CN107978374A - A kind of researcher's compliance computer measurement and control method in clinical research - Google Patents
A kind of researcher's compliance computer measurement and control method in clinical research Download PDFInfo
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Abstract
The invention discloses a kind of researcher's compliance computer measurement and control method in clinical research, including following content：Establish a kind of various dimensions observing and controlling and the scientific hypothesis of the method and apparatus of evaluation study person's compliance, including the key scientific problems for determining goal in research, determining research contents and intending to solve；Intend research approach and the feasibility analysis taken.Researcher's compliance computer measurement and control method in clinical research of the present invention, clinical test, introduce face recognition technology evaluation and the authenticity of observing and controlling researcher and patient and security integrality, ensure that clinical test quality is true and reliable, by including the relevant basic clinical data with making clinical research, warning index is obtained for clinical research and provides material evidence for clinical evaluation, make the raising of Clinical Research Quality, largely avoid relying in good researcher's compliance, researcher's compliance is improved, the authenticity and reliability of clinical research can be improved.
Description
Technical field
The present invention relates to a kind of clinical research computer measurement and control method, researcher complies with more particularly to a kind of clinical research
Property computer measurement and control method.
Under the international guiding of drug market, the trend of globalization and the general layout of medicament research and development gradually form, global synchronization
The quantity for carrying out clinical test increases rapidly, under the promotion of this trend, Chinese Clinical Trial rapid development, with medicine
Global R＆D process, more and more clinical tests of internationalizing are carried out in China, and the quality of Chinese Clinical Trial research is also just
By whole world extensive concern.Clinical drug research be medicine from researching and developing to producing, the important step of list marketing, be for the mankind
Solve the principal element of disease puzzlement.And the quality of clinical drug research be then behind marketing drugs the mankind take medicine effectively with
The principal security of safety.Since the clinical test cycle is longer, process quality control scope is wide, and difficulty is big, it is difficult to clinical test
Quality is effectively controlled.
The guideline that " disease combines, and side's card is corresponding " is studied and put into practice as evidence-based tcm clinical[15], while be
Doctor's clinical trial investigator proposes the requirement of higher.Most decoctions, Chinese patent drug are verified not only to disease, or even needs pair
Subject is carried out to demonstrate,prove the classification of system disease[16], improve the operation difficulty of a line researcher.In terms of diagnosis, researcher except
Outside with reference to doctor trained in Western medicine deagnostic test, it is also necessary to the syndrome of patient is judged by traditional four methods of diagnosis method, to decide whether to receive
Enter research.The understanding of this subjectivity suffers from the factor shadows such as horizontal researcher, medical treatment custom, attitude toward research and reception time
Ring, there is sizable uncertainty.In terms of therapeutic evaluation, tcm clinical experimental design answers the terminal of existing doctor trained in Western medicine to refer to
Mark, physical and chemical index, also comprising tcm syndrome the effect of terminal[17]Observe and measure, it is necessary to which researcher implements dynamic, and not only
It is in corresponding time window dispensing medicament.The raising of TCM clinical study quality, largely still relies on good researcher
Compliance.
According to it is existing inspection, inspection experience, we summarize tcm clinical experiment in researcher's compliance some
Deficiency：First, only relying on the selection of medicine indication without dialectical, often there is a large amount of " unknown " in syndrome one in CRF tables；Second,
The four methods of diagnosis are not in place, and tongue picture, pulse condition, symptom are not inconsistent with actual patient situation after original of tracing back, " without be card and with the side of being "；Third, overstate
The soft quota curative effect of big traditional Chinese medical science intervention, it is impossible to report strictly according to the facts on qualitative evaluations such as life quality, subjective feeling and symptom improvement
Index；Fourth, experiment branch center lacks traditional Chinese physician, doctor of Western medicine only judges the row of receiving of subject by trial drug specification, stiff
Indiscriminately imitate course for the treatment of scheme in ground.Particularly in security Centralizing inspection, due to cooperation unit, researcher selection and train it is not in place,
The deficiency of researcher's compliance causes the irrational use of Chinese medicine on the contrary.The implementation and education of dialectical treatmert in being tested due to the traditional Chinese medical science
Because being known as substantial connection, simple education and short time training can not make the researcher of qualification deficiency for experience, work limit etc.
Grasp tcm diagnosis and differentiate technical ability, it is also difficult to supervise the clinic diagnosis that the researcher for possessing qualified qualification brings into normal play horizontal.Cause
This, the observing and controlling of Chinese Traditional Herbs Drug Clinical Testing researcher's compliance is the main problem faced at this stage.
The content of the invention
Pass through the retrieval to existing patent document, it has been found that can not improve also the authenticity of clinical research with it is reliable
Property, improve researcher's compliance investigating method relevant report.
Solve the problems, such as that existing Clinical Research Quality depends on good researcher's compliance for this, the purpose of the present invention exists
In providing a kind of researcher's compliance computer measurement and control method in clinical research, can improve the authenticity of clinical research with it is reliable
Property, improve researcher's compliance, to solve the problems mentioned in the above background technology.
