Sierra Leone has one of the highest maternal mortality and infant mortality rates globally. We share findings from a Midwifery Clinical Training Needs Assessment, conducted in 2021 as a collaboration between the Government of Sierra Leone and Seed Global Health. The assessment identified existing needs and gaps in midwifery clinical training at health facilities in Sierra Leone from various stakeholders’ perspectives.The descriptive needs assessment utilized mixed methods, including surveys, focus group discussions (FGDs), interviews, and reviews of maternal medical records.The following showed needs and gaps in labor and delivery management; record keeping; triage processes; clinical education for students, recent graduates, and preceptors; and lack of infrastructure and resources.The knowledge gained from this needs assessment can further the development of midwifery clinical training programs in Sierra Leone and other low-income countries facing similar challenges. We discuss the implication of our findings. The commitment to maternal child health is a high priority for Sierra Leone’s government. In 2019, the Office of the Vice President of Sierra Leone invited Seed Global Health (Seed) to partner with the Ministry of Health and Sanitation (MoHS) to support their efforts to decrease preventable maternal mortality through strengthening midwifery training. To inform the best approach to invest in midwifery training, the collaboration sought to elucidate some of the challenges faced in clinical training. In 2021, Seed supported a rapid needs assessment focused on public midwifery training institutions and their associated practice facilities and sought the perspectives of various stakeholders in these settings. This study reports the findings from the needs assessment.Sierra Leone (SL) has a population of seven million people, 41% of whom are less than age 15. Twenty-five percent of women are of reproductive age and have an average of four children, and in 2019, 83% of births were delivered at a health facility [13While addressing maternal mortality is complex, the global shortage of midwives poses a significant challenge, one particularly acute throughout Africa . Sierra With support from the Government, Seed designed the mixed-methods, descriptive needs assessment; and the Institute for Development, a Sierra Leonean consultancy firm, collected the data between April and June 2021. Ethics approval was obtained in SL  and the United States . The assessment focused on the four public midwifery schools: National School of Midwifery, School of Midwifery Makeni, School of Midwifery Bo, and University of Sierra Leone College of Medicine and Health Science.This assessment utilized surveys, focus group discussions, and interviews with current midwifery students, recent midwifery graduates (graduated within three years), midwifery school staff, and health facility and district health management staff. Participants who volunteered to participate in the needs assessment reported on their clinical rotations and preceptorship, providing insight about their experiences. Data collection tools were developed for each format and participant type, it was important to customize the questions based on the participant type, given the nuances/perspectives from each group.The team also conducted a facility assessment and maternal patient records review within eight facilities across three districts that sought to understand: 1) how labor and delivery care was managed, 2) health outcomes at the healthcare facilities, and 3) context in which clinical training took place. Maternal patient records were reviewed for all women admitted to the labor ward from either the months between April and June 2021 or up to 100 records. While each record represents one individual patient, data was collected from a variety of sources . The tool for data collection was modified from the World Health Organization (WHO) assessment for emergency obstetric and newborn care (EmONC). Facility visits included an assessment of the use of EmONC protocols, which is an evidence-based strategy used to provide guidance for handling life-threatening complications during pregnancy, childbirth, and the postpartum period . The facFor students, a handout was developed by the assessment team and an announcement made during classes by the principal/tutors. While the school helped introduce the assessment, it was made explicit that this was not a school survey. For graduates of the programs, the team worked with the school to create a list of midwives who graduated in the last 5 years. From this roster, the team contacted potential participants. For the student and graduate focus groups, purposive selection was used to engage participants with diversity in age, background and experience. Preceptors and heads of maternity were approached with the opportunity to participate.Descriptive statistics  were used to analyze the quantitative data. Qualitative data, such as focus group discussions and individual interviews, were analyzed using a grounded theory approach, in which transcripts were examined to find generalizable themes . Those eParticipants were from four public midwifery training institutions in SL that offered three-year entry level midwifery diploma programs and included 202 current midwifery students, 74 recent midwifery graduates, 39 preceptors and 8 midwifery school staff. A total of eight district management team sisters and 35 heads of maternity were interviewed from eight district health clinics. Four hundred and eighty-seven clinical records were reviewed from four hospitals and four community health centers.Delayed referrals from Community Health Centers (CHCs) and peripheral health units (PHUs) to hospitals and late arrival from home deliveries were cited in multiple interviews as causes of poor maternal outcomes. Due to delays from the catchment villages to the first health center, women arriving at the CHC often needed a referral to a hospital with more comprehensive EmONC services. Only 25% (n = 4) of CHCs documented the time between the decision to transfer and the actual transfer. Descriptions of referral criteria varied widely.There were varying descriptions of the triage process for maternity patients at CHCs and hospitals. Heads of maternity inconsistently described how critical cases were assessed and prioritized upon admission.The patient records review assessed blood pressure (taken every four hours), temperature (taken every two hours), and pulse rate (taken every thirty minutes) as the three vital signs taken during active labor as per protocol. Blood pressure was the most consistently performed vital sign. CHCs were more consistent in completing vital signs with 74% (n = 181) of patients having documented blood pressures as per protocol, compared to 44% (n = 247) in hospitals. Hospitals documented patient temperatures 19% (n = 247) of the time and CHC’s 30% (n = 181) of the time; and patient pulse rates were documented 26% (n = 247) of the time in hospitals and 46% (n = 181) in CHCs.Women in active labor had documentation of a partograph 85% (n = 281) of the time in hospitals and 99% (n = 183) in CHCs. Fourteen percent (n = 251) of women in hospitals had a partograph that showed signs of obstructed labor versus 2% (n = 181) in CHCs. There was no standardization in record keeping between hospitals and CHCs nor between midwives and physicians, and records were paper-based with disparate and incomplete filing systems.Out of the 11 EmONC protocols, some were missing from the labor ward in both CHCs and hospitals, including protocols around obstructed labor, incomplete abortion, and manual removal of the placenta and ruptured uterus . CHC’s wBased on the records reviewed, one out of ten (11%) patients in the labor ward at hospitals were diagnosed with postpartum hemorrhage, whereas only 1% of patients at CHCs were. Nearly all women (95%) in the four hospitals and (100%) in the four CHCs where data was collected received oxytocin for active management of the third stage of labor. A variety of interventions were used to treat hospitalized patients diagnosed with postpartum hemorrhage . No womeThe level of preceptors varied, while ideally all would be midwives, there were many nurses. Of all the 39 surveyed, most preceptors (92%) reported being motivated by the opportunity to contribute to students’ training and professional development. When asked about the support preceptors sought, the majority reported a desire for increased financial compensation (56%), more training on how to precept (59%), and more access to clinical tools (67%). According to key informant interviews with maternity heads, although most preceptors in both CHCs and hospitals received training in teaching adults, little to no support was given beyond their initial preceptor training. Seventy-one percent of preceptors at CHCs and half of those at hospitals reported a need for more preceptors to support student learning.Interviews with school staff, District Health Management Team (DHMT) staff, and heads of maternity (who were involved in patient care in addition to administrative duties), indicated that increased incentives for preceptorship would be appreciated and help surmount outside pressures; this could take the form of increased compensation, access to technology, or training.Based on the data collected, there was no apparent process to oversee preceptors. Supervisory visits by the midwifery school and DHMT staff were not consistent and were often conducted concomitantly with student supervision. There was no standardization in how supervisors provided feedback or what follow-up was planned based on clinical observations. Eighty-five percent (85%) of preceptors surveyed at CHCs and 93% at hospitals reported it was challenging to balance the clinical workload with their teaching role. Some preceptors reported that abrupt shifts of staff to new facilities and scheduling issues have caused students to arrive at a site with no preceptor present.Out of the 202 students surveyed, students reported inadequate learning opportunities in the following competency areas: assisting in the operating theater (42%), perineal suturing (32%), completing partographs (27%), and estimation of blood loss (23%). Students reported sufficient access to learning opportunities in the areas of medical history taking (65%), drug calculation and administration (62%), monitoring fetal and maternal well-being (56%), and fetal palpation (48%).Qualitative data highlighted that preceptors assessed students through sign-offs on logbooks; however, this method may not have evaluated mastery. Several schools expressed concern that preceptors may not be providing honest feedback about student performance and competencies. In addition, student supervision via observation by school staff was often limited by lack of transportation and fuel costs. On the other hand, students were positive about the feedback they received from preceptors, most students reported receiving frequent feedback. Fifty percent of students reported receiving feedback daily, and 30% reported weekly feedback. However, only 40% of students reported preceptor feedback was specific and constructive. Some students reported arriving at CHCs only to have a Maternal and Child Health Aide for teaching, with no assigned preceptor. Of the 70% of students who reported attending a birth during their clinical placement, 52% attended or managed at least one delivery without a preceptor present.Out of the 74 recent graduates surveyed, some indicated they needed additional training in the management of sepsis (34%), post-abortion care (31%), assisted vaginal delivery (24%), and preeclampsia/eclampsia (22%). In their interviews, they expressed a desire for more continuing professional development and in-depth training opportunities, beyond the on-the-job training at the facility.When asked about their confidence in managing specific skills independently, recently graduated midwives expressed feeling most confident in managing the following five areas independently: providing respectful maternity care (88%), Kangaroo Mother Care (86%), assessing fetal well-being (81%), active management of stage 1 and 2 of labor (78%), and monitoring pregnancy progression (76%).The four hospitals and four CHCs reviewed had limited availability of certain drugs. Dexamethasone, effective for lung maturation of premature infants, was only available 50% of the time in either hospitals or CHC’s and IV labetalol was not available at all. Furosemide was available 25% of the time in hospitals and 0% in CHCs. CHCs also did not have access to Hydralazine .Although schools emphasized the importance of skills and simulation labs for student learning, students and preceptors voiced concerns that equipment and supplies in these labs did not reflect those in real-life clinical settings. The majority of stakeholders reflected that this reality made it difficult to apply their theoretical learning. One respondent shared that “… if they are taught the theory in school, the practical should be done in the facility, but the facility lacks all these necessary instruments.” Moreover, 50% of preceptors in CHCs and 42% of preceptors in hospitals felt strongly that their facility infrastructure and equipment were inadequate for teaching. A majority of respondents identified lack of infrastructure, equipment, and other resources as major challenges and specifically emphasized the following five areas: 1) Preceptor Lodging/Support , 2) Staffing Shortages (insufficient midwife staffing), 3) Equipment (shortages impacting student learning), 4) Facilities , and 