Multicenter evaluation of the Quantra with the QStat Cartridge in adult patients undergoing liver transplantation.

Blood loss and transfusion of blood products are key concerns during liver transplantation. Whole-blood viscoelastic testing devices have been used to monitor hemostatic function and guide the transfusion of blood products in this patient population. The Quantra System with the QStat Cartridge is a new point-of-care, closed-system viscoelastic testing device that measures changes in clot stiffness during coagulation and fibrinolysis using ultrasound detection of resonance. The aim of this multicenter prospective observational study was to evaluate the Quantra System against the ROTEM delta device in monitoring coagulation and fibrinolysis in patients undergoing liver transplantation. One hundred twenty-five (125) adult subjects (above 18 y old) were enrolled across 5 medical centers in the US. Blood samples were collected at a minimum of 3-time points: preincision (baseline), during the anhepatic phase, and after the start of reperfusion. Performance was assessed as the correlation of equivalent measurements from the QStat Cartridge and ROTEM delta INTEM, EXTEM, and FIBTEM assays. In addition, a clinical concordance analysis was performed to assess the agreement between the 2 devices related to the detection of fibrinolysis. The correlation between the 2 viscoelastic testing devices was strong, with r -values ranging between 0.88 and 0.95, and the overall agreement with respect to detecting fibrinolysis was 90.3% (CI, 86.9%-93.2%). The results indicate that the Quantra with the QStat Cartridge provides comparable information as the ROTEM delta in the assessment of hemostatic function during a liver transplant. Quantra's simplicity of use and availability of rapid results may provide clinicians with a faster, more convenient means to assess coagulation and fibrinolysis status in the operating room and critical care setting.

Airway Complications in Pregnant Patients Undergoing Electroconvulsive Therapy: A Retrospective Case-Control Study.

OBJECTIVES: Electroconvulsive therapy (ECT) is an evidence-based treatment for severe depression and bipolar disorder in pregnant women. Electroconvulsive therapy involves induction of general anesthesia, muscle relaxation, and positive-pressure ventilation. Airway manipulation may lead to complications such as vocal cord injury, aspiration, inability to ventilate, and death. The purpose of this study was to determine whether there were differences in the incidence of airway complications in pregnant patients who underwent mask ventilation (MV) versus endotracheal intubation (ETI) compared with nonpregnant control subjects. METHODS: We conducted a single-center retrospective chart review of all adult pregnant patients who underwent anesthesia for ECT from June 1, 2011, to June 30, 2020. Each ECT treatment delivered to a pregnant patient was matched with 2 ECT treatments delivered to a nonpregnant female control subject. Charts were queried for airway management (MV vs ETI), gestational age, and airway complications. Each ECT treatment was considered an independent event. RESULTS: Seventy-six ECT treatments from 11 pregnant patients were matched with 154 ECT treatments from 13 nonpregnant patients. In pregnant patients, airway management consisted of MV in 57 of the 76 treatments: 12 of 12 in the first trimester, 33 of 44 in the second trimester, and 12 of 20 in the third trimester. All 154 ECT treatments in the control group used MV. No airway complications were experienced in pregnant or nonpregnant patients with MV or ETI. CONCLUSIONS: No airway complications were observed in pregnant patients undergoing MV or ETI regardless of gestational age.

Effect of drysuit seals on intraocular pressure in non-immersed scuba divers.

