CN112489774A - Clinical trial subject recruitment system - Google Patents
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Abstract
The invention relates to the technical field of medical treatment, in particular to a clinical trial subject recruitment system, which comprises a researcher terminal, a doctor terminal, a patient terminal and a server, wherein the server comprises: the release module is used for acquiring and disclosing project information initiated by a researcher terminal; the screening module is used for receiving the recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion and exclusion standards, if so, recording the patient information and storing the patient information into a database, and generating an informed consent to be signed; the informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating the signed informed consent; binding the signed informed consent with the patient information and storing the signed informed consent into a preset selected patient information base; by adopting the scheme, the problem of low recruitment efficiency of the testees can be solved.
Description
Technical Field
The invention relates to the technical field of medical treatment, in particular to a clinical trial subject recruitment system.
Background
Clinical trials refer to prospective studies of human subjects, with subjects or groups of subjects pre-assigned to receive one or more medical interventions to assess the impact of the medical intervention on health outcome. Where "medical intervention" includes, but is not limited to, drugs, cells and other biologics, surgical treatment, radiation therapy, medical devices, behavioral therapy, alteration of treatment processes, preventive care, and the like. The definition includes the 1 st stage to 4 th stage of the test. The recruitment of subjects in clinical trials belongs to the early work of the research implementation stage, and is a very important link in clinical trials, and the process mainly comprises the steps of recruitment of subjects, screening of qualified subjects and obtaining of informed consent of the subjects. The recruitment of subjects to a sufficient number of subjects to meet the requirements of the trial will have a major impact on the quality of the trial and on the progress of the trial, and if a sufficient number of suitable subjects cannot be recruited, the clinical trial will have to be suspended or even terminated.
To this end, the document with chinese patent publication No. CN110415772A discloses a clinical trial patient recruitment and case quick matching system, which includes a storage module, in which the project information (including the basic requirements of the project) of the clinical trial is pre-stored and the received medical record information is stored; the release module is used for releasing the project information; the receiving module is used for receiving medical record information of a patient; the matching module is used for matching the medical record information according to the project information; and the pushing module is used for pushing the matched medical record information to the project personnel when the medical record information corresponding to the project information is matched.
By adopting the scheme, the medical record information of the patient can be matched with the project information of the clinical test, and the personnel meeting the clinical test conditions can be selected; however, according to survey, the best mode for recruiting patients is recommended by doctors or medical staff of the patients, the patient acceptance is high, the protection of privacy rights and right of awareness of the patients is better met, and the recruitment success rate is highest. Meanwhile, as clinical tests are continuously increased and clinical tests of various rare diseases are continuously developed, the requirements on tested persons are increasingly increased, and case systems of hospitals are relatively closed and cannot be completely communicated temporarily, if the tested patients are screened only by researchers or project personnel specially responsible for recruitment, more doctor resources or nurse resources are neglected to be used for contacting the patients, and the problem of low efficiency exists.
Disclosure of Invention
The invention aims to provide a clinical trial subject recruitment system which can solve the problem of low recruitment efficiency.
The basic scheme provided by the invention is as follows: a clinical trial subject recruitment system comprising a researcher terminal, a physician terminal, a patient terminal, and a server, the server comprising:
the release module is used for acquiring and disclosing project information initiated by a researcher terminal;
the screening module is used for receiving the recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion and exclusion standards, if so, recording the patient information and storing the patient information into a database, and generating an informed consent to be signed;
the informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating the signed informed consent; binding the signed informed consent with the patient information and storing the signed informed consent into a preset selected patient information base;
and the output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal.
The working principle and the advantages of the invention are as follows:
compared with the existing recruitment work, the project information initiated by the researcher terminal can be acquired and disclosed through the publishing module, so that more doctors can know the project condition of clinical research, the tradition of recruiting patients by taking the patients as a breakthrough in the past is broken, and the success rate of recruiting is improved by recruiting the patients by the doctors; the method comprises the steps that a screening module is arranged, recommended patient information sent by a doctor according to project information is obtained, and if the recommended patient meets screening conditions, the patient information is recorded in a database; the informed consent module sends the informed consent to be signed to the patient terminal meeting the conditions, and the signed informed consent can be generated after the patient inputs confirmation information, so that the workload of recruiting doctors is reduced, and the informed right of the patient is fully ensured; after the patient enters the confirmation information, the patient information and the signed informed consent form are immediately recorded in the selected patient database; and finally, sending the information of the selected patients and the informed consent to a researcher terminal through an output module for the researcher to check.
