CN112802564A

CN112802564A - Method for recording real medicine taking data and detailed following rate by mobile device

Info

Publication number: CN112802564A
Application number: CN201911112322.4A
Authority: CN
Inventors: 刘乃嘉; 陈玉沛; 李晧
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-11-14
Filing date: 2019-11-14
Publication date: 2021-05-14

Abstract

The invention discloses a method for recording real medicine taking data and detailed following rate by a mobile device, which is applied to the mobile device with identification software and an image acquisition unit and comprises the following steps: before taking medicine, acquiring an appearance image of the first medicine package through an image acquisition unit; performing image recognition by using recognition software to judge the first medicine amount; after the medicine is taken, an image of the appearance of the second medicine bag is obtained through the image acquisition unit; performing image recognition by the recognition software to judge the second dosage; generating and displaying a corresponding dose confirmation interface; receiving an external operation of the subject to modify or confirm the remaining amount of the drug displayed on the drug amount confirmation interface; calculating and displaying a detailed medicine taking following rate in real time according to the first medicine amount and the residual medicine amount; and recording the residual medicine amount and the current detailed medicine following rate. The invention can improve the efficiency of the treatment course and the validity of the data.

Description

Method for recording real medicine taking data and detailed following rate by mobile device

Technical Field

The present invention relates to a method for recording real medication data and an exhaustive compliance rate of a subject, and more particularly, to a method for recording real medication data and an exhaustive compliance rate by means of a mobile device.

Background

The current clinical experiment requires that the subject takes the medicine according to the prescription on time, and a certain medicine taking following rate must be reached in the whole treatment course, so that the data of the subject can become effective data. If the subject's compliance rate is too low (e.g., no medications are taken on time, or the number of medications differs from the prescription instructions), the Clinical Research institution (CRO) must recruit new subjects for additional courses of treatment to make up for the amount of valid data, which will delay the time at which new medications can be marketed.

Generally, the compliance rate needs to be inferred from the subject's medication record. In the existing clinical experiment, the medication record is mainly recorded by the subject himself or calculated by the clinical pharmacist or nurse counting the residual medicine amount in the medicine package of the subject at each return visit.

The above-mentioned medicine-taking record is the original Data of the paper book, and needs to be filed in the hospital, and manually inputted into the Electronic Data acquisition system (EDC, Electronic Data Capture, or eCRF, Electronic Case Report Form for short) of the clinical research institution by the clinical laboratory researcher in a manual manner. In addition, the clinical research institution needs to send a monitor to the hospital to apply for all original data of the paper (including prescription, hospital's dispensing records, subject's medicine-taking logs, etc.), check the original data with the electronic data in the electronic data acquisition system, perform statistical analysis with other test information, and forward the information generated after statistical analysis to the pharmaceutical factory.

As described above, the statistical analysis requires manual application and verification of the paper data by clinical laboratory researchers, and thus human errors often occur. Moreover, if it is necessary to re-check the integrity of the electronic data, the clinical research institution needs to send a monitor to the hospital again to re-apply for the original data and re-check the original data with the electronic data, which is rather inconvenient and delays the progress of the experiment.

Furthermore, no matter the subject takes his or her own record of the medication or the clinical pharmacist or nurse makes statistics of the remaining dosage during the return visit, it is impossible to know whether the subject is taking medicine abnormally during the course of treatment. For example, if a subject was overdosed (e.g., has two more medications) and under-dosed (e.g., has two fewer medications), the compliance rate for the entire course of treatment would still be calculated to be 100% because the amount remaining at the end of the pack is correct. Therefore, the data obtained at the end of the treatment course is incorrect, and the improvement is necessary.

Disclosure of Invention

The main objective of the present invention is to provide a method for recording Real Data of medicine taking and detailed following rate by a mobile device, which can directly obtain the Real Data of medicine taking (Real World Data) from a subject. The real medicine taking data is directly input into an electronic data acquisition system of a clinical experiment by a subject through a mobile device, and compared with the prior art that the prior paper data is collected by a nurse to a hospital disease case bank and then is called by a clinical experiment researcher to be input into the second-hand data acquisition system, the probability of artificial careless and the time of data delay are greatly reduced. And the detailed medicine taking following rate is calculated in real time after each medicine taking of the subject, so that the efficiency of the treatment course and the effectiveness of the data are improved.

In order to achieve the above object, the present invention provides a method for recording real medication data and a detailed compliance rate by a mobile device, which is mainly applied to a mobile device, and comprises the following steps:

a) the mobile device sends out a medicine taking notice when a medicine taking time recorded by a prescription is reached;

b) shooting a blister pack through an image capturing unit of the mobile device before a subject takes a medicine to generate a first pack appearance image;

c) the mobile device executes an image identification program on the appearance image of the first blister pack through identification software so as to identify the number of full medicine bags and the number of empty medicine bags on the blister pack to judge a first medicine amount of the blister pack;

d) shooting the blister pack through the image acquisition unit after the subject takes the medicine to generate a second pack appearance image;

e) the mobile device executes the image identification program on the second medicine package appearance image through the identification software so as to identify the number of full medicine bags and the number of empty medicine bags on the blister medicine package to judge a second medicine amount of the blister medicine package;

f) taking the second dosage as a residual dosage of the blister pack, generating a corresponding dosage confirmation interface according to the residual dosage and displaying the dosage confirmation interface on a display unit;

g) the mobile device receives an external operation of the subject to modify or confirm the residual medicine quantity displayed on the medicine quantity confirmation interface;

h) the mobile device calculates a detailed medicine taking following rate in real time according to the first medicine amount and the residual medicine amount and displays the detailed medicine taking following rate on the display unit; and

i) the mobile device records the remaining amount of the medicine and the rate of compliance of the exhaustive medicine taking.

As mentioned above, in the step i), the mobile device records a medicine taking time and a medicine taking amount at the time at the same time, wherein the medicine taking amount is a difference between the first medicine taking amount and the remaining medicine taking amount.

As mentioned above, the mobile device compares the amount of the taken medicine with the content of the prescription to determine whether the dosage is overdose or under-dose, and the mobile device calculates the rate of compliance of the detailed medicine taking in real time in the step h) according to the following calculation formula: (cumulative dosage for drug administration-cumulative dosage for drug excess-cumulative dosage for drug deficiency)/cumulative dosage for drug administration.

