Using Machine Learning to Leverage Biomarker Change and Predict Colorectal Cancer Recurrence.

PURPOSE: The risk of colorectal cancer (CRC) recurrence after primary treatment varies across individuals and over time. Using patients' most up-to-date information, including carcinoembryonic antigen (CEA) biomarker profiles, to predict risk could improve personalized decision making. METHODS: We used electronic health record data from an integrated health system on a cohort of patients diagnosed with American Joint Committee on Cancer stage I-III CRC between 2008 and 2013 (N = 3,970) and monitored until recurrence or end of follow-up. We addressed missingness in recurrence outcomes and longitudinal CEA measures, and engineered CEA features using current and past biomarker values for inclusion in a risk prediction model. We used a discrete time Superlearner model to evaluate various algorithms for predicting recurrence. We evaluated the time-varying discrimination and calibration of the algorithms and assessed the role of individual predictors. RESULTS: Recurrence was documented in 448 (11.3%) patients. XGBoost with depth = 1 (XGB-D1) predicted recurrence substantially better than all other algorithms at all time points, with AUC ranging from 0.87 (95% CI, 0.86 to 0.88) at 6 months to 0.94 (95% CI, 0.92 to 0.96) at 54 months. The only variable used by XGB-D1 was 6-month change in log CEA. Predicted 1-year risk of recurrence was nearly zero for patients whose log CEA did not increase in the last 6 months, between 12.2% and 34.1% for patients whose log CEA increased between 0.10 and 0.40, and 43.6% for those with a log CEA increase >0.40. Compared with XGB, penalized regression approaches (lasso, ridge, and elastic net) performed poorly, with AUCs ranging from 0.58 to 0.69. CONCLUSION: A flexible, machine learning approach that incorporated longitudinal CEA information yielded a simple and high-performing model for predicting recurrence on the basis of 6-month change in log CEA.

Factors associated with lung cancer risk factor documentation.

Objectives: To identify factors associated with the minimum necessary information to determine an individual's eligibility for lung cancer screening (ie, sufficient risk factor documentation) and to characterize clinic-level variability in documentation. Study Design: Cross-sectional observational study using electronic health record data from an academic health system in 2019. Methods: We calculated the relative risk of sufficient lung cancer risk factor documentation by patient-, provider-, and system-level variables using Poisson regression models, clustering by clinic. We compared unadjusted, risk-adjusted, and reliability-adjusted proportions of patients with sufficient smoking documentation across 31 clinics using logistic regression models and 2-level hierarchical logit models to estimate reliability-adjusted proportions across clinics. Results: Among 20,632 individuals, 60% had sufficient risk factor documentation to determine screening eligibility. Patient-level factors inversely associated with risk factor documentation included Black race (relative risk [RR], 0.70; 95% CI, 0.60-0.81), non-English preferred language (RR, 0.60; 95% CI, 0.49-0.74), Medicaid insurance (RR, 0.64; 95% CI, 0.57-0.71), and nonactivated patient portal (RR, 0.85; 95% CI, 0.80-0.90). Documentation varied across clinics. The reliability-adjusted intraclass correlation coefficient decreased from 11.0% (95% CI, 6.9%-17.1%) to 5.3% (95% CI, 3.2%-8.6%), adjusting for covariates. Conclusions: We found a low rate of sufficient lung cancer risk factor documentation and associations of risk factor documentation based on patient-level factors such as race, insurance status, language, and patient portal activation. Risk factor documentation rates varied across clinics, and only approximately half the variation was explained by factors in our analysis.

Racial and Ethnic Bias in Risk Prediction Models for Colorectal Cancer Recurrence When Race and Ethnicity Are Omitted as Predictors.