Objective: This study quantifies the change in intraocular pressure (IOP) secondary to wearing neck seals in scuba diving drysuits. Previous work demonstrates significant pressures exerted by these seals; we hypothesize that they would. Methods: IOP was measured in 33 divers before and while wearing a drysuit using rebound tonometry. The drysuit neck seal pressures were measured using a manometer. A paired two-sample t-test was used to compare IOP before and after drysuit donning. Pearson correlation coefficients were calculated between neck sealing pressures and IOP by side. Results: The mean IOP in the right eye was similar pre- and post-drysuit donning, with baseline mean 15.9 mmHg (3.7 mmhg) versus 15.4 mmHG (4.3 mmHg) post-donning, p=0.41. Similarly, the mean IOP in the left eye was also similar, with mean pre-donning IOP 15.6 (3.8 mmHg) versus 15.4 mmHg (4.7 mmHg) post-donning, p=0.75. The mean right and left neck seal pressures were 23.66 (10.60) mmHg and 23.67 (7.87) mmHg, respectively. Only the correlation between right neck sealing pressure for silicone neck seals and right IOP, pre- and post-donning was significant (pre: 0.97, p-value 0.03, post: 0.98, p-value 0.02). Conclusion: No significant difference overall was detected in IOP with drysuit donning.

Good working relationships: how healthcare system proximity influences trust between healthcare workers.

Trust between healthcare workers is a fundamental component of effective, interprofessional collaboration and teamwork. However, little is known about how this trust is built, particularly when healthcare workers are distributed (i.e., not co-located and lack a shared electronic health record). We interviewed 39 healthcare workers who worked with proximal and distributed colleagues to care for patients with diabetic foot ulcers and analyzed transcripts using content analysis. Generally, building trust was a process that occurred over time, starting with an introduction and proceeding through iterative cycles of communication and working together to coordinate care for shared patients. Proximal, compared to distributed, dyads had more options available for interactions which, in turn, facilitated communication and working together to build trust. Distributed healthcare workers found it more difficult to develop trusting relationships and relied heavily on individual initiative to do so. Few effective tools existed at the level of interprofessional collaborations, teams, or broader healthcare systems to support trust between distributed healthcare workers. With increasing use of distributed interprofessional collaborations and teams, future efforts should focus on fostering this critical attribute.

A systematic review of multidisciplinary teams to reduce major amputations for patients with diabetic foot ulcers.

OBJECTIVE: Multiple single-center studies have reported significant reductions in major amputations among patients with diabetic foot ulcers after initiation of multidisciplinary teams. The purpose of this study was to assess the association between multidisciplinary teams (ie, two or more types of clinicians working together) and the risk of major amputation and to compile descriptions of these diverse teams. METHODS: We searched PubMed, Scopus, Cumulative Index to Nursing and Allied Health, and Cochrane Central Register of Controlled Trials from inception through May 24, 2019 for studies reporting the association between multidisciplinary teams and major amputation rates for patients with diabetic foot ulcers. We included original studies if ≥50% of the patients seen by the multidisciplinary team had diabetes, they included a control group, and they reported the effect of a multidisciplinary team on major amputation rates. Studies were excluded if they were non-English language, abstracts only, or unpublished. We used the five-domain Systems Engineering Initiative for Patient Safety Model to describe team composition and function and summarized changes in major amputation rates associated with multidisciplinary team care. A meta-analysis was not performed because of heterogeneity across studies, their observational designs, and the potential for uncontrolled confounding (PROSPERO No. 2017: CRD42017067915). RESULTS: We included 33 studies, none of which were randomized trials. Multidisciplinary team composition and functions were highly diverse. However, four elements were common across teams: teams were composed of medical and surgical disciplines; larger teams benefitted from having a "captain" and a nuclear and ancillary team member structure; clear referral pathways and care algorithms supported timely, comprehensive care; and multidisciplinary teams addressed four key tasks: glycemic control, local wound management, vascular disease, and infection. Ninety-four percent (31/33) of studies reported a reduction in major amputations after institution of a multidisciplinary team. CONCLUSIONS: Multidisciplinary team composition was variable but reduced major amputations in 94% of studies. Teams consistently addressed glycemic control, local wound management, vascular disease, and infection in a timely and coordinated manner to reduce major amputation for patients with diabetic foot ulcerations. Care algorithms and referral pathways were key tools to their success.

The effect of participation in neoadjuvant clinical trials on outcomes in patients with early breast cancer.

