Clinical and translational research relies on a well-trained workforce, but mentorship programs designed expressly for this workforce are lacking. This paper presents the development of a mentoring program for research staff and identifies key programmatic outcomes. Research staff participating in this program were matched with a senior mentor. Focus groups were conducted to identify key program outcomes. Surveys were administered throughout the program period to assess participants’ experience, gains in skill, and subsequent careers. Analysis of the resultant qualitative and quantitative data are used to characterize the implementation and impact of the program. A total of 47 mentees and 30 mentors participated in program between 2018 and 2023. A comprehensive logic model of short-, intermediate- and long-term outcomes was developed. Participants reported positive valuations of every programmatic outcome assessed including their program experience, learning and research careers. The pool of available mentors also grew as new mentors were successfully recruited for each cohort. This mentorship program developed and implemented by senior research staff successfully provided junior research staff with professional development support, mentorship, and professional development opportunities. Junior and senior health research staff built mentoring relationships that advanced their clinical and translational research careers. Clinical and translational research relies on a workforce of highly skilled professionals who have the understanding and resources needed to carry out the tasks required to advance translational research . EvidencThis paper concerns a mentoring program for clinical research professionals (CRP) at the University of Michigan (U-M). CRP is an umbrella term that comprises various job titles, including for example clinical research coordinators, research nurses, and clinical research associates –6. CRPs The U-M Medical School (Michigan Medicine) has previously supported initiatives for mentoring the health research workforce in ways that have been shown to legitimize and professionalize their research careers . In 2016Michigan Medicine’s CTSO and the Michigan Institute for Clinical and Health Research (MICHR) partnered to provide financial and administrative support for the STEP.up program. This partnership was supported through NCATS and its Clinical and Translational Science Awards (CTSA) program . The CTSThe STEP.up program is administered by two senior clinical research professionals who developed, implemented, and are maintaining the program. An Advisory Board with rotating membership guides these lead administrators’ work, facilitates the application and mentor matching process, and provides continuous oversight of the program’s operations and evaluation. This board consists of several senior clinical and health research staff. The board meets quarterly throughout the year, supports program operations, monitors the development of the mentoring relationships, and evaluates the impact of the program.Cohorts of mentees are admitted to the program annually, with the number of new mentees ranging from 6 to 12. Mentors are recruited each year, thereby growing the pool of trained mentors over time. The application period is advertised through regular communications disseminated by the CTSO, MICHR, and other U-M schools and departments. Applicants are required to provide a letter of support from their supervisor or Principal Investigator that confirms the applicant will be able to dedicate the time required for program activities and mentor meetings. All applicants must confirm that they have had formal training in the ethical conduct of research.Mentee and mentor applications go through an initial review by the program co-leads. Personas of a mentor and mentee were developed to inform this process . This inApplications are sorted from best score  to worst and the board is convened to discuss mentee and mentor pairings. Program co-leads facilitate the discussions around acceptance and mentor pairings. The group starts with the third who scores the best, then moves to the third who scores the worst and either determines that they do not meet criteria for the program or may try to match with a suitable mentor. The group then moves through the remainder of the mentees on the list to try to identify suitable pairings. The discussion is centered on suitability for the program at the mentee’s current career stage, career aspirations, desire to stay in research, and whether there is a potential mentor match available. The selected mentor must be from an academic department different from the mentee’s. This allows for a greater degree of confidentiality between mentor/mentee pairs. Matching mentees with mentors in other departments also promotes exposure to broader sets of professional experiences and scientific areas of study.The program is structured into three phases spanning a year. At the start of the year, the Advisory Board meets to evaluate applications and admits participants to the program. Each cohort of mentees attends a two-hour orientation where they receive information about the structure and goals of the program. Participants also receive training about mentor-mentee relationships, based on training developed by the Center for the Improvement of Mentored Experiences in Research (CIMER) . ProgramA minimum of one hour per month of required contact between mentors and their mentees provides time to develop the mentoring relationship, although the actual regularity or duration of this contact varies. The first of these meetings is dedicated to setting and discussing career goals. Mentee/mentor pairs were also used to complete questionnaires. These questionnaires include questions about the progress being made toward identified goals. As outlined in the Methods section, these questionnaires were administered anonymously during the first two years of the program and then transitioned into personalized surveys to enable responses to be tracked.Professional development and networking, and further mentor training opportunities are offered to participants during the program. Key mentor responsibilities, roles, and expectations are discussed, and the importance of confidentiality and following ethical guidelines is emphasized throughout this training. A concluding ceremony is held at the end of the eight-month mentoring period to present participants with certificates recognizing their progress, typically delivered by their mentors. The final two months of the year are used to conduct program evaluations with the participants, convene the Advisory Board to review results, and adjust programing for future cohorts.The program was evaluated through a partnership with the Center for Education Design, Evaluation and Research at the U-M School of Education . The devN = 10) is a key limitation as detailed in the Discussion section.Focus groups with mentors and other mentees were conducted virtually at the end of the program in 2019 with participants recruited from the first two cohorts. The 1-hour focus groups were conducted with every participant who volunteered to participate. The small size of this sample  and over 4 years of total research experience . Changes in the collection of professional and demographic characteristics of the program participants were made in 2021. Before 2021, only participants’ job titles, funding sources, and years of research experience were collected. After 2021, participants’ sex, race, ethnicity, and disability status were collected; participants were also asked if they viewed themselves as being underrepresented minorities in the extramural research workforce after being shown a definition of the term [Since STEP.up was launched in 2018 five cohorts have been enrolled . I also found the STEP.up program to be a wealth of knowledge for research staff, and I plan to keep tapping into it as I move along my career.”Mentors thought the program benefitted both the mentees and mentors. They stated that interactions with mentees taught them about new areas of health research and scientific methods. The mentors also said they became better managers because of the program, and more creative and confident in themselves as professionals. They described how the program enabled them to meet other mentors, and that the program showed mentees fitting career paths in health research. One stated,While mentees and mentors expressed that they benefited from the program, mentors also reported encountering distinct challenges in forming effective mentorship relationships. While mentees were very positive about the experience with their mentors in STEP.up, mentors described several challenges related to learning about their mentee’s professional goals. Mentors reported that their mentees initially didn't have a goal in mind, often weren't focused sufficiently on their own professional development, and were occasionally unfamiliar with the purpose of mentoring. Mentees said the greatest potential impact of the program regarded the ways that it might have helped them get off their “research island” and give them an opportunity to talk to others with a different set of experiences. For mentors, the most potentially beneficial aspects of the program regard its potential to validate the staff role and formalize the mentee-mentor relationship.These results were used to identify and define the programmatic inputs, activities, outputs, and outcomes shown in the logic model developed by the study team Fig. . ResultsSurveys adapted from the Mentorship Profile Questionnaire were administered to evaluate the mentoring dynamics of the participants receiving mentor training every year Table . Pre-proThe measures used to assess participants’ experience in the program are also shown in Table The long-term outcomes of the program were measured using two metrics. One metric was adapted from the definition of a “Research Career” developed by NCATS through their Common Metrics Initiative . The vasThere are few mentoring programs for clinical research professionals. This study provides evidence suggesting that STEP.up had a positive and lasting impact on the professional development and advancement of mentees. In addition, the short-, intermediate-, and long-term outcomes identified through this study can be used to benchmark programmatic improvement of STEP.up, and of similarly structured mentoring programs.The findings of this study suggest that key barriers and facilitators may have affected the implementation and impact of STEP.up. Key barriers regard a range of organizational, administrative, financial, and cultural factors. These include (a) a lack of time for staff to serve as mentors or mentees; (b) feelings of imposter syndrome among new mentors; and (c) limited funding to expand the number of mentees admitted in each cohort and provide participants with professional development funding or opportunities. The impact of the program may have also been facilitated by the non-binding permission and encouragement that participants received from their Principal Investigators or supervisors to dedicate considerable time to the programs’ professional development and mentoring activities.The limitations of this study must be emphasized. This program was created without first specifying specific outcomes by which the impact of the program was to be assessed. Small sample sizes for the focus groups and low survey response rates to surveys limit the degree to which STEP.up can be inferred to have had a substantial impact on the participating mentees’ careers. The variation in response rates to the participant surveys administered during the program is also a limitation. The timing of the administration of these surveys varied across years as the structure and start-date of the program changed, particularly following the onset of the COVID-19 pandemic. Response rates ranged from above 95% to below 25% across the more than dozen participant surveys administered over the first five years of the program.Other key limitations of this evaluation regard the lack of demographic diversity of the participants and possibility that those individuals who were selected into the program were research staff already predisposed and positioned to succeed in their research careers. The process by which individuals were selected to participate in the program could have contributed to the lack of greater demographic diversity in the participating cohorts. The authors recognize and support the need for more mentoring opportunities to be made available to all health research staff, particularly those who are most at risk of leaving the profession.The results of this study demonstrate the value of organizational collaboration and partnership among disparate groups working within academic medical centers. It is likely that this program could not have been developed, implemented, maintained, and evaluated without the dedication and enthusiasm of those who created the program. Academic medical centers seeking to cultivate the professional development and advancement of their clinical and translational research workforce should endeavor to provide greater financial and organizational support for similar mentoring programs. It is reasonable to hypothesize that the provision of greater financial and organizational support would serve to increase the impact of mentoring programs designed for this workforce.Further research should evaluate the generalizability of these findings across specialists of clinical research professionals, as well as with those with above- and below-average years of experience in their roles. Future studies should also evaluate the long-term impact of these programs on the research careers of all participating clinical research professionals using valid comparison groups. Quasiexperimental methods, such as propensity score matching, have been used to demonstrate the impact of mentored research awards on the work of clinical and translational investigators, and similar methods should be used to evaluate the impact of mentoring opportunities provided to the health research workforce that supports their scientific work .


