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European Spine Journal (2020) 29:1340–1352

https://doi.org/10.1007/s00586-020-06365-z

ORIGINAL ARTICLE

What level of symptoms are patients with adult spinal deformity


prepared to live with? A cross‑sectional analysis of the 12‑month
follow‑up data from 1043 patients
A. F. Mannion1 · M. Loibl2 · J. Bago3 · A. Vila‑Casademunt4 · S. Richner‑Wunderlin1 · T. F. Fekete2 · D. Haschtmann2 ·
D. Jeszenszky2 · F. Pellisé3 · A. Alanay5 · I. Obeid6 · F. S. Pérez‑Grueso7 · F. S. Kleinstück2 · European Spine Study
Group (ESSG)4

Received: 12 September 2019 / Revised: 31 December 2019 / Accepted: 3 March 2020 / Published online: 18 March 2020
© Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract
Introduction Previous studies suggest that a meaningful and easily understood measure of treatment outcome may be the
proportion of patients who are in a “patient acceptable symptom state” (PASS). We sought to quantify the score equivalent
to PASS for different outcome instruments, in patients with adult spinal deformity (ASD).
Methods We analysed the following 12-month questionnaire data from the European Spine Study Group (ESSG): Oswestry
Disability Index (ODI; 0–100); Numeric Rating Scales (NRS; 0–10) for back/leg pain; Scoliosis Research Society (SRS)
questionnaire; and an item “if you had to spend the rest of your life with the symptoms you have now, how would you feel
about it?” (5-point scale, dichotomised with top 2 responses “somewhat satisfied/very satisfied” being considered PASS+,
everything else PASS−). Receiver operating characteristics (ROC) analyses indicated the cut-off scores equivalent to PASS+.
Results Out of 1043 patients (599 operative, 444 non-operative; 51 ± 19 years; 84% women), 42% reported being PASS+ at
12 months’ follow-up. The ROC areas under the curve were 0.71–0.84 (highest for SRS subscore), suggesting the question-
naire scores discriminated well between PASS+ and PASS−. The scores corresponding to PASS+ were > 3.5 for the SRS
subscore (> 3.3–3.8 for SRS subdomains); ≤ 18 for ODI; and ≤ 3 for NRS pain. There were slight differences in cut-offs for
subgroups of age, treatment type, aetiology, baseline symptoms, and sex.
Conclusion Most interventions for ASD improve patients’ complaints but do not totally eliminate them. Reporting the
percentage achieving a score equivalent to an “acceptable state” may represent a more stringent and discerning target for
denoting treatment success in ASD.
Graphic abstract
These slides can be retrieved under Electronic Supplementary Material.

Results of ROC curve analyses to determine the score equivalent to PASS+


for SRS-16-item instrument (subscore and subdomain scores), NRS pain
(higher value of back pain or leg pain) and Oswestry Disability Index (ODI)

n* % AUC 95% CI Threshold Sens Spec


PASS+ for being % %
Key points PASS+ Take Home Messages
SRS subscore 1033 41.6% 0.84 0.81-0.86 > 3.5 78.4 75.0
1. In the spine field, outcome is commonly assessed in terms of "feeling 1. The "patient acceptable symptom state" (PASS), which focuses on "feeling well"
better" (achieving a minimal clinically important change in a PASS+, in a patient acceptable
SRS funcon 0.72 0.69-0.74 > 3.3 71.4 63.3 rather than just "feeling better", has been proposed as a meaningful and easily
questionnaire score) rather than "feeling well" (achieving a symptom symptom state - answers ‘very understood measure of treatment outcome.
satisfied’ and ‘somewhat satisfied’ on SRS pain 0.83 0.81-0.85 > 3.5 73.5 78.5
state that is considered acceptable). symptom-specific well-being item;
Sens sensitivity; Spec specificity
* some patients failed to complete all 2. In patients with degenerative or idiopathic adult spinal deformity (ASD), the
SRS self-image 0.83 0.80-0.85 > 3.3 75.1 76.6
2. We evaluated the "patient acceptable symptom state" (PASS) in the questionnaires or had missing
responses for some items, hence the
questionnaire scores equivalent to being in PASS were >3.5 for the SRS 16-item
patients with adult spinal deformity (ASD) and derived cut-off scores numbers are lower than 1043 for
some analyses. SRS mental 0.71 0.68-0.73 > 3.8 64.9 68.8
subscore (>3.3 to >3.8 for the four SRS subdomains); ≤ 18 for ODI; and ≤3 for
commensurate with being "in PASS" for different questionnaires. health NRS pain.

3. The relative influence of factors such as age, gender, aetiology of ASD, NRS pain 971 39.5% 0.83 0.80-0.85 ≤ 3.0 68.2 83.0 3. Reporting the percentage of patients achieving a score equivalent to an
treatment-type, and baseline symptom severity on PASS cut-off scores “acceptable state” may represent a more stringent and discerning target for
ODI 1029 41.5% 0.79 0.76-0.81 ≤ 18 67.3 76.0
was quantified. denoting treatment success in ASD.

Mannion AF, Loibl M, Bago J, Vila-Casademunt A, Richner-Wunderlin S, Fekete TF, Haschtmann D, Mannion AF, Loibl M, Bago J, Vila-Casademunt A, Richner-Wunderlin S, Fekete TF, Haschtmann D, Mannion AF, Loibl M, Bago J, Vila-Casademunt A, Richner-Wunderlin S, Fekete TF, Haschtmann D,
Jeszenszky D, Pellisé F, Alanay A, Obeid I, Pérez-Grueso FS, Kleinstück FS, European Spine Study Group Jeszenszky D, Pellisé F, Alanay A, Obeid I, Pérez-Grueso FS, Kleinstück FS, European Spine Study Group Jeszenszky D, Pellisé F, Alanay A, Obeid I, Pérez-Grueso FS, Kleinstück FS, European Spine Study Group
(ESSG) (2020) What level of symptoms are patients with adult spinal deformity prepared to live with? (ESSG) (2020) What level of symptoms are patients with adult spinal deformity prepared to live with? (ESSG) (2020) What level of symptoms are patients with adult spinal deformity prepared to live with?
A cross-sectional analysis of the 12-month follow-up data from 1043 patients. Eur Spine J; A cross-sectional analysis of the 12-month follow-up data from 1043 patients. Eur Spine J; A cross-sectional analysis of the 12-month follow-up data from 1043 patients. Eur Spine J;

Electronic supplementary material The online version of this


article (https​://doi.org/10.1007/s0058​6-020-06365​-z) contains
supplementary material, which is available to authorized users.

Extended author information available on the last page of the article

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Vol:.(1234567890)
European Spine Journal (2020) 29:1340–1352 1341

Keywords Patient acceptable symptom state · Adult spinal deformity · Scoliosis Research Society (SRS) instrument ·
Oswestry Disability Index · Pain Numeric Rating Scale