BACKGROUND: Clinical trials can offer novel and more advanced and/or novel treatments to cancer patients in advance of them being approved and available for all patients. While several studies have examined the effect of clinical trial participation on prognosis, there has been no clear conclusion from these studies. Therefore, we chose to test the influence of trial participation on pathological complete response (pCR) and mastectomy rates after neoadjuvant chemotherapy. METHODS: In this retrospective study, all patients treated with neoadjuvant chemotherapy from 2001 to 2014 were selected. A total of 1038 patients with complete treatment, patient, and tumor characteristics were included. A total of 260 of those were treated in clinical trials. We examined whether study participation status in addition to commonly known predictors for pCR improves prediction of pCR. Similar analyses were conducted for the mastectomy rate outcome measure. Finally, survival analyses were also conducted as part of an exploratory analysis. RESULTS: Study participation was an independent predictor of pCR in addition to commonly known predictors. Adjusted odds ratio (OR) for trial participants versus non-participants was 1.53 (95% CI 1.03-2.28). Additionally, study participation improved the prediction of mastectomy risk. The adjusted OR for trial participants versus non-participants was 0.62 (95% CI 0.42-0.90). Subgroup-specific differences concerning the impact of study participation could not be shown for either pCR or mastectomy rate. Survival comparisons could not be conducted due to large differences in follow-up data in patients participating in clinical trials versus those who did not participate; however, pCR was a predictor of prognosis in both groups. CONCLUSION: Patients taking part in neoadjuvant chemotherapy clinical trials have a higher pCR rate and a lower mastectomy risk than patients not participating in clinical trials for their cancer care. This finding is a supporting factor for trial participation in neoadjuvant chemotherapy trials.

Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges.

BACKGROUND: Clinical trials in lung cancer increasingly require patients to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and patient selection have not been fully elucidated. METHODS: The authors retrospectively reviewed data generated by patients who consented to 1 or more interventional lung cancer clinical trials at the University of California-Los Angeles Jonsson Comprehensive Cancer Center between January 2013 and December 2014. Trials were considered to require a biopsy when enrollment was conditional on the procurement of tissue without intervening therapy between procurement and enrollment. RESULTS: In total, 311 patients underwent 368 screening incidents for 1 or more of 19 trials. Trials that required a new biopsy had a longer median screening duration (34 vs 14 days) than trials that did not require a biopsy (P < .001). Trials that required a biopsy had a greater screen failure rate (49.1% vs 26.5%; P < .001), which was largely driven by patients who did not undergo the required biopsy or lacked the required biomarker. Worsening performance status led to the majority of screen failures (56.5%) among biomarker-eligible patients. CONCLUSIONS: Although the scientific benefits of obtaining a new biopsy and requiring specific results for trial enrollment are clear, these requirements lead to a lengthening of the screening period, which, in some patients, is associated with clinical decline before enrollment. Implications for the interpretation of data from studies of this design should be explored. Cancer 2017;123:4800-7. © 2017 American Cancer Society.

Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.

Importance: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course (the ACOSOG is now part of the Alliance for Clinical Trials in Oncology). Objective: To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. Design, Setting, and Participants: The ACOSOG Z0011 phase 3 randomized clinical trial enrolled patients from May 1999 to December 2004 at 115 sites (both academic and community medical centers). The last date of follow-up was September 29, 2015, in the ACOSOG Z0011 (Alliance) trial. Eligible patients were women with clinical T1 or T2 invasive breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases. Interventions: All patients had planned lumpectomy, planned tangential whole-breast irradiation, and adjuvant systemic therapy. Third-field radiation was prohibited. Main Outcomes and Measures: The primary outcome was overall survival with a noninferiority hazard ratio (HR) margin of 1.3. The secondary outcome was disease-free survival. Results: Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3% in the SLND alone group and 83.6% in the ALND group (HR, 0.85 [1-sided 95% CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2% in the SLND alone group and 78.2% in the ALND group (HR, 0.85 [95% CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. Conclusions and Relevance: Among women with T1 or T2 invasive primary breast cancer, no palpable axillary adenopathy, and 1 or 2 sentinel lymph nodes containing metastases, 10-year overall survival for patients treated with sentinel lymph node dissection alone was noninferior to overall survival for those treated with axillary lymph node dissection. These findings do not support routine use of axillary lymph node dissection in this patient population based on 10-year outcomes. Trial Registration: clinicaltrials.gov Identifier: NCT00003855.

