Software-Enabled Distributed Network Governance: The PopMedNet Experience.
ABSTRACT: INTRODUCTION:The expanded availability of electronic health information has led to increased interest in distributed health data research networks. DISTRIBUTED RESEARCH NETWORK MODEL:The distributed research network model leaves data with and under the control of the data holder. Data holders, network coordinating centers, and researchers have distinct needs and challenges within this model. SOFTWARE ENABLED GOVERNANCE POPMEDNET:The concerns of network stakeholders are addressed in the design and governance models of the PopMedNet software platform. PopMedNet features include distributed querying, customizable workflows, and auditing and search capabilities. Its flexible role-based access control system enables the enforcement of varying governance policies. SELECTED CASE STUDIES:Four case studies describe how PopMedNet is used to enforce network governance models. ISSUES AND CHALLENGES:Trust is an essential component of a distributed research network and must be built before data partners may be willing to participate further. The complexity of the PopMedNet system must be managed as networks grow and new data, analytic methods, and querying approaches are developed. CONCLUSIONS:The PopMedNet software platform supports a variety of network structures, governance models, and research activities through customizable features designed to meet the needs of network stakeholders.
Project description:The Patient Outcomes Research to Advance Learning (PORTAL) Network was established with funding from the Patient-Centered Outcomes Research Institute (PCORI) in 2014. The PORTAL team adapted governance structures and processes from past research network collaborations. We will review and outline the structures and processes of the PORTAL governance approach and describe how proactively focusing on priority areas helped us to facilitate an ambitious research agenda.For years a variety of funders have supported large-scale infrastructure grants to promote the use of clinical datasets to answer important comparative effectiveness research (CER) questions. These awards have provided the impetus for health care systems to join forces in creating clinical data research networks. Often, these scientific networks do not develop governance processes proactively or systematically, and address issues only as problems arise. Even if network leaders and collaborators foresee the need to develop governance approaches, they may underestimate the time and effort required to develop sound processes. The resulting delays can impede research progress.Because the PORTAL sites had built trust and a foundation of collaboration by participating with one another in past research networks, essential elements of effective governance such as guiding principles, decision making processes, project governance, data governance, and stakeholders in governance were familiar to PORTAL investigators. This trust and familiarity enabled the network to rapidly prioritize areas that required sound governance approaches: responding to new research opportunities, creating a culture of trust and collaboration, conducting individual studies, within the broader network, assigning responsibility and credit to scientific investigators, sharing data while protecting privacy/security, and allocating resources. The PORTAL Governance Document, complete with a Toolkit of Appendices is included for reference and for adaptation by other networks.As a result of identifying project-based governance priorities (IRB approval, subcontracting, selection of new research including lead PI and participating sites, and authorship) and data governance priorities (reciprocal data use agreement, analytic plan procedures, and other tools for data governance), PORTAL established most of its governance structure by Month 6 of the 18 month project. This allowed science to progress and collaborators to experience first-hand how the structures and procedures functioned in the remaining 12 months of the project, leaving ample time to refine them and to develop new structures or processes as necessary.The use of procedures and processes with which participating investigators and their home institutions were already familiar allowed project and regulatory requirements to be established quickly to protect patients, their data, and the health care systems that act as stewards for both. As the project progressed, PORTAL was able to test and adjust the structures it put place, and to make substantive revisions by Month 17. As a result, priority processes have been predictable, transparent and effective.Strong governance practices are a stewardship responsibility of research networks to justify the trust of patients, health plan members, health care delivery organizations, and other stakeholders. Well-planned governance can reduce the time necessary to initiate the scientific activities of a network, a particular concern when the time frame to complete research is short. Effective network and data governance structures protect patient and institutional data as well as the interests of investigators and their institutions, and assures that the network has built an environment to meet the goals of the research.
Project description:BACKGROUND: Previous studies show that health systems governance influences health system performance and health outcomes. However, there are few examples of how to implement and monitor good governing practices in fragile and conflict affected environments. Good governance has the potential to make the health system people-centered. More research is needed on implementing a people-centered governance approach in these environments. CASE DESCRIPTION: We piloted an intervention that placed a people-centred health systems governance approach in the hands of multi-stakeholder committees that govern provincial and district health systems. We report the results of this intervention from three provinces and eleven districts in Afghanistan over a six month period. This mixed-methods exploratory case study uses analysis of governance self-assessment scores, health management information system data on health system performance, and focus group discussions. The outcomes of interest are governance scores and health system performance indicators. We document the application of a people-centred health systems governance conceptual model based on applying four effective governing practices: cultivating accountability, engaging with stakeholders, setting a shared strategic direction, and stewarding resources responsibly. We present a participatory approach where health system leaders identify and act on opportunities for making themselves and their health systems more accountable and responsive to the needs of the communities they serve. DISCUSSION AND EVALUATION: We found that health systems governance can be improved in fragile and conflict affected environments, and that consistent application of the effective governing practices is key to improving governance. Intervention was associated with a 20% increase in antenatal care visit rate in pilot provinces. Focus group discussions showed improvements across the four governing practices, including: establishment of new sub-committees that oversee financial transparency and governance, collaboration with diverse stakeholders, sharper focus on community health needs, more frequent presentation of service delivery data, and increased use of data for decision making. CONCLUSIONS: Our findings have implications for policy and practice within and beyond Afghanistan. Governance is central to making health systems responsive to the needs of people who access and provide services. We provide a practical approach to improving health systems governance in fragile and conflict affected environments.
