Browsing by Author "Crawford, Charles H"

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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
    Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.
    (Spine deformity, 2020-12) Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Kelly, Michael P; Crawford, Charles H; Yanik, Elizabeth L; Lurie, Jon D; Bess, R Shay; Baldus, Christine R; Bridwell, Keith H

    Study design

    Longitudinal comparative cohort.

    Objective

    The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.

    Methods

    Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.

    Results

    Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.

    Conclusion

    This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.

    Level of evidence

    II.
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    ItemOpen Access
    Cost-effectiveness of Operative versus Nonoperative Treatment of Adult Symptomatic Lumbar Scoliosis an Intent-to-treat Analysis at 5-year Follow-up.
    (Spine, 2019-11) Carreon, Leah Y; Glassman, Steven D; Lurie, Jon; Shaffrey, Christopher I; Kelly, Michael P; Baldus, Christine R; Bratcher, Kelly R; Crawford, Charles H; Yanik, Elizabeth L; Bridwell, Keith H
    STUDY DESIGN:Secondary analysis using data from the NIH-sponsored study on adult symptomatic lumbar scoliosis (ASLS) that included randomized and observational arms. OBJECTIVE:The aim of this study was to perform an intent-to-treat cost-effectiveness study comparing operative (Op) versus nonoperative (NonOp) care for ASLS. SUMMARY OF BACKGROUND DATA:The appropriate treatment approach for ASLS continues to be ill-defined. NonOp care has not been shown to improve outcomes. Surgical treatment has been shown to improve outcomes, but is costly with high revision rates. METHODS:Patients with at least 5-year follow-up data were included. Data collected every 3 months included use of NonOp modalities, medications, and employment status. Costs for index and revision surgeries and NonOp modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on reported employment status and income. Qualityadjusted life year (QALY) was determined using the SF6D. RESULTS:There were 81 of 95 cases in the Op and 81 of 95 in the NonOp group with complete 5-year follow-up data. Not all patients were eligible 5-year follow-up at the time of the analysis. All patients in the Op and 24 (30%) in the NonOp group had surgery by 5 years. At 5 years, the cumulative cost for Op was $96,000 with a QALY gain of 2.44 and for NonOp the cumulative cost was $49,546 with a QALY gain of 0.75 with an incremental cost-effectiveness ratio (ICER) of $27,480 per QALY gain. CONCLUSION:In an intent-to-treat analysis, neither treatment was dominant, as the greater gains in QALY in the surgery group come at a greater cost. The ICER for Op compared to NonOp treatment was above the threshold generally considered cost-effective in the first 3 years of the study but improved over time and was highly cost-effective at 4 and 5 years. LEVEL OF EVIDENCE:2.
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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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    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
    Prevalence and Indications for Unplanned Reoperations Following Index Surgery in the Adult Symptomatic Lumbar Scoliosis NIH-Sponsored Clinical Trial.
    (Spine deformity, 2018-11) Crawford, Charles H; Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Koski, Tyler R; Baldus, Christine R; Bridwell, Keith H

    Study design

    Longitudinal cohort.

    Objective

    To report on the prevalence and indications for unplanned reoperations following index surgery in the Adult Symptomatic Lumbar Scoliosis NIH-sponsored Clinical Trial.

    Summary of background data

    Reoperation following adult spinal deformity surgery exposes the patient to additional surgical risk, increases the cost of care, and decreases the potential cost-effectiveness of the intervention. Accurate data regarding the prevalence and indication for reoperation will facilitate future efforts to minimize risk.

    Methods

    A total of 153 patients underwent adult spinal deformity surgery as part of the observational, randomized, or crossover groups and were eligible for two-year follow-up. Reoperations were meticulously tracked as part of the National Institutes of Health (NIH)-mandated serious adverse event (SAE) reporting. The primary indication for reoperation was obtained from the treating surgeon's operative report.

    Results

    Thirty-two patients had one reoperation, two patients underwent two reoperations, and three patients underwent three reoperations. A total of 45 reoperations were performed in 37 patients. Eleven patients (7%) underwent reoperation within 90 days of the index surgery: two for superficial wound dehiscence, three for radiculopathy with screw removal, and six for acute proximal junctional failure (PJF). Four patients underwent reoperation for PJF more than 90 days from index surgery. Twenty-six patients underwent 28 reoperations for rod fracture/pseudoarthrosis.

    Conclusion

    In a consecutive series of adult spinal deformity surgery patients with meticulous follow-up, 24% of patients required an unplanned reoperation. The most common indication for reoperation was rod fracture/pseudoarthrosis, which occurred from 9 months to 3.7 years following the index surgery and accounted for 62% (28/45) of the reoperations. The second most common indication for reoperation was PJF, which occurred from 1 month to 1.6 years following index surgery and accounted for 22% (10/45) of the reoperations. As these complications will likely increase with longer follow-up, efforts to lower the rates of these complications are warranted.

    Level of evidence

    Level II.
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    ItemOpen Access
    SRS-22R Minimum Clinically Important Difference and Substantial Clinical Benefit After Adult Lumbar Scoliosis Surgery.
    (Spine deformity, 2018-01) Carreon, Leah Y; Kelly, Michael P; Crawford, Charles H; Baldus, Christine R; Glassman, Steven D; Shaffrey, Christopher I; Bridwell, Keith H
    STUDY DESIGN:Longitudinal cohort. OBJECTIVES:To determine if the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for the Scoliosis Research Society-22R (SRS22R) domains in patients with degenerative lumbar scoliosis are similar to those in patients with adult spinal deformity (ASD) with fusions extending into the thoracic spine. SUMMARY OF BACKGROUND DATA:The MCID and SCB thresholds for the SRS22R domains in patients with ASD and adolescent idiopathic scoliosis have been reported. METHODS:Patients enrolled in the NIH-sponsored Adult Symptomatic Lumbar Scoliosis (ASLS) trial who underwent surgery and completed the SRS22R preoperative and the SRS30 one-year postoperative were identified. One-year postoperative answers to the last eight questions of the SRS30 were used as anchors to determine the MCID and SCB for the Pain, Appearance, and Activity domains, and the Subscore and Total score using receiver operating characteristic (ROC) curve analysis. RESULTS:The sample population consisted of 147 patients. A total of 132 (89%) were females with a mean age of 59.4 years. There was a statistically significant improvement in all SRS22R scores from preoperative to one-year postoperative. There was also a statistically significant difference in domain scores among the different responses to the anchors. According to the ROC analysis, MCID was 1.17 for Appearance, 0.40 for Activity, 0.60 for Pain, 0.53 for Subscore, and 0.77 for Total; and SCB was 1.67 for Appearance, 0.60 for Activity, 0.62 for Subscore, and 1.11 for Total score. These are similar to previous reports of MCID and SCB thresholds for ASD patients who underwent fusion to the thoracic spine. CONCLUSION:The MCID and SCB thresholds for the SRS22R domains in patients with adult symptomatic lumbar scoliosis are very similar to the threshold values previously reported for adult deformity patients. LEVEL OF EVIDENCE:Level II.