Search Results

You are looking at 1 - 10 of 38 items for

  • Author or Editor: Eric Klineberg x
Clear All Modify Search
Full access

Michael P. Kelly, Lukas P. Zebala, Han Jo Kim, Daniel M. Sciubba, Justin S. Smith, Christopher I. Shaffrey, Shay Bess, Eric Klineberg, Gregory Mundis Jr., Douglas Burton, Robert Hart, Alex Soroceanu, Frank Schwab, Virginie Lafage and International Spine Study Group

OBJECT

The goal of this study was to examine the effectiveness of preoperative autologous blood donation (PABD) in adult spinal deformity (ASD) surgery.

METHODS

Patients undergoing single-stay ASD reconstructions were identified in a multicenter database. Patients were divided into groups according to PABD (either PABD or NoPABD). Propensity weighting was used to create matched cohorts of PABD and NoPABD patients. Allogeneic (ALLO) exposure, autologous (AUTO) wastage (unused AUTO), and complication rates were compared between groups.

RESULTS

Four hundred twenty-eight patients were identified as meeting eligibility criteria. Sixty patients were treated with PABD, of whom 50 were matched to 50 patients who were not treated with PABD (NoPABD). Nearly one-third of patients in the PABD group (18/60, 30%) did not receive any autologous transfusion and donated blood was wasted. In 6 of these cases (6/60, 10%), patients received ALLO blood transfusions without AUTO. In 9 cases (9/60, 15%), patients received ALLO and AUTO blood transfusions. Overall rates of transfusion of any type were similar between groups (PABD 70% [42/60], NoPABD 75% [275/368], p = 0.438). Major and minor in-hospital complications were similar between groups (Major PABD 10% [6/60], NoPABD 12% [43/368], p = 0.537; Minor PABD 30% [18/60], NoPABD 24% [87/368], p = 0.499). When controlling for potential confounders, PABD patients were more likely to receive some transfusion (OR 15.1, 95% CI 2.1-106.7). No relationship between PABD and ALLO blood exposure was observed, however, refuting the concept that PABD is protective against ALLO blood exposure. In the matched cohorts, PABD patients were more likely to sustain a major perioperative cardiac complication (PABD 8/50 [16%], NoPABD 1/50 [2%], p = 0.046). No differences in rates of infection or wound-healing complications were observed between cohorts.

CONCLUSIONS

Preoperative autologous blood donation was associated with a higher probability of perioperative transfusions of any type in patients with ASD. No protective effect of PABD against ALLO blood exposure was observed, and no risk of perioperative infectious complications was observed in patients exposed to ALLO blood only. The benefit of PABD in patients with ASD remains undefined.

Full access

Taemin Oh, Justin K. Scheer, Robert Eastlack, Justin S. Smith, Virginie Lafage, Themistocles S. Protopsaltis, Eric Klineberg, Peter G. Passias, Vedat Deviren, Richard Hostin, Munish Gupta, Shay Bess, Frank Schwab, Christopher I. Shaffrey and Christopher P. Ames

OBJECT

Alignment changes in the cervical spine that occur following surgical correction for thoracic deformity remain poorly understood. The purpose of this study was to evaluate such changes in a cohort of adults with thoracic deformity treated surgically.

METHODS

The authors conducted a multicenter retrospective analysis of consecutive patients with thoracic deformity. Inclusion criteria for this study were as follows: corrective osteotomy for thoracic deformity, upper-most instrumented vertebra (UIV) between T-1 and T-4, lower-most instrumented vertebra (LIV) at or above L-5 (LIV ≥ L-5) or at the ilium (LIV-ilium), and a minimum radiographic follow-up of 2 years. Sagittal radiographic parameters were assessed preoperatively as well as at 3 months and 2 years postoperatively, including the C-7 sagittal vertical axis (SVA), C2–7 cervical lordosis (CL), C2–7 SVA, T-1 slope (T1S), T1S minus CL (T1S-CL), T2–12 thoracic kyphosis (TK), apical TK, lumbar lordosis (LL), pelvic incidence (PI), PI-LL, pelvic tilt (PT), and sacral slope (SS).