5) Medical Supplies .Three factors have consistently played an important role in maternal deaths in low-income countries: delays in seeking care, delays in arriving at a health facility and inadequate care once at the facility 11. Acces1212The findings of Tracey et al. and Oyerinde et al. are similar to this assessment and others who have studied why pregnant women in low-income countries, especially those living in rural areas, do not receive health services 1314. The13Once patients arrive at a healthcare center in Sierra Leone, multiple challenges affect the care they receive: lack of partograph use for real-time clinical decision making, no standardization of clinical record keeping, and inconsistent and infrequent monitoring of vital signs. Our findings also revealed vague criteria for triaging and prioritizing care to women with immediate risks. Our results add to recent findings of Proos and colleagues who identified several onsite issues at Sierra Leone healthcare centers which affected care including communication and decision-making among health workers; women following up on the treatment suggestion; and logistical restrictions, including lack of equipment or medication or delays due to lack of ambulances .Data from Sierra Leone’s 2017, 2018, and 2019 Maternal Death Surveillance and Response reports found that more than 80% of maternal deaths occurred at health facilities, and 75% of these mortalities were at government hospitals . PostparTimely and appropriately delivered emergency obstetric care (EmONC) by a skilled health care professional can lower maternal morbidity and mortality 1920. Yet1921222324All sites did post the EmONC protocols for postpartum hemorrhage, preeclampsia and eclampsia. Given that appropriate management of PPH requires early recognition and quick intervention, having trained staff with access to the necessary resources, and following proper protocols is critical .Our findings confirmed earlier work which identified barriers towards effective preceptorship such as inexperienced midwives/nurses, inadequate numbers of midwives, high turnover of midwives, heavy workloads, not enough time, lack of interest, poor remuneration, lack of personal reward for teaching, and increased student to preceptor ratios 2829.28CHCs are not currently equipped to treat postpartum hemorrhage with shortages of oxytocin, misoprostol, tranexamic acid, and other drugs. The shortages or unavailability of medical supplies such as blood, PPE, delivery kits and drugs; and the unreliability of electricity, water, and space all negatively affect the learning environment for students, preceptors, staff and patients.While strengths of the present study include its context specificity and mixed approach, our findings are subject to several limitations. Data elicited from individual and focus-group interviews is inherently subject to a number of potential biases, including inaccuracy of interpretation and intentional or unintentional misleading (positive or negative skewing) by respondents. Our small sample size also frustrates any generalizability. Nevertheless, our data largely confirms previous research regarding the provision of maternal health care in Sierra Leone.Curriculum for Preceptorship Training Programme for Nursing and Midwifery, which outlines a systems approach toward building clinical competency through improving the quality of academic and professional pre-service learning [National Nursing and Midwifery Strategic plan 2019–2023 [The government of Sierra Leone and the Nursing and Midwives Board of Sierra Leone have initiated steps to address the identified issues in the needs assessment. While a lack of funding as well as physical and human resources have hindered steps forward, Sierra Leone has made progress in improving maternal care, substantially lowering its maternal mortality rate. Reducing maternal morbidity and mortality were critical objectives of the Reproductive, Newborn and Child Health Strategies of 2011–15 and 2017–21 produced by the MoHS. In partnership with the WHO, the MoHS produced the 019–2023 . This tePreceptorship Policy and Implementation Guidelines for Clinical Competency Building of Midwifery and Nursing Students and Residents to address midwifery and nursing clinical education [With national and international partners, the Nursing and Midwives Board of Sierra Leone developed the document, ducation . This poIt was evident through the needs assessment that there are multiple challenges that impact the quality of clinical education in midwifery training programs. Poor collaboration between hospitals and health training institutions, a lack of clinical instructors and preceptors, and a weak framework for assessing students’ clinical performance remain a threat to quality education. Continued momentum and increased investments are required for quality clinical midwifery training, from consumables and equipment to record availability and accuracy. While this needs assessment highlights several obstacles for midwifery education and service delivery, there was a clear commitment across all participants to learning and strengthening maternal health outcomes.


Streptococcus (Strep A) is responsible for a significant global health and economic burden. The recent prioritization of Strep A vaccine development by the World Health Organization has prompted global research activities and collaborations. To progress this prioritization, establishment of robust surveillance for Strep A to generate updated regional disease burden estimates and to establish platforms for future impact evaluation is essential. Through the activities of the Strep A Vaccine Global Consortium (SAVAC), we have refined and harmonized surveillance protocols for 7 Strep A disease endpoints with a view that these will form part of surveillance standards for ongoing research and public health activities.Group A  Streptococcus (Strep A) is a β-hemolytic, gram-positive bacterium (Streptococcus pyogenes) considered to be pathogenic only for humans. Strep A arguably has the broadest clinical spectrum of any infectious pathogen. Diseases include superficial noninvasive infections such as pharyngitis and skin infections ; invasive diseases such as bacteremia, meningitis, puerperal sepsis, and necrotizing fasciitis; immune- and toxin-mediated diseases such as scarlet fever and streptococcal toxic shock syndrome; and sequelae of immune-mediated diseases such as acute rheumatic fever (ARF), acute poststreptococcal glomerulonephritis, rheumatic heart disease (RHD), and chronic kidney disease [Group A  disease .As the disease spectrum associated with Strep A disease is wide and complex, accurately estimating the global burden of disease is challenging. The most recent global burden of Strep A disease study was published in 2005; Strep A was estimated to cause 517 000 deaths each year . In the https://savac.ivi.int)—to realize the global need for a Strep A vaccine. The mission of SAVAC is to ensure that safe, effective, and affordable Strep A vaccines are available and implemented to decrease the burden of Strep A disease among those most in need. An initial key step in this mission is the acquisition of data needed to design and plan clinical trials to measure vaccine efficacy and safety. Such data requirements include age-specific incidence of key clinical endpoints in well-characterized populations. As guided by the WHO PPCs for Strep A vaccines, these endpoints are pharyngitis and impetigo [Vaccine development for Strep A is gaining momentum, spurred by the 2018 World Health Assembly that adopted a global resolution on ARF and RHD . Prioritimpetigo , which aThe primary objectives of public health surveillance are to identify and monitor burden of disease over time, to detect trends, to determine disease risk factors and the populations at greatest risk, and to both measure the need for interventions and to monitor the effects of public health interventions. WHO has published surveillance standards providing information for countries to help understand disease burden and inform vaccine policy decisions and recommendations . AlthougAccurate and accepted case definitions and classifications are a pivotal part of effective surveillance. This can be a challenge for Strep A; some clinical endpoints  are specific to Strep A, while others  are non-specific and have multiple etiologies. This underscores the importance of clear case definitions, detailed case classifications, and well-defined case ascertainment methodologies when establishing surveillance, especially for non-specific clinical syndromes. A recent example of this is in South Africa where incidence of all-cause pneumonia was 30% lower using an existing surveillance system compared to active surveillance from a prospective birth cohort. The differences in estimated disease incidence were attributable to higher levels of nurse training to detect and classify pneumonia cases in the prospective birth cohort study with active case finding compared to the pre-existing passive surveillance study . While pA primary purpose for standardizing surveillance protocols is to allow the resulting data to be compared across multiple studies, diverse geographical locations, and time. This will not only facilitate estimations of the global burden of disease but allow for results of future vaccine efficacy trials to be applied to other jurisdictions with a similar burden of disease. Therefore, one of our motivations for compiling the suite of Strep A surveillance protocols presented in this supplement is to establish surveillance standards that can be incorporated or added to those developed for other diseases and VPDs . The WHOIn 2008, an international working group of experts in surveillance and Strep A diseases was established with support from the US National Institutes of Health in collaboration with WHO to develop standardized epidemiological surveillance protocols for both acute Strep A diseases  and their immune sequelae . These surveillance protocols were not widely disseminated and since have become outdated, largely due to advances in diagnostic testing methods. Additionally, not all clinical endpoints of Strep A (such as cellulitis and scarlet fever) were included in these original protocols.Through the activities of SAVAC, an expert Burden of Disease Working Group (BoDWG) was established comprised of 13 members from 7 geographically diverse countries (representing 5 WHO regions), with expertise covering Strep A and other VPDs, disease surveillance, and vaccine program implementation. Under the guidance of the BoDWG, we updated and expanded the original 2008 surveillance protocols. We established a formal process of review whereby the lead authors of each protocol updated case definitions and case classifications, and incorporated new diagnostic methods in conjunction with the BoDWG. We then engaged with subject-matter experts for each of the 7 key clinical Strep A endpoints: pharyngitis (which incorporates scarlet fever), impetigo, cellulitis, invasive Strep A disease, ARF, RHD, and acute poststreptococcal glomerulonephritis. An iterative review process was undertaken to harmonize each protocol.Each protocol follows a consistent structure including surveillance objectives pertinent to each clinical endpoint; case definitions and classifications including microbiological tests for detection of Strep A; methods of case ascertainment and different surveillance settings; and ideal surveillance populations including eligibility criteria. Where appropriate, the protocols also include the following additional surveillance considerations: recommendations for periods of surveillance; seasonality considerations; resources  and training needed; discussion of community engagement; suggested treatments  to monitor in some surveillance systems; measurement of disease burden ; core elements of case reporting forms; and quality assurance and control methods and ethical considerations.While some sections, such as quality assurance and ethical considerations, are consistent across each clinical endpoint , there are important differences in others. While the definitions of active and passive surveillance are consistent, the characteristics of each surveillance system will vary with each Strep A endpoint. For example, a best-practice passive surveillance system for severe disease outcomes for which infected individuals typically seek medical treatment, such as invasive infections, may involve regular review of hospital discharge records. For a milder and often self-limiting disease such as pharyngitis, which has a higher community-level burden of disease, passive surveillance in the primary healthcare setting or a school setting may be appropriate.To facilitate a contemporary global review of the burden of Strep A diseases under the auspices of SAVAC, we developed an innovative systematic framework prioritizing burden of disease data requirements for vaccines with a particular focus on Strep A . We usedAs quoted by Foege and colleagues in 1976 , “the reIn summary, this supplement presents best-practice guidelines to conduct surveillance of multiple clinical endpoints of Strep A, a pathogen responsible for a high global mortality and disease burden. With accelerated efforts of vaccine development for Strep A, we envisage these protocols to have widespread use in helping to accurately capture age-specific incidence and prevalence of Strep A infections, and establish the necessary infrastructure for sites to progress to Strep A vaccine clinical trials when a suitable vaccine candidate becomes available.ofac210_Supplementary_DataClick here for additional data file.


