US2014257844A1PendingUtilityA1
System and method for pharmacovigilance
Est. expiryJan 3, 2033(~6.4 yrs left)· nominal 20-yr term from priority
G16Z 99/00G16H 50/70G16H 50/30G06F 19/3431
61
PatentIndex Score
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Claims
Abstract
A method, computer-readable storage medium, and system for analyzing a relationship between one or more agents and one or more clinical outcomes. The method includes: receiving a selection of one or more agents; receiving a selection of one or more clinical outcomes; for each of the one or more agents, analyzing clinical data stored in a database to determine a number of occurrences of each of the one or more clinical outcomes when the agent is administered; for each of the one or more agents, calculating a risk score for each clinical outcome corresponding to the number of occurrences of the clinical outcome; and outputting the risk scores to a graphical display.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A method for analyzing a relationship between an agent and one or more clinical outcomes, the method comprising:
receiving a selection of a first agent; receiving a selection of one or more clinical outcomes; analyzing, by a processor included in a computing device, clinical data stored in a database to determine a number of occurrences of each of the one or more clinical outcomes when the first agent is administered; calculating, by the processor, for the first agent, a first set of risk scores for each of the one or more clinical outcomes, wherein calculating the risk score for a clinical outcome includes measuring a statistical significance of a relationship between the first agent and the clinical outcome based on a total number of patients in an entire population, a number of patients to whom the first agent is administered, a number of occurrences of the clinical outcome when the first agent is administered, and a total number of patients in the entire population that experienced the clinical outcome; outputting the first set of risk scores to a graphical display device, wherein, for the first agent, a first risk score indicates that the first agent is not the cause of a first clinical outcome for a first sub-population that is a subset of the entire population; and generating a first hypothesis by the processor that is based on the first risk score that indicates that the first agent is not the cause of the first clinical outcome for the first sub-population.
2 . The method of claim 1 , further comprising:
generating and outputting a message corresponding to the first hypothesis generated by the processor.
3 . The method of claim 1 , further comprising:
receiving a selection of a second agent; analyzing, by the processor, the clinical data to determine a number of occurrences of each of the one or more clinical outcomes when the second agent is administered; calculating, by the processor, for the second agent, a second set of risk scores for each of the one or more clinical outcomes; outputting the second set of risk scores to the graphical display device, wherein, for the second agent, a second risk score identifies a possible benefit of the second agent for a second sub-population that is a subset of the entire population; and generating a second hypothesis by the processor that is based on the second risk score that indicates that identifies the possible benefit of the second agent for the second sub-population that is a subset of the entire population.
4 . The method of claim 3 , further comprising:
generating and outputting a message corresponding to the second hypothesis generated by the processor.
5 . The method of claim 1 , further comprising:
filtering the clinical data stored in the database based on one or more filters, such that the risk scores are calculated using data that satisfies the one or more filters, wherein the one or more filters include age, gender, clinical stratification scores and identified conditions, and/or an indication of use of the agent.
6 . The method of claim 1 , further comprising calculating a confidence level for the first risk score based on the equation:
(
I
)
[
(
IAO
)
(
I
-
IO
-
IA
+
IAO
)
-
(
IO
-
IAO
)
(
IA
-
IAO
)
]
2
(
IA
)
(
I
-
IA
)
(
IO
)
(
I
-
IO
)
wherein:
I represents the total number of patients in the entire population;
IA represents the number of patients to whom the first agent is administered;
IAO represents the number of occurrences of the first clinical outcome when the first agent is administered; and
IO represents the total number of patients in the entire population that experienced the first clinical outcome.
7 . The method of claim 1 , wherein the first agent comprises a prescription drug.
8 . The method of claim 1 , wherein the first agent exhibits a relatively lower risk score for one of the clinical outcomes compared to the other agents in a common class of agents.
9 . The method of claim 1 , wherein the clinical data stored in a database includes demographic data, lab data, pharmacy data, claims data, diagnostic codes, procedure codes, heath reference information, medical news, standards-of-care, and/or patient-entered data.
10 . The method of claim 1 , further comprising displaying, for each combination of agent and clinical outcome, a circle corresponding to the risk score, wherein a larger circle corresponds to a larger risk score.
