CN103761437A - Scientific research data automatic generation system based on clinical data - Google Patents
Scientific research data automatic generation system based on clinical data Download PDFInfo
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- CN103761437A CN103761437A CN201410028475.1A CN201410028475A CN103761437A CN 103761437 A CN103761437 A CN 103761437A CN 201410028475 A CN201410028475 A CN 201410028475A CN 103761437 A CN103761437 A CN 103761437A
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Abstract
The invention discloses a scientific research data automatic generation system based on clinical data. According to the system, electronic medical records, an HIS system, an LIS system and a PACS system serve as data sources, the system aims at automatically generating scientific data on the basis of the electronic medical records, and the normalization, the authenticity, the reliability and the traceability of the data are improved through clinical research; meanwhile, the problem that clinical data can not be exchanged or collected due to data differences is solved.
Description
Technical field
The present invention is the scientific research data automatic creation system based on clinical data, for the basic automatic generation that realizes scientific research data at electronic health record.Take the data that record, inscribe disease, physical examination, vital sign, diagnostic message, progress note, MAR and LIS system, PACS system, HIS system in hospital of electronic health record as data source, by extracting, gathering, generate scientific research data, and realize the synthetic printing of reconstruct data.The present invention meets the requirement of the standardization of clinical research to data, authenticity, reliability, tractability, improved the quality of clinical research, be convenient to the data exchange of similar scientific research and gather, this invention belongs to the method that is extracted and changed by data message and realizes the process of knowledge reorganization.
Background technology
Case history is as the valid medical records of tool, and its data have higher authenticity, reliability, tractability.Along with management information system for hospitals (hospital management information system, HIS), clinic information system (clinical information system, CIS), electronic medical record system (electronic medical record, EMR) etc. information system management means are in the successful implementation of hospital, and the starting of digital hospital forms.A large amount of clinical data under Information Condition, for research provides a large amount of data, is directly the method for scientific research data and still lack at present ripe direct applying electronic medical record information.
Along with the development of clinical research, researcher recognizes gradually, and the conclusion that traditional control test draws is not explained situation about occurring under clinical practice condition, is necessary to carry out the real world research based on clinical practice.Real world is studied as a kind of new research form, and the form of its clinical implementation is more complicated, opening Design, and intervening measure is unfixing, and study subject is in extensive range, and intervention effect is uncertain, and the data volume that research produces is large.But what there is no at present that a kind of technology solves scientific research data based on clinical practice obtains, synthesizes, gathers the difficult problem facing.
The quality of data of research has determined the universality of clinical research result.At present, clinical data source is based upon on the basis of craft and papery, because the generation of data is hand-written cases of clinician, by data message obtain, gather, transmit, inspection, feedback system be all static, artificial disturbing factor is more, easily forms the bias of result of study.At present, there is no a kind of technology and can reduce the human factor in clinical research process, upper minimizing human factor causes the bias of result to greatest extent.
In clinical practice, the data message source of medical treatment is different, as: the data of electronic health record record, hospital HIS system, LIS system, PACS system, in traditional clinical research process, gathering of these data needs people for making a copy of, need cost manpower energetically, also increase the probability of mistake simultaneously.Simultaneously clinical data is because medical institutions are in Samples detection process, may be due to the instrument difference detecting, or same class instrument model difference, the reagent manufacturing enterprise of detecting under same model instrument is not equal, or same reagent adopts not square one of standard.Before and after so can having formed the same class data that different detection methods cause, twice testing result is inconsistent, and the same period, the widely different problem of numerical value detects in different research units.The difference of data, causes research not merge and to contrast, and has affected data Macro or mass analysis, and existing scientific research data are utilized in method can not solve the inconsistent problem of data.
Summary of the invention
The present invention seeks to realize electronic health record information and directly generate scientific research data message, solve clinical data because the same class data that different detection methods cause are inconsistent; Real world clinical research patient's secret protection; The problems such as scientific research data can not dynamically generate, data validity is poor.For erecting the bridge of a perforation between the clinical position the large-scale property practitioner of hospital and research work, realize clinical research and share.
In order to achieve the above object, technical scheme of the present invention has been to provide the scientific research data automatic creation system based on clinical data, comprising:
Front cover data generation module, has realized scientific research data CRF front cover data and has generated;
Data generation module before treating, treats front data as requirement to write, and has realized the data of course of disease data production scientific research first.
