Cysts with thin (p < 0.05) or thick walls (p = 0.001), multiple cystic lesions, (p < 0.001), cystic lesions draining to the skin (p < 0.001), and skin fistulas (p < 0.05) were detected more often in IGM. Central (p < 0.05) and periareolar (p < 0.001) location and focal skin thickening (p < 0.05) were significantly more common in IGM. Architectural distortion (p = 0.001) and diffuse skin thickening (p < 0.05) were associated with BC. Multiple regional distribution was more common in IGM, whereas diffuse distribution and clumped enhancement were more common in BC (p < 0.05). In kinetic analysis, persistent enhancement was more common in IGM, whereas plateau and wash-out types were more common in BC (p < 0.001). Independent predictors for BC were age, diffuse skin thickening and kinetic curve types. There was no significant difference in the diffusion characteristics. Based on these findings, MRI had a sensitivity, specificity and accuracy of 88%, 67.65%, and 78.32%, respectively, in differentiating IGM from BC. Conclusions: In conclusion, for non-mass enhancement, MRI can rule out malignancy with a considerably high sensitivity; however, specificity is still low, as many IGM patients have overlapping findings. Final diagnosis should be complemented with histopathology whenever necessary.Objective: To compare and determine discriminative magnetic resonance imaging (MRI) findings of idiopathic granulomatous mastitis (IGM) and breast cancer (BC) that present as non-mass enhancement. Materials and Methods: This retrospective study includes 68 IGM and 75 BC cases that presented with non-mass enhancement on breast MRI. All patients with a previous history of breast surgery, radiotherapy, or chemotherapy due to BC or a previous history of mastitis were excluded. On MRI images, presence of architectural distortion skin thickening, edema, hyperintense ducts containing protein, dilated fat-containing ducts and axillary adenopathies were noted. Cysts with enhancing walls, lesion size, lesion location, fistulas, distribution, internal enhancement pattern and kinetic features of non-mass enhancement were recorded. Apparent diffusion coefficient (ADC) values were calculated. Pearson chi-square test, Fisher’s exact test, independent t test and Mann–Whitney U test were used as needed for statistical analysis and comparison. Multivariate logistic regression model was used to determine the independent predictors. Results: IGM patients were significantly younger than BC patients ( Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast. Although IGM is a benign process, its complex clinical and heterogeneous radiologic presentation, which sometimes resembles breast cancer, may lead to difficulty in diagnosis ,2,3,4,5.The most common MRI findings of IGM are non-mass enhancement and cystic lesions that show rim enhancement in dynamic contrast-enhanced (DCE) images ,12,13. HThis multicenter retrospective study was conducted in the radiology clinics of two research hospitals and was approved by the institutional review boards with a waiver of patient informed consent. Patient files were retrospectively evaluated to list all the patients that received a pathological diagnosis of IGM or breast cancer between January 2020 and April 2022. From this list, patients who had an MRI evaluation before the onset of treatment, the images of which could be accessed from the local PACS, were determined. MRI reports of these patients were evaluated. All IGM patients with non-mass enhancement with or without cystic lesions and all invasive breast cancer patients whose disease presented predominantly as non-mass enhancement were included in the study. Patients with mass enhancement were excluded because they usually do not create a diagnostic challenge, and we planned to concentrate on patients with non-mass enhancement specifically. Furthermore, all patients with a previous history of breast surgery, radiotherapy, or chemotherapy due to breast cancer or a previous history of mastitis were excluded. Patients with incomplete or technically inadequate MRI examinations were also excluded from the study. An equal number of patients were aimed to be included in each group, but due to the exclusion of some cases, the final study group comprised 143 patients (68 with IGM and 75 with breast cancer). In all cases, histopathologic diagnoses were obtained by US-guided core needle biopsy, which were performed after the MRI examination.MRI was performed using a 1.5 T system of the same vendor  and dedicated 8-channel breast coil in prone position at both centers. Multiparametric MR images of bilateral breasts were obtained in the axial plane, including the following sequences: T1-weighted fast spin-echo, T2-weighted fat-suppressed fast spin-echo, diffusion-weighted echo-planar images (DWI) with diffusion gradients at b values of 0 and 800, and T1-weighted turbo 3D gradient echo dynamic contrast-enhanced images . The contrast agent gadoterate meglumine  was automatically injected at a rate of 2.0 mL/s. The contrast dose (0.1 mmol/kg) was based on the patient’s weight.Anonymized MR images were evaluated by two experienced breast radiologists (with 25 years and 15 years of experience). Radiologists interpreted the images in consensus.®) MRI lexicon of the American College of Radiology [Evaluation was based on the 5th edition of Breast Imaging Reporting and Data System  was grouped as regional, diffuse, or periareolar. Fat-containing ducts were defined as ducts that had the same signal intensity with fat in all sequences, including fat suppression. Edema was classified as perilesional, subcutaneous, diffuse, prepectoral, and presternal on T2-weighted images. Presence and number of cysts were recorded. In the contrast-enhanced series, lesion location  was recorded. Maximum diameter as well as the distribution  and internal enhancement pattern  of the enhancing lesions were noted. Kinetic curve analysis was performed by placing a standardized circular ROI at the enhancing areas. The early phase  and late-phase kinetics  were recorded. In the presence of cystic lesions with enhancing walls, they were categorized according to the irregularity and the thickness of their walls . Additionally presence of fistulas, cystic lesions that were draining directly to the skin, skin retraction or invasion, and nipple retraction or invasion were recorded. Suspicious axillary lymph nodes were noted. DWI and apparent diffusion coefficient (ADC) maps were analyzed, and a visual scale between 0 and 3  was used to determine the degree of diffusion restriction. Mean ADC values of 3 measurements were obtained by placing standardized circular region of interest (ROI) on ADC maps, corresponding to areas of non-mass enhancement on DCE images.n (%) for categorical variables. Categorical data were compared with Pearson chi-square test and Fisher’s exact test. We used the chi-square test if ≤20% of expected cell counts were less than 5, and we used Fisher’s exact test if >20% of expected cell counts were less than comparisons of continuous data between GM and breast cancer, which were performed by independent t test for normally distributed data and Mann–Whitney U test for non-normally distributed data. Variables with statistically significant differences in univariate analysis were included in multivariate model to determine the independent predictors for breast cancer. Odds ratio (OR) with corresponding 95% confidence intervals (95% CIs) was reported. Statistical analysis was performed with IBM SPSS Statistics for Windows, Version 23.0 . Two-sided p value less than 0.05 was considered statistically significant.The Shapiro–Wilk test was used to test the normality of the data. Descriptive analyses were presented using mean ± SD for normally distributed data and median (min-max) for non-normally distributed data or p < 0.001). Subtypes of breast cancer were as follows: ductal carcinoma in situ (n = 10), invasive ductal carcinoma (n = 47), invasive lobular carcinoma (n = 14), invasive ductal and lobular carcinoma (n = 3), and metaplastic carcinoma (n = 1).The patients’ ages ranged between 23 and 58 in the IGM group (mean ± SD: 37.1 ± 8.2) and between 27 and 80 in the breast cancer group (mean ± SD: 47.6 ± 10.5); the difference was statistically significant (p = 0.001). IGM presented with focal skin thickening more often compared to breast cancer (p < 0.05), (p < 0.05). Dilated fat-containing ducts were more frequent in IGM (16.2%) compared to breast cancer (5.3%), but the difference was not statistically significant  compared to IGM (10.3%), (< 0.05), , whereasnificant . There wnificant . p > 0.05). Mean lesion size was calculated as 72 mm (with a range of 11–154 mm) for IGM cases and 59 mm (with a range of 16–128 mm) for breast cancer patients (p < 0.05) and an OR of 0.14 (0.02–0.74). Periareolar location was also significantly more common in IGM (p < 0.001)  .p: 0.048). There was no difference in terms of linear or segmental distribution patterns. In terms of internal enhancement patterns, there was a significant difference only in the clumped pattern (p < 0.05). Clustered ring pattern was seen in 40 patients with IGM (58.8%) and 38 patients with breast cancer (50.7%); the difference was not statistically significant . Kinetic curve analysis showed significant difference only in the late-phase findings . Persistp < 0.05) or thick walls (p = 0.001) as well as multiple cysts with enhancing walls (p < 0.001) were significantly more common in IGM . The number of cases with cysts with irregular walls did not show any difference.Cystic lesions with enhancing walls were more diagnostic for IGM in general . Cysts wn in IGM . MultiplThe number of cases with retraction or invasion in the skin or the nipple as well as those with suspicious axillary lymphadenopathies showed no difference between two diseases.Independent predictors for breast cancer were the age of the patient, diffuse skin thickening and kinetic curve types of plateau and wash-out in backward stepwise multivariate model . Cystic Based on these results, we evaluated the findings of all patients again blinded to the histopathological results and tried to give a radiological diagnosis of IGM or breast cancer. Findings were re-evaluated according to the backward stepwise model; age over 50, diffuse skin thickness, and plateau or wash-out in the kinetic analysis were classified as breast cancer; age less than 50 years, containing cystic lesions and central localization were classified as IGM. We achieved a sensitivity of 88%, specificity of 67.65%, and accuracy of 78.32% for the detection of breast cancer. Positive (PPV) and negative (NPV) predictive values were 75% and 83.64%, respectively. If architectural distortion, non-mass enhancement with diffuse distribution or clumped internal enhancement pattern were also included in the malignancy criteria, sensitivity, specificity, accuracy, PPV and NPV were 97.33%, 55.88%, 79.02%, 70.87%, 95%, respectively . The mosIn this study, we compared the MRI findings of IGM and breast cancer patients