Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 20
Filter
1.
Cancer ; 128(18): 3392-3399, 2022 09 15.
Article in English | MEDLINE | ID: mdl-35819926

ABSTRACT

BACKGROUND: Opioid misuse is a public health crisis, and unused postoperative opioids are an important source. Although 70% of pills prescribed go unused, only 9% are discarded. This study evaluated whether an inexpensive pill-dispensing device with mail return capacity could enhance disposal of unused opioids after cancer surgery. METHODS: A prospective pilot study was conducted among adult patients who underwent major cancer-related surgery. Patients received opioid prescriptions in a mechanical device (Addinex) linked to a smartphone application (app). The app provided passwords on a prescriber-defined schedule. Patients could enter a password into the device and receive a pill if the prescribed time had elapsed. Patients were instructed to return the device and any unused pills in a disposal mailer. The primary end point was feasibility of device return, defined as ≥50% of patients returning the device within 6 weeks of surgery. Also explored was total pill use and return as well as patient satisfaction. RESULTS: Among 30 patients enrolled, the majority (n = 24, 80%) returned the device, and 17 (57%) returned it within 6 weeks of surgery. In total, 567 opioid pills were prescribed and 170 (30%) were used. Of 397 excess pills, 332 (84% of unused pills, 59% of all pills prescribed) were disposed of by mail. Among 19 patients who obtained opioids from the device, most (n = 14, 74%) felt the benefits of the device justified the added steps involved. CONCLUSIONS: Use of an inexpensive pill-dispensing device with mail return capacity is a feasible strategy to enhance disposal of unused postoperative opioids.


Subject(s)
Analgesics, Opioid , Neoplasms , Adult , Humans , Pain, Postoperative , Pilot Projects , Postal Service , Practice Patterns, Physicians' , Prospective Studies
2.
Am J Otolaryngol ; 43(2): 103346, 2022.
Article in English | MEDLINE | ID: mdl-35016097

ABSTRACT

PURPOSE: The goal of this study was to conduct a multi-domain, organ system-based analysis of non-surgical comorbidities amenable to pre-operative optimization in patients undergoing free tissue transfer, in order to better understand factors that influence patient outcomes. STUDY DESIGN: Retrospective review. SETTINGS: Tertiary academic center. MATERIALS AND METHODS: A retrospective analysis of 546 patients in a prospectively maintained database who underwent free tissue transfer reconstruction between 2007 and 2016 was performed. Analysis of the relationship between binary-coded system-based domains and log-transformed length of stay (LOS), rehabilitation requirement, 30-day readmission, and post-operative complications was conducted with multiple linear regression or logistic regression models. RESULTS: Poor nutritional status and the presence of anxiety/depression independently increased median hospital LOS. Endocrine and metabolic deficits, poor nutrition status, and psychiatric comorbidities were significant predictors for rehabilitation facility requirement upon discharge. CONCLUSION: Interventions targeted to patient psychiatric and nutritional health may yield substantially improved outcomes in the head and neck cancer population receiving free tissue transfer surgery.


Subject(s)
Free Tissue Flaps , Head and Neck Neoplasms , Plastic Surgery Procedures , Free Tissue Flaps/blood supply , Head and Neck Neoplasms/surgery , Humans , Length of Stay , Postoperative Complications/epidemiology , Retrospective Studies , Risk Factors
3.
Lung Cancer ; 146: 297-302, 2020 08.
Article in English | MEDLINE | ID: mdl-32619780