Make a house call and record generation module, with the requirement of making a house call of research approach design, by writing the record of making a house call:
Adverse events generation module, realized the record of adverse events and gathered:
MAR generation module, has realized the detailed record of drug combination;
HIS, LIS, PACS system data directly quote module, realized directly quoting and gather of HIS, LIS, PACS system;
Data gather and form production module, with data sheet, generate, gather and document print.
First, the present invention is for clinical large-scale medical institutions, can be according to scientific research demand data, take the data message of electronic health record and HIS system, LIS system, PACS system data as source data, as patient's essential information, the information such as not no in age, sex, nationality, wedding, first the course of disease, inscribe disease, past medical history, obsterical history, family history, allergies etc., physical examination, progress note, fox message, the summary of leaving hospital, inspection detection etc., require to generate scientific research data according to scientific research, synthesizes and gather generation scientific research document function.
Secondly, because the content of clinical research is different with object, the emphasis that data is obtained is variant.The present invention adopts the design of format masterplate in design, according to ICH, WHO and the requirement of the relevant rules of SFDA to CRF data, in order to meet scientific research data integrity, stipulated the required framework of scientific research data, in the time of these software systems of application, can need to have been adjusted concrete data message according to research.For the data from HIS system, LIS system, PACS system, in the process of Reference source data, record standard value; In order to scientific research data are final, convert and contrast.
Finally, in electronic health record information, not for adverse events record, the present invention generates the mode of employing and medical history record line item to adverse events data, guarantees, in normal medical history record, in scientific research data generating procedure, to generate adverse events record.
Maintenance data of the present invention extracts and conversion method, by knowledge reorganization pattern, has realized the automatic generation of the clinical research data based on medical case data, realize sharing of medical treatment and scientific research, save the plenty of time, realized the dynamic generation of scientific research data, improved quality of research.
Accompanying drawing explanation
Fig. 1 is the frame diagram that is applicable to computer processing system of the present invention;
Fig. 2 workflow diagram of the present invention.
Embodiment:
Below in conjunction with example, illustrate the present invention.Should be understood that these examples are only for illustrating of the present invention and being not limited to scope of the present invention.In addition should be understood that reading after the present invention lectures content, those skilled in the art can according to demand, modify or change the present invention, but the change of the equivalent form of value and revising falls within claim and this book limited range described in the application equally.
The scientific research data that the present invention is to provide based on electronic health record generate software systems.
Take the data of clinical structured electronic patient record, HIS system, LIS system, PACS system as data source, the information such as not no in: age, sex, nationality, wedding in: patient's essential information, first the course of disease, inscribe disease, past medical history, obsterical history, family history, allergies etc., physical examination, doctor's advice information, progress note, leave hospital and sum up and fox message (comprising laboratory examination, PACS systems inspection) etc., by the reconstructing method of knowledge, generate clinical research data.
Be according to the requirement of scientific research scheme, realized the generation of scientific research data Periodical front cover informations;
Be according to the requirement of scientific research scheme, realized the data before electronic health record course of disease Information generation treatment first;
Be according to the requirement of making a house call of research approach design, realized the prompting of make a house call record data production and time window;
Be, according to scientific research requirement, realized the record of adverse events and gathered;
Be, according to HIS system doctor's advice information, to have realized the complete documentation of MAR;
Be according to scientific research data demand, the data that to have realized LIS, PACS system be source data are directly quoted;
Be according to scientific research data demand, realized that data gather, form produces and document print.
The Data Source of the scientific research data automatic creation system based on clinical data provided by the invention also comprises the source data from HIS system, PACS system, LIS system, and open system interface is the guarantee of Data Source.Described interface is configurable open interface, and described data pick-up is at electronic health record terminal, by what carry out in LAN (Local Area Network) (hospital internal net), can not directly access internet.
The present invention can realize in the medical institutions that realize information system management, and required hardware is such as application server, HIS system, PACS system, LIS system, electronic medical record system, data storage device, Database Systems, network interface etc.Computer platform also comprises operating system and its instruction code.The instruction code here comprises researcher's username and password.In addition can pass through LAN (Local Area Network) (hospital internal net) by native system and and other system docking.Also can be by peripherals such as printer, data storage device is realized data-printing and derivation.
Fig. 1 is the computer system frame diagram of native system, and this system comprises basal layer 101, as application server, database, memory device, the network equipment; Data Layer 102, as HIS system data, PACS system data, LIS system data, electronic medical record system data; Supporting layer 103, as equipment interface, access controller, storage administration etc.; Application layer 104 i.e. the scientific research data automatic creation system based on clinical data.Various peripherals is as display device, keyboard and mouse etc.What it should be noted that computer system is that independently LAN (Local Area Network) (hospital internal net) is connected, and the network equipment is connecting Internet directly.Particularly, exactly in the medical institutions that have been equipped with information-based pacing items, take electronic health record, HIS system, LIS system, PACS system data as source data, by supports such as equipment interface, access controllers, the scientific research data automatic creation system of application based on clinical data.
