Clinical effect of pharmaceutical products using communication tool integrated with compound of several pharmaceutical products

Abstract

A method of treating a medical condition with a combination of substances, wherein one of the substances is adalimumab, in combination with a computer program configured for: providing a patient with sets of questions adapted to the combination, to adalimumab, and to the non-adalimumab substances, wherein at least one of the sets of questions is related to perceived and/or measured therapeutic effects; subjecting the answers to the sets of questions to functions, thereby generating patient specific feedback; and adjusting a dosage of at least one substance based at least in part on the patient-specific feedback.

1 . A method of treating a medical condition with a combination of N substances, wherein N>1, with pharmaceutical activity against the medical condition, wherein one substance is adalimumab, in combination with a computer program product comprising instructions causing a computer to perform a method comprising the steps
 providing a patient undergoing an administration and dosing regimen with the combination with a set of questions according to a question schedule, wherein said set of questions is adapted to said combination of substances;   providing the patient with a set of questions according to a question schedule, wherein said set of questions is adapted to adalimumab;   providing a patient with N-1 sets of questions according to N−1 question schedules, wherein each set of questions is adapted to one of the substances not being adalimumab in said combination; wherein at least one of the above sets of questions is related to the perceived and/or measured therapeutic effects;   collecting answers to said sets of questions from said patient;   subjecting the answers to said set of questions adapted to said combination of substances to a set of functions, thereby generating a first patient specific feedback information;   subjecting the answers to said sets of questions each adapted for one of the substances in said combination, to N sets of functions, thereby generating a second patient specific feedback information;   providing said first and second patient specific feedback to the patient; and   adjusting a dosage of at least one substance based at least in part on patient-specific feedback information to obtain an updated dosage regimen;   
       the method of treatment further comprising administering the combination of substances as part of the updated dosage regimen. 
     
     
         2 . The method according to  claim 1 , wherein the computer program product comprises instructions causing a computer to perform a method comprising the steps
 providing at least one further respondent in addition to said patient with a second set of questions according to a second question schedule, wherein said second set of questions (is adapted to the combination of substances and/or to at least one of the substances in said combination;   collecting answers to said questions from said further respondent;   subjecting said answers from said further respondent to a second set of functions adapted to the second set of questions and the combination of substances and/or to at least one of the substances in said combination thereby generating patient-specific feedback information;   providing said feedback information to the patientand, optionally, to the further respondent.   
     
     
         3 . The method according to  claim 1 , wherein the computer program product comprising instructions causes a computer to perform a method comprising the steps
 a) providing a patient and optionally a further respondent with sets of questions according to a question schedule, wherein said sets of questions are adapted to the combination of substances and/or to at least one of the substances in said combination;   b) collecting answers to said questions from said patient and optionally said further respondent;   c) subjecting said answers to a set of functions adapted for the sets of questions and the pharmaceutical product thereby generating patient-specific feedback information;   d) providing said feedback information to the patient and optionally to the further respondent;   e) extracting information from said answers and providing said information to a database adapted for storing information collected during clinical use of said combination of substances;   f) providing information stored in said database to a reviser subjecting the sets of questions and/or the sets of functions to a revision based on said information stored in said database;   g) obtaining a revised set of questions and/or a revised set of functions from said reviser; and   h) repeating steps a)-g).   
     
     
         4 . The method according to  claim 3 , wherein said database is adapted for storing information collected from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using said combination of substances in combination with said computer program product. 
     
     
         5 . The method according to  claim 3 , wherein said revision is based on information collected from said patient and/or other patients clinically using said combination of substances in combination with said computer program product. 
     
     
         6 . The method according to  claim 3 , wherein said revision is based on information obtained during clinical trials of the substance and/or commercial use of the substance. 
     
     
         7 . The method according to  claim 3 , wherein said database is adapted to store information comprising one or more of: patient identifier, respondent identifier, individual caregiver identifier, organizational caregiver identifier, substance identifier, substance combination identifier, respondent answers, type and date of occurrence of adverse events, type and degree of adverse effects of one or more substance or substance combination, probability of an adverse event, probability of an adverse effect, patient health status, patient history, patient family history, patient genetic information, prescribed dosage or administration regimen, drug-drug interactions, life-style factors. 
     
     
         8 . The method according to  claim 1 , wherein the clinical relevance of the combination of said set of questions and said set of functions has been validated in clinical trials. 
     
     
         9 . The method according to  claim 1 , wherein said set of questions and said set of functions are related to patient compliance to a preferred or prescribed dosage and/or administration regimen of said combination of substances. 
     
     
         10 . The method according to  claim 1 , wherein said set of questions and said set of functions are related to an indication of possible occurrence or development of an adverse event. 
     
     
         11 . The method according to  claim 1 , wherein said set of questions and said set of functions are related to the patient's quality of life. 
     
     
         12 . The method according to  claim 1 , wherein at least a subset of the set of questions is related to the actual administration; actual dosage; test results and/or perceived quality of life. 
     
     
         13 . The method according to  claim 1 , wherein the method further comprises subjecting said answers to a set of functions specific for the set of questions and the pharmaceutical product thereby generating an updated question schedule, wherein said set of functions optionally use Computer Adaptive Testing and/or Item Response Theory. 
     
     
         14 . The method according to  claim 1 , wherein said set of functions include functions selected from the group consisting of: calculations of target parameters and trend lines; prediction of development of a condition; rules and thresholds for defining when to give notifications. 
     
     
         15 . The method according to  claim 1 , wherein said computer program product comprises instructions causing a computer to provide feedback selected from graphs, diagrams, graphical illustrations and text messages. 
     
     
         16 . The method according to  claim 1 , wherein said method provides feedback only to the patient, or to the patient and to other individuals. 
     
     
         17 . The method according to  claim 1 , wherein the arthritis is rheumatoid arthritis or polyarticular juvenile idiopathic arthritis. 
     
     
         18 . The method according to  claim 1 , wherein at least one substance in the combination is methotrexate. 
     
     
         19 . The method according to  claim 1 , wherein said computer program product is provided on a physical medium or by means or instructions for accessing and installing the computer program product on a computer. 
     
     
         20 . A kit of parts comprising a combination of substances and a computer program product according to  claim 1 , wherein said computer program product is provided by means or instructions for accessing and installing the computer program product on a computer and said kit further comprises an identifier unique to the kit.