Sustainable implementation of early childhood programs requires resources, materials and methods that are adaptable, scalable and feasible for delivery through multiple sectors. Additional or modified program resources may be required to meet emerging needs, as programs go to scale. An active and effective monitoring, evaluation and learning (MEL) process may enable programs to be responsive to demands. The Reach Up: Early Childhood Parenting program, is designed primarily for disadvantaged children under 4 years of age in low- and middle-income countries (LMICs) to promote their development through playful caregiver interactions. The curriculum, training manuals and other materials and resources support implementers in the adaptation of the intervention, implementation, workforce training, monitoring and evaluation. This paper reports on how data collected from key informants drove modifications to program processes, materials and resources.We conducted in-depth interviews with 14 key informants  on their experiences with Reach Up across 15 LMICs where the program has been implemented. We also reviewed written records generated from (i) structured small group discussions at a Knowledge Exchange meeting of 31 Reach Up partners and (ii) notes from working groups formed at the meeting and tasked to continue working post-meeting to find solutions to support ongoing implementation. The transcripts from the in-depth interviews and the meeting records were analysed using thematic analysis with a mixture of pre-defined categories and data-driven sub-themes.The main findings indicated that there was a need to: (i) develop advocacy and communication resources and materials to aid prospective implementers and other stakeholders, to make decisions for implementation, (ii) revise and/or add to the content and format of the curriculum and add content in the training and other supporting manuals and (iii) enhance the training process.The feedback from the key global partners informed the development of new knowledge materials, resources and processes and modifications to existing program materials and resources. These will help to support advocacy, ongoing implementations, and the process of transitioning the Reach Up early childhood intervention to scale. Lancet early childhood development series in 2016, the launch of the WHO, UNICEF and World Bank Nurturing Care Framework in 2018, the special issues of Annals of the New York Academy in 2018 and the Archives of Diseases in Childhood series in 2019, highlighted the significance of addressing early childhood development (ECD), especially for children in low- and middle-income countries (LMICs). Increasing numbers of LMIC have national ECD polices  system can be important in understanding effective scaling. As Krapels et al., noted, this is needed to (i) facilitate strengthening of programs and inform the development of more effective designs, implementation and scale up and (ii) share information and knowledge gained from MEL processes with others working in the ECD and other behaviour change sectors .The Measurement for Change (M4C) approach provides a framework that can be used to measure progress and respond to developing needs as necessary, to ensure continued effective adaptation and implementation and facilitate scaling of ECD interventions. The five interconnected objectives that currently inform the use of data collected for M4C are that it should be (i) dynamic (flexible to change and use iterative learning cycles), (ii) inclusive , (iii) informative (making decisions based on the data gathered from various sources), (iv) interactive  and (v) people-centred   The framStudies on scale up of ECD programs have focused on examining of geographical coverage and reach, implementation characteristics such as dosage, frequency and mode of delivery, monitoring , evaluation of intervention outcomes, financing and the workforce . In addiIn this paper, we document lessons learnt from engagement with the Reach Up: Early Childhood Parenting program (commonly referred to as “Reach Up”) implementation partners in multiple countries. We also discuss how this informed enhancements to the Reach Up package to support the needs of program managers and delivery staff as they expand to reach more families.First, we present a brief overview of the Reach Up program. We then discuss Phase I, the evolution from the Jamaica Home Visit intervention (JHV) to Reach Up. Phase II  and Phase III  are discussed in the Results section.Madre Guias – “mother guides” in Guatemala and Colombia). The initial Reach Up package comprised weekly and fortnightly curricula for ages 6–36 months, an Adaptation and Planning Manual for program implementers, a Toy manual, a Training manual with films to be used during training workshops and a Supervisor Manual. The intervention has been adapted and used in 17 countries: Bangladesh, Bolivia, Brazil, China, Colombia, Guatemala, India, Jamaica, Kenya, Liberia, Madagascar, Peru, Turkey, Zimbabwe and Jordan, Lebanon and Syria (for Syrian refugee families). At scale, in Peru, the national home visiting program, Cuna Más, was built on Reach Up, through the adapted Colombian model (The Reach Up: Early Childhood Parenting program is based on the Jamaica Home Visiting (JHV) model developed in the 1970s . It was an model . The intAdaptations done for context prior to implementation include the inclusion of local games and songs, adaptation of pictures and toys to reflect local people and activities, and addition of content to the curriculum  and training manual . Adaptation of implementation processes to fit country infrastructure, personnel and resources include mode of delivery , personnel , engagement strategies  and training.Evidence shows that Reach Up can be feasibly delivered through health services or social services reaching families with young children in several countries . The intEvaluations of implementation processes have been conducted in Jamaica , BangladScaling of the processes, resources and materials that make up the Reach Up intervention has occurred across three phases:Phase I, the evolution from the Jamaica Home Visit intervention (JHV) to Reach Up, a comprehensive package of curricula, manuals and resource materials in 2014.Phase II, implementation and evaluation in several countries leading to a knowledge exchange meeting and the formation of the global community in 2019Phase III, interconnected with Phase II, using learnings from global partners to make systematic changes to further scale the Reach Up package in 2021.Familias en Acción) and Peru   . Randomiprogram) , 29, 30 program) , in addiprogram)  providedIn a context of growing demand for scalable ECD programs and an increase in interest in the implementation of the JHV, the developers identified challenges with the expansion related to limited technical capacity of organizations as well as capacity of the Jamaica intervention team to provide support. One of the solutions identified was to develop a comprehensive training package that could be used by implementation partners.With the support of a grant in 2014 from Grand Challenges Canada, a web-based package was developed. The curriculum layout was reorganized for easier use with drawings of toys and suggested text to introduce and explain activities included. A few new picture books, toys and activities were added to the curriculum to replace some toys and create more variety. The toy manual was revised with colourful drawings depicting step by step instructions. All pictures (used in books and puzzles) were redrawn with the use of vibrant colours to make them more attractive to young children. Three additional manuals to support implementation and training were developed . To facilitate the training, 23 short films (approximately 2–3 min each), were produced to show the methods used during visits and demonstrated specific materials and activities. Three 15-min films produced show the key steps in a home visit. All films are available in Bengali, English, French and Spanish.A meta-analysis of impact evaluations of the JHV and Reach Up in several low- and middle-income countries, showed that the intervention improved child development across diverse settings .inclusive aspiration of the Measurement for Change (M4C) framework as the intent of this paper is to highlight how learnings from Reach Up partners, who are critical stakeholders, contributed to the scaling of the Reach Up program resources.We focussed on the The data we present in this paper were collected in Phase II of the Reach Up scale-up process. We used two approaches (i) interviews with key informants on their experiences with Reach Up in the different countries where the program has been implemented and (ii) review of written records generated from meetings with members of the global Reach Up community.In November 2019, with funding from the LEGO Foundation, we convened a 3-day Knowledge Exchange Meeting to bring together 31 partners to discuss the findings from the intervention, including reflections on the challenges, successes and lessons learned from the implementation of Reach Up. The attendees at the Knowledge Exchange Meeting were program implementers familiar with the processes involved in the decision-making, adaptation and implementation of country-specific interventions, the core team of Reach Up developers, and representatives from the LEGO Foundation, The World Bank and the Inter-American Development Bank who had been involved in supporting the implementation of Reach Up. We also asked country program leads to recommend team members who would be able to contribute to the discussions on country-specific adaptations and implementations.Before the meeting, three researchers  obtained information from a purposive, non-random sample of 14 key informants over the period August to October 2019. Informants were chosen as they were experienced with the intervention and/or had first-hand knowledge of the processes involved in the decision-making, adaptation, and implementation of country-specific interventions. Reach Up developers identified persons from the existing network of partners who were experienced Reach Up trainers, country program leads who had conducted planning and adaptation of the intervention, or researchers who undertook evaluations of the intervention. We also asked program leads to recommend team members involved in frontline delivery, so that we could capture their “on the ground” experiences. The sample was deliberately restricted as the intention was to interview one key person involved in the planning and implementation of the respective programs, and to invite one or two additional key people to the Knowledge Exchange Meeting. One informant provided information for two separate country programs and two informants provided information for one country, but on different modes of delivery (groups and home visits). All persons who were approached agreed to be interviewed.via Zoom®. A structured guide consisting of 28 questions was used during the process. The guide was divided into three main sections: Program Design , Implementation (Lessons Learned and Promoting Play) and Overall Reflections. Thirteen interviews were conducted in English and one in Spanish, each lasting approximately 1 h. Due to geographical distance, the interviews were held The interviews were recorded, and the interviewers also kept written notes throughout the interview. Transcriptions of the recordings were compared with the written notes, compiled, and saved as Microsoft Word documents. The 15 transcripts from the 14 interviews (one informant was interviewed for two separate countries) were numbered R1 through R15. Approval to carry out interviews was received from the Ethics Committee of the University of the West Indies in August 2019 . Written consent forms were emailed to the participants for their signature.We also reviewed written records generated through two major sources (1) the Knowledge Exchange Meeting held in November 2019 where discussions and recommendations were documented and (2) the minutes of meetings from working groups formed at the meeting and tasked to continue working post-meeting to find solutions to support ongoing implementation. Working groups were formed to focus on three key areas – Adaptation, Capacity Building and Monitoring and Evaluation.The data from the interviews with the key informants were analysed using a qualitative content analysis framework. Specifically, we used thematic analysis, following Braun and Clarke’s  recommenTwo researchers (JC-H and JS), working independently, manually coded nine and six transcripts, respectively. The researchers were currently working with the Reach Up program and therefore understood the context of the review. At this stage, each researcher coded their respective transcripts