TITLE: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
AUTHORS: Rajamaheswari N, Ilangovan Veerappan, Chandrakala Maran, Harini Sivamani, M. Meena Mahalingam, A. Rajagopal

[DESCRIPTION]
Constant vigilance to recognize and treat Urinary Tract Infection(UTI)both asymptomatic & symptomatic bacteriuria throughout pregnancy is necessary as untreated bacteriuria can lead to maternal and fetal complications. Subjecting all pregnant women to routine Simple Urine Tests(SUT)and Conventional Urine Culture Tests(CUCT)to diagnose bacteriuria poses a great challenge in high-volume centers. There is a need to develop a Machine Learning Screening Software(MLSS) as a laboratory protocol to be used as a screening tool in predicting bacteriuria from the results of SUT without subjecting all pregnant women to CUCT unless indicated. Women attending antenatal clinics from February 2020 to January 2021(irrespective of gestational age) were studied for the variables of SUT, CUCT, and patient characteristics. The sample size of 50 was determined with the planning value of bacteriuria at 10 % within a specified 5% margin of error and validated with external data(n=2987). The multivariate diagnostic analytics determined predictors pH, specific gravity(Sp. Gr), and pus cell from SUT variables by calculating eigenvalues(scree plot)and eigenvectors (loading plot). Logistic multiple nominal regression determined 7 significant biomarkers.A combinatorial effect of these biomarkers predicted bacteriuria and classified it, leading to the development of Machine Learning Screening Software(MLSS). Embedding Fuzzy Logic Intelligence Decision Criteria(FLIDC)on MLSS enhanced its accuracy of prediction. MLSS reveals that all pregnant women attending antenatal clinics need not undergo routine CUCT; only 50% would require it. The software identifies pregnant women for whom CUCT is essential. MLSS has 96% accuracy, 85% sensitivity, and 54% specificity. This Point-of-Care screening tool has opened a new simplified pathway to screen all pregnant women for UTI from SUT without subjecting them to CUCT unless indicated. MLSS minimizes the burden of antenatal clinics managing high-volume patients and resource-restricted countries by saving time and resources.
Key words–Pregnancy, UTI, Bacteriuria, Screening software, Fuzzy logic, Point of Care

[BEFORE_START]
1. Collection of urine samples of pregnant women following standard laboratory protocol.
2. Standard calibrated measuring devices with provision to do the Simple Urine Test (SUT) which can detect urinary pH, specific gravity, pus cells, albumin, cast, and nitrite conforming to the measurements prescribed in the MLSS.
3. Basic laboratory facility attached to the antenatal clinic of the Obstetrician. 
4. Basic excel based computer facility with the availability of the internet to peruse the link provided in the google drive 

[GUIDELINES]
The computational methods are based on the statistical techniques as under:
a) The correlation of significant biomarkers from Simple Urine Test (SUT) is used to predict the probable bacteriurial event.
   b) The data mining techniques and machine learning tools analyzed the independent variables as the results of Simple Urine Test(SUT) and dependent variables as the results of the Conventional urine culture test with multivariate prediction analytics

[STEPS]
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
1. What is the scope of Machine Learning Screening Software (MLSS) for Obstetricians? 
 It is a simple screening tool used to diagnose and monitor bacteriuria throughout pregnancy from the results of the Simple Urine Test(SUT).

 
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
2. What is the advantage over present practice?
Machine Learning Screening Software (MLSS) predicts bacteriuria from Simple Urine Test (SUT) consistent with the outcome of the Conventional Urine Culture Test (CUCT) without subjecting to Conventional Urine Culture Test (CUCT) reserving CUCT only for those recommended by Machine Learning Screening Software (MLSS). 
It eliminates the need to subject all pregnant women to routine Conventional Urine Culture Test (CUCT).


SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
3. What is the outcome of this screening software ?
•	Prediction of bacteriuria and the probability of bacteriurial events.
•	Recommends Conventional Urine Culture Test (CUCT) only for those who require it.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
4. What is the basis of computation of this prediction software ?
The correlation of significant biomarkers from the Simple Urine Test (SUT) is used to predict the probable bacteriurial event.
The data mining techniques and machine learning tools analyzed the independent variables of the results of the Simple Urine Test (SUT) and dependent variables of the results of the Conventional urine culture test(CUCT) with multivariate prediction analytics using Minitab version 18.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
5. What is the preparation to use 'Machine Learning Screening Software (MLSS)?
•	Collection of urine sample from pregnant women following standard laboratory protocol.
•	Standard calibrated measuring devices with provision to do the Simple Urine Test (SUT) which can detect urinary pH, specific gravity, pus cells, albumin, cast, and nitrite conforming to the measurements prescribed in the 'Machine Learning Screening Software (MLSS).
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
6. Explain the safety aspects.
•	The usage of 'Machine Learning Screening Software (MLSS) to detect UTI in pregnant women has no adverse impact on the patient as it is only a screening tool that does not involve any intervention.
•	Check your system of data security before using the link.

SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
7. What is the infrastructure required before use?
•	Basic laboratory facility attached to the antenatal clinic of the Obstetrician. 
•	Basic excel based computer facility with the availability of the internet to peruse the link provided in the google drive
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
8. What are the steps to open the link – data1?
Click on the google drive link https://docs.google.com/spreadsheets/d/1S9eM0BZyv6_OZMTXex_HrHkgpcUVSPrXzHNaW_RIPx4/edit#gid=988619344 or copy-paste the drive link in your browser.
• Open the excel sheet number 2 - MLSS Bacteriuria of the google drive link. 
• Do not alter the other sheets in the google drive link which is only for reference.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
9. What are the steps to put input data of patient – data 2 ?
Enter the patient name and age in the appropriate box.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
10. What are the steps to put input data of patient as obligatory requirement from Simple Urine Test (SUT) results– data 3 ?
•	Enter the results of the Simple Urine Test (SUT) conforming to the measurements prescribed in the 'Machine Learning Screening Software (MLSS).  
•	Urine pH, specific gravity, and pus cells are the primary obligatory biomarkers to be filled as numerals. 
•	Albumin, cast, and nitrite are secondary obligatory parameters to be filled using dropbox choosing presence or absence.
Screeneshot of input data shown below
  
 

SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
11. What are the steps to put input data of the patient as an optional requirement from Simple Urine Test (SUT) results– data 4 ?
The remaining parameters -epithelial cells, Red Blood Cells(RBC), color, sugar, acetone, crystal, bilirubin, bile salts, urobilinogen, and yeast are optional only for further clinical reference.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
12. How are the results of Bacteriuria and the recommendation for Conventional Urine Culture Test (CUCT) displayed?
After entering all the input, the results will be displayed as the predicted type of bacteriurial event with or without the recommendation for Conventional Urine Culture Test (CUCT).
Display of result is shown as screenshot below,
  



SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
13. How was the final recommendation on Conventional Urine Culture Test (CUCT) given ?
The final recommendation on the need for the Conventional Urine Culture Test (CUCT) will be displayed based on the recommendation by the primary and secondary biomarkers.
If the recommendation by primary and or secondary biomarkers is “ yes” proceed to Conventional Urine Culture Test (CUCT).
Only if both primary and or secondary biomarkers recommend “NO” then no need to proceed Conventional Urine Culture Test (CUCT) but continue monitoring.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
14. What is the interpretation of the results on CUCT ?
The output interpretation and subsequent course of action will be done by the Obstetrician.
SECTION: Efficacy of Simple Urine Test based Machine Learning Screening Software in predicting UTI in pregnancy
15. Can the software update the history of patient records ?
This is a stand-alone protocol that needs to be documented in the respective medical/electronic records to continue the monitoring by the antenatal clinic.