WO2005079660A1

WO2005079660A1 - Method and device for verifying the adherence to a performance specification for a medical procedure performed on a patient

Info

Publication number: WO2005079660A1
Application number: PCT/EP2005/050402
Authority: WO
Inventors: Klaus Abraham-Fuchs; Rainer Kuth; Eva Rumpel; Markus Schmidt; Siegfried Schneider; Horst Schreiner; Gudrun Zahlmann
Original assignee: Siemens Aktiengesellschaft
Priority date: 2004-02-18
Filing date: 2005-01-31
Publication date: 2005-09-01

Abstract

According to a method for verifying the adherence to a performance specification for a medical procedure performed on a patient, an optically detectable verification criterion is assigned to the performance specification when performing the procedure. The procedure is performed on the patient. Image data from the performance of the measure are generated by a camera system and transmitted to an image processing system. The image data are evaluated by the image processing system by using the verification criterion, and a measure reflecting the adherence to the performance specification is established. A corresponding device comprises a camera system, which generates image data and which is oriented toward a medical workstation for performing the procedure. This device contains an image processing system and a memory for storing a verification criterion that can be optically detected when performing the measure.

Description

description

Method and device for checking compliance with an implementation regulation for a medical measure performed on a patient

The invention relates to a method and a device for checking compliance with an implementation regulation for a medical measure performed on a patient.

Many medical measures performed on a patient, such as Examinations, treatments or measurements are subject to implementing regulations. These can be medical guidelines in everyday clinical practice or detailed SOPs (Standard Operating Procedures) in the study protocol of a clinical study in which the patient takes part.

The implementing regulations and instructions are laid down in written or text form in the study protocol or the medical guidelines. The persons responsible for implementation in accordance with the relevant regulations have so far confirmed compliance by signature. The problem here is that they often do this, even though they do not implement the measure themselves, but delegate it and therefore cannot guarantee compliance or, for various reasons, confirm compliance even though the implementing regulations have not been complied with. For checking compliance with the implementation regulations, e.g. the client of a clinical study can only check the signatures. There is no objective measure of whether the regulation was actually complied with.

In day-to-day clinical practice, the lack of compliance with implementation regulations deteriorates the quality of the corresponding measure, and the recovery of patients is delayed. device and measured values are difficult to compare. Above all, in the case of approval-relevant drug studies, it is of the utmost importance to comply with the implementation regulations as precisely as possible, since this depends, for example, on the scatter of the measurement values collected as part of the study, and a large scatter disguises the final result of the study or jeopardizes the approval of the drug.

At the time of a clinical trial, large financial resources have already been invested in the research and development of a new drug. This means that compliance with the study protocol, i.e. its exact adherence as possible, is of great economic importance. Because of the usually large scatter of measured values, a large number of patients have to be enrolled in clinical studies in order to achieve statistically significant results.

The invention is based on the object of proposing a method in which the checking of compliance with implementing regulations for medical measures is improved. The invention is also based on the object of specifying a device which is suitable for carrying out the method.

With regard to the method, the object is achieved by a method for checking compliance with an implementation regulation. The implementing regulation relates to a medical measure carried out on a patient. The method has the following steps: A test criterion is assigned to the implementation rule, which can be optically determined when the measure is carried out. The measure is carried out on the patient. Image data from the implementation of the measure on the patient are generated by a camera system and transmitted to an image processing system. The image processing system evaluates the image data on the basis of the test criterion and determines a measure for compliance with the implementation regulations when carrying out the measure. Medical measures on patients include examinations, treatments, determination of measured values or therapies. The measure can be carried out by a person responsible for the measure, for example by a doctor or nursing staff (injection, blood pressure measurement) or by the patient himself (observing a rest period, physical activity, taking medication).

Many aspects of an implementation regulation for a measure can be optically recorded and their compliance can thus be optically checked. For example, Blood pressure or pulse in a sitting position can be determined after observing a patient's minimum rest phase of a few minutes, so the sitting posture, in contrast to a lying or standing position, and the sitting time can be determined optically. The positioning of the blood pressure cuff at the correct position and the time of the measurement can also be detected or checked in this way.