using the initial codes they identified.Following the individual coding of the transcripts, the researchers reviewed, and met to discuss each other’s extracted supporting quotes. Any discrepancies were resolved through discussions and consensus and consultation with an arbitrator (SW). Based on the initial coding, we identified 39 sub-themes to which data could be coded, and formulated definitions for each . The codOne researcher (JC-H) reviewed the compiled notes from the Knowledge Exchange Meeting and minutes of three of the working group meetings  to identify discussions surrounding the resources and materials and extract relevant statements, decisions and future actions.Similar to the coding process for the interviews, the nine pre-defined themes were used in the process. The notes from the Knowledge Exchange Meeting, and the Adaptation, Capacity Building and Monitoring and Evaluation working groups were read and sentences and/or paragraphs were highlighted and labelled with the most appropriate theme according to the codebook.Three male and eleven female key informants were interviewed from NGOs, and academic and funding institutions, from various regions across the world .Findings for Phases II and III of the Reach Up material and resources scale up are presented in this section. For Phase II, we present (i) the background to the formation of the global community and (ii) the systems used to share lessons and make resources accessible to implementation partners. For Phase III, we (i) highlight the learnings from the interviews with the key Reach Up partners and the review of the records of the Knowledge Exchange and working groups’ meetings, and (ii) describe the adaptations made to some of the Reach Up materials and the addition of new knowledge goods and resources.The formation of the global Reach Up community began with the participants who attended the Knowledge Exchange Meeting in November 2019. The group included Reach Up developers, implementation program leads, government representatives, lead trainers and academic researchers from Bangladesh, Bolivia, Brazil, China, Colombia, Guatemala, India, Jamaica, Jordan, Madagascar, Peru, Turkey and Zimbabwe. The 3 days of activities included presentations on experiences with home visiting (four countries) and group modalities (three countries), sharing of results from a pre-meeting survey and a summary of the indepth interviews, in-session working groups , gallery walks (comprising notes from working group discussions mounted on flip charts for participants to review and add comments), and other networking activities.Since the formation of the global community, we have established systems for sharing learnings with, and making resources available and accessible to, Reach Up partners. Networking and communication among the partners have been strengthened through:The knowledge goods produced and the new and amended materials were shared with Reach Up partners at a webinar in November 2021.A Bi-annual Newsletter to share information about implementation in the different countries, provide updates on workshops and meetings and links to reports, journal articles, evaluations, information from funding agencies, etc.®, which included country representatives, implementers, funders and Reach Up team members in Jamaica. The platform has become a place for active exchange of ideas and where members can seek possible solutions for implementation challenges.A group was formed on the instant messaging platform, WhatsApp® is used to store and organize program documents and resources as they become available. These are made available under the Creative Commons License Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0), to registered Reach Up partners and organizations and are implementing or planning to implement the program. Registered partners and organizations sign a Memorandum of Understanding on the use and citation of the materials, training by experienced trainers, and sharing of new materials.The file hosting service DropboxThe results from the coding of the four categories related to the Reach Up material and resources – Adaptation, Training process, Manuals and Curricula – are presented in this section. A few key informants identified challenges with integrating the program within an existing system. Cost and increased staff workload were mentioned, but the bureaucratic systems at State-run institutions was the main challenge experienced with integration. Suggestions made by the key informants to engage policy makers and minimize bureaucratic challenges are mentioned in Adaptation challenges included accessing/finding materials to make the toys, acceptability/suitability of toys and in some instances, costs associated with procuring the required material. The main workforce challenge was staff turnover experienced curing program delivery. Inadequate compensation and heavy workload were the two main factors contributing to staff turnover. Unfortunately, not many solutions were offered, as this issue was often out of the control of the key informants.Some key informants also noted that the workforce was affected by distance/location of families and the weather. In two countries, challenges related to the safety of the home visitors were of concern:It’s a very geographically dispersed setting with the hugest accessibility problem and some security problems. (R15)Difficult working conditions as we had violence and safety concerns in the neighborhoods. (R7)Other challenges and suggested solutions by the key informants include supervision, working relationships, cultural norms and relationships with families .After the in-depth interviews, further discussions at the Knowledge Exchange Meeting and feedback from the working groups, the following changes to the Reach Up package and resources to support scaling, were made. These were done with input from members of the global community. A communication package, developed for advocacy and communication with stakeholders with a modifiable presentation, short film, brochure and policy briefProduction of new documents and resources including guidelines on integration into existing government systems and workforce related documents with suggested terms of reference, competencies and incentivesA document on the theoretical background and content of the curriculum was developed and the curriculum extended with content for 0–5 months and 37–48 months (weekly and fortnightly).Expansion/revision of training materials including adding a section to enhance the promotion of playful interactions referencing the LEGO Foundation’s characteristics of play and the importance of play for early childhood development  and imprThe manual for training of supervisors was revised and expanded to include more content on supervisory techniques and methods, with interactive scenarios for mentoring and feedback.A Supervisor Handbook was developed to provide guidelines and resources. It covers topics/areas such as supervisory techniques and methods, responsibilities and conducting meetings and field visits.® platform and asynchronous sessions mounted on the Moodle® Learning Management System. We partnered with The University of the West Indies Centre for Excellence in Teaching and Learning to develop the Moodle platform, prepared PowerPoint presentations from the contents of the Reach Up Training Manual and 13 short videos of activities  were produced for use in the virtual training workshop. The synchronous sessions were recorded and uploaded to the Moodle platform daily. The first workshop using virtual delivery was held in June/July 2021 over 10 days, and the second in November/December 2021 reduced to 9 days.Virtual delivery of the train the trainer workshop was hastened by the restrictions on travel and social distancing due to COVID-19. In-person training workshops were suspended, and we pivoted to online delivery in 2021, delivering training content using a mix of synchronous sessions on the ZoomIn this paper, we report on how learnings from key stakeholders contributed to the enhancement of Reach Up materials and resources to support effective adaptation and implementation and facilitate scaling the program across new and within existing countries/regions. Information was collected from Reach Up global community stakeholders  who had first-hand knowledge of the processes involved in the decision-making, adaptation, and/or implementation of the intervention.The Nurturing Care Framework Handbook recommends the formation of communities of practice to facilitate innovation and scale up of ECD interventions . The gloThe expansion of the Reach Up program has been driven by networking, partnerships and collaborations over many years. Some of our partners are champions and leaders of Reach Up through their advocacy and interaction with decision makers (including government policy makers), contributing to adaptations in new countries and/or to extending coverage in countries where the program has already been implemented. Networking at the global community meeting in November 2019 also led to new collaborations and projects between implementers. For example, the International Rescue Committee (IRC) connected with the team from the International Centre for Diarrhoeal Disease Research  in Bangladesh to adapt the intervention for Rohingya refugees, and with a team from Bogazici University in Turkey for the Syrian refugee populations in that country.The feedback from the key stakeholders informed the development of new resources that can be used to present and discuss the features of the intervention with policy makers and other potential users. Content developed include the theoretical background of the curriculum and the theory of change to facilitate communication of the development and mode of action of Reach Up. The PowerPoint presentations and the short film (with footage of training sessions and home visits in various countries) provide target audiences with a better “feel” for the intervention. Overall, the new advocacy products are available to help with communicating and engaging with prospective implementers, including policy makers, community members and funders.Reach Up is designed to strengthen the capacity of parents and other caregivers to promote the development of their children through interactions with implementation staff who play a key role in the success of the program. Therefore, it is essential that the package provides the content and resources to guide, support and build capacity among the workforce. This was addressed through modifications to the curriculum, training resources and new materials related to workforce competencies and motivation. The Reach Up curriculum was designed to be delivered by facilitators with limited educational qualifications and no special knowledge of children’s development. The inclusion of information from the LEGO Foundation’s Playful Parenting Framework  providesKey informants feedback also led to improvements in guidance for supervisors/mentors who support frontline delivery staff to maintain quality. The Supervisor Training manual was enhanced with additional content on building positive, respectful relationships, and providing positive feedback for home visitors and a new Supervisor Handbook developed.Like other ECD programs, challenges remain around retention of staff, especially in contexts where Reach Up is integrated into existing services and is delivered by an existing cadre of workers , 37, 37.With restrictions on travel due to the COVID-19 pandemic beginning in early 2020, face-to-face training was suspended and the suggestions from members of the global community for more adaptable train the trainers’ workshops using technology was fast-tracked. Two virtual workshops were held during 2021 and feedback from participants is being used to continue to integrate virtual delivery into training options. Opportunities to shorten the face-to-face training time, using a blended approach with a combination of virtual and face-to-face sessions, and offering the training in phases, are now possible.We will monitor the use, of the new knowledge goods, through continued engagement and knowledge sharing with stakeholders. Use of a more structured approach to inform scaling of the intervention, was discussed at the knowledge meeting in 2019. For example, in addition to the implementation of the current systems for sharing learnings and making resources accessible  the global partners considered development of a Reach Up learning consortium. This would provide a systematic process for what information to collect, how this will be collected, co-ordinated, analysed and reported. An initial step towards developing a learning consortium will focus on within country scaling.Reach Up is a “living program” and further resources and extensions may be developed