Classifications

• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• • 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
• • 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
  • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
• • 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
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
• • 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
  • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
  • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment

Definitions

• the present invention relates to a method of screening for disease (s) by sampling from an individual, this method being implemented by a screening implementation module.
• the organization of a screening is often governed in particular according to recommendations from learned medical societies. These recommendations are designed for general use by public bodies such as the Ministry of Health, which will then seek to sensitize doctors and patients to screening. These recommendations are then applied by the identified actors in the screening process.
• a screening process for example, by taking a disease, includes the following operations:
• patient goes, for example following an awareness campaign, to a medical center (for example, in the case of cervical cancer screening, he goes to in a gynecologist or a laboratory);
• a medical center for example, in the case of cervical cancer screening, he goes to in a gynecologist or a laboratory;
• a sample is taken from the patient (in the case of cancer of the cervix: a smear takes the cells to be analyzed);
• the sample is sent to a laboratory, which then carries out a test or tests for the desired disease;
• each test is analyzed so as to produce an interpretable result as to the detection or not of the disease
• the result is sent to the doctor and / or the patient; if necessary, the patient then sees his doctor for possible consequences.
• the detection of the presence of certain pathologies is based on a redundancy of application of screening test during the typical period of development of the pathology in its early stage, to both compensate for the possibility of false negatives for the screening test. (Imperfect sensitivity), but also follow the patient during her life (especially in the context of an evolution of the disease).
• the recommended scheme for cervical cancer screening in France is the following for a woman between 25 and 65 years old: first two screenings by cytological examination at one year intervals, then screening by cytological examination every 3 years .
• the present invention aims to improve the detection of diseases by sampling.
• the invention provides a method for screening for disease (s) by sampling of the aforementioned type, characterized in that it comprises the following steps:
• a set of data relating to an individual said data set including teletransmission coordinates relating to said individual, and additional data relating to said individual from the age of the individual and / or data relating to the date and / or result of at least one previous screening relating to said individual and / or data relating to risk factors associated with said individual and / or data relating to vaccination of said individual;
• the invention thus makes it possible to improve the screening of diseases by sampling by organizing and personalizing this screening.
• the method of screening for disease (s) by sampling according to the invention further comprises one or more of the following characteristics:
• said additional data comprises an indicator of the quality of a sample used for an earlier screening carried out by said individual
• said additional data comprises a confidence index associated with the result of an earlier screening carried out by said individual
• the content of said convocation message is determined according to the geographical location of said individual;
• At least one test to be performed during said next screening is defined, by said screening implementation module, according to at least said additional data relating to said individual;
• said screening is a screening for pre-cancerous or cancerous lesions such as morphology analysis (cytology) or biology (cellular and molecular).
• the present invention proposes a screening module for disease (s) by sampling from an individual, comprising
• a database adapted to store a set of data relating to an individual and including teletransmission coordinates relating to said individual, and additional data relating to said individual from the age of the individual and / or data relating to the date and / or the result of at least one previous screening relating to said individual and / or data relating to risk factors associated with said individual and / or data relating to a vaccination of said individual;
• the present invention proposes a computer program for screening for disease (s) by sampling from an individual, said program comprising instructions for carrying out the steps of a method according to the invention. first aspect of the invention during execution of the program by processing means of said screening implementation module.
• FIG. 1 represents a system implementing screening in one embodiment of the invention
• FIG. 2 is a flowchart of the steps of a method in one embodiment of the invention.
• a screening system 1 according to the invention is implemented, comprising one or more screening implementation modules 2, similar to that shown in FIG.
• the screening implementation module 2 comprises, in the case considered, a screening control module 3, a preparation and analysis automaton 4, a database 5 and a communication interface 6.
• These different elements of the screening implementation module can be geographically grouped, or on the contrary be geographically distributed, and the necessary communications between the elements to implement the steps indicated below are then implemented via telecommunication links. .
• the screening implementation module 2 does not include a preparation and analysis automaton.
• the screening control module 3 comprises for example a microprocessor and a memory storing in particular a program of software instructions. This program, when executed by the microprocessor, is adapted to implement the steps indicated below which are the responsibility of the control module 3. In one embodiment, it further comprises a human-machine interface comprising for example a keyboard and a screen, to interact with an operator of the screening piloting module 3.
• the communication interface 6 is adapted to teletransmit messages according to different teletransmission modes, according to corresponding commands and message contents sent by the screening control module 3.
• the communication interface 6 when the content of a message is provided by the screening piloting module 3, for example in the form of electronic text, and the screening piloting module 3 commands that it be communicated by telephone call to a number given call, the communication interface 6 performs a synthesis operation voice of the electronic text using a speech synthesizer, and vocally reproduces this text after dialing the call number indicated by the screening control module 3 on a telephone network.
