Rates of price disclosure associated with the surgical treatment of early-stage breast cancer one year after implementation of federal regulations.

PURPOSE: Mastectomy, breast reconstruction (BR) and breast conserving therapy (BCT) are core components of the treatment paradigm for early-stage disease but are differentially associated with significant financial burdens. Given recent price transparency regulations, we sought to characterize rates of disclosure for breast cancer-related surgery, including mastectomy, BCT, and BR (oncoplastic reconstruction, implant, pedicled flap and free flap) and identify associated factors. METHODS: For this cross-sectional analysis, cost reports were obtained from the Turquoise Health price transparency platform for all U.S. hospitals meeting national accreditation standards for breast cancer care. The Healthcare Cost Report Information System was used to collect facility-specific data. Addresses were geocoded to identify hospital referral and census regions while data from CMS was also used to identify the geographic practice cost index. We leveraged a Poisson regression model and relevant Medicare billing codes to analyze factors associated with price disclosure and the availability of an OOP price estimator. RESULTS: Of 447 identified hospitals, 221 (49.4%) disclosed prices for mastectomy and 188 42.1%) disclosed prices for both mastectomy and some form of reconstruction including oncoplastic reduction (n = 184, 97.9%), implants (n = 187, 99.5%), pedicled flaps (n = 89, 47.3%), and free flaps (n = 81, 43.1%). Non-profit status and increased market competition were associated with price nondisclosure. 121 hospitals (27.1%) had an out-of-pocket price estimator that included at least one breast surgery. CONCLUSIONS: Most eligible hospitals did not disclose prices for breast cancer surgery. Distinct hospital characteristics were associated with price disclosure. Breast cancer patients face persistent difficulty in accessing costs.

Is the Centralization of Complex Surgical Procedures an Unintended Spillover Effect of Global Capitation? - Insights from the Maryland Global Budget Revenue Program.

OBJECTIVE: To determine if global budget revenue (GBR) models incent the centralization of complex surgical care. SUMMARY BACKGROUND: In 2014, Maryland initiated a statewide GBR model. While prior research has shown improvements in cost and outcomes for surgical care post-GBR implementation, the mechanism remains unclear. METHODS: Utilizing state inpatient databases, we compared the proportion of adults undergoing elective complex surgeries (gastrectomy, pneumonectomy/lobectomy, proctectomies, and hip/knee revision) at high-concentration hospitals (HCHs) in Maryland and control states. Annual concentration, per procedure, was defined as hospital volume divided by state volume. HCHs were defined as hospitals with a concentration at least at the 75 th percentile in 2010. We estimated the difference-in-differences (DiD) of the probability of patients undergoing surgery at HCHs before and after GBR implementation. FINDINGS: Our sample included 122,882 surgeries. Following GBR implementation, all procedures were increasingly performed at HCHs in Maryland. States satisfied the parallel trends assumption for the centralization of gastrectomy and pneumonectomy/lobectomy. Post-GBR, patients were more likely to undergo gastrectomy (DiD: 5.5 p.p., 95% CI [2.2, 8.8]) and pneumonectomy/lobectomy (DiD: 12.4 p.p., 95% CI [10.0, 14.8]) at an HCH in Maryland compared with control states. For our hip/knee revision analyses, we assumed persistent counterfactuals and noted a positive DiD post-GBR implementation (DiD: 4.8 p.p., 95% CI [1.3, 8.2]). No conclusion could be drawn for proctectomy due to different pre-GBR trends. CONCLUSIONS: GBR implementation is associated with increased centralization for certain complex surgeries. Future research is needed to explore the impact of centralization on patient experience and access.

Association between patient-surgeon race and gender concordance and patient-reported outcomes following breast cancer surgery.

