OB  is a patient safety program for health care providers and administrators in hospital obstetric units. MOREOB has been implemented widely in Canada and gradually spread to the United States. The main goal of MOREOB is to build a patient safety culture and improve clinical outcomes. In 2013, 26 Ontario hospitals voluntarily accepted provincial funding to participate in MOREOB. The purpose of our study was to assess the effect of MOREOB on participant knowledge, organizational culture, and experiences implementing and participating in the program at these 26 Ontario hospitals.MOREOB participants from 26 hospitals. The quantitative component used a descriptive pre-post repeated measures design to assess participant knowledge and perception of culture, administered pre-MOREOB and after each of the three MOREOB modules. Changes in mean scores were assessed using mixed-effects regression. The qualitative component used a qualitative descriptive design with individual semi-structured interviews. We used content analysis to code, categorize, and thematically describe data. A convergent parallel design was used to triangulate findings from data sources.A convergent parallel mixed-methods study in Ontario, Canada, with MOREn = 15) described improvements in knowledge, interprofessional communication, ability to provide safe care, and confidence in skills. Facilitators and barriers to program implementation and sustainability were identified.308 participants completed the knowledge test, and 329 completed the culture assessment at all four time points. Between baseline and post-Module 3, statistically significant increases on both scores were observed, with an increase of 7.9% (95% CI: 7.1 to 8.8) on the knowledge test and an increase of 0.45  on the culture assessment. Interview participants  contains supplementary material, which is available to authorized users. To Err Is Human identified adverse events, many of which are preventable, as a common cause of morbidity and mortality in hospitals and called for a coordinated strategy to improve patient safety [There are over 380,000 births in Canada each year  and the t safety . Althougt safety . While ot safety , obstetrt safety , the fact safety , with obt safety .OB  program was developed by the Society of Obstetricians and Gynaecologists of Canada (SOGC), and is currently administered by Salus Global, a healthcare consulting and implementation firm established by the SOGC and HIROC in 2007 [OB program aims to create a culture of patient safety in obstetrical units by using high reliability organization (HRO) principles [OB uses a “train-the-trainer” approach whereby the hospital recruits a “core team” of interdisciplinary team members, who are then trained and supported by Salus Global to implement the program at their respective hospitals. Standardization of implementation across sites is facilitated by detailed program manuals and implementation responsibilities for the core team, orientation sessions by MOREOB facilitators prior to implementation of each module, and ongoing support by program consultants [OB program goals is provided in Additional file 1.The MORE in 2007 . The MORinciples ,includininciples . The proinciples . The prosultants . AdditioOB program [OB program in all hospitals in 2004, and a subsequent evaluation found statistically significant reductions in perineal tears, length of stay, and neonatal severe morbidity rates [OB program resulted in a significant decrease in the number of reportable events and associated costs for the healthcare liability insurer [OB program did not translate to an observable decrease in adverse maternal or neonatal birth outcomes [To date, over 300 North American hospitals have participated in the MORE program , but thety rates . No signty rates . One Ont insurer . Anotheroutcomes . Howeveroutcomes .OB. In 2013, the Ontario Ministry of Health and Long-Term Care (MOHLTC) offered to fund the program for the remaining 34 provincial hospitals that were not yet engaged with MOREOB, and 26 hospitals accepted and completed the program. The implementation of the MOREOB program at these Ontario hospitals provided an opportunity to conduct a mixed-methods evaluation of the program implementation. This evaluation aimed to assess the outcomes and local implementation process for the MOREOB program in the Ontario context, provide data to facilitate comparison between provincial settings, and contribute qualitative data for more in-depth information on participant experiences with the program.In 2002 in the province of Ontario, hospitals providing obstetrical services began to voluntarily implement the program, and by 2012, 67 hospitals were involved with MOREOB program in any of the sites but conducted the comprehensive evaluation of the program with two main goals, specifically to evaluate (1) the program outcomes and (2) the implementation process .A previously developed and validated online 54-item Culture Assessment Survey (CAS)  to assesWe used data from two existing surveys administered routinely to all participants by Salus Global as part of involvement in the MOREOB, post-Module 1, post-Module 2, and post-Module 3 . Changes in mean scores across the four time points were assessed using linear mixed-effects regression analysis. Repeated measures were accounted for using an unstructured covariance pattern matrix, and clustering at hospital sites was accounted for using a random intercept. Least square means and pairwise comparisons were assessed at the 1% level. All analyses were carried out using SAS v. 9.4.OB program on health care provider knowledge, organizational culture, and barriers and facilitators to implementing and participating in the MOREOB program [We used a qualitative descriptive design , 23. Thi program , 24.OB program. The research team reviewed the initial draft interview guide, with modifications made to increase comprehensiveness and clarity . Minor modifications to the guide were made throughout the qualitative data collection period to reflect the timing of the interview in relation to program implementation and to probe new themes emerging from previously conducted interviews.A 14-question semi-structured interview guide .We used a purposeful sampling approach to recruit interview participants . SpecifiOB core team chairs to the research team for the purpose of interview participant recruitment. Interviews were conducted at two time points (post-Module 2 and post-Module 3) to capture the variety of experiences as the MOREOB program progressed. At each of the two time points, an email with an attached recruitment poster was sent by the research team to the MOREOB core team chair at each of the 26 hospitals, with instructions to circulate the invitation to all team members participating in the MOREOB program at their site. Interested participants were instructed to contact the principal investigator to learn more about the study, ascertain eligibility, and schedule a time for an interview. Reminders were sent by the research team to the MOREOB core team chairs to maximize responses. Individuals could participate in interviews at one or both time points. We welcomed participants who volunteered to be interviewed a second time as an opportunity to learn about differences they experienced between modules.Permission from each of the 26 hospitals was obtained for Salus Global to release the names and contact information of the MOREOB program), our purposive sample of participants were specific to our study aims , and we anticipated rich dialogue with participants due to the use of interviewers experienced in both qualitative research and the clinical practice area. These factors, in combination with our experience from past provincial program evaluations, led us to predict that we would need up to 20 participants to provide sufficient information power to answer our research questions.While in qualitative research there are no standardized rules for sample size, we used the concept of information power for guidance . For exan = 9) was conducted between March and April 2015 to learn about participants’ experience with modules 1 and 2 of the MOREOB program. The purpose of conducting the first round of interviews after module 2 was to allow sufficient time for participants to be able to experience and report on any perceived changes to culture and clinical processes in their setting. The second round of interviews (n = 10) was conducted between April and July 2016 to learn about participants’ cumulative experiences after completion of module 3 of the MOREOB program and plans for sustainability. Four health care providers were interviewed during both round one and two, meaning that there were a total of 15 unique interviewees. Interviewing, transcription, and analysis proceeded concurrently to permit follow-up of issues emerging from the data, and allow probing of emerging themes in subsequent interviews [Two research staff  experienced in qualitative interviewing conducted the telephone interviews. Informed written consent was obtained prior to each interview. Interviews lasted an average of 34 min. The first round of interviews   from baseline to post-Module 3 and CAS scores increased by a mean of 0.45 . Both increases were statistically significant. Least square mean estimates with standard errors across the four time points are presented in Fig. Increases in knowledge test and CAS scores for each professional group are presented in Table Between March 2015 and July 2016, 19 telephone interviews were conducted with a total of 15 health care providers from 11 sites Table .Table 4QOB program. Five main themes and their respective sub-themes were identified: communication, knowledge, safer care, increased confidence, and program implementation , which were implemented during debriefing about cases.An important focus of the MOREinterprofessional communication, resulting from bringing the different professions together to participate in the program, sometimes for the first time. These opportunities for interprofessional communication and teamwork led to participants perceiving a more familiar and collegial work environment.Participants perceived increased knowledge itself gained from the MOREOB program. MOREOB was described as a comprehensive, time efficient, and accessible resource as all information is contained in one place, both in-print and online. In addition, participants perceived that the content of MOREOB had been well-researched, was evidence-based, and relevant to the local context.Participants valued the OB program allowed all team members to share the same knowledge and language, put everyone “on the same page,” and gave everyone a common reference point.Participants described how participating in the