Research on school maladjustment has increasingly focused on social skills, such as the ability to control emotions, collaborate with others, and achieve goals. Social and emotional learning (SEL) is one approach to nurturing social skills. However, few preventive interventions to promote SEL have been conducted among young children, particularly in Asian countries, including Japan. Therefore, this study examined the effectiveness of an SEL program—Fun FRIENDS—among children in Japan.In mid-2022, the Fun FRIENDS program was administered to 115 children aged 4–5 years, who were enrolled in two kindergartens. The program was administered to the entire class as part of their kindergarten activities. The control group included 93 children in three kindergartens. This study included 94 participants (81.7%) in the intervention group and 66 (71.0%) in the control group, whose parents agreed with the assessment of their skills. Fun FRIENDS is a support program based on a cognitive–behavioral approach. The program aims to teach children how to cope with anxiety and stress and develop resilience and confidence to face difficulties. The program includes 10 sessions, each lasting approximately 1 h and conducted once per week. To examine the program’s effectiveness, teachers evaluated these children’s social skills before and after program implementation using the Social Skill Scale.Results showed significant post-intervention improvements in self-control and cooperation scores among children in the intervention group, compared with pre-intervention. Further, post-intervention self-control and cooperation scores were significantly higher among children in the intervention group than the control group.SEL implemented on a class-wide basis could be effective in early childhood. An early approach targeting preschool-aged children is necessary to prevent school maladjustment. A universal approach implemented on a whole-class basis could contribute to improving children’s social skills.The online version contains supplementary material available at 10.1186/s13034-023-00643-6. In recent years, school maladjustment has been increasing in Japan, with the number of truant students in elementary and junior high schools reaching 240000 in 2021, the highest number ever recorded in the country . KindergThe concept of social and emotional learning (SEL) involves the development of social–emotional skills , 9. The FRIENDS programs are supported by the World Health Organization as evidence-based programs, and a meta-analytic review of the programs provides evidence . FRIENDSThis program was developed in Australia, and its effectiveness has been demonstrated in Western countries. The effectiveness of the program could differ between Western and Asian countries, where there are differences in linguistic and non-linguistic expressions. This study was conducted to verify whether the program developed in Australia would be effective in Japan. The ultimate goal is to reduce the poverty gap using SEL and preventing school maladjustment. Early preventive intervention during childhood is highly effective for improving and managing mental health not only during school age but also during adolescence and adulthood –20. Howen = 7, control group: n = 23) were excluded from the statistical analysis but were still offered the intervention program. Children with language disorders or pervasive developmental disorders  were excluded from the statistical analysis; however, they were also offered the intervention program. Such disorders were assessed based on various parent and teacher reports. Consequently, the analysis included 94 children in the intervention group and 66 children in the control group  before and immediately after the intervention. The Fun FRIENDS program was implemented by facilitators who were trained teachers and have completed the educational course prescribed by Fun FRIENDS. The program was implemented over approximately 2.5 months. All sessions were attended by homeroom teachers.The Fun FRIENDS program is designed to help children learn various ways to cope with anxiety and stress and to help them develop social skills, resilience and confidence in their ability to face difficulties , 14, 22.In 2008, a pilot study was conducted with Japanese families living in Brisbane, Australia. The founder, Dr. Barrett, provided resources to Dr. Matsumoto, who led the research and translated the manual and workbook into Japanese. Cultural adaptations or considerations, such as characters, activities, and time frames, were discussed between them. Additionally, the program has been implemented with preschoolers in child care settings in Japan since 2010.never, 1 = sometimes, and 2 = very often), with higher scores indicating better social skills. The utilized subscale has shown sufficient internal consistency, construct validity, and internal reliability in previous studies. In addition, the researcher fully explained the SSQ-P to the teachers to ensure that they could use it accurately.Social skills were measured using the teacher-reported SSQ-P . The SSQThe presence or absence of the Fun FRIENDS program intervention (intervention and control groups) was the explanatory variable.Parents reported information on their family structure (single-parent or two-parent family), household income , and parents’ educational level .t-test. Further, we analyzed changes in social skills before and after the program (T1 vs. T2) in the intervention and control groups using paired-samples t-tests. All analyses were conducted using SPSS 29.0 .A chi-squared test was used to examine differences in attributes between the intervention and control groups at baseline. We also analyzed the differences between the intervention and control groups before and after program implementation using an independent As Fun FRIENDS was a preschool initiative, all children aged 4–5 years enrolled in the included kindergartens participated in the program. Prior to the intervention, the parents were informed of the study purpose and associated procedures and were made aware that participation was voluntary. Parents provided written informed consent for themselves as well as on behalf of their children before participation. This study was approved by the Kyoto University Ethics Committee (C1563).Table t-test. There were no significant differences in social skills between the intervention and control groups at T1. However, the intervention group had significantly higher self-control and cooperation scores than the control group at T2.Figures t-tests. In the intervention group, social skills were significantly higher in self-control and cooperation at T2 than at T1. However, the control group did not exhibit significant differences in social skills between T1 and T2.Table This study evaluated the effectiveness of Fun FRIENDS, a universal prevention intervention program, among preschool children. Compared with the control group, the intervention group showed significantly greater increase in self-control and cooperation after the intervention.Children’s self-control and cooperation improved after the intervention. These social competencies influence social adjustment during childhood and throughout life –33. The The results demonstrated the effectiveness of the Fun FRIENDS program for Japanese children. This program is structured based on cognitive–behavioral therapy. As such, it could be effective across cultural backgrounds. In addition, this could be because the kindergarten teachers also participated in the program, understood its content, and implemented the program’s learning outside of the program sessions. Prior research focused on the potential effectiveness of the Fun FRIENDS program as a universal school-based prevention intervention—that is, the program was offered to young children regardless of their risk status , 35. As Assertion was not affected by this program. This program teaches children a variety of cognitive–behavioral strategies to address several areas of social–emotional learning. The program utilizes play-based activities and provided skills in a developmentally appropriate manner to help children develop cooperation and self-control. The program enhances self-control and cooperation through teaching, including understanding one’s own and others’ emotions, learning how to control emotions such as anger, and recognizing the presence of people one can rely on. Therefore, contents contributing to assertion may have been scarce.Despite this study’s strengths and unique contributions, some limitations and future research directions must be noted. The greatest limitation of this analysis was that it was based solely on teachers’ reports of children’s social skills. Children’s subjective evaluations and evaluators’ objective evaluations should be added in future studies. Additionally, participants in the control group were not offered an alternative to the FRIENDS program. As the teachers in the control group were aware that the children in their classes were in the control group, a potential placebo effect could have occurred. Further, this analysis only evaluated the program immediately after its implementation. Neil and Christensen noted that without a long-term follow-up, potential effects could be missed, leading to an underestimation of the program’s effectiveness . FurtherDespite its limitations, the current results provide promising directions for future preventive interventions among young children. This study evaluated the effectiveness of Fun FRIENDS, a universal preventive intervention program, in preschool children. We hypothesized an increase in the children’s social skills post-intervention. Consistently, self-control and cooperation improved from pre- to post-intervention in the intervention group but not in the control group. This program is a unique child-centered intervention. Although further research is needed, this study indicated that direct interventions with children could be an effective strategy to improve social skills. Additionally, as this study was conducted in a general early childhood educational setting, the results can be used to assist future dissemination of the program.Additional file 1: Appendix S1. Outline of the Fun FRIENDS Session Content.