Pregnant women are particularly vulnerable to infection. Furthermore, infection from pertussis, influenza and COVID-19 increases the likelihood of adverse consequences to the mother and developing baby such as stillbirth, ICU admission, and pre-term caesarean birth. Increased rates of transmission and risk of adverse consequences from infection justifies the provision of national maternal vaccination programmes. Additionally, maternal vaccination helps protect the infant until they are able to receive their own vaccinations; a time when they are most at risk of mortality from influenza and pertussis. Vaccination during pregnancy has been repeatedly demonstrated as safe and effective in reducing harm, although rates of uptake remain low compared to the general population. The current protocol describes the methodology for an umbrella review aiming to explore the barriers and facilitators of vaccination during pregnancy for pertussis, influenza, and COVID-19. Systematic reviews that investigate the barriers and facilitators of at least one of either pertussis, influenza, or COVID-19 will be included in this review. Multiple databases will be searched, and included reviews assessed for quality (using the Joanna Briggs Institute (JBI) quality assessment for systematic reviews) and degree of overlap of included primary studies. Included reviews will be analysed according to the WHO SAGE model of determinants of vaccine hesitancy and separated by whether these explore influenza and pertussis, or COVID-19. The outcomes of this review will help inform the development of interventions to increase uptake of vaccination during pregnancy, and on whether interventions need to be tailored depending on the infectious disease. The key findings will identify the specific barriers and facilitators of vaccination hesitancy by considering contextual influences (e.g. sociodemographic variables), individual/social group influences (e.g. trust in the institutions), and vaccine-specific issues (e.g. safety and recommendations). Women during pregnancy are particularly vulnerable to infectious agents when compared with non-pregnant women of the same reproductive age, because of immunological changes that may alter their susceptibility to and severity of infectious diseases . SubsequMaternal vaccination programmes remain effective –12, and In high-income countries, the World Health Organization (WHO) recommends vaccination for pertussis, influenza  and COVIUnfortunately, achieving a good vaccination coverage among pregnant and lactating women remains a global challenge  both forThe negative consequences linked to low immunization not only impacted on the healthcare systems of Countries worldwide, but also on their economies. Thus, considering critical factors for vaccine success  and prom(I) confidence (distrust in the vaccine or provider), (II) complacency  and (III) convenience (access issues) [Among barriers to gain a high vaccination uptake we recognize “vaccine hesitancy”, a behaviour influenced by different issues:  issues) , 42, whi issues) , 44. Vac issues) –47.(I) Contextual influences ; (II) Individual and group influences ; and (III) Vaccine and vaccination-specific issues (related to the characteristics of the vaccine or the vaccination process).The WHO-SAGE “Model on determinants of vaccine hesitancy”  classifiRecent literature suggests a difference between determinants of COVID-19 vaccine hesitancy and other infectious diseases. For example, concerning influenza and pertussis vaccination, the main reasons for hesitancy among pregnant women were: limited knowledge, poor awareness of the advantages of getting vaccinated and available sites for vaccination, fear of the vaccine contents and side effects, doubt on vaccine efficacy, and healthcare workers not recommending vaccinations . RegardiUnderstanding the reasons for vaccination hesitancy and/or low coverage in pregnancy  is a prerequisite for addressing concerns , 52 and Considering the factors influencing the uptake of vaccinations for specific sub-populations such as pregnant women is an urgent need that must be met in order to direct public health vaccination campaign to prevent COVID-19, pertussis and influenza diseases.This umbrella review (or systematic review of systematic reviews) will examine factors (barriers and facilitators) and the possible domains of intervention  associated with vaccination hesitancy among pregnant women, to gain a full comprehension of the phenomena. Given the large number of primary studies and reviews on this topic in the last 11 years, an umbrella review, or review of reviews, is needed to achieve a clear overview of the evidence available and to address future research and public health policies.This umbrella review aims to identify and synthesise currently available knowledge to determine the barriers and facilitators to vaccination uptake among pregnant women.Two questions will be addressed:What are the barriers and facilitators to the uptake of vaccinations to prevent COVID-19, pertussis and influenza amongst women during pregnancy?Which are the most relevant domains  of vaccine hesitancy?blinded for referees): and designed by following the Joanna Briggs Institute guidelines for the conduct and preparation of umbrella reviews [This protocol was registered in the International prospective register of systematic review PROSPERO, available at .Systematic reviews and meta-analyses evaluating barriers, facilitators or factors associated with COVID-19, pertussis, or influenza vaccinations among women during pregnancy will be included.Any pregnant adult over 18 years of age will be included. Studies with partially overlapping age ranges will also be included . For example, whilst reviews only focusing on determinants of vaccine hesitancy in adolescents would be excluded, reviews that may include some participants over 16 would be included. The full sample must be pregnant or have been pregnant within the last two years.As the primary outcome, studies establishing the barriers and facilitators to vaccine hesitancy, using the ‘Model of determinants of vaccine hesitancy’ by Wilson et al.  as a fraAs secondary outcomes, review or meta-analysis discussing interactions between barriers and facilitators and reported descriptive data on vaccine hesitancy scores, or uptake will be eligible for inclusion.Included quantitative studies may either measure the frequency and proportion of identified barriers and facilitators by participants, or the prediction of named barriers and facilitators in predicting vaccine uptake. Thus, measures of effect may take the form of frequencies, percentages, or odds ratios. Reviews may report the frequency of studies that have explored certain barriers and facilitators, and what proportion of these yielded a significant or non-significant result.Any reviews including meta-analysis will allow for a formal measure of effect in the form of heterogeneity statistics, pooled estimates, and confidence intervals.For reviews that performed a meta-analysis on descriptive statistics on uptake and /or vaccine hesitancy scores or rates, these will be analysed as additional outcomes, again in the form of heterogeneity statistics, pooled estimates, and confidence intervals.Systematic reviews with or without meta-analysis will be included. Reviews including only or mostly quantitative studies, from all countries and all study settings, will be included.Primary studies will be excluded, although may be used for forward citation searching for reviews.nd April 2022 (when the search will be undertaken). Reviews from 2009 onwards will be included to capture the influence of the influenza pandemic, during which pregnant women were disproportionately affected [®, Nursing & Allied Health, Database, Psychology Database, and Public Health Database, EPISTEMONIKOS, and PsycARTICLES. Searches will be restricted to peer-reviewed reviews.Databases will be searched from 2009 to 22affected , the panaffected , and theaffected . The folScoping searches have been completed prior to the review search and the search strategy was discussed with a University librarian and checked against the PRESS statement . Alerts References of included studies will be searched for additional systematic reviews.The search will be run again in the synthesis stage to identify any relevant reviews published since the initial search.The search strategy will consider the following keywords as displayed in Search results will be exported via a RIS file and uploaded onto Rayyan, a free web and mobile app, that helps expedite the initial screening of abstracts and titles using a process of semi-automation while incorporating a high level of usability .initials blinded for referees) will screen all reviews for title and abstract against the inclusion criteria, followed by the remaining articles based on full text. A second member of the research team  will independently screen the first 10% of articles at both stages, sorted alphabetically by author. Decisions will be made and logged via Rayyan. Any disagreements will be discussed and resolved when both reviewers reach a consensus.One reviewer (Data will be extracted using guidance from Cochrane  (PollockThe following data will be extracted:(i) General ; (ii) Review information ; (iii) Primary included studies information ; (iv) Results ; (v) Additional information .Where there is missing or unclear reporting, study authors will be contacted where possible.The data extraction form will be completed for each review via Microsoft Excel (2018).The Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses  will be blinded for reviewers) will assess 10% of studies for quality. Cohen’s kappa statistic (k) will be calculated to ascertain the degree of agreement between reviewers [Quality of the studies will be considered when synthesising the results. If study quality is judged to be extremely low, it will be excluded from the review. Again, a second member of the research team  will be calculated using the formula provided by Pieper et al. , which dThe remaining data contained within the systematic reviews and meta-analyses will be collated, and a descriptive numerical summary and a thematic analysis will be conducted. The numerical summary will describe the characteristics of the included studies in table format. This table will include the review’s aim, search strategy, inclusion criteria, outcomes, population, and conclusions made by the authors.A narrative summary of the key determinants will be provided, which will describe in detail the barriers and facilitators of vaccine hesitancy towards the COVID-19, influenza, and pertussis vaccines.Outcome data extracted from the reviews will be analysed separately for COVID-19, and pertussis and influenza, and findings from these will be compared and contrasted in a final narrative summary.Risk of bias assessments for primary studies made by the included reviews will be presented in a table format, and a narrative summary will discuss their disagreements in terms of the quality appraisal of the reviews themselves.https://osf.io/g94nu/?view_only=42ea0601bbe246a198d35c6dacfcb56e), where the completed table will be uploaded too.All the tables and the supplementary materials will be available in an open access format in public repositories. The template spreadsheet for data extraction is available on Open Science Framework , individual/social group influences (e.g. trust in the institutions), and vaccine-specific issues (e.g. safety and recommendations), according to the WHO SAGE international model of determinants of vaccine hesitancy . This umThe umbrella review approach presents intrinsic limitations that should be discussed.While it enables the researchers to perform a global assessment of a broad topic in a systematic manner, results could be limited to the strict criteria of included studies in each systematic review. Furthermore, whilst EPSISTEMONIKOS was searched to access reviews specifically, important databases such as Cochrane were not accessed, potentially limiting the comprehensiveness of the current umbrella review. Lastly, given the extensive timespan of our umbrella review, we expect a large/moderate degree of overlap between primary studies within the included reviews, inflating the impact of these duplicated primary studies . Whilst This protocol addresses a major public health issue in a particularly vulnerable population. Despite the wide number of systematic reviews on this topic, there is no recent summary of the findings related to vaccination facilitators and barriers in the pregnant women population. This protocol fills this gap, and its outcomes will inform the policymakers about the most effective public health strategies to promote vaccination uptake among pregnant women.S1 Checklist(DOCX)Click here for additional data file.