presenting with non-mass enhancement on breast MRI and tried to determine if there were any findings that could help us in the differential diagnosis. We found that young age, single or multiple cysts with enhancing walls, cysts that drained to the skin, skin fistulas, focal skin thickening, central or periareolar location, and non-mass enhancement with multiple regional distribution were features that were significantly more common in IGM. On the other hand, breast cancer patients were more likely to be older and had significantly more architectural distortion, diffuse skin thickening, non-mass enhancement with diffuse distribution and clumped internal enhancement. The persistent type of kinetic curve was more common in IGM, while plateau and washout types of kinetics were typical for breast cancer. Studies that compare the MRI findings of IGM and breast cancer are limited in the literature ,12,13,14We included only cases with non-mass enhancement in this study. Breast cancers presenting as mass lesions on MRI are usually more typical and are easier to differentiate from IGM. However, it has been reported that 57% of nonpalpable breast cancers demonstrate non-mass enhancement on MRI . IGM alsIGM is characterized by abscess formations, and it is not surprising that significantly more cystic lesions with enhancing walls were observed in IGM patients. This finding is similar to previous reports ,13,20,21p < 0.05), while diffuse skin thickening was more common in breast cancer with an OR of (95% CI) 26,1 (2.1–314.7). Diffuse thickening was mostly detected in inflammatory breast cancer patients. In an MRI study by Renz et al. that compared breast cancer and acute mastitis, diffuse skin thickening was more common in inflammatory breast cancer, with no statistical significance [In this study, focal skin thickening was more common in IGM . Since IGM is seen mostly at postpartum period, fat-containing dilated ducts may be due to the altered biochemical content of the lactiferous ducts. It may just be a finding associated with recent lactation, or the leakage of this secretion may be an underlying etiologic factor. We think that this finding should be evaluated further in future studies with larger numbers of patients.Protein secretions in the ducts characterized by T1 hyperintensity were reported to be a possible etiologic factor for IGM . This fip < 0.001), and the central part of the breast was also a frequent site of involvement for IGM with an OR of 0.069 (0.01–0.469). We have not encountered an analysis of central or periareolar location of IGM lesions in previous studies.Altunkeser and Gautier reported retroareolar location in 12% and 27% of IGM cases in their studies, respectively ,26. In tp < 0.05). On the other hand, diffuse distribution was significantly more common in breast cancer (p < 0.05). Altunkeser et al. reported similar results, although there was no significant difference in their study, which included only 58 patients [Segmental distribution has a high PPV for breast cancer; however, it is also one of the most common patterns of distribution for non-mass enhancement in IGM ,27,28,29patients . Our stuClustered ring enhancement is another finding that is closely associated with malignancy. It has been reported in recent studies that this finding was seen in up to 63% of the BC cases ,30,31. CThere are conflicting results for DWI in IGM. Even though some authors have stated that IGM lesions show restricted diffusion ,33, a ren = 36) and granulomatous mastitis (n = 33) cases. In this study, non-mass enhancement, clustered ring enhancement, ring size, rapid contrast enhancement in univariate analysis, internal enhancement, and rapid staining in multivariate analysis were found to have significant differences ). Considering ring size (cut of 7 mm), the sensitivity of MR was 81.8%, and the specificity was 82.1% [As IGM is known for its likelihood to mimic breast cancer, correct evaluation of MRI features of this disease is crucial. Among the series evaluating comparatively between IGM and malignancy in the literature, the study closest to our series numerically is the study of Qu et al. . This stas 82.1% . The mosThis study has some limitations. First, it is a retrospective study. Second, the study was performed blinded to clinical as well as other radiological findings. Future prospective studies investigating the role of MRI in routine clinical practice may be worthwhile. A strong point for this study was the large number of patients. IGM is a rare disease in many parts of the world, and this is the largest study in the literature on differential diagnoses of IGM and breast cancer on MRI. However, larger studies are still needed in order to establish more definitive criteria and to investigate other findings such as dilated fat-containing ducts.In conclusion, according to our results, we can suggest that IGM is likely to present with one or multiple cystic lesions with enhancing walls, showing central or periareolar location and non-mass enhancement with multiple regional distribution and a persistent type of kinetics. Old age, architectural distortion, diffuse skin thickening, non-mass enhancement with diffuse distribution or clumped internal enhancement pattern with plateau, and wash-out kinetics should be warning signs for malignancy. The absence of these suspicious criteria can rule out malignancy with a considerably high NPV; however, PPV is still low, as many IGM patients have overlapping findings. A final diagnosis should be complemented with histopathology whenever necessary.


Bullying makes learning difficult for nursing students, and using real-life scenarios during training can improve the understanding of workplace bullying. Thus, to mitigate bullying experienced by nurses, this study developed and evaluated a cognitive rehearsal education program that constituted training nursing students through role-play simulations. A mixed-method research design was used to evaluate 39 nursing students from two universities. A quasi-experimental research design was applied to assess symptoms, knowledge, and perceptions of bullying, and a focus group interview was conducted with six participants. Quantitative analyses revealed that the program improved participants’ knowledge and perceptions but not their symptoms. The focus group interview revealed that the program improved participants’ coping skills and desire for education. This program could be effective in raising awareness of workplace bullying and increasing relevant coping skills. It can be further developed as part of an overall strategy to manage workplace bullying and its consequences in hospital settings. Workplace bullying refers to mental, verbal, or physical attacks conducted amongst coworkers in professional settings, exacerbated by the risks of scarce support and social exclusion for those attacked . PsycholAccording to the literature, the common nature of workplace bullying includes the negative and unwanted nature of the behavior, repetition and persistence, and imbalance of power ,2,3. A nTraditionally, individual and organizational factors have been investigated as antecedents of bullying ,3,4. IndWorkplace bullying is an important issue in nursing education and hospital management, and its incidence rates vary worldwide depending on countries’ laws and organizational characteristics . In a syIn nursing education, preparing for the fight against bullying requires a systematic approach that takes into account the specificities of university education and clinical practice ,6,7. EffBullying also makes learning difficult for nursing students, but it is tricky to teach them effective coping methods . Among tHence, this study aimed to develop a cognitive rehearsal-based simulation program to prevent workplace bullying among nursing students. The program provided simulations of clinical settings, qualitatively evaluated bullying experiences through in-depth interviews, and analyzed effects on symptom experiences, knowledge, and perceptions of workplace bullying.A concurrent embedded mixed-method research design was applied, including a focus group interview and a quasi-experimental research design involving a one-group pretest–post-test design  Figure .http://www.gpower.hhu.de/ (accessed on 28 June 2020), with a significance level of 0.05, power of 80%, and effect size of 0.5, a minimum sample size of 34 was required. Considering drop-outs, 50 participants were recruited; data from 39 who underwent the entire experimental process were analyzed, while responses from 11 were excluded due to incompletion. Data for the qualitative analysis were collected through a focus group interview with six participants who voluntarily agreed to participate in the interview and were among those whose data were included in the final analysis.Participants included fourth-year students with at least one year of clinical practice and no previous exposure to simulation education or classes in workplace bullying at four-year nursing colleges in cities A and I in Korea. Using G*Power 3.1.9.7 software  based on Jeffries’s  simulatiTo analyze their needs, individual interviews were conducted with 12 fourth-year nursing students who had undergone clinical practice. Results revealed high demand for coping skills, followed by understanding the meaning and causes of workplace bullying, respectively.The program follows the order of “Scenario running → Reflection → Debriefing,” based on the role-play bullying simulation by Gillespie et al. .Based on the demand analysis and the programs by Griffin  and StagExplain the meaning and types of workplace bullying;Accurately recognize workplace bullying;Effectively respond to workplace bullying;Utilize related resources and ask for help when required;Demonstrate appropriate coping skills.Four experts assessed the program’s validity in terms of its goals, content and composition, operating time, and method appropriateness, after which the simulations were revised and supplemented. The range of content validity coefficient was 0.75–1.00 when calculated for each item based on a 4-point scale. Subsequently, a pilot study was conducted with five junior nurses to identify and correct potential issues in operating the program. Consequently, sufficient opportunities to share comments and ask questions during debriefing were added. The final goals of this program were to enable participants to:Before implementation, the scenario was practiced with an assistant researcher three times, and the program was simulated once to enhance realism and recognize any unexpected variables in advance.The demand survey was conducted from 1 July to 5 July 2020, and the program development period was one month. The effectiveness of the program was evaluated through quantitative and qualitative analyses between 13 August and 20 September 2020.A questionnaire was administered two weeks before the program to measure participants’ characteristics, symptom experiences, and knowledge and perceptions of workplace bullying.Participants were grouped into 