CN116266477A - Medical data processing method and medical data processing system - Google Patents
Medical data processing method and medical data processing system Download PDFInfo
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Abstract
The invention provides a medical data processing method and a medical data processing system. The medical data processing method comprises the following steps: inputting patient information through a patient terminal; based on the patient information, determining whether the patient belongs to a clinical trial group entry subject; randomly grouping confirmed clinical trial-in-group subjects into either experimental or control groups; and monitoring and managing information of the grouped objects. The medical data processing method and the medical data processing system can collect the health global information of the patient, pertinently conduct grouping monitoring and management aiming at different disease types, and realize real-time dynamic grouping of the subjects under the random and double-blind principle.
Description
Technical Field
The present invention relates to the field of medical information processing technologies, and in particular, to a medical data processing method and a medical data processing system.
Background
Along with the rapid development of Internet application, the data collection of electronic products is normal, and the traditional information acquisition form is changed from paper questionnaires, handwriting input and other forms into electronic input and operation, so that the time and labor cost are greatly saved. The effective personalized health management scheme is based on the multi-dimensional complete and detailed medical health data of patients, and the medical health management scheme and corresponding products can be formed according to the representative physique crowd of different symptoms by collecting basic physical sign data, clinical dynamic data, biological indexes and other data. The fragmentation of the patient medical health data is dispersed in medical institutions such as physical examination, hospitals and the like, and centralized analysis is needed so as to further carry out scientific research on the patient data. In addition, randomization has become one of the fundamental principles that clinical trials must follow. In the current clinical research, the clinical double-blind experiment is very difficult to realize blind setting for medical staff because the medical staff plays a leading role in the treatment activity. Therefore, a more direct and convenient clinical data acquisition, random automatic grouping, and punching system and method are more important.
Disclosure of Invention
The invention provides a medical data processing method and a medical data processing system, which can collect the health global information of patients, pertinently conduct grouping monitoring and management on different disease types, realize real-time dynamic grouping of subjects under the random and double-blind principle and simultaneously ensure that selective bias is avoided.
According to one aspect, the present invention provides a medical data processing method comprising: inputting patient information through a patient terminal; based on the patient information, determining whether the patient belongs to a clinical trial group entry subject; randomly grouping confirmed clinical trial-in-group subjects into either experimental or control groups; and monitoring and managing information of the grouped objects.
Further, the randomly grouping of confirmed clinical trial-in-group subjects into experimental or control groups may include: determining a patient group where a group-entering object is located, wherein the patient group comprises an experimental group and a control group; comparing the total ratio of the total number of the experimental group to the total number of the control group of the current group-entering object with a reference ratio to obtain a first comparison result; based on the first comparison result, further comparing the number of people deflection value of the experimental group after the new patient is added with the number of people deflection value of the control group to obtain a second comparison result; and grouping the new patients into experimental or control groups based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is substantially equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is substantially equal to the reference ratio.
Alternatively, the experimental and control population bias values respectively satisfy the following equations:
m (experimental group) = |m (experimental group) +1-3×m (control group) |, and
m (control) = |m (experimental) -3× (M (control) +1) |,
wherein, M (experimental group) is the number of people deflection value of the experimental group, M (control group) is the number of people deflection value of the control group, M (experimental group) is the number of people of the experimental group before the new patient is added, and M (control group) is the number of people of the control group before the new patient is added.
Further, the experimental and control population bias values for each patient group satisfy both equations.
According to one embodiment, when it is determined that the total ratio is greater than the reference ratio, it is determined whether the experimental group population bias value is greater than the control group population bias value. When the number of people deflection value of the experimental group is larger than the number of people deflection value of the control group, grouping the newly added patients into the control group; or when the number of people deflection value of the experimental group is not larger than the number of people deflection value of the control group, the probability that the newly added patient is allocated to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
According to another embodiment, when it is determined that the total ratio is smaller than the reference ratio, it is determined whether the experimental group population bias value is smaller than the control group population bias value. When the number of people deflection value of the experimental group is smaller than the number of people deflection value of the control group, grouping the newly added patients into the experimental group; or when the number of people deflection value of the experimental group is not smaller than the number of people deflection value of the control group, the probability that the newly added patient is allocated to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
Optionally, dividing a predetermined numerical range into a first numerical range and a second numerical range in a total proportion by a reference ratio, the ratio of the number of numbers in the first numerical range to the total number of numbers in the predetermined numerical range corresponding to the first probability, the ratio of the number of numbers in the second numerical range to the total number of numbers in the predetermined numerical range corresponding to the second probability, and determining to assign the newly added patient to the experimental group or the control group based on whether the randomly extracted numbers in the predetermined numerical range fall within the first numerical range or the second numerical range.