Project description:To review the published, peer-reviewed literature on clinical research data warehouse governance in distributed research networks (DRNs).Medline, PubMed, EMBASE, CINAHL, and INSPEC were searched for relevant documents published through July 31, 2013 using a systematic approach. Only documents relating to DRNs in the USA were included. Documents were analyzed using a classification framework consisting of 10 facets to identify themes.6641 documents were retrieved. After screening for duplicates and relevance, 38 were included in the final review. A peer-reviewed literature on data warehouse governance is emerging, but is still sparse. Peer-reviewed publications on UK research network governance were more prevalent, although not reviewed for this analysis. All 10 classification facets were used, with some documents falling into two or more classifications. No document addressed costs associated with governance.Even though DRNs are emerging as vehicles for research and public health surveillance, understanding of DRN data governance policies and procedures is limited. This is expected to change as more DRN projects disseminate their governance approaches as publicly available toolkits and peer-reviewed publications.While peer-reviewed, US-based DRN data warehouse governance publications have increased, DRN developers and administrators are encouraged to publish information about these programs.
Project description:This article presents raw inferential statistical data that determine the influence of awareness on the successful implementation of IT Governance. Data were collected from respondents in all regions of Indonesia. Quantitative research methods are used to analyze data. The structured questionnaire was distributed to respondents in all regions of Indonesia who understood the field of IT Governance whose reliability and validity were confirmed. Structural equation modeling (SEM) using Smart PLS software, version 3, is used to present data. SEM path analysis shows an estimate of the relationship of the main constructs in the data. The results obtained from this dataset show a positive relationship between Risk Management, IT Resources, Budget, Stakeholder Involvement, Policy, Business Strategy, Organization, Commitment, Competence, Communication to awareness and consciousness also has a significant influence on the success of IT Governance implementation. However, politics has proven to have a negative and insignificant influence on the awareness and success of implementing IT Governance.
Project description:OBJECTIVES:As the coronavirus disease 2019 pandemic developed there was a paucity of data relevant to people living with rheumatic disease. This led to the development of a global, online registry to meet these information needs. This manuscript provides a detailed description of the coronavirus disease 2019 Global Rheumatology Alliance registry development, governance structure, and data collection, and insights into new ways of rapidly establishing global research collaborations to meet urgent research needs. METHODS:We use previously published recommendations for best practices for registry implementation and describe the development of the Global Rheumatology Alliance registry in terms of these steps. We identify how and why these steps were adapted or modified. In Phase 1 of registry development, the purpose of the registry and key stakeholders were identified on online platforms, Twitter and Slack. Phase 2 consisted of protocol and data collection form development, team building and the implementation of governance and policies. RESULTS:All key steps of the registry development best practices framework were met, though with the need for adaptation in some areas. Outputs of the registry, two months after initial conception, are also described. CONCLUSION:The Global Rheumatology Alliance registry will provide highly useful, timely data to inform clinical care and identify further research priorities for people with rheumatic disease with coronavirus disease 2019. The formation of an international team, easily able to function in online environments and resulting in rapid deployment of a registry is a model that can be adapted for other disease states and future global collaborations.
Project description:United States-based biorepositories are on the cusp of substantial change in regulatory oversight at the same time that they are increasingly including samples and data from large populations, e.g. all patients in healthcare system. It is appropriate to engage stakeholders from these populations in new governance arrangements. We sought to describe community recommendations for biorepository governance and oversight using deliberative community engagement (DCE), a qualitative research method designed to elicit lay perspectives on complex technical issues. We asked for stakeholders to provide input on governance of large biorepositories at the University of California (UC), a public university. We defined state residents as stakeholders and recruited residents from two large metropolitan areas, Los Angeles (LA) and San Francisco (SF). In LA, we recruited English and Spanish speakers; in SF the DCE was conducted in English only. We recruited individuals who had completed the 2009 California Health Interview Survey and were willing to be re-contacted for future studies. Using stratified random sampling (by age, education, race/ethnicity), we contacted 162 potential deliberants of whom 53 agreed to participate and 51 completed the 4-day DCE in June (LA) and September-October (SF), 2013. Each DCE included discussion among deliberants facilitated by a trained staff and simultaneously-translated in LA. Deliberants also received a briefing book describing biorepository operations and regulation. During the final day of the DCE, deliberants voted on governance and oversight recommendations using an audience response system. This paper describes 23 recommendations (of 57 total) that address issues including: educating the public, sharing samples broadly, monitoring researcher behavior, using informative consent procedures, and involving community members in a transparent process of biobank governance. This project demonstrates the feasibility of obtaining meaningful input on biorepository governance from diverse lay stakeholders. Such input should be considered as research institutions respond to changes in biorepository regulation.
