WO2001074229A2 - Appareil et procede permettant a un patient de mieux respecter un programme medical - Google Patents

Appareil et procede permettant a un patient de mieux respecter un programme medical Download PDF

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Publication number
WO2001074229A2
WO2001074229A2 PCT/US2000/040862 US0040862W WO0174229A2 WO 2001074229 A2 WO2001074229 A2 WO 2001074229A2 US 0040862 W US0040862 W US 0040862W WO 0174229 A2 WO0174229 A2 WO 0174229A2
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WO
WIPO (PCT)
Prior art keywords
medical
patient
medication
medical device
data
Prior art date
Application number
PCT/US2000/040862
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English (en)
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WO2001074229A3 (fr
Inventor
Eric W. Brown
James A. Littlefield
Mark F. Connaughton
Jay Q. Huang
Xiaohuo Xie
Original Assignee
Remote Medical Corporation
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Application filed by Remote Medical Corporation filed Critical Remote Medical Corporation
Priority to AU2001218183A priority Critical patent/AU2001218183A1/en
Publication of WO2001074229A2 publication Critical patent/WO2001074229A2/fr
Publication of WO2001074229A3 publication Critical patent/WO2001074229A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
    • 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
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • 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
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • 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
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/022—Measuring pressure in heart or blood vessels by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Definitions

  • TITLE Apparatus And Method For Improving Patient Compliance With A Medical Program
  • This invention relates generally to the monitoring and control of medical care data by non-medically trained individuals, and more particularly to an automated method of collecting and using patient care data for assuring a high level of healthcare vigilance with feedback to the patient and the patient's caregivers, and with provision for professional medical advice including the selection of offered medications and other medical supplies for sale.
  • U.S. 5,722,418 describes a method for mediating social and behavioral influence processes through an interactive telecommunications guidance system for use in medicine and business that utilizes an expert such as a physician, counselor, manager, supervisor, trainer, or peer in association with a computer that produces and sends a series of motivational messages and/or questions to a client, patient or employee for changing or reinforcing a specific behavioral problem and goal management.
  • the system consists of a client database and a client program that includes for each client unique motivational messages and/or questions based on a model such as the transtheoretical model of change comprising the six stages of behavioral change and the 14 processes of change, as interwining, interacting variables in the modification of health, mental health, and work site behaviors of the client or employee.
  • the client program in association with the expert utilizes the associated 14 processes of change to move the client through one of the six stages of behavioral change when appropriate by using a plurality of transmission and receiving means.
  • the database and program are operated by a computer that at preselected time periods sends the messages and/or questions to the client through use of a variety of transmission means and furthermore selects a platform of behavioral issues that is to be addressed based on a given behavioral stage or goal at a given time of day.
  • Kutzik et al, U.S. 5,692,215 describes a system that provides for monitoring a user in a user living area.
  • the system includes a system controller and an activity detection subsystem.
  • the activity detection subsystem monitors a daily living activity of the user and provides information representative of the daily living activity to the system controller.
  • the system controller includes a control circuit which generates a control signal in response to the daily living activity information obtained by the activity detection subsystem. Control information from the system controller is applied by way of a control information communication channel both to the activity detection subsystem and to a remote monitoring site.
  • the activity detection subsystem may be system for determining the movement of the user around the home, medication compliance by the user, problems with usage for stoves or other potentially dangerous appliances, and selected auxiliary appliances.
  • U.S. 4,082,084 describes a portable diagnostic device, particularly for medical field-examinations comprising a case-like housing in which replaceable electronic examining units are arranged serving for the examination of different physiological functions and/or conditions.
  • the housing comprises an electronic power supply feeding each of the electronic examining units, a common display receiving the output signals of the examining units and electrical connectors providing electrical connections between the housing and each of the examining units.
  • the inner room of the housing is divided into two separate parts, the first of which is arranged in a modular system and accommodates slide-in examining units, while the second part serves to accommodate the accessory means required for the examinations.
  • Fu, U.S.4, 803, 625 provides for a personal health monitor which includes sensors for measuring patient weight, temperature, blood pressure, and ECG waveform.
  • the monitor is coupled to a central unit via modems and includes a computer which is programmed to prompt a patient to take prescribed medication at prescribed times, to use the sensor to measure prescribed health parameters, and to supply answers to selected questions. Medication compliance information, test results, and patient answers are compiled in a composite log which is automatically transmitted to the central unit.
  • the computer is also programmed automatically to disconnect the monitor from an alternating current power source and to rely on internal battery power during certain periods of patient monitor interaction, such as during use of the ECG module. In this way, danger to the patient and complexity of the ECG module are minimized.
  • the computer is also programmed to compare measured test information with predetermined expected values, and in the event of a discrepancy, to collect additional information from the patient to assist trained personnel at the central unit in interpreting the composite log.
  • the computer is also programmed to alert the central unit promptly in the event one or more measured parameters falls outside of a prescribed normal range.
  • the normal range for a given parameter is made to vary in accordance with the measured value of one or more other parameters in order to reduce the incidence of false alarms.
  • Bornn et al., U.S. 4,827,943 provides a link between the caregiver and the subject being monitored which utilizes an intermediate base station with redundant signal paths between the base station and the caregiver.
  • the caregiver wears a unit which receives signals from the base station. Signals from the base station provide information about the subject being monitored and provides signals for use in determining whether the caregiver remains within the range of the base station.
