Access to safe water and sanitation facilities and the adoption of effective hygiene practices are fundamental to reducing maternal and child morbidity and mortality globally. In armed conflict settings, inadequate water, sanitation and hygiene (WASH) infrastructure poses major health risks for women and children. This review aimed to synthesise the existing information on WASH interventions being delivered to women and children in conflict settings in low-income and middle-income countries (LMICs) and to identify the personnel, sites and platforms being used to deliver such interventions.We conducted a systematic search for publications indexed in four databases, and grey literature was searched through the websites of humanitarian agencies and organisations. Eligible publications reported WASH interventions delivered to conflict-affected women or children. We extracted and synthesised information on intervention delivery characteristics, as well as barriers and facilitators.We identified 58 eligible publications reporting on the delivery of WASH interventions, mostly in Sub-Saharan Africa. Non-Governmental Organization (NGO)/United Nations (UN) agency staff were reported to be involved in delivering interventions in 62% of publications, with the most commonly reported delivery site being community spaces (50%). Only one publication reported quantitative data on intervention effectiveness among women or children.This review revealed gaps in the current evidence on WASH intervention delivery in conflict settings. Little information is available on the delivery of water treatment or environmental hygiene interventions, or about the sites and personnel used to deliver WASH interventions. Limited quantitative data on WASH intervention coverage or effectiveness with respect to women or children are important gaps, as multiple factors can affect how WASH services are accessed differently by women and men, and the hygiene needs of adolescent girls and boys differ; these factors must be taken into account when delivering interventions in conflict settings.CRD42019125221 Populations affected by conflict are at increased risk of poor health outcomes as a result of inadequate access to water, sanitation and hygiene (WASH) facilities and resources.Increased population displacement caused by conflict often leads to overcrowding in camps, creating optimal conditions for the transmission of communicable diseases.Provision of clean water and improved sanitation facilities have been successful methods of improving maternal and newborn child health in conflict settings.There is a lack of high-quality information and data on the delivery and effectiveness of WASH interventions for women and children in conflict settings.Many WASH interventions are reported to be delivered in community settings, but there may still be missed opportunities for delivering WASH interventions particularly to school-aged children, including the use of teachers in the delivery of hygiene promotion interventions and the distribution of soap/hygiene kits in schools or other educational settings in or outside of camps.Poor coordination between relief agencies is a key barrier to delivering WASH interventions in conflict settings.Better documentation and more research are needed on the delivery and effectiveness of WASH interventions for conflict-affected children, adolescents and pregnant and lactating women.Water, sanitation and hygiene (WASH) are fundamental determinants of an individual’s overall health,3War and conflict are responsible for the forcible displacement of more than 17 million children as of 2017,An estimated 16% of the world’s children were living in conflict-affected areas in 2016.This review is one of a series of reviews examining health and nutrition intervention delivery to conflict-affected women and children in low- and middle-income countries (LMICs). The aim of the present review was to synthesise information from the indexed and grey literature on the delivery of WASH interventions to women and children in conflict settings. The primary objective was to synthesise information on how WASH interventions have been delivered to conflict-affected women and children, with a focus on personnel, platforms and sites, with a secondary objective of synthesising the available evidence on achieved intervention coverage and effectiveness for those women and children. A third objective was to synthesise reported information on factors affecting intervention delivery, either positively or negatively.The protocol for this review is registered with PROSPERO, and its reporting adheres to PRISMA statement .10.1136/bmjgh-2019-002064.supp1Supplementary dataet alA systematic search of literature published from 1 January 1990 to 31 March 2018 was conducted in MEDLINE, Embase, CINAHL and PsycINFO using OVID and EBSCO interfaces and sets of search terms related to three concepts: (1) conflict, (2) women and children and (3) water, sanitation and hygiene. Conflict-related terms included war, crisis, refugees and IDP. Population-related words included women, children, pregnant, adolescents and newborn. WASH-related terms included drinking water, hygiene, hand washing, human excreta disposal and latrines. The complete MEDLINE search syntax is presented in For grey literature, we searched the websites of 14 major humanitarian agencies and organisations which are actively involved in researching or responding to conflict situations for reports on the delivery of health interventions to our populations of interest: Action Contre la Faim, Care International, Emergency Nutrition Network, Oxfam International, International Committee of the Red Cross, International Rescue Committee, Médecins Sans Frontières, Save the Children, Solidarités International, United Nations Population Fund (UNFPA), United Nations High Commissioner for Refugees (UNHCR), UNICEF, Women’s Refugee Commission and World Vision. We used broad terms for conflict and health interventions tailored to the search functionality of each website. Because of the large volume of grey literature available, we further restricted eligible grey literature publications to those published since 1 January 2013, in order to be able to screen and assess them feasibly. Exact publication dates are rarely reported for the grey literature and so we were unable to truncate our grey literature search to align exactly with the indexed literature search period; we therefore screened all grey literature published up to 30 November 2018, the date of our grey literature search.Eligible publications were limited to those reporting on populations affected by conflict in LMICs, as classified by the World Bank in 2017,Non-English publications, publications reporting on male populations exclusively, case reports of a single patient, studies on military personnel, refugee populations bound for a high-income country, or surgical techniques and pure economic or mathematical modelling studies were excluded from our review. Other exclusion criteria included systematic reviews, guidelines and studies where no specific health intervention was described .All retrieved indexed records were downloaded into EndNote X7 softwareWe tabulated and plotted counts and proportions to summarise key characteristics of the literature including publication type, target settings, target populations including population displacement status, delivered interventions and delivery characteristics. We tabulated available quantitative data on intervention coverage and effectiveness relating to women, children or adolescents specifically; given the extremely limited quantitative data reported for these groups, we could not undertake meta-analysis. Information on barriers and facilitators was synthesised narratively, by grouping reported factors that had positively or negatively affected intervention delivery into common themes.Our indexed database search returned 7455 records, and 30 of these publications were assessed as meeting our review eligibility criteria. The flow of literature screening and selection is presented in Most of the included publications focused on WASH interventions delivered in Sub-Saharan Africa , including six focused on interventions targeting women or children specifically  publications included in this review.