Background and objectives: The popliteal crease varies among individuals, and there has been no prior study on this aspect. We assumed that it may be associated with lower extremity alignment and osseous morphology. To demonstrate this, we conducted a radiographic analysis. Materials and Methods: The study was conducted on 121 knees of 63 patients, whose popliteal creases were well distinguished on clinical photographs. PCOA was defined as the angle between the longitudinal axis of the lower leg and the popliteal crease. Through the radiologic examinations performed, the HKA, MPTA, mLDFA, JLCA, MFCA/TEA, and PCA/TEA were measured. Pearson correlation analysis and multiple linear regression analysis were performed on the PCOA and the six radiologic measurements to analyze the relationship. Results: Pearson correlation analysis found HKA had the highest coefficient at 0.568. In multiple linear regression, only HKA was associated, excluding all other measurements. Conclusions: Popliteal crease obliquity is significantly associated with coronal plane lower extremity alignment and exhibits a stronger correlation than with underlying knee osseous morphology. If future research is conducted based on this, popliteal crease could serve as a valuable clue for predicting lower extremity alignment and the risk of osteoarthritis development. There are various skin creases in the human body known to develop in the early fetal period . Many stWe experienced some clinical cases where we observed a change in popliteal crease obliquity in patients with severe arthritis in the medial compartment of the knee after undergoing knee arthroplasty. Therefore, we conducted a study on the biomechanical correlation between popliteal crease obliquity and lower extremity alignment and osseous morphology of the knee joint. As far as we know, there has been no research on whether the popliteal crease reflects osseous anatomy to some extent, aside from studies that have given significance to the popliteal crease as an anatomical landmark for surgery. Studies comparing skin and surface anatomy with osseous morphology are quite rare. There have been studies on the association between earlobe crease shape and cardiovascular events , as wellWe aimed to demonstrate the association between popliteal crease obliquity and lower extremity alignment and knee osseous morphology. To achieve this, we conducted a radiographic study and formulated two hypotheses for verification. Firstly, we assumed that popliteal crease obliquity is associated with lower extremity alignment and osseous morphology in the coronal plane. To demonstrate this hypothesis, we measured four radiologic parameters in the coronal plane and examined their correlation with popliteal crease obliquity. Secondly, as the popliteal crease is a skin fold that folds during flexion, we hypothesized that popliteal crease obliquity is associated with osseous morphology related to flexion. To demonstrate this hypothesis, we measured two radiologic parameters related to flexion and examined their correlation with popliteal crease obliquity. Based on these investigations, our goal was to identify the primary factors influencing the formation of popliteal crease obliquity for the first time and determine whether popliteal crease obliquity can be used to predict lower extremity alignment and underlying osseous morphology.The study was conducted in patients who were admitted to our orthopedic department with knee pain for surgical or conservative treatment between July 2021 and December 2022 and whose popliteal crease was well distinguished on the clinical photograph. Plain radiography was performed, including standing knee extension anteroposterior (AP) view, standing knee 45 flexion posteroanterior (PA) view (Rosenberg view), and standing whole lower limb scanogram, and radiologic measurements were obtained and used for the analysis. Clinical photographs of the popliteal crease were taken for a total of 74 subjects, and 11 of them were excluded from the study. Exclusion criteria: subjects who had already undergone arthroplasty or other knee surgeries and had implants inside, making radiologic measurement difficult, and subjects for whom aforementioned X-rays were taken so inaccurately that radiologic measurement was impossible were excluded from the study. In addition, the subjects whose clinical photographs were not taken accurately enough to clearly identify the popliteal crease were also excluded from the study. This study was approved by the Institutional Review Board of our institution (SC23RISI0004), and all patients provided written informed consent. The analysis of the relationships between popliteal crease obliquity and various radiologic measurements was finally conducted on 121 knees of 63 patients. The patients signed informed consent regarding publishing their data and photographs. The research was performed in accordance with the Declaration of Helsinki.With the patient in a standing position, clinical photos of the popliteal crease were taken from the back of the patient. The camera was positioned at knee height, 1 m away from the patient, and the angle of capture was horizontal. The photographs were taken in the hallway of our hospital under indoor fluorescent lighting. The photographs were taken with the legs spread shoulder-width apart, but due to some problems, the widths were not constant, and the popliteal crease obliquity changes greatly due to slight differences in the width. Therefore, the popliteal crease obliquity angle (PCOA) was defined as the angle between the longitudinal axis of the lower leg and the popliteal crease, and the lower leg longitudinal axis was defined as the line connecting the center at the tibia plateau level and the center at the ankle malleolar level A. The shSeveral radiologic parameters were measured by standing whole lower limb scanogram, standing knee extension AP, and standing knee 45 flexion PA (Rosenberg view). The scanogram was taken with the patella facing the front in a full weight-bearing state . The RosThe HKA was defined as the angle between the line connecting the femur head center and the tibial spine center and the line connecting the tibial spine center and the center of the talus at the ankle joint . The MPTMany of the patients included in the study underwent magnetic resonance imaging (MRI) of the knee as they were scheduled for arthroplasty, and the MRI images from 69 knees of 49 patients were used for analysis. In patients with MRI, the angle between the TEA and the posterior condylar axis (PCA) in the axial image was determined and named as the PCA/TEA, and the correlation with PCOA was analyzed ,23. In tTwo fellowship-trained orthopedic surgeons conducted radiologic measurements, and both had sufficient knowledge in measuring angle degrees. Two orthopedic surgeons performed each of the measurements without sharing the results between them, and one of the surgeons obtained two separate measurements, resulting in a total of three measurement results. The results of the measurements were used for the reliability check, and the three results were averaged for the final analysis. The characteristics and measurements of the patient group are shown in p-values were <0.05.The intraclass relationship coefficient (ICC) was checked for each parameter in order to check the reproducibility and reliability of the measured popliteal obliquity angles and six radiologic measurements. The ICCs for interobserver variability were 0.989, 0.906, 0.837, 0.956, 0.819, 0.813, and 0.991, respectively, for each of the following parameters: HKA, MPTA, mLDFA, JLCA, MFCA/TEA, PCA/TEA, and the popliteal crease obliquity angle (PCOA). The ICCs for intra-observer variability for the same parameters were 0.983, 0.823, 0.821, 0.976, 0.899, 0.951, and 0.957, respectively . SPSS fop-value of PCA/TEA was 0.058, which was not statistically