Phase 2 employed 73 implementation strategies across 9 domains generated by the Expert Recommendations for Implementing Change project. The nine domains were used to classify each CE program implementation strategy. In Phase 3, the group used the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to define measures for each individual strategy. Phase 4 demonstrates the application of this framework and measures Year 1 outcomes for the strategy providing interactive assistance, which we implemented using a centralized consultation model. This approach can support the CTSA program in operationalizing CE program measurement to demonstrate which activities and strategies may lead to benefits derived by the program, institution, and community.This special communication provides an approach for applying implementation science frameworks to a Clinical and Translational Science Institutes (CTSIs) community engagement (CE) program that measures the use of implementation strategies and outcomes that promote the uptake of CE in research. Using an iterative multi-disciplinary group process, we executed a four-phased approach to developing an evaluation plan: 1) creating an  In the United States, the Clinical and Translational Science Award (CTSA) Program was designed to advance the efficiency of research translation, speeding up the process of bringing discoveries from the laboratory, clinic, and community to policy and practice as a means of improving individual and public health . Communisee Fig. CE itself is an evidence-based practice with est) are described most often in accounts of prioritizing, developing, and conducting specific research projects and less frequently in reports on dissemination and implementation research [Implementation science (IS) offers a set of frameworks for evaluation that delineate relevant factors in how evidence-based practices, such as CE, are enacted in real-world settings and achieve success ,14. At tresearch . Yet, CEresearch . Based oresearch ,17. We tThis study describes the methods used to create and execute a comprehensive evaluation plan for our CTSI CE program rooted in IS. We conducted a four-phase process that iteratively developed methods and metrics for determining success in the implementation of the local CE program. The phases were as follows: 1) create a CE program evaluation framework adapted from Proctor’s conceptual model of implementation research ; 2) map The specific aims of the Boston University CTSI CE program are to 1) develop new and sustain existing community-academic partnerships; 2) expand CE capacity for researchers and community members and their organizations/systems; and 3) disseminate best practices for CE research approaches. The CE program is comprised of an interdisciplinary team of researchers and practitioners, spanning University Schools across two campuses. Disciplines represented on the team include medicine, epidemiology, social policy, health services research, social work, mental health, and IS.Core functions of the CE program fall into two main areas: capacity building and partnership development. Capacity-building programs are designed for both internal and external audiences. Programs focus on preparing researchers, trainees, students, community members, and staff to engage in bidirectional partnerships, including raising awareness about the ways in which procedures, policies, and organizational culture can serve as barriers to engagement. Capacity-building activities are designed based on a competency continuum which includes skills that can be deepened over time. Capacity-building activities include guided group networking, case-based learning collaboratives, workshops, educational forums and panels, self-paced modules, the dissemination of educational materials, coaching, and consultation.Partnership development activities focus on investing in the development of authentic, longitudinal community-academic partnerships that provide a basis for co-creation of research that addresses community priorities. Specific activities include pilot funding for research projects that address a community priority and have community co-leadership; support for development of longitudinal community advisory boards (CABs) that represent diverse stakeholder perspectives to guide research programs; and the implementation of an active practice-based research network in partnership with locally affiliated federally qualified health centers.The process of applying IS frameworks to the CE program began with developing an evaluation model adapted from Proctor’s conceptual model of implementation research . The ProCommunicating to Engage educational program was classified an example of dynamic education. We then mapped each strategy to one of the Waltz et al. clusters of implementation strategies [Communicating to Engage, this was classified under the cluster of “train and educate stakeholders.” Mapping to the Waltz categories brought together related strategies to simplify reporting and allow for coordinated evaluation for strategies used across multiple interventions. Classification was done via an iterative process with program staff and faculty, whereby the rationale for the assigned strategy was presented, reviewed, discussed, and then consensus reached. This process was repeated for each intervention.One of the key mandates of the CE evaluation group was to identify evidence-based implementation strategies to guide the implementation of CE. An implementation strategy is a systematic process to adopt and integrate evidence-based innovations into routine practice . We usedrategies . For ComReach, Effectiveness, Adoption, Implementation, and Maintenance). In turn, we defined feasible measures for each RE-AIM element for each implementation strategy. Using “train and educate stakeholders” as an example, Reach could be measured as number and types of individuals participating in any of the interventions delivered via this strategy . Effectiveness and implementation will similarly be measured using a participant-reported evaluation (survey) addressing these RE-AIM domains delivered across all courses. By measuring strategies across the RE-AIM elements, the evaluation will focus on strengths and weaknesses across different phases of implementation that can guide further adaptation of the CE program interventions in an evidence-based manner.The RE-AIM framework was used to identify the metrics by which the CE program will assess program performance on uptake of CE in research practice at our institution. The RE-AIM framework was chosen to guide this analysis because it has been successfully applied across a range of settings, including public health, clinical, and community contexts ,22. The Maintenance component of RE-AIM (how the intervention strategy RE-AIM metrics compared year-to-year). The evaluation team designed a REDCap form to structure outcome reporting and balance respondent burden with sufficient detail to ensure the collection of meaningful data. With the centralized nature of the consultation model that spanned several strategies , data could be harmonized and captured in the REDCap database with relative ease. Data from capacity-building activities, including workshops and courses, were self-reported by participants via surveys. Using REDCap surveys, participants who registered for a CE program were asked to provide demographic information  and professional information . Additional data on participation, including minutes of attendance per session, were obtained by CE program staff through Zoom. In addition, the evaluation team records when the CE program connects potential partners and evaluates the effectiveness partnership building via collaboration on papers, grants, or other community-focused products.The data collection strategy for program evaluation considered long-term feasibility and sought to minimize burden on program participants, favoring data that could be documented or collected by CE program staff. We also prioritized measures that could be monitored over time to evaluate the Data generated from each intervention strategy for each of the RE-AIM metrics, using both program data and participant surveys, were compiled and summarized using descriptive statistics. Frequency measures  were used for categorical data. Means, medians, and ranges were reported for continuous measures. On an annual basis, metrics for each intervention strategy continue to be summarized and reviewed by the evaluation team and shared with CTSI leadership. Tables, similar to the one presented below for the “provide interactive assistance,” are used to summarize RE-AIM metrics for each strategy. Annual reporting is used to identify areas where implementation strategies might be enhanced or changed. It also permits the CE program to adapt to increases in capacity over time, such that new interventions or strategies may be introduced. For example, strategies may shift from those that seek to build new partnerships to those that aim to advance ongoing partnerships. The analysis of the maintenance metrics compares Year 1 data to subsequent years and is thus measured only in Years 2–5.To clarify the application of these broad concepts, we describe the methods and evaluation of one strategy: “provide interactive assistance” from the first year of data collection. The CE program operationalized the “provide interactive assistance” strategy as a consultation intervention. The CE program used a centralized consultation model to provide local, tailored technical assistance to teams seeking to incorporate CE into their research. Upon completing any consultation, the program staff entered key information into the database including 1) professional information , 2) reason for the consultation , 3) needs to be fulfilled by the consultation, 4) date the consultation request was made, 5) support and resources provided by the CE program staff , 6) amount of time CE program staff spent working on the consultation, and 7) details of the grant, if applicable .outcomes are organized by RE-AIM constructs with broad definitions for each included in Fig. The evaluation model developed by the evaluation team is detailed in Fig. train and educate stakeholders and provide interactive assistance. Within these broad domains, the CE program instigated several of the ERIC strategies. They centralized the technical assistance structure, creating unified pathways and forms for initiating consultations. They provided local technical assistance through the consultations, tailoring the length, format, and structure to individual investigators and projects. They also provided ongoing consultation that could last for multiple sessions over the lifetime of a project.In the second phase, as outlined in the evaluation model, each of the six implementation strategy clusters as defined by Waltz and colleagues was assigned to 11 CE program interventions. Table provide interactive assistance strategy as an illustrative example, we defined Reach as the number, proportion, representatives of researchers, and community members who participated in any consultations with CE program members. To assess the adoption of this strategy, we measured the number of consultations delivered. To assess Reach of providing local technical assistance, we measured the proportion of consultations conducted with community and academic partners. In measuring Effectiveness, we aimed to identify the influence of providing interactive assistance on building capacity and developing partnerships. To this end, we compiled the number and proportion of grants funded following a CE consultation. For Implementation, reason for the consultation, types of support provided, types of partnership connections made, and time spent per consultation were compiled. Maintenance monitors changes in the above dimensions and measures over time.Again, using the providing interactive assistance for consultations initiated by researchers and community members, organized by RE-AIM elements, are reported in Table Results for We report here on the development and early evaluation of an infrastructure to integrate IS methods and evaluation into a CTSI CE program. The approach is novel in combining IS frameworks to evaluate a CE program. We used the ERIC project implementation strategies to identify relevant implementation strategies employed in a CE program context. Our evaluation used RE-AIM outcome metrics, which have previously not been described in the context of CTSA programmatic evaluations, to our knowledge.providing interactive assistance, and the RE-AIM framework, we found the CE program’s reach to favor academic connections vs. community, with 88% of all consultations coming from academic sources. The need to grow the program’s reach outside of academia to promote and deliver technical support to community organizations is an area for growth. A strength of the providing interactive assistance strategy was demonstrated by the broadly distributed types of support provided, including planning for grant submissions using CE approaches and supporting implementation of CE methods on existing projects. In using these structured, systematically collected metrics, implementation can shift to support identified opportunities for growth such as those identified here.Using consultation data from