% publicaHere we synthesise retrieved information about the WASH interventions reported to have been delivered to conflict-affected women and children, and the sites and personnel that were used to deliver those interventions.Nine publicationsEleven publications reported on the delivery of source-based water treatment.Twenty-two publications reported on the provision of safe water for cooking/drinking and general use,19The provision of latrines was reported in 26  publications within our review,Of the 58 publications included, 16 reported on the delivery of soap/hygiene kit distribution interventions, with six reporting on interventions targeted specifically at women or children.23 27 30 32 38 39 51 66We identified 23 publications that described the delivery of hygiene promotion interventions, including 19 in Sub-Saharan Africa,Ten publications22The coverage and effectiveness outcomes of interest for this review were those reported for children, adolescents or women. Data stratified by age and gender were rare within the literature however, and we identified only a single publication from which relevant data could be extracted. A randomised controlled trial (RCT) conducted in Malawi in 1993 found that household water treatment in the form of improved 20 L containers with constricted openings reduced diarrhoea incidence by 31.1% in children under 5, with 84.3 diarrhoea episodes reported per 1000 child-months in households with the improved container compared with 122.4 episodes in households without.Key WASH delivery barriers and facilitators, as reported by publication authors, were available in three publications reporting on interventions targeted at women and children. Reported barriers related to inequity of access and poor communication. One publication reported on the construction of separate male and female sanitation facilities in schools in Somalia, to provide extra security for young girls, but the authors noted that a challenge to reaching the target population with this intervention is that boys are often favoured to attend school over their female siblings in this context.29Of the 58 publications included in this review on WASH intervention delivery to conflict-affected women and children, the majority were non-research reports of intervention delivery in Sub-Saharan Africa. Only 11 (19%) publications reported on interventions targeted specifically at children,33The findings of our review reveal a number of important gaps in the current evidence on WASH intervention delivery in conflict settings. First, there is very limited information available on the delivery of household water treatment, source-based water treatment or environmental hygiene interventions. The relatively infrequent reporting of these interventions may reflect the prioritisation of other WASH interventions by humanitarian organisations that are less logistically challenging to implement. Environmental hygiene interventions may be particularly challenging, as they require major infrastructure changes, and sufficient funding, whic are both often difficult to secure in conflict settings. New approaches to facilitate the delivery of source-based and household water treatment as well as environmental hygiene interventions are important areas of further investigation, especially given the burden of related diseases in such settings. Overcrowding and water scarcity in conflict settings present optimal conditions for the spread of waterborne diseases, but only about half of the included publications focused on interventions targeting such diseases. Of these, cholera was the most frequently reported 21/58, 36%), followed by diarrhoea , with only one publication reporting on interventions to control typhoid,, 36%, fo76Secondly, no information or data on WASH intervention delivery were captured in our review from countries in the Latin America and Caribbean region, and among those included publications from South Asia, East Asia and the Pacific, and the Middle East and North Africa region, only a few countries were represented within each region. These patterns indicate that the available literature is not representative in terms of the conflict-affected populations that it covers, suggesting that the WASH needs of women and children have not or are not being sufficiently considered in the humanitarian response in many conflict settings, or that documentation of such consideration is sorely lacking.Third, we were able to capture only limited information about where and by whom WASH interventions were being delivered to conflict-affected populations, constraining the value of the current literature for informing future strategies for WASH intervention programming. Based on the available information about delivery personnel, a missed opportunity appears to be the limited use of teachers in the delivery of hygiene promotion and soap/hygiene kit distribution for school-aged children. Instilling proper hygiene practices among children and adolescents and providing them with the tools to carry them out  can promote improved health and reduce the burden of waterborne and other infectious diseases. Only one study in our included literature reported the use of teachers to deliver WASH interventions, describing their participation in a mass hand washing campaign initiated to prevent cholera in refugee camps in Tanzania.18 23 43 48 66 68 71Finally, the very limited quantitative data available on WASH intervention coverage and effectiveness with respect to women and children is a very important gap in the literature, as cultural norms can impact how WASH services are accessed by women versus men, and the hygiene needs of adolescent girls and boys also differ. These differences must be taken into consideration when delivering interventions in conflict settings to ensure equity. In addition to addressing the need for more rigorous evaluation of WASH interventions generally, an important step moving forward would be to establish reliable estimates on intervention coverage and effectiveness disaggregated by age and gender to ensure the particular needs of children, adolescents and women in conflict settings are being met appropriately.Given our inclusive eligibility criteria that aimed to capture as much information as possible about intervention delivery, our review included a wider body of literature on WASH interventions in conflict settings than three previously published reviews.Conflict-affected populations, and particularly women and children, need safe water, adequate sanitation facilities and sufficient supplies to facilitate good hygiene practices, but information on how best to deliver such intervention in such settings is still very limited. Key delivery challenges for interventions targeted at women and children include inequity of access in some areas due to gender norms favouring male access to schooling and thus to school-based interventions, and ineffective communication between implementers and beneficiaries. These challenges and their potential solutions undoubtedly vary by geography and population, but the availability of data and information on WASH intervention delivery and effectiveness from several regions is limited, as are data and information on delivery and effectiveness among women and children specifically. Better documentation of current practice in the field and further research into the relative effectiveness of different delivery strategies are both needed to help overcome existing challenges and improve future WASH programming for women and children in conflict settings.


