CN105574355B - The recording method of clinical research data and system - Google Patents
The recording method of clinical research data and system Download PDFInfo
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- CN105574355B CN105574355B CN201610082231.0A CN201610082231A CN105574355B CN 105574355 B CN105574355 B CN 105574355B CN 201610082231 A CN201610082231 A CN 201610082231A CN 105574355 B CN105574355 B CN 105574355B
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- G06F19/36—
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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
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
Abstract
Recording method and system the invention discloses a kind of clinical research data, in order to overcome the reliability of data used in clinical research in the prior art poor, it is difficult to meet the strict demand of authenticity and integrity etc..The recording method includes：In blank observation table is produced for patient according to database；To patient send according to the observation table make with access volume；Receive the case history made by other hospitals uploaded with access volume and patient of patient feedback；Outer court's data of patient are obtained from other hospitals；Case history and outer court's data are merged and duplicate removal is handled, obtains outer court's scientific data；Observation table is filled in access volume according to outer court's scientific data and patient feedback.The present invention can be realized the continuous observation of large sample size, be reduced the difficulty of clinical research, enrich observation sample based on unified standardization table generation observation table.
Description
Technical field
The present invention relates to recording method and the system of clinical research, more particularly to clinical research data.
Background technology
In clinical research, accuracy of clinical data etc. is one of premise for obtaining correct clinical research result.Cause
This, for clinical research observation, the authenticities of data, integrality etc. have very strict requirement.
Being admitted to hospital in patient, either hospital can face patient by special doctor or nurse during hospitalization for diagnosis and treatment
Bed diagnosis and treatment, while can be recorded according to diagnosis and treatment situation, therefore in this stage, the authenticity and integrity of clinical data can
Obtain a degree of guarantee, but Different hospital, different doctors are directed to the patient of the same state of an illness, observed project there may be
Difference.On the other hand, once patient is mainly inquired from institute, hospital or doctor etc. by way of phone into line trace, this side
Formula is difficult to the physical condition to patient's reality, every observation index carries out constantly effectively observation.Although can also be ask from institute
Patient's active reporting clinical data, but since patient does not have professional knowledge usually, the also viewing tool without specialty and observation
Means, therefore dependent on the clinical data famine reliability of patient's active reporting.
Having some social frameworks now can help hospital or doctor to go observation from the patient of institute, but by these societies
Mechanism dominates the clinical observation process of progress, is to completely disengage hospital or the supervision of doctor, the obtained data of observation can
To have a greatly reduced quality by property, it is difficult to meet the needs of clinical research.
The content of the invention
The technical problems to be solved by the invention are can in order to overcome data used in clinical research in the prior art
It is poor by property, it is difficult to meet the strict demand of authenticity and integrity etc..
In order to solve the above technical problems, present invention firstly provides a kind of recording method of clinical research data, for curing
Institute records the clinical research data of patient, and this method includes：According to the database pre-established for patient, produce and treat for patient
The observation table filled in；Sent to the patient according to the observation table making with access volume；Receive the patient feedback with
The case history made by other hospitals that access volume and the patient upload；Outer court's number of the patient is obtained from other hospitals
According to；The case history and outer court's data are merged and duplicate removal is handled, obtains outer court's scientific data；According to the section of outer court
Grind data and the patient feedback with access volume, fill in the observation table and store.
Preferably, sent to the patient according to the observation table making with access volume, including：By in the observation table
A part observation item change into access volume, be sent to the patient with access volume by described.
Preferably, this method includes：The court's data of the patient are extracted from the information management system of the hospital；Will
The court's data are filled up in the observation table.
Preferably, this method includes：To outer court's scientific data and the patient feedback with the number in access volume
According to clinical meaning judgement is carried out, determine outer court's scientific data and the patient feedback with the data in access volume can
Reliability.
Preferably, this method includes：When making in blank observation table for patient, at least one in the observation table
Divide observation item setting index term of reference；When filling in the observation table, the numerical value for judging to have observation item exceeds corresponding index
Term of reference, then generation are reminded and alarmed.
