MEDICAL SYSTEM AND METHOD FOR DETERMINING A MAINTENANCE NEED OF A FIBER OPTIC COMPONENT OF THE MEDICAL SYSTEM
Patent Information
- Application Number
- DE502020010990
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-07-26
- Filing Date
- 2020-07-13
- Publication Date
- 2025-05-22
- Estimated Expiration
- 2040-07-13
AI Technical Summary
Existing medical systems lack a reliable and precise method to determine the maintenance requirement of light guidance components, such as light sources, lighting cables, camera heads, and endoscopes, leading to potential suboptimal functionality or premature maintenance.
A medical system that includes a data processing unit and lighting components, which collects historical data on light intensity parameters, lighting component configurations, and external intervention parameters during medical procedures. This data is used to calculate trends and generate maintenance requirement reports if specified limits are exceeded.
The system provides a reliable and precise method to determine maintenance needs of light guidance components, ensuring optimal functionality and reducing unnecessary maintenance by identifying damage to light guide fibers.
Description
[0001] The invention relates to a medical system comprising a data processing unit and optical fiber components, namely a light source, a fiber optic cable, a camera head, and an endoscope, through each of which a bundle of optical fibers is guided. Furthermore, the invention relates to a method for determining the maintenance requirement of an optical fiber component of a medical system comprising a light source, a fiber optic cable, a camera head, and an endoscope as optical fiber components, wherein a bundle of optical fibers is guided through each of the optical fiber components.
[0002] Medical endoscopes are regularly serviced to ensure their optimal functionality. Regular maintenance ensures that the inevitable wear and tear that occurs with frequent use and subsequent reprocessing of the endoscope does not negatively impact the functionality of the endoscope. Possible signs of wear include, for example, reduced image quality or insufficient illumination of the endoscope's field of view.
[0003] To determine when an endoscope requires maintenance, the number of times it has been used is often totaled. Alternatively, the number of times the endoscope has been reprocessed is counted. Once a specified maximum value is reached, the endoscope is sent to the manufacturer for maintenance, for example.
[0004] US Pat. No. 4,996,975 A discloses an endoscope that uses various usage data to determine whether the endoscope requires maintenance. This usage data includes, for example, the number of times a particular switch is actuated. Based on the number of times this switch is actuated, an algorithm determines whether the endoscope requires maintenance.
[0005] However, the actual maintenance requirements of an endoscope can only be estimated by adding up the number of uses and reprocessing cycles. It is possible, for example, that an endoscope is scheduled for maintenance even though it continues to function optimally despite frequent use. On the other hand, endoscopes may be scheduled for medical procedures that no longer achieve optimal functionality.
[0006] US 2016 / 0015247 A1 discloses a method and device for examining the light and / or image transmission properties of an endoscope or exoscope system. The light intensity emitted by the endoscope or exoscope system is measured to determine the quality of a combination of components used.
[0007] US 2011 / 0193948 A1 discloses a system for establishing a wireless connection between an endoscope and a camera head. Video signal processing parameters of the camera head are automatically adjusted based on the characteristics of a connected endoscope.
[0008] It is an object of the invention to provide a medical system and a method with which a maintenance requirement of the light guide components of the medical system, in particular a light source, a light guide cable, a camera head and an endoscope of the medical system, can be determined more reliably and precisely.
[0009] This object is achieved by a medical system according to claim 1, comprising a data processing unit and optical fiber components, namely a light source, a fiber optic cable, a camera head and an endoscope, through each of which a bundle of optical fibers is guided, wherein the medical system is further developed in that the data processing unit is configured to determine a maintenance requirement of the optical fiber components by recording the following data during a medical procedure and storing it as historical data: a luminous intensity parameter value of the light source that correlates with a luminous intensity emitted by the light source during the medical procedure, a light guide component parameter set that describes a configuration of the light guide components used during the medical procedure, an external procedure parameter that describes the type of medical procedure, wherein the data processing unit is further configured to to determine a trend of the light intensity parameter from the historical data of at least two medical interventions with the same fiber optic component parameter set and the same external intervention parameters and to generate a maintenance requirement message if a deviation exceeding a predeterminable limit value is detected in the trend, and to output the maintenance requirement message.
