CN117153424B - Centralized curative effect evaluation method and system - Google Patents
Centralized curative effect evaluation method and system Download PDFInfo
- Publication number
- CN117153424B CN117153424B CN202311435266.4A CN202311435266A CN117153424B CN 117153424 B CN117153424 B CN 117153424B CN 202311435266 A CN202311435266 A CN 202311435266A CN 117153424 B CN117153424 B CN 117153424B
- Authority
- CN
- China
- Prior art keywords
- evaluation
- efficacy
- curative effect
- result
- assessment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 238000011156 evaluation Methods 0.000 title claims abstract description 310
- 230000000694 effects Effects 0.000 title claims abstract description 92
- 238000012360 testing method Methods 0.000 claims abstract description 19
- 238000002512 chemotherapy Methods 0.000 claims abstract description 10
- 230000035945 sensitivity Effects 0.000 claims description 30
- 238000000034 method Methods 0.000 claims description 23
- 238000012544 monitoring process Methods 0.000 claims description 12
- 238000012545 processing Methods 0.000 claims description 11
- 238000013523 data management Methods 0.000 claims description 7
- 238000013500 data storage Methods 0.000 claims description 7
- 230000000973 chemotherapeutic effect Effects 0.000 claims description 6
- 238000004364 calculation method Methods 0.000 claims description 3
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- 238000012854 evaluation process Methods 0.000 abstract description 9
- 238000011084 recovery Methods 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 239000008186 active pharmaceutical agent Substances 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000010354 integration Effects 0.000 description 2
- 238000010606 normalization Methods 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010061818 Disease progression Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000008589 Obesity Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 239000002872 contrast media Substances 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 238000013499 data model Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 231100000676 disease causative agent Toxicity 0.000 description 1
- 230000005750 disease progression Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 208000030172 endocrine system disease Diseases 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 208000030159 metabolic disease Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000004084 narcotic analgesic agent Substances 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 235000020824 obesity Nutrition 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000001360 synchronised effect Effects 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H70/00—ICT specially adapted for the handling or processing of medical references
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Health & Medical Sciences (AREA)
- Medical Informatics (AREA)
- Primary Health Care (AREA)
- Public Health (AREA)
- Management, Administration, Business Operations System, And Electronic Commerce (AREA)
Abstract
The invention relates to a central chemotherapy effect evaluation method and system. The central chemotherapy effect evaluation method is characterized in that test data of the same subject are randomly transmitted to two curative effect evaluation staff, and the curative effect evaluation staff respectively and independently make curative effect evaluation; and if the curative effect evaluation results are consistent, completing the curative effect evaluation, and if the curative effect evaluation is inconsistent, making a final decision by a curative effect evaluation decision maker. According to the invention, the evaluation process is separated, so that independent curative effect evaluation personnel can perform objective and independent evaluation, and subjective bias in the evaluation process is avoided. Meanwhile, the consistency and reliability of the evaluation result are ensured by adopting multi-person evaluation and introducing the decision of a third evaluation decision-making person.
Description
Technical Field
The invention relates to the technical field of efficacy evaluation, in particular to a central chemotherapy efficacy evaluation method and system.
Background
In clinical trials, clinical trial protocols for the direction of diseases such as tumor, urinary, metabolic diseases, musculoskeletal, skin, endocrine diseases, cardiovascular, ophthalmic, infectious diseases, respiratory, gynecological, obesity, gastrointestinal, pediatric, contrast agents, central nervous, narcotic analgesic, etc., often employ subjective efficacy assessment as a surrogate endpoint, e.g., ORR, PFS, DFS, endpoint event, etc. For the design and execution of such clinical trial protocols, the accuracy and reliability of efficacy assessment is critical to assessing the efficacy of new drugs or treatment methods.
The existing curative effect evaluation technology has some defects in clinical tests, and the specific steps are as follows: 1. conventional assessment methods are typically performed by or associated with researchers, and the assessment results are susceptible to subjective bias. The evaluator may be affected by his own perspective, experience, or other factors, resulting in an insufficiently objective and fair evaluation result; 2. different evaluators may make different assessment results for the same clinical trial data. Subjectivity and individual variability of the assessment may lead to inconsistency in the assessment results, such that reliability of efficacy assessment is affected; 3. conventional assessment methods typically require face-to-face meetings or communications, which require significant time and effort by the assessors to discuss and agree on the assessment results. This approach is inefficient, extending the time of the evaluation process. In view of the above, the present invention provides a centralized efficacy evaluation method and system for solving the above problems.
Disclosure of Invention
Based on this, it is necessary to provide a centralized efficacy evaluation method and system for the existing efficacy evaluation with subjective bias, poor reliability and low evaluation efficiency.