Black adolescent and young adult women (AYAW) in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies.The aim of this study is to assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States.Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted Web-based survey of Title X clinic administrators and providers in the Southern United States, followed by key informant interviews among a purposively selected subset of responders to more comprehensively assess inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South.Phase 1 of Planning4PrEP research activities began in October 2017 and are ongoing. To date, survey and key informant interview administration is near completion, with quantitative and qualitative data analysis scheduled to begin soon after data collection completion.This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States. Data gained from this study will inform a type 1 hybrid effectiveness implementation study, which will evaluate the multilevel factors associated with successful PrEP implementation while evaluating the degree of PrEP uptake, continuation, and adherence among women seen in Title X clinics.DERR1-10.2196/12774 Women of childbearing age comprise a majority of adults living with HIV globally. They account for 20% of the 40,000+ new infections in the United States every year, with disproportionate impact on adolescent and young adult women (AYAW) in the South . Black wThe few available studies among US women report low knowledge and awareness of PrEP . For exa. However, not all FP providers provide services to large enough numbers of AYAW at high risk of HIV to justify the potential costs associated with preparing for on-site PrEP provision and monitoring. Therefore, efforts to integrate PrEP in FP services should focus on clinics with the highest anticipated impact.Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health is of great appeal, as it may offer an ideal opportunity to reach women at risk for HIV and enhance their PrEP uptake and adherence. Family planning (FP) clinics in high HIV incidence settings may be ideal PrEP delivery settings as they are accessed by sexually active women of childbearing age and already provide sexual health services, including HIV testing and prevention counseling. Rather than standard primary care or sexually transmitted infection clinics, most (60%) AYAW utilize FP clinics for sexual health and preventative services , and theSpecifically, Title X-funded FP clinics may be an ideal setting for integrating PrEP into FP services given that they (1) are important safety net sources of care for AYAW, (2) serve clients at risk for HIV infection, and (3) are expected to offer HIV prevention services as part of Quality Family Planning recommendations. The Title X National Family Planning Program provides grants to health department or county hospital–based programs, non-profit stand-alone clinics, and community health clinics such as federally qualifying health centers. Title X supports an extensive network of approximately 4000 nationwide service sites that serve over 4 million clients, 90% of whom were women, and over two-thirds of whom are younger than 30 years . The proDespite its appeal as an effective, individual-controlled HIV prevention strategy, PrEP has not been widely integrated into FP services in the United States, or specifically, in Title X clinics in the Southern United States. A 2015 national survey of FP providers in the United States, many of whom were Title X clinic providers, found low PrEP knowledge and use; FP providers in the South had lower PrEP knowledge than those in the Northeast or West . Only onKnowledge gaps exist that prevent optimal implementation of PrEP in real world settings for AYAW in the United States. Limited PrEP implementation science research has been published to date, and most PrEP demonstration projects and implementation studies in the United States have not included cis-gender women . LimitedFinally, few models exist describing the organizational processes and strategies associated with successful integration of PrEP delivery in new clinic settings, and none exist specifically for FP clinics ,25, inclThe Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is a research program that aims to defeat the rising HIV epidemic among adolescents and young adults in the United States. The overarching goal of the ATN is to increase awareness of HIV status in youth and, for those diagnosed with HIV, increase access to health care. The ATN develops and conducts behavioral, community-based, translational, therapeutic, microbicide, and vaccine trials in youth who are at risk for or living with HIV, with a focus on the inclusion of minors. Our study (ATN 155) is funded as part of the ATN. The combined findings and resulting tools and trainings will be valuable for PrEP integration in Title X-funded or similarly structured FP clinics and could inform future interventions to optimize PrEP delivery for AYAW. In this paper, we describe the research protocol for the Phase 1 study only.Phase 1 of this study utilizes an explanatory sequential, mixed methods design consisting of geographically-targeted surveys and key informant interviews among clinic administrators and providers in Title X FP clinics in the South. The Consolidated Framework for Implementation Research (CFIR) is used to provide a comprehensive set of constructs associated with effective implementation to facilitate evaluation of inner and outer contextual factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern United States.Phase I of this study has been reviewed and approved by the Emory University Institutional Review Board (IRB# 00098606) and University of North Carolina at Chapel Hill Institutional Review Board (IRB#17-2595). Written consent for the Web-based survey will be obtained for all willing participants before survey start. Written consent is asked within the survey. Survey responses are deidentified to protect participants’ privacy. Participants indicate interest in a follow-up qualitative interview during the consent process. Verbal consent is obtained over the telephone before the start of the qualitative interview.Survey administration targets a convenience sample of approximately n=600 clinic providers and administrators  at Title X FP clinics in the Department of Health and Human Services (DHHS) regions III , IV , and VI . This sample size was selected based on a previous study of PrEP knowledge and attitudes among FP clinicians . From thOnline recruitment of participants is supported by the National Clinical Training Center for Family Planning (NCTCFP). Their assistance includes emailing the survey to a Title X clinic listserv, filtering for recipients from DHHS regions III, IV, and VI. Listserv members will receive 1 to 2 email reminders per month. A total of 7 large-scale emails to the Title X clinic listserv will be sent.Additional recruitment efforts include an electronic link or banner advertisement for the survey posted on the NCTCFP website, engagement with State Title X Grant holders who oversee Title X funding and implementation in clinics within their state, and in-person recruitment at the biannual NCTCFP national meetings for Title X staff and providers.Participants interested in taking part in key informant interviews indicate their interest during Web-based survey completion. To evenly represent participant types for these interviews, selection of interviewees is based on the following demographics: DHHS region, clinic type, role in the clinic, and current PrEP delivery in the clinic.Survey participants are offered compensation for their time with a US $30 Amazon gift card, and those who complete the key informant interviews receive an additional US $50 gift card. Participants provide contact information at survey completion to receive the gift cards.Data are collected via a Web-based Qualtrics survey. Participants are aware of the survey’s approximate 20-min duration. Key informant interviews are conducted either in person or via telephone based on participant preference. Interviewees are informed the interview