[0010] The invention is based on the consideration that the need for maintenance of the fiber optic components of a medical system, in particular the fiber optic cable, the camera head, and / or the endoscope, is often due to damage to the bundle of optical fibers contained in these components. Broken optical fibers lead to light scattering within the fiber bundle and thus reduce the brightness with which the endoscope's field of view is illuminated. To achieve sufficient brightness despite broken optical fibers, a user of the endoscope will increase the light intensity of the light source accordingly during a medical procedure. Alternatively, the light source is operated such that the sufficient, preferably predetermined or predefined, brightness is achieved automatically.The value of the luminous intensity parameter, which correlates with the luminous intensity of the light source, is thus an indirect indicator of the maintenance requirements of the light-guiding components. The luminous intensity parameter is, for example, the current at which the light source is operated.
[0011] To determine the maintenance requirements of a fiber optic component, it must first be identified. For this purpose, the parameter set describing the configuration of the fiber optic components is recorded. This parameter set describes which of the fiber optic components are used together as a medical system. Individual components are identified, for example, based on their serial number.
[0012] In order to reliably determine maintenance requirements, it must also be taken into account that the light intensity of the light source depends not only on the number of broken optical fibers, but also on other external parameters of the medical procedure, the external procedure parameters. The influence of the external procedure parameters on the light intensity parameter differs depending on the type and / or execution of the medical procedure. For example, some types of medical procedures require stronger lighting, so a higher value for the light intensity parameter can generally be determined for these. Stronger lighting may also be necessary during individual phases of a medical procedure. Neither of these circumstances correlates with the need for maintenance of the light guides, so they must be isolated during data acquisition and processing.
[0013] For this reason, historical data sets are stored that include not only the luminous intensity parameter value, but also the associated fiber optic component parameter set and external intervention parameters. A luminous intensity parameter trend is then calculated from the historical data from multiple medical interventions. This is an adjusted trend of the light source's luminous intensity across several comparable medical interventions, taking the configuration of the fiber optic components into account in each case.
[0014] To calculate the trend of the luminous intensity parameter, only those values of the luminous intensity parameter that were recorded under essentially identical conditions are considered. This prevents a change in the luminous intensity parameter caused by a change in at least one external intervention parameter or in the fiber optic component parameter set from occurring in the trend, particularly over time. If a change in the luminous intensity parameter is detected in the trend, this change can be attributed to damage to the optical fibers. In this way, a maintenance requirement for the fiber optic components is reliably detected, and a maintenance requirement message is generated.
[0015] The maintenance requirement notification is primarily issued to technical personnel responsible for maintaining medical devices. This can be internal or external personnel. The maintenance requirement notification is primarily issued electronically. In this context, a message can be issued via an interface of the medical system or, in the simplest case, a warning light is activated.
[0016] The endoscope is, in particular, a video endoscope. In the context of this description, an endoscope is understood to mean both an endoscope with a rigid shaft and an endoscope with a flexible shaft. The data processing unit is, in particular, a computer, server, or the like.
[0017] According to one embodiment, the medical system is further developed in that the external intervention parameter comprises one or more of the following parameters: a phase parameter that characterizes a phase of the medical intervention, a user parameter that characterizes user data of the medical personnel performing the medical intervention, a patient parameter that includes data characteristic of a patient, a support system parameter that includes at least one parameter of a medical decision support system.
[0018] It has been recognized that the value of the light intensity parameter during a medical procedure depends on certain external procedure parameters. These external procedure parameters include the procedure type parameter, which characterizes the type of medical procedure. This information is important because certain types of medical procedures require greater brightness than others. The phase of the medical procedure also plays a role in the value of the light intensity parameter. In certain, for example, particularly critical phases of a medical procedure, a higher light intensity is required than in other phases. For this reason, the value of the light intensity parameter, the parameter set, and at least one external procedure parameter are recorded for each phase of the medical procedure.
[0019] The user parameter includes or identifies information about the usage behavior and / or preferences of medical personnel. For example, this takes into account the fact that a first physician regularly sets a higher light intensity than a second physician during a specific medical procedure.
[0020] The patient parameter includes or characterizes information that can affect the value of the light intensity parameter during a medical procedure on the patient. This includes, for example, the patient's general health status, body mass index (BMI), and / or body fat percentage.
