EP1570406A2 - Procede et base de donnees permettant de trouver des etudes medicales - Google Patents

Procede et base de donnees permettant de trouver des etudes medicales

Info

Publication number
EP1570406A2
EP1570406A2 EP03753263A EP03753263A EP1570406A2 EP 1570406 A2 EP1570406 A2 EP 1570406A2 EP 03753263 A EP03753263 A EP 03753263A EP 03753263 A EP03753263 A EP 03753263A EP 1570406 A2 EP1570406 A2 EP 1570406A2
Authority
EP
European Patent Office
Prior art keywords
studies
study
parameters
database
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03753263A
Other languages
German (de)
English (en)
Inventor
Michael Klennert
Peter Brimmers
Reinhard Griebenow
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Academy GmbH and Co KG
Original Assignee
Academy GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE10240216A external-priority patent/DE10240216A1/de
Application filed by Academy GmbH and Co KG filed Critical Academy GmbH and Co KG
Publication of EP1570406A2 publication Critical patent/EP1570406A2/fr
Withdrawn legal-status Critical Current

Links

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
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • 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
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
    • 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
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • 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

Definitions

  • the invention relates to a method for the database-assisted finding of a number of medical studies that correspond to a specific patient profile, from a large number of medical studies recorded in at least one database, which have in each case been carried out on a group of selected participants, and a database system for carrying them out.
  • the full text of the publications of the medical study is usually analyzed beforehand by medical professionals, the data which are suitable for classifying the studies being extracted from the full text, if necessary, being standardized and into one corresponding data area of the database are stored, in which the data of a class of the classification are mapped. It is the responsibility of the specialists to adapt a classification appropriately depending on the indication and to standardize the data to be stored in a suitable form.
  • the database technology including the database interface for entering search criteria via a search mask, is conventional and is not described in detail.
  • the very essential advantage of the method according to the invention and the associated database is that it is the first time that there is a possibility of correlating a specific patient profile with abstract medical content from medical science studies, which is carried out by the database and the user of the database has a clearly defined search result supplies.
  • the database can be programmed in such a way that he can have at least one piece of information from one of the studies output, in which the patient parameters correspond to the inclusion criteria of the study, in which case the patient is in the Group of study participants would have been included if he had been available for the study.
  • additional data on subgroups of the group of participants in a study are stored in the database, for example when a subgroup analysis of a study has shown that certain participants in a group with special properties observe a study result that differs from the other participants becomes. If the baseline characteristics of these subgroups correspond to the patient parameters entered in the search mask, information about the associated studies can then be displayed, even if the specified patient profile does not meet all inclusion criteria.
  • At least one piece of information from one of the studies is output, in which all patient parameters correspond to the parameters of the group of study participants, even if not all inclusion criteria are met by the patient parameters.
  • the method can be designed such that no studies are issued in which the patient parameters neither fully correspond to the inclusion criteria nor the parameters of the group of study participants.
  • the number of studies is categorized and / or output according to categories, with one of the categories including all studies where the patient parameters meet all inclusion criteria and all parameters of at least one participant, a category includes all studies in which the patient parameters meet all inclusion criteria, - a category includes all studies in which the patient parameters do not meet all inclusion criteria but all parameters of a participant, one category includes all studies in which the patient parameters do not meet all inclusion criteria or all parameters of a participant, one category includes all studies in which the patient parameters does not meet any of the inclusion criteria and none of the parameters of a participant and / or Kate All studies include those in which the patient parameters meet at least one exclusion criterion.
  • the database contains data on title, source, summary, study background, definition of the study, study design, protocol of the course of the study, the endpoints, the statistical method used, complications that occurred during the study, the result and / or the complete content of the publication of the study and / or a scientific commentary on the study are recorded in the database and assigned to a corresponding classification in the database.
  • the form of therapy and the examined substances and / or substance groups are recorded in the database and these can also be taken into account as search criteria via the search mask.
  • Quality level here means in particular the quality classification of studies defined in "Basedvidence Based Medicine", David L. Sackend, 2nd edition, Churchill Livingston, 2000 and internationally recognized as "level of evidence”.
  • levels of evidence In the case of forms of therapy, a distinction is made as to whether the study participants were treated with medication and / or invasively.
  • the inclusion criteria and / or the participant parameters recorded in the database can include the specific criteria indication, subindication and / or the severity of the indications and can be correlated with corresponding inputs of the patient parameters.
  • the group parameters preferably contain information on the age, gender, race and comorbidities of the participants as well as on existing medications and / or invasive interventions carried out on the participants. In both cases, it makes sense if patient parameters that correspond to the specific information and criteria can be entered in the search mask.
  • the endpoints preferably contain, in particular, information from the studies on the death rate, hospitalization, re-hospitalization and / or on invasive interventions necessary after the therapy, so that they are immediately available to the user when information on a study is output, regardless of the full text , This information is of particular interest for indications from the fields of cardiology, such as heart failure or coronary heart disease.