To achieve the above object, the present invention provides following technical solution：Researcher's compliance calculates in a kind of clinical research
Machine investigating method, including following content：
S1：The ways and means for determining goal in research are exactly the technology using face recognition so that the identity of patient and researcher
It is confirmed, information is accurate；
S2：Intend research approach and the feasibility analysis taken；
Preferably, the structure of the follow-up process investigating method of Part I includes the following steps in step S2：
S2-1：The preparation of problem working group, core work group is respectively by clinical research group, statistical research group, data acquisition group, meter
4 groups such as calculation machine development group undertake corresponding action respectively,
Clinical research group：Being aligned clinical research interview personnel are organized by clinical expert and postgraduate, according to subject's follow-up process
In the problem of being likely to occur, design flow table clause, the suggestion for revision and clinical implementation that screening expert proposes.
Statistical research group：By statistics and scale analysis composition of personnel, statistic analysis is mainly responsible for, including sample size is estimated
Calculate, scale reliability, validity calculates, Fuzzy comparisons and statistical analysis；
Data acquisition group：It is made of postgraduate, is mainly responsible for and relevant data acquisition is carried out to the data in subject's follow-up period
And manage and coordinate with the third-party institution；
Computer development group：Mainly multidimensional data acquisition platform is designed, is built, and technology branch is made to implementation process
Hold；
S2-2：Determine problem Integral Thought, the observing and controlling of clinical investigators compliance and evaluation method established by 3 working stages,
Evaluation and the procedure quality for improving researcher's clinical research, under the guidance of traditional Chinese medical science evidence-based medicine EBM theory, with reference to being ground in angina pectoris
The clinical characters for the person of studying carefully evaluate the compliance of researcher, so that the quality for reaching raising clinical test process study is same
Class research provides exemplary standard；
S2-3：Determine research approach；
S2-4：Feasibility analysis.
Preferably, the definite research contents of S1 includes：
S1-1：Computer and network technology based on portable medical technology develops multidimensional data observing and controlling instrument, and utilizes instrument pair
The authenticity of diagnosis and treatment during researcher's follow-up period carries out evaluation study and measures the frequency that researcher substitutes in experiment, ensures to face
The quality of bed research, protects the interests of subject；
S1-2：The development of the compliance observing and controlling instrument of traditional Chinese medical science Patients With Angina Pectoris, researcher based on scaling technique and reliability, effect
Degree, similarity evaluation research；
S1-3：Based on " researcher's compliance multidimensional observing and controlling evaluation ", Chinese medicine angina pectoris subjective clinical method build
It is vertical；
S1-4：Remote concentration inspection method observing and controlling researcher scheme based on risk inspection management performs compliance evaluation and grinds
Study carefully, remote concentration data management observing and controlling researcher's quality of data based on Oracle Clinical data management platforms is commented
Valency is studied.
Preferably, the key scientific problems intended to solve in S1 include：
1）Multidimensional observing and controlling instrument, which may determine that subject and researcher whether authenticity participates in clinic, during clinical research grinds
Study carefully follow-up process, the authenticity that measurement is participated in the control frequency that simultaneously measuring study person substitutes is complied with so as to reach traction researcher
Property the establishment of clinical research methods that improves be key scientific problems；
2）Offer clinical investigators/（Subject's follow-up process）What process quality control conceptual design and researcher's compliance were evaluated
Methodology demonstration is the important key scientific problems of this research.
Preferably, multidimensional data acquisition platform design and implementation of the first stage of step S2-3 based on portable medical technology
Including：
S2-3-1：Discovery, the differentiation of data validity in computer multidimensional data collection observing and controlling subject every dimension of follow-up period
With reorganizing research, including：1）Seminar identifies face in collector picture using android Integration ofTechnology face recognition technologies
In position, central point, eye spacing, the method for the face recognition technology of fundamental characteristics such as angle, identification follow-up period researcher's ginseng
With authenticity, calculate the frequency that researcher replaces and draw corresponding data, due to researcher people during concurrent follow-up now
For the human bias of independent subjective thought institute band；2）Seminar is identified using Android Integration ofTechnology tablet collectors sound intermediate frequency
Acquisition function the key words of subject and researcher during follow-up are subjected to information gathering and judge authenticity；3）Class
Topic group utilizes lingual diagnosis identification function in Android Integration ofTechnology tablet collectors, and the particularity of other information is examined according to the traditional Chinese medical science four methods of diagnosis
Multidate information in subject's follow-up is subjected to Image Acquisition and preserves related diagnosis and treatment data；4）Seminar utilizes Android technologies
Integrated fingerprint scanning recognition technology by researcher participate in follow-up real information be acquired, researcher confirm subject receive with
Need to carry out fingerprint identification after visit, improve the compliance that researcher participates in follow-up, improving subject indirectly participates in the true of follow-up
Property；
S2-3-2：Scaling technique design and research based on Delphi method；
S2-3-3：The carrier of Chinese medicine treatment angina pectoris researcher's compliance multidimensional investigating method based on portable medical technology is clinical
Research；
Preferably, step S2-4 feasibility analyses include：
1）Early-stage study is built on the rock, and method is feasible；
2）Computer theory is ripe with method, technical feasibility；
3）Cooperation unit's architecture is perfect, implements feasible；
4）Seminar's multi-crossed disciplines structure is reasonable, and personnel are feasible；
5）Subject study platform is perfect, and standard is feasible.
Preferably, the scaling technique design and research based on Delphi method of step S2-3-2 includes：
S2-3-2-1：The establishment of entry；
S2-3-2-2：Form primary election scale；
S2-3-2-3：Delphi Experts consultation method optimizes；
S2-3-2-4：Whole scale is formed and the inspection of letter validity.
