PHARMACEUTICAL PRODUCT AND COMMUNICATION TOOL
The present invention relates to a substance with pharmaceutical activity against a medical condition for use in a treatment of said medical condition in combination with a computer program product comprising instructions causing a computer to perform a method comprising the steps providing a patient with a set of questions according to a question schedule, wherein said set of questions is specific to the pharmaceutical product; collecting answers to said questions from said patient; subjecting said answers to a set of functions specific for the set of questions and the pharmaceutical product thereby generating patient specific feedback information; providing said feedback information to the patient; and optionally extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of said substance. The invention further relates to a corresponding kit-of-parts comprising the substance and the computer program product, and the computer program product and its method as such.
1 . Method for treatment or prevention of Acute Coronary Syndrome comprising the use of ticagrelor in combination with a computer program product comprising instructions causing a computer to perform a method comprising the steps
providing a patient with a set of questions according to a question schedule, wherein said set of questions is specific to ticagrelor;
collecting answers to said questions from said patient;
subjecting said answers to a set of functions specific for the set of questions and ticagrelor thereby generating patient-specific feedback information;
providing said feedback information to the patient.
2 . The method according to claim 1 , further comprising extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of said substance.
3 . The method according to claim 1 , wherein the computer program product comprises instructions causing a computer to perform a method comprising the steps
h) providing a patient and optionally a further respondent with sets of questions according to a question schedule, wherein said sets of questions are specific for ticagrelor;
i) collecting answers to said questions from said patient and optionally said further respondent;
j) subjecting said answers to a set of functions specific for the sets of questions and the pharmaceutical product thereby generating patient-specific feedback information;
k) providing said feedback information to the patient and optionally to the further respondent;
l) extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of ticagrelor;
m) obtaining a revised set of questions and/or a revised set of functions by subjecting the sets of questions and/or the sets of functions to a review based on clinically relevant information collected during clinical use of ticagrelor; and
n) repeating steps a)-f) for the duration of said treatment.
4 . The method according to claim 3 , wherein said review is based on information collected from the patient.
5 . The method according to claim 3 , wherein said review is based on information collected from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using ticagrelor in combination with said computer program product.
6 . The method according to claim 1 , wherein said review is based on clinically relevant information obtained during clinical trials of the substance and/or commercial use of ticagrelor.
7 . The method according to claim 1 , wherein the clinical relevance of the combination of ticagrelor, said set of questions and said set of functions has been validated in clinical trials.
8 . 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 pharmaceutical product.
9 . The method according to claim 1 , wherein at least a subset of said set of questions and said set of functions are related to an indication of possible occurrence or development of an adverse event and/or side effect.
10 . The method according to claim 1 , wherein at least a subset of said set of questions and said set of functions are related to the patient's quality of life.
11 . The method according to claim 1 , wherein at least a subset of the set of questions is related to the actual administration; actual dosage; perceived and/or measured therapeutic effects; test results and/or perceived quality of life.
12 . A 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 ticagrelor thereby generating an updated question schedule, wherein said set of functions optionally use Computer Adaptive Testing and/or Item Response Theory.
13 . The method according to claim 1 , wherein said set of functions include functions selected from the group consisting of: calculations of target parameters, threshold values and trend lines; prediction of development of a condition; rules and thresholds for defining when to give notifications.
14 . 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, such as traffic light type color signals, and text messages.
15 . The method according to claim 1 , wherein said method provides feedback only to the patient, or to the patient and to other individuals.
16 . 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.
17 . The method according to claim 1 , wherein the set of questions comprises at least one question relating to the patient's intake of ticagrelor, subjecting the answer to a set of functions generating patient-specific feedback on the adherence to the prescribed ticagrelor dosage regimen, and providing the generated patient-specific feedback to the patient.
18 . The method according to claim 17 , wherein the patient-specific feedback on adherence comprises a color signal.
19 . The method according to claim 17 , wherein the patient-specific feedback on adherence comprises a graph.
20 . The method according to claim 17 , wherein the patient-specific feedback on adherence comprises information about the patient's adherence to the prescribed ticagrelor dosage regimen for the past seven days.
21 . The method according to claim 17 , wherein the patient-specific feedback on adherence comprises a text message.
22 . The method according to claim 17 , wherein the patient-specific feedback on adherence comprises a numerical value representing the relation between the number of actual ticagrelor doses taken and the prescribed number of ticagrelor doses in a time interval.
23 . The method according to claim 1 , wherein the set of questions further comprise questions relating to at least one of: level of physical activity; weight; smoking habits; blood levels of cholesterol, lipids and/or LDL; blood levels of glucose and/or HbA1c; blood pressure.
24 . The method according to claim 1 , wherein adherence to ticagrelor treatment is improved.
25 . The method according to claim 1 , wherein the patient has an increased likelihood of lowering his or her Body Mass Index.
26 . The method according to claim 1 , wherein the patient has an increased likelihood of increasing his or her level of physical activity.
27 . The method according to claim 1 , wherein the patient's blood levels of LDL are lowered.
28 . The method according to claim 1 , wherein the patient has an increased likelihood of smoking cessation.
29 . The method according to claim 1 , wherein the patient's quality of life is improved.
30 . Method for reducing patient mortality during ticagrelor treatment, comprising a method according to claim 1 .
31 . Method for improving patient adherence to a prescribed ticagrelor dosage regimen during ticagrelor treatment, comprising a method according to claim 1 .
32 . Method for reducing Body Mass Index of a patient during ticagrelor treatment, comprising a method according to claim 1 .
33 . Method according to claim 33 , wherein said patient has a Body Mass Index>30 before start of the ticagrelor treatment.
34 . Method for aiding a patient to quit smoking during ticagrelor treatment, comprising a method according to claim 1 .
35 . Method for enhancing patient assessed quality of life during ticagrelor treatment, comprising a method according to claim 1 .
36 . Method for lowering blood levels of Low Density Lipoprotein (LDL) in a patient during ticagrelor treatment, comprising a method according to claim 1 .
37 . Method for increasing physical activity in a patient population during ticagrelor treatment, comprising a method according to claim 1 .
38 . The computer program product of claim 1 .
39 . A kit of parts comprising
a) ticagrelor; and
b) the computer program product according to claim 1 .
40 . A kit according to claim 39 , 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.
41 . A kit according to claim 39 , wherein said computer program product is provided by means or instructions for accessing and installing the computer program product on a computer.
42 . A kit according to claim 39 , 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