The purpose of this study was to conduct an implementation monitoring evaluation of a yearlong comprehensive school physical activity program (CSPAP) professional development program across eight multi-state physical education (PE) teacher cohorts. Mixed-method data were collected during a three-year implementation period via workshop attendance sheets and evaluations, post-workshop implementation plans and artifacts, and follow-up phone interviews to enumerate and evaluate the program’s process of recruitment, reach, dose delivered, dose received, fidelity, and context. Recruitment strategies reached a total of 234 PE teacher attendees across eight workshops, with 77 PE teachers  completing all program requirements. Facilitators among full program completers were participation incentives and network opportunities, while common inhibitors were difficulty with online technology and perceptions of added workload. Completers submitted implementation plans with at least three action steps, ranging from 4 to 7 months to accomplish, that predominately commenced with securing administration approval as the first step (81%), focused on implementing student physical activity initiatives beyond PE (76%), and evidenced with mostly picture artifacts (78%). Implementation was facilitated by the presence of multilevel support at school and an elevated image of PE and PE teachers at school, and was inhibited by scheduling constraints, unrealistic planning, and conflicting perceptions of physical activity and PE. Overall, this evaluation reveals unique perspectives of PE teachers regarding schoolwide PA promotion and informs future efforts to target and effectively support CSPAP leaders. A varieTo effectively deliver a CSPAP, schools should have an on-site champion to spearhead such efforts . A natio2Process evaluation has been identified as important to quantify the fidelity of program implementation, equally as important as evaluating the impacts and outcomes of an intervention . The infRecruitment refers to the procedures used to approach and attract program participants. Reach is the participation rate in the program, often measured by attendance rates and characteristics of participants. Dose delivered refers to the degree of completeness with which the intended program elements were provided to participants. Dose received is the extent to which participants were exposed to, utilized, and/or were satisfied with the intended program elements. Fidelity is the extent to which quality program interventions were implemented as planned. Context refers the potential barriers and facilitators that could be encountered when implementing program interventions. These six process aspects have served as conceptual guides for monitoring the implementation of school-based PA programs  were the target population for this evaluation with the exception of 47 PE teachers who were part of the Year 1 planning and pilot phase, and the 92 PE teachers who participated in the workshop only (see n = 234).A CSPAP professional development program was implemented in three consecutive delivery periods . During this three-year timeframe, there were a total of 440 participants in the professional development program from 24 states in the U.S. and one Canadian province. Participants were PE teachers (84.8%), higher education faculty from PE teacher education programs (10.0%), health or PE district staff (3.6%), and PE graduate students 1.6%; . The PE only see . Therefo3.2Similar to previous process evaluations of school PA promotion interventions , a conve3.3Multiple sources of data were accessed throughout the three-year implementation period to evaluate the six implementation components (indicated in parentheses after each data source below). Informed consent was obtained from participants prior to data collection. Study approval was granted by SHAPE America as the managing organization of the professional development program and the Institutional Review Board of the participating universities. All data available to the research team were included in this study.3.3.1The SHAPE America task force charged to develop the professional development program and its content served in many other capacities including: (a) the program’s principal consultants, (b) mentors during the 12-month professional development timeframe (per period), (c) website support technicians, (c) program evaluators and researchers, and (d) master instructors of the workshops. To fulfill these responsibilities, the task force members maintained regular communication with each other and SHAPE America throughout the three-year implementation period. Modes of communication were five in-person Year 1 meetings during planning and pilot phase, seven conference calls to discuss professional development program evaluation/expansion or research data management , and monthly e-mail correspondence among the task force co-chairs. Notes taken from these communications, including formal and informal observations, were distributed to the task force co-chairs who also spearheaded this evaluation research.3.3.2Teachers interested in attending the one-day on-site workshop provided basic contact information including name, school name and address, e-mail address, and phone number. This information was collected twice by different means: (a) registration data – interested teachers signed up for a training workshop via SHAPE America’s professional development webpage, or by e-mail or phone directly, and (b) attendance data – when teachers arrived at the training workshop via a sign-in sheet. The workshop was free for attendees , and as an additional incentive, attendance sheets were utilized to distribute continuing education credits to workshop attendees.3.3.3strongly disagree to 5 = strongly agree) to quantitatively measure workshop attendees’ ratings of the workshop’s: (a) content and delivery , (b) the instructor’s characteristics , and (c) their general experience . Three open-ended questions were used to supplement these workshop attendees’ ratings with qualitative data pertaining to the workshop content (“What would you like more information on?”), their general experience (“What was the most impactful part of the workshop”), and their next steps (“What action will you take at your school as a result of this workshop?”). The evaluation form was created by the task force as an expectation of: a) SHAPE America endorsed trainings, and b) earning continuing education credits.PE teachers who attended the six-hour workshop were asked to complete a 12-question evaluation form at the conclusion of the workshop. Nine questions used 5-point Likert-type scales . The implementation plan form was introduced to PE teachers near the end of the workshop and teachers were provided time to brainstorm and conceptualize some possible ideas amongst workshop attendees and the instructor. The implementation plan form provided space for PE teachers to identify the overall goal for the new PA initiative, the CSPAP component(s) the initiative would address, and the planned sequence of strategic action steps to accomplish it. Further, PE teachers were asked to outline four elements for each action step on the form: a) necessary resources, b) necessary personnel assistance, c) completion date, and d) an artifact (see next section for description) to document completion. PE teachers furnished an electronic version of their finished implementation plan to their assigned mentor  for the 12-month professional development timeframe for review, feedback, and approval. Implementation plan submissions and teacher-mentor transactions occurred primarily through the support website that accompanied the professional development program or individual e-mail. An anonymous sample of approved implementation plans were displayed on the support website as guided examples.3.3.5Another main completion criterion during the 12-month professional development timeframe was the submission of at least one artifact corresponding to each action step on the approved implementation plan. Artifacts were to be representative electronic documents, such as school schedules, revised curriculum, event materials, sample videos, and participant vignettes that supply evidence the action step was completed. The submission, review, and approval process of the artifacts, along with the posting of approved samples on the support website, was comparable to that of the implementation plans.3.3.6PE teachers were awarded a certificate after completing all criteria in the professional development program . Interviews were digitally recorded using computer software and a handheld device for back-up, scheduled on a school day and convenient time for the PE teacher, and lasted an average of 58 min (SD = 11 min).All PE teachers who attended an on-site workshop and expressed interest in seeking their completion certificate were invited to participate in one in-depth phone interview. The 20 consented PE teachers were categorized into two self-selected groups, matched by sex , tenure level (9 = 5 + years of experience) and school locale (7 = urban setting), that were based on completion rates of the professional development program: 10 cate see ; and 10 The same interview guide and clarification probes were employed with both teacher groups and corresponded to two sets of questions on the topics of perceived (a) sustainability factors and (b) multilevel benefits of the professional development program and CSPAP implementation. PE teachers were asked four questions related to their perceived sustainability of the professional development program and CSPAP implementation, with specific reference to facilitators and inhibitors of the on-site workshop and the implementation of the new PA initiative outlined on the implementation plan. Two sample questions were: “What has/would have inhibited your participation in the workshop/implementation of your plan?” and “What strategies or approaches have you considered or employed to overcome these inhibitors? The two multilevel benefits questions were: “What impact has your CSPAP implementation has on your – yourself, students, school community?” and “What specific strategies did/could you use to achieve the described benefits from CSPAP implementation?” After the 20 interviews were conducted, audio files were transcribed verbatim by a professional typist and returned to the PE teacher for accuracy checks. Partial completers were paid $50 for their participation, and full completers were paid $150 to help offset the $200 fee associated with completing the remaining criteria during the 12-month professional development timeframe see .3.4Quantitative data were analyzed with descriptive statistics consisting of cumulative frequencies, percentages, and means using IBM SPSS Statistics for Windows, Version 24.0 . All data sources, except the workshop evaluations and interview transcripts, contained quantitative data.Qualitative data were analyzed inductively using two naturalistic methods . First, 4The findings from the quantitative and qualitative data were compared, related, and integrated to produce main results across the six process aspects that are described below.4.1Procedures used to approach, attract and register participants in the professional development program occurred at both the national and state level. At the national level, the primary recruitment strategy was the website of SHAPE America, the primary professional organization for health and physical education teachers in the U.S. The CSPAP professional development program, along with others available to the 15,000+ membership community, was posted under professional development offerings where members can register for a reduced