Developing a data infrastructure for a learning health system: the PORTAL network
- Elizabeth A McGlynn1,
- Tracy A Lieu2,
- Mary L Durham3,
- Alan Bauck3,
- Reesa Laws3,
- Alan S Go2,
- Jersey Chen4,
- Heather Spencer Feigelson5,
- Douglas A Corley2,
- Deborah Rohm Young6,
- Andrew F Nelson7,
- Arthur J Davidson8,
- Leo S Morales9,
- Michael G Kahn10,11
- 1Kaiser Permanente Center for Effectiveness and Safety Research, Pasadena, California, USA
- 2Division of Research, Kaiser Permanente Northern California, Oakland, California, USA
- 3Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA
- 4Mid-Atlantic Permanente Research Institute, Kaiser Permanente Mid-Atlantic States, Rockville, Maryland, USA
- 5Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA
- 6Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, California, USA
- 7HealthPartners Institute for Education and Research, Minneapolis, Minnesota, USA
- 8Denver Public Health, Denver Health, Denver, Colorado, USA
- 9Group Health Cooperative, Group Health Research Institute, Seattle, Washington, USA
- 10Department of Pediatrics, University of Colorado, Aurora, Colorado, USA
- 11Colorado Clinical and Translational Sciences Institute, Aurora, Colorado, USA
- Correspondence to Dr Michael G Kahn, University of Colorado, Building 500, Mail Stop 563, 13001 East 17th Place, Room C1009, Aurora, CO 80045, USA;
- Received 21 February 2014
- Accepted 10 March 2014
- Published Online First 12 May 2014
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.
- comparative effectiveness research
- distributed databases
- data sharing
- colon cancer
- congenital heart defects
Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) is a network that brings together four leading healthcare delivery systems: Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health. These systems include 11 affiliated research centers and serve 11 million members across nine states and the District of Columbia (table 1; figure 1), or approximately one of every 30 people in the USA. The four PORTAL health systems own or operate 44 hospitals, 674 clinics or medical offices, and 625 in-house pharmacies. The PORTAL partners represent a great diversity of care models and practices. The Kaiser Permanente regions, for example, contract out only a small proportion of ambulatory care, inpatient care, imaging, and highly specialized tertiary services. Group Health Cooperative, on the other hand, contracts externally for a relatively large proportion of its physicians and facilities services.
The PORTAL data environment
PORTAL network sites represent large and diverse integrated health systems that include inpatient and outpatient facilities; primary care and specialty provider networks; and ancillary services, pharmacies, and ambulatory procedure centers. Detailed clinical and administrative data are integrated into a comprehensive longitudinal electronic health record (EHR). Each participating PORTAL organization maintains a separate electronic record that captures in-system encounters and incorporates billing and clinical care data from services delivered by providers outside the organization. Extensive historical records and relatively long average enrollment periods allow PORTAL sites to participate in comparative effectiveness research (CER) studies that involve long periods of time for exposure or outcomes.
The PORTAL common data model
Collaboration to conduct research among these different health plans and organizations presents challenges. PORTAL healthcare systems use different EHR vendors and different clinical, administrative, and patient-access applications to support clinical care. Institutional differences in configurations, workflows, and codes create additional barriers to sharing data directly using existing systems. Even among partners who use EHRs from the same vendor, differences in products, capabilities, versions, and local configurations create dissimilarities in data variable names, formats, and meanings.
To address these issues, PORTAL will use a common data model (CDM) that provides definitions for how each shared data element must be structured and which codes must be assigned to data values.1 CDMs have been used successfully in large-scale national data sharing networks.2–4 One data model used in multiple national networks is the HMO Research Network Virtual Data Warehouse (HMORN VDW).5 ,6 Over a 20-year period, the HMORN has developed detailed definitions, documentation, and implementation guides for the structure of each data table and the allowed codes used in each field.6 ,7 The HMORN has developed an extensive set of data validation routines to assess data quality in VDW data extractions.8
The Kaiser Permanente Center for Effectiveness and Safety Research (CESR) CDM is an expansion of the current HMORN VDW and is the data model that will be implemented across PORTAL sites. Figure 2 illustrates the data domains defined in the current and future versions of the CESR CDM. A critical priority of the Patient Centered Outcomes Research Institute (PCORI) is to include a wide range of patient-reported outcomes (PROs) in addition to traditional clinical and administrative data. The CESR CDM contains four additional Patient Reported Outcomes tables for storing patient-reported data such as exercise as a vital sign (EVS), the Patient Health Questionnaire (PHQ-9),9 and the Brief Pain Inventory Survey (BPI).10 These new tables ensure that PORTAL will be able to store and analyze PROs in alignment with a central PCORI objective.
