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.

Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review.

Background: Accurate measurement and monitoring of patient medication adherence is a global challenge because of the absence of gold standard methods for adherence measurement. Recent attention has been directed toward the adoption of technologies for medication adherence monitoring, as they provide the opportunity for continuous tracking of individual medication adherence behavior. However, current medication adherence monitoring technologies vary according to their technical features and data capture methods, leading to differences in their respective advantages and limitations.

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.

Sagittal abdominal diameter and its socioeconomic correlates: perspective of sex differences.

Background: Sagittal abdominal diameter (SAD) is an anthropometric index associated with visceral adiposity. It remains unclear whether SAD and its socio-economic correlates differ in women and men, which limits the epidemiological and clinical applications of the SAD measurement. The aims of this study are to examine the sex differences in SAD and its socio-economic correlates.

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.

Architecture and usability of OntoKeeper, an ontology evaluation tool.

Background: The existing community-wide bodies of biomedical ontologies are known to contain quality and content problems. Past research has revealed various errors related to their semantics and logical structure. Automated tools may help to ease the ontology construction, maintenance, assessment and quality assurance processes.

Cross-Network Directory Service: Infrastructure to enable collaborations across distributed research networks.

Introduction: Existing large-scale distributed health data networks are disconnected even as they address related questions of healthcare research and public policy. This paper describes the design and implementation of a fully functional prototype open-source tool, the Cross-Network Directory Service (CNDS), which addresses much of what keeps distributed networks disconnected from each other.

Methods: The set of services needed to implement a Cross-Directory Service was identified through engagement with stakeholders and workgroup members.

Trends in primary care encounters across professional roles in PCMH.

Objectives: Team-based care models, including the patient-centered medical home (PCMH), are increasingly promoted to improve the delivery of primary care. However, evaluation measures are often reported at a clinic or primary care provider (PCP) level, creating challenges in describing and analyzing the use and impact of non-PCP clinician team members. Thus, we aimed to measure clinician-specific care delivery trends and determine whether trends were responsive to systemwide PCMH implementation.

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.

Do Patient-Centered Medical Home Access and Care Coordination Measures Reflect the Contribution of All Team Members? A Systematic Review.

Patient-Centered Medical Home (PCMH) evaluations have primarily focused on primary care providers and not on the primary care team. This systematic literature review examined the extent to which access and care coordination measures in PCMH reflect the involvement of associate care providers (ACPs), which include registered and licensed practical nurses, nursing and medical assistants, clerks, pharmacists, social workers, and dietitians. Among 42 studies, few measures specified ACP roles or linked ACP care to outcomes.

Research Infrastructure for Collaborative Team Science: Challenges in Technology-Supported Workflows in and Across Laboratories, Institutions, and Geographies.

Collaborative research has many challenges. One under-researched challenge is how to align collaborators' research practices and evolving analytical reasoning with technologies and configurations of technologies that best support them. The goal of such alignment is to enhance collaborative problem solving capabilities in research.

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.

Using present-on-admission coding to improve exclusion rules for quality metrics: the case of failure-to-rescue.

Background: The Agency for Healthcare Research and Quality (AHRQ) patient safety indicator "death among surgical inpatients with serious treatable complications" (failure-to-rescue) uses rules to exclude complications presumed to be present-on-admission (POA). Like other administrative data-based quality measures, exclusion rules were developed with limited information on whether complications were POA. We examine whether the accuracy of failure-to-rescue exclusion rules can be improved with data with good POA indicators.