Due to the complexity of health system reform in the post-conflict, post-disaster, and development settings, attempts to restructure health services are fraught with pitfalls that are often unanticipated because of inadequate preliminary assessments. Our proposed Integrated Multimodal Assessment – combining quantitative and qualitative methodologies – may provide a more robust mechanism for identifying programmatic priorities and critical barriers for appropriate and sustainable health system interventions. The purpose of this study is to describe this novel multimodal assessment using emergency medicine in post-conflict Serbia as a model.Integrated quantitative and qualitative methodologies – system characterization and observation, focus group discussions, free-response questionnaires, and by-person factor analysis – were used to identify needs, problems, and potential barriers to the development of emergency medicine in Serbia. Participants included emergency and pre-hospital personnel from all emergency medical institutions in Belgrade.Demographic data indicate a loosely ordered network of part-time emergency departments supported by 24-hour pre-hospital services and an academic emergency center. Focus groups and questionnaires reveal significant impediments to delivery of care and suggest development priorities. By-person factor analysis subsequently divides respondents into distinctive attitudinal types, compares participant opinions, and identifies programmatic priorities.By combining quantitative and qualitative methodologies, our Integrated Multimodal Assessment identified critical needs and barriers to emergency medicine development in Serbia and may serve as a model for future health system assessments in post-conflict, post-disaster, and development settings. In June 1991, a series of civil wars began as the Socialist Federal Republic of Yugoslavia dissolved violently into the four independent republics of Slovenia, Croatia, Bosnia-Herzegovina, the Former Yugoslav Republic of Macedonia, and the semi-autonomous nations of Serbia and Montenegro. Kosovo remains a province of Serbia but under the administration of the international community. The events of the last decade in the Balkans have significantly impacted the health care system of Serbia. The nation and its health care system were devastated by international sanctions, soaring unemployment, political instability, near economic collapse, and the North Atlantic Treaty Organization (NATO) air campaign .A country's emergency medical services are a particularly important component of the health care system for they provide an essential front-line resource for trauma, medical emergencies, and those without other access to health care. Unfortunately, the system of emergency services in Serbia did not escape the devastation of the 1990s and continues to suffer from problems common throughout the health care system. Limited health care funding has resulted in a lack of necessary equipment, supplies, medications, personnel wages, and an economic infrastructure unable to support necessary health care reforms in the public and private sectors. Furthermore, the country has received little external support for health system reform, underscoring the need for focused assessments to best determine priorities for health care development.There is a desperate need for reorganizing and restructuring emergency medical services throughout Serbia. To better understand the problems, needs, and obstacles to development, a team of investigators from Johns Hopkins University Schools of Medicine and Public Health collaborated with the Belgrade University Emergency Center to perform a multimodal assessment of emergency medicine in Serbia. Our goal in this study was to identify the most pressing needs and achievable goals, as perceived by emergency health care personnel, in order to ensure that development programs and available funds are appropriately directed .Evaluating health care systems through the use of demographic data collection, surveys, or focus groups alone – as is often done in health system assessments – cannot adequately elucidate the intricacies of a country's health care system. In order to fully appreciate the complex dynamics of the health care system, it is necessary to perform a complete initial assessment; include strong local participation; identify and address significant barriers to change; and identify unique local needs and other cultural dimensions. To do this effectively, it is important to avoid simply introducing a "carbon copy" of a Western health care system that would further burden the system with inappropriate and unsustainable programs. We propose for the rapid assessment of health care services an Integrated Multimodal Assessment that uniquely combines diverse methodologies, whose individual effectiveness has been well described in the literature.This study used a multimodal approach to assess the strengths, needs, problems, and obstacles related to the development of emergency medical services in Belgrade. The four study modalities were 1) demographic information and observational data; 2) focus group discussions with 68 emergency medicine personnel; 3) individual, free-response questionnaires with 39 emergency medicine personnel; and 4) by-person factor analysis (or Q-methodology) of the attitudes and opinions of 36 emergency medicine personnel regarding the development of emergency medical services. Participants in the study were a non-probabilistic sampling of emergency medicine physicians, nurses, and department directors from all pre-hospital and hospital-based emergency medicine institutions in Belgrade. Many participants took part in more than one study modality. Data collection occurred during July-August 2002. The authors received institutional review board approval and the written informed consent of all participants.The capacity of emergency medical services in Serbia to provide for the needs of the country's citizens was characterized through health system data collection. Health system information was obtained through meetings with key officials in established health surveillance institutions such as the Emergency Center of the Clinical Center of Serbia; World Health Organization Belgrade office; Public Health Institute of Belgrade; Republic of Serbia Ministry of Health; European Agency for Reconstruction; Belgrade University, Institute of Social Medicine, Statistics and Health Research; as well as several non-governmental organizations with offices in Belgrade. Key officials were asked a series of quantitative, closed-response questions about the Serbian health care system and emergency medical services. Developed from a pilot health care assessment in Serbia the previous year, the questions focused on health system organization; patient population size and demographics; health care personnel; medical education and training; materials, supplies, and medications; and provider aptitude and morale .The two-fold purpose of the focus group discussions was 1) to better understand the needs, problems, and obstacles to system development as perceived by those involved directly in providing emergency medical services and 2) to collect a wide variety of opinions and attitudes for subsequent by-person factor analysis. The focus group discussions were held with 68 emergency medicine physicians, nurses, and directors through a non-probabilistic sample taken from the institute for pre-hospital emergency services, the Emergency Center of the Clinical Center of Serbia, and four of Belgrade's six community emergency departments. The discussions were conducted by the primary author in the Serbian language. The audio recordings of the 30- to 60-minute discussions were transcribed and translated into English by a native-English speaker fluent in Serbian (BDN) and a native-Serbian speaker fluent in English (MŠ). The translation was later verified by additional native-Serbian speaking co-authors fluent in English .The investigative field team  summarized the final transcripts and extracted common themes and divisive statements for by-person factor analysis.Free-response questionnaires enabled assessment of emergency health care needs and priorities for change as perceived by those most directly involved in patient care: the emergency health care providers. A non-probabilistic sample of 39 participants was obtained by open invitation, without compensation, through the director's office of each institution. As with the focus group discussions, the institute for pre-hospital emergency services, the Emergency Center of the Clinical Center of Serbia, and four of the city's six community emergency departments were represented. All subjects were administered a written Serbian-language questionnaire comprised of 10 free-response items  were designated respondent type "definers" and closely reviewed to assist in characterizing each respondent type.By-person factor analysis, or Q-methodology, avoids many of the limitations of other modalities by allowing the grouping of participants based on their subjective responses to an issue while preventing investigator preconceptions from influencing the grouping structure. In a letter to ectivity ,7. In ouectivity  followedzdravstvene stanice) and primary health centers (domovi zdravlja). In the capital city of Belgrade, there exists a network of 6 part-time, hospital-based (kliničko-bolnički centri) emergency departments that are supported by around-the-clock pre-hospital emergency services (hitna pomoć) and the academic Emergency Center (Urgentni centar) at the Clinical Center of Serbia. Like many European countries, Serbia has adopted a largely Franco-German model of emergency medicine in which pre-hospital emergency services are provided in the field by physician-staffed ambulances [Emergency medicine is not a recognized health care specialty in Serbia. In smaller communities, emergency services are provided by primary health stations , internal medicine (29%), anesthesia (12%), general medicine (7%), emergency medicine (3%), other (15%)). Discussions were held at the institute for pre-hospital emergency services, the Emergency Center, and four hospital emergency departments.The participants' comments from the focus group discussions are collectively summarized in Table In addition, physicians and medical directors report that their emergency medical system is in significant need of improved education and training programs. Suggested improvements include further training in emergency medicine during medical school, bedside training to develop practical skills, development of standardized treatment protocols, and access to continuing professional education.Questionnaires were completed by 39 physicians at the institute for pre-hospital emergency services, the Emergency Center, and four hospital emergency departments , internal medicine (31%), anesthesia (13%), general medicine (10%), emergency medicine (5%), other (10%)).Respondents show several areas of high agreement – particularly remarkable considering the questionnaire's free-response format. The most frequently reported strength of Serbia's current health care system are the health care workers (69%). Worker enthusiasm (33%) and the collaboration of various medical specialties providing emergency services (21%) are most frequently cited as the greatest positive attributes of emergency service providers. In addition, 46% of respondents report that the various emergency medical service providers  are other strengths of emergency medical services in Serbia.Thirty percent of the participants surveyed believe that lack of incentives to enter the specialty, difficulty of the work, and poor financial compensation are important barriers to becoming a physician in emergency medicine in Serbia. The poor reputation of physicians in emergency medicine relative to other physicians (reported by 46% of participants) may contribute to lower interest in specializing in emergency