As described above, the dosage verification interface at least includes the second package appearance image and a plurality of boxes, the number, position and status of the boxes correspond to the number, position and status of the blisters of the blister pack in the second package appearance image, wherein the status of the blisters includes full and empty pouches, and the remaining dosage is the same as the total number of the full pouches.

As mentioned above, the plurality of boxes and the second package appearance image are displayed in an overlapping manner or under the second package appearance image, and the mobile device receives the external operation in step g) to confirm or modify the status of each box to confirm or modify the remaining dosage.

As mentioned above, wherein step g) is followed by a step g 1): storing the second package appearance image and the plurality of frames after the subject modifies the remaining amount of the drug.

As mentioned above, the blister pack has a serial number thereon, and the step b) further includes the following steps:

b1) capturing the serial number from the first medicine package appearance image;

b2) judging whether the serial number accords with the identity of the subject;

b3) when the serial number is not consistent with the identity of the testee, sending a reminding message for requesting to scan a correct medicine package again through the display unit; and

b4) and when the serial number is consistent with the identity of the subject, marking the first medicine package appearance image as first real medicine taking data of the subject.

As mentioned above, wherein the step c) is followed by the following steps:

c1) judging whether the first dosage is consistent with a previous dosage recorded after the subject takes the medicine for the previous time or not;

c2) when the first dosage is consistent with the previous dosage, sending a medicine taking instruction for requesting the subject to take medicine;

c3) when the first dosage does not accord with the previous dosage, the first dosage is used as a current dosage, and a corresponding dosage confirmation interface is generated according to the current dosage and displayed on the display unit;

c4) the mobile device accepts the external operation of the subject to modify or confirm the pre-drug amount displayed on the drug amount confirmation interface; and

c5) when the modified or confirmed current dose is different from the previous dose, recording and notifying the condition of drug loss.

As mentioned above, wherein the step d) is followed by a step d 1): labeling the second package appearance image as a second true medication data for the subject.

As mentioned above, wherein the step g) is followed by the steps of:

g21) judging whether the residual medicine amount accords with the content of the prescription;

g22) sending out an inquiry message for inquiring whether the subject needs assistance or not when the residual medicine quantity is judged to be inconsistent with the content of the prescription; and

g23) and executing the step h) when the residual medicine quantity is judged to be consistent with the content of the prescription.

As mentioned above, the method further comprises the following steps:

j) judging whether the subject takes the medicine or not according to the first medicine amount and the residual medicine amount, and judging whether the residual medicine amount is consistent with the content of the prescription;

k) when the subject is judged not to take the medicine or the residual medicine quantity is inconsistent with the content of the prescription, judging that a compliance rate of the subject is reduced, wherein the compliance rate comprises the detailed medicine taking compliance rate and a behavior compliance rate;

l) judging that the compliance rate of the subject is increased when the subject is judged to take the medicine and the residual medicine amount is consistent with the content of the prescription.

As described above, the mobile device calculates the behavior following rate according to the following calculation formula: (cumulative administration frequency-cumulative administration error frequency)/cumulative administration frequency.

As mentioned above, the method further comprises the following steps:

m1) analyzing a change trend of the behavior following rate; and

m2) sending an alert message to a remote server when the behavior compliance rate is continuously decreased according to the variation trend, so as to inform a clinical research institution to provide assistance or start to recruit new subjects.

As mentioned above, the method further comprises the following steps:

n1) analyzing a trend of the rate of compliance of the exhaustive medication;

n2) determining whether the rate of compliance of the exhaustive dose will fall below a lower limit of demand before the end of the entire treatment session based on the trend;

n3) determining whether the subject is still permitted to take the medication incorrectly before the end of the treatment session if the rate of adherence of the exhaustive medication falls below the lower limit of demand before the end of the treatment session;

n4) when the subject is still allowed to take the medicine incorrectly, sending a query message for asking the subject whether to need assistance through the display unit; and

n5) when the subject is not allowed to take the medicine incorrectly, a request message is sent to a remote server to inform a clinical research institution to supervise the medicine taking action of the subject.

Compared with the existing clinical experiment of the medicine, the invention ensures that the testee can automatically confirm the residual medicine amount after taking the medicine by the mobile device, can effectively ensure the correctness of the recorded medicine amount, generates Real medicine taking Data (Real World Data) which can be directly used by clinical research institutions, and can simultaneously provide the following rate of the testee in Real time after taking the medicine each time so as to prompt the testee to take the medicine correctly.

The invention is described in detail below with reference to the drawings and specific examples, but the invention is not limited thereto.

Drawings

FIG. 1 is a first embodiment of a recording schematic of the present invention;

FIG. 2 is a block diagram of a mobile device according to a first embodiment of the present invention;

FIG. 3 is a first embodiment of a recording flow chart of the present invention;

FIG. 4A is a schematic view of a dose verification interface according to a first embodiment of the present invention;

FIG. 4B is a second embodiment of a dose verification interface according to the present invention;

FIG. 5A is a first portion of a recording flow diagram according to a second embodiment of the present invention;

FIG. 5B is a second portion of a second embodiment of a recording flow diagram of the present invention;

FIG. 6 is a first embodiment of an identification flow chart of the present invention;

FIG. 7 is a first embodiment of a compliance rate calculation flow chart of the present invention.

Wherein, the reference numbers:

1 … moving device;

10 … processor;

100 … identifying software;

11 … image capturing unit;

12 … display element;

13 … wireless transmission unit;

14 … storage unit;

141 … identity of the subject;

142 … prescription slip;

143 … recording taking medicine;

2 … medicated bag;

21 … a sachet;

22 … kit number;

3 … remote server;

4 … dosage confirmation interface;

41 … bag appearance image;

411 … full of the sachet;

412 … empty sachets;

42 … box selection;

S10-S26 … recording steps;

S30-S70 … recording steps;

S80-S96 …;

and S100 to S120 ….

Detailed Description

A preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

The invention is mainly applied to the plastic uptake medicine bag used in clinical experiments and general prescription labels. By the technical scheme, the test subject can obtain medicine taking reminding by the mobile device, automatically identifies the medicine bag on the blister medicine package and records the residual medicine amount before and after taking medicine each time, and simultaneously provides a corresponding interface so that the test subject can automatically confirm whether the identified residual medicine amount is correct.

