WO2016055050A1

WO2016055050A1 - Automated method for monitoring the medical condition of a patient

Info

Publication number: WO2016055050A1
Application number: PCT/DE2015/100340
Authority: WO
Inventors: Thomas LÖSER
Original assignee: Löser Medizintechnik GmbH
Priority date: 2014-10-07
Filing date: 2015-08-14
Publication date: 2016-04-14
Also published as: DE102014114560B3

Abstract

The invention relates to an automated method for monitoring the medical condition of a patient by means of a patient data management and/or decision-aiding system. Here, the following steps are provided: (a) specifying a first group of physiological and/or pathological parameters of the patient, which are characteristic for the presence of a health impairment, wherein the parameters of the first group are intended to be determined continuously, (b) continuously detecting values of parameters of the first group; (c) continuously determining the necessity of detecting microbiological parameters, on the basis of previously detected values of parameters of the first group or on the basis of previously detected values of parameters of the first group and previously detected values of microbiological parameters; and (d) detecting values of microbiological parameters if the necessity of detecting microbiological parameters was determined in step (c), wherein each microbiological parameter is a microbiological pathogen, which has at least one active ingredient as a first value and the sensitivity of the pathogen to this active ingredient as a second value.<sp />

Description

description

Automated method for monitoring the medical condition of a patient

The invention relates to an automated method for monitoring the medical condition of a patient. It further relates to a computerized system suitable for carrying out the method. Methods for analyzing and / or monitoring physiological and / or pathological parameters of a patient are known from the prior art. For example, EP 1 897 485 B1 describes a method in which a multidimensional feature space is formed on the basis of selected physiological and pathological parameters. Within this feature space, first and second spatial regions are determined, wherein the first spatial region comprises the target values of the selected parameters, while in the second spatial region, undesired values of these parameters are included. Measured values are regularly determined for the selected parameters. By means of these measured values, measuring points in the feature space which form a patient trajectory are determined. On the basis of the first measuring point, a target trajectory is formed, which represents the shortest space curve between the first measuring point and the first spatial region. At the same time, a complication trajectory is formed, which represents the shortest space curve between the first measuring point and the second spatial area. At each additional measuring point it is now checked whether it lies on or outside the target trajectory. If it lies outside the target trajectory, an action value is generated which indicates the parameters which have to be changed in order to return the patient trajectory to the first spatial area or to the target trajectory by the shortest path. The action value can be used to trigger an alarm to prompt the intervention of a physician. EP 1 897 485 B1 mentions, inter alia, parameters which are characteristic of acute or past inflammations of the patient as parameters which can be selected for carrying out the method. From DE 10 2009 035 250 AI a method for monitoring the medical condition of a patient is known. This method also uses physiological and / or pathological parameters to monitor the condition of a patient. However, the parameters are classified into a first group of parameters that are continuously monitored and a second group of parameters that are monitored intermittently. In this way, it should be achieved that medical findings obtained as the results of a laboratory medical examination are actually included in the monitoring of the medical condition of a patient. This procedure is referred to as "risk-adjusted laboratory diagnostics".

Laboratory medical examinations can provide readings for a variety of parameters that are determined in a laboratory. For heart disease, relevant parameters include myoglobin, troponin I, and CKMB. For respiratory diseases relevant parameters, for example, parameters of the blood gas analysis, z. B. the pH of the blood, the oxygen partial pressure of the blood, the carbon dioxide partial pressure of the blood and the oxygen saturation of the blood. Laboratory medical examinations also include the microbiological examination of specimens obtained from the patient for infections by pathogenic substances and / or organisms, for example germs such as bacteria, viruses, fungi, protists, parasites, viroids or prions.

The examination of the patient for the presence or absence of an infection with pathogenic substances and / or organisms is of particular importance in the intensive care of patients, especially in patients who already have sepsis or sepsis during treatment in the intensive care unit could draw. Sepsis is defined as "the totality of life-threatening clinical manifestations and pathophysiological changes in response to the action of pathogenic germs and their products, which enter the blood stream from a focal point of infection, activate the large biological cascade systems and special cell systems and trigger the formation and release of humoral and cellular mediators "(Schuster, HP, and Müller-Werdan, U.: Definition and diagnosis of sepsis and multiple organ failure in sepsis and MODS, Berlin 2005.) If additionally an organ of the patient is acutely damaged, severe sepsis is present.

Typical pathogens of sepsis are Staphylococcus aureus, coagulase-negative staphylococci, enterococci, Escherichia coli, Klebsiella spp., Enterobacter ssp. and Pseudomonas aeruginosa.

At the beginning of intensive care treatment, d. H. usually when a patient is admitted to the intensive care unit of a hospital, it is often unknown whether or not the patient suffers from an infection. On the other hand, it is known which pathogens, in particular which germs, are already present in the intensive care unit. For this reason, within the scope of a so-called "calculated therapy", one or more medicaments are administered immediately with the start of intensive care treatment, with which typical infections, in particular the infections caused by the germs known to be present on the ward, are combated Such drugs include, for example, antibiotics, antivirals and antifungals, where the calculated therapy typically provides for the administration of an antibiotic.

At the same time a sample is taken from the patient at the beginning of intensive care treatment, which is examined for pathogenic germs. This microbiological examination, which is associated, for example, with the detection of antibodies or the genetic information of pathogens (eg species-PCR) or the cultivation of cell cultures, is carried out in specialized laboratories. The results of this study are typically available after three days. The results indicate which pathogenic germs and which resistances are present in the patient. As soon as this is known, the medical treatment will be adapted to the actual condition of the patient.

