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Stones Final 09 October 2020
Stones Final 09 October 2020
Stones Final 09 October 2020
Stones, Exposure, Skin to Stone Distance) Nephrolithometry Scoring in Predicting the Stone
ABSTRACT
Distance) Nephrolithometry Scoring utilizes specific patient parameters and CT Scan findings.
The STONES Nephrolithometry score is computed, compared and against the outcome of stone-
free rate in patients who underwent ESWL for uncomplicated renal stones. The objective of the
outcome of stone free rate patients undergoing ESWL that will help improve patient selection,
METHODS: Retrospective retrieval of data from patients with uncomplicated renal stones who
underwent ESWL using EDAP Sonolith machine with electroconductive technology. Included in
study were patients with complete demographic data and CT scan findings. Specific parameters
retrieved: Stone size up to 2 cm; Topography or location of stone identified as superior, middle or
inferior calyx; Obesity based on BMI-Body Mass Index; Number of Stones, Hounsfield Unit of
Stones and Skin to Stone distance measured. “STONES nephrolithotmetry Score” (SNS) is
computed as the sum of all specific parameters. (SNS = S + T + O + N + E + S). Accuracy ratings
and receiver operator curve analysis to determine the best-predictive cut-off score was
determined.
RESULTS: 66 patients enrolled in the study with 56 patients noted to be stone free and 10
patients who were not stone free post ESWL. 28 of the 46 patients underwent multiple sessions
of ESWL before rendered stone free (Table 1). Weighted score derivations were done using
1
multivariate regression to establish the scoring system. SNS range of 96 to 129 showed the
highest stone free rate (p<0.001). The minimum cut-off that is best predictive of a stone-free rate
is a STONES Nephrolithotomy score of at least 105 with a high sensitivity rating of 98.2%.
Table 1. Number of patients who are stone-free and not-stone-free across the frequency
STONE FREE
STONES YES NO
Nephrolithometry
Score
1ST Session 2nd Session 3rd Session
n = 28 n = 18 n = 10
54 to 79 0 0 1 5
80 to 105 7 8 3 4
106 to 129 21 10 6 1
Total 28 18 10 10
CONCLUSION: The STONES scoring system is an accurate and reliable tool for predicting stone-
2
Introduction
Association of Urology, on the treatment of uncomplicated renal stones only consider the stone
location and size. Recent studies however, showed significant correlation of other independent
parameters such as BMI of the patient, number of stones, stone exposure and skin to stone
distance to stone treatment like ESWL, PCNL or retrograde intrarenal surgery (RIRS). The
development of this Nephrolithometry scoring system will correlate these independent parameters
Nomograms and scoring systems have been applied as effective tools that helped
physicians and patients on decision making, counseling and management approach. The
development of this STONES Nephrolithometry Scoring System will provide physician, urologist
or not, the patient-friendly guide if the patient is a good candidate for ESWL. In the Philippines
where cost is always a limiting factor, the STONES Nephrolithometry Scoring System will be an
objective tool that can be used to advise the patient of ESWL and its success for each individual
patient or if the patient is not a good candidate, we can offer a better option.
In the Philippines where cost is always a limiting factor, the STONES Nephrolithometry
Scoring System will be an objective tool that can be used to advise the patient of ESWL success
rate or if the patient is not a good candidate, we can offer a better option. Guidelines in the use of
ESWL from Western countries were not updated probably due to the advancement of
endourology. However, in our local setting, ESWL has been popularly used and maybe at times
abused treatment option for the management of renal stones. Thus, STONES Nephrolithometry
Scoring System may be used to inspire local urologist to revisit the guidelines and probably came
3
Kidney stones had been increasing worldwide unbounded with race, sex and age with an
annual prevalence of about 3-5% and approximate lifetime prevalence of about 15-25%1.