Importance: Including race and ethnicity as a predictor in clinical risk prediction algorithms has received increased scrutiny, but there continues to be a lack of empirical studies addressing whether simply omitting race and ethnicity from the algorithms will ultimately affect decision-making for patients of minoritized racial and ethnic groups. Objective: To examine whether including race and ethnicity as a predictor in a colorectal cancer recurrence risk algorithm is associated with racial bias, defined as racial and ethnic differences in model accuracy that could potentially lead to unequal treatment. Design, Setting, and Participants: This retrospective prognostic study was conducted using data from a large integrated health care system in Southern California for patients with colorectal cancer who received primary treatment between 2008 and 2013 and follow-up until December 31, 2018. Data were analyzed from January 2021 to June 2022. Main Outcomes and Measures: Four Cox proportional hazards regression prediction models were fitted to predict time from surveillance start to cancer recurrence: (1) a race-neutral model that explicitly excluded race and ethnicity as a predictor, (2) a race-sensitive model that included race and ethnicity, (3) a model with 2-way interactions between clinical predictors and race and ethnicity, and (4) separate models by race and ethnicity. Algorithmic fairness was assessed using model calibration, discriminative ability, false-positive and false-negative rates, positive predictive value (PPV), and negative predictive value (NPV). Results: The study cohort included 4230 patients (mean [SD] age, 65.3 [12.5] years; 2034 [48.1%] female; 490 [11.6%] Asian, Hawaiian, or Pacific Islander; 554 [13.1%] Black or African American; 937 [22.1%] Hispanic; and 2249 [53.1%] non-Hispanic White). The race-neutral model had worse calibration, NPV, and false-negative rates among racial and ethnic minority subgroups than non-Hispanic White individuals (eg, false-negative rate for Hispanic patients: 12.0% [95% CI, 6.0%-18.6%]; for non-Hispanic White patients: 3.1% [95% CI, 0.8%-6.2%]). Adding race and ethnicity as a predictor improved algorithmic fairness in calibration slope, discriminative ability, PPV, and false-negative rates (eg, false-negative rate for Hispanic patients: 9.2% [95% CI, 3.9%-14.9%]; for non-Hispanic White patients: 7.9% [95% CI, 4.3%-11.9%]). Inclusion of race interaction terms or using race-stratified models did not improve model fairness, likely due to small sample sizes in subgroups. Conclusions and Relevance: In this prognostic study of the racial bias in a cancer recurrence risk algorithm, removing race and ethnicity as a predictor worsened algorithmic fairness in multiple measures, which could lead to inappropriate care recommendations for patients who belong to minoritized racial and ethnic groups. Clinical algorithm development should include evaluation of fairness criteria to understand the potential consequences of removing race and ethnicity for health inequities.

Racial Disparities in the Ascertainment of Cancer Recurrence in Electronic Health Records.

PURPOSE: There is growing interest in using computable phenotypes or proxies to identify important clinical outcomes, such as cancer recurrence, in rich electronic health records data. However, the race/ethnicity-specific accuracies of these proxies remain unclear. We examined whether the accuracy of a proxy for colorectal cancer (CRC) recurrence differed by race/ethnicity and the possible mechanisms that drove the differences. METHODS: Using data from a large integrated health care system, we identified a stratified random sample of 282 Black/African American (AA), Hispanic, and non-Hispanic White (NHW) patients with CRC who received primary treatment. Patient 5-year recurrence status was estimated using a utilization-based proxy and evaluated against the true recurrence status obtained using detailed chart review and by race/ethnicity. We used covariate-adjusted probit regression models to estimate the associations between race/ethnicity and misclassification. RESULTS: The recurrence proxy had excellent overall accuracy (positive predictive value [PPV] 89.4%; negative predictive value 96.5%; mean difference in timing 1.96 months); however, accuracy varied by race/ethnicity. Compared with NHW patients, PPV was 14.9% lower (95% CI, 2.53 to 28.6) among Hispanic patients and 4.3% lower (95% CI, -4.8 to 14.8) among Black/AA patients. The proxy disproportionately inflated the 5-year recurrence incidence for Hispanic patients by 10.6% (95% CI, 4.2 to 18.2). Compared with NHW patients, proxy recurrences for Hispanic patients were almost three times as likely to have been misclassified as positive (adjusted risk ratio 2.91 [95% CI, 1.21 to 8.31]). Higher false positives among racial/ethnic minorities may be related to higher prevalence of noncancerous lung-related problems and substantial delays in primary treatment because of insufficient patient-provider communication and abnormal treatment patterns. CONCLUSION: Using a proxy with worse accuracy among racial/ethnic minority patients to estimate population health may misdirect resources and support erroneous conclusions around treatment benefit for these patients.