According to DE 10 2009 035 250 A1, the results of the laboratory medical, including the microbiological examinations, are to be transferred to a patient data management system via standardized interfaces (in hospitals HL7, in practices xDT) and made available to the doctor on request. Patient data management systems are used in healthcare, especially in clinics. These are systems where patient data is stored. The patient data include the so-called master data of the patient such as name, first name and date of birth, the medical findings and initiated or already completed medical or nursing measures. Such measures are also referred to below as medical measures.

However, it has been found that in clinical practice the results of the microbiological examinations are not transferred from the laboratory to the doctor or the ward via one of the standardized interfaces. If these results are actually transmitted electronically to the doctor or the ward - in a surprising number of cases, the results are transmitted by fax - the results are transferred to the patient data management system in a non-standardized form, if that is the case Case is. The results are then in the patient data management system as a text file whose structure is arbitrary. It is also unknown what information the text file contains, apart from the fact that the text file should receive a microbiological result. It is not known before receipt of the text file which germs are named in the report, with which drugs sensitivity tests have been carried out, and if sensitivity tests are carried out on which of the germs these sensitivity tests relate. It is quite possible that a finding mentions a germ, but contains no further information on this germ. Finally, the finding may contain comments that refer to one or more germs.

In rare cases, microbiological findings are also embedded embedded as text in an HL7 message. Then, the case number, the patient number of the patient or both can be clearly determined, but all other information of the findings must be extracted just as laboriously as from a text file.

It is therefore not yet possible to take the results of microbiological examinations into account when monitoring the patient in an automated process. Nor has it been possible to date to include the results of microbiological investigations in the generation of action values. Whether the doctor actually perceives the results of the microbiological examination, whether and how he considers them, and whether a representative or successor of the doctor takes them into account, and if so, in what way, is extremely uncertain - and dangerous for the patient.

One might assume that standardizing the results of microbiological investigations could solve these difficulties. However, one ignores the fact that initially a standard was found, the standard then prescribed by law and finally applied in practice. This will take several years. However, standardization does not solve the problem immediately. The results of microbiological examinations are still not included in the monitoring of the medical condition of patients and certainly not in the analysis of the physiological and pathological parameters of a patient. This has serious implications for alerting, the medical measures taken to treat the patient, and especially the medication used to treat the patient. These disadvantages not only have negative effects on the patient, but also on other patients in the same ward, especially if it is an intensive care unit. The object of the invention is to eliminate the disadvantages of the prior art. In particular, an automated method for monitoring the medical condition of a patient is to be specified, which automatically incorporates the results of microbiological examinations. Furthermore, a computerized system suitable for carrying out the method should be specified.

This object is solved by the features of claim 1. Advantageous embodiments of the invention will become apparent from the features of the dependent claims.

According to the invention, an automated method for monitoring the medical condition of a patient by means of a patient data management and / or decision support system is provided. The method comprises the steps:

(a) the specification of a first group of physiological and / or pathological parameters of the patient which are characteristic of the existence of a health disorder, wherein the parameters of the first group are to be determined continuously,

(b) continuously acquiring values of parameters of the first group;

(c) continuously determining the need to acquire microbiological parameters based on previously acquired values of parameters of the first group or based on previously acquired values of parameters of the first group and previously acquired values of microbiological parameters; and

(d) acquiring values of microbiological parameters when the need to detect microbiological parameters has been determined in step (c), each microbiological parameter being a microbiological agent which at least one active substance as the first value and the sensitivity of the pathogen against this active substance as a second value; wherein step (d) for detecting microbiological parameters comprises the sub-steps:

(dl) providing a biological sample of the patient at a time of delivery and determining an expected time at which no later than the receipt of values of microbiological parameters in the form of a microbiological finding is expected; and

(d2) triggering an alarm at the expected time when the microbiological findings have not been received or indicating that the microbiological findings have been received.

The method according to the invention ensures that microbiological findings are taken into account in the treatment of a patient. Such a finding is requested only if the monitoring of the first parameters or, if already existing values for microbiological parameters, the monitoring of the first parameters and of the microbiological parameters, the need to detect microbiological parameters, results. In this way, the unnecessary determination of microbiological parameters is prevented. If, on the other hand, a requested result does not arrive in time, an alarm is triggered.

According to the invention, it is provided that on the basis of the existing data, ie the previously recorded values of parameters of the first and, if already present, of microbiological parameters, it is checked whether values for microbiological parameters are to be recorded. The necessity of such a detection can be determined, for example, by specifying a triggering value or a triggering value range for at least one parameter of the first group. If the continuously recorded value of this predetermined parameter reaches the triggering value or the triggering value range, then it is necessary to have at least one microbiological one To determine parameters or a value of at least one microbiological parameter. As a rule, it is necessary to take a biological sample from the patient, which is subjected to a microbiological examination. Typically, such an assay will detect more than one pathogen or detect first and / or second pathogens that have already been detected in previous biological samples from the patient.

It can be provided that for several parameters of the first group separate trigger values or trigger ranges are given, wherein it is sufficient that one of these parameters reaches its trigger value or its trigger range, to determine that the necessity of detecting microbiological parameters or values of microbiological parameters.

A microbiological parameter is a microbiological agent which has at least one active substance as the first value and the susceptibility of the agent against this active substance as a second value. Microbiological agents in the present invention are pathogens. Exemplary microbiological agents are bacteria, viruses, fungi, protozoa, parasites, viroids and prions. Preferably, a microbiological parameter in the sense of the biological taxonomy is a genus, a group of species of a genus, a species or a subspecies, particularly preferably a species of a microorganism. Examples of microbiological parameters are the bacterial subspecies Enterobacter ssp., The bacterial species Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli and Pseudomonas aeruginosa, the group of bacterial species of a genus Klebsiella spp. as well as the bacterial genera coagulase-negative staphylococci and enterococci.