will take approximately 45 min to complete. Surveys  and inteintervention characteristics, outer/inner setting, characteristics of individuals, and process).The CFIR  was seleImplementation-related constructs are developed from the CFIR  guided dInner Setting: Readiness for Implementation construct. The analysis end point is a semi-continuous composite score derived from 19 and 23 Likert-scale survey items for clinic providers and administrators, respectively.The primary outcome from quantitative data analysis for the Phase 1 study is the CFIR Inner Setting: Implementation Climate, (2) Characteristics of Individuals: Knowledge and Beliefs, (3) Characteristics of Individuals: Self-Efficacy, (4) Inner Setting: Leadership Engagement, and (5) Inner Setting: Available Resources, to explore drivers of implementation readiness. Each of these secondary construct outcomes are semi-continuous composite scores derived from collections of related Qualtrics survey items.Analyses of the primary outcome will evaluate associations with the following key secondary construct outcomes: (1) Analyses of primary and secondary construct outcomes will be performed using generalized linear mixed models that account for their being multiple respondents from the same clinic and will adjust for potential confounders including race/ethnicity of the respondent, age, ability to prescribe medication , years worked at the clinic, primary role at the clinic, HIV prevalence in the clinic’s catchment area, and census track data linked to the respondents clinic as relevant for the respective analysis.Full details on the statistical analysis plan (SAP) for quantitative data are provided in the SAP provided in For coding purposes, “Clinic Type” is considered a case in our qualitative analysis of key informant interviews. We selected this as our “case” as the findings from our study may be especially informative for the provision of Title X support for PrEP scale-up in the clinics that may systematically vary based upon their clinic type . Coding of the interview will follow a content analysis and deductive approach , using tPhase 1 of Planning4PrEP research activities began in October 2017 and are ongoing. To date, survey and key informant interview administration is near completion, with quantitative and qualitative data analysis scheduled to begin soon after data collection completion.Although FP clinics may be an ideal setting for PrEP delivery, there is a lack of available data from health care providers and administrators to guide optimal integration of PrEP into various clinical settings, and in particular, for women’s health care settings ,25. Thes


Duchenne muscular dystrophy (DMD/Duchenne) is one of the ten most severe and common pediatric genetic diseases and affects an estimated 1 in every 5000 male births. While Duchenne is a 100% fatal disease, the clinical community has demonstrated that immediate identification and early clinical interventions can add years, even decades to an individual’s life span. In anticipation of the changing therapeutic landscape for the Duchenne community, Parent Project Muscular Dystrophy established a newborn screening (NBS) initiative. This initiative included a Bioethics and Legal Issues Workgroup to consider the bioethics and legal issues of NBS for Duchenne. The workgroup’s discussion focused only on Duchenne NBS and met through conference calls over a one-year period of time seeking consensus on various identified issues. This article reports on the findings and recommendations from that workgroup. In the United States newborn screening (NBS) pilots are designed to generate analytical and clinical validation data of the selected screening methodology, establish short-term follow-up algorithms to diagnose screen positive cases, and engage the community of clinicians who will care for diagnosed newborns. Due to advancements in screening technologies, disease understanding and treatments, conditions that are candidates for inclusion in a nationwide panel of disorders recommended for screening, number in the hundreds. Some of these candidate conditions present new challenges for the existing NBS system for a number of reasons including (1) molecularly targeted therapies available for a subset of the genetic variation known to cause the disease; (2) X-linked disorders in which a minority of females present with symptoms and carrier females are identified; and (3) ongoing and planned clinical trials of novel therapies that would benefit from enrollment of newborns participating in NBS pilot. We present a case study using Duchenne muscular dystrophy (DMD/Duchenne) to address these challenges and suggest solutions. Duchenne muscular dystrophy (DMD) ,2,3 is tBecause of therapeutic advances, NBS for Duchenne has become a priority of the Duchenne community as researchers made significant progress towards new treatments and screening technologies ,2,3,4. TThe goal of this national Duchenne NBS effort was to identify the public health infrastructure and support required to enable a NBS pilot and ultimate implementation of Duchenne NBS in the United States. PPMD first established a Duchenne NBS steering committee, comprised of representatives from federal agencies, the Duchenne patient community, the Muscular Dystrophy Association (MDA), PPMD, and experts in genetics, pediatrics and neuromuscular disorders. The initial action of the steering committee was to establish six workgroups focused on various actions essential to a successful Duchenne NBS program and included: (1) Outreach to and Education of Patient Community and Healthcare Providers; (2) Follow-up and Clinical Care Considerations for Pre-symptomatically Identified Infants with Duchenne; (3) Laboratory Test Validation and Refinement and Development of Screening Algorithm; (4) Building a Longitudinal Data Resource for Follow-up; (5) Evidence Review; and (6) Bioethics and Legal Issues. These workgroups have sought a wide range of expertise, with contributions from specialists in neuromuscular disorders, NBS, genetics and pediatrics, and included representatives from federal agencies, the American College of Genetics and Genomics’ (ACMG) Newborn Screening Translation Research Network (NBSTRN), Genetic Alliance’s Babies’ First Test, the Save Babies Foundation, and Legacy of Angels. The Duchenne NBS Bioethics and Legal Issues Workgroup, was tasked with examining the various ethical and legal issues raised by Duchenne NBS. The goal of the workgroup was to identify how studies for Duchenne NBS and future implementation of screening by state NBS programs could be configured to maximize benefits and minimize any harm that might be associated with a Duchenne NBS program. This paper sets out the findings and recommendations from the Duchenne NBS Bioethics and Legal Issues Workgroup, whose members are Angus Clarke, M.D. Cardiff University; Thomas Crawford, M.D. Co-Director, MDA Clinic, Johns Hopkins Medicine, Aaron Goldenberg, Ph.D., Case Western Medical School and NBSTRN; Edward Goldman, University of WI and NBSTRN; R. Rodney Howell, M.D. University of Miami Medical School and MDA; Michele A. Lloyd-Puryear, M.D., Ph.D., PPMD; Kristin Stephenson, J.D., MDA; and Tracy Trotter, M.D., FAAP.Universal screening  for an X-linked disorder. In an X-linked disorder, the potential burdens and benefits are very different for males and females: DMD has variable expression in females, and carrier females have available preconception options, andThe requirements imposed by present and proposed genotype-specific therapies in a condition where only a minority of identified patients would qualify for treatment.While ethical and legal issues associated with NBS and genetic diseases have been extensively discussed within the bioethics and NBS literature ,6, thereNotwithstanding these Duchenne-specific issues, however, it is clear that many bioethical and legal issues applicable to DMD NBS are relevant to other NBS pilots more broadly, and thus could be useful when conducting a NBS pilot for other conditions. The workgroup therefore engaged the National Institutes of Health-funded