US20150178470A1 - Clinical effect of pharmaceutical products using communication tool integrated with compound of several pharmaceutical products - Google Patents

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

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Publication number
US20150178470A1
US20150178470A1 US14/417,265 US201314417265A US2015178470A1 US 20150178470 A1 US20150178470 A1 US 20150178470A1 US 201314417265 A US201314417265 A US 201314417265A US 2015178470 A1 US2015178470 A1 US 2015178470A1
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patient
combination
questions
substances
feedback
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Johan Cederlund
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SCIENTIFICMED SWEDEN AB
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SCIENTIFICMED SWEDEN AB
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    • G06F19/363—
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
    • G16Z99/00—Subject matter not provided for in other main groups of this subclass
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/10—Services
    • G06Q50/22—Social work or social welfare, e.g. community support activities or counselling services

Definitions

  • the present invention relates to the field of improving the usage and clinical efficacy of pharmaceutical products in clinical practice, improving health situation of patients, where a combination of pharmaceutical products is one component in the combined product and a computer application is another.
  • a patient should be prescribed multiple separate pharmaceutical products in order to solve the complete health problems of the patient.
  • Patients with, for example, Acute Coronary Syndrome should be prescribed approximately six different pharmaceutical drugs.
  • Drugs on the market today are stand-alone products without any support or connection to the vast amount of data generated during the research and development phase of the product, as well as the information gathered during clinical practice, which could be used for simplifying and optimizing the relation between the patient needs and the pharmaceutical product clinical conditions.
  • the guidance for matching patient specific conditions to the use of pharmaceutical products is limited.
  • the support for finding an optimal dosage for a specific patient is also missing.
  • Medical devices enhancing the therapeutic effect of drugs are known. For instance, specifically designed inhalers are used to administer various anti-asthmatic drugs and implantable devices have been used for controlled release of anti-cancer drugs.
  • WO02095352 Patient compliance and monitoring systems are known in the art, e.g. WO02095352. Such systems are focused on monitoring patient compliance and reporting to the medical practitioner and the patient how the treatment is progressing.
  • the system disclosed in WO02095352 is relevant for a certain condition (menopause) and a general therapy (hormone replacement therapy). It is not specifically adapted for a particular pharmaceutical product.
  • a central aspect of the invention is a combination product where a computer program product is integrated with two or more included pharmaceutical products through a connected question-analysis-feedback model (QAFM).
  • QAFM question-analysis-feedback model
  • a physician will be able to prescribe the combination product, with the following included components; the computer program product, the QAFM and the pharmaceutical products, to patients.
  • This aspect of the invention can be described as a combination of N substances, wherein N>1, with pharmaceutical activity against at least one medical condition for use in a treatment of said at least one medical condition in combination with a computer program product ( 110 ) comprising instructions causing a computer to perform a method comprising the steps
  • the purpose and the effect of the combination product is to enhance and to improve the treatment of the patients, achieving improved clinical effect, safety and quality of life to the patients in clinical practice, compared to using just the particular pharmaceutical products themselves.
  • the purpose and the effect of the invention are fulfilled by several different aspects.
  • QAFM question-feedback model
  • the specific QFM is developed and adapted based on the clinical characteristics of one single specific pharmaceutical product.
  • the QAFM is adapted to each and multiple included QFM, and hence, each included pharmaceutical product.
  • the QAFM is related and adapted to the combination of the included QFM:s.
  • One feature of the invention is that the QAFM, and the QFM:s, are developed to improve the clinical effect, the safety concerns, and the quality of life of patients, based on the clinical characteristics of the included pharmaceutical products and the circumstances and conditions of every specific patient.
  • the QAFM will enable an optimization and individualization of the different included components, such as the QFM:s, the included pharmaceutical products, the adherence and the actual dosage, based upon each specific patient's circumstances, capability and behaviour, in order to achieve an improved clinical effect, safety and quality of life.
  • the optimization and individualization will be performed based upon the answers from each specific patient in relation to existing relevant information regarding clinical use of the actual pharmaceutical products and will be done by the QAFM and the computer program product. For example, a conclusion on such an evaluation can be that a particular patient shall increase the dosage of one pharmaceutical product and remove another.
  • the objective is to achieve concrete increased health for each individual based upon their specific circumstances.
  • One aspect of the invention concerning the optimization and individualization is to continuously evaluate the health situation of each specific patient based on the input from the patient, concerning his/her behaviour and specific circumstances, in relation to the existing relevant clinical information in clinical studies or clinical practice regarding the used pharmaceutical products, the actual adherence to the pharmaceutical products, the interaction between the included pharmaceutical products, the selected dosing regimens and possible other aspects of the QAFM. Based upon this evaluation the QAFM will respond to the defined users, such as the patients themselves and the healthcare personnel, about the status of the health of the patient and recommended actions, in order to improve the clinical effect, to improve the safety or to improve the quality of life.
  • the QAFM could, for example, respond with feedback to the relevant users that either a problem has occurred, such as an interaction between two drugs, or a positive change has happened. If a change in the used pharmaceutical products is recommended, it would most probably need to be handled by a physician.
  • One aspect of the invention is that the QAFM will be able to evaluate the best QFM for each specific patient based upon the specific patient's behaviour and clinical needs in relation to substance combination specific data in clinical studies and clinical practice.