Evaluation of a Multilevel Laboratory Stewardship Intervention Targeted to Cardiac and Thoracic Surgical Services at an Academic Medical Center.

CONTEXT.­: Unnecessary laboratory tests are ordered because of factors such as preselected orders on order sets, clinician habits, and trainee concerns. Excessive use of laboratory testing increases patient discomfort via unnecessary phlebotomy, contributes to iatrogenic anemia, increases risk of bloodstream infections, and increases the cost of care. OBJECTIVE.­: To address these concerns, we implemented a multilevel laboratory stewardship intervention to decrease unnecessary laboratory testing, measured by laboratory tests per day attributed to service, across 2 surgical divisions with high laboratory use. DESIGN.­: The multilevel intervention included 5 components: stakeholder engagement, provider education, computerized provider order entry modification, performance feedback, and culture change supported by leadership. The primary outcome of the study was laboratory tests ordered per patient-day. Secondary outcomes included the number of blood draws per patient-day, total lab-associated costs, length of stay, discharge to a nursing facility, 30-day readmissions, and deaths. A difference-in-differences analytic approach assessed the outcome measures in the intervention period, with other surgical services as controls. RESULTS.­: The primary outcome of laboratory tests per patient-day showed a significant decrease across both thoracic and cardiac surgery services, with between 1.5 and 2 fewer tests ordered per patient-day for both services and an estimated 20 000 fewer tests performed during the intervention period. Blood draws per patient-day were also significantly decreased on the thoracic surgery service but not for cardiac surgery. CONCLUSIONS.­: A multilevel laboratory stewardship intervention targeted to 2 surgical services resulted in a significant decrease in laboratory test use without negatively impacting length of stay, readmissions, or mortality.

Risk of Adverse Financial Events in Patients With Cancer: Evidence From a Novel Linkage Between Cancer Registry and Credit Records.

PURPOSE: Although financial toxicity is a growing cancer survivorship issue, no studies have used credit data to estimate the relative risk of financial hardship in patients with cancer versus individuals without cancer. We conducted a population-based retrospective matched cohort study using credit reports to investigate the impact of a cancer diagnosis on the risk of adverse financial events (AFEs). METHODS: Western Washington SEER cancer registry (cases) and voter registry (controls) records from 2013 to 2018 were linked to quarterly credit records from TransUnion. Controls were age-, sex-, and zip code-matched to cancer cases and assigned an index date corresponding to the case's diagnosis date. Cases and controls experiencing past-due credit card payments and any of the following AFEs at 24 months from diagnosis or index were compared, using two-sample z tests: third-party collections, charge-offs, tax liens, delinquent mortgage payments, foreclosures, and repossessions. Multivariate logistic regression models were used to evaluate the association of cancer diagnosis with AFEs and past-due credit payments. RESULTS: A total of 190,722 individuals (63,574 cases and 127,148 controls, mean age 66 years) were included. AFEs (4.3% v 2.4%, P < .0001) and past-due credit payments (2.6% v 1.9%, P < .0001) were more common in cases than in controls. After adjusting for age, sex, average baseline credit line, area deprivation index, and index/diagnosis year, patients with cancer had a higher risk of AFEs (odds ratio 1.71; 95% CI, 1.61 to 1.81; P < .0001) and past-due credit payments (odds ratio 1.28; 95% CI, 1.19 to 1.37; P < .0001) than controls. CONCLUSION: Patients with cancer were at significantly increased risk of experiencing AFEs and past-due credit card payments relative to controls. Studies are needed to investigate the impact of these events on treatment decisions, quality of life, and clinical outcomes.