the 49 consults to date, representing the strategy of Others have similarly recognized the important role that the CTSA program could have in training and disseminating IS as a field. Studies have documented the barriers to engaging in IS in the medical research community. In one recent study of 1767 health researchers, being able to define IS and having attended an IS training were associated with an approximate 3.5 odds of engaging in IS research . The autUsing implementation strategies as a model for better understanding evidence-based CTSI activities, their relationships to outcomes, and their potential contributions to generalizing program success may advance the mission of CTSIs in translating research into practice. While some institutions have IS expertise, their integration into the CTSI structure and use in evaluating CE have been variable. Identified barriers include a lack of awareness about the value of IS as a field, and having a paucity of senior mentors to train others in IS methods . BuildinThis method is not without its limitations. Data here represent a single-center approach, including aims and interventions that were informed by local history and programmatic expertise. The data presented are preliminary and incomplete. While the team designing this evaluation represented multiple academic disciplines, community representation was lacking. Future planning and evaluation will engage community partners to ensure the outcomes of the CE program reflect community priorities. In particular, we plan to design a series of community-driven metrics that overcome the limitations of focusing on implementation measurement alone. For example, we might consider measuring the extent to which study designs or procedures change as a result of engaging community members or track the influence of CE at various phases of research . Complementary measures to assess partnerships, such as social network analysis, are also under consideration as a means of quantifying connections made through the CE program.Our goal was to provide an overview of our approach to integrating frameworks to generate meaningful program evaluation data, rather than present an evaluation of the program itself. Our institution’s robust Evans Center for Implementation and Improvement Sciences, which benefits from institutional resources and support, made this approach to developing an evaluation team with IS expertise viable. This limits generalizability of the approach beyond institutions that do not have local experts on site and/or access to IS expertise. Centralizing expertise and guidance to promote the use of IS in the CTSA program may be a short-term solution to addressing gaps in institutional expertise. Other models include collaborative regional affiliations between CSTIs to support implementation research by sharing expertise .Individual CTSIs should identify the myriad ways in which IS can inform translational science and be used to evaluate CTSI evidence-based activities. The expansion of the use of implementation strategies to implement evidence-based educational, dissemination, and research programs holds great potential for increasing the impact of CSTI infrastructure. To be successful, implementation strategies require tailoring to the institutional context, including aims, activities, and partnerships . The app


Endobronchial ultrasound (EBUS) features help differentiate between benign and malignant lymph nodes (MLNs) during transbronchial needle aspiration (TBNA). B-, power/color Doppler, and elastography modes are used during EBUS-TBNA. However, only few studies have assessed them simultaneously. This study evaluated multi-EBUS features  and established a novel scoring system. Multivariable analysis revealed that short axis (>1 cm), heterogeneous echogenicity, absence of central hilar structure, presence of coagulation necrosis sign, and blue-dominant elastographic images were independent predictors of MLNs. At three or more EBUS features predicting MLNs, our scoring system had high sensitivity and specificity . The area under the receiver operating curve (AUC) was 0.894 : 0.868–0.920), higher than that of B-mode features alone (AUC: 0.840 (95% CI: 0.807–0.873)). Our novel scoring system could predict MLNs more accurately than B-mode features alone.Endobronchial ultrasound (EBUS) features with B-, power/color Doppler, and elastography modes help differentiate between benign and malignant lymph nodes (MLNs) during transbronchial needle aspiration (TBNA); however, only few studies have assessed them simultaneously. We evaluated the diagnostic accuracy of each EBUS feature and aimed to establish a scoring system to predict MLNs. EBUS features of consecutive patients and final diagnosis per lymph node (LN) were examined retrospectively. In total, 594 LNs from 301 patients were analyzed. Univariable analyses revealed that EBUS features, except for round shape, could differentiate MLNs from benign LNs. Multivariable analysis revealed that short axis (>1 cm), heterogeneous echogenicity, absence of central hilar structure, presence of coagulation necrosis sign, and blue-dominant elastographic images were independent predictors of MLNs. At three or more EBUS features predicting MLNs, our scoring system had high sensitivity (77.9%) and specificity (91.8%). The area under the receiver operating curve (AUC) was 0.894 : 0.868–0.920), which was higher than that of B-mode features alone (AUC: 0.840 (95% CI: 0.807–0.873)). The novel scoring system could predict MLNs more accurately than B-mode features alone. Multi-EBUS features may increase EBUS-TBNA efficiency for LN evaluation. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used and recommended by various worldwide guidelines for diagnosing hilar and mediastinal lesions and staging lung cancer ,2,3. TwoEvaluating EBUS features obtained during EBUS-TBNA enables efficient procedures, especially in sedated EBUS-TBNA, when the available time is limited. Various studies conducted using B-mode features alone have reported the effectiveness of each EBUS feature and prediction score of malignant lymph nodes (MLNs) ,12,13,14This study aimed to evaluate the diagnostic accuracy of each EBUS feature using prospectively recorded registry data and to establish the best scoring system for predicting MLNs.Data from consecutive patients who underwent EBUS-TBNA for diagnosis or staging of lung cancer at the National Cancer Center Hospital, Tokyo, Japan, between January 2019 and December 2019 were retrospectively collected from our prospective observational registry. All EBUS features were acquired and assessed during EBUS-TBNA by two or more bronchoscopists with over 10 years of bronchoscopic experience. They evaluated and classified LNs before obtaining the results of rapid on-site evaluations, so as to not be influenced by the pathological results. To evaluate the diagnostic accuracy of each EBUS feature, the final diagnosis per LN was analyzed.This study was approved by the Institutional Review Board of the National Cancer Center Hospital, Tokyo, Japan, (No. 2018-354) and registered at the Japan Registry of Clinical Trials (jRCT) (registration number: jRCT1032190168). The requirement for written informed consent was waived due to the retrospective observational nature of the study.A convex probe ultrasound bronchoscope  was used with intravenous midazolam or propofol; lidocaine spray was used as the local anesthetic. Several studies have indicated that there is slight change in diagnostic yield according to the gauge of the needle ,23; therWe used a dedicated ultrasound processor  to observe the B-mode features, vascular patterns with the power/color Doppler mode, and elasticity with the elastography mode at each LN’s maximum diameter. We punctured the LN according to the EBUS features, its size on CT, and the maximum standardized uptake value of PET-CT. Punctures were performed 2–4 times on each LN; each puncture consisted of approximately 20–30 strokes with negative pressure.The final diagnosis of each LN was confirmed by pathological findings obtained using EBUS-TBNA or surgery. If both EBUS-TBNA and surgical specimens were obtained, the diagnosis obtained using the latter was preferred. In cases where only EBUS-TBNA specimens were obtained and diagnosed as benign, follow-up details using CT more than 6 months later were referred to confirm the absence of disease progression. Rapid on-site cytological evaluation was performed for all patients.B-mode features were evaluated using the following six categories  16]: sh: sh16]: Vascular patterns were evaluated using the power/color Doppler mode and classified into grades 0–3  12,17].,17.12,17EBUS elastographic images were qualitatively classified into blue, intermediate , and non-blue , according to the dominant color of LNs . We diviEach EBUS feature per LN was compared with the final diagnosis to evaluate the predictive accuracy of MLNs.p-values < 0.05 were considered statistically significant. The EZR software version 1.29 was used for statistical analyses  [Descriptive statistics are presented as frequencies with percentages or medians (ranges). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each EBUS feature were calculated per lesion using standard definitions. Fisher’s exact test was used to compare the two groups. All EBUS features potentially predictive of MLNs were analyzed using multivariable logistic regression. Using the EBUS features selected by multivariable logistic regression, we summed the number of features and established a novel scoring system. The receiver operating characteristic (ROC) curve analysis and the Youden index were used to develop the predictive scoring system of MLNs. Delong’s test was used to compare the two ROC curves . p-value, Japan) .During the study period, EBUS-TBNA was performed in 345 patients (677 lesions). Among them, 302 patients (597 LNs) underwent EBUS-TBNA for the diagnosis of LNs. One patient (three LNs) was excluded because of missing clinical data. Thus, 594 LNs from 301 patients were analyzed. The flow chart of patient and lymph node recruitment is shown in The patient characteristics are summarized in The characteristics of LNs are summarized in In univariable analyses, all EBUS features, except shape, were associated with the prediction of MLNs. In the multivariable analysis, all EBUS features revealed that the following five features were independent predictive factors of malignancy: short axis (>1 cm), heterogeneous echogenicity, absence of CHS, presence of CNS, and blue-dominant elastographic images.p-values < 0.05 in the multivariable analysis (p < 0.001), 0.840 , and 0.756 , respectively , heterogeneous echogenicity, absence of CHS, and presence of CNS, as well as blue-dominant elastographic images, were independent predictive factors of MLNs. Our novel scoring system combining those EBUS features would predict MLNs more accurately than all eight EBUS features, only the six B-mode features, or the Canada LN score .Numerous studies have reported the diagnostic yields of each EBUS B-mode feature in MLNs ,26,27,28One difference between this study and previous reports is the low sensitivity and accuracy of elastography. This may be due to the calculation method for diagnostic test parameters. In this study, we divided elastographic images into two groups (blue and others), although a relevant previous study divided the images into three groups and calculated the diagnostic test parameters after excluding the intermediate group . AnotherThe ultrasound elastography currently available for EBUS is strain elastography, the technique used in this study, which measures distortion that is negatively correlated with tissue stiffness. The distribution of this distortion is a relative index that can vary with the degree of tissue compression ,34. On tAnother difference is that vascular patterns were not significant independent predictors of MLNs in our study. Nakajima et al. reported that 87.5% of LNs with grade 2/3 vascular patterns and/or bronchial artery inflow signs were malignant, while 84.7% of those without both were benign . This diThis study also suggested a novel simple scoring system, which revealed the highest predictive performance among all scoring systems ,26,27,28This study has some limitations. First, it was conducted at a single center. In addition, the same bronchoscopist did not perform all EBUS-TBNA procedures; therefore, the operator’s skills may have somewhat affected the detection of EBUS features. Moreover, this study was only a derivation cohort study to construct a novel scoring system and did not include a validation cohort study. However, all 594 LNs were prospectively evaluated during the procedure by two or more bronchoscopists with sufficient years of experience, which is considered to be representative of real-world data. Furthermore, this study included patients from various backgrounds. Non-solid tumors, such as lymphoma, usually show different EBUS patterns . TherefoEvaluation of LNs with multi-EBUS features would predict MLNs more accurately than B-mode features alone. Our novel scoring system using five EBUS features (short axis (>1 cm), heterogeneous echogenicity, absence of CHS, presence of CNS, and blue-dominant elastographic images) is useful for predicting MLNs during procedures.