[0021] The support system parameter characterizes the influence of a clinical decision support system. Such a system is often referred to as a CDS (Clinical Decision Support System). This system can indirectly influence the service life of the fiber optic components by providing medical personnel with suggested actions or instructions. The behavior of the medical personnel, in turn, directly influences the wear situation.
[0022] According to a further advantageous embodiment, the medical system is further developed in that the data processing unit is configured to receive the external intervention parameter from a hospital information system and / or from an input device operable by medical personnel.
[0023] It is further provided in particular that the data processing unit is configured to receive the luminous intensity parameter value.
[0024] The light intensity parameter value, the fiber optic component parameter set, and the external intervention parameter are transmitted to the data processing unit. The light intensity parameter value is transmitted, for example, via an interface to which the light source is coupled and controlled. The parameters are transmitted from one or more data sources. In particular, identification information of the endoscope and / or the camera head is transmitted from a video processor coupled to the endoscope and / or the camera head to the interface and processed by the data processing unit. Identification information of the fiber optic cable can be transmitted, for example, via RFID (radio frequency identification) technology. The interface is therefore, for example, an RFID interface. The user data of the medical personnel is also transmitted, for example, using RFID technology.
[0025] The input device is, in particular, a portable device or one permanently installed in an operating room, through which medical personnel transmit user data, for example. The transmission, preferably wireless, also occurs, in particular, using RFID technology or other technologies such as WLAN (Wireless Local Area Network). Additional external intervention parameters are transmitted, in particular, directly from the hospital information system to the data processing unit. For this purpose, the data processing unit is connected to the hospital information system either wired or wirelessly.
[0026] According to a further advantageous embodiment, the medical system is further developed in that the data processing unit is configured to record at least two different external intervention parameters.
[0027] For example, the medical system simultaneously records the user data of a surgeon and the type of medical procedure. This data can be transmitted, for example, from the hospital information system. It is also possible for the data to originate from different data sources; for example, a first piece of information can be obtained from the hospital information system, while a second piece of information is read via an RFID interface. By recording multiple external input parameters, the influence of the external procedure parameters on the trend of the light intensity parameter can be very effectively corrected.
[0028] According to a further embodiment, the medical system is further developed in that the data processing unit is configured to determine at least two trends of the light intensity parameter which are based on different light guide component parameter sets, wherein the two different light guide component parameter sets describe configurations of the light guide components in which a first light guide component matches and a second and third light guide component differ, wherein the data processing unit is configured to generate a maintenance requirement message for the first light guide component if a change in the light intensity parameter which exceeds a predefinable limit value can be detected in all trends.
[0029] To determine which of the fiber optic components used requires maintenance, several trends are examined. Specifically, temporal trends in which the configuration of the fiber optic components changes are examined. This allows the fiber optic component responsible for a change in the light intensity parameter to be identified. For example, if a change in the light intensity parameter occurs in the trends of all medical procedures in which a first fiber optic component was used, this is a strong indication that this component requires maintenance because some of the optical fibers in the first fiber optic component have broken.
[0030] The object is further achieved by a method for determining a maintenance requirement of a light-guiding component of a medical system according to claim 5, comprising a light source, a light-guiding cable, a camera head and an endoscope as light-guiding components, wherein a bundle of light-guiding fibers is guided through each of the light-guiding components, and wherein the method is further developed by the following method steps: Capturing the following data during a medical procedure and storing this data as historical data: a luminous intensity parameter value of the light source which correlates with a luminous intensity emitted by the light source during the medical procedure, a light guide component parameter set which describes a configuration of the light guide components used during the medical procedure, an external procedure parameter which describes the type of medical procedure, the method further comprising the following steps: calculating a trend of the luminous intensity parameter from the historical data of at least two medical procedures with the same light guide component parameter set and the same external procedure parameters, generating a maintenance requirement message if a deviation exceeding a predefinable limit value is detected in the trend, outputting the maintenance requirement message.
[0031] The same or similar advantages apply to the method as previously mentioned with regard to the medical system. Within the scope of the invention, a further embodiment provides for the light components to be permanently installed in the light source. Furthermore, within the scope of the invention, it is possible in a further aspect for the camera head to be designed without light-guiding components, in which case, for example, the light-guiding components are connected separately to the endoscope, e.g., a laparoscope.