Preferably, the second stage of step S2-3-3, Chinese medicine clinical investigators compliance multidimensional observation and control technology are ground with evaluation
Studying carefully experimental test part includes：
S2-3-3-1：Subject selects, and includes support center, diagnostic criteria, inclusive criteria, exclusion standard and the standard that comes off；
S2-3-3-2：Experimental design, including：
1）Experiment process：The subject of primary dcreening operation qualification will receive security inspection in screening and sign informed consent form；Medication
Phase A group subject takes compound danshen dripping pills+simulation 'Xue Fu Zhu Yu ' capsule, and B groups take 'Xue Fu Zhu Yu ' capsule+simulation compound Danshen Root
Dripping pill, medication terminate observation curative effect；Follow-up after 3 weeks, assists drug control person to provide by researcher's Control of Compliance group
Medicine；
2）Sample size is estimated：The main problem of non-research concern of validity comparison, according to default research scale and past experience
Design total sample size 60, every group 30；
3）Random and blind：Random using sequential encoding, blind bottom is sealed with lighttight envelope, is followed regular coding to be issued to and is ground
The person of studying carefully；
4）Drug combination：Maintained during experiment and record the original conventional western medicine treatment of patient, disable all promoting blood circulation class Chinese medicines, hair
It is spare to nitroglycerin lozenge；
5）Research stops：A. serious adverse reaction；B. sb.'s illness took a turn for the worse to take urgent measure；C. it is uncooperative；
6）Security, efficacy data are collected：Including entering security inspection when group and off-test, such as three is big conventional；Clothes
Chinese medicine syndrome integral, SAQ integrations, ECG change, coagulation function before and after medicine；And the data of the effect of after follow-up；
S2-3-3-3：The observing and controlling of researcher's compliance designs, and researcher's selection includes inclusive criteria and exclusion standard；
S2-3-3-4：Random Design, totally 30 researchers, every researcher are responsible for the inspection of 2 subjects, dialectical examine at random
Disconnected, dispensing, curative effect record and follow-up, while be three groups at random again by 30 researchers：Observing and controlling feedback group, observing and controlling feedback-less group
With simple measurement group, every group 10, during each interview, subject that researcher is responsible for also therewith again distribution enter this three
Group, performs the observing and controlling content of each group.Observing and controlling work is responsible for by RCG；
S2-3-3-5：Control design, for three observing and controlling groups after interview, researcher must fill in Self-assessment Scale, and subject is both needed to fill out
Researcher's evaluation charter is write, two deal tables all give RCG, including observing and controlling feedback group：More dimensions are carried out to the authenticity of subject
Fed back to according to collection, and by this compliance evaluation charter result to researcher, prompt researcher to carry out compliance corresponding
Change；Observing and controlling feedback-less group：Multidimensional data collection is carried out to the authenticity of subject, compliance evaluation result does not feed back to research
Person；Simple measurement group：Multidimensional data collection is not carried out to subject, subject does not use scale score；
S2-3-3-6：Compliance evaluating data gathers, including：
1）Researcher is responsible for evaluation charter, compares measurement feedback group with measuring scoring certainly for feedback-less group；Compare measurement feedback-less
Group scores certainly with simple measurement group；
2）Subject's objective evaluation scale, compares measurement feedback group with measuring the objective scoring of feedback-less group；Compare measurement without anti-
The objective scoring of feedback group and simple measurement group；
3）Subjective and objective scale similarity, compares similarity of each group certainly between scoring, objective scoring, evaluation study person's self-appraisal
Authenticity；
4）Mobile multidimensional gathered data, connects each other with each scale data, evaluation study person and subject's clinical practice behavior
Authenticity, calculates researcher in experiment and substitutes frequency；
S2-3-3-7：Statistical analysis.
Compared with prior art, the beneficial effects of the invention are as follows：Researcher's compliance computer measurement and control in this clinical research
Method, existing drug metabolic enzyme mediate active metabolite achievement in research on the basis of inquire into next step how by establish with
Based on evidence-based medicine EBM based on active metabolite evidence storehouse, identification evidence storehouse, traditional Chinese medical science individuation documented evidence storehouse multidimensional
Spend the thinking pattern in multi-layer network topology evidence storehouse.By including and the relevant basis for making Study of Medicinal Herbs and clinical number
According to, obtain warning index for clinical research and provide material evidence and foundation for clinical evaluation, make the raising of Clinical Research Quality,
Largely avoid relying in good researcher's compliance, improve researcher's compliance, the true of clinical research can be improved
Property and reliability.
Brief description of the drawings
The clinical investigators that Fig. 1 is the present invention comply with sex-related factors scale figure；
Fig. 2 is researcher's compliance observation and control technology of the present invention and clinical carrying test method route map；
Fig. 3 is the group structure block diagram of the present invention.
Embodiment
Below in conjunction with the attached drawing in the embodiment of the present invention, the technical solution in the embodiment of the present invention is carried out clear, complete
Site preparation describes, it is clear that described embodiment is only part of the embodiment of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, those of ordinary skill in the art are obtained every other without making creative work
Embodiment, belongs to the scope of protection of the invention.
