Patient Treatment Allocation Research Articles

A Machine Learning Algorithm Facilitates Prognosis Prediction and Treatment Selection for Barcelona Clinic Liver Cancer Stage C Hepatocellular Carcinoma.

Given its heterogeneity and diverse clinical outcomes, precise subclassification of BCLC-C hepatocellular carcinoma (HCC) is required for appropriately determining patient prognosis and selecting treatment. We recruited 2,626 patients with BCLC-C stage HCC from multiple centers, comprising training/test (n=1,693) and validation cohorts (n=933). The XGBoost was chosen for maximum performance among the machine learning (ML) models. Patients were categorized into low-/intermediate-/high-/very high-risk subgroups which were based on the estimated prognosis, and this subclassification was named the CLAssification via Machine learning of BCLC-C (CLAM-C). The areas under the receiver operating characteristic curve of the CLAM-C for predicting the 6-/12-/24-month survival of patients with BCLC-C were 0.800/0.831/0.715, respectively-significantly higher than those of the conventional models, which was consistent in the validation cohort. The four subgroups had significantly different median overall survivals, and this difference was maintained among various patient subgroups and treatment modalities. Immune-checkpoint inhibitors and transarterial therapies were associated with significantly better survival than tyrosine kinase inhibitors (TKIs) in the low- and intermediate-risk subgroups. In cases with first-line systemic therapy, the CLAM-C identified atezolizumab-bevacizumab as the best therapy particularly in the high-risk group. In cases with later-line systemic therapy, nivolumab had better survival than TKIs in the low-to-intermediate-risk subgroup, whereas TKIs had better survival in the high-to-very high-risk subgroup. ML modeling effectively subclassified patients with BCLC-C HCC, potentially aiding treatment allocation. Our study underscores the potential utilization of ML modeling in terms of prognostication and treatment allocation in patients with BCLC-C HCC.

Clinical outcome of Mantle Cell Lymphoma patients with high-risk disease (high-risk MIPI-c or high p53 expression)

Currently, treatment allocation of patients with Mantle Cell Lymphoma (MCL) is mainly based on age and medical fitness. The combined MCL International Prognostic Index (MIPI-c) allows to predict prognosis using clinical factors (MIPI) and the Ki-67 index. However, high p53 expression as surrogate for TP53 alterations has demonstrated to be an independent predictor for poor outcome. We aimed to define a clear high-risk group based on the combination of MIPI, Ki-67 and p53 expression/TP53 alteration. A total of 684 patients from the prospective European MCL-Younger and MCL-Elderly trials were evaluable. The classification of high-risk disease (HRD) as high-risk MIPI-c or p53 expression >50% versus low-risk disease (LRD) as low, low-intermediate or high-intermediate MIPI-c and p53 expression ≤50% allowed to characterize two distinct groups with highly divergent outcome. Patients with HRD had significantly shorter median failure-free survival (FFS) (1.1 vs. 5.6 years, p < 0.0001) and overall survival (OS) (2.2 vs. 13.2 years, p < 0.0001) compared to those with LRD. These major differences were confirmed in two validation cohorts from the Italian MCL0208 and the Nordic-MCL4 trials. The results suggest that this subset of HRD patients is not sufficiently managed with the current standard treatment and is asking for novel treatment strategies.

Risk-related clinical outcomes after minimally invasive mitral valve surgery: insights from the Mini-Mitral International Registry.

With the popularization of catheter-based mitral valve procedures, evaluating risk-specific differentiated clinical outcomes after contemporary mitral valve surgery is crucial. In this study, we assessed the operative results of minimally invasive mitral valve operations across different patient risk profiles and evaluated the value of EuroSCORE (ES) II predicted risk of mortality model for risk prediction, in the large cohort of Mini-Mitral International Registry (MMIR). The MMIR database was used to analyse mini-mitral operations between 2015 and 2021. Patients were categorized as low (<4%), intermediate (4% to <8%), high (8% to <12%) and extreme risk (≥12%) according to ES II. The observed-to-expected mortality ratio was calculated for each risk group. A total of 6541 patients were included in the analysis. Of those, 5546 (84.8%) were classified as low risk, 615 (9.4%) as intermediate risk, 191 (2.9%) as high risk and 189 (2.9%) as extreme risk. Overall operative mortality and stroke rates were 1.7% and 1.4%, respectively, and were significantly associated with patient's risk. The observed mortality was significantly lower than expected-according to the ES II-in all risk categories (observed-to-expected ratio < 1). The present study provides an international contemporary benchmark for operative outcomes after minimally invasive mitral surgery. Operative results were excellent in low-, intermediate- and high-risk patients, but were less satisfactory in extreme risk. The ES II model overestimated the in-hospital mortality. We believe that findings from the MMIR may assist surgeons and cardiologists in clinical decision-making and treatment allocation for patients with mitral valve disease.