significant , indicating that it showed a significant relationship. The multiple regression equation for PCOA was as follows: PCOA = 104.754 + 0.468 HKA  or high tibial osteotomy (HTO), both of which are common surgeries for the arthritic knee ,30,31,32The results of Pearson correlation analysis between the popliteal crease obliquity angle and six radiologic measurements showed that HKA, JLCA, mLDFA, and MPTA exhibited high correlations with parameters measured in the coronal plane in order, and exhibited low correlations with MFCA/TEA and PCA/TEA in order. This indicates that alignment or osseous morphology in the coronal plane showed a higher correlation than parameters that reflect flexion. In the multiple linear regression analysis, all other parameters except HKA were excluded, which also indicates that MFCA/TEA and PCA/TEA, the parameters reflecting the flexion state, have little relationship with the PCOA. We assumed that the relationship between flexion-related parameters and the popliteal crease would be strong since the popliteal crease is the line that is formed by folding during flexion, but results differing from the expectation were shown. As most of the patient groups included in this study showed arthritic knees, the range of changes in HKA was relatively large, so there is a possibility that the correlation between the popliteal crease and MFCA/TEA or PCA/TEA was relatively reduced. However, patients with neutral and valgus alignment were also randomly included in this study, and the overall mean HKA was 5.934, suggesting the varus alignment shown in the patients was not so severe. In addition, the total number of knees examined in this study was 121, indicating that the study was conducted with a sufficient number of samples for statistical analysis. That is, the results of the statistical analysis can be considered significant, and it can be concluded that HKA shows the greatest relationship with popliteal crease obliquity, and the effects of the other parameters on the popliteal crease are relatively small.In the case of mLDFA, MPTA, and JLCA, which were measured on the coronal plane, the value of the other parameter is also determined by HKA if two of the three parameters are determined ,36. In oTo summarize, we previously formulated two hypotheses. The first hypothesis was that “popliteal crease obliquity is associated with lower extremity alignment and osseous morphology in the coronal plane”. This was demonstrated since HKA is the most important indicator reflecting coronal plane lower extremity alignment, and its correlation with PCOA was confirmed. However, mLDFA, MPTA, and JLCA did not show significant correlations, indicating that the relationship between coronal plane osseous morphology and popliteal crease obliquity was not established. The second hypothesis was that “popliteal crease, being a skin fold that folds during flexion, is associated with osseous morphology related to flexion”. We examined the correlation of MFCA/TEA and PCA/TEA with PCOA, as indicators reflecting flexion. However, we could not establish this relationship. In summary, this study was unable to establish a clear association between popliteal crease obliquity and underlying osseous morphology. However, it was demonstrated that popliteal crease obliquity is closely associated with whole lower extremity alignment.Considering that PCOA increased as HKA increased, it is regarded that PCOA increases as arthritic changes in the medial compartment progress in the varus alignment knee. It can be hypothesized that there are three ways in which the popliteal crease can change after it is determined genetically, as a result of arthritic changes and other factors that cause HKA to change. First, a case of moving while forming a circle with a femur mechanical axis from the femoral head center as a radius can be considered. Second, a case of movement that is parallel to the ground surface in the lateral and medial directions according to the changes of varus and valgus can be considered. Lastly, a case of moving while forming a circle with a tibia axis from the talar dome center as a radius can be considered. Based on the results of this study, it can be concluded that the actual movement of the popliteal crease may occur through the first or second manner, as PCOA increases with varus progression and decreases with valgus progression. This is because PCOA is the angle between the lower leg longitudinal axis and the popliteal crease, similar to the angle between the tibia axis and the popliteal crease. It could not be concluded based on the results of this study by which of the two manners the movement of popliteal crease actually occurs. However, the popliteal crease obliquity to the ground surface decreased after TKA in many of the patients included in this study . TherefoThe first limitation of this study is that the proportion of patients with varus alignment was high, as most of the patients included in the study were scheduled to undergo arthroplasty due to degenerative arthritis. In this regard, the study was conducted with sufficient numbers of study samples for statistical analysis as mentioned above, so it is considered that there is no problem in checking the clinical significance of popliteal crease obliquity in arthritic patients. The results of this study have limitations affecting their application to the general population, and for this purpose, additional studies to get the data for popliteal crease obliquity and radiologic measurements in the general population would be required. The second limitation of this study is that most of the radiologic measurements analyzed in this study are measurements of parameters that do not have a large scale of the normal range, so the subtle differences that occurred during measurement could affect the results. In order to reduce this deviation, two researchers in this study measured and confirmed the inter-/intra-observer variability using ICC. It is considered that if the study is conducted with a large increase in the total number of patients, the correlation between PCOA and measurements of MPTA or mLDFA, which was not proven in this study, may be verified. Although these limitations exist, this study demonstrated that popliteal crease obliquity in arthritic patients is related to the HKA axis, which has sufficient value as the first clinical study on popliteal skin crease. In addition, if it is possible to estimate lower extremity alignment or predict future changes with the popliteal skin crease based on the evidence of the relationship between PCOA and the HKA axis, it would be possible to use the popliteal skin crease as a diagnostic screening tool for simple self-diagnosis in patients without radiologic examination such as X-ray. This would be a useful tool in modern society where the quality of life is gradually improving and interest in health care is increasing. For this purpose, additional studies on the popliteal skin crease in various races and in the general population would be required.We proved that the popliteal crease obliquity angle is closely related to the HKA axis. However, no significant associations were established with mLDFA, MPTA, JLCA, MFCA/TEA, and PCA/TEA. Therefore, it can be concluded that popliteal crease obliquity is significantly associated with coronal plane lower extremity alignment and exhibits a stronger correlation with this than with underlying coronal plane osseous morphology or osseous morphology reflecting flexion. This represents the first study analyzing the shape of the popliteal crease, and it is the first study to analyze which biomechanical factor the popliteal crease is most closely associated with. If future research is conducted based on this, the popliteal crease could serve as a valuable clue for predicting lower extremity alignment and the risk of osteoarthritis development.