Introduction exposing suboptimal results that were not detectable using


more traditional outcome measures [13, 14].
It is now commonly accepted that the outcome of elec- The assessment of patient-reported outcome in patients
tive spine surgery should be patient reported [1]. Self- with adult spinal deformity (ASD) has most commonly
administered questionnaires represent the current gold involved use of the condition-specific Scoliosis Research
standard for evaluating symptom status, disability, self- Society (SRS) questionnaire. This instrument was origi-
image, and health-related quality of life and have become nally designed for use in patients with adolescent idi-
an indispensable part of the patient-assessment procedure. opathic scoliosis [15] and covers the domains of pain,
However, the scores and their changes after treatment can function, mental health, and body image. Having under-
at times be difficult to interpret in a clinically meaning- gone refinement [16, 17] and validation as the SRS-22
ful and understandable manner [2] and the statistical sig- [18, 19], it is now considered the instrument of choice
nificance of group mean changes may paint an unrealistic also in patients with ASD. A recent confirmatory factor
picture of the success of treatment [3]. There is an increas- analyses of its 20 non-management items in such patients
ing demand for the reporting of health outcomes using revealed some consistently weak item loadings [20], and
concepts that are relevant to the individual patient and are it was suggested that 4 items (questions 3, 14, 15, 17) be
readily understood by clinicians, e.g. binary measures of removed, to provide an improved, shorter, 16-item version
“good” or “poor” outcome. of the instrument. The present study sought to quantify the
Most spine interventions result in some improvement scores that can be considered “acceptable”, on the differ-
in patients’ complaints, but this may not suffice—in view ent domains of the 16-item SRS and other back-specific
of the accompanying risks—especially for the complex outcome instruments commonly used in patients with
procedures typical of adult spinal deformity (ASD) sur- ASD, after operative and non-operative treatment.
gery. For these reasons, the concepts of the “minimal clini-
cally important change score ­(MCICimp)” [4, 5] or score
reflecting “substantial clinical benefit” (SCB) [6] have Methods
become popular for quantifying the achievement of “rel-
evant” improvement. However, the best methods to be used Patients
for determining the MCIC or SCB, whether statistical or
anchor-based, are controversial [3], and there is no consen- The data were analysed from patients [N = 1043 (599
sus on the interpretation of what constitutes “important” or operative, 444 non-operative), 84% female, mean ± SD
“meaningful”, and “to whom” or “for what” [7]. Further, age 51.4 ± 19 years (Table 1)] recruited into the observa-
it is known that the achievement of a given change score tional study of the European Spine Study Group (ESSG),
can sometimes be dependent on the starting point, being a multicentre European research group evaluating the out-
easier to achieve in patients with initially more extreme come of operative and non-operative treatment for ASD
values [8]. Another criticism levelled at the interpreta- [21]. The main inclusion criteria for all patients enrolled
tion of threshold change scores is that whilst they may in the ESSG study (described in detail in [21]) comprised:
indicate the achievement of relevant improvement, they age ≥ 18 years; coronal spinal curvature ≥ 20° or sagittal
still do not indicate whether an acceptable symptom state vertical axis (SVA) > 5 cm or pelvic tilt > 25° or thoracic
has ultimately been reached (i.e. whether the patient “feels kyphosis > 60°; good understanding of one of the study
good/well”), a factor that would be expected to govern languages (Spanish, German, Turkish, French). Patients
whether the patient returns to work [9, 10], requires fur- were included in the present analysis if: they were enrolled
ther healthcare/treatment [11], or improves his/her mental before March 2018 (such that they had reached 12 months’
well-being, etc. In relation to this, a more recent approach follow-up by the time of the analysis); they had 12-month
to the interpretation of treatment success in spine patients data for the main dependent variable [patient acceptable
involves the reporting of the percentage of patients whose symptom state (PASS) question; see below]; the aetiology
symptoms have reduced to an acceptable level, such that of their deformity had been documented as either degen-
they consider themselves to be in a “patient acceptable erative or idiopathic. There were no exclusion criteria. The
symptom state” (PASS) [12]. This has been shown to most appropriate treatment for the patient (non-operative
be a more discerning measure of the success of surgery, or operative, and the specific procedure to be used) was
decided based on the clinical expertise of the treating

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Table 1  Baseline demographic, comorbidity, and self-reported clini- rate of approximately 80% of all patients included at base-
cal data (mean ± SD, or % values) for the study group (N = 1043 line, and approximately 90% of these complete the neces-
patients)
sary questionnaires. For the present study, 1469 patients
Variable Mean ± SD or N (%) fulfilled the medical inclusion criteria; 1164 of these had
attended a 12-month clinical follow-up, with 1043 of them
Age (years) 51.4 ± 19.4
completing the PASS question required for the analysis.
Gender 874 (84%) F
Hence, PASS was available for 1043/1469 (71%) poten-
169 (16%) M
tially eligible patients (63% for non-operative, 78% for
Country
operative).
France 238 (22.8%)
Spain 478 (45.8%)
Switzerland 209 (20.0%)
Questionnaires
Turkey 118 (11.3%)
The analyses were carried out using the 12-month follow-up
BMI (kg ⋅ m−2) 24.4 ± 4.6
data from the validated German, Spanish, French, and Turk-
Comorbidity, ASA g­ radea (%)
ish versions of the following questionnaires:
1 160 (26.9%)
2 320 (53.9%)
1. Scoliosis Research Society-22 instrument (SRS-22).
3 113 (19.0%)
This contains 20 questions distributed in 4 dimensions
4 1 (0.2%)
(function/activity, pain, self-image, and mental health);
Years with spine problem (%)
each dimension has five items that are scored from 1
Less than 1 year 35 (3.4%)
(worst possible) to 5 (best possible). Only the 4 items for
1–2 years 55 (5.3%)
each domain that were recently recommended for inclu-
2–5 years 110 (10.5%)
sion in the 16-item version of the SR [20] were used in
5–10 years 173 (16.6%)
the analysis. Scores are presented as the mean (scored
Greater than 10 years 668 (64.2%)
1–5) for each dimension and for the subscore (i.e. for
Missing 2 (0.2%)
Prior spine surgery
all 16 items); the higher the score the better the status.
No 733 (70.3%)
(The data from the two SRS-22 “management” items,
Yes 310 (29.7%)
administered post-treatment to assess patient satisfac-
Aetiology of adult deformity
tion, were not used in the present study.)
Degenerative 399 (38.3%)
2. Oswestry Disability Index (ODI; v2.1a), comprising 10
Idiopathic 644 (61.7%)
items, each scored 0–5, and expressed as a percent score
Treatment group
ranging from 0 (no disability) to 100 (severe disability).
Non-operative 444 (42.6%)
3. Pain Numeric Rating Scale (0–10) for (a) back pain and
Operative 599 (57.4%)
(b) leg pain, where 0 is no pain and 10 is the worst pain
Back pain intensity (0–10 NRS scale) 5.9 ± 2.8
imaginable. The higher of the two pain scores was used
Leg pain intensity (0–10 NRS scale) 3.9 ± 3.5
in the analysis (­ NRSpain-higher), in accordance with previ-
Greater of the two pain scores (back or leg), 6.3 ± 2.7
ous PASS studies on spine patients with differing loca-
(0–10 NRS scale) tions (axial or peripheral) for the chief pain complaint
Oswestry Disability Score (ODI) 33.2 ± 20.6 [12].
SRS-16 item 4. The Core Outcome Measures Index (COMI) question-
Function 3.2 ± 1.1 naire [22, 23]. The COMI contains (amongst other
Pain 2.8 ± 1.0 items) an item known as “symptom-specific well-being”
Self-image 2.6 ± 0.9 which enquires about the acceptability of the current
Mental health 3.4 ± 0.9 symptoms: “if you had to spend the rest of your life with
Subscore (16 items) 3.0 ± 0.8 the symptoms you have now, how would feel about it?”,
a
answered on a 5-point Likert scale from “very satisfied”
Surgical patients only; and 5 patients with missing ASA grade
to “very dissatisfied”.
  The answers on the latter were dichotomised, with
physician. Patients with previous surgery at least 2 years the top two categories (very satisfied and somewhat sat-
ago that were not candidates for further surgical treatment isfied) being considered an acceptable symptom state
upon admission to the ESSG were considered non-opera- (PASS+), and all others (neither satisfied nor dissatis-
tive patients. The ESSG study has a 12-month follow-up fied, somewhat dissatisfied, dissatisfied) as not accept-