13 teams of three to four students. In the scenario running stage, the trained standard patient and trained senior nurse conducted the simulation. In the reflection stage, the participants completed a short questionnaire with open questions assessing self-reflections on bullying and 5-point Likert scale items to verify whether they immediately recognized bullying. In the debriefing stage, the definition and types of bullying, as well as coping skills, were discussed.A postsurvey questionnaire was administered two weeks after the program to measure symptom experiences and knowledge and perceptions of workplace bullying.To explore the longevity of changes caused by the program, a focus group interview lasting between 90 and 100 min was conducted with six participants two weeks after the program. With prior consent, the interview was recorded and transcribed. Important questions included, “How did this program affect your perception of workplace bullying?” “Are you confident that you can apply what was learned in real life?” “Are there foreseeable difficulties when applying what was learned today in real life?” “What do you think needs to be added to resolve workplace bullying in nursing?”Symptom experience was measured using the Brief Symptom Inventory-18 developed by Derogatis , which wThe tool for measuring knowledge of workplace bullying was developed by the investigator using the Negative Acts Questionnaire-Revised  and the This tool was developed by the investigator with five questions based on the tool by Quetta, who surveyed bullying perceptions among medical students . The conp = 0.05. The effects of the program were analyzed using the nonparametric Wilcoxon signed-rank test (Shapiro–Wilk test). Qualitative data from the focus group interview were analyzed using the content analysis method. After transcribing the recorded interviews, multiple reviews were conducted to extract key concepts, phrases, and words. Relationships among extracted concepts were categorized under abstract themes, which were comprehensively analyzed to derive the final themes.Quantitative data were analyzed using SPSS/WIN 23.0 , with This study was conducted after obtaining approval from the Institutional Review Board (IRB NO. 1044396-201910-HR-183-01) of G University prior to data collection. Participants were informed that the data collected would be handled anonymously, would not be used for purposes other than this study, and that they could refuse participation in the study at any time. Written consent was obtained from each participant.Participants included 34 women (87.2%) and 5 men (12.8%) with a mean age of 22.6 years, with 21 (53.8%) participants aged 21 or 22. Participants had an average of 18 months of clinical practice experience, while none of them had received education on workplace bullying .Immediate recognition of workplace bullying in the scenario learning stage was 2.75 ± 0.99 points out of 5, with recognition of personal bullying being the highest with 2.91 ± 1.09 points. Among the 10 specific bullying cases included in the scenario, “excessive monitoring” scored the highest with 3.48 ± 1.16 points, and “alienating” was the lowest with 2.48 ± 1.40 points.Participants indicated psychological abuse, anger, neglect, and discrimination as types of bullying and expected difficulties such as excessive stress, psychological pain, low self-esteem, and social phobia. In addition, their action responses were passive, such as no response, endurance, or silence, whereas some reported notifying superiors and devising solutions after checking relevant information .Z = 2.029, p = 0.049).Prior to the program, scores for total symptom experience were 1.82 ± 0.83 out of 5; after the program, scores were 1.64 ± 0.67, not showing significant differences. However, in the subcategories, scores for depression were significantly different . Similarly, scores for perceptions increased from 3.14 ± 0.39 out of 5 to 3.66 ± 0.46, showing significant differences . Among detailed items, there were significant differences in knowing the meaning of workplace bullying and perception of coping skills In addition to conventionally known examples of bullying, such as personal attacks, shouting, and abusive language, participants reported that they were able to recognize subtler instances, such as not receiving patient information, being ordered to do work below their qualifications, or being given unrealistic goals.When I was a newbie, I thought that I had to do the things that senior nurses generally don’t like to do, such as assistant jobs or errands, until I got better because I was just learning. And I thought I should not feel bad about these things … If I had not learned in this program, I would not have known that being made to do things that which do not like to do is bullying.(Participant 3)1b:Learned coping skillsParticipants indicated that they learned effective coping skills against workplace bullying.If I had not learned in this training, I would not have known what to do and felt helpless when bullied. However, now I think I can do what I have learned if I feel bullied.(Participant 5)Participants also mentioned that they learned of antibullying manuals at work, immediate recommended measures, and related laws and gained confidence that they could take more active stances against workplace bullying.I thought that I should not notify the head nurse unless I planned to resign. If there is an antibullying manual at the ward and if everyone knows about it, I plan to notify the head nurse without hesitation and with no fear of revenge when bullying occurs.(Participant 4)1c:Reduced fear of workplace bullyingParticipants expressed a fear of workplace bullying, which reduced after the program.I heard about the high turnover rates for nurses due to the bullying culture at work. I often worried about becoming a victim of bullying, how much would I be able to endure, what if I quit my job at the hospital because of bullying and so on … Now that I clearly understand workplace bullying and know what to do, I am not so afraid.(Participant 2)2:Need for continuous educationParticipants reported improved hopes of dealing with workplace bullying but were still worried about whether they could effectively cope in various clinical settings. Thus, continuous and repetitive education is required.2a:Wanting to respond effectively to various workplace bullying situationsParticipants felt limited in effectively responding to workplace bullying situations and reported requiring more education for the same.I mean, who knows which hospital and which department I would be assigned to work at after graduation? I want to go to the emergency room or the ICU, but I heard that the nurses working there are even worse and so is bullying because everyone is so busy. A lot of nurses quit. I want to receive more training in bullying situations that can occur in the emergency room or the ICU so I can adapt well when I am stationed there.(Participant 1)Participants also wished to learn coping skills against bullying by doctors or other professionals, not just nurses.I heard that doctors tend to look down on nurses. They say that work becomes difficult if you do not get along with doctors. I would like to know what to do in situations like that.(Participant 3)2b:Recognizing the possibility of becoming the bully rather than the bulliedParticipants reminded themselves of individual responsibilities in efforts to prevent workplace bullying and recognized the fact that they could be the bullies rather than the bullied.If I had become a senior nurse without properly learning about workplace bullying, I think I would have done exactly as the bullies who bullied me, without any guilt, under the name of training new nurses … To do away with the bullying culture at the hospital, I think everyone should receive this education mandatorily.(Participant 4)2c:Wanting to receive continuous and repetitive coping trainingParticipants mentioned that they might forget key learnings and requested continuous and repeated education.I wonder if I could remember what I’ve learned now when I actually experience bullying. I wish there were opportunities to repeat similar situations in clinical practice or in-class practice. If not, I wish there was a book available at the department that I could go back to for reference.(Participant 3)This cognitive rehearsal program demonstrated effectiveness in developing participants’ understanding of and coping skills for workplace bullying ,34. The In this study, the cognitive rehearsal simulation significantly improved knowledge, as demonstrated in previous studies ,26,29. ISelf-reflection and debriefing enabled effects to be maximized among participants, similar to previous studies that have applied the role-play simulation method . AdditioSelf-reflection and correction of perceptions during debriefing improved participants’ perceptions, as has been found in previous studies ,26,29. SAs workplace bullying affects psychological symptoms , the intOne limitation of this study is the usage of a single-group pre- and post-test design. We propose that future studies use a randomized, controlled pre- and post-test design. Second, it would be necessary to include students from various nationalities and practice situations and conduct additional surveys for symptom experience that reduce confounding effects. Lastly, longitudinal studies of burnout, clinical practice outcomes, and actual bullying incidences are also required ,26.The bullying experienced by nursing students in clinical practice has existed for a long time. However, it has been tolerated. In addition, it is difficult to recognize bullying and take effective and immediate action against bullying. Workplace bullying in clinical nursing education requires a systematic approach according to the developmental stage of nursing students while considering individual and organizational characteristics. This study developed, implemented, and evaluated a cognitive rehearsal-based simulation education program to develop bullying awareness and coping skills among nursing students. A mixed-method research design was applied, which included a focus group interview and a quasi-experimental research design. Quantitative analyses revealed that the role-play simulation program improved participants’ knowledge and perceptions but not their symptoms. Regarding the results of the qualitative assessments, nurse students experienced positive feedback on workplace bullying perceptions, their fear disappeared, and their confidence in coping with bullying improved. These results provide a basis for assessing educational needs and effectiveness against bullying in future studies or education programs. In addition, if a cognitive rehearsal-based simulation education program that allows nursing students to continuously experience various situations of workplace bullying in the nursing curriculum is developed, it will contribute to the development of practical nursing education that can prevent and manage workplace bullying.


