CN117133393A - Random method for adapting dynamic layering factors and IRT system - Google Patents
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
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Abstract
The scheme discloses a random method and an IRT system for adapting to dynamic layering factors, comprising the following steps: s1, recording random configuration data comprising layering factors; s2, configuring layering factors to the random table to activate the random table when the random table is generated; when the subjects are grouped, the subjects are grouped into corresponding groups, so that the subjects in the same group have the same first layering information; s3, when layering factors are newly added, adding the new layering factors to the random configuration data; s4, configuring the new layering factors to the activated random table to synchronize the newly added layering factors; when the subjects are grouped, the subjects are grouped into corresponding groups according to the subject information of the subjects including the first layering information and the second layering information, so that the subjects of the same group have the same layering information. By the method provided by the scheme, the off-line flow time when the layering factors are added can be saved while the layering factors are added, and the whole test progress is ensured while the dynamic layering factors are added.
Description
Technical Field
The invention belongs to the technical field of clinical experiments, and particularly relates to a random method and an IRT system for adapting dynamic layering factors.
Background
In clinical randomized trials, stratification factors typically need to be determined before randomization begins and the random number blind floor is bound. The random number is generated according to the statistical principle, is used for ensuring the balance of the test group and the control group on various factors, ensures the balance of the proportion in order to control the characteristics of the subjects in the process of generating the random number, the layering factors are usually determined first, then N granules are set up, the length of each granule is generally 4,6 and 8, and after the random table comes out, the random numbers corresponding to the length of the granule are allocated to each granule. Each group has the same stratification factor, e.g., gender stratified factors, then subjects placed in the same group have the same gender.
In the traditional project, the new layering factors are not allowed to be added in the grouping process, the corresponding IRT system does not naturally have the function of supporting the new layering factors in the grouping process, namely the IRT system only supports the random of layering when the layering is well established at the beginning, and the sex layering factors are taken as examples, for example, the random number of each granule group is allocated to men or women according to the gender of the testee.
However, in the actual test process, new important potential interference factors are found, or unexpected problems in test design are often caused, and as the clinical test is mature, some projects allow new layering factors to be added to non-group subjects in the group-entering process so as to better control and balance the potential interference factors in the test, improve the accuracy and reliability of the test result, optimize the test design and enhance the extrapolation of the test result, thereby better realizing the scientificity and practicability of the test.
In the IRT random system in the prior art, when a new layering factor is added in the random process, the random number is bound with the layering factor, so that the current random table is firstly deactivated, after layering is newly added, a new random table is generated to randomize, for example, the new age layering factor with 20 years old as a dividing line is newly added, then the new random table is required to be generated, the unused random number is discarded, namely, the random number in the group of no subjects is discarded, and the new random number is distributed to the group, so that the subjects with the same gender and the same age are grouped into the same group. However, this approach has the following disadvantages:
1. leading to random number waste: because of the newly added layering factors, a new random table needs to be generated, so that unused random numbers in the old random table cannot be used continuously;
2. the subject cannot register to the new stratification factor: after generating a new random table, the subjects which are already registered but not random can not register and modify the latest layering factors;
3. the workload of manual operation is increased: the old random table cannot be used, so that the random number needs to be manually uploaded again or generated, and the number of random numbers needed by the new random table needs to be calculated according to the number of random numbers of the old random table, so that the method is tedious and easy to make mistakes;
4. extension of test time: in the clinical test process, each time a new random number exists, the SOP and the sponsor need to go through the process again, and a lot of time is consumed, so that the whole test progress is affected.
Disclosure of Invention
The invention aims at solving the problems and provides a random method and an IRT system for adapting to dynamic layering factors.
A random method of adapting to dynamic layering factors, the method comprising:
s1, recording random configuration data comprising layering factors;
s2, configuring layering factors to the random table to activate the random table when the random table is generated;
when the subjects are grouped, according to the subject information of the subjects containing the first layering information, grouping the subjects to the corresponding groups so that the subjects of the same group have the same first layering information;
s3, when layering factors are added newly, adding the new layering factors to the random configuration data;
s4, configuring new layering factors to the activated random table to synchronize the newly added layering factors;
when the subjects are grouped, the subjects are grouped into corresponding groups according to the subject information of the subjects including the first layering information and the second layering information so that the subjects of the same group have the same layering information;
the first hierarchical information corresponds to an old hierarchical factor and the second hierarchical information corresponds to a newly added hierarchical factor. If the old hierarchical factor is sex, the first hierarchical information is male or female, the newly added hierarchical factor is age of 20 years old as dividing line, and the second hierarchical information is specific age.