  • the database can record which of the studies are comparable to one another, so that one or more of the studies comparable to an issued study can be queried as a quantity, regardless of whether the specified patient parameters correspond to the inclusion or exclusion criteria or the baseline characteristics . It also makes sense if guidelines, which are written, for example, by medical associations based on medical studies, are recorded in the database, in particular if the corresponding studies are also contained in the database. These guidelines can be called up via an organizational structure specially created for the guidelines in the database. Are links in the database If there are tests between the guidelines and the correlating studies, the guidelines can be output in the search for studies on a patient profile, for example in parallel with the studies on which the guidelines are based. The data output of the database can likewise be programmed such that the link to the guideline is displayed from a study displayed as part of the search and the guideline can be called up via it.
  • the output of information on a patient profile can also preferably be such that therapy recommendations based on one or more guidelines and / or on the number of studies found can be called up as a result of the search.
  • therapy recommendations resulting from a study or guideline must be recorded as independent information in the database.
  • the associated database system has at least one processor, a data memory for the medical studies and other information and for the commands and programs to be executed as part of the database query, and means for outputting information found as part of a search.
  • a particularly suitable grid has one with the classes
  • Inclusion criteria includes all criteria that a study participant had to have in order to be accepted into the group of study participants, and "Exclusion criteria” all criteria that a study participant was not allowed to have in order to be accepted into the group of study participants.
  • the classes "Protocol” and "Statistical Methods” include information on the type of observation and logging of the course of the study and the results observed, as well as information on the type of evaluation of the results.
  • FIG. 1 A typical process of the full text analysis for filtering out specific data from the full text and entering it into a database for a study is shown in FIG. 1.
  • the database is limited to studies for one indication or can include studies for a large number of indications.
  • the indication of the indication can be assumed to be known, so that it does not have to be taken into account when entering data into the database.
  • a separate grid class is provided for the indication of the indication for which studies have been carried out as part of a study.
  • the database interface is programmed in such a way that a user has the option of using a search mask in addition to the indication to specify other parameters that are suitable for describing the patient, such as information on age, gender, race, concomitant diseases, risk factors, existing medications, interventions performed, etc. as a patient profile.
  • the user can also enter further search criteria in the search mask, such as quality level, form of therapy, examined substances or groups of substances, or other information maintained in the database. This can also include information on sponsors of the studies if this information is also recorded in the database.
  • the search mask can include an input help that limits the input options to the criteria specified in the inclusion and exclusion criteria. teries and the baseline characteristics are recorded, for example by offering specific criteria for selection in an input field.
  • the studies are classified into the following categories: excluded - included not included, not excluded, but recorded in the baseline characteristics and analyzed as a subgroup, not included, not excluded, but recorded in the baseline characteristics, no subgroup analysis not included, not excluded and no further information "excluded” means that at least one of the parameters describing the patient profile corresponds to an exclusion criterion of a study, and "included” that the parameters describing the patient profile meet or at least do not contradict the inclusion criteria.
  • “recorded in the baseline characteristics” means that the entered parameters of the patient profile contradict the baseline characteristics with no characteristic and correspond to the baseline characteristics with at least one characteristic.
  • the studies included in the groups can either be grouped - and this is the preferred type - or they can be sorted according to other criteria. This categorization is particularly advantageous because it includes an assessment of the applicability of the studies found.
  • the studies can, for example, be called up sequentially on a screen, and there may also be the possibility that not the complete content of the database for a study, but only sub-areas of particular interest to the user are displayed.
  • a direct comparison of two or more studies next to or on top of one another is also possible, in this case also areas of particular interest can be compared with one another. If available in the database, a comment comparing the studies can also be called up in this context.
  • an indication or subindication e.g. Heart failure, restrictive criteria such as Severity (if definable), definable clinical situations, etc.
  • restrictive criteria such as Severity (if definable), definable clinical situations, etc.
  • map the patient profile to the profiles of the study participants examined in order to find studies relevant to the patient profile, but also to include other aspects in the research, such as querying the most important study data relating to the patient, eg the endpoints like death, re-hospitalization, intervention, etc.
  • each clinical, individual patient situation can be mapped to a corresponding situation of a study participant or a group of study participants.
  • the technical quality of the database is that the class structure makes such an adjustment possible due to its basic structure.
  • the output parameters and the associated categorization remain the same.
  • the treating physician receives a tool with which he can quickly find the medical evidence relevant to a patient and use it for his therapy decision, which was previously not possible for a large number of indications.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Primary Health Care (AREA)
  • Data Mining & Analysis (AREA)
  • Biomedical Technology (AREA)
  • Databases & Information Systems (AREA)
  • Pathology (AREA)
  • Medical Treatment And Welfare Office Work (AREA)