medicine. Poor organization (26%) and insufficient opportunities for professional development (15%) were also reported as major impediments to being an emergency service provider.Participants were asked what they believed were major problems of emergency medical services in Serbia. Inadequate finances, medications, medical supplies, and modern medical equipment were cited by 54% of the emergency medicine personnel as being a major problem , the absence of treatment protocols (27%), insufficient numbers of emergency medical physicians (17%), and the lack of government regulation (13%) were the most frequently cited priorities for improving the organization of emergency medical services. Other concerns include lack of quality control measures, burden of caring for non-emergent cases, inadequate admission and triage areas, and insufficient hours of operation of hospital-based emergency departments.Many emergency medicine personnel are also critical of the education and training of physicians in emergency medicine. Although 58% of those surveyed feel that physicians receive good theoretical training, 77% report that their educational system is in significant need of improved medical school and postgraduate training programs. Of the individuals advocating for improved education and training, 27% feel that further training in emergency medicine should be included in the medical school curriculum, and 53% believe that additional bedside training to develop practical skills is imperative. Furthermore, 56% of participants in this study express a need for better access to continuing professional education, including shared practical experiences and training between health care institutions. A large number of emergency medicine personnel (36%) stress the need for greater access to international journals, conferences, seminars, and the internet. Many (15%) also communicate a need for international collaboration and training programs between Serbia and foreign medical institutions.Survey participants cite numerous obstacles to the development of emergency medical services in Serbia, including insufficient funding and resources (69%), poor organization of emergency services (36%), lack of governmental support (26%), and inadequate education and training (18%). Also vital to development efforts are the perceptions and attitudes of the people impacted by and involved in these efforts – the public, health care community, and government officials. A slight majority (62%) of individuals surveyed believe that the health care community will support further development of emergency medical services. However, only 46% and 41% of participants feel that the public and government, respectively, will respond positively to development.Of the 36 emergency medicine personnel invited to participate in factor analysis, 33 individuals (91.7%) completed the exercise correctly , internal medicine (27%), anesthesia (27%), general medicine (6%), emergency medicine (6%), other (12%)). The institute for pre-hospital emergency services, the Emergency Center, and two hospital emergency departments participated in this component of the study.Factor analysis followed by manual factor rotation determined levels of agreement among the 33 participants and identified three unique types of respondents. Table In addition to assessing levels of agreement among participants, by-person factor analysis allowed us to identify three different respondent types, each involving multiple respondents with diverse demographics but who share common and unique perspectives relative to the remaining participants. To aid discussion of the three respondent types, each was assigned a brief label: "Utilize", "Develop", and "Invest".Respondent type "Utilize" was heavily loaded by a total of 5 respondents (15.2% of participants) and defined by 4 (12.1%). The principal concerns of the "Utilize" respondent type include the poor utilization of emergency medical services. These individuals believe that emergency personnel are well trained, educated, and prepared to address the emergent needs of the community. However, they consider their role ill-defined and misunderstood, leading to the ineffective use of their services by the public.Respondent type "Develop" was characterized by 6 loaders (18.2%) and 3 definers (9.1%). These individuals support the further development of emergency medicine as an independent specialty in Serbia. They do not consider inadequate finances, supplies, or equipment to be the chief concern of the system of emergency medicine. Instead, the "Develop" respondent type encourages the development of standardized treatment guidelines, improved coordination between the specialties providing emergency care, and additional education and training in the specialty of emergency medicine.The third respondent type, "Invest", included 4 loaders (12.1%) and 2 definers (6.1%). These individuals consider the system of emergency medicine appropriately organized but lacking adequate investment. They believe greater resources should be applied towards equipment and professional training and development. They are also concerned with an apparent lack of coordination between institutions providing primary health care and emergency services.Additional respondent types were defined by single respondents, which prevented adequate characterization. However, the demographic data on each of these isolated respondent types were closely examined to assure that the individual was not in a unique position of authority that could disproportionately influence future health system reform. The specific responses of respondent types "Utilize", "Develop", and "Invest" to the 23 Q-statements are listed in Table The purpose of a rapid assessment is to provide organizations with timely and reliable information to aid targeted interventions. Many rapid assessment methodologies have been utilized, each with its own strengths and weaknesses. One of the most commonly used methodologies is the KAP  survey, which is traditionally a standard questionnaire with pre-developed, closed-response questions . BecauseThe use of more detailed assessment tools – employing a combination of qualitative and quantitative methodologies – can more accurately characterize the country's health care needs and the significant political and cultural barriers to sustainable health care reform. Our proposed Integrated Multimodal Assessment utilizes a diverse approach for strong internal validity and by-person factor analysis to uniquely identify critical subpopulations. By understanding the concerns of subpopulations, more targeted interventions can be developed to directly address these concerns. A trial study evaluating primary health care in Serbia has demonstrated the advantages of using a combination of qualitative and quantitative tools for health system assessment . Each ofOut of the near collapse of the Serbian health care system comes the opportunity to establish a health system more effective than ever in meeting the needs of its citizens. Our focus group discussions, questionnaires, individual surveys, and by-person factor analysis reveal that most emergency medical physicians believe the greatest problems in their system are poor organization of emergency medical services; lack of essential funding, medical supplies, medication, and technical equipment; and inadequate education and training. Several respondents also share the idea that poor incentives for specializing in emergency medicine, difficulties of emergency service work, and inadequate compensation are significant barriers to advancing the field of emergency medicine in Serbia. Although many of these are problems ubiquitous to developing health systems, this study illuminates specific opportunities for emergency medicine providers, the Serbian government, and international institutions to work together to address these issues.According to the majority of emergency medicine providers and administrators surveyed, of foremost priority is reorganization of emergency medical services. In order to begin addressing this need, several participants propose the development of triage and treatment protocols. To facilitate improved routing of patients within the hospitals and to the appropriate emergency health care facility, all health care providers, including those within the primary health centers, should receive formal training in triage. Several participants suggest that leadership development and management training should be provided to medical directors and leading health care providers to improve the organization within and between emergency health care centers. Public education programs should also be developed to increase awareness of the level of care that each health care institution provides so that the public can more properly utilize available health care services.Study participants further reported that the attainment of necessary medications, supplies, and equipment should be a top priority in the development of emergency services. The professionals working in the health care system of Serbia are severely limited by a shortage of these resources and, therefore, are unable to apply their knowledge and skills for proper diagnosis and treatment. Obsolete medical equipment further constrain their diagnostic capabilities, and lack of basic medications and supplies impedes their treatment strategies.This multimodal assessment also shows that the education and training of physicians in emergency medicine need further development. Elements of the educational system needing improvement include medical school and postgraduate bedside training programs; training between health care institutions; access to continuing professional education materials including international journals, conferences, seminars, and internet access; and international collaboration between Serbia and foreign medical institutions, including opportunities for Serbian physicians to gain international clinical experience. Several participants also suggest that all health care workers, including physicians working in the primary health centers, receive periodic training in Basic Life Support (BLS), Advanced Life Support (ALS), and emergency triage.Further development of emergency medicine in Serbia will be complex and will face numerous challenges. Reform will require funding, political commitment, supportive legislation, a revised medical curriculum, multi-phasic implementation, and post-interventional evaluation. Respondents believe that the funding needed for development of emergency services represents a significant barrier to change, but that, however, it is not the universal solution.Although a majority of the emergency medicine personnel surveyed feel that the health care community will support further development of emergency services, just under half of the participants expect similar support from the public and government. Additional studies specifically assessing the needs and concerns of the public and government are recommended.The use of multiple assessment modalities and the resulting complexity of this study involve several limitations that require consideration. All participants in this study were invited to participate by the director's office at each hospital or clinic. The study participants were aware that their participation was entirely voluntary and that they would not receive compensation. Although the study did not provide an economic incentive for participation, it did provide the opportunity for those providers with strong opinions to openly voice their concerns and suggestions. As a result, the study population may not represent all emergency health care providers. While every emergency medicine institution in Belgrade participated, this study was limited to the pre-hospital and hospital-based institutions within the capital city (covering 14.9% of the population of Serbia (excluding Kosovo)). Nevertheless, the participants represent the breadth of medical specialties in Serbia, and they