Postsecondary student suicide is one of Japan’s most severe public health problems. Gatekeeper training (GKT) programs are a generally recommended suicide prevention intervention in Japan. For suicide countermeasures, an online program tailored to students may enhance self-efficacy as a gatekeeper.This study aims to describe a research protocol to investigate the effect of a newly developed internet-delivered online peer GKT program to improve postsecondary student self-efficacy as gatekeepers for suicide countermeasures in Japan.t test, where the significance level is 5% (2-sided), will be used to test the intervention effect on an intention-to-treat basis.This study is a 2-arm, parallel, randomized controlled trial with a 1:1 (intervention: waiting list) allocation. Participants (n=320) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or waiting list control group. An approximately 85-minute, 6-section, internet-based gatekeeper program for postsecondary students has been developed that includes videos to help participants acquire skills as gatekeepers. The intervention group will complete the program within 10 days. The primary outcome, self-efficacy as a gatekeeper, is measured using the Gatekeeper Self-Efficacy Scale at baseline, immediately after taking the program, and 2 months after the survey after completing the program follow-up. To compare the primary outcomes, a The study was at the stage of data collection at the time of submission. We recruited participants for this study during August and September 2021, and data collection will continue until December 2021. The data analysis related to the primary outcome will start in December 2021, and we hope to publish the results in 2022 or 2023.This is the first study to investigate the effectiveness of an online GKT program for postsecondary students to improve self-efficacy as a gatekeeper using a randomized controlled trial design. The study will explore the potential of an online peer gatekeeper program for postsecondary students that can be disseminated online to a large number of students with minimal cost.University Hospital Medical Information Network Clinical Trials Registry UMIN000045325; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051685DERR1-10.2196/34832 According to the World Health Organization, every year about 700,000 people die by suicide . SuicideFurthermore, suicide was the leading cause of death among individuals aged 15 to 39 years in Japan . TherefoRecently, COVID‐19 has spread throughout the world. Problems associated with outbreaks of infections such as COVID-19 have an undesirable impact on learning and can also lead to mental health problems . The effA gatekeeper is someone aware of the signs of suicide who can take appropriate action  . GatekeeStudents, however, may encounter obstacles in attending a GKT program. The most significant hurdle for students may be a lack of time and resources to participate in face-to-face training sessions. In addition, GKT programs conducted at a school or in a class unit often involve familiar acquaintances, and as GKT also includes private content such as sharing experiences and opinions in group work, some may not want to participate due to privacy concerns. As such, on-demand online GKT programs may be helpful in overcoming such hurdles for students. On-demand online GKT provides easy, fast, instant, and privileged access to needed knowledge about student suicide prevention at any time and from any location.Most university GKT programs focus on teachers and related staff  because of their daily interaction with students . HoweverFew programs have reported on the effectiveness of GKT programs for decreasing the number of suicides. Most studies have reported on suicide knowledge, attitudes, and skills of trainees instead of the number of suicides ,18. It iBehavior as gatekeeper has been conceptualized with the theory of planned behavior (TPB) ,20. AccoWe hypothesized that self-efficacy as a gatekeeper affects attitudes toward the behavior and perceived behavioral control from this theory, leading to actual behavior as a gatekeeper. Past research has reported that GKT programs have improved self-efficacy as a gatekeeper -25. FurtAssuming that encouraging action for suicide countermeasures as a gatekeeper lowers the suicide rate, a GKT program was created aimed at increasing self-efficacy, which affects behavior as a gatekeeper based on the attitude of TPB.To date, to the best of our knowledge, there has been no online GKT program for students in Japan. Moreover, no randomized controlled trials (RCTs) have been conducted to verify the effectiveness of online GKT programs for students. Accordingly, the aims of this research are to (1) create an online peer GKT program for students and (2) verify its effectiveness through RCTs.t0) and are randomly allocated at a 1:1 ratio either to the intervention group or the control group. All surveys will be conducted via online questionnaires. Online follow-up surveys will be implemented about 10 days after the t0 survey (t1: immediately after the intervention), and at 2 months after the t1 survey (t2). After the 2-month follow-up, the GKT program will be provided to participants in the control group who wish to attend. This manuscript has been written according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines . If there are important modifications of the protocol, we will obtain approval for the modifications from the Ethics Committee of the Faculty of Medicine and Graduate School of Medicine of the University of Tokyo and will revise the protocol on the trial registry website.Collected data will be stored as linkable anonymized data. The principal investigator will retain access to the final dataset after the trial and assume responsibility for data integrity and accuracy of the analysis.The first author conducted informal discussions with 5 students and nonprofit organization representatives that implement youth suicide countermeasures. Based on these conversations, adding 2 researchers to those mentioned, we modified the contents to reflect a real situation. One patient and public involvement (PPI) partner, a college student, reviewed the program’s draft and noted some points that might be difficult for general students to understand. These PPI partners will participate in a discussion of the study results and in making the implementation strategy after finishing the RCT. We described the PPI process based on the PPI handbook and reporting checklists.At the time this paper was submitted, the study was at the stage of data collection. We recruited participants for this study during August and September 2021, and data collection will continue until December 2021. Data analysis will begin in December 2021 for the outcome variables. We expect to publish the results in 2022 or 2023.We hypothesized that the online GKT program for students will increase self-efficacy as a gatekeeper. Moreover, we hypothesized that self-efficacy as a gatekeeper affects attitudes toward the behavior and perceived behavioral control from TPB, leading to actual behavior as a gatekeeper.The effects of an online gatekeeper program on self-efficacy will be examined for gatekeepers among postsecondary students in Japan. To the best of our knowledge, this study is the first RCT to examine the effectiveness of online GKT programs without face-to-face sessions targeting students rather than staff or faculty for their self-efficacy as gatekeepers. This online program will allow individuals to participate without worrying about their privacy anytime, from anywhere.An online GKT program requires less involvement by mental health specialists such as public health nurses. It can be provided at a low cost in a low-resource setting in which trained practitioners are seldom available. Thus, this online GKT program has much potential for dissemination as a practical tool for the prevention of suicide in schools such as universities. Once we find the online GKT program sufficiently effective, it will contribute to the dissemination of gatekeeper online training to a large number of students to prevent suicide at a low cost and, as in the COVID-19 era, where close social contact is limited.The main findings of this study will be disseminated via publications in peer-reviewed international journals. Study findings will also be presented at scientific conferences.Due to the intervention’s nature, it is not possible for both the intervention implementer and participants to be blinded to group assignments. Because all the outcomes in this study will be obtained by the self-reported questionnaire, information bias could be introduced. Generalizability will be limited because snowball sampling will be used instead of random sampling.This is the first study to investigate the effectiveness of an online GKT program for students to improve self-efficacy as a gatekeeper using an RCT design. The study explored the potential of an online peer gatekeeper program for students that can be disseminated online to a large number of students with minimal cost.


