Objectives: Children often have a lack of dementia understanding and poor attitudes toward people with dementia. Intergenerational programs are increasingly common, but the effects on knowledge and attitudes related to dementia are mixed, especially in the long-term (6 months). Using a RE-AIM framework, we quantitatively evaluated the effects of an educational dementia program  on dementia attitudes in the short and long-term, and qualitatively, which elements of the program facilitated this change.Methods: Eighty-one children  from three classes participated in an 8-week dementia education program and 52 also interacted with older adults through an intergenerational experience. Program reach was measured as the percentage of children who participated in the study. The Kids Insight into Dementia Survey (KIDS) was implemented to measure dementia knowledge and attitudes: efficacy and maintenance. Qualitative interviews with all participant groups informed both adoption and implementation. Cost-benefit analysis was used as a secondary outcome measure for efficacy.Results: The program demonstrated strong levels of impact reaching 93% of school children across the three included classes. Efficacy was demonstrated by a positive change in children's dementia knowledge and attitudes immediately post program, which remained increased (as compared to baseline) 6- months post intervention; there were no differences between groups (those who interacted with older adults and those who did not). Interviews identified positive changes in children's empathy and improved community awareness. Barriers to adoption included the project scope, time constraints incurred by school terms and the management of children-to-adult ratios.Conclusions: These findings provide the first evidence that school-based dementia education improves knowledge of and attitudes toward people with dementia long-term. We demonstrated programs such as this can be successful in both primary school and wider community settings, with support from school and community partners key to the success. People living with dementia often experience loneliness and stigma, potentially leading to a withdrawal from social activities and delays in seeking a formal diagnosis . A lack Community education programs have been developed and implemented to improve dementia knowledge and attitudes. Target populations for these programs have typically been general practitioners , public According to one government survey, as many as one-third of British children aged 8–17 years knew someone living with dementia, but two-thirds indicated a lack of dementia knowledge prevented them from assisting these individuals . SimilarA second evidence-based method used to increase children's dementia knowledge and attitudes is engaging children and older adults together in structured intergenerational programs . The proThe purpose of this study was to evaluate an 8-week school-based dementia education program with 6-weeks of embedded intergenerational interaction using the RE-AIM framework . The proRE-AIM is an evaluation framework, often used in health promotion, and broad public health initiatives . BrieflyTaken together, the predominant aim of this study was to evaluate the overall real-world sustainability and success of combining school-based dementia education with intergenerational excursions to guide future program development.Three year 4/5 classes at a publicly funded co-educational primary school participated in an 8-week, school-based dementia educational program. Two classes were also invited to attend six intergenerational excursions held at a social-day program for older adults living in independently in the community with cognitive impairment (commonly dementia).This study was approved by the University of South Australia Human Research Ethics committee (protocol no. 20070). All participants  provided informed written consent. Where participants were unable to consent for themselves  they provided assent and consent was provided by a parent or legal guardian.We employed a non-randomized, mixed methods, quasi-experimental evaluation approach whereby all students participated in dementia education lessons and two classes also attended the excursions. The allocation of classes to the excursion was non-randomized based on timetabling and excursion availability.The dementia education program was modified and extended from the Kids4Dementia (K4D) content previously developed by teachers, children, people living with dementia, carers and academics . To compThe intergenerational experience was based around “the corner store” theme. This provided an opportunity for participants to discuss their experiences of shopping, and for the older adults, to share with the students how these shopping experiences had changed over their lifetime. Activities were led by Enabling Confidence at Home (ECH) activity and lifestyle staff, and commissioned community artists. Examples included flower pot planting, 8-ball, dyeing fabric (cyanotype) to make re-usable shopping bags, and group singing. Students were split into smaller groups to reduce noise throughout the center. Each student group were assigned a different activity each week, however, there was no structured grouping of children and adults.Dementia education was led by University trained lecturers who had research expertise in dementia. One lesson was delivered each week (45 min) for 8 weeks in term 1 2018 (February – April).n = 52 students) from week 3 of the program. Each excursion was 45 min in duration. The class that did not attend the intergenerational excursions (29 students) participated in similar art activities at the school, facilitated by ECH staff and community artists, but without the older adults.Excursions began for two classes (Reach was assessed as the number of children who participated in the classroom lessons. Demographic characteristics (including previous dementia knowledge/familiarity) of the children were self-reported in class before and immediately after the program. Due to fluctuating attendance at the social day program it was not possible to assess the attendance of all older adults who attended the sessions. However, a core group were observed to participate during all sessions.To assess efficacy or change in children's dementia knowledge and attitudes the Kids Insight into Dementia Survey (KIDS) was completed individually under test conditions in a classroom environment at baseline, program completion and 6-month follow-up. KIDS provides good validity and internal consistency, strong concurrent validity and strong correlations with an adult measure of dementia attitudes in children aged 9–13 years (grades 4–7) . The 14 Following the removal of incomplete data and outliers, a one-way ANOVA was conducted with KIDS baseline total score as the dependent variable and knowledge or no knowledge of dementia as the independent variable see . Subsequpost-hoc pairwise comparisons adjusted for multiple comparisons with Bonferroni corrections. Normal distribution and homogeneity of variance of the data were assessed using the Kolmogorov-Smirnov test and Levene's statistic, respectively. Effect sizes were estimated with partial eta-squared . In ANCOVAs where assumptions of sphericity were violated, the critical value of F was adjusted using the Greenhouse-Geisser epsilon value. Unless otherwise stated all analyses were performed in SPSS v25 . Significance was accepted at p < 0.05 (prior to any correction).To investigate if the dementia education program was associated with a change in dementia knowledge and attitudes, the KIDS total and factor scores  were analyzed using separate mixed analyses of covariance (ANCOVA). The within-subjects factor was time  and the between subjects factor was condition (two levels: excursion or no excursion). All significant main effects and interactions were explored with In addition to the primary outcome of the KIDS score, secondary outcomes for parents, older adults and carers were assessed through semi-structured qualitative interviews. Parents/guardians and children were interviewed at a neutral location  during the school holidays immediately following program completion. Interviews typically lasted 20–30 min and covered topics such as expectations, impact, positives and negatives, potential improvements and examples of program translation to the home setting.Older adults and their carers' were also interviewed at program completion either within their own home, over the phone or at ECH. Interviews included open-ended and probing questions to gain insights into reasons behind program participation, participant experiences (both positive and negative aspects were probed), suggestions for program improvement and noticeable changes in the older adults observed by carers or family members.In addition to the interviews above, a cost benefit analysis of the program was also undertaken to provide a transparent method for assessing the “value for money” of the program. Cost data included: information on revenues received to run the program from Office of the Aging and additional in-kind resources reported from interviews with staff. Staff time was costed using data differentiated by Occupation from the Australian Bureau of Statistics Issue 6306.0 – Employee Earnings and Hours, Australia, May 2016. Prices were updated to 2018 prices using the Wage Price Index. Costs associated purely with the evaluation of the program were not included. The costs per unit of benefit were calculated by dividing the total cost of the program by the number of participants in the relevant groups.Interviews with key staff from all contributing organizations were held at the completion of the intervention. Responses to questions pertaining to suggested improvements, successful components and barriers were used to assess adoption through thematic analysis.Implementation was assessed by the project manager, who was onsite for all lessons and excursions. Lesson plans provided a reference for the lesson content that was delivered, and a checklist was developed for excursion activity stations. Key staff were also interviewed following the intervention to discuss issues with implementation at their respective organizations (as detailed in Adoption above).Individual level maintenance was determined as the 6-month follow up post scores on the KIDS survey for children. At the organizational level, semi-structured interviews with key staff identified the level of program related maintenance occurring at each organization as a result of the intervention.The three school classes had a combined enrolment of 87 students. Of these 81 parents provided consent for their child's data to be included in this evaluation . For equity purposes the remaining six children continued to participate in the program but their data were not used in the evaluation. Demographic characteristics for the children are presented in Twenty children reported having knowledge of dementia at baseline. Children who had knowledge or dementia familiarity at baseline .baseline , performF = 46.73, p < 0.001, partial η2 = 0.46). Post-hoc pairwise comparisons revealed improvement in dementia knowledge and attitudes from baseline to post-program (p = 0.001) and baseline to six-month follow-up (p < 0.001) (p = 0.21). There was also a main effect of dementia knowledge at baseline  and a time x dementia knowledge interaction . There was no augmentation effect of condition (excursion or no excursion).KIDS scores increased from baseline to post-program and was sustained at the 6-month follow-up (main effect of time: < 0.001)  but no d= 28.32, p < 0.001, partial η2 = 0.34), stigma  and knowledge . For both stigma and knowledge, post-hoc pairwise comparisons revealed this was due to significant improvement from pre to post-program (both p's < 0.001), and pre to 6-month follow-up (both p's < 0.001), but not from post to six-months follow-up (both p's = 1.00). For personhood, scores increased from pre to post (p < 0.001) and long-term follow-up (p < 0.001) and also from post to 6-month follow-up (p = 0.007). There were no other main effects or interactions for the individual factors . This is likely to be due to a combination of interpersonal complications that occurred during the program, and the progressive nature of participants' condition, rather than a negative effect of the program.You know sometimes I think I think I've been there, done that and it's out of your mind then, you know… But I can't recall that” Older Adult.