Present invention also offers a kind of record system of clinical research data, the clinical research number for hospital record patient
According to the system includes：Generation module, for according to the database pre-established for patient, in blank sight to be produced for patient
Examine table；Sending module, for being sent to the patient according to the observation table making with access volume；Receiving module, for connecing
Receive the case history made by other hospitals uploaded with access volume and the patient of the patient feedback；Acquisition module, is used for
Outer court's data of the patient are obtained from other hospitals；Fusion Module, for melting to the case history and outer court's data
Close and duplicate removal is handled, obtain outer court's scientific data；Module is filled in, for anti-according to outer court's scientific data and the patient
Feedback with access volume, fill in the observation table；Memory module, for storing the observation table.
Preferably, the generation module is used to change into the part observation item in the observation table described with access
Volume.
Preferably, which includes：Extraction module, for extracting the patient from the information management system of the hospital
The court's data；Wherein, the court's data are further filled up in the observation table by the module of filling in.
Preferably, which includes：Determination module, for outer court's scientific data and the patient feedback with
Data in access volume carry out clinical meaning judgement, determine outer court's scientific data and the patient feedback with access volume
In data confidence level.
Preferably, which includes：The generation module is used for when making in blank observation table for patient, is described
Observe at least a portion observation item setting index term of reference in table；The module of filling in is used to fill in the observation table
When, the numerical value for judging to have observation item exceeds corresponding index term of reference, then generation is reminded and alarmed.
Clinical research observation need continuously and effectively to carry out, but patient treatment end discharge after, except doctor or shield
Scholar is actively carried out outside phone tracking inquiry, and doctor and patient's contacts basic interruption, can only passively wait patient to come again
Institute is observed again when treating.Although doctor or nurse can actively pass through the situation of telephone questionnaire patient, telephonic communication
Process partial information may be lacked because being not easy to link up or loss of accuracy.These present situations inevitably lead to observe
Sample is subject to many limitations, it is difficult to realizes the observation of larger samples amount.Compared with prior art, it is advance to be based upon patient by the present invention
The unified database established makes observation table, and the data based on other hospitals and by patient feedback with access volume, energy
Enough realize the continuous observation of large sample size, reduce the difficulty of clinical research, enrich observation sample.
The statistical result that the present invention is formed according to case history uploaded with access volume and patient of patient feedback etc., has
The standard of higher degree, such as identical illness, different doctors or classification and item observed by different hospitals
After processing of the mesh by the present invention, there is very high uniformity and reliability, so as to avoid Different hospital and doctor's root
The observation difference and result difference brought according to oneself custom and demand, facilitate the research of scientific achievement, compare and analyze,
Including the research to same doctor or same hospital itself clinical data acquired for a long time, compare and analyze,
And the clinical data to different doctors, Different hospital even acquired in country variant research, compare and analyze, be bigger
In the range of be smoothed out the clinical research of high quality and have laid a good foundation.
Other features and advantages of the present invention will be illustrated in the following description, also, partly becomes from specification
Obtain it is clear that or being understood by implementing technical scheme.The purpose of the present invention and other advantages can by
Specifically noted structure and/or flow are realized and obtained in specification, claims and attached drawing.
Brief description of the drawings
Attached drawing is used for providing further understanding technical scheme or the prior art, and constitution instruction
A part.Wherein, the attached drawing for expressing the embodiment of the present invention is used for the technical side for explaining the present invention together with embodiments of the present invention
Case, but do not form the limitation to technical solution of the present invention.
Fig. 1 is the flow diagram of the recording method of the clinical research data of the embodiment of the present invention.
Fig. 2 is the organigram of the record system of the clinical research data of the embodiment of the present invention.
Embodiment
Carry out the embodiment that the present invention will be described in detail below with reference to accompanying drawings and embodiments, how the present invention is applied whereby
Technological means solves technical problem, and that reaches relevant art effect realizes that process can fully understand and implement according to this.This hair
Each feature in bright embodiment and embodiment, can be combined with each other under the premise of not colliding, the technical solution formed
Within protection scope of the present invention.