Evolution of management of kidney stones from medical to open renal surgery to minimally
invasive procedures, such as endourologic procedures and shockwave lithotripsy, had been seen
in the past decades. Despite the recent advancement in the field of endourology, with
Percutaneous Nephrolithotomy (PCNL) and Retrograde Intrarenal Surgery (RIRS) battling their
role in the gold standard for complicated urinary stones, extracorporeal shock wave lithotripsy
(ESWL) still remains among the options for the management of uncomplicated renal stones less
than 2 cm. ESWL’s success rate had varying results from different large number studies which
may also be attributed to patient selection. Proper patient selection is the key for the success of
any procedure and this could be maximized with identifying objective reproducible findings such
as BMI and non-contrast CT scan measurement in decision making and management in ESWL.
of Urology) Guidelines agreed on the role of ESWL as a first line of treatment for stones less than
20 mm, however EAU highlighted the need to assess the factors that affects the stone free rate
of ESWL such as stone size, location, and composition of the stones, patient’s habitus and
performance of SWL 2,3. AUA also emphasize that for lower pole stone more than 10 mm, ESWL
should not be offered as the first line of treatment admitting the limitation of ESWL in this location
We have seen the value of predictive models for treatment and management of diseases
like cancer which helped clinicians and patients alike in treatment decision making and
management course. Likewise, in the management of renal stones, there were models and
nomogram proposed which could predict the stone free rate of procedures like PCNL,
4
Onal et al, proposed a scoring system and nomogram for children4. In this study, they
have cited that previous history of ipsilateral stone treatment, stone burden, stone location, gender
and age at presentation were significant variables in predicting stone free rate in children.
Previous history of stone treatment was noted to negatively affect the stone free rate probably
due to scarring from previous ESWL which prevents good peristalsis and adequate contraction
resulting to delays in urinary drainage and subsequent passage of the stone fragments after
ESWL treatment
Kim et al recognized the need for validated prediction model for stone free rate for patient
patients who underwent ESWL, a graphical nomogram was developed and validated to predict
the stone free rate at first and within the third session of ESWL. They found that sex, stone
location, stone number, and maximal stone diameter, mean Hounsfield unit (HU) and grade of
Kent et all created a nomogram that predicts the stone free rate at 3 months after 1 session
of ESWL6. They found that size, location and number of stones are independent significant
indexes that predicts the stone free rate at 3 months following 1 session of ESWL in renal and
ureteral stones.
In 2014, Molina et al introduced The S.T.O.N.E. Score, an assessment tool to predict SFR
in patients who require ureteroscopy for ureteral and renal stone disease7. The features of
S.T.O.N.E. that are relevant in predicting SFR with URS include the Size, location, and degree of
hydronephrosis, number of stones and Hounsfield unit. This has been the inspiration of the author
to use the same acronym but a different set of parameters to predict the stone free rate for ESWL.
The author had an approval to use the STONES acronym from the author of this previous study.
5
The author used the independently studied parameters, namely stone size (S), stone
location(T), BMI(O), number of stones(N), Stone Exposure (E), and stone to skin distance(S),
which were significantly affecting stone free rate and combine them to produce the
Nephrolithometry Scoring System with the acronym STONES. The STONES Nephrolithometry
Scoring System will be used to identify the probability of stone free rate of patients who underwent
ESWL. This study is the first to the best of our knowledge to combine these parameters to develop
a scoring system that will predict the probability of stone free rate of patients undergoing ESWL
The study is limited in that it utilized only a fixed-sample size of sixty-six patients. No
subgroup of patients with complicated urolithiasis was included, hence the generalizability to this
