Public health programs in the United States screen more than four million babies each year for at least 30 genetic disorders. The Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) recommends the disorders for state newborn screening (NBS) programs to screen. ACHDNC updated the Recommended Uniform Screening Panel (RUSP) to include Pompe disease in March 2015. To support the expansion of screening for Pompe disease, the Association of Public Health Laboratories (APHL) proposed the Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) New Disorders Implementation Project, funded by the HHS’ Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB). Through this project, APHL provided financial support to 15 state NBS programs to enable full implementation of screening for Pompe disease. As of April 27, 2020, nine of the 15 programs had fully implemented Pompe disease newborn screening and six programs are currently pursuing implementation. This article will discuss how states advanced to statewide implementation of screening for Pompe disease, the challenges associated with implementing screening for this condition, the lessons learned during the project, and recommendations for implementing screening for Pompe disease. Public health programs in the United States screen more than four million babies each year for at least 30 genetic disorders. Through the newborn screening (NBS) program, states identify newborns at risk for certain metabolic, endocrine, hemoglobin, neuromuscular, and other inherited conditions. To guide this process, the Health and Human Services (HHS) Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) recommends the disorders for state NBS programs to screen . Each diThere are 35 core disorders on the RUSP, as of April 2020 [Pompe disease is a multi-systemic lysosomal storage disorder (LSD) caused by a deficiency in the acid alpha glucosidase (GAA) enzyme. This enzyme helps lysosomes breakdown glycogen, a complex sugar, in the body. Without this enzyme, glycogen accumulates in the cells, causing them to lose their ability to function properly. If left untreated, babies born with the most severe form of Pompe disease die within their first year of life . In the To implement universal screening for Pompe disease, there are many factors for state NBS programs to consider. This includes determining the cost to screen for the disorder, gaining legislative and funding approval to screen, securing fee increases if necessary, selecting a technology and methodology to screen, expanding laboratory space and capacity, acquiring the appropriate equipment, hiring laboratory and follow-up staff, and developing and implementing education initiatives for the public and for clinical providers. While these factors are important for the addition of all new disorders to state screening panels, Pompe disease introduced unique considerations for the newborn screening system. States screening for this disorder must consider establishing algorithms for the detection of infantile Pompe disease in distinction from late onset Pompe disease, defining the duration of short term follow up and late onset Pompe disease and defining the role of NBS in long term follow up (LTFU) for individuals identified with the disorder. APHL was awarded a cooperative agreement from the HHS’ Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB) to expand the ability of state NBS programs to screen for Pompe disease. Through the New Disorders Implementation Project, the APHL Newborn Screening Technical assistance and Evaluation Program (NewSTEPs) provided financial support over the course of three years to 15 state NBS programs to enable and accelerate full implementation of newborn screening for Pompe disease .APHL also selected and funded three additional states to serve as Peer Network Resources Centers (PNRCs) during the course of the New Disorders Implementation Project. The PNRCs served as content area experts providing technical assistance and training regarding laboratory techniques, follow-up procedures, and educational processes related to Pompe disease, as well as for other new disorders screening as needed. Each state NBS program and PNRC applied to participate in the project through a competitive request for proposals (RFP) and a subsequent evaluation process. In the RFP, NewSTEPs proposed a four-phase model to stratify the NBS implementation process, as seen in The 15 participating state NBS programs provided a combination of monthly and annual progress reports where they described activities and progress toward full implementation and also participated in monthly calls with NewSTEPs staff to track and describe their activities and indicate their successes, challenges, needs, lessons learned, and recommendations. Of the 15 funded state newborn screening programs, nine were also funded to implement screening for Mucopolysaccharidosis type I (MPS I) and X-linked adrenoleukodystrophy (X-ALD) simultaneously with Pompe disease and six were funded to implement MPS I simultaneously with Pompe disease. Additionally, the 15 funded programs set varied project goals and objectives to move them toward full implementation of screening for Pompe disease during the funding period. A summary of these goals are found in Upon initiation of the funded project, two of the 15 state NBS programs were working on Phase 1  to obtaiUpon initiation of the funding project, nine state NBS programs reported that they were working on Phase 2  toward eUpon initiation of funding, three state NBS programs reported that they would be working toward Phase 2  in securUpon initiation of funding, only one state NBS program reported that they would be engaging in Phase 1, Phase 2, and Phase 3  simultanIn their applications, 10 state NBS programs anticipated that they would have implemented Pompe disease screening at the end of the project period, one program anticipated that they would have entered Phase 3 , and twoParticipating state NBS programs utilized funding from the NewSTEPs New Disorder Implementation Project to purchase equipment and supplies, develop and translate educational materials, develop a statewide outreach program, host a community engagement event, hire laboratory and follow-up personnel, purchase software for sequence analysis, travel to professional meetings or to PNRCs for training, configure LSDs workflow in Laboratory Information Management Systems (LIMS), and develop a long-term follow-up program .Each program engaged at least one PNRC for technical assistance during the project. The PNRCs provided states with LSD standard operating procedures and algorithms, sample panels for validation, technical assistance around LSD test validation, LSD cost data, comparison analysis, second-tier testing guidance for Pompe disease, DNA sequence analyses for Pompe disease, and Pompe disease related educational materials for primary care providers and parents. The PNRCs also retested abnormal LSDs for state programs. One PNRC hosted an annual Tandem Mass Spectrometry, DNA Sequencing, and a Follow-up hands-on workshop. Another program prepared Pompe disease follow-up flow diagrams. State NBS programs also visited PNRCs for direct one-on-one-training to learn laboratory and follow up best practices and to observe processes.As of 27 April, 2020, nine of the 15 programs that participated in the project had fully implemented Pompe disease newborn screening, offering the screening universally to all newborns in the following states: California, Michigan, Minnesota, Nebraska, New Jersey, Ohio, Tennessee, Virginia, and Washington. The other six programs are currently pursuing screening implementation for Pompe disease.Programs participating in the NewSTEPs New Disorders Implementation project to implement Pompe Disease Newborn Screening also achieved the following milestones during the course of the funding period: created and deployed an online education module for providers and parents, educated 500 health care professional across the state regarding Pompe disease, implemented second-tier testing for Pompe disease, developed a follow-up quality improvement plan, and hosted a successful deliberative community engagement event.It is important to note that while the activities for the 15 state newborn screening programs highlighted here are specific to their pursuit of Pompe disease newborn screening, additional disorders (MPS I and x-ALD) were also pursued by a number of these programs. There are several aspects of the newborn screening multiplexing of the screening assay, development of educational materials, and training of implementation activities described above that are generalizable to these other disorders, including laboratory and follow-up staff, establishment of reporting algorithms, among others.The participating state NBS programs faced several challenges implementing screening for Pompe disease. As noted above, while many barriers and challenges in implementing newborn screening are generalizable to multiple disorders, the challenges presented below are articulated by the 15 newborn screening programs pursuing Pompe disease newborn screening during the course of the NewSTEPs New Disorders Implementation Project. These challenges are as follows :When implementing screening for Pompe disease the participating state newborn screening programs recommended allowing for sufficient time to accomplish procurement of instrumentation required for first tier detection of GAA enzyme activity. Multiple methodologies exist to perform a Pompe disease newborn screening assay, including the use of digital microfluidics or tandem mass spectrometry, and programs recommended building in sufficient time to identify the methodology to use . In addiBefore implementing full population screening for Pompe disease, the participating states noted that NBS programs should determine second-tier needs, address special populations since these infants can potentially influence the determination of cut-off values for assay analysis and may require repeat screening, and ensure LIMS integration is complete. The introduction of Pompe disease newborn screening can increase the workload for all staff involved in the testing and reporting process, therefore affecting communication with providers. At the end of the NewSTEPs New Disorder Implementation Project, the participating state NBS programs provided recommendations for implementing newborn screening for Pompe disease. The recommendations included participating in APHL NewSTEPs committees and in-person meetings to collaborate and connect with other programs and NBS stakeholders, creating standardized educational materials and long-term follow-up strategies that can be modified for state-specific use, and ensuring that all state stakeholders including pediatric subspecialties and parent representatives are involved in discussing all plans for implementation. Other recommendations include adding second-tier screening to reduce false positives and monitoring screening outcomes and refining cut-off reporting algorithms. Prior to implementing second-tier screening or refining cut-offs, states’ programs screening for Pompe disease using tandem mass spectrometry or digital microfluidics reported higher than expected false positive and referral rates, increasing the patient load at NBS follow-up coordinating and genetic centers. Implementing second-tier testing and refining cut-offs reduced false positive and referral rates. Participating state NBS programs also recommended developing long-term follow-up guidelines for cases of Late Onset Pompe Disease (LOPD). The ACHDNC updated the RUSP to include Pompe disease in March 2015. To support the expansion of newborn screening across the United States for Pompe disease, APHL proposed the NewSTEPs New Disorders Implementation Project, funded by HRSA. Through this project, 15 state NBS programs received direct funding through a competitive RFP process to implement screening for Pompe disease and all states had access to technical assistance and training via PNRCs. To provide further support to state NBS programs with the implementation of Pompe disease, APHL hosted national meetings to provide a platform for state programs to share their experiences implementing screening, hosted disease-specific webinars, and convened a NewSTEPs New Disorders Workgroup to serve as educational experts. As a result of the project, all states had access to information and resources regarding Pompe disease screening implementation.To ensure that all states have the capacity to screen for Pompe disease and newborns living with this disorder are identified and linked to care, APHL will continue to provide support through technical assistance, training, webinars, quality improvement initiatives, and national meetings.