  • the unit worn by the subject being monitored can include diagnostic circuitry for evaluating signals received from sensors to transmit an alarm signal to the base stations when the subject being monitored is in need of assistance.
  • a range monitoring system is provided which alerts the subject being monitored as well as the caregiver whenever the subject being monitored moves outside the range of the base station.
  • 4,933,873 describes an interactive patient assistance device which houses both pre-selected doses of medication and a physical testing device. Both medication and the testing device are normally retained within separate compartments within the device away from access by the patient. The device keeps track of medication and diagnostic testing schedules. The device is also capable of receiving and interpreting verbal commands of the patient. The device makes a pre-selected dose of medication available to the patient in response to either the medication schedule or the receipt of a verbal command by the patient. Likewise, the testing device is made available to the patient in response either to the testing schedule or the receipt of a verbal command from the patient.
  • Treatch U.S. 5,007,429 describes a user interface for directing the programming of operating parameters for patient blood pressure testing into and downloading blood pressure data from ambulatory patient blood pressure monitoring units.
  • the user interface operates on a system comprising a plurality of microprocessor based, ambulatory blood pressure measuring patient units, an office control unit, and a data processing center, typically accessed over telephone lines.
  • An office control unit is used to program patient units with test regimens for specific patients.
  • the control units are also used to download data from the patient units and to transfer the data, along with patient identifying data, to the central data processing facility.
  • the office control unit includes local memory which stores various interface routines, a microprocessor for executing the routines, a 12-character keypad allowing input of integers and a display for displaying prompts to the user.
  • a start up sequence and a menu selection sequence to carry out the desired functions of the system. All selections are made, and all operating parameters are entered, through a telephone like keypad.
  • the display indicates to the user which parameter entry of which is called for and which menu items are available for selection.
  • additional prompts may be given to the operator by voice over the telephone handset. Blomquist, U.S.
  • a caregiver drug pump communicates with a remote patient drug pump for data gathering, trouble shooting, and operational program changes.
  • the caregiver drug pump is at least substantially identical in configuration to the patient drug pump.
  • the caregiver drub pump transmits caregiver key input signals to the remote patient drug pump.
  • the patient drug pump receives the key input signals, accesses a desired program, and transmits information for display on the display of the caregiver drug pump.
  • a computer is provided for communicating locally and/or remotely with a drug pump.
  • the computer may include a display with an image of a pump.
  • the computer may be operated through the use of a mouse or touch screen with respect to the image of the pump, to simulate use of the pump while using the personal computer.
  • the computer may also be used as a training aid for training a caregiver and/or patient how to use the drug pump.
  • U.S. 5,347,453 describes a portable programmable medication device for aiding in the administration of medication or pharmaceuticals in accordance with a prescribed medication dosage schedule.
  • the programmable medication alarm device is manually programmed with data representative of a prescribed medication dosage schedule specifying a prescribed administration time, dosage amount, administration route, and medication instructions for each medication dosage to be administered to the patient.
  • audible dosage alarm signal is generated and graphical representations of the prescribed administration time, dosage amount, administration route and medication instructions are visually displayed in predefined visual display fields.
  • the portable medication alarm device is programmed by loading the prescribed dosage schedule data from a computer system, into the memory of the medication alarm device, using an automated data communication process. Also disclosed is a medication container holder which attaches the programmed medication alarm device to a conventional medication container, such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle, without interfering with the operation thereof.
  • a conventional medication container such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle
  • Stutman, U.S. 5,416.695 describes a medical alert system which enables an authorized user, such as a doctor, to remotely set selection and limit parameters pertaining to specific medical and geodetic information of an ambulatory patient and thereafter received updates of that information over a wireless communication network when the parameters have been met.
  • a telemetry device attached to the patient provides an inbound stream of medical and geodetic information to a host computer, which is configured to exact selected portions of that information in response to the parameters provided by a remote processing device via a communications network.
  • the host computer transfers the extracted information to the remote processing device over the network, thereby informing the doctor of a medical situation.
  • U.S. 5,495,961 describes a portable programmable medication alarm device for aiding in the administration of medication or pharmaceuticals in accordance with a prescribed medication dosage schedule.
  • the programmable medication alarm device is manually programmed with data representative of a prescribed medication dosage schedule specifying a prescribed administration time, dosage amount, administration route, and medication instructions for each medication dosage to be administered to the patient.
  • an audible dosage alarm signal is generated and graphical representations of the prescribed administration time, dosage amount, administration route, and medication instructions are visually displayed in predefined visual display fields.
  • the portable medication alarm device is programmed by loading the prescribed dosage schedule data from a computer system, into the memory of the medication alarm device, using an automated data communication process. Also disclosed is a medication container holder which attaches the programmed medication alarm device to a conventional medication container, such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle, without interfering with the operation thereof.
  • a conventional medication container such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle
  • Vasko U.S. 5,573,506 describes a remotely programmable infusion pump with interactive voice response via touch-tone phone (i.e., voice mail system in IV pump).
  • the remotely programmable infusion system also comprises a voice storage unit for storing the voice signal.
  • the remotely programmable infusion system further comprises a processor, coupled to the remote communication port, to the voice storage unit, and to the memory, for accessing the voice signal from the voice storage unit and the programmable protocol from the memory, and for processing the programmable protocol in response to receiving the remote programming signal.