According to yet another embodiment, when it is determined that the total ratio is equal to the reference ratio, it is determined whether the experimental group population bias value is smaller than the control group population bias value. When the number of people deflection value of the experimental group is smaller than the number of people deflection value of the control group, grouping the newly added patients into the experimental group; or when the number of people deviation value of the experimental group is not smaller than the number of people deviation value of the control group, assigning the newly added patients to the control group.
Alternatively, the total ratio may be a ratio of a sum of the total population of the experimental group of each of the plurality of patient groups to a sum of the total population of the control group of each of the plurality of patient groups.
Additionally, optionally, the determining the patient group in which the group-entering object is located includes determining a patient group corresponding to the group-entering object from among a plurality of patient groups according to the medical data.
According to another aspect, the present invention provides a medical data processing system comprising: the input terminal is used for inputting patient information; a group entry object confirmation unit that confirms whether or not a patient belongs to a clinical trial group entry object; a random grouping unit that randomly groups the confirmed clinical trial group-entering subjects to either an experimental group or a control group; and a monitoring unit that monitors and manages information of the grouped objects.
Further, the random grouping unit may include: a patient group determining unit for determining a patient group in which the group-entering object is located; the first comparison unit is used for comparing the total ratio of the total number of the experimental group to the total number of the control group of the current group-entering object with the reference ratio to obtain a first comparison result; the second comparison unit is used for further comparing the number of people deflection value of the experimental group after the new patient is added with the number of people deflection value of the control group based on the first comparison result to obtain a second comparison result; and a grouping subunit that groups the newly added patients into the experimental group or the control group based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is basically equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is basically equal to the reference ratio.
Optionally, the random grouping unit may further include a calculating unit that calculates the experimental group head count bias value and the control group head count bias value according to the following equation:
m (experimental group) = |m (experimental group) +1-3×m (control group) |, and
m (control) = |m (experimental) -3× (M (control) +1) |,
wherein, M (experimental group) is the number of people deflection value of the experimental group, M (control group) is the number of people deflection value of the control group, M (experimental group) is the number of people of the experimental group before the new patient is added, and M (control group) is the number of people of the control group before the new patient is added.
Alternatively, the experimental and control population bias values for each patient group satisfy both equations.
According to one embodiment, when the first comparing unit determines that the total ratio is greater than the reference ratio, the second comparing unit determines whether the experimental group population bias value is greater than the control group population bias value. When the second comparison unit judges that the number of people deflection value of the experimental group is larger than the number of people deflection value of the control group, the grouping unit groups the newly added patients into the control group; or when the second comparison unit judges that the number of people deflection value of the experimental group is not larger than the number of people deflection value of the control group, the probability that the grouping unit distributes the newly added patient to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
According to another embodiment, when the first comparing unit determines that the total ratio is smaller than the reference ratio, the second comparing unit determines whether the experimental group population bias value is smaller than the control group population bias value. When the second comparison unit judges that the population deflection value of the experimental group is smaller than the population deflection value of the control group, the grouping unit groups the newly added patients into the experimental group; or when the second comparison unit judges that the number of people deflection value of the experimental group is not smaller than the number of people deflection value of the control group, the probability that the grouping unit distributes the newly added patient to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
Further, optionally, the grouping subunit may further include a dividing unit that divides a predetermined numerical range into a first numerical range and a second numerical range by the total ratio with reference to the ratio, the ratio of the number of numbers in the first numerical range to the total number of numbers in the predetermined numerical range corresponding to the first probability, and the ratio of the number of numbers in the second numerical range to the total number of numbers in the predetermined numerical range corresponding to the second probability. The grouping subunit determines to assign the newly added patient to the experimental or control group based on the randomly extracted values falling within the predetermined range of values falling within the first range of values or the second range of values.