Subjects of the same block will be equally assigned to different groups to ensure an equalization of test and control groups over the stratification factor, so the block length is typically a multiple of the groups, e.g., the test is typically both groups of the test control group, the block length is typically an even number of 4,6,8, and when there are three groups in the test, a multiple length of 3 of 6,9 is required.
The method comprises the steps of using a factor array to independently record layering information, preparing for the subsequent new layering factors, directly copying the factor array to a random table to activate the random table for items which do not need the new layering factors, and using the factor array for the items which need the new layering factors when the subsequent new layering factors are added, so that each factor array can be easily synchronized to the random table.
In the above-mentioned random method for adapting to dynamic layering factors, in step S1, the random configuration data is recorded into a random_design set, where the random_design set is used to record a data set of random configuration, including group configuration and layering factor configuration;
and the random_design set comprises a factor array, which is used for recording corresponding layering factors, wherein each layering factor corresponds to one factor. For example, the attribute is a factor, the age is a factor, and the factor array includes hierarchical information of the attribute and the age.
In the above-mentioned random method for adapting to dynamic layering factors, in step S2, when generating a random table, a factor array is copied to the random table according to the layering factor configuration to activate the random table.
In the above random method for adapting to dynamic layering factors, the random configuration further includes a granule configuration, and the method further includes:
setting up N granules with set granule length according to the set granule configuration information.
In the above-mentioned random method for adapting to dynamic layering factors, in step S2, according to the granule length of the granule, the random numbers of the random table are randomly allocated to each granule, so that each granule obtains a number of random numbers corresponding to the granule length;
each granule group determines the corresponding layering information according to the first layering information of the first subject placed in the granule group and the old layering factors. If the first group is female, the layering information corresponding to the group is female.
In the above-mentioned random method for adapting to dynamic layering factors, in step S2, N granules are randomly arranged, when a subject is grouped, the subject is grouped into a granule corresponding to the layering information of the current subject and still having a vacancy according to the first layering information of the current subject, and the remaining random number in the granule is allocated to the subject;
if there is no group corresponding to the current subject stratification information or there is a group corresponding to the current subject stratification information but no empty space, the current subject is placed into the next group, and the stratification information of the group corresponds to the stratification information of the current subject, so that subjects having the same first stratification information are placed into the group.
In the above-mentioned random method for adapting to dynamic layering factors, in step S3, when layering factors are newly added, the new layering factors are added to the factor array of the random_design set;
in step S4, the factors array is copied to the activated random table to synchronize the newly added layering factors.
In the above-mentioned random method for adapting to dynamic layering factors, in step S4, after synchronizing the newly added layering factors, each group of granules determines the layering information corresponding to the newly added layering factors according to the first layering information, the second layering information, the old layering factors and the newly added layering factors of the first subject placed therein;
when the subjects are grouped, grouping the subjects into a group corresponding to the current subject layering information and still having empty space according to the first layering information and the second layering information of the current subject, and distributing the remaining random numbers in the group to the subjects;
if there is no group corresponding to the current subject stratification information or there is a group corresponding to the current subject stratification information but no empty space, the current subject is placed into the next group, and the stratification information of the group is corresponding to the stratification information of the current subject, so that subjects having the same first stratification information and second stratification information are placed into the group. Generally, a subject is required to input subject information including stratification information according to stratification factors at the time of registration, for example, when stratification factors are sex, the subject is required to input sex. However, when a stratification factor is added, such as new age, gender stratification factors may be available, and age stratification factors may not require subject input during enrollment, so that subject supplemental age information is required during enrollment for the IRT system to concurrently randomize based on old stratification factors.
In the above-mentioned random method for adapting to the dynamic layering factor, in step S4, it is detected whether the subject has input the first layering information and the second layering information, if yes, the subject is grouped according to the first layering information and the second layering information of the current subject, otherwise, the subject is prompted to input the first layering information and/or the second layering information as input, and then the subject is grouped according to the first layering information and the second layering information of the current subject.
An IRT system for randomisation, for performing the randomisation method of any of claims 1-9 to adapt and randomise dynamic stratification factors.