NBSTRN’s Bioethics Workgroup in the process of discussing and analyzing the identified issues. The information presented in this paper is intended to support the development of informed policy decisions and may be of use to federal agencies, professional organizations, industry, academic institutions, health-care providers, and the general public.Question of Targeted or Universal Population Screening). The workgroup asserted that it would be important for a pilot of DMD NBS to address this issue and generate new information for consideration before moving to whole population DMD NBS screening. The Duchenne NBS Bioethics and Legal Issues Workgroup first focused upon the key question of whether or not to conduct Duchenne NBS. Because there had been significant progress towards new treatments and screening technologies ,2,3 for The workgroup then framed three goals for the NBS system for Duchenne screening: (1) To enhance access to treatment trials or established therapies at an early presymptomatic time to gain maximum therapeutic benefit by leveraging use of early identification through NBS; (2) To improve the mean level of quality of care; and (3) To reduce variation in the distribution of care. In short, the DMD NBS should rest on a patient-focused and knowledge driven healthcare NBS system for individuals with Duchenne. Workgroup discussions also focused on the inclusion of family perspectives. The Duchenne NBS Bioethics and Legal Issues Workgroup, in line with recommendations from other review bodies, deemed it appropriate to consider the family perspectives that were included in the 2006 ACMG NBS Expert Group criteria . The eviHow advocacy groups can best be engaged meaningfully, ensuring that patient perspectives are integrated into the evaluation and evidence review processes.How to design the parental permission process when the range of phenotypic variation associated with positive screens is high or when benefits and harms are not completely known.Consideration of issues surrounding universal versus gender-targeted screening for X-linked conditions.Assessment of benefit should include impact of minimizing the diagnostic odyssey for patient and family alike, and other salutary effects to the family including that of enabling non-medical interventions.Consideration of special difficulties that arise with identifying carrier status—Should Duchenne NBS include reporting of carrier status and if so then when, where and how to report? The Duchenne Workgroup recommended developing specific protocols to address these issues See .Consideration of incidental findings—Should Duchenne NBS include reporting of findings incidental to the screen or to the genetic analysis of the second tier testing and if so, when, where and how to report these findings? Incidental findings secondary to an elevated CK may include, for example, a dystrophy other than Duchenne. This secondary condition/incidental finding would be ruled out as Duchenne with subsequent genetic analysis and appropriate referral See .Role of industry in conducting pilots for newborn screening, whether for evaluating clinical devices for screening and diagnoses or for therapy and clinical trials—How does industry involvement in pilots affect pricing? How does industry involvement in pilots affect access to treatments post clinical trial? What are the ethical and legal issues if enrollment in a treatment trial is dependent on NBS?Based on its discussions and review of the ACHDNC and ACMG approaches for evidence review and inclusion of ethical and legal issues and family perspectives, the Duchenne NBS Bioethics and Legal Issues Workgroup recommends the following ethical, legal and programmatic issues be considered in DMD NBS pilot studies and the subsequent evidence review:The Duchenne NBS Bioethics and Legal Issues Workgroup recognizes that there are ethical and legal questions regarding the appropriate role for advocacy organizations in the development of NBS policies, pilot studies and the nomination process for adding new conditions to the RUSP. As patient and parent preferences always have been a part of the development of NBS programs and policy development ,12,13,14In addition, within advocacy groups of the rare disease community, participation in and even driving research specific to their disease has been a high priority. Some advocacy groups that have provided major funding for clinical initiatives and research have supported methodologically sound and rigorous studies for conditions for purposes of consideration of addition to the RUSP. Patient advocacy groups have formed disease registries, have generated scientific publications, and importantly have funded research that has led to the development of treatments and understanding of disease. These efforts have been the result of collaboration among advocates, patients, researchers and clinicians. While biases can be injected in any process, collaborations with lay advocates offer unique vantage points that can enrich the process of collaboration for research and program and policy development. Lay-advocates and researchers should continue to collaborate in research and policy development including the design of research studies.Efforts should be made to design patient-centered studies when structuring pilots or clinical trials. Pilots or clinical trial designs should not focus solely on the technical aspects of screening but the designs should include a broader range of issues to assure a patient-centered approach. Lay advocates, as with academic researchers, should disclose funding from drug companies or other entities that might contribute to the perception of bias.Lay-advocate leaders should guide their actions with transparency, clearly distinguishing between instances when they are speaking for themselves, for other lay-advocates or for their organization.Therefore, the Duchenne NBS Bioethics and Legal Issues Workgroup recommends:Duchenne results from hemizygous mutations on the X chromosome of males, and when inherited is acquired from a heterozygous mother. While both male and female newborns can inherit the dystrophin mutation, the impact is very different in the two sexes. Males having only one X chromosome lack a normal second dystrophin gene to produce the necessary protein, while females generally manifest little or no symptoms. There is a range of carrier manifestation in females, however, ranging from mild increase in measured levels of the muscle-specific plasma (creatine kinase) CK to rare females who manifest the full Duchenne phenotype. An increase in maturity-onset cardiomyopathy is sufficiently common and severe that periodic cardiac assessments of known adult carrier females are recommended .DMD gene of those infants with elevated CK values in the newborn screen will be necessary for access to appropriate molecular therapies when possible. The high incidence of Duchenne is in part related to the very large dystrophin gene, vulnerable to mutation as a consequence of its size, as well as the capacity of an X-linked condition to propagate in families despite reduced reproductive fitness of affected males. Disease-causing mutations in the dystrophin gene involve the full range of errors, including large and small deletion and insertions as well as sequence changes. Present screening protocols assess the levels of CK or CK specific to skeletal muscle (CK MM) in blood with follow-up including a targeted assessment of the dystrophin gene via DNA-based molecular methods. The nature of an identified dystrophin mutation often affords some clinical insight into prognosis—Duchenne results from complete absence of the dystrophin gene, where the milder “Becker” muscular dystrophy (BMD) results from various partial impairments of dystrophin abundance or function. One approach to therapy involves manipulation of specific Dystrophin mutations that enable restoration of partial gene function, thus hopefully converting a boy destined to manifest the severe DMD phenotype to that of the milder BMD disorder. Because the use of these therapies is-based upon the exact disease-causing mutation that is