In West and Central Africa, “leaving no one behind” requires strengthening community health systems by increasing health financing, improving supply chain system, and fostering community ownership and partnerships in all settings. Countries with high child mortality rates should improve service delivery through better integration. Galvanizing context-specific country actions is fundamental to improve primary health care services and move toward universal health coverage. Challenges with health financing, essential medical products and technology, and community ownership and partnerships emerged as the severe or very severe health system bottlenecks that hampered the strengthening of community health systems, irrespective of mortality context.Country-led progress is possible. Potential strategies to overcome bottlenecks include increasing domestic allocation and leveraging innovative funding mechanisms for primary health care (PHC), integrating supply chain systems, and strengthening policy implementation with communities and local governments.Countries with high child mortality rates should improve service delivery through better integration.Countries must seize the opportunities to systematically strengthen community health systems in their efforts to achieve universal health coverage.We must galvanize efforts to mobilize resources for effective PHC, which is reliant on strong community health systems to expand access to services and live no one behind.Community-based integrated programming should be reinforced to strengthen resilience, disease surveillance, and rapid responses to health crises, including infectious diseases like COVID-19. The renewed commitment to primary health care (PHC) presents an opportunity to strengthen health systems in West and Central Africa (WCA). Though evidence-based cost-effective interventions that are predicted to prevent up to one-third of maternal, newborn, and child health complications and deaths with universal coverage have been identified, more than 50% of people living in rural areas or from poor families still do not have access to these interventions in resource-constrained settings.We conducted a multicountry systematic analysis of bottlenecks and proposed solutions to strengthen community health systems through a series of collaborative workshops in 22 countries in WCA. Countries were categorized by their under-5 mortality rate (U5MR) to assess specificities related to reported challenges. We also reviewed existing data on selected health system tracer interventions to analyze country profiles.The bottlenecks identified as severe or very severe were related to health financing , essential medical technology and products , integrated health service delivery , and community ownership and partnerships . Only the integrated service delivery was self-reported as a severe challenge by countries with high U5MR. The issue of human resources for community health was one of the least reported challenges.In WCA, strengthening community health systems as part of PHC revitalization efforts should focus on increasing health financing and innovative investments, strengthening the logistics management system, and fostering community ownership and partnerships. Countries with high U5MR should also reinforce integrated service delivery approaches through innovation. Government actions galvanized by global and regional ongoing initiatives should be sustained to ensure that no one is left behind. Studies conducted in low- and middle-income countries have shown that focusing on provision of health services at the community level not only leads to more efficient and equitable use of health resources and better health outcomes but also is a consistent component of strong, effective health systems.––,Considerable progress has been made in improving health and well-being over the past 40 years, with dramatic reductions in maternal, neonatal, and child deaths.Although interventions have been identified that are predicted to prevent up to one-third of MNCH deaths, more than 50% of people living in rural areas or from low-income families don't have access to these interventions.,Many countries, especially in West and Central Africa (WCA), are lagging far behind the health-related SDG targets, calling for increased action.,However, the achievement of expected results varies between and within countries. There seems to be a difference between high mortality and low mortality countries in terms of health system functionality, capacity, and coverage of interventions.The big challenge remains how to put health systems strengthening into practice at the community level to achieve high, equitable, and effective coverage of care.To ensure all populations have access to and use quality health services, systematic and context-specific identification of the health system barriers is needed to plan and implement community health programs. In this article, we aim to identify common community health system bottlenecks, review progress made by selected countries, and propose strategies to move forward. We also assess particularities by child mortality context through a multicountry analysis in WCA.Between January and April 2019, we contacted all 24 countries in the United Nations Children's Fund (UNICEF) WCA regionSupplement).,To assist countries in their analysis of health system bottlenecks, including identifying challenges that prevent the scale-up of community-based interventions and potential solutions, we developed the community health system bottleneck analysis tool, taking into consideration the World Health Organization (WHO)/UNICEF draft PHC operational framework , needs minimal improvements (minor bottleneck), needs important improvements (severe bottleneck), or inadequate (very severe bottleneck). Finally, participants proposed potential strategies to address priority challenges identified. The ministry of health program managers and working group members were responsible for collating all responses and submitting the final data; they also served as points of contact for clarification of any issues. In November 2019, the first high-level regional forum on community-based PHC organized in Benin was an opportunity to further discuss and validate the results with the 13 country teams who participated in the meeting.Workshop participants used the community health bottleneck analysis tool to examine the 7 health system building blocks and identify challenges.We received complete national-level data from 22 countries. We reviewed all the bottlenecks for each health system building block and all solutions presented by country participants  and 2. ITo complement the bottleneck analysis in the 22 countries in WCA, we selected tracer indicators from the health system building blocks and indicated the coverage of key indicators for children to analyze countries' progress toward reducing child mortality from a multisectoral lens. We categorized countries according to the latest U5MR, relative to one of the targets for the third Sustainable Development Goal (SDG3), which is to end preventable deaths of children under 5 years old by 2030, with all countries aiming to reduce under-5 mortality to at least 25 per 1,000 live births (LBs). Based on this target we proposed 3 groups of countries: Group 1 countries had U5MR of 25 deaths per 1,000 LB or less, Group 2 countries had U5MR between 25 and 75 deaths per 1,000 LB, and Group 3 countries had more than 75 deaths per 1,000 LB.We further analyzed health system tracer indicators from existing global data to assess the profile of countries studied, taking into consideration the health system building blocks. Selected indicators can be found in A total of 22 country teams identified and self-graded the bottlenecks to strengthen community health systems in their respective country contexts. We conducted subanalyses of these bottlenecks by further categorizing countries according to their mortality context. As displayed in The results from the grading patterns showed that overall, and irrespective of mortality context, health financing, essential medical products and technology, and community ownership and partnerships emerged as the health system building blocks that were consistently rated as having severe or very severe bottlenecks.Supplement, Table 1) self-reported by country teams (at least 50% of countries) revealed that commonly, health financing challenges were due to the lack of a budget line for community health or PHC (13 countries), inefficient financial flows (13 countries), and mostly, the absence of a clearly defined resource mobilization pathway outlining funding gaps and potential funding sources that could be tracked and collected (20 countries).Further analysis of the thematic areas , frequent stock-out of selected drugs (15 countries), nonfunctional monitoring tracking system for drugs on a real-time basis (15 countries), and inadequate or lack of quantification of community needs as part of the national annual quantification exercise (14 countries).Community ownership and partnerships was self-reported by country teams as a weak area exacerbated by the lack of a national community engagement strategy (13 countries), inadequate linkages between CHWs and community members (13 countries), and the absence of functional mechanisms for social accountability and citizen engagement (14 countries). In countries with U5MR over 75 deaths per 1,000 LB, integrated service delivery was a challenging building block mainly due to poor integration between MNCH and TB/HIV, birth registration, promotional and preventive adolescent sexual and reproductive health services, or early childhood and education. Less than 40% of country teams reported issues integrating MNCH and nutrition or water, sanitation, and hygiene interventions.Supplement, Table 2). We highlight selected country-led efforts toward strengthening their community health systems in the context of PHC with the support of stakeholders working in the field of health system strengthening. This nonexhaustive list of selected achievements includes: Primary Health Care Development Agency Act (Nigeria), Primary Health Care reform , Integration of the community health module into the district health information system or DHIS2 , National Health Insurance financing scheme (Ghana), and financial contribution of local collectivities/government through their annual investment plan (Guinea), to name a few .Despite the observed challenges, countries made progress during the past 5 years  most likely due to weak systems for restocking, inadequate quantification, or lack of funds. One strategy could be the use of information and communication technology (ICT) or computerized systems that analyze local data use to drive the supply of commodities according to need, which can be set to both forecast seasonal needs and to generate alerts when commodities fall below a specified threshold.Efforts to strengthen the supply chain should focus on ensuring a more responsive integrated supply chain management system to improve the health workers' effectiveness.,,,Community engagement was a severe challenge for most country teams in all contexts. Enhancing community participation—a fundamental principle of PHC—has proved problematic, and how it is operationalized and sustained in practice is not always well understood.,,The highest burden of mortality and morbidity is often seen where health system gaps are the greatest.