Comparison of endovascular therapies for chronic limb-threatening ischemia and claudication.

OBJECTIVE: Analysis of regional data from the Vascular Quality Initiative (VQI) suggested improved survival for patients undergoing stent placement compared with balloon angioplasty and atherectomy. Using national data from the VQI linked to Medicare claims data through the Vascular Implant Surveillance and Interventional Outcomes Network program, this study aimed to compare the rates of mortality, reintervention, and amputation after endovascular interventions (atherectomy, stenting, and balloon angioplasty) for two separate cohorts: patients with chronic limb-threatening ischemia (CLTI) and patients with claudication. METHODS: This was a secondary data analysis of Society for Vascular Surgery National VQI data linked to Medicare claims, between October 2016 and December 2019. Patients aged ≥65 years with symptoms of claudication or CLTI and a diagnosis of occlusive disease were included. Urgent or emergent interventions or those with concurrent procedures (endarterectomy, bypass, or bilateral intervention) were excluded. Interventions were grouped into (1) balloon angioplasty only; (2) stent (with or without balloon angioplasty); or (3) atherectomy (alone, with or without stent, with or without balloon angioplasty). Propensity score-matched cohorts were constructed to conduct pairwise intervention comparisons of mortality, reintervention, and amputation rates. Multivariable logistic regression was used to derive propensity scores for each patient. Kaplan-Meier estimates and Cox proportional hazards ratios (HRs) (95% confidence interval [CI]) analyses were performed. RESULTS: A total of 9785 (2665 claudication, 7120 CLTI) eligible patients were identified. After propensity score matching for the CLTI group, 2826, 3608, and 2796 pairs of cases were used to compare balloon angioplasty vs atherectomy, balloon angioplasty vs stent, and stent vs atherectomy, respectively. No statistically significant difference in mortality was observed among all interventions. However, atherectomy was associated with a significant increase in reintervention rate compared with balloon angioplasty (HR, 1.22; 95% CI, 1.06-1.39; P = .01) and compared with stenting (HR, 1.27; 95% CI, 1.10-1.46; P < .01) within the first year after the index procedure. Of note, both atherectomy (HR, 0.82; 95% CI, 0.68-0.98; P < .05) and stenting (HR, 0.76; 95% CI, 0.64-0.90; P < .01) showed lower rates of major amputation when compared with balloon angioplasty within 1 year after the index procedure. In the claudication group, there were no significant differences observed among interventions for peripheral arterial disease for mortality, reintervention, or amputation rates. CONCLUSIONS: Further studies are needed to identify appropriate indications for atherectomy, because there may be a subset of patients with CLTI who benefit from this therapy with respect to amputation rates. Until then, caution should be exercised when using atherectomy because it is also associated with higher reintervention rates.

Impact of Anesthesia selection on Post-Op Pain Management in Operatively treated Hip Fractures.

OBJECTIVES: To determine if the use of Peripheral Nerve Block (PNB) versus Local Infiltration Analgesia (LIA) for hip fracture patients, affected opioid consumption in the early post-operative period. DESIGN: Retrospective cohort study SETTING: Two level 1 trauma centers PATIENTS/INTERVENTION: 588 patients with surgically treated AO/OTA 31A and 31B fractures between February 2016-October 2017 were included. 415 (70.6%) received general anesthesia (GA) alone, 152 received GA plus perioperative PNB (25.9%), and 21 had GA plus LIA intra-operatively (3.6%). Median age was 82 years; predominantly female (67%) and AO/OTA 31A fractures (55.37%). MAIN OUTCOME MEASURES: Morphine Milligram Equivalents (MME) at 24 and 48 hours postoperatively, length of stay (LOS) and the occurrence of any complication after surgery RESULTS: The PNB cohort was less likely to use any opioid than the GA group at 24 and 48 hours postoperatively (OR: 0.36, 95% CI: 0.22-0.61 and OR: 0.56, 95% CI: 0.35-0.89 respectively). LOS ≥ 10 days had 3.24 times the odds of 24- and 48-hour opioid administration compared to LOS ≤ 10 days (OR: 3.24, 95% CI 1.11-9.42; OR: 2.98, 95% CI 1.38-6.41, respectively). The most common complication was post-operative delirium, with PNB more likely to present with any complication compared to GA (OR= 1.88, 95% CI 1.09-3.26). There was no difference when comparing LIA to general anesthesia. CONCLUSIONS: Our findings suggest PNB for hip fracture can help limit the use of post-operative opioids with adequate pain relief. Regional analgesia does not seem to avoid complications such as delirium.

