Long-term opioid medication profile of European adult spinal deformity patients: minimum five years follow-up study.

BACKGROUND CONTEXT: There remains significant variability in the use of postoperative opioids. On one end, it is proven that appropriate pain control is a critical aspect of patient management; on the other end, past few decades have been associated with major increases in opioid-related overdoses and addiction treatment. We hypothesized that several pre- and postoperative risk factors affecting long-term opioid use could be identified. PURPOSE: Evaluation of factors associated with minimum 5-year postoperative opioid use following adult spinal deformity surgery. STUDY DESIGN/SETTING: Prospectively followed study group database. PATIENT SAMPLE: Adult spinal deformity patients who underwent elective spine surgery between 2009 and 2016 were included. OUTCOME MEASURES: Opioid usage or otherwise at minimum 5 years follow-up. Use of nonopioid analgesics, weak and strong opioids METHODS: Retrospective analysis of patients undergoing elective spinal deformity surgery. A total of 37 factors comprising patient characteristics, radiographic measurements, operative details, preoperative and early postoperative opioid use, and mechanical complications and revisions were analyzed. Details on identified factors were provided. RESULTS: A total of 265 patients (215F, 50M) from five sites were included. The mean follow-up duration was 68.4±11.7 (60-102) months. On average, 10.6±3.5 levels were fused. Preoperatively, 64 (24.2%) patients were using opioids. The rate of opioid users increased to 33.6% at 6 weeks and decreased to 21.5% at 6 months. During follow-up, there were patients who discontinued opioids, while others have started and/or restarted using opioids. As a result, 59 (22.3%) patients were still on opioids at the latest follow-up. Multivariate analyses showed that factors independently affecting opioid use at an average of 68 months postoperatively, in order of significance, were opioid use at sixth weeks, preoperative opioid use and opioid use at sixth months with the odds ratios of 2.88, 2.51, and 2.38 respectively. At these time points, factors such as age, number of comorbidities, tobacco use, the time of the last prior spine surgery and postoperative sagittal plane alignment affected opioid usage rates. CONCLUSIONS: Opioid usage at 6 weeks was found to be more predictive of long-term opioid use compared to preoperative use. Patients should be well informed to have realistic expectations regarding opioid use when considering adult spinal deformity surgery.

The Association Between the Utilization of Traction and Postoperative Complications Following Growing Rod Instrumentation for Early-onset Scoliosis.

BACKGROUND: Preoperative and/or intraoperative traction have been proposed as adjunctive methods to limit complications associated with growth-friendly instrumentation for early-onset scoliosis (EOS). By gradually correcting the deformity before instrumentation, traction can, theoretically, allow for better overall correction without the complications associated with the immediate intraoperative correction. The purpose of this multicenter study was to investigate the association between preoperative/intraoperative traction and complications following growth-friendly instrumentation for EOS. METHODS: Patients with EOS who underwent growth rod instrumentation before 2017 were identified from 2 registries. Patients were divided into 2 groups: preoperative traction group versus no preoperative traction group. A subgroup analysis was done to compare intraoperative traction only versus no traction. Data was collected on any postoperative complication from implantation to up to 2 years postimplantation. RESULTS: Of 381 patients identified, 57 (15%) and 69 (18%) patients received preoperative and intraoperative traction, respectively. After adjusting for etiology and degree of kyphosis, there was no evidence to suggest that preoperative halo traction reduced the risk of any complication following surgical intervention. Although not statistically significant, a subgroup analysis of patients with severe curves demonstrated a trend toward a markedly reduced hardware failure rate in patients undergoing preoperative halo traction [preoperative traction: 1 (3.1%) vs. no preoperative traction: 11 (14.7%), P=0.083]. Nonidiopathic, hyperkyphotic patients treated with intraoperative traction were 61% less likely to experience any postoperative complication (P=0.067) and were 74% (P=0.091) less likely to experience an unplanned return to the operating room when compared with patients treated without traction. CONCLUSIONS: This multicenter study with a large sample size provides the best evidence to date of the association between the use of traction and postoperative complications. Our results justify the need for future Level I studies aimed at characterizing the complete benefit and risk profile for the use of traction in surgical intervention for EOS. LEVEL OF EVIDENCE: Level III.