According to still another embodiment, when the first comparing unit determines that the total ratio is equal to the reference ratio, the second comparing unit determines whether the experimental group population bias value is smaller than the control group population bias value. When the second comparison unit judges that the population deflection value of the experimental group is smaller than the population deflection value of the control group, the grouping subunit groups the newly added patients into the experimental group; or when the second comparison unit judges that the number of people deviation value of the experimental group is not smaller than the number of people deviation value of the control group, the grouping subunit distributes the newly added patients to the control group.
Alternatively, the total ratio may be a ratio of a sum of the total population of the experimental group of each of the plurality of patient groups to a sum of the total population of the control group of each of the plurality of patient groups.
Optionally, the patient group determining unit determines a patient group corresponding to the group-entering object among the plurality of patient groups according to the medical data.
Drawings
The above and other aspects and features of the present invention will become apparent from the following description of embodiments taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a flowchart of a medical data processing method according to an exemplary embodiment of the present invention;
FIG. 2 is a random grouping flow chart of clinical trial group entry subjects according to an exemplary embodiment of the invention;
FIG. 3 is a schematic diagram of a medical data processing system according to another exemplary embodiment of the present invention; and
fig. 4 is a block structure diagram of a random grouping unit according to an exemplary embodiment of the present invention.
Detailed Description
Illustrative, non-limiting embodiments of the present invention are described in detail below with reference to the attached drawing figures, further illustrating a medical data processing method and medical data processing system according to the present invention.
Fig. 1 shows schematically a flow chart of a medical data processing method according to the invention. As shown in fig. 1, the illustrated medical data processing method includes: step S1, inputting patient information through a patient terminal; step S2, based on the patient information, confirming whether the patient belongs to a clinical trial group-entering object; step S3, randomly grouping the confirmed clinical trial group-entering subjects into a trial group or a control group; and step S4, monitoring and managing the grouped information of the grouping objects. The medical data processing method can collect health global information for patients based on the patient terminal and pertinently group the health global information for different diseases, and can monitor and manage the grouped information of the group-entering objects in real time, for example, operations such as punching cards for physical indexes, exercise, medicine taking and the like and reserving review for contacting doctors can be performed every day.
In one embodiment, the inputting patient information via the patient terminal includes inputting identity information and body metrics of the patient and inputting assessment table information of the patient. Specifically, for example, taking a hypertensive patient as an example, the patient may first enter an information collection page from the patient terminal, fill in identity information and body indicators, such as information of name, height, BMI, etc., according to the prompt, and click to submit. After the information is submitted, a quality scale, a GAD-7 emotion scale, a PHQ-9 emotion scale, a hypertension grading and quantifying scale, an International Physical Activity Questionnaire (IPAQ), a Chinese cardiovascular risk assessment scale (China-PAR) and the like are filled in respectively. The above is merely exemplary, and different assessment table information of a patient may be acquired according to different disease types.
Furthermore, when the clinical test group-entering objects are randomly grouped, the probability that each group-entering object, namely a patient, is divided into each group is not fixed, but is adjusted according to a certain condition, and the number of the test group cases and important non-processing factors can be effectively ensured to be close to be consistent based on a dynamic random group-entering algorithm, so that the real-time grouping of the subjects under the random and double-blind principle is realized. To this end, the randomly grouping of confirmed clinical trial-in-group subjects into experimental or control groups may further comprise: determining a patient group where a group-entering object is located, wherein the patient group comprises an experimental group and a control group; comparing the total ratio of the total number of the experimental group to the total number of the control group of the current group-entering object with a reference ratio to obtain a first comparison result; based on the first comparison result, further comparing the number of people deflection value of the experimental group after the new patient is added with the number of people deflection value of the control group to obtain a second comparison result; and grouping the new patients into experimental or control groups based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is basically equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is basically equal to the reference ratio.
In one example, the total ratio may be a ratio of a sum of the population of the experimental group of each of the plurality of patient groups to a sum of the population of the control group of each of the plurality of patient groups. Further alternatively, the determining the patient group in which the group-entering object is located may include determining a patient group corresponding to the group-entering object among a plurality of patient groups according to the medical data.
Further, in one exemplary embodiment, the experimental group head count bias value and the control group head count bias value each satisfy the following equations:
m (experimental group) = |m (experimental group) +1-3×m (control group) | (1)
M (control) = |m (experimental) -3× (M (control) +1) | (2)
Wherein, M (experimental group) is the number of people deflection value of the experimental group, M (control group) is the number of people deflection value of the control group, M (experimental group) is the number of people of the experimental group before the new patient is added, and M (control group) is the number of people of the control group before the new patient is added. Furthermore, preferably, the experimental group population bias value and the control group bias value for each patient group satisfy equations (1) and (2).