Predictive factors for operative intervention and ideal length of non-operative trial in adhesive small bowel obstruction.

BACKGROUND: Small bowel obstruction (SBO) is responsible for 350,000 U.S. hospitalizations and costs ~ $2.3 billion annually. The current standard of care for SBO is to trial 3 to 5 days of non-operative management. This study evaluated the factors associated with operative management. METHODS: This retrospective cohort study included adult patients admitted with adhesive SBO. Exclusions were for operative intervention within 24 h or death. RESULTS: At baseline (N = 360), mean age was 65.9 years, 57.8% female, 72.3% white, mean BMI 26.1, 38.7% with history of SBO and 98.1% had history of abdominal surgery. Symptom onset prior to hospitalization was 1-2 days. 55.6% had successful non-operative management at discharge (median length of stay 3 days) vs. 44.4% operative conversion. In univariate analyses, BMI, SBO history, surgical history, days symptom onset, vitals, abdominal pain, obstipation, acute kidney injury, and lack of small bowel feces sign on CT scan were significantly associated with operative management. In a multivariable logistic regression, after controlling all other variables, a lack of small bowel feces sign (adjusted odds ratio, aOR = 2.25, 95% CI 1.06-4.77, p = 0.04) and history of exploratory laparotomy (aOR = 0.44, 95% CI 0.21-0.90, p = 0.03) were significantly associated with operative management. Time from admission to surgery averaged 3.89 days: small bowel resection (55/160) was 4.9 days (median = 4), compared to patients without resection (3.4 days, median = 2; p = 0.00; OR = 1.2, 95% CI 1.07-1.35). CONCLUSIONS: A lack of small bowel feces sign can be a potential indicator for operative management and should be further explored. Since the median resolution of symptoms in the non-operative management group was ~ 2 days and a 20% higher odds for bowel resection each day surgery is delayed, the conservative trial period for adhesive SBO should not exceed 3 days.

Utilization of Neoadjuvant Therapy in Gastrointestinal Stromal Tumors of the Stomach: Analysis of the 2006-2018 National Cancer Database.

BACKGROUND: Neoadjuvant tyrosine kinase inhibitor (TKI) therapy has reduced tumor burden and improved survival in both primary and recurrent gastrointestinal stromal tumors (GISTs). However, no clear guidelines exist on optimal patient selection for neoadjuvant therapy (NAT). Our aim was to analyze factors and outcomes associated with the therapeutic sequence of TKI therapy before and/or after surgery for gastric GISTs. METHODS: We performed a retrospective study of patients surgically treated for a gastric GIST utilizing the 2006-2018 National Cancer Database. We examined demographic, clinical, and pathological characteristics associated with NAT versus adjuvant therapy (AT) using logistic regression. RESULTS: Of the 3732 patients, 20.4% received NAT and 79.6% had AT. Among patients receiving therapy, NAT significantly increased over our study period (12% to 30.7%). A majority of the AT group received a partial gastrectomy (77.9%) compared with the NAT group who received more near-total/total gastrectomy or gastrectomy with en bloc resection (p < 0.001). In a multivariable model, patients were more likely to receive NAT when insured (private, aOR: 2.37, 95% CI: 1.31-4.29), treated at an academic/research program (aOR: 1.83, 95% CI: 1.49-2.56), had tumors located in the proximal stomach (aOR: 1.40, 95% CI: 1.06-1.86), tumor size > 10 cm (aOR: 1.88, 95% CI: 1.41-2.51), and received near-total/total gastrectomy (aOR: 1.81, 95% CI: 1.42-2.29). There were no differences in outcomes. CONCLUSION: NAT for gastric GIST has increased in utilization. NAT was used in patients with larger tumors and who underwent more extensive resection. Despite these factors, outcomes were similar to patients receiving only AT. More studies are required to determine the therapeutic sequence for gastric GISTs.

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials.

INTRODUCTION: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. METHODS: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. RESULTS: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. DISCUSSION: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Wound care practices after orthopaedic trauma surgery are highly variable and not evidence based.