ABSTRACT

OBJECTIVES: Lung cancer is the third most common malignancy that develops in patients following solid organ transplantation and is the leading cause of cancer deaths in the general population. The aims of this study are to examine the characteristics of patients who developed lung cancer following solid organ transplantation at our institution and to compare their outcomes to those of lung cancer patients without a history of transplant. MATERIALS AND METHODS: We performed a single-institution retrospective study of 44 solid organ transplant recipients who developed lung cancer and compared their characteristics to a cohort of 74 lung cancer patients without a history of transplant. We performed propensity score weighted analyses to compare outcomes between the two groups, including a cox proportional hazards model of overall survival. RESULTS: 52 % of post-transplant patients who developed lung cancer were diagnosed with stage III or IV disease. In the propensity score weighted analysis that accounted for age at diagnosis, sex, lung cancer stage at diagnosis, Charlson comorbidity index score, and ECOG performance score, post-transplant patients were more likely to have squamous cell histology (p < 0.01) and had worse overall survival compared to the non-transplant cohort (HR = 1.88, 95 % CI 1.13-3.12, p = 0.02). The difference in survival remained significant after accounting for differences in lung cancer histology and treatment (HR = 2.40, 95 % CI 1.27-3.78, p < 0.01). CONCLUSIONS: When compared to non-transplant patients with lung cancer, post-transplant patients have worse overall survival after accounting for differences in age, sex, lung cancer stage, comorbidities, and performance status. This survival difference is not solely attributable to differences in tumor histology and treatments received. This may suggest that post-transplant malignancies are more aggressive and difficult to treat.


Subject(s)
Lung Neoplasms , Organ Transplantation , Humans , Lung Neoplasms/epidemiology , Lung Neoplasms/etiology , Lung Neoplasms/pathology , Neoplasm Staging , Organ Transplantation/adverse effects , Retrospective Studies , Transplant Recipients
4.
Stat Methods Med Res ; 29(5): 1315-1324, 2020 05.
Article in English | MEDLINE | ID: mdl-31267845

ABSTRACT

We present a technique for adding dose modifications into seamless Phase II and Phase II/III trials featuring dose selection at an interim analysis. The method is convenient to apply and can be used either in a fully prespecified, structured way or as a response to new considerations that emerge at interim. Strong control of the familywise error rate regarding false declarations of efficacy versus control is maintained. Two examples are given. One illustrates how the method could potentially "save" a trial performed in a Phase II context. The other is a seamless Phase II/III trial that uses an adaptive exploration strategy for an assumed nonmonotonic dose-response curve. It can result in greatly improved efficiency over a standard "promote the winner" rule.


Subject(s)
Pharmaceutical Preparations , Research Design , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Pharmaceutical Preparations/administration & dosage
5.
Neuropsychopharmacology ; 44(10): 1812-1819, 2019 09.
Article in English | MEDLINE | ID: mdl-30858518

ABSTRACT

The N-methyl-D-aspartate (NMDA) receptor antagonist ketamine is associated with rapid but transient antidepressant effects in patients with treatment resistant unipolar depression (TRD). Based on work suggesting that ketamine and lithium may share overlapping mechanisms of action, we tested lithium compared to placebo as a continuation strategy following ketamine in subjects with TRD. Participants who met all eligibility criteria and showed at least an initial partial response to a single intravenous infusion of ketamine 0.5 mg/kg were randomized under double-blind conditions to lithium or matching placebo before receiving an additional three infusions of ketamine. Subsequent to the ketamine treatments, participants remained on lithium or placebo during a double-blind continuation phase. The primary study outcome was depression severity as measured by the Montgomery-Åsberg Depression Rating Scale compared between the two groups at Study Day 28, which occurred ~2 weeks following the final ketamine of four infusions. Forty-seven participants with TRD were enrolled in the study and underwent an initial ketamine infusion, of whom 34 participants were deemed to have at least a partial antidepressant response and were eligible for randomization. Comparison between treatment with daily oral lithium (n = 18) or matching placebo (n = 16) at the primary outcome showed no difference in depression severity between groups (t32 = 0.11, p = 0.91, 95% CI [-7.87, 8.76]). There was no difference between lithium and placebo in continuing the acute antidepressant response to ketamine. The identification of a safe and effective strategy for preventing depression relapse following an acute course of ketamine treatment remains an important goal for future studies.