By the technical scheme of the invention, a clinical research institution can obtain Real medicine taking Data (Real World Data of medical) which can be directly used from a subject, and can calculate the detailed medicine taking following rate of the subject in Real time according to the residual medicine quantity. Therefore, the method not only can promote the subject to take the medicine correctly, but also can greatly improve the speed of data collected by a clinical research institution and reduce the personnel and time cost.

Fig. 1 is a schematic diagram of a recording medium according to a first embodiment of the present invention. The present invention discloses a method for recording real medicine taking data and an exhaustive following rate by a mobile device (hereinafter, simply referred to as a recording method), which is applied to a mobile device 1 as shown in fig. 1.

One of the technical features of the present invention is that the subject operates the mobile device 1, the image of the medicine package 2 of the subject is captured by the image capturing unit 11 on the mobile device 1, and the remaining amount of medicine in the medicine package 2 is automatically recognized and recorded by the image recognition program. In the present invention, the medicine package 2 mainly has a plurality of medicine bags 21, and the medicine package 2 has a series of serial numbers 22 on the surface thereof. In the embodiment of fig. 1, the serial number 22 is a combination of numbers and letters (in fig. 1, a001 is taken as an example). In other embodiments, the serial number 22 can also be a text, a symbol, a pattern, a one-dimensional barcode, a two-dimensional barcode or a combination thereof, which is not limited. Alternatively, the serial number 22 may be printed on the medicine package 2 by embossing, pad printing or laser engraving, without limitation.

It is worth mentioning that the serial numbers 22 of the packs 2 of the present invention are unique and non-repeating numbers, and each serial number 22 can be associated with the identity of a subject and recorded in a database (e.g. in the mobile device 1, or in a remote server 3 wirelessly connected to the mobile device 1). If a plurality of medicine packages 2 have different serial numbers 22, the mobile device 1 can identify which subject each medicine package 2 belongs to through an image identification process.

In the present invention, the remote server 3 can be, for example, a server used by a Clinical Research Organization (CRO), and by transmitting and recording data acquired by the mobile device 1 in the remote server 3, personnel (such as pharmacists, nurses, etc.) in the Clinical Research Organization can effectively monitor the rate of compliance of each subject with detailed medication, thereby timely providing assistance to the subject when the subject needs the compliance (such as dysphagia, side effects, drug loss or withdrawal signs).

It is worth mentioning that the method of recording of the present invention allows the subject to self-verify the remaining amount of drug in the pack 2 and store it in the remote server 3, so that the clinical research institution can obtain the actual dosing information that can be used directly.

Fig. 2 is a block diagram of a mobile device according to a first embodiment of the present invention. As shown in fig. 2, the mobile device 1 of the present invention at least has a processor 10, and an image capturing unit 11, a display unit 12, a wireless transmission unit 13 and a storage unit 14 electrically connected to the processor 10.

The image capturing unit 11 may be, for example, a camera or an image sensor, and is used to take or capture a picture or an image of the medicine package 2. The processor 10 may be, for example, a Central Processing Unit (CPU), a Micro Control Unit (MCU) or a Control chip, and is used for executing the identification software 100. The processor 10 performs an image recognition process on the image captured by the image capturing unit 11 through the recognition software 100, thereby extracting information related to the medicine package 2 (e.g., the serial number 22 on the medicine package 2, the positions and numbers of the plurality of medicine packages 21, the remaining amount of medicine, etc.) from the image.

The Display unit 12 can be, for example, a Liquid Crystal Display (LCD) or a touch screen, etc., for displaying information related to the pack 2 and showing the subject's compliance rate for exhaustive dosing. The wireless transmission unit 13 may be, for example, a Wi-Fi transmission unit or a bluetooth transmission unit, etc., and is used for establishing a connection with the remote server 3 through a wireless communication protocol.

The storage unit 14 may be, for example, a memory or a hard disk, and is used to store various information, such as the identity 141 of the subject, the prescription 142 given to the subject by the hospital, and the like, without limitation. In this embodiment, the prescription 142 records the related medication regulations to be followed by the subject during the whole treatment course, such as the corresponding serial number 22, the medication time, the dosage per time, the total dosage to be taken during the whole treatment course, the time for return visit, and the like, without limitation.

It should be noted that the processor 10 may record the medicine taking record 143 of the subject after the subject finishes taking the medicine, and transmit the medicine taking record 143 to the remote server 3 for storage. In this embodiment, the medicine taking record 143 may include, but is not limited to, the medicine taking time of each medicine taking of the subject, the remaining amount of medicine before the medicine taking, the remaining amount of medicine after the medicine taking, the detailed medicine taking follow-up rate, and the like.

Please refer to fig. 3, which shows a recording flowchart according to a first embodiment of the present invention. First, the identification software 100 is installed in the mobile device 1 for the subject to use, and the prescription 142 corresponding to the subject identity 141 is recorded in the mobile device 1. In this embodiment, the identification software 100 may be management software developed by a hospital or a clinical research institution, and the mobile device 1 may implement the recording method of the present invention through the identification software 100.

In this embodiment, the subject can operate the mobile device 1 before taking the medicine to take a picture of the medicine package 2 through the image capturing unit 11 of the mobile device 1, thereby generating the first medicine package appearance image (step S10). Specifically, the first package appearance image includes at least all of the sachets 21 on package 2.

Next, the mobile device 1 performs an image recognition procedure on the first medicine package appearance image through the recognition software 100 to determine the first medicine amount of the medicine package 2 (step S12). Specifically, the recognition software 100 analyzes all the capsules 21 in the first package appearance image to obtain the first amount of drug, and the first amount of drug is the amount of drug remaining in the package 2 before the subject takes the drug.

After the first medicine package appearance image and the first medicine amount are obtained, the subject takes out the corresponding amount of medicine from the medicine package 2 and performs the medicine taking operation according to the instruction of the prescription 142 (step S14).

After the subject takes the medicine, the mobile device 1 is operated again, and the image of the medicine package 2 is captured again by the image capturing unit 11 of the mobile device 1, so as to generate a second medicine package appearance image (step S16). Next, the mobile device 1 performs an image recognition procedure on the second medicine package appearance image through the recognition software 100 to determine the second medicine amount of the medicine package 2 (step S18). Specifically, the recognition software 100 analyzes all of the capsules 21 in the second package appearance image to obtain the second amount of drug, and the second amount of drug is the amount of drug remaining in the package 2 after administration by the subject.

