The effects of major depression disorder on neurogenic thoracic outlet syndrome surgery outcomes.

OBJECTIVES: Thoracic outlet syndrome (TOS) is a group of disorders caused by impingement of the neurovascular structures at the thoracic outlet. Neurogenic TOS (nTOS), which is thought to be caused by a compression of the brachial plexus, accounts for more than 90% of the cases. Although treatment for nTOS is successful through physiotherapy and/or surgical decompression, little is known about the impact of psychosocial factors, namely, major depressive disorder (MDD), on postoperative outcomes such as non-routine discharge (NRD). Here, we assess whether MDD predicts the type of discharge following nTOS surgical intervention. METHODS: A retrospective analysis of the National Inpatient Sample database from the years 2005-2018 was performed. Using the International Classification of Diseases Clinical Modification, Ninth and Tenth revisions, patients who underwent a surgical intervention for nTOS were identified. Our primary outcome was to investigate the effects of MDD on nTOS patient disposition status after surgical management; secondary outcomes included analysis of total hospital charges and length of stay. NRD was defined as anything beyond discharge home without healthcare services. Univariate and multivariable logistic regression analyses were conducted to assess MDD and other potential independent predictors of NRD and prolonged hospital stay (> 2 days) following surgical intervention. RESULTS: A total of 6099 patients were identified: 596 (9.77%) patients with MDD and 5503 (90.23%) without MDD. On average, patients with MDD were older (39.6 ± 12.0 years vs. 36.0 ± 13.0 years; p < 0.001), female (80.7% vs. 63.5%; p < 0.001), white (89.6% vs. 85.6%; p = 0.030), and on Medicare (9.6% vs 5.2%; p < 0.001). Univariate and multivariable logistic regression models identified MDD as an independent risk factor associated with a higher risk of NRD (adjusted odds ratio [aOR], 1.50; 95% confidence interval [CI], 1.0-2.2). Additionally, chronic kidney disease (aOR, 2.60; 95% CI, 1.2-5.4), postoperative complications (aOR, 1.87; 95% CI, 1.2-2.9), and Medicare (aOR, 2.95; 95% CI, 1.9-4.7) were statistically significant predictors for higher risk of NRD. However, MDD was not associated with prolonged hospital stay (aOR, 1.00; 95% CI, 0.8-1.2) or higher median of total charges (MDD group: $27,867 vs. non-MDD group: $28,123; p = 0.799). CONCLUSION: Comorbid MDD was strongly associated with higher NRD rates following nTOS surgical intervention. MDD had no significant impact on length of hospital stay or total hospital charges. Additional prospective research is necessary in order to better evaluate the impact of MDD in patients with nTOS.

Preoperative Depression is Associated with Worse Outcomes after The Lower Extremity Revascularization.

OBJECTIVE: This retrospective study sought to describe the association between preoperative diagnosis of depression and major adverse events after infrainguinal bypass surgery or peripheral vascular intervention (PVI). METHODS: We retrospectively analyzed a consecutive series of all patients undergoing PVI and/or infrainguinal bypass surgery at a single tertiary institution between 2010 and 2019. Propensity matching and Cox regression analysis were conducted to examine the impact of comorbid depression on the incidence of major adverse events (MAEs), defined as re-intervention, major amputation, or death, within 2 years of surgery. RESULTS: Of all patients (n = 512) undergoing intervention at our institution, 166 (32.4%) suffered an MAE and 169 (33.0%) patients had a preoperative diagnosis of depression. After propensity score matching, univariate (HR, 1.7; 95% CI, 1.1-2.7) and multivariable hazard analyses (aHR, 1.50; [1.1-2.2]) demonstrate that there is a statistically significant relationship between the diagnosis of depression and increased MAE. CONCLUSION: Over one-third of our lower extremity revascularization patients were noted to have a preoperative diagnosis of depression. After intervention, these patients had worse outcomes compared to patients without depression; this finding was more evident in patients who underwent PVI mainly due to high overall mortality rate. Prospective studies are necessary to better understand this association and to ascertain if early intervention can improve post-procedure vascular outcomes.