- 3 are please referred to Fig.1, a kind of researcher's compliance computer measurement and control method in clinical research, including following content：
S1：The ways and means for determining goal in research are exactly the technology using face recognition so that the identity of patient and researcher
It is confirmed, information is accurate；This research makes full use of modern science and technology, in the mistake that nonintervention researcher normally studies
Cheng Zhong, establishes the instrument and evaluation method of the classification quality observing and controlling of researcher's compliance.It was found that researcher complies with clinical studies
Property control it is bad the reason for, and comply with property amount for the great chronic disease clinical research observing and controlling researcher of other Chinese medicines and carry
For using for reference.Research contents includes the computer and network technology based on portable medical technology and develops multidimensional data observing and controlling instrument, and
Evaluation study is carried out to the authenticity of diagnosis and treatment during researcher's follow-up period using instrument and measures what researcher in experiment substituted
Frequency, ensures the quality of clinical research, protects the interests of subject；Traditional Chinese medical science Patients With Angina Pectoris based on scaling technique, researcher
Compliance observing and controlling instrument development and reliability, validity, similarity evaluation research；Based on " researcher's compliance multidimensional observing and controlling is commented
Valency ", Chinese medicine angina pectoris subjective clinical method foundation；Remote concentration inspection side based on risk inspection management
Method observing and controlling researcher scheme performs compliance evaluation study, the remote centralized based on Oracle Clinical data management platforms
Change the evaluation study of data management observing and controlling researcher's quality of data.The key scientific problems intended to solve include 1）In clinical research
Multidimensional observing and controlling instrument may determine that whether authenticity participates in clinical research follow-up process, measurement and control to subject with researcher in journey
The frequency of the authenticity participated in and measuring study person replacement is made so as to reach the clinical research side that traction researcher compliance improves
The establishment of method is key scientific problems, solves method：Android integrated approaches are introduced based on portable medical technology, integrate face
Fuzzy recognition technology, fingerprint identification technology, audio frequency identification technique, establish authenticity observation and control technology, utilizes multi-dimensional data observing and controlling
The information that researcher in clinical studies participates in clinical research is captured, by the researcher participated in advance and subject's multidimensional information number
According to binding, and the frequency that measuring study person substitutes, ensure observing and controlling information can the validity that participates in of true image study person with it is true
Property.2）Offer clinical investigators/（Subject's follow-up process）What process quality control conceptual design and researcher's compliance were evaluated
Methodology demonstration is the important key scientific problems of this research, solves method：Establish the scale score based on Delphi method and phase
Want what is combined like degree comparison techniques and tcm diagnosis（Traditional Chinese medical science angina pectoris）MMCRO is reported, carries out reliability, validity, similarity analysis
Evaluation and clinical applicability checking research.
S2：The research approach and feasibility analysis, the structure of the follow-up process investigating method of Part I that plan is taken include
Following steps：S2-1：The preparation of problem working group, core work group is respectively by clinical research group, statistical research group, data acquisition
4 groups such as group, computer development group undertake corresponding action, clinical research group respectively：By clinical expert and postgraduate
Group being aligned clinical research interview personnel, the problem of according to being likely to occur during subject's follow-up, design flow table clause, screening
The suggestion for revision and clinical implementation that expert proposes.Statistical research group：By statistics and scale analysis composition of personnel, statistics is mainly responsible for
Work is analyzed, including sample size estimation, scale reliability, validity calculate, Fuzzy comparisons and statistical analysis.Data acquisition group：By grinding
Study carefully raw composition, be mainly responsible for and the data in subject's follow-up period are carried out with relevant data acquisition and management and and the third-party institution
Coordinate.Computer development group：Mainly multidimensional data acquisition platform is designed, is built, and technology branch is made to implementation process
Hold.S2-2：Determine problem Integral Thought, establish the observing and controlling of clinical investigators compliance and evaluation method by 3 working stages, comment
Valency and the procedure quality for improving researcher's clinical research.Under the guidance of traditional Chinese medical science evidence-based medicine EBM theory, with reference to being studied in angina pectoris
The clinical characters of person evaluate the compliance of researcher, so that the quality for reaching raising clinical test process study is similar
Research provides exemplary standard.S2-3：Determine research approach, multidimensional data collection of the first stage based on portable medical technology
Platform Designing includes with implementation：Data validity in a computers multidimensional data collection observing and controlling subject every dimension of follow-up period
It was found that, differentiate and reorganizing research, research purpose：Establish a kind of being ground suitable for TCM clinical study based on portable medical technology
The person's of studying carefully compliance computer measurement and control method, research method include：1）Seminar uses android Integration ofTechnology face recognition technologies
Identify the side of the face recognition technologies of fundamental characteristics such as position of the face in collector picture, central point, eye spacing, angle
Method.Identify the authenticity that follow-up period researcher participates in, calculate the frequency that researcher replaces and draw corresponding data, concurrently now with
By the human bias of the artificial independent subjective thought institute band of researcher during visit；2）Seminar utilizes Android Integration ofTechnologies
The acquisition function of tablet collector sound intermediate frequency identification is by subject and key words of the researcher during follow-up into row information
Gather and judge authenticity, for example, to medication situation, body-feeling, whetheing there is the emphasis vocabulary situation such as adverse events and recording
