. This, however, is very unlikely considering the fact that the overarching study findings showed only marginal changes in ventilator settings and parameters of interest over the first 4 days of invasive ventilation . Last, wOur findings are in line with those from previous investigations testing the safety, feasibility and effectiveness of INTELLiVENT-ASV in different patient groups. In one randomized clinical trial in postcardiac surgery patients , INTELLiThe findings did not change in the sensitivity analysis using an alternate equation for calculating MP. The original equation is designed for use in volume-controlled ventilation, while we used pressure-controlled ventilation before changing the ventilator mode to INTELLiVENT-ASV, and INTELLiVENT-ASV itself is a mode that is based on the principles of pressure-controlled ventilation. Findings also did not change in a sensitivity analysis in which MP was normalized. The rationale behind normalization is that ventilator-induced lung injury derives from the interaction between the causal factors of two broad categories—the machine output and the condition of a healthy or diseased lung. This means that for the same amount of MP, the lung volume determines the intensity.2 and SpO2 values were not affected. We hypothesize that the slight increase in VT resulted in the recruitment of parts of the lung sufficient to compensate for the lower minute volume.One key ventilator setting that showed a remarkable change from before to after the conversion to automated ventilation was the RR. Previous studies have shown an association of higher RR with poor outcomes . The decT. However, in most patients, VT remained largely within the widely agreed safety zone, i.e., <8 mL/kg PBW. The increased median CRS with INTELLiVENT-ASV could mean that the larger VT was applied to a better-aerated lung. The lower ΔP and lower upper airway pressure with INTELLiVENT-ASV are in line with this suggestion. With INTELLiVENT-ASV, median ΔP remained below the suggested safety limit of 15 cm H2O and was lower than with conventional ventilation in most patients. One interesting finding of our study was that when ΔP was high with conventional ventilation, VT decreased with INTELLiVENT-ASV, suggesting less overinflation after the conversion. While we acknowledge the importance of using a low VT in patients with ARDS, a small increase in VT accompanied by decreases in ΔP and MP may be acceptable.Compared to conventional ventilation, INTELLiVENT-ASV resulted in a somewhat higher median VT, as VT remained within the generally accepted safety limits. The effect of INTELLiVENT-ASV on MP seems mainly driven by a reduction in the respiratory rate.Conversion from conventional ventilation to INTELLiVENT-ASV resulted in a lower intensity of ventilation in this cohort of COVID-19 ARDS patients. The conversion resulted in a small but acceptable increase in V


Adolescents with spina bifida (SB) face challenges in their transition to adulthood due to intensive medical regimens and delayed development of independence. Despite an increasing interest in the transition of adolescents with SB to adulthood, the clinical evidence of transition care remains limited, and existing studies have focused on the effects of intervention programs. This study aims to describe the process of systematically developing an online-based transition care program for adolescents with SB using the intervention mapping (IM) protocol. IM consists of six steps: (1) logic model of the problem; (2) program objectives; (3) program design; (4) program production; (5) plan to implement the program; (6) plan for evaluation. At first, five problems faced during the transition were identified, based on which four program objectives and six program strategies were established. The online transition care program for adolescents with SB was developed as a six-week program. The main strength of this program is that it reflects the diverse perspectives of adults with SB and health care professionals and is easy to apply because it is online. We aim to further validate the feasibility of this transitional care program to evaluate its effect based on our evaluation plan. Spina bifida (SB) is one of the most common congenital malformations, known as neural tube defects, caused by a failure in the closure of the vertebrae during the early stage of pregnancy . Before From a health care perspective, the transition is the purposeful, planned passage of adolescents with chronic conditions from child-centered to adult-oriented health care systems . AdolescAdolescents with SB have experienced challenges in their transition to adulthood due to physical and psychological difficulties . Those wIndividuals with SB need to manage their complex treatment regimen throughout their lives, which includes regular hospital visits, clean intermittent catheterization (CIC), bowel management, skin checks, shunt monitoring, and the use of various orthopedic devices ,15. AdolIM is a systematic process for developing theory-, evidence-, and practice-based programs . It aimsAmong the theoretical frameworks explaining the transition of adolescents with SB, the Life Course Model is considered as providing a useful basis ,16,32. TConsidering the COVID-19 pandemic, developing an online-based transition care program for adolescents with SB would be especially useful. Therefore, this study aimed to describe the process of systematically developing an online-based transition care program for adolescents with SB using the IM protocol.IM consists of six steps, and each step is built on the decisions and results obtained from the preceding step . The sixTo identify the problems related to transition, we conducted a systematic review , a need Second, we conducted a cross-sectional study  to exploWe organized the objectives of the program to indicate which behaviors needed to be changed or achieved. After selecting the problems related to the transition in the first step, we conducted an additional literature review for establishing the program objectives. Finally, in step 2, the program objectives and rough contents of the transition care program were specified.The program was conceptualized and designed in this step. The research team established the theoretical framework and components of the program. We integrated the information acquired from previous steps, i.e., the literature review and researchers’ discussions, and used it to construct the transition educational program. This theoretical framework guided us to better understand the problems faced during the transition, to optimize factors that promote transition readiness, and to suggest solutions and outcomes.In this step, we determined the details of the topics, scope order, and sequence of the transition care program. Performance and implementation strategies were selected based on the discussion among the research team to ensure more effective delivery methods.We developed a plan to apply specific methods in the program and discussed the barriers and facilitators of the program. In regard to the educational aspect of this program, we obtained expert advice from three pediatric nurse practitioners and two social workers. The researcher team then worked with the experts to create lecture materials based on the contents of the program. We used animated content that described the transition of adolescents with SB from adolescence to adulthood to increase the participants’ understanding of this transition and to generate interest in the program.We developed an evaluation plan by finalizing the study design, main concepts, and methods for evaluating the program’s effectiveness. A group of experts conducted the content validity index (CVI) for evaluating the program’s validity. A checklist was developed to assess the level of transition for adolescents with SB, and the CVI was assessed by the multidisciplinary panel. In addition, the template of the individual transition plan was modified based on previous research  to estabBased on the systematic review  and needFrom a needs assessment study , adolescAt first, the research team created a mind map to visualize the goals to be achieved during the transition by referring to a previous study . The goaWe selected the Life Course Model for SB  as the fIn the Life Course Model, self-management includes discrete functional domains related to bladder and bowel management, mobility, skin integrity, sexuality ,32. TherThe online transition care program for adolescents with SB was developed as a six-week program . The proIn the first session, adolescents and their parents (caregivers) will be individually interviewed, and the transition program will be introduced through animation. Following this, the degree of transition of each participant will be assessed, and the individual transition plans and goals will be established through discussion with the participants and their parents. Sessions 2–5 would consist of group activities. In the second session, lectures on neurological