Biofouling, Biocorrosion and Biodeterioration: Recent Advancements of the Frontiers in Bioengineering and Biotechnology, aimed to present interdisciplinary contributions emphasizing recent developments in this important Research Topic. Biofouling, biocorrosion and biodeterioration are directly related to the presence of microorganisms and the formation of biofilms. Various advances have been made in recent years in this economically important and scientifically challenging research area. The biofilm development in service conditions influences the interplay between a solid material’s surface and the environment, often leading to accelerated materials deterioration. Strategies typically employed to control biofouling, biocorrosion and biodeterioration include physical scrubbing, biocides and corrosion inhibitors, beneficial biofilms, cathodic protection, surface modifications  and protective coatings.The Research Topic Suarez et al.; Tuck et al.; Salgar-Chaparro et al.), development of bioactive materials for tissue engineering , growth of enzymes-producing bacteria as a function of pH  and the impact of microbiologically influenced corrosion (MIC) on mechanical properties of pipeline steels . All contributions to this Research Topic focus on one or more of the aforementioned highlighted research areas.This Research Topic comprises six papers from eminent researchers worldwide, including Australia, China, Chile, Mexico, Saudi Arabia, Thailand, United Kingdom and United States. A wide range of Research Topic is covered, including corrosion protection of oil and gas equipment using corrosion inhibitors and biocides against microbial deposition  was further evaluated by employing atomic force microscopy. The most robust adhesion was found to occur at pH 6 on the surface of AA-6063, and it was attributed to the positive surface charge that this alloy exerts, reducing the repulsive electrostatic energy barrier and promoting cell adhesion.The paper by Li et al. addresses the impact of MIC on the degradation of mechanical properties of X80 carbon steel, an sub-area of MIC that deserves more attention, in view that the current MIC research focuses on pinhole leaks rather than catastrophic structural failures. Specifically, the microorganism employed was the sulfate-reducing bacterium (SRB), Desulfovibrio vulgaris, while variations in MIC severity were achieved by varying the headspace volumes in anaerobic bottles for SRB incubation. An increased headspace volume allowed more biogenic H2S to escape to the headspace, which reduced its cytotoxicity leading to better SRB growth. Corrosion pit depths and weight loss were more severe at a higher sessile cell count. It was found that SRB MIC made the X80 pipeline steel more brittle, as reflected by up to 23% ultimate strain loss in only 14 days.The article by In summary, this Research Topic demonstrates several novel developments that could benefit further advancements in this important research area.


The occupational environment is an important factor for oral health because people spend a long time in the workplace throughout their lives and are affected by work-related stress and occupational health policies. This study aimed to review evidence for the association between occupation and oral health status and behaviors. A literature search of PubMed was conducted from February to May 2022, as well as a manual search analyzing the article origins. Articles were screened and considered eligible if they met the following criteria: (1) published in English; (2) epidemiological studies on humans; and (3) examined the association between occupation and oral health status and behaviors. All 23 articles identified met the eligibility criteria. After full-text assessments, ten articles from Japan were included in this review: four on the association between occupation and dental caries, three on occupation and periodontal disease, two on occupation and tooth loss, and one on occupation and oral health behaviors. An association was apparent between occupation, oral health status and behaviors among Japanese workers. In particular, skilled workers, salespersons, and drivers who work longer hours and often on nightshifts, tended to have poor oral health. The Japanese Ministry of Health, Labour and Welfare’s Survey of Dental Diseases and the first Health Japan 21 report indicate that oral health status in children has been improving in recent years, including a decrease in the prevalence of dental caries . FurtherIn addition, recent epidemiological studies have revealed that tooth loss exerts adverse effects on various systemic health conditions, including dementia and disability ,6. BecauOral health is affected by many factors, such as socioeconomic status, cultural background, and nutritional habits ,7,8. NumTo improve oral health status, especially among adults, the provision of dental health services in the workplace environment needs to be improved. Workplace oral health examinations accompanied by oral health instruction may also be effective for the maintenance of periodontal health. To help prevent and control oral disease, a public health approach that considers the workplace environment is urgently needed. Therefore, a literature search should be conducted to collect basic data regarding the relationship between occupation and oral health status and behaviors.Therefore, to help prevent dental caries and periodontal disease, which both cause tooth loss, we aimed to collect scientific evidence and summarize the latest findings on the relationship between occupation and oral health status and behavior in the workplace using the following review question: Is occupation associated with oral health status and behaviors among workers? Furthermore, we also sought to identify which occupations are greater risk factors for poor oral health.We conducted a literature review. Our research question for this review was: “Is occupation associated with oral health status and behaviors among workers?”We set the following eligible criteria for literature screening. The following published studies were eligible: (1) those published in English; (2) epidemiological studies on humans; and (3) those that examined the association between occupation and oral health status and behaviors.Two reviewers (KI and MT) independently screened titles and abstracts for eligible studies. From February to May 2022, we searched for potentially relevant published studies using PubMed (published between 1996 and February 2022). We used the following search settings to obtain a wide range of studies:  OR  OR  OR  OR  OR . In addition, after one author assessed the titles and abstracts according to the aforementioned criteria, we also conducted a manual search of potentially suitable studies through the reference lists of the identified articles. All eligible studies were then selected for full-text reviews.n = 2); were about follow-up intervention oral health program (n = 5); were about oral symptoms (n = 2); were about oral and work performance (n = 3); were not about oral health status and occupation (n = 1). A total of 10 articles from Japan were finally included in this review.In terms of the association between occupation and dental caries, three studies assessed dental caries using self-report online surveys and one as diagnosed by a dentist ,13,14,15Regarding occupation and the prevalence of periodontal disease, periodontal examinations were performed using the Community Periodontal Index. The results of a 5-year cohort study showed that among males, the relative risks for skilled workers, salespersons, and drivers were 2.52 , 2.39 , and 2.74 -fold higher, respectively, than for other professionals .In terms of occupation and tooth loss, two studies assessed tooth loss using self-report online surveys, and one study used a diagnosis by a dentist ,17. DrivIn terms of occupation and oral health behaviors, differences in oral cleaning and dental visitation behaviors were found between occupations . The perIn this review, we summarized the existing literature on the association between occupation and oral health status and behaviors among workers. Based on the findings of this review, skilled workers, salespersons, and drivers, who work longer hours and often on nightshifts, tend to have poor oral health, such as a higher prevalence of dental caries and periodontal disease, and behaviors, thereby suggesting an association between occupation and oral health status and behaviors among workers. One possible mechanism for the differences in oral health status and behaviors among workers is that occupations that regularly involve long working hours and nightshifts tend to be associated with a lack of rest and adequate sleep, leading to higher work-related mental stress ,20,21. IIn addition, occupational classification is directly related to income and considers individual and contextual effects mainly based on the pathways linking income inequality and oral health . To reduUpstream contextual factors may also play an important role in the development of oral disease and oral health behaviors throughout the course of life, in connection with cultural and genetic factors from early stage of life. Recent research using the life-course framework suggested that exposure to adverse environments along the course of life additively contributes to oral health problems . For exaSome reports suggested that the occupational environment may be a risk factor for oral health status and behaviors, even when considering the various backgrounds of those engaged ,11,15,16Health education and guidance should be given priority in workplaces that mainly involve skilled workers, salespersons, and drivers. The present findings suggest that occupational status and shiftwork might be associated with the development of dental caries and periodontal disease. As these workplace issues might be potentially modifiable factors, the present review provides important information for dentists concerned with the prevention of dental caries and periodontal disease.Our literature review has some limitations. In this review, all studies were conducted in Japan, although the literature search was conducted without restrictions by country. This might have resulted in an overestimation or underestimation due to sample bias, which may limit our ability to extrapolate the findings to the general population. Furthermore, well-designed cohort studies that include potential confounding factors, such as working hours, income level, job position, and oral hygiene practices, which are important determinants of oral health conditions, are needed.The findings of the present review suggest the presence of an association between occupation and oral health status and behaviors among Japanese workers. In particular, skilled workers, salespersons, and drivers, who work longer hours and often on nightshifts, tended to have poor oral health status.