Despite the existence of a legal policy framework, financing of adolescent and youth sexual and reproductive health (AYSRH) services has remained weak. External donors are the main financing agents, which has implications for the sustainability of service provision. International development partners have reduced funding for health programs from historically high levels. In Kenya, the health sector's budget allocation has remained below the 15% committed to under the Abuja declaration. With Kenya's devolved government structure, a greater proportion of financial resources are dedicated towards recurrent and structural expenses as opposed to addressing health systems gaps.The purpose of this manuscript is to assess the contribution of The Challenge Initiative (TCI) Business Unusual model on AYSRH services in the counties of Kilifi and Migori, as well as to examine the institutionalization of high impact interventions (HIIs) within the annual work plan, budget, and systems of the said counties. Additionally, this study aims to analyse the trend in contraceptive uptake among adolescent and young women aged 15 to 24 in Kilifi and Migori counties.Migori and Kilifi Counties chose to partner with TCI to implement the Business Unusual model. Interested counties apply for the initiative's support and commit to contributing a portion of the funding needed to adapt and implement high impact interventions (HIIs). Based on the identified gaps, TCI supported the counties to prioritize the HIIs including integrated outreaches, youth fixed days, whole site orientation, youth champions, and youth dialogues. The program was implemented between July 2018 to June 2021 in 60 and 68 public health facilities of Kilifi and Migori Counties, respectively. The county teams identified and selected program implementation team whose key role was to coordinate, review, monitor, mobilize resources and report AYSRH program implementation progress.Sisi kwa Sisi coaching model of lead-assist-observe-monitor, 20 master coaches were trained. The master coaches cascaded the training to over 97 coaches. The coaches will continue to build capacity of peers in advocacy for resource mobilization and implementation of HIIs. At least nine of TCI's HIIs have been adopted in Kilifi and Migori County strategies and annual work plans, and there is financial support for their sustainability.The results showed a 60% increase in financial commitments on AYSRH programming from 2018 to 2021 in both counties. The average expenditure for committed funds for Kilifi and Migori Counties was 116% and 41% respectively. As the counties continued to allocate and spend funds on the implementation of HIIs, there was a noticeable increase in contraceptive uptake among the young people aged 15 to 24 who visited health facilities for services. There was a 59% and 28% percentage increase in contraceptive uptake among young people (15–24 years) between 2018 and 2021. The proportion of adolescents amongst those presenting for first ANC clinic dropped from 29.4% in 2017 to 9% in 2021 in Kilifi County and from 32.2% in 2017 to 14% in 2021 in Migori County. Using the TCI's The increase in adolescent contraceptive uptake might have been as a result of the system strengthening through self-financing of AYSRH programs, the institutionalization of HIIs, and the coaching. Local governments can invest in and sustain their own AYSRH programs, which will lead to an improvement in adolescent and youth access to contraceptive services and, as a result, a reduction in adolescent pregnancies, maternal mortality, and infant mortality. In the recent past, adolescent youth sexual reproductive health (AYSRH) needs have become a growing concern worldwide. The high number of adolescent pregnancies is attributed to inadequate access to sexual reproductive health services. This has exacerbated the vulnerability of adolescent young girls to poverty, exclusion, and exploitation . AdolescKilifi and Migori counties are among the counties recording high rates of adolescent pregnancies in Kenya. In 2018, the proportion of adolescent pregnancy (10–19 years) among women attending first antenatal clinic (ANC) in Kilifi and Migori stood at 29.4% and 32.2% respectively, much higher than national level , governments agreed to enhance access to comprehensive AYSRH services and responsive information and education for all adolescents and youth . This wiResource allocation and utilization towards AYSRH interventions enhances program improvement and sustainability. Kenya is a signatory of the Abuja Declaration, which pledges to increase African governments' spending for health to at least 15% of the total budget , but thiAlthough donor assistance for AYSRH Programs in Kenya has increased over the years, the percentage of government funds devoted to AYSRH program is still low , and KilThe Challenge Initiative (TCI) has been working in collaboration with the county Government and other implementing partners in Kilifi and Migori counties to implement select global best practices in AYSRH under the Business Unusual Model. The Business Unusual Model helps in prioritization of finance, scale-up, and sustainability of high-impact solutions for family planning and AYSRH. The select best practices are referred to as high impact interventions (HIIs). This approach is a shift in strategy from the traditional development model, in that it is demand-driven, allowing counties to self-select, as well as determine FP and AYSRH HIIs to implement based on existing gaps. This concept has cultivated a mind-set shift towards resource allocation, increased ownership, and sustainability of AYSRH of programs. The TCI program is currently being implemented by city governments in 11 countries in Africa and Asia.This paper aims to share experiences on how the TCI Business Unusual Model has contributed to the success of the AYSRH program in Kilifi and Migori counties leading to increased uptake of contraceptives and reduced adolescent pregnancies. Specifically, we present the contribution of TCI Business Unusual Model on the improvement of AYSRH program sustainability; and document trends in contraceptive uptake among adolescent and young women aged 15- 24; and adolescent pregnancy among 15–19-year-olds in Kilifi and Migori during the implementation period.•Toolkits with detailed protocols, job aids and manuals to guide implementation of the HIIs;•Coaching to build the managerial and technical capacity of local government officials, service providers, community health workers (CHWs), and other community actors;•Access to a community of practice (CoP) to share learnings and experiences.In 2010, the Bill & Melinda Gates Foundation launched the Urban Reproductive Health Initiative (URHI) to identify solutions to address the FP needs of the urban poor. The URHI demonstrated the effectiveness of a range of supply- and demand-side interventions in improving the accessibility, quality, and use of FP services. To catalyse the rapid adoption and scale-up of these high-impact interventions (HIIs), the foundation created TCI. Launched in 2017, TCI deploys a “business unusual” model, whereby interested local governments apply for the initiative's support and commit to contributing a portion of the funding needed to adapt and implement HIIs in their geographies. A diverse range of HIIs available to local governments include interventions to improve management of FP programming, support advocacy to increase funding for FP, improve service delivery, and generate demand. Starting in 2018, local governments could also elect to “layer” on programming to support adolescent and youth sexual and reproductive health (AYSRH). To effectively implement these interventions, local governments received a range of support, collectively called TCI-University. These include:Migori and Kilifi Counties, located in Kenya, are among the counties that chose to partner with TCI to implement the Business Unusual model. TCI supported the counties to prioritize the HIIs based on their existing gaps. The selected HIIs included; integrated outreaches, youth fixed days, whole site orientation, youth champions, intergenerational youth dialogues and digital/media platforms. The program was implemented between July 2018 to June 2021 in 60 and 68 public health facilities of Kilifi and Migori counties, respectively. The county teams identified and selected key program implementers, referred to as program implementation team (PIT) whose key role was to coordinate, review, monitor and report AYSRH program implementation progress. The PIT also played a role in advocacy for resource mobilization, allocation, and utilization for AYSRH Programming.•Kenya Health Information System (KHIS): used to track contraceptive uptake service data among adolescents aged 15–19 and 20–24 years from all health facilities reporting into KHIS. This system also captured antenatal care (ANC) attendance from those presenting with pregnancy at first ANC visit at facility aged 15–19 years in Kilifi and Migori counties. This data was used to calculate the total number of adolescents pregnant in a given financial year.