Reporting of Financial Conflicts of Interest in Studies of Placental Membrane Allografts.

Objective: To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. Approach: A PubMed search identified placental membrane allograft studies published between 2015 and 2019. Industry payments were collected using the Centers for Medicare & Medicaid Services Open Payments database. Self-declared COI were compared with recorded payments. Risk factors for positive product recommendation were determined at study and author levels. Results: Eighty-nine studies (417 authors) were identified. Seventy-five studies (84%) had at least one author receive undisclosed payments. From 2015 to 2019, 5,841 general payments (totaling $15,558,026) and 1,234 research payments (totaling $18,290,062) were made by 46 companies. Travel/lodging was the most commonly reported transaction (34%). Authors were comprised mostly of podiatrists (27%), plastic surgeons (15%), and orthopedic surgeons (15%). Comparative studies were less likely to have a positive product recommendation compared to noncomparative studies (odds ratio [OR] 0.204, 95% confidence interval 0.06-0.066, p = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. Innovation: The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. Conclusion: The majority of placental membrane product studies did not declare all industry payments. Whether these payments represent "relevant COI" remains unclear. In addition, not all placental product companies report to the Open Payments database, suggesting that the issue may be even more significant. This study highlights the need for improved definitions of "relevant COI," a standardized reporting system across journals, and the uniform participation of all medical product vendors.

An Analysis of Guideline Consensus for the Prevention, Diagnosis, and Management of Diabetic Foot Ulcers.

BACKGROUND: Multiple organizations have issued guidelines to address the prevention, diagnosis, and management of diabetic foot ulcers (DFUs) based on evidence review and expert opinion. We reviewed these guidelines to identify consensus (or lack thereof) on the nature of these recommendations, the strength of the recommendations, and the level of evidence. METHODS: Ovid, PubMed, Web of Science, Cochrane Library, and Embase were searched in October 2018 using the MESH term diabetic foot, the key word diabetic foot, and the filters guideline or practice guideline. To minimize recommendations based on older literature, guidelines published before 2012 were excluded. Articles without recommendations characterized by strength of recommendation and level of evidence related specifically to DFU were also excluded. A manual search for societal recommendations yielded no further documents. Recommendations were ultimately extracted from 12 articles. Strength of evidence and strength of recommendation were noted for each guideline recommendation using the Grading of Recommendations Assessment, Development, and Evaluation system or the Centre for Evidence-Based Medicine system. To address disparate grading systems, we mapped the perceived level of evidence and strength of recommendations onto the American Heart Association guideline classification schema. RESULTS: Recommendations found in two or more guidelines were collected into a clinical checklist characterized by strength of evidence and strength of recommendation. Areas for future research were identified among recommendations based on minimal evidence, areas of controversy, or areas of clinical care without recommendations. CONCLUSIONS: Through this work we developed a multidisciplinary set of DFU guidelines stratified by strength of recommendation and quality of evidence, created a clinical checklist for busy practitioners, and identified areas for future focused research. This work should be of value to clinicians, guideline-issuing bodies, and researchers. We also formulated a method for the review and integration of guidelines issued by multiple professional bodies.

A systematic review of guidelines for lymphedema and the need for contemporary intersocietal guidelines for the management of lymphedema.