MOREOBincreased their knowledge base and that of their colleagues. For some, this increase in knowledge was a reminder of the importance of ongoing training to maintain current knowledge and skills. The MOREOB program was described as being particularly helpful in a small hospital setting with low birth volumes where it can be difficult for new obstetrical nurses to gain sufficient experience in obstetrics.All participants described how MOREOB resulted in the perception that the health care team was providing safer care to patients. Participants identified concrete changes made on their units due to their participation in MOREOB. Examples of concrete changes included development or updating of policies and procedures, creating disaster carts with appropriate equipment, changes to clinical practices, posting algorithms on walls for clinicians to view, conducting case audits, and utilizing debriefing methods.Participation in MOREOBchanged the way they delivered care. First, participants described improved collaboration with their colleagues, which resulted in better ‘team work, openness, and transparency’, which ultimately improves safety for patients. For those sites who described pre-existing hierarchical relationships between obstetrical care providers, participants described a decrease in hierarchy within their team. However, a couple of sites described still struggling with hierarchy and were still working to change the culture at their sites. In addition, participants identified that participation in the MOREOB program improved the patients’ experience by improving their collaboration with women and emphasizing the importance of patient centred care.Participants described how MOREOB program had led to improved outcomes such as decreased maternal and infant morbidity and mortality, as they did not have data to refer to during the interview. One site had these data and stated they observed a reduction in critical events since participating in MOREOB. Overall, participants believed that the increased knowledge and concrete changes were ultimately improving care, outcomes, and patient experience.Generally, participants could not speak definitively as to whether their hospital’s participation in the MOREOB had on their self-confidence, particularly nurses who were described as being empowered through the MOREOB program by increasing their knowledge and skills and improving their team communication. In addition, participants described an increase in their confidence in the knowledge, skills, and judgments of their team members. As MOREOB participants improved communication, increased their knowledge base, and improved their ability to provide safer care, their confidence in themselves and others increased.Participants described the impact MOREOB program, including use of huddle boards, staff emails and staff newsletters. In general, participants described following the MOREOB activities as intended, with sites modifying the activities to make it more relevant for their setting or to fit it into limited time frames as needed. Some participants stated that the MOREOB program plan was not clear, even after attending the orientation, and felt that additional detail on upcoming activities would be beneficial.Participants described different strategies used for implementing the MOREinfluencing factors that affected how easy or difficult it was to implement the MOREOB program in their context. For example, buy-in was increased when team members were interested in the content of the module and “hungry for new knowledge.” Participants also identified organizational-level barriers including limited time of staff and lack of funding to pay staff for their time to participate in the program, and a baseline organizational culture that was more resistant to change. Organizational-level facilitators included engaged hospital administration and the presence of MOREOB champions who were highly committed to the implementation of the program.Participants described several sustainability of the MOREOB program at their hospital once their three-year funding ended. Participants were keen to keep MOREOB active at their hospital, and many sites were pursuing continued involvement, either formally with Salus Global, or when funding was not available, through internally-led education programs and skills drills. Regardless of the specific strategy, sustainability of the knowledge and skills gained through MOREOB was identified as a priority.Participants described varying levels of awareness regarding the OB program modules with the remainder of the team which presented challenges as the team was “storming and forming” all over again. A key challenge for sustainability of the program was cost, with participants perceiving that the program should be kept at a reasonable price to ensure institutions and providers can benefit from it.Staff turnover and new hospital priorities were identified as ongoing challenges to sustainability of the program. As new people joined the unit, they had not participated in the initial MOREOB program on participant knowledge, perception of organizational culture, and experiences implementing and participating in the program. Findings from both the quantitative and qualitative components of this study demonstrated increases in knowledge and positive perceptions of organizational culture. Findings from the qualitative component revealed that participants spoke positively of the program and the benefits of participating. In addition, barriers and facilitators to implementation and sustainability were identified.Our mixed-methods study evaluated the effect of the MOREOB benefits such as increased knowledge and sharing a common knowledge, as well as increased confidence in themselves and in their teammates as a result of this increased knowledge.The increases in knowledge scores occurring for all professional groups resonate with findings from our qualitative analysis, with participants describing MOREOB implementation, with all professional groups showing an increase in knowledge from baseline to post-Module 3 [Data collected in a previous study revealed similar results on the knowledge tests in Canadian hospitals after MOREModule 3 . As in oModule 3 . This maOB levels. Likewise, in the previous Canadian evaluation, there was a significant increase on all six elements of the CAS [Our study showed an overall significant increase in the safety culture from baseline to post-Module 3, with scores increasing almost half a point out of 5 from pre-MORE the CAS . Our quaOB program and may have facilitated the positive culture changes we saw in our evaluation.Team work, which is one of six categories on the CAS, has been identified as an essential element for reducing maternal and infant morbidity and mortality, as well as improving patient experience in obstetrics . CharactOB program, some sites still struggled to overcome issues with hierarchy on the interdisciplinary team, which is important as it can prevent health care providers from speaking up [OB program uses HRO principles [OB program may be required for sites to continue to decrease interprofessional hierarchy and improve their ability to work and communicate as a team.From the qualitative data, we learned that despite participation in the MOREaking up . The ongaking up . One indaking up . Specifiaking up , 34. Paraking up , 36 and aking up . Exampleaking up , 37–40. inciples  applied OB program is being implemented. The influence of site context on culture change has been observed in other healthcare settings, with a longitudinal mixed-methods study of 10 hospitals participating in a quality collaborative intervention reporting distinct differences between the hospitals with substantial culture change versus those without. Hospitals with positive culture change employed an interprofessional and inter-hierarchal approach, reported high levels of participation, and utilized strategies for managing conflict and maintaining engagement [OB program aims to improve the safety culture in birthing units, the extent to which this can be improved may be influenced by specific hospital and team characteristics.The varying experiences in culture change found in our qualitative interviews speak to the importance of the context in which the MOREgagement . AlthougOB program in improving several dimensions of a culture of safety, it is important to acknowledge that other patient safety initiatives in obstetrics, such as CRM team training, the Comprehensive Unit-based Safety Program (CUSP), and other locally developed quality improvement initiatives, have also demonstrated improvements in health care provider safety attitudes [While our quantitative and qualitative findings support the effectiveness of the MOREttitudes , 42, 43.ttitudes , 42 and ttitudes , 42, 43,ttitudes , 42, 43,ttitudes , 42, 43.ttitudes , 42, safttitudes , 42, jobttitudes , 42, 43.Lastly, there is evidence to suggest that positive workplace and organizational culture is associated with improved patient outcomes including decreased mortality rates, adverse events, readmission rates, and increased patient satisfaction across a variety of health care settings . While oOB program. Several individual- and organizational-level facilitators and barriers to implementation and maintenance of the MOREOB program were identified, some of which are consistent with factors reported in the literature, and align with existing theoretical frameworks [social influences [OB program. This was similar to lessons learned in another Canadian evaluation, where the hospitals’ MOREOB core team was identified as essential to driving the participation of members [environmental context and resources [OB program and baseline organizational culture. With limited financial, physical, and human resources within health care organizations, running and sustaining the MOREOB program can present a challenge.Overall, interview participants expressed satisfaction with their participation in the MOREameworks . For exafluences  such as  members . Second,esources  such as OB program include increased leadership engagement, conducting a baseline barriers assessment, and use of ongoing monitoring and evaluation at a local level. First, leadership has been identified as critical for developing a culture of safety [OB, the support of senior administration is key to successful implementation of the program, through direct participation on the core team, and through supporting their work [OB program implementation may assist hospitals to identify individual- and organization-level barriers, and identify existing strengths and resources that may be used to facilitate implementation [OB program had translated to improved patient outcomes at their hospital. Evaluating