–,,–Few country teams reported challenges in integrating MNCH and integrated community case management of childhood diseases.,Community-based integrated programming should be reinforced to strengthen disease surveillance, rapid responses to health crises that may emerge in different areas, including infectious diseases (like coronavirus disease [COVID-19]), first aid, and mental health as we learned from the Ebola outbreak.Community-based integrated programming should be reinforced to strengthen resilience, disease surveillance, and rapid responses to health crises, including infectious diseases like COVID-19.Although this health system block has not been self-graded as a major bottleneck by country teams, its importance cannot be overstated. Governments and communities need to plan and act to institutionalize CHWs as per the 2018 WHO policyIn terms of partnerships, there is also a need for strong intersectoral linkages beyond health alone as well as multilevel partnerships, which are crucial to driving and maintaining effective systems. More countries in WCA can also benefit from global and regional ongoing initiatives to mobilize investments and expertise to strengthen community health systems including the Global Financing Facility,,,Although this building block was not self-graded a major bottleneck, at least 50% of countries reported challenges related to lack of community data, poor quality of data reported, and the capacity of communities to analyze and use the data for decision making. This is most likely due to weak supervision of CHWs by health facility staff and insufficient number of CHWs trained on information system management. Several countries, including Liberia, Sierra Leone, Ghana, and Senegal improved their information system by integrating the community health module into the district health information system (DHIS2). In addition, Ghana moved forward with the roll-out of eHealth.,Challenges related to human resources at the community level were not perceived to be severe or very severe by most country teams, most likely due to ongoing efforts. A regional study conducted by WHO in 2019 showed that 70% of 47 African countries had a human resources strategy or plan showing their commitment to address workforce issues.,,,We categorized bottlenecks by health systems building blocks to allow the identification of issues and implementation of solutions. However, we recognize that barriers to care are inter-related and their solutions cut across several building blocks.The multicountry bottleneck analysis workshops provided an opportunity to engage country teams in identifying and prioritizing context-specific barriers to strengthen community health systems. Following this in-country exercise in 2019, countries such as Niger, Côte d'Ivoire, Sierra Leone, Mali, Burkina Faso, and Gambia have organized further dialogue with national experts and key stakeholders to review and revise their community health policy or strategy. The solutions proposed by the country teams could inform technical assistance needs and serve as a basis for further dialogue for countries to implement evidence-based, data-driven community health programs and build resilience. In the context of PHC revitalization, addressing the regional situation of accelerating the reduction of maternal, neonatal, and child deaths by 2030 requires integrated, equity-focused, and multisectoral strategies, as well as strengthened community health systems.


Big data are potentially useful for environmental management planning and actions that can be directed toward pollution control. China is using big data approaches to help reduce its current levels of pollution. However, also needed are better environmental indicators, measurement technologies, data management and reporting, and adaptive management and enforcement. Based on continental-extent monitoring and assessment programs in Europe and the USA, we recommend three major programmatic changes for China. (1) Establish long-term systemic environmental and human health objectives and indicators. (2) Adopt national standard methods for survey designs, sampling and analytical protocols, statistical analyses, and collaborative sampling programs. (3) Provide a transparent process for reporting and correcting data errors. Recently, China has made considerable progress towards ecological and environmental protection through use of big data sets and analytics, which are increasingly being used by China’s Ministry of Ecology and Environment (MEE). The MEE is currently gathering ecological and environmental information into one map via a virtual set of map overlays . Key aimThere are 5 key challenges to China’s big data initiative: indicators, monitoring and assessment, data quality, data transparency, and rigorous adaptive management. If China can meet those challenges, it can fill substantial ecological research and management gaps by markedly increasing the extent and rigor of ecological information and pollution mitigation that is currently lacking in Asia . TherefoA suite of relevant, quantitative and cost-effective indicators is needed for tracking progress toward meeting clearly stated goals and objectives . Those indicators were selected because of their known correlations with the incidence of respiratory, cardiac and cancerous diseases [USEPA’s Level 5 and 6 air quality indicators include several of those monitored in China Table , plus madiseases . They ardiseases , which iUSEPA’s water monitoring and regulation programs have two key limitations. Results have indicated that key anthropogenic pressures are largely related to minimally regulated diffuse pollution , 40, 46 Regarding USA air pollution monitoring and regulation, there are 5 shortcomings. A growing concern is USEPA’s failure to maintain its automated air monitoring stations . Also, cThe European Union (EU) approved its Water Framework Directive in 2000, with a goal of good water quality by protecting all types of water bodies, restoring ecosystems, reducing pollution, and guaranteeing sustainable water usage . Good ecThe Chinese objectives neglect information about the extent to which pollution damages the environment or human health. China measures administrative and environmental indicators involving Level 1–4 indicators such as the percentages of surface waters and airsheds meeting, or not meeting, acceptable ranges of key chemical constituents. Although increases in asthma and other chronic respiratory diseases and premature mortality occur throughout China from ambient air pollution , 24, LevChina has implemented a network of ambient air quality monitors providing data that MEE and the provincial and local environmental protection bureaus (EPBs) can use to assess progress toward meeting established goals. However, many cases of monitoring system and data manipulation by local government officials have been reported, and several key air pollutants are still not monitored , 98, Tab.Unlike water body monitoring in China, the USEPA implemented a National Aquatic Resources Survey (NARS) in 2000 based on a probabilistic design, standard sampling methods and indicators, and collaborative sampling by the states and government contractors. NARS provides statistically valid assessment of the ecological status and the relative importance of various stressors to all USA surface waters –83, 86. Key results from the USEPA’s NARS indicate that 3–40% of the sampled population of rivers contain fish tissue levels of mercury, polychlorinated biphenyls or perfluorooctanesulfunic acid that warrant fish consumption warnings , water body monitoring and assessment data from eight different institutions were easily synthesized because all used a standard survey design, standard methods, and the same environmental and biological indicators . MultiplProblems exist in China with data availability, interruptions in time series, inconsistencies between different sources reporting similar energy and air quality statistics, and a lack of data transparency , 38. ChiWe offer five recommendations for improving China’s data quality based on USEPA . (1) AllThe transparency of China’s environmental data remains problematic . Data arWe believe that a key towards continued improvement requires government employees to view themselves as ecosystem (nature) trustees always keeping in mind the goals and objectives of the empowering legislation . CitizenResource management should be based on a rigorous adaptive management paradigm , 96. RigCommon concerns to pollution control globally include government inaction, resistance of industries and citizens toward environmental protection, false arguments of jobs versus the environment and human health, externalities and lag effects, and resistance toward long-term and large-extent strategic thinking. But those also are the drivers for better analysis of big data. China can draw on international and historical experience in tackling its environmental challenges and improving its big data. The implementation of such an initiative goes beyond the technology itself. It requires the efforts of the entire society, the resolve of political leaders, and an institutional framework to fully understand the indicators developed from the data and how the country will most effectively use the data. The successes or failures that China exhibits in resolving its air and water pollution problems will serve as explicit indicators of its ability to solve environmental problems affecting human health and quality of life nationally and globally.