The Medicare 5-star quality rating system was designed to drive improvements in Medicare quality and to increase accountability among Medicare plans. Medicare star ratings provide significant bonuses for plans that improve medication adherence. Envolve’s pharmacy division, Envolve Pharmacy Solutions, which provides services for Medicare Advantage Prescription Drug plans, developed an in-house medication therapy management (MTM) program to improve adherence rates and subsequent star ratings. As part of this program, Envolve invested in motivational interviewing (MI) as a means to improve adherence to antihypertensives, antihyperlipidemics, and antidiabetics but recognized the need for additional staff training to ensure pharmacist success with MI techniques. Thus, Envolve engaged a consultant to help train pharmacists and evaluate the program. This best practices article describes the implementation of an MI program and subsequent changes in patient adherence and star ratings.A pharmacist-led, patient-centered adherence program incorporating MI for behavior change was developed and implemented at Envolve. The program used didactic learning, coaching and skills assessments, and a train-the-trainer (TtT) intervention. This approach resulted in improved adherence rates in all 3 therapeutic classes immediately. In addition, a quality improvement process was incorporated to evaluate the improvements in adherence with this new program over 24 months.P < 0.05) over 5 years and improved Medicare star ratings by 1-2 stars; (b) there is a need for support of pharmacy MTM managers to ensure continued success of the program; and (c) there is value in a TtT program for managers that allows them to provide continuous evaluation and feedback to staff for improvement.Key findings of the program are as follows: (a) the program increased adherence rates 5-9 percentage points (chi-square tests for all plans and drug classes measured, Each year, as the Medicare star ratings system matures and plans are held more accountable for improving adherence measures, high star ratings become more difficult to attain. This MI TtT program for pharmacists allows for rapid cycle change in response to these challenges. What is already known about this subjectThe Centers for Medicare & Medicaid Services (CMS) emphasize medication therapy measures, including adherence for Parts C and D plans, to achieve higher Medicare star ratings.Health plans may be able to improve multiple star ratings and overall plan performance with strategies aimed at improving medication adherence rates.Motivational interviewing (MI) is an evidenced-based and effective intervention for influencing patient behaviors and associated positive health outcomes.What this study addsPatient-centered MI techniques used in a telephonic pharmacist-led intervention at the plan level can be used to improve adherence in targeted drug classes and, thus, Medicare star ratings.A train-the-trainer model in MI for pharmacy management teams can be used to promote continuous quality improvement in medication adherence and, thus, Medicare star ratings.1 In 2011, the Affordable Care Act (ACA) strengthened the effect of the CMS star ratings by providing quality incentive payments to these plans.2 Bonus payments for improved ratings in quality measures helped plans focus efforts on strategic initiatives to improve measured areas, which include member satisfaction and clinical outcomes. The initial demonstration period (2012-2014) enabled plans scoring at least 3 stars to receive a bonus payment for quality. However, beginning with the 2015 star ratings , plans had to achieve 4 or 5 stars to receive a bonus as outlined in the ACA.3A 5-star quality rating system, implemented to drive improvements in Medicare quality and to increase accountability among Medicare Part D and Part C plans for the care provided to beneficiaries, was developed by the Centers for Medicare & Medicaid Services (CMS) in 2007.4 since clinical outcomes and quality of life measures have been shown to improve with increased adherence.7 Adherence measures are considered intermediate outcome measures and thus receive a weighting of 3. Consequently, they directly affect over 12% of a plan’s overall star rating. In addition, several Part C measures are related to the treatment of these 3 conditions; therefore, adherence to these medications could affect an additional 11% of the overall rating.4 Considering these outcome measures and the sizable bonus plans received for obtaining at least 4 stars, it benefits plans to implement programs to improve medication adherence. Envolve Pharmacy Solutions, a wholly owned subsidiary of Centene Corporation, is a pharmacy benefit manager with 20 years of experience that has focused on government-sponsored health care and commercial business. Envolve has supported MAPD plans since the implementation of Medicare Part D in 2006 and has an in-house pharmacy-run medication therapy management (MTM) program providing MTM and adherence programs for its members. In 2012, Envolve had roughly 225,000 MAPD members, 24% of whom were nonadherent in the star metrics. Pharmacy and quality teams evaluated star measures and their effect on members and the plan. They determined that the star ratings were not optimal . Consequently, an adherence program was developed with a goal of improving star ratings. This best practices article follows Evolve’s adherence program improvements between 2013 and 2018 for 4 MAPD Envolve health plans.Medicare star ratings are calculated using a weighted average of 34 Part C measures and 14 Part D measures for Medicare Advantage Prescription Drug (MAPD) plans. These measures are weighted at 1, 1.5, or 3. Adherence to medications for the treatment of diabetes, hypertension, and hyperlipidemia are heavily weighted by CMS,The Envolve adherence program evolved over time . The ini11 At the time of this intervention, few pharmacists had been trained in this approach and no evidence of MI techniques being used to improve adherence in the setting of CMS star ratings and in-house MTM programs was found in the literature.It was noted that few calls were transferred to pharmacists. The pharmacy management team concluded that future adherence programs needed to address member engagement and behavior change towards adherence to avoid continual reidentification of the same nonadherent members. A pharmacist-led adherence program based on patient-centered motivational interviewing (MI) for behavior change was then selected for the in-house, telephonic adherence MTM program because MI has been shown to change patient behavior in several settings.12 During this initial phase, the pharmacy management team reported that the pharmacists continued to rely on their standard consultation skills when talking to members, and adherence rates did not improve by the end of 2014 .The Envolve pharmacy management team met with the UCSF pharmacist consultants to develop a stepwise program that included knowledge, comprehension, and application of MI training. Because the Envolve pharmacists already had initial training in MI, during the first phase the UCSF pharmacists listened anonymously to 5 live adherence calls per pharmacist. This demonstrated whether MI skills, such as open-ended questions, affirmations, reflective listening, and summaries were used and provided an opportunity to create a tailored curriculum for pharmacist-specific process improvement. The curriculum included (a) a pharmacist self-assessment, (b) training on individualized scripted introductions, (c) feedback on MI skills and techniques, (d) role-playing, and (e) an opportunity for peer review. In addition, individual coaching sessions ranging from 30-60 minutes were provided for each pharmacist. Systems issues that prevented effective integration of MI during adherence calls were identified and discussed with plan leadership.As a result of the training and pharmacist feedback, 2 areas were initially targeted for continuous quality improvement: personalized introductory scripts for the pharmacists and identification of a patient-specific adherence barrier to promote member activation, engagement, and patient-guided problem solving. The UCSF consultants interacted with the Envolve team from February 2015 through April 2015.The Envolve pharmacy management team realized that it would take time for the pharmacists to develop the targeted MI skills and that they had to establish a process to continuously evaluate the pharmacists’ MI skills once the UCSF consultants left. The first process implemented was a peer-review model. Pharmacists were assigned to anonymously listen to another pharmacist’s live call and to provide an assessment using an MI assessment form developed by the UCSF consultants. The form provided evaluation of call structure and use of MI techniques to promote a behavior change. The assessment was divided into 2 phases over 4 months as follows:Phase 1: evaluate the pharmacist’s call structure  and use of open-ended questions.Phase 2: evaluate advanced MI techniques, such as reflective listening and evocation, to develop a patient-centered goal and plan through shared decision making.This process was initially effective for improving pharmacist call structure; however, it was not an objective process for feedback on MI techniques due to variations in MI proficiency among the pharmacists performing the evaluation. Also, listening to live calls produced delayed and incomplete assessments, rendering feedback only mildly effective. In most of the MAPD plans supported by Envolve, adherence either remained unchanged in 2015 or showed minor improvements .Because the peer review process had only moderate success in changing pharmacist behavior, Envolve engaged the UCSF consultants for a second year to resolve shortcomings. In year 2, a train-the-trainer (TtT) program with the managers was included so that MI evaluations and coaching could continue when the consultants left. Focus groups with 2 independent facilitators were conducted with the pharmacists to determine issues that they were having with their MI skills and to gather individual pharmacist feedback on knowledge, comprehension, and attitudes toward MI. The TtT program focused on 2 areas identified in these focus groups: manager evaluation of adherence calls using a standardized rubric and pharmacist coaching.13 Behavior counts on how often open-ended questions and reflections were used by the pharmacists were also assessed. Scoring ranged from a low MI score of 1 to a high MI score of 5. A score of 1 indicated that the pharmacist was antagonist or argumentative with the member. Conversely, a score of 5 meant that the pharmacist demonstrated exemplary MI skill during the conversation with the patient. The consultants and manager independently evaluated 3 calls per pharmacist and met to compare and discuss the evaluations to create 1 evaluation. This process helped the manager develop a consistent scoring system using the rubric. The consultant also attended the manager-pharmacist feedback and coaching sessions to provide evaluation and feedback on coaching skills with each pharmacist. Finally, the consultants evaluated 3 calls per pharmacist to specifically determine if they were reaching the targets set the previous year. The pharmacist introductions were deemed effective, and patient adherence barriers were readily identified, which appeared to lead to improvements in member engagement. This process was completed over 2 months.For the TtT program, UCSF consultants worked with the pharmacy management team to use a new evaluation tool and rubric to objectively assess pharmacist effectiveness on the calls. The rubric was based on the following global concepts of MI: empathy, collaboration, autonomy and support, direction, and evocation.Based on the focus group outcomes and individual call evaluations, it was determined that pharmacists struggled to identify opportunities for setting medication adherence goals with the member, which led to a lack of follow-up with patients. Accordingly, the consultants, managers, and pharmacists developed an MI skill development template that focuses on the MI skill needed to demonstrate the global MI concept. For example, the use of open-ended questions instead of closed-ended questions shows strength in collaboration. Pharmacists set individual goals for MI score improvement using the MI skill development template as part of their annual self-evaluations and established performance improvement plans when necessary to address deficiencies. These self-evaluations became part of their annual review. The consultants spent 2 months in 2016 with the Envolve pharmacists; however, the Envolve managers continued to provide ongoing evaluation and coaching throughout 2016.Given the systems challenges with call assessments, as well as inconsistencies with rubric scoring, it was decided to manually record calls for evaluation  and to transition call evaluation to a single manager. Calls were audited and scored based on the same 5-point scoring rubric focused on the global concepts of MI. The individual pharmacist met with a manager to listen to the recorded call and received written and verbal coaching based on MI proficiencies. The goal for each pharmacist was to reach a 4 or higher by November 2016 when averaging all 5 of the global MI concepts.Limitations still existed with the manually recorded calls. There were few calls available to evaluate, since not all of the pharmacists’ calls were recorded, and it was difficult for the scoring manager to mine for calls appropriate for evaluation. Consequently, feedback to pharmacists was delayed and less frequent than desired. Despite these limitations, the pharmacists were able to achieve the scoring goal, and the objective call evaluation process and feedback model validated MI proficiency for the team. In addition, the plans’ adherence rates improved for the 3 targeted drug classes , leadingDuring the third year of this program, the Envolve Medicare MTM program was implemented across the entire enterprise, resulting in significant staff growth. To support the current managers and continue to innovate and improve, Envolve hired another manager, as well as a director for the MTM program. The director was responsible for developing a calibration team to address the need for an increased number of calls to be monitored as a result of pharmacist staff growing by a factor of 3. The calibration team met monthly to listen to 1 call, score that call, and then discuss evaluations to promote consistency and scoring alignment. Each manager was then tasked with evaluating the calls for pharmacists reporting to them. The UCSF consultants were invited back for a final visit to review the progress made, evaluate 2 calls per pharmacist based on the rubric developed in year 2, and continue to provide feedback to the managers.During this visit, the consultants and the calibration team simplified the rubric to provide just 2-3 examples for MI core behaviors rated on a scale of 1-5, since the team felt it made scoring more consistent after the team felt some of the examples were duplicative. By the end of 2017, 88% of staff pharmacists were able to maintain an average MI score of 4 or greater compared with 84% at the beginning of the year. Performance improvement plans were successfully executed where necessary. Moreover, adherence rates for the 3 targeted drug classes improved by 1-2 percentage points over the previous year .14 The management staff reviews MI techniques and conducts role play sessions specific to Envolve’s call program. This approach is based on the UCSF consulting program, as well as materials from other MI experts.14Currently, the process involves a robust training plan, a call monitoring program, and a performance improvement plan. The MTM staff consists of 56 employees who serve over 240,000 members. An automated system records all pharmacist calls so that they are available in real-time for scoring. Call monitoring/scoring has transitioned to an MTM technician with a background in customer service call audits. The technician, along with the managers and program director, meet monthly for calibration calls to ensure that each pharmacist is scored and coached in a consistent manner. Newly hired pharmacists are introduced to MI with on-demand webinar training.Pharmacists attend a call review session for baseline scoring with their managers and the director within the first 90 days of training. If the pharmacist scores a 4 or better upon baseline training, they are moved to quarterly call monitoring. If pharmacists do not reach the expected goal, they are coached and monitored monthly until improvement is demonstrated or a performance improvement plan is developed.It is difficult to improve and then maintain medication adherence rates and, thus, Medicare star ratings, without novel, continuous, and real-time interventions. Plans must be willing to take a chance, fail fast, pivot, and move on to new approaches when adherence and ratings do not improve.Although the initial course of action in this program was to train pharmacists in MI, using a school of pharmacy consultant, a need for a longer-term strategy to continuously evaluate and maintain pharmacists’ skills was identified. A TtT program provided in-house managers with the skills to continuously monitor, evaluate, innovate, and implement programs to help pharmacists engage patients, with a goal of improving adherence rates in real time without the need for long-term consultants. This program successfully improved adherence rates for the 3 targeted drug classes—antihypertensives 6.8%, antihyperlipidemics 8.5%, and antidiabetics 5.8%—on average over the baseline star rating . Of noteThe 2019 CMS star rating targets for adherence measures (representing work completed in 2017) are several percentage points higher than the previous year, suggesting a need to continually improve and evolve the adherence program. This study demonstrates that an adherence program that includes rigorous training in MI and continuous quality improvement can positively affect adherence rates and CMS star ratings. Furthermore, health plans dedicated to providing targeted and ongoing coaching to MTM staff can further improve adherence rates over time. While programs that include MI training alone may improve adherence rates, this study indicates that additional improvements can be achieved if MTM staff have individual skill development plans that are continuously evaluated, acted upon, and updated.