In the medical data processing method of the present invention, it is illustratively judged whether or not the experimental group population bias value is larger than the control group population bias value when it is judged that the total ratio is larger than the reference ratio. When the number of people deflection value of the experimental group is larger than the number of people deflection value of the control group, grouping the newly added patients into the control group; when the number of people deflection value of the experimental group is not larger than the number of people deflection value of the control group, the probability of the newly added patient being distributed to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
In addition, when the total proportion is judged to be smaller than the reference ratio, judging whether the number of people in the experimental group is smaller than the number of people in the control group. When the number of people deflection value of the experimental group is smaller than the number of people deflection value of the control group, grouping the newly added patients into the experimental group; when the number of people deflection value of the experimental group is not smaller than the number of people deflection value of the control group, the probability of the newly added patient being distributed to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
Further, in one example, a predetermined range of values is divided into a first range of values and a second range of values by the total ratio, the ratio of the number of numbers in the first range of values to the total number of numbers in the predetermined range of values corresponding to the first probability, and the ratio of the number of numbers in the second range of values to the total number of numbers in the predetermined range of values corresponding to the second probability. Based on the randomly extracted values falling within the predetermined range of values either the first range of values or the second range of values, it is determined to assign a new patient to the experimental or control group.
Further, when it is determined that the total ratio is equal to the reference ratio, it is determined whether or not the experimental group population bias value is smaller than the control group population bias value. When the number of people deflection value of the experimental group is smaller than the number of people deflection value of the control group, grouping the newly added patients into the experimental group; and when the number of people deviation value of the experimental group is not smaller than the number of people deviation value of the control group, distributing the newly added patients to the control group.
After randomly grouping confirmed clinical trial-in subjects into experimental or control groups, the patient may regularly (e.g., daily) perform a punch-card of physical index measurements, exercise, medication, etc., and contact a doctor to schedule a review. Then, for example, the doctor can view details of patient group entering, follow-up visit, review diagnosis scale, card punching and the like on a background page, and can derive test patient data in batches, upload biological indexes and the like.
Next, a flowchart for randomly grouping clinical trial group-entering subjects according to an exemplary embodiment of the present invention will be described in detail with reference to fig. 2. In the embodiment shown in fig. 2, two types of hypertensive patients are exemplified, but it will be appreciated by those skilled in the art that this is only an exemplary illustration, and that other types of diseases and reference indicators may be selected for selection into a group subject depending on the actual requirements of the clinical trial.
As shown in fig. 2, a group-entering subject of a clinical trial is obtained from a plurality of medical centers (e.g., 8 medical centers), for example, the total number of people in the group-entering subject may be defined as no more than 480 people. According to the random grouping method of the present invention, a patient group in which a group-entering object is located is first determined. In this embodiment, the patient group includes a group of hypertension of a type and a group of hypertension of a type, a patient with a systolic pressure in the range of 120 to 129mmHg and a diastolic pressure of less than 80mmHg is in the group of hypertension of a type, a patient with a systolic pressure in the range of 130 to 139mmHg or a diastolic pressure in the range of 80 to 89mmHg is in the group of hypertension of a type B, and each of the hypertension groups includes an experimental group and a control group.
Next, random grouping will be performed by data analysis and comparison of the group-in objects. Referring to fig. 2, the total ratio of the total population of the experimental group to the total population of the control group of the current subject to be entered is R, the reference ratio is Q, and the experimental group population bias value and the control group population bias value after the new patient are calculated according to the above equations (1) and (2), wherein the experimental group population bias value and the control group population bias value of the group a hypertension satisfy equations (1) and (2), respectively, and the experimental group population bias value and the control group population bias value of the group B hypertension also satisfy equations (1) and (2), respectively.
Specifically, as shown in fig. 2, R and Q are first compared. When determining R>At Q, then M (experimental group) was compared with M (control group). If M (Experimental group)>M (control group), then grouping the newly added patients to the control group, otherwise grouping the newly added patients with a first probability and a second probability. That is, if M (experimental group). Ltoreq.M (control group), the probability of assigning a new patient to the experimental group and the control group is the first probability (r 1 ) And a second probability (r 2 ) Wherein r is 1 And r 2 The ratio of (2) is Q.
