US 6081786 Systems, methods and computer program products for guiding the selection of therapeutic treatment regimens

ABSTRACT – Systems, methods and computer program products for guiding selection of a therapeutic treatment regimen for a known disease such as HIV infection are disclosed. The method comprises (a) providing patient information to a computing device (the computer device comprising: a first knowledge base comprising a plurality of different therapeutic treatment regimens for the disease; a second knowledge base comprising a plurality of expert rules for selecting a therapeutic treatment regimen for the disease; and a third knowledge base comprising advisory information useful for the treatment of a patient with different constituents of the different therapeutic treatment regimens; and (b) generating in the computing device a listing (preferably a ranked listing) of therapeutic treatment regimens for the patient; and (c) generating in the computing device advisory information for one or more treatment regimens in the listing based on the patient information and the expert rules.

FIELD OF THE INVENTION

This invention concerns systems, methods and computer program products for guiding the selection of therapeutic treatment regimens for complex disorders such as cancer and HIV-1 infection, wherein a ranking of available treatment regimens is generated and advisory information clinically useful for treating patients is provided.

BACKGROUND OF THE INVENTION

Therapeutic treatment regimens for disorders such as HIV-1 infection (acquired immune deficiency syndrome or AIDS) and cancer are increasingly complex. New data and new therapeutic treatment regimens continue to modify the treatments available, and it is difficult for all but the specialist to remain current on the latest treatment information. Further, even those who are current on the latest treatment information require time to assimilate that information and understand how it relates to other treatment information in order to provide the best available treatment for a patient. Combination therapeutic treatment regimens exacerbate this problem by making potential drug interactions even more complex. Finally, an increasingly sophisticated patient population, in the face of a vast volume of consumer information on the treatment of disease, makes the mere statement of a treatment regime, without explanation, difficult for the patient to accept.

R. Miller et al., Summary Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems, Ann. Intern. Med. 127, 842-845 (1997), describes policy guidelines indicating the desirability of systems that generate advice for clinician users in a manner that users can easily override. Solutions to this need are neither suggested nor disclosed.

M. Pazzani et al., Application of an Expert System in the Management of HIV-Infected Patients, J. Acquired Immune Deficiency Syndromes and Human Retrovirology 15, 356-362 (1997) (accepted May 12, 1997), describes a rule-based expert system by which protease, reverse transcriptase, and integrase segments of HIV are cloned and entered into an expert system that recommends two, three, and four drug regimens. A means for easily overriding the advice given is neither suggested nor disclosed.

U.S. Pat. No. 5,672,154 to Sillen describes a method for giving patients individualized, situation-dependent medication advice. The recommended type of medicine may include at least two different medicines. No means for ranking multiple treatment options is disclosed, and no means for explaining why treatment options were rejected is given. Rather, this system is primarily concerned with generating new rules from patient information to optimize a particular therapy for diseases such as Parkinson’s disease, epilepsy and abnormal blood pressure.

U.S. Pat. No. 5,694,950 to McMichael describes a method and system for use in treating a patient with immunosuppressants such as cyclosporin. An expert system is employed to generate a recommendation on whether the immunosuppressant dosage should be changed and, if so, how. Ranking or selection among a plurality of different combination therapeutic treatment regimens is not suggested.

U.S. Pat. No. 5,594,638 to Iliff describes a medical diagnostic system that provides medical advice to the general public over a telephone network. This system is not concerned with generating a recommendation for a combination therapeutic treatment regimen for a known disease (see also U.S. Pat. No. 5,660,176 to Iliff).

SUMMARY OF THE INVENTION

In view of the foregoing, an object of the invention is to provide systems, methods and computer program products for selecting therapeutic treatment regimens for patients in which available treatments are listed, and optionally ranked, while unavailable or rejected treatment regimens (e.g., regimens that would not be effective, or would be dangerous) are not displayed or are assigned a low rank and are indicated to a user as not likely to be efficacious, or not preferred due to patient-specific complicating factors such as drug interaction from concomitant medications.

A further object of the invention is to provide systems, methods and computer program products for selecting treatment regimens in which the available treatment options can be readily understood.

A further object of the invention is to provide systems, methods and computer program products for selecting treatment regimens in which the implications of selecting a particular treatment regimen can be readily understood.

A further object of the invention is to provide systems, methods and computer program products for selecting treatment regimens in which the reasons for rejection of a particular regimen can be readily understood.

A still further object of the invention is to provide systems, methods and computer program products for obtaining information about the efficacy of previous treatment regimens imposed on patients.

A method of the present invention includes providing patient information to a computing device that includes various knowledge bases. For example, a first knowledge base may include a plurality of different therapeutic treatment regimens for a disease or medical condition. A second knowledge base may include a plurality of expert rules for selecting a therapeutic treatment regimen for the disease or medical condition. A third knowledge base may include advisory information useful for the treatment of a patient with different constituents of different therapeutic treatment regimens. A fourth knowledge base may include information about past therapies, such as how a patient has fared under previous therapies.

A listing (preferably a ranked listing) of therapeutic treatment regimens for a patient is generated in the computing device. Advisory information for one or more treatment regimens in the listing is generated in the computing device based on the patient information and the expert rules.

In a preferred embodiment, the method described above further includes entering a user-defined therapeutic treatment regimen for the disease (or medical condition) that may not be displayed from the system knowledge base-generated therapeutic treatment regimens, and generating in the computing device advisory information for the user-defined combination therapeutic treatment regimen.

In addition, in a preferred embodiment, the method described above further includes entering a rejected therapeutic treatment regimen for the disease (or medical condition) that is included in the first knowledge base but not recommended from the ranking (or given a very low ranking), and generating in the computing device advisory information for the non-recommended/low ranked therapeutic treatment regimen, wherein the advisory information includes at least one reason for not recommending (or low ranking) the therapeutic treatment regimen.

Further objects and aspects of the present invention are explained in detail in the drawings herein and the specification set forth below.

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