Responsiveness of Image Perception Outcome Scales After Surgical Treatment of Idiopathic Scoliosis: A Comparison Between the Trunk Appearance Perception Scale (TAPS) and Scoliosis Research Society-22 (SRS-22) Questionnaire.

STUDY DESIGN: Retrospective study of prospectively collected longitudinal data. OBJECTIVES: To analyze the Trunk Appearance Perception Scale's (TAPS's) responsiveness to surgical treatment of idiopathic scoliosis (IS). SUMMARY OF BACKGROUND DATA: TAPS is a drawing-based instrument to assess trunk deformity in IS. It shows appropriate metric properties, such as internal consistency and discriminant validity. However, no data on responsiveness to surgical treatment is available. METHODS: A total of 109 patients (85.3% females) with IS were included (mean age at surgery 18 years). In all the cases, surgery consisted of posterior spine fusion and instrumentation. The magnitude of the largest curve (MLC) was 63.8° before surgery and 26.3° (correction 58.3%) at a mean follow-up of 20.8 months. Internal and external responsiveness were analyzed on the basis of effect size (ES), standardized response mean (SRM), minimum detectable change (MDC), and correlation between percentage of MLC correction and outcome measure change. Data for TAPS were compared to those of SRS-22 Image domain. RESULTS: TAPS showed somewhat larger internal responsiveness (ES 1.96, SRM 1.73, 86.2% of patients exceeding MDC) than SRS-22 Image scale (ES 1.44, SRM 1.29, 73.4% of patients exceeding MDC). No correlation was found between the percentage of MLC correction and baseline to follow-up change in TAPS or SRS-22 Image scores. CONCLUSION: The TAPS instrument shows adequate responsiveness to surgical treatment of idiopathic scoliosis and is somewhat larger than SRS-22 Image domain data. The lack of correlation between radiologic correction and clinical improvement indicates that the two outcomes must be independently collected. These data on responsiveness complete the TAPS validation process. TAPS is a valid, reliable, and responsive instrument to evaluate the outcome of surgical treatment of idiopathic scoliosis. LEVEL OF EVIDENCE: Level IV.

The Adult Deformity Surgery Complexity Index (ADSCI): a valid tool to quantify the complexity of posterior adult spinal deformity surgery and predict postoperative complications.

BACKGROUND CONTEXT: In 2008, Mirza et al. designed and validated the first and only index capable of quantifying the complexity of spine surgery. However, this index is not fully applicable to adult spinal deformity (ASD) surgery as it does not include the surgical techniques most commonly used and most strongly associated with perioperative complications in patients with ASD. PURPOSE: The objective of this study is to develop an "Adult Deformity Surgery Complexity Index" (ADSCI) to quantify objectively the complexity of the ASD posterior surgery. STUDY DESIGN/SETTING: This is an expert consensus (Delphi process) and retrospective analysis of prospectively collected data using multiple regression models. PATIENT SAMPLE: Patients were prospectively enrolled in two comparable multicenter ASD databases sharing the same inclusion criteria. OUTCOME MEASURES: The ADSCI was internally and externally validated using R2 for intraoperative bleeding and length of surgery. Receiver operating characteristics (ROC) and area under the curve (AUC) analysis was used to assess the sensitivity and specificity of ADSCI. METHODS: The development and validation of ADSCI was based on the construction and comparison of three different tools: ADSCI score was constructed by three rounds of expert consensus (ADSCI-Delphi) and two multiple regression models (ADSCI-RM-Simple and ADSCI-RM-Mixed). Their predictive capability was compared by means of R2 values in the same subrogated of surgical complexity as in the Mirza index validation: intraoperative bleeding and duration of surgery. Sensitivity and specificity were evaluated using ROC curves and AUC analysis. The external validity was also examined by evaluating its predictive capability in another multicenter ASD database of comparable patients in the United States. RESULTS: At the time of the study, the database included 1,325 patients. Four hundred seventy-five patients were eligible for the study, having been treated surgically using a posterior approach only (52.2 years standard deviation 20; 77.7% women; 85.4% American Society of Anesthesiologists I/II). Fifty-one international experts participated in the Delphi consensus process. The surgical variables selected by consensus and included in the equation were divided into actions and factors. Actions selected were number of fused segments, decompressions, interbody fusions, and cemented levels; number and type of posterior osteotomies; and use of pelvic fixation. The factors included were implant density, revision surgery, and team experience. ADSCI-RM-Mixed (regression model with Delphi formula interactions) provided the best estimates and predictive value, well above Mirza's invasiveness index. The ADSCI-RM-Mixed, with greater AUCs (>0.70), was also the most sensitive and specific for both of the dependent variables studied and for complication prediction. ADSCI-RM-Mixed obtained also the highest R2 value in the validation cohort in predicting blood loss (R2=0.34) and surgical time (R2=0.26) with effect sizes similar to those for the derivation cohort. CONCLUSIONS: The ADSCI is the first tool to be specifically developed for the preoperative assessment of the complexity of ASD surgery. This study confirms its validity, specificity, and sensitivity, and shows that it has greater predictive capability than the more generic Mirza invasiveness index. The ADSCI should be useful for quantitatively estimating the increased risk associated with more invasive surgery and adjusting for surgical case-mix when making safety comparisons in ASDS.