Abstract

Procédé permettant de trouver, à l'aide d'une banque de données, un certain nombre d'études médicales correspondant au profil spécifique d'un patient, parmi une pluralité d'études médicales enregistrées dans au moins une base de données et ayant été menées sur un groupe de participants sélectionnés, pour permettre à un médecin de trouver des preuves médicales pertinentes en tant qu'aides à la décision pour la thérapie à prescrire. Selon ledit procédé, (a) les études médicales sont classées, (b) pour chaque étude correspondant à la classification sont enregistrés dans la base de données (i) les critères d'inclusion sur la base desquels des participants ont été sélectionnés pour participer à l'étude dans un groupe de participants possibles, (ii) les critères d'exclusion sur la base desquels des participants possibles ont été exclus de la participation à l'étude, (iii) les paramètres du groupe des participants à l'étude et (iv) au moins une information caractérisant l'étude, (c) les paramètres spécifiques d'un patient sont introduits dans un masque de recherche pour trouver les études correspondant au profil spécifique du patient, (d) les paramètres entrés relatifs au patient sont comparés dans la banque de données au moins avec les critères d'exclusion des études, (e) toutes les études pour lesquelles au moins un des paramètres entrés relatifs au patient correspond à un critère d'exclusion de l'étude sont classés comme étant non pertinentes pour le profil spécifique du patient et (f) au moins une information figurant dans une étude parmi la quantité des études restantes est produite.
EP03753263A 2002-08-31 2003-08-29 Procede et base de donnees permettant de trouver des etudes medicales Withdrawn EP1570406A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE10240216 2002-08-31
DE10240216A DE10240216A1 (de) 2002-08-31 2002-08-31 Verfahren und Datenbank zum Auffinden von medizinischen Studien
US447305 2003-05-29
US10/447,305 US20040044547A1 (en) 2002-08-31 2003-05-29 Database for retrieving medical studies
PCT/DE2003/002876 WO2004021213A2 (fr) 2002-08-31 2003-08-29 Procede et base de donnees permettant de trouver des etudes medicales

Publications (1)

Publication Number Publication Date
EP1570406A2 true EP1570406A2 (fr) 2005-09-07

Family

ID=31979461

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03753263A Withdrawn EP1570406A2 (fr) 2002-08-31 2003-08-29 Procede et base de donnees permettant de trouver des etudes medicales

Country Status (4)

Country Link
EP (1) EP1570406A2 (fr)
AU (1) AU2003271516A1 (fr)
DE (1) DE10393664D2 (fr)
WO (1) WO2004021213A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7949545B1 (en) 2004-05-03 2011-05-24 The Medical RecordBank, Inc. Method and apparatus for providing a centralized medical record system

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1259156A4 (fr) * 2000-03-03 2005-01-05 Joerg Hohnloser Systeme et procede d'evaluation des risques medicaux
US7711580B1 (en) * 2000-10-31 2010-05-04 Emergingmed.Com System and method for matching patients with clinical trials

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2004021213A2 *

Also Published As

Publication number Publication date
WO2004021213A3 (fr) 2004-10-14
WO2004021213A2 (fr) 2004-03-11
AU2003271516A8 (en) 2004-03-19
AU2003271516A1 (en) 2004-03-19
DE10393664D2 (de) 2005-07-14

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