[0032] According to an advantageous embodiment, the method is further developed in that one or more of the following parameters are recorded as external intervention parameters: a phase parameter that characterizes a phase of the medical intervention, a user parameter that characterizes user data of the medical personnel carrying out the medical intervention, a patient parameter that includes data characteristic of a patient, a support system parameter that includes at least one parameter of a medical decision support system.
[0033] In particular, it is further provided that the external intervention parameter is received by a hospital information system and / or by an input device operable by medical personnel.
[0034] According to a further embodiment, it is provided that at least two temporal trends of the luminous intensity parameter are calculated, which are based on different light-guiding component parameter sets, wherein the two different light-guiding component parameter sets describe configurations of light-guiding components in which a first light-guiding component matches and a second and third light-guiding component differ, wherein a maintenance requirement message is generated for the first light-guiding component if a change in the luminous intensity parameter exceeding a predeterminable limit value is detected in all trends.
[0035] Further features of the invention will become apparent from the description of embodiments of the invention together with the claims and the accompanying drawings. Embodiments of the invention may incorporate individual features or a combination of several features.
[0036] Within the scope of the invention, features marked with "in particular" or "preferably" are to be understood as optional features.
[0037] The invention is described below, without limiting the general inventive concept, using exemplary embodiments with reference to the drawings, whereby express reference is made to the drawings for all details of the invention not explained in more detail in the text. They show: Fig. 1 a schematically simplified representation of an endoscope, a camera head, a fiber optic cable and a light source, Fig. 2 a schematically simplified representation of a medical system for determining the maintenance requirement of fiber optic components.
[0038] In the drawings, identical or similar elements and / or parts are provided with the same reference numbers, so that a repeated presentation is omitted.
[0039] Fig. 1 shows a simplified schematic representation of an endoscope 12, which is, for example, a video endoscope with a rigid endoscope shaft. The endoscope 12 can also be designed with a flexible endoscope shaft. The endoscope 12 is connected to a schematically illustrated camera head 10. The camera head 10 is connected to a light source 6 via a fiber optic cable 8. Bundles of optical fibers 15 are guided through the fiber optic cable 8, the camera head 10 and the endoscope 12, by means of which bundles the light generated by the light source 6 is guided to a distal end of the endoscope 12. In this way, a field of view of the endoscope 12 can be illuminated during a medical procedure. The fiber optic cable 8, the camera head 10 and the endoscope 12 are referred to as fiber optic components 14.
[0040] Due to mechanical breakage of individual optical fibers 15 in the optical fiber components 14, the brightness emitted at the distal end of the endoscope 12 decreases over time, even when the light intensity of the light source 6 remains constant. For this reason, the optical fiber components must be maintained to ensure optimal functionality. However, breakage of the optical fibers 15 and thus the need for maintenance cannot be easily determined. In many cases, medical personnel cannot immediately detect a decrease in brightness. Firstly, such observations are subject to a strong subjective component, and secondly, the decrease in brightness often occurs gradually over a longer period of time.
[0041] In Fig. 2A medical system 2 is shown, which is configured to reliably determine the maintenance requirements of the fiber optic components 14. The medical system 2 comprises a data processing unit 4, for example a computer, which collects historical data during medical procedures. Fig. 2 This is indicated by the arrows pointing toward the data processing unit 4. The historical data includes a luminous intensity parameter value of the light source 6, with which it is operated during the medical procedure. A parameter is selected as the luminous intensity parameter value that, for example, correlates linearly with the luminous intensity of the light source 6. A suitable luminous intensity parameter value is the current at which the light source 6 is operated.
[0042] The luminous intensity parameter value is transmitted to the data processing unit 4 via an interface device 26. The interface device 26 is connected to the light source 6 for this purpose. Although in Fig. 2 While shown as a wired connection, it can also be configured wirelessly. Data transmission from the interface device to the data processing unit 4 can also be wired or wireless.
[0043] Identification information of the endoscope 12 and / or the camera head 10 is transmitted wirelessly or by wire from a video processor 30 connected to the endoscope 12 and / or the camera head 10 to the interface device 26, which forwards the information to the data processing unit 4. Identification information of the fiber optic cable 8 is transmitted, for example, using RFID technology or also via the interface device 26. This identification information forms, for example, a fiber optic component parameter set that describes the configuration of the fiber optic components 14.