Active substances are chemical substances that inhibit the growth of a pathogen or kill the pathogen. They include in particular antibiotics, antivirals, antifungals and antiprotozoics. Active substances are, for example, carbapenems, cephalosporins, monobactams, penicillins and tetracyclines. The sensitivity of an In the microbiological finding, regulators against an active agent are typically assigned to one of the following categories: resistant, intermediate or sensitive, which are referred to as resistance categories. Alternatively or additionally, in the microbiological finding, the sensitivity of a pathogen to a drug can be given as an MIC value. The MIC value is the minimum inhibitory concentration in this pathogen and this drug. MIC values are usually given in powers of 2, ie 1/8, Vi, Vi, 1, 2, 4, 8,. , , Based on the MIC value, the assignment to the resistance categories can be resistant, intermediate or sensitive. The MIC value is more accurate than the resistance category. In most microbiological findings, however, no MIC values are given. However, physicians with microbiological background knowledge always demand the specification of MIC values, since these values can be used to detect emerging resistances at an earlier stage. It can therefore be provided that by means of the method according to the invention not or not only the resistance categories but also the MIC values in the microbiological finding are automatically determined.

Microbiological findings are preferably provided as text files in a computer-readable format. A microbiological finding should at least contain the following information:

(i) information enabling identification of the patient whose biological sample is the subject of the microbiological findings;

(ü) information enabling identification of at least one pathogen; (iii) information enabling the identification of at least one active substance; such as

(iv) information enabling identification of the susceptibility of a pathogen to an active substance. The microbiological findings preferably contain information that makes it possible to assign an active substance as the first value to a pathogen. A pathogen can have several first values. Typically, a pathogen is associated with ten to thirty drugs. The term "assigning" is to be understood as meaning that the microbiological finding indicates that sensitivity tests have been used to determine whether the pathogen is sensitive to the specified active substance, which is referred to below as first assignment data.

The microbiological findings preferably contain information which makes it possible to assign the information on the susceptibility of a pathogen to an active substance as a second value to a pathogen and an active substance. The term "assigning" is to be understood as meaning that the microbiological finding indicates how the pathogen is sensitive to the specified active substance, namely whether it is resistant to the active substance, behaves as an intermediate or is sensitive referred to as second allocation data.

The microbiological finding may contain further information such as the date of removal of the biological sample; the date of creation of the microbiological findings; Information on the identification of the medical facility, that is, for example, a clinic or department of a clinic; Details of the laboratory that produced the microbiological findings; contain a diagnostic number and so on. For example, the Department of the Clinic may be an intensive care unit.

For example, indications that enable an identification of the patient whose biological sample is the subject of the microbiological finding are a case number, a patient number, the name of the patient, including his first name and surname, and combinations thereof, the case number being preferred because It allows a clear identification of the patient .. It can not be specified in each case, which microbiological parameters are to be determined. According to the invention, it is therefore provided that the Mood microbiological parameters is caused, without being predetermined, which genus or species of a microorganism is determined. On the other hand, each identified species or genus can represent a microbiological parameter. Often it can first be determined by means of an examination of a biological sample which microorganisms are present in the sample, so that only after receipt of a microbiological finding it is clear which microbiological parameters are important for a patient's health disorder. It can be provided that any species or, if the nature of a microorganism is unknown, its genus, which are listed in a microbiological finding, each form a microbiological parameter.

At least one microbiological parameter, ie at least one pathogen, is characterized by an active substance as the first value and the susceptibility of the pathogen to this active substance as the second value. Preferably, all microbiological parameters, ie all pathogens, each have at least one active substance as the first value and the sensitivity of the pathogen to this active substance or these active substances as a second value. That is not necessary. In many cases, a microbiological finding contains no information on the sensitivity of a pathogen mentioned there to any active substance. In some cases pathogens are listed in a microbiological finding without mentioning an active substance with which susceptibility tests have been performed for this pathogen. It may therefore happen that a microbiological parameter has only a first value but no second value. It may also happen that a microbiological parameter has neither a first value nor a second value. However, the mere existence of the pathogen in the biological sample is already a microbiological parameter within the meaning of the invention, because the pathogen occurs in the patient. With a renewed need to determine microbiological parameters, it is therefore appropriate to determine whether the pathogen is still present or not. It can be provided that one or more parameters of the first group are linked together, so that trigger values or trigger value ranges for two or more more of these parameters must be achieved before the need is determined (step (d)) to determine values for microbiological parameters. Once microbiological parameters have been determined in a biological sample and these microbiological parameters are captured by the patient data management and / or decision support system provided by the invention, the microbiological parameters detected may be included in the continuous determination of step (c). It may be provided that one or more parameters of the first group are linked to one or more microbiological parameters, wherein the parameter or parameters of the first group specific trigger value or tripping range can be specified when a certain second parameter has been detected, for example Staphylococcus epider- midis, or this second parameter has a particular first value and / or second value, for example Staphylococcus epidermidis is resistant to the active substance cefaclor. The term "specific" here means the specification of a trigger value or trigger value range that is matched to at least one second parameter or its values.

The alarm triggered in step (d2) may be an audible or visual alarm. Such an alarm may, for example, be displayed on a display device, for example the display of a client computer of the patient data management and / or decision support system. Likewise, the display provided in step (d2) of an indication that the microbiological finding has been received can be displayed on a display device, for example the display of a client computer of the patient data management and / or decision support system.