Clinical consequences of diagnostic variability in the histopathological evaluation of early rectal cancer

IntroductionIn early rectal cancer, organ sparing treatment strategies such as local excision have gained popularity. The necessity of radical surgery is based on the histopathological evaluation of the local excision specimen. This study aimed to describe diagnostic variability between pathologists, and its impact on treatment allocation in patients with locally excised early rectal cancer. Materials and methodsPatients with locally excised pT1-2 rectal cancer were included in this prospective cohort study. Both quantitative measures and histopathological risk factors (i.e. poor differentiation, deep submucosal invasion, and lymphatic- or venous invasion) were evaluated. Interobserver variability was reported by both percentages and Fleiss’ Kappa- (ĸ) or intra-class correlation coefficients. ResultsA total of 126 patients were included. Ninety-four percent of the original histopathological reports contained all required parameters. In 73 of the 126 (57.9%) patients, at least one discordant parameter was observed, which regarded histopathological risk factors for lymph node metastases in 36 patients (28.6%). Interobserver agreement among different variables varied between 74% and 95% or ĸ 0.530–0.962. The assessment of lymphovascular invasion showed discordances in 26% (ĸ = 0.530, 95% CI 0.375–0.684) of the cases. In fourteen (11%) patients, discordances led to a change in treatment strategy. ConclusionThis study demonstrated that there is substantial interobserver variability between pathologists, especially in the assessment of lymphovascular invasion. Pathologists play a key role in treatment allocation after local excision of early rectal cancer, therefore interobserver variability needs to be reduced to decrease the number of patients that are over- or undertreated.

ASO Author Reflections: Opting for a Cost-Effective Treatment Allocation in Patients with Esophageal Cancer.

ASO Author Reflections: Opting for a Cost-Effective Treatment Allocation in Patients with Esophageal Cancer.

Treatment allocation in patients with hepatocellular carcinoma: Need for a paradigm shift?

Treatment allocation in patients with hepatocellular carcinoma: Need for a paradigm shift?

Narrative review of developing new biomarkers for decision making in advanced testis cancer.

Management of testicular germ cell tumor (GCT) patients is based on clinical determinants, mainly CT scan and serum tumor markers (alpha-fetoprotein, beta subunit of HCG and LDH). Treatment decisions are usually straightforward for patients with clear evidence of metastatic disease, confirmed either by imaging tests or by unequivocal elevated tumor markers. However, there are several clinical scenarios where the assessment of metastatic disease is complicated by the limited specificity of the current imaging tests and serum tumor markers. These include patients with clinical stage IIA GCT with negative tumor markers and patients with post-chemotherapy residual disease where, in absence of clear indicators of GCT, decision making and patient treatment allocation become challenging. Therefore, more accurate biomarkers are critical to reduce the risk of under-or over-treatment and to always deliver the most optimal therapy. The objectives of this narrative review are to review the available publications about micro-RNAs in GCT s and their potential clinical applications. Two clusters of micro-RNAs, miR-371a-3p and miR-302/367, specifically expressed by both seminoma and non-seminoma GCT and easily detectable in the peripheral blood, have demonstrated to be promising in this endeavor. Large prospective trials are ongoing to define the operating characteristics of these biomarkers and their clinical utility to improve GCT patient management and reduce the error rate deriving from clinical uncertainty, therefore reducing the risk of sub-optimal treatments.