  • the type of feedback will be evaluated, as well, in order to identify and improve the feedback, given to the specific patient.
  • the objective is to use the type of feedback achieving improved clinical effect, safety and quality of life.
  • One aspect of the invention is that the development of the QAFM should be dependent on each included QFM. It will be central that the QAFM will be related to the content and the characteristics of the included QFM:s and pharmaceutical products.
  • Another aspect and central component of the invention is that the social behaviour and psychological well-being could be central aspects within the QAFM and the QFM:s.
  • the possibility to interact with both healthcare personnel, as well as other patients, will be an aspect of the invention.
  • One aspect of the invention is that the computer program product and the QAFM should be able to individualize the treatment to a patient's specific circumstances and personal objectives.
  • Another central aspect of the invention is to enable and to improve patient safety.
  • the invention will enable early warnings for each user of the invention of possible security alerts concerning the included pharmaceutical products and possible interactions between them, and propose recommended actions to take. This will enable an improved patient safety concerning prescriptions of pharmaceuticals.
  • One aspect of the invention is that the existing, available knowledge concerning pharmaceutical products forms a fundamental knowledge-base for the development of adapted QFM:s, and QAFM.
  • One aspect of the invention is that it will be possible for a physician to prescribe a computer program product with different pharmaceutical products included components within the QAFM, instead of just separated, stand-alone pharmaceutical products.
  • the physician will be able to prescribe a product more fully addressing the problems of the patient's total health situation.
  • a product based on the invention will be able to develop and adjust in order to match the guidelines which healthcare is using within a specific therapeutic area. For example, within several cardiovascular diseases guidelines for patients include both multiple identified drugs and recommendations regarding certain life-style changes. A product based on the invention can include variants of these components, making it easier and more efficient for both patients as well as healthcare personnel.
  • the invention is primarily intended for therapeutic areas in which patients with multiple diagnoses have been prescribed several pharmaceuticals and consequently patient safety is a concern.
  • a medical physician prescribing a product based on the invention, as well as a pharmacist selling a prescription or non-prescription of the invention-based product, will have certain knowledge of the product and the included pharmaceutical products.
  • pharmaceuticals may even be provided to patients by persons without proper pharmaceutical or medical training.
  • the providing person's knowledge of pharmaceutical products is based mainly on the manufacturer's information, which in turn is based on the summaries of the amount of data collected during clinical trials.
  • the providing person may further be highly specialised in the use of a product, such as a researcher with a special interest in the product and the disease it is aimed to treat, but is more likely to be a practitioner who on a daily basis treats patients with very disparate conditions and diseases.
  • Such a physician needs to be well informed about hundreds of different pharmaceutical products. This entails that certain information, such as recently discovered information or possible interactions, on the product, may be overlooked or unknown to the providing person.
  • the present invention is based on the realization fact that the integral combination of the pharmaceutical products used, and a specifically adapted system for receiving information from a user of the pharmaceutical products and providing feedback to said user can be used to achieve a number of benefits in clinical practice.
  • a patient using the integrated package of the pharmaceutical products, and the developed QAFM can directly benefit from the entire body of knowledge, such as clinical data, related to the pharmaceutical products in the possession of the manufacturer or supplier of the invention-based product, in addition to the information provided by the medical practitioner and/or pharmacist providing the product package.
  • the present invention aims to provide a technological support to the patients in order that they benefit from the most recent information about their medication, adapted to their specific situation.
  • One aspect of the invention is a combination product, or a kit-of-parts, comprising the drug(s) in question and a computer program product comprising instructions causing a computer to provide the patient with the questions, receiving answers to the questions, analysing and processing the answers and providing feedback to the patient.
  • One aspect of the invention is a method of treatment of a medical condition with the substances having pharmaceutical activities against said medical condition(s) in combination with a computer program product comprising instructions causing a computer to provide the patient with the questions, receiving answers to the questions, analysing and processing the answers and providing feedback to the patient.
  • One aspect of the invention is to improve the treatment of the patient, based on the invention, where the usage, including dosage and administration, of the included pharmaceutical products are related to the usage.
  • Another aspect of the invention is to make clinically relevant information obtained during clinical use, i.e. clinical trials or clinical practice, of the pharmaceutical products come to the benefit of individual patients in a more efficient way.
  • This is realized by continuously updating the question-analysis-feedback model, the QAFM, implemented in the Computer Program Product by including therein instructions causing the computer to perform a method comprising the steps
  • the information on which the revision is based can be collected from the individual patient or from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using said substance(s) in combination with said computer program product.
  • Revision of the set of functions may include a revision of the feedback information and type of feedback given to the patient.
  • the reviser performing the revision may be one or more persons skilled in analysis of clinical data and drafting clinical guidelines, such as a team of medical doctors, clinical statisticians and/or pharmacists. It may also be a suitable computer-implemented expert system or set of revision functions. Such a set of revision functions may include comparison of patient parameters and/or patient trend lines with reference parameters and reference trend lines calculated from the information collected from more than one patient, preferably at least 50%, such as at least 75% or substantially 100% of patients, clinically using said substance(s) in combination with said computer program product. Alternatively, the reference parameters and reference trend lines are calculated from information collected only from comparable patients, e.g. patients having the same or similar age, life-style, clinical status, clinical history, sex, ethnicity etc.