And judge to draw related data.Not only Clinical Follow-up event had been recorded, but also the contradiction between doctors and patients can be solved；3）Seminar's profit
With lingual diagnosis identification function in Android Integration ofTechnology tablet collectors, the particularity that other information is examined according to the traditional Chinese medical science four methods of diagnosis will be tested
Multidate information carries out Image Acquisition and preserves related diagnosis and treatment data in person's follow-up；4）Seminar is referred to using Android Integration ofTechnologies
The real information that researcher is participated in follow-up by line scanning recognition technology is acquired, and researcher confirms that subject needs after receiving follow-up
Fingerprint identification is carried out, the compliance that researcher participates in follow-up is improved, improves the authenticity that subject participates in follow-up indirectly.B bases
In the scaling technique design and research of Delphi method, including 1）The establishment of entry, research purpose：This stage is studied by third party's matter
Control office member designs and establishes subject respectively, researcher evaluates subjective guideline measurement entry pond；Research method：Design
Feature of the entry pond using traditional Chinese medical science four methods of diagnosis information as theoretical foundation combination patient with angina pectoris forms structure, is wrapped in the dialectical information of the four methods of diagnosis
The comprehensive of entry is screened in the corresponding dialectical information of syndrome of blood stasis containing angina pectoris, guarantee.Take literature research, expert interviewing at the same time
The methods of enrich entry pond content.Subject assessment's report database, researcher's self-appraisal report database, third party are established respectively
Measured database；2）Form primary election scale, research purpose：Literature query result is formed into the scale for clinical trial；Research
Method：Seminar's internal staff's reference patient in the course of the research retouches the level of understanding and the content of execution degree of research with doctor
State, according to literature search query entries as a result, discussing screening defined amount table clause, the form of definite response, forms primary election amount
Table；3）Delphi Experts consultation method optimizes, research purpose：The primary election scale formed by Delphi method optimization, raising amount
The feasibility of table.Research method：Consulting traditional Chinese and western medicine angina pectoris domain expert 30 in nationwide is invited, to the amount preliminarily formed
Table clause carries out the back-to-back entry screening of 4 wheels, re-scheduling and supplement；4）Whole scale is formed and the inspection of letter validity, research purpose：
Scale after will be optimized, forms researcher/patient and selects scale eventually respectively, and reliability, the effect of scale are examined by data detection
Degree.Research method：Traditional Chinese and western medicine angina pectoris domain expert 50 is selected, fills in researcher's scale.100 patient with angina pectoris of selection are filled out
Write subject's scale.The reliability of the two scales is measured using split half reliability, Cronbach α etc., using principal component analysis
The methods of method, factor analysis measurement validity.By believing the inspection of validity, further optimize entry, so as to form end
Scale.The carrier clinical research of Chinese medicine treatment angina pectoris researcher compliance multidimensional investigating methods of the c based on portable medical technology,
Form the exemplary investigation of the method for " survey-control " researcher's compliance.Research method：This carrier test is using random, double blinding, double
Parallel control design method is simulated, undergoes screening（1 week）, medication period（2 weeks）And follow-up period（Three weeks）, which includes
Need researcher to implement in general clinical test, the key link of measurement, portable medical data acquisition technology is introduced, in order to grinding
Manipulation of the person of studying carefully to implementation process, is standardized process link, can improve the authenticity and reliability of clinical research, and second
Stage, Chinese medicine clinical investigators compliance multidimensional observation and control technology include with evaluation study experimental test part：
（1）Subject selects, and includes support center, diagnostic criteria, inclusive criteria, exclusion standard and the standard that comes off, inclusive criteria
Meet coronary heart disease for a. and stablize I-III grade of diagnosis of labor angina；B. Chinese medical discrimination category syndrome of blood stasis person；C. the age<70 years old；d.
Liver, kidney, coagulation function are normal；E. informed consent form is signed；Exclusion standard includes IV grade of a. heart functions（NYHA is classified）B. merge
Severe arrhythmia, such as paroxysmal supraventricular tachycardia/room speed, atrial fibrillation/room are flutterred, third degree A-V block.C. myocarditis, cardiac muscle
Other cardiac disorders such as after disease, valve lesion, stenting.D. with the patient of the non-cardiovascular event such as malignant tumour, mental disease.
E. gestation or preparation gravid woman, women breast-feeding their children.F. there is hemorrhagic tendency Disease.G. to trial drug allergy sufferers；Come off
It is poor that standard includes a. compliances.B. serious bad hair should, complication.C. the Force Majeure cause such as resettlement, disaster.
（2）Experimental design, including：
1）Experiment process：The subject of primary dcreening operation qualification will receive security inspection in screening and sign informed consent form；Medication
Phase A group subject takes compound danshen dripping pills+simulation 'Xue Fu Zhu Yu ' capsule, and B groups take 'Xue Fu Zhu Yu ' capsule+simulation compound Danshen Root
Dripping pill, medication terminate observation curative effect；Follow-up after 3 weeks.Drug control person is assisted to provide by researcher's Control of Compliance group
Medicine；
2）Sample size is estimated：The main problem of non-research concern of validity comparison, according to default research scale and past experience
Design total sample size 60, every group 30；
3）Random and blind：It is random using sequential encoding.Blind bottom is sealed with lighttight envelope, is followed regular coding to be issued to and is ground
The person of studying carefully；
4）Drug combination：Maintained during experiment and record the original conventional western medicine treatment of patient, disable all promoting blood circulation class Chinese medicines.Hair
It is spare to nitroglycerin lozenge；
5）Research stops：A. serious adverse reaction.B. sb.'s illness took a turn for the worse to take urgent measure.C. it is uncooperative；
6）Security, efficacy data are collected：Including entering security inspection when group and off-test, such as three is big conventional；Clothes
Chinese medicine syndrome integral, SAQ integrations, ECG change, coagulation function before and after medicine；And the data of the effect of after follow-up.