rate.Four recruitment strategies were utilized at the state level. First, school health division coordinators from statewide organizations  in the states where workshops were conducted were contacted and asked to distribute information about the professional development program to PE teachers. Second, Health/PE district coordinators in the states where workshops were conducted were asked to distribute invitations to their PE teachers, along with two follow-up reminders. Third, a recruitment booth was set up at the two-day annual meeting for PE teachers in the home state of the lead researchers. Fourth, PE teacher education faculty from the largest undergraduate PE programs in the home state of the lead researchers were asked to send invitations to recent graduates now employed as PE teachers. PE teachers’ registration data for the workshops are presented in availability of funds to attend the training and the ability to obtain continuing education credits facilitated their attendance at the workshop.In addition, recruitment was measured through the assessment of teacher-reported facilitators of and inhibitors to attending the on-site workshop see . Two fac4.2As presented in 4.3M = 10 teachers/cohort; Range 3–22 teachers/cohort) were delivered the professional development program as planned by fully completing the criteria across the 12-month follow-up period and earning a certification.A total of 77 PE teachers across eight cohorts . Feedback was regularly reviewed and addressed after each workshop.Workshop evaluation scores are presented in The main post workshop criteria depicted with checkmarks in Ninety-seven PE teachers  submitted an approved implementation plan. Among these 97 teachers with approved implementation plans, 91 (94%) submitted approved artifacts, and 77 (85%) completed the 12-month professional development program and earned certification. The PE teachers who completed the program and earned certification were largely female (74%) in elementary (68%) public schools (96%), more closely representing the preponderant distribution of the national teacher population .Dose received was also measured by the reported facilitators and inhibitors teachers encountered from completing these criteria see . Two fac4.5To assess the extent of the PA initiatives proposed for implementation in participating teachers’ schools, non-PE focused implementation plans  and three inhibitor themes  emerged across the full completer group and partial completer group. Participants expressed that support from multiple sources  facilitated the initiation and implementation of their program by obtaining approval from administration and hands-on assistance from classroom teachers, parents, and students. They also expressed that having a positive image and being viewed as someone that was knowledgeable about PA facilitated respect and support from others in the school . The inhibitor theme of perceived schedule constraints differed across completer groups. Partial completers mostly reported this inhibitor due to academically prioritized schedules, whereas full completers expressed schedule constraints due to playing multiple roles in their school. Contextually unrealistic program planning inhibited implementation for both groups due to unforeseen events such as bad weather or planning an initiative without considering the absence of contextual factors . Participants also expressed conflicting perceptions of PA and PE as some PE teachers did not perceive PA as their responsibility. Two facilitator themes  recruitment strategies employed for the professional development program resulted in relatively few training cohorts and interested teachers. To no surprise, incentives in the form of a travel stipend, free registration, and continuing education credits helped ensure 94% of the registered teachers attended a workshop they reportedly regarded highly. The popularity and utility of workshop incentives for increasing attendance rates is supported by previous teacher research . Further5.2The delivery of a highly-regarded workshop did not automatically entice teachers to participate in the follow-up process and receive their certification, as less than half of teachers remained involved and initiated the next criterion of submitting an artifact. Interview data revealed that removed cost to participate in and have access to all resources in the 12-month follow-up period facilitated participation in the workshop. Likewise, research has indicated that monetary rewards could be a good initial incentive, but not necessarily an enhancement, for teacher learning . Therefo5.3The current evaluation yielded some evidence suggesting that teachers may have chosen initiatives they perceived to be the easiest to implement. The most frequent CSPAP component targeted (during school) consisted of PA initiatives teachers expected to implement in the shortest length of time (4.2 months). The likely reoccurrence of the planned initiatives also varied greatly . Initiatives were largely planned as a 5-step implementation process that included obtaining approval and buy-in from colleagues, especially from a school administrator. The common planning sequence included first obtaining administrative approval followed by preparation and implementation, which mirrors the initial steps in the CSPAP guide and emphasizes that administrator support is necessary for successful program launch and uptake . Also, aAn interesting finding was the fact that the evaluation of the implemented initiative was irregularly included in teachers’ submitted implementation plans , even though research substantiates the importance of data-driven decision making in education . This diA common inhibitor to program implementation was the perceived added workload, especially among the partial completers who noted extra workload as the reason for not participating in follow-up. It can be argued that PE is experiencing an “identity crisis” , wherein6“Other teachers look at them as the leader…And they go to them and ask them for tips and classroom teachers will come to them and be like, ‘Oh, do you have any ideas of how I can teach yoga in my class?’ or ‘Do you mind leading a stretch break at our next staff meeting?’ So they’ve gotten outside of the gymnasium, which I think is what this is all about. Really—it allows them to feel empowered and you can really see a difference in how they come and teach every day, which is great.”Despite not all CSPAP professional development criteria being completed by every participant, this mixed-method process evaluation reveals the unique perspectives of PE teachers with regard to schoolwide PA promotion and informs future efforts aiming to target and effectively support CSPAP leaders. Due to varying levels of teacher interest in and commitment to CSPAP training disclosed by the present evaluation, future work in this area should consider a tiered approach to CSPAP professional development, such as offering multilevel opportunities  that address teachers’ perceived barriers to and facilitators of participation and implementation . AdditioThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.


This study sought to determine the impact of Healthy Families Healthy Futures (HFHF) enhanced with Steps to Success (STS). HFHF is a structured home visiting program for teen parents in Houston that focuses on improving parenting skills and preventing child abuse. HFHF enhanced with STS includes content and activities aimed to reduce repeat pregnancies within 24 months after the first child’s birth.The study team recruited 248 young mothers for the study, primarily through local health clinics and schools, and then randomly assigned them to either a treatment group that was eligible to participate in HFHF enhanced with STS or to a control group. The control group was not offered any other program through the study. Outcomes were measured by a survey administered 12 months after program intake, in five domains aligned with the program’s logic model: (1) exposure to information related to program content, (2) contraception knowledge, (3) contraception use, (4) enhanced family functioning, and (5) child health and development. To estimate program impacts, we used ordinary least squares regression, controlling for demographics and baseline measures of the outcome variables, if available. We use both frequentist approaches  and Bayesian posterior probabilities to interpret the findings.p < .05) impacted exposure to information on parenting and birth control, with effects of 20.8 and 15.4 percentage points, respectively. Using Bayesian posterior probabilities, there is an 85% chance that the program had a favorable effect on these outcomes. We also calculate a probability of 77% that the program had a favorable impact on long-acting reversible contraceptive (LARC) use, but a probability of 89% that the program reduced knowledge of birth control pills; these two results were not statistically significant .HFHF enhanced with STS significantly  contains supplementary material, which is available to authorized users. What is already known on this subject: Home visiting programs for families have demonstrated evidence of effectiveness on outcomes related to maternal and child health, parenting, child maltreatment, and domestic violence  developed Healthy Families Healthy Futures (HFHF), a home visiting program to serve teen mothers. HHD has been implementing HFHF for more than a decade. Traditionally, this program has followed a home visiting format that is modeled after Healthy Families America (HFA), which focuses on preventing child abuse by building parenting skills.In 2015, to address growing concerns about rapid repeat pregnancies among teens, HHD was looking for ways to modify the program to incorporate components that more directly address contraception and healthy birth spacing, knowledge the HHD found particularly lacking in their teen clients. HHD decided to enhance HFHF with Steps to Success (STS), a 2-year curriculum developed by Healthy Families San Angelo that is intended to be combined with a home visiting program that focuses on the teen mother and her male partner (father of the baby or significant other). STS was designed to address rapid repeat births by providing contraception knowledge, discussing life planning in home visits, and involving the male partner in contraceptive decision making. To deliver STS with fidelity, both program administrators and staff delivering the program must have completed comprehensive training in a standard evidenced-based home visiting intervention such as HFA and be familiar with the specific strategies, approaches, and required benchmarks associated with a high quality, evidenced-informed home visiting program.This modified version of Houston’s HFHF Fig. , which iThis paper examines the impacts of HFHF while also exploring program implementation. Specifically, the paper addresses the successes and challenges of program implementation in its first year, the impacts of the program on the receipt of program components, and the impacts of the program on outcomes that are hypothesized to improve within 1 year of program exposure.To be eligible for the study, a pregnant or parenting teen had to be a first-time mother, pregnant or parenting a baby under the age of 90 days, speak English or Spanish, be age 14–19, and have not been enrolled in HFHF in the past 6 months. Eligible young mothers were referred to HHD by schools; Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics; and other community-based organizations. HHD screened each possible new client for study eligibility, most often over the phone, and then passed the referral to the study team, who conducted a second, in-person