We've Only Just Begun - Insights from a 25-Year Journey to Accelerate Health Care Transformation Through Delivery System Research.

Even though it is well known that quality, safety, and patient-centeredness of health care can be improved, leveraging the organizational apparatus of a care delivery environment to render improvement in a consistent and comprehensive manner has proven difficult. The Health Care Systems Research Network (HCSRN), which began as the HMO Research Network, emerged from a desire to improve health and study problems in health care in a systematic and collaborative way, spurring the delivery of true evidence-informed medicine. The HCSRN has honed network-wide data resources, a collaborative culture, and shared infrastructure, enabling multicenter health care research that is often more difficult for researchers working in less integrated settings and across organizational boundaries. The HCSRN's 25-year track record confers both an opportunity and obligation to share what we have learned through our research. Considering the quarter-century since the HCSRN was established, we describe three evolving areas-health data, new health care models, and diversified research teams that must be thoughtfully harnessed to realize a transformed health care ecosystem that generates and learns with research.

Building a Governance Strategy for CER: The Patient Outcomes Research to Advance Learning (PORTAL) Network Experience.

INTRODUCTION: 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. BACKGROUND: 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. INNOVATION: 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. CREDIBILITY: 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. DISCUSSION: 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. CONCLUSION/NEXT STEPS: 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.

Developing a data infrastructure for a learning health system: the PORTAL network.

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.

Clinical research data warehouse governance for distributed research networks in the USA: a systematic review of the literature.

OBJECTIVE: To review the published, peer-reviewed literature on clinical research data warehouse governance in distributed research networks (DRNs). MATERIALS AND METHODS: 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. RESULTS: 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. DISCUSSION: 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. CONCLUSIONS: While peer-reviewed, US-based DRN data warehouse governance publications have increased, DRN developers and administrators are encouraged to publish information about these programs.

Data warehouse governance programs in healthcare settings: a literature review and a call to action.

PURPOSE: Given the extensive data stored in healthcare data warehouses, data warehouse governance policies are needed to ensure data integrity and privacy. This review examines the current state of the data warehouse governance literature as it applies to healthcare data warehouses, identifies knowledge gaps, provides recommendations, and suggests approaches for further research. METHODS: A comprehensive literature search using five data bases, journal article title-search, and citation searches was conducted between 1997 and 2012. Data warehouse governance documents from two healthcare systems in the USA were also reviewed. A modified version of nine components from the Data Governance Institute Framework for data warehouse governance guided the qualitative analysis. RESULTS: Fifteen articles were retrieved. Only three were related to healthcare settings, each of which addressed only one of the nine framework components. Of the remaining 12 articles, 10 addressed between one and seven framework components and the remainder addressed none. Each of the two data warehouse governance plans obtained from healthcare systems in the USA addressed a subset of the framework components, and between them they covered all nine. CONCLUSIONS: While published data warehouse governance policies are rare, the 15 articles and two healthcare organizational documents reviewed in this study may provide guidance to creating such policies. Additional research is needed in this area to ensure that data warehouse governance polices are feasible and effective. The gap between the development of data warehouses in healthcare settings and formal governance policies is substantial, as evidenced by the sparse literature in this domain.

Optimizing practice through research: a new perspective to solve an old problem.

Policy makers, researchers, clinicians, and the public are frustrated that research in the health sciences has not resulted in a greater improvement in patient outcomes. Our experience as clinicians and researchers suggests that this frustration could be reduced if health sciences research were directed by 5 broad principles: (1) the needs of patients and populations determine the research agenda; (2) the research agenda addresses contextual and implementation issues, including the development of delivery and accountability systems; (3) the research agenda determines the research methods rather than methods determines the research agenda; (4) researchers and clinicians collaborate to define the research agenda, allocate resources, and implement findings; and (5) the level of funding for implementation research is commensurate with and proportional to the magnitude of the task. To keep the research agenda focused on the task of improving health and to acknowledge that the effort must be seen as more comprehensive than translating or transferring research into practice (TRIP), we suggest that the task be reframed, using the term optimizing practice through research.

Partnerships in translation: advancing research and clinical care. The 14th Annual HMO Research Network Conference, April 13-16, 2008, Minneapolis, Minnesota.

The Health Maintenance Organization Research Network held its annual meeting in Minneapolis in April of 2008, with more than 300 investigators, research staff, clinical leaders, and academic partners gathering in conjunction with the conference theme 'Partnerships in Translation: Advancing Research and Clinical Care.' This article provides some background on the network, its research activities, and the annual conference. Also featured is an article by Coleman and colleagues summarizing the conference's first plenary session, where operational leaders of health care organizations discussed the optimization of health care through research. This issue of Clinical Medicine & Research also includes a selection of scientific abstracts presented at the meeting on a wide range of clinical and population health topics.

Partnering care delivery and research to optimize health.

A close partnership between care delivery and research organizations has the potential to provide essential elements needed to optimize health and health care. This clinical leadership panel, held during the 14th Annual Health Maintenance Organization Research Network (HMORN) Conference, identifies the value, opportunities and challenges of those close partnerships between three HMORN care delivery and research organizations. The objectives of this plenary session were: (1) identify the important facets of partnership that bring value to care delivery and research, (2) pinpoint the critical alignments of care delivery and research that are needed to fulfill the promised value between clinical and research organizations, and (3) recognize the challenges that clinical and research organizations need to address.

Syndromic surveillance using minimum transfer of identifiable data: the example of the National Bioterrorism Syndromic Surveillance Demonstration Program.

Several health plans and other organizations are collaborating with the Centers for Disease Control and Prevention to develop a syndromic surveillance system with national coverage that includes more than 20 million people. A principal design feature of this system is reliance on daily reporting of counts of individuals with syndromes of interest in specified geographic regions rather than reporting of individual encounter-level information. On request from public health agencies, health plans and telephone triage services provide additional information regarding individuals who are part of apparent clusters of illness. This reporting framework has several advantages, including less sharing of protected health information, less risk that confidential information will be distributed inappropriately, the prospect of better public acceptance, greater acceptance by health plans, and less effort and cost for both health plans and public health agencies. If successful, this system will allow any organization with appropriate data to contribute vital information to public health syndromic surveillance systems while preserving individuals' privacy to the greatest extent possible.