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SPINE Volume 27, Number 18, pp 2036–2040

©2002, Lippincott Williams & Wilkins, Inc.

A Multicenter Study Analyzing the Relationship of a


Standardized Radiographic Scoring System of
Adolescent Idiopathic Scoliosis and the Scoliosis
Research Society Outcomes Instrument

Philip L. Wilson, MD,* Peter O. Newton, MD,* Dennis R. Wenger, MD,*


Thomas Haher, MD,† Andrew Merola, MD,† Larry Lenke, MD,‡ Thomas Lowe, MD,§
David Clements, MD,储 and Randy Betz, MD¶

Study Design. A multicenter study examining the as- thoracic and upper thoracic curve magnitudes were also
sociation between radiographic and outcomes measures correlated with General Function (P ⬍ 0.002). The “coro-
in adolescent idiopathic scoliosis. nal” subscore as well as the “total” score of the Harms
Objectives. To evaluate the association between an Study Group radiographic scoring system were also sig-
objective radiographic scoring system and patient quality nificantly correlated with these Scoliosis Research Soci-
of life measures as determined by the Scoliosis Research ety domain and total scores. No radiographic measures
Society outcomes instrument. taken after surgery were significantly correlated with the
Summary of Background Data. Although surgical cor- postoperative domains of the Scoliosis Research Society
rection of scoliosis has been reported to be positively outcomes instrument. Stepwise regression analysis of
correlated with patient outcomes, studies to date have these radiographic measures as predictors of Scoliosis
been unable to demonstrate an association between ra- Research Society scores resulted in adjusted R2 values of
diographic measures of deformity and outcomes mea- 0.03– 0.07 (P ⬍ 0.0001). Although these results show that
sures in patients with adolescent idiopathic scoliosis. a significant association exists between the radiographic
Methods. A standardized radiographic deformity scor- Cobb angle measure of the scoliosis and the Scoliosis
ing system and the Scoliosis Research Society outcome Research Society outcomes scores, the low R2 values
tool were used prospectively in seven scoliosis centers to indicate that variables other than the radiographic ap-
collect data on patients with adolescent idiopathic scoli- pearance of the deformity (e.g., psychosocial, functional)
osis. A total of 354 data points for 265 patients consisting must also be affecting these scores.
of those with nonoperative or preoperative curves ⱖ10°, Conclusion. The Cobb angle measure of the major
as well as those with surgically treated curves, were an- deformity has a small, but statistically significant, corre-
alyzed. Correlation analysis was performed to identify lation with the reported Total Pain, General Self-Image,
significant relationships between any of the radiographic and General Function as measured by the Scoliosis
measures, the Harms Study Group radiographic defor- Research Society outcomes instrument. None of the ra-
mity scores (total, sagittal, coronal), and the seven Scoli- diographic measures in this population correlated with
osis Research Society outcome domains (Total Pain, Gen- postoperative domain scores of the Scoliosis Research
eral Self-Image, General Function, Activity, Postoperative Society outcomes tool. [Key words: adolescent, outcome
Self-Image, Postoperative Function, and Satisfaction) as assessment, scoliosis] Spine 2002;27:2036 –2040
well as Scoliosis Research Society outcomes instrument
total scores. Radiographic measures that were identified
as significantly correlated with Scoliosis Research Society
outcome scores were then entered into a stepwise regres- The surgical treatment of adolescent idiopathic scoliosis
sion analysis. (AIS) is predicated on the basis of improving the truncal
Results. The coronal measures of thoracic curve and deformity, limiting curve progression, and ultimately
lumbar curve magnitude were found to be significantly leading to a greater quality of life. Although there is
correlated with the Total Pain, General Self-Image, and
total Scoliosis Research Society scores (P ⬍ 0.0001). The potential for pulmonary compromise when curve mag-
nitudes reach 80 –100°, the indications for surgical inter-
vention in the majority of idiopathic scoliosis cases are
From the *Children’s Hospital and Health Center, San Diego, Califor- these aforementioned concerns.2,22 The decision to per-
nia, †St. Vincent’s Hospital, New York, New York, ‡Washington Uni-
versity School of Medicine, St. Louis, Missouri, §Woodridge Orthope- form surgery for correction of idiopathic scoliosis is
dics, Wheat Ridge, Colorado, 储Temple University Hospital, and largely based on objective radiographic measures. Tradi-
¶Shriners Hospital for Children, Philadelphia, Pennsylvania. tionally, Cobb angle measures of the major coronal-
Acknowledgment date: October 2, 2001.
First revision date: January 31, 2002. plane curves have been the standard means for quantify-
Acceptance date: March 11, 2002. ing scoliotic deformity.13–15 Recently, in an effort to
The device(s)/drug(s) is/are FDA-approved or approved by correspond-
ing national agency for this indication.
more thoroughly quantify and address these spinal de-
Corporate/industry funds were received to support this work. One or formities, additional radiographic measures have been
more of the author(s) has/have received or will receive benefits for systematically used.1 Despite the use of these radio-
personal or professional use from a commercial party related directly
or indirectly to the subject of this manuscript, e.g., honoraria, gifts, graphic measures for pretreatment and posttreatment as-
consultancies. sessment of AIS, there are few data correlating the objec-
DOI: 10.1097/01.BRS.0000024169.56395.B4 tive radiographic measures to the stated treatment goals