GENERAL OBJECTIVE
To develop and validate the STONES Nephrolithometry Scoring System that will
predict the stone free rate of ESWL for patients with uncomplicated renal stones
SPECIFIC OBJECTIVES
2. To determine the best minimum cut-off score that is predictive of stone-free rate.
3. To determine the range of STONES scores and their corresponding stone-free rates.
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ETHICAL CONSIDERATION
The protocol was prepared by the authors. The protocol was submitted to the review
process of the institution’s Ethics Committee. The research was conducted in accordance
with this protocol, which was consistent with the ethical principles that have their origin in the
Declaration of Helsinki and the National Guidelines for the Biomedical/Behavioral Research of
the National Ethics Committee (NEC) Philippines. All study participants of the study were given
clear and complete instructions about the goal and study design. Withdrawal from the study for
any reasons was allowed at any time. The investigators made themselves available for any
questions or clarifications raised. Study participants were not being given remuneration but were
All study participants who passed the Criteria for inclusion were given information on the
basic elements of the REC- approved Protocol. When understood and accepted, participants
This is a retrospective cohort study of patients with uncomplicated renal stones (< 2 cm)
treated with ESWL using standard shockwave lithotripsy protocol. All patients were diagnosed
using non-contrast enhanced CT scan of the KUB. Patient who underwent previous stone
treatment, such as ESWL, PCNL, RIRS or open stone surgery, on the ipsilateral kidney were
All patients were treated at a single institution using EDAP Sonolith 4000 (Technomed,
France) with a standard protocol (Fig. 1). Patients received prophylactic antibiotics and IV
sedation. The shock wave was delivered at an asynchronized rate of 100 shocks per minute or at
electrocardiogram triggering mode with a power of 80% initially which was increased up to 100%.
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The positioning of the stone was checked by fluoroscopy after every 500 shocks. Treatment
ended after a maximum of 1000kJ was given. All the staffs, nurse and technicians, were trained
and were the only personnel who gave the treatment to our patients.
At 95% confidence level and 10% confidence interval, the minimum required number of
patients was at least 69 patients. This was based on the results of the previous study of (2012),
The ESWL treatment protocol consist of up to 3 ESWL procedure and follow up with plain
kidney-ureter-bladder X-ray (PKUB) to be performed 2-3 weeks post treatment. Patients with
PKUB X-ray showing presence of radiopaque lesion were schedule for another treatment. The
interval of re-assessment was set at 2 weeks and repeat treatment was scheduled at 3-4 weeks
from the last treatment to give ample amount of time for the kidney to recover and resolve possible
hematomas. Patients with persistence of radiopaque density on PKUB on 3 month follow up was
classified as treatment failure. Patient’s with PKUB showing no radiopaque lesion at the previous
stone site was confirmed with KUB Ultrasound. The primary outcome of the study was the stone-
free rate at 3 months. Stone free was defined as no visible or up to 3 mm radiopaque focus on
good plain KUB X-ray on the 3rd month follow up comparing with the pre-operative plain KUB.
Measurement of stone size (S), stone location/topography (T), number of stones(N), stone
exposure /Hounsfield unit (E) and stone to skin distance were reported (S). NCCTs were reviewed
by a single radiologist who was blinded with the clinical results. Data were collated by the authors
and processed using statistical analysis software to identify the predictiveness for stone free rate
of each parameters. A multivariate analysis is performed to generate the regression equation that
is used to develop the scoring system. Calibration of the scoring system and validation through
the sample population was also performed. Range and its probability of stone free rate was then
established.
In this study, six parameters were used which showed predictiveness for stone free rate
from previous studies. Stone was measured in 3 planes and the longest measurement was used
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as representative for the stone size (S). Stone size of 5 to 10 mm was assigned with 80 points
while 11 to 15 mm and 16 mm to 20mm were given 54 and 27 points respectively. The stone
location/topography (T) was identified by the location where the stone is noted either in the
calyces or renal pelvis. Superior calyx and renal pelvis stones were given 9 points, middle calyx
Baseline height and weight were recorded prior to the first treatment by the SWL nurse to
calculate for the BMI (O). Patients were categorized as normal (9 points), overweight (5 points)
and obese (4 points). Number of stones (N) was used instead of the total stone burden because
multiple stones need to be targeted separately and the need to refocus the treatment is essential.
Solitary stone was assigned with 3 points while multiple stones were given 2 points.
The Exposure/Hounsfield unit (E) was the mean of the spherical ruler pointed on the stone.
The mean stone exposure was 827. Stone exposure less than 827 was designated with 9 points
and those equal or more than 827 has 4 points. Stone skin distance/SSD (S) was measured in 3
planes from the stone with perpendicular line to the skin at 90, 45 and 30 degrees. The average
of the 3 measurements was used as the stone to skin distance. The mean SSD was 85mm. SSD
with less than 85 was assigned with 20 points while equal or more than 85 mm was given 9 points.