What's in a Number? Assessing the Burden of Diverticular Disease.

MINI-ABSTRACT: In this prospective observational cohort of patients with a history of diverticulitis, we assessed the correlation between the diverticulitis quality of life survey (DVQOL) and other patient-reported expressions of disease measures including work and activity impairment, and contentment with gastrointestinal-related health. Then, we assessed whether the DVQOL is better correlated with these measures than diverticulitis episode count. Our study results showed that the DVQOL has a stronger correlation with other disease measures than diverticulitis episode count, and our findings support the broader use of the DVQOL in assessing the burden of diverticulitis and monitoring response to management.

Cause-specific mortality of type B aortic dissection and assessment of competing risks of mortality.

OBJECTIVE: Natural history studies of type B aortic dissection (TBAD) commonly report all-cause mortality. Our aim was to determine cause-specific mortality in TBAD and to evaluate the clinical characteristics associated with aorta-related and nonaorta-related mortality. METHODS: Clinical and administrative records were reviewed for patients with acute TBAD between 1995 and 2017. Demographics, comorbidities, presentation, and initial imaging findings were abstracted. Cause of death was ascertained through a multimodality approach using electronic health records, obituaries, social media, Social Security Death Index, and state mortality records. Causes of death were classified as aorta related, nonaorta related, or unknown. A Fine-Gray multivariate competing risk regression model for subdistribution hazard ratio was employed to analyze the association of clinical characteristics with aorta-related and nonaorta-related mortality. RESULTS: A total of 275 individuals met inclusion criteria (61.1 ± 13.7 years, 70.9% male, 68% white). Mean survival after discharge was 6.3 ± 4.7 years. Completeness of follow-up Clark C index was 0.87. All-cause mortality was 50.2% (n = 138; mean age, 70.1 ± 14.6 years) including an in-hospital mortality of 8.4%. Cause-specific mortality was aorta related, nonaorta related, and unknown in 51%, 43%, and 6%, respectively. Compared with patients with nonaorta-related mortality, patients with aorta-related mortality were younger at acute TBAD (69.5 ± 11.2 years vs 61.6 ± 15.5 years; P = .001), underwent more descending thoracic aortic repairs (19.4% vs 45.8%; P = .002), and had a shorter survival duration (5.7 ± 3.9 vs 3.4 ± 4.5 years; P = .002). There was clear variation in cause of death by each decade of life, with higher aorta-related mortality among those younger than 50 years and older than 70 years and a stepwise increase in nonaorta-related mortality with each increasing decade (P < .001). All-cause mortality at 1 year, 3 years, and 10 years was 15%, 24%, and 57%, respectively. After accounting for competing risks, the cumulative incidence of aorta-related mortality at 1 year, 3 years, and 10 years was 8.9%, 16.5%, and 27.2%, respectively, and that of nonaorta-related mortality was 2.7%, 7.2%, and 29%, respectively. A maximum descending thoracic aortic diameter >4 cm was associated with an increase in hazard of aorta-related mortality by 84% (subdistribution hazard ratio, 1.84; 95% confidence interval, 1.03-3.28) on multivariate competing risk regression analysis. CONCLUSIONS: TBAD is associated with high 10-year mortality. Those at risk for aorta-related mortality have a clinical phenotype different from that of individuals at risk for nonaorta-related mortality. This information is important for building risk prediction models that account for competing mortality risks and to direct optimal and individualized surgical and medical management of TBAD.

Appropriate Management of Vertebral Fragility Fractures: Development of a Pathway Based on a Vertebral Compression Fracture Registry.

BACKGROUND: The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. OBJECTIVES: The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. STUDY DESIGN: Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. SETTING: The VCF Registry is a national ongoing registry with no specified end time or designated sample size. METHODS: Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. RESULTS: The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. LIMITATIONS: The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. CONCLUSIONS: Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. KEY WORDS: Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.