Analysis of the reliability of surgeons' ability to differentiate between idiopathic and degenerative spinal deformity in adults radiologically. What descriptive parameters help them decide?

PURPOSE: Adult spinal deformity (ASD) may be classified as idiopathic (ID) or degenerative (DD) (or other) based on classifier's perception, the reliability of and factors inherent to which remain unknown. The aim of this study is to evaluate the inter- and intra-observer reliability of surgeons' perception in differentiating ID from DD and to identify the determinants of this differentiation. METHODS: From a multicentric prospective database of ASD, 179 patients were identified with the diagnosis of ID (n = 103) or DD (n = 76); without previous surgery; and a lumbar coronal curve larger than 20°. Standing antero-posterior and lateral X-rays of these patients were sent to five experienced spine surgeons to be identified as DD or ID (or other); followed by a second round after reshuffling. Weighted kappa statistics were used, the strength of agreement for the kappa coefficient was considered as; 0.81-1 = almost perfect, 0.61-0.8 = substantial, 0.41-0.60 = moderate, 0.21-0.40 = fair, 0.01-0.20 = slight, and ≤0 = poor. Patients were then stratified based on the number of agreements on a total of 10 rounds as excellent (10 out of 10), good (more than 7 out of 10) and fair/poor (7 and less). These excellent and good agreements were further compared for additional radiological parameters. RESULTS: Agreement levels were moderate to substantial for intra but mostly fair for inter-observer comparisons. For ID patients, there were 42 cases with excellent and 38 with very good agreement whereas for DD, there were no excellent and only 17 cases with very good agreement. Upon comparison of these (ID vs DD for at least very good cases), it was seen that they were different for some coronal parameters such as lumbar Cobb angle (larger in ID, p < 0.001), central sacral vertical line (CSVL) modifier (C more common in ID, p = 0.007) and presence of rotatory subluxation (less common in DD, p = 0.017), but very different for sagittal parameters (lumbar lordosis, sagittal vertical axis, T2 sagittal tilt, pelvic tilt, sacral slope, and global tilt; increased sagittal imbalance in DD, all p ≤ 0.001). CONCLUSION: Surgeons in this study demonstrated reasonable (moderate to substantial) intra-observer agreement, but only fair agreement amongst them. Alarming as it may appear, we should be cautious in interpreting these results based on only radiology and no clinical information. In patients with good agreement, the most consistent radiologic determinant of degenerative ASD appeared to be the presence of sagittal imbalance.

Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions.

