Fast-track Procedures Research Articles

Risk factor analysis for fast track protocol failure

BackgroundThe introduction of fast-track treatment procedures following cardiac surgery has significantly shortened hospitalisation times in intensive care units (ICU). Readmission to intensive care units is generally considered a negative quality criterion. The aim of this retrospective study is to statistically analyse risk factors and predictors for re-admission to the ICU after a fast-track patient management program.Methods229 operated patients (67 ± 11 years, 75% male, BMI 27 ± 3, 6/2010-5/2011) with use of extracorporeal circulation (70 ± 31 min aortic crossclamping, CABG 62%) were selected for a preoperative fast-track procedure (transfer on the day of surgery to an intermediate care (IMC) unit, stable circulatory conditions, extubated). A uni- and multivariate analysis were performed to identify independent predictors for re-admission to the ICU.ResultsOver the 11-month study period, 36% of all preoperatively declared fast-track patients could not be transferred to an IMC unit on the day of surgery (n = 77) or had to be readmitted to the ICU after the first postoperative day (n = 4). Readmission or ICU stay signifies a dramatic worsening of the patient outcome (mortality 0/10%, mean hospital stay 10.3 ± 2.5/16.5 ± 16.3, mean transfusion rate 1.4 ± 1,7/5.3 ± 9.1). Predicators for failure of the fast-track procedure are a preoperative ASA class > 3, NYHA class > III and an operation time >267 min ± 74. The significant risk factors for a major postoperative event (= low cardiac output and/or mortality and/or renal failure and/or re-thoracotomy and/or septic shock and/or wound healing disturbances and/or stroke) are a poor EF (OR 2.7 CI 95% 0.98-7.6) and the described ICU readmission (OR 0.14 CI95% 0.05-0.36).ConclusionRe-admission to the ICU or failure to transfer patients to the IMC is associated with a high loss of patient outcome. The ASA > 3, NYHA class > 3 and operation time >267 minutes are independent predictors of fast track protocol failure.

Association between H1N1 vaccination and narcolepsy–cataplexy

After the beginning of the influenza A (H1N1 pdm09) pandemic in 2009, several monovalent pandemic H1N1 vaccines were licensed using fast track procedures, with limited safety data in children and adolescents.1 Nonadjuvant monovalent vaccines were used in the United States and Australia, and on a limited scale, in Europe (France, Spain) and other countries. Within the European Union (EU), 2 different vaccines with adjuvant were licensed, both containing a new generation of squalene-based adjuvant: Focetria (Novartis, Philadelphia, PA), with the MF59 adjuvant, and Pandemrix (GSK, Philadelphia, PA), containing AS03 (squalene and α-tocopherol). Arepanrix, similar to Pandemrix, was used in Canada and Brazil. The vaccine program started in the EU by September 2009; concurrently, the European Center for Disease Prevention & Control (ECDC), Vaccine Adverse Event Surveillance and Communication, and other agencies initiated an active surveillance program to monitor safety and adverse events associated with this vaccine.

Nutritional status assessment in colorectal cancer patients.

The present study intended to evaluate the nutritional status of Portuguese colorectal patients and associated it with surgery type as well as quality of life outcomes. Malnutrition can affect up to 85% of cancer patients and specifically 30-60% in colorectal cancer and can significantly influence health outcomes. A sample of 50 colorectal cancer patients was evaluated in what refers to several anthropometric measures, food intake, clinical history, complications rate before and after surgery procedure. The sample was divided between convention and fast-track procedures. Most of the individuals were overweight or obese but had lost weight on the past six months. Despite mild, there were signs of malnutrition in this sample with high losses of fat free mass, weight and also fat mass during the hospitalization period. These results reinforce the importance of malnutrition assessment in colorectal patients as well as consider weight loss on the past months and body composition in order to complement nutritional status evaluation.

