Association between empirical dietary inflammatory pattern (EDIP) and survival in patients with stage III colon cancer: Findings from CALGB/SWOG 80702 (Alliance).
LBA3509 Background: Systemic inflammation has been implicated in colon cancer progression. We examined whether intake of a proinflammatory diet is associated with survival among patients (pts) with stage III colon cancer. Methods: This prospective cohort study was nested within a randomized phase III trial of adjuvant therapy in pts with stage III colon cancer who had undergone curative-intent resection. EDIP score – a validated tool to classify the inflammatory nature of diets – was derived as a cumulative exposure using data from food-frequency questionnaires completed within 6 weeks of randomization and 14-16 months (mo) after randomization. Cox proportional hazards regression was used to assess the associations of EDIP with disease-free survival (DFS) and overall survival (OS). Results: Of 1625 included pts, the mean (SD) age was 60.9 (10.5) years (yrs). Compared to pts in the lowest EDIP quintile, pts in the highest quintile (a more inflammatory diet) were younger (58.7 ± 10.8 vs 61.3 ± 9.5 yrs old) and more likely to be female (64.0% vs 48.9%) and have worse performance status (ECOG 1-2: 35.7% vs 19.4%). Pts in the highest quintile were less likely to be White (76.6% vs 92.0 %) and more likely to be Black (15.4% vs 3.7%). Baseline aspirin use, assigned chemotherapy (3 mo vs 6 mo), and assigned pharmacotherapy (celecoxib vs placebo) were not significantly different across EDIP quintiles. Compared with pts in the lowest EDIP quintile, pts in the highest quintile had significantly worse OS (multivariable hazard ratio [HR] 1.87, 95% confidence interval [CI] 1.26-2.77, P trend =0.01), but not DFS (HR 1.36, 95% CI 0.99-1.86, P trend =0.22). Diet and physical activity jointly influenced OS. Those with lower EDIP scores (quintiles 1-4, 80% of the study population) and higher physical activity (≥9 MET-h/wk) had the best OS (HR 0.37, 95% CI 0.25-0.53) compared with pts in the highest EDIP quintile (20% of the study population) and lower physical activity (<9 MET-h/wk) ( P interaction <0.001). The association between higher EDIP and OS was consistent when analyzed by celecoxib and placebo treatment arms ( P interaction 0.54). The relationship between EDIP and OS did not differ significantly according to aspirin use, with HR 1.60 (95% CI 0.71-3.60) among aspirin users and HR 2.01 (95% CI 1.27-3.16) among aspirin non-users ( P interaction 0.06). Conclusions: Our findings suggest that greater intake of a proinflammatory dietary pattern is associated with worse OS in pts with stage III colon cancer. Regular physical activity may attenuate the association, and further investigation of diet and physical activity intervention is warranted. Support: U10CA180821, U10CA180882, U24CA196171, U10CA180863, CCS 707213, UG1CA233234, U10CA180820, U10CA180868, U10CA180888; https://acknowledgments.alliancefound.org. Pfizer; ClinicalTrials.gov Identifier: NCT01150045.
Core GRADE 7: principles for moving from evidence to recommendations and decisions
OBJECTIVE The purpose of this study was to evaluate the risks and benefits of removing painful pelvic/iliac screws in spine fusion surgery patients. METHODS A retrospective review identified patients who had traditional iliac and S2-alar-iliac (S2AI) screws removed for pain. The minimum follow-up was 24 months. RESULTS Fifty-two patients (75% women) were included with a mean age of 63 years, BMI of 28, and follow-up of 65 months. Most of the removed screws were S2AI (83%) compared with traditional iliac screws (17%). Forty-three patients (83%) had improvement in their pelvic screw related–pain following removal. Eight patients (15%) experienced lumbosacral mechanical complications following pelvic screw removal including sacral fracture (n = 3, 6%) and/or L4–5 or L5–S1 rod fracture (n = 7, 13%). On multivariable analysis, risk factors for mechanical complications following pelvic screw removal included a longer fusion construct (OR 1.34, p = 0.035), greater postoperative L4–S1 lordosis (OR 1.14, p = 0.04, ideal cutoff > 40°), and lack of bone morphogenetic protein (BMP; OR 0.03, p = 0.02). Ten patients (19%) underwent subsequent SI joint fusion following pelvic screw removal, and higher standing pelvic incidence (OR 1.10, p = 0.03) was the only independent predictor of SI fusion. CONCLUSIONS Removal of painful pelvic screws resulted in a high rate of postoperative pain relief, albeit with a risk of lumbosacral mechanical complications and subsequent SI joint fusion. Patients at risk for lumbosacral mechanical complications following pelvic screw removal included those with longer fusion constructs, more lordosis from L4 to S1 (> 40°), and lack of BMP. Patients at risk for receiving an instrumented SI joint fusion following pelvic screw removal included those with a higher pelvic incidence.