Transmission of Babesia microti Parasites by Solid Organ Transplantation.

Babesia microti, an intraerythrocytic parasite, is tickborne in nature. In contrast to transmission by blood transfusion, which has been well documented, transmission associated with solid organ transplantation has not been reported. We describe parasitologically confirmed cases of babesiosis diagnosed ≈8 weeks posttransplantation in 2 recipients of renal allografts from an organ donor who was multiply transfused on the day he died from traumatic injuries. The organ donor and recipients had no identified risk factors for tickborne infection. Antibodies against B. microti parasites were not detected by serologic testing of archived pretransplant specimens. However, 1 of the organ donor's blood donors was seropositive when tested postdonation and had risk factors for tick exposure. The organ donor probably served as a conduit of Babesia parasites from the seropositive blood donor to both kidney recipients. Babesiosis should be included in the differential diagnosis of unexplained fever and hemolytic anemia after blood transfusion or organ transplantation.

Population pharmacokinetic analysis of axitinib in healthy volunteers.

AIMS: Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second line treatment of advanced renal cell carcinoma. The objectives of this analysis were to assess plasma pharmacokinetics and identify covariates that may explain variability in axitinib disposition following single dose administration in healthy volunteers. METHODS: Plasma concentration-time data from 337 healthy volunteers in 10 phase I studies were analyzed, using non-linear mixed effects modelling (nonmem) to estimate population pharmacokinetic parameters and evaluate relationships between parameters and food, formulation, demographic factors, measures of renal and hepatic function and metabolic genotypes (UGT1A1*28 and CYP2C19). RESULTS: A two compartment structural model with first order absorption and lag time best described axitinib pharmacokinetics. Population estimates for systemic clearance (CL), central volume of distribution (Vc ), absorption rate constant (ka ) and absolute bioavailability (F) were 17.0 l h(-1) , 45.3 l, 0.523 h(-1) and 46.5%, respectively. With axitinib Form IV, ka and F increased in the fasted state by 207% and 33.8%, respectively. For Form XLI (marketed formulation), F was 15% lower compared with Form IV. CL was not significantly influenced by any of the covariates studied. Body weight significantly affected Vc , but the effect was within the estimated interindividual variability for Vc . CONCLUSIONS: The analysis established a model that adequately characterizes axitinib pharmacokinetics in healthy volunteers. Vc was found to increase with body weight. However, no change in plasma exposures is expected with change in body weight; hence no dose adjustment is warranted.

Barriers and facilitators of hepatitis C screening among people who inject drugs: a multi-city, mixed-methods study.

BACKGROUND: People who inject drugs (PWID) are at high risk of contracting and transmitting and hepatitis C virus (HCV). While accurate screening tests and effective treatment are increasingly available, prior research indicates that many PWID are unaware of their HCV status. METHODS: We examined characteristics associated with HCV screening among 553 PWID utilizing a free, multi-site syringe exchange program (SEP) in 7 cities throughout Wisconsin. All participants completed an 88-item, computerized survey assessing past experiences with HCV testing, HCV transmission risk behaviors, and drug use patterns. A subset of 362 clients responded to a series of open-ended questions eliciting their perceptions of barriers and facilitators to screening for HCV. Transcripts of these responses were analyzed qualitatively using thematic analysis. RESULTS: Most respondents (88%) reported receiving a HCV test in the past, and most of these (74%) were tested during the preceding 12 months. Despite the availability of free HCV screening at the SEP, fewer than 20% of respondents had ever received a test at a syringe exchange site. Clients were more likely to receive HCV screening in the past year if they had a primary care provider, higher educational attainment, lived in a large metropolitan area, and a prior history of opioid overdose. Themes identified through qualitative analysis suggested important roles of access to medical care and prevention services, and nonjudgmental providers. CONCLUSIONS: Our results suggest that drug-injecting individuals who reside in non-urban settings, who have poor access to primary care, or who have less education may encounter significant barriers to routine HCV screening. Expanded access to primary health care and prevention services, especially in non-urban areas, could address an unmet need for individuals at high risk for HCV.

