RU2823111C1 - Method for assessing severity of condition and predicting probabilistic outcome of disease - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to surgery, and can be used in assessing the severity of acute abdominal diseases. Determining such indicators as age, heart rate, average blood pressure, body temperature, respiratory rate in 1 minute, diuresis in 24 hours, blood urea nitrogen, creatinine, leukocytes, blood serum thrombocyte count, bilirubin, potassium, sodium, Glasgow coma score. Obtained indicators are assigned points in accordance with table 1 presented in the description. Then, an index of the severity of the condition I_ASCM is calculated by summing the obtained points for all indicators. If the value I_ASCM is from 0 to 4, the severity of the disease is considered to be mild, if the value I ASCM is from 5 to 12 as medium, and if the value I ASCM is from 13 to 32 as severe.

EFFECT: method enables increasing the accuracy of assessing the severity of the disease and predicting the probability of a favourable or unfavourable outcome by performing an integral assessment of the most significant values.

2 cl, 13 tbl, 2 ex

Description

The invention relates to medicine, namely to diagnostics, and can be used in surgical departments, resuscitation and intensive care units to determine the general condition, assess the severity of patients, with the ability to predict the outcome of the disease, using clinical and laboratory tests that are easily accessible for examination indicators.

Assessing severity is an integral task for doctors to determine the necessary treatment and diagnostic algorithm for providing comprehensive care to patients in severe and extremely serious condition, as well as to determine the effectiveness of treatment measures in general. Predicting disease outcomes also remains a critical aspect of clinical medicine. Interest in predicting outcome as a tool for decision making stems from the need to improve existing prognostic scales, their possible simplification and approximation to real clinical conditions [1].

The legal aspect is also important. Patients and their relatives have become increasingly involved in medical decision-making and often need more complete information about the severity of the condition and the possible consequences of the disease, prognosis and the effectiveness of treatment in general. Full participation in the treatment process and decision-making opportunities for patients and their families include access to reliable information about expected outcomes.

Currently, there are various scales and indices for assessing the general condition of patients. These scales are based on clinical data and laboratory parameters. Each of them has its own advantages and disadvantages. The most frequently used scales for assessing the severity of conditions in clinical practice are: APACHE II; SAPS II, MODS and SOFA [2, 3, 4].

In the foreign literature, there are a large number of publications devoted to the use of these prognostic scales to assess the severity of the general condition of patients. The results of numerous studies are contradictory [4, 5].

APACHE II score (mortality assessment and evaluation system - a system for classifying acute functional and chronic changes in health status) consists of three blocks: 1) assessment of acute physiological changes (acute physiology score - APS); 2) age; 3) the presence or absence of chronic diseases. Data on the block of assessment of acute physiological changes are collected during the first 24 hours of patient admission to the department of anesthesiology, resuscitation and intensive care (ICU). The result of the assessment is a prognostic integral indicator [2].

Disadvantages of the APACHE II scale, according to Yu.S. Alexandrovich and V.I. Gordeeva (2007) are 1) the impossibility of its use in patients under 18 years of age; 2) the general state of health should be assessed only in seriously ill patients, otherwise adding this indicator leads to an overestimation of the condition; 3) there is no assessment of the condition before admission to the intensive care unit; 4) in case of death in the first 8 hours after admission, data assessment is meaningless; 5) with frequent repeated use, the scale gives a slightly higher rating. In addition, the scale does not make it possible to determine the degree of dysfunction of individual systems and organs [2,3]. Finally, based on our work experience, in everyday clinical practice there are certain difficulties in determining the following indicators: acidity index (pH) of arterial blood, partial pressure of carbon dioxide in arterial blood (Pa _CO2 ) _, partial pressure of oxygen in arterial blood (Pa _O2 ).