OBJECTIVE: Lymphedema (LED) affects an estimated 35 million patients in the United States and a staggering 140,200 million people worldwide, yet LED is the forgotten vascular disease. Whereas the diagnosis and treatment of arterial and venous diseases have been strengthened by the development of clinical practice guidelines (CPGs), few CPGs are available for LED. Moreover, for CPGs to have their greatest impact, they should be both of high quality and developed using the most rigorous evidence-based methods. We performed a systematic review of the available CPGs for LED, which were assessed for breadth of content and methodologic strength. METHODS: A literature search was conducted from National Guideline Clearinghouse (www. GUIDELINES: gov), BMJ Clinical Evidence (http://clinicalevidence.bmj.com), and National Institute for Health and Care Excellence (http://www.nice.org.uk) as well as from MEDLINE and Google, which selected 245 documents. After a horizon scan that identified 13 potential CPGs, 4 satisfied the criteria for LED. These were analyzed for inclusion of key elements of diagnosis and treatment. RESULTS: A horizon scan (abstract review) of the 245 documents identified 10 potential CPGs. Of the 10 documents, 6 claimed to be CPGs, but 2 were limited in scope (rehabilitation or compression only), 2 were consensus statements, 1 was a position statement, and 1 was a systematic review. This process yielded four CPGs: Lymphedema Framework Best Practice for the Management of Lymphedema; Japanese Lymphedema Study Group-A Practice Guideline for the Management of Lymphedema; Clinical Resource Efficiency Support Team Guidelines for the Diagnosis, Assessment and Management of Lymphedema; and Guidelines of the American Venous Forum. Only one of four CPGs was based on a contemporary systematic review (2016 end date of references), whereas the remainder had older systematic reviews (end dates of 2005, 2007, and 2007). Several areas of contemporary diagnosis, treatment, and monitoring of LED were absent. CONCLUSIONS: This systematic review of available LED CPGs demonstrates a limited number of guidelines. The four CPGs identified lack contemporary references while demonstrating low overall study quality. Therefore, it is imperative for our vascular societies to develop contemporary high-quality evidence-based CPGs for LED, as they have for other vascular diseases.

A systematic review of the quality of clinical practice guidelines for lymphedema, as assessed using the Appraisal of Guidelines for Research and Evaluation II instrument.

OBJECTIVE: We assessed the quality of current clinical practice guidelines (CPGs) for lymphedema using the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. CPGs provide recommendations for the management of medical conditions such as lymphedema. However, their evidentiary quality and methodology should determine their reliability. The AGREE II instrument was developed to externally and objectively evaluate the quality of CPGs and has been used to assess other nonvascular CPGs. A systematic review identified four CPGs for lymphedema of varying content: Lymphedema Framework's Best Practice for the Management of Lymphedema (LED F); Japanese Lymphedema Study Group-A Practice Guideline for the Management of Lymphedema (J LED); Clinical Resource Efficiency Support Team (CREST) Guidelines for the Diagnosis, Assessment and Management of Lymphedema; and Guidelines of the American Venous Forum (AVF). The quality of these CPGs appeared to vary. METHODS: The four CPGs were analyzed using the AGREE II instrument by three independent graders, who were unaware of each other's scores. Six domains with 23 items were graded using a Likert scale (1, strongly disagree; to 7, strongly agree) regarding whether the CPG had satisfied the requirements of each item. The score for each domain was calculated by summing the scores for each item in that domain and scaling the total as a percentage of the maximum possible score for that domain (ie, obtained score - minimum score/maximum possible score - minimum possible score × 100 = percentage). RESULTS: CREST had the highest overall score (66.8%), as an average of all domains, and J LED had the lowest (37%). CREST also had five of five domains rated >50%. In contrast, J LED had only one and AVF had only two domains that scored >50%. Although two domains, rigor of development and applicability, scored low, with only one CPG scoring >50%, the editorial independence domain scored the lowest of all six domains. CONCLUSIONS: In addition to limitations in content and the lack of contemporary references, the four CPGs studied were judged objectively to be of low quality using the AGREE II instrument. A contemporary CPG for lymphedema, guided by the AGREE II requirements, is needed.

How ESKD complicates the management of diabetic foot ulcers: The vital role of the dialysis team in prevention, early detection, and support of multidisciplinary treatment to reduce lower extremity amputations.