National surgical quality improvement program underestimates the risk associated with mild and moderate postoperative acute kidney injury.

OBJECTIVES: In a single-center cohort of surgical patients, we assessed the association between postoperative change in serum creatinine and adverse outcomes and compared the American College of Surgeons National Surgical Quality Improvement Program's definition for acute kidney injury with consensus risk, injury, failure, loss, and end-stage kidney and Kidney Disease: Improving Global Outcomes definitions. DESIGN: Retrospective single-center cohort. SETTING: Academic tertiary medical center. PATIENTS: Twenty-seven thousand eight hundred forty-one adult patients with no previous history of chronic kidney disease undergoing major surgery. INTERVENTIONS: Risk, injury, failure, loss, and end-stage kidney defines acute kidney injury as change in serum creatinine greater than or equal to 50% while Kidney Disease: Improving Global Outcomes uses 0.3 mg/dL change from the reference serum creatinine. Since National Surgical Quality Improvement Program defines acute kidney injury as serum creatinine change greater than 2 mg/dL, it may underestimate the risk associated with less severe acute kidney injury. MEASUREMENTS AND MAIN RESULTS: The optimal discrimination limits for both percent and absolute serum creatinine changes were calculated by maximizing sensitivity and specificity along the receiver operating characteristic curves for postoperative complications and mortality. Although prevalence of risk, injury, failure, loss, and end-stage kidney-acute kidney injury was 37%, only 7% of risk, injury, failure, loss, and end-stage kidney-acute kidney injury patients would be diagnosed with acute kidney injury using the National Surgical Quality Improvement Program definition. In multivariable logistic models, patients with risk, injury, failure, loss, and end-stage kidney or Kidney Disease: Improving Global Outcomes-acute kidney injury had a 10 times higher odds of dying compared to patients without acute kidney injury. The optimal discrimination limits for change in serum creatinine associated with adverse postoperative outcomes were as low as 0.2 mg/dL while the National Surgical Quality Improvement Program discrimination limit of 2.0 mg/dL had low sensitivity (0.05-0.28). CONCLUSIONS: Current American College of Surgeons National Surgical Quality Improvement Program definition underestimates the risk associated with mild and moderate acute kidney injury otherwise captured by the consensus risk, injury, failure, loss, and end-stage kidney and Kidney Disease: Improving Global Outcomes criteria.

Barriers and facilitators of universal HIV screening among internal medicine residents.

BACKGROUND: Adoption of universal HIV screening has been low despite national recommendations. OBJECTIVE: To describe the barriers and facilitators to adoption of universal HIV screening in a low-prevalence setting. DESIGN: Qualitative, thematic analysis of focus group discussions among internal medicine residents who introduced universal HIV screening into their primary care practice in Madison, Wisconsin. APPROACH: Deductive and inductive codes constructed a hybridized thematic analysis model. Deductive codes stemmed from a knowledge-attitude-behavior framework for physician nonadherence to guidelines. Inductive codes emerged from the focus group discussions and were embedded into broader deductive codes to provide an HIV-specific model. KEY RESULTS: Residents were knowledgeable and had positive attitudes toward recommendations for universal HIV screening. Residents felt the majority of their patients were receptive to HIV screening, especially when introduced with normalizing techniques and reference to an expert authority such as the Centers for Disease Control and Prevention (CDC). They still perceived patient discussions as challenging due to stigma surrounding HIV and patients' perceptions of being at low risk. Residents employed individualized electronic medical record cues as a memory aid to discuss the issue. CONCLUSION: This qualitative study of internal medicine residents training in an area with low HIV prevalence suggests that stigma and patient perception of being at low risk are barriers that should be addressed to effectively integrate universal HIV screening into primary care.