（3）The observing and controlling of researcher's compliance designs, and researcher's selection includes inclusive criteria and exclusion standard；1）Inclusive criteria bag
Include a. worry（It is interior）Section traditional Chinese physician；B. attending doctor and above academic title, have certain coronary heart disease diagnosis and treatment experience；C. clinic grinds
Study carefully experience（Or trained by GCP）；2）Exclusion standard includes a. and lacks time reception subject.B. cannot be distinguished by tongue, arteries and veins etc.
Demonstrate,prove diagnosis person.
（4）Random Design, totally 30 researchers, every researcher be responsible at random the inspection of 2 subjects, syndrome differential diagnosis,
Dispensing, curative effect record and follow-up.It is at the same time three groups at random again by 30 researchers：Observing and controlling feedback group, observing and controlling feedback-less group and
Simple measurement group, every group 10.During each interview, also distribution enters this three groups to the subject that researcher is responsible for again therewith,
The observing and controlling content of each group is performed, observing and controlling work is responsible for by RCG；
（5）Control design, for three observing and controlling groups after interview, researcher must fill in Self-assessment Scale, and subject is both needed to fill in research
Person's evaluation charter, two deal tables all give RCG, including observing and controlling feedback group：Multidimensional data collection is carried out to the authenticity of subject,
And feed back to this compliance evaluation charter result to researcher, prompt researcher to carry out compliance and change accordingly；Survey
Control feedback-less group：Multidimensional data collection is carried out to the authenticity of subject, compliance evaluation result does not feed back to researcher；Merely
Measurement group：Multidimensional data collection is not carried out to subject, subject does not use scale score.
（6）Compliance evaluating data gathers, including：
1）Researcher is responsible for evaluation charter, compares measurement feedback group with measuring scoring certainly for feedback-less group；Compare measurement feedback-less
Group scores certainly with simple measurement group.
2）Subject's objective evaluation scale, compares measurement feedback group with measuring the objective scoring of feedback-less group；Compare measurement
The objective scoring of feedback-less group and simple measurement group.
3）Subjective and objective scale similarity, compares each group from the similarity between scoring, objective scoring, evaluation study person is certainly
The authenticity commented.
4）Mobile multidimensional gathered data, connects each other with each scale data, evaluation study person and subject's clinical practice row
For authenticity, calculate experiment in researcher substitute frequency.
（5）Statistical analysis.
S2-4：Feasibility analysis；
1）Early-stage study is built on the rock, and method is feasible：By project study early period, this research team is to researcher's compliance
Research has certain knowledge accumulation, and the basic skills for establishing researcher's compliance observing and controlling, hair have been grasped with analysis by summarizing
Table researcher's compliance related article 2；
2）Computer theory is ripe with method, technical feasibility：Computer portable medical technology is applied to multiple ambits, state
Outer medical domain has application to clinical experimental study and obtains highly recognition.The research approach that this technology possesses maturation is opened with software
Hair technology, the advanced experience of this research team foreign, the characteristics of research with reference to tcm clinical, by computer portable medical
Technology introduces compliance evaluation study observation and control technology, completes this subject study；
3）Cooperation unit's architecture is perfect, implements feasible：This research team and The First Affiliated Hospital of Tianjin University of Traditional Chinese Medic, day
There is multinomial national problem cooperative relationship in Baokang hospital of Tianjin university of TCM.Liang Jia hospitals researcher is abundant, and participates in multinomial class
Topic research, there is abundant clinical test experience, can meet needed for the research of this topic experiment；
4）Seminar's multi-crossed disciplines structure is reasonable, and personnel are feasible：Problem group membership structure is reasonable, and it is special that member includes clinical evaluation
Family, clinical cardiovascular and cerebrovascular expert, statistical analysis expert, computer development engineer and several doctors, Master degree candidate；
5）Subject study platform is perfect, and standard is feasible：Possess the clinical testing data management platform for meeting international standard for this
The data management of problem is studied with risk inspection, ensures the true and reliable of data.
To sum up study, seminar and through possessing the study condition needed for this subject study design and implementation, technical force
Relatively strong, structure of personnel is reasonable, possesses abundant Research Literature as research work theoretical foundation, it is contemplated that can complete according to plan.
The characteristic and innovation of the present invention：
1. the observation and control technology based on scale：Shown according to amount of literature data research, the growth of adjoint whole world clinical test quantity,
The quality of clinical test process management is but constantly declining, and the wherein bad influence to clinical test process of researcher's compliance is
One of very important factor, is the problem in science for being badly in need of solving.Current clinical research manages researcher's compliance usual
Using the pattern of training and education, this mode is no doubt to solve one of bad method of researcher's compliance, but with clinic
The increase of test period, the compliance of researcher cannot obtain guarantee lasting for a long time, must influence the quality of clinical test.Mesh
Preceding clinical research also lacks the method evaluated the compliance of researcher and research.It is external that researcher's compliance is evaluated
Document it is very abundant, it was also proposed that researcher's compliance is more to research by sincerity tissue to the importance of clinical research
The evaluation of person individual.
2. the observation and control technology based on portable medical：Built by advanced network mobility techniques and Software for Design development technique
Researcher's compliance evaluates monitoring platform.Portable medical technology abroad popularized very much by application, is a maturation and perfect
Technology.
3. researcher's compliance experimental design：Carry out a perspective small clinical trials, design studies person's clinical research
During compliance evaluate measuring method.The method needs to carry out blind design to researcher and carries out the survey of compliance feedback
Amount.