The patient data management and / or decision support system provided according to the invention is preferably a computer-implemented patient data management and / or decision support system. Once the microbiological finding has been received, step (d) may further comprise the substeps:

(d3) determining the microbiological parameters listed in the microbiological finding; and

(d4) determining the first and second values given in the microbiological finding for the microbiological parameters determined in step (d3). These sub-steps can directly follow sub-step (d2). Sub-steps (d3) and (d4) can be carried out successively or in parallel with each other. Sub-steps (d3) and (d4) are used to determine the microbiological parameters and, if indicated, their first and second values listed in the microbiological finding. Thus, it is no longer necessary for a doctor to study the microbiological findings themselves. The inventively provided patient data management and / or decision support system, however, provides for an automated evaluation of the microbiological findings.

It can be provided that substep (d3) comprises the steps:

(d31) providing a first electronic database containing a plurality of keywords used to designate pathogens (pathogen keyword); (d32) selecting a first keyword identifying a first agent from the first database and searching the finding for that agent keyword; and

(d33) Identification of a first pathogen if the finding contains the first pathogen keyword from the first database. The first database contains keywords that are typically used to identify pathogens. Such keywords are also referred to as exciter keywords. A keyword does not have to be a single word, it can span several consecutive words. Several keywords may be provided to designate one and the same exciter. In this way, it is ensured that the designation of a pathogen in a microbiological finding can be reliably determined even if it is not exactly designated. For example, the causative terms "Staphylococcus aureus", "S. aureus" or "aureus" can be deposited as the causative cue for the identification of Staphylococcus aureus.

As the first pathogen cue, a keyword is preferably chosen, which designates a pathogen which is very frequently listed in microbiological findings, for example Staphylococcus aureus. However, another first keyword may be chosen, for example, if the existence of a particular agent in the biological sample is expected, for example, because this agent has already been found in a previous biological sample. The specification of the first keyword can be automated. It can also be determined by a doctor. It can be provided that sub-step (d3) further comprises the steps:

(d34) determining an identification string contiguous to the first pathfinder keyword found in the finding; (d35) searching the finding for the identification string or similar strings, where a string resembles the identification string if it contains a digit at a position that differs by n from a digit that is the same Position is located in the identification string, and wherein the value n corresponds to the number of previously identified pathogens; (d36) identifying another pathogen if the finding includes the identification sequence one more time or the similar string; and

(d37) repeating steps (d35) to (d37) to identify further pathogens, unless step (d36) did not result in the identification of another pathogen.

These steps may be followed by step (d33). By means of the identification string or similar strings, patterns, for example numberings, in the microbiological finding are to be used to detect further pathogens.

Alternatively or additionally, it can be provided that sub-step (d3) further comprises the steps:

(d38) selecting a further pathogen keyword that designates a pathogen that has not yet been identified from the first database and searching the finding for that pathogen keyword; and (d39) identifying another pathogen if the finding includes the further causative keyword from the first database.

These steps may be followed by step (d33) or (d37). This is to ensure that all pathogens mentioned in the microbiological findings are actually identified.

It can be provided that sub-step (d4) comprises the steps:

(d41) providing a second electronic database containing a plurality of drug keywords used to designate drugs; (d42) selecting a first drug keyword that designates a first drug from the second database and searching the finding for that drug keyword; and

(d43) Identification of a first active substance if the finding contains the first active substance keyword from the second database and, if indicated, its sensitivity. The first database contains keywords that are typically used to identify drugs. Such keywords are also referred to as drug keywords. A keyword does not have to be a single word, it can span several consecutive words. There may be several keywords to designate one and the same agent. In this way, it is ensured that the designation of an active substance in a microbiological finding can be reliably determined even if it is not exactly designated. For example, the active substance keywords "Cefaclor" "Cefaclorum" or "Cefac" can be deposited as an active ingredient keyword for the identification of the active substance cefaclor.

As the first active ingredient keyword is preferably selected a keyword that names an active ingredient that is very often listed in microbiological findings, such as penicillin. However, another first keyword may be chosen, for example, if the mention of a particular active ingredient in the microbiological finding is expected, for example, because this drug has already been found in a previous microbiological finding, or if the existence of a particular pathogen in the expected and a susceptibility test with a particular drug against which this pathogen is possibly sensitive is standard. The specification of the first keyword can be done automatically. It can also be determined by a doctor. It can be provided that sub-step (d4) further comprises the steps:

(d44) determining an identification string adjacent to the first drug keyword found in the finding;

(d45) searching the finding for the identification string or similar strings, where a string resembles the identification string if it contains a digit at a location that differs by n from a digit that is the same Position is located in the identification string, and wherein the value n corresponds to the number of previously identified active ingredients;

(d46) identifying another active agent if the finding includes the identification sequence once more or the similar string and, if indicated, the sensitivity of the active ingredient; and

(d47) repeating steps (d45) to (d47) to identify additional active ingredients, unless step (d46) did not lead to the identification of another active substance.

These steps may be followed by step (d43). By means of the identification string or similar strings, patterns, for example numbering, in the microbiological finding are to be used to detect further active substances.

Alternatively or additionally, it can be provided that sub-step (d4) further comprises the steps:

(d48) selecting another drug keyword that designates an agent that has not previously been identified from the second database and searching the finding for that keyword; and (d49) Identification of another active substance if the finding contains the further active substance keyword from the second database and, if indicated, the sensitivity of the active substance.