informed by continued learnings from implementation partners and other stakeholders. For example, the use of tablet-based applications to support home visitors to select appropriate activities for a child and collect data for program monitoring is being tested in China, Brazil and Jordan and may be important in supporting quality delivery at scale. One extension to date, is the Parent Manual  developeCuna Más program, Colombia’s FAMI program and ChinaREACH in China, have had mixed results that provide lessons for scaling and suggest large-scale replications of the Reach Up program are possible. The revision and extension of the Reach Up program resources and materials reported here, should help to address some scaling challenges and many of the knowledge goods produced may also be useful for other ECD programs.Experiences with the integration into government services such as the primary care program in Brazil, the nutrition program in Madagascar, Peru’s The study has a few limitations. There was ongoing networking and interactions prior, during and after projects are implemented, between co-authors and country partners. Therefore, the data may be influenced by social desirability bias. We selected individuals from the existing network of Reach Up partners who were country program leads and trainers. Thus the views of other groups, for example policy makers, front line workers and families in the program, were not included.This paper illustrates the importance of including the perspectives of key stakeholders in intervention evaluation and using the information in program enhancement so that materials and resources can support scaling. The findings from this study add another dimension to the ongoing debate about “what will be scaled up and how” . This cajacqueline.coore@uwimona.edu.jm.The datasets presented in this article are not readily available because in order to maintain the confidentiality of the key informants, the interview transcripts will not be made available. Requests to access the datasets should be directed to The studies involving human participants were reviewed and approved by Ethics Committee, The University of the West Indies, Mona, Kingston, Jamaica. The participants provided their written informed consent to participate in this study.JC-H, JS, HB-H, and SW contributed to the conceptual design of the paper. JC-H, JS, and MK were responsible for data collection. JC-H and JS conducted data analysis. SC led the revision of the program materials. JC-H, JS, MK, HB-H, SC, and SW contributed to the interpretation of the findings. JC-H drafted the paper with assistance from all co-authors. All authors contributed to the article and approved the submitted version.The LEGO Foundation supported the Knowledge Exchange Meeting held in November 2019, the conduct of this study and publication. The Foundation was not involved in data collection, analysis, or interpretation.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.


Smart and intelligent xanthan gum/pluronic F-127 hydrogels were fabricated for the controlled delivery of atomoxetine HCl. Different parameters such as DSC, TGA, FTIR, XRD, SEM, drug loading, porosity, swelling index, drug release, and kinetics modeling were appraised for the prepared matrices of hydrogels. FTIR confirmed the successful synthesis of the hydrogel, while TGA and DSC analysis indicated that the thermal stability of the reagents was improved after the polymerization technique. SEM revealed the hard surface of the hydrogel, while XRD indicated a reduction in crystallinity of the reagents. High gel fraction was achieved with high incorporated contents of the polymers and the monomer. An increase in porosity, drug loading, swelling, and drug release was observed with the increase in the concentrations of xanthan gum and acrylic acid, whereas Pluronic F-127 showed the opposite effect. A negligible swelling index was shown at pH 1.2 and 4.6 while greater swelling was observed at pH 7.4, indicating a pH-responsive nature of the designed hydrogels. Furthermore, a higher drug release was found at pH 7.4 compared to pH 1.2 and 4.6, respectively. The first kinetics order was followed by the prepared hydrogel formulations. Thus, it is signified from the discussion that smart xanthan gum/pluronic F-127 hydrogels have the potential to control the release of the atomoxetine HCl in the colon for an extended period of time. Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in childhood and adolescence. This disorder affects between 2.2% and 17.8% of all school-aged children and adolescents. Different developmental deficits such as learning limitation, control of executive functions, as well as global impairments of social skills are associated with ADHD in children . The difATMH is approved in the US for the management of ADHD patients . Its absIn the current study, the authors report ATMH-loaded polymeric hydrogels of xanthan gum and pluronic F-127 fabricated by the free radical polymerization technique. The combination of natural polymer xanthan gum and synthetic polymer pluronic F-127 with synthetic monomer acrylic acid increased the pH sensitivity of the fabricated hydrogels. The mechanical strength and stability of the developed hydrogels were increased due to the intermixing of natural and synthetic contents, which not only enhanced the swelling and loading of drugs, but also sustained the release of ATMH for an extended period of time (96 h). Characterization techniques such as FTIR, TGA, DSC, XRD, and SEM were performed for the formulated hydrogels. Similarly, a set of studies including sol–gel analysis, porosity, swelling, drug loading and release, along with kinetics modeling have been performed for the fabricated networks of hydrogel. Gelation mechanism of prepared hydrogels is shown below in −1, demonstrating hydrogen-bonded OH groups and COO– groups, whereas the bending of O–H and C–H was seen by peaks at 1018 and 1420 cm−1 - based hydrogels were prepared by the free radical polymerization technique. A pre-weighed quantity of XG was dissolved in distilled water at 40 °C for 6 h. The PF-127 solution was mixed with the XG solution under constant stirring. Ammonium persulfate (APS) was poured into the mixture. After that, acrylic acid (Aa) was added in to the XG, PF127 and APS mixture. Finally, an MBA solution was mixed with the aforementioned mixture to crosslink the polymers and monomer on their specific sites. The entire mixture was kept on stirring until a transparent solution was formed, purged by nitrogen gas and then transferred into the glass molds, which were positioned in the water bath. The temperature of the water bath was maintained at 55 °C initially for 2 h, which was increased up to 65 °C later. The formulated gel was cut into 8 mm discs. A mixture of distilled water and ethanol was used for washing the prepared discs of gels. After that, hydrogel discs were placed for one week in a vacuum oven for dehydration. The dried discs were processed further for different studies. A set of formulations is shown in FTIR, TGA, DSC, XRD, and SEM were performed according to our previous publication .The sol and gel contents of the synthesized hydrogel were estimated by sol–gel analysis. The unreacted part of the hydrogel is known as the sol fraction, while the reactant part is known as the gel fraction. The weighed discs of the prepared hydrogel were placed for 12 h in distilled water. After that, the discs were removed and positioned in the oven for dryness. The dehydrated discs were weighed again . Equatio1 represents the initial weight of dried hydrogel before the extraction process, while C2 is the final weight after the extraction process.Here, C1) and immersed in ethanol for 3 days. After achieving equilibrium swelling, discs were removed and weighed (A2) again [The porosity study of the prepared hydrogels was performed in absolute ethanol. Hydrogel discs were taken, weighed (A2) again . EquatioHere, ρ is the density of absolute ethanol while V is the swelling volume of hydrogel discs.2 indicates the weight of the swollen hydrogel disc and T1 represents the weight of the dried hydrogel disc at time t.Weighed hydrogel discs were soaked in buffer solutions of pH 1.2, 4.6 and 7.4. The discs were removed at a specific interval of time, blotted with filter paper, weighed, and placed again in the respective media . DynamicA pH 7.4 phosphate buffer solution was used to prepare a 1% drug solution. For four days, precisely weighed hydrogel discs were submerged in the drug solution. Following that, discs were removed and cleaned with distilled water to remove any drugs that adhered to the hydrogel discs’ surface. The cleaned discs were placed in a vacuum oven to dry .USP dissolution apparatus-II was employed for the drug release study. The release of the drug from the formulated hydrogel and commercial product Strattera (60 mg)  was investigated at three different pH values, i.e., pH 1.2, 4.6 and pH 7.4. XG/PF127-loaded hydrogel discs and the commercial product were placed in 900 mL of each buffer solution with 50 rpm at 37 ± 0.5 °C. Samples of 5 mL were collected and fresh medium of the same quantity was added back to maintain constant sink conditions. The collected samples were analyzed by using a UV spectrophotometer  at the wavelength (λmax) of 226 nm [The order and release mechanism of the drug from the prepared hydrogel was determined by using various kinetic models. The release data were fitted into zero-order, first-order, Higuchi, and Korsmeyer–Peppas models , respectp-value < 0.05).SPSS Statistic software 22.0  was performed for the statistical analysis of all experimental data. Differences between the tests were determined by Student’s t-Test and considered significant statistically (


Appropriate health services and health promotion strategies for young people with mental health and substance use (MHSU) concerns are critical for recovery. Foundry, an integrated youth services (IYS) initiative for young people ages 12-24 in British Columbia (BC), Canada, has recently added leisure and recreational activities (referred to as the Wellness Program) into its services. The objectives of this study were to: (1) describe how the Wellness Program was implemented over a two-year period into IYS (2) provide an overview of what the Wellness Program is, who accessed the program since inception and initial evaluation results.n=2) conducted with young people (n=9).This study was part of the developmental evaluation of Foundry. A phased approach was used to implement the program at nine centres. Data was accessed from Foundry’s centralized platform ‘Toolbox’ and included activity type, number of unique youth and visits, additional services sought, information about how youth found out about the centre, and demographics. Qualitative data was also accessed from focus groups  of youth identified the Wellness Program as the first point of access to Foundry. A total of 384 different programs were offered targeting five wellness domains . The majority of youth identified as young girls/women (58.2%), 22.6% as gender diverse, and 19.2% as young men/boys. The mean age was 19 years, and most participants were between the ages of 19-24 years (43.6%). From the thematic analysis of focus groups, we found young people enjoyed the social aspect of the program with peers and facilitators, and identified program improvements that are being considered as the program grows.This study provides insight into the development and implementation of leisure-based activities (known as the Wellness Program) into IYS and can be used as a guide by international IYS initiatives. The initial reach of programs over two years is promising, and these programs are acting as a potential gateway for young people to access other health services.The online version contains supplementary material available at 10.1186/s12888-023-04809-6. Mental health and substance use (MHSU) challenges present early in life, as 50-70% develop during childhood or adolescence , and theLeisure-based activities  have been highly debated throughout the COVID-19 pandemic . Norman Integrated Youth Services (IYS) are community-based (preferably in a single location), youth- and family-centred, and provide multidisciplinary care in a youth-friendly environment , 22, 23.Foundry is an IYS that provides care for young people ages 12-24 years in BC, Canada . VirtualEthics approval was received from the University of British Columbia (ID: H21-01510). This study was done as a component of Foundry’s developmental evaluation which has supported the implementation of Foundry’s complex, diverse, and innovative interventions and allowed the capacity for real time decision-making to change and adapt the evolving system , 32. TheThe following describes the phased approach used to design and implement the