Diabetic foot ulcers do not heal as well in ESKD as in the absence of kidney failure, and rates of recurrent foot ulcers, as well as lower extremity amputation, are higher. This review of the literature highlights the vital role of the dialysis team in prevention, early detection, and support of treatment of diabetic foot ulcers. Our review has five goals-(a) increase nephrologists' understanding of the high morbidity and mortality associated with chronic foot ulcers and (lower extrimity) LE amputations in ESKD; (b) promote nephrologists' understanding of grading systems for diabetic foot ulcer severity, in order to expedite communication with local diabetic foot experts; (c) promote collaboration between nephrologists and infectious disease specialists regarding the dose, route, and delivery logistics of intravenous antibiotics for infected chronic foot ulcers, in particular in the presence of osteomyelitis and other deep-seated infections; (d) increase the awareness of dialysis nurses, technicians, dietitians, social workers and administrators regarding evidence-based and multidisciplinary approaches to patients' diabetic foot ulcers; (e) encourage the application of published works integrating patient-centered diabetic foot education into the dialysis setting to reduce lower extremity amputations.

2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

A panel of experts was convened by the Infectious Diseases Society of America to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.

2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

A panel of experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.

Where is the leak in the pipeline? Investigating gender differences in academic promotion at an academic medical centre.

BACKGROUND: Women are still under-represented in the senior ranks of academic medicine. As local surveys represent a critical initial step in addressing the challenges of gender disparities in academic promotion within institutions, we surveyed faculty at an academic medical centre to identify factors to improve the academic advancement of women. METHODS: We conducted an electronic survey of all full-time faculty members in a Department of Medicine assessing academic rank and factors important in consideration for promotion. RESULTS: 106 faculty members (46 %) responded to the survey; 40 % of the respondents were women. There was a statistically significant gender gap in faculty rank (p = 0.002), with only 2 of 17 full professor positions occupied by women. Among faculty who had not yet requested promotion, women were more likely to report that they did not think an academic promotion would benefit them (69 vs. 32 % in men, p = 0.01), and to report a lack of encouragement for requesting promotion (50 vs. 29 %, p = 0.08). CONCLUSIONS: Targeting the perceived value of academic promotion among women faculty, increasing junior faculty mentorship and modifying annual review processes could address gender disparities in academic medicine ranks.

Does electronic medication reconciliation at hospital discharge decrease prescription medication errors?

PURPOSE: Medication errors are an important patient safety issue. Electronic medication reconciliation is a system designed to correct medication discrepancies at transitions in healthcare. The purpose of this paper is to measure types and prevalence of intravenous antibiotic errors at hospital discharge before and after the addition of an electronic discharge medication reconciliation tool (EDMRT). DESIGN/METHODOLOGY/APPROACH: A retrospective study was conducted at a tertiary hospital where house officers order discharge medications. In total, 100 pre-EDMRT and 100 post-EDMRT subjects were randomly recruited from the study center's clinical Outpatient Parenteral Antimicrobial Therapy (OPAT) program. Using infectious disease consultant recommendations as gold standard, each antibiotic listed in these consultant notes was compared to the hospital discharge orders to ascertain the primary outcome: presence of an intravenous antibiotic error in the discharge orders. The primary covariate of interest was pre- vs post-EDMRT group. After generating the crude prevalence of antibiotic errors, logistic regression accounted for potential confounding: discharge day (weekend vs weekday), average years of practice by prescribing physician, inpatient service (medicine vs surgery) and number of discharge mediations per patient. FINDINGS: Prevalence of medication errors decreased from 30 percent (30/100) among pre-EDMRT subjects to 15 percent (15/100) errors among post-EDMRT subjects. Dosage errors were the most common type of medication error. The adjusted odds ratio of discharge with intravenous antibiotic error in the post-EDMRT era was 0.39 (0.18, 0.87) compared to the pre-EDMRT era. In the adjusted model, the total number of discharge medications was associated with increased OR of discharge error. ORIGINALITY/VALUE: To the authors' knowledge, no other study has examined the impact of reconciliation on types and prevalence of medication errors at hospital discharge. The focus on intravenous antibiotics as a class of high-stakes medications with serious risks to patient safety during error events highlights the clinical importance of the findings. Electronic medication reconciliation may be an important tool in efforts to improve patient safety.

Comparative outcomes of ß-lactam antibiotics in outpatient parenteral antibiotic therapy: treatment success, readmissions and antibiotic switches.