health, including the general understanding of SB, and orthopedics health, including awareness on skincare, will be provided. After that, we aim to provide time for questions and answers related to the topic and hold group counseling for cognitive behavioral motivation (CBM) related to relationships with family members. After a lecture on voiding and bowel management in SB, a question-and-answer session will be conducted in the third session. Then, group counseling on CBM related to relationships with friends will be conducted. In the fourth session, sexuality education specific to the general population and to those with SB will be conducted, and CBM group counseling will be held, focused on school experiences, and potential solutions will be discussed. In the fifth session, a lecture on the health care system will be conducted, including making hospital appointments and insurance-related information. Next, we will invite an adult mentor with SB to share their experiences at school (relationship with others) and to provide career-related tips. The sixth session will proceed similar to the first session. After evaluating the degree of transition after the program, the degree of implementation of the individual transition plans and goals will be evaluated. We also aim to discuss long-term transition goals within the family.https://youtu.be/Ti0YX1trtXI (accessed on 13 January 2022)). and English versions (https://youtu.be/AXUr8WaEXyA (accessed on 13 January 2022)). of the animation that provide an overview of the transition process. This animation will be shown to the participants at the beginning of the program. Educational videos on neurological health, orthopedics health, the hospital system, and sexual issues faced by adolescents with SB will be filmed, featuring experts (three pediatric nurse practitioners) and the research team. We will make the participants watch these educational videos together while other programs are being conducted in real-time.We plan to recruit participants by collaborating with the largest SB clinic in South Korea and the Korean Spina Bifida Patients Association. For adolescents with SB, the eligibility criteria would include the following: (1) adolescents with SB aged 12–15 years; (2) ability to use the internet; and (3) absence of cognitive impairment. Adolescents who (1) had already participated in the transition program, (2) were unable to communicate and respond to the questionnaires, or (3) had illness or disabilities other than SB will be excluded. To increase the understanding of transition among adolescents with SB, we created an animation introducing this transition process. With the help of the animation director, we created a storyboard on the transition care of adolescents with SB. Eventually, we created three-minute Korean  ranged from 0.83 to 1.00. Moreover, the program contents were supplemented according to experts’ opinions that easy terms and pictures are needed to help adolescents with SB understand self-management. For program performance, the research team, three pediatric nurse practitioners, and two social workers wrote a program scenario and discussed how to proceed with the program. The research team pre-practice was also conducted, such as confirming the use of content sharing and group division for smooth use of Zoom in the transition program.To measure the effectiveness of the program, we will measure the appropriate concepts based on the framework of the program; self-management/health domain , personal and social relationships domain , and education/employment domain (career readiness). The first and sixth sessions will be conducted online with the participants and their families to establish and evaluate the individual transition plans. For the individual transition plans, we will use the template provided in a previous study on the transition of adolescents with SB . We willTo confirm the effects of the developed program, we would use a quasi-experimental pre-post design. According to the rule stating a sample size of 12 per group for a pilot study , we willThis study described the systematic process of developing an online-based transition care program for adolescents with SB. Although most previous studies have been conducted with a focus on the effects of interventions during the transition of this population ,22,23,24The first strength of our program is that it emphasizes the practical problems faced during transition through a literature review  and asseThe second strength of the program is that it would lead to parental involvement in the transition care program. Family is an important factor during the transition of adolescents with chronic conditions , and thiThe third strength of the program is that it includes a multidisciplinary panel that consists of four young adults with SB (19–25 years), two pediatric urologists, two pediatric nurse practitioners, and a pediatric orthopedist. The program content accuracy can be verified with the participants of a large number of experts who have the latest information on how to educate individuals with SB. Moreover, we conducted the study through discussions and obtained advice from the panel at each step of the IM. The contents of the program reflect the experience of transitioning participants with SB and the clinical practice of health care professionals.The final strength of the program is that it is an online-based transition care program, which makes it easily accessible by the participants and their families . FurtherThis study suggests important implications of transition care for adolescents with chronic conditions.First, health care professionals should establish tailored transition plans by monitoring the clinical characteristics and transition levels of adolescents with SB. Moreover, health care professionals should make an effort to raise awareness and interest in transition among children and adolescents by explaining the concept of transition from childhood. Second, health care professionals should provide transition care programs that parents can participate in with their children. As parents participate in the program together, the transition care will be managed at home, which will promote the transition of adolescents with SB. Third, Adolescents with SB should be provided with an integrated transition program that focuses on physical self-management and includes interpersonal relationships, education courses, and occupational opportunities.Therefore, health care professionals should provide counseling that considers these aspects and, if necessary, link with the local community. Government-level support and efforts are also needed to create an environment and policies that can provide an integrated transition program to youth with chronic diseases.This study has some limitations. First, we developed the transition checklist based on the literature review and expert advice to assess the current level of transition for adolescents with SB; however, the checklist is limited due to a lack of validation. Therefore, it is unclear whether this checklist accurately captures the transition levels in adolescents with SB. In the future, we recommend validating this checklist in adolescents with SB for the accurate identification of transition levels. Second, although this study followed IM, a systematic intervention development process, we could not confirm its effectiveness. Therefore, we aim to conduct further studies that evaluate and demonstrate the effectiveness of the transition care program for adolescents with SB. Third, when comparing online programs with face-to-face programs, there is a limit to non-verbal communication because of the screen limitation of the online interface. Moreover, passive participation may occur depending on the participants’ characteristics, or they may feel difficult to interact. Therefore, the health care professionals and the researchers who conducted the transition care program should try to promote participation by providing questions and feedback to the participants so that continuous interaction can occur. For this, it will be necessary to pre-practice the online program in advance and understand the characteristics of the subject. Lastly, it can be difficult to collaborate with experts who have experience caring for SB in clinical practice. Therefore, it is expected that continuous multidisciplinary research and practice will be carried out in the future, an expert network will be formed, and eventually, various studies on the transition of chronic conditions will proceed.A systematic approach for developing a transitional care program is necessary to ensure the successful transition of adolescents with SB to adulthood. The transition care program, developed with a systematic approach, could provide fundamental data for developing an intervention program to guide the transition of adolescents with SB. The feasibility of this transitional care program will be validated to evaluate the effect of this program based on our evaluation plan.