Alzheimer’s disease and Related Dementia (ADRD) is a significant public health problem and improving the quality and efficiency of care for older adults with ADRD is a national priority. Approximately five million older adults in the United States, including 50% of nursing home residents and 20% of community-dwelling elderly, have ADRD or probable dementia. Although, the number of minorities affected by ADRD growing at an alarming rate, the diagnosis of ADRD and supportive care for this condition are more likely to be delayed among racial/ethnic minority groups. Given the need to ensure equity of care among racial and ethnic groups, there is a pressing need to understand disparities in diagnosis, access and quality of care among racial and ethnic groups with ADRD, specifically using nationally representative data. This symposium will feature four presentations that provide novel insight regarding racial disparities among people with ADRD in the community-, institution-based post-acute, and long-term settings. Individual presentations will describe 1) racial and ethnic differences in risk and protective factors of dementia and cognitive impairment without dementia; 2) racial and ethnic disparities in high-quality home health use among persons with dementia; 3) Within- and between-nursing homes racial and ethnic disparities in resident’s outcomes for people with ADRD; and 4) racial differences in transition to post-acute care and rehab utilization following hip fracture related hospitalization in patients with ADRD. Finally, there will be a discussion regarding policy and clinical implications, as well directions for future research.


The publicly stated timeframes of 12–18 months for availability of licensed vaccines targeted against SARS-CoV-2 are optimistic, but would have been considered fantastic even a decade ago.Over the past two decades, outbreaks of novel and re-emerging infectious diseases, particularly caused by zoonotic viruses, have prompted an international push to develop strategies addressing research, nonclinical and clinical testing, manufacturing, and regulatory evaluation that can increase the rapidity of medical countermeasure development to control outbreaks and prevent resurgence of those diseases. Most recently, the emergence of a novel coronavirus, SARS-CoV-2, and its explosive dissemination—resulting in a global disease pandemic  that, as of late April 2020, is associated with almost 3.1 million confirmed infections and 220,000 deathsIn response to other recent global public health emergencies, such as the 2014–2015 Ebola virus epidemic in West Africa and the widespread emergence of Zika virus in 2015–2016, several national and international health policy and funding agencies have prepared lists of priority pathogens considered to have potential to cause pandemic disease, and promoted the development of platform technologies that can speed the production of new vaccines against those agents, or against a previously unidentified emerging pathogen, often termed “Disease X”.3. In addition, they may benefit from simplified requirements for nonclinical safety evaluation when alternative novel sequences are inserted into a previously well characterized platform construct. Some questions remain regarding the immunogenicity of nucleic acid vaccines compared with other more traditional vaccine approaches, but significant efforts have been made to address those through optimization of vaccination routes and timing of doses, and the use of vehicles and devices that facilitate uptake of the nucleic acid by host cells, resulting in improved performance of this class of vaccines in large animal models and in clinical use3.One such group of platform technologies that is considered by many to be a key component of rapid vaccine development are nucleic acid vaccines, in which the genetic sequences for potentially immunogenic and protective antigens from the pathogen are delivered as DNA or RNA molecules. Compared with more established approaches for immunization using injection of live attenuated or inactivated pathogens, or protein subunits of those pathogens, nucleic acid-based approaches offer several advantages for rapid response including rapid adaptability, simpler manufacturing processes, enhanced physical stability, and robust safety4. In 2005, WHO developed “Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines”5 and, based on the subsequent progression of several DNA vaccines to clinical evaluation and increasing awareness of the potential utility of DNA vaccines in outbreak responses, initiated a process for revision of those guidelines in February, 2018 from which a draft was publicly disseminated in mid-2019 for comment6. The revised Guidelines focus on biologically manufactured bacterial plasmid DNA for use in humans, and address aspects related to control of manufacture and characterization, approaches to nonclinical and clinical testing, and information that may be required by national regulatory authorities for approval of clinical trials or licensure. The revised Guidelines are considered unlikely to be applicable to RNA vaccines, and development by WHO of separate document(s) covering RNA vaccines is in progress6. In this issue of npj Vaccines, Sheets et al.7 provide an overview of the revision process to date, report the outcomes from an Informal Consultation of subject matter experts held in December, 2019 to review the draft revisions and discuss public comments that had been received, and describe the timeline for further revision and subsequent approval and implementation of the new guidelines by the WHO Expert Committee on Biological Standardization during 2020.Concurrent with facilitating new approaches and technologies that may speed vaccine development, the WHO’s R&D Blueprint for action to prevent epidemics has identified alignment of regulatory expectations for the testing and evaluation of novel vaccine candidates as a key enabler for effective outbreak responses8. For the two vaccines now in Phase 1, it seems that the rapid path to clinical testing was facilitated by both the short timelines for manufacturing of initial clinical lots and streamlined requirements for nonclinical safety testing based on prior nonclinical and clinical experience with those platforms9. Evaluation of vaccine efficacy in newly developed animal models for COVID-19 can be expected to proceed in parallel with clinical safety testing. Vaccine development against SARS-CoV-2 is benefiting from prior experience with other closely related emerging coronaviruses associated with severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Currently there are no licensed vaccines for coronaviruses that cause respiratory diseases in humans, and induction of robust and durable protective immunity against infection by SARS-CoV-2 through vaccination may be challenging. Furthermore, the outcomes of nonclinical efficacy testing of some candidate vaccines for SARS and MERS suggests that another significant concern is the potential for immune potentiation of COVID-19 lung disease12. The anticipated demand for hundreds of millions of doses for SARS-CoV-2 vaccines and their use in a wide range of target populations, coupled with the likely limitations of manufacturing capacity and scalability for any single vaccine type, suggests that engagement and coordination of multiple international partners for development of a portfolio of licensed vaccines based on multiple platforms will ideally be needed13.This communication is timely, given the current global impacts of COVID-19 and the rapid development of a large number of candidate vaccines, including several based on DNA or other nucleic acid platforms. At the time of this report , and only 2–3 months following initiation of their development, a candidate DNA vaccine  and a candidate RNA vaccine (NCT04336410) are in Phase 1 clinical trials, and more than a dozen other nucleic acid vaccine candidates are in developmentThe current COVID-19 pandemic will provide nucleic acid vaccine platforms their greatest opportunity to demonstrate in practice their proposed value as key components in the rapid response to controlling global or regional emerging infectious disease threats. The availability of the revised WHO Guidelines related to DNA vaccines, currently as a draft and subsequently in a final form, should facilitate communications between vaccine developers and regulatory agencies as nucleic acid vaccine candidates progress towards possible licensure.


Early findings and insights are shared from an interpretive analysis of interviews with 15 leaders in arts-based approaches in dementia care. This was conducted as part of a larger project that has the goal of operationalizing ‘good’ literacy in social and relational care in long-term care (LTC). Interviews aimed to identify promising directions in arts-based approaches in education and training for LTC staff provincially, nationally, and internationally, and understand how they contribute to ‘good’ mental health and dementia literacy. Participants were recruited using a purposive snowball sampling method and semi-structured interview guide. Interviews were conducted in-person, via telephone and Zoom, and digitally recorded. Arts-making enhances mental health and dementia literacy of LTC staff by: 1) supporting relationships by generating trust and collaboration among persons living with mental health conditions and/or dementia, arts facilitators, and family members; 2) creating alternative communication spaces that allow people to see themselves and be seen by others from new perspectives; 3) fostering an artistic sensibility that: encourages imagination and empathy, brings spontaneity and playfulness to interactions, and disrupts restrictive expectations entrenched in typical caregiver/care receiver relationships. ‘Good’ literacy involves a relational and spatial awareness which manifests in the form of an artistic sensibility. Arts-based approaches can be used to enhance quality care by capacitating staff in the art of being open and curious, nimble and flexible, in how they know and make connections on an interpersonal level, in the moment.