PURPOSE: Surgeon- and patient-related factors have been shown to influence patient experiences, quality of life (QoL), and surgical outcomes. We examined the association between patient-surgeon race and gender concordance with QoL after breast reconstruction. METHODS: We conducted a retrospective cross-sectional analysis of patients who underwent lumpectomy or mastectomy followed by breast reconstruction over a 3-year period. We created the following categories with respect to the race and gender of a patient-surgeon triad: no, intermediate, and perfect concordance. Multivariable regression was used to correlate postoperative global (SF-12) and condition-specific (BREAST-Q) QoL performance with patient-level covariates, gender and race concordance. RESULTS: We identified 375 patients with a mean (± SD) age of 57.6 ± 11.9 years, median (IQR) body mass index of 27.5 (24.0, 32.0), and median morbidity burden of 3 (2, 4). The majority of encounters were of intermediate concordance for gender (70%) and race (52%). Compared with gender-discordant triads, intermediate gender concordance was associated with higher SF-Mental scores (ß, 2.60; 95% CI, 0.21-4.99, p = 0.003). Perfect race concordance (35% of encounters) was associated with significantly higher adjusted SF-Physical scores (ß, 2.14; 95% CI, 0.50-4.22, p = 0.045) than the race-discordant group. There were no significant associations observed between race or gender concordance and BREAST-Q performance. CONCLUSION: Race-concordant relationships following breast cancer surgery were more likely to have improved global QoL. Perfect gender concordance was not associated with variation in QoL outcomes. Policy-level interventions are needed to facilitate personalized care and optimize breast cancer surgery outcomes.

Post-Mastectomy Tissue Expander Placement Followed by Radiation Therapy: A Cost-Effectiveness Analysis of Staged Autologous Versus Implant-Based Unilateral Reconstruction.

BACKGROUND: There is no preferred approach to breast reconstruction for patients with locally advanced breast cancer (LABC) who require post-mastectomy radiation therapy (PMRT). Staged implant and autologous reconstruction both have unique risks and benefits. No previous study has compared their cost-effectiveness with utility scores. METHODS: A literature review determined the probabilities and outcomes for mastectomy and staged implant or autologous reconstruction. Utility scores were used to calculate the quality-adjusted life years (QALYs) associated with successful surgery and postoperative complications. Medicare billing codes were used to assess costs. A decision analysis tree was constructed with rollback and incremental cost-effectiveness ratio (ICER) analyses. Sensitivity analyses were performed to validate results and account for uncertainty. RESULTS: Mastectomy with staged deep inferior epigastric perforator (DIEP) flap reconstruction is costlier ($14,104.80 vs $3216.93), but more effective (QALYs, 29.96 vs 24.87). This resulted in an ICER of 2141.00, favoring autologous reconstruction. One-way sensitivity analysis showed that autologous reconstruction was more cost-effective if less than $257,444.13. Monte Carlo analysis showed a confidence of 99.99% that DIEP flap reconstruction is more cost-effective. CONCLUSIONS: For patients with LABC who require PMRT, staged autologous reconstruction is significantly more cost-effective than reconstruction with implants. Despite the decreased morbidity, staged implant reconstruction has greater rates of complication.

Reproducibility of laryngeal force sensor measurements.

OBJECTIVE: The laryngeal force sensor (LFS) measures force during suspension microlaryngoscopy (SML) procedures, and has been previously shown to predict postoperative complications. Reproducibility of its measurements has not been described. STUDY DESIGN: Prospective cohort study. SETTING: Academic medical center. METHODS: 291 adult patients had force data collected from 2017 to 2021 during various SML procedures. 94 patients had passive LFS monitoring (surgeon blinded to intraoperative recordings) and 197 had active LFS monitoring (surgeon able to see LFS recordings). 27 of these patients had repeat procedures, with unique LFS metrics for each procedure. The 27 patients were divided into three groups. Group 1 had passive use for both procedures, group 2 had passive use for the first procedure and active use for the second, and group 3 had active use for both procedures. Force metrics from the two procedures were compared with a paired samples t-test. RESULTS: For airway dilation procedures and cancer resection procedures, average force variances were significantly lower with active versus passive use of the LFS. Group 1-no significant changes in maximum force (procedure 1 = 163.8 N, procedure 2 = 133.8 N, p = 0.324) or average force (procedure 1 = 93.6 N, procedure 2 = 78.3 N, p = 0.617). Group 2-maximum force dropped by 35 % between procedures 1 (219.2 N) and 2 (142.5 N), p = 0.013. Average force dropped by 42.5 % between procedures 1 (147.2 N) and 2 (84.6 N), p = 0.007. Group 3-no significant changes in maximum force (procedure 1 = 158.6 N, procedure 2 = 158.2 N, p = 0.986) or average force (procedure 1 = 94.2, procedure 2 = 81.8, p = 0.419). CONCLUSIONS: LFS measurements were reproducible for similar procedures in the same patient when the type of LFS monitoring was not a confounder.