key outcomes using local data is an important component of the knowledge translation process [OB program by showing participants where they are (or are not) making a difference, and identifying areas of improvement for the MOREOB core team related to program implementation and participation.Previous research suggests potential strategies to facilitate implementation and uptake of the MOREf safety , and in eir work . Next, aentation . Lastly, process  to improOB program increased knowledge, changed the patient safety culture, and improved the work environment at many participating hospitals. For example, participants in the interview component of our study identified other improvements that were not within the scope of this current study to assess quantitatively. Specifically, interview participants spoke of perceived improvements from the MOREOB program related to patient experience, health care provider confidence, and interprofessional communication. These additional benefits are important to individuals and health systems because: (1) improved patient experience is an important goal for health care systems [OB program on these constructs using validated measures may be warranted.While our evaluation showed positive findings from the participant surveys and qualitative interviews, understanding the actual impact on perinatal outcomes is important, because a patient safety program should really translate into improved outcomes. As part of the larger evaluation we reported that these findings did not translate into a statistically significant reduction in adverse maternal and neonatal outcomes at the provincial level . Despite systems , and (2) systems , an esse systems . Given tOB 2.0 and MOREEX, which can support health care teams in acute settings beyond obstetrics [OB 2.0 program may consider our lessons learned from the Alberta [Considering the overall positive results from the surveys and interviews, it is not surprising that most participants expressed a desire to keep the program active at their centers. Future work to create a program model that is affordable and sustainable for participating hospitals is needed. Since the completion of this evaluation, Salus Global has launched MOREstetrics . Future  Alberta  and Onta Alberta , and eveOB program. As well, we included data from qualitative interviews carried out with 15 participants, including an administrator, nurses, midwives, and physicians, providing rich in-depth information on the MOREOB program. The fact that findings from both methods were convergent regarding improvements in knowledge and safety culture supports the effect of the program on these outcomes.The use of a mixed-methods approach is an important strength of this study. We used data from two surveys, carried out at four time points as participants progressed through the MOREOB modules. Our findings are similar to those published previously, and are an important addition to the literature due to the limited methodologic and sampling information provided in the earlier publication [To our knowledge, ours is only the second paper to publish results of the knowledge test and CAS at baseline and after implementation of the three MORElication . FurtherOB program in 2013. These sites likely differ from the 67 hospitals that voluntarily initiated participation in the MOREOB program prior to 2013, independently of any funding. As well, for the knowledge test and CAS, all of the respondents were participants in the MOREOB program, meaning that we do not have data on non-participants. This is problematic, in that one would expect knowledge scores to increase over a four-year time period, with increased time in the workplace. Due to this limitation, we cannot attribute the increases we observed solely to participation in the MOREOB program. Additionally, the majority of respondents did not complete the CAS and knowledge test at all four time points. This is not surprising given staff turnover rates on obstetric units, however, our analyses were therefore limited to the one third of respondents who completed all of the assessments. Furthermore, it is difficult to know the clinical effect of the increases in knowledge and culture that were observed. Another limitation is the lack of data available on survey respondents, for example, we do not know their age or number of years in the workforce, which could influence survey scores. While our qualitative interviews included participants from diverse hospitals and professional backgrounds, only one obstetrician participated in an interview.A limitation is the inclusion of only those 26 hospitals who received provincial funding to implement the MOREOB core team at each site, by sending multiple email reminders, and by accommodating all participant schedules for interviews, we still only managed to capture participants from about 40% of eligible hospitals. Nonetheless, the information we obtained from these interviews provided valuable insight into the MOREOB program and its implementation to answer our research questions, although these findings may not be transferable to individuals and teams at the remaining sites.Lastly, it is important to acknowledge that our sample of 15 unique interviewees only included individuals from 11 out of the 26 potential hospitals. While efforts to maximize recruitment were made by communicating through the chair of the MOREOB program. Barriers and facilitators to implementation and sustainability of the MOREOB program were identified. Strategies to address barriers, maximize facilitators, and enhance sustainability of the MOREOB program are needed. Our results also suggest that the program may have a positive effect on participant knowledge and organizational safety culture. Further work to understand how these improvements translate to outcomes for patients and health care providers is needed.Results of this mixed-methods study suggest that participants were satisfied with their participation in the MOREAdditional file 1:OB program goals. This file provides the seven main goals of the MOREOB program we evaluated in this study. (DOCX 15 kb)MOREAdditional file 2:Semi-structured interview guide. This file provides the 14 questions that were used during the semi-structured interviews. (DOCX 14 kb)


Funding statement. The correct Name for the “Chinese National Major Projects” is the “National Program Project.”There is an error in the Funding statement. The correct numbers for the “National Program Project” are “Grants 2018ZX10731301-006-001 (HS/SPH), 2013ZX10003009-002 (HS/IPS).” The correct number for the “Clinical Research Plan of SHDC” is “16CR1028B (WS/SPH),” and the correct numbers for the National Institutes of Health R01 grants are “OD015092/RR13601, HL64560, and HL129887 (ZC).”There are also errors in the grant numbers in Funding statement:A correction has therefore been made to the “This work was supported by the National Program Project Grants 2018ZX10731301-006-001 (HS/SPH), 2013ZX10003009-002 (HS/IPS), Clinical Research Plan of SHDC 16CR1028B (WS/SPH), and the National Institutes of Health R01 grants OD015092/RR13601, HL64560, and HL129887 (ZC).”The authors apologize for these errors and state that they do not change the scientific conclusions of the article in any way. The original article has been updated.


Workplace programs designed to improve the health and psychological well-being of employees are becoming increasingly popular. However, there are mixed reports regarding the effectiveness of such programs and little analysis of what helps people to engage with such programs.This evaluation of a particularly broad, team-based, digital health and well-being program uses mixed methods to identify the elements of the program that reduce work stress and promote psychological well-being, sleep quality, and productivity of employees.Participation in the Virgin Pulse Global Challenge program during May to September 2016 was studied. Self-reported stress, sleep quality, productivity, and psychological well-being data were collected both pre- and postprogram. Participant experience data were collected through a third final survey. However, the response rates for the last 2 surveys were only 48% and 10%, respectively. A random forest was used to estimate the probability of the completion of the last 2 surveys based on the preprogram assessment data and the demographic data for the entire sample . The inverse of these estimated probabilities were used as weights in hierarchical linear models in an attempt to address any estimation bias caused by the low response rates. These linear models described changes in psychological well-being, stress, sleep, and productivity over the duration of the program in relation to gender and age, engagement with each of the modules, each of the program features, and participant descriptions of the Virgin Pulse Global Challenge. A 0.1% significance level was used due to the large sample size for the final survey .P<.001). With one exception, all the program modules contributed significantly to the outcome measures with the following average improvements observed: psychological well-being, 4.1%-6.0%; quality of sleep, 3.2%-6.9%; work-related stress, 1.7%-6.8%; and productivity, 1.9%-4.2%. However, only 4 of the program features were found to have significant associations with the outcome measures with the following average improvements observed: psychological well-being, 3.7%-5.6%; quality of sleep, 3.4%-6.5%; work-related stress, 4.1%-6.4%; and productivity, 1.6%-3.2%. Finally, descriptions of the Virgin Pulse Global Challenge produced 5 text topics that were related to the outcome measures. Healthy lifestyle descriptions showed a positive association with outcomes, whereas physical activity and step count tracking descriptions showed a negative association with outcomes.The final analysis suggested that the program is more beneficial for older people, with 2.9% greater psychological well-being improvements observed on average in the case of women than men (The complementary use of qualitative and quantitative survey data in a mixed-methods analysis provided rich information that will inform the development of this and other programs designed to improve employee health. However, the low response rates and the lack of a control group are limitations, despite the attempts to address these problems in the analysis. Workplace health initiatives promoting behavioral change have been recognized as vitally important strategies for improving the health of employees -3. A word=0.24, 95% CI 0.14-0.34). The effectiveness was larger in younger populations, in interventions with weekly contacts, and in studies where the control group received no health promotion. This systematic review highlights