The invention has the advantages that:
after the layering factors are added, when the layering factors in the current subject registration are not matched with the layering factors in the random table after synchronization after the subject registration and when the layering factors are not random yet, prompting the subject to modify and then random;
after the layering factors are added, the latest configuration can be selected to be synchronized to the activated random table, so that automatic adaptation is realized;
the layering factors can be directly added in the system, random numbers do not need to be regenerated, and the influence of the added layering factors on the test progress is avoided;
according to the method provided by the scheme, the random table is synchronously adapted, offline flow time when the layering factors are newly added is saved, the dynamic newly added layering factors are realized, the whole test progress is ensured, and the test progress is not influenced by the newly added layering factors.
Drawings
FIG. 1 is a flow chart of a method of the present invention for a random method of adapting to dynamic layering factors;
fig. 2 is a schematic diagram of the random method of the present invention for adapting dynamic layering elements using granules before and after adding new layering elements.
Detailed Description
The invention will be described in further detail with reference to the drawings and the detailed description.
The scheme provides improvement aiming at a random method of the Clinflash IRT system, provides the IRT system capable of adapting to dynamic layering factors, does not cause waste of random numbers when new layering factors are needed, utilizes the unused random numbers in an automatic adaptation and synchronization mode, does not need to regenerate a random table, does not need to increase a random table flow because of the new layering factors, and does not influence test progress because of the new layering factors. As shown in fig. 1, in this embodiment, the sex is taken as an old layering factor, and the age is taken as a newly added layering factor for illustration, and the specific method is as follows:
s1, recording random configuration data comprising layering factors; the random configuration data is recorded to a random_design set, wherein the random_design set is used for recording a data set of random configuration, and the data set comprises group configuration and layering factor configuration;
and the random_design set comprises a factor array, which is used for recording corresponding layering factors, wherein each layering factor corresponds to one factor. For example, the attribute is a factor, the age is a factor, and the factor array includes hierarchical information of the attribute and the age.
S2, when the random table is generated, copying a factor array into the random_list set according to the layering factor configuration so as to configure the layering factor to the random table, and thus activating the random table.
When the subjects are grouped, the subjects are grouped into corresponding groups according to the subject information of the subjects containing the first layering information, so that the subjects of the same group have the same first layering information;
and when the subjects enter the group randomly, detecting whether the subjects input first layering information, if so, entering the group according to the first layering information of the current subjects, otherwise, prompting the subjects to enter the first layering information, and then entering the group according to the first layering information of the current subjects. Generally, after determining the stratification factor and generating the randomization table, the subject is registered, and the registration signal includes the stratification factor, in this embodiment, the sex information of the subject is included, and if no stratification factor is added, the normal randomization is performed according to the sex of the subject.
S3, when layering factors are added newly, adding the new layering factors to the factor array of the random_des i gn set; at this time, the factor array has at least two factors, in this example, there are two factors of gender and age, i.e. there are two layering factor configuration information of gender and age in the random configuration.
S4, copying the updated factors array into an activated random table to synchronize the newly added layering factors;
when the subjects are grouped, the subjects are grouped into corresponding groups according to the subject information of the subjects including the first layering information and the second layering information so that the subjects of the same group have the same layering information;
the first hierarchical information corresponds to an old hierarchical factor and the second hierarchical information corresponds to a newly added hierarchical factor. If the old hierarchical factor is sex, the first hierarchical information is male or female, the newly added hierarchical factor is age with 20 years old as a dividing line, and the second hierarchical information is specific age. Since the subject registration stage is based on the initial layering factor, the relevant information of the second newly added layering factor may not be acquired in the registration process, in this step, when the subject is randomized, it is first detected whether the subject has also input the second layering information, if yes, the subject is grouped according to the first layering information and the second layering information of the current subject, otherwise, the subject is prompted to input the second layering information, and then the subject is grouped according to the first layering information and the second analysis information of the current subject.
Specifically, the random configuration further includes a granule configuration, as shown in fig. 2, and the method further includes:
setting up N granules with set granule length according to the set granule configuration information. The granule configuration information comprises granule group number, granule length and other information, wherein the granule group number can be determined according to the number of random numbers and the granule length, for example, the granule length is 4, the number of random numbers is 100, and the granule group number can be 25. During randomization, subjects of the same block will be equally assigned to different groups to ensure equalization of test and control groups over the stratification factor, so the block length is typically a multiple of the group, e.g., the test is typically two groups of the test control group, the block length is typically an even number of 4,6,8, and when there are three or other groups in the test, the three groups require a multiple of 3 of 6, 9.