  • Kurtenbach, U.S. 5,582,323 describes a medication dispensing and monitoring system of a present invention includes a housing containing a plurality of pill dispensing compartments for dispensing medication to a patient at a desired time.
  • the invention is programmed to dispense medication at the desired time and activates alarms if the proper procedure is not completed.
  • the invention also contacts the emergency personnel through phone lines and initiates two-way hands free communication between the patient and emergency personnel.
  • the invention further includes a pendent transmitter worn by the patient to contact emergency personnel.
  • Hultman U.S. 5,582,593 describes an ambulatory medication delivery system which includes an ambulatory pump unit having a computer control linear motor pump for pumping predetermined volumes of fluid in accordance with a programmed delivery schedule which may be altered through communication with a remote monitoring location via a telephone data access line or via radio frequency communication.
  • a clinician communication unit and a patient communication unit receive and send information to the ambulatory pump unit and also communicate via a telephone data modem access to the computer at a remote monitoring location at which trained health personnel can monitor a number of patient locations and alter or change medication delivery profiles as required.
  • Tacklind U.S.
  • 5,704,366 describes a system for monitoring and reporting medical information includes a stand-alone monitor for storing data records comprising measured values and time stamps and for transmitting the records to a remote reporting unit over a communication system.
  • the remote reporting unit includes a relational data base that is updated when records are downloaded from the monitor; a report generator for generating chronological graphs of the measured values for a particular patient; and a report transmitting unit for transmitting reports to a requesting health care provider.
  • U.S. 5,710,551 describes a system for the remote monitoring of in-home self- medication to assure compliance with prescribed dosage schedules.
  • the system comprises at least one subscriber home medication station which interfaces with a communications link and a remote central monitoring station also interfaced with the link and operative to receive and analyze messages transmitted by the home medication station.
  • the preferred home medication station embodiment transmits messages to the central station over the communications link each time the home medication station is accessed for a dosage of medication.
  • Central station computer means verify receipt of such signals within each subscriber's uniquely scheduled dosage time windows, and alert an operator to take appropriate action if a dosage schedule error is detected.
  • Alternative home medication station embodiments utilize a built-in programmable timer module to verify accessing of medication within a subscriber's uniquely scheduled dosage time windows, and to initiate transmission of alarm signals to the central station over the communications link if dosage schedule errors are detected by the timer module. All embodiments provide subscribers with help-button means to initiate transmission of alarm messages to the central station over the communications link in event of adverse reaction to medication, or other emergencies. Since the central station will be alerted if any scheduled dosage is missed, no emergency rendering a subscriber unable to press a help-button or call for help can go undetected longer than the maximum time between consecutively scheduled dosages. Tacklind, U.S.
  • 5,752,709 describes a system for monitoring and reporting medical information includes a stand-alone monitor for storing data records comprising measured values and time stamps and for transmitting the records to a remote reporting unit over a communication system.
  • the remote reporting unit includes a relational data base that is updated when records are downloaded from the monitor; a report generator for generating chronological graphs of the measured values for a particular patient; and a report transmitting unit for transmitting reports to a requesting health care provider.
  • U.S. 5,767,791 describes a two-way telemetry system which displays and monitors physiologic and other patient data of multiple, remotely located patients at a central location.
  • the system comprises multiple battery-powered remote telemeters, each of which is worn by a respective patient, and a central station which receives, displays, and monitors the patient data received from the remote telemeter.
  • the telemeters communicate with the central station using a two-way TDMA protocol which permits the time sharing of timeslots, and which uses a contention slot to permit telemeters to transmit service requests to the central station.
  • Two-way special diversity is provided using only one antenna and one transceiver on each remote telemeter.
  • the remote telemeters include circuitry for turning off the active transceiver components thereof when not in use (to conserve battery power), and include circuitry for performing a rapid, low-power frequency lock cycle upon power-up.
  • the system has multiple modes of operation, including a frequency hopping (spread spectrum) mode and a fixed frequency mode, both of which preferably make use of the 902-928 MHz ISM band.
  • Patient locators are provided to allow the clinician to track the location of each patient.
  • Russo U.S. 5,807,336 describes a medical apparatus that is provided with a programmable medical device disposed at a first room location and a remote monitor and/or controller disposed at a second room location.
  • the programmable medical device is used to administer a medical treatment to a patient
  • the remote monitor/controller may be used to monitor the operation of the medical device, control the operation of the medical device, and/or transfer data from the medical device to the remote monitor/controller.
  • the apparatus may allow voice communication between the remote monitor/controller and the patient who is receiving treatment via the medical device while the medical device is being monitored and/or controlled from the remote location.
  • the remote monitor/controller may also include means for determining the type of medical device to which it is connected.
  • Brudny et al., U.S. 5,810,747 describes an interactive intervention training system used for monitoring a patient suffering from neurological disorders of movement or a subject seeking to improve skill performance and assisting their training.
  • a patient (or trainee) station is used in interactive training.
  • the patient (or trainee) station includes a computer.
  • a supervisor station is used by, for example, a medical or other professional.
  • the patient (or trainee) station and the supervisor station can communicate with each other, for example, over the Internet or over LAN.
  • the patient (or trainee) station may be located remotely or locally with respect to the supervisor station.
  • Sensors collect physiologic information and physical information from the patient or subject while the patient or subject is undergoing training. This information is provided to the supervisor station.