Hospital and Surgeon Variation in Patient-reported Functional Outcomes After Lumbar Spine Fusion: A Statewide Evaluation.

STUDY DESIGN: Statewide retrospective cohort study using prospectively collected data from the Spine Care and Outcomes Assessment Program, capturing ∼75% of the state's spine fusion procedures. OBJECTIVE: The aim of this study was to estimate the variation in patient-reported outcomes (PROs) 1 year after elective lumbar fusion surgery across surgeons and hospitals; and to discuss the potential impact of guiding patient selection using a PRO prediction tool. SUMMARY OF BACKGROUND DATA: Despite an increasing interest in incorporating PROs as part of the move toward value-based payment and to improve quality, limited evidence exists on how PROs vary across hospitals and surgeons, a key aspect of using these metrics for quality profiling. METHODS: We examined patient-reported functional improvement (≥15-point reduction in the Oswestry Disability Index [ODI]) and minimal disability (reaching ≤22 on the ODI) 1 year after surgery in 17 hospitals and 58 surgeons between 2012 and 2017. Outcomes were risk-adjusted for patient characteristics with multiple logistic regressions and reliability-adjusted using hierarchical models. RESULTS: Of the 737 patients who underwent lumbar fusion (mean [SD] age, 63 [12] years; 60% female; 84% had stenosis; 70% had spondylolisthesis), 58.7% achieved functional improvement and 42.5% reached minimal disability status at 1 year. After adjusting for patient factors, there was little variation between hospitals and surgeons (maximum interclass correlation was 3.5%), and this variation became statistically insignificant after further reliability adjustment. Avoiding operation on patients with <50% chance of functional improvement may reduce current surgical volume by 63%. CONCLUSION: Variations in PROs across hospitals and surgeons were mainly driven by differences in patient populations undergoing lumbar fusion, suggesting that PROs may not be useful indicators of hospital or surgeon quality. Careful patient selection using validated prediction tools may decrease differences in outcomes across hospitals and providers and improve overall quality, but would significantly reduce surgical volumes. LEVEL OF EVIDENCE: 3.

Comparison of outcomes in women and men following carotid interventions in the Washington state's Vascular Interventional Surgical Care and Outcomes Assessment Program.

BACKGROUND: The benefit for carotid endarterectomy (CEA) to prevent a potential stroke has been shown to be less beneficial for women compared with men and the risk of carotid stenting (CAS) is higher in women than men. We hypothesized that a community-based Washington state registry data would also reveal increased morbidity and mortality for women undergoing carotid interventions. METHODS: Deidentified data for CEA and CAS between 2010 and 2015 were obtained from 19 hospitals participating in the Washington State Vascular-Interventional Surgical Care and Outcomes Assessment Program. Data analysis compared in-hospital composite outcome of stroke and mortality from CEA and CAS between women and men. RESULTS: Over the study period, 3704 individuals underwent CEA (n = 2759; 49.5% symptomatic) and CAS (n = 945; 60.9% symptomatic). Women accounted for 39.5% of the cohort. Women were slightly younger than men (70.0 ± 10.2 vs 71.0 ± 9.6 years respectively; P < .01), less likely to be smokers (70.1% vs 75.6%; P < .01), and less likely to have a diagnosis of coronary artery disease (32.9% vs 46.5%; P < .01). Fewer women underwent CEA for symptomatic carotid disease (46.1% vs 51.8%; P < .01). There were no statistically significant differences in the postoperative in-hospital stroke and mortality among women and men undergoing CEA (asymptomatic, 0.8% vs 1.4% [P = .36]; symptomatic, 1.8% vs 2.2% [P = .58]) and CAS (asymptomatic, 1.4% vs 2.2% [P = .56]; symptomatic, 4.6% vs 2.5% [P = .18]). Hospital duration of stay and discharge disposition were similar for women and men. A subanalysis of the octogenarian cohort undergoing CAS demonstrated a substantial increase in-hospital stroke and mortality among women and men (11.6% [CAS] vs 2.2% [CEA]; P = .024). CONCLUSIONS: In the Washington state Vascular-Interventional Surgical Care and Outcomes Assessment Program registry, hospital composite outcome of stroke and mortality following carotid interventions from 2010 to 2015 were noted to be similar for women and men. The notable exception to this finding was observed in subcohort of women undergoing CAS for symptomatic carotid disease at age 80 years or older. These findings should be taken into account when risk stratifying patients for carotid interventions.