eligibility screen. The study team then collected consent for the study, administered the baseline survey, and used a study-developed website to conduct random assignment. Random assignment was conducted in two separate blocks for young mothers who (1) were pregnant or (2) were parenting (and not pregnant) at the time of random assignment. Randomly assigning young mothers within blocks enabled us to ensure the treatment and control groups were balanced with respect to pregnancy status. Participating pregnant and newly parenting teen mothers had an equal chance of being placed in the treatment and control groups. Young mothers were randomly assigned to (1) a treatment group that could receive HFHF or (2) a control group that would not. Both research groups were given information on Project Milestone, a referral program for pregnant and parenting teens offered through the WIC clinics.This paper draws on survey data from our sample of teen mothers at two points: (1) a baseline survey administered upon enrolling in the study and immediately before random assignment and 2) a 1-year follow-up survey, administered about 12 months after enrollment, when it is hypothesized that short-term outcomes could have been achieved. a 1-yearA separate implementation study examined actual program implementation against the intended plans for HFHF with STS. The study team collected administrative data on service receipt through a service log completed by the family coaches after home visit. The family coaches recorded the visit date and length; whether the visit was with the mother of the baby, the father of the baby, or both (family coaches were encouraged to meet with the father of the baby if mother and father would not or could not meet together); whether the home visit included a discussion of parent education, resources and/or referrals, contraception, and a long-term reproductive life plan ; whether the teen mother was on contraception if post-partum; and if so, what type. These data were collected from the beginning of the study until the HHD ended the study enrollment in October 2016.During a three-day site visit in fall 2016, we conducted a staff survey and interviews with four of the five staff available at the time of visit, observed four home visits for content covered and interactions between the young mother and her case manager, and extracted data from 19 case files chosen at random. The interviews were designed to better understand more about the respondent’s background and the HHD; the intended design of the program; staff hiring, training, supervision, monitoring, and support; adequacy of resources for implementation; staff perception of the program; staff experiences delivering the program, including successes and challenges; and the availability of other programming through the HHD or elsewhere in the communities. The study team reviewed the case files for information on the teen mother’s background, program delivery and adherence to the program model, teen mother experience and engagement, challenges faced by the teen mothers and strategies used to support them, and overall challenges and successes of delivering the program. In winter 2017, the study team held in-person interviews with 29 HFHF teen mothers about their experiences in the program.3All data were collected in accord with prevailing ethical principles and reviewed by an Institutional Review Board.The baseline characteristics of our sample of teen mothers by treatment group are reported in Table To provide a comprehensive assessment of HFHF after 1 year of program enrollment, we assessed impacts on a range of outcomes that align with two stages of the logic model: (1) program components and (2) short-term outcomes  exposure to information related to program content (six measures) and (2) knowledge of contraception (four measures). The six selected measures of exposure to information reflect the specific, expected content of the visits, including whether the respondent ever attended an individual discussion or group class or session on relationships, parenting, child health care, education, career, or birth control.To delay a subsequent pregnancy, HFHF seeks to improve participants’ knowledge of contraception methods and access through discussions with clients and their partners, focusing on LARC use in particular. Knowledge of contraception was measured using four multi-item scales with binary response options: knowledge of condoms (six items); knowledge of birth control pills (five items); knowledge of intrauterine devices ; and knowledge of other hormonal and LARC methods . The measures were primarily taken from the Guttmacher Institute Survey of Young Adults (The Fog Zone).4The STS curriculum content added to the original HFHF program was primarily intended to address HHD’s concerns over rapid repeat births among its clients. Within 1 year of program provision, HFHF intended to support clients in reducing sexual risk behaviors that could result in rapid repeat births. Specifically, the program supported clients in making effective birth control decisions with their partners, particularly by providing education on LARC effectiveness and availability. We selected two measures in the domain of use of contraception to reduce sexual risk behaviors: (1) LARC use (defined as either an IUD or an implant) and (2) unprotected sexual intercourse.In the short term, the program is also intended to affect outcomes that are consistent with a more traditional home visiting program, such as enhanced family functioning through improved parenting skills, the mother’s relationship with the father of the baby, and the mother’s increased capacity for self-sufficiency. We selected five measures in this domain: one on the mother’s relationship with the child; one on the father’s relationship with the child; two on the parents’ co-parenting relationship; and one on the mother’s capacity for self-sufficiency, as evidenced by her attitudes and beliefs toward goal setting, problem solving, and future orientation.Finally, the HFHF program focuses on supporting the mother to make healthy decisions related to child health and development. We selected two measures in the domain of health and development: (1) number of well-child visits and (2) whether mother has secured health insurance for the baby.ClinicalTrials.gov.In the short term (within 12-months) of program enrollment, the program was not expected to so quickly make a difference in the repeat pregnancy rates given that nearly half of the sample was pregnant upon intake and it takes time to provide information on and access to contraceptives. Therefore, the study team decided not to measure the impact of a repeat pregnancy 12-months after program enrollment even though the question was asked on the survey. This a priori decision is reflected in our plans registered at We estimated the impact of HFHF on each outcome measure using the following equation:where y_i is the outcome for individual i, T_i is an indicator equal to one for teen mothers assigned to the treatment group and zero for those assigned to the control group, X_i is a vector of individual-level covariates, and ty White .p-values is based on the multivariate t-distribution and takes into account correlations among test statistics .Because of the widespread misinterpretation of To develop a prior distribution, we conducted a meta-analysis of all findings on similar outcomes from studies rated moderate or high quality from the Home Visiting Evidence of Effectiveness (HomVEE) review. We chose HomVEE because it is a large, rigorous, systematic review of interventions serving a disadvantaged population of new parents and because HomVEE study descriptions provide enough information to support the analysis.It took HHD staff nearly a year after study enrollment began to put systems and staff in place to deliver the program as intended.In response, the developer offered additional trainings and supervision to support staff in delivering an evidence-based home visiting program with STS content. Despite early challenges, staff were able to provide content on contraception, birth spacing, parenting, and child development to most HFHF young mothers and also involve the fathers. For example, among the 111 teen mothers who received at least one visit over the course of the study, coaches discussed contraceptive choices with more than three-quarters of the teen mothers at least once and did so in nearly half of all visits recorded in the service log. Staff reports of birth control and LARC uptake among their clients, although declining in the beginning, showed a marked improvement. According to service log data, the family coaches tracked declines in their clients’ (the teen mothers’) use of birth control and LARCs during their early months of visits. The home visitor reported rate of postnatal mothers using any form of birth control climbed to 82% in the final service log received, with nearly 50% reporting using a LARC at that time.The staff also developed supportive relationships with their clients. Youth reported that the staff were the primary source of information about effective methods of birth control, sometimes supplementing and correcting information they received from the internet, family, and friends. Youth engagement and retention also improved over time, and participating young mothers described a strong relationship with staff who were like a surrogate family member or a close friend.HFHF had a significant and positive effect on teen mothers’ exposure to information on parenting and methods of birth control. After 1 year of access to HFHF, a much larger fraction of the sample of teen mothers reported having been exposed to information on parenting Table . Among tOne year of access to HFHF also appears to have decreased teen mothers’ knowledge about birth control pills, relative to the control group, although this difference is not statistically significant. Although both the treatment and control groups were more knowledgeable about birth control pills 1 year after random assignment than they were at random assignment, the control group showed a greater improvement in knowledge of birth control pills. On average, the treatment group correctly answered about 46% of questions about birth control pills, compared to about 55% correctly answered by control group members. We calculate an 89% probability that HFHF had an unfavorable effect on knowledge about birth control pills, given this estimate.10HFHF showed a 11 percentage point increase in LARC use among the treatment group—39% of the treatment group reported using a LARC, compared to 28% of the control group—but the difference was not statistically significant Table . We calc11All results were robust to the sensitivity tests described above. Results of the sensitivity tests are included in an The impact analysis results suggest that HFHF very likely increased teen mothers’ exposure to information on parenting and methods of birth control while decreasing their knowledge of birth control pills relative to what it would have been in the absence of the program. Although HFHF intended to improve teen mothers’ knowledge about contraception, the program’s focus on LARC use might have come at the expense of providing information about birth control pills. The proportion of the treatment group reporting LARC use was 11 percentage points higher than in the control group, and we calculate a 77% probability that HFHF truly had a favorable effect . We find no other statistically significant impacts.These results are primarily favorable and consistent with the program content, goals, and recent evidence on STS Below is the link to the electronic supplementary material.