In addition, the step of method of the embodiment of the present invention shown by attached drawing includes, can be in such as one group of computer
Performed in the computer system of executable instruction.Also, although the method for the embodiment of the present invention embodies in shown flow chart
The certain logical order of technical scheme upon execution is gone out, but typically, which is only limitted to pass through
Embodiment shown by the flow chart.In other embodiments of the present invention, the logical order of technical scheme
Can be by different from realizing in a manner of shown in the drawings.
The recording method of the clinical research data of the embodiment of the present invention, is primarily used to hospital and intactly records facing for patient
Bed scientific data, main process are first to be produced for the patient according to the database for the standardization established in advance for patient and wait to fill out
The observation table write, then to patient send that table according to the observation produces and generates with access volume, wait user to fill in rear feedback reception,
And the case history of patient's upload is received, the data (present invention is referred to as outer court's data) of the patient are also obtained from other hospitals, then
Data that the case history uploaded with access volume, user of synthetic user feedback and this hospital obtain from other hospitals again etc., are filled in
Go out complete observation table, for carrying out clinical research.
As shown in Figure 1, Fig. 1 is the recording method of the clinical research data of the embodiment of the present invention, mainly include the following steps.
Step S110, according to the database pre-established for patient, and the observation stage that patient is presently in, for the trouble
Person produces corresponding observation table.For all patients, the database of the unified structure pre-established, easy to by doctor according to not
The different state of an illness with patient therefrom extract some projects and produce observation table, simplify the behaviour that doctor makes observation table for patient
Make, significantly shorten the time that doctor makes observation table, reduce the amount of labour of doctor, substantially increase doctor and make observation table
Efficiency.
Step S120, the part observation item for being adapted to patient's (or family numbers of patients etc.) voluntarily to fill in the observation table is turned
Chemical conversion is sent on the terminal device that patient possessed with access volume, and by this with access volume.For being not suitable for suffering from observation table
The observation item that person's (or family numbers of patients etc.) voluntarily fills in, then wait user to upload the case history made by other hospitals, Yi Jitong
System is crossed from the outer court's data obtained at other hospitals in system, then case history and outer court's data handle laggard
Row is filled in.Observation item in the observation table, some are to be adapted to the patient's content that voluntarily can obtain and fill in, such as name, property
Not, age, height, weight, blood pressure etc., some are to be not suitable for content such as platelet content that patient voluntarily fills in, white thin
Born of the same parents' content etc..
Step S130, receive patient fill in feedback with access volume, and receive patient actively or according to access volume etc.
Prompting and make after what is uploaded check the patient by other hospitals and be supplied to the case history of patient.
Step S140, outer court's data of the patient are obtained at other hospitals out of system.In the embodiment of the present invention, this
Hospital belongs to clinical research medical system or other with some other hospital can share in the system of clinical research data,
Facilitate these hospital datas to share, reduce the obstacle of data transfer, improve data transparency and accuracy.The present invention will be from system
The data of other interior infection from hospital are referred to as outer court's data, be able to will be referred to as from the data for the patient that this hospital extracts
The court's data.
Step S150, the case history uploaded to patient and the outer court's data obtained out of system at other hospitals are carried out at fusion
Reason and duplicate removal processing, finally obtain the outer court's scientific data provided by other hospitals.The case history that patient uploads, is all by other doctors
Institute makes and is supplied to patient's.Make the hospital of case history, it may be possible to hospital in system is belonged to as this hospital, also may be used
It can be the hospital being not belonging in system.Case history for being supplied to patient by other hospitals in system, then by the case history
Data carry out duplicate removal processing to the outer court's data obtained by system from corresponding hospital；For not being by other hospitals in system
The case history of patient is supplied to, then by the data fusion in the case history into outer court's data.The number provided other hospitals is provided
According to fusion treatment and duplicate removal processing is carried out, obtain that the patient formed when other examination in hospital treats to greatest extent outside
Institute's scientific data.
Step S160, the outer court's scientific data provided by other hospitals that will be obtained, and with patient in access volume certainly
The content that row is filled in, is filled in into the corresponding observation item of observation table, the observation table finished is filled in then storage.In this way, obtain
The observation table of patient vitals' body the present situation is characterized, facilitates doctor or nurse etc. to understand the current physical condition of patient.