Role of bleeding recognition and evaluation in Black-White disparities in endometrial cancer.

BACKGROUND: Advanced stage at diagnosis is an independent, unexplained contributor to racial disparity in endometrial cancer. OBJECTIVE: We sought to investigate whether, prior to diagnosis, provider recognition of the cardinal symptom of endometrial cancer, postmenopausal bleeding, differs by patient race. STUDY DESIGN: Black and White women diagnosed with endometrial cancer (2001 through 2011) from Surveillance, Epidemiology, and End Results-Medicare who had at least 2 years of claims prior to diagnosis were identified. Bleeding diagnoses along with procedures done prior to diagnosis were captured via claims data. Multinomial logistic regression was used to evaluate the association of race with diagnostic workup and multivariate models built to determine the association of appropriate diagnostic procedures with stage at diagnosis. RESULTS: In all, 4354 White and 537 Black women diagnosed with endometrial cancer were included. Compared to White women, Black women were less likely to have guideline-concordant care: postmenopausal bleeding and appropriate diagnostic evaluation (70% vs 79%, P < .001), with adjusted relative risk ratios of 1.12-1.73 for different nonguideline-concordant pathways: bleeding without diagnostic procedures, alternative bleeding descriptions, and neither bleeding nor procedures. These pathways were associated with higher odds of advanced stage at diagnosis (adjusted odds ratio, 1.90-2.88). CONCLUSION: The lack of recognition and evaluation of postmenopausal bleeding is associated with advanced stage at diagnosis in endometrial cancer. Older Black women are at highest risk for the most aggressive histology types, yet they are less likely to have guideline-concordant evaluation of vaginal bleeding. Efforts aimed at improving recognition-among patients and providers-of postmenopausal bleeding in Black women could substantially reduce disparities in endometrial cancer.

Development and Validation of a Prediction Model for Pain and Functional Outcomes After Lumbar Spine Surgery.

Importance: Functional impairment and pain are common indications for the initiation of lumbar spine surgery, but information about expected improvement in these patient-reported outcome (PRO) domains is not readily available to most patients and clinicians considering this type of surgery. Objective: To assess population-level PRO response after lumbar spine surgery, and develop/validate a prediction tool for PRO improvement. Design, Setting, and Participants: This statewide multicenter cohort was based at 15 Washington state hospitals representing approximately 75% of the state's spine fusion procedures. The Spine Surgical Care and Outcomes Assessment Program and the survey center at the Comparative Effectiveness Translational Network prospectively collected clinical and PRO data from adult candidates for lumbar surgery, preoperatively and postoperatively, between 2012 and 2016. Prediction models were derived for PRO improvement 1 year after lumbar fusion surgeries on a random sample of 85% of the data and were validated in the remaining 15%. Surgical candidates from 2012 through 2015 were included; follow-up surveying continued until December 31, 2016, and data analysis was completed from July 2016 to April 2017. Main Outcomes and Measures: Functional improvement, defined as a reduction in Oswestry Disability Index score of 15 points or more; and back pain and leg pain improvement, defined a reduction in Numeric Rating Scale score of 2 points or more. Results: A total of 1965 adult lumbar surgical candidates (mean [SD] age, 61.3 [12.5] years; 944 [59.6%] female) completed baseline surveys before surgery and at least 1 postoperative follow-up survey within 3 years. Of these, 1583 (80.6%) underwent elective lumbar fusion procedures; 1223 (77.3%) had stenosis, and 1033 (65.3%) had spondylolisthesis. Twelve-month follow-up participation rates for each outcome were between 66% and 70%. Improvements were reported in function, back pain, and leg pain at 12 months by 306 of 528 surgical patients (58.0%), 616 of 899 patients (68.5%), and 355 of 464 patients (76.5%), respectively, whose baseline scores indicated moderate to severe symptoms. Among nonoperative patients, 35 (43.8%), 47 (53.4%), and 53 (63.9%) reported improvements in function, back pain, and leg pain, respectively. Demographic and clinical characteristics included in the final prediction models were age, sex, race, insurance status, American Society of Anesthesiologists score, smoking status, diagnoses, prior surgery, prescription opioid use, asthma, and baseline PRO scores. The models had good predictive performance in the validation cohort (concordance statistic, 0.66-0.79) and were incorporated into a patient-facing, web-based interactive tool (https://becertain.shinyapps.io/lumbar_fusion_calculator). Conclusions and Relevance: The PRO response prediction tool, informed by population-level data, explained most of the variability in pain reduction and functional improvement after surgery. Giving patients accurate information about their likelihood of outcomes may be a helpful component in surgery decision making.

