Modeling Flowsheet Data to Support Secondary Use.

The purpose of this study was to create information models from flowsheet data using a data-driven consensus-based method. Electronic health records contain a large volume of data about patient assessments and interventions captured in flowsheets that measure the same "thing," but the names of these observations often differ, according to who performs documentation or the location of the service (eg, pulse rate in an intensive care, the emergency department, or a surgical unit documented by a nurse or therapist or captured by automated monitoring). Flowsheet data are challenging for secondary use because of the existence of multiple semantically equivalent measures representing the same concepts. Ten information models were created in this study: five related to quality measures (falls, pressure ulcers, venous thromboembolism, genitourinary system including catheter-associated urinary tract infection, and pain management) and five high-volume physiological systems: cardiac, gastrointestinal, musculoskeletal, respiratory, and expanded vital signs/anthropometrics. The value of the information models is that flowsheet data can be extracted and mapped for semantically comparable flowsheet measures from a clinical data repository regardless of the time frame, discipline, or setting in which documentation occurred. The 10 information models simplify the representation of the content in flowsheet data, reducing 1552 source measures to 557 concepts. The amount of representational reduction ranges from 3% for falls to 78% for the respiratory system. The information models provide a foundation for including nursing and interprofessional assessments and interventions in common data models, to support research within and across health systems.

Expanding Interprofessional EHR Data in i2b2.

Emerging issues of team-based care, precision medicine, and big data science underscore the need for health information technology (HIT) tools for integrating complex data in consistent ways to achieve the triple aims of improving patient outcomes, patient experience, and cost reductions. The purpose of this study was to demonstrate the feasibility of creating a hierarchical flowsheet ontology in i2b2 using data-derived information models and determine the underlying informatics and technical issues. This study is the first of its kind to use information models that aggregate team-based care across time, disciplines, and settings into 14 information models that were integrated into i2b2 in a hierarchical model. In the process of successfully creating a hierarchical ontology for flowsheet data in i2b2, we uncovered a variety of informatics and technical issues described in this paper.

Modeling Flowsheet Data for Clinical Research.

Health care data included in clinical data repositories (CDRs) are increasingly used for quality reporting, business analytics and research; however, extended clinical data from interprofessional practice are seldom included. With the increasing emphasis on care coordination across settings, CDRs need to include data from all clinicians and be harmonized to understand the impact of their collaborative efforts on patient safety, effectiveness and efficiency. This study characterizes the extended clinical data derived from EHR flowsheet data that is available in the University of Minnesota's CDR and describes a process for creating an ontology that organizes that data so that it is more useful and accessible to researchers. The process is illustrated using a pressure ulcer ontology and compares ease of finding concepts in i2b2 for different data organization approaches. The challenges of the manual process and difficulties combining similar concepts are discussed.

Assessment of treatment practice patterns for severe hemophilia A: a global nurse perspective.

This paper reports findings from a global survey of practice patterns for severe hemophilia A. Nurses from 105 hemophilia treatment centers in the US, the UK, Canada and Sweden responded to a questionnaire and provided data for more than 10,100 children and adults. Forty-eight percent of the US patients and 38 and 37% of the British and Swedish patients, respectively, were reported to have severe hemophilia A. The survey found that 28% of US patients and 38% of UK patients with severe hemophilia A were on primary prophylaxis in 2005. These rates were significantly higher than those reported in a 2003 survey. Sweden continues to lead the world in prophylaxis utilization, with virtually 100% of patients aged 3-18 on primary prophylactic regimens. Bleeding history and target joint development were major reasons for initiating prophylaxis; poor adherence, inadequate family commitment and venous access problems were cited as the top causes for discontinuing treatment. Nurses in all 4 reporting countries agreed that prophylaxis is the optimal therapy for patients with severe hemophilia A because it prevents joint and muscle damage and improves quality of life. They cited patient/family education as the most appropriate strategy for overcoming the barriers to prophylaxis.

Possible synergy between recombinant factor VIIa and prothrombin complex concentrate in hemophilia therapy.

Recombinant factor VIIa (rFVIIa; Novoseven) is used for treatment of hemophilia patients with inhibitors. There are poorly defined differences in clinical responsiveness between individuals. Prior to licensure in the United States, rFVIIa was available through the compassionate use program, during which two patients described in this study demonstrated an excellent response. More recently, one of these individuals showed a sub-optimal response to rFVIIa. One possible explanation for different treatment outcomes was sequential therapy with prothrombin complex concentrates (PCC) followed by rFVIIa in the compassionate use program. In support of this, an in vitro test showed that this patient had an exceptionally strong response to rFVIIa when it was added to whole blood after the patient received PCC therapy. Results with other patients supported this hypothesis. With further evaluation, a therapeutic approach combining sequential PCC and rFVIIa may prove useful for treatment of bleeding refractory to either agent used alone.

Response of factor VIII and IX-deficient blood to wild type and high membrane affinity mutant factor VIIa in an in vitro whole blood clotting assay: possible correlation to clinical outcome.

A modified form of the activated whole blood clotting time was used to evaluate response of blood from hemophilia patients to factor VIIa. Repeated assays of individuals over a one-year period showed consistency for each individual and significant difference between individuals. Four hemophilia patients with inhibitors gave low response to factor VIIa in the assay and were characterized as low or moderate clinical responders to factor VIIa therapy. Another four patients with moderate to good clinical responsiveness to factor VIIa therapy showed a strong response to factor VIIa in the assay. A factor VIIa mutant with enhanced membrane affinity showed 10- to 13-fold higher activity than wild type factor VIIa. The results may justify larger studies to determine the utility of this assay for evaluation of patient responsiveness and to set factor VIIa therapy levels.