The present invention using outer court's data for being provided with access volume, case history and other hospitals, realize this hospital or
Whole system etc. with from the non real-time remote interaction between institute patient, overcome be formerly only available by patient it is to hospital when or doctor
Bear and examine the drawbacks of can just being inquired in patient family to observed content, doctor or nurse need special take out before also overcoming
Go out the time and patient carries out telephone questionnaire and links up the problem of existing time waste is serious, regain the initiative, facilitate doctor
School face and the interaction of patient home, efficiently use the time of fragmentation time and inoperative period.
In order to further strengthen the authenticity of data during doctor-patient interaction, the embodiment of the present invention also introduces supervisor
Supervise whole interactive process, ensure observation table and its fill in process, with access volume, the accuracy etc. of case history.On the other hand, it is convenient
While doctor or nurse can understand the observation table of individual patient at any time according to the authority of oneself, every trouble has been also convenient for
Person understands the content of itself observation table at any time.
Patient fill in feedback with access volume, case history that patient uploads, and the outer court's data obtained by system, in it
Appearance is not available for changing after typing, ensures that the authenticity of data in observation table.On the other hand, patient fill in
During access volume by mistake, it is possible to there is a possibility that to fill in.Patient is when other medical and health organizations are checked, since equipment is missed
Difference or the difference of medical staff's detection methods etc., the case history thus generated also likely to be present a degree of untrue property.For
Prevent patient's mistake from filling in access volume, or avoid in the case history that patient uploaded partial parameters there may be error, this
In the embodiment of invention, by doctor or other professionals to anti-in outer court's scientific data of other infection from hospital and patient
Feedback carries out clinical meaning judgement with the data in access volume, is respectively that these data carry out confidence level judge.Anticipated using clinic
Justice judges, the information collected by different approaches is screened and identified, also further objectively to ensure that data in observation table
The authenticity of itself and the authenticity of data source, rather than the side by doctor to the data progress error correction in observation table
Formula, subjectively to ensure the authenticity of data.Thus, even if the data in observation table are wrong, can also be judged by clinical meaning
It is identified, conveniently further contacting patient during follow-up use is screened.
This hospital recorded data can also be filled up in observation table by the present invention, can so be ensured in observation table
Data are more comprehensive.The court's data obtained from this hospital, authenticity and reliability are highest, are not usually required to consider the court
The authenticity and reliability of data.What the information management system of hospital included all managing patient information of hospital internal is
System, common are hospital information system (Hospital Information System, abbreviation HIS), laboratory calibration system
System (Laboratory Information Management System, abbreviation LIS), Picture Archiving and Communication System
(Picture archiving and communication systems, abbreviation PACS) and Radiology Information System
(Radioiogy information system, abbreviation RIS), these systems have the characteristics that updating decision, some data are even
Real-time update, ensure that the real-time of data in the database of patient.The information management system of hospital in the embodiment of the present invention,
Can be at least one of HIS, LIS, PACS and RIS.
In the embodiment of the present invention, patient passes through the initial data submitted with access volume or case history etc., doctor or shield
Scholar etc. can only judge this means come the confidence level of determination data according to clinical meaning, but can not be led according to experience etc.
Dynamic modification.The initial data (if any needing what is filled in by doctor in some observation tables) filled in for doctor,
Record modification daily record during modification, completely preserve whole observation table fills in process.
It is in the lump also at least one in observation table when making observation table according to standardization table in the embodiment of the present invention
Part observation item setting index term of reference, when filling in observation table, joins to whether the numerical value for observing item exceeds corresponding index
Scope is examined to be judged.If it is judged that the numerical value for having observation item exceeds corresponding index term of reference, or combination observation item
In there is numerical value to exceed corresponding index term of reference, generation in time is reminded and is alarmed Xiang doctor or nurse, such as Xiang doctor
Terminal device (such as mobile phone) send warning message, prompt doctor pay attention to.Doctor can contact accordingly patient verified or
Notify that patient is to hospital in time.