Clinician acceptance of complex clinical decision support systems for treatment allocation of patients with chronic low back pain

BackgroundThe uptake of complex clinical decision support systems (CDSS) in daily practice remains low, despite the proven potential to reduce medical errors and to improve the quality of care. To improve successful implementation of a complex CDSS this study aims to identify the factors that hinder, or alleviate the acceptance of, clinicians toward the use of a complex CDSS for treatment allocation of patients with chronic low back pain.MethodsWe tested a research model in which the intention to use a CDSS by clinicians is influenced by the perceived usefulness; this usefulness, in turn is influenced by the perceived service benefits and perceived service risks. An online survey was created to test our research model and the data was analysed using Partial Least Squares Structural Equation Modelling. The study population consisted of clinicians. The online questionnaire started with demographic questions and continued with a video animation of the complex CDSS followed by the set of measurement items. The online questionnaire ended with two open questions enquiring the reasons to use and not use, a complex CDSS.ResultsNinety-eight participants (46% general practitioners, 25% primary care physical therapists, and 29% clinicians at a rehabilitation centre) fully completed the questionnaire. Fifty-two percent of the respondents were male. The average age was 48 years (SD ± 12.2). The causal model suggests that perceived usefulness is the main factor contributing to the intention to use a complex CDSS. Perceived service benefits and risks are both significant antecedents of perceived usefulness and perceived service risks are affected by the perceived threat to autonomy and trusting beliefs, particularly benevolence and competence.ConclusionsTo improve the acceptance of complex CDSSs it is important to address the risks, but the main focus during the implementation phase should be on the expected improvements in patient outcomes and the overall gain for clinicians. Our results will help the development of complex CDSSs that fit more into the daily clinical practice of clinicians.

Management and survival for patients with stage-I hepatocellular carcinoma

It is controversial regarding the treatment allocation for patients with stage I hepatocellular carcinoma (SI-HCC). The aim of the present study was to compare the long-term survival in SI-HCC patients undergoing liver transplantation (LT), liver resection (LR), local tumor destruction (LTD), or none. SI-HCC patients diagnosed between 2004 and 2015 were extracted from the SEER 18 registry database. Multivariable Cox models and propensity score matching (PSM) method were used to explore the association between surgical methods and long-term prognosis. A total of 5165 patients with stage I (AJCC, 6th or 7th) HCC were included in the study. Only 36.9% of patients diagnosed with HCC in stage I received surgical therapy. The incidence of LT was decreased over time (P < .001). In the multivariable-adjusted cohort (n = 5165), after adjusting potential confounding factors, a clear prognostic advantage of LT was observed in OS (P < .0001) compared with patients after LR. Patients undergoing LTD had a worse OS in comparison with patients who underwent LR (P < .0001). Patients who received no surgical treatment had the worst OS (P < .0001) among 4 treatment groups. In stratified analyses, the salutary effects of LT vs LR on OS were consistent across all subgroups except for a similar result in the noncirrhotic subgroup (P = .4414). The inferior survival effects of LTD vs LR on OS were consistent across all subgroups, and even in the subgroup with tumor size < 3 cm (P = .0342). In the PSM cohort, patients in LT group showed a better OS (P < .001) than patients in LR group (P < .0001) and patients undergoing LTD had a worse OS compared with patients who underwent LR (P = .00059). In conclusion, LT offered a survival advantage compared with LR among patients with Stage I HCC. LT is the best surgical treatment for stage I HCC in patients with advanced fibrosis, whereas LR provides comparable long-term outcomes to LT in patients without advanced fibrosis and should be considered as the first-line surgical option. LTD can be used as an alternative method when LR and LT are unavailable.

Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial.

Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged ≥18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48·1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0·94, 95% CI 0·76-1·15; p=0·53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0·018), bone fractures (19 [3%] vs six [1%]; p=0·014), and epileptic seizures (ten [2%] vs two [<1%]; p=0·038) at 6 months. Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures. These results do not support the use of fluoxetine to improve functional outcome after stroke. National Health and Medical Research Council of Australia.

Protocolo de estadificación y asignación de tratamiento en el carcinoma hepatocelular. Algoritmo BCLC

In recent years, therapeutic possibilities available for hepatocellular carcinoma have increased exponentially. The main foundations are: resective surgery, liver transplantation, ablative techniques, intra-arterial therapies and systemic chemotherapy; a multidisciplinary approach is essential for the proper management of patients. Nowadays, Barcelona Clinic Liver Cancer (BCLC) classification is the the most widely used strategy for staging and treatment allocation of patients with hepatocellular carcinoma. Patients are classified in 5 stages (0, A, B, C and D), taking into account a widely validated pre-established prognostic variables. According to the stage group, a therapeutic strategy is recommended. It is a flexible and dynamic classification, allowing migration among stages thorough natural history of the condition. In order to optimize their benefit in terms of patient survival, adequate knowledge of the different treatments, and multidisciplinary assessment accompanied by their correct execution is key.