  • the specific information which the database is adapted to store provides the provider of the invention the possibility to collect relevant data from a significant number of patients using the invention in clinical practice and iteratively improve and further adapt the sets of questions and sets of functions to real-life conditions.
  • One aspect of the invention is to enhance the relation between the specific conditions for each particular patient, both concerning behavioural and physiological aspects, with the clinical conditions for the specific pharmaceutical products concerning used dosage, identified side effects and adverse events, and clinical effect in order to improve individualization.
  • This may be done by including existing clinical research data for the pharmaceutical product(s) in the QAFM, and separate QFM:s, and integrated data of the invention.
  • the individualization may be done in several different ways, including for example an updated QAFM concerning any recommendations of changed dosage or administration or recommendations of changed pharmaceutical products.
  • One aspect of the invention is to enhance patient adherence to the prescribed dosages or administration regimens and to enhance the clinical efficacy of the included pharmaceutical products. This may be done by including questions on the actual administration; actual dosage; perceived and/or measured therapeutic effects; the relevant life-style factors of the patient; test results and/or perceived quality of life and providing the patient with feedback correlating the positive effects of the pharmaceutical products, and/or the absence or low prevalence of negative effects, with adherence to the prescribed dosage or administration regimen and life-style factors.
  • One aspect of the invention is to give the user early indications of the occurrence or development of a possible adverse event and/or side effect, by including questions relating to the occurrence or development of a possible adverse event and/or side effect of any of the included pharmaceutical products.
  • This increased awareness of adverse events and side effects results in enhanced protection of patients from adverse events and side effects.
  • This may enable an increased patient safety, which is demanded from authorities like EMA and FDA on pharmaceutical products.
  • This may enable early introduction of pharmaceutical products with an incomplete safety profile on the market, since it allows for making each user of the pharmaceutical product aware of the occurrence or development of a possible adverse event and/or side effect and also facilitates that this may be reported directly to medical staff. It may also enable re-introduction of products withdrawn from the market due to an unacceptably high frequency of adverse events or side effects by making each user of the pharmaceutical product aware of the occurrence or development of a possible adverse event and/or side effect at an early stage.
  • One aspect of the invention is that the healthcare personnel easily will be able to get an overview report about the health situation of a specific patient, including the aspects of the QAFM, the QFM:s and the included pharmaceutical product(s), and analyzed recommendations of how to improve the clinical effect, safety or quality of life.
  • question-feedback models are central and necessary parts of the question-analysis-feedback model (QAFM).
  • One aspect of the invention is to enhance the patient's quality of life.
  • the computer program product is preferably adapted to be installed on a handheld device, such as a mobile telephone, a smart phone, a Personal Digital Assistant (PDA), tablet computer or similar devices.
  • the computer program product may also be installed on a remote computer, e.g. a. server, web or cloud-based service, and accessible to the user through a computer such as a handheld device, a stationary computer, a laptop or the like. In such a case the feedback is also preferably provided through the same device.
  • FIG. 1 illustrates the combination product and the structure and usage of two QFM:s ( 103 1 , 103 2 ) adapted to specific pharmaceutical products ( 100 1 , 100 2 ), in relation to one QAFM ( 110 ) and the patient ( 102 ).
  • 107 denotes the set of questions of QAFM and 109 the set of functions (analysis part) of QAFM.
  • 112 denotes the computer platform used for interaction with the respondent.
  • FIG. 2 illustrates the two QFM and the QAFM when adding a further respondent 102 ′.
  • FIG. 3 illustrates when the further respondent is answering the questions on a separate computer platform 112 ′.
  • FIG. 4 illustrates examples of question presented in the mobile phone and example of feedback.
  • A Numeric question
  • B Feedback graphs with patient specific data
  • C Feedback graphs with patient specific data, user interface on a regular computer.
  • FIG. 5 Development of the model
  • FIG. 6 Overview embodiment of the model in the study
  • FIG. 7 Schematic view of Set of Questions and Feedback Information
  • FIG. 8 Schematic view of the question schedules
  • FIG. 9 Overview technical implementation of the CPP
  • FIG. 10 Example of a possible patient feedback graph
  • set of questions is a questionnaire with predetermined questions or items shown to a respondent to get answers for feedback purposes.
  • the questions within the set preferably have a limited number of possible answers, such as yes/no; scale 1-10; multiple choice; etc.
  • the questions may however also have an undefined number of answers, such as a value of a test parameter (e.g. blood pressure, blood glucose level).
  • a test parameter e.g. blood pressure, blood glucose level
  • the questions in the set of question are posed to the respondent according to a certain regimen or schedule. This is denoted a “question schedule” or “question regimen” in the present application. These terms are intended to be equivalent if not otherwise indicated.
  • set of functions means a set of functions that can be applied to the answers to a set of questions to extract specified information and generate feedback based on the answers.
  • QFM The combination of a set of questions and a set of functions is referred to as a “question-feedback model”, sometimes abbreviated “QFM”.
  • QFM The combination of several included QFM: s, as well as the combination of another set of questions, another set of functions and the type of feedback, is referred to as a “question-analysis-feedback model”, sometimes abbreviated “QAFM”.
  • the QAFM and the QFM:s could together, as a group, be denoted as the “model”.