When it is determined that R is not greater than Q, then it is determined whether R is less than Q or equal to Q. When determining R<At Q, then M (experimental group) was compared with M (control group). If M (Experimental group)<M (control group), then newly added patients are grouped into experimental groups, otherwise r 1 And r 2 To group newly added patients. That is, if M (experimental group) is not less than M (control group), the probability of assigning the newly added patient to the experimental group and the control group is r, respectively 1 And r 2 . When determining r=At Q, then M (experimental group) was compared with M (control group). If M (Experimental group)<M (control group), then the new patient is grouped into the experimental group, otherwise it will be grouped into the control group. Based on the grouping method, the ratio of the total population of the experimental group to the total population of the control group is basically equal to Q, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is basically equal to Q.
When newly added patients are grouped with a first probability and a second probability, a predetermined numerical range is divided into a first numerical range and a second numerical range, illustratively, in total proportion, with Q. For example, the predetermined range of values may be 1-100, with q=3 for example, the first range of values being 1-75, the second range of values being 76-100, r 1 75%, r 2 25%. At this time, it is determined that the newly added patient is assigned to the experimental group or the control group, that is, the probability of the newly added patient entering the experimental group is 75% and the probability of the newly added patient entering the control group is 25%, based on the values randomly extracted within the predetermined value range falling within 1 to 75 or 76 to 100, as shown in fig. 2. The selection of the range of values and the selection of the reference ratio are exemplary herein, and other selections may be made as required by the clinical trial.
Fig. 3 shows a medical data processing system 100 according to an exemplary embodiment of the present invention, which comprises an input terminal 10 for inputting patient information, a group entry object confirmation unit 20, a random grouping unit 30 and a monitoring unit 40. The group-entering subject confirmation unit 20 confirms whether or not the patient belongs to the clinical trial group-entering subject, and the randomization unit 30 randomizes the confirmed clinical trial group-entering subjects into the experimental group or the control group. The monitoring unit 40 monitors and manages information of the grouped objects.
Fig. 4 exemplarily shows a block structure diagram of a random grouping unit according to one embodiment. As shown in fig. 4, the random grouping unit 30 may include a patient group determination unit 31, a first comparison unit 32, a second comparison unit 33, and a grouping subunit 34. The patient group determining unit 31 is configured to determine a patient group in which the group-entering object is located, and the first comparing unit 32 compares a total ratio of a total number of the experimental group to a total number of the control group of the current group-entering object with a reference ratio to obtain a first comparison result. The second comparing unit 33 further compares the experimental group population bias value after the new patient is added with the control group population bias value based on the first comparing result to obtain a second comparing result. Grouping subunit 34 groups the newly added patients into experimental or control groups based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is substantially equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is substantially equal to the reference ratio.
In one example, the random grouping unit 30 further includes a calculating unit 35 that calculates an experimental group head count bias value and a control group head count bias value according to the above equations (1) and (2).
In addition, the grouping subunit 34 may optionally further include a dividing unit (not shown in the figure) that divides a predetermined numerical range into a first numerical range and a second numerical range by the total ratio at a reference ratio, the ratio of the number of numbers in the first numerical range to the total number of numbers in the predetermined numerical range corresponding to the first probability, and the ratio of the number of numbers in the second numerical range to the total number of numbers in the predetermined numerical range corresponding to the second probability. The grouping subunit determines to assign the newly added patient to the experimental or control group based on the randomly extracted values falling within the predetermined range of values falling within the first range of values or the second range of values.
The medical data processing method and the medical data processing system are based on medical clinical practice, basic information is input through a patient end based on a big data technology system, automatic random grouping, personalized card punching, filling scale, follow-up visit and the like can be carried out according to different diseases after different disease modules are added, doctor terminals can check the filled information of the patient to carry out reference treatment, and multiple different test examination results can be compared, so that cognition of illness state of the patient is deepened. The data can be used for big data analysis and clinical test, and the correlation, trend and mode between the potential diseases and symptoms are searched. Therefore, the doctor can conveniently give meaningful intervention scheme guidance to the patient, and the diagnosis and treatment process of the doctor is optimized. In addition, the medical data processing method and the medical data processing system can dynamically monitor the compliance information and follow-up information of the patient, ensure the timeliness of the information, and are beneficial to doctors to further diagnose and treat the illness state of the patient according to the feedback information.