  • the patient/subject and/or the supervisor can communicate with each other, for example, via video, in real time.
  • An expert system and neural network determine a goal to be achieved during training.
  • the prior art teaches the use of electronic measuring and monitoring of patients.
  • the prior art does not teach that an automated medication and monitoring system with feedback can be used with such a method that data completeness and accuracy is assured through a novel signal repetition protocol.
  • reporting of health results to the patient may be done in an interactive manner coupled with professional medical advisers helping, through a novel remote communication protocol, to direct optimum patient behavior, including offering of medical supplies and medications associated with an ongoing management program.
  • the present invention fulfills these needs and provides further related advantages as described in the following summary.
  • the present invention teaches certain benefits in data handling apparatus and methods which give rise to the objectives described below.
  • the present invention provides a home care medical data logging, communication, product and supplies offering, incentive and reporting methods that have not been described in the prior art.
  • a primary objective of the present invention is to provide such an apparatus and method having advantages not taught by the prior art and which are capable of accurate medical data recording especially for a non-compliant patient.
  • Another objective is to provide such an apparatus and method capable of assuring the transmission of accurate medical data although a patient is not within data transmission range of a data receiving station for significant periods of time.
  • Yet another objective is to provide such an apparatus and method having means of correlating and reporting health and behavioral status on an interactive basis so as to improve compliance by a reluctant patient.
  • a further objective is to provide such an apparatus and method enabled for offering and motivating a patient to purchase supplies and medications in accordance with a medical care program.
  • FIGURE 1 is a schematic block diagram showing the relationship between major elements of the invention
  • FIGURE 2 is a schematic block diagram of a typical dispensing device thereof
  • FIGURE 3 is a typical printed report of the invention illustrating medication dosing compliance correlated to patient status
  • FIGURE 4 is a typical monitor screen display report of the invention illustrating dosing compliance correlated to patient status
  • FIGURE 5 is a typical monitor screen display report of the invention illustrating oral medication compliance
  • FIGURE 6 is a typical monitor screen display report of the invention illustrating daily sugar level variation for a diabetes patient and showing the measurement device therefor;
  • FIGURE 7 is a typical monitor screen display of the invention for inputting patient care orders for, in the present case, medication instructions;
  • FIGURE 8 is a typical monitor screen display of the invention illustrating a method of delivering health or behavior information with a nurse, clinician or other helper providing audio and video transmission of explanations, information, feedback, suggestions, instruction on ordering medication refills and supplies, behavior modification and control and other invention pertinent communications; and
  • FIGURE 9 is a typical monitor screen display of the invention illustrating a method of presenting and offering products or services as a custom shopping list which may be acted upon electronically or, alternately, may be printed out by the patient for future reference.
  • the above described drawing figures illustrate the invention, a system including apparatus and method, for improving patient compliance with a medical program.
  • the medical program may include medication dispensing elements as well as medical state sensing elements or both.
  • the invention is used to monitor and modify medical care and especially patient behavior patterns associated with medication dispensing, medical state sensing and patient behavior with respect to acquisition and maintenance of medical treatment related supplies, wherein the apparatus comprises: a portable medical device means 10 providing, in one embodiment, a medication storing means such as a pill bottle, a medication accessing means such as the cap to the pill bottle, a dispensed medication counting means such as an electronic flip-flop counting circuit 40 with a simple numerical indexer, preferably powered by a battery Bl, in communication with the pill bottle cap by any electromechanical, magnetic or other physical element known to one of skill in the art and represented by letter "M" in Figure 2, such that when the cap is removed from the pill bottle, a switch SI is made such that the circuit counting means indexes to a next higher numerical value, and a medical device wave energy
  • the portable medical device means 10 may include a single dispensing and counting unit or multiple units, and further may include a single counting unit for multiple dispensed items, or multiple counting units (for redundancy) for a single dispensed item; the dispensed medication counting means being enabled for sequencing the counting circuit 40 each time the medication accessing means is manipulated, for gaining access to the medication storing means, the device means 10 being further enabled by a logic circuit 60 for establishing a data set comprising, for example, the current numerical value of the counting circuit 40 and a corresponding time and date of the sequencing of the counting circuit 40 as through the use of a clock circuit 70, the wave energy communicating means 50 being enabled by a control program in the logic circuit 60, for example, for repetitively transmitting, as for example, every 30 minutes, a wave energy signal corresponding to each newly established data set during a selected period of transmission time, as for example 72 hours, the transmission time period being chosen to assure a selected probability of the receipt of said wave energy signal by a base station 20 which is remotely located with respect
  • the portable medical device means 10 Because the transmission range of the transceiver is limited by FCC rules, it is conceivable, and quite common for the portable medical device means 10 to be carried by the patient to a location that is not within the range of the base station 20. This would happen on a regular basis if, for instance, the patient was in the habit of taking a walk in the park between 2 PM and 4 PM each day and carries his pill bottle so as to be able to take his 3 PM pills. This dosage would be counted when the pill bottle cap is removed, but could not be received immediately at the base station 20 since the pill bottle would be out of range at that time.