Such characteristics of the implementing regulation are suitable as test criteria and can be formulated accordingly as such. Such optically usable information relating to the measure is recorded or captured in image data by the camera system, so that it can then be further processed electronically or automatically. The following are examples of test criteria: the patient sits, lies, has his eyes open or closed, a blood pressure cuff sits on the upper arm in the correct position, the patient takes a medication, sleeps or wakes up, maintaining a resting phase while lying down for a certain period of time or the performance of physical exercises, a measuring station is used at a certain time, the irradiation of a patient with infrared takes place for a given time.

The assignment of a test criterion to the measure provides a verifiable yardstick for compliance. Will the Progress, i.e. the actual implementation of the measure followed by a camera and converted into image data, the implementation is documented and the image data can be assessed objectively and reproducibly. The optically detectable criteria can thus be extracted and assessed from the image data. This is done by the image processing system. This evaluates the image data in terms of compliance with the test criteria. For this purpose it uses, for example, pattern recognition, motion detection or edge detection.

The degree of compliance with the test criteria provides a measure, e.g. a numerical value in percent, which reflects compliance with the test criteria. The image processing system that evaluates the image data is objective, e.g. not more or less attentive and cannot be influenced. Appropriate algorithms implemented in the image processing system are used to objectively and consistently produce parameters for the test criteria from the image data, which are assigned to the actual implementation of the measure. This can e.g. be an angle that the patient's torso makes to the vertical, a length of time for how long the patient is motionless or the time at which the patient opens his eyes. The corresponding determined dimensions are output by the image processing system and are therefore available as objective information, e.g. in

Form of a numerical value is available and can be included in a measurement protocol of the medical measure.

If compliance with the implementation regulations can be ensured prior to a clinical trial, fewer patients need to be enrolled, which in turn saves a considerable amount of money and time. The number of patients required for the study is reached faster and the study can start earlier.

Compliance with the implementing regulations or framework conditions defined for the measure is also in the sense of the patient, since this increases the quality of the measure, for example physiotherapy, and thus grants the patient the fastest possible recovery from an illness. In the case of measurements, the most accurate and comparable measurement values of a parameter determined on the patient can be determined. This ensures the comparability of measurement parameters between different patients.

An additional effort for the staff involved, namely the evaluation of test reports, verification of signatures etc. - usually at a later point in time, i.e. after the measure has been carried out. This means e.g. saving time and effort in the quality assurance of a clinical study. Adherence to therapy is significantly improved in everyday clinical practice.

The check can be carried out promptly on or during the implementation of the measure, so that a warning can be issued to the person carrying out the measure if the regulations are not complied with. If this is compatible with the regulations, a measure can also be repeated and still be carried out according to the regulations. If the regulation is not complied with, a message, e.g. additionally with a suggestion for improvement for the next implementation, or the person in question is reminded of the regulation. In this way systematic errors can be avoided, e.g. pull through a complete clinical trial.

The process provides a process chain that allows automatic or electronic checking of compliance with the implementation regulations when the measure is actually carried out.

An optically detectable core parameter can be assigned to the implementation rule as a test criterion. In order to comply with the implementation regulation, a target value for set the core parameter. The image processing system uses the image data to determine an actual value for the core parameter. The measure for compliance with the implementation regulation is determined from the comparison of the setpoint and actual value.

The core parameter is e.g. the angular value that a patient's upper body takes up against the vertical or a time period in minutes between the administration of a medication and the patient's waking up. Setpoints for the correct implementation of the measure and actual values for their actual implementation can be defined here in a simple manner as numerical values or numerical ranges (angle in degrees, number of minutes). The comparison of the actual and target value is then particularly simple. The degree of deviation of the actual implementation from the regulation can also be easily determined quantitatively. For example, medical personnel or a patient are trained in a measure, whereby a decreasing difference between the setpoint and actual value provides information about progress in practicing the measure.