  • That a set of questions is “specific” to a certain pharmaceutical product shall be construed to mean that it comprises questions that are applicable and clinically relevant to the pharmaceutical product.
  • the individual questions, and the set of questions in total, are preferably more applicable and clinically relevant to the pharmaceutical product in question than to any other pharmaceutical product.
  • respondent is used to denote the individual responding to a question.
  • patient is used to denote the individual using the pharmaceutical product.
  • pharmaceutical product and “medical product” shall be considered equivalent unless specifically indicated otherwise. These terms refer to pharmaceutically acceptable compositions of pharmaceutically active substances (drugs) intended for administration to a patient.
  • side effect means a secondary and potentially adverse effect of a drug or treatment.
  • adverse event means an adverse outcome that occurs during or after the use of a drug or other intervention but is not necessarily caused by it.
  • “Clinical use” shall be construed as the use of the pharmaceutical product and/or the life style factor by individual subjects. It includes the use of the pharmaceutical product in Phase II, III and IV clinical trials and the use of the product in patients in clinical practice (sometimes referred to as real life).
  • “Clinically relevant information” shall be construed as information relevant to the clinical characteristics of a pharmaceutical product, e.g. on effect, side effects, counter-indications, metabolism etc. Such information is extensively collected during clinical trials.
  • the main aspect of the present invention is a combination product comprising two or more pharmaceutical products and a computer program product comprising instructions to perform a method comprising the steps of providing a defined set of specific questions to the user, collecting answers to the questions and analysing, transforming and processing the answers by way of a defined set of specific functions to generate feedback to the patient.
  • the “question-feedback model” By adapting the combination of the set of questions and the set of functions, which combination is hereinafter called the “question-feedback model”, to be adapted to one pharmaceutical product, and optionally the therapeutic indication and/or prescribed dosage/administration regimen, it is possible to achieve clinical improvements in the therapeutic effect of the pharmaceutical product and quality of life for patients.
  • the combination of two, or more pharmaceutical products, and the corresponding adapted QFM:s into a model called the “question-analysis-feedback-model” (QAFM), it is possible to achieve an even higher, unexpected and significant improvement in the therapeutic effect of the pharmaceutical products and quality of life for patients.
  • the improved therapeutic effect within the area of the included pharmaceutical products and quality of life may be due to improved individualization concerning patient specific conditions and clinical aspects of the pharmaceutical products, due to improved adherence by the patient to the prescribed administration and/or dosage regimen, due to improved awareness of other factors influencing the relevant condition being treated with the pharmaceutical products, or due to a placebo-like effect.
  • a question-feedback model is developed and adapted to the specific characteristics of the pharmaceutical product and the behavior of the patients within the actual therapeutic area(s).
  • the development of the question-feedback model follows the same general rules for different types of pharmaceutical products, but the specific question-feedback models will be different due to the characteristics of the pharmaceutical product and its clinically relevant information.
  • a QAFM is developed and adapted to the specific characteristics of the included pharmaceutical products and the behavior of the patients within the actual therapeutic areas(s).
  • the development of the QAFM follows the same general rules for different types of pharmaceutical products and therapeutic areas, but the specific QAFM will be different due to the characteristics of the pharmaceutical products, its clinically relevant information and the patient behavior.
  • the question-feedback model, QFM comprises the following parts, of which all are adapted for the clinical effect of the pharmaceutical product:
  • the set of questions is implemented in a questionnaire giving the respondent the ability to choose any of a number of possible answers to each question or enter a number representing a test value.
  • the questions within the set preferably have a limited number of possible answers, such as yes/no; Visual Analogue Scale (VAS); Likert scale; multiple choice, including symbols (such as “happy face” and “sad face” to capture mood); etc.
  • the questions may also have an undefined number of answers, such as a value of a test parameter (e.g. blood pressure, blood glucose level, body temperature, weight) or free text.
  • a test parameter e.g. blood pressure, blood glucose level, body temperature, weight
  • the questions are posed to the patient using the invention based product because only the patient has the true first-hand knowledge of his/her situation.
  • further questions may be posed to other respondents. These may include family members, relatives or other persons close to the patient. This may be particularly useful for pharmaceutical products used in treatment of psychiatric disorders where the patient's assessment of his/her situation may be incomplete and observations made by another person may be valuable. Questions to be answered by other respondents may belong to the same set of questions as those answered by the patient, but may be implemented in a separate questionnaire.
  • the specific questions and invitations given to the respondents and the type of questions are adapted to the specific characteristics of the pharmaceutical product and the behavior of the patients within the therapeutic area in order to optimize the clinical effects.
  • a regimen for asking the respondent questions should be developed, including which questions are compulsory to answer, optionally before or after a certain time or within a certain time interval; the questions which may be left unanswered; at what time of the day the questions will show up for the respondents to answer; with what frequency the questions shall show up etc.
  • the regimen can be static over time but also change, e.g. the frequency of questions can decrease with time or change depending on the respondent's answers.
  • Such messages may include recommendations, suggestions or information intended to motivate the respondent, e.g. to continue the prescribed dosage regimen although symptoms have disappeared or are less pronounced.
  • the question-feedback model, QFM further comprises retrieving answers from the respondents in a predefined format suitable for input into the set of functions for generating feedback.