Many One Health programs are inherently complex, characterized by multiple perspectives from multiple sectors, delivery across various scales, and a focus on complex problems at the convergence of people, animals, and the environment. This complexity makes them difficult to conceptualize, requiring frameworks to organize the different program components. Evaluation frameworks that unpack the sequence of events linking program activities to outcomes  and track outcomes  show promise in supporting the development of One Health programs. While widely used in international development and health contexts, there has been little reflection on the use of Theory of Change and Outcome Mapping within One Health efforts. This paper reflects on the process of applying these frameworks to conceptualize a One Health food safety program in Vietnam. We find Theory of Change fostered the characterization of a change pathway toward safer pork, while Outcome Mapping kept us informed of where along the change pathway we were. One Health programs considering evaluation frameworks should adopt elements that make sense to them, be intentional about co-designing the evaluation, and view evaluation as a process, not a product. The interaction between humans, live animals for sale, and food products in informal and open-air food markets creates risks for food safety and emerging infectious diseases . COVID-1and evaluation that focuses on social change, placing development actors at the core of its processes  describe how ToC and OM frameworks can be applied to support the monitoring and evaluation of a One Health food safety program in Vietnam; and, (2) reflect on the process, challenges, and opportunities of developing these frameworks. In doing so, we provide lessons in developing One Health food safety programs in dynamic, low-resource settings.We focus on the ‘Market-based approaches to improving the safety of pork in Vietnam’ (SafePORK) program to explore the use of a combined ToC and OM. SafePORK is a 5-year program funded by the Australian Center for International Agricultural Research and implemented by the International Livestock Research Institute, Vietnam National University of Agriculture, Hanoi University of Public Health, and national  and international partners (University of Sydney). The development of SafePORK was motivated by a growing concern for food safety, one of the most pressing issues among people in Vietnam . In partSafePORK can be considered a complex program, characterized by a plurality of stakeholder perspectives and multiple interacting components . The resBox 1ACIAR Project No. LPS/2016/143Duration: October 2018 to June 2022Budget: A$2 MillionObjective 1: Generate evidence on the efficacy, feasibility, and reach of current approaches for improving pork safety in Vietnam. Key activities include conducting a rapid value chain assessment, and developing and applying a food safety performance tool.Objective 2: Develop light-touch, incentive-based approaches to food safety. Key activities include selecting five value chains for piloting interventions, establishing a food safety baseline for the selected value chains, conducting participatory research to develop interventions, implementing ‘best bet’ interventions, and evaluating outcomes.Objective 3: Develop a Theory of Change for market-based interventions. Key activities include forming a Food Safety Stakeholder Group, developing a theory of change, and revisiting the theory of change periodically.Objective 4: Support strategies for benefits sharing among men and women in the pig value chain. Key activities include providing gender training, conducting gender analysis of constraints to adopting interventions, and integrating gender considerations into all activities.Objective 5: Build capacity in understanding and managing food safety risks. Key activities include identifying key beneficiaries, providing risk communication training to beneficiaries, disseminating research findings, and evaluating effective communication strategies.Given the complexity of the food safety challenge in Vietnam, the engagement of multiple perspectives characteristic of One Health approaches, and the need for learning support throughout the SafePORK program, we were interested in a framework that was responsive to dynamic, real-world environments. We wanted to systematically capture and learn from our outcomes to inform adaptations to the program. As everyone has different ideas, hypotheses, and assumptions (“theories”) about how change happens, going through a ToC process can help make these theories explicit. We used ToC to establish a shared roadmap toward change and identify potential areas for monitoring and evaluation. A ToC, however, does not tell us how to assess change; we combined ToC with tools offered by OM to support SafePORK in not only learning about its change process but also in measuring it. OM is often considered well-suited to assess programs implemented under complexity in which multiple influences make it difficult to predict what will happen as a program proceeds . We usedWe developed a ToC following advice from several guidance documents –29 alongTo operationalize the methodological framework for developing a ToC, a full-day workshop was conducted with 12 SafePORK researchers (seven women and five men). The facilitator (SL) described the ToC approach using examples and then asked participants to undertake an exercise following the 5-step process. As SafePORK works extensively with several actors along the pork value chain, participants agreed to create separate actor-based ToCs while acknowledging that ToCs might be combined into one comprehensive ToC later. Participants were split randomly into two teams; one worked on slaughterhouse workers and retailers while another worked on consumers and policymakers. Toward the end of the workshop, participants were asked to reflect on the challenges and opportunities of developing a ToC.OM is a three-stage process of intentional design, outcome and performance monitoring, and evaluation planning . In the To operationalize OM, we convened a half-day workshop with SafePORK researchers (5 women and 4 men). The facilitator (SL) explained the theory of OM and provided examples of OM in practice. As most team members were already familiar with OM through the previous phase of SafePORK , we worked together quickly through the initial OM steps . More time was spent focusing on boundary partners, outcome challenges, and progress markers often considered the “essence of OM” . SpecifiThe resulting ToC in According to SafePORK researchers, the identification of cost-effective practices is important for supporting small-scale adoption of safe food practices among women and men. SafePORK intends to contribute to this outcome by piloting light-touch incentive-based interventions, training, and communication along the pork value chain. Several assumptions underlie the causal link between SafePORK activities and improved safe food practices, such as retailers', slaughterhouses', and consumers' demand safer pork. Furthermore, safe food practices need to be supported by broader environmental factors including slaughterhouse and market infrastructure, food safety procedures and enforcement, and certification and branding, which may be indirectly influenced by SafePORK.Secondly, researchers emphasized that policy-makers should strengthen policies, support the scaling-up of SafePORK pilots, develop a model for small-scale slaughterhouses, improve surveillance and inspection, and increase the budget for food safety interventions. SafePORK intends to influence these actions by presenting evidence from pilot interventions to policymakers through policy brief workshops and study tours. At the provincial level, for example, SafePORK is engaging the sub-Department of Animal Health in Hung Yen in dialogue surrounding the slaughterhouse intervention model. There are several assumptions behind this causal link, such as policy-makers must be interested in improving food safety. While this assumption may seem obvious, the experiences of SafePORK (and PigRISK) demonstrate that buy-in from policy-makers is essential and must be fostered for interventions to succeed.Researchers also considered the social and physical environments to be important factors underlying the success of SafePORK. For example, Hung Yen is an appropriate province to implement interventions given its high pig production, proximity to the capital city (Hanoi), and room for improvement of hygienic practices. In Hanoi, greater awareness of food-borne diseases, higher income, and generally stronger infrastructure make Hanoi a conducive environment to conduct food safety interventions. Interventions also need to consider who participates in and benefits from efforts aiming to improve food safety and the different roles and responsibilities of women and men. For example, slaughtering is mostly done by men while retailing and purchasing are mostly done by women, providing opportunities for targeted risk management.The articulated program theory provided us with a starting point for planning evaluation activities through outcome mapping's intentional design stage. According to SafePORK researchers, the vision of SafePORK is to improve public health by reducing the burden of food-borne disease in traditional, emerging, and niche markets of Vietnam. Its mission is to develop and test market-based, light-touch, and incentive-based interventions. While SafePORK interacts with many boundary partners with a critical role in ensuring food safety, program monitoring and evaluation will focus primarily on slaughterhouse workers and retailers. We consider slaughterhouse workers and retailers to be within SafePORK's direct ‘sphere of influence’ whereas other value chain actors are within SafePORK's indirect ‘sphere of interest’ . The maiResearchers agreed that the progress of boundary partners toward the achievement of the outcome challenge will be measured on an ongoing, real-time basis. Monitoring journals provided by OM will be used to guide this process. The outcome journal will track the behavioral changes of partners using progress markers whereas the strategy journal will document the activities conducted to achieve outcomes. Several focal points from the SafePORK team will contribute to one shared journal integrating outcomes and strategies. Specifically, the focal points will document (1) activities/strategies implemented, including with whom, where, and when; (2) reflections on what changes occurred, what worked well, and what could be done better; and, (3) and share pictures of before and after. The collected information will be used to inform adaptations to interventions and provide evidence for the final evaluation.From our ongoing monitoring efforts, we are starting to see behavioral changes during implementation (in some areas and not others), informing adaptations to the intervention. For example, at a slaughterhouse in Hung Yen, we are seeing the provided grid and tables being used during carcass handling. Importantly, some tables were co-invested by the slaughterhouse owner, highlighting the slaughterhouse owner's interest in the program. We are also seeing better separations between clean and dirty areas. However, sometimes knives are not properly cleaned after use and in some cases are put on the floor. The team makes regular visits to the slaughterhouse to encourage hygienic practices. At the traditional wet markets, we are seeing retailers now using separate cutting boards for raw meat and cooked meat. However, many retailers prefer