The above description is given for the purpose of illustrating the embodiments of the present invention and is not to be construed as limiting the invention, but is to be construed as including any modifications, equivalent alterations, improvements, etc. which do not depart from the spirit and principles of the present invention.
Claims (20)
1. A medical data processing method, comprising:
inputting patient information through a patient terminal;
based on the patient information, determining whether the patient belongs to a clinical trial group entry subject;
randomly grouping confirmed clinical trial-in-group subjects into either experimental or control groups; and
the information of the grouped objects is monitored and managed.
2. The medical data processing method of claim 1, wherein the randomly grouping confirmed clinical trial-in-group subjects into experimental or control groups comprises:
determining a patient group where a group-entering object is located, wherein the patient group comprises an experimental group and a control group;
comparing the total ratio of the total number of the experimental group to the total number of the control group of the current group-entering object with a reference ratio to obtain a first comparison result;
based on the first comparison result, further comparing the number of people deflection value of the experimental group after the new patient is added with the number of people deflection value of the control group to obtain a second comparison result; and
grouping the additional patients into experimental or control groups based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is substantially equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is substantially equal to the reference ratio.
3. The medical data processing method according to claim 2, wherein:
the experimental group head count bias value and the control group head count bias value respectively satisfy the following equations:
m (experimental group) = |m (experimental group) +1-3×m (control group) |, and
m (control) = |m (experimental) -3× (M (control) +1) |,
wherein M (experimental group) is the number of people deflection value of the experimental group, M (control group) is the number of people deflection value of the control group, M (experimental group) is the number of people of the experimental group before the new patient is added, and M (control group) is the number of people of the control group before the new patient is added.
4. A medical data processing method according to claim 3, wherein the experimental group population bias value and the control group population bias value for each patient group each satisfy the two equations.
5. The medical data processing method according to claim 2, wherein:
when the total proportion is judged to be larger than the reference ratio, judging whether the number of people deflection value of the experimental group is larger than the number of people deflection value of the control group; and
grouping the newly added patients into a control group when the number of people deflection value of the experimental group is larger than the number of people deflection value of the control group; or when the number deviation value of the experimental group is not larger than the number deviation value of the control group, the probability of the newly added patient being distributed to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
6. The medical data processing method according to claim 2, wherein:
when the total proportion is smaller than the reference ratio, judging whether the number of people deviation value of the experimental group is smaller than the number of people deviation value of the control group; and
grouping the newly added patients into an experimental group when the number of people deviation value of the experimental group is smaller than the number of people deviation value of the control group; or when the number of people deflection value of the experimental group is not smaller than the number of people deflection value of the control group, the probability of the newly added patient distributed to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
7. The medical data processing method according to claim 5 or 6, wherein:
dividing a predetermined numerical range into a first numerical range and a second numerical range according to the total proportion by the reference ratio, wherein the ratio of the number of the first numerical range to the total number of the numbers in the predetermined numerical range corresponds to the first probability, and the ratio of the number of the second numerical range to the total number of the numbers in the predetermined numerical range corresponds to the second probability; and
based on the randomly extracted values falling within the predetermined range of values either the first range of values or the second range of values, it is determined to assign a new patient to the experimental or control group.
8. The medical data processing method according to claim 2, wherein:
when the total proportion is judged to be equal to the reference ratio, judging whether the number of people deflection value of the experimental group is smaller than the number of people deflection value of the control group; and
grouping the newly added patients into an experimental group when the number of people deviation value of the experimental group is smaller than the number of people deviation value of the control group; or when the number of people deviation value of the experimental group is not less than the number of people deviation value of the control group, assigning the newly added patients to the control group.
9. The medical data processing method according to claim 2, wherein the total ratio is a ratio of a sum of a total population of the experimental group of each of the plurality of patient groups to a sum of a total population of the control group of each of the plurality of patient groups.
10. The medical data processing method of claim 2, wherein the determining the patient group in which the group-entering object is located comprises:
a patient group corresponding to the group-entering object is determined from the medical data among a plurality of patient groups.
11. A medical data processing system, comprising:
the input terminal is used for inputting patient information;
a group entry object confirmation unit that confirms whether or not a patient belongs to a clinical trial group entry object;
a random grouping unit that randomly groups the confirmed clinical trial group-entering subjects to either an experimental group or a control group; and
and the monitoring unit monitors and manages the information of the grouped objects.