The embodiment provides a kind of clinical research data record method of linkage, patient, doctor, hospital, prison
Superintend and direct etc. and common to participate in completing.In current technology, doctor mainly observes table according to itself Research Requirements personalized designs, causes not
Do not possess between the observation table used with the doctor different patients that even same doctor is directed under the same state of an illness consistent
Property.The present invention generates observation table according to the database of standard for patient, overcomes current observation table and does not possess the defects of uniformity,
Facilitate different observation tables integrated, inductive statistics research.
As shown in Fig. 2, the record system 200 of the clinical research data of the embodiment of the present invention, mainly includes generation module
210th, sending module 220, receiving module 230, acquisition module 240, Fusion Module 250, fill in module 260 and memory module
270。
Wherein, generation module 210 is used to, according to the database established for patient in advance, produce for patient in blank
Observe table.Sending module 220 is connected with the generation module 210, for sending what is produced and generated according to the observation table to the patient
With access volume.Receiving module 230, for receive the patient feedback with access volume and by the patient upload by other hospitals
The case history of making.Acquisition module 240 is used for outer court's data that the patient is obtained from other hospitals.Fusion Module 250 is with receiving mould
Block 230 and acquisition module 240 are connected, and for the case history received to receiving module 230 and have acquired in acquisition module 240
Outer court's data carry out fusion treatment and duplicate removal processing, obtain the outer court's scientific research provided by the hospital in system and/or outside system
Data.Module 260 is filled in receiving module 230 and Fusion Module 250 to be connected, for according to patient fed back with access volume with
And outer court's scientific data that Fusion Module 250 is obtained, made observation table before filling in.Memory module 270 is with filling in mould
Block 260 is connected, and fills in module 260 for storage and fills in the observation table finished.
In the embodiment of the present invention, generation module 210 is additionally operable to the part observation item in produced observation table
Change into access volume, patient is sent to by sending module 220.
The embodiment of the present invention, further includes extraction module, it is connected with filling in module 260, for the information from this hospital
The court's data of the patient are extracted in management system, module is filled in and further fills in the court's data that extraction module is extracted
Into observation table, the observation item in observation table is enriched, improves the rich of clinical research data, can be with easy to clinical research personnel
Carry out more abundant, comprehensive clinical research.
In the embodiment of the present invention, fill in module 260 and be used to be filled in observation table with access volume according to patient feedback
A part observes item, and another part observation item in the observation table is filled according to the case history that patient uploads.
As shown in Fig. 2, the record system of the clinical research data of the embodiment of the present invention, further includes determination module 280, with filling out
Writing module 260 is connected, for when filling in module 260 and filling in observation table, clinical meaning judgement to be carried out to the data in observation table,
To determine the confidence level of the data in observation table, ensure the authenticity and accuracy of clinical research data.
In the embodiment of the present invention, generation module 210 is used for when making in blank observation table for patient, is also observation
At least a portion observation item setting index term of reference in table.Fill in module 260 to be used for when filling in observation table, to observing item
Numerical value whether judged beyond corresponding index term of reference, and judging to have the numerical value of observation item to exceed corresponding finger
Term of reference is marked, generation is reminded and alarmed.
In the embodiment of the present invention, the observation table filled in of data that is provided according to patient, cannot be changed in terms of hospital
It is dynamic, clinical meaning is only carried out by doctor and judges to provide with reference to weight, has prevented the possibility that can be tampered after patient's reported data
Property, further ensures the authenticity of data.
Those skilled in the art should be understood that each part for the system that the above-mentioned embodiment of the present invention is provided,
And each step in method, they can be concentrated on single computing device, or are distributed in multiple computing device institutes group
Into network on.Alternatively, they can be realized with the program code that computing device can perform.It is thus possible to they are deposited
Storage performed in the storage device by computing device, either they are fabricated to respectively each integrated circuit modules or by it
In multiple modules or step be fabricated to single integrated circuit module to realize.In this way, the present invention be not restricted to it is any specific
Hardware and software combine.