Project description:BACKGROUND:The worldwide landscape of patient registries in the neuromuscular disease (NMD) field has significantly changed in the last 10 years, with the international TREAT-NMD network acting as strong driver. At the same time, the European Medicines Agency and the large federations of rare disease patient organizations (POs), such as EURORDIS, contributed to a great cultural change, by promoting a paradigm shift from product-registries to patient-centred registries. In Italy, several NMD POs and Fondazione Telethon undertook the development of a TREAT-NMD linked patient registry in 2009, with the referring clinical network providing input and support to this initiative through the years. This article describes the outcome of this joint effort and shares the experience gained. METHODS:The Italian NMD registry is based on an informatics technology platform, structured according to the most rigorous legal national and European requirements for management of patient sensitive data. A user-friendly web interface allows both direct patients and clinicians' participation. The platform's design permits expansion to incorporate new modules and new registries, and is suitable of interoperability with other international efforts. RESULTS:When the Italian NMD Registry was initiated, an ad hoc legal entity (NMD Registry Association) was devised to manage registries' data. Currently, several disease-specific databases are hosted on the platform. They collect molecular and clinical details of individuals affected by Duchenne or Becker muscular dystrophy, Charcot-Marie-Tooth disease, transthyretin type-familial amyloidotic polyneuropathy, muscle glycogen storage disorders, spinal and bulbar muscular atrophy, and spinal muscular atrophy. These disease-specific registries are at different stage of development, and the NMD Registry itself has gone through several implementation steps to fulfil different technical and governance needs. The new governance model is based on the agreement between the NMD Registry Association and the professional societies representing the Italian NMD clinical network. Overall, up to now the NMD registry has collected data on more than 2000 individuals living with a NMD condition. CONCLUSIONS:The Italian NMD Registry is a flexible platform that manages several condition-specific databases and is suitable to upgrade. All stakeholders participate in its management, with clear roles and responsibilities. This governance model has been key to its success. In fact, it favored patient empowerment and their direct participation in research, while also engaging the expert clinicians of the Italian network in the collection of accurate clinical data according to the best clinical practices.
Project description:3D analytical pathology imaging examines high resolution 3D image volumes of human tissues to facilitate biomedical research and provide potential effective diagnostic assistance. Such approach - quantitative analysis of large-scale 3D pathology image volumes - generates tremendous amounts of spatially derived 3D micro-anatomic objects, such as 3D blood vessels and nuclei. Spatial exploration of such massive 3D spatial data requires effective and efficient querying methods. In this paper, we present a scalable and efficient 3D spatial query system for querying massive 3D spatial data based on MapReduce. The system provides an on-demand spatial querying engine which can be executed with as many instances as needed on MapReduce at runtime. Our system supports multiple types of spatial queries on MapReduce through 3D spatial data partitioning, customizable 3D spatial query engine, and implicit parallel spatial query execution. We utilize multi-level spatial indexing to achieve efficient query processing, including global partition indexing for data retrieval and on-demand local spatial indexing for spatial query processing. We evaluate our system with two representative queries: 3D spatial joins and 3D k-nearest neighbor query. Our experiments demonstrate that our system scales to large number of computing nodes, and efficiently handles data-intensive 3D spatial queries that are challenging in analytical pathology imaging.
Project description:<h4>Background</h4>Clinical networks are being used widely to facilitate large system transformation in healthcare, by engagement of stakeholders throughout the health system. However, there are no available instruments that measure engagement in these networks.<h4>Methods</h4>The study purpose was to develop and assess the measurement properties of a multiprofessional tool to measure engagement in clinical network initiatives. Based on components of the International Association of Public Participation Spectrum and expert panel review, we developed 40 items for testing. The draft instrument was distributed to 1,668 network stakeholders across different governance levels (leaders, members, support, frontline stakeholders) in 9 strategic clinical networks in Alberta (January to July 2014). With data from 424 completed surveys (25.4% response rate), descriptive statistics, exploratory and confirmatory factor analysis, Pearson correlations, linear regression, multivariate analysis, and Cronbach alpha were conducted to assess reliability and validity of the scores.<h4>Results</h4>Sixteen items were retained in the instrument. Exploratory factor analysis indicated a four-factor solution and accounted for 85.7% of the total variance in engagement with clinical network initiatives: global engagement, inform (provided with information), involve (worked together to address concerns), and empower (given final decision-making authority). All subscales demonstrated acceptable reliability (Cronbach alpha 0.87 to 0.99). Both the confirmatory factor analysis and regression analysis confirmed that inform, involve, and empower were all significant predictors of global engagement, with involve as the strongest predictor. Leaders had higher mean scores than frontline stakeholders, while members and support staff did not differ in mean scores.<h4>Conclusions</h4>This study provided foundational evidence for the use of this tool for assessing engagement in clinical networks. Further work is necessary to evaluate engagement in broader network functions and activities; to assess barriers and facilitators of engagement; and, to elucidate how the maturity of networks and other factors influence engagement.
Project description:There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research.