These steps may be followed by step (d43) or (d47). This is to ensure that all pathogens mentioned in the microbiological findings are actually identified. The phrase "sensitivity of the active substance" in steps (d46) and (d49) and the term "its sensitivity" refer to the sensitivity of a pathogen to this active ingredient. Typically, a microbiological finding for each drug is given a sensitivity, which refers to the sensitivity of a pathogen also indicated against this drug. The inventive method may further comprise steps of identifying first and second mapping information if that information does not already arise from the locations where the pathogens and the agents were found. The latter is typically the case. The method of the invention may further comprise the steps of:

(e) providing a third electronic database containing, for each active ingredient, one or more drugs containing that active substance; (f) selecting at least one drug from the third database containing an agent against which the agent determined in step (d2) is sensitive or at least not insensitive, based on the first and second values determined in step (d3); and (g) displaying the at least one drug as a treatment recommendation. The display in step (g) may be on a display device, for example the display of a client computer of the patient data management and / or decision support system. This indication facilitates a physician's choice of a suitable drug to treat the patient's infectious health disorder caused by the identified pathogen. If multiple pathogens have been detected, steps (f) and (g) are repeated for each of these pathogens and the selected medicines can be displayed together as a treatment recommendation. It can be provided that a drug is displayed only once, even if it is proposed for the treatment of two pathogens.

It may further be provided that in the third database further information for the drug of the drug are contained for each drug and that, if the third database contains several drugs against the pathogen determined in step (d2) sensitive or at least not insensitive is selected from those drugs whose site of action, relative to the body of the patient, corresponds to the site affected by the disorder or from which the biological sample originates. For example, if the patient suffers from inflammation of a knee, this ensures that the active ingredient can actually act at the site of the inflammation. The administration of a drug that contains the same active ingredient, but is transported to the lungs and is ineffective in the treatment of the knee is thus avoided.

It may further be provided that, in the third database, there are further data for each drug on the dose with which the drug is to be administered, and the method further comprises the steps:

(h) providing a fourth electronic database containing information about medications that have been or are being administered to the patient; and (i) comparing the drug selected in step (f) and, if the drug is not listed in the fourth database, suggesting a first dose many times greater than the dose recorded in the third database.

In this way, a distinction can be made between an initial therapy in which the patient is given a drug for the first time and a maintenance therapy in which the patient has already been given the drug. In the case of an initial therapy it can be provided that the medicament according to step (i) is given in a dose that is many times higher than in a maintenance therapy. The multiple may be a dose that is two times or more, preferably three times or more, more preferably four times or more, and most preferably five times or more above the dose provided in a maintenance therapy, lies. The dose at which the drug is to be given in maintenance therapy is recorded in step (i) in the third database. The dose at which the drug is given during the initial therapy is the first dose in the meaning of the invention. The amount of the first dose can also be recorded in the third database. It may be provided that the proposal of a first dose in step (i) further includes the suggestion of a first period over which the first dose is to be given and a second dose which is below the first dose when the first period has expired , includes. Preferably, in the third database also the first period, with which a drug is to be given in an initial therapy, is recorded. The second dose may be the dose at which the drug is to be given for maintenance therapy. The second dose may also be recorded in the third database.

The first and second dose, as well as the first period, are recommendations made by the patient data management and / or decision support be automatically generated. These recommendations are not guidelines that should bind the doctor.

Typically, there are several patients in a clinic or department. It can therefore be provided that the method according to the invention in the treatment of several patients in a clinical facility comprises the steps:

(k) providing a fifth electronic database containing information about medications administered to other patients residing in the same medical facility; and

(1) Comparison of the drug selected in step (f) and, if the drug is listed in the fifth database, suggesting another drug containing an active agent against which the causative agent determined in step (d2) is sensitive or at least not insensitive if such other drug is included in the third database.

The treatment of multiple patients with the same drug is thus avoided.

It may be provided that information on the sensitivity of the pathogen to combinations of multiple drugs are recorded in the third database. If no medicament containing an active substance against which the pathogen determined in step (d2) is sensitive or at least not insensitive is present in the third database, the method according to the invention may comprise the steps:

(m) selecting at least one combination of the third database against which the pathogen determined in step (d2) is sensitive or at least not insensitive, based on the first and second values determined in step (d3); and

(n) display the at least one combination as a treatment recommendation. If, for example, a methicillin-resistant Staphylococcus aureus is found to be a pathogen, then this pathogen is resistant to all known active substances. In such a case, combinations of drugs may be used to combat this pathogen, for example, a combination of drugs containing various active ingredients. Such combinations are listed in the third database.

It can also be provided that the method comprises the steps:

(o) providing a sixth electronic database of pathogens requiring isolation of the patient; and

(p) triggering an alarm when a pathogen detected in step (d2) is recorded in the sixth electronic database.

The alarm triggered in step (p) may be an audible or visual alarm. Such an alarm may, for example, be displayed on a display device, for example the display of a client computer of the patient data management and / or decision support system.

It has been shown in some cases that despite the administration of drugs that inhibit or kill pathogens, there is no improvement in the health disorder in the patient being treated. It can be provided that in step (d) the detection of values of mycotic parameters is initiated if the necessity of detecting microbiological parameters was determined at least once in step (c) and none for a predetermined period after the first detection of microbiological parameters Improvement of the health status of the patient could be determined by the parameters of the first group. By a mycotic parameter is meant a microbiological parameter in which the pathogen is a fungus. Typical microbiological findings do not contain information on fungi. Finally, it may be provided that in step (c) the continuous determination of the need to detect microbiological parameters is additionally performed on the basis of a second group of physiological and / or pathological parameters which are predetermined and intended to be determined discontinuously.

The second group of parameters expediently includes those parameters which are determined in the previous medical practice at intervals of 24 hours or more, for example laboratory medical parameters. The second group of parameters includes, for example, parameters obtained by means of blood analyzes.

In carrying out the method according to the invention, it may turn out that a parameter which was originally assigned to the second group must be continuously determined. This parameter can then be transferred from the second to the first group. For example, it may be provided that a parameter of the second group is automatically transferred to the first group if it is determined in step (c) that determinations of this parameter were necessary in two or more successive intervals of less than 24 hours.