The MODS scale is used to assess the severity of impairment of certain organs and systems in sepsis, predicting mortality and duration of stay in the ICU. The Pa _O2 /Fi _O2 ratio (where Fi _O2 is the inspiratory oxygen fraction) is calculated without reference to the use of mechanical ventilation or PEEP (Positive end-expiratory pressure). Serum creatinine is calculated without reference to dialysis use. The Glasgow Coma Scale for patients receiving sedation and muscle relaxants is taken as normal unless there is evidence that consciousness may be impaired due to some internal reasons. Assessment of gastrointestinal tract function was excluded from the analysis, since, according to the authors of this scale, recently stress bleeding has rarely been encountered in intensive care practice, and other criteria for gastrointestinal dysfunction do not fully meet methodological requirements [3]. The disadvantage of this scale, in addition, is the difficulty in assessing the Pa _O2 /Fi _O2 indicator in clinical practice.

The SOFA (Sequential Organ Failure Assessment) scale is used to assess the prognosis of mortality and the degree of organ failure in patients in intensive care. Allows you to evaluate the effectiveness of new therapeutic measures and determine the severity of each patient’s condition over time. The scale is based on the assessment of indicators of 6 organ systems. Assessments are performed for all patients upon admission to the intensive care unit and every 24 hours until discharge. This scale can be used not only for sepsis, but also for other pathological processes and critical conditions (trauma, shock of any origin, myocardial infarction) [3]. Among the disadvantages, one can note the high dependence and, accordingly, the error of the integral indicator on the change or absence of one of the indicators.

We chose the SAPS II scale as a prototype - simplified acute physiology scale. The scale is used to assess patients in the ICU and can predict mortality risk based on 15 key variables:

- Age

- Heart rate (HR)

- Systolic blood pressure (BP)

- Body temperature

- Pa _O2 /Fi _O2 coefficient

- Diuresis

- Serum urea

- Leukocytes

- Potassium

- Sodium

- Bicarbonate

- Bilirubin

- Glasgow Coma Scale

- Type of receipt

- Concomitant diseases (AIDS, blood cancer, cancer metastasis).

Data are collected within the first 24 hours after admission to the department of anesthesiology, resuscitation and intensive care.

This scale was developed to simplify the APACHE scale and its modifications, but the main drawback, according to the literature, is the difficulty of assessing the prognosis due to the use of indicators that are not included in the medical and economic diagnostic standards [4]. In addition, in our opinion, quantitative determinations of blood bicarbonate and the Pa _O2 /Fi _O2 ratio present certain difficulties.

The solution we propose is aimed at increasing the efficiency of providing care to patients in severe and extremely serious condition, including those accompanied by multiple organ failure.

The technical result of the claimed solution is to increase the accuracy of assessing the severity of the disease, predicting the likelihood of a favorable or unfavorable outcome, as well as simplifying the assessment process and reducing the time spent on it.

The proposed method for assessing the severity of the condition and predicting the probabilistic outcome of the disease is to determine a number of patient indicators and evaluate them based on the proposed own scale “Assessment of the severity of the condition and prognosis of mortality” or “Assessment of the severity of the condition and prognosis of mortality”, abbreviated as ASCM. The ASCM scale includes the most effective and easy-to-use indicators. Each indicator is given a score from 1 to 4 points, after which, by summing the scores obtained for all indicators, the final integral indicator is calculated - the index of assessment of the severity of the condition and prognosis of mortality I _ASCM (Index assessment of the severity of the condition and prognosis of mortality) and the prognosis is determined diseases depending on the value of I _ASCM .

Table 1 presents the indicators assessed on the ASCM scale. The table below presents the interpretation of the obtained data based on a scoring system for assessing the severity of the condition.

Table 1.

Severity rating scale “Assessment of the severity of the condition and prognosis of mortality” (ASCM)