Pharmacy cost-saving programs often aim to reduce costs for members and payers by encouraging use of lower-tier or generic medications and lower-cost sales channels. In 2010, a national U.S. health plan began a novel pharmacy program directed at reducing pharmacy expenditures for targeted medications, including pregabalin. The program provided multiple options to avoid higher cost sharing: use mail order pharmacy or switch to a lower-cost alternative medication via mail order or retail. Members who did not choose any option eventually paid the full retail cost of pregabalin.To evaluate the impact of the pharmacy program on pregabalin and alternative medication use, health care costs, and health care utilization.This retrospective analysis of claims data included adult commercial health plan members with a retail claim for pregabalin in the first 13 months of the pharmacy program . Members whose benefit plan included the pharmacy program were assigned to the program cohort; all others were assigned to the nonprogram cohort. The program cohort index date was the first retail pregabalin claim during the ID period and after the program start; the nonprogram cohort index date was the first retail pregabalin claim during the ID period. All members were continuously enrolled for 12 months pre- and post-index and had at least 1 inpatient claim or ≥ 2 ambulatory visit claims for a pregabalin-indicated condition.Cohorts were propensity score matched (PSM) 1:1 with logistic regression on demographic and pre-index characteristics, including mail order and pregabalin use, comorbidity, health care costs, and health care utilization. Pregabalin, gabapentin and other alternative medication use, health care costs, and health care utilization were measured. The program cohort was also divided into 2 groups: members who changed to gabapentin post-index and those who did not.A difference-in-differences (DiD) analysis was used to compare the between-cohort change in pregabalin and alternative medication use patterns, health care costs, and health care resource utilization from pre- to post-index. The within-cohort change from pre- to post-index was analyzed by McNemar’s test  or paired t-test (continuous variables). The Rao-Scott chi-square test  and general estimating equations (continuous) were used to analyze between-cohort differences at each time point. Differences in program member characteristics of those who changed versus those who did not change to gabapentin post-index were assessed by traditional chi-square test  or two-sample t-test (continuous variables).P < 0.001). Pregabalin mail order use increased from 3.1% to 48.1% of program members versus 2.8% to 9.4% of nonprogram members . Program members were also more likely to change to the anticonvulsant gabapentin post-index than were nonprogram members . Mean total health care costs were similar between cohorts, and the pre- to post-index change did not differ between cohorts . However, mean total pharmacy costs rose from pre-index to post-index by $820 and $790 in the program and nonprogram cohorts, respectively (both P < 0.001); the increase was similar between cohorts . Program members who changed to gabapentin had a higher mean comorbidity score (P = 0.001) and greater post-index use of opioids, alternative medications, and health care resources (P < 0.050) than program members who did not change to gabapentin.A total of 1,218 members in each cohort were PSM. Mean age was 51 years, 76.7% were women, and the most common pregabalin-indicated condition was fibromyalgia (77.6%). After the program start, the mean number of pregabalin claims from mail order and retail combined decreased in the program cohort from 4.7 pre-index to 3.8 post-index, and increased in the nonprogram cohort from 4.7 pre-index to 6.2 post-index (DiD, The pharmacy program increased mail order use of pregabalin but reduced pregabalin claims from any venue. Program members were more likely to change to gabapentin than were nonprogram members, and those who changed had higher comorbidity, use of alternative medication, and health care resources. Despite increased mail order use for pregabalin and greater change to gabapentin by program members, the pharmacy program was not cost saving with respect to mean pharmacy or total health care costs. What is already known about this subjectRecent pharmacy programs aimed at controlling rising expenditures have focused on reducing copayments through formulary tier changes.Most programs have used a single intervention and have focused primarily on medications for cardiac and diabetic care for which a generic alternative is available.These programs have been widely studied and, while many have been effective in improving medication adherence, they have been largely cost neutral.What this study addsThis study evaluated the impact of a novel pharmacy program that provides members with multiple options to avoid higher cost sharing of targeted medications: use mail order pharmacy or switch to a lower-cost alternative medication via mail order or retail.Members who changed from pregabalin to gabapentin had a higher disease burden, use of alternative medications, and health care utilization.Despite a shift in pregabalin use from retail to mail order and greater use of gabapentin by program members, pharmacy costs increased after the program start. Total health care spending did not change.1 pharmacy benefit managers and health plans have developed strategies to reduce or offset expenditures. Most cost-containment programs include interventions such as switching from retail to mail order pharmacy,3 prior authorization, 4 step therapy,5 or formulary tier modifications.8 These programs are intended to reduce pharmacy costs for both members and payers by encouraging the use of lower-tier or generic medications and lower-cost sales channels. However, pharmacy cost savings typically are not evaluated in the context of overall health care spending.With rising prescription drug spending,9 While health plan savings in pharmacy costs have been realized when patient cost sharing increased,10 total health plan spending either did not decrease or it increased.14Pharmacy programs that contain a cost-sharing component have been the most widely evaluated.15More recently, pharmacy programs that provide financial incentives, rather than penalties, to patients have been introduced. The goal of incentive programs is to increase medication adherence by providing lower patient cost-sharing options, and consequently, improving health outcomes with the expectation of lower overall spending.19 Most studies of mandatory or incentivized pharmacy programs have focused on commonly used medications for diabetes and cardiac care for which a generic medication is also available. There is scarce information for other conditions, including those for which a generic medication is not available.Although reducing or eliminating prescription copayments has been associated with improved medication adherence for covered drugs, these programs have been largely cost neutral to the health plan.21 Lyrica, or branded pregabalin,22 is an anticonvulsant approved in the United States for neuropathic pain associated with DPN, PHN and spinal cord injury, fibromyalgia, and adjunctive therapy for adult partial onset seizures. However, some health plans have restricted access to pregabalin via prior authorization24 and step therapy.25 Although restricted access decreased use of pregabalin and increased use of some alternative medications, there was no impact on disease-specific24 or all-cause costs.25 Programs that offer patients multiple options to avoid higher cost sharing, including branded pregabalin, have not been investigated.Chronic pain conditions and disorders, such as painful diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and fibromyalgia, share common pharmacologic treatments that include opioids, antidepressants, and anticonvulsants.22 which was the focus of this study. Health plan members who fill medications targeted by the pharmacy program at retail pharmacies are provided two “grace fills,” after which they may change to mail order delivery of the targeted medication  or change to a less costly alternative (generic or brand) medication via mail order or retail. Members who do not elect one of these options pay the full cost of the targeted medications charged by the retail pharmacy. Members are notified of these options at the point of sale and by letter and/or phone call after the first and second grace fills.In 2010, a national health plan began a novel cost-saving pharmacy program targeting selected tier 3 medications, including pregabalin,We hypothesized that the pharmacy program would encourage members to change from retail pharmacies to mail order for their pregabalin fills or change to alternative lower-cost medications such as gabapentin (either through mail order or retail venues). Our objective was to examine changes in pregabalin and alternative medication use patterns after the pharmacy program began and how these changes translated into total health care and pharmacy costs. Specifically, we used a large administrative claims database to examine the impact of this novel pharmacy benefit program on pregabalin and alternative medication use patterns, health care costs, and health care resource utilization.International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes, site of service codes, and health plan- and patient-paid amounts from providers and facilities. Pharmacy claims encompass National Drug Code numbers for filled prescriptions, days supply, quantity of drug supplied, drug strength, and health plan- and patient-paid amounts. All study data were accessed using techniques compliant with the Health Insurance Portability and Accountability Act; therefore, a separate institutional review board approval was not sought.This retrospective study used claims data from the Optum Research Database (ORD). ORD contains medical and pharmacy claims and enrollment information from a large U.S. health plan with national coverage. Patient- and provider-reported outcomes are not available in ORD. Medical claims data include The sample included commercial health plan members who were ≥ 19 years in 2010 and had at least 1 retail pharmacy claim for pregabalin during the identification (ID) period . Benefit information was used to identify members in the pharmacy program, including the program start date for each member . Members with a retail pregabalin claim during the ID period and after the pharmacy program start date were considered the “program” cohort; the date of the first retail pregabalin claim after the program start date was the index date. Members were subject to the program design immediately upon program start date; the program did not include a washout period.Members whose benefit plan did not include the pharmacy program were assigned to the nonprogram cohort; their index date was the first retail pregabalin claim during the ID period. Members in both cohorts were continuously enrolled in the health plan for 12 months pre-index and 12 months post-index and had at least 1 inpatient claim or ≥ 2 ambulatory visit claims with an ICD-9-CM diagnosis code for DPN, fibromyalgia, PHN, or partial onset seizure (22) at any time were excluded. As an exploratory analysis, 2 subgroups within the program cohort were defined: members who changed from pregabalin to gabapentin during the post-index period, and members who did not. Inclusion in the change group required at least 1 claim for gabapentin post-index. Prior gabapentin use was not a study exclusion. Although specific alternative medications were not prescribed by the program, gabapentin was selected for