The invention is realized by adopting the following technical scheme: the central chemotherapy effect evaluation method is characterized in that test data of the same subject are randomly transmitted to two curative effect evaluation staff, and the curative effect evaluation staff respectively and independently make curative effect evaluation; if the curative effect evaluation results are consistent, the curative effect evaluation is completed, and if the curative effect evaluation is inconsistent, the curative effect evaluation arbitrator makes a final arbitration; the efficacy assessment includes the steps of:
step S1, unifying and standardizing curative effect evaluation contents, and dividing the curative effect evaluation contents into n evaluation points f;
step S2, one efficacy evaluator evaluates n evaluation points f to obtain a first efficacy evaluation result EA { f1, f2, … fn };
the other efficacy evaluator evaluates the n evaluation points f to obtain a second efficacy evaluation result EB { f1, f2, … fn };
step S3, processing the first curative effect evaluation results EA { f1, f2, … fn } through an MD5 algorithm to obtain a hash value MD5A, and storing the hash value MD 5A;
processing the second curative effect evaluation results EB { f1, f2, … fn } through an MD5 algorithm to obtain a hash value MD5B, and storing the hash value;
step S4, judging whether the hash value MD5A and the hash value MD5B are the same;
if so, marking that the subject's efficacy assessment is complete, at which point the final efficacy assessment result r=ea=eb, and storing said final efficacy assessment result R { f1, f2, … fn };
if not, comparing the first efficacy evaluation result EA { f1, f2, … fn } and the second efficacy evaluation result EB { f1, f2, … fn } one by one, and recording the evaluation point comparison result NR { f1=1, f2=0, … fn=1 }, wherein 1 represents the same evaluation point result and 0 represents the different evaluation point result;
step S5, sending the evaluation point comparison result NR { f1=1, f2=0, … fn=1 } to the efficacy evaluation arbitrator for arbitration, recording arbitration results AR { f1, f2, … fn } after arbitration is completed, and marking the subject efficacy evaluation completion, at this time, the final efficacy evaluation result r=ar, and storing the final efficacy evaluation result R { f1, f2, … fn }.
As a preferred example, in step S1, the unification and normalization includes providing the same standardized assessment table, scoring criteria and reference opinion for different efficacy assessors.
As a preferred example, in step S3, the evaluation answers of each evaluation point f in the first efficacy evaluation results EA { f1, f2, … fn } are spliced, and after the splicing, the processing is performed by the MD5 algorithm;
and splicing the evaluation answers of each evaluation point f in the second curative effect evaluation results EB { f1, f2, … fn } and processing the spliced evaluation answers through the MD5 algorithm.
As a preferred example, in step S5, the arbitration re-evaluates the evaluation points f having different results, and the evaluation points f having the same result are not changed.
As a preferred example, the central chemotherapeutic efficiency assessment method further includes a reminding method for alerting an assessment person that there is a significant difference between the assessment result and the expected result.
As a preferred example, the reminding method includes the steps of:
step S61, calculating the evaluation level of each efficacy evaluator when the efficacy evaluation of the subject is completed, wherein the evaluation level is evaluated by adopting sensitivity and specificity;
step S62, if the first efficacy assessment result EA { f1, f2, … fn } and the second efficacy assessment result EB { f1, f2, … fn } of the subject are consistent, the sensitivity and specificity of each efficacy assessor for the subject assessment are 100%;
if the subject's first efficacy assessment result EA { f1, f2, … fn } and the second efficacy assessment result EB { f1, f2, … fn } are not identical, then the formula is:
sensitivity=tp/(tp+fn)
Specificity = TN/(tn+fp)
Calculating sensitivity and specificity, wherein TP is true positive, FP is false positive, TN is true negative, and FN is false negative;
step S63, after the sensitivity and the specificity of the efficacy evaluation personnel for each subject efficacy evaluation are obtained, the overall sensitivity and the overall specificity of the efficacy evaluation personnel are calculated, and the calculation formula is as follows:
overall sensitivity =
Overall specificity =
Step S64, when any one of the overall sensitivity, the overall specificity or the sensitivity and the specificity of the individual subject is lower than the respective expected value, a reminder is sent to a system administrator.
As a preferred example, when the efficacy evaluator evaluates the evaluation point f as positive, the efficacy evaluation arbiter decides the evaluation point f as positive, the evaluation point f is defined as true positive;
when the efficacy evaluator evaluates the evaluation point f as positive and the efficacy evaluation arbitrator arbitrates the evaluation point f as negative, the evaluation point f is defined as false positive;
when the curative effect evaluation personnel evaluate the evaluation point f as negative, the curative effect evaluation judging personnel judges the evaluation point f as negative, the evaluation point f is defined as true negative;
when the efficacy evaluator evaluates the evaluation point f as negative, the efficacy evaluation arbitrator arbitrates the evaluation point f as positive, the evaluation point f is defined as false negative.