present, molecular genetic testing of the Identification of the Duchenne causing mutation in a newborn prompts genetic testing of the mother and, potentially, cascade testing of the other family members. In approximately 2/3 of identified individuals found to have Duchenne, the dystrophin mutation is present in the mother. However, a mother may screen negative as 1/3 of the Duchenne cases are because of de novo mutations. One mechanism of de novo mutations identified is germ-line mosaicism. This mechanism has important implications for the counseling of DMD families.The Duchenne NBS Bioethics and Legal Issues Workgroup therefore focused its recommendations for a pilot on the following two areas of concern: (1) targeted versus universal screening, and (2) designing follow-up infrastructure that facilitates proper diagnosis and treatment, including genetic testing and adequate counseling education for parents and health care providers.In the United States, NBS screening programs are administered by the states and all states conduct their programs in a gender neutral or universal fashion, i.e., all babies are screened for the State’s recommended NBS panel ,18. DesiThe Duchenne NBS pilot should be designed to conduct universal screening of newborns while concurrently exploring the many ethical and legal issues raised by screening for an X-linked disease. The issues include those raised in the above section as well as the following section addressing follow-up practices. An arm of the pilot might consider evaluation of parental attitudes on gender-targeted versus universal screening.Upon weighing these contrasting points of view, the Duchenne Bioethics and Legal Issues Workgroup recommends:Some of the most difficult issues in NBS for Duchenne will be the follow-up care, for not only the boys screening positive, but also for girls, mothers and the families. The Workgroup proposes the infrastructure and flow of information illustrated in Since all of the current disease modifying treatments for Duchenne depend on knowing the specific genetic defect, it is essential, and ethically required, that all screen positive infants have access to genetic testing (to define their specific mutations) and access to appropriate health care disease expertise, in order that an appropriate treatment can be provided. In addition, since the condition is X-linked, important family testing issues exist in regard to carrier status: testing mothers; testing female siblings of affected infants; and testing extended family.In establishing a Duchenne NBS pilot, the ethical and legal issues surrounding genetic testing of various family members should be evaluated. Recommendations by professional bodies are generally consistent: the majority of guidelines recommend against carrier testing of minors unless there is medical benefit to the child ,24,25,26Finally, identifying threshold CK (or CK MM) value to identify affected males efficiently is very different than that used to identify carrier females. A normal CK, or below threshold value, does not provide assurance of non-carrier status in a NBS program. The potential exists for misunderstanding of the power of a negative screen.Evaluate whether all infants identified with Duchenne or as carriers have received adequate follow-up including diagnosis after a positive screen, referral to appropriate clinical care centers, delivery of best practice treatment and management across the lifespan.▯Have diagnostic capacity in place that includes genetic sequencing, or referral for genetic sequencing, for screen positive infants.▯Consider cascade genetic testing of both families and extended families. The project should have funds necessary to carry out appropriate genetic testing for diagnosis and in the family.▯Include appropriate triage for infants with incidental findings such as sex chromosome disorders or other neuromuscular diseases.▯Protocol for reporting of findings incidental to an elevated CK. The project should determine the appropriate CK (immunoassay) cut off to minimize false negatives and detection of carriers. A CK level needs to be determined that will identify all infants with Duchenne, and at the same time determine how frequently, if at all, female carriers are identified.▯Determine an appropriate educational process that addresses public health and health care provider and parental genetic literacy about genotype/phenotype relationship/X-linked disorders/sex chromosome disorders.Ensure that the partnering state NBS program have a short-term follow-up plan in place to ensure screen positive newborns receive proper referral to appropriate center for diagnosis and referral for treatments. This short-term follow-up program should:Therefore, the Duchenne Bioethics and Legal Issues Workgroup recommends the pilot must:NBS around the world is rapidly expanding to include new conditions as technical, clinical and treatment knowledge advances. Historically pilots establish the evidence base and understanding needed for ultimate population-based screening, but they now need to evolve to also address ethical and legal issues across the lifespan. Using DMD as a case study, we presented a systematic approach to the evaluation and consideration of ethical and legal issues in the context of conducting a NBS pilot. We worked to address relevant these issues for Duchenne NBS, but this is not intended to be inclusive of all potential issues that may arise within a Duchenne NBS pilot. As we move forward toward implementation of Duchenne NBS, however we will need to address these issues, and design the public health and health care service infrastructure needed to ensure that we do not lessen the benefit of the early identification of newborns with Duchenne.


Adults with end-stage renal disease (ESRD) requiring chronic dialysis continue to suffer from poor health outcomes and represent a population rightfully targeted for quality improvement. Electronic dashboards are increasingly used in healthcare to facilitate quality measurement and improvement. However, detailed descriptions of the creation of healthcare dashboards are uncommonly available and formal inquiry into perceptions, satisfaction, and utility by clinical users has been rarely conducted, particularly in the context of dialysis care. Therefore, we characterized the development, implementation and user experience with Veterans Health Administration (VHA) dialysis dashboard.A clinical-quality dialysis dashboard was implemented, which displays clinical performance measures (CPMs) for Veterans with ESRD receiving chronic hemodialysis at all VHA facilities. Data on user experience and perceptions were collected via an e-mail questionnaire to dialysis medical directors and nurse managers at these facilities.Since 2016 the dialysis dashboard reports monthly on CPMs for approximately 3000 Veterans receiving chronic hemodialysis across 70 VHA dialysis facilities. Of 141 dialysis medical directors and nurse managers, 61 completed the questionnaire. Sixty-six percent of respondents did not find the dashboard difficult to access, 64% agreed that it is easy to use, 59% agreed that its layout is good, and the majority agreed that presentation of data is clear (54%), accurate (56%), and up-to-date (54%). Forty-eight percent of respondents indicated that it helped them improve patient care while 12% did not. Respondents indicated that they used the dialysis dashboard for clinical reporting (71%), quality assessment/performance improvement (QAPI) (62%), and decision-making (23%).Most users of the VHA dialysis dashboard found it accurate, up-to-date, easy to use, and helpful in improving patient care. It meets diverse user needs, including administrative reporting, clinical benchmarking and decision-making, and quality assurance and performance improvement (QAPI) activities. Moreover, the VHA dialysis dashboard affords national-, regional- and facility-level assessments of quality of care, guides and motivates best clinical practices, targets QAPI efforts, and informs and promotes population health management improvement efforts for Veterans receiving chronic