Information exchange, both among PORTAL sites and between the PORTAL network and other PCORnet networks, requires both syntactic (structure) and semantic (meaning) harmonization.11 ,12 For sharing data between multiple networks, mappings between CDMs can be constructed to provide syntactic harmonization. Semantic harmonization, however, can be difficult if two networks use different terms, coding systems, and data definitions.13–16 While not a complete solution to full semantic harmonization, the CESR data model uses widely adopted national and international coding systems as data elements and values (table 2, figure 3). In August 2012, the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health Information Technology released the Final Rule for Meaningful Use Stage 2, which specifies multiple terminologies that must be incorporated into certified EHR products by October 2014.17–19 The CESR CDM contains all of the terminologies specified in these regulations except for SNOMED Clinical Terms (SNOMED CT). As the delivery systems at PORTAL sites transition to these new coding systems, the CESR CDM will extract data elements encoded in these new terminologies. Because the current CESR CDM has the ability to record data in multiple coding standards (eg, diagnosis in both ICD and SNOMED CT), adding SNOMED CT as valid values for coded data elements will not require changes to the data model structure. This functionality permits the co-existence of legacy data in legacy coding systems and data captured using newer coding systems, which is critical for conducting long-term longitudinal observational CER studies.
Distributed data sharing platform
Distributed data queries and data exchange across PORTAL partners will be managed using PopMedNet (http://www.popmednet.org) technology (figure 3).20 PopMedNet provides the security, authentication, and auditing capabilities required to ensure only approved data requests are submitted and returned. PopMedNet is a data-model agnostic distributed data-sharing platform that supports a wide range of data governance models. PCORI has selected PopMedNet to support PCORnet's network-of-networks data sharing infrastructure.
Ensuring data consistency and quality across network partners
The PORTAL network will build upon the experiences of other established networks to develop new partnerships. Over the past 20 years, for example, the HMORN has developed extensive policies, procedures, and technologies for evaluating and investigating data validation, quality, and consistency. Brown and colleagues illustrate some of the ‘lessons learned’ from the vast field experience within the HMORN and Mini-Sentinel networks.21 Additionally, Kahn has published a detailed data quality assessment (DQA) model22 and, in collaboration with the Electronic Data Methods Forum, has developed a set of recommendations for standardized DQA reporting measures.23 Similarly, Bauck and colleagues developed a conceptual model for a consistent DQA framework that is being implemented across the HMORN/CESR sites.8 PORTAL will draw upon these sources when developing common DQA policies and procedures and common data quality output structures so that investigators seeking to combine data from multiple networks can evaluate data quality measures from each participating site to assess their ‘fitness for use’ for their research question prior to incorporating data from that site.
To ensure broad applicability, PCORI required each research network to develop cohorts representing a common clinical condition and a rare clinical condition. All networks were also required to develop an obesity cohort. The PORTAL network will construct three cohorts: (1) patients with a diagnosis of colorectal cancer (CRC), representing a common disease; (2) adolescents and adults with severe congenital heart disease (CHD), representing a rare disease; and (3) adults who are overweight or obese, including those who have pre-diabetes or diabetes. The characteristics of these cohorts are described briefly.
We chose CRC because it is the third most common cancer in the USA, is the second leading cause of cancer death, and affects both men and women. Approximately 1.2 million people in the USA currently live with CRC, which offers opportunities for studying issues of survivorship, including cancer treatment and transitions in care between primary and specialty physicians (eg, primary care, surgery, gastroenterology, and oncology). This allows researchers to examine differences in screening, treatment choices, and survivorship experiences by gender,24 race/ethnicity, comorbid conditions, and patient preferences. There are more than 11 000 individuals with CRC across the network.
Severe congenital heart disease
Adolescents and adults with severe CHD were selected because this group faces three generalizable challenges to healthcare systems: (1) transitions in care from adolescence to adulthood; (2) monitoring of patients at increased risk for chronic conditions and associated morbidity and mortality (specifically, chronic heart failure); and (3) interfaces between primary, specialty (general cardiology), and subspecialty (CHD-specific) care. The Centers for Disease Control and Prevention recently convened a panel of experts that identified two gaps in understanding the public health implications of this condition: long-term outcomes for persons with CHD and the appropriateness of care delivery, particularly through the transition from adolescence to adulthood.25 The PORTAL network contains approximately 330 patients with severe CHD.