wooden boards because they are better for chopping bones. To address this challenge, the program co-invested in wooden cutting boards with retailers.This paper describes the experiences of researchers in applying evaluation frameworks to conceptualize a One Health program aiming to improve food safety in Vietnam. We began applying ToC and OM during the formative stages of the program design, enabling us to better anticipate, monitor, and track outcomes early on in the program. We noticed some overlaps and differences between the two outcome-based evaluation frameworks. For example, a ToC focuses on the articulation of a goal, the causal pathways linking short- and medium-term changes to the long-term goal, and the strategies used to achieve outcomes; these steps appear to be consistent with the intentional design stage of OM. However, one notable difference is that ToC emphasizes the need to explicitly define the underlying assumptions behind the change pathways and the contextual factors that influence programming, elements that are typically unexplored in OM . Given tinterrelationships are acknowledged when ‘outcomes’ are defined as patterns of behavior and interactions among stakeholders; perspectives of specific actors are accounted for when setting ‘outcome challenges’ for specific actors; and, boundaries are considered when selecting ‘boundary partners’, including some actors and excluding others. We consider the interrelationships between stakeholders to be particularly important to monitor; in previous  and current phases of the program, we considered our partnership as a separate unit of analysis, collecting and sharing reflections about the partnership to ensure various actors operate smoothly as a functioning team  ventions . HoweverBe intentional with co-designing the evaluation. We stress the importance of being intentional about designing the outcome monitoring system. This means providing space and time for team members to come together and think about how the elements of ToC and OM might be combined. It also means working closely with focal points or key members who will collect and share the data. For SafePORK, two focal points made journal entries after each routine visit to the field, which reduced the need for additional human resources and field visits. That said, monitoring outcomes is an additional responsibility for focal points that need to be supported through ongoing training, incentives, and data quality management.(2) View evaluation as a process, not a product. While our team was familiar with OM, developing a ToC was new for some members. We intended to use ToC as a starting point for outcome mapping. The developed change pathway helped to visualize the sequences of and relationships between outcomes. Because it was the first time the team conducted a ToC, we did not expect to have a strong, initial ToC by the end of a one-day workshop. It helped that researchers were made aware of workshop objectives well in advance, creating an environment to participate fully in the exercises. However, when we shared the ToC in a SafePORK planning meeting, it was clear that the ToC could have been further detailed. For example, a researcher who was not able to make it to the workshop suggested that the outcomes are somewhat vague and could be further specified. If we were to do this process again, we would circulate the ToC earlier and on a routine basis. However, we view the ToC as a process, not a product; our next step is to share this initial ToC with our boundary partners for revision, as suggested in Mayne ((3) in Mayne . We willWe note several limitations to our study. Similar to the experiences reported in Taye et al. , we findThe challenges and opportunities of frameworks guiding the conceptualization of One Health programs are largely absent from the literature. This study critically reflects on our experiences as researchers in combining ToC and OM during the initial design stages of a One Health food safety program in Vietnam. For the SafePORK program, ToC enabled the scrutinizing of change pathways and the context and assumptions in which change occurs. Equally important, OM provided a framework to help plan and monitor strategies toward and outcomes of safer food. We echo the recommendation in Pasanen et al. when designing outcome monitoring systems: “it doesn't need to be complicated” .The original contributions presented in the study are included in the article/supplementary files, further inquiries can be directed to the corresponding author/s.Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The study is a reflection of the authors' experiences in developing a program. No additional information from human participants was collected.SL contributed to conceptualization, research, and writing. All authors read, commented, and agreed on the submitted manuscript.SafePORK was funded by the Australian Center for International Agricultural Research (LS/2016/143) and co-funded by the CGIAR Research Program Agriculture for Nutrition and Health (A4NH).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.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.


Hypertension and diabetes disproportionately impact people of color when compared to majority populations. Medication adherence among seniors with chronic diseases has been suboptimal with the estimation that only half of those taking antihypertensives are adherent. Therefore, the purpose of The Managing Your Medications (MY Rx) program was to evaluate the effectiveness of evidence-based practices used to improve rates of medication adherence through information dissemination among diabetic and hypertensive African American, Asian American, and Hispanic residents housed in senior public housing facilities in the Greater Houston Area. The program comprised an 8-week intervention with individual and group components with small incentives provided throughout the program. Individual components included one home visit and telephone consultations conducted by pharmacists. Health educators provided two group education sessions on lifestyle modifications.Qualitative analysis of focus group discussions revealed participant satisfaction with the MY Rx program and willingness to change after participation in the program.The Rx program showed the potential effectiveness of an innovative strategy in medication counseling using interdisciplinary pharmacists and health educators to promote health. It demonstrated the importance of using the patient-centered care framework in designing a community intervention program. People of color are disproportionately burdened by hypertension and diabetes when compared to whites. Hypertension impacts 45% of the adult population, being most prevalent in non-Hispanic African American adults (54%), non-Hispanic white adults (46%), Asians 39%), and Hispanics (36%) . Diabete9%, and HThe Patient-Centered Primary Care Collaborative suggests there is a need for integrating comprehensive medication management within the Patient-Centered Medical Home (PCMH) ,6. PharmA quasi-experimental pre- post-study design was used to implement the 12-week My Rx program. Teams of thirteen pharmacists and four health educators were matched to participants based on cultural/ethnic similarity and language. Baseline and follow-up assessments included: blood pressure and/or A1C screening, knowledge of hypertension and/ or diabetes, and behavioral intention related to medication adherence. A thematic analysis of participants program satisfaction was obtained through focus groups at each facility . The stuThe My Rx program took place in four senior public housing facilities operated by the Houston Housing Authority (HHA). Inclusion criteria were age 55 and older, self-identification as either African American, Asian, or Hispanic, resident of the targeted facilities, access to a telephone, and taking at least one medication for diabetes and/ or hypertension at the time of recruitment.A diverse workgroup guided program development through monthly meetings. Membership included nine residence council members , three HHA managers (1/facility), three coalition members , and four My Rx staff.A list of evidenced-based strategies was provided to the workgroup for consideration. A decision was made through a consensus building process to implement a program model that combined group health education classes and telephone and in-home counseling. The workgroup also determined the length, frequency, and dosage of the program.Bilingual health educators who were employed by the local county hospital system led the program due to their established working relationships with the facilities. Thirteen bilingual pharmacists were recruited from a local network of university pharmacy student preceptors. The pharmacists completed 20 hours of motivational interviewing training conducted by the health educators and online health literacy, hypertension, and diabetes management training. Both pharmacists and health educators were fluent in Spanish, Vietnamese, Mandarin, or Cantonese.The 12-week intervention included a pharmacist-led home visit and two telephone consultations. Pharmacists were assigned participants based on the shared languages spoken. The one-hour home visit involved a comprehensive medication review and a medication list for the patient to keep. Participants were provided a pillbox that could be used during the session to demonstrate how to sort their medication for the week and a pill cutter for use when needed. Telephone follow-up calls occurred two weeks after each group health education session.Myplate.gov nutrition education series. Participants were taught the benefits of eating healthy, balancing calories, portion control, how to read food labels, and how to tailor their diet to their chronic disease. In the “Being Active and Managing Stress” session, participants received an overview of benefits and recommended exercises.The health educators provided two sessions using culturally tailored printed materials. The curriculum for the “Healthy Eating” session was adapted from the Small incentives were provided throughout the program. After the program, participants were provided a $15 gift card to a local store to purchase groceries or home goods as an incentive for participation.MyRx staff facilitated focus groups at each facility following the program’s completion. A 13-item questionnaire was used to guide the focus group discussions. Themes captured through the questionnaire focused on the participants’ view of the program’s in-home setting, program delivery method, program satisfaction, and behavioral intentions to adopt a healthy lifestyle.A total of 51 participants enrolled in the program, and 38 completed the program for an attrition rate of 25%. Overall, seniors were satisfied with the program, had an appreciation for individual counseling, and were likely to change behavior with ongoing interactions with a health care professional. This program integrates pharmacists and health educator teams to improve patient care. Research indicates the value of interdisciplinary approaches to chronic disease state management ,12. ThisQualitative analysis of focus group discussions revealed participant satisfaction with the MY Rx program and willingness to change as a result of participation in the program. Future studies should be conducted over a more extended time to determine pharmacists and health educators’ clinical impact. Additional recommendations include further analysis of the professional team dynamics and analysis of participants’ satisfaction with processes used to engage them in planning.