Although disclosed herein embodiment as above, the content be only readily appreciate technical solution of the present invention
And the embodiment used, it is not limited to the present invention.Technical staff in any fields of the present invention, is not departing from this
On the premise of the disclosed spirit and scope of invention, any modification and change can be carried out in the form and details of implementation,
But the scope of patent protection of the present invention, still should be subject to the scope of the claims as defined in the appended claims.
Claims (10)
1. a kind of recording method of clinical research data, the clinical research data for hospital record patient, it is characterised in that should
Method includes：
According to the database pre-established for patient, in blank observation table is produced for patient；
Sent to the patient according to the observation table making with access volume；
Receive the case history made by other hospitals uploaded with access volume and the patient of the patient feedback；
Outer court's data of the patient are obtained from other hospitals；
The case history and outer court's data are merged and duplicate removal is handled, obtains outer court's scientific data；
According to outer court's scientific data and the patient feedback with access volume, fill in the observation table and store.
2. according to the method described in claim 1, it is characterized in that, to the patient send according to it is described observation table make with
Access volume, including：
Part observation item in the observation table is changed into access volume, the patient is sent to access volume by described.
3. according to the method described in claim 1, it is characterized in that, this method includes：
The court's data of the patient are extracted from the information management system of the hospital；
The court's data are filled up in the observation table.
4. the method according to claim 1 or 3, it is characterised in that this method includes：
Clinical meaning judgement is carried out with the data in access volume to outer court's scientific data and the patient feedback, is determined
Outer court's scientific data and the confidence level with the data in access volume of the patient feedback.
5. the method according to claim 1 or 3, it is characterised in that this method includes：
When making in blank observation table for patient, set index at least a portion observation item in the observation table and refer to model
Enclose；
When filling in the observation table, the numerical value for judging to have observation item exceeds corresponding index term of reference, then generation is reminded simultaneously
Alarm.
6. a kind of record system of clinical research data, the clinical research data for hospital record patient, it is characterised in that should
System includes：
Generation module, for according to the database pre-established for patient, in blank observation table to be produced for patient；
Sending module, for being sent to the patient according to the observation table making with access volume；
Receiving module, for receive the patient feedback with being made by other hospitals of uploading of access volume and the patient
Case history；
Acquisition module, for obtaining outer court's data of the patient from other hospitals；
Fusion Module, for the case history and outer court's data are merged and duplicate removal processing, obtain outer court's scientific data；
Module is filled in, for, with access volume, filling in the observation according to outer court's scientific data and the patient feedback
Table；
Memory module, for storing the observation table.
7. system according to claim 6, it is characterised in that：
The generation module is used to change into the part observation item in the observation table described with access volume.
8. system according to claim 6, it is characterised in that the system includes：
Extraction module, for extracting the court's data of the patient from the information management system of the hospital；
Wherein, the court's data are further filled up in the observation table by the module of filling in.
9. the system according to claim 6 or 8, it is characterised in that the system includes：
Determination module, it is clinical for being carried out to outer court's scientific data and the patient feedback with the data in access volume
Meaning judges, determines outer court's scientific data and the confidence level with the data in access volume of the patient feedback.
10. the system according to claim 6 or 8, it is characterised in that the system includes：
The generation module is used to, when making in blank observation table for patient, see at least a portion in the observation table
Examine item setting index term of reference；
The module of filling in is used for when filling in the observation table, and the numerical value for judging to have observation item is referred to beyond corresponding index
Scope, then generation are reminded and alarmed.
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| CN109542966B (en) * | 2018-11-09 | 2020-09-18 | 金色熊猫有限公司 | Data fusion method and device, electronic equipment and computer readable medium |
| CN110289107A (en) * | 2019-05-10 | 2019-09-27 | 南方医科大学珠江医院 | A kind of medical follow up control method |
| CN110600089A (en) * | 2019-08-14 | 2019-12-20 | 首都医科大学附属北京同仁医院 | Method for generating patient state information acquisition table after treatment |
| CN111883220A (en) * | 2020-07-03 | 2020-11-03 | 合肥森亿智能科技有限公司 | Patient follow-up visit data collection method, system, terminal and data collection integrated system |
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