A parameter is assigned to the first group if it is continuously detected. Continuous detection is understood to mean the continuous acquisition of values of the parameter or the detection of values of the parameter at intervals of 24 hours or less.

The term "physiological and / or pathological parameter" of the first or second group is understood in particular to mean a value which (a) indicates the measured value of a measured physiological parameter of a patient or of an indicator substance (eg the oxygen partial pressure in a patient) Blood gas analysis, respiratory rate, body temperature, CKMB concentration); and (b) a classification of a physiological condition of a patient (eg yellowing of the facial skin, restlessness of the patient).

As used herein, the term "indicator substance" refers to compounds or elements which, depending on their nature, are produced in biological systems or introduced into biological systems and whose presence or concentration (eg, in a particular organ) is a characteristic of Such compounds and elements include, for example, those produced by tumor cells, induced by a tumor in other body cells and / or altered as tumor-specific substances in their concentration by a tumor Macromolecules, such as proteins, or trace elements Such compounds and elements further include Bonemarker, which are characteristic of bone degradation processes such as osteoporosis, or enzymes that are important for the assessment of the function of organs.

The term "value" or "measured value" of a parameter of the first or second group refers here to all numerical values for a parameter occurring in the medical field (a) (eg an oxygen partial pressure in a blood gas analysis in the amount of 81.2 mmHg , a respiratory rate of 15 breaths per minute, a body temperature of 36.8 ° C, CKMB concentration of 152 ng / ml) or (b) on classification results of a physiological condition of a patient (eg yellow color of the facial skin: no, where classifications by means of statements such as "no" should be assigned a numerical value, for example "0").

Preferably, at least the values of one of the physiological parameters of the first or second group that are characteristic of the presence of a health disorder are determined using an indicator substance. As parameters of the first or second group physiological parameters should be selected, which are assumed on the basis of medical knowledge, that they are related to a particular health disorder, such as respiratory failure. To determine the medical risk of respiratory insufficiency, for example, physiological parameters are used, which are obtained by means of a blood gas analysis. The physiological parameters obtained by means of blood gas analysis may include the pH of the blood, the partial pressure of oxygen of the blood, the partial pressure of carbon dioxide of the blood and the oxygen saturation of the blood. Other physiological parameters which can be used in addition to the blood gas analysis values for estimating the medical risk of respiratory insufficiency in the method according to the invention include the respiratory rate (AF) of the patient and the age and sex of the patient.

The number of parameters of the first group whose values are detected in step (a) should be at least 2. If parameters of a second group are determined, then the number of parameters of the second group should be at least 1, preferably at least 2.

The specification of the parameters of the first group and, if present, the parameter of the second group can be made by a physician. However, it may also be provided that such parameters are automatically proposed by the system, whereby the proposal is based on the stated or suspected health disorder under which the patient suffers.

In accordance with the invention there is further provided a system for monitoring the medical condition of a plurality of patients in accordance with the method of the present invention. The system comprises a processor, a memory, an input device and a display device, wherein the input device allows the user to specify the medical measures taken for each patient; in the memory, the microbiological parameters, their values, the continuously acquired values of parameters of the first group and, if provided, the discontinuously acquired values of the second group of parameters of a plurality of patients and the medical measures taken are stored for each of these patients; the processor determines the need to determine microbiological parameters and / or its values (step (c)) and, if provided, evaluates the microbiological findings received (step (d)); the display device represents the detected microbiological parameters.

Furthermore, the inventively provided databases may be stored in the memory.

The system can be a computer-implemented system. The system may be patient data management and / or decision support system.

The invention will be explained in more detail below with reference to embodiments, which are not intended to limit the invention, with reference to the drawings. 1 shows a schematic representation of a first embodiment of the method according to the invention;

FIG. 2 shows a schematic representation of a screen image of the display device according to the invention; FIG. 3 shows a further schematic representation of a screen image of the display device according to the invention;

4 shows a further schematic representation of a screen image of the display device according to the invention; and

Fig. 5 is a further schematic representation of a screen image of the display device according to the invention.

In the figures la to ld flow diagrams are shown for illustrating an embodiment of the automated method according to the invention for monitoring the medical condition of a patient by means of a patient data management and / or decision support system 51. The system 51 is a computerized system that allows the user to specify a first set of parameters of the patient that are indicative of the existence of a health disorder 101 (see FIG. 1a). The parameters of the first group should be determined continuously. Values are subsequently acquired 102 continuously for the given parameters. On the basis of these values, the necessity of detecting microbiological parameters is continuously determined 103. If such a need is established, microbiological parameters are recorded 104. Details of step 104 are shown in FIGS to ld shown.

Once the need to detect microbiological parameters has been determined, system 51 requests the provision of a biological sample and its transmission to a laboratory for the preparation of a microbiological finding at 105. System 51 determines an expected time at which the arrival of the microbiological sample will begin microbiological findings is expected. The input of the microbiological findings is checked by System 51. 106. If the microbiological findings are not received by the expected time, an alarm is triggered 107. By contrast, if the microbiological result is received by the expected time, a corresponding indication is displayed on the display device of the system 108. After receipt of the microbiological findings, this is automatically evaluated in order to identify the microbiological parameters listed therein, ie pathogens, and all first and second values which are listed in the microbiological findings as a pathogen. The first values are the active substances, the second values are the sensitivity of the pathogen to each of the active substances.