Porphyromonas gingivalis. Enhancing the surface smoothness of implants helps to prevent P. gingivalis adhesion to the implant’s surface. Interaction analyses between bacteria and the surface roughness of zirconia (Zr) discs subjected to a glow discharge plasma (GDP) treatment compared with non-plasma-treated autoclaved control Zr discs were done. Examinations of the material prosperities revealed that the GDP-treated Zr group had a smoother surface for a better wettability. The GDP-treated Zr discs improved the proliferation of the osteoblast-like cells MG-63, and the osteoblastic differentiation was assessed through alkaline phosphatase detection and marker gene bone sialoprotein (Bsp) and osteocalcin (OC) induction. Scanning electron microscopy demonstrated a relatively low P. gingivalis adhesion on GDP-treated Zr disks, as well as lower colonization of P. gingivalis compared with the control. Our findings confirmed that the GDP treatment of Zr discs resulted in a significant reduction of P. gingivalis adhesion and growth, demonstrating a positive correlation between surface roughness and bacteria adhesion. Therefore, the GDP treatment of Zr dental implants can provide a method for reducing the risk of peri-implantitis.Peri-implantitis is the pathological condition of connective tissue inflammation and the progressive loss of supporting bone around dental implants. One of the primary causes of peri mucositis evolving into peri-implantitis is bacterial infection, including infection from  Porphyromonas gingivalis [P. gingivalis is a well-known pathogen involved in periodontitis progression and the invasion of host cells to cause the destructive events involved in the peri-implantitis disease [Despite improvements in dental care, millions of people worldwide suffer tooth loss, predominantly due to tooth decay, periodontal disease, or injury. The availability of dental implants represents the support for functional prosthesis and patients’ satisfaction with esthetic appearance ,2,3,4. Hngivalis ,20,21. P disease . The pro disease ,24. The P. gingivalis and the surface roughness of zirconia (Zr) discs subjected to a glow discharge plasma (GDP) treatment compared with non-plasma-treated autoclaved Zr discs (used as a control).Regarding the identification of appropriate therapies to reduce peri-implantitis, several studies have concentrated on separate aspects of blocking or reducing dental biofilm formation and accumulation ,17,18. SZr disks  were immersed in a detergent solution and cleaned using ultrasound and rinsed with distilled water. The disks were submerged in acetone, followed by two washes with distilled water. Finally, the Zr disks were sterilized using an autoclave and dried. The samples were randomly divided into two groups: Control (Ctrl) disks were only sterilized, while the GDP-treated disks were autoclaved and then subjected to a GDP treatment.The disk surfaces were treated in a plasma reactor  for the GDP treatment. The Zr disk surfaces were treated via GDP using argon (Ar-GDP) at 85 W and 13.56 MHz under 100 millitorr for 15 min .All disks were coated with nanogold particles, placed in a specimen stub, and studied using SEM with an accelerating voltage of 20 kV in vacuum mode and a secondary electron image . Five random areas of the disks were chosen at 1000× magnification for the microphotograph samples.The discs’ surface compositions were examined using an energy-dispersive X-ray spectrometer .The surface composition in the disks was determined via XPS using 1486.6 eV X-rays. The work was done using an oil-free pumped VG Scientific ESCALAB 200X electron spectrometer . Spectra were acquired using Al Kα or Mg Kα excitation  at a take-off angle of 15° relative to the sample normal. This technique is among the most utilized techniques used for the characterization of solid surfaces .−1 resolution in the wavenumber region 4000–650 cm−1.ATR-FTIR was performed using a Nicolet iS5  equipped with an iD7 crystal ZnSe in reflection mode, and the absorbance of spectra was measured using 16 scans coded with a 0.482 cmThe wettability of the disks was measured via static water contact angles on the Zr discs of each of the two groups using a 35-mm camera to illuminate the disk. A 4 μL water droplet  at a body temperature of 37 °C was settled on top of each surface and the contact angle was measured and quantified.X and Y direction over a 2 × 2 mm area. All surface roughness measurements were performed using a profilometer . The program was set according to the manufacturer’s protocol and was used to measure the surface roughness (Ra) of the two groups of Zr disc surfaces. One measurement was conducted for each specimen in the 2/95% air in the specific culture media following the protocol from our prior publication [l-glutamine (4 mmol/L), 10% fetal bovine serum, and 1% penicillin-streptomycin. The confluent cells allowed to grow until passage 3 using 0.05% trypsin-EDTA. The final concentration was adjusted to 1 × 104 cells/mL and then aliquoted on top of the GDP-treated Zr and Ctrl-Zr discs inside 24-well Petri dishes .Osteoblast-like cells were acquired from Bioresource Collection and Research Center  and were maintained at 37 °C in humidified incubators with 5% COlication , as descOn days 1, 3, and 5, the cell viability was evaluated using a 3-4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) kit . After adding the colorimetric substrate and incubating for 4 h at 37 °C according to the manufacturer’s instructions, alive cells converted the MTT into a formazan dye. The formazan dye with the addition of dimethyl sulfoxide (DMSO) for 10 min changed the color from yellow to dark blue, which was quantified using an ELISA reader  at a wavelength of 540/570 nm. Three discs were evaluated in each group.An ALPase Activity Assay kit  can be used for the detection of ALP activity in serum (plasma), tissue, cells, and other samples. ALP is a group of cytomembrane-related enzymes with hydrolysis and transfer activity that acts on a variety of phosphate substrates. Alkaline phosphatase decomposes benzene disodium phosphate to produce free phenol and phosphoric acid. Phenol reacts with 4-aminopyridine in alkaline solution and oxidizes with potassium ferricyanide to form a red quinone derivative. The enzyme activity can be calculated indirectly by measuring the OD value.™ Green PCR Master Mix  and examined using a LightCycler® 96 Instrument (Roche).The total RNA was extracted using Trizol. Freshly isolated RNA was reverse-transcribed using a high-capacity cDNA reverse transcription kit  following the manufacturer’s recommendations. The sequences of gene primers used for the real-time PCR were as follows: BSP forward 5′-GCGAAGCAGAAGTGGATGAAA-3′ and reverse 5′-TGCCTCTGTGCTGTTGGTACTG-3′; OC forward 5′-CGCCTGGGTCTCTTCACTAC-3′ and reverse 5′- CTCACACTCCTCGCCCTATT-3′; GAPDH forward 5′-TGCACCACCAACTGCTTAGC-3′ and reverse 5′-GGCATGGACTGTGGTCATGAG-3′. All primers were mixed with SYBRP. gingivalis strain ATCC 33277  was grown on TryPtic Soy Agar (ATCC Medium: 260 TryPtic Soy Agar) under an anaerobic condition with 85% N2, 5% H2, and 10% CO2 at 37 °C. After 3 days, the bacteria were inoculated into a peptone yeast extract and incubated under 85% N2, 5% H2, and 10% CO2 at 37 °C for one week. The bacterial concentrations were standardized to an optical density of 0.1, which corresponds to 106 CFU/mL, using a spectrophotometer at 660 nm. To examine the P. gingivalis infection on the treated Zr discs, the bacteria were cultivated on the Zr discs at a concentration of 106 CFU/mL and harvested at different times. The P. gingivalis suspension was centrifuged at 2000 rpm at 18 °C for 5 min and the resulting bacterial pellet was washed twice. The bacterial suspension was diluted to an optical density of 0.3. Alamar Blue/Resazurin  was used to examine the degree of bacterial adhesion. The bacterial growth after adhesion onto discs was examined later. Samples were gathered at 1–5 days after treatment. Each Zr disc was rinsed and fixed for SEM examination. After that, specimens were coated with gold and palladium after the critical point and were dried and mounted on aluminum stubs. The SEM examinations were undertaken at 20.00 kV and analyzed.The t-test was used for the analysis. A p-value < 0.05 signified statistical significance. Data were analyzed using the Statistical Product and Service Solutions software  and Microsoft Excel.All experimental values are demonstrated as the mean ± standard error of at least three recordings. Student’s Zr discs were autoclaved and then divided into two groups, control (Ctrl-Zr) and GDP-treated (GDP-Zr). Scanning electron microscopy (SEM) demonstrated similar irregular surface patterns. Zr discs with a non-plasma treatment had similar surface roughness as the plasma-treated Zr discs .The EDS analysis revealed similar elemental concentrations in the Ctrl-Zr and GDP-Zr discs. After the GDP treatment, the GDP-Zr discs had 64.2 ± 1% Zr, while the Ctrl-Zr discs had 62 ± 1% Zr. Both Zr discs had a similar oxygen weight percentage: 13.6 ± 0.6% for Ctrl-Zr and 12.5 ± 0.6% for GDP-Zr discs.In order to analyze the elemental changes in the treated Zr discs, XPS and FTIR were carried out A,B. Aftep < 0.001). A surface wettability test was used to evaluate the surface hydrophilicity of the treated Zr discs, by measuring the contact angle (p < 0.05).The surface roughness (Ra) values of the treated Zr discs were measured using a profilometer  and the ct angle . A flattCell viability was assessed using MTT assays of the MG-63 cell line A. From dTo characterize the MG-63 osteoblast phenotype, their gene expressions were analyzed using real-time Polymerase Chain Reaction (qPCR) . Bone siP. gingivalis to Zr-treated discs was quantified at each time point , the GDP-treated discs exhibited slightly lower P. gingivalis adhesion than the control discs with a statistically significant difference at 4 days (p < 0.05).The attachment of me point . At all P. gingivalis aggregation (P. gingivalis accumulation (P. gingivalis initial adhesion.The SEM images demonstrated the regation A. The comulation B, implyiP. gingivalis adhesion to implant surfaces [P. gingivalis on Zr implants, disc surfaces were treated with GDP and the interaction between the Zr discs’ surfaces after GDP treatment and P. gingivalis infection was investigated. We found that the surface roughness of Zr after GDP treatment positively correlated with P. gingivalis proliferation, indicating that GDP-treated Zr discs were slightly less susceptible to bacterial adhesion than control Zr discs (P. gingivalis (In dentistry, dental implants are widely associated with infections originating from biofilm-producing microbes that trigger inflammation ,15,16,17surfaces ,12. To tsurfaces . Treatmesurfaces ,43. Bactsurfaces . GDP tresurfaces . To bettZr discs . The difngivalis , and morP. gingivalis adhesion, bacterial attachment to the disc’s surface was benefited due to the higher roughness, indicating that a lower surface roughness resulted in lower bacterial adherence (During the initial stages of the dherence . Thus, sdherence . At the dherence .P. gingivalis adhesion and proliferation. Furthermore, GDP-treated Zr discs exhibited slightly better resistance against P. gingivalis and open the possibility to be used against other bacteria that are also present in peri mucositis and peri-implantitis infections.The preceding experimental results in this study indicated that the cell density was higher on GDP-treated Zr discs than the control Zr discs . These rP. gingivalis growth as an approach for peri mucositis treatment and the avoidance of peri-implantitis.This study has demonstrated that a GDP treatment can reduce bacterial adhesion and proliferation while stimulating cell attachment and osteoblastic differentiation without damaging the Zr disc’s surface. Therefore, GDP could be considered as a Zr dental implant treatment that reduces