As a preferred example, when the system administrator receives the reminder, the last evaluation result of the efficacy evaluator is checked, and the efficacy evaluator is investigated.
The invention also provides a central chemotherapeutic effect evaluation system, which applies the centralized therapeutic effect evaluation method as set forth in any one of the above, and comprises:
the curative effect evaluation module is used for randomly transmitting test data of the same subject to two curative effect evaluation staff, and the curative effect evaluation staff respectively and independently make curative effect evaluation; if the curative effect evaluation results are consistent, the curative effect evaluation is completed, and if the curative effect evaluation is inconsistent, the curative effect evaluation arbitrator makes a final arbitration;
the data storage and management module is used for storing results of efficacy evaluation by efficacy evaluation personnel and efficacy evaluation judging personnel, and simultaneously, a system administrator can configure various data required by efficacy evaluation according to the evaluation requirements of clinical tests;
the monitoring tracking module is used for monitoring and tracking the progress and the result of the efficacy evaluation by the efficacy evaluation personnel and the efficacy evaluation discretion personnel and reminding the evaluation problem and risk;
and a standard API module for providing an API for the EDC system to call completed efficacy assessment result data.
As a preferred example, the central chemotherapy efficacy assessment system further includes a data encryption module for encrypting each item of data in the efficacy assessment process, which is accessible and processable only by authorized efficacy assessors, efficacy assessment arbitrators and system administrators.
The invention has the beneficial effects that:
1. according to the invention, the evaluation process is separated, so that independent curative effect evaluation personnel can perform objective and independent evaluation, and subjective bias in the evaluation process is avoided. Meanwhile, the consistency and reliability of the evaluation result are ensured by adopting multi-person evaluation and introducing the decision of a third evaluation decision-making person.
2. The invention adopts an online evaluation mode, and the curative effect evaluation personnel can remotely access clinical test data and evaluate the clinical test data without face-to-face meetings or exchanges. Therefore, the evaluation efficiency is greatly improved, the time and the resources are saved, and the speed of the evaluation process is accelerated.
3. The invention ensures consistency and integrity of the evaluation data through standardized evaluation tools, data model designs and data format specifications. Thereby being beneficial to improving the quality and reliability of the evaluation data and facilitating the subsequent data analysis and research.
Drawings
FIG. 1 is a flowchart showing the steps of a centralized efficacy assessment method according to the present invention;
FIG. 2 is a logic block diagram of a central chemotherapeutic efficiency assessment method provided by the present invention;
FIG. 3 is a flow chart of the steps of the method for alerting an evaluator that there is a significant difference between the evaluation result and the expected result;
FIG. 4 is a schematic diagram of monitoring and tracking the result of efficacy evaluation;
fig. 5 is a schematic diagram of input and output of the centralized efficacy evaluation system according to the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "or/and" as used herein includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1 and 2, the centralized efficacy evaluation method provided by the present invention randomly transmits test data of the same subject to two efficacy estimators, which individually and independently make efficacy evaluations. If the curative effect evaluation results are consistent, the curative effect evaluation is completed; if the efficacy assessments are inconsistent, a final adjudication is made by the efficacy assessment adjudicator. The efficacy evaluation specifically includes the following steps:
step S1, unifying and standardizing curative effect evaluation contents is needed to divide the curative effect evaluation contents into n evaluation points f. In this step, unification and normalization includes providing the same standardized assessment tables, scoring criteria, and reference comments to different efficacy assessors. The evaluation point f is set according to the requirements of the specific project of the clinical trial. Assuming that a treatment efficacy evaluation table includes n evaluation points f, the evaluation points f are generally set in the form of option questions, and a treatment efficacy evaluation person selects an evaluation answer from options. The purpose of this is to make the evaluation answers of the efficacy evaluation personnel as identical as possible, so as to facilitate subsequent datamation and judgment.
Step S2, two efficacy assessors fill in efficacy assessment tables according to the subject data to respectively obtain a first efficacy assessment result EA { f1, f2, … fn } and a second efficacy assessment result EB { f1, f2, … fn }.
And step S3, processing the obtained first curative effect evaluation results EA { f1, f2, … fn } through an MD5 algorithm to obtain a hash value MD5A, and storing the hash value MD5A. The second efficacy evaluation results EB { f1, f2, … fn } were also processed by the MD5 algorithm to obtain a hash value MD5B, which was also stored.