In step S2, according to the length of the groups, the random numbers of the random table are randomly distributed to the groups, so that each group obtains the random numbers with the number corresponding to the length of the group. And each granule group determines the corresponding layering information according to the first layering information of the first subject placed in the granule group and the old layering factors. If the first group is female, the layering information corresponding to the group is female, and the subsequent female subjects enter the group until the group is full.
When the subjects enter the group, the sex enters the group into the group which corresponds to the layering information of the current subject and has a gap according to the first layering information of the current subject, and the remaining random numbers in the group are distributed to the subjects;
if there is no group corresponding to the current subject stratification information or there is a group corresponding to the current subject stratification information but no empty space, the current subject is placed into the next group, and the stratification information of the group corresponds to the stratification information of the current subject, so that subjects having the same first stratification information are placed into the group.
As shown in fig. 2, each block length is 4, the first subject is male, male 1 is placed into block 1, subsequent men 2, 3, 4 are all placed into block 1, and subsequent female subjects are placed into block 2. If the eighth subject is male, granule 3 is required, correspondingly, the layering information of granule 3 corresponds to male, and if the eighth subject is female, granule 2 may be provided.
Specifically, in step S4, after synchronizing the newly added layering factors, each granule determines the layering information corresponding to the newly added layering factors according to the first layering information, the second layering information, the old layering factors and the newly added layering factors of the first subject placed therein;
when the subjects are grouped, grouping the subjects into a group corresponding to the current subject layering information and still having empty space according to the first layering information and the second layering information of the current subject, and distributing the remaining random numbers in the group to the subjects;
if there is no group corresponding to the current subject stratification information or there is a group corresponding to the current subject stratification information but no empty space, the current subject is placed into the next group, and the stratification information of the group is corresponding to the stratification information of the current subject (i.e., corresponding to the first stratification information and the second stratification information) so that subjects having the same first stratification information and second stratification information are placed into the group.
In fig. 2, three subjects of female 1, 2, 3 are placed in the block 2, four subjects of male 1, 2, 3, 4 are placed in the block 1, the user adds an age stratification factor, if the original random table is still used, the newly added stratification factor cannot be considered, the suitability is only good, the random number can be only allocated to male or female, and conventionally, the random table containing the newly added stratification factor is regenerated, which causes the waste of the random number and affects the test progress. The scheme provides that a factor array is designed in an IRT system, the addition of newly added layering factors of a user to the factor array is supported, and the newly added layering factors are synchronized to a random table by copying the factor array to an activated random table, so that each random number carries two layering factors. Thereafter, when the eighth subject enters the group, the subject is asked to enter age and put it into group 3, fig. 2, the eighth subject is a 18 year old female, and the stratification information of group 3 is a female under 20 years old; if the ninth subject is a female under 20 years old, the ninth subject is a female under 25 years old, the next group, namely, group 4, is required to be placed, if the tenth subject is a female under 20 years old, group 3 is required to be placed, if the tenth subject is a female under 20 years old and above, and if the tenth subject is a male under 15 years old, and eleven is a male under 26 years old, group 5 is required to be placed, and if the tenth subject is a female under 20 years old, the layering information of group 5 is a male under 20 years old and above. To this end, four granules have covered four combinations of two stratification factors, and subsequent subjects will be placed into granules 3, 4, 5 or 6 depending on their age and sex until the respective granules are full, leaving another granule.
According to the scheme, layering factors can be newly added in random configuration, layering information is independently recorded by using the factor arrays, each factor corresponds to one layering factor, preparation is made for the subsequent newly added layering factors, the factor arrays are directly copied to a random table to activate the random table for items which do not need the newly added layering factors, and the factor arrays can be easily synchronized to the random table for the items which need the newly added layering factors.
Preferably, the method further provides a synchronization button by which the user synchronizes the latest configuration to the activated random table after the user newly adds the layering factors, taking into account the need for the current random table to synchronize the latest layering configuration.