  • the question-feedback model further comprises a set of functions to generate patient-specific feedback based on the answers of the respondent or respondents. These functions may comprise:
  • Patient-specific feed-back is generated by the above described set of functions based on answers supplied by the patient.
  • the feedback may be provided through any medium favorable to the patient, e.g. through a website, a handheld device (mobile phone, smart phone, tablet computer, PDA, etc), paper, voice, e-mail, fax, SMS, or corresponding type of message etc.
  • feedback may also be provided to other than the patient, such as the health care staff (e.g. treating medical practitioner or nurse, pharmacist etc.).
  • Such feedback may include:
  • the question-feedback model, QFM may be adapted to the specific pharmaceutical product by using the information on the pharmaceutical product available from clinical trials carried out in preparation for an application for marketing approval for the pharmaceutical product. Such trials are designed to find all relevant information about the pharmaceutical product and that information can be used to design the set of questions with applicable answers, the set of functions for generating the feedback from the answers, and the form of feedback provided to the patient.
  • the continuous development of the QFM, for a specific pharmaceutical product will also take into consideration relevant knowledge from clinical practice concerning the specific pharmaceutical product, other studies, patient behavior concerning the specific pharmaceutical product, etc.
  • Information on the normal effect of the pharmaceutical product can be used to provide the patient with feedback on how he/she achieves a better or worse effect than normal when using the pharmaceutical product. It may also be used to give the patient feedback on how the treated condition will have developed if the pharmaceutical product had not been used, or used to a different extent than the patient actually is using it.
  • Information on known possible side effects may be used to include questions giving early feedback on occurrence of side effects, which may guide the user to change or cease the administration or dosage regimen according to guidelines based on the information about the side effects, or to contact the treating physician if advised.
  • Information on known counter-indications for using the pharmaceutical product may be used to include questions giving early feedback warning for possible side effects or adverse events. It may be that during treatment with the pharmaceutical product the patient contracts a condition which may lead to an adverse event or side effect in combination with the pharmaceutical product. If such risks are known, it is possible to include questions resulting in feedback making the patient and optionally the treating physician aware of this complication, which may lead to an adjustment or change in treatment implying an improved patient safety of the pharmaceutical product.
  • an earlier registered pharmaceutical product indicated for treatment of obesity was known to worsen depressions.
  • the majority of questions and feedback in a question-feedback model for an obesity drug would probably focus on diet, physical activity, weight loss and the like.
  • the inclusion of one or more mood-related questions would however been able to indicate early if the patient was at a risk of developing a depression which would have been a strong indication to the patient to cease the administration of the actual pharmaceutical product.
  • These questions should have been specifically designed to retrieve relevant information on the types of mood-related adverse events or side effects associated with the specific pharmaceutical product.
  • additional information not supplied directly by the patient can be used. This may include:
  • a candidate specific question-feedback model For each combination of a specific pharmaceutical product and the computer program product a candidate specific question-feedback model, QFM, has to be developed.
  • This candidate model has to be developed based on all considerations mentioned above.
  • the development of the candidate question-feedback model, QFM includes the following steps:
  • a suitable set of questions is identified and developed.
  • the intention is to develop an optimal set of questions and normally this is an iterative process.
  • the following aspects should be considered, as well as the concerns mentioned above describing what is included in the set of questions.
  • a suitable set of functions is identified and developed.
  • the intention should be to develop an optimal set of functions and normally this is an iterative process.
  • the following aspects should be considered, as well as the concerns mentioned above describing what is included in the set of functions.
  • a suitable type of feedback should be identified and developed. The intention should be to develop an optimal type of feedback and normally this is an iterative process. In this, the following aspects should be considered, as well as the concerns mentioned above describing what is included in the type of feedback:
  • the question-analysis-feedback model comprises the following parts:
  • the set of functions, as well as the type of feedback, in the QAFM may relate to the following, the list being illustrative and non-exhaustive:
  • the set of functions and the type of feedback considerations should be done in order to optimize the total questionnaire and the feedback for the simplicity of the patients.
  • the development of the QAFM will be iterative and similar to the development of the QFM, clearly adding the further aspects of the QAFM in relation to the QFM, such as the evaluation of the pharmaceutical products and their adapted QFM: s.
  • the respondent may be desirable to furthermore optimize the set of questions and the feedback for use on a certain computer platform. For instance, if the respondent will use a simple mobile telephone the questions will be adapted so that they can be answered simply by pressing buttons 0-9 and yes/no/up/down and feedback may be provided in short text messages and simple graphs. If the respondent uses an advanced mobile telephone or tablet computer the questions may be constructed to give more complex answers and still be easy to use, and the feedback may also be made more complex, such as color-coded graphs and longer messages.
  • the candidate QAFM including the QFM:s is then validated in one or more steps.
  • the validation of the model aims to evaluate and ensure the therapeutic effect of the integrated combination of the computer program product and pharmaceutical products, minimize the amount of adverse events and side effects, and increase the quality of life for the patients.
  • the evaluation of the clinical effect and the value of the candidate QAFM including the QFM:s for specific pharmaceutical products are preferably performed through clinical trials, which is usually referred to as a Phase II clinical trial or a corresponding study. In this the candidate model for the pharmaceutical products is evaluated regarding clinical efficacy such as positive medical effect and increased security level for the combination product.