Distal junctional failure following pelvic instrumentation in spinal fusion: a novel classification system
OBJECTIVE While traditional literature in adult spinal deformity (ASD) examining mechanical complications has focused on proximal junctional kyphosis and failure, distal junctional failure (DJF) of constructs ending at the sacrum with or without spinopelvic fixation remains less explored. The current study sought to 1) propose a new DJF classification with a panel of experienced deformity surgeons, and 2) analyze intra- and interreliability of the novel classification. METHODS A prior review study was completed that identified all types of distal complications for lumbosacral fusions. A panel of 25 experienced spinal deformity surgeons used a modified Delphi approach with three rounds of review to create a classification system. Ten deformity surgeons then reviewed a representative series of 14 de-identified cases to assess the interrater reliability of the classification system using the intraclass correlation coefficient (ICC). A second round of review was conducted by each investigator to determine intrarater reliability using Cohen’s kappa coefficient. RESULTS Complications were classified as acute (< 90 days from the date of surgery) or chronic (≥ 3 months from the date of surgery). Acute failures included mechanical failure of the screws or screw-rod interface, such as pelvic set plug dissociation, tulip head dissociation, and fracture of the pelvic screw at any point along its trajectory. Fractures of the rod (proximal vs distal to S1) and distal bony anatomy (sacrum vs pelvis) were included, as was failure of the offset connector. Chronic failures also consisted of pseudarthrosis at distal levels, sacroiliac joint (SIJ) pain, screw halo formation, and painful screw prominence. The intrarater and interrater reliability were both high with Cohen’s kappa of 0.91 and an ICC of 0.98, respectively. CONCLUSIONS These data provide a comprehensive and systematic classification scheme of distal complications following long-segment ASD fusion to the sacrum. This new paradigm will allow for more detailed and consistent reporting of distal junctional complications following spinopelvic fusion, with or without supplemental pelvic fixation and/or concomitant SIJ fusion. This classification scheme resulted in high intra- and interrater reliability.
Introduction. Scoliosis surgery in adults: navigating complexity and optimizing outcomes
Outcome metrics for primary endoscopic endonasal surgery for low-risk patients with Cushing’s disease: an evidence-based position statement from the Registry of Adenomas of the Pituitary and Related Disorders consortium
OBJECTIVE Reports of surgical outcomes for Cushing’s disease are mostly limited to single-center experiences by expert surgeons. Therefore, no generalizable surgical outcome metrics for endoscopic endonasal Cushing’s disease surgery are available for practitioners to guide quality-improvement efforts. This is potentially problematic, given the high morbidity and excess mortality observed in patients who do not achieve remission. This study proposes a bundle of evidence-based metrics for low-risk patients with Cushing’s disease, for whom optimal outcomes would be expected, that focus on the cost efficiency of care and surgical outcomes from multicenter collaboration of US pituitary centers. METHODS The steering committee of the Registry of Adenomas of the Pituitary and Related Disorders (RAPID) consortium proposed the metrics based on available data from 12 US pituitary centers. A benchmarking population of low-risk patients undergoing first-time surgery was identified. Patient characteristics and outcomes were aggregated and analyzed by a data coordinating center. Metrics were reported using 2 approaches. RESULTS A total of 431 patients from 12 centers who underwent primary endoscopic transsphenoidal surgery from January 1, 2006, to December 31, 2022, were included. There were 227 patients in the low-risk cohort (age < 70 years, BMI < 50, microadenoma, and Knosp grade 0–2). For the cost-efficiency metrics, the mean (SD) length of stay was 3.8 (4.8) midnights, and the percentage of patients readmitted was 11.1%. The rate of disposition to a skilled nursing facility was 2.2%. For surgical outcomes, the rate of postoperative CSF leakage was 1.3%, and the rate of 1-year sustained surgical remission was 81.2%. The rates of permanent and temporary arginine vasopressin deficiencies were 1.8% and 11.9%, respectively. The 75th percentile performance by center was 3.0 midnights for length of stay, 6.3% for 90-day unplanned readmission, < 1% for disposition to a skilled nursing facility, < 1% for CSF leakage, and 92.2% for 1-year sustained remission. The 75th percentile was < 1% for both permanent and temporary arginine vasopressin deficiencies. CONCLUSIONS An evidence-based bundle of metrics in a Cushing’s disease patient population at low risk who underwent first-time endoscopic pituitary surgery is proposed. Surgeons can use these metrics to assess and improve the quality of their clinical pathways.