Individuals with opioid use disorder (OUD) have a high prevalence of smoking and frequently experience unmet social determinants of health (SDOH), which may be barriers to smoking cessation. Hospitalization is an opportunity to encourage smoking cessation. Unfortunately, many clinicians do not provide tobacco treatment to support the maintenance of cessation achieved during hospitalization. Interventions are required to support these high-risk individuals after hospital discharge.This study aimed to test the feasibility and acceptability of a 28-day SMS text messaging program tailored to individuals with OUD, which provides smoking cessation support and addresses unmet SDOH needs.ready to quit within 30 days or the not ready to quit within 30 days program based on their readiness to quit. Automated SMS text messages were sent twice daily for 4 weeks. The topics included health and cost benefits of quitting, both general and opioid specific (16 messages); managing mood and stress (8 messages); motivation, coping strategies, and encouragement (18 messages); addressing medication misconceptions (5 messages); links to resources to address substance use , tobacco dependence (1 message providing a link to the Massachusetts Quitline), and unmet SDOH needs (6 messages assessing SDOH needs with links to resources if unmet SDOH needs were identified). Questionnaires and interviews were conducted at baseline and at 2 and 4 weeks after enrollment.From July to December 2019, we enrolled 25 individuals who were hospitalized with tobacco dependence and OUD at our large safety net hospital. The SMS text messaging program was initiated during hospitalization and continued for 28 days. Participants were enrolled in either the The participants were 56% (14/25) female, 36% (9/25) African American, 92% (23/25) unemployed, and 96% (24/25) Medicaid insured. Approximately 84% (21/25) activated the program, and none of the participants unsubscribed. Approximately 57% (12/21) completed either the 2- or 4-week questionnaires. Program satisfaction was high . Many perceived that the SMS text messaging program provided social support, companionship, and motivation to stop smoking. Messages about the health benefits of quitting were well received, whereas messages on how quitting cigarettes may prevent relapse from other substances had mixed views, highlighting the importance of tailoring interventions to patient preferences.SMS text messaging to promote smoking cessation and address SDOH needs may be an effective tool for improving quit rates and health outcomes in individuals with tobacco dependence and OUD. Our study adds to the growing body of evidence that SMS text messaging approaches are feasible and acceptable for providing tobacco treatment to all individuals who smoke, even among low-income populations who have OUD and are not ready to quit. Individuals with opioid use disorder (OUD) smoke at rates as high as 83% to 97% ,2. Co-ocAlthough individuals with OUD desire assistance with smoking cessation , tobaccoIndividuals who smoke are 1.5 to 2 times more likely to quit smoking when enrolled in SMS text messaging programs for smoking cessation -21. SMS There is nearly universal agreement in scientific and public health communities that social determinants of health (SDOH)—the social circumstances in which people are born, grow, live, work, and age—influence access to resources and opportunities that affect health ,27. SDOHMany individuals with OUD also experience unmet SDOH needs  ,33, whicFrom July to December 2019, we enrolled 25 individuals who were hospitalized with tobacco dependence and OUD at the Boston Medical Center (BMC), the largest safety net hospital in New England. We identified participants from a list of individuals who were hospitalized, who triggered consultation with the Tobacco Treatment Consult service based on current smoking status in the electronic health record , and whoA total of 96 participants met the screening criteria by electronic health record review , of whom 42 (44%) were ineligible by face-to-face screening , 2 (2%) were unavailable, and 27 (28%) declined or were not interested in learning about the study.Following the provision of study information, 25 individuals agreed, provided informed consent, and were enrolled. Participants were compensated up to US $50 for participation: US $10 for completing the baseline survey and interview, US $15 for completing a 2-week follow-up survey and interview, and US $25 for completing a 4-week follow-up survey and interview. This study was approved by our institutional review board (protocol number H-38709).Measures section). There were 2 tracks: one for individuals ready to quit within 30 days and the other for individuals not ready to quit within 30 days, as assessed by their answer to an introductory SMS text message assessment. The program had bidirectional or 2-way SMS text messaging capabilities; for example, participants could text a keyword  to receive strategies and tips.The SMS text messaging program lasted 28 days, with the first day of SMS text messages sent during hospitalization. Participants were sent 2 intervention SMS text messages daily (9 AM and 5 PM) in addition to weekly SMS text message assessments . Agile Health, Inc notified the research team members of the urgent unsolicited SMS text messages sent to the server. All SMS text messages sent by the participant to, and responded by, the system were reviewed by the research team weekly.The topics of the SMS text messages included (1) health and cost benefits of quitting, both general and opioid specific (16 messages); (2) managing mood and stress (8 messages); (3) motivation, coping strategies, and encouragement (18 messages); (4) addressing medication misconceptions (5 messages); (5) links to resources to address substance use (2 messages providing links to the Massachusetts Substance Use Helpline and BMC resources), tobacco dependence (1 message providing link to Massachusetts Quitline), and resources for unmet SDOH needs (6 messages assessing SDOH needs with links to resources if SDOH needs were unmet). Messages were obtained from three sources: (1) the National Cancer Institute’s Smokefree TXT , (2) conAssessments and links to resources were provided for the following 6 SDOH needs: difficulty with transportation to medical appointments, inability to pay for medications, risk of becoming homeless, food insecurity, trouble paying for heat or electricity, and the likelihood of needing to look for a job . IndividAssessments for the 6 SDOH needs were adapted from the validated Tool for Health and Resilience In Vulnerable Environments (THRIVE) screening tool and accompanying referral guide ; the THRready to quit track, an SMS text message on coping strategies was “Cravings will get weaker and less frequent with every day that you don’t smoke.” In the not ready to quit track, a parallel message was “Don’t let cravings get in the way of deciding to quit. There are good meds to help with cravings. Cravings get weaker with each passing day.” Messages in the not ready to quit track were directed toward developing participants’ personal reasons for change and increasing their motivation and self-efficacy to stop smoking. Examples of such messages are “Thought: What is the best result you can imagine if you quit smoking? Imagine all the ways your life would change. How would you spend the extra money? How would you feel? Who would you spend time with? Where would you spend your time?” and “Thought for the day: Fall down 7 times, get up 8. The key to success is to persist even if you have previously failed.” Messages in the ready to quit track provided encouragement; an example was “Stay positive. Your journey to a smokefree life may be a struggle, but looking back it will be well worth it.”Several SMS text messages (3-5 messages per week) were customized based on the readiness to quit. In the The study staff administered baseline questionnaires and interviews in person at the time of hospitalization and conducted 2- and 4-week questionnaires and interviews by telephone. Questionnaires followed by qualitative interviews were administered at the same encounter.Baseline demographics, use of substances, and comorbid mental health disorders were collected at the time of enrollment. Mobile technology use and smoking characteristics were assessed, including the level of cigarette dependence measured using the Fagerstrom Test for Cigarette Dependence ,39. Scortotalresponse rate by computing the number of participant-submitted responses to SMS text messages in which a response was expected and dividing this by the number of solicited responses. The number of unsolicited SMS text messages  was an additional index of engagement.Engagement was assessed through participants’ interactions with the program. We calculated the Results section.Program satisfaction was measured via 2- and 4-week questionnaires, using several indices of satisfaction. The “share-worthiness” of the SMS text messages was assessed by asking whether participants showed the SMS text messages to others (response: yes/no) and the extent to which they believed the SMS text messages would be helpful to family and friends . The perceived quality of the SMS text messages was measured using 2 items from the Mobile Application Rating Scale : one usiResults section.Satisfaction was additionally measured by eliciting responses on the helpfulness of the content of 8 specific SMS text messages . The 8 specific SMS text messages that were assessed for the helpfulness of the content are presented in the Weekly SMS text messages assessed the degree to which the program was helpful in motivating smoking cessation (range 1=not helpful to 5=very helpful) . The 2- We qualitatively measured feasibility and acceptability at 2 and 4 weeks using semistructured interview guides. The guide assessed the participants’ (1) perceived impact in motivating smoking cessation, (2) experiences with the program, (3) preference of content, and (4) suggestions for improvement.Basic descriptive statistics were calculated using SPSS  to summarize the quantitative responses. For qualitative interviews, we used inductive content analysis to analyze transcripts and performed unstructured coding of the transcripts to identify themes. A total of 2 members developed a codebook, independently reviewed all transcripts, and added codes until the team reached a consensus. We finalized the conceptual categories, grouped themes in each category, and identified quotes that best highlighted the themes. The interviews were audio recorded and transcribed verbatim.The participants were 56% (14/25) female, 36% (9/25) African American, 20% (5/25) Hispanic, 92% (23/25) unemployed, and 96% (24/25) Medicaid insured. The mean age was 45.8  years. Of the 25 participants, 12 (48%) reported current opioid use, and 12 (48%) were receiving medication-assisted treatment for OUD. Participants smoked for an average of 26.2  years. The Fagerstrom Test for Cigarette Dependence scores averaged 5.1 (SD 2), suggesting moderate nicotine dependence . Approxiactivate) the program. Of the 25 participants, 21  responded with yes. Of the 25 participants, 2 (8%) did not activate the program and expressed concern about not having access to a phone after discharge ; the other 2 (8%) were not available to assess reasons for not activating. Of the 21 participants, 13  submitted at least one response to the helpfulness assessments of 8 intervention SMS text messages ; 13  submitted at least