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able (PASS−), in accordance with previous studies [12, from the binary subgroup variables (treatment, aetiology,
14, 24]. age group, baseline status, and sex) together with the given
instrument’s 12-month score (all variables simultaneously
entered, with separate analyses for each of the three outcome
Statistical analyses instruments, SRS, ODI, N ­ RSpain-higher) to evaluate the statis-
tical significance of the effect of the subgroup variables on
Descriptive data are presented as means ± standard devia- the likelihood of being PASS+, controlling for 12-month
tions (SD) and % distributions of responses regarding the instrument score and adjusting for all other subgroup effects.
acceptability of the symptom state. The differences between The analyses were carried out using StatView 5.0 (SAS
groups were analysed using analysis of variance (ANOVA) Institute Inc, San Francisco, USA), MedCalc (MedCalc Sta-
with post hoc Fisher’s PLSD tests for continuous data and tistical Software, Mariakerke, Belgium) and SPSS version
contingency analyses with Chi-squared/Fisher’s exact P test 24 (IBM Corp., USA, 2013). p values < 0.05 were consid-
for categorical variables. ered to be statistically significant.
Receiver operating characteristics (ROC) curves were
used to describe the probability of the instrument scores
(SRS and its subdomains; ODI; ­NRSpain-higher) correctly clas- Results
sifying patients who considered their state to be acceptable
(PASS+) and those who did not (PASS−) according to the Satisfaction with symptom state at 12 months’
external criterion, the dichotomised response for PASS (see follow‑up
earlier). This is considered analogous to evaluating a diag-
nostic test, in which the instrument score is the diagnostic The distribution of ratings for satisfaction with the symp-
test and the dichotomised PASS response is the gold stand- tom state at 12 months’ follow-up for all patients was: very
ard. The ROC curve combines information on sensitivity satisfied, 181/1043 (17.3%); somewhat satisfied, 250/1043
and specificity for detecting PASS and comprises a plot of (24.0%); neither satisfied nor dissatisfied, 207/1043 (19.8%);
“true-positive rate” (sensitivity) versus “false positive rate” somewhat dissatisfied, 225/1043 (21.6%); very dissatisfied,
(1-specificity) for each of several possible cut-off points in 180/1043 (17.3%). Hence, a PASS+ state (very/somewhat
instrument score. The area under the curve (AUC) (with satisfied with state; see methods) was achieved by 431/1043
exact binomial confidence intervals) was used to indicate the (41.3%) patients. The proportion in PASS+ at 12 months’
probability of correctly discriminating between the dichot- follow-up differed significantly in relation to the base-
omised outcome (i.e. being in PASS or not) based on the line symptom status (51% for those with a baseline SRS
instrument’s score. An AUC of 0.5 indicates discrimination subscore equal to or better than the median, and 33% for
no better than chance, and an AUC of 1.0 indicates perfect those with a score worse than the median; p < 0.001), and
discrimination (100% sensitivity and 100% specificity). The treatment received (47% for operative, and 34% for non-
cut-off giving the best combination of sensitivity and speci- operative; p < 0.0001) but other subgroups showed no dif-
ficity (Youden index) was used to indicate the value on the ferences: 39% for degenerative and 43% for idiopathic aeti-
given instrument equivalent to PASS+. This represents the ologies (p = 0.31); 44% for patients < 50 years and 39% for
lowest overall misclassification (i.e. minimum of false posi- those ≥ 50 years (p = 0.13); 46% for men and 40% for women
tives and false negatives or the maximum sum of specificity (p = 0.16).
and sensitivity [25]).
Separate analyses of the following subgroups were car- Relationship between 12‑month instrument scores
ried out to assess the robustness of the findings: treatment and satisfaction with state
(operative vs non-operative); aetiology of deformity (degen-
erative vs idiopathic); age group (< 50, ≥ 50 years); baseline The mean SRS subscores corresponding to each of the cat-
status (dichotomised by the group median value for SRS-16 egories of “satisfaction with state” at 12 months’ FU for
subscore); and sex (male, female). the whole group are shown in Fig. 1. There was a steady
Logistic regression analyses with either forward condi- decrease in the mean score from “very satisfied” down to
tional or simultaneous entry of the independent variables “very dissatisfied”, with significant differences (p < 0.0001)
(depending on the analysis in question) were used to: (1) between each subsequent step. The Spearman’s rank cor-
evaluate the relative importance of the different outcome relation coefficients between the 5-point “satisfaction with
instruments’ 12-month scores (the 4 SRS subdomains, state” ratings and the 12-month scores for each instrument
ODI, ­NRSpain-higher; forward conditional entry) in explaining are shown in Table 2. The highest coefficients were for the
whether a patient was in PASS+ or not; (2) predict PASS+ correlations with the SRS-16 subtotal score (rho = 0.70) and

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Table 2  Spearman’s rank correlation coefficients between outcome


instrument scores at 1-year follow-up and responses to the 5-point
PASS question

Variable Na Spearman’s rho

SRS subscore 1033 − 0.70


SRS function 1033 − 0.48
SRS pain 1031 − 0.66
SRS self-image 1033 − 0.66
SRS mental health 1033 − 0.46
NRS pain 971 0.64
ODI 1029 0.60
a
Some patients failed to complete all the questionnaires or had miss-
ing responses for some items; hence, the numbers are lower than
1043 for some analysis

Fig. 1  Mean (95% CI) SRS-16 subscores for each response category
of the “symptom-specific well-being” item of the COMI enquiring state” item was a valid external criterion (or “anchor”) for
how the patient would feel if they had to spend the rest of their life the ROC analyses with these variables; for SRS function
with the symptoms they have now (0 very satisfied, 1 somewhat sat-
isfied, 2 neither satisfied nor dissatisfied, 3 somewhat dissatisfied, 4
(Rho = 0.45) and SRS mental health (Rho = 0.44), the cor-
very dissatisfied) relations were somewhat lower than the recommended 0.5
[26].
Figure 2 shows the SRS subscores and subdomain scores
for the dichotomised “satisfaction with state” groups; there
was a significant (p < 0.001) difference in scores for the
PASS+ and PASS− groups for each variable, with the great-
est differences being seen for the SRS subscore and the SRS
pain and self-image subdomains.

Receiver operating characteristics analysis


of 12‑month scores

The ROC areas under the curve (AUC) were between 0.71
and 0.84 (p < 0.001; Table 3) for the different instruments,
suggesting the questionnaire scores discriminated well
between those patients who were in an acceptable state and
those who were not. AUCs were highest for the SRS sub-
score (0.84), SRS self-image, SRS pain, and ­NRSpain-higher
(each 0.83), indicating that these domains were the strong-
est determinants of being in a satisfactory state or not.
This was also confirmed with multiple logistic regression
which showed that, out of the ODI, N ­ RSpain-higher and four
SRS domain scores, only SRS self-image (OR 3.57; 95%
CI 2.67–4.76; p < 0.0001), SRS pain (OR 1.72, 95% CI
1.26–2.34; p = 0.001), and ­NRSpain-higher scores (OR 0.76;
Fig. 2  Box and whisker plot for the SRS-16 subscore and SRS sub-
95% CI 0.69–0.84; p < 0.0001) made a significant unique
domain scores for patients in a patient acceptable symptom state contribution to explaining whether the patient was in an
(PASS+) or not (PASS−) at 12 months’ follow-up (p < 0.0001 for all acceptable state (PASS+) or not.
variables) The cut-off scores corresponding to being in PASS+ were
as follows: SRS subscore > 3.5 (with the subdomains vary-
ing depending on the specific SRS domain); ODI ≤ 18; and
with the SRS subdomain scores for “pain” and “self-image”
­NRSpain-higher ≤ 3 (Table 3). The sensitivity with which the
(each rho = 0.66), although those with ­NRSpain-higher and ODI
different instruments indicated being in PASS+ ranged from
were also each > 0.60, indicating that the “satisfaction with
65% (for SRS mental health) to 78% (for SRS subscore) and

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Table 3  Results of ROC curve na % PASS+ AUC​ 95% CI Threshold for Sens% Spec%
analyses to determine the being PASS+
score equivalent to PASS+
for SRS-16-item instrument SRS subscore 1033 41.6 0.84 0.81–0.86 > 3.5 78.4 75.0
subscore and subdomain scores,
SRS function 0.72 0.69–0.74 > 3.3 71.4 63.3
NRS pain higher value of back
pain or leg pain and Oswestry SRS pain 0.83 0.81–0.85 > 3.5 73.5 78.5
Disability Index (ODI) SRS self-image 0.83 0.80–0.85 > 3.3 75.1 76.6
SRS mental health 0.71 0.68–0.73 > 3.8 64.9 68.8
NRS pain 971 39.5 0.83 0.80–0.85 ≤ 3.0 68.2 83.0
ODI 1029 41.5 0.79 0.76–0.81 ≤ 18 67.3 76.0