constitute a large number of the stakeholders involved in further development of emergency medicine.Despite the challenges, development of emergency services in Serbia can be accomplished through the dedication and commitment of providers. As a result of studies on emergency services in Kosovo, developmental programs similar to those suggested here have been successfully implemented to improve the training in and provision of Kosovo's emergency medical services . VisitinIt is the hope of the authors that similar reforms will also be implemented to address the specific situation in the Republic of Serbia and that this multimodal assessment will assist by identifying the critical needs, barriers, and priorities for sustainable development. By utilizing both quantitative and qualitative methodologies, the authors submit that this Integrated Multimodal Assessment tool offers a more robust alternative to standard surveys, KAP studies, or the use of anecdotal information for quickly identifying priorities in health system reconstruction in the post-conflict, post-disaster, or development setting.KAP: knowledge, attitudes, and practicesRAP: rapid assessment proceduresThe authors declare that they have no competing interests.Each author has participated sufficiently in the work being reported to take public responsibility for the content. BDN, KD, and MVR conceived and designed the study and obtained research funding. MVR and MM supervised the completion of the study. BDN, KD, MS, MV, and LM undertook recruitment of participating centers and physicians. BDN, KD, and MS completed the data collection, statistical analysis, and first draft of the manuscript. All authors reviewed and contributed to the revision of the manuscript.The pre-publication history for this paper can be accessed here:


It is widely accepted that the development of atherosclerosis starts at an early age. However, there are very few studies evaluating the prevalence of the common clinical and behavioral cardiovascular disease (CVD) risk factors among children, especially in developing countries. The aim of the present cross-sectional survey was to evaluate the distribution of blood lipid profile and various behavioral  factors related to CVD risk and its relationships to paternal (PEL) and maternal educational level (MEL) among primary schoolchildren in Turkey.In three major metropolises in Turkey , a random sample of 1044 children aged 12 and 13 years old was examined. ANOVA was applied to evaluate the tested hypothesis, after correcting for multiple comparisons (Tukey correction).After controlling for energy and fat intake, physical activity status and Body Mass Index (BMI), it was found that mostly PEL had a significant positive effect for most of the subgroups examined (Lower vs. Higher and Medium vs. Higher) on TC and HDL-cholesterol and a negative effect on TC/HDL ratio for both genders. Furthermore, both boys and girls with higher PEL and MEL were found to have higher energy intake derived from fat and protein than their counterparts with Medium and Lower PEL and MEL, while the opposite was observed for the percentage of energy derived from carbohydrates.Our study provides indications for a possible association between an adverse lipid profile, certain dietary patterns and Higher PEL and MEL among schoolchildren in Turkey. These findings underline the possible role of social status, indicated by the degree of education of both parents, in developing certain health behaviors and health indices among Turkish children and provide some guidance for Public Health Policy. Cardiovascular disease (CVD) is the primary cause of mortality in developed countries and generates a major burden of morbidity throughout life ,2. AdditThe continuing modernization and technological advancement of the developing world has brought about rapid lifestyle changes , which are known to have a major impact on the development of CVD and other chronic diseases ,9. Many As far as Turkey is concerned, the available data on the possible effect of parental educational level on the clustering of CVD risk factors among children are limited. Turkey, which has experienced rapid urbanization and industrialization in the past few decades, is a middle-income country, located between Europe and Asia and bordering the Mediterranean, Aegean and Black Seas. The purpose of the present study was to examine the influence of PEL and MEL on CVD risk factors, namely the lipid profile and behavioral indices, among children of Turkey. Expanding our knowledge and understanding on the interrelationship of all these parameters could effectively guide Public Health Policy in early prevention of CVD risk factors in childhood.th grade primary school children registered in the selected schools, 1044 pupils  were finally examined. Inclusion of subjects was on a voluntary basis; prior to acceptance, children's parents or guardians were fully informed about the objectives and methods of the study and were asked to sign a consent form.The first phase of this cross-sectional study took place during March-May 2001 and the second phase during January-May 2002. The study population consisted of primary schoolchildren aged 12 and 13 years old, living in three urban areas of Turkey, namely Istanbul, Ankara and Izmir. Out of totally 1320 6The study population was selected from nine primary schools (three from each city) using the multi-stage sampling method. Schools were selected taking into consideration the available records of the Ministry of National Education and the National Statistical Center of Turkey, in an attempt to obtain a representative sample from the overall population. In the case of Ankara and Izmir data were collected from three public schools respectively, while in the case of Istanbul sample came from one private and two public schools. All children in the same class were invited to participate in the study to avoid ethical problems.Approval to conduct this survey was granted by the Ethical Committee of Marmara University and the Turkish Ministry of Education.Baseline data was collected during face-to-face interviews with children by a team of trained personnel. The data collected from the children consisted of physiological indices, namely biochemical and behavioral indices, such as dietary habits, estimation of energy and nutrient intake and physical activity assessment. These data are presented in more detail below.A coded questionnaire was developed and administered to the study participants, in order to obtain information on socioeconomic conditions and their personal characteristics, such as family size, parental academic qualifications, occupation and car ownership. Both Paternal (PEL) and Maternal Educational Level (MEL) were classified into three categories. "Lower" PEL and MEL corresponded to illiterate, literate with no formal education and to primary school graduates. "Medium" PEL and MEL was attributed to those parents, who had completed junior high school or high school, whereas the category of "Higher" PEL and MEL included parents who possessed a college or a university diploma.Early morning venous blood samples were obtained from each child for biochemical screening tests, following a 12-h overnight fast. Professional staff performed venipuncture, using vacutainers to obtain 10 ml of whole blood. Blood was centrifuged for plasma separation at the local University Hospital and 1.5 ml aliquots were pipetted into plastic Eppendorf tubes and stored at -80°C. When blood collection from each city was completed, all samples were sent to Marmara University, Faculty of Health Education, where the actual biochemical analysis took place.Total cholesterol (TC) was determined using Allain's method , while FLDL-C = TC - (HDL-C + TG/5) .2).Body weight was measured using a digital scale (Seca) with an accuracy of ± 100 g. Subjects were weighed without shoes, in the minimum clothing possible, i.e. underwear. Standing height was measured without shoes to the nearest 0.5 cm with the use of a commercial stadiometer, with the shoulders in relaxed position and arms hanging freely . Body MaFood consumption of children was assessed by the 24-hour recall technique on three consecutive days. Dietary data was collected from children during a face-to-face interview with a trained dietician. Dieticians were trained as a group to minimize inter-observer variation. During the interview, food models and photos of common Turkish dishes of various portions, as well as household cups and measures were used to define amounts, in order to obtain as accurate information as possible, regarding the type and amount of food and beverages consumed during the previous day. Macronutrient and micronutrient intake were calculated using the food database available in Marmara University, Faculty of Health Education. This database contains Turkish food composition tables for all food, including cooked Turkish dishes. Information on processed foods was obtained from food companies and national as well as international fast food chains.Physical activity during school hours and leisure time was assessed using a standardized physical activity diary completed by the children for two consecutive weekdays and one weekend day. A member of the research team crosschecked diary information during daily interviews. The diary was constructed for searching various physical activities ranging from mild to vigorous , while tActivities were classified into two groups, namely Sedentary and Light Activities (< 4 METs) and Moderate to Vigorous Physical Activities (MVPA) (> 4 METs). Typical activities in the Sedentary and Light category were watching TV, board and computer games, studying and extra curricular classes , etc. The MVPA category included activities such as walking, bicycling, rhythmic-gymnastics, dancing, basketball, soccer, athletics, tennis, swimming, running up and down, jumping rope and general participation in active outdoors games. Given the age group, MVPA was defined as continuous vigorous activity causing sweating and heavy breathing for periods longer than 15 minutes, but with occasional breaks in intensity, rather than the strict aerobic definition of 20 continuous minutes appropriate for adults.th and 75th percentile for not normally distributed variables. The 2- sample Z test was used to compare proportions regarding values above normal range among the different categories of parental education for both genders. One- way analysis of variance (ANOVA) with a Tukey post- hoc analysis and multivariate analysis of variance (MANOVA) controlling for certain confounding factors, was conducted to determine whether differences derived from the comparison of continuous variables among the educational categories were statistically significant. For not normally distributed variables the non- parametric univariate Mann-Whitney test was used to verify the statistical significance of the existing differences among the three educational categories. All analyses were conducted using the SPSS 10.0 statistical software package for Windows. In all analyses a 5% significance level was used.Descriptive statistics of continuous variables were expressed as the Mean ± standard deviation (s.d.), as well as median and 25Table Table Dietary and physical activity characteristics of the under study population are reported in Tables Despite the traditional notions of CVD as a Western disease of "affluence", more than three quarters of global CVD mortality now occurs in middle- and lower- income nations  . FurtherAccording to the findings of the current study there was a higher prevalence of "borderline or high risk", with respect to TC levels, for children with Medium and Higher parental educational level Table . SeveralThe effect of diet on serum lipids and lipoproteins has been extensively studied in various clinical trials and epidemiological studies, and although dietary content is clearly an important determinant, several environmental and metabolic factors