Stakeholder involvement in research has been demonstrated to increase the effectiveness, validity, and quality of a study. This paper describes the engagement of a stakeholder panel in the development and implementation of an animal-assisted intervention (AAI) assessment and program for children diagnosed with Autism Spectrum Disorder (ASD). Canines for Autism Activity and Nutrition (CAAN) aims to promote physical activity and wellness among children diagnosed with ASD by integrating activities with their pet dog during the child's ongoing Applied Behavioral Analysis (ABA) in-home therapy sessions. Feedback from stakeholders guided program development at each stage of the research process, including this publication. Utilizing a stakeholder-informed approach was essential for the development of assessment tools, program materials, and program design. Methods that may assist others to effectively partner with stakeholders to implement an AAI among children diagnosed with ASD or related disorders are described. Stakeholder engagement is a rapidly expanding approach to program development and applied research which has been demonstrated to increase the effectiveness, validity, and quality of a study , 2 and hThe purpose of the AAI, Canines for Autism Activity and Nutrition (CAAN), is to promote physical activity and healthy eating behaviors in youth with Autism Spectrum Disorder (ASD) delivered by applied behavioral analysis (ABA) therapists with the family pet dog in home settings. Children and adolescents diagnosed with ASD are at an increased risk of overweight or obesity compared to their peers , 10. FooIn child obesity prevention programs, stakeholder engagement in the development phase has been shown to support positive outcomes and improve intervention acceptance, inclusion of underrepresented populations, and participant engagement , 18. WheThe purpose of this paper is to describe the use and impact of a stakeholder panel in the development and planned implementation of the CAAN obesity prevention program for youth with ASD and their pet dogs. Specifically, we hope to provide information that will be helpful to other researchers considering a stakeholder-engaged approach to their investigations and to lay the groundwork for future research. The paper will explore how a stakeholder panel can be used effectively, discuss lessons learned during the process, and serve as additional support for the benefits of stakeholder engagement, particularly in AAI.At the beginning of the CAAN project, co-investigators identified that stakeholders would be critical to the successful development of the intervention. At the time of proposal development for grant funding, stakeholder engagement was included as a prominent aspect of the research approach, incorporated into the aims and budget of the grant. The individuals identified with relevant experience and expertise in one or more aspects of the project were invited to serve on the stakeholder panel, provide feedback on the proposal, and provide letters of support to submit with the proposal. In addition, two ABA service providers were contacted to serve as recruitment sites in the active pilot phase of the project. Following this partnership, an additional stakeholder from one of the agencies was identified and asked to join the stakeholder panel after the grant was funded and intervention development began.The investigative team includes a diverse group of multidisciplinary faculty members that identified stakeholders who would complement the investigative team's strengths and backgrounds. Dr. Linder is a board-certified veterinary nutritionist at the Tufts University Cummings School of Veterinary Medicine as well as co-director of the Tufts Institute for Human-Animal Interaction who brought knowledge and experience in AAI, pet obesity, and nutritional management to the project. Dr. Mulé is a pediatric psychologist who at the time of the study provided care at the Center for Children with Special Needs at Tufts Medical Center. She also has extensive expertise in the diagnosis and treatment of ASD, physical activity promotion in autism, as well as stakeholder engagement. Dr. Must is a nutritional epidemiologist whose research efforts focus on observational and intervention studies of obesity in vulnerable populations, with an emphasis on youth with developmental disabilities. She serves as co-director of the Department of Health and Human Services Maternal and Child Health Bureau's Healthy Weight Research Network for Children with Autism and other Developmental Disabilities. She brought expertise on interventions for this population. Dr. Folta is a behavioral scientist who developed and disseminated the Strong Women–Healthy Hearts Program, a community nutrition and physical activity program for older women. She brought expertise in qualitative research methods and has extensive experience conducting in-depth interviews among youth with autism. Dr. Cash is an economist whose work with interdisciplinary teams focuses on economic aspects of behavior around food and nutrition and is the parent of a child with autism. His work includes investigating how children behave when engaging in autonomous food purchasing activities and developing child food literacy measures. Drs. Mulé, Must, and Folta all have previously used stakeholder-engaged approaches in their research.Based on the research and clinical background of the investigative team, an objective for the stakeholder panel was to include perspectives from individuals with practical and personal experience with various areas of the project: specifically, ASD, ABA, and AAI. To this end, the diverse stakeholder panel included: a provider of AAI (Debra Gibbs), two Board Certified Behavior Analysts , two parents of children with ASD , and a young adult with ASD . Debra Gibbs, Animal-Assisted Programs Coordinator at the Tufts Institute for Human-Animal Interaction, is a licensed Pet Partners Handler instructor with years of experience in evaluating the safety and efficacy of human-animal partnerships for AAI. More specifically, she is also involved in AAI work for children with disabilities. Dr. Candice Colón is a BCBA-D who specializes in ABA research and the assessment and treatment of behavioral challenges for children diagnosed with ASD and provided a hands-on perspective to the panel. Edward Sanabria, also a BCBA, specializes in the integration of behavior analytic interventions in the home and community settings for children diagnosed with ASD. The two parents of children with ASD are Sandy Sullivan and Terri Farrell, each with different backgrounds and insight into raising a child with ASD. Sandy and her daughter primarily experienced challenges with language development and behavior regulation while issues with weight maintenance were emerging in the background. Terri Farrell works for the Autism Insurance Resource Center at the University of Massachusetts Chan Medical School and is the parent of a young adult with ASD and owner of two pet dogs. She has been active in several autism advocacy groups, has personal experience observing the relationships between pet dogs and her child with autism, and has professional experience working with other families and insurance agencies. Our final stakeholders were, Jeremy Nesbit, a young adult with ASD, who brought his valuable perspective on the intervention and emphasized key areas of social validity along with his mother, Jennifer Nesbit, who attended meetings with him.The stakeholder panel met with the investigative team in-person or by telephone or videoconference four times over the project year . Agendas for each meeting were created to follow the project's larger goal for intervention development .Stakeholder engagement impacted CAAN in three major domains: development of materials, development of program modules and planned implementation of the intervention, and planned assessment of the intervention.The first stakeholder meeting was used to review the facilitator's guide. A draft was shared with stakeholders in advance of the meeting so that members had time to prepare thoughtful feedback. During the meeting, stakeholders were asked to share their initial impressions of the facilitator's guide, feasibility concerns/appropriateness of the intervention for children with ASD, and personal experiences related to working with children with ASD and AAI. A discussion followed for how these experiences should be incorporated or accounted for in the guide. Following this meeting, the facilitator's guide was revised based on stakeholder input. Specifically, feedback from stakeholders informed who would be the primary implementers of the program and eligibility considerations for participating families and ABA therapists. The feedback led to the refinement of the specific skills and qualities to look for in an ABA therapist, and to focus more heavily on the ABA therapist. Additionally, the stakeholders provided input on the usability of the materials, such as including a table of contents, which was added as the result of a stakeholder suggestion.The third stakeholder meeting was used to review and refine the final draft of materials. The revised facilitator's guide was shared with the stakeholder panel prior to meeting. During the meeting, stakeholders were asked to share their perspectives on how the guide could be further strengthened. At this meeting, barriers and facilitators to the success of the program were discussed and identified, which led to the addition and improvement of an additional section in the guide for strategies to troubleshoot challenges that could arise, such as the dog as a potential distraction during treatment and on-site injuries that would include