Ethics statement
The study was carried out in agreement with applicable laws and regulations and good clinical practices and ethical principles. This study was approved by the Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University(Reference Number:2018-1117).
Materials and Instruments
Disposable urinary bags, disposable 10 ml and 50ml syringes, quantitative pipette(100ul~5ml). Sysmex UF-5000 automated urinalysis analyzer, UC-3500 urine dry chemical analyzer and XN-Series automatic hematology analyzer, HD cameras (Canon, EOS M50). The specimen is required for making a hematuria colorimetric card coming from a healthy research volunteer. The urine samples left are fresh yellowish urine, tested by an automatic urine analyzer, urine analysis results should be within the biological reference range. The hemoglobin content (125 g/L) and erythrocyte count (4.23×1012/ L) of the same type mixed fresh anticoagulant ( A blood group selected in this study); Hemoglobin content and erythrocyte count are in the biological reference range of blood erythrocyte count in normal adult men and women in China. All subjects were informed of the use of the specimens and informed consent was obtained.
Study design
Assuming a correlation coefficient of 0.99, andαandβvalues of 0.05 and 0.10 for type I and II errors, respectively, the minimal sample size required to achieve the desired statistical power (0.80) was n=5. A total of 30 urological medical staffs were included in this study to evaluate the consistency of hematuria colorimetric card, including 10 urologists, 10 urological nurses and 10 medical students who practice in urology[7]. All people are screened by the Color Blind Examination Chart, and none of them was color blind and weak. Thirty subjects independently completed the hematuria samples assessment. Depending on their evaluation, the hematuria colorimetric card was optimized, and then the consistency test was carried out with the new hematuria colorimetric card to determine the effectiveness of the blood urine colorimetric card.
Research method
First, creating hematuria colorimetric cards. According to the materials, preparation of colorimetric card color scale, making colorimetric card master board, printing and plastic sealing colorimetric card reference to this research group patent program [9]. First, adding fresh normal urine to No.0~9 urine drainage bags, then adding fresh blood with quantitative fluid remover, the specific configuration is shown in Table 1. Then choosing the color scale with better discrimination to make hematuria color card, For this study, the No.0, No.2, No.3, No.5, No.7, No.8 were selected as 0~5 color clock respectively. The 0th color block is the original urine, the color of hematuria gradually deepened with increase of the color number. Blood loss per 100 ml of drainage fluid matches each color in the Fig. 1.
Table 1- configuration of hematuria colorimetric card
number
|
No.1
|
No.2
|
No.3
|
No.4
|
No.5
|
No.6
|
No.7
|
No.8
|
No.9
|
No.10
|
No.11
|
urine(ml)
|
50
|
49.9
|
49.8
|
49.6
|
49.2
|
48.8
|
48
|
47
|
46
|
44
|
42
|
Fresh anticoagulant blood(ml)
|
0
|
0.1
|
0.2
|
0.4
|
0.8
|
1.2
|
2
|
3
|
4
|
6
|
8
|
*blood loss(ml)
|
0
|
0.2
|
0.4
|
0.8
|
1.6
|
2.4
|
4
|
6
|
8
|
12
|
16
|
*Indicates blood loss per 100 ml of drainage fluid.
Second step was to Preparing and numbering samples to be evaluated. Continue to prepare hematuria samples for consistency test according to the above method. In this study, 31 samples of blood and urine were prepared, except for 0 color, at least 3 samples of each color number were prepared. Taking No.2 color hematuria sample for the sample which explains the usage method of hematuria colorimetric card and color of naked hematuria description as study object. The hematuria sample is prepared in a disposable drainage bag. Number 1 to 30 will be pasted on the upper left corner of the drainage bag for all other hematuria samples except the sample with “Explanation- No.2”, see Table 2. The compilers put "Table 2 Hematuria Sample Composition" in the sealed envelope and gave it to the data statistician and data analyst.Well prepared hematuria samples are handed over to the research personnel. Compilers were not involved hematuria sample evaluation process.
Table 2 - Quantity and Numbering for Sample Preparation
Color code
|
0
|
1
|
2
|
3
|
4
|
5
|
Sample numbers
|
2
|
5
|
7
|
7
|
5
|
4
|
Sample’s code
|
1-2
|
3-7
|
8-14
|
15-21
|
22-26
|
27-30
|
Study on the consistency of hematuria colorimetric card
Renumbering the samples, researchers hang 30 hematuria samples via sorting by random numbers, 20cm distance for each sample, and block the upper left corner of the original urine bag number, then renumbering 1~30.
Testing consistency of inter-observer assessment results. The researchers explain usage method of hematuria color card to each evaluator with “Explanation No.2”, (Leave the disposable urine bag in vertical, pinching two edges in angles of the diagonal line of the drainage bag about 180 degree for shaking 2-3 times, running color contrast after mixing the fluid inside the drainage bag and colorimetric). In the same lighting environment, each evaluator independently completed the description of the color of the hematuria sample for "Explanation 2", and scored 30 hematuria samples according to 6 grades (0-5). There was no communication during the evaluation. The experiment was conducted under the supervision of a researcher. The researchers do not participate in the evaluation process and avoid communication with evaluators. After the assessment completed,the researchers record and collate the results.
Intra-observer consistency test. 1 hour after the end of the intra-observer consistency test (to prevent color changes in hematuria for a long time), the researchers hang 30 blood urine samples after reordering them according to random digital, 20 cm. distance among each hematuria sample. Renumber 1~30 after sorting again with black cover paper hiddening urine bag upper left corner number. Using convenient sampling method, 5 urological nurses, 5 urological doctors and 5 urological practice students are selected from the original evaluators to re-evaluate 30 cases of blood and urine samples. Each evaluator independently complete the evaluation process of 30 blood and urine samples and records the results.
Statistical analysis
The Microsoft Excel 2007, SPSS 20.0 software was used to input and analyze the data, the inter-observer consistency test adopted the Kendall W coordination coefficient, and the intra-observer consistency two times adopted the Cohen’s kappa coefficient test. The measurement data are expressed by(±SE), and the counting data are expressed by percentage.