After step S18, the mobile device 1 regards the second amount of drug as the remaining amount of drug of the drug package 2, and generates a corresponding drug amount confirmation interface according to the remaining amount of drug and displays the interface on the display unit 12 (step S20). Through the medicine quantity confirmation interface (the medicine quantity confirmation interface 4 shown in fig. 4A), the subject can confirm whether the medicine quantity taken this time is correct after the medicine is taken, and confirm whether the remaining medicine quantity in the medicine package 2 is correct (for example, whether the indicated medicine quantity of the prescription 142 is met), thereby enhancing the medicine taking impression of the subject.

Next, the subject may operate the dosage verification interface 4 through the display unit 12 (e.g., a touch screen) or an input unit (e.g., a physical button, a gesture input module, a voice input module, etc., not shown) to verify or modify the remaining dosage displayed on the dosage verification interface 4 (step S22). In this embodiment, the subject can compare the remaining amount of drug displayed on the drug confirmation interface 4 with the physical drug package 2 to determine whether the remaining amount of drug is correct. In addition, the test subject can confirm the residual medicine quantity on the medicine quantity confirmation interface 4 when the residual medicine quantity is displayed correctly, and modify the residual medicine quantity when the residual medicine quantity is displayed incorrectly.

It should be noted that the recording method of the present invention can transmit and store the remaining amount of drug confirmed or modified by the subject in the remote server 3, so as to be used as the actual drug administration information of the subject. For this purpose, the processor 10 and/or the remote server 3 are/is adapted to the remaining amount of medicament when the subject modifies the remaining amount of medicament and the modified remaining amount of medicament is different from the amount of medicament remaining automatically generated after recognition by the recognition software 100

Preferably, the modified residual drug amount of the subject is used as the real residual drug amount.

After step S22, the processor 10 calculates the rate of compliance of the subject with the detailed medication in real time according to the first amount of medication and the remaining amount of medication, and displays the rate of compliance on the display unit 12 (step S24). The mobile device 1 records the remaining amount of medicine and the rate of compliance of the detailed medicine in the local storage unit 14, or wirelessly transmits the remaining amount of medicine and the rate of compliance of the detailed medicine to the remote server 3 for storage (step S26).

In an embodiment, the mobile device 1 may record the current medication time of the subject at the same time in step S26. And the mobile device 1 can automatically calculate the current medicine taking amount of the testee according to the first medicine amount and the residual medicine amount and simultaneously record the medicine taking amount. In this way, the mobile device 1 can determine whether the subject has Overdose (Overdose) or Underdose (Underdose) behavior according to the comparison between the dose and the prescription 142, and obtain the excess amount (e.g. two more doses) and the insufficient amount (e.g. one less dose).

In this embodiment, the mobile device 1 can continuously calculate the cumulative dosage of the subject (for example, fifty drugs should be taken in ten times if five drugs should be taken each time), the cumulative excess dosage (the cumulative excess dosage if the subject has taken too much medication) and the cumulative insufficient dosage (the cumulative insufficient dosage if the subject has taken too little medication) through the identification software 100. In the recording method of the present invention, the mobile device 1 can calculate the current exhaustive medication compliance rate in real time according to the following calculation formula one after the subject takes a medication each time through the identification software 100:

calculating a first formula: (cumulative dosage for drug administration-cumulative dosage for drug excess-cumulative dosage for drug deficiency)/cumulative dosage for drug administration.

By calculating the exhaustive medication compliance rate in real time, excessive and insufficient medication doses can be tracked in detail and the subject can be effectively urged to take medication, thereby avoiding experimental culling of the collected data due to the low compliance rate of the subject. In addition, the recording method of the invention calculates the detailed medication compliance rate in real time after the subject takes the medicine each time, so that a clinical research institution can predict whether the compliance rate of the subject can meet the minimum requirement of the experiment in advance before the treatment course is finished by a plurality of detailed medication compliance rates. If the clinical research institution predicts that the final compliance rate of the subject may not meet the minimum requirement, a new subject may be recruited in advance to re-perform the therapy session to supplement the amount of valid data, thereby shortening the time that the experiment may take.

Specifically, the recognition software 100 can calculate and record the following forms according to the dosage schedule of the subject and the prescription 142:

as described above, in the present invention, the recognition software 100 calculates the exhaustive medication compliance rate of the subject in real time according to the calculation formula of "cumulative medicine dose-cumulative excessive medicine dose-cumulative insufficient medicine dose)/cumulative medicine dose", and thus, taking the 10 th taking action as an example, the recognition software 100 calculates the exhaustive medication compliance rate of the subject to be 83% according to the calculation formula of "30-1-4)/30".

It should be noted that if the compliance rate is calculated according to the compliance rate calculation method of the conventional clinical trial of medicine, i.e., "cumulative medicine dose/cumulative medicine dose", the compliance rate of the subject after the 10 th medicine taking action is "27/30 ═ 90%", which is higher than the exhaustive medicine taking compliance rate calculated by the calculation formula of the present invention. Therefore, the window is established, and the problem that the existing calculation mode possibly offsets the phenomena of excessive medicine taking and insufficient medicine taking of a subject to influence the accuracy and the effectiveness of the compliance rate can be solved.

Please refer to fig. 4A and fig. 4B for a first embodiment and a second embodiment of a dose verification interface according to the present invention, respectively. As shown in fig. 4A, the dosage verification interface 4 comprises at least a second package appearance image 41 taken by the subject and a plurality of boxes 42 automatically generated by the mobile device 1 (i.e., the recognition software 100).

In this embodiment, the recognition software 100 performs image recognition on the second medicine package appearance image 41 to obtain the number, position and status of the plurality of medicine packages 21 in the medicine package 2, and then generates a plurality of selection frames 42 according to the number, position and status of each medicine package 21. As shown in fig. 4A, the number, position and status of the plurality of boxes 42 in the medicine quantity confirmation interface 4 correspond to the number, position and status of the plurality of capsules 21 in the second medicine package appearance image 41.

In this embodiment, the status of the plurality of sachets 21 includes a full sachet 411 and an empty sachet 412, the full sachet 411 representing that the medicament in the sachet has not been taken by the subject, and the empty sachet representing that the medicament in the sachet has been taken by the subject. By identifying the status of a plurality of sachets 21, the identification software 100 can accurately calculate the amount of drug remaining in the pack 2. Specifically, the recognition software 100 recognizes that the remaining amount of drug is the same as the total number of full sachets 411 of the plurality of sachets 21.

