Understanding specific program costs through efficiency analyses and geospatial targeting allows national stakeholders to make strategic, targeted investments, making the first steps toward sustainability. Costs required for community health worker programs can be reduced without sacrificing quality, and spending can be geographically targeted to optimize service use by rural populations. Results from Mali provide an example for other sub-Saharan African countries. In 2015, cost-saving opportunities of US$6.16 million were identified in 41 of 44 districts.Costs required for community health worker (CHW) programs can be reduced without sacrificing quality and spending can be geographically targeted to optimize service use by rural populations.Program managers and stakeholders should use geospatial analyses to reflect critically on CHW resource planning and make evidence easier to act upon.Key decision makers should assess what efficiency gains in funding can be achieved with geospatial targeting and mapping. In Mali, community health workers (CHWs) deliver essential community care (ECC) to rural populations. The dominance of external funding for the program threatens the sustainability of this critical workforce as donor financing decreases. This article summarizes results of analyses aimed at assisting Mali's decision makers and leaders in initiating a transition to a sustainable CHW program supported by domestic funding through strategic and rational investment.Data on ECC implementation norms, workforce, coverage, utilization, cost, and geospatial features were collected between 2016 and 2019. The data informed interlinked CHW financing analyses—situational, services costing, efficiency, and geospatial mapping. Analysis showed distribution of reported expenditures, estimates of required CHW funding, cost-saving options, and spatially visualized discrepancies between spending estimates and normative costs.Thirteen financing sources contributed to CHW program expenditures, 88% of which were from international donors, for a package of 23 curative, preventive, and promotive interventions. In 2015, the CHW program spent US$13.01 million; an estimated US$8.36 million would have been needed to achieve the same service volume under standard care protocols. Medicines and start-up training had US$6.88 million more than needed; supervision, program management, and recurrent training components were underfunded by US$2.2 million. Cost-saving opportunities of US$6.16 million were identified in 41 of 44 districts. Funding reallocation opportunities  were identified in 20 of 44 districts (US$2.56 million). Use of geospatial targeting and mapping suggests district- and village-level reallocation options for theoretical funding surpluses.CHW costs can be significantly reduced without sacrificing service technical quality. Spending can be geographically targeted to optimize service use by rural populations. Efficiency analyses provide evidence to build stronger engagement, support improved decision making, efficiently prioritize resources, and target investments for sustainable financing of CHW programs. Health system leaders are increasingly challenged to look beyond their clinical frameworks and find approaches and models that further expand the services they provide outside of the conventional hospital setting. Community health systems (CHSs) provide an alternative to traditional facility-based health systems through a set of local actors, relationships, and processes supporting health at community and household levels. Community health workers (CHWs) have been the cornerstone of CHSs playing a crucial role in providing preventive, promotive, and curative health services to local communities. Countries worldwide seek to leverage the skills, community knowledge, and cultural competency that CHWs can bring, connecting those most at risk for poor health outcomes with the formal health system.With nearly 60% of its population living in rural areas,For the past 3 decades, Mali's community health system has played a significant role in determining the supply of and demand for community-level health services. Populations across the country ensure that key health services are available in communities through public-private partnerships. Community-level health service delivery is built on a network of privately owned nonprofit community health centers (CHCs) founded by communities and managed by elected community health boards (CBs).Efficiently run CHW programs are vital in resource-limited health systems. Providing evidence to guide rational use of scarce public funds can catalyze country governments' transition to greater domestic funding and contribute to their “journey to self-reliance.”Providing evidence to guide use of public funds can catalyze country governments' transition to greater domestic funding and contribute to their “journey to self-reliance.”The U.S. Agency for International Development (USAID)-funded Health Policy Plus (HP+) project conducted the following interlinked analyses—situational, costing, efficiency, and geospatial mapping—between 2016 and 2019. These analyses covered 5 regions in southern Mali that implemented the CHW program, gathering 2015 program data.The situational analysis defined sustainability concerns raised by USAID/Mali as it prepared to decrease its support to CHWs. The situational analysis had the objective of identifying CHW program components and determining the distribution of reported expenditures and related patterns. The costing analysis followed and had the dual objectives of estimating the necessary CHW funding based on national standard care protocols and examining required program financing changes. Lastly, the combined efficiency and geospatial mapping analyses had the objectives of identifying potential cost-saving options through efficiency improvements, quantifying and spatially visualizing discrepancies between spending estimates and normative costs, and identifying geographic areas for better-targeted funding.Information was collected in-country between 2016 and 2018 using semistructured key informant interviews, questionnaires, consultative meetings with community health experts and secondary information sources. The study team used Microsoft Excel-based templates to obtain expenditure data, service input costs, and utilization data. HP+ designed questionnaires that were administered through semistructured key informant interviews to explore the landscape, opportunities, and challenges of the CHW program.Supplement.Key informants were purposively selected based on their institution's role in the CHW program such as funding, implementation, advocacy, norm-setting, management, coordination, and policy responsibilities. Experts were chosen based on their ability to exercise legitimate authority over or influence on one of the following: the choice of CHW location, recruitment and training needs, stakeholder coordination, key program management functions , and regulatory and normative decisions. Table 1The situational analysis identified and examined CHW program information related to workforce, health services provided, funding sources, and expenditures. Entry, cleaning, and aggregation of data were conducted manually using Microsoft Excel. The quantitative depiction of the data using descriptive statistics, presented through tabulation and graphs, included (but was not limited to) the number of active CHWs, location, remuneration, and reported program expenditures by location, funding source, and category.Identifying efficiency opportunities and related financial implications requires comparing actual expenditures to the normative cost of delivering the CHW service package in compliance with national standard care protocols. To derive the normative cost of each service, we analyzed national norms and standards, calculated direct costs of the resources or "ingredients" required for each service (a “bottom-up” activity-based approach), and allocated indirect costs in proportion to the share of CHW time spent on each service (a “top-down” approach). This provider perspective approach to calculating cost per service focuses on the supply-side dimension of service quality. Provider communication, bias, and other key aspects of service quality from the client's perspective client were excluded.The national ECC implementation guide defines the ECC package provided by CHWs. We analyzed its composition by identifying individual services and their link to public health programs. Building from the expenditure information identified in the situational analysis, we traced the main program elements with identifiable costs needed to deliver services. Labor, medicines, and supplies were classified as direct costs entirely attributable to service delivery. Management, supervision, equipment, and training were considered indirect costs incurred regardless of whether service delivery occurs and cannot be assigned solely to a specific service. CHW equipment  was considered an indirect cost as specific aspects, like length and frequency of use directly attributable to each service, were not measured.Determining a standard level of inputs for the ECC package provided by CHWs involved direct measurement or estimation of the time needed to provide each individual service plus required diagnostic tests, medicines, and supplies. We combined contributions from the expert panel with existing national standard care protocols for child health (a MOHSA document) to determine or confirm standard treatment guidelines and estimate standardized normative inputs required for all ECC services. The CHW standardized treatment sheet for sick children was considered a reference to assess and compare quality of care among children and was designed to encourage efficiency through resource optimization and rational use of treatment inputs. Community health experts confirmed data from nationally published statistics. Information was collected from health authorities and implementing partners on costs of personnel supporting the program (CHWs and managers), expected frequency, and cost of training and supervision.–The analysis unit was cost per service considered from the provider perspective. We analyzed cost using the Community Health Planning and Costing Tool, which estimates unit costs of different program elements  per service multiplied by the total estimated number of services.Expected frequency, numbers, and costs of supervision visits and meetings per year were adjusted by region. Travel time and related costs were estimated during meetings with CHW program experts. Fuel forecasts were determined based on expected geographic distances (roundtrip) and fuel consumption per 100 km by type of motor vehicle used. An average percentage mark-up on medicines for transport, storage, management, and distribution was derived from all 5 regions and applied to each unit cost. Capital costs linked to accommodation and working space provided to CHWs by communities were based on a sample of 120 villages in 15 health districts across the 5 regions.After calculating the normative cost of each service provided by CHWs, we estimated the technical efficiency of service provision within each health district using program data on the average expenditure per CHW in each region and the number of CHWs active in each district .AED=AERWe calculated the normative cost of providing all services to the CHW-covered population in each district. This calculation used district-level service volumes reported by program implementers in 2015 and the normative cost per service for each of the 23 services. The normative cost for the covered population represents the efficient cost of providing all services delivered by CHWs in 2015 while complying with the MOHSA's national quality standards.The difference between normative cost and actual expenditure is the technical efficiency gap—how much money was spent beyond or below the normative cost.The normative district-level cost of full rural population coverage included the normative costs per service from the Community Health Planning and Costing Tool application, the size of the rural population, and the number of services provided per person in covered villages. The normative service cost calculation for the full rural population is based on 3 key assumptions: (1) all individuals in villages covered by CHWs who seek care would be able to access a given service; (2) current CHW service volumes meet demand  within the covered population; and (3) the volume of services used per person would be the same within the noncovered rural population as in the covered population if CHWs were available.The allocative efficiency gap is the difference between actual expenditure and normative cost to cover the total rural population. This value represents each health district's funding surplus or deficit after the technical efficiency gap has been addressed.We analyzed the geographic distribution of community health resources for the baseline year (2015) and its relationship with normative costs using a GIS tool developed between May 2017 and March 2018 by Palladium as a part of the HP+ project.The types of information needed to create maps for geospatial analysis included geocoded villages; administrative boundaries for health districts, municipalities, and communes; population; 2015 district-level program expenditure; and 2015 district-level normative cost of services used by the population. We compared expenditures supporting population use of the ECC package with corresponding normative costs to provide a visual representation of how opportunities for technical and allocative efficiencies are geospatially