the importance of sound methodologies for statistical analyses and the handling of missing data in studies of this nature [In an earlier meta-analytic review of workplace health promotion programs , 18 studs nature . It was s nature . In partHowever, studies have shown that missing data in mHealth are closely linked to the level of engagement , suggestMuch of the research has focused on the overall effectiveness of workplace health and exercise programs and workplace health promotion programs rather than investigating the characteristics of more successful programs and investigating the characteristics of employees for whom such programs are more or less beneficial. It is this gap in the literature that this research attempts to fill, using a workplace health and exercise program entitled the Virgin Pulse Global Challenge (VPGC). In this study, we use modern missing value approaches to model outcomes of interest, including various measures of engagement as predictors in these models.mixed methods [The evaluation of interventions usually involves a quantitative comparison of baseline and postassessment and/or follow-up performance using measures relevant to the intervention focus. However, postassessment surveys usually collect qualitative as well as quantitative data by way of open-ended questions. Although these qualitative data may be reported in a descriptive sense, there is seldom any attempt to incorporate this information into the analysis of how and why an intervention may fail or succeed. Due to the recent availability of sophisticated text mining tools, it is now possible to augment quantitative evaluations of an intervention with qualitative data using  methods ,13. In tIn this paper, we address the following 4 hypotheses:Virgin Pulse is a global Software-as-a-Service vendor providing several health and well-being programs designed to improve the psychological well-being of employees. The Global Challenge is one of the Virgin Pulse programs that features a team-based health and well-being challenge. The challenge consists of a 100-day virtual journey around the world, referred to as the 100-Day Journey. As part of the 100-Day Journey, employees are placed in teams of 7 individuals from their organization and provided with an activity tracker (the Pulse Device or other third-party-supported devices) and access to an app that is available through Web browsers and on mobile devices. Teams compete with one another to accumulate steps measured by their activity trackers.The VPGC program differs from most other workplace health and exercise programs in terms of its breadth. In particular, the simultaneous focus on social, physical, and mental health is regarded as a strength of this program, which is seldom seen in other programs. In addition to promoting physical activity, the program incorporates a number of modules that focus on encouraging improvement in sleep, nutrition, and psychological well-being. The Balance module addresses mental health issues, and the Heart Age module provides 2 evaluations: a lifestyle score out of 1000 and heart age relative to real age.The program is gamified to encourage employees to develop healthy habits through education, goal setting, and positive reinforcement using progress monitoring and achievement awards .The target population for this research was participants from all the organizations that were enrolled in the VPGC program that commenced in May 2016. Participants agreed to the use of their personal data by any agencies engaged by Virgin Pulse for the purposes of quality control. They did this when they signed up for the VPGC program on the internet , when enThe VPGC platform and its practices around data security and privacy have been externally audited and certified against the following standards: ISO 27001:2013, TRUSTe privacy seal, and General Data Protection Regulation governing data protection and privacy. The data were deidentified and password protected before being made available to the researchers and were held on university password-protected computers. Ethics approval for the evaluation of this program by the Swinburne University of Technology was obtained from the Swinburne University Research Ethics Committee (SHR Project 2017/061).pages to drive an easy and engaging completion process. All questions were voluntary, and there was no review step.The data were automatically collected using 3 electronic Web-based surveys, administered on the internet as closed (password-protected) voluntary surveys. The initial Web-based survey was completed early in May 2016, the second Web-based survey was completed toward the end of the 100-Day Journey, and the final Participant Experience Survey (PES) was completed 2 weeks later. There was no randomization of items in any of these Web-based surveys and no adaptive questioning. The first Web-based survey included 28 questions and the second survey included 29 questions, all with a Likert scale (0-6) or Yes/No responses. For the PES, there were 27 questions in a variety of formats . Questions were presented to users in approximate groupings of To measure psychological well-being, this study used the independently validated World Health Organization 5-item questionnaire (WHO-5) on psychological well-being. A total of 5 simple and noninvasive questions constitute this measure of subjective psychological well-being, which has been validated as a sensitive and specific screening tool for depression. This scale was first published in 1998; it has been translated into 30 languages and used all over the world . ResponsIn this study, the WHO-5 score was used as the primary outcome measure. Secondary outcome measures were self-assessed levels of work-related stress, sleep quality, and productivity for the last month . In all cases, higher scores indicated a more desirable state. All the above outcome measures were collected at the start (T1) and end (T2) of the VPGC program.In the final PES (T3), an attempt was made to identify the engagement factors perceived to be particularly beneficial by the participants. In particular, participant perceptions were considered with regard to (1) the best program modules  and (2) the best program features . These variables were all measured on a binary scale (0 for a negative response and 1 for a positive response). In this final T3 survey, participants also provided a response to the following question: “How would you describe the Global Challenge to a friend or colleague?” As described below, these responses were used to create 25 text topic scores for each respondent, consisting of values between 0 and 1 .Response rates often have little meaning in the context of workplace health and exercise programs and workplace health promotion programs  because The analysis was divided into 4 phases. In phase 1, descriptive statistics were presented for the final (T3) PES. Phase 2 involved predicting completion of this T3 survey and the WHO-5 psychological well-being measure for the second (T2) survey, using data collected in the first (T1) survey (including any missing data for the first survey). This predicted probability was inverted to produce the IPWs that were used in the ensuing analyses to reduce any estimation bias arising from missing data. Phase 3 consisted of the text mining used to produce the 25 topics and topic scores relating to the final PES question: “How would you describe the Global Challenge to a friend or colleague?” In the fourth phase, hierarchical linear model analyses were conducted for each of the outcome measures using IPW to address the problem of missing data. These analyses allow the research hypotheses to be addressed while attempting to adjust for any estimation bias caused by the low response rates. Phase 1 was conducted with IBM SPSS Version 25 software. Phase 2 and phase 3 analyses were conducted using the SAS Institute Enterprise Miner Version 14.2, whereas R software was used to produce a word cloud for the responses to the VPGC descriptions. Phase 4 was conducted using SSI Central HLM7 software.t tests for the outcome measures and Fisher exact tests for the crosstab tests.Responses for males and females were compared using independent samples Various tools were considered for modeling the completion of the PES (T3) and the T2 WHO-5 in terms of the first survey (T1) responses. In particular, a random forest was compared with single trees, gradient boosting, a neural network with 3 hidden nodes, support vector machines, and probit/logistic regression analyses -20. All Text mining was applied to analyze unstructured responses to the question “How would you describe the Global Challenge to a friend or colleague?”, producing text topics ,21. The The hypotheses were then addressed for each of the outcome measures using a hierarchical (multilevel) linear model analysis. For all these analyses, the IPWs calculated in phase 2 were applied to correct the estimation bias caused by low response rates. These hierarchical linear models  used allϕ<0.1).P<.001, ϕ=.07), suggesting that shared physical activity was probably not contributing very much to this improvement in colleague connections. Other features such as the mini-challenges, the leaderboard used for comparing the performance of all teams, and personal daily step count performance (My_Stats) were also important. There were several significant but very small gender differences in the case of program feature preferences, with females favoring the mini-challenges, My_Location , and Trophy features more than males, whereas males tended to favor the competitive program features more than women.As shown in As shown in d<0.2). The above descriptive statistics suggest improvements in the 4 outcome measures over the duration of the program, with large to moderate effect sizes (η2) of 0.37, 0.30, 0.23, and 0.11 for psychological well-being, sleep, work-related stress, and productivity, respectively. However, the low response rates for the T2 and particularly the T3 sample make any such claims premature. To address this issue of nonresponse bias, IPWs were calculated as indicated below, and a hierarchical (multilevel) regression analysis was conducted in phase 4.As shown in Perhaps not surprisingly, the random forest produced the best results for predicting completed responses, with an area under the ROC curve of 0.719 for the test data. However, single trees were not far behind, with areas under the ROC curve of 0.704. Other methods  produced disappointing results, with areas of less than 0.62 in all cases.weight (kg) variables were particularly useful for identifying missing survey responses. It seems that people who refused to supply their weight in the first survey (T1) are unlikely to complete 1 or more of the last 2 