For identification of the first pathogen, a first pathogen keyword is selected 110 from the first database 109. Subsequently, the microbiological finding is searched for this pathogen keyword 111. If the microbiological finding contains the first pathogen keyword, the first pathogen could be included in the finding 112. However, if the first causative keyword is not found, steps 110 through 112 are repeated until a first pathogen has been identified. At the position where the first pathogen is listed in the microbiological finding, an identification string adjacent to the found first exciter keyword is determined 113, for example a multi-digit alphanumeric code, with which the line is initiated, in the the first pathogen in microbiological findings is called. Subsequently, the finding for the identification string or a similar string is searched 114. For example, if the identification string is 101, the first similar string may be 102. If the finding once again contains the identification sequence or if it contains the first similar string, a second pathogen can be identified at the position of the recurrence of the identification string or at the position of occurrence of the similar string 115. Could in this way a second exciter is identified, step 114 is repeated to determine a third occurrence of the identification string or similar string, the similar string now being 103. Step 114 is repeated until no pathogen can be identified. If all pathogens are now identified, then a first active substance keyword is selected from a second database 116 and the finding for this active substance keyword is searched. If the microbiological finding contains the first active substance keyword, the first active ingredient in the finding could be identified. 119. If, on the other hand, the first active ingredient keyword is not found, steps 117 to 119 are repeated until a first active ingredient has been identified.

At the position where the first active substance is listed in the microbiological finding, an identification string which is adjacent to the found first active substance keyword is determined 120, for example a multi-digit alphanumeric code with which the line is introduced, in which the first active ingredient in microbiological findings is called. Subsequently, the finding for the identification string or a similar string is searched 121. For example, if the identification string is 506, the first similar string may be 507. If the finding once again contains the identification sequence or if it contains the first similar string, a second active substance can be identified at the position of the recurrence of the identification string or at the position of occurrence of the similar string 122. Could in this way have become a second Agent is identified, step 121 is repeated to determine a third occurrence of the identification string or similar string, the similar string now being 508. Step 122 is repeated until no pathogen can be identified. Together with each active substance, the data on the susceptibility of the agent to this active substance are determined in the microbiological findings.

In this way, from the microbiological finding all pathogens and the active ingredients that have been tested to determine the sensitivity of each pathogen against these drugs, and the information on the respective sensitivity of a pathogen against these drugs are determined. On the basis of this information, the system 51 then proposes for each pathogen at least one drug which contains an active substance against which this pathogen is sensitive or, if such an active substance does not exist. The term is 124. Available drugs and their active ingredients are listed in the third database 123. If there is no drug in the database 123 with an agent against which the agent is at least intermediate, the system may suggest a combination of drugs. Such combinations are also recorded in the third database 123.

Screen 1 shown in FIG. 2 illustrates how the results of the method according to the invention can be presented to a doctor by means of the system according to the invention. The results refer to a patient identified by case number 2. The previously recorded microbiological findings 3 are listed in a table 4, wherein in each case a report number, the date of taking a biological sample, the receipt of the microbiological findings and internal numbers of the laboratory are given. In addition, multidrug-resistant microbes are reported for each microbiological finding, for example, 15 MRSA (Methicillin-Resistant Staphylococcus aureus), 3-MRGN (Multidrug-resistant Gram-negative rods resistant to three of the four antibiotic groups) and 4-MRGN (Multidrug-resistant Gram-negative rods with resistance to four of the four antibiotic groups). FIG. 2 shows the finding 3a with the finding number 15 from the previously received findings 3, so that details of this finding are displayed. However, the physician can also use button 5 to display the microbiological findings transmitted by the laboratory in its original form. The displayed details include a list 6 which lists the pathogens 7 indicated in the finding 3a. Each pathogen 7 is identified by its name. From the list 6, the pathogen 7a is selected, which is the bacterium Staphylococcus epidermidis. Table 8 shows the active ingredients that were tested in susceptibility tests to determine the susceptibility of pathogen 7a to these drugs. The sensitivity of the pathogen is assigned to the classes "resistant", "intermediate" or "sensitive", whereby the classes are visually separated by a colored coding in table 8. Red stands for resistant, yellow for intermediate, green for sensitive. In addition, in Table 8, MIC values may be given for at least one, preferably all listed active ingredients.

In addition, the drugs 9 are shown, which are used to inhibit or kill the selected pathogen. The presentation is made as a diagram in which the administrations of the drugs 9 are plotted as a function of time. For more details on the medication, the physician may refer to the screens shown in Figures 4 and 5. The screen shown in Figure 4 allows the physician to enter and edit prescriptions. In particular, it may determine the nature of the active ingredient, the drug containing this active ingredient, the dose and the periods of administration of the drug. For this he can use the suggestions that automatically generate the method according to the invention. The screen shown in Fig. 5 gives him an overview of the prescription of the drug in a time-lapse chart as abscissa.

On the screen 1 additionally indicated in the microbiological findings multiresistant pathogens 10 are shown. Details of these multidrug-resistant pathogens, the doctor can be found in the screen shown in Fig. 4. In addition, in Figure 1 of Figure 2, details 11 of the biological sample, namely, material, sampling location, sampling mode and purpose of sampling are shown. The specification of the material identifies the type of biological sample. The purpose of the removal, referred to in Fig. 2 as a question, is the study of the sample on microorganisms and their resistance to drugs. Finally, the infections already diagnosed in the patient 12 are also shown. Details of these infections, the doctor can be found in the screen shown in Fig. 3.

Claims

An automated method of monitoring the medical condition of a patient by means of a patient data management and / or decision support system

(b) continuously acquiring values of parameters of the first group;

(d) acquiring microbiological parameter values when the need to detect microbiological parameters has been determined in step (c), each microbiological parameter being a microbiological agent comprising at least one active agent as the first value and the susceptibility of the agent against that agent as second value; wherein step (d) for detecting microbiological parameters comprises the sub-steps: (dl) providing a biological sample of the patient at a time of delivery and determining an expected time at which no later than the receipt of values of microbiological parameters in the form of a microbiological finding is expected; and

A method according to claim 1, characterized in that, when the microbiological finding has been received, step (d) further comprises the sub-steps:

(d4) determining the first and second values given in the microbiological finding for the microbiological parameters determined in step (d3).

