The Consistency Testing and Improving of A Hematuria Colorimetric Card

Background: A Hematuria colorimetric card could unify the description of gross hematuria, but the consistency in assessing hematuria samples of a hematuria colorimetric card for gross hematuria is still inconclusive. The consistency testing and improving of hematuria colorimetric card has potential clinical application value. Methods: According to 6 color scales (0~5), 31 hematuria samples were made. One sample was used to explain the use of hematuria colorimetric cards, and then the evaluator was asked to describe the color. After the remaining 30 samples were arranged in a random number table, 30 evaluators independently completed the hematuria sample assessment under the same conditions. Kendall W coordination coecient was used to test inter-observer consistency. After 1 hour, 30 hematuria samples were rearranged by random digital table method, 15 of which were randomly selected from 30 evaluators, and 30 samples were evaluated independently under the same conditions. Adopt the method of Kappa to test the consistency of the two evaluation results. Results: In the study, the evaluator lacked unity in describing the same hematuria color, including six groups of descriptive words: gross hematuria, light blood, light red, blood, scarlet, carmine. Inter-observer (inter-group) consistency test, Kendall coordination factor was 0.881(F=766.34), P<0.05), the result indicats higher inter-observer agreement. For intra-observer (intra-group) consistency test, the kappa value of nurses was 0.909~1(P<0.05), the value of doctors was 0.818~0.95(P<0.05), and the value of students was 0.863~0.911(P<0.05), the results showed that intra-observer agreement was also high. Consistency results between grade evaluation results of hematuria samples and standard color numbers: the average consistency of evaluation results of standard color numbers 0~5 was 100%, 100%, 94.2%, 65.2%, 38%, 65.8% respectively. The the 4 th color block with low discrimination in the primary hematuria colorimetric card was eliminated, and the 5 th color

0.909~1(P<0.05), the value of doctors was 0.818~0.95(P<0.05), and the value of students was 0.863~0.911(P<0.05), the results showed that intra-observer agreement was also high. Consistency results between grade evaluation results of hematuria samples and standard color numbers: the average consistency of evaluation results of standard color numbers 0~5 was 100%, 100%, 94.2%, 65.2%, 38%, 65.8% respectively. The the 4 th color block with low discrimination in the primary hematuria colorimetric card was eliminated, and the 5 th color block was reassigned to 4 th . Thus the modi ed hematuria colorimetric card was divided into 5 grades.
Conclusions: The improved hematuria colorimetric card has good consistency in hematuria evaluation and is an effective tool for evaluating hematuria grade, which is helpful to unify the evaluation standard of gross hematuria grade.

Background
Hematuria is one of the common symptoms and postoperative complications of urinary system diseases such as prostatic hyperplasia, kidney stones, ureteral stones, bladder cancer or urinary tract infection, etc. Assessing hematuria is an important aspect for nurses to observe the condition of the patients, it can provide evidence for doctors and nurses to decide and carry out nursing measures in time [1][2] through evaluating bleeding amount. Nowadays, most clinical nurses still estimate the color of the drainage uid based on their subjective evaluation, but there is individual difference existing among them with big deviation, unscienti c and inaccurate which may affect clinical outcomes depending on each nurse's clinical experience and skill level. In addition, some medical personnel calculate the amount of blood loss based on the red blood cell counting, hemoglobin concentration in the drainage uid or the formula to calculate the amount of blood loss Page 3/13 [3][4][5], This way with more accurate, however, none has been widely adopted in general practice because requiring more time, more energy and increasing hospitalization costs. There are also some nursing scholars using self-made hematuria colorimetric card when assessing the degree of the hematuria, they have achieved certain success in evaluating postoperative gross hematuria , such as, using this hematuria colorimetric card can reduce anxiety levels of patients and their families and improve effective communication between doctors and nurses because they have a uni ed language [6]. Our team also designed and applied for a patent on a colorimetric card(ZL200420062702.8). However, different evaluators were found to have different colorimetric results for the same hematuria during clinical application, therefore, it is necessary to carry out consistency test to optimize and improve this card. Evaluate the degree of agreement regarding the assessment of various hematuria samples obtained by nurses, general practitioners, and urologists, and then according to the assessment, further optimize be needed.

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 A liated 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 (4.23×10 12 / 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 coe cient 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 uid remover, the speci c con guration is shown in Table 1 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.