Severe subluxations or dislocations were more likely to be present in those with more dysplastic bony and cartilaginous hips. In conclusion, our study provides the first systemic description of bony and cartilaginous characteristics in the hip morphology of MPS IVA patients. We have demonstrated that plain radiography alone leads to a misunderstanding of hip morphology and that MRI measurements with PFR are an essential tool to evaluate the ‘true’ characterization of hips for MPS IVA patients.Patients with mucopolysaccharidoses IVA (MPS IVA) have a progressive accumulation of the specific glycosaminoglycans (GAGs): chondroitin-6-sulfate (C6S) and keratan sulfate (KS), leading to the degeneration of the cartilage matrix and its connective tissue perturbing the regular microarchitecture of cartilage and successively distorting bone ossification and growth. Impaired cartilage quality and poor bone mineralization lead to serious hip disorders in MPS IVA patients. Although hip dysplasia is seen widely in musculoskeletal abnormality of this disorder, the pathophysiology of the hip bone and cartilage morphology in these patients remains unclear. Until now, no systemic study of the hip joints in MPS IVA has been reported by using the combined images of plain film radiographs (PFR) and Magnetic Resonance Imaging (MRI). This study aimed to assess the bony and cartilaginous features of hip joints and to explore the potentially related factors of femoral head osteonecrosis (FHN) and hip subluxation/dislocation in patients with MPS IVA. Hip joints in MPS IVA patients were retrospectively reviewed, based on the findings of PFR and MRI data from 2014 to 2019. Demographic information was also collected and analyzed with imaging measurements. A total of 19 patients (eight boys and 11 girls) were recruited, and 38 hip joints in these patients were examined. Eleven patients (57.9%) had FHN. FHN patients were statistically compared with those without FHN. Correlations between cartilaginous femoral head coverage (CFHC) and acetabular index (AI), cartilaginous AI (CAI), or neck-shaft angle (NSA) were investigated in patients with hip subluxation or dislocation. The greater cartilaginous coverage of the hips than their osseous inherency was observed. Significant correlation was observed between CFHC and AI (r =−0.351,  Morquio A syndrome (Mucopolysaccharidosis (MPS) IVA (MPS IVA)) is a lysosomal storage disease caused by the deficiency of N-acetylgalactosamine-6-sulfate sulfatase (GALNS) . This enMusculoskeletal disorders almost occur in all types of MPS; however, patients with MPS IVA have unique clinical features compared with other types of MPS, since the skeletal abnormality is more dominant with the laxity of joints . Hip abnIn this study, by using the combined images of PFR and MRI, we have aimed to assess the bony and cartilaginous features of hip joints and to explore the potentially related factors of FHN and hip subluxation/dislocation in patients with MPS IVA.Confirmed MPS IVA patients with established biochemical and genetic identification were retrospectively reviewed between 2014 and 2019 from our databases. All patients were Chinese and were recruited at Shanghai Children’s Medical Center in China. The inclusion criteria consisted of available plain film radiographs and MRI of the hips using standard techniques. Demographic and clinical information included sex, age, age at hematopoietic stem cell transplantation (HSCT), height, and weight. Informed consent was obtained, and institutional review board approval was acquired .Supine anteroposterior pelvic plain film radiographs (PFR) with the hips in the neutral rotation was performed in all the patients. The acetabular index (AI), center-edge angle (CEA) of Wiberg, femoral head coverage  , and necMagnetic resonance imaging (MRI) scans were performed with a maximal slice thickness of 3 mm under sedation. Measurements in MRI imaging included the same angles measured on the PFR . These parameters were measured under the consideration of the cartilaginous roof , which were used to describe the cartilaginous morphology of hips. The measurement center of the femoral head was defined by the Siddesh method . The larThe differences between osseous and cartilaginous AI, osseous and cartilaginous CEA, and osseous and cartilaginous FHC were calculated and recorded as ∆AI, ∆CEA, and ∆FHC, which represented the ‘true’ cartilaginous characteristics and coverage of the femoral head.Descriptive statistics were performed for all the included patients. Patients were divided into two groups, according to whether FHN was present or not. The patients’ age, age at HSCT, height, weight, AI, CEA, FHC, CAI, CCEA, CFHC, ∆AI, ∆CEA, and ∆FHC were statistically compared between the two groups.The patients with subluxation or dislocation of hips, negative value of CCEA, were selected. The extent of subluxation/dislocation of hips was indicated by the values of CFHC. The correlations of CFHC to AI, CAI, and NSA were statistically analyzed.p < 0.05.Data from measured parameters were expressed as mean ± standard deviation (x ± s). We compared the data between the FHN group and the non-FHN group by using the Fisher exact tests for categorical variables and independent t-tests for quantitative variables. Spearman’s 2-tailed correlation analysis was used to test the correlations of CFHC to AI, CAI, and NSA in subluxation/dislocation patients. We analyzed the data using SPSS version 18 , and the significance level was set at A total of 19 MPS IVA patients (eight boys and 11 girls) were included in this retrospective study. The data from 38 hip joints of these patients were collected and investigated . All 19 p = 0.002) and were significantly higher and heavier than those without FHN . The AI value in the PFR was significantly larger in the FHN group .FHN in MPS IVA hips is a pathologic process that results from the dysplasia of bone and cartilage by growth disturbance. In this study, eleven patients  were presented with FHN and eight patients without FHN at the time of imaging . No signp = 0.049), and CFHC and CAI . No significant correlation was found between CFHC and NSA .There were 15 patients with subluxation/dislocation of hips (see ‘*’ in Accumulation of the glycosaminoglycans (GAGs) (C6S and KS) leads to the degeneration of the cartilage matrix and its connective tissue, perturbing the regular microarchitecture of cartilage and successively distorting bone ossification and growth. MPS IVA patients present impaired cartilage quality because of distortion of geometric shape, collagen disposition in the extracellular matrix (ECM), and remodeling, resulting in reduced bone mineralization ,27. SecoIn this study, we have demonstrated: (1) that the bony and cartilaginous features of the hip joints in MPS IVA are assessed more accurately by using the combined images of PFR and MRI; (2) that the cartilaginous coverage of the hip is higher than the bony inherent in those with severe hip dysplasia; (3) that severe subluxations or dislocations are present in those with more dysplastic bony and cartilaginous hips with reverse correlations between CFHC and AI or between CFHC and CAI; and (4) that the patients with FHN were older, higher, and heavier than those without FHN.Skeletal and joint abnormalities are the most apparent and prevalent clinical manifestations in MPS IVA patients ,29. The FHN is a common manifestation of hip disorders in MPS IVA patients ,18,29. EBecause of the excessive cartilaginous coverage of the MPS IVA hips, we used CCEA as cartilaginous parameters for the accurate identification for subluxation/dislocation patients. For patients with a ‘-’ value of CCEA, it was indicated that their hip instability would still exist, even if cartilage was considered. For the same reason, the extent of dislocation was represented by CFHC for measuring cartilaginous coverage of head directly. The AI reflected the bony morphology of acetabula, and CAI represented the cartilaginous morphology of acetabula. In all our patients with subluxations/dislocations, we found a correlation between CFHC and AI; and also, between CFHC and CAI; however, we found no correlation between CFHC and NSA. It was implied that the extent of hip instability was related to both bony and cartilaginous acetabula dysplasia, and had no correlation with coxa valgus in MPS IVA patients. In addition to the above bony or cartilaginous factors, including AI, CAI, and NSA at the hip joint, ligament laxity cannot be ignored in MPS IVA patients ,28,34. IOne of the strengths of this study is the fact that we are the first to describe the bony and cartilaginous characteristics of MPS IVA hips in detail. The inconsistency between bone and cartilage was identified in MPS IVA hips. There is also increased cartilaginous coverage of the hip in specific patient populations. The evaluation of cartilage should be considered. Hip MRI is now getting a standard procedure to assess the accurate condition for many bone diseases. In our hospital, all MPS patients with skeletal dysplasia have received hip MRI in combination with the plain film as a clinical indication.This study also had several limitations. First, it was a single-center study with relatively small sample size and a single image per patient. It is not quite representative of the overall situation of the MPS IVA population. Second, the data of the age-matched normal controls from the literature, which came from a different country, may lead to bias by the difference of racial populations. Third, fewer positive results were obtained. Although our purposes were to explore the potentially related factors of femoral head osteonecrosis and hip subluxation/dislocation in MPS IVA hips, the expected results were not obtained, due to the limitations of retrospective studies. Significant differences were found between FHN and non-FHN patients in the age of HSCT and AI in plain film radiography; however, the conclusion cannot be generalized because of the retrospective study. Similarly, the correlation of hip instability and bony/cartilaginous acetabula dysplasia was shown, but we could not investigate the influence of ligament laxity on MPS IVA hips. The further longitudinal study with multiple points with age is required to clarify the correlation between many factors contributing to hip diseases in MPS IVA.The appropriate treatment of MPS IVA patients remains controversial since ERT does not provide any impact on bone dysplasia with the high cost. HSCT has been already approved by Japanese (1995) and Chinese (2005) governments much earlier than ERT. Over 25 years, MPS IVA patients have been treated with HSCT until now. Recently, insurance companies in the USA also insured HSCT for MPS IVA patients, and HSCT has been conducted. There are two international guidelines for MPS IVA. One is sponsored by the pharmaceutical industry . MeanwhiWe have demonstrated that MPS IVA patients exhibit significantly higher cartilaginous coverage of the hips than their osseous inherency. Evaluation by plain radiography alone is inadequate for the MPS IVA hips. MRI can be considered as a further modality to assess the ‘true’ characteristics of hips before surgical intervention. Severe subluxation or dislocation is more likely to be present in more dysplastic bony and cartilaginous acetabula for MPS IVA hips. The risk factors of FHN should be further investigated for the MPS IVA patients.


