Methods and Systems for Assessing Clinical Outcomes

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.

1 .- 30 . (canceled) 
     
     
         31 . A computer-implemented method of predicting the occurrence of a medical condition, the method comprising:
 (a) measuring concentrations of a first set of biomarkers present in a subject at a given frequency, wherein the first set of biomarkers are suspected to be predictive of the medical condition;   (b) based on the concentrations measured in (a) and with the aid of a computer processor, (i) generating from the first set a subset of biomarkers that are more correlative with the occurrence of the medical condition as compared to the first set and/or (ii) generating a new frequency of measurement of the first set and/or the subset of biomarkers; and   (c) measuring (i) concentrations of the subset of (b) and/or (ii) following the new frequency of measurement of the first set or the subset of biomarkers to yield a trajectory that is predictive of the occurrence of the medical condition, which trajectory is within a probability space that is defined by discrete clinical outcomes associated with said medical condition, wherein each discrete clinical outcome is characterized by a statistical distribution of a set of biological marker(s) among said first set of biomarkers.   
     
     
         32 . The method of  claim 31 , wherein (a) further comprises measuring one or more physiological indicators of said subject at said given frequency. 
     
     
         33 . The method of  claim 31 , further comprising analyzing data reflecting the concentrations and/or the physiological indicators with multivariate statistical software. 
     
     
         34 . The method of  claim 31 , wherein the biomarkers are present in a biological sample of said subject. 
     
     
         35 . The method of  claim 31 , further comprising notifying a medical personnel or the subject of a need for taking a medical action based upon said trajectory. 
     
     
         36 . A computer-implemented method for characterizing a medical condition of a subject, comprising:
 (a) obtaining, from the subject, a set of subject data over a series of time points, wherein said set of subject data corresponds to a first set of biological parameters comprising at least one biological marker and at least one physiological parameter;   (b) determining, with the aid of a computer processor, the probability that, at a given time point in said series, said subject data belongs to a given discrete clinical outcome among a plurality of discrete clinical outcomes associated with said medical condition, each of which discrete clinical outcomes is characterized by a statistical distribution comprising a subset of biological parameters among said set of biological parameters; and   (c) producing, with the aid of a computer processor, a time series analysis of said set of subject data to characterize, in a probability space defined by said plurality of discrete clinical outcomes, a state or trend of the medical condition of said subject.   
     
     
         37 . The method of  claim 36 , further comprising selecting a second set of subject data from said set of subject data, wherein said second set of subject data is more indicative of the probability of the medical condition as compared to said set of subject data. 
     
     
         38 . The method of  claim 37 , further comprising obtaining said second set of subject data from the subject at various time points. 
     
     
         39 . The method of  claim 36 , further comprising notifying a medical personnel or the subject of a need for taking a medical action based upon said state or trend. 
     
     
         40 . A computer-implemented method for monitoring subject response to therapy, comprising:
 (a) obtaining longitudinal subject data corresponding to at least one biomarker in a set of biomarkers for a clinically relevant condition to generate a trend of the subject data in a probability space that is defined by a plurality of discrete clinical outcomes associated with said clinically relevant condition, each of which discrete clinical outcomes is characterized by a statistical distribution of biomarker(s) selected from said set of biomarkers, wherein the longitudinal subject data is obtained from a subject receiving a therapy;   (b) monitoring, with the aid of a computer processor, a periodicity of the trend; and   (c) corresponding the periodicity of the trend to a response to the therapy received by the subject.   
     
     
         41 . The method of  claim 40 , further comprising identifying said set of biomarkers prior to (a). 
     
     
         42 . The method of  claim 40 , wherein said trend of the subject data comprises a trajectory that is indicative of the likelihood of progression of the subject data to a discrete clinical outcome. 
     
     
         43 . The method of  claim 40 , wherein (c) further comprises measuring values of peak measurements of the periodicity of the trend. 
     
     
         44 . The method of  claim 43 , further comprising characterizing the values of the peaks, thereby characterizing the periodicity of the clinically relevant condition. 
     
     
         45 . The method of  claim 44 , further comprising calculating, with the aid of a computer processor, a velocity based on said trend and/or said characterization, wherein said velocity is indicative of the progression, regression or state of the medical condition of the subject. 
     
     
         46 . The method of  claim 40 , further comprising notifying a medical personnel or the subject of a need for taking a medical action based upon a correspondence between the periodicity of the trend and the response to the therapy. 
     
     
         47 . A computer-implemented method for monitoring health or a medical condition of a subject, comprising:
 (a) obtaining longitudinal subject data corresponding to at least one set of markers for a clinically relevant condition to obtain a trend of the subject data in a probability space that is defined by a plurality of discrete clinical outcomes associated with said clinically relevant condition, wherein said trend is characterized by a time-dependent probability of said subject data belonging to a cluster of data associated with each set characterizing each discrete clinical outcome, and wherein the subject data is obtained from the subject receiving a therapy;   (b) monitoring, with the aid of a computer processor, a time dependent change of the probability; and   (c) correlating, with the aid of a computer processor, the time dependent change of the probability to the therapy received by the subject, thereby monitoring the health or medical condition of said subject.   
     
     
         48 . The method of  claim 47 , further comprising measuring one or more physiological indicators of said subject at a given frequency prior to monitoring said time dependent change. 
     
     
         49 . The method of  claim 47 , further comprising generating a report that indicates the correlation of the time dependent change of the trend to the therapy received by the subject. 
     
     
         50 . The method of  claim 47 , further comprising notifying a medical personnel or the subject of a need for taking a medical action based upon said monitoring.