The data source of scientific research data as shown in Figure 2, is from electronic health record, LIS system, HIS system, PACS system two parts.The Periodical front cover information of scientific research data generates by front cover data and generates 111 modules realizations, before treatment, data generates by treating front data and generates 211 modules realizations, the record data of making a house call generate by the record of making a house call and generate 311 modules realizations, adverse events data recording generates by adverse events and generates 411 modules realizations, MAR data generate 511 modules by MAR and realize, and synthesizing and gather by data of data synthesized and gathered 611 modules realizations.Wherein treat before data and make a house call record need fox message by LIS system data 101, PACS system data 102 by directly quoting realization; MAR and adverse events need MAR message part by reference HIS system data 103 realize.
As Fig. 2 illustrated scientific research data based on electronic health record source and reconstruct, now as an example of " clinical research of therapy of combing traditional Chinese and Western medicine Treating Stable Angina Pectoris of Coronary Artery Disease " example, its application process is described.
Data take electronic health record data as data source generate: as: patient's electronic health record is diagnosed as " coronary disease and angina pectoris ", researcher enables the scientific research data automatic creation system based on clinical data, according to patient be in hospital the large medical record information of case history enable front cover data generate 111, automatically generate the required front cover data message of scientific research data as patient's name, patient's numbering, researcher's name, research unit etc.
As: after scientific research Periodical front cover information completes, according to the large medical record information of being in hospital of electronic health record, as: name, sex, age while being admitted to hospital, national, marital status, native place, occupation, morbidity solar term, admission date and and course of disease information first, as: main suit is (as uncomfortable in chest in symptom, 7 years duration, breathe hard, continue 4 days), present illness history is (uncomfortable in chest, degree uncomfortable in chest, breathe hard, the degree of breathing hard etc.), physical examination, past medical history, personal history, family history, traditional Chinese medical science four methods of diagnosis information, as: corpulent tongue is large, small and wiry pulse, vital sign is as body temperature, pulse, breathe, blood pressure, Western medicine diagnose is as coronary disease and angina pectoris, tcm diagnosis is as the obstruction of qi in the chest, Qi deficiency blood stasis type etc., data information before the automatic generation treatment of data generation 211 before treating by startup.
As: after before treating, data completes, according to the requirement of making a house call of scientific research scheme, obtain the corresponding record data of being in hospital of electronic health record, as: cardinal symptom is as " uncomfortable in chest ", " breathing hard " and degree thereof, " the tongue picture " of the traditional Chinese medical science four methods of diagnosis, " pulse condition " information is as data source, by the startup record of making a house call, generated 311 and automatically generated the record data of making a house call.
As: as there being adverse events to occur in research process, as there is " diarrhoea " in patient's diagnosis and treatment process, poor starting event generates 411 separately, by record " diarrhoea " time of origin, processing mode, medication information, finally go through transition and filled in adverse events record and fill in, realized the generation of adverse events data.
If: the doctor's advice information of HIS system data 103 is as the data source of MAR, start MAR and generate 511, quote the medicine name of doctor's advice information, dosage, route of administration, doctor's advice time and fill in medication reason and realize the generation of MAR data.
As: before treating, data generation 211 and the record of making a house call generate 311 and need to quote LIS system data 101, PACS system data 102, as " routine blood test " can select to study the data that need by sql statement, as " white blood cell count(WBC) ", " red blood cell count(RBC) ", " haemoglobin ", " platelet count ", treats front data and makes a house call and look record data by selecting and being cited as, and realizes the automatic selection of LIS system data 101 and PACS system data 102 and quotes and gather.
Data are synthesized and gathered is after data generates, log-on data is synthetic and gather 611, by the front cover data of scientific research document, treat before data, the record of making a house call, adverse events, MAR, fox message be aggregated into the forms such as WORD, PDF, EXCEL, and realize and print item by item and gather printing.