Pharmacy residents must complete research as part of their program; however, challenges exist in providing experiences that result in successful research dissemination outcomes. A university-based research team, integrated into an ambulatory care pharmacy residency program aimed to improve presentation and publication rates of pharmacy resident research projects. Data on the number of postgraduate year-2 (PGY2) residents and their productivity were collected and summarized to assess progress. A total of 13 residents completed their residency over seven years. Each resident produced one regional presentation, and one national presentation beginning in year four. To date, three peer-reviewed papers have been published, with another one in-press. Responses from residents found lack of guidance, lack of data availability for projects and feedback fatigue were barriers to a positive research experience. To address these problems, a university-based research team was integrated to provide research mentor guided support, ensure study feasibility, and provide structured feedback. This program evaluation highlighted the integration of a PGY2 ambulatory care pharmacy residency with a designated, interprofessional university-based research team. Future work is warranted to reduce research-related barriers and formally evaluate resident post-program knowledge, skills, and subsequent dissemination rates. During postgraduate pharmacy training, second year ambulatory care residents are required to develop and present, in writing, a final research project suitable for publication as part of their longitudinal professional program activity requirements, upon completion of a 12-month program. However, submission for publication during the residency year is not required by the American Society of Health-System Pharmacists (ASHP) accrediting organization to successfully complete a postgraduate year-2 (PGY2) ambulatory care residency program , and lowPresently, there are notable challenges for program staff and trainees alike . Some reFrom a programmatic standpoint, the goal of integrating a designated, university-based research team was to expand trainees’ knowledge, broaden their research experiences, meet the American Society for Health-System Pharmacists (ASHP) requirements for residency programs , and impThe purpose of this paper was to describe the development, evolution, and outcomes of a PGY2 ambulatory care pharmacy residency program research learning experience, in collaboration with a designated, university-based research team aimed to improve presentation and publication rates of pharmacy resident research projects. This paper also highlights areas of success and those requiring improvement for the community of existing or upcoming pharmacy residency programs. This program evaluation used previously collected quality improvement outcomes data from June 2012 to June 2019 provided by the residency program director. Written summative evaluation data from both the residents and preceptors were systematically collected at the end of the residency program year by the residency program director through a web-based residency evaluation system. The variables of interest collected by the residency program director included: (1) number of presentations; (2) number of publications; (3) program feedback provided by the resident to the preceptor; (4) program feedback provided by the preceptor to the resident; (5) proposed changes for the next residency program year; and (6) number of residents each program year. This program evaluation was exempt from institutional review board review, as it was deemed a quality improvement project. Descriptive statistics were used to present the summative evaluation data. The PGY2 ambulatory care pharmacy residency program in southern Arizona was established in 2012 and was fully accredited by ASHP in 2019, for an additional 8 years. The program was designed to prepare the resident to be a successful ambulatory care pharmacist upon completion of the program. Each year, the program supervised 1 to 2 PGY2 ambulatory care pharmacy residents. This team consisted of 1 residency program director, 1 orientation preceptor, 1 professional activities preceptor, 3–4 chronic disease management preceptors, 2 primary care preceptors, 1 geriatric pharmacy preceptor, 2 business and administration preceptors, 2 elective preceptors, and 2 research preceptors. The PGY2 ambulatory care pharmacy residency program research learning experience employed innovative approaches to foster successful knowledge and skill acquisition, and encompassed multiple components to facilitate and promote valuable, research-related, postgraduate and lifelong learning experiences. Each resident completed a 12-month longitudinal research experience, and was provided one-half day each week dedicated to complete research related activities and avoid time constraints. The research learning experience team consisted of: a PGY2 ambulatory care pharmacy resident; a residency program director ; research experience preceptors ; a university-based research director (TW); a medical editor (AT); and graduate research student mentor(s). The residency program director provided oversight and guidance throughout the resident’s year-long learning experience. The preceptor and residency program director’s role, based on the ASHP resident feedback method, integrated: (1) direct instruction; (2) modeling; (3) coaching; and (4) facilitating . The university-based research director (TW), medical editor (AT), and graduate research student mentor(s) provided guidance and mentorship in research design, data collection and analysis, evaluation, and dissemination. The university-based research director was a tenured faculty member at a southern Arizona accredited college of pharmacy, with expertise in health and pharmacoeconomic outcome research. Each year, the university-based research director was required to supervise 3 to 5 doctoral students. This team typically published between 5 and 12 peer-reviewed papers per year in high-impact journals, in addition to delivering several poster and podium presentations. The senior graduate research students served as the graduate research student mentor to the PGY2 resident. Through this layered mentoring approach , the graResidents were expected to demonstrate ability to conduct a research project by successfully achieving the objectives listed in Residents were immersed in this team-based research learning experience within four weeks of beginning their residency program, with the goal of presenting their completed project at both a regional and a national conference and publishing it in a peer-reviewed journal. The PGY2 pharmacy residency program research learning experience was structured to guide residents through the process in a logical sequence, and to facilitate completion of goals in a timely manner. During Month 01, the resident collaborated with the university-based research team to select a project, aligning with the organization’s mission, vision, and strategic growth initiatives. The resident also attended an onsite Institutional Review Board (IRB) orientation session at the Human Subjects Protection Program office and completed all relevant collaborative institutional training initiative (CITI) courses ,12. To iDuring Month 02, the resident drafted a proposal for peer-review and approval by their respective research team. Given the short timeframe to prepare and submit a conference abstract, the resident simultaneously began drafting a conference abstract for both a national and regional meeting. The resident also completed the second and third ASPIRE modules, emphasizing study design, population, procedures, data elements , and data analysis . In Month 03, the proposal content was used to draft either the Determination of Human Research Form or the Application for Human Research form , dependiIn Month 04, once all aforementioned approvals were granted, the resident completed the online conference abstract submission. The resident further refined the statistical analysis approach with the graduate research student mentor, and the research preceptor ensured that all categories of the data dictionary were readily available for the collection phase. In Months 05 and 06, the resident began data collection and analysis, leading the team in identifying relevant outcomes (results) and discussion points. Conversations among the resident, research preceptor and graduate student research mentor(s) then ensued, regarding manuscript content, tables and figures, and potential journals to consider for submission.During Months 07 and 08, once the resident’s presentation abstract was accepted, the resident was expected to draft poster/slide content, using a standardized template developed to guide poster/slide content and graphic creation. The content was collectively peer-reviewed within the research team, and once approved by the medical editor, was transposed to a poster/slide template, for printing prior to the conference. During the later Months (09–12) of the PGY2 pharmacy residency program research learning experience, the resident presented the research poster/slides at the selected conference(s); and audience feedback regarding the poster/slides was incorporated into the manuscript discussion and limitation sections. During this time, the research team peer-reviewed and provided mentorship as the resident finalized the manuscript sections. The manuscript then underwent final medical editor approval. The goal was to submit the manuscript to a peer-reviewed journal by completion of the residency program. Finally, the residency program director and resident met to discuss their research learning experience, where the resident had an opportunity to provide verbal feedback on their experiences. The residency program director completed qualitative documentation of verbal feedback to record resident progress and provide direction to the residents and vital information for the residency program director and future preceptors. Documentation was a required element of pharmacy residency standards . This inThe residency advisory committee met every quarter to discuss continuous quality improvement initiatives to improve the learning experience of the resident, develop and implement program improvement activities in response to the results of the resident assessment of the research learning experience, and evaluate whether residents were successfully