• the communication interface 6 develops an SMS and transmits it to the call number indicated by the screening piloting module 3.
• the communication interface 6 incorporates the text into an IP message and transmits it to the indicated internet address. Etc.
• the preparation and analysis automaton 4 is an automaton adapted to, from biological sampling vials, in particular cytological or even blood samples, which are provided to it, to carry out, in an automated manner, treatments comprising the preparation and the application of test methods. detection of one or more diseases on the samples, based on parameters defined according to the sample to be analyzed.
• the automaton 4 comprises trays into which sample bottles are inserted, bearing identification markings, for example of the barcode or RFID tag type. It is adapted to extract a sample of the sample from each bottle, to deposit the sample in a biology (cell or molecular) or cytology type of analysis system, such as for example a settling chamber, so that that the sample is deposited, in the form of a cell spread to be analyzed, on an analysis slide disposed under the chamber, or for example an aliquoting tube. Each cell sample selected in a tube or on the analysis slide also has an identification marking.
• the automaton 4 is adapted, when preparing an analysis slide, to read, by means of reading means integrated therein, the identification marks on the sampling bottle and on the blade of the sample.
• the automaton 4 is adapted to store a correspondence, for example in the database 5, between the identification marking of the analysis slide and the identification marking of the sampling flask recorded in correspondence with the data of the patient from whom the sample comes.
• the automaton 4 is adapted to carry out a pre-analytical check (for example the measurement of the cell density of the sample) and the determination that this sample contains enough cells to obtain a sample. sufficient cellular analysis, ie able to allow a reliable diagnosis (for example, for cervical cytology, the classification of Bethesda prescribes 5000 cells by cell spreading).
• the automaton 4 gives a pre-analytical information of the sample, for example on the cell density, and can enrich the sample by taking more cells from the sampling vial corresponding to the slide and adding them to the sample. the settling chamber above the slide, and trace this secondary enrichment, or determine that the sample is not sufficiently provided in cells and invalidate it.
• the automaton 4 is adapted to determine, for carrying out an analysis, a value indicating the quality of the sampling according to this pre-analytical check and to store this value in the database 5. correspondence with the identification marking of the blade. In one embodiment, this value is a function of the sufficiency or otherwise of the cell density present initially and / or the fact that the sample is enriched or not.
• the automaton 4 is also adapted to carry out one or more tests on each analysis slide, in particular of molecular biology (genomics, proteomics, or other) and / or to perform a cytology analysis of the content of the slide by practicing, if appropriate, complementary biology techniques such as immuno-cytochemical studies or any other technique for demonstrating biomarkers.
• the automaton 4 and / or a scanner associated with a type of scanner scanning the cytological spreading blades performs an image capture of the content of the slide, using image capture means. , then implements algorithmic image analysis treatments delivering a result characterizing the presence or absence of the desired pathology, for example cancer of the cervix.
• the automaton 4 is then adapted to store the result of the tests and analyzes in the database 5.
• the automaton 4 is further adapted to record in the database 5 a confidence index on the result, determined during algorithmic processing image analysis or input by the practitioner supervising the analysis of the sample, as well as for example a practitioner's identifier.
• the automaton 4 is, for example, of the type described in application EP 2 550 536 or in application EP 2 198 259.
• a step 100 during a visit of a patient to an entity, for example an administrative body or a medical analysis laboratory associated with the screening implementation module 2, the patient's coordinates are entered. by an operator of the screening piloting module 3, via the human-machine interface, and then are recorded by the screening piloting module 3 in the database 5.
• the mode or modes of contact of the patient are recorded with the corresponding teletransmission coordinates. Its preferred mode of contact is further indicated.
• the contact mode is the phone call or SMS
• the phone number of the patient will be stored.
• the mode of contact is the sending of messages via social networks
• the internet address of the patient will be stored.
• the contact mode is the email
• at least one email address of the patient will be stored.
• the mode of contact is the indication of a third party, such as a doctor, a social worker, a friend etc., teletransmission details such as telephone number, email address etc. third will be stored.
• additional DS data characterizing the patient is further entered by the operator, and recorded by the screening piloting module 3, into respective fields of the database 5.