  • the QFM and QAFM may of course be adjusted or revised in order to improve its clinical effect, safety or aspects of quality.
  • the combination of the models and pharmaceutical products may also be compared to existing approved treatments in Phase III-type clinical trials before being put on the market.
  • the question-feedback model, and the question-analysis-feedback model are implemented in one or more computer-program products running on one or more computer platforms, wherein the computer program product and the computer platform together have means for providing the set of questions, for receiving the answers, for applying the analysis and the set of functions to generate the patient-specific feedback and preferably also for providing said feedback to the patient.
  • the computer program product may be supplied on a suitable carrier together with the pharmaceutical product, as a kit-of-parts. Suitable carriers are well-known to the skilled person and depend on the platform on which the computer program product shall run, but includes without limitation, CD-ROM, USB-memory sticks, flash memory cards.
  • the computer program product may also be made available to the end user separately from the physical pharmaceutical product. This can be done e.g. by supplying information on how to access the computer program product on a remote server and install the computer program product on the relevant platform with the pharmaceutical product.
  • the computer program product can also be run on a remote server and be accessed via an internet service using a user interface like a web browser or client application for the relevant platform.
  • Ways of accessing and implementing the computer program product can also include barcode scanning techniques.
  • the computer program product may be included in the kit-of-parts in the form of instructions for accessing and/or installing the computer program product from a remote location, such as a remote server. Information about how to get started with the computer program product and how to use it can be given in the instructions related to the pharmaceutical product or the computer program product.
  • a unique identifier may be provided with each individual kit. The identifier may be used to confirm that the respondent has got the correct combination of computer program product and pharmaceutical product and to confirm that the respondent has the right to use the computer program product.
  • the computer program product is an essential part of the main aspect of the invention and is itself one aspect of the invention, as is the method implemented in the computer program product.
  • the pharmaceutical product may be any pharmaceutical product for which there exists a preferred or prescribed administration and/or dosage regimen. This includes all pharmaceutical products that have been approved for marketing based on results of clinical trials defining a therapeutically effective dose or dose range and pharmaceutical products for which a medical or other practitioner prescribes an individual administration or dosage regimen to an individual patient based on information supplied by the manufacturer of the pharmaceutical product. It furthermore includes pharmaceutical products for which an application for marketing approval is to be submitted, pending, or has been refused.
  • the pharmaceutical product may or may not be subject to regulation by a Medical Products Agency or other governmental agency, it may be a prescribed medication, an over-the-counter product or any other allegedly therapeutically active product, such as a herbal medicinal product.
  • Examples of pharmaceutical products that can be used in the present invention are, the list being illustrative and non-exhaustive (trade names within parentheses): Aripiprazol (Abilify), Rimonabant (Acomplia), Pioglitazon (Actos), glucoseamine (Glucosine), Octocog alfa (Advate, Advair), Flutikason in combination with Salmeterol (Seretide), zolpidem (Ambien, Stilnox), Insulin glulisin (Apidra), Donepezil (Aricept), irbesartan (Avapro, Aprovel), rosiglitazone (Avandia), metformin in combination with rosiglitazone (Avandamet), glimepiride in combination with rosiglitazone (Avandaryl), bevacizumab (Avastin), Interferon beta (Avonex), Darbepoetin alfa (Aranesp
  • Two sets of questions ( 106 ) and two sets of functions ( 108 ), one for each QFM ( 103 ), together with a set of questions ( 107 ) and a set of functions ( 109 ) of the QAFM, for converting the answers to the questions into patient feedback are implemented in the computer program product ( 110 ) running on a computer platform ( 112 ) having means ( 104 ) for interacting with patient/respondent 102 , i.e.
  • the computer platform further has means ( 114 ) for receiving patient feedback from the sets of functions ( 108 ) and ( 109 ), and communicating said feedback to said patient ( 102 ).
  • FIG. 2 shows an alternative embodiment of the invention, wherein a further respondent ( 102 ′) answers further sets of questions ( 106 ′) for the QFM and ( 107 ′) for the QAFM through means ( 104 ′) for receiving answers to said sets of questions from said further respondent.
  • the answers to the sets ( 106 ′) and ( 107 ′) are then provided together with the answers to the sets ( 106 ) and ( 107 ) to the sets of functions ( 108 ) for the QFM and ( 109 ) for the QAFM respectively to generate feedback to patient ( 102 ) through computer platform means ( 114 ) for receiving patient feedback from the sets of functions ( 108 ) and ( 109 ) and communicating said feedback to said patient ( 102 ).
  • feedback is also provided to the further respondent ( 102 ′), shown with a dotted line.
  • the further respondent may be a person close to the patient, such as a family member.
  • the means ( 104 ′) for receiving answers from the further respondent may be implemented on a separate computer platform ( 112 ′), cf FIG. 3 .
  • a computer program product integrated with two pharmaceutical products (PP:s), using an adapted question-analysis-feedback model (QAFM) and two question-feedback models (QFM:s), should be evaluated versus only the two separate PP:s.
  • the purpose is to evaluate different aspects in order to show the effect of the invention.
  • the objective of the study should be to evaluate the clinical effect of a combination of two PP:s and a CPP, in relation to only the two PP:s.
  • the integration in the combination product should be done through a QAFM and two QFM:s.