one response to the SMS text messages assessing SDOH needs ; 15  responded to at least one weekly text SMS message assessment regarding the degree to which the program was helpful in motivating cessation ; and 14  sent at least one unsolicited SMS text message for a total of 143 unsolicited messages. None of the participants unsubscribed.While in the hospital, and after obtaining informed consent, participants were asked via SMS text message whether they would like to begin  completed either the 2- or 4-week questionnaires:6  completed both questionnaires ; 4  completed only the 2-week questionnaire; and 2  completed only the 4-week questionnaire.Of the 21 participants, 12  rated the program ≥4 stars, and 2  rated the program 3 stars. Of the 12 participants, 4  wanted the program to last up to 2 months longer, and 8  indicated that they wanted the program to last ≥3 months longer. None of the participants thought that the program had interfered with their schedules. Of the 12 participants, 9  shared the SMS text messages with others. Participants believed that the SMS text messages would be helpful to family and friends . Of the 12 participants, 11  were very likely or likely to recommend the program to others, and 1 (8%) person in the not ready to quit track was somewhat likely to recommend the program to others.Of the 12 participants, 10 . Participants reported that the content was trustworthy . Most liked the frequency  and timing  of the SMS text messages  rated SDOH the SMS text messages  helpful, and 10  rated the SMS text messages on managing mood and stress as helpful. All 12 participants rated the SMS text messages on resources for quitting smoking as helpful, and 11  rated the SMS text messages about where to find help for other substances as helpful. The overall response rates for the SMS text message assessments on helpfulness  of the 8 specific intervention messages were low  had 1 unmet need, 3 (23%) had 2 unmet needs, 1 (8%) had 3 unmet needs, and 4 (31%) had 4 unmet needs. Responses for SDOH needs were as follows: trouble getting transportation for medical appointments , trouble paying for medications , risk of becoming homeless , frequency of running out of food without having money to pay for more , trouble paying for heat or electricity , and likelihood of looking for a job in the near future .ready to quit, and n=4, 50% not ready to quit) agreed or strongly agreed with “The program made me think that it is okay to quit tobacco and other drugs at the same time”; 1 (8%) participant in the ready to quit track was undecided, and 3  disagreed. Participants perceived that the program increased their motivation to quit  individuals who responded to at least one weekly SMS text message assessment on the helpfulness in motivating smoking cessation (1=not helpful to 5=very helpful) believed the program was helpful: 12  in week 1, a total of 10  in week 2, a total of 6  in week 3, and a total of 7  in week 4.ready to quit or not ready to quit), and interview week (2 or 4 weeks).Of the 21 participants, 13 (62%) participated in the 2- and 4-week interviews: 6 (46%) completed both, 4 (31%) completed only the 2-week interview, and 3 (23%) completed only the 4-week interview. Supporting quotes were identified by patient number, enrolled track  of participants had low response rates for the SMS text message assessments. When probed for the reasons, they responded as follows:I responded to a couple of them and then didn’t respond anymore 'cause I didn’t know if it was being charged to my account.P10, ready to quit, 4 weeksI can’t read or write that much. I wait until my friend comes. When she comes, she reads them to me. Sometimes I got to wait two or three days.P14, not ready to quit, 2 weeksParticipants were satisfied with the program, largely because they found the SMS text messages understandable:The thing I liked about the text messaging program is that it was straightforward. It wasn't hard for me to grasp the concept of what it was talking about.P7, not ready to quit, 4 weeksSeveral described how they liked being able to go back to look at the messages:Sometimes I would go back and look and see if there was anything helpful that could help me at the time. It was helpful.P10, ready to quit, 4 weeksFeatures participants thought particularly helpful included the interactive features:I didn’t think they were going to answer that quick. For them answering quick, it helped with my craving.P1, ready to quit, 4 weeksMany described the cost-saving messages as helpful:I used to buy two packs, and now I’d buy one pack, so I’d say I’m going to smoke one, and I’d put the rest of the money in the piggy bank. Since I started with you guys, I have $120 in my piggy bank.P14, not ready to quit, 4 weeksSome described how receiving links to resources was helpful:Because it gave you all the information, where to call or how to get in contact with people to try to get help...they definitely helped me out, ‘cause at that time when the message came in I was low on canned food’.P1, ready to quit, 4 weeksOthers preferred communicating directly with an advocate:I would’ve liked that somebody get in touch with me and to advocate to help me finish housing.P9, ready to quit, 4 weeksParticipants found the SMS text message tips on handling stress helpful:When I had the stress tips—proper breathing we do. Yeah, I found that helpful.P1, ready to quit, 4 weeksFor some, the SMS text messages about how quitting cigarettes and opioids together could help them remain abstinent from all substances were particularly helpful:I like the ones for quitting other things at the same time as smoking 'cause that seems really hard for me to do.P4, not ready to quit, 4 weeksOthers did not find these messages relevant as they were already on medication-assisted treatment for OUD:I didn’t need help for that (opioids). I just needed help for smoking.P9, ready to quit, 4 weeks:SMS text messages regarding where to find smoking cessation resources were viewed as helpfulIt has nice little facts about smoking. You have a number that gets you on medication. And, once I tried medication, it helped me out.P5, not ready to quit, 2 weeksIndividuals indicated that the program was beneficial for motivating smoking cessation:It was like your mother in your ear, reminding you of stuff. Not in a nagging way. I was kind of surprised that it worked as well as it did but happily so.P3, ready to quit, 4 weeksParticipants described that a major reason for increased motivation to stop smoking was social support:Sometime I was having cravings, and that moment I would receive those text message like it was telling me somebody’s out there. I’m not by myself with quitting smoking. It’s like I have a sponsor.P21, ready to quit, 4 weeksSuggestions for improvement were (1) providing supportive phone calls when needed, (2) including personal success stories, and (3) including educational videos:Maybe have live people to talk to when you crave something.P5, not ready to quit, 2 weeks...to have people that have already smoked and quit have some of their personal story incorporated.P10, ready to quit, 4 weeksI like to receive education video about quitting smoking.P21, ready to quit, 4 weeksIndividuals with OUD meet the definition of an underserved population: they have a higher smoking prevalence than the general population, disproportionate burden of tobacco-related health disparities, increased risk factors for treatment failure, and lack of protective factors . TailoreOur SMS text messaging program is unique because it (1) focuses on an understudied and underserved population, (2) assesses and provides resources for unmet SDOH needs that may make the path to quitting easier, and (3) offers individualized tracks based on readiness to quit. The main findings were as follows: (1) participants reported high satisfaction with the program content and structure, and (2) participants reported that the program helped motivate smoking cessation. The vast majority of participants in our study were Medicaid insured. Medicaid recipients in Massachusetts  have access to all Food and Drug Administration–approved medications, two 90-day treatment regimens per year, and 16 tobacco cessation counseling sessions per year; however, the quit rates are low. Our study adds to the growing body of evidence that SMS text messaging approaches are feasible and acceptable for providing tobacco treatment to all individuals who smoke, even among low-income Medicaid populations who have OUD and are not ready to quit.ready to quit within 30 days or not ready to quit within 30 days track. SMS text messages on managing stress and providing tobacco treatment resources were perceived as particularly helpful. Many perceived that the SMS text messages provided social support, companionship, and the motivation to stop smoking. Messages about the health benefits of quitting were well received, whereas messages on how quitting cigarettes may prevent relapse from other substances had mixed views, highlighting the importance of tailoring interventions to patient preferences.Individuals reported that the program made them think about stopping smoking, regardless of whether they were enrolled in the Participants made suggestions for improvement. Some discussed how increasing the duration to 3 months would enhance the program, as would receiving supportive calls or supplemental in-person interactions as needed. Although some perceived that providing links to resources for unmet SDOH needs was adequate, others suggested that an advocate should additionally help address these needs. As suggested by the data, we plan to refine the intervention by increasing the program duration and adding supplemental in-person interactions, particularly to address unmet SDOH needs.A previous intervention using SmokefreeTXT  with individuals experiencing homelessness demonstrated a median response rate of 2.1% to interactive SMS text messages, with many individuals reporting that the SMS text messages felt impersonal . Our SMSIn another study that analyzed the completion of the SmokefreeTXT program, 46% of those who set a quit date remained enrolled for the entire 42-day program. Among users who did not complete the program  before program completion, the mean number of days in the program was 12 days . In our This study has several strengths and limitations. The strengths include focusing on the understudied and underserved population of individuals with OUD and including individuals regardless of readiness to quit. These inclusions are important as evidence supports “opt-out” approaches to offering tobacco treatment to all individuals, regardless of readiness to quit -52. ManySMS text messaging to promote smoking cessation may be an effective tool for improving quit rates and health outcomes in individuals who smoke cigarettes and have OUD. Our results provide valuable insights into the development and acceptability of such programs. An innovative component of our SMS text messaging intervention was screening for and providing tailored resources for unmet SDOH needs. In future studies, we will assess whether identifying unmet SDOH needs and intervening in these modifiable factors  affects smoking cessation. Our next steps are to further refine the program based on patient suggestions, such as adding a community health worker or coach to address unmet SDOH needs and providing supportive phone calls when needed, and assess the effects of the refined program on smoking cessation in a randomized controlled trial.