distributed. Maps and spatial derivatives were generated using Quantum GIS.In 2015, the CHW program spent US$13 million to support 2,337 active CHWs affiliated with 84% of CHCs assigned to more than 2,000 villages across 44 health districts in the 5 southern regions of Mali plus the Bamako District. The program provided access to CHW-provided services to more than 3 million people living in rural areas. Thirteen different financing sources contributed to overall expenditures, 88% from implementing partners funded by international donors. Program expenditures and the number of active CHWs varied across regions , althougSupplement.According to the national ECC implementation guide, CHWs offered 23 curative, preventive, and promotive interventions. Roles and responsibilities were defined, and guidelines were provided to ensure that delivery of these services, supervision, and reporting are integrated as a package across 5 public health programs. The ECC package is linked to services under community mobilization/behavior change communication, nutrition, reproductive health/family planning, malaria, and maternal and child health. Direct and indirect labor costs for CHWs contributed to 20% of total cost per service. Activity reporting was the most labor-intensive and expensive “service” with 95% of its cost attributed to indirects. Management of moderate acute malnutrition was the second most expensive service due to high supplies and medicines costs because of extensive use of ready-to-use supplementary food (RUSF) for child nutritional rehabilitation . ResultsThe CHW program spent US$10.50 on average per service in 2015 to provide 1.24 million ECC services, 55% more than the estimated US$6.80 on average per intervention that would have been needed to achieve the same service volume if standard care protocols were followed which would reduce aggregate spending by 36% (US$8.36 million). The number of ECC services provided per CHW in 2015 varied significantly across districts, with estimates ranging between 94 to 2,287. The proportion of CHW total time available for ECC services in a year spent on direct service provision also varied widely between districts, from 3% to 43%. Comparably low shares of time spent on direct service provision were observed in similar work on integrated community case management programs in other sub-Saharan African countries.Some areas of the CHW program (defined as areas with quantifiable costs related to an identifiable source) benefited from a funding surplus, while others faced a deficit. Understanding the geographic distribution of CHW program inefficiencies and funding to need misalignments is important to assess what efficiency gains can be achieved with geospatial targeting. In Significant cost-saving opportunities exist if CHW services implement technical efficiencies by adhering to published norms and guidance from the MOHSA .Supplement.In most districts, a significant portion of the rural population is not covered by a CHW. Providing services to the currently covered rural population at normative costs could free up funding to extend services to the remaining rural population . TechnicRepurposing funding from technical efficiency improvements within districts could cover over 2.1 million more people in rural areas without any redistribution across districts.Supplement.The initial situational analysis shows that compartmentalization of international donor interventions makes the CHW program in Mali vulnerable, exposing leadership and coordination issues as real challenges. Program funding and management information was asymmetric between implementing partners but most importantly between implementing partners and national/local community health stakeholders. None of the 10  external funding sources identified in the situational analysis supported all program resource areas needed to operationalize CHW activities across all southern regions in 2015.According to CHW program managers at the MOHSA, choice of CHW program geographic (region or district) or program  by a donor is discretionary to a donor regardless of what is being provided by others. The mapping process of funding sources for some program areas is another good example of how donor compartmentalization issues are reflected not only in the data collected but also in the approach used to access the information. Nine different funding sources were recorded in 2015 for CHW remuneration and equipment, and 5 for medicines and supplies. This information was not available at central level at the time of the study. Program data including CHW funding source, workforce, and service utilization were gathered directly at the regional level and from implementing partners and donors. Key informants consulted further underscored the lack of information sharing between donors, for example, that an implementer could continue to remunerate CHWs while being unaware that they did not have the necessary medicine and supplies to continue working effectively.The big challenge at the moment is the lack of control over the cost and availability of medicines. —Implementing partner, October 2016Such challenges result in a wide variety of funders, each having different mandates and interests that are not necessarily aligned with national priorities, leading to investments with no clear transition to the government or another partner, which can also cause temporary suspension of CHW services. MOHSA leadership needs to make decisions to bring expenditures on key program areas closer to less costly normative levels of funding. Reaching this stage of efficiency in programming at the central management level requires coordination and consensus among all funding sources for reprioritizing historic spending allocations according to country-endorsed national standards.Reflecting on why expenditures on certain program areas were significantly higher than for the normative costs is critical so that implementers or practitioners outside Mali (but in similar contexts) can also use these results. One way of ensuring that limited budgets go further is increasing efficiency, potentially by adhering to national service delivery guidelines. Our results in Mali suggest that service delivery, supervision, and medicine and supply distribution did not fully comply with standards, which led to a waste of resources. Lack of compliance to service standards by CHWs not regularly supervised might have led to input overuse which inflates consumption, making the forecast of expensive medicines and supplies, particularly RUSF, unreliable.Management of moderate acute malnutrition is the most commodity-intensive service provided by CHWs as evidenced by a cost structure dominated by variable costs with RUSF comprising 73% of the total cost per service. Spending on RUSF is driven by its overall use which is expected to increase proportionally as the volume of services increases. The relationship between spending on RUSF and outputs  might not be necessarily linear in practice. In addition to potential wastage at CHW level, other factors might affect use of RUSF and other medicines or supplies distributed directly to CHCs by implementing partners. Evidence from Ethiopia has shown that in certain settings micronutrient enhanced commodities can be subject to particularly high levels of leakage and misuse with products ending up for sale in shops.Some implementing partners sought quick results at the expense of systemic integration and efficiency. —NFCB member, September 2016The vertical nature of such approaches has also been echoed by other stakeholders concerned about its negative effects on the relationship between communities and CHWs ultimately affecting ownership of the program.CHWs are identified according to their donors …, they are not identified as an integral part of the community.—Regional Health Office Director, October 2016Furthermore, 1 high-ranking MOHSA civil servant interviewed indicated that new CHW-covered villages or staff replacements (which drive start-up training costs) were not necessarily controlled or recorded accurately by the government nor reported by implementing partners. This gap in coordination links back to donor compartmentalization issues and leads to asymmetric information between central management of the CHW program overseen by the MOHSA and field operations supported by implementing partners.National ECC implementation guide and standard care protocols such as the CHW standardized treatment sheet for sick children  offer op,Complying with standards can reduce program spending to achieve the same service volume, generating savings to be invested elsewhere in the ECC program. For example, CHW supervision, often considered one of the weakest links in CHW programs ,Mali could make better use of CHW program funding if guided by data that inform efficient use of domestic resources mobilized.,Given budget and health workforce constraints in lower- and middle-income countries, CHWs face challenges without receiving the needed support in providing expected services. The productivity differences were discussed with local stakeholders. These discussions generated possible explanations, including the presence of user fees and variability in population density (captured by the population-to-CHW ratio) linked to the mining industry. Although user fees are authorized in Mali, they are known to inhibit access to care in other settings.Optimizing limited resources through cost savings provides opportunities to increase coverage to currently noncovered populations. Mali geospatial analyses illustrate options for decision makers. Planning can be more engaging by visually supporting identification and prioritization of districts with the highest opportunities for technical efficiency improvements. Using recognizable maps makes advocating for funding surplus reallocations and investments easier. Location data (distance and proximity) used in geospatial targeting help stakeholders reflect critically on CHW resource planning and make evidence easier to act upon. Geospatial analytics and supported interfaces facilitate analytical reasoning for decision makers by turning data into information, information into insight, and insight into practical decision making. Geospatial analytics can further help organizations anticipate and prepare for upcoming changes due to evolving spatial conditions or location-based events such as a community-level response to the COVID-19 pandemic.Our findings in Mali are relevant to the bigger discussion around system integration and sustainability of CHW programs, given that primary health care is the key to reaching universal health coverage. In Mali, CHWs are essential to delivering that care.Implementing cost-saving approaches would allow Mali, with adequate government prioritization, to financially sustain the CHW program.–International donor assistance is volatile and has inherent limitations, such as being temporary with "short-cycle" characteristics and strings attached.,–Fragmented funding, due in part to limited donor coordination, combined with insufficient government leadership, inhibits sustainable financing and contributes to inefficient spending in many countries.Expenditure information self-reported by implementing partners could not be independently verified. Potential supply-side limitations of the ECC package were not considered. Assessment or recording of time required for delivering each service was made through limited direct observation and estimates relied mainly on expert opinion. Demand-side factors such as financial barriers affecting use of services in CHW-covered areas were not assessed, as information on user fees possibly charged by CHWs for some of the services provided were not collected. Costs did not include health system strengthening activities required to increase compliance with norms and standards of care. Differences affecting use of ECC services were not accounted for between CHW-covered and noncovered villages within the same health district. Elements that might explain the variation in CHW productivity such as workload, adequate supplies and equipment, and acceptance and respect from the community and health systems were not explored in our analyses.Mali's CHW program is hampered by fragmentation of funding and interventions compounded by leadership challenges, noncompliance with national standards of care, and inadequate re-sourcing of key program areas. Results from Mali's case show how efficiency analyses can provide an evidence base to build stronger stakeholder engagement and support improved decision making for CHW financing. Our analyses bring a level of understanding of CHW program costs and challenges that allows the Malian government and other stakeholders to prioritize resources efficiently, and thus afford targeted investments to begin sustainably financing the CHW program.Evidence presented indicates system and program implementation changes that could be tested to suggest future adaptations. Such changes could further guide operations research in other sub-Saharan African countries to improve community health and the sustainability of CHW programs. Building CHSs from the ground up, while carefully considering local contexts, is essential to inform decisions about where, when, and how care is provided within a community. Our findings can also further contribute to global thinking and local actions around system integration. They can debunk frequent misconceptions which present CHW programs as a unidimensional human resource solution to health care access at the community level without recognizing the dynamics of CHS local actors, implementing partners, and the broader health system.


Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision.This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible.We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8).We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program.The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program. People with multiple sclerosis live with high rates of depression and anxiety, with prevalence rates of approximately 31% , respectd=0.570).A recent meta-analysis of 13 studies in multiple sclerosis (MS)  revealedd=0.8) and anxiety (d=0.6). This was a high-quality randomized controlled trial (RCT) of 150 people with multiple sclerosis, showing that face-to-face MBSR was effective across a range of outcomes compared with treatment as usual. Indeed, mindfulness has been shown to have significant mental health benefits for people with a range of physical health conditions, including chronic pain, fibromyalgia, arthritis, and cancer [A single study of mindfulness-based stress reduction (MBSR)  demonstrd cancer ,11. Howed cancer -7. Thered cancer .Both RCTs in MS were based on the traditional MBSR program  and invoThe aim of this study is to develop a web-based mindfulness program tailored specifically for people with multiple sclerosis via a qualitative investigation of (1) the psychological experiences and unmet needs of people with multiple sclerosis, (2) attitudes toward a proposed web-based mindfulness program designed to address such needs, and (3) iterative feedback from people with multiple sclerosis and experts in the field.Participants were recruited from the MS Clinic, Brain and Mind Centre, Sydney, Australia, between August 2017 and July 2018. Ethics approval was obtained from the University of Sydney Human Research Ethics Committee (2016/049). Potential participants were approached at the MS Clinic waiting room consecutively and given an invitation letter with the opportunity to fill out their contact details. We did not exclude participants with comorbid physical or mental health conditions. Participants were required to be older than 18 years and to have a neurologist-confirmed diagnosis of MS. Interview times were arranged via telephone and were conducted face-to-face at the MS Clinic at an appointed time, with written consent, by a registered psychologist (AS).Demographic data were collected via interviews and self-report questionnaires. To characterize the sample, we administered valid and reliable measures of depression, anxiety, and pain. Depression symptomatology was measured using the Center for Epidemiological Studies for Depression questionnaire  CES-D;  with appData were analyzed using NVivo Qualitative Data Analysis Software , via indThe web-based mindfulness program was developed on the basis of core components from the MBSR program by Kabat-Zinn , with thThe 5 modules were scheduled as follows: module 1 at the start of week 1 and module 2 at the start of week 2. The remaining modules contain instructions for the next 2 weeks, that is, module 3 would be delivered at the start of week 3 and again for the option of repetition, at the beginning of week 4, etc. The amount of time  dedicated to each module was decided based on the complexity of the mindfulness concepts and strategies described. It was written by a registered psychologist (AS) with clinical psychology and mindfulness training in collaboration with a clinical psychologist with experience in the development and evaluation of evidence-based psychological interventions for people with chronic health conditions (LS) and a clinical neuropsychologist with experience in the delivery of web-based therapeutic interventions (SN).Direct, face-to-face feedback on the program was provided by a subsample of the original participants interviewed (n=11), who indicated that they were interested and willing to review the modules of the program. In total, 8 women and 3 men with MS  took part in the review process. Two neurologists and 4 mindfulness experts including 2 clinical psychologists, 1 emergency care physician and 1 general practitioner provided written feedback on the program. Feedback was then coded and analyzed inductively, forming subheadings with overarching themes. Feedback from both people with multiple sclerosis and experts was discussed in team meetings among the 3 lead authors . Further iterations of the program were cocreated where there was consensus and scope to make the suggested changes.All participants had a neurologist-confirmed diagnosis of MS (N=19). There were 6 males and 13 females. A total of 63% (12/19) of participants had clinically significant depressive symptoms according to a cut-off score of 16 on the CES-D . MoreoveThe thematic analysis of this qualitative study was divided into 3 parts, in accordance with the research aims. For detailed thematic maps, including illustrative example quotations, please see Most participants reported that their psychological experiences were characterized by uncertainty, worry about the future and possible disease progression, and difficulty grappling with unknowns surrounding the disease. The inability to predict possible relapse was a major source of continual stress and anxiety, and it interfered with planning, for example, whether and when they should have children, how long their physical capabilities would allow them to stay in the workforce, and the potential financial burden that they would place on their families. Going to neurologist appointments and having to face the possibility of receiving bad news, such as the identification of new lesions in the brain or spinal cord, or changing treatments, was a source of excessive worry and distress. Some participants worried about whether their physical or cognitive problems were part of their MS or due to other factors, such as the natural process of aging.normal life and preserve their sense of self and identity, which many feared was at risk of erosion.An overarching theme was the participants’ experience of grief and loss due to the gradual decline in their physical and cognitive abilities and their sense of independence and identity. They also expressed anguish and sorrow over the loss of their illness-free life. Many people with multiple sclerosis reported that they were faced with having to give up on future plans and accept changes to their ability to travel and participate in family life. This process of adjustment experienced by people with multiple sclerosis was depicted as challenging and repetitive, as people developed new or worsening symptoms over time. People with multiple sclerosis experiencing cognitive difficulties described experiences of memory loss and how this impacted their daily functioning as well as their ability to recall cherished memories , which reinforced feelings of disconnection from family life. Those experiencing physical challenges, such as ataxia, muscle weakness, and bladder dysfunction, reported feelings of helplessness and a great sense of vulnerability, as they gradually lost confidence in themselves. Participants across all ages, genders, and types of MS emphasized the need to separate themselves from the disease, to try to lead a Participants reported experiencing social isolation and difficulties communicating with people in their support networks about their MS. Barriers to receiving social support included difficulties with participating in social activities due to loss of function and emotional avoidance when faced with opening up to people about their MS as well as other people’s failure to respond appropriately. Some participants reported that they were given unsolicited and often ill-informed advice from friends and family, which was perceived as highly distressing and alienating. Many participants reflected a sense of apathy and disinterest on behalf of their wider social circles and work environment and others’ general lack of understanding that MS is largely an invisible disease. Two participants reported facing blatant rejection from others because of stigma and unfounded beliefs about MS being contagious.Most participants reported an unmet need for psychological support, which they attributed to a lack of follow-up, lack of funding or resources, lack of knowledge regarding where to go for psychological support, and lack of psychologists or therapists specializing in MS. Of the 63% (12/19) participants with clinically significant symptoms of depression, only half reported that they were either currently seeing a psychologist or had seen one in the past.A major barrier to receiving psychological support was that the overwhelming majority of participants did not want to meet other people with multiple sclerosis in a face-to-face therapeutic setting, despite wanting to know how others cope. This was largely because meeting people with more severe symptomatology or disability generated feelings of uncertainty and fear around their own illness progression. For representative participant quotations for each subtheme, please see These main themes underlying the psychological experiences of people with multiple sclerosis were incorporated into the program development through the use of fictional characters featured in each module, whose stories