RESULTS

Fifty-seven patients with a mean age of 49.1 ± 14.6 years met the study inclusion criteria. The preoperative prevalence of increased CL (CL > 15°) was 48.9%. Both 3-month and 2-year apical TK improved from baseline (p < 0.05, statistically significant). At the 2-year follow-up, only the C2–7 SVA increased significantly from baseline (p = 0.01), whereas LL decreased from baseline (p < 0.01). The prevalence of increased CL was 35.3% at 3 months and 47.8% at 2 years, which did not represent a significant change. Postoperative cervical alignment changes were not significantly different from preoperative values regardless of the LIV (LIV ≥ L-5 or LIV-ilium, p > 0.05 for both). In a subset of patients with a maximum TK ≥ 60° (35 patients) and 3-column osteotomy (38 patients), no significant postoperative cervical changes were seen.

CONCLUSION

Increased CL is common in adult spinal deformity patients with thoracic deformities and, unlike after lumbar corrective surgery, does not appear to normalize after thoracic corrective surgery. Cervical sagittal malalignment (C2–7 SVA) also increases postoperatively. Surgeons should be aware that spontaneous cervical alignment normalization might not occur following thoracic deformity correction.

Free access

Kristina Bianco, Robert Norton, Frank Schwab, Justin S. Smith, Eric Klineberg, Ibrahim Obeid, Gregory Mundis Jr., Christopher I. Shaffrey, Khaled Kebaish, Richard Hostin, Robert Hart, Munish C. Gupta, Douglas Burton, Christopher Ames, Oheneba Boachie-Adjei, Themistocles S. Protopsaltis and Virginie Lafage

Object

Three-column resection osteotomies (3COs) are commonly performed for sagittal deformity but have high rates of reported complications. Authors of this study aimed to examine the incidence of and intercenter variability in major intraoperative complications (IOCs), major postoperative complications (POCs) up to 6 weeks postsurgery, and overall complications (that is, both IOCs and POCs). They also aimed to investigate the incidence of and intercenter variability in blood loss during 3CO procedures.

Methods

The incidence of IOCs, POCs, and overall complications associated with 3COs were retrospectively determined for the study population and for each of 8 participating surgical centers. The incidence of major blood loss (MBL) over 4 L and the percentage of total blood volume lost were also determined for the study population and each surgical center. Complication rates and blood loss were compared between patients with one and those with two osteotomies, as well as between patients with one thoracic osteotomy (ThO) and those with one lumbar or sacral osteotomy (LSO). Risk factors for developing complications were determined.

Results

Retrospective review of prospectively acquired data for 423 consecutive patients who had undergone 3CO at 8 surgical centers was performed. The incidence of major IOCs, POCs, and overall complications was 7%, 39%, and 42%, respectively, for the study population overall. The most common IOC was spinal cord deficit (2.6%) and the most common POC was unplanned return to the operating room (19.4%). Patients with two osteotomies had more POCs (56% vs 38%, p = 0.04) than the patients with one osteotomy. Those with ThO had more IOCs (16% vs 6%, p = 0.03), POCs (58% vs 34%, p < 0.01), and overall complications (67% vs 37%, p < 0.01) than the patients with LSO. There was significant variation in the incidence of IOCs, POCs, and overall complications among the 8 sites (p < 0.01). The incidence of MBL was 24% for the study population, which varied significantly between sites (p < 0.01). Patients with MBL had a higher risk of IOCs, POCs, and overall complications (OR 2.15, 1.76, and 2.01, respectively). The average percentage of total blood volume lost was 55% for the study population, which also varied among sites (p < 0.01).

Conclusions

Given the complexity of 3COs for spinal deformity, it is important for spine surgeons to understand the risk factors and complication rates associated with these procedures. In this study, the overall incidence of major complications following 3CO procedures was 42%. Risks for developing complications included an older age (> 60 years), two osteotomies, ThO, and MBL.