Convex probe endobronchial ultrasound transbronchial needle aspirations (CP-EBUS-TBNAs) and radial probe endobronchial ultrasound transbronchial lung biopsies (RP-EBUS-TBLBs) can be performed under moderate sedation or general anesthesia. Moderate sedation is more convenient, however patient discomfort may result in inadequate tissue sampling. General anesthesia ensures better patient cooperation but requires more logistics and also carries sedation risks. We aim to describe the diagnostic yield and safety of CP-EBUS-TBNAs and RP-EBUS-TBLBs when performed under moderate sedation at our center. All patients who underwent CP-EBUS-TBNA and/or RP-EBUS-TBLB under moderate sedation, between January 2015 and May 2017, were reviewed. Primary outcomes were defined in regard to the diagnostic yield and safety profile. A total of 336 CP-EBUS-TBNAs and 190 RP-EBUS-TBLBs were performed between January 2015 and May 2017. The mean sedation doses used were 50 mcg of intravenous fentanyl and 2.5 mg of intravenous midazolam. The diagnostic yield of the CP-EBUS-TBNAs and RP-EBUS-TBLBs were 62.5% and 71.6%, respectively. Complication rates were low with: transient bleeding 11.9%, transient hypoxia 0.5%, and pneumothorax 0.1%. None required escalation of care, post procedure. Performing CP-EBUS-TBNAs and RP-EBUS-TBLBs under moderate sedation is safe and provides good diagnostic yield. These procedures should, therefore, be considered as first-line sampling techniques. Convex probe endobronchial ultrasound transbronchial needle aspiration (CP-EBUS-TBNA) is widely used in the diagnosis of mediastinal lymphadenopathy , mediastGeneral anesthesia is administered by trained anesthetists, while moderate sedation can be administered by trained endoscopic nurses with instructions from bronchoscopists, or by bronchoscopists themselves. Yarmus et al. reported better patient cooperation when CP-EBUS-TBNAs are performed under general anesthesia, thereby allowing more lymph nodes to be sampled and thus achieving a higher diagnostic yield . A laterIn pursuit of patient-centric practice, our center has routinely performed CP-EBUS-TBNAs with or without RP-EBUS-TBLBs in a single session under bronchoscopist-directed moderate sedation. In this article, we describe our performance of CP-EBUS-TBNAs with or without RP-EBUS-TBLBs in a single session under bronchoscopist-directed moderate sedation, while looking at indications of better diagnostic yields and safety profiles.A retrospective review of all patients who underwent CP-EBUS-TBNA and RP-EBUS-TBLB between January 2015 and May 2017 at the National University Hospital Singapore  was performed. The study protocol and waiver of informed consent was approved by the NHG Domain Specific Review Board  given the observational nature of the study. All outpatients and hospitalized patients above the age of 18 years undergoing CP-EBUS-TBNAs and/or RP-EBUS-TBLBs during the study period were included. Indications for both procedures were recorded through the review of case notes. Common indications for CP-EBUS-TBNA included the presence of enlarged mediastinal lymph nodes, suspicions of lung cancer, and the mediastinal staging of lung cancer. Common indications for RP-EBUS-TBLBs included the presence of lung nodules or masses accessible via bronchoscopy. Age, gender, body mass index, comorbidities—such as underlying malignancy, chronic kidney disease, chronic liver disease, and ischemic heart disease—baseline creatinine, coagulation profile, and use of antiplatelets or anticoagulants were also recorded.All CP-EBUS-TBNA and RP-EBUS-TBLB procedures were performed by an accredited pulmonologist and a specialist trainee. At our center, bronchoscopists undergo 3 years of specialist training and have 3–20 years of postgraduate experience. Procedures are performed with 1–2 bronchoscopist(s), 1 scrub nurse, and 1 float nurse. Parameters such as blood pressure, heart rate, and oxygen saturations are monitored every 5 min. Patients are given topical anesthesia with 1% lignocaine before the induction of moderate sedation with boluses of midazolam, fentanyl, or pethidine that are administered by nurses with instructions from the bronchoscopists. Moderate sedation is administered about 5 min before the start of procedure. At our center, we routinely perform fiberoptic bronchoscopy before CP-EBUS-TBNAs and also followed by RP-EBUS-TBLBs, as required.CP-EBUS-TBNAs were performed with a real-time ultrasound biopsy bronchoscope . A linear ultrasound transducer (range of 5–12 MHz) was connected to a processor (Olympus EU-ME 1). Transbronchial needle biopsies were performed with a dedicated 22-gauge needle (Olympus NA–201SX-4022) or (Boston Scientific M00558220). Rapid on-site evaluation (ROSE) was performed by a staff pathologist for all EBUS-TBNA procedures. Only 1 type of needle was used per patient.RP-EBUS-TBLBs were performed using a flexible bronchoscopy , a radial probe (Olympus UM-520-17S diameter 1.8 mm), and single-plane fluoroscopy with an alligator jaw step fenestrated forceps, which were 1.9 mm in diameter (Olympus). A flexible bronchoscopy and a radial probe were both connected to a processor (Olympus CV-260SL or CV-290). A guide sheath was not used for the RP-EBUS-TBLB procedures that were reviewed in this study.Post procedure, patients were monitored for 3 h and the bronchoscopist would be informed about clinical status of the patient before they are deemed safe for discharge. Patients who underwent RP-EBUS-TBLBs underwent a post procedure chest radiography in order to evaluate for any delayed pneumothorax.The primary endpoints were the diagnostic yield and safety profiles of CP-EBUS-TBNAs and RP-EBUS-TBLBs. Diagnostic yield was defined by the number of patients who obtained a specific diagnosis from either CP-EBUS-TBNAs or RP-EBUS-TBLBs. Specific diagnosis included primary lung cancer; lung metastasis; caseating granulomatous inflammation indicative of tuberculosis, non-caseating granulomatous inflammation indicative of sarcoidosis; and any other infections. For cases without a specific diagnosis after CP-EBUS-TBNAs and/or RP-EBUS-TBLBs, attempts were made to collect information on follow up or on further investigations that were performed in order to arrive at an eventual diagnosis. Safety profile was evaluated by looking at the incidence of procedure-related complications , sedation-related complications , and re-admission within a week after the procedure for any delayed complications.Secondary endpoints were defined as the adequacy of sample and procedure time. Adequacy of sample was defined as a composite endpoint of specific diagnosis, and the presence of either lymphocytes (in the case of CP-EBUS-TBNAs) or lung tissue (in the case of RP-EBUS-TBLBs). Procedure time was defined as the time from administration of sedation till the withdrawal of the bronchoscope.The primary analysis of the diagnostic yield of CP-EBUS-TBNAs and RP-EBUS-TBLBs were calculated as the percentage of patients for whom the procedures obtained a specific diagnosis. Simple calculations were conducted for characteristics of the sampled lymph nodes and lung masses.A total of 421 patients underwent the procedures during the study period between January 2015 and May 2017. Of all the procedures, only one subject was unable to proceed with the procedure despite the maximizing of conscious sedation due to intolerance. A total of 104 patients underwent both CP-EBUS-TBNA and RP-EBUS-TBLB; further, 237 patients underwent CP-EBUS-TBNA only, while 79 patients underwent RP-EBUS-TBLB only. Amongst these patients, a total number of 577 lymph nodes were sampled and 201 lung biopsies were performed. There were 21 bronchoscopists involved, out of whom 6 were specialist trainees. The average number of CP-EBUS-TBNAs performed by each bronchoscopist was 16 . The average number of RP-EBUS-TBLBs performed by each bronchoscopist was 11 . There were four bronchoscopists specializing in interventional pulmonology, who thus also had the most numbers of procedures.The mean age of patients was 62 years . The meaThe top three indications for both procedures of CP-EBUS-TBNA and RP-EBUS-TBLB were mediastinal lymphadenopathy, abnormal findings on lung imaging, and the presence of lung mass .For CP-EBUS-TBNAs, the average number of lymph nodes sampled in each procedure was 1.7 . Further, the average number of needling per lymph node was 2.38 . The most commonly sampled lymph node stations were in the right lower paratracheal (207 samples), subcarinal (151 samples), left paratracheal (93 samples), right interlobar (42 samples), and right upper paratracheal nodes (24 samples).For RP-EBUS-TBLBs, 197 lesions were targeted. In six patients, RP-EBUS-TBLBs were performed in two separate lobes, while the rest of the patients had RP- EBUS-TBLBs performed in only one lobe. The average number of biopsy passes was 4.3 . The average diameter of lung nodules that were sampled was 27.72 mm as measured on the computer tomography scans that were performed prior to procedure . The most common locations of the target lesion were in the right upper lobe (63 biopsies), right lower lobe (36 biopsies), left upper and lower lobe (30 biopsies each), and right middle lobe (20 biopsies).The diagnostic yields of CP-EBUS-TBNAs and RP-EBUS-TBLBs were found to be 62.5% and 71.6%, respectively. An adequate sample was obtained in 89.4% of the subjects. The most common diagnosis from both procedures was lung malignancy . The mosIn cases where either CP-EBUS-TBNAs or RP-EBUS-TBLBs were undiagnostic, a proportion of patients underwent further