Subject(s)
Antidepressive Agents/therapeutic use , Depressive Disorder, Major/drug therapy , Depressive Disorder, Treatment-Resistant/drug therapy , Excitatory Amino Acid Antagonists/therapeutic use , Ketamine/therapeutic use , Lithium Compounds/therapeutic use , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged , Treatment Outcome
6.
J Cardiothorac Vasc Anesth ; 33(1): 137-145, 2019 Jan.
Article in English | MEDLINE | ID: mdl-30072271

ABSTRACT

OBJECTIVE: This study sought to determine if 3-dimensional (3D) echocardiography would more closely correspond to direct surgical measurements of the maximal tricuspid valve (TV) annular diameter than 2-dimensional (2D) measurements. DESIGN: Prospective study. SETTING: The cardiothoracic operating rooms (ORs) at Mount Sinai Medical Center in New York, NY. PARTICIPANTS: Fifty-nine patients over 18 years of age underwent elective mitral valve surgery for severe mitral regurgitation from 2014 to 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Two-dimensional and 3D data sets and surgical TV annular dimensions were measured. Bland-Altman analysis was conducted and absolute differences were compared using paired t tests and the McNemar test. The observed mean difference between the 2D measurements by transgastric right ventricular diastolic view and the surgical measurements was 0.21 cm (standard deviation [SD] = 0.36 cm); the mean difference between the 3D measurements and surgical measures was -0.03 cm (SD = 0.19 cm). The McNemar test showed that the rate of highly successful measurements, defined as those within 0.2 cm of the true surgical score, using the 3D technique (66%) was significantly better than the rate of highly successful measurements using the 2D technique (25%), p< 0.01, 2-sided. CONCLUSION: Three-dimensional imaging and measurement of the TV annular diameter is feasible in the OR setting. The superiority of the 3D measurements versus 2D measurements allows for greater precision and accuracy and may guide better intraoperative surgical decision-making.


Subject(s)
Cardiac Surgical Procedures/methods , Echocardiography, Three-Dimensional/methods , Echocardiography, Transesophageal/methods , Mitral Valve Insufficiency/surgery , Tricuspid Valve/diagnostic imaging , Female , Follow-Up Studies , Humans , Intraoperative Period , Male , Middle Aged , Mitral Valve Insufficiency/diagnosis , Prospective Studies , Reproducibility of Results , Tricuspid Valve/surgery
7.
J Health Care Poor Underserved ; 29(3): 1123-1134, 2018.
Article in English | MEDLINE | ID: mdl-30122687

ABSTRACT

OBJECTIVE: In the United States, hepatocellular carcinoma (HCC) is more common among communities with low socioeconomic status (SES), and these groups tend to be diagnosed with later-stage cancers. Sorafenib is the primary treatment for advanced HCC, however its substantial cost raises concern for access to treatment. METHODS: The newly developed Case-Background method was used to estimate odds ratios for the impacts of various sociodemographic factors on sorafenib access in clinically eligible patients. Socioeconomic status was defined as a factor of median income and education level based on ZIP code of residence. RESULTS: There was a strong association between sorafenib prescription and residence in an area of higher SES. While controlling for age, race/ethnicity, and insurance status, high SES residence doubled the odds of sorafenib prescription (OR=2.05, p<.01). CONCLUSIONS: Low socioeconomic status communities appear to have a reduced chance of receiving the only effective treatment for advanced HCC.


Subject(s)
Carcinoma, Hepatocellular/drug therapy , Healthcare Disparities/economics , Liver Neoplasms/drug therapy , Residence Characteristics/statistics & numerical data , Social Class , Sorafenib/therapeutic use , Carcinoma, Hepatocellular/pathology , Humans , Liver Neoplasms/pathology , Neoplasm Staging , Sorafenib/economics , United States
8.
Contemp Clin Trials ; 64: 210-218, 2018 01.
Article in English | MEDLINE | ID: mdl-28988992

ABSTRACT

We propose a two-stage strategy, called the Limb-Leaf method, to explore the dose-response curve using dose promotion and addition in the context of adaptive seamless Phase II/III trials. Strong control of the overall type 1 familywise error rate of the proposed method is enforced by the closed testing principle. The design constants are determined to minimize the risk-adjusted expected total sample size while maintaining a target power. In the case of a nonmonotonic dose response curve where more doses are required to adequately explore the curve, substantial savings in sample size are achieved compared with a traditional strategy which offers only selection and promotion from among initial first stage doses.