Scleroderma autoantibodies in guiding monitoring and treatment decisions.

PURPOSE OF REVIEW: One of the key clinical challenges of systemic sclerosis (SSc) is diversity in clinical presentation, organ involvement and disease progression. Antinuclear autoantibodies (ANA) are central to the diagnosis of SSc. ANA specificities associated with distinct clinical patterns of organ and skin involvement. Understanding of the molecular differences and pathogenesis of scleroderma has helped further inform clinical acumen. Here, we provide an update on ANA on clinical profiling, management and future direction of SSc. RECENT FINDINGS: There has been further development in delineating clinical patterns in ANA, genetic susceptibility and antigen triggers predisposing to ANA subtypes. Sub-group analysis of recent clinical trials shows differing treatment responses to novel therapeutics. SUMMARY: ANA subtyping is likely to be firmly embedded into future classification systems. Beyond informing current management and monitoring of scleroderma patients, ANA subsets have implication on future research and clinical trial design.

Acupuncture and Postoperative Pain Reduction.

PURPOSE OF REVIEW: Acupuncture is an analgesic technique that has long been utilized in Eastern medicine. In recent times, various acupuncture techniques have been used in integrated pain management approaches in Western medicine. It has even been adopted as an analgesic method in surgical patients. Currently, no review exists regarding various acupuncture techniques used in perioperative pain management and data describing the utility of these techniques. This paper synthesizes the latest literature regarding the role of acupuncture in perioperative pain management. The authors sought to describe various acupuncture modalities used to help manage surgical pain and synthesize the current body of literature to help readers make informed judgements on the topic. RECENT FINDINGS: Patients undergoing abdominal, spine/neuro, and gynecologic pelvic surgery generally benefit from acupuncture. Out of the various acupuncture techniques, electroacupuncture, transcutaneous electric acupoint stimulation, and traditional total body acupuncture seem to be most promising as adjuncts to multimodal perioperative analgesia. Benefits include improved analgesia and/or reduced narcotic requirements, decrease in PONV, and shorter time to return of bowel function. Acupuncture is a low-risk method that has the potential to enhance perioperative analgesia, decrease opioid requirement, and reduce unwanted side effects of anesthesia, surgery, and opioid administration such as nausea/vomiting. Given the variety of patient populations, various acupuncture techniques, and small patient populations for most current studies; it remains difficult to determine which acupuncture method would most benefit specific patients. Future studies with more robust sample sizes and prospective comparison on acupuncture technique would help better characterize acupuncture's role in perioperative pain management.

Integration of clinical pharmacists into a heart failure clinic within a safety-net hospital.

BACKGROUND: Management of heart failure with reduced ejection fraction (HFrEF) requires timely initiation and up-titration of guideline-directed medical therapy (GDMT). In safety-net hospitals (SNHs), limited health care staff and resources make achievement of optimal medical therapy challenging. Recent studies have shown that medication titration performed by clinical pharmacists can improve outcomes in ambulatory management of HFrEF; however, the impact of these services within an SNH remains unknown. OBJECTIVE: Determine the impact of integrating clinical pharmacists into a heart failure (HF) clinic on initiation and titration of GDMT within an SNH. METHODS: We performed a single-center retrospective cohort study of patients with HFrEF treated in an ambulatory HF medication titration clinic within an SNH before and after clinical pharmacist integration. Primary outcomes included dose optimization rates of GDMT, time between clinic visits, and time to optimization of GDMT. Exploratory secondary outcomes were all-cause, HF, and cardiovascular acute care service utilization and all-cause, HF, and cardiovascular mortality before and after clinical pharmacist integration up to 6 months after initial clinic visit. RESULTS: A total of 153 patients with HFrEF were treated. Baseline characteristics in the pre- and postintervention groups were comparable. After clinical pharmacist integration, there was a statistically significant improvement in optimization of renin-angiotensin-aldosterone system inhibitor or hydralazine-nitrate equivalent (82% vs. 94%, P = 0.02). Dose optimization rates of beta-blockers (90% vs. 83%, P = 0.22) and mineralocorticoid receptor antagonists (57% vs. 57%, P > 0.99) were unchanged. There was a statistically significant reduction in mean time between clinic visits (26 vs. 14 days, P < 0.001) and in mean time to optimization of GDMT (88 vs. 45 days, P = 0.002). All-cause mortality was reduced (13% vs. 2%, P = 0.01). CONCLUSION: In SNHs, where limited health care staff and resources present as barriers to timely initiation and titration of GDMT, integration of clinical pharmacists into HF clinics can serve as a practical solution.