  • the invention comprises: the portable medical device means 10 providing a medical state sensing means and the medical device wave energy communicating means 50 of the first embodiment; the medical state sensing means is enabled for sensing a medical state variable, such as body temperature, body weight, blood pressure level, or blood glucose level each time the sensing means, i.e., thermometer, weight scale, sphygmomanometer or blood glucose measurement system, respectively, is manipulated in accordance with any well known medical state variable manipulation protocol, i.e., common to any medical examination office or clinic, and further enabled, by a simple mechanical arrangement "M" such as the use of a sensor for sequencing the electronic counter 40, as described above, each time the sensing means is manipulated and for establishing a data set comprising a value of the measured medical state, a numerical value of the counter 40 and a corresponding time and date of the measurement from the clock circuit 70, the wave energy communicating means 50 being enabled, as above, for repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of
  • the invention further preferably comprises a human responsive signaling means, such as an audible alarm or a vibration generating device (not shown), enabled in accordance with the patient's medication and state measurement schedule, referred to below as the “medical schedule," to alert the patient when medication dosing or medical state sensing is required.
  • a human responsive signaling means such as an audible alarm or a vibration generating device (not shown)
  • the patient's medication and state measurement schedule referred to below as the "medical schedule”
  • Such audible and vibration alarms i.e., attention demanding techniques, are well known in the personal pager industry.
  • the base station 20 comprises a base station wave energy communicating means, such as a radio transceiver 50 similar or identical to that of the medical device means 10, and is preferably physically located in the patient's home for example, for enabling reception of at least one repetition of the wave energy signal of the medical device wave energy communicating means 50 and also for transmitting the medical schedule to the medical device means 10, the base station 20 further providing a primary, two-way communicating means 90 shown in Figure 1, such as a telephony or other communication means, enabled by logic circuits and software programming, as is well known in systems engineering, for automatically transmitting the data set values of the medical device means 10, as received via the wave energy signal, in accordance with a selected communicating schedule.
  • a base station wave energy communicating means such as a radio transceiver 50 similar or identical to that of the medical device means 10
  • a primary, two-way communicating means 90 shown in Figure 1 such as a telephony or other communication means, enabled by logic circuits and software programming, as is well known in systems engineering, for automatically transmitting the data set values
  • the information received at the base station 20 from one or more of the portable medical device means 10 is transmitted via the two-way communicating means 90 to a remote monitoring station 30, the remote monitoring station 30 further comprising a computation means, such as a general purpose computer, for computing summary information of interest to medical professionals and caregivers and the patient him/herself, such as a correlation analysis between the received data set values and a selected medical state parameter that is being monitored, the remote monitoring station 30 comprising further enablement, by modem or other means, for transmitting information of interest to the primary, two-way communicating means via the secondary, two-way communicating means 90 and for transmitting the selected medical schedule, usually a schedule defined by a primary medical care giver such as the patient's medical doctor.
  • a computation means such as a general purpose computer
  • the base station 20 receives a unique identification code "PB187” representing "pill bottle 187” or “BPM456” representing blood pressure monitor 456," and "1030A-120198" representing a time-date stamp corresponding to, 10:30 AM on Dec. 1, 1998, and, in the case of a medical state measurement, additionally a measured value code such as "125/80” representing blood pressure levels at the time and date of the measurement.
  • PB187 unique identification code
  • BPM456 representing blood pressure monitor 456
  • 1030A-120198 representing a time-date stamp corresponding to, 10:30 AM on Dec. 1, 1998
  • a measured value code such as "125/80” representing blood pressure levels at the time and date of the measurement.
  • Such a transmission would therefore be coded as “BPM456.1030A-120198.125/80” and may be transmitted in binary coded decimal form or converted to digital form prior to transmission.
  • Other transmissions from the various medical device means 10 may include a low battery status, out of medication, or other supply, "active,” “standby,” or “inoperative” status, etc. along with the time/date identification.
  • the software protocol used in the medical device means 10 or in the base station 20, or both, is preferably configured for identification of an emergency state, as when blood pressure or glucose level are at a dangerous level. In this case the medical device means 10 will immediately set an audible or other alarm to request a repeat of the measurement by the patient or his caregiver.
  • the use of "patient” should be recognized as including the actual patient, or his immediate caregiver such as a family member or a care provider such as a practical nurse or a medical worker. It is intended that preferably the patient will be active with respect to the present invention, at least in part, but if the patient is not active, a caregiver acts for the patient and as such, the caregiver must be at least frequently in close proximity to the actual patient.
  • the base station 20 is configured to immediately send an alarm message to the remote monitoring station 30 for immediate authoritative supervision and decision making, etc.
  • the means for accomplishing these results, i.e., enablement, is most efficaciously completed through software logic programs controlled by microprocessor means within the medical device means 10 and the base station 20 means. Such enablement is considered to be within the ability of those of average skill in the art, and are therefore not defined here in further detail.
  • the portable medical device means 10 may be any one or more of the well known dispensing devices in use in pharmacy and medicine such as an inhalant dispenser, an intravenous dispensing system, an oral or anal medication dispenser, a topical formulation dispenser, etc., for dispensing a selected dosage of a medicinal inhalant, intravenous medication, medicaments formulated as pills, capsules, caplets or other forms of solid medications or liquid or other forms of internal medications, as well as topical formulations.
  • the medication accessing means such as a bottle cap, a dispensing tube winder, an inhalant pump, or a IV flow meter, is adapted by any simple well known sensing arrangement to trigger the counting means while simultaneously dispensing a previously selected dosage of the medication.
  • the dispensed amount may be controlled by the patient or the on-site caregiver.