intervene to modulate the dietary effect 36). Previously conducted surveys in urban regions of Turkey have provided strong evidence that children coming from more affluent and/or well-educated families consumed diets higher in animal protein and fat, while the typical diet of less privileged children was rich in carbohydrates, including cereal grains and sugar (37). These findings, regarding the macronutrient content of the consumed diet, are in consistency with the current study, since children from Medium and Higher PEL and MEL were found to consume higher percentage of energy derived from fat and protein, while the opposite was observed for carbohydrate intake (Table 6. PrevioRegarding physical activity, it is well established that higher levels of physical activity are associated with higher HDL-C and lower TC to HDL-C ratio values in both children and adolescents -42. HoweThe findings of the current study are in agreement with previous surveys conducted in Turkey indicating that parental education, either as a single estimate of social status or combined with other social and/or economic indices, is a "reliable index" of socioeconomic status ,46. BothThe underlying influence of socio-economic status on health status is far more complex than diet and physical activity alone, since many other factors interact in producing the differences observed for serum lipids or other health indices. Based on the data provided by the current study it could be concluded that the differences regarding the lipidemic profile of children with different parental educational level could possibly be attributed to the differences observed on their dietary and macronutrient intake. Any attempt for the development and implementation of a health and education programme should consider these findings and set priorities accordingly. However further research is needed in order to develop an effective index for assessing socioeconomic level, as well as in better understanding its multidimensional role on public health. All these will help the public health authorities to develop effective strategies, which will efficiently tackle these health issues early in life.The pre-publication history for this paper can be accessed here:


Caring for the well-being of older adults is one of the greatest challenges in modern societies. Improving the quality of care and life for older adults and the work lives of their care providers calls for effective knowledge translation of evidence-based best practices.This study’s purpose is to contribute to knowledge translation by better understanding the roles of organizational context (workplace environment) and facilitation (process or role) in implementation and improvement success. Our study has 2 goals: (1) to advance knowledge translation science by further developing and testing the Promoting Action on Research Implementation in Health Services framework  and (2) to advance research by optimizing implementation success via tailoring of modifiable elements of organizational context and facilitation.This is secondary analyses of 15 years of longitudinal data from the Translating Research in Elder Care (TREC) program’s multiple data sources. This research is ongoing in long-term care (LTC) homes in western Canada. TREC data include the following: 5 waves of survey collection, 2 clinical trials, and regular ongoing outcome data for LTC residents. We will use a sequential exploratory and confirmatory mixed methods design. We will analyze qualitative and quantitative data holdings in an iterative process: (1) comprehensive reanalysis of qualitative data to derive hypotheses, (2) quantitative modeling to test hypotheses, and (3) action cycles to further refine and integrate qualitative and quantitative analyses. The research team includes 4 stakeholder panels: (1) system decision- and policy makers, (2) care home managers, (3) direct care staff, and (4) a citizen engagement group of people living with dementia and family members of LTC residents. A fifth group is our panel of external scientific advisors. Each panel will engage periodically, providing their perspectives on project direction and findings.This study is funded by the Canadian Institutes of Health Research. Ethics approval was obtained from the University of Alberta (Pro00096541). The results of the secondary analyses are expected by the end of 2023.The project will advance knowledge translation science by deepening our understanding of the roles of context, the interactions between context and facilitation, and their influence on resident and staff quality outcomes. Importantly, findings will inform understanding of the mechanisms by which context and facilitation affect the success of implementation and offer insights into factors that influence the implementation success of interventions in nursing homes.DERR1-10.2196/40611 Concerns about quality in long-term care (LTC) homes are not new—the literature overflows with decades of calls to improve quality of care in LTC -4. InterThe Promoting Action on Research Implementation in Health Services (PARIHS) framework is widely used in implementation science -18 and oThe PARIHS definition of context is highly general: the setting where a proposed change is to be implemented . PARIHS Elements of context  are associated with outcomes for direct care staff in LTC homes, such as job satisfaction, burnout, use of best practices, and tasks rushed or left undone ,27,34-39However, despite decades of work on context, no coherent body of evidence clearly demonstrates context conditions for success ,24,25. WThe PARIHS framework considers a second component, facilitation, as both a role  and a process (of enabling others) . EmerginDespite these insights, a lack of theoretical grounding is one factor that continues to limit our understanding of the effects of facilitation on implementation success ,48. TheoThe PARIHS framework suggests that context factors and facilitation interact in complex ways, but neither the PARIHS developers nor other researchers have addressed directionality, addressed mechanisms of interactions, or actively and empirically assessed wider context factors  ,51. SomeOur integrated knowledge translation program, Translating Research in Elder Care  (TREC), The purpose of this study is to contribute to knowledge translation science by better understanding the roles of organizational context and facilitation in implementation and improvement success. We have 2 broad goals: (1) to advance knowledge translation science by further developing and testing the PARIHS framework for research implementation and (2) to lay foundations to advance research by optimizing implementation success via effective tailoring of modifiable elements of organizational context and facilitation. Our specific study aims are to as follows: (1) to identify how context influences success of implementation and of quality improvement initiatives, (2) to identify and map context conditions in which facilitation affects outcomes for staff quality of work life, and (3) to identify and map context conditions in which facilitation affects resident outcomes.We propose that improvements in care and better implementation success can be achieved by modifying elements of context, particularly inner context , and through both optimal use of facilitation roles and enabling of facilitation processes ,48,59.Ethics approval for this study was obtained from the institutional review board of the University of Alberta (Pro00096541).In these secondary analyses, we will apply convergent mixed methods and sequential mixed methods designs  to concuThe research team includes a multidisciplinary group of researchers, 4 panels of key stakeholders who are end users, and a fifth panel of external scientific experts: (1) system-level decision- and policy makers, (2) LTC home managers, (3) direct care staff working in LTC homes, (4) people living with dementia and their family members (citizen engagement), and (5) scientists with substantive knowledge of organizational context and learning, the PARIHS framework, context, facilitation, leadership, and implementation science.We will analyze TREC’s comprehensive data holdings  in an iterative process  where we maintain a cohort of 94 participating LTC homes. The cohort sample is a stratified  random sample  of urbanWe have longitudinal data  from 2 mWe are able to link TREC data from multiple sources at the level of the clinical microsystem (LTC resident care unit). Data are linked by assigning residents and staff to specific care units  to create longitudinal data sets at the care unit level within LTC homes. The clinical microsystem, a central concept in quality improvement science, is the level where care is organized and delivered ,65 and wData captured in the TREC survey include (1) structural characteristics: LTC home surveys completed by the LTC home administrator and unit surveys completed by the unit care manager and (2) individual measures from managers, regulated nursing staff, allied health staff, and unregulated care aides (nursing assistants).Examples of structural characteristics are size and the owner-operator model of LTC homes and type and staffing level of care units. Individual surveys are a suite of instruments and questions that capture demographic characteristics, best practice use, quality of work life, and organizational context. Quality of work life variables are captured using validated measures. They include burnout (Maslach Burnout Inventory) , physicaOrganizational context is captured using the Alberta Context Tool (ACT) ,55. We dWe have access to deidentified resident data from the RAI-MDS 2.0 for each of the 94 participating LTC homes. From our 5 large waves of data collection, we have over 500,000 resident data records. Further, we can link these data to external Continuing Care Reporting System data nationally  and proThe SCOPE trial examined the effects of empowering care aides to lead quality improvement strategies in their care unit. SCOPE included 408 participants from 45 LTC homes. It gathered quantitative data as rich survey data from individuals, teams, and leadership, and qualitative data from interviews, focus groups, and observation .We have data from 3 extensive ethnographic case studies completed in TREC phase 1 (2007-2012) ,88. We oFacilitation, implementation success, and improvement success are not directly available in our data, but we will derive the variables from our INFORM and SCOPE trial data. Many quality improvement interventions in health care settings target health care providers’ adoption of evidence-based best practices . Our teaWe have published one conceptualization of facilitation . Other dWe will examine qualitative data from our case studies and INFORM and SCOPE trials . For the case study data, we will search for evidence on context elements that most strongly influence the association between facilitation and staff quality of work life, and between facilitation and improvements in resident outcomes. We will propose hypotheses for quantitative analysis that will contribute toward aims 2 and 3. For the trial data, we will look for evidence on the context elements that most strongly drive better trial intervention delivery, enactment, and receipt, and on improvement success of the trial. This will contribute toward our first aim of understanding implementation success. We will use ATLAS.ti software  to suppoWe will examine the data first with the lens of the PARIHS framework  and then augment with other key theoretical perspectives  ,95. We wCoders will then use the summaries to synthesize findings into a matrix to illustrate the concepts of interest and potential relationships among them. They will include sample quotes to exemplify the concepts. Matrices will be examined by senior team members and refinements made as needed. We will use the matrices to create network figures, using the network feature of ATLAS.ti software to depict relationships identified in