“The costs associated with delivering the dementia education lessons and intergenerational excursions are estimated in Australian Dollars, AUD. These include both direct and in-direct costs and were estimated at $42,001 for the entire program. The direct costs incurred during the program included, set up and management costs , school programming costs  and intergenerational program costs . Direct program costs include estimations of implementing the art program (excursions), creating lesson plans and hire of charter buses. Indirect costs related to staff time used for program preparation , and implementation of the program . Costs for simply running the school-based dementia education program, without the intergenerational component were estimated at $7,919.n = 70), and those who had data available at 6-month follow up (n = 59). Together per unit of student benefit was estimated at $600 per student who demonstrated an increase in dementia knowledge and attitudes at post program when compared to baseline . The aged care partnership was more problematic, with two community based not for profit organizations offered the same opportunity. Both organizations provided initial quotes for their services (one for education component and one for art program) however due to the project requirements these partners withdrew their interest. A third partner was approached to assist with facilitating the excursions who accepted and was able to provide significant in kind staffing assistance to reduce the costs of excursions.Interviews with key staff from all organizations were overwhelmingly positive. Staff recognized that the successful partnership between all four organizations  was key to the success of the project as each partner provided their own lens in design, implementation and program support. Barriers that were raised throughout the interview series included noise at the center, the large number of children and subsequent high ratios of children to older adults (buddying or 2:1 preferable), and the distance to transport students to attend excursions.Education sessions were provided separately for all three classes by trained university researchers. Educational content was mapped to curriculum priority areas and shared with teachers prior to lessons occurring see . SessionSimilarly, excursions were also supported as a timetabled activity at the aged-care provider. With ECH agreeing to allow full access to their facility for the duration of the program, as well as sufficient time and staffing before and after sessions to allow for set up, and pack down of activity stations and art/music projects.p = 0.21; Results from the follow-up KIDS survey indicated there were no decline in KIDS scores from post-program to 6-month follow-up  and activity stations (with aged care staff) was one of the driving factors behind the successful implementation of the project. The co-location of settings, both in the school and in the aged-care facility also helped to ensure strong engagement from both the children and older adults, as they were familiar with the environment and viewed the intergenerational engagement as novel and exciting.These outcomes align strongly with the aims of the World Health Assembly's Global Action Plan on the public response to dementia 2017–2025 . In partThe strong maintenance effect at the individual level, as seen in this program is another key strength. It is possible that the detailed program of education, where the children received 6 h of education across 8 weeks led to this effect (45 min × 8 lessons). Across the 8 weeks, children were exposed to a range of topics including communication, environment, memories, cognitive reserve, sensory changes and prevention . In contIt was interesting to note, intergenerational experiences alongside the dementia education lessons did not have cumulative benefits for children's knowledge and attitudes. This suggests that dementia education alone is enough to change children's knowledge and attitudes in the following 6-months. Qualitative interviews with parents and children provided further important insights into the role of the intergenerational experience that were not captured with the KIDS. For example, interviewed parents reported additional benefits directly attributed to the intergenerational excursions such as: improvements in empathy, and reductions in children's negative judgement of older people and people living with dementia, within the community. Assessment of these additional benefits were not specifically targeted in the KIDS. One key difficultly commonly reported in intergenerational literature is how best to operationalise the benefits attributed to intergenerational interactions , 28.The cost burden of these types of studies was the main barrier for future implementation raised by the non-adopters of our program. While our calculations show a $600 AUD cost per student who demonstrated an increase in dementia knowledge/attitudes, there are alternative approaches to assist in reaching an economy of scale. For instance, program preparation has now occurred, with educational content created and mapped to the curriculum. Variable costs including student transport could be reduced or eliminated if school and providers were in close proximity to each other. It is important to note that some fixed costs will remain to ensure participant safety, such as staff to student/older adult ratios.The costs incurred per child appear to be within the range of similar programs run in pre-school or primary schools in Australia. Total costs for the Cool Little Kids intervention (designed to prevent anxiety and depression in preschool age children and incorporating six 90-min face to face group sessions with a psychologist) were similar at $549 per child . The intBy comparison, the costs appear higher than a volunteer-driven multicomponent intervention for people with dementia and their caregivers (£75 per dyad) . HoweverKey strengths of our program included its co-design with council, aged care and primary school teachers, co-implementation and evaluation based on the RE-AIM framework. A potential limitation not considered or controlled for in the current study, was how the classroom teachers extended and applied extra dementia education across other aspects of the curriculum, outside of the dementia lessons each week. Indeed, it is possible that the class not attending the excursions were exposed to more dementia education delivered by their classroom teacher, outside of the weekly lessons so the students did not feel disadvantaged by missing out on excursions each week. This may potentially account for the lack of differences we observed between the excursion and non-excursion classes. In future, controlling for, or keeping a record of how much time teachers spent discussing dementia, outside of the program should be considered. Future studies could also consider implementing the program across multiple schools instead of having the excursion and non-excursion groups within the same school.Whilst we show here that dementia education is sufficient to improve children's knowledge and attitudes 6-months after the completion of the program. It is possible that the specific benefits of the intergenerational excursions were not fully captured in our chosen primary outcome assessment. Building on the novel findings, future studies should consider further refining the intergenerational formats based on identified successful elements of other intergenerational dementia programs , 33–35. Using a RE-AIM evaluation approach, our findings suggest that 8-weeks of school-based dementia education can be successfully presented and implemented in a community setting. Such a program can significantly improve children's knowledge and attitudes toward dementia for at least 6 months. Importantly, improvements were seen for the total KIDS score as well as each of the individual factor scores of personhood, stigma and knowledge and no differences in knowledge or attitudes toward dementia occurred between the groups of students who interacted with older adults and those who did not. Given the absolute increase in the number of people living with dementia worldwide, programs of this nature will be important to improve dementia knowledge and reduce dementia-related misinformation and stigmatization of people living with dementia.De-identified datasets generated for this study are available on reasonable request to the corresponding author.The studies involving human participants were reviewed and approved by University of South Australia Human Research Ethics Committee. Written informed consent to participate in the study was provided by all participants. Where participants could not consent for themselves  written assent was obtained from the children and consent to participate in the study was provided by the participants' legal guardian/next of kin.AS planned the study, supervised the data analysis, and drafted the manuscript. GK, SL, and MH undertook data collection, cleaned the data, performed all statistical analyses, and contributed to revising the paper. JB helped plan the study, informed the educational program, and revised the manuscript. RM and JR supervised the economic analysis and revised the manuscript. TL and HK helped plan the study, contributed to educational program delivery, and revised the manuscript. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The aim of this project was to determine revenues and costs over time to assess the sustainability of the Baby Bridge program.The Baby Bridge program was developed to promote timely, consistent and high quality early therapy services for high-risk infants following neonatal intensive care unit (NICU) discharge. Key features of the Baby Bridge program were defined as: 1) having the therapist establish rapport with the family while in the NICU, 2) scheduling the first home visit within one week of discharge and continuing weekly visits until other services commence, 3) conducting comprehensive assessments to inform targeted interventions by a skilled, single provider, and 4) using a comprehensive therapeutic approach while collaborating with the NICU medical team and community therapy providers. The Baby Bridge program was implemented with infants hospitalized in an urban Level IV NICU from January 2016 to January 2018. The number of infants enrolled increased gradually over the first several months to reach the case-load capacity associated with one full-time therapist by mid-2017. Costs of the therapists delivering Baby Bridge services, travel, and equipment were tracked and compared with claim records of participants. The operational cost of Baby Bridge programming at capacity was estimated based on the completed and anticipated claims and reimbursement of therapy services as a means to inform possible scale-ups of the program.In 2016, the first year of programming, the Baby Bridge program experienced a loss of $26,460, with revenue to the program totaling $11,138 and expenses totaling $37,598. In 2017, the Baby Bridge program experienced a net positive income of $2,969, with revenues to the program totaling $53,989 and expenses totaling $51,020. By Spring 2017, 16 months after initiating Baby Bridge programming, program revenue began to exceed cost. It is projected that cumulative revenue would have exceeded cumulative costs by January 2019, 3 years following implementation. Net annual program income, once scaled up to capacity, would be approximately $16,308.There were initial losses during phase-in of Baby Bridge programming associated with operating far below capacity, yet the program achieved sustainability within 16 months of implementation. These costs related to implementation do not consider the potential cost reduction due to mitigated health burden for the community and families, particularly due to earlier receipt of therapy services, which is an important area for further inquiry. Preterm infants have a high risk of developmental delays, including motor, cognitive, and language difficulties, as well as behavioral and learning problems –3. The CAlthough therapy referrals at NICU discharge are the standard of care in most NICU settings –17 and dThe Baby Bridge program was developed as an implementation strategy aimed at ensuring early and continuous therapy services following NICU discharge for preterm infants with alterations in neurodevelopment until other community-based therapy services commence. The Baby Bridge program utilizes a specialized licensed therapist who sees the infant and family in the NICU prior to discharge, completes a comprehensive neurodevelopmental assessment to inform targeted interventions, and provides early therapy services in the home environment within one week of discharge and weekly thereafter, until other community-based services are initiated. The therapist also educates the family on ways to support their infant’s neurodevelopment between sessions and provides support and assistance during the transition from hospital to home. The Baby Bridge therapist also uses a comprehensive therapeutic approach and collaborates with the NICU medical team and community therapy providers.Previous work has demonstrated improvements in access to early therapy services with Baby Bridge programming . This prIn healthcare, many programs are implemented because they are believed to be beneficial, even when they are not cost effective. However, many programs fail to be implemented or are discontinued due to concerns about cost or to lack of return on investment. In order for new programming to become a standard of care, cost is an issue, especially during a time when health care organizations are seeking to reduce costs. Understanding the cost versus benefit is important for others who may consider implementing Baby Bridge or similar programming.This study aims to calculate the costs of the Baby Bridge program to compare it against revenues in order to assess sustainability for possible scale-up across sites.This study was approved by the study site institutional review board.This study compared the total costs and revenues of Baby Bridge programming over a span of 2 years. Infants were enrolled in the Baby Bridge program and received weekly therapy services in their homes until other community-based (early intervention) services commenced. Therapy services were billed within a therapy practice using standard billing paradigms. Total cost of the therapist, mileage and travel expenses, and equipment were calculated. Claims were then compared to cost over time to assess sustainability of Baby Bridge programming.This study enrolled 95 high-risk infants who were being discharged from the NICU at St. Louis Children’s Hospital. Infants were recruited prior to discharge home. Infants were excluded for the following reasons: therapy was not recommended by the medical team at discharge, the infant did not receive therapy in the NICU, the family resided in a county that was greater than 50 miles away from St. Louis Children’s Hospital, the family lived outside of Missouri, the infant was a ward of the state, or the family did not speak English. All infants who were eligible for the study also qualified for early intervention services through the Individuals with Disabilities Act (IDEA) Part C. These are therapy services provided for children from birth to 3 years old who are at risk of developmental disabilities. For the first 6 months of Baby Bridge programming, inclusion criteria consisted of preterm infants born between 28–30 weeks estimated gestational age. After the first 6 months, as program capacity increased, the criteria were expanded to include preterm infants born ≤30 weeks gestation. In the final year of implementation, the inclusion criteria were expanded to include all high-risk infants in the NICU who were referred for therapy  at NICU discharge.Eligible infants were recruited from consecutive discharges from the St. Louis Children’s Hospital Level IV NICU, a 125-bed unit serving urban St. Louis and surrounding areas, during the study time periods (January 2016 to January 2018).The Baby Bridge program was developed to minimize the gaps in therapy services that high-risk premature infants often experience after discharge from the NICU. The Baby Bridge program was developed as a partnership between St. Louis Children’s Hospital and the Program in Occupational Therapy at Washington University in St. Louis, in close collaboration with Missouri’s First Steps program. Key features of the Baby Bridge program were designed to address barriers, provide skilled care to high-risk infants, and improve the quality and consistency of services and included:The development of a relationship between the Baby Bridge therapist and family that began while the infant still resided in the NICUHome visits, scheduled within one week of discharge, that continued weekly until other early therapy services commencedBaby Bridge therapist with neonatal expertise, defined as at least one year of education and experience in the NICU setting and with high-risk infantsBaby Bridge therapist with a commitment to the success of the program; therapist willing to not only provide therapy interventions, but drive the administration and communication needed for program successUse of standardized, comprehensive assessments to guide targeted interventionsCollaboration with the NICU team: including nurses, neonatologists, social workers, and therapists before and after discharge homeComprehensive therapeutic approach that included education, advocacy, support, fostering an appropriate environment to promote developmental skill acquisition, providing resources, and providing targeted interventions for the infant and familyCollaboration with the community therapy providers to ensure the referral reached the source, follow-up on planned intake and evaluations, equipping parents with appropriate language to advocate for services, and communicating current function and medical status to the new providers during the transition.Data were collected on the number of visits, total payments, and total expenses of the Baby Bridge program and were aggregated by month from January 2016-January 2018.The Baby Bridge program was implemented from January 2016 to January 2018, and all expenses were documented. The total cost of the Baby Bridge program included the cost of the Baby Bridge therapists, based on time allocation proportional to salaries and benefits, as well as cost of mileage to client locations. Few equipment/supplies, totaling less than $200, were purchased for the provision of Baby Bridge services. This included hand sanitizer, copies, and a few feeding bottles. In addition, the cost of graduate student assistance, which related to administrative costs, was included. The cost of the Baby Bridge therapists was determined based on salary data from Washington University Human Resources, corrected for the percentage of effort dedicated to Baby Bridge services. Fringe benefits were added to salary data, and for the study site were approximately 29%. Mileage reimbursement costs were determined by logs and expense reports filled out by the therapist, with the cost of reimbursement being 53 cents per mile.Beginning in January 2016, a single occupational therapist dedicated 50% of a full time equivalent (FTE) position to evaluate and provide treatment through the Baby Bridge program. In mid-November of 2016, the original therapist began to phase out but remained with 50% FTE until December 2016. A new Baby Bridge therapist, an occupational therapist, was hired January 2017 and contributed 33% effort from January 2017 to June 2017, as she built a caseload. She increased her time with the program to 95% FTE for July 2017 to December 2017. Due to other projects, she reduced her time to 75% in January 2018 until the completion of the study. An additional physical therapy (PT) provider, who assisted with caseload overflow based on PT needs of clients, began working in the program in May 2017. The PT worked an average of 1 hour per week (3% FTE) for the Baby Bridge program from May 2017 to December 2017.The Baby Bridge therapists provided direct services, but also engaged in communication with families, communication with the medical team, scheduling, reminder phone calls/texts, identifying eligible infants, generating referrals, and working with discharge coordinators for referrals to be signed. All infants who received therapy services in the NICU and had