surveys. Younger age (<50 years) or missing age was also highly predictive of missing survey responses. The third most important variable for the random tree was psychological well-being (WHO-5 T1). A missing or very low WHO-5 T1 score (<22) was also associated with failure to complete surveys, suggesting that people who are depressed are more likely to drop out. This result confirms that the estimation bias is inevitable if analyses are conducted on the completer data, without making any attempt to account for this bias. The inverse of the estimated completion probabilities obtained from the random forest model was therefore used as weights (IPWs) to control for bias in the hierarchical (multilevel) regression models described below.In the random forest and the single tree shown in The PES included the following question: “In one or two sentences, how would you describe the Global Challenge to a friend or colleague?” The program modules have significant relationships with improvements in outcomes for psychological well-being (4.1%-6.0% on average), quality of sleep (3.2%-6.9% on average), work-related stress (1.7%-6.8% on average), and productivity (1.9%-4.2% on average). However, engagement with the Physical Activity module is not significantly related to improvements in work-related stress. The Nutrition program has the strongest association with improvements in psychological well-being, the Sleep module has the strongest association with improvements in the quality of sleep, and the Balance module has the strongest association with improvements in work-related stress and productivity.However, as shown in Text topic 2 relates to physical levels of activity, and the negative association with quality of sleep suggests that participants with this perception of the program saw a decline in their quality of sleep over the duration of the program. Text topic 3 relates to a healthy lifestyle, and topic 15 relates to the perception of the VPGC as a good or great motivator. The results suggest that for people with these perceptions of the program, there was evidence of an improvement in psychological well-being and quality of sleep. Topic 20 again relates to a healthy lifestyle, suggesting that stress at work is also reduced for these people. Finally, topic 23 relates to the daily tracking of step counts, and this perception of the program is associated with negative changes in psychological well-being and stress at work.R2 values ranging from 3.3% in the case of productivity to 11.9% in the case of psychological well-being. However, adding demographic variables, engagement with program modules, and features and perceptions of the program, as described to a friend or colleague, makes little difference to these R2 values, with an increase of only 2.5% for psychological well-being, 0.7% for quality of sleep, 1.4% for stress at work, and 2.2% for productivity. This means that although some support has been found for all 4 hypotheses, the size of these effects is small.This study has identified program modules and features of a workplace health and exercise program that are particularly helpful to employees, with differences observed between men and women, and more benefit for older people. Although these gender effects are small, they are significant. Two methods have been used in an attempt to address the low response rates for the second and third surveys. A random forest has been used to create IPWs, and these weights have been utilized in hierarchical (multilevel) models, utilizing maximum likelihood methods to minimize the estimation bias resulting from missing data. The study has used text mining to incorporate qualitative data in the hierarchical linear models, which is rarely seen .The research hypotheses are all supported to some extent as explained below.The VPGC program is associated with greater improvements in psychological well-being, quality of sleep, and work-related stress in the case of older employees. Greater improvements in psychological well-being were found for female employees than for male employees.All the modules contributed positively to psychological well-being, quality of sleep, work-related stress, and productivity, with 1 exception. The association was not significant for the Physical Activity module in the case of work-related stress.Employee perceptions for 3 of the program features were significantly associated with improvements for all 4 outcome measures. These 3 features were connections with colleagues nurtured using team structures, the mini-challenges, and  trophies. VPGC community sharing  was associated with improvements in quality of sleep and improved levels of work-related stress.Descriptions of the program by participants provide additional context. In particular, it was found that physical activity levels had a negative association with quality of sleep, whereas daily tracking of step counts had a negative association with psychological well-being and stress at work. However, perceptions of the program as a great motivator for a healthy lifestyle were associated with improvements in psychological well-being and stress at work.The combination of methods used in this analysis provides a better understanding of how the VPGC program may achieve behavioral change. The results suggest that although the Physical Activity module of the program is the most popular, it does not make a significant contribution to reduced work-related stress, and perhaps through its emphasis on step tracking, it has a negative association with sleep and psychological well-being as well. However, there were many positive associations, which suggest that the other modules and several of the program features are associated with positive outcomes. Perceptions of the VPGC as a tool for motivating a healthy lifestyle are especially conducive to positive outcomes.It has been recommended that modules addressing nutrition and mental health are particularly advantageous and that a variety of program features are beneficial to address the differing preferences of men and women. The VPGC program appears to be more effective with older participants, and future work is required to explain this. However, no rigorous evaluation of the effectiveness of the VPGC is possible on account of the data limitations presented below.Survey completion rates were particularly low for the final (T3) survey, which is crucial for this analysis because it contains the engagement data with the program modules and features and the description of the VPGC data used to create the text topics. With so many variables missing for 90% of the T3 data, IPW was the only way to address the threat of estimation bias. Furthermore, hierarchical linear models were needed to address the problem of missing T2 outcome values for many of the T3 respondents, ensuring that all T3 participants could be retained for the analysis. However, it is still not certain that estimation bias has been avoided. The predictors in our model  relate to engagement only indirectly. Other studies involving Web-based programs have used more direct engagement measures, such as the number of sessions completed , time toMoreover, as there is no control group in this study, it is not possible to claim that the program and its individual modules are beneficial because we have no participants outside of the VPGC. In addition, none of the effects considered in this analysis were strong and must therefore be treated with caution in view of the limitations described above.Finally, there were no follow-up data that could be used to assess the long-term effects of the program. Future studies should allow for a control group, ideally utilizing an RCT and should provide follow-up data to address these limitations.The VPGC program is an internet-based program that previous research suggests is not the best way to conduct a workplace health and exercise program . HoweverAge was identified as a significant predictor of engagement with the VPGC. Specifically, the results of this study showed that in terms of stress, sleep, and psychological well-being, the VPGC is more successful with older people. This is consistent with some previous workplace health and exercise program evaluations, which have reported that older employees tend to remain more engaged in workplace health and exercise programs in comparison with younger employees -30. Howeϕ=0.07).Results of this study confirmed that improving connections with colleagues is a particularly important feature of the VPGC. Previous mixed-methods and qualitative studies have reported that team-based workplace health and exercise programs increase motivation for exercise due to not wanting to let the team down and creating positive topics of conversation among employees ,32. ThisAlthough the Physical Activity module was the most popular module, engagement with this module had no significant association with work-related stress. In addition, descriptions of the VPGC relating to physical activity had a negative association with quality of sleep, and the results suggested that the step-tracking component of the Physical Activity module might, for some participants, detract from psychological well-being. However, further investigation is required to determine why this is the case.The Balance module, which aimed to promote psychological well-being, was found to be an important module with regard to reduced stress and enhanced sleep quality, productivity, and psychological well-being, with the Nutrition module also strongly associated with psychological well-being. This suggests that future workplace health and exercise programs may benefit from incorporating modules focusing on mental health and nutrition, rather than just targeting physical activity.According to our results for the participants who completed the final T3 survey, the VPGC program is associated with reduced work-related stress, improved quality of sleep, and improved productivity. It is also associated with increases in psychological well-being, especially in the case of women. The qualitative analysis identified a healthy lifestyle as a beneficial perception of the program, whereas the quantitative analysis indicated that the Nutrition and Balance modules contribute the most to program outcomes. However, despite the Physical Activity module being the most popular module, its contribution to reduced work-related stress appears to be limited. The social and gamified features of the program, especially the mini-challenges, appear to make the program a lot of fun.However, these results must all be regarded as preliminary because of the lack of a control group, the low response rate for the final PES, and the lack of follow-up measures. Further work is required to provide greater certainty.