Full access

Justin K. Scheer, Virginie Lafage, Justin S. Smith, Vedat Deviren, Richard Hostin, Ian M. McCarthy, Gregory M. Mundis, Douglas C. Burton, Eric Klineberg, Munish C. Gupta, Khaled M. Kebaish, Christopher I. Shaffrey, Shay Bess, Frank Schwab, Christopher P. Ames and the International Spine Study Group (ISSG)

Object

Spinal osteotomies for adult spinal deformity correction may include resection of all 3 spinal columns (pedicle subtraction osteotomy [PSO] and vertebral column resection [VCR]). The relationship between patient age and health-related quality of life (HRQOL) outcomes for patients undergoing major spinal deformity correction via PSO or VCR has not been well characterized. The goal of this study was to characterize that relationship.

Methods

This study was a retrospective review of 374 patients who had undergone a 3-column osteotomy (299 PSOs and 75 VCRs) and were part of a prospectively collected, multicenter adult spinal deformity database. The consecutively enrolled patients were drawn from 11 sites across the United States. Health-related QOL outcomes, according to the visual analog scale (VAS), Oswestry Disability Index (ODI), 36-Item Short-Form Health Survey (SF-36, physical component score [PCS] and mental component score), and Scoliosis Research Society-22 questionnaire (SRS), were evaluated preoperatively and 1 and 2 years postoperatively. Differences and correlations between patient age and HRQOL outcomes were investigated. Age groupings included young (age ≤ 45 years), middle aged (age 46–64 years), and elderly (age ≥ 65 years).

Results

In patients who had undergone PSO, age significantly correlated (Spearman's correlation coefficient) with the 2-year ODI (ρ = 0.24, p = 0.0450), 2-year SRS function score (ρ = 0.30, p = 0.0123), and 2-year SRS total score (ρ = 0.30, p = 0.0133). Among all patients (PSO+VCR), the preoperative PCS and ODI in the young group were significantly higher and lower, respectively, than those in the elderly. Among the PSO patients, the elderly group had much greater improvement than the young group in the 1- and 2-year PCS, 2-year ODI, and 2-year SRS function and total scores. Among the VCR patients, the young age group had much greater improvement than the elderly in the 1-year SRS pain score, 1-year PCS, 2-year PCS, and 2-year ODI. There was no significant difference among all the age groups as regards the likelihood of reaching a minimum clinically important difference (MCID) within each of the HRQOL outcomes (p > 0.05 for all). Among the PSO patients, the elderly group was significantly more likely than the young to reach an MCID for the 1-year PCS (61% vs 21%, p = 0.0077) and the 2-year PCS (67% vs 17%, p = 0.0054), SRS pain score (57% vs 20%, p = 0.0457), and SRS function score (62% vs 20%, p = 0.0250). Among the VCR patients, the young group was significantly more likely than the elderly patients to reach an MCID for the 1-year (100% vs 20%, p = 0.0036) and 2-year (100% vs 0%, p = 0.0027) PCS scores and 1-year (60% vs 0%, p = 0.0173) and 2-year (70% vs 0%, p = 0.0433) SRS pain scores.

Conclusions

The PSO and VCR are not equivalent surgeries in terms of HRQOL outcomes and patient age. Among patients who underwent PSO, the elderly group started with more preoperative disability than the younger patients but had greater improvements in HRQOL outcomes and was more likely to reach an MCID at 1 and 2 years after treatment. Among those who underwent VCR, all had similar preoperative disabilities, but the younger patients had greater improvements in HRQOL outcomes and were more likely to reach an MCID at 1 and 2 years after treatment.

Full access

Justin S. Smith, Manish Singh, Eric Klineberg, Christopher I. Shaffrey, Virginie Lafage, Frank J. Schwab, Themistocles Protopsaltis, David Ibrahimi, Justin K. Scheer, Gregory Mundis Jr., Munish C. Gupta, Richard Hostin, Vedat Deviren, Khaled Kebaish, Robert Hart, Douglas C. Burton, Shay Bess and Christopher P. Ames

Object

Increased sagittal vertical axis (SVA) correlates strongly with pain and disability for adults with spinal deformity. A subset of patients with sagittal spinopelvic malalignment (SSM) have flatback deformity (pelvic incidence–lumbar lordosis [PI-LL] mismatch > 10°) but remain sagittally compensated with normal SVA. Few data exist for SSM patients with flatback deformity and normal SVA. The authors' objective was to compare baseline disability and treatment outcomes for patients with compensated (SVA < 5 cm and PI-LL mismatch > 10°) and decompensated (SVA > 5 cm) SSM.

Methods

The study was a multicenter, prospective analysis of adults with spinal deformity who consecutively underwent surgical treatment for SSM. Inclusion criteria included age older than 18 years, presence of adult spinal deformity with SSM, plan for surgical treatment, and minimum 1-year follow-up data. Patients with SSM were divided into 2 groups: those with compensated SSM (SVA < 5 cm and PI-LL mismatch > 10°) and those with decompensated SSM (SVA ≥ 5 cm). Baseline and 1-year follow-up radiographic and health-related quality of life (HRQOL) outcomes included Oswestry Disability Index, Short Form–36 scores, and Scoliosis Research Society–22 scores. Percentages of patients achieving minimal clinically important difference (MCID) were also assessed.

Results

A total of 125 patients (27 compensated and 98 decompensated) met inclusion criteria. Compared with patients in the compensated group, patients in the decompensated group were older (62.9 vs 55.1 years; p = 0.004) and had less scoliosis (43° vs 54°; p = 0.002), greater SVA (12.0 cm vs 1.7 cm; p < 0.001), greater PI-LL mismatch (26° vs 20°; p = 0.013), and poorer HRQOL scores (Oswestry Disability Index, Short Form-36 physical component score, Scoliosis Research Society-22 total; p ≤ 0.016). Although these baseline HRQOL differences between the groups reached statistical significance, only the mean difference in Short Form–36 physical component score reached threshold for MCID. Compared with baseline assessment, at 1 year after surgery improvement was noted for patients in both groups for mean SVA (compensated –1.1 cm, decompensated +4.8 cm; p ≤ 0.009), mean PI-LL mismatch (compensated 6°, decompensated 5°; p < 0.001), and all HRQOL measures assessed (p ≤ 0.005). No significant differences were found between the compensated and decompensated groups in the magnitude of HRQOL score improvement or in the percentages of patients achieving MCID for each of the outcome measures assessed.

Conclusions

Decompensated SSM patients with elevated SVA experience significant disability; however, the amount of disability in compensated SSM patients with flatback deformity caused by PI-LL mismatch but normal SVA is underappreciated. Surgical correction of SSM demonstrated similar radiographic and HRQOL score improvements for patients in both groups. Evaluation of SSM should extend beyond measuring SVA. Among patients with concordant pain and disability, PI-LL mismatch must be evaluated for SSM patients and can be considered a primary indication for surgery.

Free access

Christopher P. Ames, Justin S. Smith, Justin K. Scheer, Christopher I. Shaffrey, Virginie Lafage, Vedat Deviren, Bertrand Moal, Themistocles Protopsaltis, Praveen V. Mummaneni, Gregory M. Mundis Jr., Richard Hostin, Eric Klineberg, Douglas C. Burton, Robert Hart, Shay Bess, Frank J. Schwab and the International Spine Study Group

Object

Cervical spine osteotomies are powerful techniques to correct rigid cervical spine deformity. Many variations exist, however, and there is no current standardized system with which to describe and classify cervical osteotomies. This complicates the ability to compare outcomes across procedures and studies. The authors' objective was to establish a universal nomenclature for cervical spine osteotomies to provide a common language among spine surgeons.

Methods

A proposed nomenclature with 7 anatomical grades of increasing extent of bone/soft tissue resection and destabilization was designed. The highest grade of resection is termed the major osteotomy, and an approach modifier is used to denote the surgical approach(es), including anterior (A), posterior (P), anterior-posterior (AP), posterior-anterior (PA), anterior-posterior-anterior (APA), and posterior-anterior-posterior (PAP). For cases in which multiple grades of osteotomies were performed, the highest grade is termed the major osteotomy, and lower-grade osteotomies are termed minor osteotomies. The nomenclature was evaluated by 11 reviewers through 25 different radiographic clinical cases. The review was performed twice, separated by a minimum 1-week interval. Reliability was assessed using Fleiss kappa coefficients.

Results

The average intrarater reliability was classified as “almost perfect agreement” for the major osteotomy (0.89 [range 0.60–1.00]) and approach modifier (0.99 [0.95–1.00]); it was classified as “moderate agreement” for the minor osteotomy (0.73 [range 0.41–1.00]). The average interrater reliability for the 2 readings was the following: major osteotomy, 0.87 (“almost perfect agreement”); approach modifier, 0.99 (“almost perfect agreement”); and minor osteotomy, 0.55 (“moderate agreement”). Analysis of only major osteotomy plus approach modifier yielded a classification that was “almost perfect” with an average intrarater reliability of 0.90 (0.63–1.00) and an interrater reliability of 0.88 and 0.86 for the two reviews.

Conclusions

The proposed cervical spine osteotomy nomenclature provides the surgeon with a simple, standard description of the various cervical osteotomies. The reliability analysis demonstrated that this system is consistent and directly applicable. Future work will evaluate the relationship between this system and health-related quality of life metrics.

Full access

Justin S. Smith, Eric Klineberg, Virginie Lafage, Christopher I. Shaffrey, Frank Schwab, Renaud Lafage, Richard Hostin, Gregory M. Mundis Jr., Thomas J. Errico, Han Jo Kim, Themistocles S. Protopsaltis, D. Kojo Hamilton, Justin K. Scheer, Alex Soroceanu, Michael P. Kelly, Breton Line, Munish Gupta, Vedat Deviren, Robert Hart, Douglas C. Burton, Shay Bess, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications.

METHODS

As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years.

RESULTS

Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82 patients (28.2%). A total of 270 perioperative complications (145 minor; 125 major) were reported, with 152 patients (52.2%) affected, and a total of 199 delayed complications (62 minor; 137 major) were reported, with 124 patients (42.6%) affected. Overall, 469 complications (207 minor; 262 major) were documented, with 203 patients (69.8%) affected. The most common complication categories included implant related, radiographic, neurological, operative, cardiopulmonary, and infection. Higher complication rates were associated with older age (p = 0.009), greater body mass index (p ≤ 0.031), increased comorbidities (p ≤ 0.007), previous spine fusion (p = 0.029), and 3-column osteotomies (p = 0.036). Cases in which 2-year follow-up was not achieved included 2 perioperative mortalities (pulmonary embolus and inferior vena cava injury).

CONCLUSIONS

This study provides an assessment of complications associated with ASD surgery based on a prospective, multicenter design and with a minimum 2-year follow-up. Although the overall complication rates were high, in interpreting these findings, it is important to recognize that not all complications are equally impactful. This study represents one of the most complete and detailed reports of perioperative and delayed complications associated with ASD surgery to date. These findings may prove useful for treatment planning, patient counseling, benchmarking of complication rates, and efforts to improve the safety and cost-effectiveness of patient care.

Free access

Taemin Oh, Justin K. Scheer, Justin S. Smith, Richard Hostin, Chessie Robinson, Jeffrey L. Gum, Frank Schwab, Robert A. Hart, Virginie Lafage, Douglas C. Burton, Shay Bess, Themistocles Protopsaltis, Eric O. Klineberg, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness.

METHODS

The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (−MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and –MCID groups.

RESULTS

A total of 234 patients met inclusion criteria (+MCID 129, −MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for −MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002).

CONCLUSIONS

A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

Free access

David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

Restricted access

Michael P. Kelly, Michael A. Kallen, Christopher I. Shaffrey, Justin S. Smith, Douglas C. Burton, Christopher P. Ames, Virginie Lafage, Frank J. Schwab, Han Jo Kim, Eric O. Klineberg, Shay Bess and the International Spine Study Group

OBJECTIVE

After using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society–22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).

METHODS

PROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.

RESULTS

In total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).

CONCLUSIONS

The authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS–computer adaptive test instruments in ASD.