•Program progress reports: these tracked program outputs, financial expenditure and system strengthening qualitative data. Financial data was reviewed from existing documents like annual work plans and financial commitments made by Kilifi and Migori counties for the financial year 2017 to 2021. Financial expenditure on AYSRH was tracked and reviewed against the county budgets, compared before and after intervention.•Most Significant Change (MSC) technique was used to capture voices of the implementers, stakeholders and community members about the impacts of the AYSRH program on their lives and communities. MSC stories were also collected from targeted key decision makers at the county level and healthcare providers.The various indicators of program progress were regularly monitored using data from the following information systems:Over the years of program implementation there were increases in financial commitments and expenditure on AYSRH Program in both Kilifi and Migori Counties. Kilifi County spent more than they had initially committed which demonstrates the County's commitment to addressing adolescent health matters see  below.TCI trained 20 master coaches who cascaded the training to over 97 coaches in Kilifi and Migori to ensure provision and implementation of AYSRH HIIs. The five-day standardized training curriculum broadly entailed preparing master coaches at county level to spearhead the implementation of the AYSRH program, applying transformative leadership and coordination to implement the AYSRH program, how to adapt and implement HIIs using the TCI—University toolkit, managing resources effectively and utilizing data for AYSRH program monitoring and decision making.Some of the interventions targeting adolescents implemented included 700 AYSRH whole site orientation sessions—an approach to provide basic AYSRH knowledge to all staff  working in the health facility, 209 integrated youth outreaches—a health service delivery activity done outside the health facility aimed at bringing services closer to the youths, 184 youth dialogue days—a dialogue forum that bring young people together to discuss their needs and challenges, training 145 youth champions—young people who advocate for AYSRH services- trained on AYSRH, and 15 advocacy meetings in both Kilifi and Migori supporting increased expenditure and commitments for the next financial years.The MSC stories collected demonstrated that HIIs and processes, including the establishment of AYSRH coordinators, have been institutionalized in Kilifi and Migori County health systems, budgets and annual work plans, and there is support for their scalability. Here are quotes from select key county leadership and health management teams.The TCI’s business model came in at the right time, and as a county, we had to adopt and adapt the interventions to start the journey in reducing our negative indicators in AY. (Adolescent and Youth)”“Political leader- Kilifi County.When TCI introduced the adolescent and youth program we knew we had to be part of it…. We did not even have a policy as a county to guide us on how to implement AY programs. One of the indicators to be addressed was contraceptive uptake among adolescents……, we focused on interventions that would also reach the youth. We had a starting point in that we picked interventions that had worked.”“County Health Department representative—Kilifi County.The establishment of the County AYSRH Coordinators’ position ensured that the program gets a differentiated share of budget allocation from the main Reproductive Maternal Newborn Child and Adolescent Health (RMNCAH) budget, it was given space in the annual work plan as a subprogram within RMNCAH. The Co-ordinator was tasked with consolidating all the partners together hence establishment of AYSRH Technical Working Group (TWG). The co-ordination mechanism also saw the development of the county AYSRH strategic plan document, which borrowed a lot from TCI-University, to guide AYSRH programming.”“County Adolescent Health Representative—Kilifi CountyThe position of county AY coordinator enabled the mapping of all AY stakeholders and formation of taskforce including the development of Migori county AY multisectoral action plan which borrowed a lot of HIIs from the TCI—University. The positions were also cascaded down to all the 8 subcounties”“County Adolescent Health Representative—Migori CountyIn both Kilifi and Migori Counties, there was an increase in contraceptive uptake among adolescents (15–24 years) with a percentage increment of 59% and 28% respectively over the period of three years. However, there was a decrease of 21% in from 2018/2019 to 2019/2020 in Kilifi County for the 15–19 years see  below. TThe lack of age-disaggregated facility data on adolescents presenting with pregnancy and the absence of surveys hindered impact assessment on contraceptive uptake by age and measures of universal contraceptive services coverage. During the study period, data on adolescent contraceptive access from private facilities, including pharmacies and drug shops, was not obtained.Since 2018, both Kilifi and Migori Counties of Kenya progressively increased their financial commitments to AYSRH Program. This indicates that these counties have appreciated the importance of addressing the prevailing sexual and reproductive health related challenges which exacerbate the vulnerability of adolescents and youth to poverty, exclusion, and exploitation. These counties have assumed a greater role and responsibility of abating AYSRH challenges within their jurisdiction. This progress makes Kilifi and Migori Counties particularly exceptional in a country where the percentage of government funds devoted to AYSRH program is small despite increasing donor assistance for AYSRH Programs. The increase in financial commitments towards AYSRH by Kilifi and Migori Counties is in accordance with the treaties of the 2019 ICPD, where governments, including Kenya, agreed to enhance access to comprehensive AYSRH services and responsive information, education to all adolescents and youth (The sustained increased allocation of more resources to tackle AYSRH challenges within these counties may have resulted from successful smart advocacy efforts by various partners, including TCI, which cultivated a mind-set shift towards resource allocation, increased ownership, increased adolescent contraceptive uptake and sustainability of AYSRH of programs. According to Korir et al., international NGOs and foundations have been the main financing agents in the provision of FP services in the country and it is not sustainable . If KiliThe relative increase in expenditure on AYSRH Programs in both Kilifi and Migori Counties illustrate enthusiasm of the counties' structures to implement planned AYSRH interventions, which could eventually abate the prevailing AYSRH challenges, especially high rates of adolescent pregnancies. Evidence from research studies and other projects shows that effective FP interventions improve adolescent access to contraceptive services and hence reduction of adolescent pregnancies, maternal and infant mortality.The allocated funds were spent in implementation of AYSRH Program HIIs. These HIIs have been adapted into Kilifi and Migori Counties' strategies and annual work plans, which increases the likelihood of sustained implementation. The early positive and promising results from the interventions may inspire the leadership of these two counties to sustain allocation of funds for AYSRH Program in future. The establishment of the position of AYSRH Coordinators across the two counties would strengthen coordination, accountability, management, and implementation quality of the AYSRH HIIs and ensure use of evidence for action. The conceptual framework, depicted in Local governments can invest and sustain their own AYSRH programs contributing to improved adolescent and youth access to contraceptive services and hence reduction of adolescent pregnancies, maternal and infant mortality. This would also create an opportunity for women and girls to advance in their education and careers while improving their economic outcomes. To meet the needs and fulfill the rights of adolescents and youth, local governments should allocate funds and ensure their utilization for AYSRH interventions. Galvanization of political will and commitment for AYSRH at county leadership will ensure prioritization of adolescent health interventions. Continuous advocacy will ensure allocation and release of funds for health programs by empowering local community-based organizations, civil society organizations and youth groups to hold the leaders accountable on their promises. Local governments should embrace public private partnerships to leverage on resources in expanding FP commodities and services availability.