As shown in fig. 4A, the status of each box 42 may be preset to "full" or "empty" based on the status of the corresponding sachet 21. In step S22 of fig. 3, the subject may operate the medicine quantity confirmation interface 4 through the display unit 12 or the input unit of the mobile device 1 to modify the state of each of the boxes 42. For example, when the subject touches any of the boxes 42 whose state is "full", the state of that box 42 can be modified to "empty", and vice versa. For another example, when the subject touches any of the boxes 42 with the status "full", a pull-down menu (not shown) can be displayed, and the subject can select the status of the box 42 by using the pull-down menu. However, the above description is only an exemplary embodiment of the present invention, and not intended to limit the present invention.

When the recognition result of the recognition software 100 is incorrect (e.g., the empty sachet 412 is recognized as the full sachet 411 by mistake), the status of one or more of the boxes 42 is also incorrect. At this time, the subject can modify the box 42 with the wrong status setting on the medicine quantity confirmation interface 4.

In the embodiment of fig. 4A, the boxes 42 are displayed below the second package appearance image 41. In another embodiment, a plurality of boxes 42 can be displayed in a manner overlapping the second package appearance image 41 (i.e., the display position of each box 42 is overlapped with the display position of each sachet 21), thereby facilitating the comparison of the status of the subjects.

When the subject modifies the status of one or more of the boxes 42 or confirms that the status of the boxes 42 is correct (i.e. the status of the second medicine package 21 in the external image 41 matches the status of the identification software 100, indicating that the identification result of the identification software 100 is correct), the "confirmed medicine amount" button displayed on one side of the medicine amount confirmation interface 4 can be triggered, so that the identification software 100 can calculate and record the information of the medicine taking time, the medicine taking amount and the residual medicine amount (modified or unmodified) after the medicine taking.

Next, as shown in fig. 4B, when the remaining amount of the drug is confirmed on the drug amount confirmation interface 4, the recognition software 100 can calculate the current compliance rate of the subject for thorough drug administration (for example, 85% in fig. 4B) in real time and display the calculated compliance rate on the drug amount confirmation interface 4. Through the real-time calculation and display of the detailed medication following rate, the medication behavior of the subject at each time can be effectively promoted.

Referring to fig. 5A and 5B, a first portion and a second portion of a recording flow chart according to a second embodiment of the invention are respectively shown. FIG. 5A and FIG. 5B disclose another embodiment of a recording method according to the present invention.

In this embodiment, the mobile device 1 stores the identification software 100 and the prescription 142 corresponding to the identity 141 of the subject. The identification software 100 may be management software developed by a hospital or a clinical research institution, and at least includes functions of reminding a subject to take medicine, performing image identification on the medicine package 2 to obtain a remaining amount of medicine, calculating an exhaustive medicine taking compliance rate of the subject in real time, and wirelessly transmitting data such as the remaining amount of medicine and the exhaustive medicine taking compliance rate to the remote server 3, but is not limited thereto.

In this embodiment, the mobile device 1 can automatically or passively execute the recognition software 100 through the operation of the subject, and the recognition software 100 can issue the medicine taking notification through the mobile device 1 when the medicine taking time recorded by the prescription 142 arrives (step S30). Specifically, the medication notification may include, but is not limited to, a message for reminding the subject to take the medication, the contents of the prescription, an instruction for taking a picture of the medicine package 2, and the manner of taking the picture.

After the subject sees the medication notification on the mobile device 1, the subject can prepare to take the medication according to the medication notification.

In the present embodiment, the subject first takes a picture of the medicine package 2 by the image capturing unit 11 of the mobile device 1 and generates an image of the appearance of the medicine package (step S32). The package appearance image here is the first package appearance image before the subject takes the medicine, and the first package appearance image includes at least the serial number 22 of the package 2 and the images of all the medicine bags 21.

Next, the mobile device 1 performs an image recognition procedure on the first medicine package appearance image through the recognition software 100 to obtain the serial number 22 of the medicine package 2 from the first medicine package appearance image, and the processor 10 determines whether the serial number 22 matches the subject identity 141 (step S34), i.e., determines whether the medicine package 2 is a correct medicine package. If the processor 10 determines that the identified serial number 22 does not match the subject id 141, a reminder message requesting the subject to rescan the correct medicine package can be sent through the display unit 12 (step S36), and the process returns to step S32 to take the correct picture of the medicine package 2 again through the image capturing unit 11. Through the identification and comparison of the serial number 22, the problem that the subject takes wrong medicines can be effectively avoided.

If the processor 10 determines that the identified serial number 22 does match the subject identity 141, the first package appearance image can be further labeled as the first actual medication data of the subject (step S38). Specifically, the first actual medication data can be used to prove the condition of the medicine package before the subject takes the medicine.

More specifically, the person in the clinical research institution may manually review the first actual medication data (i.e., the first package appearance image) to track the condition of the package (e.g., the amount of remaining medication) before each medication by the subject. Moreover, the first real medicine taking data can be directly transmitted and stored in a database (such as the remote server 3) of a clinical research institution, so that the trouble that the paper medical record data is manually input into the database and is requested to be read by a monitor is avoided.

Next, the processor 10 obtains the remaining amount of drug currently remaining in the pack 2 from the first pack appearance image by using the image recognition result of the recognition software 100 (step S40). For the sake of distinction, the remaining amount of drug obtained in step S40 will be referred to as a first amount of drug hereinafter.

In this embodiment, the storage unit 14 of the mobile device 1 or the remote server 3 stores the medication record 143 of the subject, wherein the medication record 143 includes the remaining amount of medicine in the medicine package 2 after the previous medication. For the sake of distinction, the remaining amount of the drug of the subject after the previous administration is hereinafter referred to as the previous dose.

After step S40, the processor 10 obtains the previous dose and determines whether the first dose matches the previous dose (step S42). If the first amount of medicine matches the previous amount of medicine, it means that the current amount of medicine remaining in the medicine package 2 is correct, so the mobile device 1 can issue a medicine taking instruction through the display unit 12 to request the subject to take medicine, and the subject can take medicine according to the medicine taking instruction (step S44). After the subject takes the medicine, the amount of medicine remaining in the medicine package 2 is necessarily reduced correspondingly.