and case examples reflected the common challenges, and mental-health related difficulties that participants reportedly faced. For screenshot examples, please see Participants reported positive attitudes toward seeking psychological support online. It is widely regarded as convenient, easy, and allowing access to therapeutic support with a sense of anonymity, in the privacy and comfort of their homes, without the need for travel. Reservations toward the use of an internet-delivered psychological intervention were noted by 11% (2/19) participants. One experienced MS-related vision problems and another expressed apprehension surrounding internet security.Participants’ experiences and knowledge of mindfulness varied from having no understanding of what it was to having years of experience. Potential barriers to participating in the proposed mindfulness program included not having enough time in the day to meditate, difficulties getting in a routine, problems with attention and concentration, low mood, and inability to find a quiet space to meditate, particularly for those with young families.Methods section). People with multiple sclerosis with more experience with mindfulness meditation tended to advocate for longer meditation practices. Features that were identified to engage participants in the program and reduce dropout included incorporating case examples, email reminders, and guiding participants through the program via weekly telephone calls. Three participants reported that they would be more likely to participate in the program if their neurologist or psychiatrist recommended it. Many reported that a program tailored to people with multiple sclerosis was preferable compared with a generic web-based mindfulness program. For representative participant quotations, please see Most participants reported that they would be interested in participating in the proposed web-based mindfulness intervention  who commented that the program was too simplistic and could be perceived as patronizing. Following this feedback, participants and experts were explicitly asked about their views in this regard, and these concerns were not widely shared by other respondents. Some changes to the program graphics and language were incorporated to further improve the relatability of the program: graphics were changed to make the characters look older and the scenes more realistic, and some of the language was edited to be less repetitive and more direct.monkey chatter) and how the mindfulness concepts were presented. Experts in mindfulness commented that the concepts were well explained and consistent with MBSR principles; however, some suggested involving a mindfulness expert, which we did. One area in which there was disagreement among experts was on the degree to which more reference to research should be included. Some experts recommended integrating scientific evidence on the efficacy of mindfulness into the program to improve treatment adherence, whereas others disagreed. We decided that including specific scientific research and results of studies was not necessary. For representative quotations of the feedback provided by participants and experts in the field, please see In terms of the program content, 8 participants gave specific, positive feedback on the analogies used to explain mindfulness concepts (eg, Participants reported psychological support as a common unmet need and were generally positive about the idea of an MS-specific, web-based mindfulness intervention. Among the participants, the anticipated use of such a program was high, particularly if it was endorsed by treating physicians. A thematic analysis of 19 face-to-face interviews with people with multiple sclerosis revealed 3 overarching themes characterizing their psychological experiences: uncertainty, grief and loss, and social isolation. These themes were used in the development of narratives throughout the mindfulness program.The first theme of uncertainty is unsurprising, considering that MS is an unpredictable illness. Participants indicated that they were fearful of progression, worried about whether symptoms might indicate deterioration, and worried about relapse. The lack of knowledge about the causes of MS exacerbated the uncertainty and worry and made attending medical appointments the source of anxiety. For some, the fear of progression was related to fear of becoming a burden on their family. Fears of progression have been previously documented in MS and found to be associated with poorer psychosocial outcomes ; therefoThe second theme was grief and loss. Participants described the struggle to accept the limitations imposed on them by MS. They experienced losses of their future plans, which led to a loss of independence. Specific losses such as loss of cognitive abilities and loss of confidence led to a loss of a sense of self and identity. The importance of loss and its impact on self and identity have been previously described as important in the context of adjustment to illness . Hence, The third theme was social isolation. In terms of social isolation, people with MS felt that family and friends could not understand their difficulties, which sometimes led to inappropriate responses or apathy from others. Some people with MS described having lost friendships, which they experienced as rejection due to the stigma of having MS. Many people with MS described emotional avoidance, which allowed them to not express their emotions to others as a way of trying to avoid negative responses from others. However, this led to an overwhelming feeling of social isolation, which has been previously recognized in the literature .We used these qualitative results to provide narratives to supplement the mindfulness content of our program. Once a draft version of the program was available on the basis of early interviews, we also gained feedback from both the people with multiple sclerosis and experts in MS and mindfulness. Iterative feedback allowed modifications to be made to the program content and graphics to improve relatability and ensure adherence to MBSR principles. However, overall feedback from mindfulness experts, neurologists, and people with multiple sclerosis were positive. The adapted mindfulness program appeared to be an acceptable and highly relatable program, tailored to the unmet needs and experiences of people with multiple sclerosis, and consistent with the basic principles and teachings of MBSR by Kabat Zinn .illness uncertainty has been found to predict adjustment problems for people with multiple sclerosis, over and above demographic and disease characteristics [As previously described, the primary reason for including the psychological experiences of people with multiple sclerosis was to ensure that the narratives included in our program were relevant to the end users of the program. It seems that the issues raised in our sample were similar to those previously raised in the literature. Prior research has shown that there is a lack of psychological support and continuity of psychosocial care after receiving the initial diagnosis ,34. Preveristics , and theeristics  as well eristics ,39,40. Feristics . Previoueristics . This maeristics ,44. Commpresent moment, cultivating acceptance and letting go, seems an appropriate intervention for reducing psychological distress and improving HRQoL. Furthermore, the delivery of a mindfulness intervention, tailored to the needs and experiences of people with multiple sclerosis via the web, can be used to normalize the challenges of living with the disease and decrease feelings of isolation while maintaining anonymity and increasing access to psychological support.Given the difficulties with anxiety and uncertainty about the future and the experiences of grief and loss experienced by people with multiple sclerosis, a mindfulness-based approach that focuses on the Although we attempted to interview a range of people with multiple sclerosis with various demographic and disease characteristics, we acknowledge that the experiences of people with multiple sclerosis reported here were a reflection of a small sample from one recruitment center. Another limitation of this study was that the reviewers were shown PowerPoint versions of the modules and not the web-based multimedia versions, which would have allowed for further analysis of the program’s usability. Finally, the evaluation of efficacy was beyond the scope of this study. A study protocol for an RCT evaluating the efficacy of the mindfulness program described in this study has been developed . ClearlyIn summary, we have developed a web-based mindfulness intervention using an iterative co-design process that reflects the common challenges reported by people with multiple sclerosis. We included narratives that were developed from the themes derived from a qualitative study. The modules appropriately reflected the principles of MBSR, and the included narratives were viewed as relatable by people with multiple sclerosis. Future research will determine whether the developed intervention is effective. If it proves to be beneficial, the developed program would likely meet an important need for people with multiple sclerosis.