Subject(s)
Clinical Trials, Phase II as Topic/methods , Clinical Trials, Phase III as Topic/methods , Dose-Response Relationship, Drug , Research Design , Data Interpretation, Statistical , Humans
9.
JAMA Otolaryngol Head Neck Surg ; 143(6): 574-579, 2017 06 01.
Article in English | MEDLINE | ID: mdl-28301644

ABSTRACT

Importance: Elevated body mass index (BMI) has been proposed as a risk factor for morbidity and mortality among patients undergoing surgery. Conversely, an elevated BMI may confer a protective effect on perioperative morbidity. Objective: To examine whether an elevated BMI is an independent risk factor for perioperative and postoperative infectious complications after free tissue transfer in head and neck reconstructive surgery. Design, Setting, and Participants: This cohort study included patients undergoing major head and neck surgery requiring free tissue transfer at a tertiary care center. Data were collected for 415 patients treated from January 1, 2007, through December 31, 2014. Main Outcomes and Measures: The outcome of interest was postoperative infection and complications after head and neck surgery using free flaps. Covariates considered for adjustment in the statistical model included alcohol consumption (defined as >5 drinks per day [eg, 360 mL of beer, 150 mL of wine, or 45 mL of 80-proof spirits]), type 2 diabetes, prior radiotherapy, anesthesia time, hypothyroidism, smoking, American Society of Anesthesiologists classification, antibiotic regimen received (defined as a standard regimen of a first- or second-generation cephalosporin with or without metronidazole hydrochloride vs an alternative antibiotic regimen for patients allergic to penicillin), and primary surgeon. A multiple logistic regression model was developed for the incidence of the infection end point as a function of elevated BMI (>30.0). Results: Among the 415 patients included in this study (277 men [66.7%] and 138 women [33.2%]; mean [SD] age, 61.5 [13.9] years), type 2 diabetes and use of an alternative antibiotic regimen were found to be independently associated with increased infectious complications after free flap surgery of the head and neck, with estimated odds ratios of 2.78 (95% CI, 1.27-6.09) and 2.67 (95% CI, 1.14-6.25), respectively, in the multiple logistic regression model. However, a high BMI was not found to be statistically significant as an independent risk factor for postoperative infectious complication (estimated odds ratio, 1.19; 95% CI, 0.48-2.92). Conclusions and Relevance: Elevated BMI does not seem to play a role as an independent risk factor in postoperative complications in free tissue transfer in head and neck surgery.


Subject(s)
Body Mass Index , Head and Neck Neoplasms/surgery , Plastic Surgery Procedures , Postoperative Complications/epidemiology , Surgical Wound Infection/epidemiology , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Treatment Outcome
11.
J Surg Oncol ; 114(4): 469-74, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27334650

ABSTRACT

INTRODUCTION: We report our institutional experience with extrahepatic metastasectomy (EM) in a cohort of hepatocellular carcinoma (HCC) patients with focus on predictors of survival. METHODS: All patients diagnosed with metastatic HCC from 2001 to 2014 were retrospectively reviewed to identify those who underwent EM with therapeutic intent. Associations among multiple clinicopathological variables and survival after EM were analyzed by univariate and multivariate analyses. RESULTS: Out of 440 metastatic HCC cases, we identified 85 patients (mean age 58.8 ± 11.7 years, 81.2% males) who underwent lung (n = 36), peritoneal (n = 22), lymph node (n = 19), musculoskeletal (n = 18), and adrenal (n = 9) metastasectomy. Most patients (84.7%) underwent metachronous EM following primary liver resection or transplantation. The median follow-up period was 20.9 months, during which 55 patients (64.7%) died. The 1-/2-/5-year overall survival rates after EM were 77.4, 53.1, and 25.1%, respectively. On multivariate analysis, number of metastases resected >2 correlated independently with poor survival (HR = 2.058, P = 0.0099). EM patients had superior median survival compared to all (n = 194) metastatic HCC patients treated with sorafenib without EM during the study period (27.2 vs. 7.4 months, P < 0.001). CONCLUSION: Long-term survival may be achieved in highly selected HCC patients following EM. The presence of greater than two extrahepatic lesions correlates independently with poor survival. J. Surg. Oncol. 2016;114:469-474. © 2016 Wiley Periodicals, Inc.