Method according to claim 2, characterized in that sub-step (d3) comprises the steps:

(d31) providing a first electronic database containing a

Variety of keywords that are used to designate pathogens (pathogen keyword);

(d32) selecting a first keyword identifying a first agent from the first database and searching the finding for that agent keyword; and (d33) Identification of a first pathogen if the finding contains the first pathogen keyword from the first database.

A method according to claim 3, characterized in that sub-step (d3) further comprises the steps of:

(d34) determining an identification string contiguous to the first pathfinder keyword found in the finding;

(d35) searching the finding for the identification string or a similar string, where a string resembles the identification string if it contains a digit at a position that differs by n from a digit that is the same Position is located in the identification string, and wherein the value n corresponds to the number of previously identified pathogens;

(d36) identifying another pathogen if the finding includes the identification sequence one more time or the similar string; and

(d37) repeating steps (d35) to (d37) to identify additional ones

Pathogen, unless step (d36) did not lead to the identification of another pathogen.

A method according to claim 3 or claim 4, characterized in that it further comprises the steps

(d38) selecting a further exciter keyword that designates a pathogen that has not yet been identified from the first one Database and searching the findings for this pathogen keyword; and

(d39) Identification of another pathogen if the finding contains the further pathogen keyword from the first database.

6. The method according to any one of claims 2 to 5, characterized in that sub-step (d4) comprises the steps:

(d41) providing a second electronic database containing a plurality of drug keywords used to designate drugs;

(d42) selecting a first drug keyword that is a first

Drug labeled, from the second database and searching the findings for this drug keyword; and

(d43) Identification of a first active substance if the finding is the first

Contains drug keyword from the second database, and, if indicated, its sensitivity.

A method according to claim 6, characterized in that substep (d4) further comprises the steps of:

(d44) determining an identification string contiguous to the first drug keyword found in the finding;

(d45) Searching the Find by Identification String or Similar Strings, where a string resembles the Identifier string when placed in a position Contains a digit which differs by the value n from a digit located at the same position in the identification string, and where the value n corresponds to the number of previously identified active substances;

(d46) Identification of another active substance if the finding is

Identification sequence one more time or the similar string contains, and if indicated, the sensitivity of the drug; and

(d47) repeating steps (d45) to (d47) to identify additional ones

Active substances, unless step (d46) has not led to the identification of another active substance.

A method according to claim 6 or claim 7, characterized in that it further comprises the steps

(d48) Selecting another drug keyword that designates an agent that has not previously been identified from the second database and searching the report for it

Drug keyword; and

Identification of another active substance if the finding contains the additional active substance keyword from the second database and, if indicated, the sensitivity of the active substance.

Method according to one of claims 2 to 8, characterized in that further comprises the steps: (e) providing a third electronic database containing, for each active ingredient, one or more drugs containing that active substance;

(f) selecting at least one drug from the third database containing an agent against which the agent determined in step (d2) is sensitive or at least not insensitive, based on the first and second values determined in step (d3); and

(g) display of the at least one drug as a treatment recommendation.

10. The method according to claim 9, characterized in that in the third database also for each drug information on the site of action of the drug are included and that, if the third database contains several drugs against the in step (d2) determined pathogens sensitive or at least It is not insensitive to choose from these medicaments a drug whose site of action, relative to the body of the patient, corresponds to the place affected by the disorder or from which the biological sample originates.

11. The method according to claim 9 or claim 10, characterized in that in the third database also for each drug are listed dose data with which the drug is to be administered, and the method further comprises the steps:

(h) providing a fourth electronic database containing information about medications that have been or are being administered to the patient; and

(i) comparing the drug selected in step (f) and, if the drug is not listed in the fourth database, suggesting a first dose many times higher than the dose recorded in the third database.

A method according to claim 11, characterized in that the proposal of a first dose in step (i) further proposes a first period over which the first dose is to be given and a second dose which is below the first dose, if the first Period has expired.

Method according to one of claims 9 to 12, characterized in that it further comprises the steps of treating a plurality of patients in a clinical facility:

Providing a fifth electronic database containing information on medications administered to other patients residing in the same medical facility; and

Comparing the drug selected in step (f) and, if the drug is listed in the fifth database, suggesting another drug containing an active agent against which the causative agent determined in step (d2) is sensitive or at least not insensitive when such other drug is included in the third database.

Method according to one of claims 9 to 13, characterized in that information on the sensitivity of the pathogen to combinations of several drugs are recorded in the third database and, if no drug is contained in the third database containing an active ingredient against which in Step (d2) is sensitive or at least not insensitive, comprising the steps of: (m) selecting at least one combination of the third database against which the pathogen determined in step (d2) is sensitive or at least not insensitive, based on the first and second values determined in step (d3); and

(n) display the at least one combination as a treatment recommendation.

15. The method according to any one of claims 2 to 14, characterized in that it further comprises the steps:

(p) triggering an alarm if a pathogen detected in step (d2) is recorded in the sixth electronic database.

16. Method according to one of the preceding claims, characterized in that in step (d) the detection of values of mycotic parameters is initiated if in step (c) the necessity of detecting microbiological parameters has been determined at least once and over a predetermined period of time after the initial detection of microbiological parameters no improvement in the patient's health could be established by the parameters of the first group.

17. The method according to any one of the preceding claims, characterized in that in step (c) the continuous determination of the need to detect microbiological parameters is additionally performed on the basis of a second group of parameters that are predetermined and to be determined discontinuously.