ISBCR-ABL1/ABL1 transcript levels to <10% after 3 months or <1% after 6 months of tyrosine kinase inhibitor therapy are associated with superior clinical outcomes in chronic myeloid leukemia (CML) patients. In this study, we investigated the reliability of multiple BCR-ABL1 thresholds in predicting treatment outcomes for 184 subjects diagnosed with CML and treated with standard-dose imatinib mesylate (IM). With a median follow-up of 61 months, patients with concordant ISBCR-ABL1/ABL1 transcripts below the defined thresholds (10% at 3 months and 1% at 6 months) displayed significantly superior rates of event-free survival (86.1% vs. 26.6%) and deep molecular response  compared to individuals with ISBCR-ABL1/ABL1 levels above these defined thresholds. We then analyzed the outcomes of subjects displaying discordant molecular transcripts at 3- and 6-month time points. Among these patients, those with ISBCR-ABL1/ABL1 values >10% at 3 months but <1% at 6 months fared significantly better than individuals with ISBCR-ABL1/ABL1 <10% at 3 months but >1% at 6 months . Likewise, subjects with BCR-ABL1/ABL1IS at 3 months >10% but <1% at 6 months showed a higher cumulative incidence of MR4 compared to patients with ISBCR-ABL1/ABL1 <10% at 3 months but >1% at 6 months . Finally, lower ISBCR-ABL1/GUS transcripts at diagnosis were associated with ISBCR-ABL1/ABL1 values <1% at 6 months (p < 0.001). Our data suggest that when assessing early molecular responses to therapy, the 6-month ISBCR-ABL1/ABL1 level displays a superior prognostic value compared to the 3-month measurement in patients with discordant oncogenic transcripts at these two pivotal time points.A reduction in  BCR-ABL1 fusion chimeric gene, encoding an oncoprotein with constitutive tyrosine kinase activity that alters the proliferation rate, survival signaling, immunological interactions, and cytoskeletal dynamics of the hematopoietic stem cell  have been employed to predict CML response to IM at the time of diagnosis, thereby recognizing patients that will display inferior overall survival (OS) rates ,20,21,22patients . SubsequML to IM . This boISBCR-ABL1/ABL1 transcripts (ISBCR-ABL1/ABL1 <10% at 3 months but >1% at 6 months or ISBCR-ABL1/ABL1 >10% at 3 months but <1% at 6 months) at the 3- and 6-month time points. In this study, we investigated the clinical implications of these molecular landmarks, in subjects with discordant transcripts at the 3- and 6-month time points, in order to translate these molecular data into clinically meaningful information for CML patients receiving IM as first-line treatment for their disease.In this complex clinical and molecular scenario, a challenging issue is how to manage patients who display discordant 3) , and 90 (48.9%) achieved a deep molecular response (MR4) . Median follow-up of the accrued population was 61 months . According to the 2013 ELN recommendations, 126 (68.5%) patients achieved an optimal response, 39 (21.2%) failed IM, 10 (5.4%) were classified as “warning”, and 9 (4.9%) discontinued IM due to drug intolerance. All individuals who discontinued IM because of drug failure or intolerance received 2G TKIs.Patient characteristics are summarized in BCR-ABL1/ISABL1 levels of 10% at 3 months and 1% at 6 months are predictive of OS, progression-free survival (PFS), event-free survival (EFS), and CCyR [ISBCR-ABL1/ABL1 levels at 3 and 6 months, we found that 63% of the patients had concordant low transcripts  while 15.8% of individuals displayed concordant high transcripts . EFS probability was 86.1% vs. 26.6% (p < 0.001) in patients respectively displaying concordant low values (group A) or concordant high values (group D)  A.ISBCR-ABL1/ABL1 at 3 months but high (>1%) levels at 6 months (group B), and 6% displayed high (>10%) ISBCR-ABL1/ABL1 at 3 months, but low (<1%) levels at 6 months (group C). Among subjects with discordant BCR-ABL1 expression, group B (<10% at 3 months but >1% at 6 months) achieved significantly lower 6-year EFS as compared to group C (>10% at 3 months but <1% at 6 months)  ISBCR-ABL1/ABL1 levels would predict subsequent molecular responses to IM. Therefore, we compared the cumulative incidence of MR3 and MR4 in the four groups described above. As expected, there were significant differences between groups A and D. Specifically, patients with low transcripts at both 3 and 6 months showed significantly higher cumulative incidences of both MR3  and D (21.3%), which were those that presented ISBCR-ABL1/ABL1 values >1% at 6 months. On the contrary, both groups A and C - displaying ISBCR-ABL1/ABL1 values <1% at 6 months - expressed lower ISBCR-ABL1/GUS at diagnosis (12.9% for group A and 11.6% for group C). These differences were statistically significant  and were then stratified into the four previously described groups (A–D) according to their ISBCR-ABL1/ABL1 levels at 3 and 6 months. By considering the Sokal score, we found a significant correlation in groups with concordant BCR-ABL1/ABL1IS transcripts at 3 and 6 months . In groups with discordant transcripts, we found that individuals with ISBCR-ABL1/ABL1 levels >1% at 6 months (group B) displayed a three-fold greater number of subjects with a high Sokal risk as compared to individuals with ISBCR-ABL1/ABL1 levels >10% at 3 months . However, these differences were not statistically significant. When we repeated this analysis considering the ELTS score, we again found a significant correlation between different risk groups and patients displaying concordant ISBCR-ABL1/ABL1 transcripts at 3 and 6 months  presented low/intermediate ELTS scores compared to subjects with higher BCR-ABL1 levels at 3 and 6 months . No significant correlation was achieved in groups with discordant BCR-ABL1 transcripts at the two time points, possibly due to the low number of patients in each of these patient subsets.Multiple findings have established that low Sokal and ELTS scores are associated with better OS ,21,22. WISBCR-ABL1/ABL1 transcripts after 3 and 6 months of TKI therapy has become routine practice for the management of CML, as BCR-ABL1 levels below the conventional 10% (at 3 months) and 1% (at 6 months) thresholds are associated with higher probabilities of achieving excellent failure-free survival (FFS), EFS, PFS, and OS [ISBCR-ABL1/ABL1 transcripts below the indicated thresholds at both the 3- and 6-month landmarks presented superior outcomes compared to those with BCR-ABL1 transcripts above the 10% and 1% values. However, we also wanted to investigate the clinical impact of ISBCR-ABL1/ABL1 transcripts when the values measured at the 3- and 6-month time points were discordant: i.e., a satisfactory (<10%) value followed by an unsatisfactory one (>1%) or vice versa. A previous publication by the Hammersmith group, authored by Neelakantan and colleagues, showed that when the 3 and 6 months transcripts were discordant, the 3-month levels displayed a superior prognostic value compared to the 6-month measurement [BCR-ABL1/ISABL1 transcripts >10% at 3 months that have already acquired resistance to IM and are unlikely to benefit from additional treatment with the same drug. This can justify the lower predictive value of BCR-ABL1 transcripts at the 6-month time point in the UK cohort. This hypothesis is in line with the different number of patients included in the group with high BCR-ABL1 transcripts at 3 months but low levels at 6 months in our series (6%), compared to the UK cohort (2%). It should also be noted that our results are in agreement with those previously published by the Korean group, indicating that BCR-ABL1 transcripts below the 1% threshold at 6 months are a reliable molecular parameter capable of identifying a subset of patients that will benefit from their assigned treatment even if their BCR-ABL1 levels at 3 months were above the 10% value [Quantification of , and OS ,24,27. Asurement . Interes0% value . UnfortuBCR-ABL1 expression is a useful parameter to discriminate, at diagnosis, patients unlikely to benefit from standard-dose IM [BCR-ABL1 quantification with the molecular transcripts detected at 3 and 6 months. We confirm a direct association between BCR-ABL1 expression levels at diagnosis and IM response, as patients with BCR-ABL1 values <1% at 6 months (groups A and C) were those expressing lower BCR-ABL1 transcripts at diagnosis.Both the NCCN and the ELN recommendations for the management of CML patients require disease molecular evaluations at 3, 6, and 12 months during TKI treatments. In our previous study, we demonstrated that baseline quantification of -dose IM . In the 4) could be considered for TKI discontinuation as they may remain in treatment-free remission (TFR), even after drug cessation. TFR is an attractive possibility because of relief from TKI toxicities, desire to plan a pregnancy, and general improvement in quality of life. Moreover, even with the advent of generic IM, TKI discontinuation may greatly relieve the financial toxicity associated with CML treatment [Finally, several clinical trials have demonstrated that patients who achieve and maintain a deep molecular response  CML were accrued to this study. Diagnosis of CP-CML was defined by conventional criteria. No prior treatment for CML other than hydroxyurea was allowed.BCR-ABL1 transcripts at 3 and 6 months were included in this study.All patients received IM 400 mg daily as first-line therapy. The drug was discontinued in the presence of grade 3/4 toxicities with treatment resumed after toxicity reduction to grade 1 or complete resolution. IM responses were evaluated according to the 2013 ELN criteria . Only thThe research ethics committee  of each A complete hematological response was defined as previously reported . CytogenBCR-ABL1 and ABL1 expression were measured from peripheral blood (PB) samples drawn at diagnosis and then every three months using real-time PCR (qPCR) as previously described [ABL1 was used as the reference gene at any time point other than diagnosis. In addition, at diagnosis, BCR-ABL1 expression was measured by using GUS as a