4. centralization inspection and centralization data management：By the inspection of centralization risk with centralization data-management application in grinding
One of the person's of studying carefully compliance evaluation quality control method means, for improving researcher's compliance.
In conclusion researcher's compliance computer measurement and control method in clinical research proposed by the present invention, in existing medicine
How inquired into next step by establishing based on evidence-based medicine EBM on the basis of metabolic enzyme mediation active metabolite achievement in research
The think of based on active metabolite evidence storehouse, the various dimensions multi-layer network topology evidence storehouse in traditional Chinese medical science individuation documented evidence storehouse
Road pattern.By including the relevant basic and clinical data with making Study of Medicinal Herbs, warning index is obtained for clinical research,
And material evidence is provided for clinical evaluation, make the raising of Clinical Research Quality, largely avoid relying in good research
Person's compliance, improves researcher's compliance, can improve the authenticity and reliability of clinical research.
The foregoing is only a preferred embodiment of the present invention, but protection scope of the present invention be not limited thereto,
Any one skilled in the art the invention discloses technical scope in, technique according to the invention scheme and its
Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (8)
1. a kind of researcher's compliance computer measurement and control method in clinical research, it is characterised in that including following content：
S1：The ways and means for determining goal in research are exactly the technology using face recognition so that the identity of patient and researcher
It is confirmed, information is accurate；
S2：Intend research approach and the feasibility analysis taken；
Researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 1, it is characterised in that step
The structure of the follow-up process investigating method of Part I includes the following steps in S2：
S2-1：The preparation of problem working group, core work group is respectively by clinical research group, statistical research group, data acquisition group, meter
4 groups such as calculation machine development group undertake corresponding action respectively,
Clinical research group：Being aligned clinical research interview personnel are organized by clinical expert and postgraduate, according to subject's follow-up process
In the problem of being likely to occur, design flow table clause, the suggestion for revision and clinical implementation that screening expert proposes.
2. statistical research group：By statistics and scale analysis composition of personnel, statistic analysis is mainly responsible for, including sample size is estimated
Calculate, scale reliability, validity calculates, Fuzzy comparisons and statistical analysis；
Data acquisition group：It is made of postgraduate, is mainly responsible for and relevant data acquisition is carried out to the data in subject's follow-up period
And manage and coordinate with the third-party institution；
Computer development group：Mainly multidimensional data acquisition platform is designed, is built, and technology branch is made to implementation process
Hold；
S2-2：Determine problem Integral Thought, the observing and controlling of clinical investigators compliance and evaluation method established by 3 working stages,
Evaluation and the procedure quality for improving researcher's clinical research, under the guidance of traditional Chinese medical science evidence-based medicine EBM theory, with reference to being ground in angina pectoris
The clinical characters for the person of studying carefully evaluate the compliance of researcher, so that the quality for reaching raising clinical test process study is same
Class research provides exemplary standard；
S2-3：Determine research approach；
S2-4：Feasibility analysis.
3. researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 1, it is characterised in that S1
Definite research contents include：
S1-1：Computer and network technology based on portable medical technology develops multidimensional data observing and controlling instrument, and utilizes instrument pair
The authenticity of diagnosis and treatment during researcher's follow-up period carries out evaluation study and measures the frequency that researcher substitutes in experiment, ensures to face
The quality of bed research, protects the interests of subject；
S1-2：The development of the compliance observing and controlling instrument of traditional Chinese medical science Patients With Angina Pectoris, researcher based on scaling technique and reliability, effect
Degree, similarity evaluation research；
S1-3：Based on " researcher's compliance multidimensional observing and controlling evaluation ", Chinese medicine angina pectoris subjective clinical method build
It is vertical；
S1-4：Remote concentration inspection method observing and controlling researcher scheme based on risk inspection management performs compliance evaluation and grinds
Study carefully, remote concentration data management observing and controlling researcher's quality of data based on Oracle Clinical data management platforms is commented
Valency is studied.
4. researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 1, it is characterised in that S1
In the key scientific problems that intend to solve include：
1）Multidimensional observing and controlling instrument, which may determine that subject and researcher whether authenticity participates in clinic, during clinical research grinds
Study carefully follow-up process, the authenticity that measurement is participated in the control frequency that simultaneously measuring study person substitutes is complied with so as to reach traction researcher
Property the establishment of clinical research methods that improves be key scientific problems；
2）Offer clinical investigators/（Subject's follow-up process）What process quality control conceptual design and researcher's compliance were evaluated
Methodology demonstration is the important key scientific problems of this research.
5. researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 2, it is characterised in that step
Multidimensional data acquisition platform design and implementation of the first stage based on portable medical technology of rapid S2-3 includes：
S2-3-1：Discovery, the differentiation of data validity in computer multidimensional data collection observing and controlling subject every dimension of follow-up period
With reorganizing research, including：1）Seminar identifies face in collector picture using Android Integration ofTechnology face recognition technologies
In position, central point, eye spacing, the method for the face recognition technology of fundamental characteristics such as angle, identification follow-up period researcher's ginseng
With authenticity, calculate the frequency that researcher replaces and draw corresponding data, due to researcher people during concurrent follow-up now
For the human bias of independent subjective thought institute band；2）Seminar is identified using Android Integration ofTechnology tablet collectors sound intermediate frequency
Acquisition function the key words of subject and researcher during follow-up are subjected to information gathering and judge authenticity；3）Class
Topic group utilizes lingual diagnosis identification function in Android Integration ofTechnology tablet collectors, and the particularity of other information is examined according to the traditional Chinese medical science four methods of diagnosis
Multidate information in subject's follow-up is subjected to Image Acquisition and preserves related diagnosis and treatment data；4）Seminar utilizes Android technologies
Integrated fingerprint scanning recognition technology by researcher participate in follow-up real information be acquired, researcher confirm subject receive with
Need to carry out fingerprint identification after visit, improve the compliance that researcher participates in follow-up, improving subject indirectly participates in the true of follow-up
Property；
S2-3-2：Scaling technique design and research based on Delphi method；
S2-3-3：The carrier of Chinese medicine treatment angina pectoris researcher's compliance multidimensional investigating method based on portable medical technology is clinical
Research；
Researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 2, it is characterised in that step
S2-4 feasibility analyses include：
1）Early-stage study is built on the rock, and method is feasible；
2）Computer theory is ripe with method, technical feasibility；
3）Cooperation unit's architecture is perfect, implements feasible；
4）Seminar's multi-crossed disciplines structure is reasonable, and personnel are feasible；
5）Subject study platform is perfect, and standard is feasible.
6. researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 5, it is characterised in that step
The scaling technique design and research based on Delphi method of rapid S2-3-2 includes：
S2-3-2-1：The establishment of entry；
S2-3-2-2：Form primary election scale；
S2-3-2-3：Delphi Experts consultation method optimizes；
S2-3-2-4：Whole scale is formed and the inspection of letter validity.
7. researcher's compliance computer measurement and control method in a kind of clinical research as claimed in claim 5, it is characterised in that step
The second stage of rapid S2-3-3, Chinese medicine clinical investigators compliance multidimensional observation and control technology are wrapped with evaluation study experimental test part
Include：
S2-3-3-1：Subject selects, and includes support center, diagnostic criteria, inclusive criteria, exclusion standard and the standard that comes off；
S2-3-3-2：Experimental design, including：
1）Experiment process：The subject of primary dcreening operation qualification will receive security inspection in screening and sign informed consent form；Medication
Phase A group subject takes compound danshen dripping pills+simulation 'Xue Fu Zhu Yu ' capsule, and B groups take 'Xue Fu Zhu Yu ' capsule+simulation compound Danshen Root
Dripping pill, medication terminate observation curative effect；Follow-up after 3 weeks, assists drug control person to provide by researcher's Control of Compliance group
Medicine；
2）Sample size is estimated：The main problem of non-research concern of validity comparison, according to default research scale and past experience
Design total sample size 60, every group 30；
3）Random and blind：Random using sequential encoding, blind bottom is sealed with lighttight envelope, is followed regular coding to be issued to and is ground
The person of studying carefully；
4）Drug combination：Maintained during experiment and record the original conventional western medicine treatment of patient, disable all promoting blood circulation class Chinese medicines, hair
It is spare to nitroglycerin lozenge；
5）Research stops：A. serious adverse reaction；B. sb.'s illness took a turn for the worse to take urgent measure；C. it is uncooperative；
6）Security, efficacy data are collected：Including entering security inspection when group and off-test, such as three is big conventional；Clothes
Chinese medicine syndrome integral, SAQ integrations, ECG change, coagulation function before and after medicine；And the data of the effect of after follow-up；
S2-3-3-3：The observing and controlling of researcher's compliance designs, and researcher's selection includes inclusive criteria and exclusion standard；
S2-3-3-4：Random Design, totally 30 researchers, every researcher are responsible for the inspection of 2 subjects, dialectical examine at random
Disconnected, dispensing, curative effect record and follow-up, while be three groups at random again by 30 researchers：Observing and controlling feedback group, observing and controlling feedback-less group
With simple measurement group, every group 10, during each interview, subject that researcher is responsible for also therewith again distribution enter this three
Group, performs the observing and controlling content of each group.
8. observing and controlling work is responsible for by RCG；
S2-3-3-5：Control design, for three observing and controlling groups after interview, researcher must fill in Self-assessment Scale, and subject is both needed to fill out
Researcher's evaluation charter is write, two deal tables all give RCG, including observing and controlling feedback group：More dimensions are carried out to the authenticity of subject
Fed back to according to collection, and by this compliance evaluation charter result to researcher, prompt researcher to carry out compliance corresponding
Change；Observing and controlling feedback-less group：Multidimensional data collection is carried out to the authenticity of subject, compliance evaluation result does not feed back to research
Person；Simple measurement group：Multidimensional data collection is not carried out to subject, subject does not use scale score；
S2-3-3-6：Compliance evaluating data gathers, including：
1）Researcher is responsible for evaluation charter, compares measurement feedback group with measuring scoring certainly for feedback-less group；Compare measurement feedback-less
Group scores certainly with simple measurement group；
2）Subject's objective evaluation scale, compares measurement feedback group with measuring the objective scoring of feedback-less group；Compare measurement without anti-
The objective scoring of feedback group and simple measurement group；
3）Subjective and objective scale similarity, compares similarity of each group certainly between scoring, objective scoring, evaluation study person's self-appraisal
Authenticity；
4）Mobile multidimensional gathered data, connects each other with each scale data, evaluation study person and subject's clinical practice behavior
Authenticity, calculates researcher in experiment and substitutes frequency；
S2-3-3-7：Statistical analysis.
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