Subject(s)
Carcinoma, Hepatocellular/surgery , Liver Neoplasms/surgery , Metastasectomy , Adult , Aged , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/pathology , Female , Hepatectomy , Humans , Liver Neoplasms/mortality , Liver Neoplasms/pathology , Male , Middle Aged , Retrospective Studies
12.
HPB (Oxford) ; 18(5): 411-8, 2016 05.
Article in English | MEDLINE | ID: mdl-27154804

ABSTRACT

BACKGROUND & AIMS: It is unknown whether the addition of locoregional therapies (LRTx) to sorafenib improves prognosis over sorafenib alone in patients with advanced hepatocellular carcinoma (HCC). The aim of this study was to assess the effect of LRTx in this population. METHODS: A retrospective analysis was performed of patients with advanced HCC as defined by extrahepatic metastasis, lymphadenopathy >2 cm, or gross vascular invasion. Sorafenib therapy was required for inclusion. Survival of patients who received LRTx after progression to advanced stage was compared to those who did not receive LRTx. RESULTS: Using an intention to treat analysis of 312 eligible patients, a propensity weighted proportional hazards model demonstrated LRTx as a predictor of survival (HR = 0.505, 95% CI: 0.407-0.628; P < 0.001). The greatest benefit was seen in patients with the largest tumor burden (HR = 0.305, 95% CI: 0.236-0.393; P < 0.01). Median survival in the sorafenib arm was 143 days (95% CI: 118-161) vs. 247 days (95% CI: 220-289) in the sorafenib plus LRTx arm (P < 0.001). CONCLUSIONS: These results demonstrate a survival benefit with the addition of LRTx to sorafenib for patients with advanced HCC. These findings should prompt a prospective clinical trial to further assess the role of LRTx in patients with advanced HCC.


Subject(s)
Ablation Techniques , Antineoplastic Agents/therapeutic use , Carcinoma, Hepatocellular/drug therapy , Chemoembolization, Therapeutic , Chemoradiotherapy, Adjuvant , Liver Neoplasms/drug therapy , Niacinamide/analogs & derivatives , Phenylurea Compounds/therapeutic use , Ablation Techniques/adverse effects , Ablation Techniques/mortality , Aged , Antineoplastic Agents/adverse effects , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/secondary , Chemoembolization, Therapeutic/adverse effects , Chemoembolization, Therapeutic/mortality , Chemoradiotherapy, Adjuvant/adverse effects , Chemoradiotherapy, Adjuvant/mortality , Chi-Square Distribution , Female , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Liver Neoplasms/mortality , Liver Neoplasms/pathology , Logistic Models , Male , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Niacinamide/adverse effects , Niacinamide/therapeutic use , Phenylurea Compounds/adverse effects , Propensity Score , Proportional Hazards Models , Retrospective Studies , Risk Factors , Sorafenib , Time Factors , Treatment Outcome
13.
J Clin Anesth ; 30: 24-32, 2016 May.
Article in English | MEDLINE | ID: mdl-27041259

ABSTRACT

BACKGROUND: Health care service bundling experiments at the state and regional levels have showed reduced costs by providing a single lump-sum reimbursement for anesthesia services, surgery, and postoperative care. Potential for cost savings related to the provision of anesthesia care has the potential to significantly impact sustainability. This study defines and quantifies routine and preventable anesthetic drug waste and the patient, procedure, and anesthesia provider characteristics associated with increased waste. METHODS: Over a 12-month period, the type and quantity of clean drugs prepared by the anesthesia team for the first case of the day were recorded. The amount of each drug administered was obtained from the computerized anesthesia record, and data were analyzed to determine the incidence and cost of routine and preventable drug waste. The monthly and yearly cost of preventable waste, including the cost of pharmacy tech labor and materials where applicable, was estimated based on surgical case volume at the study institution. All analyses were performed using SAS software v9.2. RESULTS: Anesthetic drugs prepared for 543 separate surgical cases were observed. Less than 20% of cases generated routine waste. Preventable waste was generated most frequently for ephedrine (59.5% of cases), succinylcholine (33.7%), and lidocaine (25.1%), and least frequently for ondansetron (1.3%), phenylephrine (2.6%), and dexamethasone (2.8%). The estimated yearly cost of preventable anesthetic drug waste was $185,250. CONCLUSIONS: Significant potential savings with little impact on clinically significant availability may be achieved through the use of prefilled syringes for some commonly used anesthetic drugs. An intelligently implemented switch to prefilled syringes for select drugs is a potential cost saving measure, but savings might be diminished by disposal of prefilled syringes when they expire, hidden costs in the hospital pharmacy, and inability to supply some medications in prefilled syringes due to stability or manufacturing issues.