Claims (2)
1. the scientific research data automatic creation system based on clinical data, it is characterized in that, system comprise front cover data generation module, treat before data generation module, make a house call record generation module, adverse events generation module, MAR generation module, HIS, LIS, PACS system data directly quotes module and data gather and form production module 7 submodules totally, wherein:
(1) front cover data generation module, has realized scientific research data CRF front cover data and has generated;
(2) treat front data generation module, to write, treat front data as requirement, realized the data of course of disease data production scientific research first;
(3) make a house call and record generation module, with the requirement of making a house call of research approach design, by writing the record of making a house call;
(4) adverse events generation module, has realized the record of adverse events and has gathered;
(5) MAR generation module, has realized the detailed record of drug combination;
(6) HIS, LIS, PACS system data are directly quoted module, have realized directly quoting and gather of HIS, LIS, PACS system;
(7) data gather and form production module, with data sheet, generate, gather and document print.
2. a kind of scientific research data automatic creation system based on clinical data as claimed in claim 1, it is characterized in that, this system is take clinical electronic health record as basis, having merged LIS system, HIS system, PACS system data is source data, can extract the essential informations such as age, sex, nationality, the wedding of patient in electronic health record be no, and first the course of disease, inscribe disease, past medical history, obsterical history, family history, allergies, physical examination, diagnosis, MAR, progress note, fox message, leave hospital document and the data such as summary.
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| CN105574355A (en) * | 2016-02-05 | 2016-05-11 | 西部天使（北京）健康科技有限公司 | Method and system for recording clinical scientific research data |
| CN105760667A (en) * | 2016-02-05 | 2016-07-13 | 西部天使（北京）健康科技有限公司 | Clinical observation table filling method and system |
| CN107154005A (en) * | 2016-03-03 | 2017-09-12 | 南京理工大学 | Shield calling system in examination ＆ verification based on intelligent drugstore |
| CN107220476A (en) * | 2017-04-06 | 2017-09-29 | 广州慧扬信息系统科技有限公司 | The statistical analysis system of medication effect |
| CN108133735A (en) * | 2016-11-30 | 2018-06-08 | 北京经纬传奇医药科技有限公司 | Clinical testing data collects transmission and analysis system outside a kind of research center |
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| CN114566247A (en) * | 2022-04-20 | 2022-05-31 | 浙江太美医疗科技股份有限公司 | Automatic CRF generation method and device, electronic equipment and storage medium |
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Cited By (16)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105574355B (en) * | 2016-02-05 | 2018-05-08 | 西部天使（北京）健康科技有限公司 | The recording method of clinical research data and system |
| CN105760667A (en) * | 2016-02-05 | 2016-07-13 | 西部天使（北京）健康科技有限公司 | Clinical observation table filling method and system |
| CN105574355A (en) * | 2016-02-05 | 2016-05-11 | 西部天使（北京）健康科技有限公司 | Method and system for recording clinical scientific research data |
| CN105760667B (en) * | 2016-02-05 | 2018-12-28 | 西部天使（北京）健康科技有限公司 | A kind of filling method and system of clinical observation table |
| CN107154005B (en) * | 2016-03-03 | 2020-10-20 | 南京理工大学 | Checking, screen-loading and number-calling system based on intelligent pharmacy |
| CN107154005A (en) * | 2016-03-03 | 2017-09-12 | 南京理工大学 | Shield calling system in examination ＆ verification based on intelligent drugstore |
| CN108133735A (en) * | 2016-11-30 | 2018-06-08 | 北京经纬传奇医药科技有限公司 | Clinical testing data collects transmission and analysis system outside a kind of research center |
| CN108461110A (en) * | 2017-02-21 | 2018-08-28 | 阿里巴巴集团控股有限公司 | Medical information processing method, device and equipment |
| CN108461110B (en) * | 2017-02-21 | 2021-07-23 | 阿里巴巴集团控股有限公司 | Medical information processing method, device and equipment |
| CN107220476A (en) * | 2017-04-06 | 2017-09-29 | 广州慧扬信息系统科技有限公司 | The statistical analysis system of medication effect |
| CN107220476B (en) * | 2017-04-06 | 2020-08-11 | 广州慧扬健康科技有限公司 | Statistical analysis system for drug treatment effect |
| CN109542966A (en) * | 2018-11-09 | 2019-03-29 | 金色熊猫有限公司 | Data fusion method, device, electronic equipment and computer-readable medium |
| 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 |
| CN111739594A (en) * | 2020-04-09 | 2020-10-02 | 卫宁健康科技集团股份有限公司 | Method and system for acquiring clinical scientific research data |
| CN111739594B (en) * | 2020-04-09 | 2021-06-04 | 卫宁健康科技集团股份有限公司 | Method and system for acquiring clinical scientific research data |
| CN114566247A (en) * | 2022-04-20 | 2022-05-31 | 浙江太美医疗科技股份有限公司 | Automatic CRF generation method and device, electronic equipment and storage medium |
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