PASS+, in a patient acceptable symptom state with answers “very satisfied” and “somewhat satisfied” on
symptom-specific well-being item; Sens sensitivity; Spec specificity
a
Some patients failed to complete all the questionnaires or had missing responses for some items; hence,
the numbers are lower than 1043 for some analyses

Table 4  Results of ROC and of multiple regression analyses examining PASS cut-offs for the SRS-16-item subscore in subgroups of patients
Num- % PASS+ AUC​ AUC 95% CI Threshold for Sens % Spec % p in multiple reg OR (95% CI)
ber of being in PASS
­patientsa

All patients
12 mo FU 1033 41.6 0.84 0.81–0.86 > 3.5 78.4 75.0
Treatment ­group#
Operative 590 47.1 0.85 0.81–0.87 > 3.3 85.6 68.9 0.02 1.53 (1.06–2.21) for
Non-operative 443 34.3 0.83 0.79–0.87 > 3.6 82.2 72.9 operative versus
non-op
Aetiology
Degenerative 391 40.2 0.86 0.82–0.89 > 3.2 85.4 70.9 0.99
Idiopathic 642 42.5 0.84 0.80–0.86 > 3.7 75.1 78.3
Age (years)#
≥ 50 609 39.9 0.85 0.82–0.88 > 3.3 80.3 76.5 0.0005 2.08 (1.38–3.15)
< 50 424 44.1 0.84 0.80–0.87 > 3.7 82.9 69.6 for older versus
younger
Baseline ­symptoms#,b
High (< median) 522 33.5 0.87 0.83–0.89 > 3.3 73.7 85.6 0.049 1.53 (1.003–2.33)
Low (≥ median) 488 51.2 0.79 0.75–0.82 > 3.8 72.0 71.4 for high versus low
symptoms
Sex
Women 865 40.7 0.85 0.82–0.87 > 3.8 73.0 82.3 0.26
Men 168 46.4 0.73 0.65–0.79 > 3.7 74.4 66.7

Bold values indicate p < 0.05


PASS+, patient acceptable symptom state—answers “very satisfied” and “somewhat satisfied” on symptom-specific well-being item; AUC, area
under the receiver operating characteristics curve; 95% CI, 95% confidence intervals; Sens sensitivity; Spec specificity; p in multiple reg, p value
for the significance of this variable in multiple logistic regression analysis to predict PASS+ (see text for further details); OR, odds ratio for this
variable in multiple logistic regression to predict being PASS+
a
Some patients had missing responses for some items in the questionnaire; hence, the numbers are lower than 1043 for some analysis
b
Based on the median value for SRS subtotal score for the SRS 16-item instrument
#
Significant variable in multivariable logistic regression to predict PASS from all 5 subgroup variables and SRS-16-item subscore at 12 months’
follow-up

the specificity for PASS−, from 63% (for SRS function) to variability between the thresholds for the SRS subscore than
83% (for ­NRSpain-higher) (Table 3). for ODI and ­NRSpain-higher, but generally, across all instru-
The results of the ROC subgroup analyses for the cut-off ments, in univariable analyses a worse status was considered
scores for SRS subscore, ODI, and ­NRSpain-higher are shown acceptable at 12 months by patients that had a degenerative
in Tables 4, 5, and 6, respectively. There was less subgroup aetiology, had a worse baseline status (SRS subscore < median

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Table 5  Results of ROC and of multiple regression analyses examining PASS cut-offs for the ODI in subgroups of patients
Number of % PASS+ AUC​ AUC 95% CI Threshold for Sens % Spec % p in multiple reg OR (95% CI)
­patientsa being in PASS

All patients
12 mo FU 1029 41.5 0.79 0.76–0.81 ≤ 18 67.3 76.0
Treatment ­group#
Operative 590 46.9 0.80 0.77–0.84 ≤ 22 71.5 68.9 < 0.0001 2.30 (1.63–
Non-operative 439 34.4 0.80 0.76–0.84 ≤ 16 72.2 75.0 3.25) for
operative
versus non-
op
Aetiology
Degenerative 390 40.0 0.80 0.76–0.84 ≤ 29 73.1 73.5 0.23
Idiopathic 639 42.6 0.80 0.77–0.83 ≤ 13 67.7 79.0
Age (years)#
≥ 50 607 39.9 0.81 0.77–0.84 ≤ 29 76.9 69.9 0.0007 1.98 (1.34–
< 50 422 44.1 0.80 0.76–0.84 ≤ 11 72.0 77.1 2.94) for
older versus
younger
Baseline ­symptomsb
High (< median) 519 33.5 0.80 0.76–0.83 ≤ 32 76.4 68.7 0.64
Low (≥ median) 487 51.1 0.75 0.71–0.79 ≤ 12 69.9 69.3
Sex
Women 861 40.7 0.81 0.78–0.83 ≤ 22 76.6 70.5 0.42
Men 168 46.4 0.70 0.62–0.76 ≤ 10 50.0 81.1

Bold values indicate p < 0.05


PASS+, patient acceptable symptom state—answers “very satisfied” and “somewhat satisfied” on symptom-specific well-being item; AUC, area
under the receiver operating characteristics curve; 95% CI, 95% confidence intervals; Sens, sensitivity; Spec, specificity; p in multiple reg, p
value for the significance of this variable in multiple logistic regression analysis to predict PASS+ (see text for further details); OR, odds ratio
for this variable in multiple logistic regression to predict being PASS+
a
Some patients had missing responses for some items in the questionnaire; hence, the numbers are lower than 1043 for some analysis
b
Based on the median value for SRS subtotal score for the SRS 16-item instrument
#
Significant variable in multivariable logistic regression to predict PASS from all 5 subgroup variables and ODI at 12 months’ follow-up

value), were older, were female, or had received surgery, com- or restore them to a normally aligned and fully functional
pared with their respective counterparts. To an extent, these state. Accepting that the achievement of perfect results is
subgroup characteristics overlapped, and in logistic regression uncommon, and that many patients inevitably experience
analysis, the statistically significant factors for predicting the residual problems [27], it was considered useful to know the
likelihood of being in PASS+, controlling for the 12-month maximum level of symptoms that patients regarded as accept-
outcome score and all other subgroup variables were: for the able and felt they could live with. Each of the questionnaire
SRS subscore—being older, having received surgery, and hav- scores that we evaluated (16-item SRS subscore; ODI; and
ing a worse baseline status; for ODI—being older and hav- ­NRSpain-higher) was highly predictive of whether the patient
ing received surgery; and for ­NRSpain-higher—having a better was in PASS+ 1 year after inclusion in the study, confirm-
baseline status and being female (Tables 4, 5, 6). ing the validity of the approach. The cut-off scores for the
whole collective were > 3.5 points (1–5 scale) for SRS sub-
score, ≤ 18 points (0–100 scale) for ODI, ≤ 3 for NRS (higher
Discussion of the back pain and leg pain scores; 0–10 scale).