Patient Disposition and Clinical Outcome After Referral to a Dedicated TAVI Clinic.

Introduction: Transcatheter aortic valve implantation (TAVI) is the standard of care for the majority of patients with severe symptomatic aortic stenosis (AS) at excessive-, high- and intermediate-surgical risk. A proportion of patients referred for TAVI do not undergo the procedure and proceed with an alternate treatment strategy. There is scarce data describing the final treatment allocation of such patients. Hence, we sought to evaluate the final treatment allocation of patients referred for TAVI in contemporary practice.Methods: We performed a single center prospective observational study, including all patients referred to our institution for treatment of severe aortic stenosis between February 2014 and August 2017. Baseline demographic and clinical data were recorded. Patients were categorized according to treatment allocation: TAVI, surgical aortic valve replacement (SAVR) or optimal medical therapy (OMT). Clinical outcomes were adjudicated according to VARC-2 definitions. All patients were discussed at a dedicated Heart Team meeting.Results: Total of 245 patients were referred for assessment to a dedicated TAVI clinic during the study period. Patients with moderate (N = 32; 13.1%) and asymptomatic (N = 31; 13.1%) AS were excluded. Subsequently, 53.9% (N = 132) received TAVI, 12.7% (N =31) were managed with OMT, and 7.3% (N =18) had SAVR. Reasons for OMT included primarily: patient's preference (N = 12; 38.7%); excessive surgical risk (N = 4; 12.9%) and severe frailty (N = 5; 16.1%). Reasons for surgical referral included low surgical risk (N = 11; 61.1%), excessive annulus size (N = 5; 27.8%), and aortic root dilatation (N = 2; 11.1%). Patients proceeding to SAVR had lower surgical risk than those in either the OMT or TAVI cohorts (P < 0.001). Mean STS score in SAVR group was 2.2 ± 1.3 vs. 4.5 ± 2.4 in OMT cohort and 6.1 ± 4.9 in TAVI cohort. Six-month all-cause mortality was 16.7, 19.4, and 9.3% among those receiving SAVR, OMT, and TAVI, respectively.Conclusions: Almost half of all patients with severe AS referred to a dedicated TAVI clinic did not receive a TAVI. A considerable proportion of patients were reclassified as moderate AS (13%), were asymptomatic (13%), or intervention was determined to be futile (13%) due to advanced frailty. Early detection and increased awareness of valvular heart disease are required to increase the number of patients that can benefit from TAVI.

Development of a nomogram to predict outcome after liver resection for hepatocellular carcinoma in Child-Pugh B cirrhosis

Treatment allocation in patients with hepatocellular carcinoma (HCC) on a background of Child-Pugh B (CP-B) cirrhosis is controversial. Liver resection has been proposed in small series with acceptable outcomes, but data are limited. The aim of this study was to evaluate the outcomes of patients undergoing liver resection for HCC in CP-B cirrhosis, focusing on the surgical risks and survival. Patients were retrospectively pooled from 14 international referral centers from 2002 to 2017. Postoperative and oncological outcomes were investigated. Prediction models for surgical risks, disease-free survival and overall survival were constructed. A total of 253 patients were included, of whom 57.3% of patients had a preoperative platelet count <100,000/mm3, 43.5% had preoperative ascites, and 56.9% had portal hypertension. A minor hepatectomy was most commonly performed (84.6%) and 122 (48.2%) were operated on by minimally invasive surgery (MIS). Ninety-day mortality was 4.3% with 6 patients (2.3%) dying from liver failure. One hundred and eight patients (42.7%) experienced complications, of which the most common was ascites (37.5%). Patients undergoing major hepatectomies had higher 90-day mortality (10.3% vs. 3.3%; p = 0.04) and morbidity rates (69.2% vs. 37.9%; p <0.001). Patients undergoing an open hepatectomy had higher morbidity (52.7% vs. 31.9%; p = 0.001) than those undergoing MIS. A prediction model for surgical risk was constructed (https://childb.shinyapps.io/morbidity/). The 5-year overall survival rate was 47%, and 56.9% of patients experienced recurrence. Prediction models for overall survival (https://childb.shinyapps.io/survival/) and disease-free survival (https://childb.shinyapps.io/DFsurvival/) were constructed. Liver resection should be considered for patients with HCC and CP-B cirrhosis after careful selection according to patient characteristics, tumor pattern and liver function, while aiming to minimize surgical stress. An estimation of the surgical risk and survival advantage may be helpful in treatment allocation, eventually improving postoperative morbidity and achieving safe oncological outcomes. Liver resection for hepatocellular carcinoma in advanced cirrhosis (Child-Pugh B score) is associated with a high rate of postoperative complications. However, due to the limited therapeutic alternatives in this setting, recent studies have shown promising results after accurate patient selection. In our international multicenter study, we provide 3 clinical models to predict postoperative surgical risks and long-term survival following liver resection, with the aim of improving treatment allocation and eventually clinical outcomes.

