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Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.

ABSTRACT: A prospective study with randomized and observational cohorts.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.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.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.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].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.

SUBMITTER: Neuman BJ

PROVIDER: S-EPMC4792651 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.

Neuman Brian J BJ Baldus Christine C Zebala Lukas P LP Kelly Michael P MP Shaffrey Christopher C Edwards Charles C Koski Tyler T Schwab Frank F Glassman Steven S Parent Stefan S Lewis Stephen S Lenke Lawrence G LG Buchowski Jacob M JM Smith Justin S JS Crawford Charles H CH Kim Han Jo HJ Lafage Virginia V Lurie Jon J Carreon Leah L Bridwell Keith H KH

Spine 20160301 6

<h4>Study design</h4>A prospective study with randomized and observational cohorts.<h4>Objective</h4>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.<h4>Summary of background data</h4>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 ASL ...[more]

PMID: 26571162

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Project description:BackgroundThe 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.MethodsPatients 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.ResultsSixty-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.ConclusionsOn 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 evidenceTherapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:ObjectiveAlthough 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.

Project description:Background:This study aims to determine if (1) loss of lumbar lordosis (LL), often associated with degenerative scoliosis (DS), is structural or rather largely due to positional factors secondary to spinal stenosis; (2) only addressing the symptomatic levels with a decompression and posterolateral fusion in carefully selected patients will result in improvement of sagittal malalignment; and (3) degree of sagittal plane correction achieved with such a local fusion could be predicted by routine pre-operative imaging. Methods:A retrospective study design with prospectively collected imaging data of a consecutive series of surgically treated DS patients who underwent decompression and instrumented fusion at only symptomatic levels was performed. Pre- and post-operative plain radiographs and pre-operative magnetic resonance imaging (MRIs) of the spinopelvic region were analyzed. LL, pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS) were assessed in all patients. As a requirement for the surgical strategy, all patients presented with a pre-operative PI-LL mismatch greater than 10°. Post-operative complications were assessed. Results:Pre-operative MRIs and lumbar extension radiographs revealed a mean LL of 42° (range 10-66°) and 48° (range 20-74°), respectively, in 68 patients (mean follow-up 29?months). LL post-operatively was corrected to a mean PI-LL of 10°. Of patients who achieved PI-LL mismatch within 10o on their pre-operative extension lateral lumbar radiographs, 62.5% were able to maintain a PI-LL mismatch within 10° on their initial post-operative films. Only 37.5% were not able to achieve that mismatch on extension radiographs (p?=?0.001, OR?=?9.58). Similarly, 54.2% were able to achieve a PI-LL?<?10° on initial post-operative radiographs, when pre-operative MRI revealed a PI-LL mismatch within 10°. In contrast, only 20.5% achieved that goal post-operatively if their mismatch was greater than 10o on their MRI (p?=?0.003, OR?=?4.25). Conclusion:With a decompression and instrumented fusion of only the symptomatic levels in symptomatic DS patients, we were able to achieve a PI-LL mismatch to within 10°. The loss of LL observed pre-operatively may be largely positional rather than structural. The amount of LL correction observed immediately after surgery can be predicted from pre-operative lumbar extension radiographs and supine sagittal MRI.

