WO2022025344A1 - Method for assigning integrity of follow-up data - Google Patents

Abstract

A method for assigning integrity of follow-up data according to one embodiment of the present invention comprises the steps of: receiving first follow-up data of a patient from a first terminal; receiving clinical data of the patient from a second terminal; generating second follow-up data by processing the clinical data; and assigning integrity points to the first follow-up data by comparing the first follow-up data with the second follow-up data. The step of assigning integrity points comprises a step for increasing the integrity points of the first follow-up data if the first follow-up data and the second follow-up data match, and decreasing the integrity points of the first follow-up data if the first follow-up data and the second follow-up data do not match.

Description

How to give reliability to follow-up data

The present invention relates to a method for granting reliability of follow-up data.

As the bio industry expands, clinical trials for new drug development are also increasing. Recently, case report form (CRF) used in clinical trials is more and more managed electronically instead of on paper, and research on how to efficiently and safely manage data used in clinical trials is being actively carried out.

When a patient visits a hospital for a clinical trial and performs various tests or questionnaires, these test records are first recorded on paper or in an in-hospital medical record system (EMR) managed by the hospital. Thereafter, the clinical research nurse (CRC) of the hospital performs the task of transferring the source data created/recorded in the hospital to the electronic case record sheet (eCRF). Since many input errors occur at this time, in most clinical trials, a separate source data verification (SDV) process is performed.

In the case of medical data, since the source data is limited to hospitals, data verification (SDV) as described above is usually entered into the hospital's medical record system and electronic case record (eCRF). This is done through the process of comparing the collected data with the eyes of someone at the hospital. Accordingly, there is a need for a method of measuring the integrity of each data, quantifying it, and assigning a score.

On the other hand, in the case of clinical trials, it is very important to collect follow-up data since a follow-up step is performed to check whether the patient survives/death/relapses/metastases after the clinical trial. In the case of follow-up, medical staff such as nurses usually call the patient and collect data, but there is no method to separately verify this data.

However, the technical tasks to be achieved by the embodiments of the present invention are not limited to the tasks mentioned above, and various technical tasks may be derived from the content to be described below within the scope obvious to those skilled in the art.

A method for granting reliability of follow-up data according to an embodiment of the present invention comprises the steps of: receiving first follow-up data of a patient from a first terminal; receiving clinical data of the patient from a second terminal; generating second follow-up data by processing the clinical data; Comparing the first follow-up data with the second follow-up data, assigning a confidence point to the first follow-up data; including, and assigning the confidence point includes, the first follow-up data and the second follow-up data match, increase the confidence point of the first follow-up data, and if the first follow-up data and the second follow-up data do not match, the confidence point of the first follow-up data reducing; including.

In the case of an embodiment of the present invention, the accuracy of data verification is improved because the verification of the tracking data is performed by comparing the data transmitted from two different terminals through the tracking data reliability granting device, rather than by the human eye. It is possible to quantitatively measure the reliability of the data, so that the overall reliability of the database can be grasped.

On the other hand, since different patients directly perform their own data verification tasks, the overall data verification duration is shorter than performing data verification at any one institution.

1 is a diagram illustrating a system for implementing a method for granting reliability of follow-up data according to an embodiment of the present invention.

2 is a flowchart illustrating a comprehensive process of a method for granting reliability of follow-up data according to an embodiment of the present invention.

Advantages and features of the present invention, and a method of achieving them will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and can be implemented in various forms, only these embodiments make the disclosure of the present invention complete, and 　 with ordinary knowledge in the art to which the present invention pertains It is provided to fully inform the person of the scope of the invention, and the scope of the present invention is only defined by the claims.

In describing the embodiments of the present invention, detailed descriptions of well-known functions or configurations will be omitted except when actually necessary in describing the embodiments of the present invention. In addition, the terms to be described later are terms defined in consideration of functions in an embodiment of the present invention, which may vary according to intentions or customs of users and operators. Therefore, the definition should be made based on the content throughout this specification.

The functional blocks shown in the drawings and described below are merely examples of possible implementations. Other functional blocks may be used in other implementations without departing from the spirit and scope of the detailed description. Also, although one or more functional blocks of the present invention are represented as separate blocks, one or more of the functional blocks of the present invention may be combinations of various hardware and software configurations that perform the same function.