Alô Enfermeiro programaiming at elucidating the existing structure, activities carried out, andexpected results, allowing the program implementation systematicevaluation.To develop the logical model of the This is an evaluative study with a qualitative approach. The development ofthe logical model was based on systematic methodologies, constituted fromthe analysis of institutional documents, literature review, search foressential elements that supported the implementation of the program, and theparticipation of stakeholders for discussion and validation of the dataobtained.Alô Enfermeiro,target audience, general and specific objectives, as well as to structurethe necessary components, such as inputs and activities, indicating theexpected results in the short, medium, and long term. The logical modelallowed the identification of the Alô Enfermeiro Programevaluation question, directed to the evaluation of results.It was possible to define the macro problem that gave rise to the program,establish the definition of the Program Alô Enfermeiro”.The logical model developed allowed the comprehension of the programstructure, the interaction among the activities carried out and the expectedresults of the “ PAE operationsbegan in 2006 with the Oncology nursing team at the Radiology Institute (InRAD), andwere transferred after the inauguration of ICESP. The volume of daily consultationshas grown progressively over the years. In 2021, PAE made more than54 thousand receptive consultations, that is, the ones in which thepatient/companion contacts the program center, and about 30,000 activeconsultations, that is, those that the nurse contacts the patient/companion.At the Cancer Institute of the State of São Paulo (ICESP), the implementation of a24-hour care TN program was required. Currently, this program is called “. To design anevaluation plan, it is important to understand the program structure and tocorrelate available resources and interventions with desired outcomes.A program evaluation allows the monitoring of its progress towards goals, theidentification of necessary modifications, and the judgment of success when reachingthe results–11, and pointed out as a tool thatcan guide the development, implementation, and evaluation of a givenprogram.The logical model (LM) has been widely used for structuring complex healthintervention programs,13,14.The LM is defined as a graphical representation that allows the broad visualizationof program components, to support the decision-making of managers in charge of theimprovement and achievement improvement of results of the intervention inquestion.The LM can help conceptualize complexity by describing the intervention componentsand the relations among them, making the “theory of change” and assumptions aboutcausal pathways between the intervention and various outcomes explicit, anddisplaying the interactions between the intervention and the system in which it isimplemented. It provides a framework to support the assessment, help interpret theresults, as well as identify new evaluative questions and areas where more evidenceis required.The participation of stakeholders in the LM construction is pivotal to the obtainmentof different points of view about each topic discussed, and based on them, reach theconsensus of those involved. In general, the stakeholders are from three groups: theindividuals involved in the operation; those who are directly affected by theprogram; and those who will use the assessment results. The interaction andagreement among stakeholders is a key factor for the LM to generate assessments thatactually represent the needs of the team and its beneficiariesThe literature on the development of the LM of a 24-hour care TN program for cancerpatients in the Brazilian public health system is scarce.PAE toelucidate the existing structure, activities carried out, and expected results,allowing the program implementation systematic evaluation.This study aims at developing the logical model of the PAE at ICESP. The process ofimplementing PAE since 2006 was considered, time whenoperations took place at InRAD. Then, the program was transferred, formallystructured, and implemented at ICESP in 2008. The construction of the LMconstituted the first step in the analysis of the PAEimplementation process.This is an evaluative research, with a qualitative approach, to analyze theimplementation of IPEA), Centers for Disease Control and Prevention(CDC) and theINTEGRATE-HTA Project,with some adaptations to avoid impacting the stakeholders’ work routine.The development of the LM followed the recommendations of the Institute ofApplied Economic Research , with exclusive care for the Brazilian Public HealthSystem (SUS) oncology patients, located in the city of São Paulo, Brazil, andcertified by important institutions that value patient safety and quality of thecare provided, such as the Joint Commission International (JCI).The LM development and validation process took place from July 2020 to October2021, in 11 stages .,21,22,23. Theinstitutional documents related to the program were analyzed, which included thestandard operating protocol (SOP) with the fundamentals and details of theactivities carried out by the program, the guidelines for thenon-pharmacological management of symptoms and the structural models used torecord the attendances in the patient’s electronic medical record (EMR).The literature review on the development of LM included articles indexed innational and international databases, technical notes, guides and manuals issuedor disseminated from 2004 to 2020PAE management position, includingquestions related to the history and elements necessary for the construction ofthe LM. These interviews were included in the LM development process in thisstudy, as an adaptation due to the pandemic scenario and in the face of thestakeholders’ routine, aiming to optimize and reduce the duration of in-personmeetings.Then, semi-structured interviews were carried out in person and individually,with two people in a PAE’s operational sector,coordination, management and direction, with two nurses and three people inPAE’s managerial position. All the stakeholders signed theFree and Informed Consent Form (FICF), after the principal investigator hadexplained the purpose of the study and the steps that would be carried out.Five ICESP’s employees were invited to participate in the stakeholders’ panel.The sample definition used, as an inclusion criterion, the selection ofemployees who work in the Based on the content obtained from the analysis of institutional documents andsemi-structured interviews, the first version of the LM was developed, accordingto the elements described in the flowchart illustrated in PAE; general and specific objectives; targetaudience; the first version of LM containing pillars such as the context inwhich the PAE is inserted, inputs, activities, immediate andintermediate results and impact) were separated by topics with previouslycollected content, a table with the options “agree”, “partially agree” and“disagree ”, followed by a free space to enter comments. The context wasrepresented by the following components: 1) setting, which describes theenvironment and conditions in which the program is inserted, 2) epidemiological,specifies the user’s profile regarding the pathology, 3) socioeconomic, whichrefers to the patient’s socioeconomic conditions, and 4) sociocultural,indicates beliefs, traditions, and habits.All the information collected, including the first version of the LM, was writtenand organized in a didactic material sent by e-mail to the stakeholders fivedays before the first in-person meeting. In this didactic material, a briefexplanatory text was inserted about the concept of LM, its functionality and thedefinition of stakeholders, so that there was a better understanding of thecontent, and consequent optimization of the diagram development process. Theelements of the LM  and the free space for comments.The material filled during the meeting was handed over to the principalinvestigator, so that the suggestions presented could be included in the LMsecond version and the diagram redrawn. With all participants’ authorization,the meeting was recorded using audiovisual resources.The first in-person meeting with the stakeholders was held on October 1, 2020,coordinated by the principal investigator, and aimed to discuss the topics ofthe submitted material and validate the first version of the LM. It lastedapproximately 1 hour and 30 minutes. Forty minutes were allotted for the historyof the PAE to be retold by the stakeholders who participated in the program’sinitial operation, with the objective of helping the others to understand thereal reasons that generated the The LM second version was developed, inserted into the didactic material with thesame format as the previous one, and sent by email for prior analysis by theparticipants, seven days before the second in-person meeting with thestakeholders.The second in-person meeting with the stakeholders was held in person on May 5,2021 for the review and validation of the LM second version, which was developedbased on the suggestions indicated at the last meeting. The schedule followedthe same format as the previous meeting. New suggestions and corrections wererecommended in the following elements: consequences of the macro problem,program definition, general objective, specific objective, context , inputs, activities,products, results, correlation arrows between activities and products, andbetween products and results.The LM third version was developed from the recommendations and suggestionsraised at the second meeting, and signaled in the didactic material madeavailable on the stakeholders panel, which was given to the principalinvestigator, so that she could count the votes . For the items voted as “partially agree” or “disagree”, thecorrections recommended in the considerations field, for each element, wereapproved by the stakeholders panel at the time of the meeting and included inthe LM third version.To minimize possible impacts on the stakeholders’ work routine, LM third andfinal version was sent via email in a file in PDF format with the contentupdated according to the recommendations of the second meeting. Informationvalidation took place in the body of the same email sent through standardizedresponse boxes  and a free fieldintended for considerations for each element of the LM mentioned above.Alô Enfermeiro, were used to identify thestakeholders, followed by an Arabic number for each participant: AE1, AE2, AE3,AE4 and AE5.The research project was submitted to and approved by the Ethics Committee forthe Analysis of Research Projects of the Hospital das Clínicas, Medical Schoolof Universidade de São Paulo (CAPPesq-HCFMUSP), according to resolution 466/2012of the National Health Council – Ministry of Health. of Health, with ResearchProtocol No. 4.513.242/2021. The five stakeholders consented to participate inthe study after reading and signing the FICF, and a printed copy was deliveredto each participant. To preserve the participants’ identity, the letters AE,corresponding to PAE was described as “patients ofhigh complexity in the oncological setting”. Based on this, the causes that turnthis patient into a high-complexity individual were identified, and the possibleimpacts of this context. To reach the definition of these elements, a voting tookplace in the first in-person meeting with the