11 . A non-transitory computer-readable storage medium storing instructions that when executed by a processor cause a computer system to analyze a relationship between an agent and one or more clinical outcomes, by performing the steps of:
receiving a selection of a first agent; receiving a selection of one or more clinical outcomes; analyzing, by a processor included in a computing device, clinical data stored in a database to determine a number of occurrences of each of the one or more clinical outcomes when the first agent is administered; calculating, by the processor, for the first agent, a first set of risk scores for each of the one or more clinical outcomes, wherein calculating the risk score for a clinical outcome includes measuring a statistical significance of a relationship between the first agent and the clinical outcome based on a total number of patients in an entire population, a number of patients to whom the first agent is administered, a number of occurrences of the clinical outcome when the first agent is administered, and a total number of patients in the entire population that experienced the clinical outcome; outputting the first set of risk scores to a graphical display device, wherein, for the first agent, a first risk score indicates that the first agent is not the cause of a first clinical outcome for a first sub-population that is a subset of the entire population; and generating a first hypothesis by the processor that is based on the first risk score that indicates that the first agent is not the cause of the first clinical outcome for the first sub-population.
12 . The computer-readable storage medium of claim 11 , further comprising:
generating and outputting a message corresponding to the first hypothesis generated by the processor.
13 . The computer-readable storage medium of claim 11 , further comprising:
receiving a selection of a second agent; analyzing, by the processor, the clinical data to determine a number of occurrences of each of the one or more clinical outcomes when the second agent is administered; calculating, by the processor, for the second agent, a second set of risk scores for each of the one or more clinical outcomes; outputting the second set of risk scores to the graphical display device, wherein, for the second agent, a second risk score identifies a possible benefit of the second agent for a second sub-population that is a subset of the entire population; and generating a second hypothesis by the processor that is based on the second risk score that indicates that identifies the possible benefit of the second agent for the second sub-population that is a subset of the entire population.
14 . The computer-readable storage medium of claim 13 , further comprising:
generating and outputting a message corresponding to the second hypothesis generated by the processor.
15 . The computer-readable storage medium of claim 1 , further comprising:
filtering the clinical data stored in the database based on one or more filters, such that the risk scores are calculated using data that satisfies the one or more filters, wherein the one or more filters include age, gender, clinical stratification scores and identified conditions, and/or an indication of use of the agent.
16 . The computer-readable storage medium of claim 11 , further comprising calculating a confidence level for the first risk score based on the equation:
(
I
)
[
(
IAO
)
(
I
-
IO
-
IA
+
IAO
)
-
(
IO
-
IAO
)
(
IA
-
IAO
)
]
2
(
IA
)
(
I
-
IA
)
(
IO
)
(
I
-
IO
)
wherein:
I represents the total number of patients in the entire population;
IA represents the number of patients to whom the first agent is administered;
IAO represents the number of occurrences of the first clinical outcome when the first agent is administered; and
IO represents the total number of patients in the entire population that experienced the first clinical outcome.
17 . The computer-readable storage medium of claim 11 , wherein the first agent comprises a prescription drug.
18 . The computer-readable storage medium of claim 11 , wherein the first agent exhibits a relatively lower risk score for one of the clinical outcomes compared to the other agents in a common class of agents.
19 . The computer-readable storage medium of claim 11 , wherein the clinical data stored in a database includes demographic data, lab data, pharmacy data, claims data, diagnostic codes, procedure codes, heath reference information, medical news, standards-of-care, and/or patient-entered data.
20 . A system comprising:
a clinical data database; and a healthcare organization computing device executing one or more processors to analyze a relationship between a prescription drug and one or more clinical outcomes, by performing the steps of:
receiving a selection of a first prescription drug;
receiving a selection of one or more clinical outcomes;
analyzing, by a processor included in a computing device, clinical data stored in a database to determine a number of occurrences of each of the one or more clinical outcomes when the first prescription drug is administered;
calculating, by the processor, for the first prescription drug, a first set of risk scores for each of the one or more clinical outcomes, wherein calculating the risk score for a clinical outcome includes measuring a statistical significance of a relationship between the first prescription drug and the clinical outcome based on a total number of patients in an entire population, a number of patients to whom the first prescription drug is administered, a number of occurrences of the clinical outcome when the first prescription drug is administered, and a total number of patients in the entire population that experienced the clinical outcome;
outputting the first set of risk scores to a graphical display device, wherein, for the first prescription drug, a first risk score indicates that the first prescription drug is not the cause of a first clinical outcome for a first sub-population that is a subset of the entire population; and
generating a first hypothesis by the processor that is based on the first risk score that indicates that the first prescription drug is not the cause of the first clinical outcome for the first sub-population.Join the waitlist — get patent alerts
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