The sum of the values of the S-T-O-N-E-S is the STONES Nephrolithometry score. The
accuracy of the scoring system was confirmed using statistical analysis presented.
STATISTICAL ANALYSIS
All analyses were done using the Statistical Package for the Social Sciences (SPSS
Version 23, with license). Numerical summaries were done using mean and their standard
deviations for continuous numerical variables and percentages for categorical data. Multivariate
analysis of the different variables in the STONES criteria was done using binary logistic regression
by forward technique. Variables with odd ratios of above 1, with p-values less than 05 were
considered statistically significant. Statistical precision of the OR estimates was pegged at 95%
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confidence level. For factors with more than two categories in the encoding, a categorical analysis
was separately performed to determine the individual odd ratios for each level. To formulate the
scoring model, a multivariate analysis was conducted to derive the beta-coefficients. A weighted
point was computed by dividing the specific beta-coefficient by the lowest beta-coefficient in the
predictor set multiplied by the regression constant. The resultant weighted score was rounded off
to the nearest whole integer. The regression equation was derived to determine the probability of
stone-free status using the six variables in the scoring tool. The Hosmer-Lemeshow's goodness
of fit test was utilized to determine any significant variation in the scoring model that can be
explained by factors that are not significant and to test for significant calibration or discriminative
power of each score set. Each score was applied to the same set of subjects (validation set). The
sum of all scores was utilized to run a receiver operator curve analysis to determine the accuracy
of the scoring model, and to determine the minimum best score that is predictive of a stone-free
status. The sensitivity and false-positive rate were plotted against each score. Three ranges of
scores were calculated by subtracting the lowest score from the highest score divided by three to
come up with specific range of STONES scores. Stone free rates in each range were determined
and compared using Chi-Square Test. An area under the curve with p-value of less than .05 was
RESULTS
A total of sixty-six patients who underwent lithotripsy were included in this validation study
with their profile shown (Table-2). The mean age was 47 years old, with male predominance
(63.6%). Nine patients were classified as obese (13.6%). In terms of stone topography, twelve
(18.2%) were categorized as superior, 23 (34.8%) were in the middle region and 31 (47%) in the
inferior region. In terms of laterality, left sided stones were slightly more common (54.5% versus
45.5%). More than half of the stones were between 5 to 10 millimeters (53%). The average
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Hounsfield units and skin-to-stone distance was 827.9 and 85.1 cm respectively. Stones were
commonly solitary (77.3%). Overall average of “shocks” utilized was 3178. A total of 56 patients
00Characteristic No. %
Total patients 66 --
Mean age (SD) 47 (11.4) --
Sex
Male 42 63.6
Female 24 36.4
BMI
Normal 9 13.6
Overweight 28 42.4
Obese 29 43.9
Topography of stone
Superior (Calyx, Pelvis) 12 18.2
Middle Calyx 23 34.8
Inferior Calyx 31 47.0
Laterality
Left 36 54.5
Right 30 45.5
Mean stone size
5-10 35 53.0
11-15 23 34.8
16-20 8 12.1
Number of stones
1 51 77.3
2 15 21.7
Mean Hounsfield Units (SD) 827.9 (297) --
Mean skin-to-stone distance (SD) cm 85.1 (13.1) --
Mean shocks (SD)
First session 3248 (523) --
Second session 3213 (532) --
Third session 3051 (526) --
Overall mean 3178 (521) --
Stone-free status
Yes 56 84.8
No 10 15.2
SD-standard deviation
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MULTIVARIATE AND CATEGORICAL ANALYSIS OF “S-T-O-N-E-S” CRITERIA IN
PREDICTING STONE-FREE STATUS
Of all the variables analyzed, only stone size was predictive of a stone free status (OR=
.081, p=.008). Other variables in the criteria were not predictive. (p-values were >.05) (Table-3)
FACTOR OR 95% CI p
Stone Size (S) .081 .013-0.52 .008*
Stone Topography (T) 1.25 0.31-5.0 0.75
Obesity (O) 0.171 .008 -3.46 0.17
Number of stones (N) 0.35 0.039-3.3 0.36
Exposure (Hounsfield Units) (E) 0.996 0.99-1.0 .086
Skin-to-stone distance (S) 1.058 0.96-1.16 .23