therapy needs at discharge were referred to the program. This included infants with prematurity, congenital anomalies, prenatal drug exposure and cerebral injury. Therapy services in the home consisted of direct therapy to the infant to improve neurodevelopmental outcome and feeding, parent education and training, in addition to assessment and resources for parent mental health needs. The Baby Bridge therapist aimed to see an average of 4–5 infants in the home each 8-hour day, with each visit lasting an average of one hour.Baby Bridge services were provided through Washington University Occupational Therapy (WUOT), which is affiliated with the study site NICU. WUOT provides occupational therapy services to clients in a variety of treatment settings and across the lifespan. WUOT manages billing through the Washington University Physicians Billing Services, which coordinates processing of bills, insurance claim submission, and collections. Washington University is a non-profit organization. The billing infrastructure already existed for WUOT, and we aimed to assess the cost of Baby Bridge programming as a program nested under this umbrella, recognizing that this study does not include the cost of the billing infrastructure. Standard OT and PT evaluation services were billed at a rate of $160-$168 per hour, with each evaluation lasting approximately one hour. Therapy evaluations were billed based on evaluation complexity or as a comprehensive developmental screening. Standard OT and PT treatments were billed at a rate of $42 per 15 minutes. The typical therapy visit was one hour in length, resulting in billing of $168 for a treatment session. For treatment sessions, treatments were typically billed in units of time, using the current procedural terminology (CPT) codes “therapeutic activities” or “therapeutic exercise”. However, reimbursement was based on payer fee schedules that were set when contracted with the provider, and this varied across insurers and plans. In addition, for infants with Medicaid, charges for OT and PT were made to one of the three contracted managed care organizations providing Medicaid services to all Missouri children. For private insurance, copayments and/or deductibles may have been the responsibility of the client, depending on the requirements of each plan. Copayments typically ranged from $0-$50 per session. Reimbursements varied within and between plans. For Medicaid, most managed care plans did not have an obligation of copayments.The generated revenue and anticipated revenue from claims sent to Medicaid and private insurance were calculated. The claims, or total amount billed, as well as the reimbursement, or amount received in payment, were determined overall and by insurance type. When actual reimbursement data was missing for a service provided to a particular patient, reimbursements received from that payer for other patients who received the same service were assumed to apply. The missing data were typically the result of slow payment from Medicaid and other payers and were anticipated to ultimately be posted to the patient’s account, thus representing anticipated revenue to the program. However, payments may be prone to denials and appeals that could take time for processing and resolution.A health economist conducted a cost analysis of Baby Bridge services in order to assess the question of long-term sustainability of the program and to help inform potential replication across other sites with a similar payer mix. This was estimated based on anticipated claims and reimbursement of therapy services, given current billing paradigms.Sustainability of the program at the rate and level of enrollment observed was assessed by calculating the ratio of total program cost to claim income. The need to interpret findings on sustainability within the context of the scale of the program and the payer mix is discussed.In addition, revenues and costs were estimated based on full capacity, which was defined as 4 visits per day (21 days per month) for a full time therapist. An estimate of monthly reimbursement at full capacity was made by fitting a linear relationship to the monthly data on number of visits and total reimbursement based on billing/reimbursement history.See Infants received a range of 1–41 Baby Bridge visits, for an average of 6.8 ± 7.5  Baby Bridge visits.The total cost of programming from January 2016 to January 2018 was $88,617.98.Program payments (January 2016-January 2018) totaled $41,067.32, but with Medicaid and private insurance reimbursement imputed at the average rates for each service billed, based on other history of payments, the total becomes $65,126.42.The average payment for a one-hour visit (billed at a rate of $160-$168) by Medicaid was ($95.37 ± $22.25) and by private insurance was ($128.10 ± $25.74). Private insurance payments were significantly higher than Medicaid payments (P<0.0001).The total loss (January 2016-January 2018) of the entire program was $16,626.56. However, in 2016, the first year of Baby Bridge programming, the program experienced a loss of $26,460.44 during phase-in, with revenue to the program totaling $11,137.56 and expenses totaling $37,598. In 2017, the second year of Baby Bridge Programming, the program experienced a net gain of $2,968.88, with revenues to the program totaling $53,988.86 and expenses totaling $51,019.98. By Spring 2017, 16 months after implementation, the program began to cover its costs. If the program had continued, it is estimated that by January 2020, 3 years after implementation, the program would have earned enough cumulative revenue to offset initial losses, with ongoing annual profit of approximately $16,308.Based on full capacity , reimbursement was estimated at $8,126 per month. Expenses were estimated at $6,017 for the full time therapist and $750 for mileage, totaling $6,767. Based on this estimation, a monthly profit of $1,359 would be expected, which amounts to an annual profit of $16,308 for the Baby Bridge program.The key findings of this study are that Baby Bridge programming required an initial commitment to an expected loss; however, after 16 months of operation the program began to cover its costs. It is estimated that after 3 years of implementation, initial start-up costs would have been recuperated given the upward trends in revenues. Following scale-up, with an average of 4 visits per day for a full time Baby Bridge therapist, it is estimated that an annual revenue of $16,308 could be generated by the Baby Bridge program. Organizations can use this information to plan follow-up services aimed at optimizing therapy programming for high-risk infants at NICU discharge, while considering cost versus expense.Programs aimed at improving access to care require clinical program coordination and/or intake coordinators or navigators, which has been estimated to cost millions of dollars to taxpayers each year through federally mandated therapy programming . DespiteWhile support of Baby Bridge programming may occur at some sites from philanthropic efforts, understanding the cost and sustainability of such programming is important for replication at other sites. Initial losses were assumed, as it takes time for program development and to build a caseload that fully occupies the therapist’s time; however, the program was sustainable after 16 months of operation. Other hospitals with a similar caseload and payer mix may experience a comparable trajectory when implementing a similar program. Cost of programming is an important factor for others who may consider implementation of Baby Bridge programming; however, cost savings related to health burden is another important area for future inquiry. While this may be challenging to fully ascertain, improving the transition from NICU to home for families may result in improved quality of life, less mental health strain, and decreased readmission rates. Improving access to early therapy services can optimize outcome and reduce the risk of long-term impairment, which can decrease necessary special services later in life and reduce the burden of disability on the infant and family.Previous research has studied the impact of Baby Bridge programming using a single occupational therapist as the Baby Bridge therapist. However, potential optimization may include expansion of the single provider to a multidisciplinary team equipped to handle the multiple complex challenges of the infant and family following NICU discharge, such as nursing, physical therapy, speech-language pathology, and social work. Data reported here document profits/losses related to a single provider. In addition, revenue/losses here are reliant on the payer mix related to the study site and community served, at which 56% of those served were on Medicaid. This could be different in other settings that provide services to a different payer mix. In addition, reimbursements can be different across different states and insurance providers. Lastly, the cost of therapists specialized in the care of neonates may vary by geographical location.This study did have limitations. It was conducted in urban St. Louis with a specific payer mix with a high proportion of infants/families with Medicaid. With a different sociodemographic mix and/or in a state with higher Medicaid reimbursement, Baby Bridge programming would likely have higher revenue with quicker achievement of sustainability; therefore, our findings likely represent a lower estimate on timing to recuperate costs and annual revenue. This study relied on billing records that were in various stages of submission and payment, requiring estimation of reimbursement based on previous billing. In some cases, it was unclear why billing had not occurred, so inferences based on billing capacity were also made. Revenue/losses reported here rely on accurate and complete billing/claims and follow-through until payment is received. This study did not account for costs related to billing infrastructure, such as a person to verify payment sources and process claims, address credentialing issues, and deal with denials because it was nested within an already existing clinical program. Replication at sites that do not have a billing infrastructure would need to consider the cost of a billing/administrative person. This study projected profits that extended after the study ended. Fringe benefits at the study site were 29%, which impacts the cost of programming at the study site and may differ at other sites where they may be calculated at a different rate. This study reported on the profit/loss related to Baby Bridge program implementation, but does not report on the social and long-term benefit of such programming. Despite these limitations, this is the first study that we know of that has investigated and reported on sustainability of new programming designed to improve early therapy delivery in order to impact outcomes of high risk infants being discharged from the NICU.S1 Data(XLSX)Click here for additional data file.