Wellness Program, and is a summary from a written log kept by the project coordinator during the timeline provided.Communities were given the opportunity to assess the needs of youth in their region. The project coordinator informed centre staff at eight Foundry centres of the initiative to implement the Wellness Program. Staff then shared this by word of mouth with youth, family and peer support workers and those interested in providing input were given the project coordinator’s contact information. An environmental scan was conducted in collaboration with centre staff to identify assets, gaps and community need in services through team meetings, individual meetings, centre tours, discussions, and the administration of a survey  and research opportunities, and implement group programming within IYS. Formal community partnerships were established with local and provincial agencies. Centres worked with their community members to develop and draft an outline for their Wellness Program and co-design a custom curriculum to meet their unique needs. The project coordinator sent initial draft curriculum content to centres. Centres then sought input from Youth Advisory Committees, peer support workers, and Indigenous youth and families. Content was also reviewed by FCO staff. Changes were then made to the content, specifically inclusion of the voice of youth in conceptualizing wellness, tools and templates for group development and facilitation, and risk management.Pilot Programs began at each centre . The project coordinator identified centre champions, developed waivers, liability and consent forms, as well as service agreements and contracts with community partner organizations. They also provided ongoing centre support and practical toolkits and resources while continuing to develop the wellness curriculum. In parallel, an evaluation team co-designed the evaluation framework and research questions to understand the impact of this pilot phase. Youth Peer Evaluators working with FCO’s Research and Evaluation teams were consulted when establishing a framework.The COVID-19 global pandemic was declared in March 2020 . Public The project coordinator continued to collaborate with community partners, provided a report and updates to funders, and held a Foundry network-wide knowledge exchange workshop to share information about the Wellness Program offered at different centres. They also supported centres with creative problem-solving during pandemic restrictions to offer hybrid program ideas or smaller in-person scenarios and began exploring opportunities for youth peer engagement within the Wellness Program and development of the program with an Indigenous perspective. A team comprised of a researcher, a research and evaluation associate, and four youth peer evaluators began program evaluation (including conducting of focus groups with young people).The project coordinator consulted and worked with the Foundry Indigenous Wellness Team, centre champions and FCO team members to develop and publish the Wellness Program Guide which outlines program vision, intent, examples and working templates to run programs . The TabEthics approval was received from the University of British Columbia Behavioural Research Ethics Board (ID: H21-01510). Data for this study were collected from two sources, the first being Foundry’s centralized data platform called ‘Toolbox’ for all young people who accessed the Wellness Program over a two-year period (September 2019- September 2021). These data are routinely collected in accordance with the BC Freedom of Information and Protection of Privacy Act (FIPPA) and the BC Personal Information Protection Act (PIPA) for the purposes of service delivery, evaluation and research. Informed consent was received from youth prior to survey completion, and youth do not have to complete the survey in order to receive services . Youth voluntarily consent to the data being used for research purposes by indicating they have read and understood the purpose of the survey and how data are collected, stored and reported. Data are de-identified, stored, accessed, and analyzed in a secure research environment. Data are not linked in any way back to personal identifiers. Specific to the Wellness Program, data was collected on activity type, number of unique youth and visits. The forms also collected information about the type of services sought in addition to the Wellness Program ; information about how the youth found out about Foundry; and demographic data including identity, age, sexual orientation, ethnic/cultural background. Descriptive analyses were conducted calculating proportions  for all variables.n=2) were conducted with young people (n=9 participants) via the platform Zoom© from April-September 2021. It was optional for participants to have their video camera on, and participants could use the chatroom feature and type versus answer verbally. Focus groups were conducted to meet evaluation objectives outlined in  who participated in the Wellness Program at any Foundry centre across BC, Canada since program inception (September 2019) were eligible to participate. Young people were invited to participate and recruited through Foundry’s social media and through staff offering the program at centres and offered a $30 gift card for participation. Verbal consent was gained by young people at the time of the focus group. These data are routinely collected in accordance with the BC FIPPA and the BCPIPA for the purposes of service delivery, evaluation and research (as further described above). Semi-structured virtual focus groups , followed by emotional/mental , social , physical  and spiritual . There were 64 (18%) activities with acronyms and names that could not be classified and thus labelled as “other”. Examples include ‘KOB CMP’; ‘KVR RADAR’; ‘BLIP’; and ‘Drop-in’ (See Table Results are based on ‘Toolbox’ data collected at Foundry centres over the two-year period after program launch (September 2019-September 2021). The results suggest a wide range of leisure activities offered within the Wellness Program across this IYS network. A total of 384 different leisure activities were offered within five wellness domains  and August 2021 , and no visits occurred in April and May 2020. The highest number of unique youth visited the program in August 2021 , and no youth visited in April and May 2020. Almost half  of youth identified that the Wellness Program was the first point of access to Foundry. In addition, 75% (n= 265) of youth accessed other programs at Foundry either before or after accessing the Wellness Program. The most commonly accessed services in addition to the Wellness Program were mental health , walk-in counselling , and physical health  , most identified a healthcare provider , school counselor/teacher , family member , friend , or a worker . When asked, “If the centre was unavailable, I would have gone to … ” (n = 173 responses), 56 (32.9%) said nowhere/I wouldn’t have gotten help, 38 (22%) said family members/friends, and 30 (17.3%) answered my healthcare provider.Three hundred and fifty-five unique youth accessed the Wellness Program, with 1319 unique visits. Figure n= 103; 58.2%), followed by gender diverse  or young boys/men . The mean age was 19 years, and most participants were between the ages of 19-24 years . Youth identified as heterosexual , bisexual , gay or lesbian  or preferred not to answer . For ethnicity/cultural background, 104 (58.2%) young people were White, 35 (19.2%) Indigenous, 7 (3.9 %) Chinese, and 7 (3.9%) Filipino.The demographic profile of youth accessing programs is provided in Table n=3) identified as female, and in regard to ethnic/cultural background almost half were Caucasian/white (n=3). Results specific to the evaluation objectives . One young person explained, “Having it virtually so we feel included and less isolated in person and virtually”. Another young person stated,“I do think it is a little bit hard to get involved in them … just because there tends to be tighter knit groups and also just like, not as much accessibility if you don't know what you're doing. I think it could be more clear, at least for my location where it is and what's happening and how to get into them”.Young people identified they wanted better communication about and within the programs. From program leaders, they wanted discussions around mental health and other health topics. One person stated “More in depth conversation would have helped me feel more connected”. Youth also discussed a lack of clarity around the program, and a lack of advertising about it. One person explained this, “My one criticism is there's like no marketing so like people don't know that Foundry holds socials and the only reason I know is ‘cause the youth worker in my school told me”. Another young person explained this communication breakdown as an accessibility issue:Young people shared that their ideal program would be accessible, educational and fun, arts-based, social, and include a range of activities. One young person highlighted the need for social interactions and education, “I dislike the repetition of the same conversation topics that seems surface level. The topics don’t let us get to know each other very well”. Another young person summarized the need for a range of physical activities, “I would love to do activities like canoeing for example, because just being in the water, being out in nature, I have like a list written down of things I want to do after the pandemic is over. I would love to go bowling, go ice-skating, like using your body”.n=122; 9.2 %) and August 2021 , with the greatest number of unique youth also visiting in August 2021 . No visits occurred in April and May 2020. This corresponds with the start of the COVID-19 pandemic lockdown, subsequent waves, and ease of restrictions in the province of BC. The province entered Step 3 of its Restart Plan July 1st, 2021, marked as a major milestone allowing indoor and outdoor group gatherings [To the best of our knowledge, this is the first study to describe development and phased implementation of leisure-based activities (known as the Wellness Program) across an IYS network. This study was done as part of a developmental evaluation , 32 to utherings . Almost therings . ResultsAt a national level, youth mental health has been identified as a top priority for health care in Canada . HoweverAt an international level, investment in and consideration of the long-term mental health needs of young people have been deemed essential . Other wn=9) the perspective of young people and their experience participating in the program as initial program evaluation has helped to understand the program and how it can be improved. The COVID-19 pandemic posed difficulties with navigating the offering, implementation, and tracking of programs. 'Toolbox' data did not capture youth participating virtually, thus the numbers reported in this study are likely an underrepresentation. Staff required 'Toolbox' training and had limited resources/capacity for data entry during the pandemic. The rapid development and expansion of Foundry centres pose challenges for research and program evaluation to keep up alongside. Each Foundry centre could develop its own unique program, which ultimately led to a wide variety of activities offered, and at times it was challenging to understand details .This study provides novel insight into the development and implementation of unique leisure-based activities over a phased approach into IYS and offering alongside traditional health services as a means of health promotion. Although the sample size was small (As this work was part of developmental evaluation, multiple iterations over the course of the evaluation period are being done , 32. OurThis study provides novel insight into the development and implementation of leisure-based activities known as the Wellness Program into IYS which can be leveraged as a health promotion tool. This work provides a template for guidance that can be utilized within international IYS settings to develop, tailor, and implement similar programming suited to needs of young people, their families/caregivers, and communities. The initial reach of the Wellness Program over two years is promising, and it may be acting as a gateway for young people to access other health services. From initial program evaluation, young people enjoyed the social aspect with peers and facilitators, and identified important program improvements that are being considered as the program grows. Further work is needed to understand youth health outcomes and experiences associated with participation in such programs.  A multidisciplinary team is continuing to conduct evaluation of the Wellness Program using mixed-methods over multiple iterations as part of developmental evaluation.Additional file 1.