No. Index Values Points Age Less than 40
40- 59
60-69
70-79
More than 80 0
1
2
3
4 Heart rate Less than 40
40-59
70- 90
91-110
More than 120 4
3
0
3
4 Mean arterial pressure More than 160
130-159
110-129
70-109
50-69
Under 49 4
2
1
0
3
4 Body temperature Less than 39°C
More than 39° C 0
4 Respiratory rate (per 1 min.) More than 50
35-49
25-34
12-24
10-11
6-9 4
3
2
0
2
4 Diuresis in 24 hours.
(in ml) Less than 500
500-999
More than 1000 4
2
0 Blood urea nitrogen
(mmol/l) Less than 7.4
7.4-29.9
More than 30.0 0
2
4 Creatinine
(mg/dl) Less than 110
110-170
171-299
300-400
More than 440 0
1
2
3
4 Leukocytes
(x10 ⁹ ) Less than 4.0
4.0-9.0
10.0-14.0
15.0- 20.0
More than 20.0 4
0
2
3
4 Serum platelet count
(x10 ⁹ ) More than 400
320-400
220-319
120-219
61-119
21-60 4
2
1
0
2
4 Bilirubin, (µmol/l) Less than 20
20-32
33-101
102-204
More than 204 0
1
2
3
4 Potassium
(mmol/l) less than 3.0
3.0-4.9
More than 5.0 2
0
2 Sodium
(mmol/l) less than 125
125-144
More than 145 2
0
2 Glasgow Coma Scale scores Less than 6
6-8
9-10
11-13
14-15 4
3
2
1
0

Integral severity assessment Number of points
I _ASCM Probability of death in % Mild disease, favorable prognosis 0 0% 1-4 1.5% Moderate degree of disease, high probability of favorable prognosis. 5-8 3.8% 9-12 19.2% Severe disease, low probability of a favorable prognosis. 13-16 38.4% 17-20 57.6% Severe disease, poor prognosis. 21-24 76.9% 25-28 85% 29-32 100%

This method of assessing the severity of the condition and predicting the probable outcome of the disease is proposed to be used at the time of admission of the patient to the ICU or on the first day after surgery; at the time of transfer of the patient from the ICU to the surgical department or in any other situation requiring assessment of the severity of the condition. Depending on the number of points obtained from the examination results, a conclusion can be made about the severity of the disease and the probabilistic prognosis of the disease.

In the process of developing the ASCM scale, 14 patients undergoing treatment in ICU conditions were studied, including 9 patients with diffuse purulent fibrinous peritonitis and 5 patients with severe pancreatitis. The distribution by nosology and type of treatment is presented in Table 2.

Of the 14 patients analyzed, 5 patients died, 9 patients were discharged in satisfactory condition (Table 3).

To achieve results assessed the general condition and severity of patients using the APACHE II scale; SAPS II; MODS; SOFA and according to our proposed ASCM scale, with definition I_ASCM. Integral indicators were calculated at the time of admission to the ICU, at the time of transfer of the patient from the ICU to the surgical department and at the time of discharge. Patients with fatal outcomes were assessed immediately before death (12–24 hours). At the time of assessment, all patients had a severe or extremely severe general condition.

The assessment of the general condition of the patients at the time of admission to the ICU is presented in Table 4 (average values).

Table 4

Condition of patients at the time of admission to the ICU

Scales: SOFA MODS SAPS II APACHE II I _ASCM Probability of death: 10% ±
0% 11.09% ± 4.7% 10.83% ± 9.869% 11.52% ± 4.436% 49.06% ±13.948%
(Moderate disease, high probability of favorable prognosis).

An assessment of the general condition of the patients at the time of transfer from the ICU to the surgical department is presented in Table 5.

Table 5

Condition of patients at the time of transfer from ICU to surgical department

Scales: SOFA MODS SAPS II APACHE II I _ASCM Probability of death: 10% ±
0% 7% ±
0% 8.8% ± 3.603% 10.05% ± 3.249% 30.72% ±10.516%
(Moderate disease, high probability of favorable prognosis).

The assessment of the general condition of the patients at the time of discharge is presented in Table 6.

Table 6

Condition of patients at the time of discharge from hospital

Scales: SOFA MODS SAPS II APACHE II I _ASCM Probability of death: 10% ±
0% 7% ±
0% 7.85% ± 3.919% 11.18% ± 2.751% 3.41% ± 0.938%
(Mild degree of disease, favorable prognosis).

An assessment of the general condition of deceased patients at the time of death is presented in Table 7.