Step S4, judging whether the hash value MD5A and the hash value MD5B are the same. In the judging process, the adopted MD5 algorithm (information-digest algorithm) is a widely used cryptographic hash function and is generally applied to the security field. The invention uses it to judge the difference of the evaluation results. Specifically, the evaluation answers of each evaluation point f in the first efficacy evaluation results EA { f1, f2, … fn } are spliced and subjected to data processing to obtain a set of evaluation result data. The evaluation result data is then input into the MD5 algorithm, and the MD5 algorithm processes the input evaluation result data in 512-bit packets, and each packet is divided into 16 32-bit sub-packets. After a series of processing, the output of the MD5 algorithm consists of four 32-bit packets, which are concatenated to generate a 128-bit hash value. The hash value is the characteristic value processed by the first efficacy evaluation result EA { f1, f2, … fn }, and is referred to as a hash value MD5A. The second efficacy evaluation results EB { f1, f2, … fn } were processed in the same manner to obtain a hash value MD5B.
If the hash value MD5A and the hash value MD5B are the same, it is indicated that the evaluation results made by the two efficacy assessors are identical. The subject was marked as complete in the efficacy assessment at which point the final efficacy assessment result r=ea=eb and the final efficacy assessment result R { f1, f2, … fn }, was stored.
If the hash value MD5A and the hash value MD5B are not identical, it is necessary to compare the first efficacy evaluation result EA { f1, f2, … fn } and the second efficacy evaluation result EB { f1, f2, … fn } one by one. Specifically, the evaluation result of each evaluation point f is dataized and then is processed by an MD5 algorithm alone to obtain a plurality of hash values. The hash values of the same evaluation points in the first efficacy evaluation result EA { f1, f2, … fn } and the second efficacy evaluation result EB { f1, f2, … fn } are compared one by one and recorded as evaluation point comparison results NR { f1=1, f2=0, … fn=1 }, wherein 1 represents the same evaluation point result (i.e., the hash values of the corresponding evaluation points are the same), and 0 represents the different evaluation point results (i.e., the hash values of the corresponding evaluation points are different).
And S5, transmitting the obtained evaluation point comparison result NR { f1=1, f2=0 and … fn=1 } to a third person, namely, a curative effect evaluation and decision-making person to decide. After the arbitration is completed, the efficacy assessment arbitrator records arbitration results AR { f1, f2, … fn }, while marking the subject's efficacy assessment as completed, at which point the final efficacy assessment result r=ar, and stores the final efficacy assessment result R { f1, f2, … fn }.
In this step, the content of the treatment effect evaluation arbitrator arbitrating includes re-evaluating the result at a different evaluation point f, and not changing the result at the same evaluation point f. The judging content made by the curative effect evaluation judging personnel is the final curative effect evaluation result.
In the whole central chemotherapy effect evaluation method, the final curative effect evaluation result is obtained. The invention also provides a reminding method for warning that the evaluation result of the evaluation personnel has obvious difference from the expected result, as shown in fig. 3, comprising the following steps:
step S61, each time the efficacy evaluation of the subject is completed, the evaluation level of each efficacy evaluator is calculated. The evaluation level was evaluated using sensitivity and specificity.
Step S62, if the first efficacy assessment result EA { f1, f2, … fn } and the second efficacy assessment result EB { f1, f2, … fn } of the subject are identical, the sensitivity and specificity of each efficacy assessor for the subject assessment are 100%.
If the subject's first efficacy assessment result EA { f1, f2, … fn } and second efficacy assessment result EB { f1, f2, … fn } are not identical, then the formula is:
sensitivity=tp/(tp+fn)
Specificity = TN/(tn+fp)
Sensitivity and specificity were calculated. In the formula, TP is true positive, FP is false positive, TN is true negative, and FN is false negative. The evaluation point f in the evaluation result in this step involves true positive, false positive, true negative and false negative being judged according to the following definition:
true Positive (TP): the curative effect evaluation personnel evaluate positive, and the curative effect evaluation discretion personnel arbitrate positive;
false Positives (FP): the curative effect evaluation personnel evaluate positive, and the curative effect evaluation discretion personnel arbitrate negative;
true Negative (TN): the curative effect evaluation personnel evaluate negative, and the curative effect evaluation discretion personnel arbitrate negative;
false Negative (FN): the efficacy assessors assessed negative and the efficacy assessors decided positive.
The positive and negative are one way of expressing the test result in medicine. Symptoms, tests, examinations, disease progression, occurrence or non-occurrence, etc. can be expressed as positive and negative. In general, positive indicates that there is a causative agent or is abnormal, while negative indicates that there is an adverse effect. According to the definition, the number of the evaluation points f about the types in the evaluation result of the curative effect evaluation personnel is calculated and substituted into a formula to obtain the sensitivity and the specificity.