Using the National Institute on Minority Health and Health Disparities framework to better understand disparities in major amputations.

Recently, the United States experienced its first resurgence of major amputations in more than 20 years. Compounding this rise is a longstanding history of disparities. Patients identifying as non-Hispanic Black are twice as likely to lose a limb as those identifying as non-Hispanic White. Those identifying as Latino face a 30% increase. Rural patients are also more likely to undergo major amputations, and the rural-urban disparity is widening. We used the National Institute on Minority Health and Health Disparities framework to better understand these disparities and identify common factors contributing to them. Common factors were abundant and included increased prevalence of diabetes, possible lower rates of foot self-care, transportation barriers to medical appointments, living in disadvantaged neighborhoods, and lack of insurance. Solutions within and outside the health care realm are needed. Health care-specific interventions that embed preventative and ambulatory care services within communities may be particularly high yield.

Association of rurality and identifying as black with receipt of specialty care among patients hospitalized with a diabetic foot ulcer: a Medicare cohort study.

INTRODUCTION: Rural patients with diabetic foot ulcers, especially those identifying as black, face increased risk of major amputation. Specialty care can reduce this risk. However, care disparities might beget outcome disparities. We aimed to determine whether a smaller proportion of rural patients, particularly those identifying as black, receive specialty care compared with the national proportion. RESEARCH DESIGN AND METHODS: This 100% national retrospective cohort examined Medicare beneficiaries hospitalized with diabetic foot ulcers (2013-2014). We report observed differences in specialty care, including: endocrinology, infectious disease, orthopedic surgery, plastic surgery, podiatry, or vascular surgery. We used logistic regression to examine possible intersectionality between rurality and race, controlling for sociodemographics, comorbidities, and ulcer severity and including an interaction term between rurality and identifying as black. RESULTS: Overall, 32.15% (n=124 487) of patients hospitalized with a diabetic foot ulcer received specialty care. Among rural patients (n=13 100), the proportion decreased to 29.57%. For patients identifying as black (n=21 649), the proportion was 33.08%. Among rural patients identifying as black (n=1239), 26.23% received specialty care. This was >5 absolute percentage points less than the overall cohort. The adjusted OR for receiving specialty care among rural versus urban patients identifying as black was 0.61 (95% CI 0.53 to 0.71), which was lower than that for rural versus urban patients identifying as white (aOR 0.85, 95% CI 0.80 to 0.89). This metric supported a role for intersectionality between rurality and identifying as black. CONCLUSIONS: A smaller proportion of rural patients, particularly those identifying as black, received specialty care when hospitalized with a diabetic foot ulcer compared with the overall cohort. This might contribute to known disparities in major amputations. Future studies are needed to determine causality.

The AANS Harvey Cushing Medal: a demographic and academic analysis of its recipients.

Background: The Harvey Cushing Medal, awarded by the American Association of Neurological Surgeons, is the premier accolade in neurosurgery. The study's purpose was to examine the qualities and accomplishments of previous winners, emphasizing potential selection biases, with the aim to promote social justice and guide young neurosurgeons in their career paths. Results: Predominantly, recipients graduated from top-ranked United States News and World Report institutions and specialized in cerebrovascular and neuro-oncologic/skull base neurosurgery. A significant proportion held roles as department or division chairs and led neurosurgical organizations. All awardees were male, and there was a notable trend of increasing publication counts among more recent recipients. Conclusions: Commonalities among Harvey Cushing Medal winners include graduating from top institutions, holding significant leadership roles, and having an extensive publication history. However, the absence of female and underrepresented minority awardees underscores an urgent need for greater diversity in the selection process.