A yes / no signal can be issued as a measure of compliance with the implementation regulation. The yes signal means that the medical measure was carried out correctly, i.e. according to the regulations. The output of a No value indicates to the patient or the person responsible that there is a deviation from the specified measurement conditions or the test protocol. The corresponding process can then be repeated or treated as unusable. Does the patient hold e.g. If a resting phase arranged before a measurement does not occur, the doctor knows that he does not need to take the measurement at all. The output of a binary yes / no signal does not allow any room for interpretation and thus relieves the person carrying out the measure with regard to responsibility and decisions. A clear structuring of work processes is possible because there are no different ways for different degrees of

Compliance must be provided. Especially in In an automated process chain, binary decisions can easily be reused.

As a medical measure, a measured value can be collected from a patient as part of a clinical study. at

Yes signal, the measured value for the study is released and stored in a study database.

The measured value can be determined here, for example, by a blood pressure measurement, a pulse measurement or a blood sample with a subsequent blood analysis. As test criteria e.g. an upright sitting posture, a break of several minutes before the pulse measurement or taking medication immediately before taking blood. The yes / no signal informs the person carrying out the measurement whether the determined measured value is valid or not. In the event of an invalid case, the measurement can be repeated if necessary or the measured value determined can be treated as invalid. Is this e.g. Part of a series of measurements, it is not recorded and therefore does not falsify the series of measurements.

With a no signal, e.g. Depending on the stipulation in the implementation regulation, either the measured value is rejected, i.e. declared invalid, e.g. if the measurement can only be carried out once at a certain point in time or the measurement is repeated, e.g. if a measured value only has to be determined once a day at any time.

The study database contains all data, measurements, etc. recorded in the course of the study. The final evaluation of the study is carried out on the study database after completion of the data acquisition. The quality of the results of the study is significantly increased because the database does not contain any falsified measurement values, i.e. measurements that were not determined in accordance with the implementing regulation. The scatter of measured values in the study database of the clinical study due to Exercise errors are significantly reduced. The quality of the data improved significantly.

Up to now, such errors have to be compensated for by an increased number of study participants. The method according to the invention therefore leads to the fact that the quality control in the clinical study starts at the earliest possible point in time, namely when the measured values are collected. This means fewer patients have to take part in the study and the costs and effort for the medical study are reduced.

With regard to the device operating according to the method, the object is achieved by a device for checking compliance with an implementation regulation for a medical measure carried out on a patient. The device contains a camera system which generates image data and which is aimed at a medical work station for carrying out the measure. An image processing system is connected to the camera system. The device contains a memory for storing a test criterion that can be optically recorded when the measure is carried out.

A workplace is any place where a medical measure is carried out on a patient. This can e.g. a treatment room, a hospital room, a laboratory place, a therapy place or an open area.

The camera, which is geared towards the patient or the workplace, allows the medical measure to be observed on the patient and documented with image data in the form of, for example, film recordings, or to visually depict the implementation of the measure in image data. The image data recorded during the medical measure is evaluated or evaluated in the image processing system. For this purpose, algorithms are stored in the image processing system which evaluate the image information, for example for motion detection, edge filtering or position detection. The algorithms are selected so that they implement test criteria of the implementation regulation, which can be optically recorded, as a measure of compliance with the corresponding test criterion.

The image processing system can measure accordingly e.g. Output on a display or terminal or transmit it to another data processing device.

In a preferred embodiment, the image processing system is connected to a database system which records data from a clinical study.

This ensures that the study database is informed whether the medical measure has been carried out correctly without an intermediate manual step and thus without the possibility of manipulation or susceptibility to errors.

In addition, a measuring device that performs a measurement on the patient during the medical process and ascertains a measured value can also be connected to the image processing system.

As a result, the measured value on the patient determined in the measurement process can be recorded in the database system when released by the image processing system and thus as a valid date of the medical study in the database without a manual intermediate step. This effectively prevents manipulation of the study by manual entry or reading and transmission of measured values without approval by the image processing system.