the data. Networks will be reviewed by the full team and refined. Matrices and networks will be examined across cases to identify patterns and areas of contradiction. Questions from the full team will be explored by the coding team, who will look back at the original source data and examine the audit trail of the initial coding, summaries, matrices, and networks.Our quantitative working group will analyze quantitative data from TREC surveys and RAI-MDS 2.0. We will be able to measure many constructs derived from qualitative analyses. TREC data are of high quality (few missing data and high response rates) and have been collected, cleaned, and processed through a rigorous process . We willWe will conduct basic descriptive and bivariate analyses, followed by more advanced statistical modeling using; for example, general estimating equations, hierarchical linear mixed models, and generalized linear mixed models. These enable us to adjust for complex nested structures of our data ,38. We wWe will adopt convergent and sequential mixed methods models to obtain different but complementary data on the same problem for a more complete understanding . In a coAs an example, we will complement the PARIHS framework with other conceptual frameworks  ,95,102 aWe will work iteratively with our stakeholder and expert panels to further inform and refine analyses. We will hold 2 virtual facilitated meetings with all panels . Before The results of the secondary data analysis are expected by the end of 2023.This project responds to (1) calls to improve understanding of the mechanisms by which context and facilitation function, (2) criticisms that the aging field (like many) is rich in data but impoverished in theory, and (3) calls for optimized use of longitudinal data to advance the science of aging and appropriately inform policy makers on complex issues affecting aging populations ,103,104.We expect to advance the PARIHS framework by better describing the mechanisms by which context and facilitation influence implementation and improvement processes. We will identify specific factors of organizational context  and facilitation and understand how they interact and affect outcomes. We will elaborate on inner  versus outer  context conditions.We anticipate generating a stronger evidence base for large pragmatic implementation and quality improvement trials. An advantage of our study is the potential to generate both scientific and practical working knowledge through our integrated knowledge translation approach . This ma


The foundational principles of global health (GH) organizations are rooted in the recognition and amelioration of inequities that result in poor health. Despite capacity enhancing strategies designed as bilateral partnerships with colleagues in low- and middle-income (LMIC) settings, international organizations from high-income countries (HIC) still struggle to address the lack of opportunities for professional development amongst LMIC partners.The pursuit of equitable representation in GH meetings is crucial to capacity enhancing, as there is more to a conference than networking and knowledge transfer; presentation at a conference is often a defining career development stepping-stone. However, most international conferences favour the participation of persons from HIC by being held in expensive locations, frequently with strict visa requirements hindering inclusive engagement. Authors additionally face competitive abstract selection processes that may constitute barriers for junior colleagues from LMICs who often lack essential resources and mentorship; however, these are the very individuals principally involved in programs at the ground level. As a result, GH conference attendance and participation are skewed towards representatives from HIC . The SARThe Baylor College of Medicine International Pediatric AIDS Initiative (BIPAI) Network includes nine local and independent partner organizations (Foundations) that provide paediatric and maternal health care for vulnerable populations across sub-Saharan Africa, South America, and Eastern Europe. Collectively, these Foundations employ nearly 2600 local staff serving over 365 000 patients in their communities. Texas Children’s Hospital (TCH) and Baylor College of Medicine (BCM) provide the Network with technical assistance and capacity enhancing opportunities in partnership with each Foundation.Historically, BIPAI has hosted an annual in-person meeting for an average of 100 people, 70% from the Foundations and 30% from TCH/BCM. BIPAI sponsored approximately five individuals from each Foundation, resulting in an exclusive meeting not available to most Foundation staff. BIPAI re-evaluated this in-person meeting model in light of the SARS-CoV2 pandemic. Online education has been suggested as a long-term strategy for achieving equitable progress in GH if barriers such as unreliable internet connectivity, time zone differences, and lack of meaningful attendee engagement are addressed . We percWith this vision in mind, we conceptualized and piloted a virtual event, the RAISE Symposium, in July 2021. We built the Symposium around five thematic areas , designing each session to be highly interactive and usable, nurturing scientific curiosity and abilities of local staff.To foster collaboration and input from the global community, we chose to host the live event on Zoom as it is a free online platform, with minimal bandwidth requirements and accessibility from smartphones. We preferred the “meeting” over “webinar” option to allow for more interaction and inclusiveness. We chose VoiceThread©, a multimedia-based, virtual collaboration platform that allows users to upload, share, and discuss videos and presentations, as the venue for e-posters and art exhibits. Organizers and participants could post written or audio comments and questions on posters, with easy access through a computer or mobile device. Virtual discussions developed organically and enabled stimulating conversations that promoted collaboration and networking.Collaborative scholarship is a BIPAI core value that demands innovative approaches to improve access to professionals across disciplines. The GH Scholarship Community of Practice (CoP) is a pre-existing network-wide program fostering a culture for scholarship through enhancing fundamental scholarly skills and building community. The CoP helped establish the virtual event, providing the educational framework for a supportive learning event where participants could practice their scholarly skills, showcase their work, and allow for true knowledge transfer .We integrated resources by providing coaching and educational activities facilitated through CoP and offered a variety of topics and activities to encourage both active and passive engagement of staff other than clinicians and researchers. The goal was to catalyse the exchange of ideas across the Network beyond the traditional abstract showcase, making scientific and programmatic research more accessible and appealing. The Symposium was organized through eight months, the majority of which was dedicated to coaching activities for submitting authors and foundations.All individual submissions underwent a double-blinded peer review process and were accepted into three categories  based on scientific merit. We identified 46 expert reviewers across the Network through an online survey and matched them with abstracts meeting their scientific interests. Three independent reviewers assessed each abstract. Reviewers used scoring rubrics to guide evaluations and provided a numerical score and anonymous written feedback to the authors.Comprehensive coaching support, facilitated by CoP satellite activities, was the primary capacity enhancing initiative incorporated into every step for preparing the Symposium. The immediate goal of coaching was to support preparations of scientifically robust abstracts for submission, support the development of effective and engaging posters or presentations, while enabling authors to present their work. We also intended for coaching to enable ongoing collaborative or mentoring relationships through the CoP; this would continue to foster the scholarship-rich culture beyond the event.Prior to the abstract submission deadline, we paired 29 authors from various Foundation sites with 20 experienced volunteer faculty members with expressed interest and experience in GH. They provided advice for 37 abstracts related to content, research design, statistical analysis, and writing. We accepted 23 abstracts from 19 authors who had received coaching for presentation . More than 90% of authors reported gaining skills transferable to future submissions, with our coaching encouraging iterative processes for the long-term improvement of their work. Authors selected for oral presentations joined an hour-long CoP satellite session about effective oral communication; it introduced the concept of 5-minute presentations and the creation of engaging slide decks. Attendees reflected that they “felt more confident mastering a short oral presentation.”Recognizing the need for standardized and novel poster designs to improve quality and communication of key results, we embraced the “#betterposter” movement -9. We ofTo highlight the potential of cross-network discussions, we invited authors of closely aligned scientific abstracts to co-present at the Symposium. Joint presentations connected authors and allowed the audience to learn dynamically and be inspired by the potential of network-wide collaboration. For example, one joint presentation paired a presenter that described a 3rd line antiretroviral therapy (ART) program with a second country’s team that evaluated ART drug resistance patterns.The pandemic highlighted the importance of holistic health and human connection, as well as that of novel means of communication such as art as a conduit to well-being -12. In aThe inclusion of artwork transformed the Symposium into an opportunity to discuss the wellness benefits of art, especially considering the negative mental health impact of the pandemic on patients and frontline workers. Additionally, it enabled the engagement of HIV-positive youth, highlighted the different cultures across the network and helped foster a sense of belonging to an international community.To showcase the relevance of art therapy in unleashing the creative imagination of children with chronic illnesses, the opening day showcased an art therapist who set the tone for the intention and power of marrying art and medicine. Additionally, short videos highlighting patients and staff artworks were presented daily. Artists from across the network talked about art in their personal and professional lives, highlighting the myriad of strengths  that art can bring to life. Frontline workers often disclosed their personal use of art as an emotional outlet for coping and resilience, enabling them to develop a robust sense of self and hope as they dealt with pandemic-generated anxieties.Over 500 participants from more than 20 countries registered, with an average of 49 participants per Foundation, 47 participants from TCH and BCM, and 19 external participants.  though not to a degree that impeded the Symposium or appreciably impacted its outcome.The RAISE Symposium celebrated holistic health, innovation, and teamwork; its interdisciplinary approach, easily accessible virtual format, and culture of scholarship challenged the norms of traditional conferences and served as a means of inclusion to balance participation inequalities in meetings. By sharing our experience, we hope to inspire international organizations to seize the moment and re-think educational objectives and mentoring strategies for the long-term career accomplishments of LMIC staff. Thinking holistically about the lives of our colleagues around the world, rising to emerging needs and being generous with both time and resources will continue to push the needle closer to the goal of global health equity.