OBJECTIVE: Given the tremendous medical, social and financial costs of surgical site infections, the pressure to minimize these complications has been mounting. There remains a substantial gap in evidence-based practice for postoperative wound care after orthopaedic trauma surgery. The purpose of this study is to determine what standards are currently in practice for postoperative wound management. METHODS: A 16-question web-based survey was published on the Orthopaedic Trauma Association website and disseminated to members through the association's quarterly email. The survey gathered data on postoperative wound care practices; specifically, when wound checks are performed, and when providers allow patients to get the incisions wet. RESULTS: 102 Orthopaedic surgeons completed the survey. Ninety-one percent were trauma fellowship trained, and 95% worked at either a Level I (76%) or Level II (19%) trauma center. There were over 100 different proposed protocols captured by the survey. The majority of surgeons (54%) perform a wound check within the first three days after surgery. Additionally, half of surgeons (50%) do not permit patients to get their incisions wet until sutures and staples are removed. CONCLUSION: Wound care routines following surgical management of orthopaedic trauma injuries are highly variable. Diverse protocols are performed at the discretion of the treating surgeon without scientific basis. This study defines immense variability in one aspect of peri-operative care that could play an important role in surgical site infections and provides a foundation for future studies to explore the potential influence of standardized wound care routines on post-operative infections and wound healing.

Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial.

Importance: Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective: To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions: A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures: The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results: The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance: Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

Managing work flow in high enrolling trials: The development and implementation of a sampling strategy in the PREPARE trial.

INTRODUCTION: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. METHODS: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. RESULTS: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001). CONCLUSIONS: Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.

Engaging patients as partners in a multicentre trial of spinal versus general anaesthesia for older adults.

Engaging patients-defined broadly as individuals with lived experience of a given condition, family members, caregivers, and the organisations that represent them-as partners in research is a priority for policymakers, funders, and the public. Nonetheless, formal efforts to engage patients are absent from most studies, and models to support meaningful patient engagement in clinical anaesthesia research have not been previously described. Here, we review our experience in developing and implementing a multifaceted patient engagement strategy within the Regional Versus General Anesthesia for Promoting Independence After Hip Fracture (REGAIN) surgery trial, an ongoing randomised trial comparing spinal vs general anaesthesia for hip fracture surgery in 1600 older adults across 45 hospitals in the USA and Canada. This strategy engaged patients and their representatives at both the level of overall trial oversight and at the level of individual recruiting sites. Activities spanned a continuum ranging from events designed to elicit patients' input on key decisions to longitudinal collaborations that empowered patients to actively participate in decision-making related to trial design and management. Engagement activities were highly acceptable to participants and led to concrete changes in the design and conduct of the REGAIN trial. The REGAIN experience offers a model for future efforts to engage patients as partners in clinical anaesthesia research, and highlights potential opportunities for investigators to increase the relevance of anaesthesia studies by incorporating patient voices and perspectives into the research process.

Intramedullary Nailing of Open Tibial Fractures: Provisional Plate Fixation.

Tibia fracture is the most common type of long bone fracture, and intramedullary nailing is the preferred treatment. In open fractures, a provisional plate is often used to maintain reduction. It is unknown whether this practice increases the risk of infection or other complications. This study retrospectively compared patients who were treated at a level 1 trauma center with intramedullary nailing of an open tibia fracture. Patients who were included: (1) were 18 years or older; (2) were treated between January 1, 2005, and June 30, 2013; (3) had an open fracture of the tibia; and (4) were treated operatively with intramedullary nailing, with or without provisional plate fixation. Patient sex, history of diabetes, history of smoking, mechanism of injury, and side of injury were analyzed. Postoperative complications included infection, delayed union or non-union, compartment syndrome, and death. After the authors controlled for age, Gustilo-Anderson type, and AO/Orthopaedic Trauma Association classification, they found that provisional plate use did not significantly increase the risk of infection (adjusted odds ratio, 1.64; 95% confidence interval, 0.51-5.32; P=.41) or any other complications (adjusted odds ratio, 1.24; 95% confidence interval, 0.46-3.35; P=.67). In the subgroup of patients who had a provisional plate (n=35), removal of the plate did not significantly decrease the risk of infection (adjusted odds ratio, 0.43; 95% confidence interval, 0.07-2.69; P=.36) or other complications (adjusted odds ratio, 0.55; 95% confidence interval, 0.12-2.46; P=.44). In open tibia fractures treated with intramedullary nailing, provisional plate stabilization, a valuable reduction aid, did not increase the risk of infection or other complications. Because of the small subgroup size, however, definitive conclusions cannot be drawn about removal of these provisional plates. [Orthopedics. 2016; 39(5):e931-e936.].