For a further description of the invention, reference is made to the exemplary embodiments of the drawings. Each shows in a basic diagram: Fig. 1 shows a medical work station with patient, doctor and camera system, Fig. 2 shows a flow chart for a measurement process carried out at the work station from Fig. 1 as part of a clinical study.

1 shows a medical work station 2 to which a camera system 4 detecting it is oriented. The camera system 4 is connected to a database station 6, which does not show a memory. The medical work station 2 contains a patient table 8 on which a patient 10 rests, on which a blood pressure measurement 7 is carried out.

Patient 10 is a clinical trial participant. A study doctor 14 is assigned to the patient 10, who supervises the doctor during the study. An antihypertensive drug 11 is being tested in the study. The study protocol prescribes the following implementation instructions (15) for the medical measure “blood pressure measurement” 7 for patients 10 stored in the database station 6: - The medication 11 must be administered to the patient 10 at 8 am - The patient 10 must then - The patient's blood pressure must be determined 10 hours after the medication has been administered - The patient may only stand up after the blood pressure measurement - If the measurement conditions are not met, the measurement value is discarded and the measurement cannot be repeated Blood pressure values determined in accordance with the regulations are to be stored in a study database 60.

The drug administration is shown in Fig.l by the arrow 13 and takes place at 8:04 a.m. by the patient taking the medication ment 11 swallows in the form of a capsule. The patient 10 then rests in the position shown in FIG.

To measure blood pressure (7), the doctor 14 presses a start button (not shown) of an automatic blood pressure monitor 16 at 8:37 a.m. The blood pressure monitor comprises a cuff 18 fastened to the upper arm 12 of the patient 10 and a base station 20 which are connected to one another via a connecting line 22. The measured value 51 determined for the blood pressure is stored in the base station 20 at 8:37 am and stored there together with the time.

The entire medical measure is observed by the patient 10 from entering the work place 2 until the blood pressure measurement is completed by the camera system 4, the camera 24 filming the entire process, that is to say generating image data 43 thereof and storing it in the camera 24. The camera 24 is connected to the image processing system 28 via a data line 26. An output unit 34 in the form of a screen is attached to the image processing system 28. Messages and information from the image processing system 28 can be displayed on this.

The base station 20 is connected to the image processing system 28 via a data line 30. The database station 6 is also connected to the image processing system 28 via a data line 32.

In order to be able to check compliance with the study protocol when measuring blood pressure, e.g. by a team of experts, optically detectable test criteria 31, which are also stored in the database station 6:

- The time T1 is the time at which the patient 10 takes the medication 11.

- The time T3 is the time of the blood pressure measurement. - The period T2 is the period from T1 to T3 during which the patient must lie.

- The patient lies when the central longitudinal axis 70 of the upper body of the patient 10 takes an angle 74 of less than +/- 15 ° with the horizontal 72.

These test criteria are assigned numerical values 47 or ranges for the test criteria 31, which are tolerable within the scope of the measurement. They are stored in a setpoint memory 29:

- Tl between 7:55 a.m. and 8:05 a.m.

- T3 is 30-35 minutes after Tl.

- The patient must lie down during T2.

FIG. 2 shows the flowchart 40 of the entire medical measure explained in connection with FIG. 1.

In the processing step “data input” 42, the image data 43 recorded by the camera 24, that is to say the film material, are transmitted to the image processing system 28 via the data line 26.

In the image processing system 28, the processing step "parameter extraction" 44 is carried out using image processing methods. The image data 43 is evaluated automatically. For the example explained in FIG. 1, actual values 45 are determined from the image data 43 for the following test criteria 31: - Tl is the time of drug delivery, i.e. the time when the patient delivers the drug to the mouth.

- T3 is the point in time at which the doctor 14 actuates the start button on the blood pressure monitor 16.