BCR::ABL1-like acute lymphoblastic leukaemia (BCR::ABL1-like ALL) is characterized by inferior outcomes. Current efforts concentrate on the identification of molecular targets to improve the therapy results. The accessibility to next generation sequencing, a recommended diagnostic method, is limited. We present our experience in the BCR::ABL1-like ALL diagnostics, using a simplified algorithm.BCR::ABL1-like features. Among them, we identified 6 patients with BCR::ABL1-like features (15.4%). Notably, we documented CRLF2-rearranged (CRLF2-r) BCR::ABL1-like ALL occurrence in a patient with long-term remission of previously CRLF2-r negative ALL.Out of 102 B-ALL adult patients admitted to our Department in the years 2008–2022, 71 patients with available genetic material were included. The diagnostic algorithm comprised flow cytometry, fluorescent in-situ hybridization, karyotype analysis and molecular testing with high resolution melt analysis and Sanger Sequencing. We recognized recurring cytogenetic abnormalities in 32 patients. The remaining 39 patients were screened for BCR::ABL1-like ALL cases in settings with limited resources.An algorithm implementing widely available techniques enables the identification of  BCR::ABL1-like features as a separate entity. It is characterized by a similar gene expression profile to the ALL with BCR::ABL1-fusion, but lacks the BCR::ABL1 fusion gene [BCR::ABL1 fusion, KMT2A rearrangement, ETV6::RUNX1 and TCF3::PBX1 fusions [BCR::ABL1-like ALL is impacted by the age and ethnicity of distinct cohorts and the identification methodology. The incidence increases with age, with a peak in young adults population [B-cell acute lymphoblastic leukaemia (B-ALL) is a malignancy resulting from the transformation of a B-cell lineage progenitor cell . The halion gene , 5. It ipulation . It is cpulation –11.BCR::ABL1-like ALL and can be divided into several classes: (1) alterations activating JAK-STAT pathway signaling (including rearrangements of cytokine receptor-like factor 2 (CRLF2) gene, Janus kinase 2 (JAK2) gene and erythropoietin receptor (EPOR) gene); (2) rearrangements of ABL-class genes ; (3) Ras pathway mutations  and other uncommon rearrangements [Diverse genetic alterations dysregulating kinase and receptor signaling are the hallmark of the ngements , 7, 12.BCR::ABL1-like ALL remain of significant interest due to the possibility of incorporation of targeted therapy with tyrosine kinase inhibitors (TKI) and JAK inhibitors [BCR::ABL1-like ALL subtype, including targeted fusion testing, tiered algorithms and broad-based testing [The underlying molecular changes in the hibitors , 14. Sevhibitors . Current testing –19. NeveBCR::ABL1-like ALL diagnostics. We applied an integrated algorithm which allowed a cost-effective detection of this entity. The frequency and clinical outcome of BCR::ABL1-like ALL cases were analyzed and compared with the existing literature data, with a particular emphasis on the potential therapeutic options.Herein, we present our experience in the The study was conducted at the Department of Hematology and Bone Marrow Transplantation of Poznan University of Medical Sciences. Adult patients diagnosed with B-cell ALL treated at our Department in the years 2008–2022 were included (n = 102). Thirty-one patients were excluded from further analysis due to the lack of cytogenetic material or essential clinical data. We performed a retrospective analysis of the clinical data, cytogenetic and molecular characteristics in patients treated in the years 2008–2020 (n = 63). Independently, a prospective analysis of cases diagnosed in the years 2020–2022 was performed (n = 8). This study was conducted in accordance with the Declaration of Helsinki. The study was approved by the Poznań University of Medical Sciences Bioethical Committee (Resolution No. 705/20). 63 patients (88.7%) enrolled in the study were treated with B-ALL protocols according to the Polish Adult Leukemia Group (PALG) guidelines. Remaining patients were treated according to hyper-CVAD protocol.CRLF2) with an anti-TSLP antibody  was performed using the 10-color multiparameter flow cytometry method  using the strategy of internal negative control.The expression of TSLPR (predictive of the rearrangement of the CRLF2 rearranged (CRLF2-r) cases . At least 200 interphase nuclei were scored for each probe by two independent examiners. The cut-off threshold for the BCR::ABL1-like FISH probes of > 10% of cells was established.The karyotype analysis was performed using G banding (GTG). The results were described according to the International System for Human Cytogenetic Nomenclature (ISCN). FISH studies were performed on the interface nuclei using break-apart probes for TCF3::PBX1, CRFL2, JAK2, EPOR, ABL1, ABL2  and for BCR::ABL1, KMT2A, and PDGFRb  and, additionally, for IGH and P2RY8 in the JAK2 exon 16 sequence was conducted using DNA extracted from whole-blood leukocytes at the time of diagnosis QIAmp DNA Mini Kit (Qiagen) and high resolution melt analysis (HRMA). For the variant type identification screened by HRMA, Sanger sequencing was applied using the BigDye Terminator v3.1 Cycle Sequencing kit  and the following primers—forward: 5ʹ-TGCTCCAGTACTTGTGGACTGA-3ʹ and reverse: 5ʹ-CCACTGCCCAAGTAAAGCTTAG-3ʹ.The analysis of the BCR::ABL1-like ALL cases, we implemented a stepwise algorithm integrating all the above-mentioned techniques . Patients expressing TSLPR on leukemic blasts were enrolled for the FISH analysis with a CRLF2 break-apart probe. Patients lacking the TSLPR expression were recognized as non-CRLF2-rearranged (non-CRLF2-r) and subsequently proceeded to the analysis with remaining FISH probes . In a case of retrospective analysis, the patients were primarily examined for the presence of CRLF2 rearrangement with a FISH probe. In CRLF2-r cases, the next step included an analysis with IGH and P2RY8 FISH probes to identify the fusion gene. Non-CRLF2-r cases proceeded to the analysis with the remaining FISH probes .Firstly, the presence of the recurring cytogenetic features was evaluated. Patients with recurring cytogenetic lesions were excluded from screening for CRLF2-r B-ALL with available DNA were enrolled in the analysis of the JAK2 exon 16 mutational status.Additionally, all patients with BCR::ABL1-like features. Out of the prospectively analyzed subjects (n = 8), we revealed high expression of CRLF2 in 3 cases in FCM. Second step analysis with FISH revealed CRLF2::IGH fusion in all 3 patients. In a retrospectively analyzed group, we revealed CRLF2-r in one patient and ABL-class genes rearrangements in 2 patients.The median age of the patients at the time of initial diagnosis was 40 (range 18–69 years). Most of the individuals were diagnosed with the B-common phenotype (n = 50). 32 patients from the study group were recognized as B-ALL with recurring cytogenetic abnormalities. The remaining patients (n = 39) were screened for CRLF2 was absent. The results of the cytogenetic analysis in the relapsed case is presented in Fig. Interestingly, one of the patients was enrolled in the study due to a relapse of B-ALL within 13 years after the treatment with chemotherapy and an allogeneic hematopoietic stem cell transplantation  in the first complete remission (CR1). Notably, we performed a retrospective analysis on the basis of cytogenetic material obtained at the time of the initial diagnosis, however, the rearrangement of BCR::ABL1-like ALL among patients lacking recurrent cytogenetic features was 15.4% and in the whole study group of B-ALL patients it was 8.5%. Most of the cases were CRLF2-r . Overall, we distinguished 5 subtypes of B-ALL in the study group: BCR::ABL1 positive ALL, BCR::ABL1-like ALL, ALL with KMT2A-r, TCF3::PBX1 positive ALL and other B-ALL. In Table BCR::ABL1-like ALL patients. The incidence of distinct entities is presented in Fig. The incidence of the CRLF2-r were enrolled in the analysis of the JAK2 exon 16 mutational status. HRMA revealed different melting profile in one studied sample (CRLF2-r case). We confirmed the presence of the variant LRG_612:c.2049A>C(p.Arg683Ser) using Sanger sequencing in this case , accounting for 25% of CRLF2-r cases. Notably, the mutation occurred in the patient with a relapse after a prolonged remission post-alloHSCT. The relatively low frequency of JAK2 mutations in the study may be explained by the applied technique, which is less sensitive than the next generation sequencing implemented in numerous reports, a small study group and the fact that JAK2 mutations in the BCR::ABL1-like ALL may occur in other coding regions.Herein we present a strategy to identify cases with potentially targetable genomic lesions which can be applied in a limited resource setting. A similar approach integrating FISH and FCM has been implemented by Sharma and Virk , 21. In ure data , 7. It mreported . Among Jof cases , 9, 20. H::CRLF2 . ApproxiAK2 gene . In our BCR::ABL1-like ALL is debatable. As far as the molecular background of this subtype is concerned, the combination of standard chemotherapy with TKI remains promising. Several preclinical studies and case studies reported safety, activity and efficacy of the JAK inhibitor, ruxolitinib, in BCR::ABL1-like ALL harboring JAK-STAT-activating aberrations and ABL-class inhibitors in cases with rearrangements of ABL-class genes [JAK2 mutated ALL cells depended on several signaling pathways activity [JAK2-r leukemic cells were found to be susceptible to JAK inhibitors, both ruxolitinib and momelotinib, the efficacy of JAK specific therapy may be limited in JAK2 mutated cells. Similar results were observed by Schwartzman et al. [JAK2 mutations may be secondary lesions in the leukemic process, while JAK2 rearrangements are leukemic drivers. Therefore, it is suggested to combine JAK inhibitors with Ras pathway inhibitors to avoid clonal selection [The optimal treatment strategy of the ss genes , 23–28. activity . Hence, n et al. . Furtherelection –32. A syelection .CRLF2-r ALL [CRLF2-r and JAK2-r should be considered as candidates for alloHSCT [CRLF2-r clones. These relapses occur irrespective of the MRD-negativity achievement, since CRLF2 