Associations between specialty care and improved outcomes among patients with diabetic foot ulcers.

OBJECTIVE: Specialty care may improve diabetic foot ulcer outcomes. Medically underserved populations receive less specialty care. We aimed to determine the association between specialty care and ulcer progression, major amputation, or death. If a beneficial association is found, increasing access to specialty care might help advance health equity. RESEARCH DESIGN AND METHODS: We retrospectively analyzed a cohort of Wisconsin and Illinois Medicare patients with diabetic foot ulcers (n = 55,409), stratified by ulcer severity (i.e., early stage, osteomyelitis, or gangrene). Within each stratum, we constructed Kaplan-Meier curves for event-free survival, defining events as: ulcer progression, major amputation, or death. Patients were grouped based on whether they received specialty care from at least one of six disciplines: endocrinology, infectious disease, orthopedic surgery, plastic surgery, podiatry, and vascular surgery. Multivariate Cox proportional hazard models estimated the association between specialty care and event-free survival, adjusting for sociodemographic factors and comorbidities, and stratifying on ulcer severity. RESULTS: Patients who received specialty care had longer event-free survival compared to those who did not (log-rank p<0.001 for all ulcer severity strata). After adjusting, receipt of specialty care, compared to never, remained associated with improved outcomes for all ulcer severities (early stage adjusted hazard ratio 0.34, 95% CI 0.33-0.35, p<0.001; osteomyelitis aHR 0.22, 95% CI 0.20-0.23, p<0.001; gangrene aHR 0.22, 95% CI 0.20-0.24, p<0.001). CONCLUSIONS: Specialty care was associated with longer event-free survivals for patients with diabetic foot ulcers. Increased, equitable access to specialty care might improve diabetic foot ulcer outcomes and disparities.

Regional and racial disparities in major amputation rates among medicare beneficiaries with diabetes: a retrospective study in the southeastern USA.

Objective: While rates for non-traumatic lower extremity amputations (LEA) have been declining, concerns exist over disparities. Our objectives are to track major LEA (MLEA) rates over time among Medicare beneficiaries residing in a high diabetes prevalence region in the southeastern USA (the diabetes belt) and surrounding areas. Methods: We used Medicare claims files for ~900 000 fee-for-service beneficiaries aged ≥65 years in 2006-2015 to track MLEA rates per 1000 patients with diabetes. We additionally conducted a cross-sectional analysis of data for 2015 to compare regional and racial disparities in major amputation risks after adjusting for demographic, socioeconomic, access-to-care and foot complications and other health factors. The Centers for Disease Control and Prevention defined the diabetes belt as 644 counties across Appalachian and southeastern US counties with high prevalence. Results: MLEA rates were 3.9 per 1000 in the Belt compared with 2.8 in the surrounding counties in 2006 and decreased to 2.3 and 1.6 in 2015. Non-Hispanic black patients had 8.5 and 6.9 MLEAs per 1000 in 2006 and 4.8 and 3.5 in 2015 in the Belt and surrounding counties, respectively, while the rates were similar for non-Hispanic white patients in the two areas. Although amputation rates declined rapidly in both areas, non-Hispanic black patients in the Belt consistently had >3 times higher rates than non-Hispanic whites in the Belt. After adjusting for patient demographics, foot complications and healthcare access, non-Hispanic blacks in the Belt had about twice higher odds of MLEAs compared with non-Hispanic whites in the surrounding areas. Discussion: Our data show persistent disparities in major amputation rates between the diabetes belt and surrounding counties. Racial disparities were much larger in the Belt. Targeted policies to prevent MLEAs among non-Hispanic black patients are needed to reduce persistent disparities in the Belt.