Indicators to facilitate the early identification of patients with major depressive disorder in need of highly specialized care: A concept mapping study.

BackgroundEarly identification of the subgroup of patients with major depressive disorder (MDD) in need of highly specialized care could enhance personalized intervention. This, in turn, may reduce the number of treatment steps needed to achieve and sustain an adequate treatment response. The aim of this study was to identify patient‐related indicators that could facilitate the early identification of the subgroup of patients with MDD in need of highly specialized care.MethodsInitial patient indicators were derived from a systematic review. Subsequently, a structured conceptualization methodology known as concept mapping was employed to complement the initial list of indicators by clinical expertise and develop a consensus‐based conceptual framework. Subject‐matter experts were invited to participate in the subsequent steps (brainstorming, sorting, and rating) of the concept mapping process. A final concept map solution was generated using nonmetric multidimensional scaling and agglomerative hierarchical cluster analyses.ResultsIn total, 67 subject‐matter experts participated in the concept mapping process. The final concept map revealed the following 10 major clusters of indicators: 1‐depression severity, 2‐onset and (treatment) course, 3‐comorbid personality disorder, 4‐comorbid substance use disorder, 5‐other psychiatric comorbidity, 6‐somatic comorbidity, 7‐maladaptive coping, 8‐childhood trauma, 9‐social factors, and 10‐psychosocial dysfunction.ConclusionsThe study findings highlight the need for a comprehensive assessment of patient indicators in determining the need for highly specialized care, and suggest that the treatment allocation of patients with MDD to highly specialized mental healthcare settings should be guided by the assessment of clinical and nonclinical patient factors.

Positron emission tomography/computed tomography with 18F-fluorocholine improve tumor staging and treatment allocation in patients with hepatocellular carcinoma

Hepatocellular carcinoma (HCC) staging according to the Barcelona Clinical Liver Cancer (BCLC) classification is based on conventional imaging. The aim of our study was to assess the impact of dual-tracer 18F-fluorocholine and 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) on tumor staging and treatment allocation. A total of 192 dual-tracer PET/CT scans (18F-fluorocholine and 18F-fluorodeoxyglucose PET/CT) were performed in 177 patients with HCC. BCLC staging and treatment proposal were retrospectively collected based on conventional imaging, along with any new lesions detected, and changes in BCLC classification or treatment allocation based on dual-tracer PET/CT. Patients were primarily men (87.5%) with cirrhosis (71%) due to alcohol ± non-alcoholic steatohepatitis (26%), viral infection (62%) or unknown causes (12%). Among 122 patients with PET/CT performed for staging, BCLC stage based on conventional imaging was 0/A in 61 patients (50%), B in 32 patients (26%) and C in 29 patients (24%). Dual-tracer PET/CT detected new lesions in 26 patients (21%), upgraded BCLC staging in 14 (11%) and modified treatment strategy in 17 (14%). In addition, dual-tracer PET/CT modified the final treatment in 4/9 (44%) patients with unexplained elevation of alpha-fetoprotein (AFP), 10/25 patients (40%) with doubtful lesions on conventional imaging and 3/36 patients (8%) waiting for liver transplantation without active HCC after tumor response following bridging therapy. When used for HCC staging, dual-tracer PET/CT enabled BCLC upgrading and treatment modification in 11% and 14% of patients, respectively. Dual-tracer PET/CT might also be useful in specific situations (an unexplained rise in AFP, doubtful lesions or pre-transplant evaluation of patients without active HCC). Using a combination of tracers 18F-fluorocholine and 18F-fluorodeoxyglucose when performing positron emission tomography/computed tomography (PET/CT), often called a PET scan, helps to identify new tumor lesions in patients with hepatocellular carcinoma. This technique enabled staging modification of patients' tumors and led to changes in treatment allocation in certain patients.