Monitoring the safety of medicines used in public health programs (PHPs), including the neglected tropical diseases (NTD) program, is a WHO recommendation, and requires a well-established and robust pharmacovigilance system. The objective of this study was to assess the pharmacovigilance systems within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community Harmonized Pharmacovigilance Indicators tool for PHPs was used to interview the staff of the national NTD programs. Data on four components, (i) systems, structures, and stakeholder coordination; (ii) data management and signal generation; (iii) risk assessment and evaluation; and (iv) risk management and communication, were collected and analyzed. The NTD programs in the four countries had a strategic master plan, with pharmacovigilance components and mechanisms to disseminate pharmacovigilance information. However, zero individual case safety reports were received in the last 12 months (2017/2018). There was either limited or no collaboration between the NTD programs and their respective national pharmacovigilance centers. None of the NTD programs had a specific budget for pharmacovigilance. The NTD program in all four countries had some safety monitoring elements. However, key elements, such as the reporting of adverse events, collaboration with national pharmacovigilance centers, and budget for pharmacovigilance activity, were limited/missing. Neglected tropical diseases (NTDs) represent a group of infections caused by a range of viruses, bacteria, protozoa, and parasitic worms that are prevalent in tropical and subtropical regions in 149 countries worldwide. Globally, more than 1.5 billion people suffer from at least one NTD, and over 600 million people live in Africa ,3. Most NTDs have been associated with long-term disabilities and adverse consequences, such as hydrocele and/or swelling of the lower limbs or breasts (LF), blindness (onchocerciasis and trachoma), stunting, anemia and malnutrition (STHs), liver and bladder fibrosis, and cancer (schistosomiasis) . Due to The drugs used for mass administration deployed under the NTD programs include albendazole or mebendazole for STHs, azithromycin for trachoma, diethylcarbamazine and ivermectin for LF, and praziquantel for schistosomiasis. The medications have a good safety profile when used in a single dose in PC, but mild and transient adverse events (AEs), such as vomiting, drowsiness and dizziness (praziquantel), gastro-intestinal symptoms , fever, skin rashes, muscle ache, orthostatic hypotension, tachycardia, lymphadenopathy, amongst others (ivermectin), following MDA are reported . Rarely,The drugs used for MDA were tested in a population that was different and not comparable to the target MDA population, hence, this is another strong rationale for safety monitoring. It is important for PHPs to identify, assess, quantify, and characterize the risks to individuals and communities. Improvement of practices based on observed problems and learnings should be an integral part of all programs to minimize harm and sustain public confidence in the safety of the medicines used in the NTD programs . A comprIn Ethiopia, Kenya, Rwanda, and Tanzania, MDA campaigns for the treatment and control of NTDs are organized by the NTD programs that were launched in 2009, 2002, 2008, and 2002, respectively, and since then, the countries have been involved in conducting MDAs for the treatment and prevention of NTDs. However, due to financial and administrative challenges, MDA has not always been implemented regularly per the WHO recommendations. Moreover, safety monitoring has not been given the same prominence as treatment coverage within PHPs, especially in NTD programs, partly because of limited financial resources, among other factors. Therefore, little is known about the safety of the drugs used in PC for NTDs in the community. Even though, globally, approximately one billion people receive MDA for NTDs every year, little attention has been given to research and funding on safety monitoring ,16,20.In 2018, 382 million people were exposed to medicines for treatment and control of NTDs in Africa . The safThe objective of this study was, therefore, to assess and compare the pharmacovigilance systems and practices within the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania.This was a cross-sectional descriptive study assessing and comparing the present pharmacovigilance systems within the national NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania. The East African Community (EAC) Harmonized Pharmacovigilance Indicators tool for PHPs, derived from the WHO pharmacovigilance indicators and the Indicator-Based Pharmacovigilance Assessment Tool (IPAT) ,23, was The assessment and data collection in the four countries were conducted between July and December 2018. The EAC Harmonized Pharmacovigilance Indicators tool was used as a guide for semi-structured interviews. The assessment team consisted of three individuals, while the respondents were between two to three staff members from the national NTD program, except for Ethiopia, where only one staff member was available for the interview. Apart from the assessment tool, follow-up questions were also asked when deemed necessary until the assessors had gained enough understanding of the availability and functionality of the relevant structure, process, systems, or output/outcome. The responses were recorded on a template developed for data collection for this study, and then the documents were sent back to the respondents for verification. The respondents were pharmacists (in Tanzania and Kenya), a medical doctor, a public health officer (in Rwanda), and a public health officer (in Ethiopia) working for the program.The data from the individual country assessments were collated and entered into a template developed for the purpose of this study based on the four pharmacovigilance components of the assessment tool. Tables and a figure were used to present findings of pharmacovigilance performance indicators within the same component.This study assessed the national pharmacovigilance systems at the national NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania to identify the presence or absence of key pharmacovigilance performance indicators, thereby identifying gaps for future targeted interventions. No personal data were collected, and the informants did not disclose any personal data. Therefore, a waiver of informed consent was requested and obtained from the respective institutional ethics review boards in each participating east African country.This component of the assessment tool had six indicators, as presented in As shown in The NTD programs in all four countries had at least one mechanism in place to disseminate pharmacovigilance information. An information sheet, radio programs, and MDA training were the key mechanisms for the dissemination of pharmacovigilance information. However, none of the NTD programs had a newsletter or information bulletin for dissemination.In Rwanda, the NTD program provided healthcare workers with information sheets about the drugs and known AEs associated with the drugs used in MDA. The information sheets were also shared with the community through health centers. Safety information was also included during MDA preparatory meetings and trainings. Additionally, during social mobilization for MDA, the NTD programs addressed issues related to safety on the radio.In Ethiopia, the NTD program disseminated pharmacovigilance information during workshops, review meetings, and trainings. The program communicated with the public through the radio services about possible known AEs of the medicines used in MDA and how to report them. However, the program was careful with communicating safety-related issues to minimize misunderstanding and prevent any negative repercussions for the MDA campaign.In Kenya, community health extension workers (CHEWs) and CDDs were trained on and briefed about possible adverse drug reactions (ADRs), what to look for, and how to report and address them.In Tanzania, like Kenya, the dissemination of pharmacovigilance information was done through MDA training. However, in case of any safety-related issues, the affected person was managed, and information was contained within the area in which the event occurred. Additionally, during community and social mobilization for MDA, the NTD program had a radio program.The Tanzania NTD program was the only program that had a website with information about the overall program activity, but nothing on pharmacovigilance. Although the Ethiopia NTD program did not have a website, information on the general MDA programs was advertised on the Ministry of Health website, but, again, there was no information on pharmacovigilance.None of the NTD programs in the four countries had a toll-free number for the public on issues related to the program including pharmacovigilance information. The Ethiopian NTD program shared the national medicine regulatory authority’s (NMRA) toll-free hotline for reporting/seeking medicine safety information. In Kenya, the NTD program shared the NMRA hotline number with the MDA trainees. However, this was initiated for the first time in 2018. In Rwanda, the NTD program did not have a publicly advertised toll-free number or phone line. People were advised to contact the local health centers if they suspected that they may be suffering from AEs. In Tanzania, the NTD program did not have a toll-free number, however, the program distributed leaflets to the community with the contact information of the program for those who sought more information about the program, but this is not specifically for pharmacovigilance. The Tanzania NTD program depended on the NMRA to provide medicine safety and pharmacovigilance information.In Rwanda, if there was a critical concern, then the national team would be notified through the campaign supervisors. The national program worked in close collaboration with district hospital supervisors in charge of the MDA campaign (a WhatsApp group has been created to facilitate communication). Like in Tanzania, the NTD program may not know about all SAE- or AE-related hospitalization if the cases were handled at the health center and hospital level when they were not reported. The Kenyan NTD program did not receive individual case safety reports (ICSRs), but AEs were reported, handled, and dealt with at the level at which they occurred.All of the NTD programs in the four countries used the training of the trainers’ cascade model, as shown in Regarding NTD treatment guidelines, in Ethiopia and Tanzania, the NTD program treatment guidelines provided information and guidance on pharmacovigilance activities. The Ethiopian NTD program treatment guideline was developed in collaboration with the NMRA, Ethiopian Food and Drug Authority (EFDA), and other partners. The guideline is updated yearly, and the most recent one was the 2018 version. Rwanda had a draft NTD program treatment guideline that also included instruction for pharmacovigilance activities. The NTD program in Kenya used the WHO NTD treatment guidelines.The NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania reported that they would consider evidence on safety data when developing/updating standard treatment guidelines. However, local safety data were limited.There was only one indicator of this component of the assessment tool, which was the AE reporting tool used by the NTD program. In Ethiopia and Tanzania, the NTD programs used the national ADR reporting forms of their respective NMRA. In Kenya, the NTD program gave healthcare workers alternatives: to either report using the NMRA reporting form or the WHO generic form. The Rwandan NTD program used the national AE reporting form adapted from the WHO.Eight indicators were assessed in this component of the assessment tool, i.e., AE information (six indicators), active surveillance (one indicator), and collaboration on risk management (one indicator). Zero ICSRs were received by the NTD programs in Ethiopia, Kenya, and Tanzania in the last 12 months (2017/2018), despite the large number of individuals that received MDA, as presented in The number of suspected product quality issues detected through the NTD programs in the last 12 months was zero in all four countries. In Kenya, the NTD programs assumed that the products were of good quality, as they were from the WHO pre-qualified manufacturing companies. The