Drosophila guttifera (D. guttifera) are emerging as model systems for studying evolutionary and developmental processes. Studies regarding these processes depend on overexpression and downregulation of developmental genes, which ultimately rely upon an effective transgenic system. Methods describing transgenesis in Drosophila melanogaster (D. melanogaster) have been reported in several studies, but they cannot be applied to D. guttifera due to the low egg production rate and the delicacy of the eggs. In this protocol, we describe extensively a comprehensive method used for generating transgenic D. guttifera. Using the protocol described here, we are able to establish transgenic lines, identifiable by the expression of enhanced green fluorescent protein (EGFP) in the eye disks of D. guttifera larvae. The entire procedure, from injection to screening for transgenic larvae, can be completed in approximately 30 days and should be relatively easy to adapt to other non-model Drosophila species, for which no white-eyed mutants exist.The complex color patterns on the wings and body of  Drosophila has been largely achieved by transposase-mediated transgenesis . EG. EG20]. Dissolve 2 g of sorbic acid and 0.6 g of methyl paraben in 200 mL of 95% ethanol. Roll ~20 paper towels and stick them into a 1-L glass beaker. Slowly pour the anti-fungus solution over the towels to soak them evenly. Unfold the towels and let them dry completely. Anti-fungus paper does not go bad and can be stored for years.Use a 50-mL Falcon tube, add 35 mL of Halocarbon oil 700 and 5 mL of Halocarbon oil 27. Homogenize the mixture on a nutator overnight. D. melanogaster. We quickly learned that “whatever works for D. melanogaster does not work for/kills D. guttifera.” It took therefore several years of innovations and deviations from the original protocol to make D. guttifera survive the procedure from the beginning to the end and to obtain the first transgenic animals. Key innovations are (1) establishing a large cage population (this compensates for the low egg-lay rate), (2) having good cage aeration , (3) using sponges as egg-lay surfaces , (4) no ethanol wash step to visualize the interior of the eggs before injection (this prevents the egg chorion from becoming rock-hard), and (5) washing larvae out of the food for transgenic screening (no need for a white-eyed mutant). We believe that our method, developed for a very delicate species, should be useful to transform most drosophilid species that can be reared in the laboratory on a standard fly-food medium, such as Drosophila tripunctata, Drosophila quinaria, Drosophila subquinaria, and Drosophila deflecta. For recommendations on collecting and rearing many non-model species, please refer to our book [The starting point for this protocol was the standard method that was optimized for our book .


Earthquakes are one of the most destructive natural disasters in which many people are injured, disabled, or died. Iran has only 1 % of the world’s population, but the percentage of its earthquake-related deaths is absolutely higher. Therefore, this study aimed to determine the level of earthquake preparedness of households and its predictors using the Health Belief Model (HBM).This observational descriptive and analytical study was conducted on 933 households in Hamadan province, located in the west of Iran, in 2019. Multi-stage cluster random sampling was used for selecting the participants. The inclusion criteria were being at least 18 years old and being able to answer the questions. A questionnaire was used for data collection including earthquake preparedness, awareness of earthquake response, predictors of earthquake preparedness based on the HBM, and demographic information. Analysis of variance, independent t-test, and a linear regression model was used.P < 0.001), homeownership (P < 0.001), marriage status (P < 0.001), education (P < 0.001), and previous earthquake experience (P < 0.001). Regarding the HBM constructs, perceived benefits (P < 0.001), cues to action (P < 0.001), and self-efficacy (P < 0.001) were significant predictors of earthquake preparedness.The mean age of participants was 38.24 ± 12.85 years. The average score of earthquake preparedness was low (approximately 30%). There was a significant relationship between earthquake preparedness and gender (Earthquake preparedness was insufficient. Besides, perceived benefits, cues to action, and self-efficacy were predictors of earthquake preparedness. These predictors can be taken into account, for designing and implementing related future interventions. Earthquakes are one of the most dangerous natural hazards that occur suddenly and uncontrollably. They cause physical, psychological, and social damages in human societies . Over thThe Health Belief Model (HBM) describes the decision-making process that individuals use to adopt healthy behavior. It can be an effective framework for developing health promotion strategies . TheoretThere are some studies on earthquake preparedness that have assessed the readiness of individuals based on their knowledge and skills –15. SomePrevious studies in Iran showed that most households did not have enough readiness and had a relatively high vulnerability to possible earthquake hazards , 20. AlsTo the best of the authors’ knowledge, this is the first study in Iran that examines earthquake preparedness of households, using a behavior change model. Considering the importance of earthquake preparedness of households, this study aims to asses the level of earthquake preparedness of households and its predictors based on HBM.This observational descriptive and analytical study was carried out in all counties of Hamadan province, located in the west of Iran, in 2019. These counties includes Hamadan , Malayer, Tuyserkan, Nahavand, Razan, Bahar, Kabudarahang, Asadabad, and Famenin. Based on the previous study [Participants have been selected by multi-stage cluster random sampling. First, stratified sampling was used for each county based on its urban and rural populations. Then, in urban and rural areas, a list of urban or rural health centers was listed and one health center was randomly selected in each county. After that, from the list of all households covered by the selected health center, one household was selected by simple random sampling and sampling started taking the clockwise direction of the selected household and continued until the required sample was collected. For selecting the sample of the urban population of Hamadan County, we selected one health center from each district by simple random sampling . In the next stage, from the list of covered households, one household was randomly selected and the sampling was started taking the clockwise direction until the required sample in each district was collected.Demographics included age, sex, occupation, education, economic status, family size, number of individuals over 60 years old and under 16, earthquake experience, homeownership, marital status, and having a person with a disease that needs medication at their home.We measured earthquake preparedness by an earthquake preparedness checklist . This chThe awareness on earthquake response questionnaire included seven questions with true/false answers . One point was given for each correct answer. Therefore, the total score of this domain was seven points.The adapted questionnaire of earthquake preparedness based on the HBM was used. The original questionnaire has been established and validated by Inal et al.  in TurkeThe questionnaire used for data collection comprises four domains including 1) demographics, 2) earthquake preparedness 3) awareness on earthquake response, and 4) predictor of earthquake preparedness based on the HBM. Earthquake preparedness was response variable.We used the analysis of variance (ANOVA) and independent t-test to determine the relationship between variables. Besides, the multivariate linear regression model was used to determine the predictors of household earthquake preparedness. The Stata 14.2 software was used to analyze the data.In this study, 933 questionnaires were analyzed (response rate: 93.3%). The mean age of participants was 38.24 ± 12.85 years. Besides, 228 (24.44%) participants were male and 656 (70.31%) were female. About 80% of the participants did not have an academic education and had a diploma degree or less than a diploma degree. Also, 573 (61.41%) participants were homeowners , homeownership (P < 0.001), marital status (P < 0.001), and previous experience of a destructive earthquake (P < 0.001). Also, the mean score of earthquake preparedness was higher in those who reported moderate or good economic status. The mean difference was statistically significant by the Scheffe test (P < 0.001). Furthermore, the one-way ANOVA/Scheffe’s test showed that there was a significant difference between illiterate people and those who had either university education or diploma degree and similarly, a significant difference in earthquake preparedness was observed between primary education and those who had either academic education or diploma degree (P < 0.001) (Table The participants’ preparedness for the earthquake had a significant relationship with gender (1) Table .Table 3P < 0.006), cues to action (P < 0.001), and self-efficacy (P < 0.001), significantly predicted the earthquake preparedness  but after using stepwise regression, only perceived benefits (ss Table .Table 4In this study, we determined the level of earthquake preparedness of households and its predictors based on HBM. The earthquake preparedness of the participants was low. The participants’ preparedness for the earthquake had a significant relationship with homeownership, education, and previous experience of a destructive earthquake. Also, perceived benefits, cues to action, and self-efficacy significantly predicted the earthquake preparedness.Despite the strong emphasis on earthquake preparedness to prevent its damaging effects, the findings of this study showed that most people had low preparedness for earthquakes which is similar to the findings of previous studies , 23–25. Besides, education was significantly correlated with households’ earthquake preparedness, which is similar to the results of the studies by Russell et al. and Ghadiri & Nasabi , 30. OneIn this study, we found that the preparedness of participants has a significant relationship with homeownership. Two previous studies showed homeowners were more prepared for earthquakes than renters , 33, wheWe adjusted for multiple possibly confounding factors in our analysis. After adjusting the model, perceived benefit, cues to action, and self-efficacy had significant predictors of earthquake preparedness. It is more possible that people’s earthquake preparedness increases when they are aware of the benefits of earthquake preparedness. Furthermore, people with high self-efficacy feel they can prepare for earthquakes . On the This study has several limitations. Firstly, using a self-reporting approach for data gathering, and secondly, due to the low number of relevant studies on earthquake preparedness based on behavioral change models, it was less possible to compare different studies with the findings of this study. Third, it should be noted that the results of this study can be generalized in the study population and setting, but for other settings it should be done with caution. Despite these limitations, this study had some strengths, we use a theoretical framework for identifying factors that influence earthquake preparedness with a large sample size. Also, the findings of this study are useful for emergency service providers, health authorities, and policymakers in designing and implementing earthquake preparedness programs. This research is also useful for researchers as it can be used as a basis for future researches. It is recommended to design and implement interventions to improve household preparedness for an earthquake based on self-efficacy, perceived benefits, and cues to action.Households’ earthquake preparedness was insufficient and low. Controlling the damaging consequences of earthquakes is related to the preparedness for earthquakes and can prevent its devastating effects. Perceived benefits, cues to action, and self-efficacy had a significant relationship with earthquake preparedness. The possibility of people being more prepared is increased when they are aware of and understand properly the benefits of being prepared for earthquakes and other disasters. People with high self-efficacy also feel more empowered for taking better care of themselves and their families during disasters. Cues to action would also encourage earthquake preparedness. Since health centers and TV and radio programs were the primary sources of learning about earthquakes for the people, it is recommended that broadcasting provides related programs and educates people about earthquake preparedness. The predictors that were assessed in this study can be taken into account for designing and implementing proper interventions in this field.


