Medical statistical analyzing method

• US 5,199,439 A
• Filed: 01/16/1990
• Issued: 04/06/1993
• Est. Priority Date: 01/16/1990
• Status: Expired due to Term

• Current Assignee: Lonnie Brown, Stanley Zimmerman, Steven Zimmerman
• Original Assignee: Lonnie Brown, Stanley Zimmerman, Steven Zimmerman
• Inventors: Brown, Lonnie, Zimmerman, Stanley, Zimmerman, Steven
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): Manuel, George
• Application Number:
  US07/465,049
• Time in Patent Office: 1,176 Days
• Field of Search: 128/670, 128/668, 128/731, 128/733, 128/734, 364/413.02, 364/413.03, 364/413.05
• US Class Current: 600/483
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

A method of using existing and new hardware in order to derive statistical information and control charts reflecting statistical changes in a monitored individual utilizing patient monitoring devices, communications between patient monitoring devices and computer systems. The process involves (1) selection of data from the stream of data originating from the monitoring device, (2) compartmentallization of data into records, (3) selection and isolation of that portion of each selected record related to the monitored event (e.g. blood pressure), (4) determining for significantly statistical consecutive groups, the average average, and the standard deviation (sigma) (5) repeating the said process steps 1 through 4 after a delay in order to avoid covariance until, after a significant number of repetitions, the number of which are selected by the user, it is possible to set control chart limits (upper and lower control limits and the theory of runs), (6) setting control limits (the upper control limit and lower control limit are functions of sigma, usually the same, and adjustable by the user) (7) to set up appropriate control charts on a moving screen (either internally or on displays); (8) continuously determining average-average and standard deviation as set out in steps (1) through (4) above; (9) continuously graphing and displaying sigma, x-bar and range against the control charts; (10) marking statistically significant deviations on the chart as by circling readings which deviate farther than the control limits and where the theory of runs, as controlled by the user, indicates a statistically consistent number of deviations on one side of the average for each chart (11) readjusting the x-double bar (or center line of the x-bar chart) and sigma as set out in steps (1) through (4) above and/or the R chart sigma bar (center line) and control limits as needed during the process (12) and restarting steps (5) through (12); (13) sending data from an isolated portion of said control chart to a database; (14) comparing the isolated portion to the database collection of similar segments and categorizing the same; (15) matching said categorized portions to accepted treatments and diagnosis, (16) grouping such sets of treatments and diagnosis with the corresponding portions sent by the user and (19) displaying on the screen in response to a request from the user the accepted options as to diagnosis and treatment.

Claims

1. The process of monitoring patient vital signs from a monitoring device which is generating data using control charts with at least one control chart limit comprising the steps of:

(a) collectioning said data from said monitoring device;

(b) placing said data into statistically significant subgroups of at least one datum each;

(c) calculating for said statistically significant subgroups statistics to graph against said control charts;

(d) repeating the process steps (a) through (c) continuously;

(e) selecting for a statistically significant number of repetitions of steps (a) through (c) the data necessary to set at least one control chart limit;

(f) setting at least one control chart limit with said data;

(g) setting up at least one control chart with said at least one control chart limit;

(h) continuously graphing said statistics against said at least one control chart making a diagnosis or performing a treatment on said patient using said monitored vital signs graphing statistics.

2. The process of claim 1 wherein the statistically significant subgroups are consecutive.

5. The process of claim 1 wherein the control chart limit comprises at least one lower control limit.

6. The process of claim 1 wherein the control chart comprises at least one midline.

7. The process of claim 6 wherein there is a first and second different control limit on a single side of the control chart, midline being a first control limit and second control limit and wherein one of the two control chart limits is farther out than the other control limit.

8. The process of claim 7 comprising the additional step of giving a warning signal when the first control limit is reached.

9. The process of claim 8 comprising the additional step of directing a separate action when the second limit is reached.

10. The process of claim 7 wherein the information is sent to a database after the first control limit is reached.

11. The process of claim 1 wherein the control chart has a midline, at least one upper control limit and at least one lower control limit.

12. The process of claim 1 wherein the process includes the additional step of (1) marking statistically significant deviations.

13. The process of claim 1 wherein the statistics comprise the average and the standard deviation (sigma) for each of the statistically significant subgroups.

14. The process of claim 13 wherein the step of selecting for a significant number of repetitions the data necessary to set said control chart limits comprises the additional step of calculating the average of the averages (x-double bar) and the average of the standard deviations for said statistically significant number of repetitions.

15. The process of claim 1 comprising the additional step of:

(i) readjusting the control chart limits by repeating the steps (a)-(g) for originally setting the control chart limits as set forth above as the patient'"'"'s condition varies requiring new control charts.

16. The process of claim 1 comprising the additonal steps of:

(i) sending data from the first isolated portion of a first control chart to a database;

(j) categorizing said first isolated portion to the database collection of similar segments and categorizing by similarity;

(k) grouping said first isolated portions with medical data in said database;

(l) comparing said first isolated portion in said database to second portions of a second control chart so as to match said second control chart portion to the first database portion; and

(m) displaying the accepted medical data with said portion first.

17. The process of claim 16 wherein the medical data comprises treatment.

18. The process of claim 16 wherein the medical data comprises diagnosis data.

19. The process of claim 1 wherein (a) further comprises the steps of:

(l) selecting data from the stream of data originating from the monitoring device;

(ll) compartmentalizing data into records;

(lll) isolating that datum of each selected record related to the monitored vital sign.