Is CT perfusion helpful in the treatment allocation of patients with acute ischemic stroke? An expert-opinion analysis.

Intravenous tPA is the standard treatment for acute ischemic stroke within 4.5 hours of symptom onset. Neuroradiological selection is currently based upon non-contrast- brain CT scan (NCCT). To verify, in an "expert-opinion setting", the possible usefulness of CT perfusion (CTP) in decision-making toward i.v. thrombolysis. One hundred and three consecutive patients with acute ischemic stroke who underwent NCCT and CTP were re-evaluated by an expert in cerebrovascular disease, to verify if adding CTP information would have changed expert's opinion. After CTP, a definitive decision was made for 20 more patients, changing the proportion of patients candidate to i.v. tPA from 44% to 51%, and reducing uncertainty from 29% to 10%. CTP results were useful inmilder stroke (p = 0.01). In a "real world" setting, CT perfusion could be useful for clinical decision, in particular for milder stroke.

Treatment allocation in patients with early-stage esophageal adenocarcinoma: Prevalence and predictors of lymph node involvement.

In considering treatment allocation for patients with early esophageal adenocarcinoma, the incidence of lymph node metastasis is a critical determinant; however, this has not been well defined or stratified by the relevant clinical predictors of lymph node spread. Data from the Surveillance, Epidemiology, and End Results database of the National Cancer Institute were abstracted from 2004 to 2010 for patients with early-stage esophageal adenocarcinoma. The incidence of lymph node involvement for patients with Tis, T1a, and T1b tumors was examined and was stratified by predictors of spread. A total of 13,996 patients with esophageal adenocarcinoma were evaluated. Excluding those with advanced, metastatic, and/or invasive (T2-T4) disease, 715 patients with Tis, T1a, and T1b tumors were included. On multivariate analysis, tumor grade (odds ratio [OR], 2.76; 95% confidence interval [95% CI], 1.58-4.82 [P<.001]), T classification (OR, 0.47; 95% CI, 0.24-0.91 [P =.025]), and tumor size (OR, 2.68; 95% CI, 1.48-4.85 [P = .001]) were found to be independently associated with lymph node metastases. There was no lymph node spread noted with Tis tumors. For patients with low-grade (well or moderately differentiated) tumors measuring <2 cm in size, the risk of lymph node metastasis was 1.7% for T1a (P<.001) and 8.6% for T1b (P = .001) tumors. For patients with low-grade Tis or T1 tumors measuring ≤2 cm in size, the incidence of lymph node metastasis appears to be comparable to the mortality rate associated with esophagectomy. For highly selected patients with early esophageal adenocarcinomas, the results of the current study support the recommendation that local endoscopic resection can be considered as an alternative to surgical management when followed by rigorous endoscopic and radiographic surveillance. Cancer 2016;122:2150-7. © 2016 American Cancer Society.