Patient Frailty Is Independently Associated With the Risk of Hospitalization for Acute-on-Chronic Liver Failure.

There is significant interest in identifying risk factors associated with acute-on-chronic liver failure (ACLF). In transplant candidates, frailty predicts wait-list mortality and posttransplant outcomes. However, the impact of frailty on ACLF development and mortality is unknown. This was a retrospective study of US veterans with cirrhosis identified between 2008 and 2016. First hospitalizations were characterized as ACLF or non-ACLF admissions. Prehospitalization patient frailty was ascertained using a validated score based on administrative coding data. We used logistic regression to investigate the impact of an increasing frailty score on the odds of ACLF hospitalization and short-term ACLF mortality. Cox regression was used to analyze the association between frailty and longterm survival from hospitalization. We identified 16,561 cirrhosis hospitalizations over a median follow-up of 4.19 years (interquartile range, 2.47-6.34 years). In adjusted models, increasing frailty score was associated with significantly increased odds of ACLF hospitalization versus non-ACLF hospitalization (odds ratio, 1.03 per point; 95% CI 1.02-1.03; P < 0.001). By contrast, frailty score was not associated with ACLF 28- or 90-day mortality (P = 0.13 and P = 0.33, respectively). In an adjusted Cox analysis of all hospitalizations, increasing frailty scores were associated with poorer longterm survival from the time of hospitalization (hazard ratio, 1.02 per 5 points; 95% confidence interval, 1.01-1.03; P = 0.004). Frailty increases the likelihood of ACLF hospitalization among patients with cirrhosis, but it does not impact short-term ACLF mortality. These findings have implications for clinicians caring for frail outpatients with cirrhosis, including tailored follow-up, risk mitigation strategies, and possible expedited transplant evaluation.

Acute-on-chronic liver failure: update on pathogenesis, therapeutic targets, predictive models, and liver transplantation.

PURPOSE OF REVIEW: Acute-on-chronic liver failure (ACLF) is a clinical syndrome in patients with chronic liver disease that is associated with multiple organ failures and a high short-term mortality. Systemic inflammation is suggested to play a key role in its pathogenesis, although the precise causative mechanism is unknown. The purpose of this review is to present and discuss new findings related to: mechanisms underlying ACLF, therapeutic targets, risk prediction models for developing ACLF, and liver transplantation for ACLF. RECENT FINDINGS: Recent studies of ACLF pathophysiology classified the immunosuppressive phenotype in monocytes. Investigation of therapeutic strategies identified inhibition of toll-like receptor-4 (TLR-4) and glutamine synthetase (GLUL) as potential targets. Recent studies identified novel risk prediction models for developing ACLF and enhanced our understanding of liver transplantation for ACLF to guide clinicians in determining that patients will benefit from transplantation. SUMMARY: Improved knowledge on the pathogenesis of ACLF and identification of TLR-4 and GLUL may lead to clinical trials to study the efficacy of these novel therapeutic targets for patients with ACLF. Liver transplantation is the only current treatment for ACLF. Given the limited availability of donor organs, recent studies have identified ACLF patients who may merit the highest waitlist priority.

Outcomes among pediatric patients with cancer who are treated on trial versus off trial: A matched cohort study.