  • the medical device wave energy communicating means 50 of the medical device means 10 is adapted for accomplishing certain inventive methods, through any common or well known data manipulation process for receiving and implementing the medical schedule as transmitted from the base station 20, a simple matter of data transmission and receival.
  • the medication or state sensing schedule is remotely set-up within a memory device or circuit 80 of the medical device means 10, and may also be changed at any time.
  • the remote monitoring station 30 is adapted by these methods, i.e., simple tracking protocols, for composing a refill request message, at appropriate times when its calculations show that supplies are low, and for transmitting the refill request message to the base station 20 to alert the patient by, for instance, illuminating a lamp or presenting a written message on an LCD, or similar display on the base station, and, or on the medical device means 10.
  • the methods of the present invention are adapted for composing graphical summary reports showing, for instance, when each medication was, in fact, taken and when each medical measurement was, in fact, completed.
  • a history of events may be for a week, month or longer so as to enable the patient to see trends.
  • the portable medical device means 10 of the invention is enabled, by memory device 80, for storing a list of all said data sets established over the selected period of transmission time, e.g., 72 hours, the list being transmitted repetitively at a selected frequency of transmission, e.g., every 30 minutes, so as to improve, through transmission redundancy, the probability of receipt, by the base station 20, of all data sets established by the medical device means 10.
  • each of the data sets is paired with a check-sum and with a CRC, the base station 20 providing check-sum and CRC error-reducing protocol operating on the data sets as received for providing error reduction.
  • CRC Cyclic Redundancy Check
  • the patient notifies the remote monitoring center as to the master medical schedule for medications and/or medical state measurements required. This may be accomplished by telephone, fax, written communication, or internet screen, the latter being illustrated in Figure 7.
  • a database is established at the remote monitoring center for the patient.
  • the master medical schedule information is downloaded to the base station 20 through the primary and the secondary communicating means, generally via telephony.
  • the base station 20 then transmits an appropriate portion of the master medical schedule to each of the medical device means 10 which will be used by the patient.
  • Each of the medical device means 10 then alerts the patient when a medication or a measurement should be taken.
  • the medical device means 10 continues to remind the patient that such event is required until it is accomplished. The fulfillment of each event is recorded as described above and entered into the event list.
  • the entire list is transmitted to the base station 20, as defined above, every selected period, such as every 30 minutes over a time duration of 72 hours for example or other selected duration.
  • Each time the list is received by the base station 20 it is compared with the resident list at the base station 20 and any blanks in the resident list are filled-in from the newly received list. The duplicate entries are then discarded so that the resultant list is complete and non-redundant.
  • the invention further provides a reporting function which is illustrated in Figures 3-6 and
  • Figure 3 illustrates a correlation report which may be used to highlight the importance of behavioral compliance with a medication schedule for maintenance of a health parameter, such as blood pressure level or blood glucose level.
  • a health parameter such as blood pressure level or blood glucose level.
  • Individual data reports are well-known in the medical industry, but graphical reports of patient behavior versus one or more health statistics, as defined by a chart, such as a bar chart, is novel and considered distinct from the prior art.
  • the reports are generated by the remote monitoring station 30, they are delivered to the patient, to enable action to be taken.
  • Delivery modalities include hardcopy paper reports sent by mail delivery, faxed copies, or internet web-page delivery.
  • the internet web-page delivery is preferred because it economically allows the use of color graphics. Color might be used in Figures 4 and 5, for example, to highlight deviations from the scheduled dosage time such that missed dosages or delayed dosages are shown in red and on-time dosages are shown in green. Highlighting good and bad behavior patterns to the patient is functional for establishing improved behavior.
  • Figure 4 illustrates the use of reports similar to Figure 3, but in a web-page format. Often patients become confused when they must use many different of the medical devices means.
  • Figure 6 illustrates how information can be more readily associated with a specific device to enhance patient recognition and understanding, i.e., the inclusion of a picture of the device the patient is using.
  • Figure 6 also shows controls (screen buttons) whereby the patient or local caregiver may send commands pertaining to device settings directly to the remote monitoring station 30.
  • the remote monitoring station 30 is enabled for relaying these control messages to the base station 20 located in the patient's residence.
  • the web-page format is used to provide the patient with information and can also be used by a clinician at a remote location to control a patient's instruments, for example, based upon the health data statistics that are compiled.
  • Figure 7 illustrates how the web-page format can be entirely dedicated to the setup and control of a medical device means 10, such as a medication dispenser.
  • a clinician at the remote monitoring center or at any remote location can enter dosing related information and instructions and the medical schedule for that medication dispenser.
  • Figure 8 illustrates an advance in the reporting of medical information to patients.
  • the advance includes the correlation of two or more behavior and/or health data graphics which are constructed from actual measurements of the patient's compliance or health statistics.
  • the report includes a human image and related spoken message which is preferably a video message but may be live. This human image is preferably a clinician, such as a nurse, but may also be a doctor or other primary caregiver.
  • the message may be delivered in real-time, but is preferably delivered in a stored format, such as by e-mail or a stored streaming video, so that the patient may view it or replay it more than once, at his or her convenience. Such replay is facilitated by a dedicated replay button as shown in the figure.
  • the video message report may include elements of encouragement, education, information, reinforcement, or reprimand, as may be needed to modify the behavior of the patient to comply with instructions. Such elements may further include a list of items which the patient may need or want to purchase or otherwise obtain, such as medication refills, information flyers, insurance information, and miscellaneous items such as flowers, greeting cards, etc. for improving the patient's morale.