stakeholders, recorded in the printedteaching material and reviewed by the principal investigator. In this voting, anopposition to the first suggestion of the constructed macro problem was observed,which led to a discussion about the best definition for this element.The macro problem that generated increase in the number of hospitalizations(AE2) and increase in the number of admissions to theOncological Complications Care Center (CAIO) (AE1). This CAIO is thedepartment dedicated to urgent and emergency care for ICESP’s patients. Identifying“possible consequences” rather than “consequences” was suggested by fourstakeholders . The stakeholders agreed with the suggestedrecommendations and recorded the considerations in the didactic material, which waslater revised by the principal investigator, who included the changes that generatedthe third version of the macro problem explanation. This latest version was sent viaemail to the stakeholders for analysis, and obtained the unanimous vote of “agree”. This recommendation was reiterated bytwo other stakeholders (AE4 and AE5) and a consensus was reached in favor ofincluding the words “patient/companion” in the program’s definition elements andspecific objectives.At the second meeting, there were some important statements for the program onthe topic “specific objectives”, such as the insertion of “guiding behaviordirected at the patient’s/companion’s complaint/doubt, support decision-making”,validated by stakeholders for the next version. One of the stakeholdershighlighted the following recommendation relevant to the program’s definitionand specific objectives: The definition of the PAE, target audience, general objective, and specificobjectives was approved by the five stakeholders in the third version sent.The stage preceding the construction of the diagram consisted of the descriptionof the context in which the PAE is inserted. This was presented at the base ofthe diagram, with the interaction with the LM being represented by arrowstowards the five pillars, which symbolizes that the entire program is insertedwithin the same context. During the second meeting, four of the fivestakeholders partially agreed with the version developed so far. Threestakeholders brought the same suggestions for the socioeconomic andsociocultural topics: precariousness of the basic health network in primary careand religious resistance. The other stakeholders agreed with the insertion ofthese suggestions.The LM diagram was represented by five pillars :PAE functioning.Inputs: structure required for program functioning. This pillar was subdividedinto physical structure and human resources . At the second collective meeting, threestakeholders proposed the use of the current structure of the PAE, which, due tothe pandemic scenario and the significant increase in the demands of theprogram, had the physical and human resources expanded. The other stakeholdersagreed with this suggestion, since it represents the structure required for thecurrent PAE. According to the stakeholders’ suggestion, this pillarwas subdivided into receptive team training, when the patient/companion contactsthe PAE center, and active team training, when the nurse contacts thepatient/companion. In the second in-person meeting, four stakeholdershighlighted the importance of including the following activities in the topic“active”: return of unanswered calls and resolution of demands requiringdiscussion with the patient’s home outpatient’s team. Such recommendations werehighlighted in view of the volume of associated demands. In addition to these,two stakeholders (AE1 and AE2) suggested the insertion of another activity inthe topic “active”: monitoring the preparation for simulated prostateradiotherapy. The suggested recommendations were approved by the stakeholders’panel and inserted in the LM third version.Activities: These are the activities carried out daily in theInclude a call to the outpatient clinic or supportnetwork (AE3).Call to the outpatient clinic for evaluation of tubes/probes or,depending on the complaints, emergency room near the patient’sresidence (AE4).Call to the ICESP’s outpatient clinic or refer the patient tothe health network (AE5).Products: These are short-term results, that is, those achieved with theimplementation of activities. At the second collective meeting four stakeholderspartially agreed with the version presented, three of these signaling similarconsiderations: The above considerations were presented to the stakeholders panel, who agreed toinsert the following description: a call was made to the CAIO, the outpatientclinic of origin or the closest support network.(AE2) suggested theinsertion of the item: doubts about the use of oral antineoplastic drugs andpreparation of a simulated prostate clarified. This item was inserted in view ofthe cause and effect component arising from the activities: remote monitoring ofpatients undergoing oral chemotherapy at home and monitoring of preparation forsimulated prostate radiotherapy.Still in the pillar “product”, a stakeholder I believe that we managed to avoidhospitalization and not to reduce the time (AE5).Results: These are the medium-term results. In this pillar, the five stakeholderspartially agreed during the second collective meeting and signaled the sameitem: reduction of hospitalization time for unmanaged adverse events (AEs). Oneof stakeholders emphasized: Based on this statement, it was decided that the item in question would bechanged to: avoid hospitalization due to an unmanaged AE complication. Theconsent of the five stakeholders for that item was obtained.Impacts: These are the long-term results of the PAE. There was unanimous approvalof this pillar by the stakeholders during the second collective meeting.The interaction between the columns, which represents the program complexity, wassymbolized by arrows from left to right, which indicated the action and expectedeffect of each item. In the columns products and results, it was observed thatthe components inserted in the same pillar could present the phenomenon of causeand effect among themselves, as for example, in the pillar “product” the item“implemented center” has the effect of “disclosure carried out”, which in itsturn generates the “answered calls”.Consensus was reached by the five stakeholders in the third version of the LM,after obtaining the “I agree” vote on all the elements presented.Based on the LM, it was possible to identify, in fact, the main gap of the PAE,in which evaluation is required. Consensually, the program evaluation should bedirected towards the analysis of the results obtained with the implementation,aiming to assess the impact of TN on the admission of patients undergoingchemotherapy to the CAIO.. A TN program developed to optimize the care of patientsaffected by the SARS-COV2 virus (COVID-19), and to promote agile communicationbetween the family and the health professional, used the LM to support the programevaluation, and as a tool for potential replication in other services.According to previous studies on program evaluation, the LM is considered one of thebest tools to direct and define the evaluative question and the feasibility of theprocess of a given interventionThe LM with a theoretical approach contributed to detailing the reason behind theidealization and implementation of the program, promoting the in-depth stakeholders’analysis of the causes and consequences. In addition, the concept of the program’sbasic references, such as definition, target audience, general and specificobjective, promoted a consolidated and consensual discourse when describing thePAE..Studies indicate that starting the construction of the LM based on the macro problemand its respective causes facilitates the process of defining the program objectiveand activities that will be used to achieve the expected change. The context in which the PAE is inserted reflects a range ofintrinsic and extrinsic challenges to the oncological condition, faced by thepatient/caregiver and professionals who are part of the program. Based on thecontext and its possible impacts on the desired results, it can be observed that theactivities making up the PAE were developed and implemented, aiming at theperformance of individualized care by a team capable of recognizing the barriers andneeds presented by the patient/caregiver. Based on the identified demand, it ispossible to establish strategies adapted to the individual’s particularities, aimingat promoting targeted and effective care, seeking to achieve the results outlined inthe LM.Context description is a fundamental element for understanding the factors that caninfluence the program, acting as a facilitator or barrier for the implementationprocess and/or achieving results. Thecomplexity of a telehealth service that provides support to children in ruralAustralia was based on the development of LM, in addition to allowing a commonunderstanding of the program, and justifying its expansion.In view of the LM structuring, it was possible to understand PAE as a complexintervention in health. This phenomenon is defined from the numerous interactionsthat exist among the components of an intervention, the amount and level ofbehaviors required by those who carry out or receive a certain intervention, theorganizational levels involved, the different possibilities of results and potentialfor adaptationsThe product obtained through the LM construction process consisted of defining theresearch question aimed at evaluating results, based on the organization of thecomponents that make up PAE, detailing, and meticulous analysis of the expectedresults. The “reduction in unnecessary attendance at CAIO” was highlighted in theexpected results, as it is directly related to the creation of the program, whichaims to early manage possible adverse events resulting from the treatment and thusavoid unnecessary admission to the emergency service.PAE. Furthermore, the failure to include the expectations,interests, and values of policymakers and program funders may have compromised thedescription of complexity in the proposed LM. The involvement of multiplestakeholders favors a shared and broader view of what the PAE can do and increasesthe chance of successful implementation.The participation of only five stakeholders, and the absence of a person to representthose who are directly affected by the program, such as the patient and companion,were limiting factors for this study. The absence of the patients’ and companions’point of view about the PAE limits the understanding of how the program may affectits target audience. Individual values, cultural and socioeconomic factors canaffect users’ perception of the program, becoming barriers to the implementation ofthe After the construction of the PAE LM, other institutions will be able to implementsimilar programs aiming to promote the continuity of care, quality and safety ofcare provided to the patient/family, and it is also possible to use the methodologyto organize the elements of other interventions, aiming at the success in achievingthe results and establishing evaluative questions that are essential for the use ofimprovements.PAE. It is concluded that LM is afunctional tool for planning, implementing, and defining evaluative research.The development of the LM allowed the comprehension of the existing structure, andthe observation of the interaction between the activities carried out and theexpected results of the