Abstract:
A system and method of documentation and categorization of medical obstetrics data, such as fetal heart rate characteristics. The automatic categorization of fetal heart rate characteristics into three categories, Category I—strongly predictive of normal fetal acid-base balance, Category II—not predictive of abnormal fetal acid-base balance and Category III—predictive of abnormal fetal acid-base balance.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. provisional patent application, Ser. No. 61/492,688, filed on 2 Jun. 2011. This provisional patent application is hereby incorporated by reference herein in its entirety and is made a part hereof, including but not limited to those portions which specifically appear hereinafter. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to a system and a method of electronic documentation and categorization of medical obstetrics data. 
     2. Discussion of Related Art 
     In 2008, the National Institute of Child Health and Human Development (NICHD) issued guidelines to provide Labor and Delivery clinicians with unambiguous definitions for the interpretation of fetal heart rate tracings. Fetal heart rates (FHR) are defined by characteristics including baseline FHR, variability, accelerations and decelerations. These combined characteristics allow the fetal heart rate to be classified as Category I (strongly predictive of normal fetal acid-base balance), Category II (indeterminate—not predictive of abnormal fetal acid-base balance, yet there is not enough evidence to classify as Category I or III) or Category III (predictive of abnormal fetal acid-base balance). These, in turn, help clinicians determine appropriate patient management. 
     Currently, a clinician must evaluate the fetal heart rate tracing, document all required characteristics and then make a determination of the fetal heart rate category, based upon the total of those characteristics. This proves to be a challenge under even optimal conditions, which tend to be rare in today&#39;s labor and delivery world. Accordingly, there is a need for a system to automatically categorize medical obstetrics data, such as fetal heart rate patterns. 
     SUMMARY OF THE INVENTION 
     The present invention provides a system and method of electronic documentation of medical obstetrics data, such as fetal heart rate monitoring (also known as cardiotocograph monitoring in Europe) and automatic categorization of risk characteristics. The automatic categorization of risk characteristics allows the fetal heart rate to be classified as Category I (strongly predictive of normal fetal acid-base balance), Category II (indeterminate—not predictive of abnormal fetal acid-base balance, yet there is not enough evidence to classify as Category I or III) or Category III (predictive of abnormal fetal acid-base balance). This automatic categorization allows clinicians to determine appropriate patient management quickly and easily and without potential errors of previously known methods. 
     Although the following description focuses on NICHD documentation guidelines, other standards exist and a similar approach could be taken to appropriately categorize FHR information to these other standards. The present invention includes a fetal heart rate (FHR) categorization tool connected to a data processing unit that processes FHR characteristics into the three categories. The FHR categorization tool may include an interface, such as a graphical user interface (GUI), which allows a clinician to manually enter FI-IR characteristics into the FHR categorization tool. In a preferred embodiment, the FHR categorization tool is connected to an electronic fetal monitoring system that gathers FHR information. The electronic fetal monitoring system is capable of algorithmically analyzing the FHR information and automatically inputting FHR characteristics into the FHR categorization tool. 
     In an embodiment of this invention, the GUI includes a window for entering data and displaying results. The window allows the clinician to enter data about the patient such as FHR characteristics. The window may further include a plurality of menus which allow for the selection of a type of FHR categorization; for example but not limited to, fetal heart rate evaluation and fetal heart rate status. The menus may further include a selection to choose FHR categorization based on NICHD documentation guidelines or other standards. The interface further includes a plurality of fields for entry of FHR characteristics such as, baseline FHR, variability, accelerations, decelerations, recurrent (a further classification with respect to decelerations), and sinusoidal. These fields may be manually entered by a clinician and/or automatically populated from data collected and analyzed by the electronic fetal monitoring system. After all required fields are entered, the system activates an add button on the interface and the system calculates and displays a Category I, II or III when the add button is selected. Alternatively, the system may automatically calculate the category upon entering all of the required fields. The category calculation is preferably color-coded to give an additional clear visual indicator as to where the patient falls on the continuum of normal to abnormal. For example, Category I may be color-coded green, Category II may be color-coded yellow and Category III may be color-coded red. However, the categories need not be color-coded or may be color-coded with another set of colors. Other categorization systems (based on standards or protocols other than NICHD standards) may have more than three categories and more than three colors might be used to clearly depict those categories. 
     This system assists clinicians in NICHD nomenclature-correct documentation of the characteristics of the FHR tracing—baseline, variability, accelerations, and decelerations—through the use of standardized pick-lists. Intelligent documentation prompting will be utilized if additional information about one of the characteristic is necessary, as would be the case for variable or late decelerations with the additional prompting that would occur related to whether or not those are recurrent. 
     This system also contributes to thoroughness and thoughtfulness of documentation. Categorization of the FHR will preferably not be calculated until the clinician fully documents all of the required characteristics. 
     This system also provides a “snapshot” view of FHR patterns through a flow sheet including a current evaluation as well as previous evaluations. This allows the clinician to quickly view recent trends over time without having to navigate to another screen. The FHR categorization tool also provides a clear time frame indicator that displays how much time has elapsed between FHR assessments. This includes the date and time of each exam, as well as an automatically calculated interval between each of the posted assessments. 
     Other advantages will be apparent to those skilled in the art from the following detailed description taken in conjunction with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates an embodiment of the electronic fetal monitoring system of this invention; 
         FIG. 2  is a screen shot showing an initial screen for automatic categorization of fetal heart rate characteristics according to one embodiment of this invention; and 
         FIG. 3  is the screen shot of  FIG. 2  with fetal heart rate characteristics entered and a category calculated; and 
         FIG. 4  is a flow chart for a method of calculating categories according to one embodiment of this invention and based on NICHD standards. 
     