Klasse2000 is the most widely adopted school-based prevention program in Germany. It addresses health promotion, addiction, and violence prevention in primary schools. As a universal prevention program, it has reached more than 1.4 million German children in the past 25 years.The effectiveness of Klasse2000 will be evaluated with a large representative survey among students. Students who have participated in the prevention program (intervention group) will be compared with students who did not participate (control group). The comparison will cover the following outcome domains: well-being, self-esteem, emotion regulation, food habits, behavioral problems, and school and classroom atmosphere. Furthermore, victimization and perpetration regarding bullying, alcohol consumption, smoking, and media consumption are assessed.To control for potential group differences, treatment effects will be estimated using propensity score-matching, which matches students from the intervention and control groups based on an identical propensity score or a propensity score that does not differ by more than a previously defined distance. The treatment effect will then be estimated in the matched sample taking the matching process into account.Enrollment of schools began in March 2017. A total of 6376 students participated in the survey . The parent survey was returned by 52.13% (3324/6376) of parents. Results are expected in mid-2020.The results on the effectiveness of the Klasse2000 prevention program will form an empirical basis for legitimizing universal prevention programs and for planning future prevention approaches.German Clinical Trials Register DRKS00014332; https://tinyurl.com/y2trvq4pDERR1-10.2196/14371 Although most children in Germany can be regarded as physically and mentally healthy, there are numerous studies that report alarming findings regarding pediatric health risks. The study of the health of children and adolescents in Germany (KiGGS), for example, reports that 15.0% of all primary school children are overweight. Among these, 6.4% require treatment due to obesity . FurtherAnother important health-related aspect is bullying and school-based violence. A German representative survey among students from the years 2007 and 2008 showed that a significant number of 15-year-olds had been violent offenders in the previous school year. For example, 24.2% of students had hit or kicked fellow students, 34.3% had purposefully ignored others, and 51% had more than once picked on another student or said mean things . AnotherAccording to the life skills approach , problemThe primary goal of the Klasse2000 program is the promotion of a healthy lifestyle in parents, children, and teachers as well as other youth workers involved in leisure activities . Klasse2For the promotion of general health and life skills, Klasse2000 addresses the following domains:Healthy food and beverage choicesExercise and relaxationPositive self-image and friendshipsSolving problems and conflictsCritical thinking and saying no Specially trained Klasse2000 health promoters  visit the classrooms and introduce new focus areas to the lesson plan . After these visits, the teacher further discusses these topics and includes them in the regular curriculum (10 to 12 units per school year) using detailed aids such as lesson guides, student worksheets, posters, CDs, and parent information material, etc.Furthermore, Klasse2000 includes various interactive components such as games, visits by the health promoter, visits from the mascot, KLARO , and speThe parents are included using a parent newspaper, information meetings, and a yearly information letter . Of special importance are research tasks for the children that are accompanied by take-home material. These reinforce the topics addressed at school in the home environment. To account for individual differences, especially regarding special needs children or classes spanning varying grade levels, all student material is available for various levels of ability. The aim is to provide each child with appropriate worksheets that are neither too boring nor beyond the student’s capabilities . The conChildren know their body and know what they can do to promote health and well-being, for example, regarding nutrition, exercise, and relaxationChildren perceive health as important and are confident that they can contribute to their own healthChildren possess important life skills such as handling emotions and stress, communicating and cooperating with others, solving conflicts and saying no The Klasse2000 program has previously been evaluated by the University of Bielefeld and the Institute for Therapy and Health Research (IFT-Nord). The University of Bielefeld conducted four consecutive surveys in primary school children. In their evaluation study with a randomized waiting control group design, they concluded that the dietary behavior has worsened considerably less in the intervention group. Regarding exercise, they could merely conclude that the commute to school became more passive in control group children. Furthermore, it became apparent that baseline well-being had been very high, not allowing for the detection of any differential effects. According to the parents’ perspective, the children in the intervention group had less frequently become victims of violence .A study by IFT-Nord compared Klasse2000 participants to a control group of nonparticipating students in a nonrandomized control group design. Assessment took place during primary school years as well as 16 months and 3 years after the intervention. A positive effect of the Klasse2000 program on the incidence and life-time prevalence of smoking could be observed in the first and second follow-up ,15. A reThis study protocol outlines an evaluation study of the Klasse2000 intervention. Short-term effects on all four target areas are investigated via a survey among 4th grade primary students, their parents, teachers, and school principals. The evaluation of the prevention program Klasse2000 in Lower Saxony  is funded by the BZgA.The evaluation study can be subdivided into 6 domains: (1) training of test administrators, (2) correspondence with school principals, (3) school survey, (4) data preparation and integration, (5) data analysis, and (6) dissemination of results. The sponsoring institution Kriminologisches Forschungsinstitut Niedersachsen  is involved in all domains, and the State Police College of Baden-Wuerttemberg is involved in domain 1. An overview of the evaluation schedule can be found in In this evaluation study, 4th graders were assessed on the classroom level. Since 19.4% of students in Lower Saxony participate in the Klasse2000 program, it seemed feasible to base group comparisons on a sufficiently high number of students . For thiThe evaluation as described in this protocol has been approved by the ethics committee of the Georg Elias Müller Institute for Psychology at the Georg August University Göttingen . FurtherThe study was registered March 22, 2018, with the German Clinical Trials Register [DRKS00014332]. The main sponsor of the study is the KFN (primary investigator SK). Furthermore, the KFN cooperates with TM of the State Police College of Baden-Wuerttemberg.All primary schools located in Lower Saxony and providing general education were part of the sample population. A complete list for sampling was obtained from the national office for statistics of Lower Saxony. It was not assessed whether the schools participated in any other prevention programs apart from Klasse2000. Any other prevention measures of a general or specific nature were regarded as the standard the Klasse2000 prevention program should be contrasted with. The adherence to the Klasse2000 protocol was also not essential for eligibility as this evaluation is explicitly interested in assessing the treatment effect on an intention-to-treat basis.Test administrators underwent several hours of training by the project staff of the Klasse2000 evaluation at the KFN. The training covered general information on the study, survey contents, coordination of scheduling the individual survey appointments, and professional behavior toward teachers and students. Test administrators received detailed instructions on the survey tools to ensure a standardized procedure. All test administrators were blinded regarding intervention versus control group membership of the relevant classrooms.The schools of the selected classes were contacted by postal mail addressed to the school principal . In thisThe student survey was conducted in a classroom context in the presence of the teacher using standardized questionnaires. A trained test administrator guided the children through the questions with the help of a fully standardized testing manual (about 28 pages). At the beginning of the survey, the children were informed of the content and nature of the questions. They were told that their participation is entirely voluntary and anonymous and that nonparticipation would not yield any negative consequences. The majority of questions and possible answers were read aloud and explained by the test administrator. Additionally, the corresponding pages were shown on a screen using an overhead or video projector. After the survey, the questionnaires were collected by the test administrator. To ensure anonymity, student and teacher questionnaires were sealed in an envelope on site and sent to the KFN by mail. Details on the assessment tools can be found in In accordance with the World Medical Association Declaration of Helsinki, the parents and children who took part in the study were informed about our institution, the voluntary nature, aims, methods, and financing of the study by means of a parent information letter prior to the survey being conducted . The infAfter the student survey was conducted, the children were asked to give an envelope with the parent questionnaire and a return envelope with prepaid postage to their parents. The parents could return the completed questionnaire directly to the KFN by mail. Due to the study design that provides for complete anonymization and therefore no collection of real names, no signature of the participating adults could be obtained. Parents, teachers, and principals decided on their own participation by sending the completed questionnaire to the institute. To match the children’s and the parents’ questionnaires, the children wrote a code on their parents’ questionnaire. This code is only used for matching and does not include any identifiable information. After the matching has been performed, this code will be deleted, rendering the final data completely anonymous. Due to anonymity, parents cannot be reminded to return the questionnaires nor are any incentives offered for participation.Data assessment and management is completed by the KFN data protection official. The data protection official is employed directly by the KFN and has neither monetary nor scientific involvement in the project. All project staff members were obliged to uphold data protection rules and regulations. Participants do not reveal their names at any point in the study. The students provide their month of birth, age, and gender. The parents provide the same information, which will be used for matching should matching via the matching code not be possible. Children and their parents can be matched to a school by a field code. This field code is necessary to determine whether a school participates in the Klasse2000 program without endangering the blinding of the test administrators. After successful matching of parents, children, principals, and schools, all corresponding field codes are deleted. The data are then fully anonymous .It is of special interest whether the underlying constructs are based on the direct efficiency hypothesis of the Klasse2000 program (primary outcome) or based on an efficiency hypothesis but one that must be regarded as less probable than the primary outcome . For some outcomes , the expected prevalence is generally low.The evaluation focuses on the following research questions:Research question 1 : How does participation in the Klasse2000 prevention program influence children’s well-being?Hypothesis 