If the first dose is not equal to the previous dose, it indicates that the identification result of the identification software 100 in step S32 is incorrect (i.e., the first dose is incorrect), or the subject has lost the drug after the previous dose. At this time, the processor 10 considers the first amount of drug as the current amount of drug of the pack 2, and generates and displays the corresponding drug amount confirmation interface 4 according to the current amount of drug (step S46).

In this embodiment, the dosage verification interface 4 is similar to the dosage verification interface 4 shown in fig. 4A and 4B, and at least includes the first package appearance image captured in step S32 and a plurality of boxes 42 generated according to the first package appearance image. The present invention allows the subject to self-verify the remaining amount of drug in the package 2 by providing a dose verification interface 4, thereby generating actual dosing information useful to clinical research institutes.

Similar to the aforementioned step S22 of fig. 3, the subject may operate the drug quantity confirmation interface 4 through the display unit 12 or the input unit to confirm or modify the current quantity of the drug displayed on the drug quantity confirmation interface 4 (step S48). That is, if the recognition result of the recognition software 100 is incorrect, the subject can correct the incorrect current dosage through the dosage confirmation interface 4; on the contrary, if the recognition result of the recognition software 100 is correct, the subject can perform secondary confirmation to improve the accuracy of the real medicine taking data.

After the subject confirms or modifies the dosage, the processor 10 determines again whether the confirmed or modified current dosage (i.e., the status of the boxes 42) matches the previous dosage (step S50). If the current amount of medicine confirmed or modified by the subject matches the previous amount of medicine, it indicates that the medicine in the medicine package 2 is not lost, so the mobile device 1 can further issue the medicine taking instruction, and the subject takes medicine according to the medicine taking instruction (step S44). If the current amount of the drug confirmed or modified by the subject does not match the previous amount of the drug, it indicates that the drug in the drug package 2 is lost, so the mobile device 1 can record and notify the remote server 3 that the subject has the drug loss (step S52).

In the present invention, the identification software 100 can continuously monitor the status of the drugs held by the subject according to the above procedure, and if the subject continuously has a drug loss, the identification software can notify the remote server 3, so that the personnel in the clinical research institution can schedule the subject to make a return visit for the drug replacement in advance. Through the loss reporting function, the invention can assist the medicine checking work in clinical experiments, and a pharmaceutical factory can master which hospital needs to be supplemented with medicines according to the content of the loss reporting, thereby avoiding the situation that the accuracy of experimental data is influenced because part of testees pause the medicine taking because of the medicine loss.

In addition, the clinical research institution may provide the content of the loss notification to the experimental drug insurance company, whereby if the person irrelevant to the current course of treatment accidentally eats the drug and has any adverse reaction, the pharmaceutical factory and the experimental drug insurance company may also establish relevant response measures in advance.

When the identification software 100 notifies the loss in step S52, the mobile device 1 can issue the medication instruction, and the subject takes medication according to the medication instruction (step S44).

Then, as shown in fig. 5B, after the subject finishes taking the medicine, the mobile device 1 is operated to take a picture of the medicine package 2 again by the image capturing unit 11 of the mobile device 1 and generate another medicine package appearance image (step S54). The package appearance image here is the second package appearance image after the subject took the medicine, and the second package appearance image includes at least the images of all of the sachets 21 in package 2.

After step S54, the processor 10 of the mobile device 1 marks the second medicine package appearance image as the second actual medicine taking data of the subject (step S56). Specifically, the second actual medication data can be used afterwards to prove the condition of the drug package after the subject takes the medicine. More specifically, the personnel of the clinical research institution can manually review the second actual medication data (i.e., the second package appearance image) to track the package condition (e.g., the amount of remaining medication) of the subject after each medication. Moreover, the second real medicine taking data can be directly transmitted and stored in a database (such as the remote server 3) of a clinical research institution, so that the trouble that the paper medical record data is manually input into the database and is requested to be read by a monitor is avoided.

After the second package appearance image is obtained, the processor 10 performs an image recognition procedure on the second package appearance image through the recognition software 100 to obtain the current remaining amount of the medicine package 2 from the second package appearance image (step S58). Next, the processor 10 generates and displays a corresponding medicine amount confirmation interface 4 according to the remaining medicine amount (step S60). In this embodiment, the dosage verification interface 4 is similar to the dosage verification interface 4 shown in fig. 4A and 4B, and at least includes the second package appearance image captured in step S54 and a plurality of boxes 42 generated according to the second package appearance image.

It is worth mentioning that the pharmaceutical factory can set the detection rigor of the remaining amount of drug according to the requirements of clinical experiments. For example, if the pharmaceutical factory requires strict data, the identification software 100 can be configured to generate the dose confirmation interface 4 for the subject to confirm the remaining amount of drug after the subject takes the medicine and takes the second pack appearance image each time; if the pharmacy requires only relatively loose data, the identification software 100 can be configured to generate the drug quantity verification interface 4 only when the remaining drug quantity is found to be inconsistent with the contents of the subject's prescription 142, without limitation.

While the medicine quantity confirmation interface 4 is displayed, the mobile device 1 may receive an external operation from the subject through the display unit 12 or the input unit to modify or confirm the residual medicine quantity generated by the recognition software 100 (step S62). If the subject modifies the remaining drug quantity (i.e., modifies the state of the corresponding box or boxes 42), the recognition software 100 will use the subject's modified remaining drug quantity as the actual remaining drug quantity of the package 2.

It should be noted that if the recognition result of the recognition software 100 is incorrect and the subject modifies the remaining dosage by modifying the status of one or more boxes 42, the mobile device 1 may further record the second medicine package appearance image and the one or more boxes 42 modified by the subject, so that the personnel of the clinical research institution can confirm again whether the real medicine taking data reported by the subject is correct or not according to the recorded second medicine package appearance image and the plurality of boxes 42 afterwards, thereby preventing the artificial fraud.

Next, the recognition software 100 determines whether the remaining amount of the drug pack 2 matches the amount of the drug indicated by the prescription 142 of the subject (step S64), and when the remaining amount of the drug does not match the amount of the drug indicated by the prescription 142, an inquiry message is sent via the display unit 12 to inquire whether the subject needs assistance (step S66).