Summary of findings Comparison with the literature

Most interventions for the treatment of adult spinal deformity It is difficult to compare the values defined for the patient
result in some improvement in symptoms, disability, and self- acceptable symptom state (PASS) for the SRS, since no pre-
image; however, they rarely render patients totally pain-free vious studies have investigated this phenomenon. At most,

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European Spine Journal (2020) 29:1340–1352 1347

Table 6  Results of ROC and of multiple regression analyses examining PASS cut-offs for NRS pain (the higher of the values for back pain and
leg pain) for subgroups of patients
Number of % PASS+ AUC​ AUC 95% CI Threshold for Sens % Spec % p in multiple reg OR (95% CI)
­patientsa being in PASS

All patients
12 mo FU 971 39.5 0.83 0.80–0.85 ≤ 3.0 68.2 83.0
Treatment group
Operative 533 43.9 0.81 0.77–0.84 ≤ 3.0 68.8 79.3 0.18
Non-operative 438 34.2 0.84 0.81–0.88 ≤ 3.0 67.3 86.8
Aetiology
Degenerative 368 38.0 0.80 0.76–0.84 ≤ 4.9 67.1 80.3 0.28
Idiopathic 603 40.5 0.84 0.81–0.87 ≤ 3.0 75.4 80.2
Age (years)
≥ 50 576 37.8 0.82 0.79–0.85 ≤ 4.9 70.6 79.1 0.22
< 50 395 42.0 0.83 0.79–0.86 ≤ 3.0 78.3 76.9
Baseline ­symptomsb,#
High (< median) 499 31.7 0.83 0.79–0.86 ≤ 4.9 69.6 80.9 0.03 0.61 (0.40–
Low (≥ median) 451 49.2 0.80 0.76–0.83 ≤ 3.0 75.2 74.2 0.93) for high
versus low
symptoms
Sex#
Women 819 38.8 0.85 0.82–0.87 ≤ 4.9 75.5 79.0 0.02 1.65 (1.07–
Men 152 43.4 0.72 0.64–0.79 ≤ 3.0 72.3 68.6 2.53) for
women
versus men

Bold values indicate p < 0.05


PASS+, patient acceptable symptom state—answers “very satisfied” and “somewhat satisfied” on symptom-specific well-being item; AUC, area
under the receiver operating characteristics curve; 95% CI, 95% confidence intervals; Sens, sensitivity; Spec, specificity; p in multiple reg, p
value for the significance of this variable in multiple logistic regression analysis to predict PASS+ (see text for further details); OR, odds ratio
for this variable in multiple logistic regression to predict being PASS+
a
Some patients had missing responses for some items in the questionnaire; hence, the numbers are lower than 1043 for some analysis
b
Based on the median value for SRS subtotal score for the SRS 16-item instrument
#
Significant variable in multivariable logistic regression to predict PASS from all 5 subgroup variables and ­NRSpain-higher at 12 months’ follow-up

mean values for so-called normal adults, with no history was reported for patients with various spine degenerative
of spine disease are available for comparison [28, 29] and disorders, including adult spinal deformity [12], patients
reveal a value of approximately 4.2 for the SRS subscore referred to outpatient physical therapy for general ortho-
(mean of 20 non-management items) in patients of compara- paedic conditions (pathology of the cervical spine, lumbar
ble age and gender distribution to those in the current study. spine, upper or lower extremity) [30], and patients with hip
Strictly speaking, it is illogical to calculate “normal healthy” and knee osteoarthritis [11, 31]. The similarity in cut-off
scores for condition-specific questionnaires, since without across these studies raises the interesting possibility that the
the condition there can be no valid response to the specific definition of an acceptable level of pain may be independent
questions regarding its associated consequences. However, of the disease or condition [30], and the threshold of ≤ 3/10
these values at least provide a ball-park figure for reference, could be applied as a “one size fits all” figure to other pain-
appearing slightly higher than the threshold value for being ful medical conditions in patients of a similar demographic.
in PASS of 3.5, but almost identical to the mean value for The values defined in the present study for PASS+ for
the group that was “very satisfied with their symptom state” the ODI, i.e. ≤ 18 points for the whole group and ≤ 22
(4.2; see Fig. 1) in the present study. points in the operative group, compare well with the
For pain, as measured using a NRS or VAS, a score score of ≤ 22 reported by van Hooff et al. [24] for 1288
equivalent to ≤ 3 out of 10, as found in the present study, patients with various types of degenerative lumbar spine
has frequently been identified as an acceptable threshold in disorders who had undergone elective spine surgery and
studies investigating painful musculoskeletal pathologies of were registered in the EUROSPINE Spine Tango Spine
middle-aged and older adults. For example, a cut-off of ≤ 3 Surgery Registry. In the latter study, sensitivity analyses

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1348 European Spine Journal (2020) 29:1340–1352

showed that the ODI threshold was robust at two follow- for a given level of pain; instead, it slightly decreased
up time points (1 year and 2 years post-operatively) and the odds (as did being male), although the effects were
was relatively stable across subgroups of age, gender, not marked. A greater variability in PASS estimates for
previous surgery, type of surgery, and complication sta- disability/functional impairment than for pain has been
tus. The same authors had previously reported a score reported before, where it was suggested that patients may
of ≤ 22 for the threshold, indicating the functional status be better able to adapt to functional impairments over
of “normal healthy individuals” [32] (although the afore- time than to high levels of pain, resulting in more similar
mentioned caveat must again be borne in mind, regard- cut-offs for pain across subgroups [30, 31].
ing the scores recorded on condition-specific instruments
by people without the condition). A survey of a random The use of PASS in clinical practice and research
sample of 1200 registered members of a Japanese Inter-
net research company found that the mean ODI score of There are many advantages to the use of PASS cut-off
individuals with LBP but no disability was 11.9, whereas scores in both clinical practice and research. For many
in those with LBP and disability it was 22.1; a cut-off for years the minimal clinically important change score
ODI of ≥ 12 best discriminated between the two groups (MCIC) has been considered the best metric to confer
[33]. In another study of a series of 774 inpatients being clinical importance to any observed numeric change in an
treated non-surgically for low back pain, the ODI that instrument’s score. However, whilst the MCIC indicates
distinguished those who were satisfied from those who whether the change is substantial enough to be consid-
were not satisfied with their current state was ≤ 30 [34]. ered clinically relevant, it says nothing about the actual
The optimal cut-off scores derived for all the instru- state that the patient finds himself in after treatment. For
ments differed slightly depending on whether the patient example, a patient may reduce their pain score from 8 to 5
had undergone surgery, his/her age, sex and baseline and hence achieve the 2-point MCIC for pain, but a post-
symptom state, and the aetiology of the deformity. treatment pain score of 5 points is unlikely to be considered
Many of these factors carried overlapping information, an “acceptable state”. It has been suggested that the PASS
e.g. operative patients were more likely to have a worse may be preferable to the MCIC because it seems to best
baseline status; older patients were more likely to have reflect what is important to patients: the MCIC concerns
degenerative ASD, etc. When all factors were considered the concept of improvement (i.e. feeling better, even if not
together in multiple regression analysis, patients that had feeling great in the end), whereas the PASS reflects a state
undergone surgery, were older, and had a worse baseline of well-being or remission of symptoms (i.e. feeling well)
status were more likely to consider their state acceptable, [11]. Arguably, fulfilment of both conditions (achieving
for a given level of “impairment” as measured by the SRS MCIC and PASS) may be what is required to consider the
subscore. Similarly, for a given 12-month ODI disability outcome an overall success.
score, the surgical and older patients were more accepting At a time when subtle differences in the results of new
of their symptom state. Hence, in general, it would appear treatments and techniques are becoming harder to detect
that older patients, and those who have more severe base- using established metrics, the PASS cut-offs may represent
line symptoms, and have undergone surgery, are more a more discerning outcome measure and be considered a
accepting of their remaining symptomology 12 months more clinically relevant treatment target. Evaluation of the
after treatment. The effect of baseline status has been proportion of patients achieving this “acceptable” level
observed before, especially for “functional impairment” would provide an easily interpretable indication of treatment
[11, 30]. Possibly, patients that are older have fewer success. A knowledge of the score most patients could live
demands in terms of their everyday activity levels and with and the likelihood of achieving it, along with the fact
cosmetic appearance. Similarly, those with more severe that complete recovery is unlikely, may also provide a use-
and prolonged disability at baseline may be more resigned ful framework for discussing realistic expectations with the
to their functional impairment, adapting to their limita- patient regarding the potential outcome of treatment. Real-
tions with time. If they once struggled to perform simple istic expectations are pivotal to patient satisfaction [35, 36].
daily activities, they may report their state of health as It is possible that the achievement of PASS may also serve
acceptable when they find themselves able to complete as a more stringent target in prognostic models identifying
those same tasks with just minor or moderate difficulty; predictors of success. Since PASS appears to be harder to
in contrast, those reporting very little disability to begin achieve than MCIC, it “raises the bar” in terms of what we
with may be seeking a perfect state of health and report consider a good outcome and this might allow for a more
anything less than this as unacceptable [30]. In the present differentiated prognosis of outcome and the identification of
study, in multivariable analyses, worse baseline status did different predictors to those that simply predict some mini-
not significantly increase the odds of being in PASS+ mal level of improvement.