Results
The results about the colour obtained by the 20 examiners considered collectively were not in high agreement. There are 6 description phrases from evaluators on standard hematuria sample color description result from "Explanation No.2" prepared in the laboratory: naked hematuria, light blood, rose, blood, vermillion/scarlet and carmine. The speci c statistical results are shown in Table 3.  The modi ed hematuria colorimetric card was divided into ve grades ( Fig.2 and Table 5), and the 4 th color block with low discriminant degree in the original hematuria colorimetric card was eliminated, and the 5 th color block was reassigned to 4 th .    [8][9] . For doctors, unifying the color standard of hematuria not only enable doctors to observe the process of patient's condition accurately and dynamically with different working years, but also bene t the effective information exchange between doctors and nurses, doctors and patients as well. For nurses, unifying the color standard of hematuria not only standardize urological hematuria observation and recording speci cation, but also help nurses to carry out accurate nursing practice and research [10][11]. Therefore, it is very important to unify the color description of hematuria with naked eye to ensure the accurate communication of the medical team and the safety of hematuria patients.
Hematuria colorimetric card provides a standard for medical staff to objectively evaluate the color of hematuria The results show that nurses had a good consistency in the description of hematuria color, while doctors had poor consistency in the description of hematuria, and the description of hematuria in medical students were obviously lack of unity. This may be because medical students were still in the learning stage, the internship period of each department was mostly one month, so the unity of the description of clinical phenomenon was still lacking. Nurses are the most frequent clinical contact with patients, but also the link between doctors and patients, so nurses had a more better uni ed view of clinical phenomenon in order to communicate with doctors and patients better. Lack of uniformity in the description of hematuria may lead to obstacles during handovering on patients' conditions and in communication between medical teams.
Hematuria is one of the important bases for clinical urology to judge postoperative blood loss [12]. Because, bad communication will not only cause medical errors, but also lead to medical incident [13], so there should be a uni ed descriptive language for communication and exchange between medical teams. The use of the hematuria colorimetric card standardized and provided a scienti c basis for color evaluation , which facilitated communication between physicians, nurses, and patients, thereby improving patient satisfaction [14]. The results of this study show that this hematuria colorimetric card can well unify the description of hematuria among medical staff.

Guidance of the hematuria colorimetric card on clinical work and research
The optimized hematuria colorimetric card is easy to make and carry, The card is convenient for patients and medical personnel to be kept in their pockets. Thus it will be facilitate widespread use. The card can also be designed as paste type which xed to the drainage bag, and can also store the electronic version of the  [15][16], but too fast irrigation will increase intravesical pressure, and high velocity will cause certain stimulation to the bladder wall. Enhancing parasympathetic excitability is a very important risk factor for bladder spasm [17]. As a result, the correct and reasonable adjustment of washing speed can improve nursing quality and bring relatively comfortable experience to patients [18]. With this hematuria colorimetric card, nurses can decide whether to carry out bladder irrigation and the speed of bladder irrigation according to the depth of hematuria color in the patient's drainage bag. Bladder irrigation should be carried out when the color number is 2 or above. The washing speed can be adjusted to 80~120 drops per minute. When the hematuria color is 3 or above, the washing speed should be accelerated, and the recommended speed should be adjusted to 160 drops per minute or more, the rate of irrigation is based on our experience in clinical. In addition, hematuria colorimetric card designed in this study marked the color number and corresponding blood loss (converted to blood content per 100 ml of drainage uid). Nurses can directly judge the postoperative blood loss. For example, the total amount of bladder drainage uid was 1000 ml within 2 hours after urological operation, the drainage uid matches the No.3 colour, the blood concentration corresponding to the No.3 is 1.6%, the estimated blood loss was 1.6%×1000 ml≈16 ml. Based on the total blood loss assessed by the nurses, the lost hemoglobin content can also be further calculated.
The formula is: the lost hemoglobin = the hemoglobin concentration×the total blood loss.
Because the haematuria card marks the amount of blood loss for each color, nurses can conduct a multicenter, large sample study based on this haematuria colorimetric card about the changes of postoperative bleeding in different urinary diseases [19]. Besides, by using this haematuria colorimetric card, the color of drainage uid, the amount of drainage uid and the amount of bleeding were plotted on the urine color observation table after urological operation. Medical staff can see the data curve intuitively, it is convenient for medical personnel to understand the patient's condition in time, and it is bene cial to nurses to carry out ne nursing.

Conclusions
This study carried on the consistency test and the improvement to the hematuria colorimetric card, provided a convenient, e cient and uni ed hematuria evaluation tool for the medical personnel, received the unanimous a rmation of the clinical medical personnel, and had certain guiding signi cance to the clinical work.
However, there are still some shortcomings. To evaluate the color of the hematuria is still depends on the eyes of the medical staff, and it is inevitable that there will be a certain subjective judgment. Furthermore for limited by light and photography technology, color is not completely accurate. Nowadays, with the rapid development of information technology and digital technology, the accuracy and convenience of the hematuria colorimetric card can be improved, which expected further research in subsequent experimental studies.

Declarations
Ethics approval and consent to participate Figures Figure 1 hematuria colorimetric card