Methods and systems for assessing clinical outcomes

a clinical outcome and system technology, applied in the field of methods for assessing a patient's clinical outcome, can solve the problems of reducing patient care, affecting patient care, and affecting patient care,

Inactive Publication Date: 2009-12-24
THERANOS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0004]The present invention provides a medical information system for subject data analysis. In one aspect, a system of the present invention is particularly useful for advancing the future of blood testing and data analysis. For example, the system can be part of an integrated infrastructure built around real-time, point-of-care consumer blood monitoring devices which analyze a small blood sample (e.g., 500 ul, 50 ul, 25 ul, 10 ul or even less) and wirelessly transmit t

Problems solved by technology

The conventional methods generally involve laboratory tests, patient surveys and office visits at isolated time points, all of which are not scalable for a time series analysis, especially for one that tracks or predicts the trend of a patient's clinical outcome in real time.
Intrinsic to the conventional methodologies is the profound drawback that a relatively small set of information such as a single clinician's personal preference

Method used

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  • Methods and systems for assessing clinical outcomes
  • Methods and systems for assessing clinical outcomes
  • Methods and systems for assessing clinical outcomes

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0240]Prostate Cancer and Anti-Angiogenesis Treatment

[0241]A Phase I or Phase IIa clinical trial for treating a subject diagnosed with prostate cancer with an anti-angiogenic drug allows for dose adjustments during the trial. The subject is monitored over a course of time during the clinical study. The method of action of the anti-angiogenic drug is to halt the growth of blood vessels in and around the tumor, thereby depriving the tumor of adequate blood supply. This may induce ischemia and nutritional necrosis in the tumor, thereby debulking the tumor.

[0242]After the method of action is determined, discrete clinical outcomes are chosen by medical personnel, such as a physician or clinical monitor. The discrete clinical outcomes chosen in this example are complete response (CR), partial response (PR), non-response (NR), and adverse drug reaction (ADR). The ADR related to the anti-angiogenic drug is hypertensive encephalopathy in this example.

[0243]Six biomarkers representative of th...

example 2

[0248]Sepsis and Anti-TNF Treatment

[0249]Subjects with confirmed or suspected sepsis or systemic inflammatory response syndrome (SIRS) are treated with an anti-TNF therapeutic during a Phase Ilb (dose adjustment allowed) or a Phase III (no dose adjustment allowed) clinical trial. The subject is monitored over a course of time during the clinical study. The method of action of the anti-TNF drug is anti-inflammatory. The drug is aimed at preventing or circumscribing downstream sequellae of sepsis. Typically, the anti-TNF drug is given in conjunction with a broad spectrum antibiotic.

[0250]After the method of action is determined, discrete clinical outcomes are chosen by a physician. The discrete clinical outcomes chosen in this example are response (R), non-response (NR), and four sequellae (disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), acute liver failure (ALF), and acute renal failure (ARF))

[0251]Twenty biomarkers representative of the medi...

example 3

[0257]Diabetes and Insulin Sensitization

[0258]Subjects with non-insulin-dependent Type 2 diabetes are treated with a commercially available insulin sensitizer and are monitored for efficacy and safety wherein the primary ADR of concern is congestive heart failure (CHF). The subject is monitored over a course of time during the clinical study. The method of action of the insulin sensitizer involves re-establishing insulin sensitivity in the subject via antagonism of a nuclear receptor in the adipose tissue and the liver. The insulin sensitizer and method of action act to increase glucose uptake in the peripheral tissues and thus reduce the circulating glycemia.

[0259]A subject and a physician choose the best set of discrete clinical outcomes and rules for the subject based on personal information. The discrete clinical outcomes are response (R), non-response (NR), and adverse drug reaction (ADR). The ADR is congestive heart failure.

[0260]After the three clinical outcomes are chosen, b...

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Abstract

Described herein are methods and systems useful for characterizing clinical outcomes of a subject. Provided herein includes computer-assessed methods, medical information systems, and computer-readable instructions that can aid an end-user in diagnosis, prognosis, and treatment of a clinical outcome.

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 039,721, fled Mar. 26, 2008, which application is incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Conventional methods for assessing a patient's clinical outcome are primarily based on clinicians' judgment and past experience. The conventional methods generally involve laboratory tests, patient surveys and office visits at isolated time points, all of which are not scalable for a time series analysis, especially for one that tracks or predicts the trend of a patient's clinical outcome in real time. Intrinsic to the conventional methodologies is the profound drawback that a relatively small set of information such as a single clinician's personal preference is taken into consideration in reaching a clinical decision. As such, under the existing medical system, patient care becomes increasingly difficult when multiple variables are involved. In particular, there lacks a sy...

Claims

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Application Information

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IPC IPC(8): A61B5/00G06Q10/00G16B40/30G16H40/20
CPCG06F19/24G06F19/3443G06F19/3437G06Q50/22G06Q10/10G06Q10/00G16H50/50G16H50/70G16B40/00G16C20/70G16C20/90Y02A90/10G16H40/20G16B40/30G16H10/00
Inventor MICHELSON, SETHKEMP, TIMOTHY MICHAELGIBBONS, IANHOLMES, ELIZABETH A.
Owner THERANOS
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