Browsing by Author "McCarthy, Ian M"
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Item Open Access Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period.(Spine, 2015-07) Saigal, Rajiv; Clark, Aaron J; Scheer, Justin K; Smith, Justin S; Bess, Shay; Mummaneni, Praveen V; McCarthy, Ian M; Hart, Robert A; Kebaish, Khaled M; Klineberg, Eric O; Deviren, Vedat; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher PStudy design
Recall of the informed consent process in patients undergoing adult spinal deformity surgery and their family members was investigated prospectively.Objective
To quantify the percentage recall of the most common complications discussed during the informed consent process in adult spinal deformity surgery, assess for differences between patients and family members, and correlate with mental status.Summary of background data
Given high rates of complications in adult spinal deformity surgery, it is critical to shared decision making that patients are adequately informed about risks and are able to recall preoperative discussion of possible complications to mitigate medical legal risk.Methods
Patients undergoing adult spinal deformity surgery underwent an augmented informed consent process involving both verbal and video explanations. Recall of the 11 most common complications was scored. Mental status was assessed with the mini-mental status examination-brief version. Patients subjectively scored the informed consent process and video. After surgery, the recall test and mini-mental status examination-brief version were readministered at 5 additional time points: hospital discharge, 6 to 8 weeks, 3 months, 6 months, and 1 year postoperatively. Family members were assessed at the first 3 time points for comparison.Results
Fifty-six patients enrolled. Despite ranking the consent process as important (median overall score: 10/10; video score: 9/10), median patient recall was only 45% immediately after discussion and video re-enforcement and subsequently declined to 18% at 6 to 8 weeks and 1 year postoperatively. Median family recall trended higher at 55% immediately and 36% at 6 to 8 weeks postoperatively. The perception of the severity of complications significantly differs between patient and surgeon. Mental status scores showed a transient, significant decrease from preoperation to discharge but were significantly higher at 1 year.Conclusion
Despite being well-informed in an optimized informed consent process, patients cannot recall most surgical risks discussed and recall declines over time. Significant progress remains to improve informed consent retention.Level of evidence
3.Item Open Access How the neck affects the back: changes in regional cervical sagittal alignment correlate to HRQOL improvement in adult thoracolumbar deformity patients at 2-year follow-up.(Journal of neurosurgery. Spine, 2015-08) Protopsaltis, Themistocles S; Scheer, Justin K; Terran, Jamie S; Smith, Justin S; Hamilton, D Kojo; Kim, Han Jo; Mundis, Greg M; Hart, Robert A; McCarthy, Ian M; Klineberg, Eric; Lafage, Virginie; Bess, Shay; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P; International Spine Study GroupOBJECT Regional cervical sagittal alignment (C2-7 sagittal vertical axis [SVA]) has been shown to correlate with health-related quality of life (HRQOL). The study objective was to examine the relationship between cervical and thoracolumbar alignment parameters with HRQOL among patients with operative and nonoperative adult thoracolumbar deformity. METHODS This is a multicenter prospective data collection of consecutive patients with adult thoracolumbar spinal deformity. Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society-22 Patient Questionnaire (SRS-22), and 36-Item Short-Form Health Survey (SF-36). Cervical radiographic parameters were correlated with global sagittal parameters within the nonoperative and operative cohorts. A partial correlation analysis was performed controlling for C-7 SVA. The operative group was subanalyzed by the magnitude of global deformity (C-7 SVA ≥ 5 cm vs < 5 cm). RESULTS A total of 318 patients were included (186 operative and 132 nonoperative). The mean age was 55.4 ± 14.9 years. Operative patients had significantly worse baseline HRQOL and significantly larger C-7 SVA, pelvic tilt (PT), mismatch between pelvic incidence and lumbar lordosis (PI-LL), and C2-7 SVA. The operative patients with baseline C-7 SVA ≥ 5 cm had significantly larger C2-7 lordosis (CL), C2-7 SVA, C-7 SVA, PI-LL, and PT than patients with a normal C-7 SVA. For all patients, baseline C2-7 SVA and CL significantly correlated with baseline ODI, Physical Component Summary (PCS), SRS Activity domain, and SRS Appearance domain. Baseline C2-7 SVA also correlated with SRS Pain and SRS Total. For the operative patients with baseline C-7 SVA ≥ 5 cm, the 2-year C2-7 SVA significantly correlated with 2-year Mental Component Summary, SRS Mental, SRS Satisfaction, and decreases in ODI. Decreases in C2-7 SVA at 2 years significantly correlated with lower ODI at 2 years. Using partial correlations while controlling for C-7 SVA, the C2-7 SVA correlated significantly with baseline ODI (r = 0.211, p = 0.002), PCS (r = -0.178, p = 0.009), and SRS Activity (r = -0.145, p = 0.034) for the entire cohort. In the subset of operative patients with larger thoracolumbar deformities, the change in C2-7 SVA correlated with change in ODI (r = -0.311, p = 0.03). CONCLUSIONS Changes in cervical lordosis correlate to HRQOL improvements in thoracolumbar deformity patients at 2-year follow-up. Regional cervical sagittal parameters such as CL and C2-7 SVA are correlated with clinical measures of regional disability and health status in patients with adult thoracolumbar scoliosis. This effect may be direct or a reciprocal effect of the underlying global deformities on regional cervical alignment. However, the partial correlation analysis, controlling for the magnitude of the thoracolumbar deformity, suggests that there is a direct effect of cervical alignment on health measures. Improvements in regional cervical alignment postoperatively correlated positively with improved HRQOL.Item Open Access Impact of age on the likelihood of reaching a minimum clinically important difference in 374 three-column spinal osteotomies: clinical article.(Journal of neurosurgery. Spine, 2014-03) Scheer, Justin K; Lafage, Virginie; Smith, Justin S; Deviren, Vedat; Hostin, Richard; McCarthy, Ian M; Mundis, Gregory M; Burton, Douglas C; Klineberg, Eric; Gupta, Munish C; Kebaish, Khaled M; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P; International Spine Study GroupObject