OBJECTIVES: ß-Lactam antibiotics are commonly used in outpatient parenteral antimicrobial therapy (OPAT), but data regarding outcomes of long-term therapy are limited. The purpose of this study was to compare treatment success, readmission and antibiotic switch rates in patients treated with ß-lactam antibiotics as OPAT. METHODS: We carried out a retrospective review of all patients, discharged from Tufts Medical Center with cefazolin, ceftriaxone, ertapenem or oxacillin, between January 2009 and June 2013. A competing risks analysis was used to compare the cumulative incidence of first occurrence of treatment success, antibiotic switch and 30 day readmission for each drug. RESULTS: Four hundred patients were identified (cefazolin n = 38, ceftriaxone n = 104, ertapenem n = 128 and oxacillin n = 130). Baseline demographics were similar. Treatment success rates were higher for ceftriaxone and ertapenem (cefazolin 61%, ceftriaxone 81%, ertapenem 73% and oxacillin 58%; P < 0.001). Thirty-day all-cause readmissions were similar (cefazolin 21%, ceftriaxone 14%, ertapenem 20% and oxacillin 15%; P = 0.46). In 400 OPAT courses, 37 out of 50 antibiotic switches were accomplished without readmission. Adverse drug events (ADEs) were the most common reason for outpatient antibiotic switches (31/37, 84%). The ADE rate was higher for the oxacillin group (cefazolin 2.0 versus ceftriaxone 1.5 versus ertapenem 2.9 versus oxacillin 8.4 per 1000 OPAT days; P < 0.001). CONCLUSIONS: OPAT with ß-lactam antibiotics is effective, but antibiotic switches for adverse events were more frequent with oxacillin use. Clinicians should be cognizant of the risk of readmissions and ADEs in OPAT patients, as the value of OPAT lies in reducing patient morbidity and readmissions by managing ADEs and preventing clinical failures.

A national survey of infectious disease practitioners on their use of outpatient parenteral antimicrobial therapy (OPAT).

BACKGROUND: The use of outpatient parenteral antimicrobial therapy (OPAT) is standard medical practice; however, significant heterogeneity in practice exists. We hypothesized that formal OPAT programs are associated with increased physician participation in patient safety activities. METHODS: United States Infectious Disease (ID) physicians were contacted and asked to participate in an electronic survey from April through June 2012. Data were analyzed using SPSS version 20. RESULTS: In all, 3718 physicians were contacted and 316 (8.5%) responded. Respondents practice in 47 states; the majority (79%) practice adult ID, 11% pediatric ID, 10% a combination of the two. Sixty percent reported that ID consultation was not mandatory before OPAT, and 75% of these respondents thought it should be compulsory. The most common indications were osteomyelitis, prosthetic joint infections, and endocarditis, and the most common antibiotics were vancomycin, ceftriaxone, and ertapenem. Most respondents (59%) discharge patients with OPAT weekly, and have a median number of 11 OPAT patients (95% confidence interval (CI) 8.5-13.4). Half of respondents have a formal OPAT program. Fifty-two percent report no systematic method of communication between inpatient and outpatient physicians when patients are discharged with OPAT, 49% have no systematic method of lab tracking, and 34% have no method of ensuring patient adherence to clinic visits. All of these patient safety measures were more likely to be present in practice sites with formal OPAT programs (p < 0.001). CONCLUSIONS: Opportunities exist for improving OPAT monitoring and patient safety. Formal OPAT programs provide the framework for safe and effective care and are to be encouraged.

Prediction model for 30-day hospital readmissions among patients discharged receiving outpatient parenteral antibiotic therapy.