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European Spine Journal (2020) 29:1340–1352 1349

The PASS is sometimes preferred to the MCIC because seen that before surgery 13.2% of the operative patients1
it is reputedly less sensitive to baseline levels of symp- were already PASS+ according to their SRS subscore,
toms [31]. For example, a previous study in patients with 16.1% according to their ODI, and 8.3% according to
knee osteoarthritis revealed that, for low, middle, and high their ­NRSpain-higher (detailed data not shown). This may at
baseline pain tertiles, the MCICs were 10.8, 27.4, and 36.6 first sight suggest a shortcoming of the PASS concept, if
points out of 100, respectively (i.e. an almost fourfold dif- interpreted as evidence for a ceiling effect, beyond which
ference from the lowest to the highest), whilst the respec- no improvement could have been detected. However, with
tive scores for the PASS were 27.0, 34.5, and 36.4 points conditions such as ASD that can manifest themselves in
for the three tertiles (i.e. much more constant across the a variety of ways—with pain, cosmetic appearance, pos-
baseline pain tertiles) [31]. The authors concluded that ture, walking, or neurological deficits each being of greater
the MCIC appears to be equivalent to the change in score or lesser importance to the given patient, and with some
needed to achieve the PASS, whatever the baseline level patients simply requiring prophylactic procedures—it is
of symptoms, making the PASS the more relevant target to conceivable that patients may be deemed PASS+ based on
strive for. In the present study, whilst there was some influ- one measure but not based on another (most likely the one
ence of baseline symptom severity on the scores equivalent describing their specific motivation for treatment). Indeed, in
to PASS+ for the different instruments (see earlier), for the the present study, before surgery only a fraction of patients
SRS subscore the effect (about 15% difference between the (4/583; 0.7%) were PASS+ on all three main measures (SRS
high and low symptom groups) was small and much less subscore, ODI, and NRS pain) as well as the specific sub-
than that reported by Tubach et al. [31] (approximately domains of the SRS.
30–40% for a joint-specific measure in knee OA and rota- Our analyses showed, not wholly surprisingly (see [31]),
tor cuff patients), although even the latter was considered that patients with a better symptom status to start with were
minimal compared with the corresponding variation in generally more likely to be PASS+ at 12 months’ follow-up.
MCIC that they recorded. Another advantage of the PASS In other words, those with fewer symptoms preoperatively
over the MCIC is that if baseline questionnaire scores had “less distance to go” in order to achieve an acceptable
are not available for a given patient—whether within the symptom state after surgery. If using the PASS as a measure
confines of a study or in the clinical setting—the success of success, the logical corollary of this would then be that
(or otherwise) of treatment can still be assessed by inter- surgeons should preferentially treat “relatively well” patients
pretation of the individual’s post-treatment questionnaire (who are just short of the PASS+ threshold before surgery)
score alone. Assessment according to the MCIC, in con- to increase the chances of their reaching PASS+ afterwards.
trast, always needs a baseline score in order to calculate Clearly such a strategy would not be viable or make sense
the extent of the change in score, post-operatively. This pragmatically, although the question of whether surgery
makes the PASS more practicable for assessing treatment would be more beneficial at a somewhat earlier stage of the
outcome where the timely acquisition of baseline data is disease, before patients are extremely symptomatic, may be
perhaps difficult, e.g. due to emergency admissions, or in worthy of further investigation. The present study cannot,
busy clinical departments that do not have the infrastruc- and was never intended to, shed any light on this issue.
ture for organising the administration of questionnaires
prior to treatment, but are able to collect data under less Limitations of the study
time pressure at follow-up.
Theoretically, the derived PASS cut-off scores could A number of limitations of our study must be recognised.
assist in guiding decisions as to when, whether, and what Whilst the data obtained were from a prospective study, the
type of treatment should be initiated, by indicating whether analysis was retrospective in nature, with the inherent weak-
and to what extent a patient exceeds the cut-off value for nesses of such a study design, e.g. data items were not spe-
“acceptable symptoms” at presentation. The presence of cifically designed to answer the given research question. The
a given minimum level of symptoms is commonly one of follow-up rate for the ESSG study, 1-year post-inclusion, is
the criteria for the “appropriate use of surgery” in various approximately 80%, but only approximately 90% of these
fields of orthopaedics [37–40]. For example, one of the key
criteria of Chen et al., for the appropriateness of surgery
for degenerative scoliosis, was “at least moderate to severe” 1
The same data are not presented in detail for the non-operative
symptoms [37–40]; in the criteria for hip joint replacement, patients, since many who were included in the database were not
it was “severe” pain [39]; and the criteria for degenerative actively seeking treatment but were simply under observation or were
spondylolisthesis, severe disability [40]. presenting for routine follow-up from a previous surgery, more than
2 years prior to recruitment in ESSG. Overall, 12% (54/442) reported
Interestingly, in the present study, using the generic cut- being in PASS for all of the three main outcome measures as well as
offs derived from the whole-group ROC analyses it was the SRS subdomains at baseline.

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1350 European Spine Journal (2020) 29:1340–1352

typically complete the patient-rated questionnaires. Hence, to satisfaction with having to spend the rest of one’s life with
the data from approximately 30% of patients in the database the current symptoms. And, finally, our analysis involved
were not represented in the analysis. Further, the non-oper- a large cohort of patients from a multicentre prospective
ative patients had a lower compliance with questionnaire study including 6 centres in 4 countries. Intercultural differ-
completion than did the operative patients. This is perhaps ences may have influenced the relationship between PASS
to be expected, since surgical patients are more likely to and symptom levels for specific centres. However, the dif-
return for post-operative check-ups, but this may nonetheless ferent countries did not always refer the same proportions
have introduced bias into the analyses. It has been suggested of operative/non-operative, degenerative/idiopathic, old/
that follow-up rates should ideally be at least 80% to avoid young patients, and these factors would need to be taken into
major bias [41]. account for a valid analysis of the “country/language” effect
The PASS concept was originally conceived as a sin- per se. This will be done when the sample size has increased,
gle question requiring a binary answer (yes/no) to indicate as the database grows. A benefit of the multicentre study
whether the current symptom state would be considered was that our results as a whole are generalisable to a broader
acceptable, if it were to persist for the next few months range of patient demographic characteristics, cultures, and
[42], for the rest of one’s life [43], or without reference to hospital settings than those of a single-centre study would
any particular time frame [11]. This item was then used be. Further studies should externally validate the PASS cut-
as the external criterion (anchor) to determine the cut-off off values in other patient collectives. We had few patients
scores, indicating achievement of an acceptable symptom with acute or subacute symptoms (only 3% with their spine
state at follow-up. In our study, the 5-point SSWB item problem for less than 1 year; see Table 1), preventing mean-
from the COMI (which employs the “rest of your life” time ingful analyses of the influence of duration of symptoms on
frame) was used to determine PASS, with the responses the PASS cut-offs, a factor previously considered of possible
being dichotomised as described in other studies [12, 14, importance [12].
24]. Although the PASS concept has been generally well-
accepted and integrated into the field of rheumatology, its
implementation in assessing the outcome of spine surgery
is not without criticism [44]. The response categories have Conclusion
been described as non-specific, ambiguous and requiring
abstraction, and their dichotomisation, arbitrary, and objec- It is useful to know the maximum level of symptoms that
tions have been raised to the notion that patients with just the patient considers “acceptable” and could live with.
minimal pain changes may be considered surgical “failures”, The questionnaire cut-off scores equivalent to an accept-
despite their severe and complex symptoms at baseline [44]. able state were relatively robust, although, in general, older
In an attempt to evaluate whether the SSWB item was psy- patients with more severe baseline symptoms were satisfied
chometrically valid as an anchor in our analyses, we exam- with greater impairment than were their younger counter-
ined the relationship between the 12-month scores on each parts with a better baseline status. Reporting the percentage
instrument and the responses on the SSWB’s 5-point scale, of patients achieving an outcome score equivalent to the
seeking correlation coefficients ≥ 0.5 [26]. These were found acceptable symptom state represents a novel outcome met-
to be sufficiently strong [45], being 0.6–0.7 for all variables ric in the field of adult spinal deformity and may be a more
except SRS mental health and function (which were just stringent target for denoting “success” in its treatment.
0.44 and 0.45, respectively). The latter finding indicates that
function and mental health were less influential in govern-
ing whether the current state was viewed as acceptable or Compliance with ethical standards
not, further confirmed by the lower areas under the ROCs
Conflict of interest None of the authors have any conflict of interest in
for these two variables. In the present study, we used the relation to the current work. The ESSG is partially funded by research
responses “very satisfied” and “somewhat satisfied” on the grants from Depuy Synthes Spine and Medtronic.
COMI SSWB item to define an acceptable symptom state,
as used in previous studies [12, 14, 24]. However, the deci-
sion as to what should count as an “acceptable state”, and
especially whether “neither satisfied nor dissatisfied” should References
be included as “acceptable”, remains somewhat arbitrary,
1. Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Cor-
and we cannot assume that patients would have answered bin TP, Costa LO, Foster NE, Grotle M, Koes BW, Kovacs FM,
similarly to a different question with a different number of Lin CW, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk
response options. Future studies should evaluate this 5-point DC, van Tulder MW, Ostelo RW (2015) Core outcome domains
answer with a direct binary response (“yes/no”), in relation