hemodialysis. The delivery of high quality and cost-effective chronic dialysis care for adults with end-stage renal disease (ESRD) remains a daunting challenge as evidenced by stagnant poor health outcomes and high costs across the United States (U.S.) , 2. The Quality measurement for chronic dialysis care is well established in the U.S. Beginning in the 1990’s, the Centers for Medicare and Medicaid Services (CMS) required ESRD Networks to monitor and improve the quality of dialysis care. Over the past decade, CMS has iteratively developed and refined a variety of clinical performance measures (CPMs) for ESRD for public reporting  and value-based purchasing  using clinical practice guidelines as an initial framework, but extending beyond consensus guidelines. Although there is little formal evidence that use of quality measures improve healthcare quality , they haTo further improve quality of healthcare, the U.S. government has prioritized and devoted substantial resources to promoting adoption of electronic health records and more broadly spurring on health information technology in medicine as illustrated by the Health Information Technology for Economic and Clinical Health Act in 2009 . One sucSurprisingly, formal inquiry into the impact of dashboards on end-users in the healthcare environment has been rarely conducted . While dThe Veterans Health Administration (VHA) has been a leader in healthcare quality and leveraging quality measurement and health information technology –22. In 2We employed a four-phase process to create a national VHA dialysis dashboard for capturing and reporting CPMs for approximately 3000 Veterans with ESRD receiving chronic hemodialysis at 70 VHA dialysis facilities across the U.S. Fig. . CreatioThe analysis phase involved establishing goals, forming a dashboard team, and selecting CPMs. There was broad consensus amongst VHA specialty care clinicians that the overarching goal was to report quality of VHA dialysis care through CPMs on an electronic dashboard that would be accessible to diverse stakeholders for patient care. A VHA dialysis dashboard team was assembled to serve as a steering committee. The team attended a dialysis summit meeting in November 2012 with representatives from various program offices that included the VHA National Program for Kidney Disease and Dialysis, VA Center for Applied System Engineering (VA CASE), VA Inpatient Evaluation Center (IPEC), VA Allocation Resource Center (ARC), VA Support Services Center (VSSC), VA Decision Support System (DSS), VA Patient Care Services (PCS), VA Health Services Research and Development (HSR&D), and VA Office of Information and Analytics (OIA). Early in this process, a CPM subcommittee with representation from leadership, operations, clinical services, and research was assembled to review, discuss, and select CPMs for this evaluation. The diversity of this stakeholder committee was deemed essential to achieve broad consensus for CPMs and ensure acceptance in the field.Selecting ESRD CPMs for inclusion in the VHA dialysis dashboard consisted of an 8-month-long transparent, stakeholder-driven process. The first several meetings focused on establishing the principles to guide CPM selection. In consideration of known principles guiding selection criteria for performance measures, the CPM subcommittee sought to include measures that were timely, clinically relevant to chronic hemodialysis care, informed by solid evidence, and feasible and usable in VHA to enable robust improvement in the quality of VHA ESRD . The subde-novo because these measures had already gained acceptance, would afford benchmarking, and lastly because of internal resource constraints. An environmental scan revealed five key sources for the potential ESRD CPMs: CMS, American Medical Association-Physician Consortium for Performance Improvement (AMA-PCPI), Kidney Care Quality Alliance (KCQA) and organizations that review, endorse, and adopt measures  and Ambulatory Care Quality Alliance (AQA). A total of 78 measures from these organizations were identified and they spanned broad ESRD clinical domains such as mortality, hospitalization, dialysis adequacy, vascular access, anemia, bone and mineral metabolism, infection, immunization, transplant, and end-of-life planning  but creating a web-based application for field reporting as well. Significant human resources and close collaboration across VA program offices and service lines were required to design a dashboard and were carried out through coordinated teleconferences over a 12-month period. The CPM subcommittee detailed specifications of the required data elements for each CPM, including acceptable ranges for laboratory values and proper calculation of derived values. For each selected CPM, the CPM subcommittee specified criteria for patient eligibility and inclusion/exclusion from numerator and denominator. A patient was eligible for inclusion in the CPM denominator if the patient had been receiving in-center outpatient hemodialysis treatments at the facility for at least 30 days as of the last day of the study period . Secondary filters  were applied when applicable, in accordance with the technical specifications of the source where the measure was adopted from . The subcommittee found that numerator and denominator specifications for established CPMs were often incomplete or insufficient for implementation in healthcare systems. Therefore, additional details were sought from available technical specification documents of measure developers, and/or reasonable standards were employed based on similar measures employed elsewhere. Specifications and eligibility naturally impacted CPM reporting and results. For example, for a few CPMs , an additional requirement of ≥90 days since initiating maintenance HD was required for denominator inclusion. Also, some CPMs  required a patient to have ≥7 outpatient HD treatments at the dialysis facility during the calendar month for inclusion (in concurrence with CMS QIP criteria at that time), while others  required ≥4 outpatient hemodialysis treatments during the calendar month for patient inclusion. The time period for numerator specifications also varied across CPMs. The majority required monthly assessment of whether patients met numerator criteria but a few such as the proportion of patients with hypercalcemia CPM required a 3-month rolling average assessment.The technical subcommittee investigated the specific data elements needed for the CPMs and designed the general dashboard format, based on technology available in the VSSC. Analogous to the experience of others with national dashboards , signifi□ numerical values achieve the goal of reporting CPM values better than charts □ including a goal of ‘H’  or “L’  or a value where available, close to the actual values related to each measure allows for comparisons □ presentation of historical values allows for local trend analysis □ use of color □ horizontal and vertical color shading separate CPM and historical groupings to reduce conjunction search time  □ muted colors selected for their non-distracting appeal □ not to use color to indicate CPM value proximity to goal because they would overwhelm end-users □ linking to a file containing data definitions and to an email to the help desk if needed (help and documentation Heuristic and a VSSC standard)□ allowing export to other applications if needed (flexibility and efficiency of use Heuristic and a VSSC standard)The resultant web-based dashboard design was iteratively reviewed by human factors experts who applied usability heuristics and recommended format changes . The teaThe implementation phase of VHA dialysis dashboard included pilot testing, a coordinated series of national rollout calls, and user acceptance testing. First, several VA dialysis facilities volunteered for pilot testing which involved validating eligible patient identification and extracted laboratory and medication data displayed on the dashboard. This process was critical in improving and refining the use of electronically abstracted data  for CPM calculation and patient identification. Identification