fulfilling the purpose of a PGY2 pharmacy residency program through graduate tracking. The committee consisted of core preceptors, residents, and the residency program director. Each preceptor offered suggestions regarding ways to improve the resident research learning experience the following year. Upon completion of the research learning experience, the research preceptors reflected on the summative feedback provided by the resident, to further implement solutions for these areas of improvement. A total of 13 residents completed the PGY2 ambulatory care pharmacy residency program research learning experience over seven years . All residents that started the program successfully achieved the objectives for the residency research learning experience listed in Each year, the pharmacy residency research projects ranged in study design and complexity appropriate to the options available and interests of the resident. Studies employed quantitative and qualitative techniques and included surveys, focus groups, database analyses, systematic reviews, and program evaluations, among others, using retrospective, cross-sectional, and prospective perspectives.This program evaluation highlights the integration of designated, collaborative research team approaches employed in a university-based PGY2 ambulatory care pharmacy residency program, designed to improve presentation and publication rates of pharmacy residency research projects. The collaborative training processes outlined above addressed an important gap in the literature regarding the need for formalized research training for residents. Specifically, the academic institution and their affiliates provided formalized training to respective trainees, utilizing strategies to improve confidence, as well as competence . Given tThe formal training program experienced multiple successes. Based on former resident feedback, residents are now paired with graduate research student mentors early in the research experience, to: (a) conduct one-on-one focused sessions to help guide the research study design, data analysis and interpretation; (b) provide assistance and support to residents; and (c) mentor residents to help hone their knowledge and skills. Moreover, the layered mentoring process ,21, bridThe university-based research team was able to mentor and guide residents in all research phases, especially study design and data analysis, to ensure use of appropriate statistical tests and interpretation of results. The effects of the pharmacy residency mentorship program approach parallel other studies and proved to be beneficial in this PGY2 ambulatory care residency training program . HoweverThe various challenges, revisions, and successes of this PGY2 residency offer ‘lessons learned’ to upcoming and seasoned program directors. The results of this collaborative research team approach also lend evidence to the value of incorporating key aspects of health economic and outcomes research training into residency programs . One novDespite the versatility of the partnership, this program evaluation only describes a small sample of residents. Thus, these findings are not generalizable to all PGY2 ambulatory care pharmacy residency programs or research fellowships. In addition, this review was not able to capture evidence to describe whether other confounding factors, specifically one’s personal publication goals, influenced the ability to successfully disseminate research findings.This program evaluation highlights the integration of a collaborative research team approach between a PGY2 pharmacy residency program and a university-based research team, and lends preliminary evidence to support its value in improving presentation and publication rates of pharmacy residency research projects. The collaborative training processes addressed an important gap regarding the need for formalized research training for PGY2 residents, and may provide useful insight for residency directors facing challenges with the research component of their programs, or to programs with more than one resident in need of structured research mentorship. Yet, a more formalized assessment of residency graduates is warranted to investigate their skill acquisition and subsequent presentation and publication rates beyond the completion of residency training.


Increasingly, health researchers must demonstrate the impact and real-life applications of their research. We investigated how health researchers with expertise in knowledge translation report research translation activities and impact on their curriculum vitae (CV).We conducted a cross-sectional survey of health researchers with expertise in knowledge translation as we anticipated best practices in CV reporting from this specialized group. Our survey asked participants about their reporting of research translation and impact activities on their CVs, intention to report, and barriers and facilitators to reporting such activities on their CVs. We calculated univariate descriptive statistics for all quantitative data. Linear regression models determined predictors of researchers’ intention to report research translation and impact activities on their CVs. We analyzed open-ended qualitative responses using content analysis.One hundred and fifty-three health researchers responded to the survey (response rate = 29%). Most respondents were Canadian, were female, and had a doctoral degree. Eighty-two percent indicated they reported at least one research translation and/or impact indicator on their CVs. Of those, health researchers commonly reported the following: advisory/regulatory committee membership related to research program (83%), research translation award(s) (61%), and academic performance assessments (59%). Researchers least commonly indicated the following: citation metric scores (31%), summaries of impact (21%), and requests to use research materials and/or products (19%). Fewer than half of the health researchers intended to report knowledge translation (43%) and impact (33%) on their CVs. Strong beliefs about capabilities and consequences of reporting research translation and/or impact were significant predictors of intention. Main barriers were as follows: CV templates do not include research translation and impact activities, participants perceived employers do not value research translation and impact activities, and lack of metrics to evaluate research translation and impact. Ninety-six percent were unaware of a CV template formatted to include research translation and/or impact reporting.Knowledge translation and impact indicators on the CV are inconsistently reported by our sample of health researchers. Modifiable barriers should be addressed to support more consistent reporting of such activities, including providing a CV template that includes research translation and impact as well as clear metrics to quantify them. Contributions to the literatureHealth researchers are increasingly asked to demonstrate the application of their research findings in clinical practice and/or policy. The curriculum vitae (CV) is one means of recording and communicating such activities.Our findings show that knowledge translation and impact indicators on the CV are inconsistently reported and health researchers face numerous, but potentially modifiable, barriers to reporting research translation and/or impact activities on their CVs.Health researchers suggest that a CV template that includes research translation and impact would facilitate meeting academe’s expectations for demonstrating and reporting such activities.For the academic researcher, the curriculum vitae (CV) is the main document used to record and communicate accomplishments and impact –4. AcadeResearch translation and impact activities aim to close the research-practice gap, leading to better patient and health system outcomes , 14. ThiAccountability for research translation and impact is only beginning to be recognized, and little is known about how health researchers document impact and research translation on their CVs. The purpose of this study was to investigate health researchers’ practices for, and barriers to, reporting research translation and impact activities on their CVs.We conducted a cross-sectional survey of an international cohort of health researchers. We received Research Board Ethics approval from the University of Ottawa (#H12-15-01), and participants provided informed consent. We followed the STROBE reporting guidelines .https://www.cahspr.ca/en/themegroups/chips). These two groups were specifically chosen given their research is focused on application of research findings to inform practice, education, and health policy.We recruited a convenience sample of health researchers with expertise in knowledge translation because we anticipated best practices in CV reporting from this specialized group. Health researchers were recruited from the 2015 Knowledge Utilization Colloquium invitee list and those belonging to the Collaborative Health Improvement Partnerships (CHIPs) group of the Canadian Association of Health Services and Policy Research (CAHSPR). Health researchers were defined as individuals who were actively conducting health research. Knowledge Utilization Colloquium attendees included an international group of multidisciplinary academics, researchers, knowledge users, and graduate students.n = 522) that included an introductory letter, request to participate, and the link to the survey. Non-respondents received three reminder emails at scheduled intervals. Surveys were coded with a unique identifier to ensure no duplicate responses and to protect personal information.We built an online survey using Fluid Surveys TM software and administered it using Dillman’s online survey approach . In 2016Our survey consisted of five sections: (1) demographic questions, (2) a list of potential research translation and impact activities that could be included on a CV, (3) an assessment of intention and related factors influencing reporting translation and impact activities on their CVs based on the Continuing Professional Development Reaction Questionnaire , and (4)The Continuing Professional Development Reaction Questionnaire (CPDRQ) is based on the theory of planned behavior and is appropriate for evaluating factors influencing intention to change practice . The insresearch translation activities as the diffusion, dissemination, and application of knowledge that researchers undertake once the findings