2036
Scoliosis Research Society Outcomes Instrument • Wilson et al 2037

Table 1. Radiographic Measures instrument for patients evaluated or undergoing treatment for
AIS. This validated, disease-specific questionnaire consists of
Measure Points seven domains: Pain, General Self-Image, General Function,
Overall Level of Activity, Postoperative Self-Image, Postoper-
Coronal measurements
Thoracic curve 20
ative Function, and Satisfaction. The questionnaire is format-
Upper thoracic curve 5 ted in two sections. Section 1 consists of the first four domains
Lumbar curve 20 listed above and applies to pretreatment as well as posttreat-
Coronal C7 to CSL 5 ment patients. Section 2 applies to posttreatment patients only
Apical translation (apex to CSL) 4 and consists of the last three domains listed above. Postopera-
Apical vertebral body rotation (Nash-Moe) 3
T1 rib angle 5 tive patients complete Sections 1 and 2. This outcomes instru-
End instrumented vertebrae angulation 4 ment provides individual domain scores as well as an overall
Disc angulation 4 total score.
Classification of CSVL 5 Data were gathered for patients evaluated or treated for AIS
Total coronal and axial score 75
Lateral radiographs
from 1995 to 2000 at the seven scoliosis centers. A total of 620
T2–T12 (N ⫽ 20–45°) 5 patients from the Harms Study Group AIS database were avail-
T5–T12 (N ⫽ 20–40°) 5 able for review. Data for 355 of the patients were excluded
T2–T5 (10° normal) 5 because they did not meet the following inclusion criteria:
T12–L2 (N ⫽ ⫾10°) 5 11–18 years of age at diagnosis of AIS, curve magnitude ⱖ10°
Lordosis (N ⫽ ⫺40 to – 60°) 5
Total sagittal score 25 (diagnosis of scoliosis), radiographic and SRS outcomes data
recorded concurrently (measured ⬍1 month apart), and only
Deformity score 100 data recorded at latest surveillance visit or final preoperative
visit for presurgical data and latest postoperative visit (1, 2, 3,
or 4 years) for postsurgical data. These criteria result in no
of improved quality of life and reduced truncal more than two data sets per patient included for review. The
deformity.1,3,12,23 application of these inclusion criteria yielded 354 data sets
The Scoliosis Research Society (SRS) outcomes instru- from 265 patients available for review. Eighty-nine patients
had two data points: preoperative and latest postoperative. Of
ment is a disease-specific health-related quality-of-life
the 176 remaining patients with only one data point, 106 were
questionnaire that has been validated for use in the AIS preoperative data points and 70 were postoperative.
patient population.9 Although improvement in SRS out- Pearson’s correlation coefficient was calculated to identify
comes scores following surgery for AIS has been docu- associations between any of the radiographic measures, total
mented,3,12 there is little evidence of direct correlation of radiographic deformity scores, and the seven SRS domains as
the primary clinical measure of scoliosis (i.e., radio- well as the total SRS score. The SRS outcome domain scores
