Background
Drug adverse events (AEs), or called adverse drug events (ADEs), are ranked one of the leading causes of mortality. The Ontology of Adverse Events (OAE) has been widely used for adverse event AE representation, standardization, and analysis. OAE-based ADE-specific ontologies, including ODNAE for drug-associated neuropathy-inducing AEs and OCVDAE for cardiovascular drug AEs, have also been developed and used. However, these ADE-specific ontologies do not consider the effects of other factors (e.g., age and drug-treated disease) on the outcomes of ADEs. With more ontological studies of ADEs, it is also critical to develop a general purpose ontology for representing ADEs for various types of drugs.
Results
Our survey of FDA drug package insert documents and other resources for 224 neuropathy-inducing drugs discovered that many drugs (e.g., sirolimus and linezolid) cause different AEs given patients’ age or the diseases treated by the drugs. To logically represent the complex relations among drug, drug ingredient and mechanism of action, AE, age, disease, and other related factors, an ontology design pattern was developed and applied to generate a community-driven open-source Ontology of Drug Adverse Events (ODAE). The ODAE development follows the OBO Foundry ontology development principles (e.g., openness and collaboration). Built on a generalizable ODAE design pattern and extending the OAE and NDF-RT ontology, ODAE has represented various AEs associated with the over 200 neuropathy-inducing drugs given different age and disease conditions. ODAE is now deposited in the Ontobee for browsing and queries. As a demonstration of usage, a SPARQL query of the ODAE knowledge base was developed to identify all the drugs having the mechanisms of ion channel interactions, the diseases treated with the drugs, and AEs after the treatment in adult patients. AE-specific drug class effects were also explored using ODAE and SPARQL.
Conclusion
ODAE provides a general representation of ADEs given different conditions and can be used for querying scientific questions. ODAE is also a robust knowledge base and platform for semantic and logic representation and study of ADEs of more drugs in the future.
Electronic supplementary material
The online version of this article (10.1186/s12859-019-2729-1) contains supplementary material, which is available to authorized users.
BACKGROUND
Severe chemotherapy-induced peripheral neuropathy (CIPN) can cause long-term dysfunction of the hands and feet, interfere with activities of daily living, and diminish quality of life. Monitoring to identify CIPN before it progresses to life-altering severity relies on patients self-reporting subjective symptoms to their clinical team. Objective assessment is not a standard component of CIPN monitoring due to the requirement for specially trained healthcare professionals and equipment. Smartphone apps have the potential to conveniently collect both subjective and objective CIPN data directly from patients, which could improve CIPN monitoring.
OBJECTIVE
The objective of this cross-sectional pilot study was to assess the feasibility of functional CIPN assessment via smartphone app.
METHODS
Twenty-six patients who had completed neurotoxic chemotherapy were enrolled and classified as CIPN cases (n=16) or controls (n=10) based on self-report symptoms. All participants completed CIPN assessments within the NeuroDetect app a single time including patient-reported surveys (CIPN20 and PRO-CTCAE) and functional assessments (Gait and Balance and 9 Hole Peg Test).
RESULTS
Exploratory comparisons between CIPN cases and controls indicate CIPN cases had shorter step length (P=.003), unique swaying acceleration patterns during a walking task, and shorter hand moving distance during a manual dexterity task.
CONCLUSIONS
Our results confirm that remote CIPN assessment via a smartphone app is feasible and suggest that functional data may be indicative of CIPN manifestations in the hands and feet. Additional work is needed to determine which functional assessments are most indicative of CIPN and could be used for CIPN monitoring within clinical care.
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