1.1: The prevention program Klasse2000 has a positive influence on the children’s well-being.Hypothesis 1.2: The prevention program Klasse2000 has a positive influence on the children’s self-esteem.Hypothesis 1.3: The prevention program Klasse2000 has a positive influence on the children’s emotion regulation.Hypothesis 1.4: The prevention program Klasse2000 reduces the severity of behavioral problems.Research question 2 : How does participation in the Klasse2000 prevention program influence children’s health-related behavior?Hypothesis 2.1: The prevention program Klasse2000 increases fruit and vegetable consumption.Hypothesis 2.2: The prevention program Klasse2000 increases the consumption of water and unsweetened tea.Hypothesis 2.3: The prevention program Klasse2000 decreases the consumption of sweets, salty snacks , and sweetened beverages.Hypothesis 2.4: The prevention program Klasse2000 increases the time children spend exercising.Research question 3 : How does participation in the Klasse2000 prevention program influence the school and classroom atmosphere and school-based violence?Hypothesis 3.1: The prevention program Klasse2000 has a positive influence on the school and classroom atmosphere.Hypothesis 3.2: The prevention program Klasse2000 decreases the probability of engaging in bullying.Hypothesis 3.3: The prevention program Klasse2000 decreases the probability of becoming a victim of bullying.Research question 4 : How does participation in the Klasse2000 prevention program influence media use?Hypothesis 4.1: The prevention program Klasse2000 decreases the time spent on media.Hypothesis 4.2: The prevention program Klasse2000 decreases the probability of watching movies with an age rating of 16 or 18.Hypothesis 4.3: The prevention program Klasse2000 decreases the frequency of watching movies with an age rating of 16 or 18.Hypothesis 4.4: The prevention program Klasse2000 decreases the probability of playing video games with an age rating of 16 or 18.Hypothesis 4.5: The prevention program Klasse2000 decreases the frequency of playing video games with an age rating of 16 or 18.Research question 5 : How does participation in the Klasse2000 prevention program influence the children’s alcohol and tobacco consumption?Hypothesis 5.1: The prevention program Klasse2000 decreases the probability of drinking alcohol.Hypothesis 5.2: The prevention program Klasse2000 decreases the frequency of alcohol consumption.Hypothesis 5.3: The prevention program Klasse2000 decreases the probability of smoking cigarettes.Hypothesis 5.4: The prevention program Klasse2000 decreases the smoking frequency.Details on the assessment tools can be found in The decision to participate in the Klasse2000 program is made at the school level. Hence, schools self-select for implementing the intervention. This selection bias must be controlled for when comparing the outcomes of children participating in the Klasse2000 and those who did not. The gold standard for preventing selection bias is randomization. There are three major factors that made a randomized trial highly infeasible for this evaluation: (1) as a general intervention, the Klasse2000 targets a high number of outcomes, (2) effect sizes in universal prevention programs can be expected to be rather small, (3) the intervention is implemented during the entire primary school time . Hence, a very high number of schools would need to be randomized to participate in an intervention over several years. An attractive alternative to an randomized controlled trial is a natural experiment. However, the Klasse2000 is implemented all over Germany, and there are no immediately comparable intervention programs. Hence, neither regional implementation nor the comparison of a comparable program lend themselves for overcoming selection bias. Given these circumstances, a propensity score-matching approach will be implemented as a feasible alternative. The basic idea of a matching approach is as follows: for each student who is currently participating in the Klasse2000 program, a control student will be selected who matches the treatment group participant as closely as possible regarding criteria that are relevant yet unrelated to the participation in the prevention program . The matching will be performed with a matching algorithm that assigns weights to each individual in the control group . The estimation of treatment effects will be completed using regression-based analyses that take these weights into account. Simulation studies show that the propensity score-matching approach enables an unbiased estimation of intervention effects .Prior to analysis, data will be checked for outliers, inconsistencies, and possible transformation. We predict that our sample size will be large enough for our statistical tests to be robust regarding nonnormally distributed variables. Power analyses  based on a type I error rate  of α=.05, statistical power of 1−β=.80, and a minimum detectable effect size of ES=0.2 resulted in a required sample size of n=310 (1-tailed) students in each group (intervention and control).Missing data will be handled using state-of-the-art imputation techniques . WheStudy results will be disseminated in a final report for the funder (BZgA), who will further disseminate the findings in their own publications. In addition, findings will be submitted to suitable peer-reviewed journals.Schools were first contacted in March 2017. Between April and June 2017, students and teachers were surveyed. Teachers and principals returned their questionnaires by mail resulting in questionnaires being returned by mail until November 2017. Data entry and cleansing began in May 2018 and was estimated to take until mid-2019.During the period this protocol was under revision, data integration was completed. Data integration included linking the child and parent data. Matching was performed with the help of the codes. The aim of the study is a large-scale evaluation of the effectiveness of the Klasse2000 prevention program. The effects of the program as implemented in the field shall be evaluated using a representative sample. As a randomized design was not feasible within the framework of this evaluation, a propensity score-matching approach is used to control for potential selection bias.Intervention effects in the following domains are assessed: well-being, health-related behavior, classroom atmosphere, school violence, alcohol and tobacco consumption, and media use. These domains are investigated from the perspective of the students and their parents. Klasse2000 is a large universal prevention program. It is financially supported with donations from well-known institutions such as health care providers and banks and endorsed by experts of national recognition . The proAs outlined in the introduction, this evaluation is part of an ongoing evaluation effort of the Klasse2000 intervention. With the timepoint of evaluation in the 4th grade, this evaluation addresses short-term effects. To tentatively quantify medium-term effects, results from a student survey among 9th grade students will be used. The study among 9th grade students did not specifically focus on the target areas but assessed similar domains relating to criminal and health-related behavior. Students from the 9th grade survey indicated whether they had participated in the Klasse2000 prevention program when they attended primary school.The main limitation of the study is the missing randomization. The main problems of missing randomization are potential selection effects at the school level. Schools that are problem-prone might be more likely to participate in the Klasse2000 program, hoping that participation might reduce prevailing problems. On the other hand, the exact opposite might also be the case. Schools that can be characterized as especially committed and dedicated might decide to participate in the Klasse2000 program. Such selection effects might be counterbalanced with the propensity score-matching approach. It should also be noted that the study design does not include any measurement prior to the intervention. This is a cross-sectional survey that can identify correlations but cannot map causal relationships. The results should be checked within the framework of a longitudinal study design and a preliminary survey and offer necessary space for future research projects.


Background and objectives: Acquired brain injury (ABI) is the first cause of disability and physical activity (PA) is a key element in functional recovery and health-related quality of life (HRQoL) during the subacute and chronic phases. However, it is necessary to develop PA programs that respond to the heterogeneity and needs of this population. The aim of this study was to assess the effectiveness of a PA program on the HRQoL in this population. Materials and Methods: With regard to recruitment, after baseline evaluations, participants were assigned to either the intervention group  or the control group . Functional capacity, mood, quality of life and depression were measured pre- and post-intervention. The IG underwent the “Physical Activity and Sport for Acquired Brain Injury” (PASABI) program, which was designed to improve HRQoL . The CG underwent a standard rehabilitation program without PA. Results: Results for the IG indicated significant differences and large effect sizes for the physical and mental dimensions of quality of life, as well as mood and functional capacity, indicating an increase in HRQoL. No significant differences were found for the CG across any variables. Conclusions: The PASABI program was feasible and beneficial for improving physiological and functionality variables in the IG. The wide range of the activities of the PASABI program allow its application to a large number of people with ABI, promoting health through PA, especially in the chronic phase. Acquired brain injury (ABI) requires specific training programs based in neurorehabilitation with the aim of achieving the highest possible level of autonomy and participation during the subacute and chronic phases . The conHealth-related quality of life (HRQoL) includes the physical, psychological, and social dimensions, which requires the evaluation of different variables to know this multidimensional concept . LiteratThe International Classification of Functioning (ICF) developed by the World Health Organization (WHO)  is the bAs the systematic review carried out by Jones et al.  points oA total of 73 subjects were recruited into this study according to the following inclusion criteria: (a) being over 18 years of age; (b) not having language problems that make oral and written comprehension impossible; (c) being able to walk independently or with auxiliary material; (d) having had at least 1 year of evolution since the ABI; (e) having received at least 3 months of rehabilitation for the ABI; (f) residing at home and not in a rehabilitation center; (g) not having resumed working life; and (h) having a sufficient level of cognitive functioning to answer questionnaires coherently. With regard to recruitment , after bThe present study was a non-randomized clinical trial. Pre-post intervention design, with measurements at baseline and after 18 weeks of intervention. Different instruments, according to the dimensions of the ICF, were used to assess the program’s effects on the HRQoL of participants. For demographic data, a collection form was used with the sociodemographic data referring to date of birth, gender, housing, profession prior to the ABI, etiology of the injury, months since the injury, type of displacement, mobility, prior PA practice, and whether the participant was currently receiving therapies in a rehabilitation center or not. Additionally, the Spanish version of the Beck Depression Inventory II (BDI-II)  was used to evaluate depressive symptoms. Mood with respect to factors of a negative  and positive (vigor and friendliness) nature were evaluated using the Spanish version of the Profile of Mood States (POMS) . Furthermore, the SF-36 version 1.4 was used to assess quality of life ,30. ThisFirst, participants were provided with general information about the study and informed consent, in addition to recording demographic