For example, in a clinical trial, there are a total of 10 evaluation points in the efficacy evaluation table for subjects. The evaluation result of a certain curative effect evaluation person is as follows:
tp=2 (efficacy evaluator assessed positive, efficacy evaluator arbitrated positive);
fp=3 (efficacy evaluator assessed positive, efficacy evaluator arbitrated negative);
tn=4 (efficacy evaluator assessed negative, efficacy assessment adjudicator adjudicated negative);
fn=1 (efficacy evaluator evaluates negative and efficacy evaluator arbitrates positive).
The sensitivity and specificity of the efficacy assessor for this subject efficacy assessment at this time were:
sensitivity=tp/(tp+fn) =2/(2+1) =2/3≡0.667 (about 66.7%)
Specificity = TN/(tn+fp) = 4/(4+3) = 4/7+.0.571 (approximately 57.1%)
Step S63, after the sensitivity and the specificity of the efficacy evaluation personnel for each subject efficacy evaluation are obtained, the overall sensitivity and the overall specificity of the efficacy evaluation personnel are calculated, and the calculation formula is as follows:
overall sensitivity =
Overall specificity =
Step S64, when any one of the overall sensitivity, the overall specificity or the sensitivity and the specificity of the individual subject is lower than the respective expected value, a prompt is sent to a system administrator, a curative effect evaluator who finds out that the curative effect evaluation work is problematic is processed in time, and the last evaluation result made by the curative effect evaluator is checked. As shown in fig. 4, to achieve monitoring and tracking of the results of efficacy assessment.
The invention also provides a centralized efficacy evaluation system, which applies the centralized efficacy evaluation method as in step S1-step S5, and specifically comprises an efficacy evaluation module, a data storage and management module, a monitoring tracking module and a standard API module.
The efficacy evaluation module is used for randomly transmitting test data of the same subject to two efficacy evaluation staff, and the efficacy evaluation staff independently make efficacy evaluation by using a tool or an interface provided by the efficacy evaluation module; and if the curative effect evaluation results are consistent, completing the curative effect evaluation, and if the curative effect evaluation is inconsistent, making a final decision by a curative effect evaluation decision maker.
And the data storage and management module is used for storing results of the efficacy evaluation by the efficacy evaluation personnel and the efficacy evaluation discretion personnel. Meanwhile, a system administrator can set and manage rules and authorities of data storage according to evaluation requirements of clinical tests, and safety and consistency of data are ensured. Meanwhile, various data required by efficacy evaluation are configured, including various data of clinical test subjects, efficacy evaluation tables and the like.
The stored data includes structured data and unstructured data. The structured data includes: subject structured clinical trial data such as demographic data, vital signs, laboratory exams, imaging exams, treatment records, medication records, adverse event records, and the like. Unstructured data includes: unstructured clinical trial data of the subject, such as pictures, audio, video, DICOM image data, and the like.
The data storage and management module also comprises a data backup and recovery function and a data synchronization function. The data backup and recovery function can provide a regular data backup and recovery function to ensure the safety and the recoverability of the data. The collected clinical data is backed up periodically to prevent data loss or damage, and at the same time, data recovery can be performed when needed. The data synchronization function allows the central chemotherapeutic efficiency assessment system to be data synchronized and integrated with other related systems. Such as with an EDC system or data warehouse for clinical trials. Thus, the consistency and the integrity of the data can be realized, and the reliability and the usability of the data are improved.
And the monitoring tracking module is used for monitoring and tracking the progress and the result of the efficacy evaluation by the efficacy evaluation personnel and the efficacy evaluation discretion personnel and reminding the evaluation problem and risk.
Monitoring trace content includes: progress tracking, which can monitor the progress of efficacy assessment by efficacy assessors in real time. By monitoring the working state and the evaluation progress of the evaluation personnel, the system can know the overall progress situation of evaluation in time; and (3) result tracking, which can track the evaluation result of the curative effect evaluation personnel. The assessment results submitted by the assessors are recorded and stored, and the system can track and inquire the results so as to carry out subsequent analysis and processing; and the problem reminding can detect potential problems and risks in the evaluation process and send reminding to related personnel. For example, if there is a significant difference in the assessment results for the assessors from the expected results, the system may issue an alert to alert the assessors and the manager to a possible problem.
And the standard API module is used for providing a standard API (application programming interface) for other related systems to call the completed efficacy evaluation result data. As shown in fig. 5, an EDC (electronic data acquisition) system may obtain efficacy assessment results and correlate and analyze with other clinical trial data by calling these APIs. Standard APIs may employ commonly used data transfer protocols, such as HTTP or HTTPs protocols, to ensure secure transfer and reliability of data. Meanwhile, different data exchange formats, such as JSON or XML, can be supported to meet the requirements of different systems, cross-system integration and application of data are realized, comprehensive analysis and comprehensive research of clinical test data are promoted, and the availability and the utilization rate of the data are improved.