12. The medical data processing system of claim 11, wherein the random grouping unit comprises:
a patient group determining unit for determining a patient group in which the group-entering object is located;
the first comparison unit is used for comparing the total ratio of the total number of the experimental group to the total number of the control group of the current group-entering object with the reference ratio to obtain a first comparison result;
the second comparison unit is used for further comparing the number of people deflection value of the experimental group after the new patient is added with the number of people deflection value of the control group based on the first comparison result to obtain a second comparison result; and
a grouping subunit that groups the newly added patients into an experimental group or a control group based on the second comparison result such that: the ratio of the total population of the experimental group to the total population of the control group is substantially equal to the reference ratio, and the ratio of the total population of the experimental group to the total population of the control group in the same patient group is substantially equal to the reference ratio.
13. The medical data processing system of claim 12, wherein the random grouping unit further comprises:
a calculation unit that calculates the experimental group population bias value and the control group population bias value according to the following equations:
m (experimental group) = |m (experimental group) +1-3×m (control group) |, and
m (control) = |m (experimental) -3× (M (control) +1) |,
wherein M (experimental group) is the number of people deflection value of the experimental group, M (control group) is the number of people deflection value of the control group, M (experimental group) is the number of people of the experimental group before the new patient is added, and M (control group) is the number of people of the control group before the new patient is added.
14. The medical data processing system of claim 13, wherein the experimental and control population bias values for each patient group each satisfy the two equations.
15. The medical data processing system of claim 12, wherein:
when the first comparison unit judges that the total proportion is larger than the reference ratio, the second comparison unit judges whether the number of people deviation value of the experimental group is larger than the number of people deviation value of the control group; and
when the second comparison unit judges that the experiment group population bias value is larger than the control group population bias value, the grouping unit groups the newly added patients into the control group; or when the second comparison unit judges that the number of people deflection value of the experimental group is not larger than the number of people deflection value of the control group, the probability that the grouping unit distributes the newly added patient to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
16. The medical data processing system of claim 12, wherein:
when the first comparison unit judges that the total proportion is smaller than the reference ratio, the second comparison unit judges whether the number of people deviation value of the experimental group is smaller than the number of people deviation value of the control group; and
when the second comparison unit judges that the population bias value of the experimental group is smaller than the population bias value of the control group, the grouping unit groups newly added patients into the experimental group; or when the second comparison unit judges that the number of people deflection value of the experimental group is not smaller than the number of people deflection value of the control group, the probability that the grouping unit distributes the newly added patient to the experimental group and the control group is respectively a first probability and a second probability, wherein the ratio of the first probability to the second probability is the total ratio.
17. The medical data processing system of claim 15 or 16, wherein:
the grouping subunit further includes a dividing unit that divides a predetermined numerical range into a first numerical range and a second numerical range by the total ratio, a ratio of the number of the numbers in the first numerical range to the total number of the numbers in the predetermined numerical range corresponding to the first probability, and a ratio of the number of the numbers in the second numerical range to the total number of the numbers in the predetermined numerical range corresponding to the second probability; and
the grouping subunit determines to assign a new patient to the experimental or control group based on values randomly drawn within a predetermined range of values falling within the first range of values or the second range of values.
18. The medical data processing system of claim 12, wherein:
when the first comparison unit judges that the total proportion is equal to the reference ratio, the second comparison unit judges whether the experiment group population bias value is smaller than the control group population bias value; and
when the second comparison unit determines that the experiment group population bias value is smaller than the control group population bias value, the grouping subunit groups newly added patients into an experiment group; or when the second comparing unit judges that the number of people of the experimental group is not smaller than the number of people of the control group, the grouping subunit distributes the newly added patients to the control group.
19. The medical data processing system of claim 12, wherein the aggregate ratio is a ratio of a sum of experimental group population for each of the plurality of patient groups to a sum of control group population for each of the plurality of patient groups.
20. The medical data processing system according to claim 12, wherein the patient group determination unit determines a patient group corresponding to the group-entering object from among a plurality of patient groups according to medical data.
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| CN116631552B (en) * | 2023-07-21 | 2023-11-21 | 浙江太美医疗科技股份有限公司 | Random grouping scheme generation method, device, equipment and medium |
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