Integrating data across heterogeneous research environments is a key challenge in multi-site, collaborative research projects. While it is important to allow for natural variation in data collection protocols across research sites, it is also important to achieve interoperability between datasets in order to reap the full benefits of collaborative work. However, there are few standards to guide the data coordination process from project conception to completion. In this paper, we describe the experiences of the Clinical Sequence Evidence-Generating Research (CSER) consortium Data Coordinating Center (DCC), which coordinated harmonized survey and genomic sequencing data from seven clinical research sites from 2020 to 2022. Using input from multiple consortium working groups and from CSER leadership, we first identify 14 lessons learned from CSER in the categories of communication, harmonization, informatics, compliance, and analytics. We then distill these lessons learned into 11 recommendations for future research consortia in the areas of planning, communication, informatics, and analytics. We recommend that planning and budgeting for data coordination activities occur as early as possible during consortium conceptualization and development to minimize downstream complications. We also find that clear, reciprocal, and continuous communication between consortium stakeholders and the DCC is equally important to maintaining a secure and centralized informatics ecosystem for pooling data. Finally, we discuss the importance of actively interrogating current approaches to data governance, particularly for research studies that straddle the research-clinical divide. Research data coordination is a challenging process with few guiding standards. This study identifies 14 lessons learned from data coordination in the Clinical Sequence Evidence-Generating Research (CSER) Consortium and offers 11 recommendations for data coordination in other multi-institutional research projects in the areas of planning, communication, informatics, and analytics. Large projects, like the Electronic Medical Records and Genomics (eMERGE) Network, the Alzheimer’s Disease Research Centers (ADRCs), the Digitalis Investigation Group (DIG) trial, the model organism Encyclopedia of DNA Elements (modENCODE) project, and the Li-Fraumeni Exploration (LiFE) Consortium, have implemented DCCs to facilitate data sharing and integration across heterogeneous research environments.The Clinical Sequence Evidence-Generating Research (CSER) Consortium is a multi-site program funded by the National Human Genome Research institute (NHGRI), National Cancer Institute (NCI), and National Institute on Minority Health and Health Disparities (NIMHD) and has been navigating the complexities of data sharing across a network of projects. In its second phase of funding, CSER is investigating the effectiveness of integrating genomic sequencing into clinical care, particularly in diverse and medically underserved populations.As of March 2022, over 55% of the planned consortium manuscripts intended to use harmonized measures and/or case-level sequencing metrics data.In this paper, we first describe the CSER consortium and its data coordination needs and then describe the consortium’s experience with implementing a DCC to manage heterogeneous survey, phenotypic, and genomic data across sites. Using our own successes, opportunities for growth, and lessons learned as a guide, we offer a set of recommendations for other research consortia to consider when designing data coordination plans for multi-site collaborative projects, particularly in the field of clinical genomics.3EGS), (6) HudsonAlpha Institute for Biotechnology (SouthSeq), and (7) The National Human Genome Research Institute (ClinSeq). Consortium activities were facilitated by a coordinating center based at the University of Washington and were guided by an external committee, the CSER Advisory Panel, consisting of six experts in genomic medicine and a community advocate. While all CSER sites shared a common goal of investigating the applications and outcomes of genomic sequencing in clinical care, the patient populations, specific research aims, and study protocols differed widely between sites (CSER consisted of a Steering Committee and eight main working groups with members from the following contact institutions and CSER projects: (1) Baylor College of Medicine (KidsCanSeq), (2) Kaiser Permanente Northwest (CHARM), (3) University of North Carolina at Chapel Hill (NCGENES 2), (4) Icahn School of Medicine at Mount Sinai (NYCKidSeq), (5) University of California, San Francisco  and the Project Managers working group (established in Spring 2019). Interactions largely consisted of monthly video calls and ad hoc calls with individual site analysts and project managers.,The DCC collaborated with several external organizations that helped maintain the technical infrastructure that the consortium used to securely manage its aggregated survey and sequence data. The Institute of Translational Health Sciences (ITHS) at the University of Washington managed the Research Electronic Data Capture (REDCap) databaseThe second phase of CSER began in August 2017. Harmonized measures were developed throughout 2018, and sites adopted the harmonized measures in late 2018. As described in Goddard et al.,The DCC utilized a suite of informatics tools and platforms to securely store and share consortium data. The following tools and platforms were used to coordinate CSER data.Data was collected and stored locally by each CSER site before it reached the DCC. Sites collected survey data using platforms including REDCap, SurveyMonkey, and custom-developed web applications. Some measures (like participant ages) were pulled directly from the Electronic Health Record (EHR) by sites if they were not collected through harmonized surveys. Methods for survey data storage also varied by site, with some sites using REDCap databases or similar platforms designed for clinical research and others using relational or non-relational database-management systems for optimized storage and querying of large datasets. The vast majority of survey data quality assurance (QA) and quality control (QC) was performed at CSER sites prior to DCC submission. These QA/QC measures included, but were not limited to, checks for missing data, range value checks, and outlier analyses. Genomic data were stored on servers with high disk capacity at each site or using secure cloud storage services like Amazon S3 or Microsoft Azure.A secure instance of REDCap was hosted and maintained by the University of Washington ITHS and populated by CSER sites using data-submission tools maintained by the DCC. All harmonized survey measures, case-level sequencing results, and participant-level sequencing metrics  were centrally stored in REDCap and were linked at the participant level using a unique identifier called a “CSER ID.”The DCC used a custom R Shiny web interface called the “Data Hub” to securely exchange harmonized survey data, case- and participant-level sequencing metrics, and documentation within the consortium. See “The NIH-funded AnVIL consortium develops and maintains the AnVIL cloud ecosystem, which was built using Google Cloud storage and compute resources. The AnVIL is a component of the emerging federated data ecosystem paradigm in genomics,To collect common survey measures administered at each site, the DCC developed a REDCap database using the harmonized survey measures developed by the consortium in 2018To facilitate mapping between site datasets and the DCC harmonized database, the DCC developed tab-delimited import templates and accompanying data dictionaries for six harmonized survey types . All patSite analysts developed semi-automated variable mapping pipelines using the data-handling software(s) of their choice  and used these pipelines to generate harmonized datasets from the harmonized data model developed in phase 1.Staff at each site shared their harmonized datasets through a custom data-upload interface on the Data Hub, which ensured that the datasets met the specifications of the models developed during phase 1, and automatically transferred data to the DCC REDCap database using the redcapAPI R package.All sites repeated phases 2 and 3 on a quarterly basis until the end of follow-up to update existing participant records, and to create records for newly recruited participants.The CSER DCC facilitated the transfer of genome and exome data and metadata from site platforms to the AnVIL platform. The DCC developed harmonized metadata models in collaboration with members of the AnVIL team and other CSER members, using standards previously developed by dbGaP and The Cancer Genome Atlas (TCGA) Program as references. To facilitate the transfer of sequence data and metadata to the AnVIL platform, the DCC developed sample scripts for securely transferring data to Google Cloud buckets and made these scripts available for download on an SFTP server hosted by the University of Washington Genome Sciences department. The DCC also provided step-by-step instructions for preparing data, submitting required data ingest forms, and using sample scripts for batch sequence data transfers.Throughout 2020 and 2021, the DCC worked to meet the evolving data coordination needs of the CSER consortium as it actively collected sequence and survey data from study participants. The following section describes the approaches that the CSER consortium used to navigate the complexities of multi-site data sharing and offers a set of lessons learned from its data coordination experiences . LessonsAs the DCC integrated with the consortium throughout 2020, additional communication channels beyond monthly Data Wranglers working group calls were formed to fully support the consortium’s data coordination requirements. While the Data Wranglers primarily served the role of handling site-level survey and sequence data and developing computational pipelines to convert data into a harmonized format, the Project Managers provided the necessary project-level guidance to ensure that