BACKGROUND: Factors associated with readmission for patients prescribed outpatient parenteral antibiotic therapy (OPAT) at hospital discharge have not been definitively identified. The study aim was to develop a model of 30-day readmissions for OPAT patients. METHODS: A database comprising 782 OPAT patients treated between 2009 and 2011 at a single academic center was created. Variables collected included patient demographics, comorbidities, infections, and antibiotic classes. Final model discrimination was assessed using the c-statistic, and calibration was examined graphically. RESULTS: Mean patient age was 58 years (range, 18-95 years), 43% were women, and the most common diagnoses were bacteremia (24%), osteomyelitis (20%), and pyelonephritis (13%). The unplanned 30-day readmission rate was 26%. The leading indications for readmission were non-infection related (30%), worsening infection (29%), and new infection (19%). The final regression model consisted of age (odds ratio [OR], 1.09 per decade; 95% confidence interval [CI], 0.99-1.21), aminoglycoside use (OR, 2.33; 95% CI, 1.17-4.57), resistant organisms (OR, 1.57; 95% CI, 1.03-2.36), and number of prior hospital discharges without intravenous antibiotics in the past 12 months (OR, 1.20 per prior admission; 95% CI, 1.09-1.32). The c-statistic was 0.61 and the highest-risk quintile of patients had almost a 3-fold higher rate of readmission compared to the lowest. CONCLUSIONS: Patients prescribed OPAT are at risk for readmission. A subgroup of patients at especially high risk can be identified using easily obtainable clinical characteristics at the time of hospital discharge. More intensive interventions to prevent OPAT readmissions should be targeted and tested with those at highest risk.

Are we ready for an outpatient parenteral antimicrobial therapy bundle? A critical appraisal of the evidence.

Healthcare "bundles" have been developed to help providers improve the reliability and delivery of essential healthcare processes. Bundles have been shown to be effective in reducing healthcare-associated infection rates and are increasingly used to ensure the quality of patient care. Outpatient parenteral antimicrobial therapy (OPAT) is now standard medical practice in the treatment of a wide variety of infections. We review 6 components that we believe comprise an OPAT bundle and the evidence supporting each: patient selection, infectious disease consultation, patient/caregiver education, discharge planning, outpatient monitoring/tracking, and OPAT program review. To ensure that patients are receiving optimal care, further program development and outcomes research should target these bundle components to bring the evidence base up to date with current medical practices.

Systemic antibody responses to the immunodominant p23 antigen and p23 polymorphisms in children with cryptosporidiosis in Bangladesh.

Cryptosporidium is a major cause of diarrhea in children in developing countries. However, there is no vaccine available and little is known about immune responses to protective antigens. We investigated antibody responses to p23, a putative vaccine candidate, in children in Bangladesh with cryptosporidiosis and diarrhea (cases) and uninfected children with diarrhea (controls), and p23 gene polymorphisms in infecting species. Serum IgM, IgG, and IgA responses to p23 were significantly greater in cases than controls after three weeks of follow-up. Cases with acute diarrhea had significantly greater serum IgA and IgM responses than those with persistent diarrhea, which suggested an association with protection from prolonged disease. The p23 sequences were relatively conserved among infecting species and subtype families. Although most children were infected with Cryptosporidium hominis, there was a cross-reactive antibody response to C. parvum antigen. These results support further development of p23 as a vaccine candidate.

Antibody responses to the immunodominant Cryptosporidium gp15 antigen and gp15 polymorphisms in a case-control study of cryptosporidiosis in children in Bangladesh.

Although Cryptospridium hominis is the dominant Cryptosporidium species infecting humans, immune responses to cognate antigens in C. hominis-infected persons have not been reported. We investigated antibody responses to the immunodominant gp15 antigen from C. hominis and C. parvum, in C. hominis-infected Bangladeshi children less than five years of age with diarrhea (cases) and uninfected children with diarrhea (controls). We also investigated polymorphisms in the C. hominis gp15 sequence from cases. Serum IgG responses to gp15 from both species were significantly greater in cases than controls. In spite of polymorphisms in the gp15 sequence, there was a significant correlation between antibody levels to gp15 from both species, indicating cross-reactivity to conserved epitopes. Cases with acute diarrhea had a significantly greater serum IgA response to gp15 compared with those with persistent diarrhea, suggesting that this response may be associated with protection from prolonged disease. These findings support further investigation of gp15 as a vaccine candidate.