  • the actual therapy area is type 1 diabetes and the effect variable should be the level of HbA1c.
  • the actual PP:s are Apidra and Lantus.
  • the used model should consist of the following parts:
  • the development of the used model (QAFM and QFM) for the PP:s in the study should include mainly the steps described earlier in the detailed description and clinically relevant information of the specific PP:s and the patient category. It is an iterative process (see FIG. 5 ) before optimal models for the specific PP:s (see FIG. 6 ) have been developed with the set of questions and feedback information (see FIG. 7 ) and the question schedules (see FIG. 8 ). As said earlier in the detailed description, many aspects and considerations need to be taken into account when developing the specific model.
  • the technical realization and implementation of the CPP in the study is illustrated in FIG. 9 .
  • the patients should first be registered in the system by the health care personnel and after that the patients should download, via mobile internet, the mobile phone application to their mobile phones.
  • the mobile phone application will process, handle and present the questions and answers to the patient.
  • the CPP will also consist of a web client application which has the primary user interface for the health care personnel.
  • a server application with a data base will also be an integral part of the implementation of the CPP.
  • Diabetes is an auto-immune disease in which the body's immune system destroys the insulin-producing beta cells in the pancreas.
  • This type of diabetes also known as juvenile-onset or insulin-dependent diabetes, accounts for 10-15% of all people with the disease. People with type 1 diabetes must inject themselves with insulin several times a day and follow a careful diet and exercise plan.
  • Glycated hemoglobin (hemoglobin A1c, HbA1c, A1C) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This serves as a marker for average blood glucose levels over the previous months prior to the measurement.
  • HbA1c is recommended by WHO (World Health Organization) as a test to diagnose diabetes.
  • WHO World Health Organization
  • the American Diabetes Association recommends that the HbA1c should be below 53 mmol/mol (7.0%) for most patients.
  • Rapid-acting insulin begins working very quickly inside the body—usually within 5 and 10 minutes. This type of insulin should be taken just before or just after eating. It operates at maximum strength for one to two hours and duration is typically up to four hours. Rapid-acting insulin's are very convenient because they allow diabetic patients to inject themselves, at the time, when they eat. Long-acting insulin should be taken once a day at the same time each day to lower the blood glucose.
  • the study objective is to evaluate the clinical effect of using the combination product, the two PP:s and a CPP, in type1 diabetes in comparison of using only the stand-alone PP:s themselves.
  • the measured variable should be HbA1c.
  • the variable should be measured directly before the patients entered into the study and directly afterwards when they had concluded their participation.
  • the patients in the intervention group should be given the combination product, meanwhile the patients in the control group will be given only the separate PP:s.
  • Used PP s: Rapid-acting insulin; Apidra and a long-acting insulin; Lantus
  • the used set of questions can be seen in table 1.
  • the different questions were grouped together in questions groups with corresponding response times (see table 2).
  • Some of the questions were asked three times a week, some more seldom, and some were “spontaneous”, i.e., always available for the patient to answer.
  • the question regime appeared to the patient, could be another than the one presented in the table.
  • the set of questions for the QAFM is to be the following: 1-5, 8-16, 20-23
  • the set of questions for the QFM of Apidra (the first PP) is to be the following: 6, 7
  • the set of questions for the QFM of Lantus (the second PP) is to be the following: 17-19
  • the feedback to the patients is crucial in order to achieve a positive clinical effect of the combination product.
  • the used set of questions for the specific QFM:s and QAFM in the combination product based on Brilique and ASA is the following:
  • adherence to Brilique For the defined set of questions adherence to Brilique, adherence to ASA, physical activity and weight/BMI will be prioritized in order to gain effect for the patient.
  • the prioritization implies that the feedback messages and also the visual feedback will be focused on these questions, resulting in higher frequency of showing them, and the visual feedback will be prominent compared to the other questions.
  • the set of functions for physical activity are utilizing both personal and official goals, based upon the following structure:
  • the personal goal can, for the Brilique QFM, be defined as zero since some patients are ordinated not to be physically active during the first treatment period. After a period of time, the healthcare personnel may update the goal to normal levels.
  • the patient will be shown feedback messages depending on which of the above levels he/she has registered.
  • the patient will have registered either a clearly decreasing or increasing trend of the BMI, the patient will be given messages concerning the purpose of either maintaining the trend or trying to interrupt it.
  • an evaluation concerning the frequency and type of given feedback messages for adherence will be performed by the set of functions.
  • the result of the level of adherence for the first hundred patients will be compared to the result of the second hundreds of patients. If the first hundred patients are more adherent to Brilique concerning the actual period of green status for the patients, than the others, the frequency of given adherence messages will be as the used frequency for the first hundred patient. If the second hundred patients are more adherent, frequency for the first hundred will be increased.
  • the similar evaluation is done concerning the level of friendliness in the messages.
  • Corresponding evaluations is then performed, also de-coupling the level of frequency and the level of friendliness in the messages, in order to optimize the level of adherence to Brilique among the patients using the combination product.
  • Corresponding evaluations is then performed, also de-coupling the level of frequency and the level of friendliness in the messages, in order to optimize the level of adherence to Brilique among the patients using the combination product.
  • a similar evaluation is performed concerning the illustration of the visual graph for the type of feedback for adherence, where different types of illustrations are compared to each other in order to optimize the level of adherence.