Older adults with cognitive impairment have more emergency department visits and 30-day readmissions and are more likely to die after visiting the emergency department than people without cognitive impairment. Emergency department providers frequently do not identify cognitive impairment. Use of cognitive screening tools, along with better understanding of root causes for emergency department visits, could equip health care teams with the knowledge needed to develop individually tailored care management strategies for post–emergency department care. By identifying and directly addressing patients’ and informal caregivers’ (or care partners’) psychosocial and health care needs, such strategies could reduce the need for repeat acute care. We have used the terms “caregiver” and “care partner” interchangeably.We aimed to describe the protocol for a randomized controlled trial of a new care management intervention, the Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED) trial, compared with usual care. We described the research design, intervention, outcome measures, data collection techniques, and analysis plans.Emergency department patients who were aged ≥75 years and screened positive for cognitive impairment via either the Mini-Cog or the proxy-reported Short Informant Questionnaire on Cognitive Decline in the Elderly, with a planned discharge to home, were recruited to participate with their identified informal (family or friend) caregiver in the 2-site POISED randomized controlled trial at New York University Langone Health and Indiana University. The intervention group received 6 months of care management from the POISED Care Team of registered nurses and specialty-trained paraprofessionals, who perform root cause analyses, administer standardized assessments, provide advice, recommend appropriate referrals, and, when applicable, implement dementia-specific comorbid condition protocols. The control group received care as recommended at emergency department discharge  and were given information about resources for further cognitive assessment. The primary outcome is repeat emergency department use; secondary outcomes include caregiver activation for patient health care management, caregiver depression, anxiety, and experience of social support as important predisposing and time-varying enabling and need characteristics. Data were collected from questionnaires and patients’ electronic health records.Recruitment was conducted between March 2018 and May 2021. Study findings will be published in peer-reviewed journals and presented to peer audiences, decision makers, stakeholders, and other interested persons.The POISED intervention is a promising approach to tailoring care management based on root causes for emergency department admission of patients with cognitive impairment with the aim of reducing readmissions. This trial will provide insights for caregivers and emergency department and primary care providers on appropriate, personalized, and proactive treatment plans for older adults with cognitive impairment. The findings will be relevant to audiences concerned with quality of life for individuals with cognitive impairment and their caregivers.ClinicalTrials.gov NCT03325608; https://clinicaltrials.gov/ct2/show/NCT03325608DERR1-10.2196/36607 An emergency department visit can be a “sentinel event” for an older adult; the need for urgent attention may signal a potentially serious new problem or failure in managing a chronic condition -3. AlthoCognitive impairment is present in an estimated 25% to 40% of older patients in the emergency department -22 and iMost daily care needs of people with clinically significant cognitive impairment living in the community are provided for by unpaid caregivers, usually family or friends . CaregivOur research team includes experienced investigators  who have conducted trials of dementia detection and implemented dementia-specific collaborative care management programs. Our team also includes emergency department providers and international experts in psychosocial support for dementia caregivers and demonstrated an association between caregiver support and long-term reductions in nursing home placement . We applWe aim to report the protocol for the design, implementation, and evaluation of a care management intervention, POISED, compared with usual care. The specific aims of this study are as follows:To test whether the POISED intervention will reduce patients’ recurrent acute care use over 6 months when compared with post–emergency department care for dyads not receiving POISED. We hypothesize that rates of recurrent acute care use over 6 months will be lower for patients whose family caregivers participate in POISED.To test whether the 6-month POISED intervention will activate family care partners to improve management of care recipients’ health care at 3 and 6 months compared with post–emergency department care without POISED. We hypothesize that POISED will increase family caregiver activation in managing the health care of patients.To test whether POISED will improve care partner psychosocial outcomes compared with post–emergency department care without POISED at 3 and 6 months. We hypothesize that caregiver depression, anxiety, and experience of social support will improve more for caregivers who are enrolled in POISED than for those referred to other care management programs.This is a 2-site single-blind randomized clinical trial. The randomized trial of the POISED intervention is conducted in 2 cities, New York City, New York, and Indianapolis, Indiana, and in the emergency departments of their respective academic institutions: New York University Langone Health and Indiana University Health and Eskenazi Health. Both emergency departments are academic teaching facilities used to participate in clinical trials. Both have multiple sites, which are in predominantly urban and racially diverse environments. Although these were the locations for recruitment, study procedures following consent occurred outside of the emergency department environment.The 6-month intervention is led by the POISED Care Team, consisting of a registered nurse (the care manager) and a specially trained paraprofessional (care manager associate), who administer structured assessments and perform root cause analysis. These initial assessments are used to prepare the care management team with a comprehensive understanding of the problems leading to the emergency department visits and are the basis for creating a personalized, structured dyadic outpatient care management plan to address the needs of both patients and caregivers. The intervention is delivered via telephone or in person.Patients in the emergency department, at New York University Langone Health and Indiana University Health and Eskenazi Health, aged ≥75 years, who screened positive for cognitive impairment and had a planned discharge to home, were recruited to participate with their identified informal care partner. Potential participants were excluded if they lacked consent capacity and had no identified care partner, or were likely to be admitted to an inpatient service. Care partners were those persons who self-identified or were identified by the patient in the emergency department as the person most likely to assist with day-to-day activities if needed. Care partners had to (1) be English- or Spanish-speaking, (2) be able to speak by telephone, (3) have adequate hearing, (4) be at least 21 years old, and (5) demonstrate capacity to consent. If they did not meet all 5 criteria, they were excluded.This noninvasive health service intervention included cognitive screening administered by research staff at any point during their emergency department admission, which was inclusive of being in an observation unit. Each potential participant was screened with one of two screening tools: the Mini-Cog , for patThe POISED model is designed to maximize effectiveness, improve clinical outcomes, enhance family caregivers’ skills in both self-management and health care management for the care recipient , and to maximize their coping behaviors. The model is designed to promote reproducibility and has 3 main overlapping phases: the initial assessment phase, the collaborative care plan development phase, and ongoing collaborative care management.predisposing factors, such as the care partner relationship  with the care recipient, type and severity of cognitive impairment, and behavioral complications; enabling factors, such as care partner activation for health care management of the care recipient, in-home support resources, adequacy of the caregiving social network of family and friends); and need factors, such as specific treatment related to the care recipient’s acute health conditions or lack of access to medication. The POISED intervention targets these basic factors and dementia-specific factors, including knowledge about dementia and other chronic comorbid conditions, social networks (mobilizing family and friends) and support, and perceptions about health states. Dementia-specific characteristics we targeted included care partner psychological factors, effective patient and care partner self-management skills , health system navigation skills, and health perceptions.The POISED intervention was adapted from the Behavioral Model for Vulnerable Populations  originatThe POISED model components were motivated by dementia care quality standards as developed by the American Medical Association Physician Consortium for Quality Practice-convened Dementia Measures Work Group  and suppThe burden of dementia can be reduced with collaborative management of dementia care. In 2002, Boustani et al  at IndiaThe Care Transitions Intervention, tested and implemented in >750 health care organizations in 40 states across the United States . The CarUsing paraprofessionals who are educated to support care management activities drives workforce development and ensures the scalability of the POISED model. Boustani et al  translatThe 6-month POISED care management intervention includes up to 2 in-person home visits between the dyad and the care manager and care manager associate (POISED Care Team), after an in-emergency department or phone call assessment and during the first 6 weeks after enrollment, supplemented by weekly care manager associate calls for the first month, twice-monthly calls during the second and third months, and monthly calls for the following 3 months. Although home visits are preferred, dyads remain in the intervention group even if all contacts are telephonic. Additional phone calls are scheduled with the care manager or care manager associate, as needed. A personalized dyadic care plan, “Our Action Plan,” is prepared and placed in a Care Partner Notebook  with appropriate disease-specific infographic educational materials to teach skills for managing the dyad’s health needs on a day-to-day basis. “Our Action Plan” is a collaborative list of the care partner’s priority problems or goals (in care partner’s own words), titles of infographics, and next steps for the care partner and care manager to do. Care planning steps within the POISED disease-specific infographic educational sheets are as follows: (1) assess further; (2) inform by providing materials and education; (3) teach problem-solving and self-management or self-care; (4) make a clinical referral or follow-up appointment with a clinician; and (5) offer resources within New York University Langone