from a study are available [Impact is the demonstrable contribution that research makes to the economy and the society, beyond academic contributions  [Our primary outcome was health researchers’ reporting of research translation and impact activities on their CVs. Our secondary outcomes were intention to report research translation and impact on the CV, predictors of intentions, and barriers and facilitators to reporting. We defined vailable . Impact tations) . IndicatR2) to determine the proportion of variance between the theoretical constructs and intention to report research translation and impact activities on CVs.Raw survey data were exported from Fluid Survey TM and transferred to Microsoft Excel  and Statistical Analysis Software for Windows . We calculated univariate descriptive statistics for all quantitative data, including means and standard deviations for the 7-point Likert scores of factors influencing health researchers reporting of research translation and impact. To calculate intention to report research translation and impact activities on CVs, we assigned a construct score for the CDPRQ by calculating the mean and standard deviation of items within each construct. Associations between theoretical constructs and intention to report research translation and impact activities on CVs were calculated using univariate (unadjusted) and multivariable (adjusted) ordinary least squares linear regression models. We calculated a coefficient of determination  using content analysis involving five steps: reading the data in its entirety, developing codes to reflect the data, coding the data, a second review of the data, and establishing consensus between the reviewers .Descriptive data were analyzed using a complete case approach. Missing data for inferential analyses of the CDPRQ responses were handled using multiple imputation. As these responses were continuous variables, we used PROC MI and PROC MIANALYZE to perform multiple imputation of missing responses based on fully conditional specification regression methods. We created five multiple imputed datasets, with imputation informed by responses of non-missing items from the CDPRQ.Of the 522 invited health researchers, 153 responded to the survey with a response rate of 29%  reported at least 1 research translation and/or impact indicator on their CVs. Most commonly, health researchers reported membership on advisory/regulatory committees related to their research (83%) , awards and/or recognitions for research translation activities (61%) , others’ assessments of one’s academic performance (59%) , publications targeting specific audiences/professions (56%)  policy and guidance reports), and training provided to knowledge users (55%)  (Table R2 = 0.36).Of the respondents, 52/121 43%) indicated they intended to report research translation and 38/115 (33%) indicated they intended to report impact activities on their CVs. The CPDRQ rating for intention to report research translation and impact activities on their CVs was 4.6 out of 7.0 (Table % indicatFor the quantitative questions asking participants to rate the strength of the barriers/facilitator (1 low to 7 high), the main barriers were (1) lack of time to report research translation and/or impact, (2) lack of support for health researcher’s organization, and (3) access to resources to support reporting of research translation and impact on their CVs Table . The higBarriers to reporting research translation and impact that emerged on the open-ended survey question included the perception that employers, funders, and/or colleagues do not value or expect reporting of research translation and impact activities on the CV; concerns that others will perceive reporting of research translation and impact as an attempt to embellish accomplishments and/or bolster the CV; lack of valid and reliable metrics and/or indicators for reporting research translation and impact activities; and space constraints on the CV Table . Open quHealth researchers are increasingly required to show evidence of translation of their research findings to demonstrate real-world impact , 24. As First, although most health researchers reported at least one research translation and/or impact activity, few provided a comprehensive account of the application of their research to practice or policy, suggesting that reporting practices could be improved. Furthermore, there were inconsistencies in what was reported on the CV across respondents. A recent systematic review evaluated the reporting quality of research translation and impact case studies and found a lack of consistent reporting approaches, including few demonstrated evidence for the reported impact . Our stuSecond, our study could have increased participants’ awareness of reportable research translation and impact activities and their intention to report. Predictors of intention included health researchers’ beliefs about their capabilities and beliefs about consequences of reporting. These constructs align with qualitative statements that health researchers lacked skills to report (capabilities), perceived that others did not value such reporting on CVs (consequences), and that reporting these activities could be negatively perceived as inflating one’s CV (consequences). However, health researchers wanted training to improve their research translation and impact skills (enhance capabilities). These findings suggest that interventions to promote the reporting of research translation and impact should include strategies that improve health researchers’ beliefs about their capabilities and the potential positive consequences of such reporting. For example, interventions could build knowledge and skill regarding reportable research translation and impact activities. Health researchers’ beliefs about consequences could be leveraged with strategies that incentivize and reinforce the behavior, such as validating research translation and impact metrics and having universities more systematically consider research translation and impact for tenure and promotion , 26.should support researchers to improve this reporting, and if the reported lack of time actually indicates a lack of prioritization. Certainly reporting additional items might be seen simply as not worthwhile if there are no perceived personal benefits  or organizational imperatives around documentation of translation and impact. Furthermore, documentation of impact and translation is more labor intensive than documentation of traditional measures of research performance , and may warrant assistance from organizations .Third, although some intend to report research translation and/or impact on their CVs, health researchers indicated several barriers to doing so. Engaging in, monitoring, and reporting research translation activities were deemed time-consuming, requiring energy, resources, and funds, all of which are commodities that health researchers invariably feel are in short supply. This raises questions such as whether organizations A recent systematic review found that accurately and transparently measuring research translation and impact is challenging . In factHealth researchers’ ability to report research translation and impact is often influenced by systematic structures, such as specific CV templates used for different agencies and/or purposes . Traditionally, existing research structures do not readily support monitoring and evaluation of research translation and impact . IncreasFinally, health researchers in our study suggested that templates and guidance documents for research translation reporting are required and could help incentivize and shift research thinking from “outputs” to include “impact.” However, our study suggests that most respondents were unaware of existing CV templates that include research translation and impact. When we asked respondents to share templates, many responded with requests for guidance on how to better report on these activities. For example, national granting agencies, such as the Canadian Institutes of Health Research and the National Institutes of Health, invite researchers to briefly describe their impact but this is limited to including up to five important contributions to science.Our study findings should be considered within the context of its limitations and strengths. Our survey had a low response rate (29%), which increases the likelihood of non-response bias. In fact, those interested in reporting knowledge translation and impact activities may have been more likely to participate, and our findings could represent a best-case scenario of research translation and impact reporting on the CV, which could have led to selection bias. Similarly, our results might have been different had we sampled from a broader population of health researchers . Another potential bias is social bias . However, our study was strengthened by the inclusion of international perspectives and use of a validated measure to evaluate intention and related barriers. Our study is a starting point for a larger multicountry survey of a broad representation of health services researchers to understand how responses may differ across countries.Funding agencies are increasingly holding health researchers accountable for demonstrating the value and impact of their publically funded research. The CV is one medium for health researchers to document the practical importance of their research and communicate it to others. Our study suggests that health researchers, who recognize the importance of research translation, are reporting research translation and impact in ways that appear unsystematic and non-structured. This inconsistency can be in part explained by the barriers to reporting research translation and impact, such as unaware of how to report it, whether it is accurate, and whether it is valued by funders and employers. Academe must evolve to better value research translation and support health researchers in adjusting to a shifting research landscape requiring demonstration of impact. As a first step, health researchers who participated in this study suggested that CV templates be expanded to include research translation and impact. Additionally, our study might provide an impetus for funders and academic institutions to recognize and credit research that is impactful and applied to practice or policy.Additional file 1. Suggestions of research translation and impact activities to be reported in Academic Curriculum Vitae.