data were being shared securely and responsibly, such as tracking regulatory documents, overseeing data collection, and developing data QA/QC measures. Together, the two working groups contributed to the development of feasible and efficient DCC harmonized data-upload requests and data dictionaries, assisted in coordinating responses to new data requests (including site-specific data), assisted in troubleshooting challenging data elements , responded to requests for project-specific information, and kept track of data submission timelines (lesson learned 1a). The DCC, Data Wranglers, and Project Managers communicated through an iterative, multi-directional feedback loop throughout the project period to ensure that all groups were equipped to fulfill their respective data coordination responsibilities (lesson learned 1b).Multiple working groups requested that the DCC share important data coordination updates with the rest of the consortium. To increase transparency of ongoing work and maintain an organized list of action items, the DCC sent update emails to the Data Wranglers working group, Project Managers working group, Sequence Analysis and Diagnostic Yield working group, and principal investigators (PIs), first on a biweekly and eventually on a monthly basis to communicate important DCC activities, inform consortium members of key resources, and track new data coordination requirements. To communicate DCC activities and goals with the broader consortium, the DCC also gave regular progress updates during biweekly and monthly Coordinating Center and Steering Committee calls, respectively. These updates helped other working groups and consortium stakeholders anticipate availability of shared data and allowed consortium members outside of the Project Managers, Data Wranglers, and Sequence Analysis and Diagnostic Yield working groups to regularly provide feedback and ask questions about current and planned DCC initiatives (lesson learned 1c).Interactions between the DCC and groups external to the consortium were largely facilitated by weekly or biweekly standing meetings, including those with AnVIL project managers and the University of Washington ITHS staff. These meetings helped the DCC receive timely assistance and feedback from technical support teams and to communicate questions and concerns raised by CSER members. Throughout 2020 and 2021, the DCC developed a variety of strategies to facilitate the harmonization and intake of common survey measures. As described in Goddard et al.,In CSER’s experience, achieving and sharing semantically interoperable data was far more complex than simply sharing data. As described in “The primary goal of the survey mapping phase (phase 2) was for each site to develop a semi-automated pipeline that could be used to quickly update harmonized datasets with new or modified data on a quarterly basis. However, the pipeline development process was complex and time intensive for each site and involved frequent updates to mapping logic. Updates included relatively simple changes, like variable name modifications and harmonized response scale adjustments, but also included more complex updates, like the addition of new variables that were deemed necessary for accurate, reliable, and secure downstream analysis of harmonized data . For exaTo minimize burden placed on Data Wranglers and Project Managers due to change requests and to maximize transparency, the DCC maintained a “change log” page in the Data Hub, which listed the changes made between import template and data dictionary versions. During the last quarter of 2020, the DCC began distributing quarterly checklists that documented all new, removed, and modified variables for each quarterly data resubmission and made these documents available for download on the Data Hub (lesson learned 2b). Beginning in January 2021, the DCC also implemented a new “change request schedule,” which specified time intervals when consortium members could make change requests and blocked off 2-month intervals before each quarterly resubmission, during which site data analysts could modify mapping pipelines without having to address incoming change requests. These strategies helped manage the computational and organizational burden of maintaining harmonized mapping pipelines but nonetheless did not eliminate all tensions between site-level burden and consortium-level data-sharing expectations (lesson learned 2c).The AnVIL replaced dbGaP as the primary repository for NHGRI-funded genomic, phenotypic, and survey datasets in mid-2019, during the CSER phase II funding period.The CSER DCC used the Data Hub platform to host data coordination resources in a centralized, secure, and easily accessible location. The Data Hub made it possible to link multiple data-management platforms with one another  and to qBefore submitting harmonized data to the Data Hub or sequence data to the AnVIL, all CSER sites were required to remove personally identifiable information (PII) from their datasets in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.Although the DCC took steps to prevent identifiable information from being uploaded to its platforms, multiple layers of security were built into the DCC informatics architecture to protect data in the unlikely event that sensitive, identifiable information was to be uploaded to a DCC platform (lesson learned 3c). First, the Data Hub was deployed on a secure web server hosted by the University of Washington ITHS. All requested connections from client web browsers were established using the Apache HTTP Server software, and ITHS required that all hosted web applications establish encrypted connections between the server and the client browser. Second, all Data Hub users were required to log in to the Data Hub using University of Washington credentials, which were sponsored by the DCC team. Third, the Data Hub was designed in alignment with standards put forth by the HIPAA Security Rule, including the use of activity logs, password-protected access, automatic password timeout, and HIPAA-compliant data storage in REDCap. And fourth, the DCC developed standard protocols for removing records of participants that had withdrawn consent for sharing data and continuously updated and distributed a list of CSER IDs that should be removed from previously downloaded datasets.CSER did not have a central study IRB and thus relied on IRBs at each CSER site  and the University of Washington—the Coordinating Center home institution—to make decisions about appropriate data sharing. All site and Coordinating Center PIs signed a Data Use Agreement in early 2019 detailing the data-sharing terms between participating institutions in CSER, and the DCC used this document to broadly define the terms of data sharing across CSER sites and beyond the consortium.While the use of local IRBs facilitated the implementation of varied clinical study designs across diverse patient populations at each site, the lack of a central CSER IRB also resulted in substantial heterogeneity in how data-sharing consent groups were defined across CSER sites. Because the dbGaP Authorized Access System typically inherits consent group specifications from study institutional certifications,To develop consortium-wide data sharing consent categories, the DCC convened a multidisciplinary “Data Access Subgroup” of data analysts, project managers, and data ethicists to discuss key considerations and requirements for consent harmonization (lesson learned 4a). The subgroup met twice over a period of 2 months in mid-2020 to develop a plan for mapping site-level consent categories to harmonized consent groups. Using a combination of standard NIH consent groups  and data use limitations The movement of data storage and computation to cloud platforms like Google Cloud, Amazon Web Services (AWS), or Microsoft Azure is widely regarded as a necessary next step in the field of genomics, given the large volume of genomic data generated daily, the increasing sophistication and scalability of cloud resources, and the need for extensive collaboration in genomic research.Given the heterogeneity in how common survey measures were modeled and administered at each CSER site, the DCC developed strategies to document differences in site-level measure implementations. The DCC initially used separate Google Sheet data dictionaries for each site to document unique implementations of common measures. These site-level data dictionaries were then compiled into a single “adaptation dictionary,” which documented the adaptations made to each harmonized variable across all CSER sites and was designed to highlight the degree to which each measure might be subject to data integration or reliability issues during analysis. To facilitate quick assessments of data reliability, the DCC implemented a cover sheet within the adaptation dictionary that indicated to what extent each measure was adapted . Step-byIn addition to documenting adaptations to harmonized measures, the DCC developed a centralized help document for current and future users of CSER data. The document contained descriptions of all CSER projects, explanations for how key variables were harmonized, rationale for and descriptions of items that were added to the harmonized measures , and frequently asked questions (FAQs) related to database structure and use (lesson learned 5a).The DCC also implemented several automated, on-demand variable calculation features in the Data Hub to generate measures that could be programmatically derived from the harmonized measures. The CSER “Underserved Framework,” developed by members of the CSER Ethical, Legal, and Social Implications and Diversity working group, employed different combinations of demographic factors  to form nine distinct risk groups, indicating either direct barriers to medical care access or social factors that might indirectly impede access. Using the Data Hub download tool, consortium members could elect to download automatically calculated Underserved Framework variables along with documentation about how each variable was calculated.The AnVIL platform seeks to enable users