Surgical Versus Nonsurgical Management of Rotator Cuff Tears

Background: Rotator cuff tears are a common shoulder disorder resulting in significant disability to patients and financial burden on the health care system. While both surgical and nonsurgical management are accepted treatment options, there is a paucity of data to support a treatment algorithm for care providers. Defining variables to guide treatment allocation may be important for patient education and counseling, as well as to deliver the most efficient care plan at the time of presentation. Purpose: To identify independent variables at the time of initial clinical presentation that are associated with preferred allocation to surgical versus nonsurgical management for patients with known full-thickness rotator cuff tears. Study Design: Case control study; Level of evidence, 3. Methods: A total of 196 consecutive adult patients with known full-thickness rotator cuff tears were enrolled into a prospective cohort study. Robust data were collected for each subject at baseline, including age, sex, body mass index (BMI), shoulder activity score, smoking status, size of cuff tear, duration of symptoms, functional comorbidity index, the American Shoulder and Elbow Surgeons (ASES) score, the Western Ontario Rotator Cuff index (WORC), and the Veterans Rand 12-Item Health Survey (VR-12). Logistic regression was performed to identify variables associated with treatment allocation, and the corresponding odds ratios were calculated. Results: Of the 196 patients enrolled, 112 underwent surgical intervention and 84 nonoperative management. With covariates controlled for, significant baseline patient characteristics predictive of eventual allocation to surgical treatment included younger age, lower BMI, and durations of symptoms less than 1 year. Increasing age, higher BMI, and duration of symptoms longer than 1 year were predictive of nonsurgical treatment. Factors that were not associated with treatment allocation included sex, tear size, functional comorbidity score, or any of the patient-derived outcome scores at presentation (ASES, WORC, VR-12, shoulder activity score). Conclusion: Patient demographics at the time of initial presentation for a symptomatic rotator cuff tear are more predictive of treatment allocation to a surgical or nonoperative approach than the patient-derived outcome scores for activity level and shoulder disability. Further study is warranted to help define appropriate indications for treatment allocation in patients with rotator cuff tears.

Surgical versus Non-surgical Management of Rotator Cuff Tears: Predictors of Treatment Allocation

Objectives:Rotator cuff tears are a common shoulder disorder resulting in significant disability to patients and strain on the health care system. While both surgical and non-surgical management are accepted treatment options, little data exist to guide the surgeon in treatment allocation. Defining variables to guide treatment allocation may be important for patient education and counseling, as well as to deliver the most efficient care plan at the time of presentation. The objective of this study was to identify patient characteristics at the time of initial clinical presentation that are associated with allocation to surgical versus non-surgical management for patients with known full-thickness rotator cuff tears.Methods:185 consecutive adult patients with known full-thickness rotator cuff tears were enrolled into a prospective cohort study. Robust data were collected for each subject at baseline, including age, gender, body mass index (BMI), shoulder activity score, smoking status, size of cuff tear, duration of symptoms, functional comorbidity index, treating surgeon, the American Shoulder and Elbow Society (ASES) score, the Western Ontario Rotator Cuff Index (WORC), and the Veterans Rand 12 Item Health Survey (VR-12). Logistic regression was performed in order to identity variables associated with treatment allocation, and the corresponding odds ratios were calculated.Results:Of the 185 subject enrolled, 100 underwent surgical intervention and 85 non-operative management. While controlling for co-variates, significant baseline patient characteristics predictive of eventual allocation to surgical treatment included the following: non-smoking status [OR .039 (0.005, 0.300) p=0.002], lower functional comorbidity index [OR 0.739 (0.518, 1.055) p=0.096], younger age [OR 0.872 (0.820, 0.927) p<0.001], lower BMI [OR 0.895 (0.826, 0.970) p=0.007], and symptoms present for fewer than 4 months [OR 3.258 (1.070, 9.921) p=0.038]. Factors that were not associated with treatment allocation included gender, tear size, diabetes, treating surgeon, or any of the patient derived outcome scores at presentation (ASES, WORC, VR-12, shoulder activity score).Conclusion:This prospective cohort study suggests that the factors predictive of treatment allocation are related more to patient demographics at presentation than patient derived outcome scores or intrinsic characteristics of the rotator cuff such as tear size. Further study is warranted to help define appropriate indications for treatment allocation in patients with rotator cuff tears.

Relationship between Patient Characteristics and Treatment Allocation for Patients with Personality Disorders

Within a large multi-center study in patients with personality disorders, we investigated the relationship between patient characteristics and treatment allocation. Personality pathology, symptom distress, treatment history, motivational factors, and sociodemographics were measured at intake in 923 patients, who subsequently enrolled in short-term or long-term outpatient, day hospital, or inpatient psychotherapy for personality pathology. Logistic regressions were used to examine the predictors of allocation decisions. We found a moderate relationship (R(2) = 0.36) between patient characteristics and treatment setting, and a weak relationship (R(2) = 0.18) between patient characteristics and treatment duration. The most prominent predictors for setting were: symptom distress, cluster C personality pathology, level of identity integration, treatment history, motivation, and parental responsibility. For duration the most prominent predictor was age. We conclude from this study that, in addition to pathology and motivation factors, sociodemographics and treatment history are related to treatment allocation in clinical practice.