In addition, the expression including certain components is an open expression and merely refers to the existence of the corresponding components, and should not be construed as excluding additional components.

Furthermore, when it is said that a component is connected or connected to another component, it may be directly connected or connected to the other component, but it should be understood that another component may exist in the middle.

In addition, expressions such as 'first, second', etc. are used only for distinguishing a plurality of components, and do not limit the order or other characteristics between the components.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

1 is a diagram illustrating a system 1 for implementing a method for granting reliability of follow-up data according to an embodiment of the present invention.

Referring to FIG. 1 , a system 1 for implementing a method for granting reliability of tracking data according to an embodiment of the present invention includes a first terminal 10 , a device for granting reliability of tracking data 100 , and a second terminal 20 . ) may be included.

The first terminal 10 is, for example, a terminal that can be used in a hospital conducting a clinical trial, and transmits the patient's first follow-up data to the follow-up data reliability granting apparatus 100 . In this case, the first follow-up data may include information corresponding to the purpose of the database 101 . The database 101 may include information on clinical trials, such as patient's disease information, tissue image information, genetic information, pathology information, medication history information, side effects information, blood test information, and hospital visit date. The database 101 may include an electronic case record (eCRF).

Follow-up data reliability granting apparatus 100 receives the patient's first follow-up data from the first terminal (10). On the other hand, the follow-up data reliability granting apparatus 100 receives the patient's clinical data from the second terminal 20, and generates the second follow-up data by processing the clinical data. The follow-up data reliability granting apparatus 100 compares the first follow-up data input through the first terminal 10 with the second follow-up data processed by the clinical data input through the second terminal 20 . If the tracking data reliability granting device 100 matches the first tracking data and the second tracking data, the reliability point of the first tracking data is increased, and the first tracking data and the second tracking data do not match. Otherwise, a confidence point may be given to the first tracking data by reducing the confidence point of the first tracking data. The credit points may be stored in the database 101 . In this case, the first terminal 10 , the tracking data reliability granting apparatus 100 , and the second terminal 20 may transmit/receive information through a wired/wireless network.

The second terminal 20 is, for example, a terminal that can be used by a patient or a guardian participating in a clinical trial, and transmits the patient's clinical data to the follow-up data reliability granting apparatus 100 .

A follow-up data reliability grant method for realizing the system 1 for implementing the follow-up data reliability grant method according to an embodiment of the present invention will be described with reference to FIG. 2 .

2 is a flowchart illustrating a comprehensive process of a method for granting reliability of follow-up data according to an embodiment of the present invention. Each step of the method for granting reliability of follow-up data according to FIG. 2 may be performed by the apparatus 100 for granting reliability of follow-up data. Each step performed by the tracking data reliability granting apparatus 100 will be described as follows.

The method for granting reliability of follow-up data according to an embodiment includes the steps of receiving first follow-up data of a patient from a first terminal (S100), receiving clinical data of a patient from a second terminal (S200), Generating second follow-up data by processing clinical data (S300), comparing the first follow-up data with the second follow-up data to give a confidence point to the first follow-up data and the second follow-up data (S400) is included.

Referring to FIG. 2 , the step ( S100 ) of receiving the patient's first follow-up data from the first terminal 10 in the follow-up data reliability granting apparatus 100 is performed. The first terminal 10 may be used, for example, by a clinical research nurse (CRC) in a hospital, and the clinical research nurse (CRC) performs various tests/questions from the patient and then inputs the first follow-up data related thereto. .

[Table 1] below is an example of the first tracking data transmitted from the first terminal. A user using the first terminal may, for example, call the patient to confirm whether he or she is alive, and then input the following data into the first terminal to transmit the first follow-up data to the follow-up data reliability granting apparatus 100 .

number	Survival Follow-up	effective date	survival check
One	Yes	2020-06-07	Yes
2	Yes	2020-06-08	Unknown
3	Yes	2020-06-09	Unknown
4	Yes	2020-06-10	No

For example, the first terminal user may input 'survival confirmation' data as "Yes" or "No" when contacting the patient or guardian and confirming whether the patient is alive or not. Alternatively, the user of the first terminal can enter 'survival confirmation' data as "Unknown" when it is unknown whether the patient is alive or not because the patient or guardian cannot be contacted.