graphic Cobb angle) and the quality-of-life measures and total scores were normalized because the number of ques-
(i.e., SRS outcomes instrument scores). tions answered pretreatment differ from the number answered
Understanding that the radiographic process mea- posttreatment. The scores were normalized by dividing the
sures of patients with scoliosis reflect a component of the score by the number of questions answered. Because of the
disorder that is different from those measured by the SRS number of statistical comparisons being made, a P value of
⬍0.005 was considered statistically significant. Radiographic
outcomes instrument, it remains reasonable to assume
measures that were identified as being significantly correlated
that this disease-specific questionnaire would have some with SRS scores were then entered into a stepwise regression
correlation with the radiographic assessment of disease analysis. Linear regression analysis was also used to examine
severity. The purpose of this study was to test the validity whether gender, age, exposure to surgery, or severity of initial
of this assumption and determine whether any measures curve was predictive of SRS scores. Statistical measures were
in a standardized radiographic deformity system directly performed using Statistical Package for Social Science (Chica-
correlate with patient-reported quality of life as mea- go, IL).
sured by the SRS outcomes instrument.
Methods Results
A review of data collected on patients between 1995 and 2000 Of the 265 patients included for study, 36 (13.6%) were
at seven scoliosis centers within the United States provided male and 229 (86.4%) were female. Patient age ranged
material for study. All of the centers used a radiographic defor- from 11 to 21 years with a mean age of 14.7 years (SD
mity scoring system developed by the Harms Study Group to 2.5 years). Curve magnitude before treatment ranged
evaluate patients with AIS.3 This radiographic system assigns from 32° to 96° with a mean curve magnitude of 52.5°
point values to direct numerical measures taken from the stan- (SD 9.7°). Normalized SRS total score ranged from 1.32
dard posteroanterior and lateral upright scoliosis radiographs.
to 4.23 with a mean score of 2.8 (SD 0.43).
Therefore, standard coronal and sagittal Cobb angle measures
and radiographic measures of coronal and sagittal balance
A significant negative correlation, as indicated by
were available for study. The 15 radiographic measurements Pearson’s correlation coefficient, was found between the
and the respective points for the deformity scoring system are coronal measure of the thoracic scoliosis curve and the
presented in Table 1. Total Pain domain (r ⫽ ⫺0.22, P ⬍ 0.001), General
During the study collection period, centers began prospec- Self-Image domain (r ⫽ ⫺0.23, P ⬍ 0.001), General
tively using the SRS outcomes questionnaire as a quality-of-life Function domain (r ⫽ ⫺0.18, P ⬍ 0.003), and total SRS
2038 Spine • Volume 27 • Number 18 • 2002