this comparison because of its similar mechanism of action, generic (low cost) availability, and common use in step-therapy programs.Members whose pharmacy program status changed post-index or whose estimated average dose of pregabalin was > 600 milligrams per day , Charlson Comorbidity Index score,26 and the presence/absence of comorbid conditions,27 defined as at least 1 claim for the condition at any site of service  and the proportion of members using mail order for pregabalin fills. Use of alternative medications was defined by at least 1 claim for drug classes that may be prescribed for pain conditions: gabapentin, opioids (short- and long-acting), serotonin and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), and tricyclic antidepressants , ER visits, and inpatient admissions.Costs, both medical and pharmacy, were computed as the combined health plan- and member-paid amounts and categorized as medical , pharmacy, and total costs . All costs were inflation-adjusted to 2012 dollars.We also defined post-index discontinuation of pregabalin as the first gap in pregabalin days supply > 90 days computed from each prescription claim date and the number of days supply on the claim. A 30-day gap was a secondary discontinuation measure. The proportion of members filling a prescription for any medication by mail order in the pre-index and post-index periods was also assessed. As an exploratory analysis, we also examined the pre- and post-index characteristics of program members who changed from pregabalin to gabapentin in the post-index period.29 Independent variables considered for inclusion in the propensity score were characteristics where the between-cohort P value was ≤ 0.250 in pre-PSM comparisons or likely to have meaningful impact on primary outcome variables. The final logistic regression controlled for age , gender, U.S. Census region, pre-index Charlson Comorbidity Index score , binary indicators of pre-index fibromyalgia and DPN , count of pre-index pregabalin pharmacy claims , a binary indicator of pre-index mail order pregabalin use, proportion of total pre-index pharmacy claims obtained via mail order , a binary indicator of pre-index inpatient hospitalization, pre-index all-cause medical costs, and pre-index all-cause pharmacy costs (30 and required matching within 0.2 of the standard deviation of the logit of the propensity score.32Members in the nonprogram cohort were propensity score matched (PSM) 1:1 to program cohort members.33 Between-cohort matched comparisons were assessed by the Rao-Scott chi-square test34 for categorical variables and general estimating equations for continuous variables .Between-cohort unmatched comparisons were assessed with traditional chi-square tests for categorical variables and two-sample t-tests using Satterthwaite adjustment for unequal variances where appropriate for continuous variables.33 for categorical variables and paired t-tests for continuous variables.Within-cohort between time period comparisons (pre-index vs. post-index) were assessed using McNemar’s testWithin the program cohort, differences between members who changed to gabapentin and those who did not were computed by traditional chi-square test for categorical variables and two-sample t-test for continuous variables.35 to compare the between-cohort change from pre-index to post-index. The DiD analyses adjusted for period (pre-index vs. post-index), cohort (program vs. nonprogram), and period by cohort interaction, and used robust errors to account for the correlation between multiple records per subject. The P value of interest in these analyses corresponds to the period by cohort interaction. A gamma distribution was used for cost measures, a negative binomial distribution was used for count variables , and a logistic distribution was used for binary measures. A log link was used for all measures. Independent working correlation structures were used in all generalized estimating equation models.The primary outcomes measures  were analyzed using a difference-in-differences (DiD) approachThere were 4,528 members  who met the inclusion criteria . After PP = 0.912), and 99% of pregabalin claims in both cohorts were filled at retail pharmacies . The proportion of all medication fills from mail order was also similar between cohorts.P < 0.001). At the retail level, the mean number of pregabalin claims decreased in the program cohort from 4.60 to 2.46 and increased in the nonprogram cohort from 4.61 to 5.96 . Only 30.4% of program cohort members had retail pharmacy claims for pregabalin after the 2 grace fills provided under the program compared with 66.8% of the nonprogram cohort . Program members were also more likely to discontinue pregabalin (from any venue) than were nonprogram members: 64% of program members versus 52% of nonprogram members discontinued based on a 90-day supply gap threshold and 84% versus 74% using a 30-day supply gap .After program implementation, the mean number of claims for pregabalin from any venue decreased in the program cohort  and increased in the nonprogram cohort . The DiD analysis for the between-cohort change was significant (P < 0.001). The mean number of mail order pregabalin claims also increased in both cohorts, but the rise was more pronounced among program (0.06 to 1.34) than nonprogram members (0.07 to 0.20) and the between-cohort change was significant .The proportion of program members using mail-order pharmacy for pregabalin rose from 3.1% pre-index to 48.1% post-index compared with an increase from 2.8% to 9.4% among nonprogram members  and make the change to gabapentin more quickly than nonprogram members . P ≥ 0.162). SSRI use declined modestly in the program cohort and increased slightly in the nonprogram cohort .After the program start, program members were more likely to change from pregabalin to gabapentin than were nonprogram members  and total costs  between cohorts was not significant. Although mean pharmacy costs rose significantly from pre-index to post-index by $820 and $790 in the program and nonprogram cohorts (P < 0.001), respectively, the increase in pharmacy costs was similar between cohorts .All-cause total medical and pharmacy costs were similar for both cohorts in both the pre-index and post-index periods . The preP = 0.004) as a result of a post-index decline in the likelihood of inpatient service use among program members and a slight increase among nonprogram members with inpatient service use. The pre-index to post-index change in the count of resource utilizations was significant only for office visits  as a result of a larger post-index decline among nonprogram members compared with program members.Pre-index resource utilization was similar between cohorts for both the proportion of members using each service category and the mean count of encounters, with the exception of the mean count of pre-index office visits, which was higher in the nonprogram cohort. The pre- to post-index change in the proportion of members using inpatient services was significant . Members who changed also had higher mean pre-index Charlson Comorbidity Index scores  and greater pre-index total health care costs . After the pharmacy program began, program members who changed to gabapentin were more likely to use short- or long-acting opioids (P = 0.041), TCAs (P = 0.018), and SSRIs (P = 0.029) than were program members who did not change. The likelihood of outpatient, ER, and inpatient resource utilization and the mean count of office and outpatient visits were also higher among pharmacy program members who changed to gabapentin (P ≤ 0.020).Pharmacy program members who changed to gabapentin were more likely to have a pre-index diagnosis of DPN and less likely to have a pre-index diagnosis of partial onset seizure than were program members who did not change  after instituting a reduced-cost pharmacy program for medications commonly used in chronic conditions; yet the insurer’s $5.7 million decline in nondrug spending was not fully offset by the $6.4 million increase in drug spending.17 with the exception of a plan that coupled reduced cost sharing with disease management among diabetic patients and demonstrated a positive return on investment.36Studies of single employer plans that provided lower member cost-sharing programs via reduced copayments have also been cost neutral for total spending,37 When the pharmacy program cohort was stratified by members who changed to gabapentin versus those who did not, we found that members who changed had higher comorbidity scores; were more likely to use opioids, TCAs, or SSRIs; were higher health care users; and had higher costs. Further study is warranted to understand the circumstances that cause the higher-using/sicker members in the program to change from pregabalin to gabapentin.Program members were more likely to discontinue pregabalin and change to gabapentin, which is consistent with previous studies of higher cost-sharing pharmacy programs.Ultimately, changes in pharmacy benefit design must be judged in the context of both clinical and economic outcomes. More than 90% of the members in this study had a condition for which patient-reported outcomes, such as pain severity, should be a consideration for clinical management of the condition. These measures and the patient and physician rationale for switching to alternative medication use should be included in future studies to provide a more comprehensive assessment of the impact of pharmacy program changes that provide cost savings to members for alternative medication use.The ability of claims data to accurately capture an individual’s medical and pharmacy history can be limited. Health care services that occurred before or after the study were not evaluated. We tracked utilization and costs for 12 months; cost savings may be realized with longer examination periods if the 12-month post-index period were extended well beyond the 60- to 90-day post-implementation window when most members were expected to select a cost-saving option.This program was available only to commercially insured plans. The results may not be generalizable to public plans such as Medicare or Medicaid.Additionally, benefit packages are often customized to specific employer groups. Our study used a general benefit package identifier to determine pharmacy program eligibility. Some employer groups could have had customized agreements that were not captured in the available data, resulting in incorrect attribution to a study cohort. We expect this miscapture to happen infrequently and to be equally applicable to the miscapture of members in either of the study cohorts; it would therefore not be expected to bias the outcomes. Additional unobservable differences between the study cohorts may have influenced the findings that could not be included in this analysis.Finally, this was an independent analysis of a pharmacy program implemented by a large health plan. The study investigators had no role in the design or execution of the pharmacy program. The metrics by which the relative success or failure of the pharmacy program were judged were not available to the investigators of this study.A novel pharmacy cost-saving program affected use of pregabalin but did not change overall health care costs. As the literature suggests, this program was effective in increasing use of mail order pregabalin and use of gabapentin as an alternative medication. Members who changed from pregabalin to gabapentin were sicker and higher health care users. While the overall objective of the pharmacy program was to reduce costs by changing member use of retail pregabalin to less expensive options, no cost savings were observed in the first year after the pharmacy program was implemented.