The first follow-up data may include data on whether or not survival follow-up was performed, data on the date of implementation of survival follow-up, data on follow-up methods, data on survival confirmation, data on tumor event types, detailed recurrence/metastasis site data, data on how to confirm recurrence/metastasis, and data on the date of examination. However, the present invention is not limited thereto.

On the other hand, the step (S200) of receiving the clinical data of the patient from the second terminal 20 in the follow-up data reliability granting apparatus 100 is performed. In this specification and drawings, for convenience, after receiving the patient's first follow-up data from the first terminal 10 (S100), the step (S200) of receiving the patient's prescription data from the second terminal 20 is performed. Although described, the present invention is not limited thereto. The temporal order of the two steps ( S100 , S200 ) may be opposite to the above, or may be performed substantially simultaneously.

The second terminal 20 may be used by the patient himself/herself or a guardian. The patient enters clinical data. Clinical data is data related to a patient's health, and may include side effects data, prescription data, medical record data, and log data containing a record using the second terminal 20 , but the present invention is not limited thereto. .

According to an embodiment, the clinical data may include log data containing a record of using the second terminal 20 . For example, the tracking data reliability granting apparatus 1 may send a message to the second terminal 20 in the form of a push alarm or the like. When the user of the second terminal 20 responds by pressing a specific button on the second terminal 20 in response to this, the second terminal 20 transmits data related thereto to the tracking data reliability granting apparatus 1 can do. In this case, the response message transmitted by the second terminal 20 may include medication adherence data and response date/time data.

According to an embodiment, the clinical data may be image data obtained by photographing or scanning a medical record copy or a prescription. According to an embodiment, the clinical data may be text data obtained by performing optical character recognition (OCR) on the image data.

Since the patient can read/receive a copy of his/her medical record and prescription, he/she may check all source data about himself/herself generated in the hospital. Accordingly, the patient may participate in source data verification (SDV) through the second terminal 20 .

Thereafter, the step (S300) of generating the second follow-up data by processing the clinical data in the follow-up data reliability granting apparatus 100 is performed. In this step, the clinical data is processed to generate second follow-up data in the same format as the first follow-up data.

Hereinafter, an embodiment of the step of generating the second follow-up data by processing the clinical data will be described.

[Table 2] shows some examples of clinical data received by the apparatus 100 for granting reliability of follow-up data from the second terminal 20 .

number	Ingredient name	alarm generation time	alarm confirmation time	medication status
One	Tamoxifen	2020-06-07 20:10:20	2020-06-07 20:11:20	Yes
2	Tamoxifen	2020-06-08 20:10:20	2020-06-08 21:10:20	No
3	Tamoxifen	2020-06-09 20:10:20	2020-06-0920:15:32	Yes
4	Tamoxifen	2020-06-10 20:10:20

The follow-up data reliability granting apparatus 100 may receive clinical data regarding the patient's medication history from the second terminal 20 . The clinical data may include data on the answer to the question of whether a specific drug was taken (medication status) and the time (alarm confirmation time) at which it was confirmed and answered. When the tracking observation data reliability granting apparatus 100 receives the 'alarm confirmation time' data in [Table 2] from the second terminal 20, it processes the data to generate "survival confirmation" data as 'Yes' can do. Alternatively, when the 'alarm confirmation time' data in [Table 2] is not received from the second terminal 20, "survival confirmation" data may be generated as 'Unknown'. Through this, the follow-up data reliability granting apparatus 100 may process clinical data to generate second follow-up data as shown in [Table 3] below.

number	Survival Follow-up	effective date	survival check
One	Yes	2020-06-07	Yes
2	Yes	2020-06-08	Yes
3	Yes	2020-06-09	Yes
4	Yes	2020-06-10	Unknown

Thereafter, by comparing the first follow-up data and the second follow-up data, a step (S400) of assigning a confidence point to the first follow-up data and the second follow-up data is performed.

In the present specification, the 'reliability point' refers to an indicator quantitatively expressed with respect to how reliable the data received by the tracking data reliability granting apparatus 100 is.

