Machine learning-based donor permission extraction from informed consent documents.

Background: With more clinical trials are offering optional participation in the collection of bio-specimens for biobanking comes the increasing complexity of requirements of informed consent forms. The aim of this study is to develop an automatic natural language processing (NLP) tool to annotate informed consent documents to promote biorepository data regulation, sharing, and decision support. We collected informed consent documents from several publicly available sources, then manually annotated them, covering sentences containing permission information about the sharing of either bio-specimens or donor data, or conducting genetic research or future research using bio-specimens or donor data.

CRENO: An ontology to model concepts relating to culture, race, ethnicity, and nationality for health data.

Generating categories and classifications is a common function in life science research; however, categorizing the human population based on "race" remains controversial. There is an awareness and recognition of social-economic disparities with respect to health which are sometimes impacted by someone's ethnicity or race. This work describes an endeavor to develop a computable ontology model to represent a standardization of the concepts surrounding culture, race, ethnicity, and nationality - concepts misrepresented widely.

The case for expressing nursing theories using ontologies.

Nursing and informatics share a common strength in their use of structured representations of domains, specifically the underlying notion of 'things' (ie, concepts, constructs, or named entities) and the relationships among those things. Accurate representation of nursing knowledge in machine-interpretable formats is a necessary next step for leveraging contemporary technologies. Expressing validated nursing theories in ontologies, and in particular formal ontologies, would serve not only nursing, but also investigators from other domains, clinical information system developers, and the users of advanced technologies such as artificial intelligence that seek to learn from the real-world data and evidence generated by nurses and others.

Evaluating and Extending the Informed Consent Ontology for Representing Permissions from the Clinical Domain.

The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms.

Tolerance to oral anticancer agent treatment in older adults with cancer: a secondary analysis of data from electronic health records and a pilot study of patient-reported outcomes.

Background: More than 60% of cancer cases occur in older adults, and many are treated with oral anticancer agents. Yet, the treatment tolerability in older adults has not been fully understood due to their underrepresentation in oncology clinical trials, creating challenges for treatment decision-making and symptom management. The objective of this study was to investigate the tolerance of capecitabine, an example of oral chemotherapy, among older adults with cancer and explore factors associated with capecitabine-related side effects and treatment changes, to enhance supportive care.

Expressing and Executing Informed Consent Permissions Using SWRL: The All of Us Use Case.

The informed consent process is a complicated procedure involving permissions as well a variety of entities and actions. In this paper, we discuss the use of Semantic Web Rule Language (SWRL) to further extend the Informed Consent Ontology (ICO) to allow for semantic machine-based reasoning to manage and generate important permission-based information that can later be viewed by stakeholders. We present four use cases of permissions from the All of Us informed consent document and translate these permissions into SWRL expressions to extend and operationalize ICO.

Infrastructuring an organizational node for a federated research and data network: A case study from a sociotechnical perspective.

Background: Local nodes on federated research and data networks (FR&DNs) provide enabling infrastructure for collaborative clinical and translational research. Studies in other fields note that infrastructuring, that is, work to identify and negotiate relationships among people, technologies, and organizations, is invisible, unplanned, and undervalued. This may explain the limited literature on nodes in FR&DNs in health care.

Regulations and Norms for Reuse of Residual Clinical Biospecimens and Health Data.

Nurse scientists are increasingly interested in conducting secondary research using real world collections of biospecimens and health data. The purposes of this scoping review are to (a) identify federal regulations and norms that bear authority or give guidance over reuse of residual clinical biospecimens and health data, (b) summarize domain experts' interpretations of permissions of such reuse, and (c) summarize key issues for interpreting regulations and norms. Final analysis included 25 manuscripts and 23 regulations and norms.

Lessons Learned for Identifying and Annotating Permissions in Clinical Consent Forms.

Background: The lack of machine-interpretable representations of consent permissions precludes development of tools that act upon permissions across information ecosystems, at scale.

Objectives: To report the process, results, and lessons learned while annotating permissions in clinical consent forms.

Methods: We conducted a retrospective analysis of clinical consent forms.

Acceptance and Use of Home-Based Electronic Symptom Self-Reporting Systems in Patients With Cancer: Systematic Review.

Background: Electronic symptom self-reporting systems (e-SRS) have been shown to improve symptoms and survival in patients with cancer. However, patient engagement in using e-SRS for voluntary symptom self-reporting is less optimal. Multiple factors can potentially affect patients' acceptance and engagement in using home-based e-SRS.

A Concept Analysis of Oral Anticancer Agent Self-management.

Background: The rapid development and adoption of oral anticancer agents (OAAs) for cancer management have shifted patients' roles from recipient to owner of their care delivery, assuming their responsibilities for self-managing their OAA treatments at home, while the concept of oral anticancer agent self-management (OAA-SM) has not been well clarified and defined.

Objective: This study was to clarify the concept of OAA-SM and identify major components, influential factors, and consequences of OAA-SM, as well as propose a representative conceptual model of OAA-SM.

Methods: A literature review was conducted concerning the concept and application of OAA-SM.

Side Effects, Self-Management Activities, and Adherence to Oral Anticancer Agents.

Purpose: There are growing concerns about patients' adherence to oral anticancer agents (OAAs), and the need for patients to engage in self-management of OAA-related side effects. We assessed associations among adherence, severity of side effects, and effectiveness of self-management of side effects in patients taking capecitabine.

Methods: Adherence to capecitabine at 6 weeks was measured by the Medication Event Monitoring System among 50 patients with gastrointestinal cancers.

Expressing Biomedical Ontologies in Natural Language for Expert Evaluation.