And the data encryption module uses mechanisms such as identity authentication and access tokens and the like to carry out identity authentication and authority control on the caller. Only authorized systems or users can obtain the access rights, and the security and confidentiality of the data are ensured.
The core of the invention is to separate the efficacy evaluation process from researchers by adopting a centralized evaluation mode, and evaluate the efficacy evaluation process by independent evaluation personnel. The mode can effectively avoid subjective bias of researchers and improve objectivity and reliability of evaluation. Meanwhile, through centralized data storage and management, clinical test data can be managed in a centralized way, and an evaluator can access and evaluate the data on the same platform. This simplifies the process of data management, improving the consistency and reliability of the data. In addition, the system provides a monitoring and tracking function, can monitor the evaluation progress and result, and reduces the workload of a manager.
By requiring independent evaluation personnel to evaluate and introducing a consistency judging mechanism, consistency and reliability of an evaluation result are ensured. Independent evaluation can eliminate interaction among evaluation personnel, and deviation of evaluation results is reduced. The consistency judging mechanism can judge whether the evaluation results are consistent or not, if so, the evaluation results are directly used as final results, and if not, a third evaluator performs final decision.
In summary, the central chemotherapy effect evaluation method and system of the invention bring a plurality of beneficial effects by improving the objectivity and reliability of evaluation, improving the evaluation efficiency, reducing the time cost, facilitating management and reducing the workload, promoting the consistency and the integrity of data, supporting the cross-system integration and application of data and the like, and provide better technical support and solution for clinical test curative effect evaluation.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (8)
1. The central chemotherapy effect evaluation method is characterized in that test data of the same subject are randomly transmitted to two curative effect evaluation staff, and the curative effect evaluation staff independently make curative effect evaluation; if the curative effect evaluation results are consistent, the curative effect evaluation is completed, and if the curative effect evaluation is inconsistent, the curative effect evaluation arbitrator makes a final arbitration; the efficacy assessment includes the steps of:
step S1, unifying and standardizing curative effect evaluation contents, and dividing the curative effect evaluation contents into n evaluation points f;
step S2, one efficacy evaluator evaluates n evaluation points f to obtain a first efficacy evaluation result EA { f1, f2, … fn };
the other efficacy evaluator evaluates the n evaluation points f to obtain a second efficacy evaluation result EB { f1, f2, … fn };
step S3, processing the first curative effect evaluation results EA { f1, f2, … fn } through an MD5 algorithm to obtain a hash value MD5A, and storing the hash value MD 5A;
processing the second curative effect evaluation results EB { f1, f2, … fn } through an MD5 algorithm to obtain a hash value MD5B, and storing the hash value;
step S4, judging whether the hash value MD5A and the hash value MD5B are the same;
if so, marking that the subject's efficacy assessment is complete, at which point the final efficacy assessment result r=ea=eb, and storing said final efficacy assessment result R { f1, f2, … fn };
if not, comparing the first efficacy evaluation result EA { f1, f2, … fn } and the second efficacy evaluation result EB { f1, f2, … fn } one by one, and recording the evaluation point comparison result NR { f1=1, f2=0, … fn=1 }, wherein 1 represents the same evaluation point result and 0 represents the different evaluation point result;
step S5, sending the evaluation point comparison result NR { f1=1, f2=0, … fn=1 } to the efficacy evaluation arbitrator for arbitration, recording arbitration results AR { f1, f2, … fn } after arbitration is completed, and simultaneously marking that the subject efficacy evaluation is completed, at this time, the final efficacy evaluation result r=ar, and storing the final efficacy evaluation result R { f1, f2, … fn };
the central chemotherapy effect evaluation method further comprises a reminding method for warning that obvious differences exist between the evaluation result and the expected result of the evaluation personnel, and the reminding method comprises the following steps of:
step S61, calculating the evaluation level of each efficacy evaluator when the efficacy evaluation of the subject is completed, wherein the evaluation level is evaluated by adopting sensitivity and specificity;
step S62, if the first efficacy assessment result EA { f1, f2, … fn } and the second efficacy assessment result EB { f1, f2, … fn } of the subject are consistent, the sensitivity and specificity of each efficacy assessor for the subject assessment are 100%;
if the subject's first efficacy assessment result EA { f1, f2, … fn } and the second efficacy assessment result EB { f1, f2, … fn } are not identical, then the formula is:
sensitivity=tp/(tp+fn)
Specificity = TN/(tn+fp)
Calculating sensitivity and specificity, wherein TP is true positive, FP is false positive, TN is true negative, and FN is false negative;
step S63, after the sensitivity and the specificity of the efficacy evaluation personnel for each subject efficacy evaluation are obtained, the overall sensitivity and the overall specificity of the efficacy evaluation personnel are calculated, and the calculation formula is as follows:
overall sensitivity =
Overall specificity =
Step S64, when any one of the overall sensitivity, the overall specificity or the sensitivity and the specificity of the individual subject is lower than the respective expected value, a reminder is sent to a system administrator.