- In the time range from T1 to T3, the angle 74 is determined once per second. The actual values 45 obtained from the image data 43 are transmitted to a “comparison step” 46. This is also carried out by the image processing system, which thus also serves as an evaluation unit. There they are compared with the target values 47. The result is: T1 lies at 8: 04 o'clock in the permitted range T3 is also in the permitted range at 8:37 a.m. (33 minutes after Tl) .The angle 74 fluctuates in the time frame Tl to T3 between -12 ° and + 8 ° and is therefore also in the permitted range.

In comparison step 46, a decision is made as to whether the actual values 45 meet the target values 47 of the test criteria, that is to say the measurement was carried out in accordance with the SOP. Ultimately, it is therefore decided in the comparison step 46 on the basis of the image data 43 whether the entire measurement process has complied with the measurement specification and thus the measurement values 51 are valid or invalid. The test criteria 31 are met in the present case and thus the measured value 51 determined is declared valid.

The measurement values 51 are, as the measuring process is valid so properly im- .. _* read step "data input" 50, ie from the base station 20 via data line 30 to the image processing system 28 transmitted. Since the comparison 46 provides the yes decision 56 , the measured values 51 are provided with the corresponding patient data, time information, etc. in the “release step” 58 and are stored in the study database 60 via the data line 32.

Alternatively, the course of a measurement that is not in accordance with the regulations is explained below. The blood pressure measurement takes place at 8:45 a.m. The time period T2 is then 41 minutes. The measurement regulations are not complied with, which is determined on the basis of the test criteria, that is to say the comparison of the actual value 45 of T2 with the target value 47 of T2. The comparison step 46 provides a no decision 52.

A corresponding error message 54 is therefore output on the output unit 34 of the image processing system 28. This means that the blood pressure value was determined 6 minutes late, the measurement cannot be repeated and the measured blood pressure value is not included in the study. As a reminder for the next measurement on the following day, the doctor is again shown that he must measure blood pressure 30-35 minutes after taking the medication.

It applies to the entire device according to FIG. 1 that the locations at which data are stored are only assigned to specific devices etc. by way of example. For example, The test criteria 31 or implementation regulations 15 can also be stored remotely in a memory connected via a network.

Claims

claims

1. A method for checking compliance with an implementation regulation (15) for a medical measure (7) carried out on a patient (10), comprising the following steps:

- The implementation rule (15) is assigned a test criterion (31) that can be optically determined when the measure (7) is carried out,

- the measure is carried out on the patient (10), - image data (43) from the implementation of the measure (7) are generated by a camera system (4) and transmitted to an image processing system (28),

- The image data (43) are evaluated by the image processing system (28) on the basis of the test criterion (7) and a measure of compliance with the implementation regulation (15) is determined.

2. The method according to claim 1, wherein

- The implementation regulation (15) is assigned an optically detectable core parameter as a test criterion (7),

- a setpoint (47) for the core parameter is defined for compliance with the implementation regulation (15),

- The image processing system (28) determines an actual value (45) for the core parameter from the image data (43), - The measure for compliance with the implementation regulation (15) is determined from the comparison of the setpoint and actual value (47, 45).

3. The method according to claim 1 or 2, in which a yes / no signal (52, 56) is determined as a measure of compliance with the implementing regulation (15).

4. The method of claim 3, wherein:

- As a medical measure (7), a measured value (51) is collected on a patient (10) as part of a clinical study, - With a yes signal (56), the measured value (51) is released for the study and stored in a study database (60).

5. The method according to any one of the preceding claims, which is carried out automatically when a measure (7) is carried out.

6. Device for checking compliance with an implementation regulation (15) for a medical measure (7) carried out on a patient (10), with image data (43) aimed at a medical work station (2) for carrying out the measure (7) ) producing camera system (4), with an image processing system (28), with a memory (6) for storing a test criterion (15) that can be optically determined when the measure (7) is carried out.

7. Device according to claim 6, with a, a measured value (51) forming medical measuring device (16) and a data transmission interface (32) to a study database (60).