*significant predictor if p-value is < .05
Categorical analysis was done in three variables having more than two categories. These
are the stone sizes, topography and the body mass index categories. Patients with smaller stone
sizes (5-10 mm) had a higher probability of stone-free status than those above this range
(OR=20,95% CI 12-34, p=.001). For stone topography, similar odds ratios were reported, whether
the stone was lodged in the superior pole (OR=0.99), in the middle region (OR=.0.84) or in the
inferior region (OR=0.94). Those who had normal BMI was 1.87 times associated with stone free
status (OR 1.87, 95% CI 0.44-2.87, p=.07), while those who were either overweight or obese had
a slightly lower association (OR 1.78, 95% CI 0.27-11.8 and OR 1.71, 95% CI 0.26- 11.4, p=.57
respectively). (Table-4)
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TABLE-4 Categorical Analysis for Variables with more than Two Categories in
the STONES Nephrolithometry Scoring System for Predicting Stone-
Free Status
FACTOR OR 95% CI p
Stone Size (S)
5-10 20.0 12 -34 .001
11-15 6.1 0.56-66.2 .14
16-20 3.1 0.44 – 5.4 .23
Stone Topography (T)
Superior (Calyx, Pelvis) 0.91 0.04-2.8 0.71
Middle Calyx 0.84 .05-14.4 0.91
Inferior Calyx 0.94 .094-9.38 0.96
BMI Category
Normal 1.87 0.44 – 2.87 .07
Overweight 1.78 0.27 – 11.8 .55
Obese 1.71 0.26 – 11.4 .57
*OR with values less than 1 were rounded off the nearest integer
The two factors above have more than 2 encoding categories
The proposed STONES scoring system below categorizes each variable and a weighted
point is assigned (Table-5). The equation for defining the chances of a “stone-free” state is
determined by summing up the weighted points. Hence, the Probability of Stone Free is = 1.5
multiplied by the sum of [stone size + stone topography + obesity + number of stones + Hounsfield
The test of the goodness of fit of this model is shown to be well calibrated (Hosmer-
13
TABLE-5 Weighted Points in the STONES Nephrolithometry Scoring System
for Predicting Stone-Free Status
Obtaining an overall STONES Score is summing up all the individual scores of the 6 domains.
Regression Equation for Probability of Stone Free Rate= 1.5 * [stone size + stone topography + BMI Category +
number of stones + Hounsfield Units + Skin-to-stone distance]
and the maximum score was 129 points, with an average score of 108 (± 21).
Figure-1 displays the receiver operator curve (ROC) of the STONE Scoring System in
predicting stone-free status as validated in the set of sixty-six patients. The overall accuracy (area
14
under the curve-AUC) of the tool is 88% with a standard error of 5.2%. (95% CI 77.9, 98.2%,
p<.001)
Based on the validation set, the minimum cut-off that is best predictive of a stone-free rate
Figure-1 Receiver Operator Curve of the STONE Scoring System in Predicting Stone-Free
Status
was 129 points, with an average score of 108 (± 21). If the STONE score is between 54 to 79,
the stone-free rate was 16.6%. When STONE scores approach the range of 80 to 105, the stone
15
free rate was 81.8%; while scores between 106 to 129, the stone-free rate was 97.3% (Table-5).
Overall percentage of patient who were stone-free and not stone free across each range is
presented in Figure 2.
TABLE-6 Stone-Free Rates According to Range of the STONES Score, Validation Set
Involving 66 Patient
Distribution of Patient with Stone Free and Not Stone Free Status Post
ESWL
2%
15%
27%
56%
SNS 54-79 SNS 80-105 SNS 106-109 Not Stone Free
Figure 2: The distribution of patient STONES Scores who were Stone-Free and Not-
Stone-Free Across STONES Score Ranges
Of the 66 cases, 56 or 84.8% were stone free after ESWL. The distribution of stone free across
16
TABLE-6 Stone Free Rates Across Frequency of ESWL Sessions
DISCUSSION
The present study investigates the validity and reliability of the STONES tool in predicting
stone free status in patients with nephrolithiasis post-lithotripsy. The validation sample is
composed of sixty-six patients with data retrospectively collated from medical records using a
lithotripsy (ESWL) procedures was done by examining the PKUB X-rays upon follow up. The
Our initial analysis shows that among all factors in the STONES Nephrolithometry Scoring
analyzed, only stone size showed a significant regression coefficient and odds. Increasing stone
size as depicted in three categories, was highly associated with a lower rate of stone-free status.