    
    
     DESCRIPTION OF THE INVENTION 
     The present invention provides a tool for automatic categorization of fetal heart rate information and methods of use thereof. The device for automatic categorization of fetal heart rate information is preferably useable in connection with Electronic Fetal Monitoring (EFM) systems, such as those EFM systems currently used by and available to medical professionals. 
     Those skilled in the art and following the teachings herein provided will appreciate that while the descriptions below include preferred configurations, such configurations are used for illustrative purposes only and may be modified as appropriate, depending on need. 
     The following description of the invention of this application uses the National Institute of Child Health and Human Development&#39;s standards for fetal heart rate monitoring and categorization. However, the invention of this application is not limited to this standard and may utilize any standard for categorization of fetal heart rate. 
       FIG. 1  diagrammatically illustrates an embodiment of a categorization system  10  of this invention. In this embodiment, a fetal heart rate (FHR) categorization tool  11  is connected with a representative EFM system  12 . In a preferred embodiment, the EFM system  12  of  FIG. 1  may include an algorithmic processor  13 . The EFM system  12  may also be connected to an electronic fetal monitor  15  which may be connected to a sensor  14  positionable on or about patient  16  for the purpose of gathering fetal heart rate information. Typically, in instances where the measure of fetal heart rate is desired, the sensor(s)  14  are placed upon the abdomen of the patient mother. The sensor  14  can be a single sensor or an array of sensors. The electronic fetal monitor  15  processes the signals from the sensor  14 , and the algorithmic processor  13  of the EFM system analyzes the output of the electronic fetal monitor. 
     Data collected by the sensor  14  is sent to the electronic fetal monitor  15  and/or the EFM system  12 . The data processor receives and processes the FHR information to obtain the desired readable output, which is ultimately displayed to a clinician. In one embodiment of this invention, a data processor includes a signal acquisition circuit, a signal analysis circuit, a memory circuit and a display circuit. The term “circuit” as used herein broadly refers to hardware, software, or combination of hardware and software which performs or enables the described function. In one embodiment, the FHR characteristics are collected from at least one of the EFM system  12 , the electronic fetal monitor  15  and the sensor  14  and sent to the FHR categorization tool  11  of this invention. In another embodiment of this invention, the FHR categorization tool  11  is only connected to the EFM system  12  and is not connected to the electronic fetal monitor  15  or the sensor(s)  14 . In this embodiment, the clinician may read the fetal heart rate characteristics and manually enter this data into the FHR categorization tool  11 . 
     The automatic categorization of FHR is preferably completed in a specialty or niche electronic medical records system within a perinatal clinical area of a hospital. Alternatively, the automatic categorization of FHR is completed in a general or generic electronic medical record (EMR) system used in all or most all the clinical areas including the perinatal area and throughout a healthcare organization.  FIGS. 2 and 3  illustrate an exemplary general user interface (GUI)  20  of the 
     FHR categorization tool  11 . Initially, as shown in  FIG. 2 , the GUI  20  includes a plurality of inputs that may be manually entered and/or automatically populated from the data gathered by the EFM system  12 , the electronic fetal monitor  15  and the sensor  14 , or automatically populated based on data previously entered by the clinician. 
     At the top of  FIG. 2 , an identifier  22  is displayed. The identifier  22  creates an association of the FHR categorization to a patient. In this embodiment, the identifier  22  includes entries for last name, first name, middle name, medical record number and date of birth. However, the identifier  22  is not limited to these entries and may include additional entries. The identifier  22  information is provided to the GUI  20  by the Electronic FMS  12  and is not directly entered in the tool. 
     Preferably, the clinician then selects a grouping  24  from a drop-down menu of FHR Evaluation. Alternatively, the category can be selected in another way including but not limited to manual entry and/or radio buttons. In this embodiment, the grouping  24  is selected as FHR Evaluation. 
     In a preferred embodiment, upon selection of the grouping  24 , a list of keywords  26  may be selected. In the embodiment of  FIG. 2 , the keywords include, but are not limited to, FHR Eval, and FHR Status. 
     In a preferred embodiment of this invention, the GUI  20  provides a plurality of inputs  28 . As shown in  FIGS. 2 and 3 , the inputs  28  include a baseline input  30 , a variability input  32 , an acceleration input  34 , a deceleration input  36 , a recurrent input  38 , and a sinusoidal input  40 , however the inputs  28  are not limited to the inputs listed and may include additional inputs. In an alternative embodiment of this invention, the GUI  20  may display different inputs  28  depending on the selected grouping  24 , keywords  26  and/or selection of previous inputs  28 . In this embodiment, values for each of the baseline input  30 , the variability input  32 , the acceleration input  34 , the deceleration input  36  and the recurrent input  38  are entered using a drop-down menu and the sinusoidal input  40  is selected with a check box. In a preferred embodiment, the drop-down menus allow for the selection of multiple values for each of the inputs. However, the method of selecting each input  28  is not limited to drop-down menus and check boxes and may comprises any input device, including but not limited to, slider bars, type-in entry boxes and radio buttons. In an alternative embodiment, one or more of the baseline input  30 , the variability input  32 , the acceleration input  34 , the deceleration input  36 , the recurrent input  38  and the sinusoidal input  40  may be automatically populated from data algorithmically analyzed and collected by the EFM system  12 , the sensor  14  and/or previously entered inputs  28 . Table 1 shows a preferred embodiment of the possible inputs to the baseline input  30 , the variability input  32 , the acceleration input  34 , the deceleration input  36 , the recurrent input  38  and the sinusoidal input  40 . 
     