  • the reports are preferably interactive so as to enable the patient to easily reply to questions or ask questions via a dedicated contact button.
  • a button will, in one embodiment, activate an e-mail reply screen, as is well-known, that may generate text, voice or video image formats for composing a reply message.
  • the report includes purchasing reminders, clues or requests made by the clinician image, such as to remind the patient to purchase refills on medication or medical device supplies, such as blood glucose monitoring test strips, to order home supplies such as flowers, books, videos, music recordings, or other household goods, or to order new equipment such as an additional pill bottle for a new medication. Even further, the report allows the patient to respond to such reminders, clues or requests via a "place order" button, as illustrated in Fig. 9.
  • the place order button may immediately fulfill the order suggested by the video image or it may lead to order selection and confirmation screens, as is well-known in the art.
  • a "shopping list button” may replace the "place order button” for patients that do not have an established account for automatic fulfillment.
  • the shopping list button places the items which would have been on the automatic fulfillment list on a printable shopping list.
  • the patients receive the benefit of an automatically generated list of medications and supplies that they may then bring to their preferred retail drugstore or other retail establishment. Since many patients are forgetful due to age. medication side- effects or other reasons, the shopping list becomes an important feature to ensure that quality, on-time refills and supplies are available when needed.
  • the list of items for automatic fulfillment or for inclusion on the shopping list is created by comparing the prior known status of the patient's medication and supplies with the current measured status of behavioral and health parameters. For instance, during the setup of a new patient on the monitoring system, the patient would provide certain details as follows:
  • What recommended health parameter values should be obtained from the patient's physician, nurse and other professional clinician, such as that the patient's blood pressure should be between 130/85 and 110/75 or the patient's blood glucose should not exceed 200 mg/dl or drop below 40 mg/dl. 5. Whether or not the patient wants to receive reminders, such as from a beeper, and from which of the monitored devices. Also, when does the patient want to receive such reminders, e.g., remind patient to measure blood glucose level 25 minutes before the meal and remind to him/her to take medications 15 minutes after each meal but do not remind at breakfast time on weekends because patient wishes to sleep late.
  • contact information for the pharmacy such as address, phone number, facsimile number and e-mail address.
  • Inventory information for medications and supplies The initial inventory may include such details as 12 tablets of medication A, 22 capsules of medication B, three lOcc vials of insulin, and a count of all other remaining medications. Other inventory details may include supplies such as 17 syringes, 20 needles, 35 blood glucose test strips, etc. 10. What are typical purchase quantities for medications and supplies. Syringes are typically packed in boxes of 100 units, blood glucose test strips in vials of 50, medications are dispensed in 30 day supply, etc.
  • the setup data is stored on the server with the patient event data history.
  • the inventory information is used as the baseline value and after the patient takes a pill or uses a disposable supply, the number remaining is appropriately decreased.
  • Certain flagged values for minimum level of inventory are applied, such as a minimum of two weeks medications and supplies.
  • the server automatically adds that item to the shopping list.
  • the server automatically increments the number of units in inventory.
  • flagged values pertain to personal information, such as a birthday. For example, if the patient's grandson is having a birthday in two weeks the server will put a reminder for a birthday card on the shopping list.
  • flagged values pertain to supplies, such as syringes, blood glucose monitoring strips, and other supplies that are associated with a measured health parameter or monitored behavior parameter.
  • the measuring of health parameters and the monitoring of behavior parameters drives the generation of a shopping list.
  • This list may be printed out and taken to the drugstore or it may be the basis for an electronically fulfilled order, as illustrated in
  • the list may serve as the basis for a competitive marketing tool in which various manufacturers provide incentives or inducements to the patient to purchase one brand over another. For example, when the need for aspirin has been identified by monitoring that the patient has a higher than normal body temperature, the medication is placed on the shopping list. This, in turn, may trigger a flag to provide the patient with coupons for a discount on one brand of the medication. The provision of the coupon serves as an incentive to the patient.
  • the M-C operator may view the shopping list before or during the creation of the video message so that appropriate references and reminders may be put into the video. The M-C operator may also mention specials, incentives and other available discounts during the video message.
  • the M-C operator may manually add or remove items from the list, such as when a patient has been taken off a medication by the physician.
  • items which are prescribed for intermittent use may be manually or automatically added or removed from the list, for example: when a patient develops a fever and it is detected by a health parameter measuring device, the server may automatically add aspirin to the shopping list.
  • the interactive report may further include an invitation to reply to any questions posed by the clinician image, or to pose new questions to the clinician image, or to respond to previous questions posed by the patient to the clinician image. Additionally, the clinician image may suggest that the patient replay the video message to reinforce an understanding of its contents.
  • the use of interactive reports as defined herein is considered novel in the present field, so as to distinguish over the prior art.
  • Capture health event data e.g., pill bottle access times, blood pressure, etc.
  • M-C operator accesses event record server and retrieves patient specific information
  • M-C operator views patient specific information including most recent entries, historical entries, supply and refill status, other pertinent patient specific information. Viewing is preferably done graphically with concurrent charts displayed on screen.
  • M-C operator activates camera and microphone, preferably mounted on top of monitor (this way operator can speak while viewing patient information).
  • M-C operator dictates video message into camera and microphone.