financial and liability considerations. Critical factors of support that stakeholders identified were clarity and ease of use of the guide and that the treatment be evidence-based. Following this meeting the guide was revised based on stakeholder input. Specifically, the guide was revised to include specific information for BCBAs, which clarified how the program could be integrated by the practitioner into their client's existing treatment plan. See The second stakeholder meeting was used to review the three modules that comprise the AAI. During this meeting, stakeholders were asked to provide their feedback that focused on the appropriateness of the intervention for children with ASD in an ABA setting as well as any feasibility concerns. Following this meeting, modules were revised based on stakeholder input. Specifically, modifications were made to make the module instructions more specific, as a stakeholder noted that many children diagnosed with ASD generally prefer for everything to be as concrete as possible in a plan. Additionally, based on feedback, contingency plans were included for what would happen if implementation of the module did not proceed as described. For example, if the task is too difficult for the child or if the dog has eaten just prior to the session. Once revisions were made, revised documents were circulated to the stakeholder panel for a second round of review.During the third meeting, the modules and implementation plan were also reviewed with stakeholders to further strengthen this component. As with the facilitator's guide, the critical factors that were focused on—to increase the likelihood of support and commitment from ABA service providers—were clarity, minimal response effort, and ease of integration into existing ABA treatment plans. The modules were again revised after this meeting to incorporate this stakeholder input. In particular, the modules were amended to allow BCBAs the flexibility to individualize ABA teaching strategies used to implement the AAI program.Lastly, a fourth meeting was held to discuss how the program could be adapted in relation to the COVID-19 pandemic. This meeting was conducted via videoconference. The transition to videoconference could potentially increase the feasibility of organizing stakeholder meetings, especially for stakeholders who live far away. Stakeholders and the investigative team acknowledged and discussed the specific difficulties that COVID-19 could bring to families with a child with ASD and further modified the program modules to incorporate mask-wearing and social distancing and to ensure compliance with Centers for Disease Control and Prevention (CDC) guidelines for the safety of all participants during in-home ABA therapy. The decision was made to rely on the ABA service providers to determine when families felt comfortable having in-person sessions again, even after any federal or state social distancing measures or guidelines were eased. Additionally, the decision not to transition the program to a virtual format was discussed with stakeholders; it was agreed upon that even if the research could be conducted in person, the results could be influenced by the disruptive nature of COVID-19. See During the fourth meeting, stakeholders were also asked to share their opinions on the post-intervention in-depth interview guide and usability scales. The usability rating scales, namely the Usage Rating Profile  and ChilA stakeholder engagement approach was essential for the development of the CAAN program; it also proved to be very feasible, as the benefits to program design, implementation, and distribution far outweighed the monetary or time costs of engaging the stakeholder panel. As detailed in Stakeholder input was integral to the development of planned assessment and intervention inclusive of program materials to ensure applicability and feasibility of the CAAN program. The facilitator's guide, program modules, and interview guide were greatly strengthened and improved by feedback and guidance from the stakeholder panel. Collaboration with a diverse stakeholder panel and allowing each member of the panel to freely contribute new insights (that might have otherwise been overlooked by an investigative team) were invaluable, especially when developing novel interventions and pilot studies. The importance of the multidisciplinary aspect of the stakeholder panel cannot be overstated, as members of the panel were able to draw upon their unique expertise to provide input and feedback. Various technical aspects of the intervention were modified and further developed to have the greatest feasibility for use with the respective population within their current individualized treatment plan. In addition to technical feedback, the stakeholder panel was instrumental in guiding the larger study design and had a major role in developing the intervention. The experiences described in this paper highlight the impact and importance of stakeholder engagement in complex interventions such as AAI in populations with unique needs such as children with ASD. It is the intention of the authors that publication of this stakeholder-engaged approach will contribute to the growing body of evidence in support of stakeholder inclusion in the design and implementation of future research.The next step in the CAAN program will be to pilot the CAAN intervention among families that have a child with ASD, a family pet dog, and currently receive in-home ABA therapy. As part of that pilot implementation, an assessment will be conducted with ABA service providers, parents, and youth participants with ASD utilizing the stakeholder-informed interview guides. Future plans for the stakeholder panel include inviting stakeholders to participate in the next stage of the CAAN research program. This will include reviewing findings from the assessment of the pilot intervention and consideration of additional grant proposals and study design for a future randomized clinical trial of the intervention. Lastly, stakeholders will also have the opportunity to provide input on future dissemination of results. For publications such as this one describing stakeholder engagement, stakeholders have been engaged as co-authors. The project stakeholders also intend to participate in disseminating results to non-scientific audiences such as parent support groups and advocacy groups. They may also present results at local or national meetings of ASD, ABA or AAI professional organizations.Future directions also include an evaluation of the impact of the stakeholder panel on the effectiveness of the program and its outcomes, which could be achieved by including members of the research team and members of the stakeholder panel in qualitative interviews as a part of the planned future pilot intervention. In addition to the interviews, the research team will assess the degree to which study materials and procedures changed based on advice from the stakeholder panel. Additionally, engagement with study findings will be considered, including the relative reach of traditional dissemination vs. the more holistic approach taken by the stakeholder panel. Because the research team has involved the stakeholder panel at all stages of the study, it will be difficult to uncouple the effectiveness of the program from the panel. However, these measures should provide valuable insights into the effectiveness of a stakeholder-engaged approach. Our intent is to pilot the intervention itself with families and to evaluate the overall stakeholder-engaged approach and its impact on the program outcomes.Utilizing a stakeholder-informed approach to develop an AAI increased the feasibility and potential effectiveness of the intervention through input into three main activities of the research team: materials development, program implementation, and development of assessment tools. The research team believes that this stakeholder-engaged approach will lead to greater potential uptake by ABA agencies, which will make the intervention more accessible to children receiving ABA therapy for treatment related to their ASD diagnosis. The experiences outlined in this paper highlight the impact and importance of stakeholder engagement in complex interventions such as AAI in populations with unique needs such as children diagnosed with ASD. The authors of this paper, which include the investigative team and members of the stakeholder panel, would like to emphasize a call to action for future AAI to consider incorporating a stakeholder panel into their study designs to drive the social validity and feasibility of such interventions with various unique populations.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.DL, SF, AM, CM, and SC designed research. DL, SF, AM, CM, SC, EH, CC, SS, ES, DG, and TF contributed to manuscript preparation. DL had primary responsibility for final content. All authors read and approved the final manuscript.The project described was supported by the Tufts Institute for Global Obesity Research (TIGOR), the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UL1TR002544, and the Healthy Weight Research Network, Health Resources and Services Administration, and Maternal and Child Health Bureau (UA3MC25735).The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.DL is a faculty advisor and DG is the program coordinator for a Pet Partner Community Partners group at Tufts University. DG is also a Pet Partners trainer and evaluator. CC was employed by company Behavioral Concepts, Inc. ES was employed by company Perfect Piece LLC. 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. The funders were not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.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.