Health or Indiana University Health and Eskenazi Health, or community social services in their respective regions. For clarity and usefulness, we prepared colorful infographics about disease-specific management designed to reflect the experience of caring for a person with cognitive impairment and written at an eighth grade reading level. The notebook also includes an “Introduction Letter,” “POISED Care Team Contact Sheet,” and other documents such as log sheets and an Advance Directive form, as appropriate. Supervision for the POISED Care Team is provided in twice-monthly team videoconferences with experienced dementia specialist clinicians who may help clarify root causes and make other care management suggestions. Although POISED is not embedded within the primary care context, contact is made with the patient’s primary care provider when necessary .The POISED Care Team is structured to maximize the skill sets of specialty-trained nurses functioning as care managers and paraprofessionals in the role of care manager associates in a collaborative model. The care manager and care manager associate conduct a biopsychosocial needs assessment by phone within 48 hours of emergency department discharge if not possible during the emergency department stay. This assessment includes a demographic and psychosocial interview focused on achieving problem identification. The program uses standardized assessment tools including “Managing Your Loved One’s Health” for chronic disease management . The carThe POISED Care Team documents the initial and follow-up visits, focuses on problem clarification, and reviews the assessment findings, medical records, medication lists, emergency department discharge plans, and pharmacist consultation. The care manager also reviews any diagnostic testing, any brain imaging results, and functional details of the assessment to determine the presence or absence of a likely dementia diagnosis, identifying any reversible and comorbid conditions and, for complex cases, the need for referral for further evaluation at either New York University Langone Health’s or Indiana University Health’s or Eskenazi Health’s well-developed dementia assessment centers. After reviewing the findings from prior data and the first encounter, the care manager and care manager associate create an initial plan and identify areas needing further assessment at the first home visit (within 2 weeks after enrollment). This visit enables the POISED Care Team to conduct additional cognitive and functional testing. In addition, the care manager uses the time to address more sensitive issues that the care partner may be uncomfortable discussing in the presence of the care recipient.This phase starts with the emergency department visit and concludes with the second home visit by the POISED care team. The goal of this phase is to create an individualized care plan through the lens of cognitive impairment, which aligns with the goals and capacities of the family care partner and care recipient. After the initial assessment is completed, any urgent issues are addressed, including consulting with the program geriatrician and primary care physician as needed. The POISED care team maps out a proposed care plan and schedules a second home visit to review the findings, discuss identified problems, and propose a collaborative plan of culturally sensitive interventions. During the second home visit, this team reviews the identified problem list, seeks input from the dyad on the continuing relevance of this list, and prioritizes the most important problems. From this consensus, the care manager discusses a proposed plan of care and customizes interventions to the dyad; explains the diagnosis, natural history, and the prognosis of dementia as necessary; and implements medical care protocols and connects patients and care partners to in-home services and community resources as needed. The POISED care team prepares and mails a personalized Care Partner 3-ring binder and follows up with a phone call to explain the binder and review materials with the care partner and patient, if able and appropriate.Criteria for Discharge From the POISED Intervention section). During the follow-up phase, the POISED care team (primarily the care manager associate) continues to interact with the dyad by telephone, by video, by email, by fax, by mail, or face to face at their home, demonstrating a commitment to patient-centered care. The minimum amount of care manager associate contact during this time is weekly for the first month, twice-monthly calls during the second and third months, and monthly calls for the final 3 months. Interaction intensity is dictated by presenting needs and circumstances but is set at this minimum to reflect an anticipated high level of need. During these interactions, the care manager or care manager associate answers questions generated from previous visits, collects care recipient and care partner feedback, has the care partner complete a brief assessment to identify the need for specific care protocols, and facilitates care partner participation in community services already available in either the New York or Indianapolis areas. The care manager reconciles medication and reviews medication adherence at the initial and second home visit. Medication questions are referred to the study pharmacist. Throughout the follow-up phase, the team continues to work with the dyad, with contact with the patient’s primary care provider as needed, to monitor, implement, and adjust the individualized care plan. Referrals are made to local support programs that include caregiver support groups and respite care.This phase continues throughout the 6-month intervention or until the dyad is discharged from the program for reasons stipulated  behavior or mental, (3) brain or cognition, (4) buddy or caregiver, and (5) bank or financial and social capital and resources. These calls also focus on ideas and methods to (1) involve the care partner and patient (as able) in goal setting and making plans to live as well as possible and (2) maximize collaboration to tailor patient-centered interventions to increase success for the care partner and patient throughout the 6-month intervention and the future. Another purpose for the video calls is to serve as an important collegial support mechanism within and across the New York University and Indiana University–based POISED care teams.Videoconference calls among the POISED care teams are regularly scheduled (weekly to biweekly) during the study period. These calls include at least one physician specializing in dementia care and a dementia nurse specialist to offer guidance on root cause analysis discussions of patients’ emergency department visits. The root cause analysis review is structured across a 5-part domain dementia care model: (1) The POISED care team used the following discharge criteria: (1) death of the patient, (2) patient or care partner declines to continue in the program, (3) primary care provider requests patient to be discharged from the program, (4) patient transitions to another health care system, (5) living situation or environment becomes unsafe for patient or care partner and therefore requires long-term skilled nursing home care, or (6) dyad completes the 6-month study.The comparison group are participants randomized to usual care. They receive referrals to services at the time of enrollment. The usual care group does not receive the POISED structured assessment, root cause analysis, or associated strategies for managing chronic disease in individuals with cognitive impairment. As for intervention dyads, usual care dyads receive a laminated card showing the stress thermometer  to be trTo assess for potential influence on any emergency department use after the index emergency department visit (primary outcome), we will use electronic medical records within each study site and identify all emergency department visits for 12 months before the index emergency department visit or study enrollment and 12 months after enrollment. We will also search all-payer databases in New York and the Indiana State Network for Patient Care  to identify any episode of ambulatory or acute care that occurred within the 12 months before and 12 months after enrollment (6-month intervention and 6-month follow-up). Finally, a one-item survey question will identify any additional visits that might have occurred outside the indicated state regions. For descriptive purposes, the International Classification of Diseases discharge diagnoses will be included for any emergency department use. We will structure continuous variables that describe the number of ambulatory or acute care episodes.r=0.76; a strong factor structure; and strong construct validity by Rasch analysis. Domains include recognizing, anticipating, and managing day-to-day symptoms and challenges for care recipient health; managing care recipient medications; recognizing and managing sudden changes in care recipient health; accessing health services and advocating for the care recipient in the health care space; and managing caregiver self-care. Four-level item responses range from “agree completely” to “disagree completely” with an additional option, “not my job.” We will use the total score to measure activation.After consenting the care partner, we will measure caregiver activation, a multidimensional construct developed by Borson et al  that incThese include caregiver depression, anxiety, experience of social support, and stress. We will use the Patient Health Questionnaire–9 PHQ-9; ,59) and  and 59])Additional outcome measures , in addiUsing conservative prevalence statistics for cognitive impairment in patients presenting to the emergency department at New York University Langone Health, Indiana University Health, and Eskenazi Health, numbers (6100 patients in 2015) exceed those needed  to achiet test at a .05 significance level. The detectable effect size of 0.28 used in our power estimation is reasonable and justified given that previous studies on collaborative care management of dementia patients have shown an effect size of 0.45 SD on a number of caregiver psychosocial outcomes [For aims 2 and 3, assuming that 205 (64%) dyads will complete the 6-month evaluation , we willoutcomes . Previououtcomes ,58,59,61To produce comparable groups and insure against accidental bias in treatment assignments, we used a computer-generated web-based stratified randomization scheme. Dyads were randomized to intervention or usual care groups in random blocks of 4 or 6 stratified by site .We will compare randomization results to the preplanned schedule to ensure randomization integrity. To verify the comparability of the randomized groups, we will compare dyads between the 2 groups to identify differences in their baseline characteristics , care recipient comorbid medical conditions, and the Charlson comorbidity index ,75. We wWe will use logistic regression models to compare the rates of emergency department admission during the 6-month intervention period following the index (recruitment) emergency department visit. Emergency department readmission within 6 months will be used as a binary outcome in the logistic model, and the randomization group will be the independent variable while adjusting for site. Baseline characteristics that are shown to be unbalanced in univariate comparisons between the 2 groups will also be adjusted. Although not a primary outcome, we will also