This supports the external validation study of Noureldin et.al.7, involving 155 percutaneous
nephrolithotomy procedures, where stone size and the number of involved calyces were still the
most predictive of all factors combined for a given procedure. However, there was not significant
difference in the calculated odds whether the stone was lodged in the superior, middle, inferior
Obesity (BMI), categorically speaking, was not a predictor of stone-free rate in our scoring
model. This is partly explained by the fewer subjects falling within the body mass index range of
above 30 kg/m2. Majority of the participants in this study are soldiers and hence obesity was
17
underrepresented in this study. The study of Yarimoglu et.al.9 demonstrated that stone-free
In our predictive model, the stone-to-skin distance average of three angle measurements,
contributed to a higher weighted score than the stone exposure (Hounsfield units), although both
parameters were not strongly predictive. This again is due to the disproportionate distribution of
subjects falling in the categories for stone exposure and stone-to-skin distance. The study of Niwa
et.al.10 showed that stone size, maximum HU of the stone, and SSD at 90° were significant
predictors of successful shock wave lithotripsy outcome in patients with a proximal ureteral stone.
In our study, we utilized the average of SSD to categorize patients. An arbitrary cut-off of
less than 85 mm stone-to-skin distance was associated with a higher odd of stone-free rate. One
study showed that a median SSD of 125 mm (range 81-165 mm) were associated with successful
stone-free outcomes while those 141 mm (range 108-172 mm) had treatment failure.11 When
examining stone exposure, the study of Sugino et.al.12 revealed that maximum HU and mean HU
have equivalent predictive accuracy, and maximum HU is easier to measure and less biased than
mean HU.
The overall derived accuracy for the STONES predictive scoring index was fairly high
(87.1%). As depicted above, the STONES nephrolithometry scoring tool is an easy, fast and
accurate tool. One of the drawbacks for its use is the weighted scores assignment that needs to
be simplified. Because of the inherent small sample size of this study, the weighted scores in
some variables were overinflated like the stone size and skin-to-stone distance which makes it
cumbersome to remember. But the ease of summing up the scores is the same mathematical
procedure in determining the probability of stone-free rates as seen in the other scoring models
presented. A comparison of the area under the receiver operating characteristic (ROC) curves for
stone burden, the Guy's, STONE score, CROES core and S-ReSC scores showed good results
(0.737/0.674/0.762/0.746/0.710) respectively. 15
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The STONES score is based on factors determined through CT imaging, which is the
currently preferred imaging modality for patients with nephrolithiasis. The potential problem will
probably stem from inaccurate reporting of the imaging results. The discriminative power
(calibration) of this tool is highly dependent partly on the specific CT measurements on high
resolution, the degree and the body morphology of obesity, the ability to detect the multiplicity of
stones in relation to their site in the pelvo-calyceal regions, the variability in reading the HU and
the SSD.
The development of this STONES scoring system has its own limitations. Due to the
inherently small sample size, some categories were underrepresented. The skewed frequency
distribution in the mentioned categories of the scoring system explains the lack of significant
association. We presented an arbitrary range of scores and their corresponding stone free rates.
The predictive accuracy of the tool even at low scores could have been improved by enrolling
more participants. The retrospective nature of the study is prone to recall bias; hence validation
design.
CONCLUSION:
• The STONES nephrolithometry scoring system composed of stone size, topography, obesity,
RECOMMENDATIONS:
independent and blind personnel doing the scoring and determining the stone free rate.
• It is useful to validate the scoring system using a higher sample size. This will adjust the
19
• There is a need to standardize the utilization of the STONES prediction tool by training
20
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