Examining the health information-seeking behaviors of Korean Americans.

Many Korean Americans suffer from high levels of cancer incidence and have low cancer screening rates. A significant number of Korean Americans lack adequate information about cancer screening tests. However, little is known about their health behaviors. This article examines exposure to mass media and health information-seeking behaviors for Korean Americans, and their associations with demographic characteristics influencing variations in exposure to the different health information and trust in health information sources. The authors gathered data for this study using a cross-sectional, community-based survey conducted in the Washington, DC, metropolitan area during 2006 and 2007. It was administered to 254 Korean Americans who were 40 years of age or older. This study is part of the first health-related program of research to study exposure to mass media, health and cancer information sources, and seeking preferences and experiences of Korean Americans. Results indicated that Korean ethnic media sources and Internet are important sources used regularly. Age, years of education completed, and English proficiency levels for Korean Americans significantly predicted the likelihood of their Internet use. Low-income Korean Americans with less education were more likely to seek health information in Korean ethnic magazines and newspapers, whereas Korean Americans with higher education and English proficiency were more likely to seek information online. The most trusted source of health information among respondents was from a doctor or other health care professional. Future research should be conducted to determine whether physicians are actually used as a primary source for health information.

Cancer information seeking and awareness of cancer information sources among Korean Americans.

Many Korean Americans (KAs) suffer high cancer incidence levels and have low cancer screening rates. A significant number of KAs lack adequate information about cancer screening tests. However, little is known about the health information seeking behaviors of KAs. This study examines the types of cancer information searched for, the cancer information seeking experiences, and the awareness of major cancer information sources, such as the National Cancer Institutes (NCI) and the NCI's Cancer Information Service, among KAs. It also examines associations with demographic characteristics and media use influencing variations in the awareness of cancer information sources. Data for this study were gathered with a cross-sectional, community-based survey (254 KAs). The survey results indicated that KA's involvement in cancer information seeking is relatively low, and they have somewhat negative experiences in seeking cancer information. In addition, their awareness of cancer information sources was limited. Despite of the heavy use of Korean ethnic media, it did not connect to cancer information source awareness. Rather, use of US mainstream media was significantly related with awareness. Campaigns using the Korean language through partnerships with Korean ethnic media to inform KAs about credible sources of health information appear to be warranted by our findings.

Health-related quality of life in patients with chronic hepatitis B.

UNLABELLED: Although chronic hepatitis C (CH-C) has consistently been shown to impair patients' health-related quality of life (HRQL), the impact of chronic hepatitis B (CH-B) on HRQL has not been fully explored. AIM: Compare HRQL between patients with CH-B, CH-C, primary biliary cirrhosis (PBC) and healthy controls. DESIGN: Three HRQL questionnaires [Chronic Liver Disease Questionnaire (CLDQ), Short Form 36 (SF-36) and the Health Utility Index (HUI Mark-2 and Mark-3)] were administered prospectively. Additional clinical and laboratory data and normative data for healthy individuals, were available. ANALYSIS: Scores were compared using analysis of variance and multiple regression. RESULTS: One hundred and forty-six patients with CH-B, CH-C and PBC were included [mean age 47.1 years (+/-11.6), 41% female, 33% cirrhosis]. CH-C and PBC patients scored the lowest on all CLDQ, SF-36 and HUI domains compared with CH-B patients and healthy controls. CH-B patients had scores similar to the healthy population, measured by most CLDQ and SF-36 scales. However, the HUI scores for CH-B patients showed more impairment than population norms. Having CH-B and not having cirrhosis were predictive of utility and HRQL scores in multivariate models. CONCLUSIONS: CH-B patients have better HRQL than CH-C, PBC and population norms. CH-B patients' overall utility scores are lower than population norms.

Anger experiences among hepatitis C patients: relationship to depressive symptoms and health-related quality of life.

The authors examined anger among hepatitis C (HCV) patients and its relationship to health-related quality of life (HRQL) and depression. Eighty-seven HCV patients who received pegylated interferon-alpha(2b) and ribavirin were included. Patients' mean age was 48 years; 42% were women, and 60% were white. Patients experienced moderate anger while undergoing HCV treatment. Angry feelings increased during treatment in some domains, specifically, Control Over Anger and Angry Reaction. Greater anger was associated with more depression and poorer HRQL. Findings point to the importance for physicians to screen for a wide range of neuropsychiatric side effects of interferon, including anger.