In conclusion, the method can improve the diffusion degree of clinical research project information among different medical institutions, and besides researchers who are specially responsible for recruitment work, more doctors can also know what patients need to be recruited and the recruitment progress of the project at any time; and mobilize the doctor to assist the patient's recruitment, solve and rely on the medical record to match and can't screen the limitation of outpatient or rare disease purely; through the standardized enrollment process of the screening module and the informed consent module, the workload of a doctor for learning and executing a project screening scheme is reduced, and different effects caused by different medical backgrounds in doctor-patient communication are reduced. Therefore, the breadth of information resources is ensured, the misreading of project information is prevented, the standardization and the normalization are ensured, and the patient recruitment efficiency is improved.
Further, the screening module is also used for comparing the patient information with the selection standard to obtain the matching degree; and judging the matching degree according to the preset recommended proportion information, if the matching degree is greater than the recommended proportion, judging that the patient meets the conditions, pushing the patient information to a researcher terminal, calculating the labor reward according to the matching degree, and paying the labor reward to the doctor.
Has the advantages that: the screening module is arranged, the matching degree is generated according to the comparison result of the patient information and the selection standard, if the matching degree is greater than the preset recommended proportion information, the patient basically meets the conditions, and the matching degree can be pushed to a researcher terminal for further perfecting the verification and check of the researcher; so far, as the doctor has already assisted to finish part of the work, a patient meeting the selection condition is recommended, the reward can be calculated according to the matching degree, and the reward is paid to the doctor; therefore, the doctors are stimulated to mobilize and improve the enthusiasm of the doctors for participating in the recruitment of the subjects.
And further, the screening module is also used for acquiring a patient medical record picture uploaded by the doctor terminal, processing the medical record picture according to an image processing algorithm to obtain character information, and judging that the patient meets the selection condition if the character information is matched with the selection standard.
Has the advantages that: the doctor can shoot the patient case history, and the screening module extracts the text information in the picture according to the image processing algorithm, matches the text information with the selection standard, thereby judging whether the patient meets the conditions or not and facilitating the use of the doctor.
Further, the database is also used for pre-storing a plurality of pieces of video information for introducing clinical trials and standard answer information;
the informed consent module also comprises a project introduction submodule which is used for pushing the video information of the clinical test to the patient terminal when sending the informed consent to be signed;
the project introduction submodule is also used for collecting voice information of the questions asked by the patient, converting the voice into character information through a voice recognition algorithm, matching standard answer information from the database according to the character information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal.
Has the advantages that: as the specific schemes and the target degrees of the clinical tests of doctors with different backgrounds are inconsistent, the scheme collects the voice information of the questions asked by the patients through video description and an intelligent voice answering mode, and after the voice information is converted into characters, the corresponding answering information can be matched from a database, and finally the answering information is played through a terminal; therefore, the problem of doctor-patient communication is solved, and the patient can watch the project introduction video and ask questions to know corresponding rights and obligations, so that the informed consent can be completed efficiently.
Further, the screening module is also used for acquiring doctor-patient question and answer information input by the doctor terminal, extracting character information in the doctor-patient question and answer information, and if the character information is matched with the exclusion standard, judging that the patient does not accord with the selection condition.
Has the advantages that: correspondingly, when the doctor recruits the testees, the doctor can also adopt a form of oral questions and answers with the patients, the question and answer information needs to be input into the screening module, the text information in the question and answer information is matched with the exclusion standard, and the patients who do not meet the conditions are determined.
Further, the system also comprises a nurse terminal; the screening module is also used for acquiring patient laboratory test report pictures and medical history information uploaded by the nurse terminal.
Has the advantages that: by adopting the scheme, the nurse resources can be fully utilized, the laboratory sheet pictures and the medical history information of the patients are sent to the screening module by the nurse terminal, the recruitment of the subjects is assisted, and the recruitment efficiency is improved.
Further, the recommended patient information comprises an identification number; the screening module is also used for inquiring the database according to the identity card number, and prompting that the patient is selected if the same identity card number exists in the database; otherwise, the ID card number is recorded in the database.
Has the advantages that: the ID card number is used as the unique identification of a person, and whether the person is selected or not can be inquired according to the ID card by applying the ID card number to the scheme, so that the actual requirement is met, and the operation is convenient and fast.