Fast-track laparoscopic bariatric surgery: a systematic review

This study aimed to systematically evaluate the evidence-based literature on fast-track laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic adjustable gastric banding (LAGB) to determine the feasibility and safety of fast-track laparoscopic bariatric surgery. A literature search of PubMed, EMBASE and Cochrane Library using the MeSH terms "bariatric surgery", "ambulatory surgical procedures" and related terms as keywords was performed. The study included articles that reported on intended next-day discharge for LRYGB and same-day discharge for LAGB. Data were extracted on study design and size, patient demographics, patient-selection criteria, patient preparation, perioperative management, operative details, clinical outcomes, and follow-up. The review included 13 studies classified as level 3b or 4 evidence. There were seven studies that investigated LAGB, five studies investigated LRYGB and one study detailed outcomes from both LRYGB and LAGB. Next-day discharge rate ranged from 81 to 100% for LRYGB. Same-day discharge rate ranged from 76 to 98% for LAGB. In LRYGB and LAGB complication, re-admission and mortality rates (≤10.5, ≤7.5, ≤0.1%, respectively) were comparable with the conventional perioperative care. From our results, the fast-track management of patients undergoing LRYGB and LAGB is feasible. With careful patient selection and preparation within high-volume centres, and application of care pathways including close outpatient follow-up, outcomes for fast-track bariatric procedures can compare favourably with those reported in the literature for standard management, but with decreased cost. However, further studies from independent researchers are required to determine the safety of a generalised adoption of this approach outside of dedicated bariatric units, and to formally demonstrate the cost-benefit of fast-track bariatric surgery.

Retrospective analysis of pre- and intraoperative risk factors for readmission to the intensive care unit after fast track cardiac surgery

Objectives: The introduction of fast-track treatment procedures following cardiac surgery has significantly shortened hospitalisation times in intensive care units (ICU). Readmission to intensive care units is generally considered a negative quality criterion. The aim of this retrospective study is to statistically analyse risk factors and predictors for re-admission after a fast-track patient management program. Methods: 229 operated patients (67 ± 11 ys, 75% male, BMI 27 ± 3, 6/2010 – 5/2011) with use of extracorporeal circulation (70 ± 31 min aortic crossclamping, CABG 62%) were selected for a preoperative fast-track procedure (transfer on the day of surgery to an intermediate care (IMC) unit, stable circulatory conditions, extubated). 58 items were recorded and analysed. Results: Over the 11-month study period, 36% of all preoperatively declared fast-track patients could not be transferred to an IMC unit on the day of surgery or had to be readmitted to the ICU after the first postoperative day usually because of bleeding- (22%), pulmonary- (14%) or renal (11%) problems. Readmission signifies a dramatic worsening of the patient outcome (mortality 0/10%, hospital stay 10.3 ± 2.5/16.5 ± 16.3, transfusion rate 1.4 ± 1.7/5.3 ± 9.1). Predicators for failure of the fast-track procedure are a preoperative ASA> 3, NYHA>III and an operation time > 267 min ± 74. The significant risk factors for a major postoperative event are a poor EF (OR 2.7 CI 95% 0.98 – 7.6) and the described ICU readmission (OR 0.14 CI95% 0.05 – 0.36). Conclusions: The failure of a fast-track patient management concept is associated with a high loss of patient outcome. Major pre-operative selection factors of suitable fast-track patients are the ASA- and NYHA classes as well as intraoperatively recorded operation time.

Did Canada Kill Fast Track?

Fast track procedures have been key institutional mechanisms for U.S. trade policy making for nearly three decades. In April 2008, the U.S. House of Representatives made a small change to rules for considering the U.S.-Colombia Free Trade Agreement that significantly undermined fast track. However, these actions are really the culmination of the erosion of the utility of fast track in managing U.S. trade policy in the context of the challenges brought by increased openness in the global economy. Those challenges were laid bare with the first major bilateral agreement considered under fast track rules, the Canada-U.S. Free Trade Agreement in the late 1980s.

Safety of pandemic H1N1 vaccines in children and adolescents

During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children.We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines.As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines – particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally.

P1-186 Challenges in natural experiment research: potential lessons from the H1N1 pandemic

IntroductionResearch on natural experiments (NEs) allows investigation into topics that are important for policy-makers, including many social determinants of health. NEs can be conceptualised as differing from other research in...

Thoracic Epidural Analgesia and Acute Pain Management

AIN continues to be a significant problem for many patients after major surgery. In addition to improving patient satisfaction and decreasing pain scores, enhanced perioperative pain control can improve clinical outcomes. Thoracic epidural analgesia (TEA) remains a critical tool for anesthesiologists to use in acute pain management. TEA is particularly effective for reducing pain after thoracic and upper abdominal surgery and likely permits major surgical procedures to be performed on patients with moderate to severe comorbid diseases, who several years ago may have been determined to be too great a risk for surgery. In the past 10 yr, peripheral nerve blockade has improved perioperative analgesia for patients undergoing extremity surgery. Although nerve blocks have reduced the use of continuous lumbar epidural analgesia, anesthesiologists must understand the indications, placement techniques, solutions administered, potential complications, and evidence-based outcomes for TEA in acute pain management. Indications

The Privatization of Control over Labour Migration in the Netherlands: In Whose Interest?