Subject(s)
Anesthesia/economics , Anesthesiology/economics , Anesthetics/administration & dosage , Adult , Aged , Anesthetics/economics , Cost Savings , Efficiency , Humans , Middle Aged , Syringes
14.
Med Teach ; 38(7): 730-7, 2016 Jul.
Article in English | MEDLINE | ID: mdl-27052665

ABSTRACT

INTRODUCTION: There is considerable controversy as to whether the simulator should die during high-fidelity simulation (HFS). We sought to describe the physiologic and biochemical stress response induced by simulated patient death as well as the impact on long-term retention of Advanced Cardiovascular Life Support (ACLS) knowledge and skills. METHODS: Twenty-six subjects received an American Heart Association (AHA) ACLS provider course. Following the course, subjects participated in HFS and were randomized to simulated death or survival. Heart rate and salivary cortisol (SC) and dihydroepiandrosterone (DHEA) were collected at this time. Subjects returned six months later for a follow-up simulation in which ACLS knowledge and skills were tested. RESULTS: For all participants, there was an increase in heart rate during simulation compared with baseline heart rate (+ 32 beats/minute), p < 0.0001. Similarly, SC and DHEA were higher compared with baseline levels (+ 0.115 µg/dL, p <0.01 and + 97 pg/mL, p < 0.001, respectively). However, the only statistically significant difference between groups was an increase in heart rate response at the end of the simulation compared with baseline in the death group (+ 29.2 beats/minute versus + 18.5 beats/minute), p < 0.05. There was no difference on long-term knowledge or skills. CONCLUSIONS: Learners experience stress during high-fidelity simulation; however, there does not appear to be a readily detectable difference or negative response to a simulated patient death compared with simulated survival.


Subject(s)
Advanced Cardiac Life Support/education , Clinical Competence , Death , Simulation Training/methods , Stress, Psychological/psychology , Students, Medical/psychology , Adult , Biomarkers , Dehydroepiandrosterone/analysis , Female , Health Knowledge, Attitudes, Practice , Heart Rate , Humans , Hydrocortisone/analysis , Learning , Male , Manikins , Saliva/chemistry , Stress, Psychological/physiopathology
15.
BMJ Qual Saf ; 25(10): 739-46, 2016 10.
Article in English | MEDLINE | ID: mdl-26590199

ABSTRACT

BACKGROUND: Anaesthesiologists work in a high stress, high consequence environment in which missed steps in preparation may lead to medical errors and potential patient harm. The pre-anaesthetic induction period has been identified as a time in which medical errors can occur. The Anesthesia Patient Safety Foundation has developed a Pre-Anesthetic Induction Patient Safety (PIPS) checklist. We conducted this study to test the effectiveness of this checklist, when embedded in our institutional Anesthesia Information Management System (AIMS), on resident performance in a simulated environment. METHODS: Using a randomised, controlled, observer-blinded design, we compared performance of anaesthesiology residents in a simulated operating room under production pressure using a checklist in completing a thorough pre-anaesthetic induction evaluation and setup with that of residents with no checklist. The checklist was embedded in the simulated operating room's electronic medical record. RESULTS: Data for 38 anaesthesiology residents shows a statistically significant difference in performance in pre-anaesthetic setup and evaluation as scored by blinded raters (maximum score 22 points), with the checklist group performing better by 7.8 points (p<0.01). The effects of gender and year of residency on total score were not significant. Simulation duration (time to anaesthetic agent administration) was increased significantly by the use of the checklist. CONCLUSION: Required use of a pre-induction checklist improves anaesthesiology resident performance in a simulated environment. The PIPS checklist as an integrated part of a departmental AIMS warrant further investigation as a quality measure.