Further, the researcher terminal, the doctor terminal, the patient terminal and the nurse terminal are all mobile phone terminals.
Has the advantages that: the mobile phone has portability and complete functions, and is convenient for doctors and nurses to collect and send pictures and character information.
Further, the confirmation information includes a fingerprint and a signature.
Has the advantages that: in the scheme, the electronic informed consent is sent to the patient terminal, and compared with the traditional paper-version informed consent, the patient does not need to carry the informed consent at any time and any place; moreover, the fingerprint and signature mode is adopted, so that the operation can be directly carried out through a mobile phone, the workload is saved, and the user experience of a patient is improved; thereby showing the advantages of paperless, standardization and intellectualization.
Further, the informed consent module is also used for starting timing after sending the informed consent book to be signed, and generating waiting time; and if the waiting time is greater than the preset time threshold, sending prompt information to the patient terminal.
Has the advantages that: by adopting the scheme, the condition that the patient does not process the informed consent for a long time or forgets to process the informed consent can be avoided, so that the recruitment efficiency and progress of the subject are ensured.
Drawings
Fig. 1 is a system block diagram of a clinical trial subject recruitment system according to a first embodiment of the invention.
Detailed Description
The following is further detailed by the specific embodiments:
example one
A clinical trial subject recruitment system, as shown in fig. 1, comprising a researcher terminal, a physician terminal, a patient terminal, and a server, wherein: the researcher terminal, the doctor terminal and the patient terminal are all mobile phone terminals; the server includes:
the release module is used for acquiring and disclosing project information initiated by a researcher terminal; medical staff of all cooperative medical institutions can know the disease condition and the recruitment schedule of the research project in time through the information of the public presentation project, so that suitable subjects can be purposefully mined in the subsequent diagnosis and treatment process of the medical staff;
the screening module is used for receiving the recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion and exclusion standards, if so, recording the patient information and storing the patient information into a database, and generating an informed consent to be signed; specifically, the selection criteria in this embodiment may be predefined as "1. male or female, age ≥ 18 years, according to actual needs; 2. taking antiplatelet drugs "and may also be defined as" 1 "with HF symptoms at visit 1 (NYHA class II-iv); 2. structural heart disease as evidenced by abnormalities in one or more of the following echocardiograms; "accordingly, the exclusion criteria in this example can be defined as" 1. associated severe disease and life expectancy ≦ 6 months; 2. is participating in an interventional clinical study "in another embodiment the exclusion criteria are defined as" 1. any previous LVEF detection value < 45%; 2. patients with a history of angioedema are known.
After the doctor finds the patients, the doctor orally obtains the consent of the patients, and can obtain the information of the patients by photographing the medical records of the patients and also by orally asking and answering the patients; the screening module in the scheme is also used for acquiring a patient medical record picture uploaded by a doctor terminal, processing the medical record picture according to an image processing algorithm to obtain character information, and judging that the patient meets the selection condition if the character information is matched with the selection standard; the screening module is also used for acquiring doctor-patient question and answer information input by the doctor terminal, extracting character information in the doctor-patient question and answer information, and if the character information is matched with the exclusion standard, judging that the patient does not accord with the selection condition.
In another embodiment, the system further comprises a nurse terminal, wherein the nurse terminal is a mobile phone terminal; after the nurse finds the suitable patient, the nurse orally acquires the consent of the patient, and the screening module is also used for acquiring the patient laboratory test report picture and the medical history information uploaded by the nurse terminal; the nurse terminal can send the laboratory test report pictures and the medical history information of the patients to the screening module by utilizing nurse resources, so as to assist in recruitment of the subjects and improve recruitment efficiency.
In order to facilitate the search of whether the patient is in the selected group, the recommended patient information in the scheme comprises an identification number; the screening module is also used for inquiring the database according to the identity card number, and prompting that the patient is selected if the same identity card number exists in the database; otherwise, the ID card number is recorded in the database. By using the patient identification card as the identification condition, the probability that different centers and different doctors select the same patient to enter the group can be reduced.