Table 2. Correlations*
Total General General Postoperative Postoperative Total
Pain Self-Image Function Activity Self-Image Function Satisfaction SRS

Thoracic curve ⫺0.22 ⫺0.23 ⫺0.18 — — — — ⫺0.22


Upper thoracic curve — — ⫺0.19 — — — — —
Lumbar curve ⫺0.20 ⫺0.23 — — — — — ⫺0.26
Coronal–axial 0.24 0.24 0.17 — — — — 0.26
subscore
Sagittal subscore — — — — — — — —
Total deformity score 0.24 0.25 0.16 — — — — 0.26
* All displayed r values are significant at the P ⬍ 0.005 level. Missing values indicate nonsignificant r values, which were all above the P ⬎ 0.05 level.

scores (r ⫽ ⫺0.22, P ⬍ 0.001). The coronal measure of taken in postoperative patients were correlated with the
the lumbar scoliosis curve was found to be negatively postoperative domains of the SRS outcomes instrument
correlated with the Total Pain domain (r ⫽ ⫺0.20, P ⬍ (Postoperative Self-Image, Postoperative Function, Ac-
0. 001), General Self-Image domain (r ⫽ ⫺0.23, P ⬍ tivity, and Satisfaction).
0.001), and total SRS scores (r ⫽ ⫺0.26, P ⬍ 0.001). The The radiographic measures that were found to have a
upper thoracic curve measure was found to be negatively significant linear association with SRS scores were then
correlated with the General Function domain (r ⫽ entered into a stepwise linear regression analysis as pre-
⫺0.19, P ⫽ 0.001). As curve magnitude (Cobb angle) dictors of SRS scores. These predictors included thoracic,
increases, domain and total scores on the SRS tend to upper thoracic, and lumbar curve magnitudes. The tho-
decrease, hence the negative correlation. The coronal ra- racic curve size was found to be the best predictor of
diographic deformity subscore as well as the total radio- Total Pain domain scores (adjusted R2 ⫽ 0.05, P ⬍
graphic deformity score were significantly positively cor- 0.001) (Figure 1). The upper thoracic curve was found to
related with the same SRS domain and total scores (r ⫽ be the best predictor of General Function domain scores
0.1– 0.26, P ⬍ 0.005) (Table 2). These correlations are (adjusted R2 ⫽ 0.03, P ⬍ 0.001). The lumbar curve was
positive because of the radiographic scoring system in found to be the best predictor of General Self-Image do-
which higher scores are indicative of a smaller deformity. main scores (adjusted R2 ⫽ 0.05, P ⬍ 0.001) and total
As values on the radiographic score increase (indicating a SRS score (adjusted R2 ⫽ 0.07, P ⬍ 0.001) (Figure 2).
decreasing deformity), domain and total scores on the The radiographic deformity score was the next best pre-
SRS tend to increase as well. The remaining radiographic dictor of total SRS score (adjusted R2 ⫽ 0.06, P ⬍ 0.001)
parameters did not have a significant correlation with (Figure 3).
any of the SRS scores. Neither age nor gender was found to be a significant
Thus, the coronal radiographic measures of the tho- predictor of the three domains above (Total Pain, Gen-
racic curve, lumbar curve, and upper thoracic curve were eral Self-Image, General Function) or total SRS score, as
significantly correlated with selected SRS outcome mea- indicated by adjusted R2 values ⬍0.001 (P ⬎ 0.10).
sures. The Harms Study Group radiographic “coronal” When examined as an independent variable, a patient’s
deformity subscore and the Harms Study Group radio- exposure to surgery was found to predict the same or
graphic “total” deformity score were found to have sim- more of the variance in SRS scores, as did the coronal
ilar significant correlations. No sagittal radiographic measures of lumbar curve, thoracic curve, and upper
measures were significantly correlated with SRS out- thoracic curve. Exposure to surgery was a significant
comes scores. Additionally, no radiographic measures predictor of improvement in the following domains: To-

Figure 1. Thoracic curve as a predictor of pain scores (*total pain Figure 2. Lumbar curve as a predictor of total SRS scores (*total
score/number of pain questions answered); adjusted R2 ⫽ 0.05, SRS score/number of questions answered); adjusted R2 ⫽ 0.07,
P ⬍ 0.001. P ⬍ 0.001.
Scoliosis Research Society Outcomes Instrument • Wilson et al 2039