Project description:ObjectiveAdult symptomatic lumbar scoliosis (ASLS) is a widespread and debilitating subset of adult spinal deformity. Although many patients benefit from operative treatment, surgery entails substantial cost and risk for adverse events. Patient-reported outcome measures (PROMs) are patient-centered tools used to evaluate the appropriateness of surgery and to assist in the shared decision-making process. Framing realistic patient expectations should include the possible functional limitation to improvement inherent in surgical intervention, such as multilevel fusion to the sacrum. The authors' objective was to predict postoperative ASLS PROMs by using clustering analysis, generalized longitudinal regression models, percentile analysis, and clinical improvement analysis of preoperative health-related quality-of-life scores for use in surgical counseling.MethodsOperative results from the combined ASLS cohorts were examined. PROM score clustering after surgery investigated limits of surgical improvement. Patients were categorized by baseline disability (mild, moderate, moderate to severe, or severe) according to preoperative Scoliosis Research Society (SRS)-22 and Oswestry Disability Index (ODI) scores. Responder analysis for patients achieving improvement meeting the minimum clinically important difference (MCID) and substantial clinical benefit (SCB) standards was performed using both fixed-threshold and patient-specific values (MCID = 30% of remaining scale, SCB = 50%). Best (top 5%), worst (bottom 5%), and median scores were calculated across disability categories.ResultsA total of 171/187 (91%) of patients with ASLS achieved 2-year follow-up. Patients rarely achieved a PROM ceiling for any measure, with 33%-43% of individuals clustering near 4.0 for SRS domains. Patients with severe baseline disability (< 2.0) SRS-pain and SRS-function scores were often left with moderate to severe disability (2.0-2.9), unlike patients with higher (≥ 3.0) initial PROM values. Patients with mild disability according to baseline SRS-function score were unlikely to improve. Crippling baseline ODI disability (> 60) commonly left patients with moderate disability (median ODI = 32). As baseline ODI disability increased, patients were more likely to achieve MCID and SCB (p < 0.001). Compared to fixed threshold values for MCID and SCB, patient-specific values were more sensitive to change for patients with minimal ODI baseline disability (p = 0.008) and less sensitive to change for patients with moderate to severe SRS subscore disability (p = 0.01).ConclusionsThese findings suggest that ASLS surgeries have a limit to possible improvement, probably due to both baseline disability and the effects of surgery. The most disabled patients often had moderate to severe disability (SRS < 3, ODI > 30) at 2 years, emphasizing the importance of patient counseling and expectation management.

Project description:Study designA post hoc analysis.ObjectiveAdvances in machine learning (ML) have led to tools offering individualized outcome predictions for adult spinal deformity (ASD). Our objective is to examine the properties of these ASD models in a cohort of adult symptomatic lumbar scoliosis (ASLS) patients.Summary of background dataML algorithms produce patient-specific probabilities of outcomes, including major complication (MC), reoperation (RO), and readmission (RA) in ASD. External validation of these models is needed.MethodsThirty-nine predictive factors (12 demographic, 9 radiographic, 4 health-related quality of life, 14 surgical) were retrieved and entered into web-based prediction models for MC, unplanned RO, and hospital RA. Calculated probabilities were compared with actual event rates. Discrimination and calibration were analyzed using receiver operative characteristic area under the curve (where 0.5=chance, 1=perfect) and calibration curves (Brier scores, where 0.25=chance, 0=perfect). Ninety-five percent confidence intervals are reported.ResultsA total of 169 of 187 (90%) surgical patients completed 2-year follow up. The observed rate of MCs was 41.4% with model predictions ranging from 13% to 68% (mean: 38.7%). RO was 20.7% with model predictions ranging from 9% to 54% (mean: 30.1%). Hospital RA was 17.2% with model predictions ranging from 13% to 50% (mean: 28.5%). Model classification for all three outcome measures was better than chance for all [area under the curve=MC 0.6 (0.5-0.7), RA 0.6 (0.5-0.7), RO 0.6 (0.5-0.7)]. Calibration was better than chance for all, though best for RA and RO (Brier Score=MC 0.22, RA 0.16, RO 0.17).ConclusionsASD prediction models for MC, RA, and RO performed better than chance in a cohort of adult lumbar scoliosis patients, though the homogeneity of ASLS affected calibration and accuracy. Optimization of models require samples with the breadth of outcomes (0%-100%), supporting the need for continued data collection as personalized prediction models may improve decision-making for the patient and surgeon alike.