diagnostic evaluation—such as transthoracic needle aspirations of the lung nodule, surgical resection, and endoscopic ultrasound fine needle aspiration (EUS-B-FNA), which all obtained the diagnosis.Complications rates were low at an overall of 12.5%. A total of 50 patients (11.9%) had transient bleeding where hemostasis was achieved by the intrabronchial administration of cold saline, adrenaline, or tranexamic acid. Further, one patient developed pneumothorax after RP-EBUS-TBLB, thereby requiring chest drain insertion. Additionally, two patients (0.5%) had transient hypoxia where oxygenation improved without the need for supplementation post procedure. No subject required escalation of care to the high dependency unit or intensive care unit post procedure. A total of 10 patients (2.4%) were hospitalized for respiratory complaints or fever within 1 week of procedure.As endoscopic ultrasound procedures become more widely employed around the world, there is an increased interest in the most ideal modality for periprocedural sedation. It is a balance between resource availability, cost consideration, bronchoscopist preference, patients’ comfort, and diagnostic yield .Over the past decade, there have been many studies comparing the diagnostic yield of CP-EBUS-TBNAs that are performed under general anesthesia and moderate sedation. Yarmus et al., in 2013, reported a higher diagnostic yield for CP-EBUS-TBNAs performed under general anesthesia; further they attributed this to the larger number of lymph node sites that were sampled and the greater number needle passes that were performed . HoweverOur study reports a reasonable diagnostic yield, sample adequacy, and low complication rate in the use of bronchoscopist-directed moderate sedation for endobronchial procedures conducted in an academic teaching hospital. To maximize the yield and convenience for patients, CP-EBUS-TBNAs and RP-EBUS-TBLBs were performed in the same session for patients who required both procedures.We report diagnostic yield and sample adequacy that is consistent with real world data from the AQUIRE registry . Our patOverall, evidence seems to suggest that diagnostic yield is dependent on multiple factors and the type of sedation may not be a major contributory factor ,19. We sOur dual use of CP-EBUS-TBNAs and RP-EBUS-TBLBs in the same session for patients requiring both procedures accounted for a longer procedure duration. Our practice is similar to that of Bailey et al. except for the use of moderate sedation rather than general anesthesia . Our RP-To increase the diagnostic yield of CP-EBUS-TBNAs under moderate sedation, newer technology can be employed. One example is that of elastography, which uses a color map to identify the areas of lymph nodes to target, which has a reported sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy rates of 100, 92.3, 94.6, 100, and 96.7%, respectively . In certTo increase the yield of RP-EBUS-TBLBs under moderate sedation, techniques such as virtual navigational bronchoscopy and electromagnetic navigation bronchoscopy have been used. Ishida et al. reported a higher diagnostic yield of 80.4% with virtual-bronchoscopy-assisted EBUS as compared to a diagnostic yield of 67.0% with conventional EBUS- TBLB . A meta-We report a complication rate of 12.5%. All were minor complications and self-limiting. This is comparatively higher than published complication rates , likely The limitations of our study are found in its retrospective nature and the inability to directly compare general anesthesia vs. moderate sedation. We have no data on patient satisfaction, though studies have shown good satisfaction with endobronchial procedures performed under moderate sedation . AdditioIn conclusion, balancing resource utilization, comfort, and convenience while in pursuit of ideals of patient-centric practice, we report reasonable diagnostic yields with a good safety profile in our practice of EBUS procedures under bronchoscopist-directed moderate sedation. Further studies can be conducted in order to look at patient satisfaction with EBUS procedures when performed under moderate sedation.


Lymphovascular invasion (LVI) predicts a poor outcome of breast cancer (BC), but LVI can only be postoperatively diagnosed by histopathology. We aimed to determine whether quantitative parameters of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can preoperatively predict LVI and clinical outcome of BC patients.Ktrans, Ve, Kep) and semiquantitative DCE-MRI parameters , and clinicopathological features were compared between LVI-positive and LVI-negative groups. All variables were calculated by using univariate logistic regression analysis to determine the predictors for LVI. Multivariate logistic regression was used to build a combined-predicted model for LVI-positive status. Receiver operating characteristic (ROC) curves evaluated the diagnostic efficiency of the model and Kaplan-Meier curves showed the relationships with the clinical outcomes. Multivariate analyses with a Cox proportional hazard model were used to analyze the hazard ratio (HR) for recurrence-free survival (RFS) and overall survival (OS).A total of 189 consecutive BC patients who underwent multiparametric MRI scans were retrospectively evaluated. Quantitative . N2 stage , N3 stage , and Kep value  were associated with LVI positivity. The combined-predicted LVI model that incorporated the N stage and Kep yielded an accuracy of 0.735 and a specificity of 0.801. The median RFS was significantly different between the LVI-positive and LVI-negative groups  and between the combined-predicted LVI-positive and LVI-negative groups . The median OS was not significantly different between the LVI-positive and LVI-negative groups  and between the combined-predicted LVI-positive and LVI-negative groups . LVI status (HR = 2.40), N2 (HR = 3.35), and the combined-predicted LVI model (HR = 1.61) were independently associated with disease recurrence.LVI-positive patients had a higher Kep could predict LVI. LVI status, N stage, and the combined-predicted LVI model were predictors of a poor RFS but not OS.The quantitative parameter of The online version contains supplementary material available at 10.1186/s40644-022-00499-7. Lymphovascular invasion (LVI), defined as the infiltration of tumor cells into lymphatic or blood vessels at the periphery of invasive carcinoma –3, has bAs a significant preoperative examination for BC patients, dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) are effective tools for evaluating tumor microcirculation , 8–13. TThus, the purpose of this retrospective study was to determine whether quantitative parameters of DCE-MRI can preoperatively predict LVI and to investigate the relationship between the prediction model and survival in terms of disease-specific recurrence and mortality in BC patients to guide clinical decision-making.Figure E1 in the supplementary materials. The study patients are part of a large retrospective DCE-MRI database, of which 165 patients have been reported in a previously published study . This may be the reason why we only found a significant difference in Kep but no difference in Ktrans between LVI-positive and LVI-negative groups. Furthermore, another reason for a correlation with Kep but not with Ktrans or Ve in our study could be due to the complexity of the underlying pathophysiology of heterogeneous BC. Thus, our study showed that Kep might be a more stable parameter than Ktrans and Ve, consistent with the findings in a previous study [The simpler qualitative parameters, such as internal enhancement pattern, the initial enhancement percentage, maximum enhancement, slope, and kinetic enhancement curve, have been shown significantly correlated with LVI by other investigators, but little attention was paid to the relationship between quantitative parameters of DCE-MRI and LVI. Thus, we developed this novel model to preoperatively predict LVI and clinical outcome of BC patients in this study. ace area , 10, 18.ironment . Howevereability . Moreoveeability , becauseus study , 29, 30.Kep value and N stage to predict the histopathology LVI status. ROC analysis showed that the combined-predicted LVI model achieved moderate performance in predicting LVI, with an accuracy of 0.735 and a specificity of 0.801. However, the combined-predicted LVI model overestimates the LVI + case  based on the cutoff point value determined by the largest Youden index. We used the chi-squared test to analyze these data, and the results showed that there were no significant differences (P = 0.405). A similar result was also found in previous studies for a model that predicted LVI in hepatocellular carcinoma  and gastric cancer patients  [In the present study, we combined the VI + 68) . A potenP = 0.016). Multivariate Cox regression analysis showed that LVI (HR = 3.38), N2 (HR = 6.13), and the combined-predicted LVI model (HR = 3.61) were independent predictors of disease recurrence. The median RFS was lower for patients with LVI than for those without LVI , which was also observed in the combined-predicted LVI model . These results were comparable with previous studies. For instance, Ejlertsen et al. [P < 0.001). Matsunuma et al. [In this study, the recurrence rate was significantly higher in patients with LVI than in those without LVI  by the minimum chi-square value of the fitted time concentration curve to ensure the accuracy and robustness of the pharmacokinetic parameters, the population-based AIF is different from the true AIF to some extent, leading to some bias in the results [The present study had some limitations. First, the study results were assessed in a single institution in a relatively large cohort study with 189 patients, and the inclusion of more patients in a multicenter study will make the results more reliable. Second, LVI status was only classified as positive or negative in this study. Our study did not separate LVI into the vascular invasion and lymphatic invasion. A study by Fujii T et al.  found the tissue . Perfusi results .Kep from DCE-MRI, and N2 are independent predictors of LVI in BC patients. LVI status, N stage, and the combined-predicted LVI model were confirmed to predict a poor RFS, but no evidence was found that these features were related to OS.In conclusion, the quantitative parameters of Below is the link to the electronic supplementary material.Supplementary Material 1