data. Then, general cognitive functioning, depressive symptoms, mood, quality of life, activity level, and functional ability were assessed before and after 18 weeks of the PASABI program. The 18-week exercise program was developed in six municipal sports centers of Madrid in people with ABI in the chronic phase, with participants performing two to four sessions per week at 1 h per session. The PASABI program aims to increase autonomy in the conduct of DLAs, generate social relationships, and achieve greater reintegration into the community. It defines the type of activity to be carried out related to the level of affectation and proposes specific tasks focused on key aspects of improving the HRQoL of people with ABI. It includes games as a key element, because they are a resource that involves fun, socialization, interactions that incite instinctive learning, organization, and the development of complex skills not only for the child but also for the adult. Furthermore, diverse activities designed according to abilities based on the proposal of García-Hernández and Pérez-Rodríguez , as wellp ≤ 0.05, and the SPSS 22.0 statistical package was used. For descriptive statistics, data were checked for normality using the Kolmogorov–Smirnov test, which indicated the need for non-parametric tests. A descriptive analysis (by group) of the variables studied was carried out using, as reference values, the means and standard deviations for continuous variables and frequencies and percentages for categorical variables. The chi-square test was used for categorical variables, and the Mann–Whitney U test was used for continuous variables. After the intervention, the Wilcoxon W test of related samples was used to establish intragroup differences, and the Mann–Whitney U test of independent samples was used to analyse the differences between groups. Cliff’s Delta was calculated for the estimation of the non-parametric effect size in the comparisons. An r-value higher than 0.1, 0.3 or 0.5 was considered as a small, medium, or large effect size, respectively . The sigAll participants signed the informed consent form. The design of the research was supervised and approved by the Ethics Committee of the leading institution of the study, and the recommendations of the Declaration of Helsinki were followed at all times . This prDemographic characteristics of all the participants in the IG and CG at baseline are presented in p < 0.001), and mental health (p < 0.05), producing an increase in the scores, as well as a generalized decrease in the scores of the variables, depression-B, depression, anger (p < 0.05), and stress (p < 0.01). Regarding the QA score, significant differences were found in the variables sedentary (p < 0.01), friendship and fatigue (p < 0.05), producing a general increase in the scores, also in the IG. p < 0.05, r = 0.28), functional capacity , physical function , showing the CG with the highest score in the sedentary variable, and the IG in the functional capacity and physical function variables.With respect to the comparison of scores after the intervention, differences were found between the QA and IG in the variables sedentary  and the 18 weeks of intervention could have been decisive in the positive results of the study. Likewise, a frequency of two to four sessions per week allowed participants to adapt to their possibilities and led to a transfer beyond the study. Most participants in the IG continued to engage in the program after the completion of the study.Previous studies considered age as a predictor of PA practice; however, the mean age between the two groups evaluated was similar, and the IG had greater age differences between the minimum and the maximum. Likewise, the results revealed that the severity of the injury and the sport practice before the injury could be indicators for participation after ABI in PA programs .With respect the content of the PASABI program, it seems that group activities like those provided by the program are efficient and allow participation and high rates of engagement, as mentioned. Regarding aquatic activities, we agree with authors in affirming the effectiveness of this type of exercise to improve HRQoL ,40.In relation to the improvement of the quality of life measured with the SF-36, the results indicated significant improvements of the IG in the physical and mental dimensions, which corroborates the capacity of a group PA to generate benefits in the different areas, coinciding with authors who also point this out ,42. The Due to the importance of depression in the functional recovery of people with ABI, in this study, the BDI-II was used to assess depressive symptoms. A tendency to decrease in the IG and increase in the CG after the intervention was observed, coinciding with other authors who found improvement in depressive symptoms after an intervention ,44 and sMoreover, the findings show that there was no improvement in the level of activity after the intervention. It should be noted that the increase in the score in the sedentary variable was greater in the CG, although it increased in both groups. This data may be due to the fact that 56% of the IG did not receive therapy in rehabilitation centers or return to work, compared to 100% of the CG, who did receive therapy during this time, providing more active hours. Nonetheless, it is remarkable that the IG has increased physical function and functional capacity; although, the hours of activity did not increase. So, in order to achieve an adequate physical condition and an adequate mood, it seems essential to perform PA as an indispensable complement to the standard rehabilitation programs in the chronic phase .All studies confirm the impact of functional capacity on HRQoL in people with ABI . StudiesAs limitations of this research, we can indicate that the study sample was limited to voluntarily participating individuals, leading to a possible selection bias. The sample consisted of participants mildly to moderately affected by ABI, not including people with more affectation given the characteristics of the PASABI program. The positive results of the study in a population with ABI open a fruitful line of research in the role of PA-oriented health in this population, with application to other ABI levels of impairment. In this regard, this study could be a starting point for future investigations with a randomized clinical trial design. The bio-psycho-social framework proposed by the ICF is adequate to encompass all aspects to be taken into account in the design of a group PA program in people with chronic ABI.Having professional staff, minimizing barriers, and selecting schedules and facilities close to the place of residence are critical to achieving a high level of attendance and adherence to the program.This research has shown that the PASABI program, with content based on different sports modalities and adapted activities designed specifically for people with ABI in the chronic phase to achieve the highest autonomy and participation, has positive effects on HRQoL.


The Children’s Cancer Hospital of Egypt (CCHE) and the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) collaborate to offer a Doctor of Pharmacy (Pharm.D.) degree to international pharmacists holding a bachelor’s degree in pharmacy. The experiential training is provided by CCHE’s clinical pharmacist preceptors at CCHE. Clinical pharmacists at CCHE had prior experience precepting baccalaureate pharmacy students, but not Pharm.D. students when this program commenced. Therefore, the SSPPS faculty provided a live preceptor development program for select CCHE clinical pharmacists in 2017. Primary deliverables of the program included the preparation of individual preceptor development plans and experiential syllabi for program participants. Preceptor development plans and experiential syllabi were evaluated by the SSPPS faculty. Program participants were also evaluated on their assessment of learner case scenarios using introductory pharmacy practice experience (IPPE) and advanced pharmacy practice experience (APPE) assessment tools created for the CCHE program. Participant performance on submitted preceptor development plans and experiential syllabi, and performance on the learner cases were all utilized for participant selection as Pharm.D. preceptors in the CCHE Pharm.D. program. This paper describes this preceptor development program, the process utilized to determine selection of Pharm.D. preceptors, and plans for providing continuing preceptor development for preceptors at CCHE. As the global need for advanced clinical pharmacy services is recognized, an increasing number of international programs have developed post-baccalaureate Doctor of Pharmacy (Pharm.D.) degree (or similar) programs to meet those needs. However, the didactic curricula and experiential training within these international post-graduate Pharm.D. programs vary significantly and many lack qualified and experienced clinical pharmacists and practice sites to facilitate proper experiential training for Pharm.D. students to provide advanced clinical pharmacy services ,2,3,4,5.In 2016, CCHE, a comprehensive pediatric cancer hospital and leader of clinical innovation in the region, and the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS), nationally recognized for educational innovation and producing excellent pharmacists for over 100 years, entered into a memorandum of understanding. The two institutions partnered to create a Pharm.D. program offered by CCHE in collaboration with the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences (SSPPS) to provide baccalaureate-trained pharmacists with state-of-the-art didactic and clinical education. The SSPPS faculty with experience in Pharm.D. program design and implementation guided the CCHE in the development of the mission, vision, outcomes, curriculum, policies, procedures, and administrative services for the Pharm.D. program. This program started in 2017. The experiential training for the CCHE/SSPPS Pharm.D. program takes place at the CCHE in Egypt.Other pharmacy programs within the United States have described international collaborations expanding Pharm.D. training internationally. The University of Purdue, College of Pharmacy supports a clinical practice site in Kenya for advanced pharmacy practice experience (APPE) rotations for students from Purdue and Kenyan pharmacy interns since 2004 ,8. The UAn inaugural class of 8 students enrolled into the CCHE/SSPPS Pharm.D. program in May 2018. The program is a two-year post-baccalaureate PharmD program consisting of six sequential semesters. The didactic portion of the curriculum is offered online by the SSPPS faculty while the experiential training is completed at the CCHE in Cairo, Egypt. The objectives for the experiential rotations for the CCHE/SSPPS Pharm.D. program are modeled on introductory pharmacy practice experiences (IPPE) and advanced pharmacy practice experiences (APPE), similar to those required in Pharm.D. programs in the United States. The experiential curriculum consists of IPPE rotations to be completed over the first four semesters (90 h per semester) followed by six APPE rotations  to be completed over the following two semesters. Each APPE rotation length is five weeks. Each student is required to complete two assigned APPE rotations in inpatient general medicine, one assigned APPE rotation in ambulatory care, and three elective APPE rotations.The CCHE is an ideal experiential site for Pharm.D. students to gain exposure to multiple advanced clinical pharmacy services provided by experienced clinical pharmacists. In the United States, the Accreditation Council for Pharmacy Education (ACPE) accreditation standards for experiential training  emphasizPreceptors at the CCHE were already experienced at precepting baccalaureate degree pharmacy students prior to the start of the Pharm.D. program at the CCHE. Preparation to precept Pharm.D. students for IPPEs and APPEs required for the CCHE/SSPPS post-graduate Pharm.D. program, was a new expectation and requirement within the CCHE. The CCHE identified many potential Pharm.D. preceptors within their current pharmacist preceptors; however, none of the