In the scheme, when the subjects detect that layering information registered by the current subjects is not matched with layering factors in a random table after synchronization in the randomization process, prompting the subjects to carry out modification and then randomization, and prompting the subjects which are not in the group after the new layering factors to consider the new layering factors by checking and matching the latest configuration of the random table after synchronization.
The IRT system provided by the scheme allows the project to newly add layering factors in the random process, the random number is not wasted, meanwhile, the unused random number can be utilized, so that manual re-uploading or random number generation is not needed, and the process of running down with a sponsor due to the generation of the new random number is not needed. But also the registered subjects can also indicate the subjects to perfect the subject information related to the stratification information by automatically detecting the stratification information of the subjects and the random table after synchronization, allowing the subjects to register the latest stratification factors,
the specific embodiments described in this application are merely illustrative of the spirit of the invention. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.
Claims (10)
1. A random method for adapting to dynamic layering factors, the method comprising:
s1, recording random configuration data comprising layering factors;
s2, configuring layering factors to the random table to activate the random table when the random table is generated;
when the subjects are grouped, according to the subject information of the subjects containing the first layering information, grouping the subjects to the corresponding groups so that the subjects of the same group have the same first layering information;
s3, when layering factors are added newly, adding the new layering factors to the random configuration data;
s4, configuring new layering factors to the activated random table to synchronize the newly added layering factors;
when the subjects are grouped, the subjects are grouped into corresponding groups according to the subject information of the subjects including the first layering information and the second layering information so that the subjects of the same group have the same layering information;
the first hierarchical information corresponds to an old hierarchical factor and the second hierarchical information corresponds to a newly added hierarchical factor.
2. The method according to claim 1, wherein in step S1, the random configuration data is recorded to a random_design set, where the random_design set is used to record a data set of random configuration, including group configuration and hierarchical factor configuration;
and the random_design set comprises a factor array, which is used for recording corresponding layering factors, wherein each layering factor corresponds to one factor.
3. The method according to claim 2, wherein in step S2, when generating the random table, a factor array is copied to the random table according to the hierarchical factor configuration to activate the random table.
4. A random method for adapting to dynamic layering considerations according to claim 3 wherein said random configuration further comprises a granule configuration, the method further comprising:
setting up N granules with set granule length according to the set granule configuration information.
5. The method according to claim 4, wherein in step S2, according to the granule length of the granule, the random numbers of the random table are randomly allocated to each granule, so that each granule obtains a number of random numbers corresponding to the granule length;
each granule group determines the corresponding layering information according to the first layering information of the first subject placed in the granule group and the old layering factors.
6. The method according to claim 5, wherein in step S2, N granules are arranged randomly, when the subjects are grouped, they are grouped into granules corresponding to the current subject layering information and still having a room according to the first layering information of the current subject, and the remaining random numbers in the granules are assigned to the subjects;
if there is no group corresponding to the current subject layering information or there is no vacancy, the current subject is placed into the next group, and the layering information of the group corresponds to the layering information of the current subject, so that subjects with the same first layering information are placed into the group.
7. The method according to claim 6, wherein in step S3, when the layering factor is newly added, the new layering factor is added to the factor array of the random_design set;
in step S4, the factors array is copied to the activated random table to synchronize the newly added layering factors.
8. The method according to claim 7, wherein in step S4, after synchronizing the newly added layering factors, each group of blocks determines the corresponding layering information according to the first layering information, the second layering information, and the old layering factors and the newly added layering factors of the first subject placed therein;
when the subjects are grouped, grouping the subjects into a group corresponding to the current subject layering information and still having empty space according to the first layering information and the second layering information of the current subject, and distributing the remaining random numbers in the group to the subjects;
if there is no group corresponding to the current subject layering information or there is no vacancy, the current subject is placed into the next group, and the layering information of the group corresponds to the layering information of the current subject, so that subjects having the same first layering information and second layering information are placed into the group.
9. The method according to claim 8, wherein in step S4, it is detected whether the subject has entered the first hierarchical information and the second hierarchical information, if yes, the subject is grouped according to the first hierarchical information and the second hierarchical information of the current subject, otherwise, the subject is prompted to enter the first hierarchical information and/or the second hierarchical information as input, and then the subject is grouped according to the first hierarchical information and the second hierarchical information of the current subject.
10. An IRT system for randomisation, characterised by adapting and randomising dynamic layering factors for performing the randomisation method of any of claims 1-9.
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