BACKGROUND: Approximately 50% of children with cancer in the United States who are aged <15 years receive primary treatment on a therapeutic clinical trial. To the authors' knowledge, it remains unknown whether trial enrollment has a clinical benefit compared with the best alternative standard therapy and/or off trial (ie, clinical trial effect). The authors conducted a retrospective matched cohort study to compare the morbidity and mortality of pediatric patients with cancer who are treated on a phase 3 clinical trial compared with those receiving standard therapy and/or off trial. METHODS: Subjects were aged birth to 19 years; were diagnosed between 2000 and 2010 with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), rhabdomyosarcoma, or neuroblastoma; and had received initial treatment at the Children's Hospital of Philadelphia. On-trial and off-trial subjects were matched based on age, race, ethnicity, a diagnosis of Down syndrome (for patients with ALL or AML), prognostic risk level, date of diagnosis, and tumor type. RESULTS: A total of 428 participants were matched in 214 pairs (152 pairs for ALL, 24 pairs for AML, 32 pairs for rhabdomyosarcoma, and 6 pairs for neuroblastoma). The 5-year survival rate did not differ between those treated on trial versus those treated with standard therapy and/or off trial (86.9% vs 82.2%; P = .093). On-trial patients had a 32% lower odds of having worse (higher) mortality-morbidity composite scores, although this did not reach statistical significance (odds ratio, 0.68; 95% confidence interval, 0.45-1.03 [P = .070]). CONCLUSIONS: There was no statistically significant difference in outcomes noted between those patients treated on trial and those treated with standard therapy and/or off trial. However, in partial support of the clinical trial effect, the results of the current study indicate a trend toward more favorable outcomes in children treated on trial compared with those treated with standard therapy and/or off trial. These findings can support decision making regarding enrollment in pediatric phase 3 clinical trials.

Comparing Resource Use in Medical Admissions of Children With Complex Chronic Conditions.

BACKGROUND: Children with complex chronic conditions (CCCs) utilize a disproportionate share of hospital resources. OBJECTIVE: We asked whether some hospitals display a significantly different pattern of resource utilization than others when caring for similar children with CCCs admitted for medical diagnoses. RESEARCH DESIGN: Using Pediatric Health Information System data from 2009 to 2013, we constructed an inpatient Template of 300 children with CCCs, matching these to 300 patients at each hospital, thereby performing a type of direct standardization. SUBJECTS: Children with CCCs were drawn from a list of the 40 most common medical principal diagnoses, then matched to patients across 40 Children's Hospitals. MEASURES: Rate of intensive care unit admission, length of stay, resource cost. RESULTS: For the Template-matched patients, when comparing resource use at the lower 12.5-percentile and upper 87.5-percentile of hospitals, we found: intensive care unit utilization was 111% higher (6.6% vs. 13.9%, P<0.001); hospital length of stay was 25% higher (2.4 vs. 3.0 d/admission, P<0.001); and finally, total cost per patient varied by 47% ($6856 vs. $10,047, P<0.001). Furthermore, some hospitals, compared with their peers, were more efficient with low-risk patients and less efficient with high-risk patients, whereas other hospitals displayed the opposite pattern. CONCLUSIONS: Hospitals treating similar patients with CCCs admitted for similar medical diagnoses, varied greatly in resource utilization. Template Matching can aid chief quality officers benchmarking their hospitals to peer institutions and can help determine types of their patients having the most aberrant outcomes, facilitating quality initiatives to target these patients.

A Comprehensive Framework to Optimize Short-Term Experiences in Global Health (STEGH).

Increasing demand for Short-term Experiences in Global Health (STEGH), particularly among medical trainees, has seen a growth in programming that brings participants from high-income countries to low and middle-income settings in order to engage in service, teaching or research activities. Historically the domain of faith-based organizations conducting "missions", STEGH are now offered by diverse groups including academic institutions, non-profit organizations, and the private sector, either as dedicated for-profits or through corporate social responsibility arms.The growing popularity of STEGH has resulted in concerns about their negative impacts on host communities. Traditional STEGH are often crafted with little or no input from host community leaders, and this results in activities that do not address locally identified priorities. Other concerns include culturally incongruent programming and the creation of parallel systems that disrupt established local services and redirect scarce local resources, which fosters dependency instead of building capacity. One concern specific to trainees also includes trainee provision of services beyond their scope and training level.To address these concerns, this paper presents a comprehensive framework that aims to categorize promising interventions that might promote greater responsibility in STEGH. Based on the micro-meso-macro framework, this paper proposes various interventions as incentives and disincentives to be deployed at the individual, program, and societal levels to promote greater responsibility in STEGH. Deployed altogether, the interventions contemplated by this framework would foster the optimal context  required to encourage responsibility, minimize harms, and optimize host community outcomes for STEGH.