  • Video message has components of information that preferably may include any or all of the following:
  • Familiar commentary i.e., patient name, recognition of chronic condition, recognition of other household members or pets, mention of hobbies, etc.
  • Health parameter trend information review (e.g., blood glucose),
  • Device supply refills e.g., glucose monitoring strips
  • M-C operator presses "stop recording” button after completing message.
  • M-C operator optionally reviews message and re-records if changes are necessary
  • M-C operator forwards video message and associated graphical charts to Web-server for storage
  • Web-server receives video message and associated graphical charts. Automatically saves in web- or WebTV-, or other multimedia format.
  • Web-server transfers formatted video message and associated graphical charts to patient or other viewer upon receiving password access from a remotely located web browser.
  • the Web-server may be programmed to send an automatic e-mail notification to patient, caregiver and/or clinician that an updated video report is available.
  • Patient or family caregiver decides to check on patient status. The decision is based upon occurrence of a predetermined time to check on status, or a reminder received from M-C, or a change in patient's status, or curiosity or initiative.
  • Viewing Person uses regular PC with internet browser, WebTV, or other commonly known viewing device to access the M-C Web server.
  • Video message starts playing.
  • Viewing Person presses "Replay Video” button to start video message playback.
  • Video message starts playing. Viewing Person presses "Place Orders” button to order suggested supplies and refills. (Alternatively, for Viewing Persons without an electronic fulfillment account, the list of suggested supplies and refills may be printed as a shopping list.)
  • a printed version of the shopping list may be carried to a retail drugstore or other retail establishment to obtain the needed medications and supplies.
  • the printed version of the list may also include incentives, such as discount coupons to encourage the purchase of needed items at a given retail location or from a selected manufacturer. (Viewing Persons without an electronic fulfillment account may skip the next two steps.))
  • Viewing Person is automatically returned to report page (with graphic reports and video message).
  • Viewing Person composes message which is sent to M-C (or other authoritative party) and presses "send message” button, as is well-known in the art.
  • the Pill Bottle Screen Is Used Patient or family caregiver (referred to as the "Viewing Person") decides to check on patient status.
  • the decision is based upon occurrence of a predetermined time to check on status, or a reminder received from M-C, or a change in patient's status, or curiosity or initiative.
  • Viewing Person uses regular PC with internet browser, WebTV, or other commonly known viewing device to access the M-C Web server.
  • Viewing Person enters data into blanks for setting reminders, frequency of medication administration, Pill Bottle ID code, and other items as requested.
  • Data from the B-S is automatically uploaded to Event Record Server.
  • new schedule data from the Event Record Server is automatically downloaded to the B-S.
  • B-S generates "beep" and visual signal indicating that new schedule information has been received
  • B-S generates visual indicator for which device(s) it has a new schedule.
  • Patient or family caregiver uses data transfer means, either wireless, wave energy or hardwire, to effectuate a link between the device(s) and the B-S.
  • B-S senses the link and automatically transfers data to the appropriate device(s).
  • the unique ID codes prevent the wrong schedule from being loaded into the wrong device.
  • Patient uses device(s) as directed.
  • the present invention provides for a method for creating video screens in a medical monitoring and control system comprising the sequenced steps: a) automatic logging of health event data from dispensing devices and/or medical state measurement devices, into a storage means at the time of such events as enabled by actions of a patient or a patient with the help of a caregiver usually in the patient's home; b) automatic transmitting of the health event data to a local base station for storage therein, the base station being generally in the patient's home; c) automatic transmitting of the health event data on a predetermined schedule to a remote monitoring center for storage therein, the center being located outside the patient's home and usually in a distant location, possibly near a hospital or doctor's office; d) automatic merging of each new transmission of the event data with an existing record of all previously recorded event data from the same base station; e) deleting duplicate entries of the event data; f) retrieving the event data as an event data report comprising charts, graphs, etc.; g

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Abstract

La présente invention concerne un appareil et un procédé d'équipement médical. Ce procédé consiste à utiliser des dispositifs de distribution de médicaments et de prise de données portables, qui sont conçus pour être utilisés par un patient externe et pour communiquer avec une station de base, généralement à l'intérieur du domicile du patient. Ladite station de base communique de manière périodique avec une station de commande à distance, qui charge un programme médical sur la station de base et, par conséquent, sur les dispositifs portables, et reçoit également des informations concernant l'habitude et l'état médical, issues du patient, par l'intermédiaire desdits dispositifs portables et de la station de base. L'utilisation d'un protocole de répétition de transmission permet d'assurer avec une grande certitude que les informations du patient seront bien reçues par la station à distance. La station à distance surveille les activités et l'état du patient et génère des rapports et des requêtes de remplissage lorsque les fournitures se trouvent à un niveau bas. Les présentations au patient sont effectuées au moyen d'Internet ou d'autres techniques simplifiées, qui affichent notamment des graphiques historiques, tout en décrivant des caractéristiques importantes et en recommandant des achats de fournitures et de médicaments.
PCT/US2000/040862 2000-04-04 2000-09-10 Appareil et procede permettant a un patient de mieux respecter un programme medical WO2001074229A2 (fr)

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US11367512B2 (en) 2011-11-29 2022-06-21 Eresearchtechnology, Inc. Methods and systems for data analysis
US11798660B2 (en) 2011-11-29 2023-10-24 Eresearch Technology, Inc. Methods and systems for data analysis
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