  • the 65 th percentile of the registered average values of performed level of physical activity from this population will be used as the official objective for physical activity instead of the original set-up value. For every new patient this official objective will continuously be updated in order to achieve a proper objective.
  • the official objective for physical activity will be structured, as well, according to separate objectives for each month, based on the performed registrations from patients in the test, starting from the initiation of using the combination product. Hence, the official objective for physical activity will most probably be different for each month for the new patients using the combination product.
  • the official objectives for physical activity will be structured, as well, according to separate objectives for each week, based on the performed registrations from patients in the test, starting from the initiation of using the combination product. Hence, the official objective for physical activity will most probably be different for each week for the new patients using the combination product.
  • the feedback to the patient will be immediate in the sense that also the latest registration will be able to affect the set of functions.
  • This set-up will be verified in a small initial test prior to the example as important for achieving clinical effect, especially for the visual type of feedback.
  • a visual graph illustrating the patient adherence to Brilique and to ASA the last week will be showing a diagram with twenty-one different symbols for the actual seven days, fourteen for Brilique and seven for ASA, since the patient shall take Brilique twice and ASA once a day. If the patient doesn't answer the question whether he/she has taken the specific pharmaceutical for a specific occasion, a red cross will be shown. If the patient will register that he/she took the pharmaceutical, a green tick is shown instead.
  • An example of an individual message for physical activity when the patient has fulfilled both the personal and official objectives is: “Good job! By remaining at this level of physical activity, which you are at now, a longer period of time you will substantially decrease the risk of getting another heart disease.”
  • the patient will be given feedback messages for physical activity with a similar frequency to the patient as for adherence to Brilique and ASA.
  • a visual graph showing the actual achieved amount of physical activity per week the last month, for the patient will be shown in the software application. It is illustrated through different staples in relation to both the personal goal and the official goal of the amount of physical activity.
  • a visual graph will be shown indicating the patient's actual BMI level, and in the background of the graph different colors with green for BMI less than 25; light yellow for BMI above 25 and less than 30; darker yellow for BMI above 30 and less than 35; light red for BMI above 35.
  • blood glucose and HbA1c only general feedback messages will be given to the patient without relation in the set of functions to the actual registered patient values.
  • the messages will be focusing on general health, such as physical activity and food intake, but also mention blood pressure, blood glucose and HbA1c in order to make the patient aware of them.
  • visual graphs are to be shown for the actually registered patient values.
  • the set of functions for physical activity was utilizing both personal and official goals.
  • the personal goal was able to update by the patient whenever he/she wanted.
  • the physical activity official goal was higher than for both Brilique and only using Zoloft.
  • the patient was given feedback messages for physical activity using the following structure:
  • the patient was given individual feedback messages depending on which of the above levels he/she registered.
  • Set of functions for Blood glucose was configured to detect possible hyperglycemia and/or hypoglycemia for the patient.
  • a predefined amount of registrations above a defined level for hyperglycemia or below another for hypoglycemia triggered predefined messages.
  • Set of functions for both Depression and Anxiety was configured to detect a predefined amount of registrations above a certain level of the variable performed during a specific time interval; at least three registrations above the level eight during at least three days. When that criterion was fulfilled a predefined message was shown to the patient.
  • the feedback to the patient was immediate in the sense that also the latest registration should be able to affect the set of functions.
  • An example of a feedback message to the patient with a green status on adherence to Metformin was: “It's good that you are taking Metformin according to prescription. By doing so you are improving your situation with diabetes”.
  • An example of an adherence message with red status was: “You shouldn't miss taking Metformin, it would help you with your diabetes”
  • a visual graph illustrating the patient adherence to Zoloft, Metformin and Januvia the last week showed a diagram with twenty-one different symbols for the actual seven days, three for each day the patient is supposed to take the daily dose for the respective pharmaceutical. If the patient didn't answer the question whether he/she had taken the specific pharmaceutical for a day, or denied to take it, a red cross was shown for the actual pharmaceutical. If the patient had registered that he/she took the pharmaceutical, a green tick was shown instead in the diagram.
  • the patient was given feedback messages depending on which of the levels of physical activity he/she registered.
  • Corresponding messages were also shown if the patient reached their personal goal, but since the official goal was relatively high, the most positive messages were given for that.
  • a visual graph was shown indicating the patient's actual BMI level, and in the background of the graph different colors with green for BMI less than 25; light yellow for BMI above 25 and less than 30; darker yellow for BMI above 30 and less than 35; light red for BMI above 35.
  • HbA1c registrations were illustrated in a graph, but didn't cause any feedback messages to the patient.
  • the following message was shown to the patient if he/she had fulfilled the criteria for level one; “You seem to have . . . [the actual symptoms] and should contact your responsible doctor and tell him/her about your situation and how you feel.” If the patient had fulfilled the criteria for level two, the following message was shown: “You seem to have . . . [the actual symptoms] and should promptly contact your responsible doctor and tell him/her about your situation and how you feel, if you haven't already done it.”
  • the patient decreased 8 mmol/mol in HbA1c implying a decrease of 16%.
  • the actual dose of Zoloft and Metformin was changed once during the period, starting at respectively 50 mg and 2000 mg, and ending on 25 mg and 1500 mg.
  • the actual dose of Januvia was not changed during the period.

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