In this embodiment, if the remaining amount of the drug package 2 does not match the content of the prescription 142 after the subject has taken the drug, it indicates that the subject may take too much or too little drug, and therefore the clinical research institution personnel can intervene in real time to provide assistance (e.g., to arrange the subject to go to an emergency or to evaluate the cessation of the drug). In particular, the prescription 142 can, for example, keep track of the total number of full and empty doses in the pack 2, as well as the amount of medication taken by the subject each time, so that the identification software 100 can calculate what the correct amount of remaining drug is currently in the pack 2 based on the contents of the prescription 142, thereby performing the above-described decision process.

In one embodiment, the recognition software 100 can also provide an active reporting interface (not shown). Through the active reward interface, a subject can actively reward when encountering difficulty (e.g., swallowing difficulty, the appearance of severe side effects, or overdose). Through the active reward interface, the subject can be informed by the clinical research institution in real time, thereby ensuring the safety of the subject and maintaining the validity of experimental data.

After each administration, no matter whether the administration amount of the patient is correct or not, the recognition software 100 can calculate and display the detailed administration following rate of the subject according to the first amount of the drug (the amount of the drug before administration) and the remaining amount of the drug (the amount of the drug after administration) (step S68), and further record the remaining amount of the drug and the detailed administration following rate in the local storage unit 14 or the remote server 3 (step S70). If the subject takes the correct dose, the rate of follow-up of exhaustive medication will increase, otherwise it will decrease.

By the recording method of the present invention, the subject can obtain a current exhaustive dosing compliance rate after each dose, thereby enhancing the dosing impression. In addition, the clinical research institution can obtain real medicine taking data generated by the subject after each medicine taking in real time, thereby being beneficial to tracking and monitoring the detailed medicine taking following rate of the subject.

Please refer to fig. 6, which shows a first embodiment of the identification flow chart according to the present invention. Fig. 6 is a diagram illustrating how the recognition software 100 of the present invention performs image recognition and obtains the remaining drug amount and the actual drug administration data.

As shown in fig. 6, first, the recognition software 100 acquires the medicine package appearance image captured by the image capturing unit 11 (step S80), preprocesses the medicine package appearance image, and places the image of the medicine package portion in the medicine package appearance image in the display unit 12 of the mobile device 1 (step S82). In one embodiment, the pre-processing includes automatically capturing, rotating and scaling the external image of the medicine package, wherein the external image of the medicine package is the external image of the first medicine package before taking the medicine or the external image of the second medicine package after taking the medicine, but not limited thereto.

Next, the recognition software 100 performs an image recognition procedure on the appearance image of the medicine package to recognize the number, position and status of the plurality of medicine bags in the medicine package (step S84), wherein the recognition software 100 can analyze and count the status of all the medicine bags in the medicine package, thereby obtaining the remaining amount of the medicine in the medicine package (for example, the remaining amount of the medicine in the medicine package is four bags including four full medicine bags, which can be calculated). The recognition software 100 generates and displays the dose confirmation interface 4 including the boxes 42 as shown in fig. 4A and 4B according to the number, position and status of the plurality of sachets (step S86), wherein the number, position and status of the boxes 42 correspond to the number, position and status of the plurality of sachets.

After step S86, the mobile device 1 accepts the external operation of the subject through the display unit 12 or the input unit, and the recognition software 100 continuously determines whether the subject has modified the state of any of the boxes 42 (step S88), for example, whether to modify the state of any of the boxes 42 from "full" to "empty" or from "empty" to "full".

In this embodiment, if the recognition software 100 determines that the subject has indeed modified any of the boxes 42, the appearance image of the pack obtained by the mobile device 1 in step S80 and one or more boxes 42 modified by the subject in step S88 are stored (step S90). By storing the image of the package appearance and the modified box or boxes 42, the clinical research institution personnel can make a final determination of the modification of the subject to confirm that the identification software 100 has made a mistake or that the subject has made a mistake.

If the recognition software 100 determines in step S88 that the subject has not modified any of the boxes 42, or the image of the appearance of the pack and the modified one or more boxes 42 have been stored in step S90, the recognition software 100 further determines whether the subject has taken the medicine (step S92). In one embodiment, the identification software 100 can determine whether the subject has taken the drug based on the remaining amount of drug (modified or unmodified) and the contents of the prescription 142. In another embodiment, the identification software 100 can determine whether the subject has taken the medicine according to whether the second actual medicine taking data is generated.

If the subject has taken the medication, the recognition software 100 marks the plurality of boxes 42 (including the unmodified box 42 and the modified box 42) as the third actual medication taking data for the subject (step S94). Conversely, if the subject has not taken the drug, the recognition software 100 marks the plurality of boxes 42 (including the unmodified box 42 and the modified box 42) as the subject' S true drug inventory data (step S96). Furthermore, the identification software 100 can transmit the third actual medication data/actual medication count data to the remote server 3 via the wireless transmission unit 13 of the mobile device 1 as the actual data related to the subject.

In this embodiment, the third real medication data is used to left-verify the dosage of the subject at the present stage, and the real inventory data is used to notify the left-verify the medication loss. However, the above description is only an exemplary embodiment of the present invention, and should not be construed as limiting the invention.

Please refer to fig. 7, which is a flowchart illustrating a first embodiment of the following rate calculation according to the present invention. Fig. 7 is used to illustrate how the invention reacts in real time or in advance by calculating the rate of compliance in real time.

First, the recognition software 100 of the mobile device 1 determines whether the subject takes a medicine normally (step S100). In one embodiment, the identification software 100 can determine whether the subject takes medicine normally according to the information of the medicine taking time, the first medicine amount, the remaining medicine amount, and the like of the subject. In another embodiment, the identification software 100 can determine whether the subject takes medicine normally according to whether the second real medicine taking data is generated. The recognition software 100 also determines whether the recognized remaining amount of medicine matches the contents of the prescription 142 (step S102).

If the user does not take the medicine normally, or if the medicine is taken normally but the remaining amount of medicine in the medicine package does not match the contents of the prescription 142 (i.e., the amount of medicine taken is wrong), the recognition software 100 can judge that the compliance rate of the subject is decreased (step S104), and if the user takes the medicine normally and the remaining amount of medicine in the medicine package matches the contents of the prescription 142 (i.e., the amount of medicine taken is correct), the recognition software 100 can judge that the compliance rate of the subject is increased (step S106).