When examined as an independent predictor, surgical


status was also found to be a significant but weak pre-
dictor of Total Pain, General Self-Image, and total SRS
scores, with a general trend showing improvement in
scores after exposure to surgery. When examining the
relative R2 values (0.05– 0.07 for surgical status vs. 0.03–
0.07 for coronal radiographic measures), it can be seen
that the independent effect of undergoing surgery is as
powerful a predictor of SRS outcome domain scores as
that of coronal curve magnitudes. This finding would
support previous studies that report improvement in SRS
Figure 3. Total radiographic deformity score as a predictor of total outcomes scores after surgery.
SRS scores (*total SRS score/number of questions answered); Whereas the Cobb angle measure of the coronal ra-
adjusted R2 ⫽ 0.06, P ⬍ 0.001. diographic deformity is correlated with reported Total
Pain, General Self-Image, General Function, and total
tal Pain scores (adjusted R2 ⫽ 0.07, P ⬍ 0.001), General SRS outcome scores in this study, the relatively low R2
Self-Image scores (adjusted R2 ⫽ 0.05, P ⬍ 0.001), and values indicate that there must be other variables that are
total SRS scores (adjusted R2 ⫽ 0.06, P ⬍ 0.001). It was influencing the SRS outcomes scores. It is reasonable that
not found to be a significant predictor of General Func- psychosocial factors may have a significant influence on
tion scores (adjusted R2 ⫽ 0.002, P ⬎ 0.2). SRS scores. Issues regarding self-image, confidence, and
self-esteem may predominate over physical complaints.
Discussion
These psychological issues are difficult to measure and may
Early reviews examining outcomes of treatment for AIS or may not relate directly to a patient’s deformity.8,11,16
focused on patient-reported pain, largely without refer- Recent literature does suggest that children and ado-
ence to curve magnitude. Edgar and Mehta6 as well as lescents can provide self-assessments that correlate with
Dickson et al4 reported that instrumentation and fusion physician assessment of outcomes.16 Parental reports on
resulted in decreased reported pain compared with non- two quality-of-life indexes, the Child Health Question-
operatively treated patients. naire and the American Academy of Orthopedic Sur-
Subsequently, numerous questionnaires were used to geons Pediatric Outcomes Data Collection Instrument
attempt to study the association of surgical treatment (AAOS-PODCI), were found to correlate with a clini-
and curve magnitude to patient-reported out- cian’s subjective rating of patient health.20 There were
come.5,17,18,21 In 1995, Haher et al10 performed a meta- several domains on each instrument that distinguished
analysis of reports on 11,000 patients spanning 35 years between patients with different diagnoses, in particular
and concluded that curve correction was associated with cerebral palsy and scoliosis. However, these correlations
an increase in patient-reported satisfaction. These inves- were found to exist between functional outcome assess-
tigations pointed out the need for a standardized out- ments with no comparison to objective process mea-
comes questionnaire for use in the study of AIS treatment. sures. Additionally, outcomes literature suggests that
In 1999, Haher et al9 reported the results of a validated, change occurring in relatively small amounts, as might
disease-specific outcomes instrument developed with the be expected concerning physical complaints in AIS, is
support of the SRS for use in the study of AIS. difficult to measure.7,19 All of these issues may be rele-
Recent investigations regarding the SRS outcomes in- vant when examining the disparity between objective ra-
strument report an increase in scores following surgical diographic process measures and patient-reported out-
treatment for AIS; however, no significant correlation come measures in AIS.
with radiographic measures has been observed.3,12,23 As a retrospective review, this study may be subject to
The purpose of our current study was to further investi- the sampling problems inherent to that mode of investi-
gate the association of radiographic measures and pa- gation. Undoubtedly, some patients with AIS presenting
tient-reported outcomes. An attempt was made to exam- at the seven centers were not evaluated with the radio-
ine whether radiographic parameters are directly graphic deformity system or the SRS instrument. Many
predictive of patient-reported quality-of-life measures patients were excluded from the study because of incom-
independent of the effect of surgery. plete data, as the inclusion criteria required the radio-
The results of this study indicate that the Cobb angle graphs and SRS questionnaire to be obtained within 1
measure of the coronal radiographic deformity is corre- month’s time of each other. This issue of heterogeneity
lated with reported Total Pain, General Self-Image, Gen- within the sample may have been diminished by the large
eral Function, and total SRS outcome scores. In examin- sample size. The other issue concerns bias within the
ing this association further, the relatively low R2 values sample. Because the questionnaires were not adminis-
indicate that a greater Cobb angle is minimally predictive tered within a standard protocol, patients may have been
of a lower SRS score (symptomatic) compared with a biased by prior knowledge gained during previous con-
smaller Cobb angle. sultations. The effects of this potential bias within our
2040 Spine • Volume 27 • Number 18 • 2002