       
         
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 DATA POINT 
                 OPTIONS 
                 COMMENTS 
               
               
                   
               
             
             
               
                 Baseline 
                 Numerical; any increment 
                 Numerical value list 
               
               
                   
                 of 5 bpm between 30 and 
                 (30-240, increments 
               
               
                   
                 240 bpm 
                 of 5) 
               
               
                 Variability 
                 Absent 
                 Multi-select checklist 
               
               
                   
                 Minimal 
                 Only 1 can be checked 
               
               
                   
                 Moderate 
               
               
                   
                 Marked 
               
               
                   
                 Cannot Determine 
               
               
                 Accelerations 
                 Present 
                 Multi-select checklist 
               
               
                   
                 Absent 
                 Only 1 can be checked 
               
               
                   
                 Cannot Determine 
               
               
                 Decelerations 
                 Absent 
                 Multi-select checklist 
               
               
                   
                 Early 
                 Check ALL that apply 
               
               
                   
                 Variable 
                 If ABSENT is checked and 
               
               
                   
                 Late 
                 the user selects another 
               
               
                   
                 Prolonged 
                 answer, an error message 
               
               
                   
                 Cannot Determine 
                 should be displayed 
               
               
                 Recurrent 
                 Present 
                 Multi-select checklist 
               
               
                 Decelerations 
                 Absent 
                 Only 1 can be checked 
               
               
                   
                 Cannot Determine 
                 Should only present to user 
               
               
                   
                   
                 if Early, Variable, Late or 
               
               
                   
                   
                 Prolonged decelerations are 
               
               
                   
                   
                 checked 
               
               
                 Sinusoidal 
                 Absent 
                 Check-box; Check in Box = 
               
               
                 Pattern 
                 Present (for at least 20 
                 Present, No Check in Box = 
               
               
                   
                 minutes) 
                 Absent 
               
               
                   
               
             
          
         
       
     