Use of patient-reported outcomes and satisfaction for quality assessments.

OBJECTIVES: Recent focus on patient-reported outcomes (PROs) has created a new challenge as we learn how to integrate these outcomes into practice along with other quality metrics. We investigated the relationship between PROs and satisfaction among spine surgery patients. We hypothesized that there would be significant disparities between patient satisfaction and PROs at the 1-year postoperative time point. STUDY DESIGN: Retrospective cohort study of adults undergoing elective lumbar spine surgery at 12 hospitals participating in the Spine Surgical Care and Outcomes Assessment Program. METHODS: Satisfaction, pain, and function scores were collected at 1 year post operation, along with clinical information, to determine the relationship between PROs and satisfaction at the patient level. RESULTS: Among 520 patients (mean age = 63 ± 13 years; 47% male), the majority of patients (82%) reported being satisfied with surgery. Satisfaction was associated with both improvement in pain (odds ratio [OR], 1.33; 95% CI, 1.17-1.51) and function (OR, 1.06; 95% CI, 1.04-1.08). However, even among patients who did not improve in pain or function, more than half (59%) reported being satisfied. CONCLUSIONS: Overall, patients undergoing elective lumbar spine surgery reported being satisfied with outcomes, but the reported responses in PROs were much more variable. As the expectations increase to include PRO measures as valid quality indicators, it is necessary to dedicate time and consideration to understanding the relationships among these measures to support meaningful translations into healthcare policy.

Grade Assignment by Ki-67 Proliferative Index, Mitotic Count, and Phosphohistone H3 Count in Surgically Resected Gastrointestinal and Pancreatic Neuroendocrine Tumors.

OBJECTIVES: The aim of this study was to evaluate the concordance in grade assignment for gastroenteropancreatic neuroendocrine tumors using mitotic count (MC), Ki-67 proliferative index (KPI), and phosphohistone H3 count (PHH3C). METHODS: Resected gastroenteropancreatic neuroendocrine tumors were graded based on MC, KPI, and PHH3C. Concordance was determined using a weighted κ statistic. Median survival across each grade category was determined using Kaplan-Meier methods. RESULTS: Of the 110 patients, the majority had gastrointestinal primaries and grade 1 or 2 tumors. Rates of discordance in grade assignment were 29% of cases for KPI versus MC (κW = 0.26), 32% for PHH3C versus MC (κW = 0.34), and 32% for PHH3C versus KPI (κW = 0.37). There was fair agreement between grading by KPI and MC. Relative to grade by KPI and MC, PHH3C tended to upgrade tumors. The proportion alive at 3 and 5 years was not significantly different for patients with grade 1 versus grade 2 tumors. CONCLUSIONS: The concordance between KPI and MC was fair. Phosphohistone H3 count tended to upgrade tumors using the cutoffs established by MC. Grade 1 and grade 2 tumors were associated with similar survival regardless of grading method. The overall relevance of the current cutoff values used in grading neuroendocrine tumors may need to be revisited.