ScltTA/TRE-BCR::ABL1 mouse model for chronic phase CML, we previously demonstrated that the loss of the docking protein GAB2 counteracts the infiltration of mast cells (MCs) in the bone marrow (BM) of BCR::ABL1 positive mice. Here, we show for the first time that BCR::ABL1 drives the cytokine independent expansion of BM derived MCs and sensitizes them for FcεRI triggered degranulation. Importantly, we demonstrate that genetic mast cell deficiency conferred by the Cpa3Cre allele prevents BCR::ABL1 induced splenomegaly and impairs the production of pro-inflammatory cytokines. Furthermore, we show in CML patients that splenomegaly is associated with high BM MC counts and that upregulation of pro-inflammatory cytokines in patient serum samples correlates with tryptase levels. Finally, MC-associated transcripts were elevated in human CML BM samples. Thus, our study identifies MCs as essential contributors to disease progression and suggests considering them as an additional target in CML therapy.The persistence of leukemic stem cells (LSCs) represents a problem in the therapy of chronic myeloid leukemia (CML). Hence, it is of utmost importance to explore the underlying mechanisms to develop new therapeutic approaches to cure CML. Using the genetically engineered  BCR::ABL1 transgene is expressed in hematopoietic stem cells in their native microenvironment [Gab2−/− mice showed neither MC infiltration in the BM or kidney nor hydronephrosis at all. This might be explained by a synergistic effect of GAB2 as a common downstream signaling effector of BCR::ABL1 and cytokine receptor signaling pathways [+ phenotype reminiscient of systemic mastocytosis in xenografts of BCR::ABL1 transduced human cord blood cells [Gab2−/− mice provided the rationale for further analysis of MCs in CML. Therefore, we aimed to analyze the role of MCs in CML in more detail. In particular, we were interested whether this MC accumulation could be driven by BCR::ABL1 itself or whether these cells reacted as bystanders to an inflammatory reaction induced by leukemic infiltrates.Chronic myeloid leukemia (CML) represents about 20% of all adult leukemia cases and is caused by a chromosomal translocation between chromosomes 9 and 22, leading to the expression of the fusion kinase BCR::ABL1 . Due to ironment , 14. We ironment . Surprispathways . MCs plapathways , 17. Verpathways . Howeverod cells . Interesod cells . These mScltTA/TRE-BCR::ABL1 CML mouse model, we now show for the first time that BCR::ABL1 drives the cytokine independent expansion of BM derived mast cells (BMMCs) and sensitizes them for degranulation, IL-6 and TNF release. Importantly, by crossing in the MC-deficient Cpa3Cre mouse line, we discover a crucial role of MCs in CML development. We demonstrate that MC deficiency prevents BCR::ABL1 induced splenomegaly and elevation of pro-inflammatory cytokines. Furthermore, we provide supportive data from CML patients showing that splenomegaly is associated with high BM MC counts and that upregulation of pro-inflammatory cytokines in patient serum samples correlates with tryptase levels. In addition, we detected an increase of MC-associated transcripts in BM samples of CML patients.Using the ScltTA/TRE-BCR::ABL1 mice [Gab2−/− mice [Cpa3Cre/+ mice [ad libitum. Animal experimentation was approved by local authorities . For genotyping primers see supplementary methods.BL1 mice  were eit−/− mice  (mixed C−/− mice ) or withe/+ mice  -specific IgE overnight and stimulated with DNP-HSA. Degranulation was quantified by measuring β-hexosaminidase activity and cytokine release by ELISA. Detailed procedure can be found in supplementary methods.Murine BM and spleen cell lysates or serum samples from CML patients were subjected to a multiplex cytokine analysis (Bio-Plex Mouse Cytokine 23-plex or Human Cytokine 48-plex) using the Bio-Plex 200 System (Bio-Rad).Gene expression array data (Affymetrix Human Gene 1.0 ST Array) was obtained from the Gene Expression Omnibus database (accession number GSE47927)  for diffCML patient samples from the University Hospitals Aachen and Freiburg .Statistical analysis was performed using GraphPad Prism 9 and one- or two-way ANOVA and t-tests were performed as described in the figure legends. Data are presented as mean ± SEM and Gab2 genotypes and myeloablative irradiated C57BL/6 N mice as recipients.  and measured β-hexosaminidase activity to quantify degranulation. First, we titrated the amount of IgE and DNP-HSA Fig. , followeCpa3Cre/+ mouse line [+ / GR-1+ cells in BM and spleen from mice that received BCR::ABL1 positive BM compared to BCR::ABL1 negative controls. This was accompanied by a decrease of B220+ cells in the CML mice  was significantly lower in BM from mice transplanted with BCR::ABL1 positive Cpa3Cre/+ cells. In the spleen, an unsignificant trend was pointing in the same direction. Spleen weight was elevated in the BCR::ABL1 positive groups, but we did not observe a difference between the WT and Cpa3Cre/+ group  in BM biopsies of 20 CML patients at diagnosis  after three month of TKI therapy (Fig. Finally, we analyzed gene expression profiles, spleen size, tryptase and cytokines levels from CML patients Fig. . First, sis Fig. . Interessis Fig. . Furthersis Fig. . Strikinapy Fig. . Moreoveapy Fig. . Remarkaapy Fig. .Fig. 5MCRASGRP4, which was downregulated, upregulation was more pronounced in blast crisis than in chronic phase, suggesting MC expansion along with disease progression. The fact that RASGRP4 is downregulated supports our hypothesis of the development of a malignant MC pool, as functionally inactive RASGRP4 mutants were also found to be expressed in patients with mastocytosis and MC leukemia [Gab2−/− mouse strain showing less degranulation and cytokine gene expression after antigen stimulation [MCs play a key role in allergic responses, in the pathogenesis of immunologic disorders and are implicated in cancer due to their contribution to a pro-inflammatory tumor microenvironment , 17. Herleukemia . Next, wleukemia . This ismulation . We confmulation .Cpa3Cre/+ mice characterized by genetically induced MC deficiency [CpaCre/+ mice and then transplanted into WT recipients (Supplementary Fig. Cpa3Cre/+ donor cells attenuates the increase in immature, CD11b+/GR-1low, cells compared to their MC-competent counterparts (Supplementary Fig. CpaCre allele into the ScltTA/TRE-BCR::ABL1 model. Remarkably, and in contrast to the retroviral model, BCR::ABL1-positive MC-deficient mice showed no signs of splenomegaly (Fig. BCR::ABL1 transgene is expressed in hematopoietic stem cells in their native microenvironment, allowing analysis under steady-state conditions [Encouraged by these results, we further probed the role of MCs in CML by using ficiency . Mice fraly Fig. . These anditions , 14. Thinditions . In addiScltTA/TRE-BCR::ABL1 mice (Fig. Cpa3Cre/+ mice, suggesting that BCR::ABL1 positive MCs are also involved in the regulation of these cytokines (Fig. Importantly and in line with the data from the genetic model, we observed a correlation of splenomegaly and high BM MC counts in our patient cohort Fig . As showice Fig. . Strikinice Fig. . Moreoveice Fig. . Taken tice Fig. . The uprnes Fig. . This isnes Fig. . Finallynes Fig. . This suIn summary, we demonstrate that BCR::ABL1 can drive the expansion of murine MCs and that these BCR::ABL1 transformed MCs, as part of the malignant clone, are essential for the disease associated development of splenomegaly and for the elevation of pro-inflammatory cytokines, known to be important in disease initiation and progression. These data are supported by our CML patient analyzes in which we show that splenomegaly is associated with high BM MC counts and that upregulation of pro-inflammatory cytokines in patient serum samples correlates with tryptase levels. Thus, our study suggests that MCs play an essential role in CML and might serve as an additional target in the clinic. This is of particular relevance, as BCR::ABL1 positive MCs might be resistant against TKIs in the cytokine rich BM niche. This is supported by our observation that IL-3 protects BCR::ABL1 positive BMMCs from TKI induced cell death.As pro-inflammatory cytokines are known to be important for many other cancer entities, our data also invites for the evaluation on the role of MCs beyond CML. In addition, this data and our previous work on GAB2 also highlights the possibility that GAB2, as a common player in BCR::ABL1 and MC signaling could serve as an additional target in the treatment of CML.Supplemental Information


Physicians experience higher rates of burnout relative to the general population. Concerns of confidentiality, stigma, and professional identities as health care providers act as barriers to seeking and receiving appropriate support. In the context of the COVID-19 pandemic, factors that contribute to burnout and barriers to seeking support have been amplified, elevating the overall risks of mental distress and burnout for physicians.This paper aimed to describe the rapid development and implementation of a peer support program within a health care organization located in London, Ontario, Canada.A peer support program leveraging existing infrastructures within the health care organization was developed and launched in April 2020. The “Peers for Peers” program drew from the work of Shapiro and Galowitz in identifying key components within hospital settings that contributed to burnout. The program design was derived from a combination of the peer support frameworks from the Airline Pilot Assistance Program and the Canadian Patient Safety Institute.Data gathered over 2 waves of peer leadership training and program evaluations highlighted a diversity of topics covered through the peer support program. Further, enrollment continued to increase in size and scope over the 2 waves of program deployments into 2023.Findings suggest that the peer support program is acceptable to physicians and can be easily and feasibly implemented within a health care organization. The structured program development and implementation can be adopted by other organizations in support of emerging needs and challenges. Physicians experience a multitude of stressors and challenges associated with their day-to-day work. In addition to the demands of care provision, physicians also provide supervision, take on leadership and administrative duties, and act as educators in various capacities. Paralleling the multitude of stress experienced, physicians also report higher levels of burnout, depression, suicidal ideation, and mental distress relative to the general public . For manThe COVID-19 pandemic amplified much of these challenges. Physicians experienced increased demands placed upon them at work, whereas the availability of support and resources decreased systematically within the health care system ,9. FurthFollowing observations of mental distress in physicians, the decanal office at Western University Schulich School of Medicine