The ß-isoform of BCCIP promotes ADP release from the RAD51 presynaptic filament and enhances homologous DNA pairing.

Homologous recombination (HR) is a template-driven repair pathway that mends DNA double-stranded breaks (DSBs), and thus helps to maintain genome stability. The RAD51 recombinase facilitates DNA joint formation during HR, but to accomplish this task, RAD51 must be loaded onto the single-stranded DNA. DSS1, a candidate gene for split hand/split foot syndrome, provides the ability to recognize RPA-coated ssDNA to the tumor suppressor BRCA2, which is complexed with RAD51. Together BRCA2-DSS1 displace RPA and load RAD51 onto the ssDNA. In addition, the BRCA2 interacting protein BCCIP normally colocalizes with chromatin bound BRCA2, and upon DSB induction, RAD51 colocalizes with BRCA2-BCCIP foci. Down-regulation of BCCIP reduces DSB repair and disrupts BRCA2 and RAD51 foci formation. While BCCIP is known to interact with BRCA2, the relationship between BCCIP and RAD51 is not known. In this study, we investigated the biochemical role of the ß-isoform of BCCIP in relation to the RAD51 recombinase. We demonstrate that BCCIPß binds DNA and physically and functionally interacts with RAD51 to stimulate its homologous DNA pairing activity. Notably, this stimulatory effect is not the result of RAD51 nucleoprotein filament stabilization; rather, we demonstrate that BCCIPß induces a conformational change within the RAD51 filament that promotes release of ADP to help maintain an active presynaptic filament. Our findings reveal a functional role for BCCIPß as a RAD51 accessory factor in HR.

Long-term Survival After Surgery Compared With Concurrent Chemoradiation for Node-negative Small Cell Lung Cancer.

OBJECTIVE: To determine whether surgery with adjuvant chemotherapy offers a survival advantage over concurrent chemoradiation for patients with cT1-2N0M0 small cell lung cancer (SCLC). BACKGROUND: Although surgery with adjuvant chemotherapy is the recommended treatment for patients with cT1-2N0M0 SCLC per international guidelines, there have been no prospective or retrospective studies evaluating the impact of surgery versus optimal medical management for cT1-2N0M0 SCLC. METHODS: Outcomes of patients with cT1-2N0M0 SCLC who underwent surgery with adjuvant chemotherapy or concurrent chemoradiation in the National Cancer Data Base (2003-2011) were evaluated using Cox proportional hazards analyses and propensity-score-matched analyses. RESULTS: During the study period, 681 (30%) patients underwent surgery with adjuvant chemotherapy and 1620 (70%) underwent concurrent chemoradiation. After propensity-score matching, all 14 covariates were well balanced between the surgery (n = 501) and concurrent chemoradiation (n = 501) groups. Surgery was associated with a higher overall survival (OS) than concurrent chemoradiation (5-year OS 47.6% vs 29.8%, P < 0.01). To minimize selection bias due to comorbidities, we limited the propensity-matched analysis to 492 patients with no comorbidities; surgery remained associated with a higher OS than concurrent chemoradiation (5-year OS 49.2% vs 32.5%, P < 0.01). CONCLUSIONS: In a national analysis, surgery with adjuvant chemotherapy was used in the minority of patients for early stage SCLC. Surgery with adjuvant chemotherapy for node-negative SCLC was associated with improved long-term survival when compared to concurrent chemoradiation. These results suggest a significant underuse of surgery among patients with early stage SCLC and support an increased role of surgery in multimodality therapy for cT1-2N0M0 SCLC.

Disparities in Breast Cancer Survival by Socioeconomic Status Despite Medicare and Medicaid Insurance.