• additional data DS appear for example:
• the indication of vaccinations carried out by the patient for example a vaccination against cancer of the cervix of the uterus; and or
• data relating to the dates and / or results of one or more screening operations previously performed by the patient indicate whether a pathology has been detected or not (generally, in well-monitored populations, less than 5% of the tests detect an abnormality that may correspond to either a transient inflammatory state or a condition pre-cancerous or cancerous that must be monitored or treated to prevent the occurrence of an invasive carcinoma), and / or indicate a value, determined for example in pre-analytical control of a blade of analysis and representing the quality of sampling used, and / or indicate a confidence index on the result of the screening; and or
• the date of one or more messages of convocation of the patient to screenings transmitted to the patient which may be of a normal periodicity if no abnormality has been detected or a suitable periodicity or even a consultation and processing if an anomaly has been detected, and possibly a copy of the transmitted content.
• these additional data may be entered in the database 5 during a first registration of the patient in the database 5, while others of this additional data will be recorded as and when events relating to successive screenings belonging to a pre-established periodicity, for example the provision of results of analyzes, or following visits of the patient to persons who can update the database 5, for example during subsequent visits of the patient to the testing laboratory, or to physicians or other entities authorized to perform such updates in the database 5.
• This step 100 for the same patient can therefore be performed in several times.
• This step 100 is furthermore implemented for each of a plurality of patients, among which in particular the patients referenced A and B in FIG.
• the screening piloting module 3 is adapted to automatically create a convocation message intended for a patient registered in the database 5.
• the message created to convoke the patient is related to a future screening to be performed by the patient.
• the screening control module 3 is then adapted to extract from the database 5 the teletransmission coordinates corresponding to the preferred mode of contact indicated for this patient and to command the communication interface 6, the teletransmission destined for these coordinates of teletransmission, the convocation message created.
• the convocation message is then tele-transmitted by the communication interface 6 to the teletransmission coordinates.
• the patients A and B thus receive the convocation messages which are intended for them according to their respective preferred mode of contact, for example in an email message accessible on a computer 10 A via the Internet 100 A for the patient A or by SMS on his mobile phone 10 B via a mobile telephone network 100 B for patient B.
• the screening piloting module 3 determines, as a function of one or more of the additional data DS mentioned above and relating to the patient, the content of the convening message and / or the moment of teletransmission. of said convening message.
• the instant of teletransmission of a message of convocation to cervical cancer screening is calculated by the screening piloting module 3 based in particular on the date of the last cervical cancer screening. uterus performed by the patient who indicated no pathology.
• the periodicity of teletransmission of a convocation message to a patient is determined according to supplementary data DS, for example a combination of some of this additional data.
• the content of the convening message and / or the instant of teletransmission of said convening message and / or the periodicity of teletransmission of a message of convocation to a patient is / are determined (s) based on recommendations from medical scholarly societies and / or national or international public bodies.
• the periodicity is for example a few months, or N years, with N whole number.
• the screening piloting module 3 is for example adapted to determine that a message of convocation to a screening must be tele-transmitted to a patient when she reaches 30 years, 35 years and 40 years, but that a message of Screening will be sent at respective higher given frequencies for patients for whom a quality value of an earlier sample is below a given threshold and / or a confidence index on the result of previous screening is less than one.
• the screening piloting module 3 is adapted to, when the result of a sample taken previously as stored in the additional data DS indicates the existence of a pathology, create a message convening a thorough screening with the indication of additional tests to be performed, determined by the screening piloting module 3 according to the pathology detected.
• the screening piloting module 3 is adapted to, when the result of a sample taken previously as stored in the additional data DS indicates the existence of a pathology, define an additional test according to this pathology detected, determine the address of the health organization (s) able to carry out this additional test (possibly by retaining only the closest geographically to the patient) and to create a message of summons indicating the additional test to be carried out and indicating in addition the address of the specific health organization or bodies.
• this convocation message is to be sent within a given time after the date of the previous sample as stored in the supplementary data DS, or at a prescribed age of the patient or at a date resulting from the combination of several additional data stored in the database 5 in accordance with the operating rules of the screening piloting module 3.
• a JAVA applet is transmitted in the convocation message, intended to run on the telephone, or on the computer, indicated as the recipient of the patient, and able to identify among the suitable health organizations indicated in the message, those who are geographically closer to the patient, based on patient geolocation data available from the phone (for example GPS data from the mobile phone) or on the recipient computer.
• the screening piloting module 3 is adapted to generate a convening message, the content of which, for example in the case of a pathological test, directs the patient to a specialized center where she can carry out the examinations.
• diagnostic and / or prognostic kits for close monitoring purposes (3 to 6 months, indicated for example in the initial invitation message with reminders of the convocation by regular messages before the necessary examinations) or specific treatment, medical or surgical.
• the screening piloting module 3 is adapted to send the convocation message to the teletransmission coordinates of the patient other than those of the preferred mode of contact of the patient, possibly in addition to the transmission according to the preferred mode of contact, when it determines based on the additional DS data relating to the date of the last convocation message sent and the date of the last screening carried out, no screening has taken place for the patient following the sending of the last convocation message.