identified pharmacists held a Pharm.D. degree or had prior experience precepting Pharm.D. students. Therefore, the CCHE and SSPPS felt these pharmacists would benefit from formal preceptor development to prepare them to precept Pharm.D. students.In 2017, three SSPPS faculty experienced in the development and precepting of Pharm.D. students facilitated a 5-day live preceptor development program at CCHE. Participants were selected from the CCHE clinical pharmacists group based on their potential to be Pharm.D. preceptors by the CCHE based on prior success precepting baccalaureate degree pharmacy students. The objectives developed for the preceptor training program included: assess preceptor practice sites for opportunities for student engagement, design learning outcomes and a plan for experiential rotations, examine learning styles and techniques for precepting, differentiate formative and summative assessment processes, implement effective techniques to provide constructive feedback, and identify challenging student situations and resolution strategies.The schedule for the preceptor development program is summarized in Program activities and assignments enabled participants to create a personal continuing preceptor development plan and a rotation syllabus for their proposed Pharm.D. rotation. Creation of an individual preceptor development plan was incorporated as a key outcome for the program to help participants match strategies covered within the program with self-identified areas of interest for preceptor development as they embark on their new roles as Pharm.D. preceptors and to contribute to participant continuing professional development (CPD). CPD, is a cyclical process involving reflection, planning, learning, evaluation, and application . IncorpoParticipants were also coached on how to create structured rotation syllabi in alignment with the objectives for the CCHE/SSPPS post-graduate Pharm.D. IPPE and APPE rotations. Constructing rotation syllabi was included as a program outcome to achieve development of the participant’s envisioned Pharm.D. rotation by the end of the preceptor development program. Draft rotation syllabi were reviewed with feedback from peers and the SSPPS faculty before submission to the SSPPS faculty for final evaluation. Rotation syllabi were evaluated on alignment with IPPE or APPE specific rotation descriptions, objectives, schedule/calendar, prerequisites, and non-patient care assignments .On the final day of the program, participants completed case-based assessments from the perspective of a Pharm.D. preceptor. Participants were assessed on their ability to identify Pharm.D. learner strengths or weaknesses, apply CCHE/SSPPS Pharm.D. program specific assessment tools, provide feedback for the learner, or adjust the learning experience based on learner feedback as applicable to the learner case. Cases included components of professionalism and communication.Participant performance on submitted preceptor development plans, rotation syllabi, and the case-based assessments contributed towards ultimate selection as a Pharm.D. preceptor at the CCHE. The SSPPS faculty evaluated each assessment using rubrics created for this preceptor development program. Twenty-eight clinical pharmacists participated in the live training program. All participants held baccalaureate Pharmacy degrees. All participants submitted a final preceptor development plan and completed the learner case assessments on the final day. However, only twenty of twenty-eight participants (71%) submitted a completed rotation syllabus. Participants needed to earn a passing score of 70% in each assessment  for selection to precept Pharm.D. students at the CCHE. Most of the participants had never before created a rotation syllabus. Sixteen of the twenty-eight participants (57%) scored above 70% on all assessments. These 16 participants were recommended by the SSPPS faculty to precept Pharm.D. students at the CCHE. Six specialized in acute care, five specialized in ambulatory care, two specialized in compounding, one specialized in transitions of care, one specialized in pharmacogenomics, and one specialized in research. Participants that were not selected as Pharm.D. preceptors initially are encouraged to repeat Pharm. D. preceptor development training in the future.After identification of the Pharm.D. preceptor group, specific APPE rotations for the CCHE/SSPPS Pharm.D. program were determined. APPE rotations in neuro-oncology, infectious diseases, bone marrow transplant, and the intensive care unit (ICU) were developed by the inpatient preceptors. Ambulatory care preceptors prepared Pharm.D. APPE rotations in the emergency room, multi-specialty clinic, general outpatient clinic, and day care unit. Specialty elective rotations were set up in the pharmacy managed pharmacokinetics laboratory, radiology pharmacy, nuclear pharmacy, and clinical nutrition.Following the live training program, the selected CCHE Pharm.D. preceptors participated in ongoing virtual mentoring and preceptor development sessions with the three SSPPS faculty over the course of another 10 months. Each preceptor was assigned to present a learner case reflecting on their precepting skills including discussion on their own strengths and opportunities incorporating preceptor development concepts. The SSPPS faculty provided feedback on these preceptor-learner case presentations and peer discussion for modification of the learning experience/precepting approach was encouraged by the group.The CCHE Pharm.D. preceptors also completed a survey to identify desired topics of interest for further preceptor development topics provided by the SSPPS faculty. An analysis of the global pharmacy workforce published in 2016 found variations in availability of pharmacy workforce and provision of patient-centered care between countries and regions worldwide . HelpingEd Global Education Report 2013 found a shortage of clinical preceptors available internationally to educate pharmacy students in experiential rotations [Ed 2016 Global Vision for Education and Workforce supports “all teachers and tutors have access to teacher training programmes and development in order to become high quality teachers and trainers for our profession [The Pharm.D. preceptor development program described within this paper supports Pharm.D. training via preceptor development at the CCHE in alignment with the SSPPS mission of excellence and innovation in professional, graduate, and post-graduate education. Preceptor development programs are needed to ensure appropriate training of future pharmacy graduates to provide patient-centered pharmacy services globally. The FIPotations . The FIPofession ”.Strengths of the CCHE/SSPPS preceptor development program included live delivery by experienced SSPPS clinical pharmacy faculty preceptors, active participation by the CCHE pharmacists to apply program content to their rotation plans and precepting styles, and opportunities for concurrent discussion with CCHE peers also completing the program. Live and virtual discussions were focused on familiarizing participants with experiential objectives within the Pharm.D. program and encouraging active interaction of students with other health care professionals during IPPE and APPE rotations. The CCHE pharmacists had been taught predominantly by observation models themselves so expecting active participation by Pharm.D. learners was a less frequently utilized precepting concept. While other described preceptor development programs included components of self-study for flexibility, ours was designed to maximize participant engagement with peers during the live program and virtual mentoring ,29. PartPreparing a rotation syllabus for their planned Pharm.D. rotations experiences contributed to the participants informally expressing feeling more prepared to take on the new Pharm.D. precepting expectations. Assessment of participants’ rotation syllabi also served as a peer review process and enabled SSPPS faculty to determine which participants understood the objectives of IPPE versus APPE rotations, set learner level appropriate expectations, planned time for routine feedback and evaluation of students, and expected the appropriate amount of non-patient care specific learning activities. These actions collectively are expected to enhance the quality of training and instill pedagogical rigor.This program was successful in cultivating the development of Pharm.D. preceptors who worked in an exclusively pediatric population, focused on cancer. Nonetheless, this program was effective in training and identifying qualified and capable preceptors. Additionally, because the focus of this preceptor development was on training of Pharm.D. students’ skills, rather than knowledge, preceptor development was population and disease state agnostic.Skills gained within the preceptor development program could be also applied beyond Pharm.D. student rotations. The CCHE also began offering pharmacy practice residencies in alignment with the American Society of Health-System Pharmacy (ASHP) Accreditation Standards for International Pharmacy Practice Residency Programs  in 2017.Limitations of this preceptor development program include the feasibility for other international pharmacy education programs to offer onsite preceptor development  from experienced clinical pharmacy faculty preceptors, and challenges of providing ongoing training for the Pharm.D. preceptors. Group-based discussions were not as successful during the ongoing virtual sessions. The CCHE pharmacists were challenged to participate in the virtual training sessions after their work day and many CCHE preceptors had not yet precepted Pharm.D. students by the start of the virtual sessions limiting group discussions. A half-day onsite  workshop at least six months after the initial program may be beneficial to facilitate preceptor attendance and generate group discussion. CCHE preceptors preferred actual case-based discussions of challenging scenarios the SSPPS preceptors had worked through over further didactic training during the ongoing virtual sessions. Additionally, providing ongoing mentoring from the SSPPS faculty on an as needed basis may be better suited than ongoing virtual group discussions.There are several opportunities for improvement in further offerings of this preceptor development program. Shortening the length of the onsite program would decrease financial barriers. Developing and incorporating more video-based scenarios to help participants interpret and work through precepting scenarios would provide more opportunities for the application of skills included in the preceptor development program. Conducting a post training course evaluation and offering a half-day refresher and discussion workshop  may also be more feasible and beneficial for preceptors. The authors plan to revise and offer this preceptor development program for other interested international pharmacy programs.Subsequent preceptor development is currently under development for the CCHE preceptors. A “train-the-trainer” approach utilizing the current Pharm.D. preceptors at the CCHE in collaboration with the SSPPS faculty to provide preceptor development for additional clinical pharmacists at the CCHE to become Pharm.D. preceptors is being considered. Finally, preceptors not initially selected to precept Pharm.D. students may benefit from peer mentoring from the current CCHE Pharm.D. preceptors, similar to the “preceptors-in-training” model in ASHP residencies .This preceptor development program was successful in training and identifying Pharm.D. preceptors. These preceptors were familiarized with programmatic experiential expectations and facilitated the inclusion of students in the provision of advanced clinical pharmacy practice during experiential rotations. Development of individual preceptor development plans provided participants with opportunities for continuing professional development as they increase the precepting experience of Pharm.D. students. Evaluating experiential syllabi was needed for the selection of preceptors for this program to ensure that requirements and structure of the PharmD program was pedagogically sound.