Transbronchial needle aspiration (TBNA) is a minimally invasive procedure performed to diagnose lymph node (LN) adenopathy. TBNA with and without endobronchial ultrasound (EBUS) guidance has a high diagnostic yield for malignant LN enlargement, but the value for diagnosing benign LN enlargement has been less thoroughly investigated.We retrospectively evaluated 3540 patients with mediastinal LN enlargement who received TBNA. One hundred sixty-six patients with benign mediastinal lymphadenopathy were included and 293 LNs were biopsied. A positive result was defined as a specific histological abnormality. Conventional TBNA (cTBNA) and EBUS-TBNA, as well as cTBNA and transbronchial forceps biopsy (TBFB), were compared. The subgroup analysis was stratified by disease type and LN size.P < 0.05). EBUS-TBNA was superior to cTBNA for both granulomatous  and non-granulomatous disease . In contrast, the diagnostic yield of EBUS-TBNA was higher than that of cTBNA for LNs < 20 mm , but for LNs > 20 mm the difference was marginal. These findings were confirmed in a group of independent patients who received cTBNA plus EBUS-TBNA. The diagnostic yield did not differ between cTBNA and TBFB, but significantly increased to 76.67% when both modalities were employed.A diagnosis was made in 76.84% of the EBUS-TBNA and 61.31% of the cTBNA (EBUS-TBNA is the preferred minimally invasive diagnostic method for benign mediastinal LN disease. Combined cTBNA and TBFB is a safe and feasible alternative when EBUS is unavailable. Transbronchial needle aspiration (TBNA) is a minimally invasive diagnostic modality for patients with mediastinal and hilar diseases . EndobroWe retrospectively reviewed 3540 patients with mediastinal and hilar LN enlargement who received TBNA, registered in the inpatient system of the Second Affiliated Hospital of Zhejiang University School of Medicine from January 2012 to June 2019. Based on a careful review of the patients’ medical records  scans, tracheoscopy, and cytological and histological results), 166 patients diagnosed with benign mediastinal LN enlargement who underwent cTBNA or EUBS-TBNA were included in the study. Patients were excluded if there was no final diagnosis or the pathology report noted a malignancy . The LNs were detected and measured using an ultrasound scanner . A 22-gauge needle  was employed for the LN biopsy under real-time visualization. Each LN was biopsied three times.TBFB plus TBNA was performed in 30 LNs from 24 patients. cTBNA was carried out first, and a 21-gauge biopsy forceps  was then passed through the opening in the bronchial wall. The forceps were opened and pushed forward slightly, and then closed to finish the biopsy. Each LN was biopsied twice.Each aspirate obtained by TBNA or TBFB was either smeared onto numbered glass slides or placed into PreservCyt solution . Then we picked out the visible tissue like materials from the smeared slides and PreservCyt solution, and the specimens were fixed in 4.0% buffered formalin solution and delivered to the pathology department, where they underwent dehydration, paraffin embedding, and sectioning. Meanwhile, we sent the smeared slides and rest of PreservCyt solution to the cytology laboratory for cytological analysis. Two experienced pathologists evaluated the cytological and histological results independently after hematoxylin and eosin staining using standard methods. Immunohistochemistry was performed where required for definitive diagnosis.P-value < 0.05 was considered significant.The baseline characteristics of all enrolled patients are provided in Table A total of 166 patients (76 men and 90 women) with a definitive diagnosis of benign hilum of the lung or mediastinal lymphadenectasis were included in the final analysis. The mean age of the patients was 54 years . The mean LN size was 2.05 cm (95% CI 1.97–2.14). There were 25 current (21.6%), 25 former (21.6%), and 116 never smokers (56.9%). The 166 benign cases were divided into 94 with granulomatous disease and 72 with non-granulomatous disease. All patients underwent TBNA  and/or TBFB, and 293 LNs were biopsied. cTBNA and EBUS-TBNA were performed in 106 patients with 168 LNs and 94 patients with 177 LNs, respectively. Prior cTBNA followed by EBUS-TBNA was carried out in 34 patients with 52 LNs, and both cTBNA and TBFB were conducted in 24 patients with 30 LNs. The detailed demographic data are shown in Table In this retrospective study, the overall diagnostic yield was 73.37% 215/293). The diagnostic rate of EBUS-TBNA for hilum of the lung and mediastinal adenopathy was 76.84% (136/177), while that of cTBNA was 61.31% (103/168) (Table 15/293. TP < 0.05).We compared the diagnostic efficiency of cTBNA and EBUS-TBNA for benign LN adenopathy. As shown in Table P = 0.004). Similarly, EBUS-TBNA also had a higher diagnostic rate for non-granulomatous inflammation than cTBNA  (Table P < 0.05), but it was only marginally superior for LNs > 20 mm (P = 0.051) (Table P < 0.05)  received both cTBNA and TBFB. The diagnostic rate was 63.33% (19/30) using cTBNA alone, 53.33% (16/30) using TBFB alone, and 76.67% (23/30) using cTBNA plus TBFB (Table The current study provides strong evidence of the effectiveness of cTBNA, EBUS-TBNA, and TBFB for diagnosing benign mediastinal lymphadenopathy. The major findings of this retrospective comparative study were as follows: TBNA was effective for revealing enlargement of benign LNs; EBUS-TBNA had a higher diagnostic yield than cTBNA, but cTBNA was not inferior for LNs > 20 mm; and TBFB without EBUS guidance is a safe and feasible option for diagnosing benign LN adenopathy. However, combined cTBNA and TBFB achieved a higher diagnostic yield. Our study provides solid evidence that EBUS-TBNA is the optimal approach for diagnosing benign LN enlargement, although combined cTBNA and TBFB is a viable alternative when EBUS guidance is not available.Both cTBNA and EBUS-TBNA are important tools for diagnosing mediastinal and hilar lymphadenopathy, including benign and malignant diseases . A largeIt is worth noting that EBUS-TBNA requires specialized, relatively expensive equipment, and thus is not available in many hospitals, particularly those in developing countries. Hence, it is important to explore ways to achieve higher diagnostic efficiency without EBUS. We aimed to devise a safe, efficient, feasible and easy-to-perform method to meet this need. In this study, we confirmed the diagnostic value of cTBNA; the poorer performance of cTBNA in the granulomatous cases was mainly due to the small volume of specimens available to support the histological findings. Forceps biopsy is a classic clinical approach used to obtain larger-volume specimens than needle biopsies. Several pilot studies reported a diagnostic yield of EBUS-guided mediastinal LN forceps biopsy above 80% for nonmalignant disease –23. HoweIn addition to sampling techniques, preparation technique is also a pronounced determinant for diagnostic performance. Accumulated evidence shows that conventional cytological evaluation is capable to provide diagnostic clues in non-granulomatous diseases, such as amyloidosis, necrotizing lymphadenitis , 38. On Our study had several limitations. First, used a retrospective design and various confounders may have affected the results. Second, we performed EBUS-TBNA with a 21-gauge TBNA needle only, rather than a 19-gauge histology needle, so could not address the potential effect of needle size on sensitivity. Third, the number of patients with benign lymphadenopathy enrolled to determine the efficacy of TBFB was relatively small. The type of forceps used for TBFB is also worthy of more in-depth investigation. Several factors, such as stiffness, size of the forceps cup, design of the forceps tip, and even the putative forceps-needle integrated design, should be considered in future studies.Both cTBNA and EBUS-TBNA are feasible and safe, and can provide histological specimens of enlarged mediastinal or hilar LNs. Due to its high sensitivity, EBUS-TBNA is the preferred option for diagnosing enlargement of benign LNs. Combined cTBNA and TBFB is a viable alternative when EBUS is not available, due to its relatively high diagnostic rate. We strongly advocate the use of minimally invasive techniques for diagnosing of enlargement of benign mediastinal LNs.