Although non-significant, the scores in the remaining outcomes indicated a general positive trend in emotional dysregulation, mental health, and life satisfaction. The adapted DBT STEPS-A was very well-accepted and helped overcome some emotional regulation difficulties in Spanish adolescents.Emotional dysregulation is a key factor in the development and maintenance of multiple disabling mental disorders through a person’s lifespan. Therefore, there is an urgent need to prevent emotional dysregulation as early as possible. The main aim of this study was to evaluate the acceptability and preliminary effectiveness of an adapted Dialectical Behavior Therapy Skills Training program for Emotional Problem Solving in Adolescents (DBT STEPS-A) during secondary school. The sample included 93 adolescents  studying in their 2nd year of secondary school in a public center in Catalonia (Spain). Measures of acceptability, difficulties of emotional regulation, mental health problems, and life satisfaction were completed before and after participation in the DBT STEPS-A program during one academic year. The majority of students rated the program as useful (64%) and enjoyed the classes (62%) and 48% of them reported practicing the newly learned skills. Statistically significant improvements were revealed in some emotional regulation-related variables, namely the number of peer problems ( Difficulties in emotional regulation play a key role in the development and maintenance of numerous emotional disorders . These eSchools are considered adequate environments for the implementation of mental health promotion programs, as they serve as a natural and accessible way to reach young people . StudentDialectical Behavior Therapy (DBT) ,14 is anWith respect to the effectiveness of DBT programs for adolescents in the educational system, Zapolski and Gregory  conducteEven though a few adaptations of DBT have shown encouraging findings in relation to emotional dysregulation in adolescents during school, rigorous studies are needed to replicate and enhance the reliability of the results. Furthermore, although one study has evaluated the effectiveness of the DBT STEPS-A program in a sample of Spanish-speaking young adults, to the best of our knowledge, there are no studies that have investigated the DBT STEPS-A specifically for adolescents in Spanish-speaking countries. The main goal of the study was to evaluate the acceptability and preliminary effectiveness of an adapted DBT STEPS-A program during one academic year in a sample of students attending secondary school in a public educational center in Catalonia (Spain). Our main hypothesis was that the adapted DBT STEPS-A treatment would be well accepted by students, as measured by an anonymous satisfaction survey combining quantitative and qualitative data at the end of the program. Secondly, after the implementation of a quasi-experimental design, we expected that the program would result in significant improvements in emotional dysregulation, psychopathology , and satisfaction with life.The total sample was composed of 93 students from four school groups (range of 24–27 students per group) studying in their second year of secondary school in a public school in Terrassa . Given that the curriculum is designed at a universal level, all the students of the four groups received the program, which was implemented during the academic schedule. The characteristics of the sample are detailed in the results section. Because this is a pilot study with a convenience sample, no a priori sample size calculation was made.Acceptability and skills practice: A 12-item anonymous survey developed by the research team was administered to measure acceptability of the adapted DBT STEPS-A intervention. Questions regarding DBT STEPS-A skills practice were also included. In addition to the quantitative questions, four qualitative questions were added. The survey questions are detailed in the results section. This survey was evaluated at the end of the program.Satisfaction with life: The Satisfaction with Life Scale (SWLS) , which hMental health difficulties and strengths: The Strengths and Difficulties Questionnaire (SDQ)  was admiDifficulties in Emotional Regulation: The Difficulties in Emotional Regulation Scale (DERS)  was seleA public school from Terrassa (Barcelona) was selected to conduct this pilot study within a larger co-funded project  “Health Care Innovation Lab Orbital 40”), which aimed to evaluate efficacy of the DBT STEPS-A program in different schools of Terrassa, Barcelona (Spain). The ethical committee of the Hospital General of Catalonia  approved the study procedures (2017/05-PSQ-HGC).The head teacher and the schoolteachers were informed about the study by the research team. The teachers received an introductory training course on DBT STEPS-A (8 h) by two intensively trained DBT therapists before conducting the study. The adapted DBT STEPS-A program in the public secondary school was conducted by two clinical psychologists working at the Personality Disorders Unit of the Hospital General of Catalonia . One of the psychologists (not an author on this manuscript) was trained in the United States of America (USA) by the treatment developers of the DBT-STEPS-A, and the other clinical psychologist (X.G.) was trained by another psychologist trained in the USA (M.V.N.-H.). Trained teachers participated as observers and co-teachers during the program to learn how to teach the skills during the following academic year.Adolescents and their caregivers were informed of the study in-person at the beginning of the academic year (September 2019) and, if they were interested in participating, caregivers signed an informed consent to accept the participation of the adolescent. The instruments detailed above were administered via an online survey before (September 2019) and after the program (November 2020). The academic course usually ends in June and students have a vacation period until September. However, due to the COVID-19 restrictions, the program was interrupted for three months starting from March 2020. Therefore, the academic and research team decided to extend the program for three months in the following academic year, so the students finished the DBT STEPS-A sessions by the end of November 2020, as opposed to June as originally planned. During the COVID-19 lockdown, the students were sent a set of video pills to help them review and practice the skills that they had learned until lockdown.All the students received the adapted DBT STEPS-A lessons during the academic schedule. Previously, the head teacher and the teachers discussed the best strategy to include the DBT STEPS-A program into the course curriculum. Due to similarities in the general learning goals, the academic team decided to include this program in the context of the “Ethical Values” course.Adapted DBT STEPS-A : The DBTAlthough the length, contents, and structure of the program were respected, some adaptations were done from the original program. Firstly, the contents were translated into Spanish by two intensively trained DBT clinicians. Secondly, the lessons were taught by clinical psychologists instead of teachers. Teachers were observers and, if needed, acted as co-teachers. The lessons were taught by the psychologists to train teachers so that they could apply the program in the following year. Finally, some of the contents were shortened for time reasons. The adapted DBT STEPS-A 30-lesson curriculum is presented in p-value of ≤0.01 was considered statistically significant. Effect sizes were calculated with Cohen’s d. With respect to the quantitative data, descriptive statistics were calculated for demographic characteristics, satisfaction with the program, and effectiveness outcomes. To compare statistical differences between pre- and post-intervention instrument scores, a non-parametric signed-rank Wilcoxon test was conducted because some of the data did not show homogeneity of variances and/or a normal distribution. A On the other hand, to analyze the qualitative data, a replication process based on the principles of thematic analysis was used . First, The total sample was composed of 93 adolescents studying in their second year of secondary school. The participants’ age ranged from 12 to 15 years  and the gender distribution was 53% females and 47% males. Although 93 students completed the pre-assessment measures, only 51 of them completed the post-assessment as well. The reasons for non-completion varied: 15 students were at home the day of the post-assessment due to COVID-19 restrictions , 14 survey responses were not valid due to incompleteness, and 13 students preferred not to answer. As presented in “that we can learn about ourselves and learn ways to regulate our emotions in everyday situations”, as well as “that we can express our feelings”, and “skills are interesting and help us to feel better”. In addition, another participant commented that they liked “when we do activities in which we can participate and we all laugh a lot”. On the other hand, some of the negative comments regarding the program included the perceived amount of homework that the students were asked to do, the difficulties in performing the Mindfulness skills, and the theoretical aspects of the class. In terms of homework and theoretical classes, the participants reported: “I didn’t like doing homework because it was difficult” and “sometimes there is a lot of theory and sometimes it takes a long time”. On the other hand, regarding Mindfulness, the concerns were that “maybe there are people who like it, but I don’t fit in that group” and “staring at something or being with my eyes closed makes me dizzy”;Pros and Cons: Different pros and cons about the emotional regulation training program were found in the sample of adolescents. On the one hand, the program was perceived positively due to the repertoire of skills learned. Being able to communicate and express thoughts and emotions with others, increasing pleasant emotions, the usefulness of these skills, and the participation in activities during the program were the most frequently reported benefits. What the participants liked most about this program was: more doing things instead of writing things down”, “more participation and less theory, more everyday examples”, “do more activities and