fusions are considered early events in the leukemogenesis and CRLF2-r malignant clone may persist in a quiescence during the treatment, and eventually escape the immune system or gain a proliferative state trough acquired mutations [CRLF2-r which occurred during a relapse after a prolonged remission, despite the absence of CRLF2-r in at the initial diagnosis. Conversely, we could not exclude the possibility of overexpression of CRLF2 on leukemic blast at the original diagnosis, since it was not evaluated in flow cytometry at that time. Shah et al. described a similar case of an individual with a relapse of CRLF2-r ALL after a prolonged remission, however, the authors did not analyze the presence of CRLF2-r in the material from the initial diagnosis [The role of alloHSCT in the first CR is also a subject of debate, since the prognostic impact of MRD negativity post-induction remains questioned , 34. An F2-r ALL . It is palloHSCT . On the utations –39. Notaiagnosis .BCR::ABL1-like ALL diagnosis, it did have some drawbacks. The first is the small number of patients enrolled in the study and its mainly retrospective nature due to a relatively low incidence of B-ALL in the adult population. A substantial proportion of patients was eventually excluded as a result of lack of adequate cytogenetic material, which could impact the overall incidence of BCR::ABL1-like cases in the analyzed group. The second limitation is the use of standard diagnostic techniques which, however, are acceptable, if next generation techniques are unattainable [BCR::ABL1-like ALL incidence and outcomes from real-world settings. Our study demonstrates that smaller centers can potentially provide useful information regarding BCR::ABL1-like ALL, regardless of the limited techniques employed. Our results remains also essential considering the potential advent of molecularly targeted therapy in BCR::ABL1-like patients.Although our study provided valuable results regarding tainable . AnotherBCR::ABL1-like ALL. The presented approach may be particularly appropriable in settings with limited resources.The diagnostic strategy implementing widely available techniques enables the identification of high risk and therapeutically targetable cases of


Smoke-free policies are essential to protect people against tobacco smoke exposure. To successfully implement smoke-free policies that go beyond enclosed public places and workplaces, public support is important. We undertook a comprehensive systematic review of levels and determinants of public support for indoor (semi-)private and outdoor smoke-free policies.In this systematic review and meta-analysis, six electronic databases were searched for studies (published between 1 January 2004 and 19 January 2022) reporting support for (semi-)private and outdoor smoke-free policies in representative samples of at least 400 respondents aged 16 years and above. Two reviewers independently extracted data and assessed risk of bias of individual reports using the Mixed Methods Appraisal Tool. The primary outcome was proportion support for smoke-free policies, grouped according to location covered. Three-level meta-analyses, subgroup analyses and meta-regression were performed.14,749 records were screened, of which 107 were included; 42 had low risk of bias and 65 were at moderate risk. 99 studies were included in the meta-analyses, reporting 326 measures of support from 896,016 individuals across 33 different countries. Support was pooled for indoor private areas : 66–79), indoor semi-private areas , outdoor hospitality areas , outdoor non-hospitality areas , outdoor semi-private areas  and outdoor private areas . Subcategories showed highest support for smoke-free cars with children , playgrounds  and school grounds . Non-smokers and ex-smokers were more in favour of smoke-free policies compared to smokers. Support generally increased over time, and following implementation of each smoke-free policy.Our findings suggested that public support for novel smoke-free policies is high, especially in places frequented by children. Governments should be reassured about public support for implementation of novel smoke-free policies.10.13039/100002129Dutch Heart Foundation, 10.13039/501100014780Lung Foundation Netherlands, 10.13039/501100004622Dutch Cancer Society, 10.13039/501100003092Dutch Diabetes Research Foundation and 10.13039/501100012028Netherlands Thrombosis Foundation. Smoke-free policies can protect people against the harmful effects of tobacco smoke exposure. When implementing such policies, information on public support is essential to policy makers. We identified any existing or planned systematic reviews investigating public support for smoke-free policies in indoor (semi-)private and outdoor (semi-)private areas, i.e., “novel” smoke-free policies. Google Scholar was searched on 23 January 2020 using the terms: “systematic review”, “meta-analysis”, “smoking”, “policy”, “regulation”, “legislation”, “law”, “outdoor”, “private”, “support”. We identified five systematic or scoping reviews focusing on support for specific smoke-free locations, or within specific countries showing high or increasing levels of support for outdoor smoking regulations, smoke-free multi-unit housing and smoke-free cars.Our systematic review and meta-analysis provides the first comprehensive overview of support for smoke-free policies that go beyond smoke-free indoor public places and workplaces without any language or geographic restrictions. Overall, the findings from over 100 studies of which 99 could be included in meta-analysis, indicate that public support for novel smoke-free policies is generally high, particularly in areas where children are commonly exposed to tobacco smoke.Smoke-free policies can benefit health and more and more countries are implementing smoke-free policies in novel places. Governments should be reassured by the considerable public support for implementation of smoke-free policies in (semi-)private areas and outdoor public places.,Exposure to second-hand smoke (SHS) poses a major burden to population health globally. Each year, 1.2 million deaths and 36.3 million disability-adjusted life years (DALYs) are attributed to SHS exposure.Public support is important for policymakers to consider implementing novel smoke-free policies and to maximise compliance.Therefore, the primary objective of this study was to systematically review evidence on the levels and determinants of public support for smoke-free policies covering outdoor places or (semi-)private places, henceforth referred to as ‘novel smoke-free policies’. To our knowledge this is the first comprehensive overview of support for novel smoke-free policies that is not limited to a specific smoke-free place or geographic region. Our secondary objective was to identify which personal and country-level characteristics are associated with public support for these policies.We undertook a systematic review and meta-analysis in accordance with our peer-reviewed review protocol.Eligible studies investigated support for smoke-free policies in indoor private places , indoor semi-private places , outdoor semi-private places , outdoor hospitality places , or outdoor non-hospitality places . Policies could already have been in place, were planned, or were hypothetical . Studies were only eligible when support was assessed in a population aged 16 years or above, representing the majority of a population affected by the policy . Studies were excluded if: 1) fewer than 400 participants were included; this limit is based on survey sample size calculations to ensure a margin of error of 5%,Three authors independently performed the data extraction , and cross-checked one another. The following information was extracted: first author’s name, publication year, type of publication, study design, location of the study, description of the policy, policy information , observational period, selection of participants , method of data collection, definition of support, method of assessment , statistical analysis (if applicable), numbers and percentages of missing values and non-response (if applicable), techniques for handling missing data, level of support , personal characteristics , any conflict of interest reported by the authors and funding sources. Furthermore, information was extracted regarding whether the degree of support was for a hypothetical scenario or for a policy that was (about to be) implemented. For reports including pre- and post-implementation support, information was sought on all measurement points.,Country income level according to World Bank classifications and information on traditional comprehensive smoke-free legislation in place according to WHO was sought externally for each report.The Mixed Methods Appraisal Tool (MMAT)not in favour of the policy outcome estimates were reversed. If Likert scales were used, all answer options that were more positive than neutral were combined to indicate support. Policies were categorised by the places that they cover: 1) indoor private places, 2) indoor semi-private places, 3) outdoor private places, 4), outdoor semi-private places, 5) outdoor hospitality places, and 6) outdoor non-hospitality places. When multiple estimates per category were presented , the average support across the category was calculated. For studies based on the same samples a hierarchy of criteria was used to include one of them; the included study was most representative of the general population, had the lowest risk of bias, was based on the largest sample size. If relevant data were missing, corresponding authors were contacted.Reported support was expressed as the proportion of the surveyed population endorsing the smoke-free policy. When studies reported the proportion that was All analyses were conducted with R V.3.6.5 . Support reported as proportions ranging between 0 and 1 did not meet the normality assumption, and therefore logit transformations were applied.If the Likert scale ranged between 0 and a maximum score, the mean score was divided by the highest scale value. For ease of interpretation, proportions were converted to percentage support. We