Improved Risk Prediction Following Surgery Using Machine Learning Algorithms.

BACKGROUND: Machine learning is used to analyze big data, often for the purposes of prediction. Analyzing a patient's healthcare utilization pattern may provide more precise estimates of risk for adverse events (AE) or death. We sought to characterize healthcare utilization prior to surgery using machine learning for the purposes of risk prediction. METHODS: Patients from MarketScan Commercial Claims and Encounters Database undergoing elective surgery from 2007-2012 with ≥1 comorbidity were included. All available healthcare claims occurring within six months prior to surgery were assessed. More than 300 predictors were defined by considering all combinations of conditions, encounter types, and timing along with sociodemographic factors. We used a supervised Naive Bayes algorithm to predict risk of AE or death within 90 days of surgery. We compared the model's performance to the Charlson's comorbidity index, a commonly used risk prediction tool. RESULTS: Among 410,521 patients (mean age 52, 52 ± 9.4, 56% female), 4.7% had an AE and 0.01% died. The Charlson's comorbidity index predicted 57% of AE's and 59% of deaths. The Naive Bayes algorithm predicted 79% of AE's and 78% of deaths. Claims for cancer, kidney disease, and peripheral vascular disease were the primary drivers of AE or death following surgery. CONCLUSIONS: The use of machine learning algorithms improves upon one commonly used risk estimator. Precisely quantifying the risk of an AE following surgery may better inform patient-centered decision-making and direct targeted quality improvement interventions while supporting activities of accountable care organizations that rely on accurate estimates of population risk.

Intra-Wound Antibiotics and Infection in Spine Fusion Surgery: A Report from Washington State's SCOAP-CERTAIN Collaborative.

BACKGROUND: Surgical site infection (SSI) after spine surgery is classified as a "never event" by the Centers for Medicare and Medicaid. Intra-wound antibiotics (IWA) have been proposed to reduce the incidence of SSI, but robust evidence to support its use is lacking. METHODS: Prospective cohort undergoing spine fusion at 20 Washington State hospitals (July 2011 to March 2014) participating in the Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP) linked to a discharge tracking system. Patient, hospital, and operative factors associated with SSI and IWA use during index hospitalizations through 600 days were analyzed using a random effects logistic model (index), and a time-to-event analysis (follow-up) using Cox proportional hazards. RESULTS: A total of 9,823 patients underwent cervical (47%) or lumbar (53%) procedures (mean age, 58; 54% female) with an SSI rate of 1.1% during index hospitalization. Those with SSI were older, more often had diabetes mellitus, and more frequently underwent lumbar (versus cervical) fusion compared with those without SSI (all p < 0.01). Unadjusted rates of SSI during index hospitalization were lower in patients who received IWA (0.8% versus 1.5%). After adjustment for patient, hospital, and operative factors, no benefit was observed in those receiving IWA (odds ratio [OR] 0.65, 95% confidence interval [CI]: 0.42-1.03). At 12 mo, unadjusted rates of SSI were 2.4% and 3.0% for those who did and did not receive antibiotics; after adjustment there was no significant difference (hazard ratio [HR] 0.94, 95% CI: 0.62-1.42). CONCLUSIONS: Whereas unadjusted analyses indicate a nearly 50% reduction in index SSI using IWA, we did not observe a statistically significant difference after adjustment. Despite its size, this study is underpowered to detect small but potentially relevant improvements in rates of SSI. It remains to be determined if IWA should be promoted as a quality improvement intervention. Concerns related to bias in the use of IWA suggest the benefit of a randomized trial.