Subject(s)
Anesthesiology/education , Checklist , Internship and Residency/organization & administration , Operating Rooms/organization & administration , Work Performance/standards , Clinical Competence , Electronic Health Records , Humans , Internship and Residency/standards , Operating Rooms/standards , Patient Safety , Simulation Training/standards , Single-Blind Method , Time Factors
16.
Otolaryngol Head Neck Surg ; 154(2): 272-8, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26573570

ABSTRACT

OBJECTIVE: The development of surgical site infections (SSIs) can put the viability of free tissue transfer reconstructions at risk, often resulting in considerable postoperative morbidity and prolonged hospitalization. Current antibiotic prophylactic guidelines suggest a first- or second-generation cephalosporin with metronidazole for clean-contaminated cases and recommend clindamycin as an alternative choice in penicillin-allergic patients. This study was designed to examine the rates of postoperative infection associated with prophylactic antibiotic regimens, including patients receiving clindamycin as an alternative due to penicillin allergy. STUDY DESIGN: Case series with chart review. SETTING: Tertiary academic medical center. SUBJECTS: Patients undergoing major ablative head and neck resection involving the pharynx and oral cavity reconstructed via free tissue transfer. METHODS: The sample included patients (n = 266) who underwent free tissue transfer involving the oral cavity and pharynx from 2009 to 2014. Data included demographic data, medical comorbidities, anatomic tumor subsite and surgical procedure, and prophylactic antibiotic regimen. SSI data were examined up to 30 days after the initial surgical procedure. Multivariate logistic regression analysis was performed to determine the overall risk for SSI. Culture data were also reviewed. RESULTS: The data indicated that clindamycin was associated with an approximate 4-fold increased risk for SSI (odds ratio, 3.784; 95% confidence interval: 1.367-10.470 [P = .010]) after controlling for possible confounding factors. CONCLUSION: For patients with a true penicillin allergy, we recommend broader gram-negative coverage with alternative antibiotics, such as cefuroxime, when undergoing free tissue transfer in the head and neck.


Subject(s)
Antibiotic Prophylaxis/adverse effects , Clindamycin/adverse effects , Free Tissue Flaps , Neck Dissection/methods , Plastic Surgery Procedures/methods , Surgical Wound Infection/epidemiology , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Clindamycin/administration & dosage , Female , Follow-Up Studies , Head and Neck Neoplasms/surgery , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Factors , Surgical Wound Infection/etiology , United States/epidemiology
18.
Liver Transpl ; 21(1): 89-95, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25283640

ABSTRACT

The anesthesiologist has been recognized as an integral member of the liver transplant team, and previous studies have demonstrated that inter-anesthesiologist variability can be a driver of outcomes for high-risk patients. We hypothesized that anesthesiologist experience, defined as the number of previous liver transplants performed at our institution, the Icahn School of Medicine at Mount Sinai, would be independently associated with outcomes for liver transplant patients. Eight hundred forty-nine liver transplants performed between January 2003 and January 2013 with a total of 22 anesthesiologists were analyzed. Each transplant was assigned an incremental case number that corresponded to the number of transplants that the attending anesthesiologist had already performed at our institution. Several perioperative covariates were controlled for in the context of a generalized linear mixed effects model to detail the influence of threshold levels of the incremental case number on the primary outcome, 30-day mortality, and a secondary outcome, 30-day graft failure. Sensitivity analyses were conducted to confirm the robustness of these findings. An incremental case number ≤ 5 was associated with a significantly greater risk of 30-day mortality (odds ratio = 2.24, 95% confidence interval = 1.11-4.54, P = 0.025), and there was evidence suggestive of a greater risk of 30-day graft failure (odds ratio = 1.93, 95% confidence interval = 0.95-3.93, P = 0.071). Sensitivity analyses ruled out threats to the validity of these findings, including dropout effects and time trends in the overall performance of the transplantation unit. In conclusion, this study shows that an anesthesiologist's level of experience has a significant effect on outcomes for liver transplant recipients, with increased mortality and possibly graft failure during a provider's first 5 cases. These findings may indicate the need for increased training and supervision for anesthesiologists joining the liver transplant team.