The informed consent module is used for sending video project introduction to the patients meeting the selection conditions, explaining the right and obligations to participate in the project, providing on-line intelligent answering and completing the doctor-patient communication process; after the patient finishes knowing the items, the patient correspondingly sends the informed consent to be signed to the patient terminal meeting the conditions, inputs the confirmation information of the patient and generates the signed informed consent; binding the signed informed consent with the patient information and storing the signed informed consent into a preset selected patient information base; specifically, in order to facilitate the patient to know the project, the database is also used for pre-storing a plurality of pieces of video information for introducing clinical trials and standard answer information; the right and obligation of the patient to participate in the project are introduced in the video information;
the informed consent module also comprises a project introduction submodule which is used for pushing the video information of the clinical test to the patient terminal when sending the informed consent to be signed; according to the scheme, the clinical test items are introduced to the patient through the video description, so that the patient can know more information about the items, and the development of subsequent test work is facilitated.
The project introduction submodule is also used for collecting voice information of the questions asked by the patient, converting the voice into character information through a voice recognition algorithm, matching standard answer information from the database according to the character information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal. Wherein: the voice to text conversion or the text to voice generation can be realized by the existing science news aircraft voice engine, and the details are not repeated herein; the standard answering information matched from the database according to the text information mainly adopts a keyword matching technology, and the intelligent voice answering mode can solve doctor-patient communication problems and is convenient for completing informed consent efficiently.
The informed consent to be signed comprises the elements of research project name, subject undertaking unit, contact person of my hospital, contact telephone, consent statement, subject signature, date, telephone and the like; the confirmation information of the patient comprises the fingerprint and the signature, the patient can complete the signature of the informed consent through the mobile phone operation and the fingerprint input or signature collection means, so that the informed consent communication link is not limited by places and the medical background of the recruited doctors or nurses, the operation process is more convenient and faster, the workload is greatly saved, and the user experience of the patient can be improved.
And the output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal.
Example two
Compared with the first embodiment, the difference is that the screening module is also used for comparing the patient information with the inclusion standard to obtain the matching degree; and judging the matching degree according to the preset recommended proportion information (set to 45% in the embodiment), if the matching degree is greater than the recommended proportion, judging that the patient meets the conditions, pushing the patient information to a researcher terminal, calculating the labor reward according to the matching degree, and paying the labor reward to the doctor. For example, if the recommended doctor matches up to 50%, the patient information may be sent to the researcher; the subsequent researchers are responsible for follow-up, perfecting the selection and finally selecting. Then the recommending doctor can obtain 50% of the recommended labor cost; therefore, doctors are stimulated in time, the enthusiasm of the doctors for participating in the recruitment of clinical scientific research subjects is improved, and the recruitment efficiency of clinical tests is remarkably improved.
In order to ensure the recruitment efficiency and progress of the subjects, the informed consent module is also used for starting timing after sending the informed consent book to be signed to generate waiting time; and if the waiting time is greater than a preset time threshold (preset to be 2 days), sending prompt information 'please sign an informed consent form in time' to the patient terminal.
EXAMPLE III
Compared with the first embodiment, the patient terminal is used for acquiring a requirement file of a clinical test program, reading the requirement file and generating a detection instruction according to the keyword information in the standard file; for example, in a clinical test for drugs, the document is required to specify that a subject should not drink alcohol from their diet; therefore, after the requirement file is interpreted, a detection instruction generated according to the keyword 'diet' is 'the diet condition of the subject is shot by the camera at the time of eating'; the server is used for receiving the detection instruction and prompting the patient according to the detection instruction; the prompting means in this embodiment may be sending a push message to the patient terminal, and in other embodiments, a similar existing robot phone may be used, which is the prior art and is not described herein again; compared with the general message pushing, the method can perform better prompting effect on the subjects.
The server is also used for acquiring sound information uploaded by a mobile phone end sound pick-up of a patient, converting the sound information into characters according to a voice recognition algorithm (adopting a science news communication voice recognition technology), and generating a detection instruction according to keywords in the characters; for example, when a subject speaks keywords similar to 'eat', a camera on a mobile phone end is awakened to collect the diet condition; the problem of power consumption of the camera in a working state all the time can be avoided, and image privacy of a user can be effectively protected.
The patient mobile phone end is also used for acquiring image information through the camera and sending the image information to the server; the server is used for judging whether the image information is an illegal article image, and if so, generating alarm information 'illegal operation of the subject' and sending the alarm information to the researcher terminal. Specifically, a plurality of illegal article images and names thereof are stored in a database of the server in advance, the function of screening the illegal article images from the images can be realized through the existing image comparison algorithm, and finally, the images are indicated as illegal articles through a comparison requirement file if the names of the illegal articles specified in the requirement file are the same as the names of the articles identified by the images; in order to avoid that the detection of the illegal article is invalid because the article in the image information is not stored in the database; in the embodiment, if the image information is not identified to be the illegal object image, whether the illegal object image identical to the image information is stored in the database is judged, and if the illegal object image is not stored, the image information is sent to the doctor terminal, and the name of the object sent by the doctor terminal is received; the database is also used for receiving and storing the image information and the article names, completing self-learning, enhancing the identification capability of the database and facilitating next judgment.