Project description:ObjectivesTo compare re-rupture rate, complication rate, and functional outcome after operative versus nonoperative treatment of Achilles tendon ruptures; to compare re-rupture rate after early and late full weight bearing; to evaluate re-rupture rate after functional rehabilitation with early range of motion; and to compare effect estimates from randomised controlled trials and observational studies.DesignSystematic review and meta-analysis.Data sourcesPubMed/Medline, Embase, CENTRAL, and CINAHL databases were last searched on 25 April 2018 for studies comparing operative versus nonoperative treatment of Achilles tendon ruptures.Study selection criteriaRandomised controlled trials and observational studies reporting on comparison of operative versus nonoperative treatment of acute Achilles tendon ruptures.Data extractionData extraction was performed independently in pairs, by four reviewers, with the use of a predefined data extraction file. Outcomes were pooled using random effects models and presented as risk difference, risk ratio, or mean difference, with 95% confidence interval.Results29 studies were included-10 randomised controlled trials and 19 observational studies. The 10 trials included 944 (6%) patients, and the 19 observational studies included 14?918 (94%) patients. A significant reduction in re-ruptures was seen after operative treatment (2.3%) compared with nonoperative treatment (3.9%) (risk difference 1.6%; risk ratio 0.43, 95% confidence interval 0.31 to 0.60; P<0.001; I2=22%). Operative treatment resulted in a significantly higher complication rate than nonoperative treatment (4.9% v 1.6%; risk difference 3.3%; risk ratio 2.76, 1.84 to 4.13; P<0.001; I2=45%). The main difference in complication rate was attributable to the incidence of infection (2.8%) in the operative group. A similar reduction in re-rupture rate in favour of operative treatment was seen after both early and late full weight bearing. No significant difference in re-rupture rate was seen between operative and nonoperative treatment in studies that used accelerated functional rehabilitation with early range of motion (risk ratio 0.60, 0.26 to 1.37; P=0.23; I2=0%). No difference in effect estimates was seen between randomised controlled trials and observational studies.ConclusionsThis meta-analysis shows that operative treatment of Achilles tendon ruptures reduces the risk of re-rupture compared with nonoperative treatment. However, re-rupture rates are low and differences between treatment groups are small (risk difference 1.6%). Operative treatment results in a higher risk of other complications (risk difference 3.3%). The final decision on the management of acute Achilles tendon ruptures should be based on patient specific factors and shared decision making. This review emphasises the potential benefits of adding high quality observational studies in meta-analyses for the evaluation of objective outcome measures after surgical treatment.

Project description:PurposeTo systematically review the operative versus nonoperative methods for management of iliotibial band syndrome (ITBS) with comparison of the respective clinical outcomes.MethodsBy adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines, 3 databases (Medline, Scopus, Web of Science) searched from inception to October 2019 for randomized clinical trials (RCTs) and observational studies on humans that reported the outcomes following operative or nonoperative management of ITBS. Excluded were case reports, case series with <5 participants, review articles, non-English articles, and non-peer-reviewed articles. The Methodological Index for Non-Randomized Studies (MINORS) criteria for observational studies and the Cochrane Risk of Bias Tool for RCTs were used for quality control.ResultsThere were 15 eligible studies (9 for operative,6 for nonoperative treatment) examining 179 athletes (mean age 27.3 years, range: 17-53) who received conservative therapy for ITBS and 200 athletes (mean age 30.1 years, range: 14-63) who underwent surgical treatment. Most athletes were runners (65%). The mean follow-up time was significantly longer in studies reporting the outcomes following operative compared with nonoperative ITBS treatment (33.5 vs 2 months, respectively, P < .05). Significant variability in the methods used to assess the clinical outcomes precluded meta-analysis. The most commonly reported (7/9 studies, 77.7%) variable for postoperative evaluation in athletes was the return to sport rate (range: 81%-100%). Significant reduction in pain was consistently (6/6 studies,100%) found among the studies reporting the results of conservative ITBS treatment. The included RCTs were of good (1/5, 20%), fair (2/5, 40%), or poor (2/5, 40%) quality, whereas the average MINORS score was 7.4 (range: 3-13) for observational studies. The level of evidence ranged from Level II (6/15 studies) to IV (9/15 studies).ConclusionsBased on the current literature and at a maximum follow-up time of 6 months, conservative therapy can effectively reduce ITBS symptoms in athletes. Multiple surgical options exist for athletes who do not respond to nonoperative measures, with a reported return to sport rate between 81% and 100%.Level of evidenceSystematic review of Level II and IV studies.

Project description:ContextFor patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care.ObjectiveTo compare the treatment effects of diskectomy and usual care.Design, setting, and patientsProspective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003.InterventionsStandard open diskectomy vs usual nonoperative care.Main outcome measuresChanges from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version).ResultsOf the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery -37.6 vs nonoperative care -24.2; treatment effect, -13.4; 95% CI, -17.0 to -9.7).ConclusionsPatients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously.Trial registrationclinicaltrials.gov Identifier: NCT00000410.

Dataset Information

Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.

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Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.

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