examine 12-month emergency department use data.We will use mixed effects models with caregiver activation scores at 3 months and 6 months as the outcome measure and randomization group as the independent variable while controlling for baseline activation score and site. We will conduct post hoc comparisons of the activation scores between the POISED group and the usual care group at 3 and 6 months using linear contrast from the mixed effects model following a significant group effect. To explore what changes are responsive to the POISED intervention, we will also use the mixed effects model to examine differences in activation domain scores between the 2 groups. The mixed effects model will account for potential correlations between repeated measures from the same individual and deal with missing data appropriately when the probability of missing data is unrelated to the missing observation.We will use mixed effects models with repeatedly measured PHQ-9, GAD-7, and MOS social support scores collected at 3 and 6 months as dependent variables. The independent variable for the mixed effects model will be the indicator variable for the randomization group while controlling for baseline scores and site. We will use post hoc analysis to determine group differences in these measures between the 2 groups at the 3- or 6-month evaluations. The modeling approach resembles that for aim 2.The analysis plan outlined above assumes that outcome measures at follow-up are missing at random with respect to demographic characteristics and baseline results. We will compare baseline characteristics of participants with missing outcomes because of death or withdrawal to detect potential violations of the missing-at-random assumption. Further sensitivity analyses will involve various imputation methods or a full parametric likelihood approach that assumes various patterns of missing data .To proactively maintain high quality in data collection, data are routinely checked as they are stored within study databases. Data are quality-checked before analysis.Data will come from 3 sources. First, the web-based tracking system of data entered by the POISED Care Team will use a REDCap  database . These dDataCore, a resource launched by the New York University Langone School of Medicine, housed within its Information Technology Department and formed in collaboration with the Clinical and Translational Science Institute, the Biomedical Informatics and Translational Library Programs, and the Department of Population Health, will provide enterprise level support to ensure the integrity of electronic data during its capture, storage, management, extraction, and sharing. DataCore will merge these 3 data streams using unique identifiers assigned to the study participants and provide regular backups onto a secure server.The Institutional Review Boards of New York University Langone Health and Indiana University Health provided permission on February 24, 2017, and April 27, 2017, respectively, to conduct the POISED study . The clinical trial registration (NCT03325608) was listed on October 30, 2017. At enrollment, we obtained consent from patients (or assent with care partner proxy consent when the patient lacked the capacity to consent) to enable the review of their medical records. The proxy consent was the next of kin using a defined hierarchy in the absence of a Durable Power of Attorney or by consenting the proxy who is the Durable Power of Attorney. Participants completed an “education session” during the consent process regarding the potential risks and benefits of participating in a noninvasive health services research study for valid informed consent. Electronic data are stored in password-protected files on secure servers at New York University and Indiana University. Research staff are trained in the institutional review board–approved methods for collecting, recording, storing, and reporting research data to protect the privacy of participants and maintain the confidentiality of data.Data collection began in March 2018 and was completed in February 2022. We have recruited 643 dyads (patients and care partners). Data are currently being analyzed. The study results will be published in peer-reviewed journals and presented to peer conferences, decision makers at the participating university medical centers, and other interested audiences.Studying care management for older adults living with cognitive impairment and possible undetected dementia who are identified at emergency department visits may lead to low-cost strategies to reduce high-cost acute care. It may also improve caregivers’ ability to optimally assist patients in the management of chronic disease that is particularly challenging in older adults with cognitive impairment. Related impacts may be improved health outcomes of patients and psychosocial well-being of caregivers.The most significant limitation will be the dependence on one care management team at each site, as findings may reflect the personal qualities of the care manager and care manager associate. However, a clearly communicated and structured intervention protocol and standardized education and training program will limit the quality and reproducibility concerns. We may find no change in caregiver activation while demonstrating reductions in acute care use. An absence of change (aim 2) may reflect an inadequate measure or a factor that is not in the pathway of health service use. However, the opportunity to demonstrate a causal relationship between activation and use for this population is profoundly important. Given that usual care participants may receive dementia-specific resources given well-developed programs at both institutions, the comparative between-group differences might be diminished. However, engagement for usual care participants is not likely to occur for at least 2 months after the index emergency department visit and will not be focused on management strategies that reflect an applied root cause analysis for that visit. Although some emergency department patients will have a diagnosis of Alzheimer disease or Alzheimer disease–related dementia before their emergency department visit, some patients may not have Alzheimer disease or related dementia (even after a positive screen) and generalizability to future Alzheimer disease or related dementia patients might be questioned. However, the cognitive screener and older age group for inclusion should limit false positives, and diagnostic errors should be equivalent across groups.Cognitive impairment is prevalent among older adults who visit the emergency department, but often this is unrecognized. Root cause analysis linked to care management strategies may better focus the intervention resulting in more reductions in acute care use while more directly addressing care partners’ needs. This study may provide effective low-cost approaches for reducing high-cost acute care use and related improvements in care partners’ abilities to optimize management of chronic diseases particularly challenging for care recipients with cognitive impairment. Moreover, this highly standardized and reproducible approach has the potential for direct application in large multisite clinical intervention trials. The use of paraprofessionals as care management assistants increases the scalability of this work and provides opportunities for large-scale implementation and dissemination if proven efficacious.The POISED program is a promising approach to address the root causes for emergency department admission in older adults with cognitive impairment and prevent repeated readmissions. The results from this trial will provide insights for care partners and medical staff on proactive treatment plans with appropriate and personalized management plans for these older adults and for care partners themselves. These findings will be relevant to both professionals and nonprofessionals concerned with the quality of life for individuals with cognitive problems and their care partners.


To describe the IMPACTO-MR, a Brazilian nationwide intensive care unitplatform study focused on the impact of health care-associated infectionsdue to multidrug-resistant bacteria.We described the IMPACTO-MR platform, its development, criteria for intensivecare unit selection, characterization of core data collection, objectives,and future research projects to be held within the platform.The core data were collected using the Epimed Monitor System® andconsisted of demographic data, comorbidity data, functional status, clinicalscores, admission diagnosis and secondary diagnoses, laboratory, clinical,and microbiological data, and organ support during intensive care unit stay,among others. From October 2019 to December 2020, 33,983 patients from 51intensive care units were included in the core database.The IMPACTO-MR platform is a nationwide Brazilian intensive care unitclinical database focused on researching the impact of healthcare-associated infections due to multidrug-resistant bacteria. Thisplatform provides data for individual intensive care unit development andresearch and multicenter observational and prospective trials. This representativeness aspect is markedly important in low- andmiddle-income countries, such as Brazil, where within-country disparities clearlyimpact the care process and patient outcomes.,7 Not acknowledgingthese differences might undermine the external validity of both epidemiological andrandomized clinical trials.,9From a research standpoint, a multicentric clinical database of intensive care units(ICUs) that takes into account regional and economic heterogeneities and providesprospective capture of a large amount of data from individual patients creates newperspectives for observational and epidemiological research,-12 whichis especially relevant in ICUs, where the frequency of health care-associatedinfections (HAIs) and antimicrobial utilization are higher,,14 coupled with higher densities of HAIs in developingcountries, we have asuitable and rich scenario for data generation and future clinical trials.Given the epidemic of antimicrobial resistance worldwide,This manuscript describes the development and characterization of the Impact ofInfections by Antimicrobial-Resistant Microorganisms in Patients Admitted to AdultIntensive Care Units in Brazil: Platform of Projects to Support the National ActionPlan for the Prevention and Control of Antimicrobial Resistance (IMPACTO-MR), aBrazilian nationwide ICU platform study focused on the impact of HAIs due tomultidrug-resistant (MDR) bacteria.Programa de Apoio ao DesenvolvimentoInstitucional do Sistema Único de Saúde -PROADI-SUS): Hospital Alemão Oswaldo Cruz (HAOC),Hospital Israelita Albert Einstein (HIAE), HospitalMoinhos de Vento (HMV), HospitalSírio-Libanês (HSL), and HCor-Hospital doCoração (IP-HCor) in a collaboration with theBrazilian Research in Intensive Care Network (BRICNet) and is supported andoverseen by the Department of Science and Technology from the Brazilian Ministryof Health (DECIT/SCTIE/MS) and by the General Management of Health Technologiesof the Brazilian Health Regulatory Agency . In 2022, BP - ABeneficência Portuguesa de São Paulo joined the otherhospitals in coordination with the project. The project is funded by thePROADI-SUS, a nationwide program aimed at strengthening and qualifying theBrazilian Universal Health System (SUS) throughout the country.The IMPACTO-MR program is developed and coordinated in a partnership between thehospitals members of the Program to Support Institutional Development ofUniversal Health System  on a specific data capture system that constitutes the study’score database. This core database would initially provide data to prospectiveobservational studies within the platform, and each database might havespecifically designed additional databases as needed. Additionally, thisplatform would provide data for future randomized embedded controlled trials .Discussion on the platform and database design began in late 2018. The study’sprotocol was approved by the coordinator site’s Institutional Review Board (IRB)in November 2018 . In addition, before eachparticipant site startup, the protocol was approved by their IRB. All but oneinstitution waived the need for informed consent for patient data capture.Patient inclusion began in October 2019 and is expected to continue untilDecember 2023.Each hospital had to fulfill all the following eligibility criteria toparticipate in the study:- Have an Infection Prevention and Control Committee.