23. The process of claim 1 wherein step (g), setting up at least one control chart, further comprises:

a. selecting of standards from a present group;

b. selecting the at least one control chart from the following set;

(i) Average charts

(ii) Range charts

(iii) P charts, percent effective or defective

(iv) U charts, defect charts

(v) C charts, defect per instance charts

(vi) NP charts, number of occurrences charts

(vii) sigma charts.

24. The invention of claim 23 wherein the sigma and average chart are used together and wherein the invention comprises the additional steps of:

a. determining at least one of the following standards;

the size of the sample subgroup, the method for introducing delay, the number or set of subgroups, the statistical method to be used, the confidence level for entering limits, the confidence level for action limits, setting the theory of runs.

25. The process of claim 24 wherein a range chart is substituted for the sigma chart.

26. The process of claim 23 wherein steps (a) through (h) further comprise:

i. Inputting of data;

ii. compartmentalization of data into records;

iii. grouping of preferably consecutive data into subgroups;

iv. finding an average (x-bar) and finding the standard deviation (sigma) for each subgroup;

v. storing the x-bar and sigma;

vi. Repeating steps i through ii continuously with a delay selected by the user;

vii. selecting a statistically significant number of subgroups;

viii. calculating control chart values for an average (x-bar) control chart for a sigma control chart;

ix. generating two charts, an x-bar chart or average chart, and a sigma chart;

x. continuously graphing information from step s on the charts.

27. The process of claim 23 wherein the step of determining the average-average, x-double bar, and sigma is replaced with the step of specifying x-double bar and sigma bar.

28. The process of claim 27 comprising the additional step of stabilizing the patient to a set range and deviation for medically specified average and sigma values.

29. The process of claim 23 wherein the step of setting up a control chart limit comprises the additional steps of identifying all possible instrumentation and non-medical outliers and eliminating the causes if possible establishing control charts free of the identified outliers and eliminating all possible instrumentation and non-medical outliers.

30. The process of claim 1 wherein the entire process is used for at least two of the following data types known in the art:

variable data, binomial data, and percentage data from the processes analyzed.

31. The process of claim 1 wherein the chart features generated are shown numerically.

32. The process of claim 31 wherein chart and numeric display comprises:

a. at least one of either a sigma chart or a range chart or an x-bar chart;

b. numeric displays of the upper and lower control limit and midline the same being displayed numerically beside the graphical display for both the x-bar chart and the sigma chart.

33. The process of claim 1 wherein the statistics comprise the average and the range for each of the statistically significant consecutive subgroups.

34. The process of claim 33 wherein the step of selecting for a significant number of repetitions the data necessary to set said control chart limits comprises the additional step of calculating the average of the averages (x-double bar) and the average of the ranges for said statistically significant number of repetitions.

35. The process of claim 33 further comprising the step of displaying the results on the time dependent scale so that each subgroup is matched with the associated time.

3. The process of claim wherein the control chart limit comprises at least one upper control limit.

4. The process of claim 3 wherein the control chart has at least one lower control limit.

20. The process of claim 20 wherein the graphing further comprises matching each subgroup with an associated time.

21. The process of claim 20 wherein the device has a device display and comprising the additional step of comparing the display of the monitoring device against the control charts to determine the reliability of the monitoring device display.

22. The process of claim 20 further comprising the step of graphing the control chart using a time dependent scale to mark the distances between markings.

36. A method of monitoring a patients'"'"'s vital signs comprising the steps of:

(a) examining a patient to get data;

(b) isolating data from a patient;

(c) sending the data to a database;

(d) statistically (as compared with medical) analyzing the data relative to the database;

(e) matching pattern recognition of the portions of the control chart comparing the isolated portion to similar portions of control charts in the database;

(f) comparing the isolated portion or segment to the database collection of similar segments and categorizing the same; and

(g) displaying diagnosis to the user.

(h) using said diagnosis and treatment information to make a diagnosis or perform a treatment on said patient.

37. The process of the claim 36 comprising the additional step of implementation of treatment displayed.

38. A method of analyzing data from new medical patients comprising the following steps:

a. determining the number of consecutive runs;

b. determining factor times for an x-bar chart, standard deviation chart, and range chart for upper and lower control limits;

c. determining number of data samples to be used in each sub-group;

d. determining number of repetitions for sampling for determining the average standard deviation on midline for the sigma, range, and average control charts;

e. determining sample rates;

f. inputting data;

g. compartmentalizing data into records;

h. isolating significant portions of each record for graphing on control charts;

j. selecting consecutive subgroups of statistically significant size;

k. calculating the average, standard deviation, and range for each subgroup;

l. pausing as necessary to avoid co-variance between subgroups;

m. repeating steps of selection, calculating, and pausing for a number of repetitions set by the user in step (d) above;

n. averaging the averages over all subgroups, standard deviation over all subgroups, and range or standard deviation over all subgroups for the number of repetitions;

o. setting control limits by multiplying the B factor times the average sigma in order to determine the upper and lower control limits;

p. set up control charts utilizing the averages for averages, standard deviations, and ranges calculated above;

q. continuously repeating the steps of input of data, compartmentalization of data, isolation of significant portions of records, selecting consecutive subgroups, calculating the average, standard deviation, and range;

r. continuously graphing on or against a control chart and displaying on a control chart each of the consecutive subgroups;

s. marking deviations as to the theory of runs as set out above, subgroups whose statistical information goes over the control limits;

t. readjusting the control limits as desired;

u. isolating segments of the control charts;

v. comparing isolated portions of the control charts to similar isolated portions of the control charts in a database;

w. displaying and using said isolated portions and said similar isolated portions to make a diagnosis or perform a treatment on said patients.