This scheme of adoption carries out the shooting of image through the work and rest condition to the testee, discerns out the action of irregularity, avoids appearing the action of irregularity in clinical trial's preparation stage, leads to the fact the influence to experimental effective going on.
The foregoing is merely an example of the present invention, and common general knowledge in the field of known specific structures and characteristics is not described herein in any greater extent than that known in the art at the filing date or prior to the priority date of the application, so that those skilled in the art can now appreciate that all of the above-described techniques in this field and have the ability to apply routine experimentation before this date can be combined with one or more of the present teachings to complete and implement the present invention, and that certain typical known structures or known methods do not pose any impediments to the implementation of the present invention by those skilled in the art. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.
Claims (10)
1. A clinical trial subject recruitment system comprising a researcher terminal, a physician terminal, a patient terminal, and a server, the server comprising:
the release module is used for acquiring and disclosing project information initiated by a researcher terminal;
the screening module is used for receiving the recommended patient information sent by the doctor terminal according to the project information, judging whether the patient meets the conditions according to preset inclusion and exclusion standards, if so, recording the patient information and storing the patient information into a database, and generating an informed consent to be signed;
the informed consent module is used for correspondingly sending the informed consent to be signed to the patient terminal meeting the conditions, inputting the confirmation information of the patient and generating the signed informed consent; binding the signed informed consent with the patient information and storing the signed informed consent into a preset selected patient information base;
and the output module is used for pushing the patient information in the selected patient information base and the signed informed consent to the researcher terminal.
2. The clinical trial subject recruitment system of claim 1, wherein: the screening module is also used for comparing the patient information with the selection standard to obtain the matching degree; and judging the matching degree according to the preset recommended proportion information, if the matching degree is greater than the recommended proportion, judging that the patient meets the conditions, pushing the patient information to a researcher terminal, calculating the labor reward according to the matching degree, and paying the labor reward to the doctor.
3. The clinical trial subject recruitment system of claim 1, wherein: the database is also used for pre-storing a plurality of video information for introducing clinical trials and standard answer information;
the informed consent module also comprises a project introduction submodule which is used for pushing the video information of the clinical test to the patient terminal when sending the informed consent to be signed;
the project introduction submodule is also used for collecting voice information of the questions asked by the patient, converting the voice into character information through a voice recognition algorithm, matching standard answer information from the database according to the character information, synthesizing the standard answer information into sound, and playing the sound by the patient terminal.
4. The clinical trial subject recruitment system of claim 1, wherein: the screening module is also used for acquiring a patient medical record picture uploaded by the doctor terminal, processing the medical record picture according to an image processing algorithm to obtain character information, and judging that the patient meets the selection condition if the character information is matched with the selection standard.
5. The clinical trial subject recruitment system of claim 4, wherein: the screening module is also used for acquiring doctor-patient question and answer information input by the doctor terminal, extracting character information in the doctor-patient question and answer information, and if the character information is matched with the exclusion standard, judging that the patient does not accord with the selection condition.
6. The clinical trial subject recruitment system of claim 1, wherein: the system also comprises a nurse terminal; the screening module is also used for acquiring patient laboratory test report pictures and medical history information uploaded by the nurse terminal.
7. The clinical trial subject recruitment system of claim 1, wherein: the recommended patient information comprises an identification number; the screening module is also used for inquiring the database according to the identity card number, and prompting that the patient is selected if the same identity card number exists in the database; otherwise, the ID card number is recorded in the database.
8. The clinical trial subject recruitment system of claim 6, wherein: the researcher terminal, the doctor terminal, the patient terminal and the nurse terminal are all mobile phone terminals.
9. The clinical trial subject recruitment system of claim 1, wherein: the validation information includes a fingerprint and a signature.
10. The clinical trial subject recruitment system of claim 1, wherein: the informed consent module is also used for starting timing after sending the informed consent book to be signed to generate waiting time; and if the waiting time is greater than the preset time threshold, sending prompt information to the patient terminal.
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