Rwandan NTD program did not have access to a quality control laboratory to check the quality of drugs. In the last 12 months, the number of medicine-related hospital admissions of individuals exposed to medicines in the NTD programs in all four countries were unknown. The Rwandan NTD program mentioned that some hospital admissions related to praziquantel administration, reported through the campaign supervisory channel, were investigated by the district and hospital team under the coordination of the national NTD team. However, no ICSRs on the abovementioned cases were recorded and submitted to the program or national pharmacovigilance center. Additionally, cases handled and managed at the health center and hospital level were not always communicated/reported to the national NTD programs.None of the four NTD programs had conducted an active surveillance safety/efficacy study in the last three years. Only a storage condition study was conducted by the Kenyan NTD program.In Ethiopia, the NTD program and national pharmacovigilance center collaborated for the planning and development of national guidelines, as well as pre-MDA trainings. There were no regular meetings between the two institutions, but they met when there was a need. In Kenya, Rwanda, and Tanzania, the NTD programs and the respective national pharmacovigilance centers hosted at the respective NMRAs did not communicate on risk management plans.There were five indicators in this component of the assessment tool, including: (i) the average time between the identification of safety signal to communication to stakeholders, (ii) the presence of a program-related newsletter, (iii) the number of requests on the safety of medicine received in the previous calendar year (2017/2018), (iv) the number of medicine safety issues identified from outside sources acted on locally in the previous calendar year (2017/2018), and (v) the number of public or community education on medicine safety in the previous calendar year (2017/2018).In Ethiopia and Kenya, the NTD programs did not have a specified time lag between the identification of safety signal/SAE/significant medicine safety issues generated nationally and communication to health care workers and the public. The NTD programs did not have a standard procedure in place for this. In Rwanda and Tanzania, the NTD programs reported an average lag time between 24 h and one week, depending on the severity/seriousness of the AE, but this was not documented, hence, it could not be verified.None of the four countries’ NTD programs had a program-related newsletter that featured ADRs observed or medicine safety information in general. Neither had they received/recorded requests for information about medicine safety. In Ethiopia and Tanzania, information about medicine safety was said to be discussed during trainings, supervisory visits, and/or review meetings. In Rwanda, it was reported that the national NTD program staff received calls about medicine safety from the public, but this was not recorded. Initially, the program used to receive many calls when the MDA interventions were newly introduced. That phase has died out, and currently, they receive approximately 10 calls/year on medicine safety. The staff addressed all of the calls they received in the last 12 months (2017/2018). In all four countries, the NTD programs did not act on any medicine safety issues identified from outside sources in the previous 12 months (2017/2018), and, according to their knowledge, no safety issues were identified.Regarding public or community education activities relating to medicine safety, although the NTD programs in all four countries carried out a pre-MDA campaign, community mobilization and sensitization activities were focused on program implementation. In Ethiopia, local media, village criers, community leaders, and a health development army are used for these activities. Medicine safety is covered during sensitization campaigns in Ethiopia and Tanzania. In Kenya, safety monitoring is not given prominence during these sensitization campaigns. In Rwanda, prior to drug administration, an education session is provided to the community (mainly for praziquantel) through radio, village criers, schools, churches, and cars mounted with speakers. The radio sessions included a question and answer session, where questions on medicine safety from the public were addressed. The NTD program also had adverts that included medicine safety information. These public/community activities on medicine safety were irregular, partly due to the lack of enforcement of MDA guidelines.This study assessed and compared the pharmacovigilance systems within the respective NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania to provide an overview of the current status, identify gaps, and provide recommendations for targeted interventions. The EAC Harmonized Pharmacovigilance Indicators tool derived from the WHO pharmacovigilance indicators and the IPAT ,23 was uOur findings indicate that all of the NTD programs in the four countries had an operational document, such as a strategic master plan and treatment guidelines, that included pharmacovigilance, however, the Rwanda NTD strategic plan was in the form of a draft pending approval from the Ministry of Health at the time of data collection. The Rwanda NTD strategic plan has now been approved. Additionally, all of the NTD programs in the four countries have AE reporting forms, either the national reporting form or the WHO generic form. The availability of such documents highlights the NTD programs’ commitment to medicine safety monitoring .The main strength of the NTD programs in all four countries was the inclusion of a medicine safety component during pre-MDA campaign trainings for healthcare workers and drug distributers. This information indicates that pre-MDA preparatory activities include the planning and management of safety during MDA. However, this is not reflected in the number of ICSRs and AEs that the NTD programs received or reported to the respective NMRAs. For example, in the last calendar year 2017/2018), both NTD programs and the respective NMRAs in all four countries received zero ICSRs following MDA. This may indicate that information on the medicine safety component was either limited or not sufficiently addressed during the pre-MDA trainings, or there was a lack of follow-up after completion of the MDA implementation process. Therefore, there is a need for more emphasis on medicine safety monitoring and reporting of AEs as recommended by the WHO [/2018, boAnother strength noted was that the NTD programs in all four countries had mechanisms to disseminate pharmacovigilance information. The main mechanisms were pre-MDA trainings and radio programs. Although the cascade model for training used by all four countries is cost-effective, it is well-known that such a long chain (3–4 steps) of information sharing also carries a risk of distortion of the message . No effoAt present, the identification and reporting of MDA-related harms are not being captured within the respective NTD programs in all four countries. When many millions of people are exposed to drugs annually, both mild and serious AEs temporally related to treatment are likely to occur. However, in all four countries, there was no established system to identify and record such events or to establish whether they might be treatment-related or coincidental. Furthermore, there is no available data to determine whether mass treatment is safe under field conditions or not. Pharmacovigilance following MDA in NTD programs in all of the four countries is as neglected as the diseases. No proper follow-up assessment of individual benefit/harm balance or active surveillance study to determine the safety and effectiveness of the medicines given in MDA are conducted. Moreover, in all four countries, there was no standard procedure for identification of the safety signal/serious AE/safety issue/to communication with the healthcare workers and the public (if necessary). Although Tanzania and Rwanda reported that the lag time was between 24 h and one week depending on severity of AEs, no documentation or standard operating procedure was available for verification.Resources for the ensuring of medicine safety during community MDA is limited. There was no specific budget allocated for pharmacovigilance activities, and this may have contributed to the underreporting of AEs. To implement the pharmacovigilance components in the masterplan and treatment guidelines, thereby monitoring medicine safety, the NTD programs need to have a specific budget for pharmacovigilance, as reported by other PHPs, such as malaria, HIV/AIDS, TB, and immunization programs . None ofA recent study reported that the national pharmacovigilance centers in Africa found it challenging to engage PHPs in a sustainable way due to several factors, including limited collaborations . Our finIn all four countries, the NTD programs inform healthcare workers to report suspected AEs directly to the health facility/NMRA. This further emphasizes the need for a collaboration between NTD programs and their respective NMRAs to keep the NTD programs informed on the number of AEs associated with the medicines used in MDA.On the other hand, the respective countries’ NMRAs should give feedback to the NTD programs on the number of ICSRs received by the national pharmacovigilance programs and safety profiles of the medicinal products used in MDA. Zero ICSRs associated with medicines used in MDA for targeted NTDs were submitted in the last calendar year (2017/2018). In 2017/2018, the majority of ICSRs that were submitted to the national pharmacovigilance center in Ethiopia and Kenya were from the tuberculosis and HIV/AIDS programs . Unlike In 2006, WHO reported that, in most developing countries, there were insufficient resources within the public health system, including PHPs, for competence development, capacity building, and monitoring the efficacy and safety of medicines . The majTo improve the current status of the pharmacovigilance systems within the NTD programs, strong collaboration and coordination with all stakeholders, including the national pharmacovigilance center of the respective NMRA, is crucial. Engagement of pharmacovigilance experts in providing training of CHEWs, CDDs, and schoolteachers on how to prevent, monitor, manage, and report suspected AEs following MDA during the MDA campaign is important. Providing relevant information for the community on the PHP’s website about known AEs and their associated risk factors, as well as how to manage and report MDA-associated AEs, would boost public confidence in the program. Budget allocation for pharmacovigilance activities in the PHP program is key to improve the identified gaps. As the number of new drugs, vaccines, and interventions being introduced into low- and middle-income countries is on the rise, safety and efficacy monitoring in the local indigenous target population is critical to identify and prevent rare AEs.Overall, most of the information captured in this study was verified using operational documents, including strategic masterplans and guidelines. However, it was not possible to verify all of the information gathered through structured interviews and discussions with representatives (interviewees) of the national NTD program, and there we relied on the respondents’ accuracy of gathered information.All four countries had started to integrate pharmacovigilance within their NTD programs, and a strategic master plan and treatment guidelines, including pharmacovigilance components, an AE reporting form, and mechanisms to disseminate medicine safety information, are in place. However, key elements to monitor safety, such as the reporting of AEs, specific budget for pharmacovigilance, sustainable collaboration between the NTD programs and the national pharmacovigilance centers (NMRAs), communication with other stakeholders, and pharmacovigilance capacity building are limited/missing. Our finding highlights key gaps for targeted intervention to promote public medicine safety and increase the success of the NTD programs in Ethiopia, Kenya, Rwanda, and Tanzania.


While 48% reported burnout upon enrollment, there was an average 50% stress reduction perceived post-attendance. This project has shown that peer groups can make a difference in the daily experience of psychiatry residents at our institution.There is an increasing awareness of high burnout found among physicians. Resident physicians particularly face heightened stress due to inherent pressures of training in addition to systemic challenges common to healthcare. It is crucial that medical training programs and organizations create a culture which promotes physician well-being. We conducted an evaluation of a quality assurance pilot program aimed at creating a safe space for increasing burnout awareness and well-being among resident physicians. The program was voluntary, offered to psychiatry residents enrolled at McMaster University, and comprised an online resilience curriculum, peer groups, and wellness newsletters. Data analysis took place between December 15, 2018 and July 15, 2019. The educational goals were evaluated by outcome measures obtained over time in aggregated response data through residents’ anonymous survey feedback. All aspects of the triad received positive feedback, with peer groups being perceived as most helpful. Of all residents, 31% ( Residents and practicing physicians are at heightened risk for burnout, such that this is a growing endemic . PhysiciThe practice of medicine itself and the rigorous training process involved seem to be closely associated with these issues, as a study of matriculating medical students has shown lower rates of depression and higher resilience compared with age-matched college graduates . AlthougWhen left unaddressed, burnout can be devastating to one’s professional development and functioning, particularly as this pertains to patient care as well as physicians’ own health and safety . InteresHere we aim to evaluate a program that could lead this cultural shift by integrating digital technology and in-person activities. Integrating web-based and other digital resources into residents’ training allows them to learn at their own pace, and supports the growing popularity of such programs . This maThis quality assurance pilot program used mixed methods for an exploratory sequential design. In this well-being building program, three infrastructural supports were used to promote adaptive skills: a) an electronic curriculum on resident resilience, b) wellness newsletters, and c) peer groups. Tab. The McMaster University medical school is an urban, research-intensive institution in Ontario, Canada. In 2019, McMaster University placed second in the world in The Times Higher Education Impact ranking that recognized the impact universities are making in their own countries and on a global scale including good health and well-being of students [This program was voluntary and offered to all psychiatry residents enrolled at McMaster University in the 2018–2019 academic year. All residents received unlimited, open access to the online curriculum (a resource guide containing exercises and interventions designed to educate and enhance resident physician well-being) throughout the academic year. Between December 15, 2018 and July 15, 2019, they also received a total of three quarterly electronic newsletters distributed through the group listserve. Residents were invited through the group listserve to participate in the two in-person peer groups included in this evaluation, which utilized convenience sampling. They received two electronic invitations, first a month prior to and then a week prior to the event. The group meetings were resident-only, peer-run, confidential debriefing sessions. The McMaster psychiatry program provided four 90-minute unprotected time slots after the educational activities on residents’ weekly academic day, with a stipend for refreshments for a period of 12 months. Discussions included perceived difficult topics around experiences within and outside their life as a resident. Through guided and open discussions led by a senior peer, residents were introduced to the concept of peer-support dynamics that spontaneously emerged early in the program within peer groups. Tab. The preliminary educational goals were evaluated through survey collections over 7 months obtained immediately post attendance at quarterly peer groups. Data were obtained through residents’ anonymous survey feedback in aggregated form. Data analysis occurred concurrently with data collection for early analysis to iteratively inform subsequent data collection. Two evaluators (a fourth-year psychiatry resident (TR) and a faculty member (AH)) analyzed peer group data using thematic key analysis. Evaluators drafted 15 survey items that each mapped phases of a framework which assessed the perceived stress level, level of engagement, adjusting, and learning of new skills. Respondents rated their level of agreement for each quantitative item on a 10-point Likert-type scale  and provided free-form answers to qualitative items. The two evaluators independently coded the transcripts and reviewed the coded data to synthesize information into themes. Preliminary data collection took place between December 15, 2018 and July 15, 2019 until sufficient information was obtained about the infrastructural supports to inform program design. Evaluators shared a reflexive approach [In the email sent to residents, we indicated the voluntary nature of their participation in this quality assurance activity. In addition, we prefixed our survey with informed consent information. Survey respondents who decided not to take part after attending the informed consent information were instructed to exit the survey. As a quality assurance project, the project was exempt from review by the authors’ institutional review board.n = 22) of the total psychiatry resident cohort, representing a sample from across the 5‑year program. The survey respondent rate was 85%. Of all participants, 63% were senior residents (postgraduate training year 3–5) and 48% reported currently feeling burned out. The online resilience curriculum and wellness newsletters were appreciated, and the in-person peer groups were extremely well received. In the narrative comments, 100% of participants described peer groups as ‘very helpful’ and would attend again. Thus, the return attendance rate at the peer groups grew by 57%. Finally, whereas 83% perceived that external factors influenced their well-being, there was a perceived average stress reduction of 50% among attendees. Participants learned that peer support is a tool that can be utilized to monitor their progress and create learning goals to cope with stress.Tab. Several limitations of this analysis should be noted including the single setting, relatively small sample, and preliminary self-reported outcome measures. Pre-post data collection did not include surveys of those who did not choose to participate. The questionnaire utilized was part of the preliminary pilot testing and was a non-validated, home grown tool that our department had developed. Although stress reduction was perceived among attendees, multiple factors may have been at play; therefore, it was impossible to fully ascertain whether participation in the program was the only determining factor for the stress reduction. Another limitation was psychiatry as a specific specialty. Many physicians affected by burnout do not seek help. In a 2019 report, though nearly two-thirds of physicians who reported burnout or depression stated they had not sought care for these concerns, psychiatrists were in fact the ones most likely to seek help . It woulThe reality is that practicing physicians are burning out, and physicians in training are not doing any better as reflected in our findings. Burnout is not just about exhaustion, detachment and inefficiency (the three core elements of burnout), it is about loneliness and isolation as well , 3. BurnOur well-being curriculum incorporated infrastructure supports through innovative electronic tools and peer-facilitated, in-person debriefing and coaching groups, with structured time for goal setting. Preliminary feedback from residents suggests that residents identified value of learning strategies, including from their peers, to increase their well-being. In those who attended the program, there was perceived subjective reduction in stress, suggesting that residents may have efficiently assimilated new practices to cope with stress and burnout. Interestingly, in contrast to formal supports, using informal supports or activities was associated with increased feelings of coping well with burnout Tab. . In the In this profession, we have to find a balance. Healthcare settings and training programs may jointly need to begin implementing innovative approaches that could lead the way to community building through collaboration and peer-support networks, perhaps by creating programs such as a “resident physician well-being hub.” Designing such programs, however, must involve learners to best understand their needs and ensure confidentiality, including from the perspective of job availability and licensing, as psychological safety is paramount when expressing such vulnerability.In conclusion, further trial of this triad may better examine its concrete benefits. Even though there are ongoing struggles that we do not have answers to, it was clear that the program’s electronic resilience toolkit, wellness newsletter, and peer groups were valuable. Although peer groups cannot counter the root causes of a burnout crisis alone, it can help build an engaged community of support and offer regular moments of connection over shared values with resident peers as a source of meaningful catharsis and reflection. As the focus on managing burnout shifts towards a shared responsibility between physicians and the healthcare system , it is t