PURPOSE: Medical and health policy providers should be aware of the impact of adult spinal deformity (ASD) on health-related quality of life (HRQL). The purpose of this study was to compare the relative burden of four chronic conditions with that of ASD. METHODS: The International Quality of Life Assessment project gathered data from 24,936 people and published the SF-36 scores of patients with self-reported arthritis, chronic lung disease, diabetes and congestive heart failure from 8 industrialized countries (3 continents) Alonso et al. (Qual Life Res Int J Qual Life Asp Treat Care Rehabil 13:283-298, 2004). We compared these with the SF-36 baseline data of consecutive patients with ASD enrolled in a prospective multicentre international database with the following inclusion criteria: age >18 years and scoliosis >20°, sagittal vertical axis >5 cm, pelvic tilt >25° or thoracic kyphosis >60°. Four ASD groups were considered: all ASD patients, surgical candidates (preop HRQL scores), and non-surgical candidates with and without previous surgery. Adjusted estimates of the impact of chronic disease were calculated using separate multivariate linear regression models. Individuals without chronic conditions were used as the reference group. Coefficients for each chronic condition and ASD represent the difference compared with this healthy group. RESULTS: 766 patients (mean age 45.8 years) met the inclusion criteria for ASD. The scores on all SF-36 domains were lower in ASD patients than in any other chronic condition. Differences between ASD and the other chronic conditions were always greater than the reported minimal clinically important differences. When compared with individuals reporting no medical conditions, SF-36 scores from the population with self-reported chronic conditions ranged from -2.5 to -14.1. Comparable scores for patients with ASD ranged from -10.9 to -45.0. Physical function, role physical and pain domains showed the worst scores. Surgical candidates with ASD displayed the worst HRQL scores (-17.4 to -45.0) and patients previously operated the best (-10.9 to -33.3); however, even the latter remained worse than any scores for the other self-reported chronic conditions. CONCLUSIONS: The global burden of ASD was huge compared with other self-reported chronic conditions in the general population of eight industrialized countries. The impact of ASD on HRQL warrants the same research and health policy attention as other important chronic diseases.

Outcome instruments to assess scoliosis surgery.

PURPOSE: To review and summarize the current knowledge regarding the outcome measures used to evaluate scoliosis surgery. METHODS: Literature review. RESULTS: Outcome instruments should be tested to ensure that they have adequate metric characteristics: content and construct validity, reliability, and responsiveness. In the evaluation of scoliosis, generic instruments to assess health-related quality of life (HRQL) have been used, such as the SF-36 questionnaire and the EuroQol5D instrument. Nonetheless, it is preferable to use disease-specific instruments for this purpose, such as the SRS-22 Patient Questionnaire and the quality of life profile for spinal deformities (QLPSD). More recently, these generic and disease-specific instruments have been complemented with the use of super-specific instruments; i.e., those assessing a single aspect of the condition or specific populations with the condition. The patients' perception of their trunk deformity and body image has received particular attention, and several instruments are available to evaluate these aspects, such as the Walter-Reed Visual Assessment Scale (WRVAS), the Spinal Appearance Questionnaire (SAQ), and the Trunk Appearance Perception Scale (TAPS). The impacts of brace use can also be measured with specific scales, including the Bad Sobernheim Stress Questionnaire (BSSQ) and the Brace Questionnaire (BrQ). The available instruments to evaluate the treatment for non-idiopathic scoliosis have not been sufficiently validated and analyzed. CONCLUSIONS: Evaluation of scoliosis treatment should include the patient's perspective, which can be obtained with the use of patient-reported outcome measures.

Minimal important differences of the SRS-22 Patient Questionnaire following surgical treatment of idiopathic scoliosis.

The responsiveness of an instrument measuring health-related quality of life is an important indication of its construct validity. The SRS-22 Patient Questionnaire has become the most widely used patient-reported outcome instrument in the clinical evaluation of patients with idiopathic scoliosis. The responsiveness of the SRS-22 following surgical treatment in patients with idiopathic scoliosis has not been fully assessed. The aim of this study is to evaluate this factor by calculating the minimal important differences (MIDs) of the SRS-22 Questionnaire. The study included 91 patients with idiopathic scoliosis (77 females and 14 males), who underwent surgical treatment; mean age at the time of surgery was 18.1 years. Patients completed the SRS-22 questionnaire before surgery and at a follow-up visit (mean follow-up, 45.6 months). At follow-up, patients rated their overall situation as related to before surgery with a four-point Likert scale: 1-Worse, 2-Same, 3-Better, 4-Much Better. This evaluation represented the global perceived effect (GPE) and served as the anchor criterion for calculating the MID. MIDs were calculated using two approaches. The anchor-based MID (MID-A) was defined as the mean preoperative/follow-up difference in SRS-22 scores in the group of patients who stated they were much better than before surgery (GPE = 4). Using the same anchor criterion, the optimal cut-off value able to identify patients that had clearly improved was determined on a receiver operating characteristic (ROC) curve. In addition, the distribution-based MID (MID-D) was calculated by the standard error of measurement method. The MID-As found for the different subscales and the sum score were: pain 0.6, function 0.3, image 1.3, mental health 0.3, average sum score 0.6, and raw sum score 13.1. The cut-off values on the ROC curve were: pain 0.2, function 0.0, image 1.6, mental health 0.4, average sum score 0.4, and raw sum score 10. The MID-Ds were: pain 0.6, function 0.8, image 0.5, mental health 0.4, average sum score 0.5, and raw sum score 6.8. As was expected, the MID values differed according to the calculation method used. In light of the fact that the MID-As for the function and mental health subscales are below the measurement error of the instrument, it seems preferable to use the MID-D values for determining subscale changes. If the purpose is to analyze sum score changes (either the raw or average values), the MID-A is preferable because it includes the patient's evaluation of the results of surgery.

Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire.

STUDY DESIGN: A cross-sectional multicenter study was performed to validate the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVES: To determine the construct validity and convergent validity of the instrument. METHODS: The Spanish version of the SRS-22 was given to 175 patients with scoliosis (mean age, 19 years old and 86% women). A subgroup of 31 patients also received the Quality of Life for Spine Deformities Profile (QLSDP). Construct validity was studied by factor analysis. Discriminant validity was assessed analyzing the relation between SRS-22 scores and the variables of deformity severity. Convergent validity as related to the QLSDP was studied with a multitrait-multimethod matrix analysis. RESULTS: Factor analysis offered a solution of four factors coherent with the dimensions of the original instrument. SRS-22 scores were worse in older patients (r = -0.34); patients using analgesics demonstrated lower scores (P < 0.001). Patients treated with a brace had a poorer self-image and were less satisfied with their treatment (P < 0.001) than the other treatment groups. Angular improvement of the curves was associated with better self-image scores (r = 0.34). The SRS-22 and QLSDP demonstrated high correlation coefficients in the convergent validity tests (r = 0.84). CONCLUSION: The Spanish version of the SRS-22 is valid. It has a factorial structure similar to that of the original questionnaire. Moreover, it relates to known severity characteristics of the disease, distinguishes among scoliosis patient groups, and shows concordant values with another valid instrument for measuring self-perceived health.

The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis.

STUDY DESIGN: Validation of the transcultural adaptation of a questionnaire for measuring health-related quality of life. OBJECTIVES: To translate and culturally adapt the SRS-22 questionnaire to Spanish. To determine the metric qualities (internal consistency and test-retest reproducibility) of this questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 Patient Questionnaire has proven to be a valid instrument for clinical assessment of patients with idiopathic scoliosis. The widespread use of the SRS-22 in non-English-speaking countries requires its transcultural adaptation. METHODS: Transcultural adaptation of the SRS-22 was carried out according to the International Quality of Life Assessment Project guidelines and included two translations and two back-translations of the material. A committee of experts decided on the final version. The questionnaire was administered to 175 individuals (152 women and 23 men) with idiopathic scoliosis. The mean age of the participants at the time they received the questionnaire was 18.9 years, thoracic curve magnitude was 28.8 degrees, and lumbar curve magnitude was 28.1 degrees. At this time, 85 patients had been treated surgically, 45 had been treated with orthesis, and 45 were under observation. A subgroup of 30 patients completed the questionnaire a second time 1 week later. Internal consistency was determined with Cronbach's alpha coefficient and test-retest reliability with the intraclass correlation coefficient. RESULTS: The overall alpha coefficient of the questionnaire was 0.89. Coefficients for individual domains were as follows: function/activity, 0.67; pain, 0.81; mental health, 0.83; self-image, 0.73; and satisfaction, 0.78. The questionnaire as a whole had an intraclass correlation coefficient of 0.96. Intraclass correlation coefficients for individual domains were as follows: pain, 0.93; function, 0.82; self-image, 0.94; mental health, 0.94; and satisfaction, 0.98. CONCLUSIONS: The Spanish version of the SRS-22 Patient Questionnaire demonstrated adequate internal consistency for the majority of domains and excellent reproducibility. These results suggest that the process of adaptation has produced an instrument that is apparently equivalent to the original and suitable for clinical research.