13
European Spine Journal (2020) 29:1340–1352 1351

for clinical trials in non-specific low back pain. Eur Spine J 31:593–597. https​://doi.org/10.1097/01.brs.00002​01331​.50597​
24:1127–1142. https​://doi.org/10.1007/s0058​6-015-3892-3 .ea000​07632​-20060​3010-00018​
2. Schunemann HJ, Akl EA, Guyatt GH (2006) Interpreting the 18. Bridwell KH, Cats-Baril W, Harrast J, Berven S, Glassman S,
results of patient reported outcome measures in clinical trials: Farcy JP, Horton WC, Lenke LG, Baldus C, Radake T (2005) The
the clinician’s perspective. Health Qual Life Outcomes 4:62 validity of the SRS-22 instrument in an adult spinal deformity
3. Carragee EJ (2010) The rise and fall of the “minimum clini- population compared with the Oswestry and SF-12: a study of
cally important difference”. Spine J 10:283–284. https​://doi. response distribution, concurrent validity, internal consistency,
org/10.1016/j.spine​e.2010.02.013 and reliability. Spine (Phila Pa 1976) 30:455–461
4. Hagg O, Fritzell P, Nordwall A, Swedish Lumbar Spine Study 19. Bago J, Climent JM, Ey A, Perez-Grueso FJ, Izquierdo E (2004)
Group (2003) The clinical importance of changes in outcome The Spanish version of the SRS-22 patient questionnaire for idi-
scores after treatment for chronic low back pain. Eur Spine J opathic scoliosis: transcultural adaptation and reliability analysis.
12:12–20 Spine (Phila Pa 1976) 29:1676–1680
5. Lauridsen HH, Hartvigsen J, Manniche C, Korsholm L, Grunnet- 20. Mannion AF, Elfering A, Bago J, Pellise F, Vila-Casademunt A,
Nilsson N (2006) Responsiveness and minimal clinically impor- Richner-Wunderlin S, Domingo-Sabat M, Obeid I, Acaroglu E,
tant difference for pain and disability instruments in low back pain Alanay A, Perez-Grueso FS, Baldus CR, Carreon LY, Bridwell
patients. BMC Musculoskelet Disord 7:82 KH, Glassman SD, Kleinstuck F, European Spine Study Group
6. Glassman SD, Copay AG, Berven SH, Polly DW, Subach BR, (2018) Factor analysis of the SRS-22 outcome assessment instru-
Carreon LY (2008) Defining substantial clinical benefit following ment in patients with adult spinal deformity. Eur Spine J 27:685–
lumbar spine arthrodesis. J Bone Joint Surg Am 90:1839–1847 699. https​://doi.org/10.1007/s0058​6-017-5279-0
7. Gatchel RJ, Lurie JD, Mayer TG (2010) Minimal clinically impor- 21. Pellise F, Vila-Casademunt A, Ferrer M, Domingo-Sabat M, Bago
tant difference. Spine (Phila Pa 1976) 35:1739–1743. https​://doi. J, Perez-Grueso FJ, Alanay A, Mannion AF, Acaroglu E (2015)
org/10.1097/brs.0b013​e3181​d3cfc​9 Impact on health related quality of life of adult spinal deform-
8. Hays RD, Woolley JM (2000) The concept of clinically mean- ity (ASD) compared with other chronic conditions. Eur Spine J
ingful difference in health-related quality-of-life research. How 24:3–11. https​://doi.org/10.1007/s0058​6-014-3542-1
meaningful is it? Pharmacoeconomics 18:419–423 22. Mannion AF, Elfering A, Staerkle R, Junge A, Grob D, Sem-
9. Agarwalla A, Gowd AK, Liu JN, Puzzitiello RN, Cole BJ, Romeo mer NK, Jacobshagen N, Dvorak J, Boos N (2005) Outcome
AA, Verma NN, Forsythe B (2019) Predictive factors and the assessment in low back pain: how low can you go? Eur Spine J
duration to pre-injury work status following biceps tenode- 14:1014–1026
sis. Arthroscopy 35:1026–1033. https​://doi.org/10.1016/j.arthr​ 23. Mannion AF, Porchet F, Kleinstück F, Lattig F, Jeszenszky D, Bar-
o.2018.10.144 tanusz V, Dvorak J, Grob D (2009) The quality of spine surgery
10. Veron O, Tcherniatinsky E, Fayad F, Revel M, Poiraudeau S from the patient’s perspective: part 1. The Core Outcome Meas-
(2008) Chronic low back pain and functional restoring program: ures Index (COMI) in clinical practice. Eur Spine J 18:367–373
applicability of the Patient Acceptable Symptom State. Ann 24. van Hooff ML, Mannion AF, Staub LP, Ostelo RW, Fairbank JC
Readapt Med Phys 51:642–649. https​://doi.org/10.1016/j.annrm​ (2016) Determination of the Oswestry Disability Index score
p.2008.08.003 equivalent to a “satisfactory symptom state” in patients undergo-
11. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, ing surgery for degenerative disorders of the lumbar spine-a Spine
Bombardier C, Felson D, Hochberg M, van der Heijde D, Dou- Tango registry-based study. Spine J 16:1221–1230. https​://doi.
gados M (2005) Evaluation of clinically relevant states in patient org/10.1016/j.spine​e.2016.06.010
reported outcomes in knee and hip osteoarthritis: the patient 25. Altman DG, Bland JM (1994) Diagnostic tests 3: receiver operat-
acceptable symptom state. Ann Rheum Dis 64:34–37. https​://doi. ing characteristic plots. BMJ 309:188
org/10.1136/ard.2004.02302​8ard.2004.02302​8 26. Guyatt GH, Norman GR, Juniper EF, Griffith LE (2002) A critical
12. Fekete TF, Haschtmann D, Kleinstuck FS, Porchet F, Jeszenszky look at transition ratings. J Clin Epidemiol 55:900–908
D, Mannion AF (2016) What level of pain are patients happy to 27. Crawford CH 3rd, Glassman SD, Bridwell KH, Carreon LY
live with after surgery for lumbar degenerative disorders? Spine (2016) The substantial clinical benefit threshold for SRS-22R
J 16:S12–S18. https​://doi.org/10.1016/j.spine​e.2016.01.180 domains after surgical treatment of adult spinal deformity. Spine
13. Impellizzeri FM, Mannion AF, Naal FD, Hersche O, Leunig M Deform 4:373–377. https​://doi.org/10.1016/j.jspd.2016.05.001
(2012) The early outcome of surgical treatment for femoroac- 28. Baldus C, Bridwell KH, Harrast J, Edwards C 2nd, Glassman S,
etabular impingement: success depends on how you measure Horton W, Lenke LG, Lowe T, Mardjetko S, Ondra S, Schwab
it. Osteoarthr Cartil 20:638–645. https​: //doi.org/10.1016/j. F, Shaffrey C (2008) Age-gender matched comparison of SRS
joca.2012.03.019 instrument scores between adult deformity and normal adults: are
14. Mannion AF, Impellizzeri FM, Leunig M, Jeszenszky D, Becker all SRS domains disease specific? Spine (Phila Pa 1976) 33:2214–
H-J, Haschtmann D, Preiss S, Fekete FT (2018) Time to remove 2218. https​://doi.org/10.1097/brs.0b013​e3181​7c046​6
our rose-tinted spectacles: a candid appraisal of the relative suc- 29. Baldus C, Bridwell K, Harrast J, Shaffrey C, Ondra S, Lenke
cess of surgery in over 4,500 patients with degenerative disorders L, Schwab F, Mardjetko S, Glassman S, Edwards C 2nd, Lowe
of the lumbar spine, hip or knee. Eur Spine J 27:778–788 T, Horton W, Polly D Jr (2011) The Scoliosis Research Society
15. Haher TR, Gorup JM, Shin TM, Homel P, Merola AA, Grogan Health-Related Quality of Life (SRS-30) age-gender normative
DP, Pugh L, Lowe TG, Murray M (1999) Results of the Scoliosis data: an analysis of 1346 adult subjects unaffected by scoliosis.
Research Society instrument for evaluation of surgical outcome Spine (Phila Pa 1976) 36:1154–1162. https​://doi.org/10.1097/
in adolescent idiopathic scoliosis. A multicenter study of 244 brs.0b013​e3181​fc8f9​8
patients. Spine (Phila Pa 1976) 24:1435–1440 30. Wright AA, Hensley CP, Gilbertson J, Leland JM 3rd, Jackson
16. Asher MA, Min Lai S, Burton DC (2000) Further development S (2015) Defining patient acceptable symptom state thresholds
and validation of the Scoliosis Research Society (SRS) outcomes for commonly used patient reported outcomes measures in gen-
instrument. Spine (Phila Pa 1976) 25:2381–2386 eral orthopedic practice. Man Ther 20:814–819. https​://doi.
17. Asher MA, Lai SM, Glattes RC, Burton DC, Alanay A, Bago org/10.1016/j.math.2015.03.011
J (2006) Refinement of the SRS-22 Health-Related Quality 31. Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud
of Life questionnaire Function domain. Spine (Phila Pa 1976) P (2006) Feeling good rather than feeling better matters more to