BMI and osteoporosis were not statistically significantly related to DRF. Conclusions: Women with low skeletal muscle mass and CVD may be more responsible for DRF than osteoporosis.Objectives: Sarcopenia is a skeletal muscle loss disease with adverse outcomes, including falls, mortality, and cardiovascular disease (CVD) in older patients. Distal radius fractures (DRF), common in older people, are strongly related to falls. We aimed to investigate the correlation between DRF and low skeletal muscle mass, which strongly correlated to sarcopenia. Methods: We performed a retrospective review of data from patients diagnosed with or without DRF in our institute between 2015 and 2020. Finally, after propensity score matching, data from 115 patients with and 115 patients without DRF were used for analyses. Multivariate logistic regression analysis was performed for sex, body mass index (BMI), the presence of low skeletal muscle mass, bone quality measured by dual-energy X-ray absorptiometry (DXA), and comorbidities . Results: We found that female sex (odds ratio = 3.435,  Sarcopenia is a Greek term signifying “poverty of the flesh”; which was first described in the 1980s as an age-related decline in skeletal muscle mass affecting mobility, nutritional status, and independence ,3,4. In In order to diagnose sarcopenia in the primary health care or community preventive services setting, calf circumference  or a SARC-F questionnaire (≥4), or SARC-F administration combined with CC measurement  was presented at the start of the study. Then, muscle strength measurement or physical performance was measured by the process of assessment; this measured handgrip strength  and a physical performance measure 5-time chair stand test (≥12 s), before proceeding to the final diagnostic process. In the final diagnosis step, the following three were considered:Low muscle strength as handgrip strength of <28 kg for men and <18 kg for women;Low physical performance as a 6-m walk of <1.0 m/s or short physical performance battery score of ≤9, or a 5-time chair stand test of ≥12 s;2 in men and <5.4 kg/m2 in women by dual-energy X-ray absorptiometry (DXA); or <7.0 kg/m2 in men and <5.7 kg/m2 in women by bioimpedance;Low appendicular skeletal muscle mass (ASM) as a <7.0 kg/mAt this time, sarcopenia was defined as low ASM + low muscle strength or low physical performance; and severe sarcopenia was defined as low ASM + low muscle strength and low physical performance .Distal radius fractures (DRF) are among the most common fractures 18%) in patients aged 65 years and older % in pati and costAccording to a meta-analysis that included 10 cohort studies, sarcopenia is associated with falls . SarcopeHere, we investigated the relationship between DRF and low skeletal muscle mass; being strongly related to sarcopenia.This was a retrospective comparative study of patients with DRF who visited the CHA Bundang Medical Center between January 2015 and December 2020 under approval of the CHA Bundang Medical Center Institutional Review Board (CHAMC 2022-07-024-002). All the patients with DRF underwent open reduction and internal fixation surgery using a 2.4 mm variable-angle LCP two-column volar distal radius plate . Indications for surgery included the following Lafontaine criteria : dorsal Data on individuals who underwent DXA for a health check-up without any specific history of osteoporotic fracture , which measures bone mineral density (BMD) and ASM, were used as a patient collective for the control group.2) were collected. Subsequently, propensity score-matching was performed for age. Finally, the participants were divided into two groups based on whether they had been diagnosed with DRF (n = 115 in each group)  .Variables included sex; age; BMI; T-score from BMD; the presence of osteoporosis; and comorbidities, including diabetes mellitus (DM) and cardiovascular disease (CVD). This study’s definition of cardiovascular disease included hypertension, coronary heart disease, peripheral arterial disease, and aortic disease.2; women <5.4 kg/m2).BMD was measured at both the lumbar spine and one proximal femoral area . According to the World Health Organization criteria, osteopenia was defined as a T-score standard deviation (SD) −2.5< T <−1.0; and osteoporosis was defined as T ≤ −2.5. Appendicular lean body mass without fat and bone mass were measured separately in the upper and lower extremities through DXA. Appendicular lean mass corresponds approximately to the ASM ,29. The http://www.r-project.org/, accessed on 15 July 2022). Continuous normally distributed data are presented as mean and SD. Statistical significance was set at p < 0.05. A Pearson’s chi-squared test for categorical variables and a Student’s t-test for continuous variables were used to compare the groups. Univariate analysis was performed to determine factors associated with DRF. Multivariate logistic regression analysis was used, adjusting for factors and covariates, to confirm the simultaneous effect of multiple factors associated with DRF. The results are presented as odds ratios (OR) with 95% confidence intervals (CIs) and Akaike information criteria (AIC) values, which estimate the quality of each model. We applied a propensity score matching method to reduce the possible bias originating from the difference in the patients’ demographic characteristics. The patients with DRF were matched with the non-DRF group on the basis of a greedy algorithm of nearest neighbor matching at a 1:1 fixed ratio. Age was considered as a predefined covariate. We obtained the same number of individuals for the DRF and non-DRF groups.Data manipulation and statistical analyses were performed using the R software . The patients with a low skeletal muscle mass were significantly associated with DRF in all the models. After adjusting for all the variables, the OR of low skeletal muscle mass was 8.062 (p = 0.001) in model 4. CVD was also statistically related to DRF; the OR of CVD was 5.431 (p < 0.001) in model 4. The presence of osteoporosis, T-score, and BMI were not related to DRF in model 4.The association between low skeletal muscle mass and DRF according to the multistep adjustments is shown in p = 0.015), patients with a low skeletal muscle mass , and CVD , compared with the control group.In our study, after propensity score matching was adjusted for age, DRF was associated with the female sex . In this study, low skeletal muscle mass was related to DRF; however, there were conflicting results in previous literature. Hence, further research is needed on this matter.Few studies have investigated the direct relationship between sarcopenia and DRF. In addition, the results are controversial. According to Caliskan et al. , a crossp < 0.001) [In our study, DRF patients had the characteristics of CVD. A multicenter cross-sectional study reported that hypertension was associated with an increased risk of sarcopenia at least twice . Moreove< 0.001) . Several< 0.001) ,36. Consp = 0.947). Since DRF is considered a fracture type that defines “severe or established osteoporosis” [p = 0.01). Additionally, in this study, patients aged 45–64 years had lower T-scores (p = 0.09); however, there was no difference in falls. These results suggest that not only osteoporosis, but also the effects of falls, should be considered as risk factors for DRF in relatively older patients. As an additional point to consider, the World Health Organization criteria define osteoporosis as low BMD, with a T-score of ≤−2.5 in the spine and neck of the femur [This study showed that osteoporosis was not associated with DRF (OR 0.983, porosis” , the resporosis”  reportedporosis”  reportedhe femur . The facA limitation of this study is that only ASM from DXA was used to diagnose low skeletal muscle mass. There were no data on handgrip strength or physical performance; therefore, this study did not meet the sarcopenia criteria corresponding to the AWGS 2019. As this study was conducted only with patients with DRF, the measurement of hand grip strength was limited due to pain and immobilization. Moreover, according to a recent scoping review of DRF with sarcopenia, only 3 out of 13 studies defined sarcopenia based on AWGS or EWGSOP criteria that consider age-related loss of muscle mass, low muscle strength, and/or low physical performance . Second,Although DRF is highly associated with osteoporosis in the literature, considering the above, factors related to general activity, such as low skeletal muscle mass and CVD, may be more important factors in causing DRF in women. In addition, research related to sarcopenia and DRF has been actively conducted. Moreover, future studies on sarcopenia will be of great assistance in the management of DRF, which is prevalent in society.