Mathematical therapeutic outcomes model for predicting...

Surgery – Diagnostic testing

Reexamination Certificate

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C128S920000, C128S897000

Reexamination Certificate

active

06666820

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of methods and systems for aiding clinical health care providers in choosing the most appropriate therapy for a given clinical situation and predicting the effectiveness of a prescribed course of action in treating disease.
2. Description of the Prior Art
Traditionally, a medical practitioner has applied clinical findings and circumstances, along with his experience, knowledge, and training, to predict the effectiveness of one course of treatment over another. Such a prediction has assisted the health care provider in choosing the most appropriate therapy for a given clinical situation. In many cases, the clinician has used subconscious decision-making algorithms. Given the relatively large number of variables and factors that can be involved in making even the simplest medical decisions, it is possible that certain factors or considerations may not always be given the proper weight in determining the most effective treatment for a specific clinical condition or disease.
In recent years, computers have been adapted in a variety of ways to assist clinicians in determining a course of treatment for their patients. For example, in U.S. Pat. No. 6,081,786, titled Systems, Method and Computer Program Products For Guiding The Selection of Therapeutic Treatment Regimens, Barry et al. taught a way to guide a health care provider in the selection of a therapeutic treatment regimen for a known disease, such as HIV. The method included providing patient information to a computer, generating a ranked listing of therapeutic treatment regimens, and generating information for one or more treatment regimens in the listing based on patient information and expert rules. The computer used three knowledge bases, including different therapeutic treatment regimens, expert rules, and advisory information useful for the treatment of a patient with different constituents of the different therapeutic treatment regimens.
Similarly, in U.S. Pat. No. 6,126,596, titled Apparatus and Method For Evaluating a Client's Condition and The Concordance of a Clinician's Treatment With Treatment Guidelines, Freedman taught a system to collect data directly from a patient and use this data to diagnose and to establish the severity of a client's condition. The system used this data to look up one or more appropriate treatments according to treatment guidelines stored in its memory. The system then used this information to monitor if the treatment decisions made by the treating clinician or other medical provider was consistent with the stored treatment guidelines.
Many such systems have been proposed which attempt to harness the vast analysis capability of a computer, and to exploit the computer's speed in taking into account a large number of variables. Unfortunately, none of the systems thus far proposed utilize a dynamic system to predict the effectiveness of a proposed treatment protocol, in order to assist the clinician in selecting the most effective course of treatment for a patient. The present invention is directed to this shortfall in the art.
SUMMARY OF THE INVENTION
The present invention provides a method and system which allows a user, such as a physician or other clinical care provider, to consistently and logically place and correlate the various interdependent facts or assumptions made during the examination and testing of a patient in a fashion that provides a numerical estimate of treatment effectiveness.
When a patient or other person presents with an unknown disease or condition, a physician or other care giver typically conducts a physical examination of the patient, which may include certain laboratory or other tests, as well as an interview, in an attempt to ascertain the nature of the patient's problems. After conducting an examination and interview, the physician typically possesses certain facts which bear on his or her determination of the patient's disease. Through the use of appropriate algorithms and/or formulas, certain facts from a particular case may be used to produce and describe the efficacy of a specific treatment modality for a particular disease or ailment.
For instance, in the case of bacterial rhinosinusitis, certain variables are known to effect the outcome of various types of treatment. Typically, bacterial rhinosinusitis is treated with antibiotics. However, in some cases, the disease may spontaneously resolve or may not resolve even after a course of antibiotics, such as in the case where the cause of the sinusitis is viral rather than bacterial. In practicing the present invention, the physician provides the system with the required data which corresponds to the variables identified for the given disease or condition which is being considered. The system of the invention then processes these variables using certain predetermined algorithms to generate a probability of effectiveness. These indicators correspond to the efficacy of various treatment options to aid the physician in selecting an appropriate option for a particular patient.
Thus, in specific aspect, the present invention provides a method of predicting the efficacy of a medical treatment. More particularly, that method comprises the steps of developing a clinical diagnosis of a disease; determining the statistical incidence of incorrect diagnosis of the disease; determining the statistical incidence of the contribution of known pathogens to the correctly diagnosed disease; determining the statistical incidence of disease caused the determined pathogens, which does not spontaneously resolve; determining the statistical efficacy of predetermined treatments for the incidence of the determined disease; and based on these determinations, calculating the likelihood of resolution of the disease, indicative of the efficacy of the predetermined treatments. The present invention further provides a means of carrying out this method.
The present invention also provides a method and a system which comprises an interdependent array of data, wherein alteration of any entry in the array of data alters the end results of the prediction of the efficacy of the treatment. The array of data comprises the clinical picture of the patient having the presumed diagnosis, as well as the enumerated factors which alter that clinical picture.
The system and method of the present invention may be employed in a number of embodiments. For instance, it may be used as part of a spreadsheet which may be used in conjunction with any conventional personal computer or similar computer device. It may be employed as a stand alone or self contained computer application or applet or it may be used in conjunction with a suitable database program.


REFERENCES:
patent: 6520917 (2003-02-01), Kunig et al.
Sinus and Allergy Health Partnership, “Antimicrobial Treatment Guidelines for Acute Bacterial Rhinosinusitis,” Otolaryngol Head Neck Surg. Jul. 2000; 123 No. 1, Part 2, (Suppl.): ppS1-S31, and particularly pp. S5-S31.

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