• the rules can further be updated according to the evolutions of the recommendations by the learned societies.
• patient behavior of the database 5 in response to convening messages can be analyzed and modeled to update the determination rules, by the screening piloting module 3 and on the basis of additional patient DS data, the content of the convening messages and / or the time of transmission of the convocation messages.
• a vial having an identification marking and including a cervical smear of a patient, the patient 10 A for example, is provided to the controller 4 for analysis of the smear taken.
• the identification marking on the vial is recorded in correspondence with the other data of the database 5 relating to the patient.
• the automaton 4 then implements the steps of preparation and analysis of the sample in the bottle indicated above. He reads the identification marking on the bottle, determines, in the database 5, the patient according to the read mark and records in the additional data DS relating to the patient, the determined value of quality of the sample, and then the result of the cytology analysis and, where appropriate, of complementary biology techniques and the confidence index on the result.
• the automaton 4 is further adapted to personalize one or more treatments that it performs as a function of at least some of said additional data DS and recorded for the patient in the database 5 or function combining some of these additional data.
• it adapts the minimum number of cells during the pre-analytical control step, for example according to the comparison of the confidence index of the result of an earlier sampling with a threshold given.
• it is adapted to carry out a double sampling from the outset, then perform respectively molecular biology and cytology tests (in English "co-testing") and / or to perform a first sampling followed by a HPV "reflex-testing" on this first sample (in English "cytological screening") or the reverse (in English "HPV primary screening”), or a second sample in case of insufficient first sampling.
• Step 102 is optional. In addition, in Figure 2, it is indicated after step 101, but could be earlier.
• steps of registration in the database 5 of additional data DS relating to a patient indicated above as performed by the controller 4 are performed by the module.
• tracking pilot 3 following the provision of said additional data by the controller 4 to the control module 3.
• the example of cervical cancer was considered. Nevertheless, the invention can be implemented for the detection of any type of disease by removal, for example cancer of the prostate, bladder, breast, thyroid, lung etc.
• the same database 5 can be filled in by several entities, for example by several analysis laboratories, doctors, etc., with the aid of the data relating to their respective patients, with the appropriate setting of the data. in place of validation mechanisms before registration, the various additional data entered in the database.
• analysis laboratories each comprise a screening implementation module, which may or may not include a preparation and analysis automaton. The organization of the screening is then done locally at the laboratory of the laboratory. analysis.
• the invention makes it possible to improve the detection of disease (s), in particular by increasing the respect of the recommended frequency of the screening operations and by personalizing the convocations according to the individuals, the elements of their medical history, and / or recommendations related to screening and / or geographical locations.
• optimized screening is implemented, adapting to changes in the practices and techniques of the proposed examinations and thus helping to reduce the effects of the disease, including the associated mortality rate, and to reduce the costs in terms of public health.
• a screening operation for a disease makes it possible, in particular, to organize a massive screening and to send convocation messages to a population of healthy individuals (ie considered to have not contracted the disease. and which are not the subject of any treatment of this disease).

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• Health & Medical Sciences (AREA)
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• Epidemiology (AREA)
• General Health & Medical Sciences (AREA)
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• Biomedical Technology (AREA)
• Business, Economics & Management (AREA)
• General Business, Economics & Management (AREA)
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• Databases & Information Systems (AREA)
• Pathology (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Medical Treatment And Welfare Office Work (AREA)
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• 2013
  • 2013-10-11 FR FR1359886A patent/FR3011963B1/fr active Active
• 2014
  • 2014-10-09 JP JP2016521760A patent/JP2016532855A/ja active Pending
  • 2014-10-09 US US15/028,701 patent/US20160267256A1/en not_active Abandoned
  • 2014-10-09 EP EP14781899.1A patent/EP3055799A1/de not_active Withdrawn
  • 2014-10-09 CA CA2926744A patent/CA2926744A1/en not_active Abandoned
  • 2014-10-09 CN CN201480065229.1A patent/CN105981018A/zh active Pending
  • 2014-10-09 RU RU2016118150A patent/RU2016118150A/ru not_active Application Discontinuation
  • 2014-10-09 WO PCT/EP2014/071702 patent/WO2015052302A1/fr not_active Ceased
  • 2014-10-09 AU AU2014333743A patent/AU2014333743A1/en not_active Abandoned
  • 2014-10-09 KR KR1020167009520A patent/KR20160088289A/ko not_active Withdrawn
  • 2014-10-09 MX MX2016004547A patent/MX2016004547A/es unknown

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