housekeeping gene as it is a more appropriate reference gene for specimens expressing high BCR-ABL1 [BCR-ABL1/ABL1 and BCR-ABL1/GUS were converted to the international scale (IS), as previously reported [3 was defined by ISBCR-ABL1/ABL1 ≤0.1% (3-log reduction from the standardized baseline) [4 was defined by ISBCR-ABL1/ABL1 ≤0.01% (≥4-log reduction from standardized baseline) [GUS copies or 10,000 ABL1 copies, as previously reported [escribed . ABL1 waBCR-ABL1 . All samBCR-ABL1 . qPCR dereported . MR3 wasaseline) ,36, whilaseline) ,36. qPCRISBCR-ABL1/GUS, at diagnosis, in the four groups of patients defined according to their ISBCR-ABL1/ABL1 levels at 3 and 6 months, were calculated using the ANOVA test, followed by the Tukey HSD post hoc test. Events included in our definition of EFS were death from any cause, a progression from chronic phase, IM failure according to the 2013 ELN recommendations, and development of intolerance. FFS was defined as survival without evidence of drug failure according to the latest ELN recommendations.Probabilities of event-free and failure-free survival, and cumulative incidence (CI) of different molecular responses, were calculated using the Kaplan–Meier method. Statistical significance between different Kaplan–Meier curves was evaluated using the Mantel–Haenszel test, as previously described . Differep-values with 95% confidence intervals. All statistical analyses were performed using R software [Differences in the occurrence of specific risk scores  among the four groups of patients were assessed using the Fisher exact test computing two-sided software .


Purpose: Low-income Latino immigrants lack access to mental health providers. We explored the feasibility of training promotores to deliver a stress management program in community settings.Methods: We trained promotores to deliver an 8-week intervention program comprising evidence-based cognitive-behavioral stress management techniques. Trained promotores then delivered the program to Spanish-speaking Latino immigrants.Results: Promotores (n=10) improved their knowledge significantly after the training (p<0.001) and delivered the program demonstrating excellent fidelity. Participants who received the program (n=50) had significantly improved scores on immigration stress, perceived stress, and depressive symptoms (p<0.001).Conclusion: It is feasible to train Latino promotores to deliver an effective stress management program to low-income Latino immigrants in their communities. Results contribute to a growing literature on the value of such interventions in community settings. If it is found to be effective in future studies, the program could help fill a large need in the Latino community. Promotores can easily establish rapport and transmit self-care knowledge and model desired behaviors. However, the participation of promotores in the delivery of mental health programs is not well understood.The purpose of this article is to describe the results of a feasibility study in which promotores were trained to deliver an intervention called Mentes Positivas en Acción (Positive Minds in Action) created to teach stress management skills to Spanish-speaking Latino immigrants. We aimed to develop a program that could be delivered in local communities to increase the likelihood of participation of this vulnerable group. We first trained promotores in the content and delivery of the program, and they then delivered the program to Latino immigrants in several community settings.The feasibility study was conducted in Concord, California in 2015. We sought to partner with a community-based organization that already served the Latino immigrant population and could sustain the program if successful. Monument Impact is a community-based organization located in Concord, California that primarily serves disadvantaged, underserved residents by providing programs and services to facilitate their becoming civically engaged, economically self-sufficient, healthy, and safe. Monument Impact already had a promotores model for service delivery and was interested in adding Mentes Positivas en Acción to their set of programs, thus a partnership was established.23; (2) Nuevo Amanecer24, and (3) La Prevención de la Depresión.25 Program manuals were obtained in English and Spanish from the programs’ authors.The Mentes Positivas program is a group-based stress-management program designed to manage stress and reduce depressive symptoms in lower income, Spanish-speaking Latino immigrants. The intervention draws from three evidence-based programs designed to teach Latinos skills for stress management and prevent and manage depressive symptoms. The programs included: (1) El Curso de Mamas y BebésThe resulting Mentes Positivas is a manualized program comprised of eight sessions lasting 2 h each; topics covered during each session are shown in Participants received the program in small groups of about six to eight participants per group. Groups were offered at a variety of locations in their community, for maximum convenience for participants who lacked transportation. Locations varied and included the conference room of Monument Impact, a community clinic, an apartment complex clubroom, and a classroom in a collaborating community-based organization.We designed a 14-week training for promotores to deliver the intervention using a multifaceted strategy that included didactic presentation of information on stress and depression, several cognitive-behavioral stress management techniques, and guided practice of those techniques and skills. The training curriculum paralleled the content of the Mentes Positivas program and consisted of weekly sessions lasting 3 h each. Training sessions took place in Monument Impact's conference room and were conducted in Spanish by the Principal Investigator, a bilingual/bicultural doctoral-level registered nurse from Chile.Ten sessions covered the content of the program and four pertained to program delivery skills. The content-based sessions included cognitive and behavioral stress management techniques, methods to gain greater control over one's mood, cognitive reframing, the role of increasing pleasant activities, and social skills training. The sessions on program delivery methods included training in communication, group facilitation, and presentation skills. For each session, the promotores participated in didactic activities, such as discussions of information included in the manual, and received information and tangible resources  that could be shared with program participants.Promotores also participated in group discussion about how these principles could be applied to fictitious case studies. We paired the promotores so that they would deliver the program as a paired team. Discussions on techniques for working as a team were discussed and practiced during the last four classes of the training. As the training proceeded, we allowed time for promotores to share their own stories of coping with stress and depressive symptoms; occasionally, this led to slight modifications in the program.Promotores received incentives, including program materials, a certificate of training completion, and a graduation ceremony. Each promotor (men and women) received a $150 gift card for participating in the training. Promotores received an additional $200 gift card upon completing delivery of the 8-week program to community participants.To provide ongoing technical assistance and enhance fidelity of delivery, promotores were offered continuing education sessions while they were implementing the program in the community. The promotores met monthly with the trainer and research assistant as a group; these group sessions were used to reinforce skills, share their experiences delivering the program to groups in the community, and obtain feedback from one another and the trainer. Fidelity ratings and observations were used to provide feedback to promotores during these sessions.Each team of promotores delivered the 8 weekly sessions lasting 2 h each. The trainer and research assistant assessed fidelity of delivery of the intervention through direct observations as the promotores delivered the intervention. Two sessions were observed for each team, chosen randomly.We assessed several aspects of fidelity using a 16-item structured rating scale that assessed the extent to which the teams accurately delivered the program. Examples of fidelity items include the frequency with which follows manual, explains concepts in words that participants can understand, guides participants to practice cognitive reframing, and emphasizes the importance of the homework. Items were rated from 1 to 4 with 1=not at all, 2=a fair amount, 3=a great deal, and 4=consistently. Scores between 3 and 4 indicate good fidelity. Fidelity ratings and observations were used as feedback given to promotores during the continuing education sessions.Promotores recruitment. The trainer and research assistant, in collaboration with Monument Impact, identified potential promotores. We conducted information sessions at Monument Impact's monthly promotores meetings and presented the training program's objectives and how the intervention was designed to be delivered in Spanish to Latino immigrants in the community. Inclusion criteria for promotores included previous experience as a promotor (man) or promotora (woman) in the community, interest in mental health, and ability to speak, read and write Spanish fluently. After providing written informed consent, promotores completed a questionnaire that included information about their age, education, birthplace, marital status, and language spoken at home.In addition, a needs assessment of their work schedules, family obligations, and transportation was done, to make the training classes congruent with their availability.Participant recruitment. Participants were recruited in the community through flyers posted at Monument Impact briefly describing the 8-week program being tested for Spanish-speaking Latinos who were feeling stressed