assumed support was related to country of residence and thus violated the meta-analysis independence assumption if multiple studies from a single country were included. Hence, a three-level meta-analysis was conducted to account for within-study, between-study and country-level clustering.Subgroup analyses were conducted by gender , smoking status , parental status (parents vs. others), and age group (youngest age group vs. oldest age group reported). Log odds ratios (ORs) were pooled; if ORs were not reported the following formula was used:Finally, pooled log ORs were back-transformed to ORs for ease of interpretation.In addition to the subgroup analysis three-level meta-regression analysis was conducted. Variables of interest were: calendar year in which the study was conducted, country income level (high- vs. low- and middle-income (LIMC)), and the comprehensiveness of traditional smoke-free policies in place .no or can’t tell on at least one of the MMAT criteria). As appropriate for proportional data, publication bias was assessed using funnel plots of study size against log odds.,Finally, a sensitivity analysis to explore the impact of risk-of-bias of individual studies on the findings was performed by repeating the meta-analyses separately for studies with low risk of bias and studies at higher risk of bias  assessed support for hypothetical scenarios, i.e., support for smoke-free places not yet in place without referring to concrete plans for implementation or actual implementation see .22, 23, 27 assessedRisk-of-bias assessment of individual reports is reported in ,,,Eight reports were not included in meta-analyses: three because public support estimates from the same study population in more recent years were available,In total, data from 896,016 participants were included in the meta-analyses. Some studies provided multiple estimates of public support for policies covering different places, therefore the total number of observations was 1,938,700. Support was highest for policies making cars carrying children smoke-free , followed by playgrounds  and school grounds . For all subcategories except outdoor private areas, we found a mean pooled support higher than 50%. Places with relatively low levels of support included: parks and beaches , outdoor hospitality places  and outdoor private places .Heterogeneity was assessed within (level 1) and between (level 2) studies, and between countries level 3, . OverallSupport was almost uniformly significantly higher among non-smokers and former smokers than among current smokers with ORs ranging between 2.45 and 6.13 . Non-smoMeta-regression analyses indicated no significant associations between question type, study year, and number of indoor public places covered by smoke-free legislation and support for novel smoke-free policies . People ,,,,,,,,,,,,,We identified 12 studies that evaluated support for smoke-free policies before and after implementation . Only onIs the risk of non-response bias low?”. Funnel plots of sample size against log odds were not suggestive of publication bias private places. Support was particularly high for smoke-free places where children are commonly exposed to tobacco smoke, such as cars carrying children, playgrounds, and school grounds. Except for outdoor private areas, support was 50% or higher for all places evaluated. Non-smokers and ex-smokers were more in favour of smoke-free policies than smokers.Strengths of the study include the comprehensive search in six databases, and the absence of any language restriction. With 107 reports included covering data from 33 different countries, the body of existing literature describing support was substantial. Data from 99 studies were pooled for 15 different areas of smoke-free policies, and we accounted for potential clustering at country-level by applying a three-level meta-analysis. Hence, we accounted for variance at participant, study, and country level. In addition to the meta-analysis we conducted subgroup analyses, meta-regression, and sensitivity analyses, providing additional insight in the patterning of public support for novel smoke-free policies. Sensitivity analyses generally showed no meaningful differences in support between lower and higher risk-of-bias studies, suggesting that the evidence is robust.A limitation of this study is that generalisability to other countries from which no surveys were available may be limited. Although there was no indication for publication bias, countries included might be subject to bias, as it is likely that countries planning for novel ways to reduce negative harms of tobacco among the population are more likely to survey support for such policies. This is reflected by the large number of studies from the USA where traditional smoke-free policies are already commonplace, and the low proportion of studies from LMICs, where governmental actions regarding tobacco are commonly more limited. Thirteen reports with 69 estimates in our systematic review were from 11 LMICs. The majority of estimates included in the meta-analysis (33%) however, were from one country . Other limitations of this study concern the different ways in which support was assessed. We did take into consideration the type of answer categories, and did not find large differences when participants were asked if they supported smoke-free policies with a yes-no question or on a Likert scale. Some papers reported proportion not in favour of a policy and outcome estimates were reversed. Although for one study this led to the reported outcome including neutral and positive answers, potentially overestimating support, any bias resulting from this will be very limited. Negative or positive framing of a question might also influence the response.,,,,,,,,Previous studies have shown strong increases in support for novel smoke-free policies over time,Public support is an essential element facilitating policy implementation. We identified highest levels of support for places where children are frequently exposed to tobacco smoke. For example, support for smoke-free cars when driving with children was much higher (86%) compared to a generic policy making cars smoke-free (57%). Similarly, support for smoke-free playgrounds (80%) was higher compared to support for smoke-free parks and beaches (53%). On average, support was highest for indoor private places; this was primarily driven by the high level of support for smoke-free cars carrying children. Apart from that, support was generally higher for semi-private places compared to private places. For example, support for smoke-free regulations in multi-unit housing (76%) was higher compared to private housing (59%).,Of all places evaluated in our study, the highest level of support was found for smoke-free cars: eight out of ten participants were in favour of cleaning the air in cars when children are present. This is in agreement with a previous brief review of support for smoke-free cars, which included studies up to 2008.,,A similarity between the places with highest support was their link with children, suggesting the effectiveness of approaching tobacco control as a child health issue.,The large number of reports included enabled us to evaluate differences in support between population subgroups. Perhaps unsurprisingly, higher levels of support were found among non-smokers and former smokers compared to current smokers.,The results presented in this paper indicate that the majority of the surveyed population is in favour of smoke-free environments beyond places currently being legislated. The consistent high level of support for smoke-free policies in cars carrying children in particular, indicates momentum for increased implementation of regulation in this area. Support was consistently high not only for cars carrying children but for all places where children often go. Framing smoke-free policies as a children’s rights or child health issue as part of a broader smoke-free or tobacco-free generation initiative can provide a good starting point for implementing novel smoke-free policies.Support for novel smoke-free policies is generally high across countries, especially for policies in places where children are present. This indicates that there is substantial momentum for policy-makers to take the next step in protecting the public, and children in particular, from the harmful effects of tobacco smoke exposure by expanding smoke-free policies.JVB secured funding for this work. NWB, FJMM, AzS, AB, FJvL and JVB designed the study and wrote the protocol paper. NWB, AsS and EL contributed to the search, study selection, data extraction and risk of bias assessment. NWB conducted the data analyses and created the figures. JVB supervised the review process. NWB, FJMM and JVB verified the underlying data. NWB, FJMM and JVB drafted the manuscript, AzS, AB and FJvL provided feedback. All authors interpreted the analyses, read and approved the final manuscript, had full access to all the data in the study and had final responsibility for the decision to submit for publication.All datasets generated and analyses are available in the article and the NWB was funded by the Smarter Choices for Better Health Programme from Erasmus University. JVB is PI of a research project to tailor a National Smoking Cessation Programme for (future) parents funded by the Erasmus Initiatives Smarter Choices for Better Health Programme and the Dutch Ministry of Health, Welfare and Sports payed to Erasmus MC. JVB is member of the National Taskforce Smokefree Start, a collaboration of professional organisations involved in the care of pregnant couples, parents, and children aimed at supporting a smoke-free start. This Taskforce is supported by the Trimbos Institute and the Dutch Ministry of Health, Welfare and Sports. Fees for participation in the Taskforce are paid to Erasmus MC. JVB chairs the Taskforce Smokefree Erasmus MC which aims to support a smoke-free hospital environment and optimise smoking cessation support for patients and employees. JVB is a committee member for the national multidisciplinary guideline on tobacco addiction treatment and smoking cessation support.