     Baseline refers to baseline fetal heart rate (baseline FHR). The National Institute of Child Health and Human Development (NICHD) defines baseline FHR as the mean FHR rounded to increments of 5 beats per minute (bpm) during a 10 minute window, excluding accelerations and decelerations and periods of marked FHR variability (greater than 25 bpm). There must be at least 2 minutes of identifiable baseline segments (not necessarily contiguous) in any 10 minute window or the baseline for that period is indeterminate. The normal baseline FHR range is typically between about 110 and about 160 bpm. Fetal bradycardia is generally determined if the baseline FHR is below 110 bpm, and fetal tachycardia is generally determined if the baseline FHR is above 160 bpm. 
     The NICHD nomenclature defines variability as fluctuations in the baseline FHR that are irregular in amplitude and frequency. The fluctuations are visually quantitated as the amplitude of the peak-to-trough in beats per minute (bpm). The variability is categorized by the quantitated amplitude as: (1) absent—undetectable;. (2) minimal—greater than undetectable, but less than or equal to 5 bpm; (3) moderate—greater than or equal to 6 bpm and less than or equal to 25 bpm; and (4) marked—greater than 25 bpm. Baseline FHR variability is determined in a 10 minute window, excluding accelerations and decelerations. 
     NICHD defines acceleration as a visually apparent abrupt increase in FHR. An abrupt increase is defined as an increase from the onset of acceleration to peak in less than or equal to 30 seconds. To be called an acceleration, the peak must be greater than or equal to 15 bpm, and the acceleration must last greater than or equal to 15 seconds from the onset to return. A prolonged acceleration is greater than or equal to 2 minutes but less than 10 minutes in duration. An acceleration lasting greater than or equal to 10 minutes is defined as a baseline change. Before 32 weeks of gestation, acceleration are defined as having a peak greater than or equal to 10 bpm and a duration of greater than or equal to 10 seconds. 
     NICHD Identifies Four Types of Deceleration:
         1. Early deceleration: Visually apparent, usually symmetrical, gradual decrease and return of the FHR associated with a uterine contraction. A gradual FHR decrease is defined as one from the onset to the FHR nadir of greater than or equal to 30 seconds. The decrease in FHR is calculated from the onset to the nadir of the deceleration. The nadir of the deceleration occurs at the same time as the peak of the contraction. In most cases the onset, nadir, and recovery of the deceleration are coincident with the beginning, peak, and ending of the contraction, respectively.   2. Late deceleration: Visually apparent usually symmetrical gradual decrease and return of the FHR associated with a uterine contraction. A gradual FHR decrease is defined as from the onset to the FHR nadir of greater than or equal to 30 seconds. The decrease in FHR is calculated from the onset to the nadir of the deceleration. The deceleration is delayed in timing, with the nadir of the deceleration occurring after the peak of the contraction. In most cases, the onset, nadir, and recovery of the deceleration occur after the beginning, peak, and ending of the contraction, respectively.   3. Variable deceleration: Visually apparent abrupt decrease in FHR. An abrupt FHR decrease is defined as from the onset of the deceleration to the beginning of the FHR nadir of less than 30 seconds. The decrease in FHR is calculated from the onset to the nadir of the deceleration. The decrease in FHR is greater than or equal to 15 beats per minute, lasting greater than or equal to 15 seconds, and less than 2 minutes in duration. When variable decelerations are associated with uterine contractions, their onset, depth, and duration commonly vary with successive uterine contractions.   4. Prolonged deceleration: A prolonged deceleration is present when there is a visually apparent decrease in FHR from the baseline that is greater than or equal to 15 bpm, lasting greater than or equal to 2 minutes, but less than 10 minutes. A deceleration that lasts greater than or equal to 10 minutes is a baseline change.
 
Additionally, decelerations can be recurrent or intermittent based on their frequency (more or less than 50% of the time) within a 20 minute window.
       