13
1352 European Spine Journal (2020) 29:1340–1352

patients. Arthritis Rheum 55:526–530. https​://doi.org/10.1002/ 39. Quintana JM, Arostegui I, Azkarate J, Goenaga JI, Elexpe X,
art.22110​ Letona J, Arcelay A (2000) Evaluation of explicit criteria for total
32. van Hooff ML, Spruit M, O’Dowd JK, van Lankveld W, Fair- hip joint replacement. J Clin Epidemiol 53:1200–1208
bank JC, van Limbeek J (2014) Predictive factors for successful 40. Mannion AF, Pittet V, Steiger F, Vader JP, Becker HJ, Porchet F
clinical outcome 1 year after an intensive combined physical and (2014) Development of appropriateness criteria for the surgical
psychological programme for chronic low back pain. Eur Spine J treatment of symptomatic lumbar degenerative spondylolisthesis
23:102–112. https​://doi.org/10.1007/s0058​6-013-2844-z (LDS). Eur Spine J 23:1903–1917. https​://doi.org/10.1007/s0058​
33. Tonosu J, Takeshita K, Hara N, Matsudaira K, Kato S, Masuda K, 6-014-3284-0
Chikuda H (2012) The normative score and the cut-off value of 41. Straus SE, Glasziou PP, Richardson S, Haynes RB (2018) Evi-
the Oswestry Disability Index (ODI). Eur Spine J 21:1596–1602. dence-based medicine: how to practice and teach EBM. Elsevier,
https​://doi.org/10.1007/s0058​6-012-2173-7 Amsterdam
34. Park SW, Shin YS, Kim HJ, Lee JH, Shin JS, Ha IH (2014) The 42. Pham T, Tubach F (2009) Patient acceptable symptomatic state
dischargeable cut-off score of Oswestry Disability Index (ODI) (PASS). Joint Bone Spine 76:321–323. https​://doi.org/10.1016/j.
in the inpatient care for low back pain with disability. Eur Spine jbspi​n.2009.03.008
J 23:2090–2096. https​://doi.org/10.1007/s0058​6-014-3503-8 43. Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bom-
35. Mannion AF, Junge A, Elfering A, Dvorak J, Porchet F, Grob D bardier C, Felson DT, Hajjaj-Hassouni N, Hochberg M, Logeart I,
(2009) Great expectations: really the novel predictor of outcome Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados
after spinal surgery? Spine 34:1590–1599 M (2012) Minimum clinically important improvement and patient
36. Witiw CD, Mansouri A, Mathieu F, Nassiri F, Badhiwala JH, acceptable symptom state in pain and function in rheumatoid
Fessler RG (2018) Exploring the expectation-actuality discrep- arthritis, ankylosing spondylitis, chronic back pain, hand osteoar-
ancy: a systematic review of the impact of preoperative expec- thritis, and hip and knee osteoarthritis: results from a prospective
tations on satisfaction and patient reported outcomes in spinal multinational study. Arthritis Care Res (Hoboken) 64:1699–1707.
surgery. Neurosurg Rev 41:19–30. https​://doi.org/10.1007/s1014​ https​://doi.org/10.1002/acr.21747​
3-016-0720-0 44. Hobart J (2016) Measuring spinal surgical success: the proportion
37. Chen PG, Daubs MD, Berven S, Raaen LB, Anderson AT, Asch achieving acceptable symptoms: keep it simple but not simplistic.
SM, Nuckols TK, the Degenerative Lumbar Scoliosis Appropri- Spine J 16:S19–S20. https:​ //doi.org/10.1016/j.spinee​ .2016.01.221
ateness Group (2015) Surgery for degenerative lumbar scolio- 45. Cohen J (1988) Statistical power analysis for the behavioural sci-
sis: the development of appropriateness criteria. Spine (Phila Pa ences. Lawrence Earlbaum Associates, Hillsdale
1976). https​://doi.org/10.1097/brs.00000​00000​00139​2
38. Escobar A, Quintana JM, Arostegui I, Azkarate J, Guenaga JI, Publisher’s Note Springer Nature remains neutral with regard to
Arenaza JC, Garai I (2003) Development of explicit criteria jurisdictional claims in published maps and institutional affiliations.
for total knee replacement. Int J Technol Assess Health Care
19:57–70

Affiliations

A. F. Mannion1 · M. Loibl2 · J. Bago3 · A. Vila‑Casademunt4 · S. Richner‑Wunderlin1 · T. F. Fekete2 · D. Haschtmann2 ·


D. Jeszenszky2 · F. Pellisé3 · A. Alanay5 · I. Obeid6 · F. S. Pérez‑Grueso7 · F. S. Kleinstück2 · European Spine Study
Group (ESSG)4

4
* A. F. Mannion Spine Research Unit, Spine Research Unit, Vall d’Hebron
anne.mannion@yahoo.com Institute of Research (VHIR), Passeig Vall Hebron 119‑129,
08035 Barcelona, Spain
1
Department of Teaching, Research and Development, 5
Department of Orthopaedics and Traumatology, Acibadem
Spine Center Division, Schulthess Klinik, Lengghalde 2,
University School of Medicine, Büyükdere cad, 40 Maslak,
8008 Zurich, Switzerland
344457 Istanbul, Turkey
2
Spine Center, Schulthess Klinik, Lengghalde 2, 8008 Zurich, 6
Pellegrin Bordeaux University Hospital, Place Amélie Raba
Switzerland
Léon, 33000 Bordeaux, France
3
Spine Unit, Hospital Universitari Vall Hebron, Passeig Vall 7
Hospital Universitario, La Paz Paseo de la Castellana 261,
Hebron 119‑129, 08035 Barcelona, Spain
28046 Madrid, Spain

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