Increasing prevalence of obesity poses challenges for public health. Men have been under-served by weight management programs, highlighting a need for gender-sensitized programs that can be embedded into routine practice or adapted for new settings/populations, to accelerate the process of implementing programs that are successful and cost-effective under research conditions. To address gaps in examples of how to bridge the research to practice gap, we describe the scale-up and scale-out of Football Fans in Training (FFIT), a weight management and healthy living program in relation to two implementation frameworks. The paper presents: the development, evaluation and scale-up of FFIT, mapped onto the PRACTIS guide; outcomes in scale-up deliveries; and the scale-out of FFIT through programs delivered in other contexts . FFIT has been scaled-up through a single-license franchise model in over 40 UK professional football clubs to 2019 (and 30 more from 2020) and scaled-out into football and other sporting contexts in Australia, Canada, New Zealand, England and other European countries. The successful scale-up and scale-out of FFIT demonstrates that, with attention to cultural constructions of masculinity, public health interventions can appeal to men and support them in sustainable lifestyle change. Rising levels of physical inactivity, sedentary behavior and consumption of foods that contain high levels of sugar and fat have contributed to rising levels of obesity worldwide . Obesity2) is higher amongst men than women throughout adult life, and notably so between the ages of around 20 to 60 years ). ITo consider whether scaled-up deliveries of FFIT reach the target group, we compare baseline data  for weight, waist and blood pressure as indicators of future risk of ill-health) from participants in scaled-up routine deliveries with baseline data from FFIT RCT participants. We also compare the socio-economic characteristics of participants (quintiles of deprivation of area of residence (SIMD)). To consider whether outcomes in scaled-up routine FFIT deliveries are comparable to the FFIT RCT, we compare changes from baseline (week 0) to post-program (12 weeks) in mean values (SD) for key physical measures (weight (kg and %), waist (cm), systolic and diastolic blood pressures (mmHg)).2). However, we recognize that there can be cultural differences between the target populations described below, meaning a case could be made for regarding the populations from different countries as being different, despite having the same inclusion criteria for age and body composition.We have mapped scaled-out adaptations of FFIT (delivery to other target groups and/or in other sports settings and/or in other countries) to Aarons et al.’s typology of scaling-out  as defi. In drawAfter summarizing the development and evaluation of FFIT in relation to the PRACTIS guide , which iFFIT is a 12-week group-based, weight management and healthy living program delivered originally to men aged 35–65 years who are overweight (‘population’) in professional football clubs (‘setting’) by trained club coaches to support them in losing weight and maintaining their weight loss long term, through cumulative, sustainable changes in their physical activity, diet  (‘target outcomes’) . From thA key underlying principle of FFIT is to use the popularity of professional football amongst many men in the UK as a ‘hook’. Thus, a key component is that the program is delivered within the stadia and facilities of professional football clubs (place) to attract men aged 35–65 years who are overweight. FFIT was designed using adult learning styles which build on existing experience. Coaches adopt an interactive, non-didactic style of delivery, which encourages the use of positive banter with and between men to encourage strong group interactions, mutual support and vicarious learning amongst participants, and between the participants and the club coaches. Each weekly session comprises an ‘educational’ component (~30–45 min), focusing on a topic related to food, physical activity or alcohol. Each session also teaches or rehearses a behavior change technique . This is followed by group-based physical activity led by the coaches, with each man working to a level appropriate to his current fitness and ability  and subsequent routine deliveries (Phase 3), the minimum BMI eligibility was increased so men with a BMI ≥ 28 kg/m2 are eligible to undertake the program (people) , the program was open to men with a BMI ≥ 27 kg/m(people) . Club coProvisions: In Phase 1, recruitment leaflets to pilot deliveries displayed club insignia and emphasized the chance to be ‘part of the club’ by joining a program at the club grounds (using phrases like ‘Get off the bench’ and ‘Why don’t you join your club and get into shape?’). In Phase 2 recruitment was extended through greater use of word-of-mouth; local and national newspapers and radio; workplaces; and direct in-stadia approaches to men at pre-season matches by the research team. Recruitment leaflets again stressed the chance to be ‘part of’ the club . In Phase 3 recruitment is led by clubs and facilitated by SPFL-T mainly using word of mouth, and club and SPFL-T websites and social media.Coaches are provided with a manual detailing key delivery points each week; participants’ manuals provide accessible information (described positively by men as ‘science but not rocket science’) that mirrors the coach manuals. To facilitate self-monitoring of physical activity in daily life, participants are provided with a pedometer in week 1 and encouraged to work each week to set goals to increase their step count following the graduated Walking for Wellbeing in the West program  which enAfter engagement with relevant stakeholders about the aims of the program and evaluation, funding for deliveries was provided by Scottish Government and the Football Pools during initial piloting and the full-scale RCT. The Scottish Government provided funding for scaled-up post-trial deliveries in Scotland .Principles: Football Fans in Training (FFIT) was developed in 2009/10 (see ) with anFFIT builds on (and has strengthened) existing structures within football to support community programs delivered by club coaches. Post-evaluation, implementation continues through the strong ‘football in the community’ expertise and experiences of SPFL-T see .While at the time that FFIT was being developed, the potential of professional sports organizations to attract men to public health and health promotion initiatives was recognized , From the outset (Phase 1), we also discussed with coaches, clubs, SPL-T and funders not just the importance of assessing the potential appeal of the program to men, but also of evaluating the effectiveness and cost-effectiveness of FFIT through a pragmatic RCT. This and subsequent engagement, including with the Scottish Professional Football Trust (SPFL-T)  enabled us to appraise key stakeholders of progress in FFIT’s development and the requirements and conduct of the research. It also allowed us to ensure that the program aligned with Government targets and priorities for the prevention and management of obesity and for men’s health, with constraints and opportunities within clubs, and with priorities for SPL-T/ SPFL-T. Meetings between the core research team  and SPL-T/SPFL-T over the decade since FFIT was first conceived  proved essential at all stages, particularly in facilitating the pilot and full-scale RCT, and in developing a sustainable model for scale-up in Phase 3   football clubs, in autumn (September-December) 2010 and spring (February-April) 2011. At the same time we conducted a two-arm pilot randomized trial, including a mixed methods process evaluation, in two of these clubs , with 102) ; and weight loss and improvements in other outcomes were all sufficiently promising to proceed to a full-scale trial . Results2) randomly allocated to this group post-baseline measurements could be offered the program after 12 month outcome measurements had been completed. Recruitment to the full trial began in summer 2011 as soon as funding and ethical approvals for the evaluation were confirmed.During Phase 2, we undertook a two-group, pragmatic RCT (primary outcome weight loss at 12 months), with embedded process evaluation and assessment of cost-effectiveness; procedures and results are described in detail elsewhere ,12. FundWe recruited sufficient men to fill places in all three deliveries across 13 professional football clubs. Men in the intervention group began FFIT within two weeks of baseline measurement; those allocated to the 12-month waitlist comparison group were guaranteed a place on FFIT post-RCT in August to December 2012; men allocated to the February deliveries 2012 did not participate in the RCT, but enabled additional research on understanding how the program was delivered and received ,44,49, wQualitative interviews and focus groups, conducted post-program with participants and coaches, and with men in the non-trial deliveries of FFIT, identified cultural and organizational/provider level facilitators: men were motivated to improve their lifestyles and the football club setting was a powerful ‘draw’; men highly valued