or depressed. Eligibility criteria for participants were age 18 years or older and self-identified as Latino who speaks primarily Spanish. Screening was done in person, in Spanish, at Monument Impact's office by the research assistant. Participants were invited to review the schedule of classes and then assigned to a group. At the first session, the research assistant obtained written informed consent and then participants completed a short demographic questionnaire. Participants received a $100 gift card at the end of the study.Promotores’ knowledge: We assessed promotores’ pre- and post-training knowledge of the program content. At the beginning of each of the first 10 training sessions, promotores completed a brief multiple-choice test assessing their knowledge of the content of each session (sample questions were: What is depression? What are automatic thoughts?). There were no tests administered during the last four sessions dedicated to teaching back and to practicing, and reinforcing promotores’ presentation and facilitation skills.At the end of the training program (week 14), a 29-item multiple-choice test was administered to measure promotores’ knowledge of the entire training. A sample question was: Automatic thoughts are: (1) necessary to survive, (2) can be thoughts we are not aware that we have, (3) are thoughts we stop having when we are adults, (4) are thoughts we use when we don't when to think too much [with (2) as the correct answer]. The test was scored as the total number of correct answers (range 0–29).Participant outcome measures: For this feasibility study, we employed a single group pre–post design to evaluate the potential efficacy of the program on participants’ post-intervention stress and depressive symptoms. The research assistant conducted baseline assessments at the beginning of the first session. Spanish questionnaires were self-administered by most participants. Promotores administered questionnaires to a few low literacy participants who could not read and to two who were visually impaired.Questionnaires assessed basic demographics  and the main outcome measures. The outcome measures were also assessed by the research assistant at the end of the final session.Self-reported outcome measures were the: (1) Stress of Immigration Scale (SOIS), (2) Perceived Stress Scale-7 (PSS-7), and (3) Patient Health Questionnaire-9 (PHQ-9).26 The SOIS was originally tested with a sample of Mexican immigrant women, and its internal consistency reliability exceeded 0.80 for all subscales. Scale scores range from 1 to 5 with higher scores indicating more stress.The SOIS is a 21-item measure that assesses five domains of stress related to language, immigrant status, work issues, yearning for family and home country, and cultural dissonance among Latino immigrants residing in the United States.27 was used to assess general stress. We modified the PSS based on evidence from several studies among Mexican immigrant women that some items did not meet basic psychometric criteria.28A modified version of the Perceived Stress Scale (PSS)The modified scale consisted of the seven negatively worded statements . Each item is rated from 0 to 4, with 4 indicating high stress; we transformed items to a 1–5 scale, thus the final score ranged from 1 to 5. The 7-item scale demonstrated good reliability in this sample .29 Total scores range from 0 to 27 with higher scores indicating more depressive symptoms. The Spanish version of the PHQ-9 has been found to have good internal consistency reliability .30The PHQ-9 is a 9-item self-report measure that assesses depressive symptoms on a 4-point scale .This study was approved by the University of California San Francisco Institutional Review Board.We calculated means and proportions for descriptive variables. We calculated means and standard deviations for each of the variables of stress of immigration, general stress, and depressive symptoms. Using linear mixed models to control for clustering within promotores, we assessed changes in participants’ pre- and post-intervention scores on measures of stress of immigration, general stress, and depressive symptoms.Ten promotores were recruited and completed the training. Promotores’ mean age was 48.4 years . Half was male. By design, all were fluent in Spanish; one-third was fluent also in English. Most were married (90%) and had children (90%). Seventy percent worked outside the home. The average number of years they had worked as a promotor was 6 . Half had some college education. Promotores attendance was excellent; only one person missed one class. Nine promotores went on to deliver the intervention in community settings.p<0.001).Promotores’ knowledge of stress management and depression (possible range of score 0–29) improved significantly after the training. Before the training, the mean knowledge score was 11.9 , whereas after the training, the mean was 17.6 . A linear mixed model comparing pre- and post-training scores demonstrated significant increases in promotores’ knowledge from pre- to post-training  on a 1–4 scale (higher scores=greater fidelity) indicating excellent fidelity to the program. The range of scores across pairs (and one single person) was 2.6–3.9.n=2) and health issues (n=2). Additionally, two missed the last two classes and did not complete the post-program measures.We recruited 50 participants to receive the Mentes Positivas program, all of whom were Latino immigrants (one U.S.-born raised in Mexico). Four were unable to finish the eight sessions due to family commitments , a difference of about 0.5 SD. Stress of immigration scores improved from 2.3 (SD=0.9) at baseline to 1.8 (SD=0.9) post-program (p<0.001), also a difference of about 0.5 SD. Depressive symptom scores improved from 8.8 (SD=6.9) at baseline to 4.4 (SD=6.0) post-program (p<0.001), a difference of about 0.75 SD.Participants’ scores on all three outcome measures improved significantly after completing the program . ParticiThrough this feasibility study, we demonstrated the ability to train successfully community promotores to deliver a cognitive-behavioral stress management program to vulnerable Latino immigrants in community settings. Promotores were able to follow the manual with excellent fidelity and demonstrated improved knowledge of stress and mood management techniques. In turn, participants who completed the eight-session program delivered by the trained promotores demonstrated significant improvements in their levels of immigration stress, general stress, and depressive symptoms.Our academic–community partnership was unique because Monument Impact already had a promotores model of delivering services to vulnerable Latinos. We utilized this important community asset to house the project, while building its additional capacity to deliver stress management programs. The process of translating evidence-based programs, such as cognitive-behavioral stress management, involved negotiating important tradeoffs between internal and external validity while maximizing program adoption. For example, in each training class, the importance of adhering to the manual was discussed as well of not adding components such as music or exercise to the classes, as was sometimes suggested by promotores. Negotiations required excellent and respectful communication by partners.The fact that we were able to recruit and retain participants with very low levels of education and income is noteworthy. This supports our model of partnering with a community organization that already serves this population. By conducting all study procedures in the local community and by holding the group sessions in a variety of community settings, we maximized the convenience of participating in the program and the research study.20 The community partner and promotores were very motivated to complete the program because they felt a strong need on the part of the community for such interventions. We believe that teams of two promotores were better able to manage the groups and exercise greater accountability to follow the program manual with minimal deviation, than the one person who delivered the program alone (due to attrition of one promotore).As in other studies of promotores, our findings indicate that successful promotores-led programs require identification of appropriate promotores, needs assessment of promotores, a significant amount of training, and monitoring of program fidelity.During the ongoing technical assistance provided to promotores while they were delivering the program in the community, promotores expressed great satisfaction with the training and the delivery of the program and reported finding great personal meaning in helping their fellow community members. For example, one expressed how participating in this training improved the way she felt about herself as well as how her family and friends perceived her. For her, renewed self-confidence meant a new and improved relationship with her husband, children, extended family, and friends.Strengths of this feasibility study include near-perfect retention of promotores and excellent attendance of participants. Promotores demonstrated very good fidelity in delivering the program. Limitations include a small sample, lack of a randomized design, and no follow-up assessment after the program was completed.Our results show the potential benefits of training promotores to deliver a mental health program to low-income Latino immigrants in community settings. The intervention addressed barriers of the stigma of seeking care for depression and the lack of access to culturally appropriate, Spanish-language mental health services. The high prevalence of stress and depressive symptoms in the Latino immigrants who joined the study is consistent with the literature. If the program is found to be effective in future studies using larger samples and a randomized design, it could help fill the large need for such services in the Latino community and reduce mental health disparities for this growing population.