[0044] In addition to recording the light intensity parameter value and the fiber optic component parameter set, an external intervention parameter is recorded. The external intervention parameter can, in turn, comprise one or more parameters. The external intervention parameter affects the light intensity parameter value during a medical procedure, so it must be taken into account when evaluating the light intensity parameter value.
[0045] Parameters that individually or jointly form the external intervention parameter include, for example, the type of medical intervention and / or the phase of the medical intervention. Furthermore, the external intervention parameters include user data of the medical personnel 20 performing the medical intervention. For example, a first doctor may prefer a brighter image than a second doctor. This is represented in a user parameter. Patient characteristics also influence the value of the light intensity parameter, for example, the body mass index (BMI). This influence is represented in a patient parameter. If a decision support system, i.e. a so-called CDS system, is used, parameters of this system are also recorded as external intervention parameters. This is due to the fact that the system parameters affect the service life of the light-guiding components 14.
[0046] Many of these external intervention parameters, for example, concerning patient characteristics or the parameters of the decision support system, are transmitted from a hospital information system 24 to the data processing unit 4. Other external intervention parameters that are not stored in the hospital information system 24 are recorded by the medical staff 20 and transmitted to the data processing unit 4. For this purpose, an input device 28 is used, for example, which can be either a portable device or a device permanently installed in the operating room. In the Fig. 2 The example shown is a tablet computer. The external intervention parameters transmitted by medical staff 20 include, for example, the user data of medical staff 20.
[0047] The light intensity parameter values, the fiber optic component parameter sets, and the external intervention parameters together form a data set for the medical intervention. From the historical data of several medical interventions, the data processing unit 4 calculates one or more trends 16 of the light intensity parameter value. The trends 16 are adjusted for the influence of the external intervention parameters, for example, by considering only historical data with the same external intervention parameters in each temporal progression of a trend 16. In order to determine the maintenance requirements of the fiber optic components 14, only historical data recorded with the same configuration of the fiber optic components 14 is considered for each trend 16.
[0048] The maintenance requirements of the light-guiding components 14 can be determined from the temporal trends 16 thus determined. For this purpose, it is evaluated whether the light intensity parameter value changes over time, in particular increases, and whether this change exceeds a predeterminable limit. The limit is set large enough so that a random or statistical change does not result in a maintenance requirement message being issued. A change in the light intensity parameter that exceeds the limit indicates that a certain number of optical fibers 15 in the light-guiding components 14 are no longer intact and, for example, broken. To compensate for the resulting reduced brightness emitted at the distal end of the endoscope 12, the medical personnel 20 will increase the light intensity of the light source 6.This leads to an increase in the luminous intensity parameter in trend 16 - an indication of a need for maintenance of the light guide components 14.
[0049] If the data processing unit 4 detects a change in the light intensity parameter value in the trends 16, it generates a maintenance requirement message 18. This maintenance requirement message 18 is, for example, brought to the attention of the technical personnel 32. The technical personnel 32 may be, for example, the hospital's own personnel or external personnel, for example, from the manufacturer of the medical system 2. The maintenance requirement message 18 is, for example, an electronic message. Alternatively or additionally, the maintenance requirement message 18 can be output directly to the light-guiding components 14, for example, by illuminating a signal lamp or the like directly on the light-guiding components 14.
[0050] To determine which of the fiber optic components 14 requires maintenance, several trends 16 are analyzed, each of which has a light intensity parameter value recorded using different configurations of fiber optic components 14. For example, several trends 16 are analyzed, each of which has a light intensity parameter value recorded using the same endoscope 12 but different camera heads 10 and fiber optic cables 8. In this way, it can be determined whether a change in the light intensity parameter value is actually due to defective optical fibers 15 in the endoscope 12 or whether one of the other fiber optic components 14 is damaged.