sample is difficult to address because we do not know 3. D’Andrea LP, Betz RR, Lenke LG, et al. Do radiographic parameters corre-
late with clinical outcomes in adolescent idiopathic scoliosis? Spine 2000;23:
what knowledge of scoliosis the patients had when an- 1795– 802.
swering these questionnaires. Despite these issues, we 4. Dickson JH, Erwin WD, Rossi D. Harrington instrumentation and arthro-
think this retrospective review serves an important desis for idiopathic scoliosis. J Bone Joint Surg Am 1990;72:678 – 83.
5. Dickson JH, Mirkovic S, Noble PC, et al. Results of operative treatment of
purpose. idiopathic scoliosis in adults. J Bone Joint Surg Am 1995;77:513–23.
6. Edgar MA, Mehta MG. Long-term follow-up of fused and unfused idio-
pathic scoliosis. J Bone Joint Surg Br 1988;70:712– 6.
Conclusion 7. Fischer D, Stewart AL, Bloch DA, et al. Capturing the patient’s view of
change as a clinical outcome measure. JAMA 1999;282:1157– 62.
In this series of patients, the Cobb angle measure of the 8. Guyatt GH, Jaeschke R. Measurements in clinical trials: choosing the appro-
major deformity has a statistically significant but weak priate approach. In: Spiker B, ed. Quality of Life Assessment in Clinical
Trials. New York, NY: Raven Press, 1990; 37– 46.
correlation with the reported total pain, general self- 9. Haher TR, Gorup JM, Shin TM, et al. Results of the Scoliosis Research
image, and general function as measured by the SRS out- Society instrument of evaluation of surgical outcome in adolescent idiopathic
comes instrument. These correlations are relatively low, scoliosis: a multi-center study of 244 patients. Spine 1999;24:1435– 40.
10. Haher TR, Merola A, Zipnick RI, et al. Meta-analysis of surgical outcome in
and none of the radiographic measures in this population adolescent idiopathic scoliosis: a 35-year English literature review of 11,000
correlated with postoperative domain scores of the SRS patients. Spine 1995;20:1575– 84.
outcomes tool. Other studies have shown that the SRS 11. Johnson J. Outcomes analysis in spinal research: how clinical research differs
from outcomes analysis. Orthop Clin North Am 1994;25:205–13.
outcomes instrument may be of some use in assessing 12. Merola A, Brkaric M, Panagopoulos G, et al. A multi-center prospective
individual patients before and after surgery.12 However, study of the surgical treatment of adolescent idiopathic scoliosis utilizing the
the current study suggests that additional factors must Scoliosis Research Society outcome instrument [abstract]. Scoliosis Research
Society, 35th Annual Meeting Program, Cairns, Australia, 2000.
largely be affecting outcome scores aside from the radio- 13. Mielke CH, Lonstein JE, Denis F, et al. Surgical treatment of adolescent
graphic measures of deformity. idiopathic scoliosis. J Bone Joint Surg Am 1989;71:1170 –7.
14. Moe JH. A critical analysis of methods of fusion for scoliosis: an evaluation of
two hundred and sixty-six patients. J Bone Joint Surg Am 1958;40:529 –54.
15. Moskowitz A, Moe HH, Winter RB, et al. Long-term follow-up of scoliosis
Key Points fusion. J Bone Joint Surg Am 1980;62A:364 –76.
16. Pencharz J, Young NL, Owen JL, et al. Comparison of three outcomes
● The Cobb angle measure of the major deformity instruments in children. J Pediatr Orthop 2001;21:425–32.
has a statistically significant correlation with the 17. Roye DP Jr, Farcy JP, Rickert JB, et al. Results of spinal instrumentation of
reported total pain, general self-image, and gen- adolescent idiopathic scoliosis by King type. Spine 1992;17:270 –3.
18. Simmons ED Jr, Kowalski JM, Simmons EH. The results of surgical treat-
eral function as measured by the SRS outcomes ment for adult scoliosis. Spine 1993;18:718 –24.
instrument. 19. Taylor SJ, Taylor AE, Foy MA, et al. Responsiveness of common outcome
● This correlation, although statistically signifi- measures for patients with low back pain. Spine 1999;24:1805–12.
20. Vitale MG, Levy DE, Moskowitz AJ, et al. Capturing quality of life in
cant, is weak. pediatric orthopedics: two recent measures compared. J Pediatr Orthop
● Postoperative radiographic measures did not 2001;21:629 –35.
correlate significantly with the postoperative do- 21. Waddell G, Reilly S, Trosney B, et al. Assessment of the outcome of low back
surgery. J Bone Joint Surg Br 1988;70:723–7.
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low-up and prognosis in untreated patients. J Bone Joint Surg Am 1981;63:
Acknowledgments 702–12.
The authors thank Tracey Gaynor, MA, Gail Huss, RN, 23. White SF, Asher MA, Lai SM, et al. Patient’s perception of overall function,
pain, and appearance following primary posterior instrumentation and fu-
and Michelle Marks, PT, for their assistance with data sion for idiopathic scoliosis. Spine 1999;24:1693–9.
management and manuscript preparation and Depuy
AcroMed for their support of the Harms Study Group.
Address reprint requests to
References Peter O. Newton, MD
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1095–100. E-mail: pnewton@chsd.org
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