2. The method of claim 1, wherein in step S1, the unifying and normalizing comprises providing the same standardized assessment table, scoring criteria and reference opinion for different efficacy assessors.
3. The centralized efficacy assessment method according to claim 1, wherein in step S3, the assessment answers of each assessment point f in the first efficacy assessment results EA { f1, f2, … fn } are spliced, and then processed by the MD5 algorithm;
and splicing the evaluation answers of each evaluation point f in the second curative effect evaluation results EB { f1, f2, … fn } and processing the spliced evaluation answers through the MD5 algorithm.
4. The method of claim 1, wherein in step S5, the decision is to re-evaluate the evaluation points f having different results, and the evaluation points f having the same result are not changed.
5. The method of claim 1, wherein the step of determining the central therapeutic effect comprises,
when the efficacy evaluator evaluates the evaluation point f as positive, the efficacy evaluation arbiter decides the evaluation point f as positive, the evaluation point f is defined as true positive;
when the efficacy evaluator evaluates the evaluation point f as positive and the efficacy evaluation arbitrator arbitrates the evaluation point f as negative, the evaluation point f is defined as false positive;
when the curative effect evaluation personnel evaluate the evaluation point f as negative, the curative effect evaluation judging personnel judges the evaluation point f as negative, the evaluation point f is defined as true negative;
when the efficacy evaluator evaluates the evaluation point f as negative, the efficacy evaluation arbitrator arbitrates the evaluation point f as positive, the evaluation point f is defined as false negative.
6. The centralized efficacy assessment method according to claim 1, wherein the last assessment of the efficacy assessor is checked and the efficacy assessor is investigated when the system administrator receives the reminder.
7. A central chemotherapeutic efficacy assessment system, to which the centralized efficacy assessment method according to any one of claims 1 to 6 is applied, characterized in that the central chemotherapeutic efficacy assessment system comprises:
the curative effect evaluation module is used for randomly transmitting test data of the same subject to two curative effect evaluation staff, and the curative effect evaluation staff respectively and independently make curative effect evaluation; if the curative effect evaluation results are consistent, the curative effect evaluation is completed, and if the curative effect evaluation is inconsistent, the curative effect evaluation arbitrator makes a final arbitration;
the data storage and management module is used for storing results of efficacy evaluation by efficacy evaluation personnel and efficacy evaluation judging personnel, and simultaneously, a system administrator can configure various data required by efficacy evaluation according to the evaluation requirements of clinical tests;
the monitoring tracking module is used for monitoring and tracking the progress and the result of the efficacy evaluation by the efficacy evaluation personnel and the efficacy evaluation discretion personnel and reminding the evaluation problem and risk;
and a standard API module for providing an API for the EDC system to call completed efficacy assessment result data.
8. The central chemo-efficacy assessment system of claim 7, further comprising a data encryption module for encrypting each item of data during the efficacy assessment process, which is accessible and processable only by authorized efficacy assessors, efficacy assessment arbitrators and system administrators.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311435266.4A CN117153424B (en) | 2023-11-01 | 2023-11-01 | Centralized curative effect evaluation method and system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311435266.4A CN117153424B (en) | 2023-11-01 | 2023-11-01 | Centralized curative effect evaluation method and system |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN117153424A CN117153424A (en) | 2023-12-01 |
| CN117153424B true CN117153424B (en) | 2024-02-23 |
Family
ID=88908615
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311435266.4A Active CN117153424B (en) | 2023-11-01 | 2023-11-01 | Centralized curative effect evaluation method and system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117153424B (en) |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106709247A (en) * | 2016-12-16 | 2017-05-24 | 遵义医学院附属医院 | System for pre-warning unplanned extubation of ICU patients |
| CN108601548A (en) * | 2015-12-31 | 2018-09-28 | 布赖恩斯科普公司 | For Neural monitoring and the system and method for auxiliary diagnosis |
| CN109273094A (en) * | 2018-09-14 | 2019-01-25 | 苏州贝斯派生物科技有限公司 | A kind of construction method and building system of the Kawasaki disease risk evaluation model based on Boosting algorithm |