of eligible patients from electronic records who met inclusion criteria was difficult because of issues such as patient vacation, interfacility transfers, and hospitalizations. Therefore, iterative modifications were required in selection algorithms with validation by these facilities. The pilot testing also allowed users to provide feedback regarding the web application for data entry. Second, a series of formal training sessions and rollout calls were held via teleconference with dialysis facility managers and the VHA dialysis dashboard team, which were critical for introducing the dashboard and receiving feedback. These sessions allowed for a detailed description of the functionality of the dashboard, including links to data definitions and patient level data, ways to export data for reports, and help desk links. Data security and dashboard access policies were reviewed at these sessions because of the importance to protect patient confidentiality. All stakeholders were reminded of VHA policies regarding patient identifying information (PII) and patient health information (PHI), including the required training for and regular review of all who access these data in conjunction with their job description and role in VHA. Moreover, access to the dashboard was subsequently enforced through network security measures. Finally, in collaboration with a usability lab, the VHA dialysis dashboard offered an extended period of user acceptance testing that was key to promoting an open forum for feedback and further validation from the field.The final dashboard displays VHA’s dialysis facility performance on the CPMs in table form.It affords the user the ability to compare VHA national and facility performance with CMS benchmarks, other VHA facilities, and VHA national average Fig. . It dispDuring the maintenance phase, while the field used the dashboard, the development team developed a questionnaire to evaluate the constructs of Perceived Ease of Use and Usefulness as defined in the Technology Acceptance Model (TAM) . AccordiThe questionnaire consisted of three parts: seven questions about demographics and professional experience, seven closed- and open-ended questions about use and application of the dashboard, and fifteen questions to assess perceptions of the dialysis dashboard on a Likert scale from one to five, representing ‘strongly disagree’ to ‘strongly agree’. A mix of negative and positive questions was used to reduce acquiescence bias . ApproxiOf the 141 VHA dialysis medical directors and nurse managers who were invited, 61 (43%) responded. Among the 61 respondents, 55 were aware of the VHA dialysis dashboard and had accessed it, 3 were aware of it but had not accessed it, and 3 were not aware of its availability. The final analytic cohort consisted of the 52 respondents who were aware of the VHA dialysis dashboard, had accessed it, and completed at least a portion of the questionnaire.More than two-thirds of the respondents were 41 to 60 years of age (71%), female (69%), and nurse managers (73%) Table . Nearly Dialysis staff indicated the predominant uses of the dialysis dashboard included clinical reporting (71%) and quality assessment and improvement (62%) Table . They alSixty-six percent of respondents do not find the dashboard difficult to access and furthermore 64% agree that the dashboard is easy to use Table .Table 4During the 12-month period following full implementation of the VHA dialysis dashboard , reporting of process measures  on the dashboard revealed consistently high performance across all facilities with rather small performance gaps requiring improvement. In contrast, reporting of several intermediate outcome measures  revealed a consistent performance gap across most facilities and a substantial variation in performance across facilities.Since initial implementation, the VHA dialysis dashboard has reported monthly clinical performance for 11 quality measures for approximately 3000 Veterans at 70 VHA maintenance HD facilities across the United States. This electronic dashboard is accessible by VHA operations and clinical dialysis staff, and is being used for administrative reporting as well as quality assurance and performance improvement (QAPI) activities in important clinical areas of dialysis adequacy, vascular access, anemia, bone and mineral metabolism, and infection surveillance. Among VHA dialysis medical facility physician directors and nurse managers using the dialysis dashboard 1 year after its implementation with 100% facility participation, the majority found it accurate, up-to-date, easy to use, and helpful in improving the care of their patients. Nearly two-thirds of these users not only used the dialysis dashboard for clinical reporting and QAPI activities but also in combination with other clinical applications to enhance patient care.As recently noted, healthcare organizations are increasingly implementing quality or clinical dashboards to improve patient care . SimilarAlthough considerable heterogeneity exists in the clinical foci and settings of dashboards previous published studies, none focused on kidney disease . ConsideOnly two prior studies queried user satisfaction and perceptions of their dashboards , 19. In The experience and satisfaction of nurse and physician users of the dialysis dashboard appears similar to that of these prior reports , 19. LikIn contrast to prior studies, we also sought to understand how the dialysis dashboard was being used and incorporated by providers into patient care. Consistent with the objectives for creating the dialysis dashboard, nearly 2 two-thirds of physicians and nurse managers utilized the dashboard for clinical reports and QAPI activities. Moreover, users appear to be integrating the dashboard with other clinical applications such as existing CMS reporting portals and patient education materials for care delivery. However, the impact of the dialysis dashboard alone or in combination with other tools on processes of care and patient outcomes could not be assessed in this study. As noted elsewhere, there is scant evidence that clinical and quality dashboards have a positive effect on health outcomes, and more investigation is needed . MoreoveThere are limitations to our study. Although we sampled all end users of the dialysis dashboard, our response rate was 43% and a higher proportion of nurse managers responded than physician medical directors; therefore, our findings may be subject to non-response bias. Because healthcare providers are generally more homogenous than the public in regard to knowledge, attitudes, and behavior, this concern is lessened . MoreoveThe VHA clinical-quality dialysis dashboard affords national and facility level assessments of the quality of chronic dialysis care, guides and motivates best clinical practices, targets QAPI efforts at the facility and patient level, and promotes a cohesive approach to process improvement efforts at a national level for population management. The detailed multistep interdisciplinary stakeholder and user-driven implementation process for developing and implementing the dialysis dashboard serves as a prototype for dashboards of other chronic illnesses. Furthermore, characterizing the data selection and extraction processes for quality measurement and conveying an understanding of these methods is especially important since they have a large impact on the reliability of quality measure reporting, which is essential for the integrity of enterprise wide assessments and comparisons as well as stakeholder buy-in. While the dialysis dashboard offers tremendous potential to facilitate improvement in health outcomes for Veterans with ESRD requiring chronic dialysis, future work is needed to formally evaluate its impact on health outcomes.Additional file 1: Supplementary Table 1. Initial Clinical Performance Measures Identified by the VHA Dialysis Dashboard Committee.Additional file 2: Supplementary Table 2. Level of Agreement with Statements Regarding the VHA Dialysis Dashboard: Subgroup Findings.Additional file 3. Survey of Dashboard Users – Medical Directors and Nurse Managers.