- Perform monthly notifications of HAIs and MDR to the HealthCare-associated Infections National Epidemiological SurveillanceSystem.- Have an ICU with at least six beds.- Have a microbiology laboratory. European Committee on AntimicrobialSusceptibility Testing (EUCAST) or Clinical and Laboratory Standards Institute(CLSI).- Utilize or be willing to utilize one of the following antimicrobialsusceptibility testing criteria: Brazilian Committee on AntimicrobialSusceptibility Testing (BrCAST),The aim was to include at least 50 ICUs nationwide and to account for thegeographical and socioeconomic heterogeneity of Brazil, so some proportions wereto be followed. First, the proportion of 70% of public or philanthropichospitals and 30% of private hospitals, and second, the number of ICUs includedin each Brazilian geographic region  should be proportional to the availability of ICU beds in eachregion; therefore, more populated areas, such as South and Southeast, would havemore ICUs.From a provided list of 2,000 ICUs (that had regularly reported HAIs data to theANVISA in 2016), we sent a feasibility questionnaire to 728 ICUs from which wehad contact information available. Given the need to have 10 hospitals with aminimum infrastructure of costs and the ability to provide such data on apatient-level basis (for the costs’ substudy), a second look into theabovementioned list  was performed to complete theselection. The criteria for the cost substudy were as follows: (1) local use ofa computerized cost system; (2) local accounting system using different costcenters per area; and (3) material and medications controlled at the patientlevel (without any type of apportionment). Six additional hospitals indicated bythe ANVISA and Ministry of Health were also considered for the cost substudy andreceived the invitation. The platform design allowed for ICU exclusions andinclusions during the study, with the aim of maintaining approximately 50 ICUsparticipating. Six hundred fifty-four ICUs did not meet the inclusion criteriaor were unwilling to participate in the study, and 19 ICUs were not selectedbecause the number of participating ICUs in their geographic region was alreadyachieved. Of the 61 initially selected ICUs, 51 were included in the study and 2. customized for the study’sobjectives. The software was provided to all participating centers. We collecteddemographic data, comorbidity data (using the Charlson ComorbidityIndex), functionalstatus (adapted from the Eastern Cooperative Oncology Group - ECOG), Simplified Acute PhysiologyScore III (SAPS 3),Sequential Organ Failure Assessment (SOFA) score, admission type , admission diagnosis and secondary diagnoses,laboratory, clinical, and microbiological data, and organ support during ICUstay, among others. The core individual patient data collected are displayed inData were collected using the Epimed Monitor System® , a secured commercial cloud-basedregistry for quality improvement and benchmarking purposes,Data input was performed through a structured electronic case report form (eCRF)by manual entry or, in some cases, through integration with the hospital’selectronic records. Patient data are entered into the eCRF prospectively, excepton weekend and holiday admissions (for some ICUs), and pass through an automatedanonymization process within the Epimed System. Unique identifiers weregenerated for each patient included in the database and each participatingICU.Regarding costs, patient-level fixed and variable costs were calculated monthlyand informed  or quarterly (the other 5) andvalidated by a team of specialists in the field. A proprietary system  was developed to consolidate patient-leveland item-level data and integrate it with Epimed data (by an ApplicationProgramming Interface - API).Clinical data quality control and data management were centralized with the datamanagement team of HCor Research Institute, which generated biweekly dataquality reports sent to each site. Additionally, the Epimed System providesautomatic interactive assessment of the data. Each participating institutiondesignated data collectors who were trained by the IMPACTO-MR team and by EpimedSolutions®. Additionally, the study organization provided operationalmanuals and telephone support to each participating center. Regarding cost data,a specific Data Management Plan was created, and HIAE was responsible for itsexecution.in-loco initiation visit was planned for each participatingcenter; however, due to travel restrictions in Brazil during the COVID-19pandemic, some centers were initiated after an online visit.An Data are stored initially in the Epimed cloud system, according to theinternational security protocol. These data were automatically anonymized beforebeing sent to the study’s data management team. Only the study committee anddata management team have access to these data. In the same way, “e-Custos”handles only anonymized data and has restricted access controlled by differentprofiles authenticated by unique login/passwords.Each contributing ICU shares ownership of its submitted data with the studycommittee and the Brazilian Ministry of Health. Patient deidentified data mightbe available to research teams from the participating institutions upon approvalby the study committee and the Brazilian Ministry of Health.From October 2019 to December 2020, 33,983 patients from 51 ICUs were included inthe core database . TheproInitially, the platform subsided core data to five prospective observationalprojects aimed at evaluating different aspects of the MDR dynamics and itsconsequences. Briefly, these projects studied the following aspects:- Evaluation of the Infection Control Committees and microbiology labswithin each participating institution.- Evaluation of the clinical impact of MDR acquisition.- Evaluation of the economic impact of MDR.- Evaluation of risk factors for acquisition of MDR.- Comparison of reported and notified data on HAIs.Proposals for observational studies and secondary analyses using the database canbe submitted by each participating site center and are individually evaluated bytheir scientific merits by the study committee. Additionally, beginning in early2022, the platform will provide data to two observational trials and fourprospective randomized trials, including two trials on antibiotic duration forspecific HAIs and two cluster randomized trials on interventions to decrease MDRincidence.This manuscript describes the development and core structure of the IMPACTO-MRplatform, a multicenter database of Brazilian ICUs, and a pioneering initiative inLatin America that is providing real world data allowing for focused research inHAIs.Successful databases share common characteristics: a multidisciplinary team, stablefunding, focused goals, data collection, focused design, and relevantleadership.In a continental country such as Brazil, having a comprehensive and representativeclinical database is a monumental task. Regional socioeconomic disparities andresource availability limit nationwide data collection. Research underfundinghistorically led Brazilian researchers to rely on voluntary efforts for datacollection. The IMPACTO-MR platform can overcome these barriers by providing fundingfor data collection in all participant ICUs (guaranteed until 2023), along withmultidisciplinary site staff training  and a single data collection systemfocused on critical variables, which can also be used for benchmarking andperformance evaluation.For the first time, Brazilian ICUs have a nationwide representative database allowingfor better generalization of results and introduction of platform trials.Furthermore, the system used for data collection is a commercial system widely usedfor quality improvement and benchmarking. This was an advantage for participant ICUsas data entered into the system are used not only for clinical research but also formanagement and quality improvement. The direct leadership of prominent researchinstitutions helps guide the database purpose to relevant research prospects.A gap between clinical practice and clinical research has been acknowledged for along time. The problem occurs in two ways: the uptake of research evidence intopractice, the central aim of evidence-based medicine, is faulty and lengthy.Conversely, the aspiration of learning and generating systematic knowledge fromclinical practice is rarely achieved and is far from reality. Research is usually acostly, complex, and bureaucratic endeavor conducted by supplementary individuals,many of whom are not directly involved with patient care. Most studies arestand-alone initiatives with specific databases, which are discontinued after thestudy conclusion. Therefore, how the research conclusions are incorporated into theclinical practice of even the participating centers is lost. Solutions to overcomethis problem are needed. A platform with a continuous collection of routine data ofall patients should facilitate embedding multiple observational studies and trialsinto practice - the care of every patient should generate knowledge. Conversely, theimplementation of newly generated evidence from studies conducted on the platformcan be systematically measured. However, the project implementation faced somedifficulties. First, one of the advantages of the IMPACTO-MR platform, itsnationwide representativeness, imposed logistical challenges for implementation andstaff training. Second, the lack of a centralized process for IRB approval forobservational trials in Brazil led to some disparities in the regulatory phase. Onesite center demanded obtaining informed consent for all patients admitted to theICU. Third, despite training and funding, continuous data input for all ICUadmissions is a monumental task, implying variability in the data collected in eachparticipant ICU, demanding extra effort directed to data management (curation).Finally, the COVID-19 pandemic, which overwhelmed health care systems throughout theworld, led to interruptions in data collection for some ICUs, with some unitsabandoning the platform.The IMPACTO-MR platform is a Brazilian nationwide intensive care unit clinicaldatabase focused on research on the impact of health care-associated infections dueto multidrug-resistant bacteria. With more than 50 intensive care units and morethan 70,000 patients included, the platform provides data for individual intensivecare unit development and research and multicenter observational and prospectivetrials.