| CN112785256A (en) * | 2021-01-14 | 2021-05-11 | 田进伟 | Real-time assessment method and system for clinical endpoint events in clinical trials |
| WO2022027714A1 (en) * | 2020-08-06 | 2022-02-10 | 深圳市第二人民医院(深圳市转化医学研究院) | Diagnostic capability evaluation method, system and device for diagnosis model, and storage medium |
| CN114842969A (en) * | 2022-03-23 | 2022-08-02 | 中国电子科技集团公司第十四研究所 | Mild cognitive impairment assessment method based on key fiber bundles |
| CN115349828A (en) * | 2022-08-19 | 2022-11-18 | 遵义医科大学附属医院 | Neonate pain assessment system based on computer deep learning |
| CN116705325A (en) * | 2023-06-26 | 2023-09-05 | 国家康复辅具研究中心 | Wound infection risk assessment method and system |
-
2023
- 2023-11-01 CN CN202311435266.4A patent/CN117153424B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108601548A (en) * | 2015-12-31 | 2018-09-28 | 布赖恩斯科普公司 | For Neural monitoring and the system and method for auxiliary diagnosis |
| CN106709247A (en) * | 2016-12-16 | 2017-05-24 | 遵义医学院附属医院 | System for pre-warning unplanned extubation of ICU patients |
| CN109273094A (en) * | 2018-09-14 | 2019-01-25 | 苏州贝斯派生物科技有限公司 | A kind of construction method and building system of the Kawasaki disease risk evaluation model based on Boosting algorithm |
| WO2022027714A1 (en) * | 2020-08-06 | 2022-02-10 | 深圳市第二人民医院(深圳市转化医学研究院) | Diagnostic capability evaluation method, system and device for diagnosis model, and storage medium |
| CN112785256A (en) * | 2021-01-14 | 2021-05-11 | 田进伟 | Real-time assessment method and system for clinical endpoint events in clinical trials |
| CN114842969A (en) * | 2022-03-23 | 2022-08-02 | 中国电子科技集团公司第十四研究所 | Mild cognitive impairment assessment method based on key fiber bundles |
| CN115349828A (en) * | 2022-08-19 | 2022-11-18 | 遵义医科大学附属医院 | Neonate pain assessment system based on computer deep learning |
| CN116705325A (en) * | 2023-06-26 | 2023-09-05 | 国家康复辅具研究中心 | Wound infection risk assessment method and system |
Also Published As
| Publication number | Publication date |
|---|---|
| CN117153424A (en) | 2023-12-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Horton et al. | Practice guidelines for ocular telehealth-diabetic retinopathy | |
| Harle et al. | Decision support for chronic pain care: how do primary care physicians decide when to prescribe opioids? a qualitative study | |
| US20110118555A1 (en) | System and methods for screening, treating, and monitoring psychological conditions | |
| Ferryman et al. | Considering biased data as informative artifacts in AI-assisted health care | |
| US20210057112A1 (en) | Method and system for mobile triage | |
| US20140006045A1 (en) | Systems and methods for reporting and notifying parties of injuries | |
| Snyder et al. | From pilot to practice: implementation of a suicide risk screening program in hospitalized medical patients | |
| Morash et al. | Is the nature of communication relevant to the supportiveness of women’s relationships with probation and parole agents? | |
| van Schuppen et al. | Understanding the prehospital physician controversy. Step 2: analysis of on-scene treatment by ambulance nurses and helicopter emergency medical service physicians | |
| US11437126B2 (en) | Methods and systems for analyzing accessing of medical data | |
| WO2014106825A2 (en) | Methods and devices for identifying improper medical reporting | |
| Schaekermann et al. | Remote tool-based adjudication for grading diabetic retinopathy | |
| Hansen | Continuity of care in family practice | |
| Wurster et al. | Standardizing the initial resuscitation of the trauma patient with the Primary Assessment Completion Tool using video review | |
| Jin et al. | Applying intelligent algorithms to automate the identification of error factors | |
| Roberts | The art of apology: When and how to seek forgiveness | |
| CN117153424B (en) | Centralized curative effect evaluation method and system | |
| Lin et al. | Medical staff and resident preferences for using deep learning in eye disease screening: discrete choice experiment | |
| Tzimenatos et al. | The pediatric emergency care applied research network: a history of multicenter collaboration in the United States | |
| Roy et al. | Rapid development of a tool for prioritizing patients with coronavirus disease 2019 for intensive care | |
| Bolton et al. | A magnet nursing service approach to nursing's role in quality improvement | |
| US20160092879A1 (en) | Switch Server System Interoperable With Mobile Devices Providing Secure Communications For Transactions | |
| CN111028938A (en) | Breathing machine monitoring method and system | |
| Chinwah et al. | Risk factors affecting maternal health outcomes in Rivers State of Nigeria: Towards the PRISMA model | |
| EP3791404A1 (en) | Method, apparatus, and computer readible media for artificial intelligence-based treatment guidance for the neurologically impaired patient who may need neurosurgery |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |