Browsing by Author "Edwards, Charles"

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    ItemOpen Access
    Baseline Patient-Reported Outcomes Correlate Weakly With Radiographic Parameters: A Multicenter, Prospective NIH Adult Symptomatic Lumbar Scoliosis Study of 286 Patients.
    (Spine, 2016-11) Chapman, Todd M; Baldus, Christine R; Lurie, Jon D; Glassman, Steven D; Schwab, Frank J; Shaffrey, Christopher I; Lafage, Virginie; Boachie-Adjei, Oheneba; Kim, Han J; Smith, Justin S; Crawford, Charles H; Lenke, Lawrence G; Buchowski, Jacob M; Edwards, Charles; Koski, Tyler; Parent, Stefan; Lewis, Stephen; Kang, Daniel G; McClendon, Jamal; Metz, Lionel; Zebala, Lukas P; Kelly, Michael P; Spratt, Kevin F; Bridwell, Keith H

    Study design

    Prospective, cross-sectional study.

    Objective

    The aim of the study was to determine which radiographic parameters drive patient-reported outcomes (PROs) in primary presentation adult symptomatic lumbar scoliosis (ASLS).

    Summary of background data

    Previous literature suggests correlations between PROs and sagittal plane deformity (sagittal vertical axis [SVA], pelvic incidence-lumbar lordosis [PI-LL] mismatch, pelvic tilt [PT]). Prior work included revision and primary adult spinal deformity patients. The present study addresses only primary presentation ASLS.

    Methods

    Prospective baseline data were analyzed on 286 patients enrolled in an NIH RO1 clinical trial by nine centers from 2010 to 2014.

    Inclusion criteria

    40 to 80 years old, lumbar Cobb (LC) 30° or higher and Scoliosis Research Society-23 score 4.0 or less in Pain, Function or Self-Image domains, or Oswestry Disability Index (ODI) 20 or higher. Patients were primary presentation (no prior spinal deformity surgery) and had complete baseline data: standing coronal/sagittal 36" radiographs and PROs (ODI, Scoliosis Research Society-23, Short Form-12). Correlation coefficients were calculated to evaluate relations between radiographic parameters and PROs for the study population and a subset of patients with ODI 40 or higher. Analysis of variance was used to identify differences in PROs for radiographic modifier groups.

    Results

    Mean age was 60.3 years. Mean spinopelvic parameters were: LL = -39.2°; SVA = 3.1 cm; sacral slope = 32.5°; PT = 23.9°; PI-LL mismatch = 16.8°. Only weak correlations (0.2-0.4) were identified between population sacral slope, SVA and SVA modifiers, and SRS function. SVA and SVA modifiers were weakly associated with ODI. Although there were more correlations in subset analysis of high-symptom patients, all were weak. Analysis of variance identified significant differences in ODI reported by SVA modifier groups.

    Conclusion

    In primary presentation patients with ASLS and a subset of "high-symptom" patients (ODI ≥ 40), only weak associations between baseline PROs and radiographic parameters were identified. For this patient population, these results suggest regional radiographic parameters (LC, LL, PT, PI-LL mismatch) are not drivers of PROs and cannot be used to extrapolate effect on patient-perceived pathology.

    Level of evidence

    2.
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    ItemOpen Access
    Changes in radiographic and clinical outcomes with primary treatment adult spinal deformity surgeries from two years to three- to five-years follow-up.
    (Spine, 2010-09) Bridwell, Keith H; Baldus, Christine; Berven, Sigurd; Edwards, Charles; Glassman, Steven; Hamill, Christopher; Horton, William; Lenke, Lawrence G; Ondra, Stephen; Schwab, Frank; Shaffrey, Christopher; Wootten, David

    Study design

    Retrospective analysis of data entered prospectively into a multicenter database-clinical and radiographic outcomes assessment.

    Objective

    Our hypothesis is that between the 2-year and the 3- to 5-year points surgically treated adult spinal deformity patients will show significant reduction in outcomes by Scoliosis Research Society (SRS), Oswestry Disability Index (ODI), and numerical rating scale back and leg pain scores and will show increasing thoracic kyphosis, loss of lumbar lordosis, and loss of coronal and sagittal balance.

    Summary of background data

    Most analyses of primary presentation adult spinal deformity surgery assess 2-year follow-up. However, it is established that in some patients unfavorable events occur between the 2-year and 5-year points.

    Methods

    The cohort of 113 patients entered into a multicenter database with complete preoperative, 2-year, and 3- to 5-year data. All patients who had adult spinal deformity and surgical treatment represented their first reconstruction. Diagnoses were scoliosis (82.5%), kyphosis (10%), and scoliosis and kyphosis combined (7.5%). Outcome measures and basic radiographic parameters (curve size, thoracic and lumbar sagittal plane, coronal and sagittal balance) were assessed at those 3 time intervals. Complications (pseudarthrosis/implant failure, infection, and junctional deformities) were assessed at the 2-year and the 3- to 5-year (mean, 3.76 years) points. RESULTS.: The mean major curve Cobb angle (preoperative, 57°; 2-year, 29°; 3-5 year, 26°); thoracic kyphosis T5 to T12 (30°, 31°, 32°) and lumbar lordosis T12 to sacrum (48°, 49°, 51°) did not change from the 2-year to ultimate follow-up. Likewise, coronal and sagittal balance parameters were the same at 2-year and ultimate follow-up. SRS total scores and modified ODI were similar at the 2 year and final follow-up (SRS: 3.89-3.88; ODI: 19-18). Preoperative SRS total score was 3.17. Six patients demonstrated complications at the 2-year point and additional 9 patients demonstrated complications at the 3- to 5-year point. Those 9 patients with complications at ultimate follow-up demonstrated significant deterioration in their ODI and SRS scores when compared with the patients who did not have complications at ultimate follow-up.

    Conclusion

    Contrary to our hypothesis, we could not establish deterioration in mean radiographic or clinical outcomes between the 2-year and 3- to 5-year follow-up points when analyzing the group as a whole. However, for the 9 patients who experienced complications between 3- and 5-year follow-up, their outcomes were significantly worse than for the other 104 patients.One should not anticipate an overall radiographic and clinical deterioration of the outcomes of surgically treated primary presentation adult spinal deformity patients in this studied time interval. However, close to 10% of patients will experience a new complication at the 3- to 5-year point, most commonly implant failure/nonunion and/or junctional kyphosis, which will negatively effect the patient-reported outcome.
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    ItemOpen Access
    Effect of Serious Adverse Events on Health-related Quality of Life Measures Following Surgery for Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2019-09) Smith, Justin S; Shaffrey, Christopher I; Kelly, Michael P; Yanik, Elizabeth L; Lurie, Jon D; Baldus, Christine R; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Bridwell, Keith H

    Study design

    Secondary analysis of prospective multicenter cohort.

    Objective

    To assess effect of serious adverse events (SAEs) on 2- and 4-year patient-reported outcomes measures (PROMs) in patients surgically treated for adult symptomatic lumbar scoliosis (ASLS).

    Summary of background data

    Operative treatment for ASLS can improve health-related quality of life, but has high rates of SAEs. How these SAEs effect health-related quality of life remain unclear.

    Methods

    The ASLS study assessed operative versus nonoperative ASLS treatment, with randomized and observational arms. Patients were 40- to 80-years-old with ASLS, defined as lumbar coronal Cobb ≥30° and Oswestry Disability Index (ODI) ≥20 or Scoliosis Research Society-22 (SRS-22) ≤4.0 in pain, function, and/or self-image domains. SRS-22 subscore and ODI were compared between operative patients with and without a related SAE and nonoperative patients using an as-treated analysis combining randomized and observational cohorts.

    Results

    Two hundred eighty-six patients were enrolled, and 2- and 4-year follow-up rates were 90% and 81%, respectively, although at the time of data extraction not all patients were eligible for 4-year follow-up. A total of 97 SAEs were reported among 173 operatively treated patients. The most common were implant failure/pseudarthrosis (n = 25), proximal junctional kyphosis/failure (n = 10), and minor motor deficit (n = 8). At 2 years patients with an SAE improved less than those without an SAE based on SRS-22 (0.52 vs. 0.79, P = 0.004) and ODI (-11.59 vs. -17.34, P = 0.021). These differences were maintained at 4-years for both SRS-22 (0.51 vs. 0.86, P = 0.001) and ODI (-10.73 vs. -16.69, P = 0.012). Despite this effect, patients sustaining an operative SAE had greater PROM improvement than nonoperative patients (P<0.001).

    Conclusion

    Patients affected by SAEs following surgery for ASLS had significantly less improvement of PROMs at 2- and 4-year follow-ups versus those without an SAE. Regardless of SAE occurrence, operatively treated patients had significantly greater improvement in PROMs than those treated nonoperatively.

    Level of evidence

    2.
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    ItemOpen Access
    Operative versus nonoperative treatment for adult symptomatic lumbar scoliosis at 5-year follow-up: durability of outcomes and impact of treatment-related serious adverse events.
    (Journal of neurosurgery. Spine, 2021-04) Smith, Justin S; Kelly, Michael P; Yanik, Elizabeth L; Baldus, Christine R; Buell, Thomas J; Lurie, Jon D; Edwards, Charles; Glassman, Steven D; Lenke, Lawrence G; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Errico, Thomas J; Lewis, Stephen J; Koski, Tyler; Parent, Stefan; Lafage, Virginie; Kim, Han Jo; Ames, Christopher P; Bess, Shay; Schwab, Frank J; Shaffrey, Christopher I; Bridwell, Keith H

    Objective

    Although short-term adult symptomatic lumbar scoliosis (ASLS) studies favor operative over nonoperative treatment, longer outcomes are critical for assessment of treatment durability, especially for operative treatment, because the majority of implant failures and nonunions present between 2 and 5 years after surgery. The objectives of this study were to assess the durability of treatment outcomes for operative versus nonoperative treatment of ASLS, to report the rates and types of associated serious adverse events (SAEs), and to determine the potential impact of treatment-related SAEs on outcomes.

    Methods

    The ASLS-1 (Adult Symptomatic Lumbar Scoliosis-1) trial is an NIH-sponsored multicenter prospective study to assess operative versus nonoperative ASLS treatment. Patients were 40-80 years of age and had ASLS (Cobb angle ≥ 30° and Oswestry Disability Index [ODI] ≥ 20 or Scoliosis Research Society [SRS]-22 subscore ≤ 4.0 in the Pain, Function, and/or Self-Image domains). Patients receiving operative and nonoperative treatment were compared using as-treated analysis, and the impact of related SAEs was assessed. Primary outcome measures were ODI and SRS-22.

    Results

    The 286 patients with ASLS (107 with nonoperative treatment, 179 with operative treatment) had 2-year and 5-year follow-up rates of 90% (n = 256) and 74% (n = 211), respectively. At 5 years, compared with patients treated nonoperatively, those who underwent surgery had greater improvement in ODI (mean difference -15.2 [95% CI -18.7 to -11.7]) and SRS-22 subscore (mean difference 0.63 [95% CI 0.48-0.78]) (p < 0.001), with treatment effects (TEs) exceeding the minimum detectable measurement difference (MDMD) for ODI (7) and SRS-22 subscore (0.4). TEs at 5 years remained as favorable as 2-year TEs (ODI -13.9, SRS-22 0.52). For patients in the operative group, the incidence rates of treatment-related SAEs during the first 2 years and 2-5 years after surgery were 22.38 and 8.17 per 100 person-years, respectively. At 5 years, patients in the operative group who had 1 treatment-related SAE still had significantly greater improvement, with TEs (ODI -12.2, SRS-22 0.53; p < 0.001) exceeding the MDMD. Twelve patients who received surgery and who had 2 or more treatment-related SAEs had greater improvement than nonsurgically treated patients based on ODI (TE -8.34, p = 0.017) and SRS-22 (TE 0.32, p = 0.029), but the SRS-22 TE did not exceed the MDMD.

    Conclusions

    The significantly greater improvement of operative versus nonoperative treatment for ASLS at 2 years was durably maintained at the 5-year follow-up. Patients in the operative cohort with a treatment-related SAE still had greater improvement than patients in the nonoperative cohort. These findings have important implications for patient counseling and future cost-effectiveness assessments.
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    ItemOpen Access
    Operative Versus Nonoperative Treatment for Adult Symptomatic Lumbar Scoliosis.
    (The Journal of bone and joint surgery. American volume, 2019-02) Kelly, Michael P; Lurie, Jon D; Yanik, Elizabeth L; Shaffrey, Christopher I; Baldus, Christine R; Boachie-Adjei, Oheneba; Buchowski, Jacob M; Carreon, Leah Y; Crawford, Charles H; Edwards, Charles; Errico, Thomas J; Glassman, Steven D; Gupta, Munish C; Lenke, Lawrence G; Lewis, Stephen J; Kim, Han Jo; Koski, Tyler; Parent, Stefan; Schwab, Frank J; Smith, Justin S; Zebala, Lukas P; Bridwell, Keith H

    Background

    The effectiveness of operative compared with nonoperative treatment at initial presentation (no prior fusion) for adult lumbar scoliosis has not, to our knowledge, been evaluated in controlled trials. The goals of this study were to evaluate the effects of operative and nonoperative treatment and to assess the benefits of these treatments to help treating physicians determine whether patients are better managed operatively or nonoperatively.

    Methods

    Patients with adult symptomatic lumbar scoliosis (aged 40 to 80 years, with a coronal Cobb angle measurement of ≥30° and an Oswestry Disability Index [ODI] score of ≥20 or Scoliosis Research Society [SRS]-22 score of ≤4.0) from 9 North American centers were enrolled in concurrent randomized or observational cohorts to evaluate operative versus nonoperative treatment. The primary outcomes were differences in the mean change from baseline in the SRS-22 subscore and ODI at 2-year follow-up. For the randomized cohort, the initial sample-size calculation estimated that 41 patients per group (82 total) would provide 80% power with alpha equal to 0.05, anticipating 10% loss to follow-up and 20% nonadherence in the nonoperative arm. However, an interim sample-size calculation estimated that 18 patients per group would be sufficient.

    Results

    Sixty-three patients were enrolled in the randomized cohort: 30 in the operative group and 33 in the nonoperative group. Two hundred and twenty-three patients were enrolled in the observational cohort: 112 in the operative group and 111 in the nonoperative group. The intention-to-treat analysis of the randomized cohort found that, at 2 years of follow-up, outcomes did not differ between the groups. Nonadherence was high in the randomized cohort (64% nonoperative-to-operative crossover). In the as-treated analysis of the randomized cohort, operative treatment was associated with greater improvement at the 2-year follow-up in the SRS-22 subscore (adjusted mean difference, 0.7 [95% confidence interval (CI), 0.5 to 1.0]) and in the ODI (adjusted mean difference, -16 [95% CI, -22 to -10]) (p < 0.001 for both). Surgery was also superior to nonoperative care in the observational cohort at 2 years after treatment on the basis of SRS-22 subscore and ODI outcomes (p < 0.001). In an overall responder analysis, more operative patients achieved improvement meeting or exceeding the minimal clinically important difference (MCID) in the SRS-22 subscore (85.7% versus 38.7%; p < 0.001) and the ODI (77.4% versus 38.3%; p < 0.001). Thirty-four revision surgeries were performed in 24 (14%) of the operative patients.

    Conclusions

    On the basis of as-treated and MCID analyses, if a patient with adult symptomatic lumbar scoliosis is satisfied with current spine-related health, nonoperative treatment is advised, with the understanding that improvement is unlikely. If a patient is not satisfied with current spine health and expects improvement, surgery is preferred.

    Level of evidence

    Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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    ItemOpen Access
    Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2016-03) Neuman, Brian J; Baldus, Christine; Zebala, Lukas P; Kelly, Michael P; Shaffrey, Christopher; Edwards, Charles; Koski, Tyler; Schwab, Frank; Glassman, Steven; Parent, Stefan; Lewis, Stephen; Lenke, Lawrence G; Buchowski, Jacob M; Smith, Justin S; Crawford, Charles H; Kim, Han Jo; Lafage, Virginia; Lurie, Jon; Carreon, Leah; Bridwell, Keith H

    Study design

    A prospective study with randomized and observational cohorts.

    Objective

    The aim of this study was to determine baseline variables affecting adult symptomatic lumbar scoliosis (ASLS) decision making to participate in randomization (RAND), observational nonsurgical (OBS-NS), or observational surgical (OBS-S) cohorts.

    Summary of background data

    Multiple factors play a key role in a patient's decision to be randomized or to choose an OBS-NS or OBS-S course for ASLS. Studies evaluating these factors are limited.

    Methods

    Eligible candidates (patients with ASLS and no prior spinal fusion deformity surgery) from 9 centers participated in a RAND, OBS-NS, or OBS-S cohort study. Baseline variables (demographics, socioeconomics, patient-reported outcomes [PROs], Functional Treadmill Test, radiographs) were analyzed.

    Results

    Two hundred ninety-five patients were enrolled: 67 RAND, 115 OBS-NS, 113 OBS-S. Subanalysis of older patients (60-80 years) found 54% of OBS-NS had college degrees compared with 82% of RAND and 71% of OBS-S (P = 0.010). Patients deciding to be part of a RAND cohort have similar clinical characteristics to the OBS-S cohort. OBS-S had more symptomatic spinal stenosis (57% vs. 39%, P = 0.029) and worse scores than OBS-NS on the basis of PROs (Back Pain Numerical Rating Scale [NRS 6.3 vs. 5.5, P = 0.007]; Scoliosis Research Society [SRS] Pain [2.8 vs. 3.0, P = 0.018], Function [3.1 vs. 3.4, P = 0.019] and Self-Image [2.7 vs. 3.1, P = 0.002]; Oswestry Disability Index (ODI) [36.9 vs. 31.8, P = 0.029]; post-Treadmill back [5.8 vs. 4.4, P = 0.002] and leg [4.3 vs. 3.1, P = 0.037] pain NRS and larger lumbar coronal Cobb angles (56.5 degrees vs. 48.8 degrees, P < 0.001). RAND had more baseline motor deficits (10.4% vs. 1.7%, P = 0.036) and worse scores than OBS-NS on the basis of ODI (38.8 vs. 31.8, P = 0.006), SRS Function [3.1 vs. 3.4, P = 0.034], and Self-Image [2.7 vs. 3.1, P = 0.007].

    Conclusion

    Patients with worse PROs, more back pain, more back and leg pain with ambulation, and larger lumbar Cobb angles are more inclined to select surgical over nonsurgical management.
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    ItemOpen Access
    Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up: Nonoperative, Multicenter, Prospective NIH Study of 105 Patients.
    (Spine, 2018-06) Pugely, Andrew J; Kelly, Michael P; Baldus, Christine R; Gao, Yubo; Zebala, Lukas; Shaffrey, Christopher; Glassman, Steven; Boachie-Adjei, Oheneba; Parent, Stefan; Lewis, Stephen; Koski, Tyler; Edwards, Charles; Schwab, Frank; Bridwell, Keith H

    Study design

    This is an analysis of a prospective 2-year study on nonoperative patients enrolled in the Adult Symptomatic Lumbar Scoliosis (ASLS) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trial.

    Objective

    The purpose was to evaluate the impact of serious adverse events (SAEs) on patient-reported outcomes (PROs) in nonoperative management of ASLS as measured by Scoliosis Research Society-22 (SRS-22), Oswestry Disability Index (ODI), and Short Form-12 (SF-12) at 2-year follow-up.

    Summary of background data

    Little is known about PROs in the nonoperative management of ASLS or the prevalence and impact of SAEs on PROs.

    Methods

    The ASLS trial dataset was analyzed to identify adult lumbar scoliosis patients electively choosing or randomly assigned to nonoperative treatment with minimum 2-year follow-up. Patient data were collected prospectively from 2010 to 2015 as part of NIAMS R01-AR055176-01A2 "A Multi-Centered Prospective Study of Quality of Life in Adult Scoliosis." SAEs were defined as life-threatening medical events, new significant or permanent disability, new or prolonged hospitalization, or death.

    Results

    One hundred five nonoperative patients were studied to 2-year follow-up. Twenty-seven patients (25.7%) had 42 SAEs; 15 (14.3%) had a SAE during the first year. The SAE group had higher body mass index (29.4 vs. 25.2; P = 0.008) and reported worse SRS-22 Function scores than the non-SAE group at baseline (3.3 vs. 3.6; P = 0.024). At 2-year follow-up, SAE patients experienced less improvement (change) in SRS-22 Self-Image (-0.07 vs. 0.26; P = 0.018) and Mental Health domains (-0.19 vs. 0.25; P = 0.002) than non-SAE patients and had lower SRS-22 Function, Self-Image, Subscore, and SF-12 Mental and Physical component scores (MCS/PCS). Fewer SAE patients reached minimal clinically important difference (MCID) threshold in SRS-22 Mental Health (14.8% vs. 43.6%; P = 0.01).

    Conclusion

    A high percentage (25.7%) of ASLS patients managed nonoperatively experienced SAEs. Those patients who sustained a SAE had less improvement in reported outcomes.

    Level of evidence

    2.
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    ItemOpen Access
    The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis.
    (Spine, 2011-06) Baldus, Christine; Bridwell, Keith; Harrast, John; Shaffrey, Christopher; Ondra, Stephen; Lenke, Lawrence; Schwab, Frank; Mardjetko, Steven; Glassman, Steven; Edwards, Charles; Lowe, Thomas; Horton, William; Polly, David

    Study design

    Prospective, cross-sectional study.

    Objective

    To determine Scoliosis Research Society (SRS)-30 health-related quality of life (HRQOL) reference values by age and gender in an adult population unaffected by scoliosis thereby allowing clinicians and investigators to compare individual and/or groups of spinal deformity patients to their generational peers.

    Summary of background data

    Normative data are collected to establish means and standard deviations of health-related quality of life outcomes representative of a population. The SRS HRQOL questionnaire has become the standard for determining and comparing treatment outcomes in spinal deformity practices. With the establishment of adult SRS-30 HRQOL population values, clinicians, and investigators now have a reference for interpretation of individual scores and/or the scores of subgroups of adult patients with spinal deformities.

    Methods

    The SRS-30 HRQOL was issued prospectively to 1346 adult volunteers recruited from across the United States. Volunteers self-reported no history of scoliosis or prior spine surgery. Domain medians, means, confidence intervals, percentiles, and minimum/maximum values were calculated for six generational age-gender groups: male/female; 20-39, 40-59, and 60-80 years of age.

    Results

    Median and mean domain values ranged from 4.1 to 4.6 for all age-gender groups. The older the age-gender group, the lower (worse) the reported domain median and mean scores. The only exception was the mental health domain scores in the female groups which improved slightly. Males reported higher (better) scores than females but only the younger males were significantly higher in all domains than their female counterparts. In addition, all male groups reported higher Mental Health domain scores than their female counterparts (P=0.003).

    Conclusion

    This study reports population medians, means, standard deviations, percentiles, and confidence intervals for the domains of the SRS-30 HRQOL instrument. Clinicians must be mindful of age-gender differences when assessing deformity populations. Generational decreases noted in the older adult volunteer scores may provide a basis for future investigators to interpret observed score decreases in patient cohorts at long-term follow-up.