Policy Points Patients with low socioeconomic status (SES) experience poorer survival rates after diagnosis of breast cancer, even when enrolled in Medicare and Medicaid. Most of the difference in survival is due to more advanced cancer on presentation and the general poor health of lower SES patients, while only a very small fraction of the SES disparity is due to differences in cancer treatment. Even when comparing only low- versus not-low-SES whites (without confounding by race) the survival disparity between disparate white SES populations is very large and is associated with lower use of preventive care, despite having insurance. CONTEXT: Disparities in breast cancer survival by socioeconomic status (SES) exist despite the "safety net" programs Medicare and Medicaid. What is less clear is the extent to which SES disparities affect various racial and ethnic groups and whether causes differ across populations. METHODS: We conducted a tapered matching study comparing 1,890 low-SES (LSES) non-Hispanic white, 1,824 black, and 723 Hispanic white women to 60,307 not-low-SES (NLSES) non-Hispanic white women, all in Medicare and diagnosed with invasive breast cancer between 1992 and 2010 in 17 US Surveillance, Epidemiology, and End Results (SEER) regions. LSES Medicare patients were Medicaid dual-eligible and resided in neighborhoods with both high poverty and low education. NLSES Medicare patients had none of these factors. MEASUREMENTS: 5-year and median survival. FINDINGS: LSES non-Hispanic white patients were diagnosed with more stage IV disease (6.6% vs 3.6%; p < 0.0001), larger tumors (24.6 mm vs 20.2 mm; p < 0.0001), and more chronic diseases such as diabetes (37.8% vs 19.0%; p < 0.0001) than NLSES non-Hispanic white patients. Disparity in 5-year survival (NLSES - LSES) was 13.7% (p < 0.0001) when matched for age, year, and SEER site (a 42-month difference in median survival). Additionally, matching 55 presentation factors, including stage, reduced the disparity to 4.9% (p = 0.0012), but further matching on treatments yielded little further change in disparity: 4.6% (p = 0.0014). Survival disparities among LSES blacks and Hispanics, also versus NLSES whites, were significantly associated with presentation factors, though black patients also displayed disparities related to initial treatment. Before being diagnosed, all LSES populations used significantly less preventive care services than matched NLSES controls. CONCLUSIONS: In Medicare, SES disparities in breast cancer survival were large (even among non-Hispanic whites) and predominantly related to differences of presentation characteristics at diagnosis rather than differences in treatment. Preventive care was less frequent in LSES patients, which may help explain disparities at presentation.

Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review.

BACKGROUND: The primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials. METHODS: Pilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT). RESULTS: The initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question. CONCLUSIONS: Based on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Addressing the Health and Wellness Needs of Vulnerable Rockaway Residents in the Wake of Hurricane Sandy: Findings From a Health Coaching and Community Health Worker Program.

OBJECTIVES: To describe the design and participants of a program that employed health coaches and community health workers to address the social, health, and long-term disaster recovery needs of Rockaway residents roughly 2 years after Hurricane Sandy made landfall. DESIGN: Baseline and exit questionnaires, containing demographic, health, and health care utilization measures, were administered to participants at the start and end of the program. Enrollment and encounter information was captured in program administrative records. Descriptive statistics were used to summarize participant characteristics, personal goals, referrals to local organizations and agencies, and outcomes. Qualitative analyses were used to identify recurring themes in challenges faced by participants and barriers to health and wellness. RESULTS: The program served 732 community residents, of whom 455 (62%) completed baseline and exit questionnaires. Participants were directly and/or indirectly impacted by Hurricane Sandy through property damage, closures of health care facilities, limited employment opportunities, and trouble securing affordable housing. Furthermore, many participants faced considerable adversities and struggled to manage chronic health conditions. Personal goals set by participants included locating health care and other resources (44%), weight management and healthy eating (35%), and self-management of chronic conditions (24%). Health coaches and community health workers engaged participants an average of 4 times-providing counseling and referrals to local organizations and services, including medical and dental services (29%), city-issued identification cards (27%), and health insurance and other entitlements (23%). Comparisons of baseline and exit surveys indicated significant improvements in self-reported health, health care utilization, and confidence managing health issues. No significant improvement was observed in the use of preventive health care services. CONCLUSIONS: The program represents a model for engaging vulnerable populations and addressing social and economic barriers to health and wellness during the long-term disaster recovery phase. Health coaches and community health workers may be instrumental in helping to address the health and wellness needs of vulnerable residents living in disaster-affected areas.