Risk Analysis Index for Estimation of 30-Day Postoperative Mortality in Hip Fractures
ImportanceHip fractures present a substantial public health challenge, with projections of more than 500 000 per year by 2040. As such, frailty indices such as the Revised Risk Analysis Index (RAI) and the Modified Five-Item Frailty Index (mFI-5) have been recently investigated as metrics for preoperative risk stratification for these patients.ObjectiveTo understand the accuracy of frailty, as measured by the RAI and the mFI-5, for estimating 30-day mortality following surgically managed hip fractures.Design, Setting, and ParticipantsThis retrospective cross-sectional analysis used the American College of Surgeons’ National Surgical Quality Improvement database. Patients aged 65 years old with surgically managed traumatic hip fracture from 2015 to 2019 were included. Frailty was evaluated using the RAI, a 5-domain scale with 14 weighted variables graded from 0 to 81, and the mFI-5, a 2-domain scale with 5 unweighted variables graded from 0 to 5; for both, a higher score denotes worse frailty. Data collection occurred from May to June 2024.ExposureDiagnosis of hip fracture and undergoing surgical fixation, hemiarthroplasty, or total hip arthroplasty.Main Outcomes and MeasuresThe primary outcome was 30-day mortality. Multivariable regression was conducted to assess the estimating value of frailty scales. Discriminatory accuracy was assessed using a receiver operating characteristic curve and quantified using a C-statistic.ResultsThe cohort consisted of 114 359 patients (70 038 female [69.9%]; median [IQR] age, 84 [77-89] years) with 51 071 prefrail patients (44.7%) according to the mFI-5 and 31 883 very frail patients (27.9%) according to the RAI comprising the largest frailty groups. Increasing frailty status was associated with greater odds ratio (OR) for 30-day mortality for both the mFI-5 (prefrail OR, 1.35 [95% CI, 1.24-1.47]; frail OR, 2.11 [95% CI, 1.94-2.30]; severely frail OR, 3.53 [95% CI, 3.20-3.90]; P &lt; .001 for all) and RAI (normal OR, 1.55 [95% CI, 1.35-1.79]; frail OR, 2.97 [95% CI, 2.59-3.42]; very frail OR, 6.17 [95% CI, 5.38-7.08]; P &lt; .001 for all). The RAI demonstrated superior discriminatory accuracy for 30-day mortality compared with the mFI-5 (area under the receiver operating characteristic curve, 0.73 [95% CI, 0.72-0.73] vs 0.61 [95% CI, 0.60-0.62]; P &lt; .001).Conclusions and RelevanceIn this cross-sectional study of 114 359 patients, the RAI demonstrated superior odds and discriminatory accuracy for estimating 30-day mortality following surgical management of hip fractures. The RAI may be considered as a risk stratification tool for orthopedic surgeons to adjunct surgical planning, thereby reducing postoperative mortality.