Introduction
The Core Outcome Measures Index for the back (COMI-back) is a very brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, ...symptom-specific well-being, quality of life, disability). However, it might be expected to be less responsive than a disease-specific instrument when evaluating specific pathologies. In patients with adult spinal deformity, we compared the performance of COMI-back with the widely accepted SRS-22 questionnaire.
Methods
At baseline and 12 months after non-operative (
N
= 121) and surgical (
N
= 83) treatment, patients (175 F, 29 M) completed the following: COMI-back, SRS-22, Oswestry Disability Index (ODI) and SF-36 PCS. At 12 months' follow-up, patients also indicated on a 15-point Global Rating of Change Scale (GRCS) how their back problem had changed relative to 1 year ago. Construct validity for the COMI-back was assessed by the correlation between its scores and those of the comparator instruments; responsiveness was assessed with receiver operating characteristics (ROC) analysis of COMI-back change scores versus the criterion ‘treatment success’ (dichotomized GRCS).
Results
Baseline values for the COMI-back showed significant (
p
< 0.0001) correlations with SRS-22 (
r
= −0.85), ODI (
r
= 0.83), and SF-36 PCS (
r
= −0.82) scores; significantly worse scores for all measures were recorded in the surgical group. The correlation between the change scores (baseline to 12 months) for COMI and SRS-22 was 0.74, and between each of these change scores and the external criterion of treatment success were: COMI-back,
r
= 0.58; SRS-22,
r
= −0.58 (each
p
< 0.0001). The ROC areas under the curve for the COMI-back and SRS-22 change scores were 0.79 and 0.82, respectively.
Conclusion
Both baseline and change scores for the COMI-back correlated strongly with those of the SRS-22, and differed significantly in surgical and non-operative patients, suggesting good construct validity. With the “change in the back problem” serving as external criterion, COMI-back showed similar external responsiveness to SRS-22. The COMI-back was well able to detect important change. Coupled with its brevity, which minimizes patient burden, these favourable psychometric properties suggest the COMI-back is a suitable instrument for use in registries and can serve as a valid instrument in clinical studies emerging from such data pools.
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 questionnaire 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.
Introduction
The Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) are two commonly used self-rating outcome instruments in patients with lumbar spinal disorders. No formal ...crosswalk between them exists that would otherwise allow the scores of one to be interpreted in terms of the other. We aimed to create such a mapping function.
Methods
We performed a secondary analysis of ODI and COMI data previously collected from 3324 patients (57 ± 17y; 60.3% female) at baseline and 1y after surgical or conservative treatment. Correlations between scores and Cohen’s kappa for agreement (
κ
) regarding achievement of the minimal clinically important change (MCIC) score on each instrument (ODI, 12.8 points; COMI, 2.2 points) were calculated, and regression models were built. The latter were tested for accuracy in an independent set of registry data from 634 patients (60 ± 15y; 56.8% female).
Results
All pairs of measures were significantly positively correlated (baseline, 0.73; 1y follow-up (FU), 0.84; change-scores, 0.73). MCIC for COMI was achieved in 53.9% patients and for ODI, in 52.4%, with 78% agreement on an individual basis (
κ
= 0.56). Standard errors for the regression slopes and intercepts were low, indicating excellent prediction at the group level, but root mean square residuals (reflecting individual error) were relatively high. ODI was predicted as COMI × 7.13–4.20 (at baseline), COMI × 6.34 + 2.67 (at FU) and COMI × 5.18 + 1.92 (for change-score); COMI was predicted as ODI × 0.075 + 3.64 (baseline), ODI × 0.113 + 0.96 (FU), and ODI × 0.102 + 1.10 (change-score). ICCs were 0.63–0.87 for derived versus actual scores.
Conclusion
Predictions at the group level were very good and met standards justifying the pooling of data. However, we caution against using individual values for treatment decisions, e.g. attempting to monitor patients over time, first with one instrument and then with the other, due to the lower statistical precision at the individual level. The ability to convert scores via the developed mapping function should open up more centres/registries for collaboration and facilitate the combining of data in meta-analyses.
Purpose
The aim of this study was to evaluate factors that distinguish between patients with adult spinal deformity (ASD) with and without an indication for surgery, irrespective of their final ...treatment.
Methods
Baseline variables (demographics, medical history, outcome measures, coronal, sagittal and neurologic parameters) were evaluated in a multicentre, prospective cohort of patients with ASD. Multivariable analyses were carried out for idiopathic and degenerative patients separately with the dependent variable being “indication for surgery” and baseline parameters as independent variables.
Results
In total, 342 patients with degenerative ASD and 624 patients with idiopathic ASD were included in the multivariable models. In patients with degenerative ASD, the parameters associated with having an indication for surgery were greater self-rated disability on the Oswestry Disability Index odds ratio (OR) 1.04, 95% confidence interval (CI) 1.02–1.07 and a lower thoracic kyphosis (OR 0.97 95% CI 0.95–0.99), whereas in patients with idiopathic ASD, it was lower (worse) SRS self-image scores (OR 0.45 95% CI 0.32–0.64), a higher value for the major Cobb angle (OR 1.03 95% CI 1.01–1.05), lower age (OR 0.96 95% CI 0.95–0.98), prior decompression (OR 3.76 95% CI 1.00–14.08), prior infiltration (OR 2.23 95% CI 1.12–4.43), and the presence of rotatory subluxation (OR 1.98 95% CI 1.11–3.54) and sagittal subluxation (OR 4.38 95% CI 1.61–11.95).
Conclusion
Specific sets of variables were found to be associated with an indication for surgery in patients with ASD. These should be investigated in relation to patient outcomes for their potential to guide the future development of decision aids in the treatment of ASD.
Graphical abstract
These slides can be retrieved under Electronic Supplementary Material.
Purpose
Designed for patients with adolescent idiopathic scoliosis, the SRS-22 is now widely used as an outcome instrument in patients with adult spinal deformity (ASD). No studies have confirmed the ...four-factor structure (pain, function, self-image, mental health) of the SRS-22 in ASD and under different contexts. Factorial invariance of an instrument over time and in different languages is essential to allow for precise interpretations of treatment success and comparisons across studies. This study sought to evaluate the invariance of the SRS-22 structure across different languages and sub-groups of ASD patients.
Methods
Confirmatory factor analysis was performed on the 20 non-management items of the SRS-22 with data from 245 American English-, 428 Spanish-, 229 Turkish-, 95 French-, and 195 German-speaking patients. Item loading invariance was compared across languages, age groups, etiologies, treatment groups, and assessment times. A separate sample of SRS-22 data from 772 American surgical patients with ASD was used for cross-validation.
Results
The factor structure fitted significantly better to the proposed four-factor solution than to a unifactorial solution. However, items 14 (personal relationships), 15 (financial difficulties), and 17 (days off work) consistently showed weak item loading within their factors across all language versions and in both baseline and follow-up datasets. A trimmed SRS (16 non-management items) that used the four least problematic items in each of the four domains yielded better-fitting models across all languages, but equivalence was still not reached. With this shorter version there was equivalence of item loading with respect to treatment (surgery vs conservative), time of assessment (baseline vs 12 months follow-up), and etiology (degenerative vs idiopathic), but not age (< vs ≥50 years). All findings were confirmed in the cross-validation sample.
Conclusion
We recommend removal of the worst-fitting items from each of the four domains of the SRS-instrument (items 3, 14, 15, 17), together with adaptation and standardization of other items across language versions, to provide an improved version of the instrument with just 16 non-management items.
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