[0051] All mentioned features, including those revealed solely in the drawings as well as individual features disclosed in combination with other features, are considered essential to the invention, both individually and in combination. Embodiments according to the invention may be fulfilled by individual features or a combination of several features. List of reference symbols
[0052] 2Medical system 4Data processing unit 6Light source 8Fiber optic cable 10Camera head 12Endoscope 14Fiber optic components 15Fiber optic fibers 16Trend 18Maintenance requirement message 20Medical personnel 24Hospital information system 26Interface device 28Input device 30Video processor 32Technical personnel
Claims
1. A medical system (2), comprising a data processing unit (4) and optical waveguide components (14), namely a light source (6), an optic fiber cable (8), a camera head (10) and an endoscope (12), through each of which a bundle of optical fibers (15) is guided, wherein the data processing unit (2) is configured to determine a maintenance requirement of the optical waveguide components (14) by capturing the following data during a medical procedure and storing said data as historical data: - a light intensity parameter value of the light source (6), which correlates with a light intensity emitted by the light source (6) during the medical procedure, - an optical waveguide component parameter set which describes a configuration of the optical waveguide components (14) utilized during the medical procedure, - an external procedure parameter which describes the type of medical procedure, wherein the data processing unit (4) is further configured to determine a trend (16) of the light intensity parameter from the historical data of at least two medical procedures having the same optical waveguide component parameter set and the same external procedure parameters and to generate a maintenance requirement message (18) and, if a deviation which exceeds a predefinable limit value can be ascertained in the trend (16), to output the maintenance requirement message (18).
2. The medical system (2) according to Claim 1, characterized in that the external procedure parameter comprises one or more of the following parameters: - a phase parameter which characterizes a phase of the medical procedure, - a user parameter which characterizes user data of the medical staff (20) performing the medical procedure, - a patient parameter which comprises data characteristic of a patient, - a support system parameter which comprises at least one parameter of a system for medical decision support.
3. The medical system (2) according to Claim 1 or 2, characterized in that the data processing unit (4) is configured to receive the external procedure parameter from a hospital information system (24) and / or from an input device (28) which can be operated by medical staff (20).
4. The medical system (2) according to any one of Claims 1 to 3, characterized in that the data processing unit (4) is configured to establish at least two trends (16) of the light intensity parameter, which are based on different optical waveguide component parameter sets, wherein the two different optical waveguide component parameter sets describe configurations of the optical waveguide components (14) in which a first optical waveguide component (14) matches and a second and third optical waveguide component (14) differ, wherein the data processing unit (4) is configured to generate a maintenance requirement message (18) for the first optical waveguide component (14) if a change in the light intensity parameter, which exceeds a predefinable limit value, can be ascertained in all of the trends (16).
5. A method for determining a maintenance requirement of an optical waveguide component (14) of a medical system (2), comprising a light source (6), an optic fiber cable (8), a camera head (10) and an endoscope (12) as optical waveguide components (14), wherein a bundle of optical fibers (15) is guided in each case through the optical waveguide components (14), the method comprising the following method steps: capturing the following data during a medical procedure and storing said data as historical data: - a light intensity parameter value of the light source (6), which correlates with a light intensity emitted by the light source (6) during the medical procedure, - an optical waveguide component parameter set which describes a configuration of the optical waveguide components (14) utilized during the medical procedure, - an external procedure parameter which describes the type of medical procedure, wherein the method further comprises the following steps: - calculating a trend (16) of the light intensity parameter from the historical data of at least two medical procedures having the same optical waveguide component parameter set (14) and the same external procedure parameters, - generating a maintenance requirement message (18) if a deviation which exceeds a predefinable limit value is ascertained in the trend (16), - outputting the maintenance requirement message (18).
6. The method according to Claim 5, characterized in that one or more of the following parameters are detected as the external procedure parameter: - a phase parameter which characterizes a phase of the medical procedure, - a user parameter which characterizes user data of the medical staff (20) performing the medical procedure, - a patient parameter which comprises data characteristic of a patient, - a support system parameter which comprises at least one parameter of a system for medical decision support.
7. The method according to Claim 5 or 6, characterized in that the external procedure parameter is received from a hospital information system (24) and / or from an input device (28) which can be operated by medical staff (20).
8. The method according to any one of Claims 5 to 7, characterized in that at least two temporal trends (16) of the light intensity parameter are calculated, which are based on different optical waveguide component parameter sets, wherein the two different optical waveguide component parameter sets describe configurations of optical waveguide components (14), in which a first optical waveguide component (14) matches and a second and third optical waveguide component (14) differ, wherein a maintenance requirement message (18) is generated for the first optical waveguide component (14) if a change in the light intensity parameter (14), which exceeds a predefinable limit value, is ascertained in all of the trends (16).