In this embodiment, the compliance rate includes, but is not limited to, the behavioral compliance rate and the detailed medication compliance rate described above. The recognition software 100 can calculate the behavior following rate of the subject in real time according to the following two calculation formulas:

calculating a second formula: (cumulative administration frequency-cumulative administration error frequency)/cumulative administration frequency.

Specifically, the recognition software 100 can calculate and record the following forms according to the taking condition of the subject and the prescription 142:

as described above, the identification software 100 calculates the behavior compliance rate of the subject in real time according to the calculation formula of "cumulative administration time-cumulative administration error time)/cumulative administration time". Also, the recognition software 100 may record the number of medication errors as 1 when the amount of medication taken by the subject per time is different from the amount of medication taken as indicated by the prescription 142.

Taking the 10 th taking movement as an example, the recognition software 100 calculates the current behavior compliance rate of the subject to be 70% according to the calculation formula of "10-3)/10". The invention can enable personnel of a clinical research institution to quickly judge whether intervention is needed to provide medicine taking assistance or whether a subject is possible to quit the experiment or not by calculating the behavior following rate.

In the present invention, the recognition software 100 may periodically execute the compliance rate determination procedure, and automatically analyze the variation trend of the compliance rate of exhaustive medication and the compliance rate of behavior according to the historical data of the compliance rate of exhaustive medication and the compliance rate of behavior of the subject (step S108).

In this embodiment, the recognition software 100 can determine whether the behavior following rate of the subject continuously decreases according to step S108 (step S110), and send an alert message to the remote server 3 to notify the clinical research institution to provide assistance or start to recruit a new subject when the behavior following rate of the subject continuously decreases (step S112). Through trend analysis of the behavior following rate, a person in a clinical research institution can judge in advance whether the subject needs assistance or whether there is a sign of quitting the experiment, thereby stabilizing the subject's medication action and reducing the risk of the clinical experiment being delayed.

Also, the recognition software 100 can determine whether the subject' S exhaustive medication compliance rate is likely to be below the lower requirement limit of the clinical trial before the end of the entire treatment session according to step S108 (step S114). If it is determined that the subject 'S exhaustive medication compliance rate may indeed be below the lower demand limit before the end of the therapy session (i.e., the subject' S data may be shaved), the recognition software 100 further determines whether the subject is still allowed to take medication errors before the end of the therapy session (step S116). For example, if the lower demand limit is 80% and the subject's current adherence rate to exhaustive dosing is 90%, then the subject may be considered to be still permitted to take the medication incorrectly before the end of the course of treatment. For another example, if the lower demand limit is 80% and the subject's current compliance rate for exhaustive medication is also 80%, then the subject may be deemed to have not been allowed the medication error.

If it is determined that the subject is still allowed to take the medication mistake, the recognition software 100 may issue an inquiry message through the display unit 12 of the mobile device 1 (step S118), thereby actively inquiring whether the subject has difficulty (e.g., swallowing difficulty or side effect) to need assistance. By understanding the difficulties that a subject may currently encounter, a person of a clinical research institution may intervene in a timely manner to assist the subject in taking a drug to avoid a sustained decline in the subject's rate of compliance with a detailed medication.

Furthermore, if it is determined that the subject is not allowed to take the medicine incorrectly, the recognition software 100 can send a request message to the remote server 3 via the wireless transmission unit 13 of the mobile device 1 to notify the personnel of the clinical research institution to supervise the medicine taking action of the subject (step S120). The personnel of the clinical research institution actively supervise the medicine taking action of the subject each time, can ensure that the detailed medicine taking following rate of the subject does not decrease any more, and can meet the requirement lower limit at the end of the treatment course.

By the recording method, the subject can deepen the medicine taking impression, and clinical research institutions can obtain real data with extremely high correctness, so that the recording method has extremely high economic benefit for clinical experiments.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention.

The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. A method for recording real medicine taking data and detailed following rate by a mobile device is applied to the mobile device and is characterized by comprising the following steps:

2. The method as claimed in claim 1, wherein the mobile device records a current dosage time and a dosage amount at the same time in step i), wherein the dosage amount is a difference between the first dosage amount and the remaining dosage amount.

3. The method as claimed in claim 2, wherein the mobile device compares the amount of the taken medicine with the content of the prescription to determine whether the medicine is overdose or under-dose, and the mobile device calculates the rate of compliance of the taking medicine in real time in step h) according to the following calculation formula: (cumulative dosage for drug administration-cumulative dosage for drug excess-cumulative dosage for drug deficiency)/cumulative dosage for drug administration.

4. The method of claim 1, wherein the dose confirmation interface comprises at least the second package appearance image and a plurality of boxes corresponding to the number, position and status of the blister packs in the second package appearance image, wherein the status of the plurality of the medicine packs comprises full medicine packs and empty medicine packs, and the remaining dose is equal to the total number of the full medicine packs.

5. The method according to claim 4, wherein the plurality of boxes are displayed in a manner of overlapping with or under the second package appearance image, and the mobile device receives the external operation to confirm or modify the status of each box in step g) to confirm or modify the remaining dosage.

6. The method for recording real dose data and exhaustive compliance rate by mobile device according to claim 4, wherein the step g) is followed by a step g 1): storing the second package appearance image and the plurality of frames after the subject modifies the remaining amount of the drug.

7. The method of claim 4, wherein the blister pack has a serial number, and the step b) further comprises the following steps:

b2) judging whether the serial number accords with the identity of the subject;

8. The method as claimed in claim 4, wherein the step c) is followed by the steps of:

9. The method as claimed in claim 4, further comprising a step d1) after the step d): labeling the second package appearance image as a second true medication data for the subject.

10. The method of claim 4, wherein the step g) is followed by the steps of:

11. The method of claim 4, further comprising the steps of:

12. The method of claim 11, wherein the mobile device calculates the compliance rate according to the following calculation formula: (cumulative administration frequency-cumulative administration error frequency)/cumulative administration frequency.

13. The method of claim 12, further comprising the steps of:

m1) analyzing a change trend of the behavior following rate; and

14. The method of claim 11, further comprising the steps of:

n1) analyzing a trend of the rate of compliance of the exhaustive medication;

n2) determining whether the exhaustive medication compliance rate will fall below a lower limit of demand before the end of the entire treatment session based on the trend;