the setting and style of delivery, affording them privileged access to the club  and being with ‘men like them’ ). They valued the ‘team’ spirit, and the interactive, non-didactic style of delivery  enabled them to take on the messages of the program and enjoy increasing their physical activity week-by week, but also supported some of them to renegotiate their identities as men in relation to health and health-related behaviors ,12,43,44Longer-term follow-up, using the same protocols for measurements as for the FFIT RCT, has shown that men in the intervention group sustained many improvements in health and behavioral outcomes 3.5 years from baseline ; 32.2% weighed > 5% less than at baseline, reduction in systolic blood pressure −3.13 mmHg (95% CI: −5.15 to −1.11)). The level of sustained weight loss compares well with other gender-sensitized weight loss programs for men . In addi2 to ≥28 kg/m2. Feedback to key stakeholders  through oral presentations, a lay report and media coverage of the program helped to raise awareness of the program.The Phase 1 feasibility and pilot study identified a few minor amendments that were needed to the program and led to the increase of the minimum BMI eligibility criterion from ≥27 kg/mThe successful outcomes and cost-effectiveness demonstrated in the FFIT trial ,11,12 . The premise underlying the licensing model was to create a support structure that could underpin and quality-assure the scale-up of FFIT, ensuring that coaches from every club delivering FFIT were trained to deliver the core components, with oversight and support to new and existing clubs where needed  but soon realized more was needed to ensure fidelity and quality of future program deliveries. The research team had trained club coaches to deliver FFIT in the pilot RCT and full-scale RCT (Phases 1 and 2); a more sustainable model was required for the long-term scale-up of FFIT. The reorganization of Scottish professional football in 2013 to encompass 42 clubs in the Scottish Professional Football League (SPFL) (noted above) was again highly fortuitous. Under the new SPFL-T, with enthusiastic and committed leadership to enhance community activities across the 42 SPFL clubs, SPFL-T were well-placed to take on the oversight of training and delivery of FFIT across the expanded League long-term. In 2014–2015, the FFIT research team secured UoG funding to co-develop (with a FFIT coach and SPFL-T staff) a two-day program to train new coaches/clubs to deliver FFIT. This ‘Train the Trainers’ package became a key pillar underpinning the move from an easy-access license to a single-license agreement between the UoG (which holds the IP for FFIT) and SPFL-T, which allowed SPFL-T to oversee the scale-up of FFIT in the UK and beyond in a ‘single-license franchise’ model. SPFL-T led a rebranding of the program promotion materials and website at this time , and onm et al. ) for theAs noted in 2 (SD 5.37) (FFIT RCT-I 35.5 (SD 5.1)); mean systolic BP was 150.02 mmHg (18.94) (FFIT RCT-I 139.4 mmHg (SD 17.6)); and mean diastolic BP was 90.1 mmHg (SD 11.8) (FFIT RCT-I 88.2 mmHg (SD 10.3)).The mean age at baseline of men participating in these ‘routine’ scaled-up deliveries of FFIT was 47.6 years (SD 9.5), based on 2940 (88.6%) for whom age was recorded. Baseline physical measurements on these 2940 men show that routine FFIT deliveries continue to be successful in attracting the original target group   from the 2016/17 season . www.southamptonfc.com/news/2016-09-30/saints-foundation-saints-fans-in-training) and Swindon Town FC  lack of interaction on the social network limited the potential of the network to support their progress during the minimally-supported phase”  a considerable impediment to population-wide health improvement as it denies or delays community access to effective services. Even where there is evidence of the efficacy or effectiveness of public health interventions, hanisms”   , and with clear identification of facilitators and barriers and strategies to overcome them, and the involvement of key stakeholders throughout three phases of implementation that we have been able to scale-up the FFIT program from feasibility work and a pilot randomized trial (Phase 1), through a full scale RCT and long-term follow-up (Phase 2), to routine deliveries in a scaled-up model (Phase 3). This is summarized in a Theory of Change model drawing out key components of FFIT in The data presented here also clearly demonstrate the sustainability (“the extent to which an evidence-based intervention can deliver its intended benefit over an extended period of time”) and sustainment   With respect to contextual factors, the “interaction of the intervention with individual, community, cultural, political, workforce and organizational contexts” This is probably a crucial factor in the rapid scale-up of FFIT. The fact that many football clubs in the UK have a community department also provides an ideal and sustainable workforce at club level to deliver the program. These community coaches are valued by participants for their skills in both providing non-didactic direction in ‘classroom’ parts of the sessions and leading the group-based physical activity; their banter with participants, weaving in background knowledge of the clubs and players, is crucial in making participants feel ‘part of the club’ and in fostering team spirit. The single-license franchise model with SPFL-T has provided a successful organizational infrastructure for wider delivery. The ‘Train-the-Trainers’ model ensures that delivering coaches and clubs have the required technical expertise and training to deliver FFIT, and the collection of pre- and post-program data allows for evaluation and performance monitoring. The single-license franchise model has enabled us to address the “workforce, technical and organizational resources required” and the integration of quality control and performance monitoring systems https://www.efltrust.com/efl-trust-are-helping-10000-fans-tackle-their-weight/) evidences its adoption by different settings and organizations. This widespread uptake of “intervention delivery” and testimonies on participating club websites and social media, also evidences the continuing acceptability to participants and to other stakeholders, as first shown in our more detailed research in the first two phases of implementation of FFIT [Another key factor in FFIT’s scale-up has been building robust evidence on effectiveness and cost-effectiveness of the program, including that beneficial outcomes are sustained not just 12 months after joining the program  but also of FFIT ,43,44.This paper also demonstrates that the FFIT program can readily be translated for delivery in a range of different sports and countries and to different populations, with greater or lesser degrees of adaptation—that is that it can be scaled-out. Crucial to this process, as for the scale-up of the model, has been the widespread popularity and cultural embeddedness of professional sport, together with robust evidence on effectiveness and cost-effectiveness of the program. The place of sport in many men’s sense of identity, and indeed sometimes people’s national identity, as a ‘hook’ has transferred well to other settings and countries. This suggests great potential for other sports and, in more rural or remote areas, for the use of local sporting clubs. Here we have documented scale-out of FFIT into football and other professional sporting contexts in Australia, Belgium, Canada, England, Germany, Hungary, the Netherlands, New Zealand, Norway and Portugal to date, and there is increasing interest in programs for women which adopt a more holistic and sustainable approach to weight management than many commercially available ‘diets’ which are targeted at women, as evidenced by the popularity of FFIT amongst some women in more recent years.Movsisyan et al. noted that: “decisions on when, to what extent, and how to adapt interventions are not straightforward, particularly when conceptualising intervention effects as contingent upon contextual interactions in complex systems” . Aarons Peters et al. have noted that “Context plays a central role in implementation research. Context can include the social, cultural, economic, political, legal, and physical environment, as well as the institutional setting, comprising various stakeholders and their interactions, and the demographic and epidemiological conditions”  (p. 1 ofhttp://hattrick.ok.ubc.ca/), has been developed at the University of British Columbia (UBC) and successfully piloted in Canadian ice hockey clubs in British Colombia. While this program draws to some degree on the experience of FFIT, the informational resources, tailored messaging and weekly PA and dietary tracking logs are based principally on the UBC team’s prior research on gender-sensitized interventions for men . Its. Itshttpn (e.g.,  (p. 2159n (e.g., .Evidence on what works for men’s health is accumulating rapidly, and programs that focus on “masculine ideals and gender influence to engage men in increasing their physical activity” have been shown to have strong potential for promoting men’s health ,37,38. EThis body of research, and research conducted in Australia ,78,79,80