examples”, “more participation activities”, and “we should do more practices by standing in front of the class”;Areas for improvement: Doing practical exercises during the theoretical classes was an important aspect in the perception of program satisfaction. The participants reported that they would have liked more practical exercises in class, instead of written exercises, as well as a greater variety of examples to be included into the theoretical explanations. The teenagers’ comments were as follows: “it has helped me to relax when I get angry”, “the truth is that there are times when the course has helped me a lot, as I am a guy who gets nervous quickly, and the breathing and getting into the cold water was very useful”, and “the course has helped me solve and manage problems”. One of the participants said that “this course has helped me a lot to understand reactions that I myself had and did not know why; with this course I have understood that feelings cannot be controlled, but they can be regulated”.Participants’ general opinions: Some of the participants reported that the emotional regulation skills program helped them to make decisions and manage problems, to regulate anger and anxiety, to understand emotional reactions, to know the process of emotional regulation, and to resolve interpersonal conflicts. The participants mentioned that “Questions regarding the qualitative variables of the satisfaction survey are detailed in “This lockdown has been a bit hard. Although I am an indoor person, staying with my parents 24/7 for 3 months has made it much easier for us to get angry, and, actually, practicing emotional regulation has saved me a lot of trouble with them” and “during the lockdown, the course has helped me a lot to relax and to not stress too much”.Furthermore, several adolescents have referred to the use of skills during the COVID-19 restrictions. Specifically, they commented on the utility of the skills in regulating their emotions: With respect to the adolescents’ Satisfaction with Life Scale (SWLS), as seen in p < 0.05) and effect sizes were small (Cohen’s d below 0.20). A significant effect, particularly a decrease, occurred in peer problems from pre- (cut-off 3 “slightly raised”) to post-test (cut-off 0–2 “close to average”) with a medium effect size . In the same line, a statistically significant increase from pre- (cut-off 6 “slightly lowered”) to post-intervention (cut-off 7–10 “close to average”) in prosocial behavior was found and this effect was large . Regarding mental health difficulties (SDQ), pre- and post- mean scores on emotional, conduct, hyperactivity/inattention problem subscales, as well as total difficulties score correspond with cut-offs “close to average” , thus inFinally, in relation to the Difficulties in Emotional Regulation Scale (DERS), the means of the DERS total score in our sample were slightly above the normative means in Spanish samples . The resThe main aim of this research study was to evaluate the acceptability and preliminary effectiveness of an adapted DBT STEPS-A program, in order to prevent emotional dysregulation and increase resilience at a universal level in a Spanish sample of students attending secondary school in a public educational center. To our knowledge, there are only two published studies that have evaluated the effectiveness of a DBT STEPS-A program for adolescents in the school system. The main findings of these studies suggest that this program has been well accepted by students and that the program might help reduce emotional dysregulation and improve social resilience in adolescents at a universal level. In this regard, research shows that when interventions are delivered at a universal level, relatively more severe and at-risk young persons may be screened for mental health concerns and provided with support ,37. TherWe hypothesized that students would show good acceptance of the adapted DBT STEPS-A program, as measured by a satisfaction survey. The results of this study showed that most adolescents thought that the emotional regulation course was useful for life, and they enjoyed the classes. Students also rated teacher performance and the course as remarkable. In addition, half of them have used the learned DBT STEPS-A skills since the course started. These findings are interesting since only one study evaluating DBT skills-use found good feasibility outcomes . Includiconsiderate of other people’s feelings; often volunteers to help others) and decreased in peer problems . To our knowledge, only one study measured social variables and also encountered significant improvements in social resiliency  [Secondly, we expected that the adapted DBT STEPS-A would lead to significant differences in emotional dysregulation dimensions , general symptoms of psychopathology , and satisfaction with life when comparing before and after the program. Regarding the difficulties in emotional regulation (as measured by the DERS), there was a pre- to post-test decrease in all the variables . However, no statistically significant differences were found in these DERS scales. These findings are in line with the results of the study by Flynn et al. which indicated that although difficulties in emotion regulation improved after a briefer DBT STEPS-A program, there were no statistically significant differences . Howeverempathy) . These rempathy)  and mighempathy) . Finallyempathy) , was notDespite there being good acceptability and a tendency to improve in several components after the DBT STEPS-A program, it is important to highlight that no statistically significant pre–post-improvements were found in the majority of the effectiveness outcomes and some of them showed small effect sizes. This might be due to a number of limitations. A possible explanation of the results would be that this program was delivered at a universal level. A review on the effectiveness of universal interventions has shown mixed results . In geneResearch suggests that the psychological well-being and mental health of adolescents should be the first target of every prevention plan. Emotional dysregulation has been shown to be a key etiology and maintenance factor for mental disorders in youth. DBT skills training has demonstrated good evidence to reduce emotional dysregulation in adolescents. The goal of this study was to evaluate the acceptability and preliminary effectiveness of a DBT skills program for Spanish adolescents in secondary school at a universal level. The general findings show good acceptance of the DBT STEPS-A and that the program could modestly help improve difficulties in emotional regulation, mental health difficulties , and life satisfaction in Spanish adolescents from the community. Evaluating the effectiveness of the DBT STEPS-A program in adolescents with higher scores on emotional dysregulation at baseline might help confirm if this program has a larger effect specifically on the difficulties in emotional regulation. Future studies including larger samples and control groups would also help replicate these results.


Benign anastomotic intestinal strictures are difficult to manage as there may be limited response to dilation. Fully covered self-expanding metal stents have been utilized in small case series; however, stent suturing is required due to the high risk of stent migration. Lumen-apposing metal stents (LAMS) are fully covered and have a novel dumbbell shape that prevents stent migration. Initial reports identify low migration rates and good clinical success rates. This is the first report of perforation following treatment of an ileosigmoid stricture in a 52-year-old female, three weeks after LAMS placement. Lumen-apposing metal stents (LAMS) are fully covered dumb-bell shape stents with flanged ends that were originally designed to drain pancreatic fluid collection . IntestiA 52-year-old female had a past medical history of ischemic pancolitis with transmural necrosis of the splenic flexure, status post subtotal colectomy with end ileostomy and subsequent takedown with ileosigmoid anastomosis. She presented with abdominal pain, nausea and vomiting. CT of the abdomen showed small bowel obstruction at the ileosigmoid anastomosis level Figure . FlexiblThree weeks later, the patient presented to the emergency room with severe abdominal pain. CT of the abdomen showed small bowel obstruction with multiple foci of intraperitoneal air concerning for perforation Figure  and a 6 Anastomotic strictures often present a management challenge. Endoscopic balloon dilation with or without steroid injection is typically the first-line therapy for gastrointestinal (GI) anastomotic strictures. Temporary placement of fully covered SEMS has been utilized for the treatment of upper intestinal tract anastomotic strictures; however, endoscopic suturing of the stent to the intestinal wall to prevent stent migration is required . FrequenYang et al identified a clinical success rate of 64% in a retrospective study of 30 patients treated with LAMS for benign gastrointestinal strictures . Irani eAlthough LAMS placements are well-tolerated procedures, they are not free of complications. Adverse events with LAMS included abdominal pain with subsequent ulceration identified at the time of stent removal from the site of gastrojejunal anastomotic strictures, in two of 25 patients, one to three weeks after stent placement . In anotAdditional adverse events reported in extensive review analysis of the literature available until 2017 were bleeding, vomiting, stent migration, death, and formation of new strictures proximal to the LAMS. In this review, they also included one study in which a perforation happened immediately after the procedure requiring surgery that they considered a technical failure . Here weManaging anastomotic strictures often present a great challenge. Endoscopic balloon dilation with or without steroid injection is first-line therapy. Temporary placing fully covered SEMS is another option; however, has its own limitations and complications. On the other hand, lumen-apposing metal stents (LAMS) provide another approach to manage gastrointestinal strictures. It has great therapeutic potential with its novel dumbbell shape; however, ulceration and perforation are major concerns that require further consideration of the optimal design of the stent design for this indication.