with scalable compute power, large-scale data access, and shared resources for analysis.Although the potential benefits of using a platform like the AnVIL for sequence data storage, sharing, and analysis are numerous, the unfamiliarity of the platform may limit the ability of investigators to anticipate exactly how data might be shared and/or used and may therefore make early-stage decisions about data modeling and sharing difficult. For example, the automatic linkage of survey, phenotypic, and sequence data in a shared cloud workspace is a novel concept, and investigators will undoubtedly need to make challenging decisions regarding the best way(s) to prepare, share, and utilize such data. Large clinical genomics research consortia like the eMERGE Network and the Implementing Genomics in Practice (IGNITE) Consortium will likely face similar challenges to those experienced by CSER, and the AnVIL platform will be a valuable space for investigators from all disciplines to unite and support one another in this new generation of genomic data sharing and analytics (lesson learned 5b).After dedicating much time and effort to developing and implementing strategies for harmonizing and coordinating consortium-wide datasets, the CSER consortium is well positioned to contribute an impactful and wide-reaching dataset to facilitate research in medical genomics. While the DCC developed tailored strategies to facilitate CSER data coordination, the principles behind these strategies are applicable to other research settings in which data are pooled from heterogeneous sources. Clear and consistent communication on the part of research leadership and data coordination teams should be a high priority, from project conception to completion. Ideally, funding opportunity announcements (FOAs) issued by funding agencies should plan for and communicate data-sharing expectations  to allow research sites to budget and plan for data coordination activities . When possible, the DCC should be involved in the research planning phase and should continually facilitate conversations surrounding data collection, QA/QC, reporting, modeling, and sharing, so that research sites are sufficiently prepared to participate in data sharing at all project stages . Given the availability of appropriate experience and expertise, the DCC may act as a stakeholder proxy across research sites and working groups and facilitate data coordination conversations and decision-making. As a liaison between project stakeholders, the CSER DCC was ideally positioned to assume the role of “translator” and facilitate adaptive communication between groups with unique roles and areas of expertise . Translation should also take place between the consortium and the greater scientific community, since data in controlled-access repositories are expected to have a lifespan beyond the consortium from which they originate. As such, clear documentation of shared data and resources should be developed to encourage appropriate data use and alert users to any unusual or unique data elements prior to analysis .The translator also has a responsibility to communicate data needs centrally and concisely. Separate lines of communication that request different (but related) data coordination action items should be avoided, and requests should instead be aggregated and contextualized with one another . The expected contributions of stakeholders to different data coordination activities should also be transparent, both to increase task accountability and to assess the equitable distribution of tasks across the consortium . Stakeholder communication should be a two-way, responsive process in which DCC processes are adjusted in response to stakeholder feedback and vice versa.An often-overlooked aspect of data coordination is the importance of interpersonal relationships and team morale within and between stakeholder groups. Making expectations transparent and achievable is critical to demonstrating respect and appreciation for team members’ time and efforts . Similarly, giving team members the space and time to regularly voice ideas and concerns to the leadership and data coordination team is essential for maintaining a culture of mutual respect and understanding across stakeholder groups. Decisions that will impact research workflows and workloads of consortium members should be made mutually and transparently, both to demonstrate respect for one another’s time and to avoid situations in which stakeholders must retrospectively address issues introduced earlier in the research process due to a lack of communication or collaborative planning. Strengthening these interpersonal relationships is essential for building a culture of trust within the research team and facilitating a positive data-sharing experience.Access points to important data coordination tools and resources should be consolidated to minimize burden placed on sites and improve resource transparency . Each resource should also be designed to withstand frequent modifications, both on the database and user-interface ends, to accommodate inevitable changes in consortium needs . Building iterative design principles into the platform-development process is far more effective at achieving a useful and usable system than deploying a static, pre-designed system.While there is an understanding among scientific communities worldwide that sharing research data is a necessary component of scientific progress, the mechanisms for protecting against potential harm while maximizing usefulness are not well-defined.,One important tension that arises in clinical research is the need to accommodate varying data-governance expectations across clinical and research settings, particularly for participant privacy and informed consent for data sharing. For example, the Federal Policy for the Protection of Human Subjects  is a set of federal regulations that dictates requirements for the ethical management and distribution of data collected from human research subjects, while the HIPAA Privacy Rule is a federal law that enforces standards for the protection of patient medical data. While these regulations are intended to complement one another in clinical research settings, the details of how each set of rules should be applied to the operational components of a data-governance strategy are not well defined, leading to potential gaps in data protections.In the case of informed consent for data sharing, the details and implications of policies that govern data protections should be made transparent to clinical research participants who are asked to consent to broad data sharing, but researchers and policymakers themselves are still grappling with these details. For example, on the FAQ page of the NIH GDS policy description, a common perception among genomic researchers is that the “NIH requires that investigators obtain consent for broad data sharing and that the participant is disqualified from participating in the study if consent is not obtained,” although the NIH clarifies on the same page that this was not the intent of the policy.While these recommendations were designed to generalize to other multi-site research projects, we recognize that smaller or less well-funded projects may not be able—or even need—to implement all of the recommendations. For example, a smaller project with two homogeneous research sites  may not need to establish a formal DCC (recommendation 3) or deploy a multi-user web application (recommendations 7–9). However, the same project would still benefit from having a dedicated group of investigators to oversee data coordination, encourage communication, and facilitate documentation . While the costs of these recommendations pale in comparison to funding an entire DCC or developing a web application, they are nontrivial. A “bare bones” implementation of a data coordination core would require part-time participation of at least one investigator at each site with data science expertise (similar to the CSER Data Wranglers), one investigator at each site with detailed knowledge about the study (similar to the CSER Project Managers), and one central coordinator to facilitate communication and track progress. As funding agencies increasingly expect research projects to contribute high-quality, harmonized data to public repositories, funders and researchers alike should recognize these dedicated groups as an essential component of any research program and provide appropriate budget support accordingly (recommendations 1 and 2).Research projects should consider how the size, complexity, and privacy considerations of their anticipated datasets impact the relative importance of different data coordination needs (see the “needs” column in ,Finally, while these recommendations are most translatable to NIH-funded projects within the United States, the basic principles still apply to non-NIH-funded and multi-national projects. Other types of projects may have data-sharing expectations and policies that differ considerably from those of NIH-funded projects, but using well-reasoned communication and informatics practices is ubiquitously beneficial for managing heterogeneous datasets. For example, a 2017 report by the Organisation for Economic Co-operation and Development identified common challenges across 32 international research data networks, including the need for clear roles and responsibilities, transparency, mutual respect, and clear data-governance plans.Data coordination is key to harnessing the full potential of multi-site research projects, yet there exist few guidelines for how the coordination process should be executed. The CSER Data Coordinating Center faced a host of challenges while aggregating common measures data and genomic sequence data across clinical projects and developed a suite of communication and informatics techniques to address these challenges. CSER is not alone in its data coordination odyssey. Other collaborative research projects face similarly complex decision points, and the CSER experience provides insight into how those complexities may be addressed or even prevented with early action.