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.Item Open Access Maintenance of radiographic correction at 2 years following lumbar pedicle subtraction osteotomy is superior with upper thoracic compared with thoracolumbar junction upper instrumented vertebra.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2015-01) Scheer, Justin K; Lafage, Virginie; Smith, Justin S; Deviren, Vedat; Hostin, Richard; McCarthy, Ian M; Mundis, Gregory M; Burton, Douglas C; Klineberg, Eric; Gupta, Munish; Kebaish, Khaled; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P; International Spine Study Group (ISSG)Purpose
The goal of this study was to characterize the spino-pelvic realignment and the maintenance of that realignment by the upper-most instrumented vertebra (UIV) for adult deformity spinal (ASD) patients treated with lumbar pedicle subtraction osteotomy (PSO).Methods
ASD patients were divided by UIV, classified as upper thoracic (UT: T1-T6) or Thoracolumbar (TL: T9-L1). Complications were recorded and radiographic parameters included thoracic kyphosis (TK, T2-T12), lumbar lordosis (LL, L1-S1), sagittal vertical axis (SVA), pelvic tilt, and the mismatch between pelvic incidence and LL. Patients were also classified by the Scoliosis Research Society (SRS)-Schwab modifier grades. Changes in radiographic parameters and SRS-Schwab grades were evaluated between the two groups. Additional analyses were performed on patients with pre-operative SVA ≥ 15 cm.Results
165 patients were included (UT: 81 and TL: 84); 124 women, 41 men, with average age 59.9 ± 11.1 years (range 25-81). UT had a lower percentage of patients above the radiographic thresholds for disability than TL. UT had a significantly higher percentage of patients that improved in SRS-Schwab global alignment grade than the TL group at 2 years. Within the patients with pre-operative SVA ≥ 15 cm, TL developed significantly increased SVA and had a significantly higher percentage of patients above the SVA threshold at 3 months, and 1 and 2 years than UT.Conclusions
Patients undergoing a single-level PSO for ASD who have fixation extending to the UT region (T1-T6) are more likely to maintain sagittal spino-pelvic alignment, lower overall revision rates and revision rate for proximal junctional kyphosis than those with fixation terminating in the TL region (T9-L1).Item Open Access Total hospital costs of surgical treatment for adult spinal deformity: an extended follow-up study.(The spine journal : official journal of the North American Spine Society, 2014-10) McCarthy, Ian M; Hostin, Richard A; Ames, Christopher P; Kim, Han J; Smith, Justin S; Boachie-Adjei, Ohenaba; Schwab, Frank J; Klineberg, Eric O; Shaffrey, Christopher I; Gupta, Munish C; Polly, David W; International Spine Study GroupBackground context
Whereas the costs of primary surgery, revisions, and selected complications for adult spinal deformity (ASD) have been individually reported in the literature, the total costs over several years after surgery have not been assessed. The determinants of such costs are also not well understood in the literature.Purpose
This study analyzes the total hospital costs and operating room (OR) costs of ASD surgery through extended follow-up.Study design/setting
Single-center retrospective analysis of consecutive surgical patients.Patient sample
Four hundred eighty-four consecutive patients undergoing surgical treatment for ASD from January 2005 through January 2011 with minimum three levels fused.Outcome measures
Costs were collected from hospital administrative data on the total hospital costs incurred for the operation and any related readmissions, expressed in 2010 dollars and discounted at 3.5% per year. Detailed data on OR costs, including implants and biologics, were also collected.Methods
We performed a series of paired t tests and Wilcoxon signed-rank tests for differences in total hospital costs over different follow-up periods. The goal of these tests was to identify a time period over which average costs plateau and remain relatively constant over time. Generalized linear model regression was used to estimate the effect of patient and surgical factors on hospital inpatient costs, with different models estimated for different follow-up periods. A similar regression analysis was performed separately for OR costs and all other hospital costs.Results
Patients were predominantly women (n=415 or 86%) with an average age of 48 (18-82) years and an average follow-up of 4.8 (2-8) years. Total hospital costs averaged $120,394, with primary surgery averaging $103,143 and total readmission costs averaging $67,262 per patient with a readmission (n=130 or 27% of all patients). Operating room costs averaged $70,514 per patient, constituting the majority (59%) of total hospital costs. Average total hospital costs across all patients significantly increased (p<.01) after primary surgery, from $111,807 at 1-year follow-up to $126,323 at 4-year follow-up. Regression results also revealed physician preference as the largest determinant of OR costs, accounting for $14,780 of otherwise unexplained OR cost differences across patients, with no significant physician effects on all other non-OR costs (p<.05).Conclusions
The incidence of readmissions increased the average cost of ASD surgery by more than 70%, illustrating the financial burden of revisions/reoperations; however, the cost burden resulting from readmissions appeared to taper off within 5 years after surgery. The estimated impact of physician preference on OR costs also highlights the variation in current practice and the opportunity for large cost reductions via a more standardized approach in the use of implants and biologics.