Systems and methods for tracking patient events
Inventors
Kuchibotla, Anand • Green, Dominic • Konigsburg, Eitan Meir • Donegan, Janet • Tseng, Jessie • Sutton, Lauren • Bafna, Rahul • Choudhry, Raman • Leung, Angel • Greenleaf, Paul • Wang, Victor J.
Assignees
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Publication Number
US-11783923-B2
Publication Date
2023-10-10
Expiration Date
Abstract
A system for tracking adverse events may include at least one processing device programmed to receive a request from a user to record an adverse event experienced by a patient; receive a search term input by the user; identify, in an adverse event database and based on the search term, at least one database record for an adverse event, wherein the at least one database record includes an adverse event type and at least one characteristic; receive, via an input field, a rating of the at least one characteristic for the patient; generate an adverse event record based on the adverse event type and the rating; and store the adverse event record in an adverse event log.
Core Innovation
A point-of-care software system and workflow track patient adverse events during clinical trials by receiving a user request to record an adverse event experienced by a patient and receiving a search term input by the user. The system identifies, in an adverse event database, at least one database record for an adverse event based on the search term, where the at least one database record includes an adverse event type and at least one characteristic.
The system receives, via an input field, a rating of the at least one characteristic for the patient and generates an adverse event record based on the adverse event type and the rating. The system stores the adverse event record in an adverse event log and assigns the adverse event record an initial record status used for assigning the adverse event record for review based on the storage of the adverse event record.
The system displays, on a first graphical user interface, an indication of the initial record status of the adverse event record. The workflow includes sign-off and audit control using a supervising physician alert and digital signature credentialing, and it provides graphical user interfaces and modules associated with trial regimen, concomitant medication, and medical history while using similar search, relevance, and ranking concepts.
Claims Coverage
The independent claim coverage includes three independent claims (system, method, and computer-readable medium) that share the same core inventive sequence of receiving a user request and search term, retrieving adverse-event database records with an adverse event type and characteristics, receiving a rating, generating and logging an adverse event record, assigning an initial record status for review, and displaying an indication of the initial record status on a graphical user interface.
Search-term based adverse-event database record identification
Receive a request from a user to record an adverse event experienced by a patient; receive a search term input by the user; identify, in an adverse event database and based on the search term, at least one database record for an adverse event, wherein the at least one database record includes an adverse event type and at least one characteristic.
Characteristic rating to generate an adverse event record
Receive, via an input field, a rating of the at least one characteristic for the patient; generate an adverse event record based on the adverse event type and the rating.
Adverse event logging with initial record status assignment for review
Store the adverse event record in an adverse event log; based on the storage of the adverse event record, assign the adverse event record an initial record status used for assigning the adverse event record for review.
Initial record status indication on a first graphical user interface
Display, on a first graphical user interface, an indication of the initial record status of the adverse event record.
Supervising physician sign-off via digital signature credentialing
Transmit an alert about a stored adverse event record to a supervising physician device, receive a digital signature for the adverse event record, and update the displayed initial record status to a signed record status.
Relevance scoring and ranking of database records by search term
Generate relevance scores for each database record by comparing each database record to the search term; rank the database records by the relevance scores; display a predetermined number of the top ranked records to the user.
Rating as a severity level of the adverse event
Define the rating such that the rating indicates a level of severity of the adverse event experienced by the patient.
Trial regimen relatedness measure tied to adverse event type
Receive a measure of how related an adverse event type is to a trial regimen.
Unsigned initial record status indication
Constrain the displayed initial record status for an adverse event record to include an indication that the record status is unsigned.
Supervising physician authentication prior to digital signature
Authenticate the supervising physician before receiving a digital signature.
Across the independent claims, the invention centers on search-term driven retrieval of adverse-event database records (with adverse event type and characteristics), patient-provided rating of characteristics to generate an adverse event record, storage in an adverse event log with assignment of an initial record status for review, and display of an initial record status indication on a graphical user interface. Dependent claim refinements include relevance scoring and ranked results, mapping rating to severity, trial-regimen relatedness measures, and a supervising physician review workflow using digital signatures with unsigned-to-signed status updates and supervising-physician authentication.
Stated Advantages
Supports review workflows by assigning an initial record status used for assigning the adverse event record for review.
Provides sign-off and audit control using a supervising physician alert and digital signature credentialing, including status update to a signed record status.
Enables retrieval of relevant adverse-event records using a search term with relevance scoring and ranking.
Supports patient adverse-event capture in a point-of-care software system during clinical trials via graphical user interfaces and associated modules (trial regimen, concomitant medication, medical history).
Documented Applications
Tracking patient adverse events during clinical trials in a point-of-care software system.
Review/sign-off workflow for stored adverse event records involving a supervising physician, digital signatures, and audit controls.
User-guided selection and association of adverse event records with trial regimen, concomitant medication, and medical history using search, relevance, and ranking concepts.
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