Table 7

Condition of patients 12-24 hours before death

Scales: SOFA MODS SAPS II APACHE II I _ASCM Probability of death: 17.5% ±
5% 22.75% ± 4.5% 6.8% ± 1.732% 16.47% ± 7.96% 76.12% ± 12.926%
(Severe disease, low probability of favorable prognosis)

Analyzing the data presented in Tables 4-7, we can state that more detailed and accurate information is provided by our proposed I _ASCM , calculated using the proposed ASCM scale.

Example 1. Patient F., 35 years old, was admitted on September 23, 2021, with complaints of intense pain throughout the abdomen and general weakness. History of gastric body cancer T ₄ N ₂ M ₀ , combined gastrectomy, subtotal resection of the esophagus, splenectomy, resection of the tail and body of the pancreas, with D2 lymph node dissection, Meidl jejunostomy. Diagnosis: “Subphrenic abscess on the left, opened into the abdominal cavity. Diffuse purulent fibrinous peritonitis." The operation was performed: “Laparotomy, opening and drainage of the subphrenic abscess on the left. Sanitation and drainage of the abdominal cavity. Laparostomy." After surgery, the patient was sent to the ICU for further treatment. The general condition of the patient at the time of admission to the ICU, assessed using the APACHE II, SAPS II, MODS, SOFA scales and our proposed ASCM severity rating scale, is presented in Table 8. According to our data, the patient’s condition corresponds to a severe degree of the disease, a low probability of a favorable prognosis, unlike the other 4 rating scales.

Table 8

Estimation of the probability of death at the time of patient admission to the ICU

Scales: SOFA MODS SAPS II APACHE II I _ASCM Points 2 points 5 points 19 points 4 points 18 points Probability of death: less than 10% 16% 3.3% 5.1% 57.6%
(severe disease, low probability of a favorable prognosis).

On September 25, 2021, the patient’s condition worsened, symptoms of intoxication increased, severe abdominal pain and symptoms of peritonitis appeared. It was decided to perform relaparotomy on an emergency basis. The assessment of the condition at the time of transfer to the ICU from the operating room is presented in Table 9.

Table 9

Assessment of the patient’s general condition after emergency relaparotomy and transfer to the ICU

Scales SOFA MODS SAPS II APACHE II I _ASCM Points 1 point 4 points 16 points 4 points 11 points Probability of death: less than 10%. 16%. 2.3%. 5.1%. 19.2%
(Moderate severity of the disease, high probability of a favorable prognosis).

It should be noted that the patient’s general condition stabilized, and the symptoms of multiple organ failure did not increase. However, subsequently the patient’s condition began to progressively deteriorate and after 6 days the patient died. The day before death, the results of the study are presented in Table 10.

Table 10

Assessment of the patient’s general condition the day before death

Scales SOFA MODS SAPS II APACHE II I _ASCM Points 2 points 5 points 28 points 6 points 17 points Probability of death: less than 10% 16% 8.8% 6.7% 57.6%
(severe disease, low probability of a favorable prognosis).

Based on the assessment of the patient’s general condition using four diagnostic scales and the ASCM proposed by us, we can conclude that _ASCM I most accurately reflected the patient’s condition compared to other diagnostic scales.

Example 2. Patient S., 27 years old, was admitted to the hospital on January 11, 2022, with complaints of intense pain throughout the abdomen and general weakness. I considered myself sick since January 10, 2022, when, after prolonged consumption of alcoholic beverages, intense pain appeared in the upper abdomen. Diagnosis: “Acute severe pancreatitis.” The patient was hospitalized, intensive conservative therapy was carried out in the surgical department, and the condition was stabilized. The results of assessing the severity of the condition and predicting the probabilistic outcome of the disease are presented in Table 11.

Table 11

Assessment of the patient's condition at the time of admission to the surgical department

Scales: SOFA MODS SAPS II APACHE II I _ASCM Points 5 points 3 points 14 points 5 points 5 points Probability of death: less than 10% 7% 1.7% 5.8% 3.8%
(Mild degree of disease, high probability of favorable prognosis).