     NICHD guidelines define a sinusoidal heart rate as a pattern of regular variability resembling a sine wave, with fixed periodicity of 3-5 cycles per minute and amplitude of 5-40 beats per minute. Sinusoidal patterns are categorized as Category III tracings and may indicate fetal anemia caused by fetomaternal hemorrhage or alloimmunization. If a clinician checks the sinusoidal input  40 , the tracing is automatically considered to be Category III tracing. In a preferred embodiment of this invention, checking the sinusoidal input  40  box causes at least one of the other input fields to be grayed-out, preventing entry of a value. 
     In a preferred embodiment of this invention, the GUI  20  includes columns  41  listing values  42  of the inputs  28  for a plurality of previous exams. The columns  41  are preferably resizable to accommodate the length of inputs  28 . The GUI  20  also preferably includes a date and time stamp  44  for each of the plurality of exams at a top of the column and an interval  46  of time elapsed between each of the plurality of exams. In a preferred embodiment, at least one of the date and time stamp  44  and the interval  46  may be stored and/or sent to flowsheet. 
     In a preferred method of operation, the clinician enters the identifier  22  information into the FHR categorization tool  11  and selects at least one of the grouping  24  and the keyword  26 . The clinician then enters values for the baseline input  30 , the variability input  32 , the acceleration input  34  and/or the deceleration input  36 . In a preferred embodiment, if the deceleration input  36  is entered with variable deceleration or late deceleration, a selection box (yes or no) displays for the recurrent input  38 . Alternatively, the recurrent input  38  is displayed regardless of an entry to the deceleration input  36 . In a preferred embodiment, the clinician must either enter an entry into all of the baseline input  30 , the variability input  32 , the acceleration input  34  and the deceleration input  36  (with the recurrent input  38 , if applicable) or select the sinusoidal input  40  in order for the FHR category  48  to be calculated and displayed. In one embodiment, entering in values for each the inputs  30 ,  32 ,  34 ,  36 ,  38  or the sinusoidal input  40  causes the FHR categorization tool  11  to automatically calculate the FHR category  48 . In an alternative embodiment, the entering in values for each the inputs  30 ,  32 ,  34 ,  36 ,  38  or the sinusoidal input  40  activates an add button  50  that must be selected to calculate the FHR category  48 . In another embodiment of this invention, the FHR category  48  calculation is dynamic, meaning that the FHR category  48  is calculated as the clinician is entering information. 
       FIG. 4  shows a flowchart  100  for FHR categorization according to one embodiment of this invention. In this embodiment, the categorization process begins by evaluating whether the FHR is sinusoidal  102 . If the FHR is sinusoidal  103 , the FHR is categorized as Category III  104 , a FHR Category output  48  on the GUI  20  displays “III” in a red box indicating that the clinician should take appropriate steps to monitor and treat the patient. 
     If the categorization process determines that the FHR is not sinusoidal, the process checks for a type of variability  106 —absent, minimum, moderate, marked or cannot determine. 
     If the variability is minimum or marked  108 , the FHR is categorized as Category II  110 , the FHR Category output  48  on the GUI  20  displays “II” in a yellow box indicating that the clinician should take a cautious approach with the patient. 
     If the variability is moderate  112 , the baseline FHR is evaluated to determine if it is between 110-160 bpm. If the baseline FHR is not between 110-160 bpm  116 , the FHR is categorized as Category II  110  and the FHR Category output  48  on the GUI  20  displays “II” in a yellow box indicating that the clinician should take a cautious approach with the patient. If the baseline FHR is between 110-160 bpm  118 , the FHR categorization process 100 checks for a type of deceleration  120 —none, early, variable, late, prolonged, or cannot determine. If the deceleration is none or early  122 , the FHR is categorized as Category I  124  and the FHR Category output  48  on the GUI  20  displays “I” in a green box indicating that the clinician should take a standard approach with the patient. If the deceleration is variable, late prolonged or cannot determine  126 , the FHR is categorized as Category II  110  and the FHR Category output  48  on the GUI  20  displays “II” in a yellow box indicating that the clinician should take a cautious approach with the patient. 
     If the variability is absent or cannot determine  128 , the FHR categorization process  100  checks for a type of deceleration  130 —none, early, variable, late, prolonged, or cannot determine. If the decelerations are none, early, prolonged or cannot be determined  132 , then check if the baseline FHR is greater than or less than 110 bpm  134 . If the baseline FHR is less than 110 bpm  136 , the FHR is categorized as. Category II  110  and the FHR Category output  48  on the GUI  20  displays “II” in a yellow box indicating that the clinician should take a cautious approach with the patient. If the baseline FHR is greater than or equal to 110 bpm  138 , then the FHR is categorized as Category III  104 , the FHR Category output  48  on the GUI  20  displays “III” in a red box indicating that the clinician should take appropriate steps to monitor and treat the patient. If the decelerations  130  are variable or late  140 , then check for recurrent decelerations  142 . If there are recurrent decelerations  144 , then the FHR is categorized as Category III  104 , the FHR Category output  48  on the GUI  20  displays “III” in a red box indicating that the clinician should take appropriate steps to monitor and treat the patient. If there are no recurrent decelerations  146 , then check if the baseline FHR is greater than or less than 110 bpm  134 . If the baseline FHR is less than 110 bpm  136 , the FHR is categorized as Category II  110  and the FHR Category output  48  on the GUI  20  displays “II” in a yellow box indicating that the clinician should take a cautious approach with the patient. If the baseline FHR is greater than or equal to 110 bpm  138 , then the FHR is categorized as Category III  104 , the FHR Category output  48  on the GUI  20  displays “III” in a red box indicating that the clinician should take appropriate steps to monitor and treat the patient. 
     The invention illustratively disclosed herein suitably may be practiced in the absence of any element, part, step, component, or ingredient, which is not specifically disclosed herein. 
     While in the foregoing detailed description this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purposes of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein can be varied considerably without departing from the basic principles of the invention.