When the user of the first terminal inputs the first follow-up data to the first terminal, the patient is confused, the data is input/selected incorrectly, or the data itself cannot be collected for other reasons, etc. may occur. In this case, the reliability of the first follow-up data is lowered.

In the present invention, a reliability point is given to the first tracking data by processing the data input through the second terminal and comparing it with the first tracking data.

[Table 4] below is an example of assigning confidence points to "survival confirmation" data after comparing [Table 1] and [Table 3].

number	First follow-up data - survival check	Second follow-up data - survival check	first follow-up data Confidence points increase or decrease
One	Yes	Yes	+10
2	Unknown	Yes	-10
3	Unknown	Yes	-10
4	No	Unknown	-5

For example, looking at the first row of [Table 4], the 'survival confirmation' data of the first follow-up data and the second follow-up data match "Yes". In this case, the tracking data reliability granting apparatus 100 may increase the reliability point of the first tracking data by a preset value.

Looking at the second and third rows, the first follow-up data transmitted by the first terminal is 'Unknown', and the second follow-up data obtained by processing the clinical data of the second terminal is 'Yes'. Since both data are inconsistent, the apparatus for granting reliability of tracking data 100 may decrease the reliability point of the first tracking data by a preset value.

Looking at the fourth row, the first follow-up data transmitted by the first terminal is 'No', and the second follow-up data obtained by processing the clinical data of the second terminal is 'Unknown'. Since both data are inconsistent, the apparatus for granting reliability of tracking data 100 may decrease the reliability point of the first tracking data by a preset value.

According to an embodiment, the increase or decrease of the reliability point of the first follow-up data may vary according to the value of the second follow-up data. For example, when the second follow-up data has a clear value, the reliability point of the first follow-up data may be reduced more than when the second follow-up data is unconfirmed data (Unknown). This is because, when the second follow-up data is unconfirmed data, the probability that the first follow-up data is a correct value is higher than when the second follow-up data has a clear value.

In the case of an embodiment of the present invention, since the verification of the tracking data is not performed by human eyes, but data transmitted from two different terminals is compared through the tracking data reliability granting device 100 and performed, the data verification is Accuracy is improved, and data reliability can be measured quantitatively, so the overall reliability of the database can be grasped.

On the other hand, since different patients directly perform their own data verification tasks, the overall data verification duration is shorter than performing data verification at any one institution.

The method for granting reliability of tracking data according to an embodiment may further include the step of giving a credit point to the first terminal 10 . According to one embodiment

When the reliability point of the first tracking data increases, the reliability point of the first terminal 10 itself may be increased. Conversely, when the reliability point of the first tracking data decreases, the first terminal 10 itself may reduce the reliability point. Through this, it is possible to evaluate the data input accuracy of the user of the first terminal 10 who inputs the patient's first follow-up data, and to induce more accurate data input.

The method for granting reliability of tracking data according to an embodiment may further include granting a reward point to the second terminal 20 . The follow-up data reliability granting apparatus 100 may reward the patient for participating in the data verification (SDV) process by granting a reward point to the second terminal 20 . The reward points may be, for example, digital assets such as digitized cash, points, gift certificates, cryptocurrency, contribution, reliability, rank, and emoticons, but the present invention is not limited thereto.

According to the above-described embodiment, the quality of the first follow-up data can be improved by allowing the patient to participate in the source data verification (SDV) to verify the first follow-up data without a problem of personal information infringement. have. On the other hand, reward points can be given to patients who have contributed to the improvement of data quality, leading to voluntary participation of patients.

According to an embodiment, the tracking data reliability granting apparatus 100 may transparently manage the reception and modification details of the first tracking data and the second tracking data by recording them on the block chain.

As an example, the follow-up data reliability granting apparatus 100 generates a block including information obtained based on the patient's first follow-up data, and connects to blocks of other patients participating in the construction of the database 101 to create a block chain can be stored on

For example, when the tracking data reliability granting device 100 receives the first follow-up data from the new patient, the patient's public key (public key) corresponding to the identification information (or address), the first follow-up data By creating a block including information (time series information, qualitative information or quantitative information) and reward points included in , it can be linked to a block containing information of a previous patient.