More than one-third of adults in the USA are obese.26 The prevalence of obesity is similar for men and women, more common among persons age 60 and older, and varies by race/ethnicity, with non-Hispanic black individuals having the highest age-adjusted rates of obesity (49.5%). Obesity's relationship to diabetes is well established, with more than 10% of the US adult population currently diagnosed with diabetes and with a prevalence greater than 25% for adults over the age of 65 years. Another 79 million adults have pre-diabetes, a condition of abnormally high blood glucose levels and a precursor to diabetes. Compared with white individuals, Mexican Americans and black individuals have a 87% and 77% higher risk of developing diabetes, respectively.26 Each of the clinical data research networks will develop a cohort of persons who are overweight or obese that will demonstrate PORTAL's ability to work across the network of networks that comprise PCORnet. The PORTAL network has over 3 000 000 individuals who meet the criteria for obesity.
Incorporating patient-reported data in routine clinical practice
PORTAL members recognized the importance of capturing patient-reported data directly into the EHR many years ago. Three measures are routinely collected at all Kaiser Permanente and Group Health Cooperative sites: EVS, the BPI, and the PHQ-9, making these variables available to investigators seeking to link patient outcome measures to disease states, therapeutic interventions, and clinical outcomes.
PORTAL members have identified six critical success factors/barriers for incorporating patient-reported data into routine care delivery. First, clinicians are more likely to adopt and use measures that enhance the clinician's ability to deliver high-quality care. Clinicians often see disease-specific measures, such as the PHQ-9, as more relevant than general measures of overall functional status. Second, data collection must be hard-wired into daily workflows to ensure complete data capture. EVS measures, for example, are integrated into the routine information gathering performed by the medical assistant or nurse during the visit intake process. Third, resources must be available to ensure that the necessary functionality is implemented and is consistent with regulatory and compliance requirements. Fourth, the placement of information in the clinical record must be convenient and interpretable. All too often, PROs appear as a separate tab in the record or as a PDF that must be selected separately to view. Fifth, in some instances, patients have been reluctant to have these data incorporated into their medical record. For example, only 65% of members who take a Total Health Assessment Survey through Kaiser Permanent’s web portal agree to share this information with their physician. Sixth, patients’ willingness to provide this information depends on their belief that the data will be used in practice. These six principles, gleaned from many years of experience with a wide range of measures, will guide PORTAL's development of a sustainable data collection strategy within routine clinical practice.
With nearly 11 million people and more than 15 years of collaborative history among most of its partner sites, the PORTAL network offers a robust and experienced platform for comparative effectiveness and patient-centered outcomes research. This network holds promise for enhancing, storing, and analyzing patient-reported data and adopting new approaches for patient, clinician, and stakeholder engagement in all aspects of research, from the development of high-impact questions to the design of interventions and data collection approaches. These results will ultimately improve healthcare practices. As a partner in PCORnet, PORTAL can be a significant contributor to, and benefactor from, the rapidly evolving new model for interoperable large-scale national collaborative patient-centered research networks.
Lilia Grigoryan and Tamara Lischka provided graphics expertise.
Contributors All authors meet all four ICMJE criteria for authorship. MGK was responsible for the initial draft manuscript that was reviewed, edited, and expanded by all listed authors. MGK was responsible for the final draft that was reviewed and approved by all authors prior to submission. Organizational descriptions in table 1 and geographic distributions in figure 1 were provided by the authors from those institutions. They are responsible for the accuracy of these data.
Funding This work was supported by PCORI Contract CDRN-1306-04681 (all), the Kaiser Permanente Center for Effectiveness and Safety Research (EAM, TAL, MLD, AB, RL), NIH/NCATS ITHS Grant UL1TR000423 (LSM), AHRQ R24 HS022143-01 Developing Infrastructure for Patient-Centered Outcomes Research at Denver Health (AJD), AHRQ 1R01HS019912-01 Scalable Partnering Network for CER: Across Lifespan, Conditions and Settings (MGK) and NIH/NCATS Colorado CTSI Grant Number UL1 TR001082 (MGK).
Competing interests None.
Provenance and peer review Commissioned; internally peer reviewed.
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