Evaluating community-based programs provides value to researchers, funding entities, and community stakeholders involved in program implementation, and can increase program impact and sustainability. To understand factors related to program implementation, we aimed to capture the perspective of community partners engaged in organizing and executing community-engaged programs to distribute COVID-19 at-home tests in underserved communities.We conducted semi-structured interviews and focus groups with community-based stakeholders informed by the Outcomes for Implementation Research framework.Findings describe how community-engaged communication and dissemination strategies drove program adoption among grassroots stakeholders. Establishing and sustaining trusted relationships was vital to engaging partners with aligned values and capacity. Respondents characterized the programs as generally feasible and appropriate, and community partners felt capable of delivering the program successfully. However, they also described an increased burden on their workforce and desired more significant support. Respondents recognized the programs’ community engagement practices as a critical facilitator of acceptability and impact.Implementation evaluation aims to inform current and future community outreach and engagement efforts with best practices. As we continue to inform and advance community-engaged disaster response practice, a parallel reimagining of public health funding mechanisms and timelines could provide a foundation for trust, collaboration, and community resiliency that endures beyond a given crisis. Communities of color were disproportionately impacted by the COVID-19 pandemic, seeing higher morbidity and mortality from the virus . SeveralMounting evidence supports that partnering with communities to execute public health programs is important for impact and sustainability –10. AmonSay Yes COVID Test (SYCT) and the related You and Me COVID Free (YMCF) initiatives were disseminated and implemented as part of the Rapid Acceleration of Diagnostics in Underserved Populations (RADx-UP) program  felt like the stepchild, [and] almost walked out’ (I.8).Respondents were also asked about the questions or needs requiring communication across program teams . Respondents generally reported having almost no questions (4) or only minor needs requiring input (3); they felt the program was straightforward or simple to understand/execute. Participants reflected on significant issues in one FG, describing communication breakdowns that caused ‘stress’ and ‘conflict’ among those on the ground. Overall, however, most respondents (7) described communication during the program as positive, expressing appreciation for the SYCT program teams’ willingness to communicate through their preferred method or channel , and be proactive and responsive in providing needed information. In two instances, one FG and one interview from the same community, communication was described as somewhat or majorly flawed. These participants commented explicitly on communication with the academic lead organizations as challenging, convoluted, and even condescending, saying ‘[All respondents that outlined their reasons for participating (8) described a sense of ‘shared mission’ or ‘mission alignment’ with the SYCT program. Respondents talked about participating in the program as a ‘no brainer’ because it would help their community, and helping their community was at the heart of their work.Three respondents also discussed the potential impact of the program’s strategy (increasing testing accessibility) on community transmission as a prime motivator. FG participants were explicitly asked how the idea of community collaboration, i.e., working on the project with a coalition of local organizations/stakeholders, impacted their decision to participate. In two discussions, FG participants reported the program’s collaborative nature had been their deciding factor. Although participants were split in one of these FGs, some said their participation was more influenced by their trust in the lead organization than the idea of working with a coalition.Just being involved in the community already providing information and things like that. It fit in perfect with the, with the Covid—it was a natural fit to us’ (NC FG 8.25). Although some noted initial, but temporary, challenges as they defined and implemented new or modified processes. Five respondents described SYCT program tasks as easy for their organization to execute and integrate with their normal work. Surprisingly, one respondent for whom tasks were highly aligned, felt they were nonetheless very difficult to accomplish, citing the intense fear around COVID-19 mitigation measures. Respondents were asked what additional resources their organization required to execute SYCT program tasks. Most reported needed very minimal support, if any. The most common need was additional person power (5); organizations marshaled additional staff time, volunteers, or new partnerships to meet program requirements and made investments to train this new workforce. Being able to leverage their existing networks and communication channels was discussed as key. A few of this group expressed the need for support from SYCT planners to compensate staff/partners for their efforts. Other support needs included capital investments to develop needed infrastructure (2) , or support developing and distributing marketing and promotional materials.When asked why they were a good fit for the program, respondents described their organization’s reach or location in communities prioritized for test kit distribution (3), the perceived alignment of their organization’s mission or goals with that of the program (4), and their access to needed infrastructure, specifically warehouse space (1). Five respondents described SYCT tasks as strongly aligned with their organizations’ normal scope or capacities, saying ‘—Respondents were asked to describe their county’s needs around COVID-19 broadly. Seven respondents indeed focused on the need for more, and more convenient/accessible, tests, citing major barriers to accessing in-person testing which were perceived to be heightened in their communities . Other needs mentioned included education around testing to help overcome misconceptions and hesitation (3), linguistically inclusive services and supports (2), and broader issues that predated, but intersected with, the COVID-19 pandemic such as homelessness, food insecurity, and limited internet access (1). Reflecting on the extent to which the program addressed these needs, most (7) agreed that it at least partially had, with one noting the need to provide education/marketing to help community members accept the intervention, once available. They explicitly attributed this success to the community-engaged dissemination approach. The program being planned and implemented by community stakeholders enabled them to harvest local wisdom to tailor intervention elements AND engendered trust among resident, One FG participant said the program did not meet the needs of their community, citing the confusion around online data collection activities and expressing frustration at the assumption that everyone in their community would have a smartphone or internet access. They also felt that the program had failed to fully consider and accommodate the needs of specific vulnerable groups including non-English speakers and the visually impaired. Focusing just on testing barriers, seven respondents said the program had effectively addressed their county’s barriers to testing.Seven discussions included explicit recommendations. The most common recommendation for program planners, mentioned five times, was to extend the program. From the respondents’ perspective, the program ended before the need for test kits ended, with some even noting an increase in need just as the kits became unavailable. One respondent also commented that they would have preferred to have kits earlier. Like with the program ending, the beginning of kit availability did not correspond with the beginning of the need for kits, and by the time they were available, the perception was that COVID-19 had “already gotten out of control”. Other recommendations for improvement included keeping future program efforts targeted to those most vulnerable to testing barriers (1), more streamlined or professional logistics  (1), emphasizing or including community voices in all areas of program design (1), and clearly defined processes for coordinating/communicating across on-the-ground community groups from the outset (1).Our findings support and provide insight into how community-engaged program dissemination strategies can catalyze grassroots mobilization in public health disasters. To facilitate program adoption, SYCT/YMCF used communication and engagement strategies that centered and leveraged existing community relationships , 42. WheGenerally, findings support the feasibility and appropriateness of SYCT/YMCF implementation strategies, both which are established drivers of success in implementation science studies . RespondOverall, respondents felt like they were able to implement the program in a way that overcame barriers to testing in their communities, while noting opportunities to strengthen future efforts. The strongest recommendation for improvement was the need to better align implementation timelines to community need, both beginning efforts earlier, when the need first arose, and extending efforts until community members felt the need was resolved. Respondents described facing complex external barriers, including widespread misinformation and fear of vaccines and testing. Overcoming this barrier required building trust over time and having tests available and accessible when community members were ready to accept them . Many reDespite its strengths, our study has a number of limitations. Due to the time lapse from the implementation of the study to its evaluation, we recognize the likelihood of participants’ recall bias that might impact the plausibility of the evaluation results. The number of participants recruited for this study was smaller than the initial recruitment goal due to changes in stakeholders’ affiliation with program organizations. It was not feasible to pilot the instruments and data collection processes prior to their implementation. In analysis, we ultimately combined acceptability and feasibility because, although conceptually distinct, the questions and probes used did not elicit data that enable us to explore them separately, as intended. Piloting the instrument could have prevented this limitation. Although our sampling approach engaged key players in the program implementation, findings represent the specific perspective of those who chose to partner on the project and were perhaps more favorably inclined. Other voices could have yielded different results. Even though the evaluation was conducted by an external group, and steps were taken to minimize any power differentials between participants and data collectors and protect privacy so respondents felt comfortable being candid, it is possible participants perceived the UNC evaluation team to be the same as the UNC program implementation team, opening the possibility of social desirability bias . FinallyOur findings provide insight into how community-engaged communication and dissemination strategies drive program implementation among grassroots stakeholders. Leveraging trusted relationships is key to engaging partners with aligned values and capacity. The purpose of an implementation evaluation is to inform current and future community outreach and engagement efforts with best practices. A parallel reimagining of public health funding mechanisms and timelines could support the advancement and optimization of community-engaged disaster response practice, which could provide a foundation for trust, collaboration, and community resiliency that endures beyond a given crisis.S1 Table(DOCX)Click here for additional data file.S1 Dataset(ZIP)Click here for additional data file.