We report on a study of our custom Hootation software for the purposes of assessing its ability to produce clear and accurate natural language phrases from axioms embedded in three biomedical ontologies. Using multiple domain experts and three discrete rating scales, we evaluated the tool on clarity of the natural language produced, fidelity of the natural language produced from the ontology to the axiom, and the fidelity of the domain knowledge represented by the axioms. Results show that Hootation provided relatively clear natural language equivalents for a select set of OWL axioms, although the clarity of statements hinges on the accuracy and representation of axioms in the ontology.

Acceptance and Use of eHealth/mHealth Applications for Self-Management Among Cancer Survivors.

Cancer survivors' acceptance and use of eHealth/mHealth applications for self-management can be unique and are not fully understood. We used data from the Health Information National Trends Survey 4 Cycle 4 to examine cancer survivors' acceptance and use of eHealth/mHea applications for key self-management processes, and conducted logistic regression and Rao-Scott design-adjusted Chi-square tests to assess bivariate associations between potential predictors and actual use. Potential factors were selected based on the Individual and Family Self-Management theory.

The Ontology of Biological and Clinical Statistics (OBCS) for standardized and reproducible statistical analysis.

Background: Statistics play a critical role in biological and clinical research. However, most reports of scientific results in the published literature make it difficult for the reader to reproduce the statistical analyses performed in achieving those results because they provide inadequate documentation of the statistical tests and algorithms applied. The Ontology of Biological and Clinical Statistics (OBCS) is put forward here as a step towards solving this problem.

Harmonizing and extending standards from a domain-specific and bottom-up approach: an example from development through use in clinical applications.

Objective: Currently, the processes for harmonizing and extending standards by leveraging the knowledge within local documentation artifacts are not well described. We describe a collaborative project to develop common information models, terminology bindings, and term definitions based on nursing documentation systems, and carry the findings through to the adoption in standards development organizations (SDOs) and technical implementations in clinical applications.

Materials And Methods: Nursing flowsheet documents from six large organizations were analyzed to generate a common information model and terminologies that fully expressed documentation across all systems, and were sufficient for evidence-based decision support, reporting, and analysis.

Collaborative software development for a Brazilian telehealth program.

Telehealth services in the State of Pernambuco, Brazil are led by the Telehealth Center (RedeNUTES) and based on HealthNet 2.0 software. Among the tele-assistance services, health professionals have clinical discussions focused on second opinions.

Leveraging EHR data for outcomes and comparative effectiveness research in oncology.

Along with the increasing adoption of electronic health records (EHRs) are expectations that data collected within EHRs will be readily available for outcomes and comparative effectiveness research. Yet the ability to effectively share and reuse data depends on implementing and configuring EHRs with these goals in mind from the beginning. Data sharing and integration must be planned both locally as well as nationally.

Representation of Clinical Nursing Protocols Using GEM II & GEM Cutter.

The machineable representation and execution of clinical guidelines has been the focus of research efforts for some time, however there is less examination of whether the methods and techniques for guidelines are sufficient for clinical protocols. The objective of this study was to test the feasibility of using the Guideline Elements Model II (GEM II) and GEM Cutter for the representation of clinical protocols, specifically clinical protocols commonly used by nurses. After downloading the GEM Cutter 2.

Nurses' ratings of their health and professional work environments.

Interactions between nursing work environments and nurses' health are of growing significance, given the aging work force, nursing shortage, and workplace health risks. This study examined relationships among nurses' ratings of health behaviors, health status, and professional work environments. Registered nurses (N = 3,132) from five multi-state settings completed an electronic survey.

Implementing a health system-wide evidence-based practice educational program to reach nurses with various levels of experience and educational preparation.

This article describes a system-wide evidence-based practice (EBP) educational initiative implemented with a geographically, educationally, and clinically diverse group of nurses with the intent of increasing their EBP skill set and efficacy as local change agents and leaders. The overall scope of the larger National Quality Forum Scholar Program is described, and then the focus is narrowed to describe the EBP components of the initiative with case examples and lessons learned.

Using expert rules to automate pressure ulcer alerts for the clinical nurse specialist.

Hospital acquired pressure ulcers are the focus of national attention. We report on a decision support system that notifies clinical nurse specialists of patients with pressure ulcers or risk for developing pressure ulcers. Auto-summed pressure ulcer risk and pressure ulcer occurrence data are embedded in nursing flowsheets, while the expert system technology runs in a separate application and sends a message back to the EMR environment; a system is successfully implemented across 60 inpatient units.

The first step toward data reuse: disambiguating concept representation of the locally developed ICU nursing flowsheets.

Although an unambiguous and consistent representation is the foundation of data reuse, a locally developed documentation system such as nursing flowsheets often fails to meet the requirement. This article presents the domain modeling process of the ICU nursing flowsheet to clarify the meaning that its contents represent and the lessons learned during the activity. This study has been done as a first step toward reusing the data documented in a computerized nursing flowsheet for an algorithmic decision making.

Formalizing the International Classification of Functioning, Disability, and Health (ICF) using Formal Concept Analysis (FCA).

analysis (FCA) to support the formal description of the International Classification of Functioning, Disability,and Health (ICF). An ontology-based framework based on Protégé platform was adopted for the formalization tasks. The ICF was represented as a local terminology which contains a family of lists of pre-coordinated phrases.

The Stability and Workload Index for Transfer score predicts unplanned intensive care unit patient readmission: initial development and validation.

Objective: Unplanned readmission of hospitalized patients to an intensive care unit (ICU) is associated with a worse outcome, but our ability to identify who is likely to deteriorate after ICU dismissal is limited. The objective of this study is to develop and validate a numerical index, named the Stability and Workload Index for Transfer, to predict ICU readmission.

Design: In this prospective cohort study, risk factors for ICU readmission were identified from a broad range of patients' admission and discharge characteristics, specific ICU interventions, and in-patient workload measurements.