and Dentistry developed a peer support program, named Peers for Peers (P4P). The program sought to provide support to physicians across diverse departments and clinical divisions within the hospital network. This paper aimed to outline the process of development and highlight initial findings from program evaluations on the reach of the P4P program.Findings of this paper were conducted as part of a program evaluation for the P4P program, and thus was exempt from obtaining human subject research ethics review. Information collected were anonymous. No identifying information were collected as part of the program evaluation.The development of the P4P program was led by faculty members within the Schulich School of Medicine and Dentistry following recommendations in the literature for providing support to clinicians . SpecifiThe P4P program sought to engage various clinical departments through the appointment of Well-being Leads to ensure adoption, quality control, and sustainability. Built on the principles of providing support for peers in a nonevaluative, confidential, and psychologically safe manner, the P4P program sought to provide empathetic listening, supportive resources, and external referrals to knowledgeable experts. The P4P program also sought to build capacity in its Well-being Leads by providing them with the necessary knowledge and tools. To do so, a faculty-wide survey was implemented to identify different themes of focus that were prioritized by physician leaders when providing support. Identified priorities were formalized into a Royal College Continuing Professional Development–accredited skills training curriculum that covered empathetic listening; recognizing signs of mental distress; professionalism and ethics; unconscious bias; harassment and intimidation; and ethics, inclusion, and diversity. In addition to the training curriculum, Well-being Leads also attended monthly rounds for continued support, networking, and involvement in continued program development.In addition to a formal announcement of the program availability throughout the faculty, Well-being Leads were tasked with outreach and promotion of the program. Participation in the program were envisioned to be both formal and informal and followed the 7 basic steps to empathetic listening. Physicians seeking support could connect with their Well-being Leads by invitation, and a conversation using the empathic skills of opening, listening, reflecting, reframing, sense making, coping, and closing would occur in a nonjudgmental supportive environment.The program was developed in March and launched in April 2020. Potential Well-being Leads were either identified by the Department Chair or through self-identification. Criteria for the attributes of Well-being Leads and participation outcomes are noted in Attributes of Well-being LeadsExperience in providing peer support in the pastInterest in physician well-beingBackground in education or research in physician burnoutAlignment to personal values that suited the roleoptional)Nonleadership role , family issues , and COVID-19–related concerns . Moreover, 83% (239/288) of encounters required no further referral for additional help. Furthermore, 5.2% (15/288) were referred to the decanal office for support provided by the Assistant Dean, Faculty Wellbeing with consultant resources  through Western University’s human resources, and another 5.2% (15/288) wished to pursue additional help privately.Despite the high levels of mental distress, physicians continue to report low levels of engagement with the use of support services. Due to the elevated stress reported by physicians and the complexities surrounding professional issues and stigma, researchers have proposed solutions that are created for physicians by physicians . In our The reach and uptake of the program over both waves reflect its continued expansion into 2023. The acceptability of the program is in part reflected in the organizational commitment and infrastructural support.To support program deployment, a Well-being Executive Committee was formed as part of Schulich’s strategy to provide departments with support for expansion into other divisions, sections, and sites. In addition, the training was formalized through accreditation via Continuing Professional Development and Continuing Medical Education programs. These formalized processes, infrastructures, and training legitimized the program and facilitated subsequent participation across a range of programs within the larger institution. In addition, as the program evolved, new approaches were also utilized to engage physicians. Specific examples of engagement approaches included faculty-wide training offered to assess their own well-being and connect with peer leads, as well as offering monthly program support, newsletter, and individual rounding for Well-being Leads. Together, these efforts contribute to ongoing, collective, and cultural shifts in the organizational approach to mental health support.As of January 2023, the P4P program continues to grow and expand. The training curriculum continues to evolve based on feedback from Well-being Leads. Efforts are made to streamline participation online to reduce barriers of participation. The ease of access, confidential, and peer-based approach has been well accepted by the community of physicians. Indeed, the P4P program has gained interest from external entities. To date, the training curriculum has been utilized in Ontario, British Columbia, and Saskatchewan. With the information and processes identified through this paper, we urge future research to continue to examine processes of scaling up the P4P program for adoption in other organizations and communities to support physicians and other highly stressed workforces.


Editorial on the Research TopicSport as a tool for social inclusion, employment, and improved healthCurrently, sports are well-known as a prominent means to address a wide spectrum of social goals. This acknowledgement of sports' social impact has been achieved through international acts and advocacy actions involving the United Nations (UN), the International Olympic Committee (IOC), sport federations, national governments and civic society over time . A recenAs a consequence of the identification of sports as catalysts for diverse social outcomes on the global and national agenda, the sport for development and peace (SDP) movement has emerged. SDP encompasses a wide range of actions, programs and studies wherein sports are utilised and investigated as means to promote non-sporting and peace building goals . SDP stuDespite the richness of studies in the field, some open questions remain concerning the efficient use of sports as a tool for social and developmental purposes. First, the literature lacks frameworks and models guiding efficient sport-based program planning, structuring and management to maximize social outcomes –24. SecoMost of the researches of the Research Topic draw upon data from diverse sport-based interventions aimed at various social goals  and implemented in different geographical areas, ranging from southern Africa to China, and from northern and southern Europe to Latin America. Despite the variety of social goals promoted by the programs analyzed in these studies and their geographical diversity, the articles provide similar evidence-based insights guiding: (i) the development of theoretically grounded sport initiatives; (ii) effective action planning; and (iii) efficient monitoring and evaluation of these initiatives.Burnett demonstrates that engaging in such an initiative provided the participants with a high level of soft skills transferable to the working environment. The study advocates for a robust monitoring, evaluation, and learning (MEL) framework capable of capturing the nuances of the different contexts of program implementation.Analyzing the results of a 6-month government-funded sport-for-development program implemented in Africa, with a focus on youth employability, Gozzoli et al. describe the participatory development of a training framework aimed at promoting sport coaches' awareness of their role in enhancing employability skills. The authors highlight the lack of clarity regarding the theoretical and methodological assumptions that guide the design of training courses and propose a constructivist approach to structure effective training programs for coaches.In their contribution, Commers et al. analyze a program in Flanders aimed at transferring job skills to young people through sports. The research underscores the absence of clear definitions and theoretical operationalization of program outcomes, leading to gaps in efficiently monitoring and evaluating the participants’ progress within the intervention. The authors advocate for theory-based program planning, which could help outline the desired outcomes and impacts of the sport-based interventions more effectively.Gadais et al. describe the experiences of Colombian youth from disadvantaged backgrounds and program managers who participated in an SDP intervention that took them from a local community sports club to the Olympic Games. The authors recommend the intensification of evaluation research on SDP programs, including close collaboration between academics, community-based organizations, donors, and the international community.Kunlun et al. study the spatio-temporal distribution and evolution pattern of Chinese Go League Clubs and emphasize their cultural and economic impact at the local level.Finally, Commers et al. advocate for grounding and planning sport-based programs based on the principles of the theory of change. Employing the theory of change offers the advantage of anticipating desired outcomes and impacts, providing a logical sequence of actions and inputs to achieve specific social changes. On the other hand, Gozzoli et al. suggest adopting less top-down approaches and promoting participatory methods for program development, involving local stakeholders and beneficiaries at all stages of the planning process. Future research should analyze and compare the opportunities and challenges of both approaches to advance the understanding of this field.The comprehension of programme components, structure, planning and effective management remains a fundamental area for analysis to advance research and implementation in SDP . The artBurnett and Gadais et al. underscore the need to enhance M&E research in SDP. Future M&E investigations should encompass the nuanced impact of these interventions from various stakeholders' perspectives and should consider not only the individual effects of sport-based programs but also their broader economic and cultural implications .Effective program planning in sport-based initiatives is not only crucial for action delivery and impact but also has significant implications for monitoring and evaluation (M&E). There exists a circular relationship between planning, program implementation, and M&E.