On the other hand, the information to be recorded in the block may be information including the patient's digital identification information and the first follow-up data, but it can be designed so that the information to be recorded on the block chain and the information to be stored in the server are separately divided according to the administrator's choice. may be

On the other hand, the apparatus 100 for granting reliability of tracking data according to an embodiment of the present invention may include a receiving unit and a data reliability point granting unit.

The receiver may receive the first follow-up data and clinical data from the first terminal 10 and the second terminal 20, respectively.

The data reliability point granting unit compares the first follow-up data and the second follow-up data generated by processing the clinical data, and gives a reliability point to the first follow-up data.

On the other hand, since the process for the components included in the tracking data reliability granting apparatus 100 according to the above-described embodiment to perform the corresponding operation has been described together with FIGS. 1 and 2 , the redundant description will be omitted.

Meanwhile, the receiving unit and the data verifying unit included in the above-described embodiment may be implemented by a memory including instructions programmed to perform these functions, and an arithmetic device including a microprocessor for performing these instructions.

The above-described embodiments of the present invention may be implemented through various means. For example, embodiments of the present invention may be implemented by hardware, firmware, software, or a combination thereof.

In the case of implementation by hardware, the method according to embodiments of the present invention may include one or more Application Specific Integrated Circuits (ASICs), Digital Signal Processors (DSPs), Digital Signal Processing Devices (DSPDs), and Programmable Logic Devices (PLDs). , FPGAs (Field Programmable Gate Arrays), processors, controllers, microcontrollers, microprocessors, and the like.

In the case of implementation by firmware or software, the method according to the embodiments of the present invention may be implemented in the form of a module, procedure, or function that performs the functions or operations described above. A computer program in which a software code or the like is recorded may be stored in a computer-readable recording medium or a memory unit and driven by a processor. The memory unit may be located inside or outside the processor, and may transmit and receive data to and from the processor by various known means.

In addition, combinations of each block in the block diagram attached to the present invention and each step in the flowchart may be performed by computer program instructions. These computer program instructions may be embodied in the encoding processor of a general purpose computer, special purpose computer, or other programmable data processing equipment, such that the instructions executed by the encoding processor of the computer or other programmable data processing equipment may correspond to each block of the block diagram or Each step of the flowchart creates a means for performing the functions described. These computer program instructions may also be stored in a computer-usable or computer-readable memory which may direct a computer or other programmable data processing equipment to implement a function in a particular way, and thus the computer-usable or computer-readable memory. The instructions stored in the block diagram may also produce an item of manufacture containing instruction means for performing a function described in each block of the block diagram or each step of the flowchart. The computer program instructions may also be mounted on a computer or other programmable data processing equipment, such that a series of operational steps are performed on the computer or other programmable data processing equipment to create a computer-executed process to create a computer or other programmable data processing equipment. It is also possible that instructions for performing the processing equipment provide steps for carrying out the functions described in each block of the block diagram and each step of the flowchart.

In addition, each block or each step may represent a module, segment, or part of code including one or more executable instructions for executing a specified logical function. It should also be noted that in some alternative embodiments it is also possible for the functions recited in blocks or steps to occur out of order. For example, it is possible that two blocks or steps shown one after another may in fact be performed substantially simultaneously, or that the blocks or steps may sometimes be performed in the reverse order according to the corresponding function.

As such, those skilled in the art to which the present invention pertains will understand that the present invention may be embodied in other specific forms without changing the technical spirit or essential characteristics thereof. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. The scope of the present invention is indicated by the following claims rather than the detailed description, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be construed as being included in the scope of the present invention. .

The present invention can be applied to the medical data acquisition and analysis industry.

Claims (1)

1. Receiving first follow-up data of the patient from the first terminal;

   receiving clinical data of the patient from a second terminal;

   generating second follow-up data by processing the clinical data;

   Comparing the first follow-up data with the second follow-up data, giving a confidence point to the first follow-up data; includes;

   Allocating the reliability point comprises:

   If the first follow-up data and the second follow-up data match, increase the reliability point of the first follow-up data,

   When the first follow-up data and the second follow-up data do not match, reducing the confidence point of the first follow-up data; Containing, the follow-up data reliability imparting method.

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