Mycobacterium tuberculosis complex (MTBC) isolates, based on 24 loci, is still widely used as the standard for routine molecular surveillance of tuberculosis (TB). QIAxcel system is proposed as an affordable tool that could replace conventional gel electrophoresis and provide high concordance with the reference methods regarding MIRU-VNTR typing of MTBC. We aimed to evaluate the QIAxcel accuracy for allele calling of MIRU-VNTR loci in two regional reference laboratories. A total of 173 DNA were used for the study. Results obtained with QIAxcel were compared to the reference results obtained with an ABI 3730 DNA analyzer. In Albania, the overall agreement with the reference method was 97.92%. A complete agreement result was obtained for 17 loci. In Tunisia, the overall agreement with the reference method was 98.95%. A complete agreement result was obtained for 17 loci. Overall agreement in both centers was 98.43%. In our opinion, use of QIAxcel technology has the potential to be reliable, given an optimized algorithm. Inaccuracies in sizing of long fragments should be solved, especially regarding locus 4052.Mycobacterial interspersed repetitive units variable number tandem repeat (MIRU-VNTR) typing of  Mycobacterium tuberculosis complex (MTBC) does matter [Tuberculosis (TB) currently remains one of the top 10 global causes of mortality, as well as the leading cause of death from a single infectious pathogen [s matter , alongsis matter . Some ges matter . Thus, gMycobacterial Interspersed Repetitive Units Variable Number Tandem Repeat (MIRU-VNTR) typing by the 24-loci is a mini-satellite typing system that was first proposed by Supply et al. 2006) as a new standard for first-line routine epidemiological discrimination of MTBC isolates  and it l as a newThe QIAxcel 12-channel capillary electrophoresis instrument utilizes disposable, multiple-use cartridges and provides an automated analysis of the results. Regarding MIRU-VNTR typing of MTBC isolates, the QIAxcel system is proposed as an affordable tool that could replace conventional gel electrophoresis and provide high concordance with the reference methods. A fairly recent multicenter evaluation study carried out in two large reference centers in UK and Italy  revealedAlbania is a Southeastern European country with an upper-middle income economy according to the World Bank list of economies . As of 1Tunisia is a North African country with a lower-middle income economy. As of 1 July 2016, Tunisian population included about 11.3 million inhabitants . NationaThe study was carried out simultaneously in Tirana, the capital of Albania and Ariana, Tunisia in 2016. In Albania, the study was conducted at the TB NRL in Tirana at the University Hospital “Shefqet Ndroqi,” which constitutes the largest national TB hospital and reference center of the country. A convenience sample of 90 native DNA belonging to the NRLs 2011 collection of MTBC was chosen for the study. DNA was manually extracted by thermal lysis of TE-suspended pellets of liquid MTBC cultures on a TE  buffer and stored at −20 °C. Before typing, DNA was purified and concentrated by a cold ethanol precipitation procedure.In Tunisia, the study was conducted at the NRLM of the A. Mami Hospital of Pulmonology in Ariana. DNA belonged to 83 MTBC strains isolated from confirmed pulmonary TB in 2015. DNA was extracted and purified using the QIAmp DNA Blood mini kit .In both countries, PCRs were performed according to an optimized PCR protocol using primers as described by Supply et al. (2006) for a 24-loci panel. PCR products were uploaded in the QIAxcel instrument for separation of fragments and allele designation by electrophoresis under controlled conditions as per manufacturer’s instructions. QIAxcel DNA High Resolution Kit (1200) containing the QIAxcel DNA High Resolution Gel Cartridge was used for the study in both countries. A positive control (H37Rv) was included in each PCR and QIAxcel run. QX Alignment Marker (15 bp–5 kb) and QX DNA Size Marker (100 bp–2.5 kb) were included in every QIAxcel run. Allele calling was performed by using QIAxcel ScreenGel software. Results were entered into an Excel spreadsheet and analyzed further for accuracy and concordance of results.All 173 DNA samples from both countries were analyzed in Milan, Italy by an automated sequencer, with a 3730 DNA analyzer , as a reference method. Multiplex PCRs were performed using the 24 MIRU-VNTR typing kit . Analysis of results was performed using the GenneMapper v3.7 software.p-values ≤ 0.05 were considered as statistically significant. Statistical Package for Social Sciences  was used for data analysis.The accuracy of the QIAxcel method was assessed through the comparison with the reference method and the analysis of the overall concordance. Additionally, the standard deviation and the size deviation from the reference size were calculated. Wilcoxon signed-rank test, a non-parametric test, was used to compare mean ranks (paired differences) between each pair of alleles for Albania and Tunisia, separately. No ethical permission for the study was sought as the MTBC DNA samples were anonymized and no patient information could be retrieved from them.In Albania, the mean age of patients was 44 (range 2–83) years old and the male to female ratio was 2:6 (65 to 25). In Tunisia, the mean age of patients was 40 (range 15–80) years old and the male to female ratio was 4:9 (69 to 14).A total of 173 DNA (90 in Albania and 83 in Tunisia) were compared to the reference method with a total of 4152 run assays. A PCR failure was observed in 14 assays (4 in Albania and 10 in Tunisia). The allele distribution and the molecular size ranges are summarized in the In Albania, the overall agreement with the reference method was 97.92%. Forty-five discrepant results were obtained, of which 25 (55.6%) were in locus 4052. All discrepant results in locus 4052 had a molecular size equal or greater than 877 bp. Two discrepant results in locus 424, two in locus 960, five in locus 1644, two in locus 3690, and one in locus 4348 had a molecular size greater than 750 and the allele designation was one unit higher than the reference value. Only eight discordant results could not be explained with the large molecular weight, of which seven were in locus 960 (range 454–509 bp). The latter seemed to be a systematic error, the only one found in the study; seven discordant results with an underestimation of three units . We were not able to explain the reasons for this error. A complete agreement result was obtained for 17 loci. VNTRs 424, 960, 1644, 2687, 3690, 4052, and 4348 showed an agreement rate ranging from 72.22% to 98.89%.In Tunisia, the overall agreement with the reference method was 98.95%. Twenty-one discrepant results were obtained. A complete agreement result was obtained for 17 loci. VNTRs 960, 2165, 300, 3192, 3690, 4052, and 4156 showed an agreement rate ranging from 91.57% for VNTR 4052 to 98.80% for VNTR 4156. Fourteen of the 21 discordant results  had a molecular size higher than 700 bp. It was observed with VNTRs 960 (2/2), 3007 (1/2), 3192 (2/3), 3690 (2/4), 4052 (6/6), 4156 (1/1). Locus 4052 had the largest proportion of discordant result  with a molecular size equal or greater than 742 bp in all cases. The miscalculation of the number of repeats by the QIAxcel was due to an under- or overestimation of the molecular size in 10 and five cases, respectively. A difference of one unit was observed in 11 discordant results. Seven discordances were due to a miscalculation of two to five units.The analysis of all the discordant results is summarized in The observed ranking  of molecular weights obtained by QIAxcel in Albania was significantly different from their reference value for all loci, except for VNTR 802, 3007, 3690, 4052, 4156, and 4348. In Tunisia, the observed ranking of molecular weights obtained by QIAxcel was significantly different from their reference value for all loci.Currently, as next-generation sequencing (NGS) technologies of typing based on whole genome sequencing (WGS) seem to be the future of MTBC typing, many large reference centers are increasingly using all available genetic information these technologies offer. However, as we still miss standardization of WGS analysis pipelines, databases for sharing WGS data at a global level, and international agreement on the relevant genomic distances for cluster definition, these technologies will need more time to be implemented worldwide . For theIn both sites, the QIAxcel system was easy to introduce. A two-day, on-site training was enough for staff to become familiar with the MIRU-VNTR genotyping of MTBC. It was also a lot faster to get the results compared to the MIRU-VNTR manual gel-electrophoresis procedure. Although cost calculation was not among the objectives of this study, cost information collected in Albania and Tunisia show that cost of QIAxcel typing of MTBC  is less than cost of genotyping by automated sequencers.As 37 out of 45 and 5 out 21 discrepancies observed in Albania and Tunisia were due to an overestimation of the molecular size and subsequently erroneous allele designation (one unit higher), algorithm optimization of QIAxcel technology would make this method very useful in these settings. It would increase accuracy to 99.63% in Albania and 99.19% in Tunisia with a very high overall rate of concordance of 99.41%. These results are in line with other studies performed so far on MIRU-VNTR typing of MTBC with the QIAxcel system ,15.The QIAxcel system is an accurate method that detects allele lengths with a precision of 5 bp in more than half of the cases. For a proper allele calling, the maximum sizing deviation must not exceed half of the shortest repeat length . Sizing The new approach to variable number tandem repeats (VNTR) analysis using the QIAxcel capillary electrophoresis system and a software-integrated peak calling function was first reported in Japan in 2013 . The mulA PCR failure was observed in four assays in Albania and 10 in Tunisia. In Milan, PCR failure was confirmed for all four assays in Albania and only one out of ten in Tunisia. This may be related to different DNA extraction methods used for the study in Albania and Tunisia, hence an optimized protocol for DNA extraction could be of benefit to the users of QIAxcel methodology.Seemingly, use of QIAxcel technology may be reliable and easy to use in regional reference TB laboratories, given a good DNA quality and optimized algorithm. Inaccuracies in sizing of long fragments should be solved, especially regarding locus 4052. MIRU-VNTR typing of MTBC, used in a timely manner, could effectively assist the control of susceptible and drug-resistant TB in Albania and Tunisia.