On January 13, 2022, the patient’s condition sharply worsened, the patient was transferred to the ICU with suspected pancreatic necrosis. Further treatment was continued in the ICU. The patient's condition at the time of transfer to the ICU is presented in Table 12.

Table 12

Assessment of the patient's condition at the time of transfer to the ICU

Scales: SOFA MODS SAPS II APACHE II I _ASCM Points 5 points 3 points 18 points 3 points 13 points Probability of death: less than 10% 7% 2.9% 4.4% 38.4%
(Moderate disease, high probability of favorable prognosis).

Assessing the general condition of the patient as of January 13, 2022 using the ASCM severity rating scale proposed by us, it can be stated that the proposed scale analyzes the deterioration of the patient’s general condition more accurately compared to the four compared diagnostic scales.

On January 17, 2022, the patient’s condition improved and he was transferred to the surgical department (Table 13). On January 28, 2022, he was discharged in satisfactory condition.

Table 13

Assessment of the patient's condition at the time of transfer to the ICU

Scales: SOFA MODS SAPS II APACHE II I _ASCM Points 1 point 3 points 17 points 5 points 5 points Probability of death: less than 10% 7% 2.6% 5.8% 3.8%
(Mild degree of disease, high probability of favorable prognosis).

Assessing the general condition of the patient as of January 17, 2022 using the ASCM scale we proposed, we get 5 points, which corresponds to a mild degree of the disease and a high probability of a favorable prognosis.

Thus, our proposed method for assessing the general condition and severity of patients with symptoms of multiple organ failure, using the new ASCM scale and the integral indicator I _ASCM , allows a more accurate reflection of the clinical picture compared to the scales: APACHE II; SAPS II; MODS; SOFA. In this case, easily determined indicators included in the medical and economic diagnostic standards are used.

This scale is nonspecific and, due to its uniqueness and ease of implementation, can be used at the stage of providing highly specialized medical care to assess the severity of the condition and predict the probable outcome of the disease both in intensive care and resuscitation departments, surgical departments, and in various severe conditions and pathologies in non-surgical patients.

Bibliography

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2. Aleksandrovich Yu. S., Gordeev V. I. Rating and prognostic scales in critical care medicine. St. Petersburg: Sotis, 2007. – pp. 22-43.

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Claims (14)

1. A method for assessing the severity of acute diseases of the abdominal organs, including determining the following patient indicators: age; heart rate; mean arterial pressure; Body temperature; respiratory rate per minute; diuresis in 24 hours; blood urea nitrogen; creatinine; leukocytes; serum platelet count; bilirubin; potassium; sodium; Glasgow Coma Scale score; Moreover, each indicator according to the assessment scale “Assessment of the severity of the condition and prognosis of mortality” is assessed from 1 to 4 points in accordance with Table 1 presented in the description, after which the severity assessment index I _ASCM is calculated by summing the obtained points according to all indicators and interpret the value of I _ASCM as follows: I _ASCM value from 0 to 4 - mild severity of the disease; I _ASCM value from 5 to 12 - average severity of the disease; I _ASCM value from 13 to 32 - severe severity of the disease. 2. The method according to claim 1, characterized in that if the I _ASCM value is 0-4 points and the severity of the disease is mild, the probability of death is predicted to be up to 1.5%, if the I _ASCM value is from 5 to 8 points and the average severity of the disease, the probability of death is predicted to be 3.8%, if the I _ASCM value is from 9 to 12 points and the average severity of the disease, the probability of death is predicted to be 19.2%, if the I _ASCM score is from 13 to 16 points and the severity of the disease is severe, the probability of death is predicted to be 38.4%, if the I _ASCM score is from 17 to 20 points and the severity of the disease is severe, the probability of death is predicted to be 57.6%, if the I _ASCM score is from 21 to 24 points and the severity of the disease is severe, the probability of death is predicted to be 76.9%, if the I _ASCM score is from 25 to 28 points and the severity of the disease is severe, the probability of death is predicted to be 85%, if the I _ASCM score is from 29 to 32 points and the severity of the disease is severe, the probability of death is predicted to be 100%.