Subject(s)
Anesthesia/mortality , Clinical Competence , Learning Curve , Liver Transplantation/mortality , Patient Care Team , Postoperative Complications/mortality , Workload , Adult , Aged , Female , Humans , Linear Models , Male , Middle Aged , New York , Odds Ratio , Postoperative Complications/physiopathology , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
19.
Geriatr Orthop Surg Rehabil ; 2(4): 128-34, 2011 Jul.
Article in English | MEDLINE | ID: mdl-23569682

ABSTRACT

PURPOSE: Patients with acute hip fractures who are on maintenance warfarin for anticoagulation present a significant challenge and their management remains controversial. The purpose of this study was to assess thromboembolic and systemic complications associated with pharmacological reversal of warfarin-associated coagulopathy in a population of geriatric patients with hip fractures. METHODS: This retrospective cohort study identified patients with operative hip fractures on oral warfarin therapy who had an international normalized ratio (INR) >1.50 on admission (N = 93) approximately over a 13-year span. The control group consisted of patients whose warfarin was held upon admission without further intervention preoperatively (n = 23). The treatment group consisted of patients who underwent pharmacologic reversal of elevated INR with vitamin K and/or fresh frozen plasma (FFP) in addition to holding warfarin (n = 70). Primary outcomes included thromboembolic and other complications as well as mortality within 3 months of presentation. Time to surgery was a secondary outcome. RESULTS: The 3-month mortality rate was 4% in the pharmacological intervention group and 17% in the watch-and-wait group; this difference trended toward statistical significance (P = .06). There were no significant differences in the likelihoods of other thromboembolic or nonthromboembolic complications between groups. While the difference in mean time to surgery was not significantly different overall between groups, this difference was significant in a subgroup of patients with higher baseline INRs (n = 46, INR >2.17), with a mean difference of 4.0 fewer days until surgery in the pharmacological intervention group (P < .01). CONCLUSIONS: Pharmacological reversal of warfarin-associated coagulopathy with a combination of vitamin K and FFP appears to be a safe way to optimize patients for operative fixation of hip fractures and is associated with a shorter delay to surgery in patients with more elevated INRs preoperatively. LEVEL OF EVIDENCE: retrospective cohort study (level III).

20.
Physiol Meas ; 28(5): 489-502, 2007 May.
Article in English | MEDLINE | ID: mdl-17470983

ABSTRACT

Extracellular water (ECW) is a large and clinically important body compartment that varies widely in volume both in health and disease. Interpretation of ECW measurements in the clinical setting requires consideration of potential influencing factors such as age, race, sex and other variables that influence fluid status. An important gap in physiological research is a lack of normative ECW values against which to reference perturbations in fluid homeostasis. The current study's aim was to develop conditional quantile equations for ECW based on weight, height, age, sex and race using a large (n = 1538, 854 females and 684 males) healthy adult multi-ethnic (African American, Asian, European American, Hispanic) sample. ECW was derived from total body water and potassium measured by isotope dilution and whole-body 40K counting, respectively. Quantile regression methods were used to identify five percentile levels (10th, 25th, 50th, 75th, 90th). Weight and height were significant variables at each quantile in both males and females; age made a significant contribution in the male but not the female sample. These regression equations provide ECW quantile reference values based on a large multi-ethnic adult population that should not only prove useful in clinical settings and physiological research, but serve as a model approach for developing body composition normative ranges.


Subject(s)
Extracellular Fluid/physiology , Adult , Age Factors , Aged , Female , Humans , Male , Middle Aged , Models, Biological , Reference Values , Sex Factors
SELECTION OF CITATIONS
SEARCH DETAIL
...