AbstractMigration control has become subject to ‘privatization’ and is more often than not in the form of internal control, such as for example with employer sanctions. This privatization has taken place through coercive and permissive state action. Coercive state action is the implementation of employer sanctions. It is demonstrated how the drive for efficiency and the consequences of the implementation of employer sanctions in the Netherlands in the sphere of private law create a disaggregation between the state and society. In addition to their influence on contracts and civil law suits, employer sanctions in the Netherlands have created a system of private policing. Another form of privatization is the more permissive form of state action entailing the approval by the state of certain employers. These employers are entitled to fast-track and simple procedures, mainly for highly skilled migrant workers, in exchange for acts of migration control. The question is in whose interest these privatizations are taking place. It is argued that the consequences of privatization, however efficient it may be, may in the end not necessarily be in the interest of the nation-state.

Intranasal ketorolac for acute postoperative pain

Background:Efficacy and tolerability of intranasal ketorolac (SPRIX®) was assessed in abdominal surgery patients.Methods:Adult patients were randomly assigned to receive ketorolac 31.5 mg (n = 214) or placebo (n = 107) every 6 hr after surgery for 48 hr, then up to 4 times/day for up to 5 days. Morphine sulfate via patient controlled analgesia was available in both groups as needed.Results:Least square mean 6 hr summed pain intensity difference scores were significantly greater in the ketorolac group indicating better analgesic efficacy compared to placebo (117.4 vs. 89.9, p = 0.032; difference 27.6, 95% CI 2.5–52.7). Pain intensity difference indicated significantly better pain relief in the ketorolac group at 20 min after the first dose (p = 0.01). Morphine use over 48 hr decreased 26% in the ketorolac group compared to placebo (p = 0.004). Day 1 global pain control scores were significantly higher in the ketorolac group compared to placebo (p = 0.009). Quality of analgesia was rated significantly higher (p = 0.009) in the ketorolac group by 20 min after first dose. Adverse event and serious adverse event incidences were similar in both groups. Rhinalgia and nasal irritation, generally mild and transient in nature, occurred more frequently in the ketorolac group.Conclusion:Intranasal ketorolac was well tolerated and provided effective pain relief within 20 minutes with reduced opioid analgesia use. While IN ketorolac was assessed in an inpatient, conventional surgery setting in this study, IN ketorolac use may have more relevance for use in outpatient settings and ambulatory surgery or fast-track surgical procedures.

Section 337 Patent Investigation Management Guide

The U.S. International Trade Commission has emerged as one of the most salient patent enforcement venues in the United States. Its fast-track procedures – typically producing determinations within 12 to 16 months of initiation of an investigation – and potent exclusion remedy have brought the ITC to center stage in patent enforcement over the past several years. The ITC now conducts more full patent adjudications on an annual basis than any district court in the nation. The ITC’s six Section 337 administrative law judges (ALJs) focus almost exclusively upon patent investigations, making the ITC the only specialized trial-level patent adjudication forum in the nation. Given the importance of international trade to high technology markets, the ability to exclude goods at the border provides a valuable strategic option for a growing number of patent owners. This guide, modeled after the Patent Case Management Judicial Guide, provides comprehensive analysis of the management of Section 337 investigations.

Clinical Evaluation of Immediate Removal of Transurethral Catheter after Radical Gastrectomy: A Result of Feasibility Study

Purpose: Transurethral catheterization is restricted to fewer procedures and a limited time with an increase in enhanced recovery after surgery (ERAS) programs or fast-track surgical procedures. We aim to evaluate the feasibility of immediate removal of transurethral catheter in hemodymically stable patients undergoing radical gastrectomy prior to a prospective randomized control trial. Methods: A total 63 gastric cancer patients undergoing elective radical gastrectomy were enrolled in a feasibility study. Patients were randomized to either the active group (immediate removal group) or control group (removal at postoperative day 1 group) with blinding, and 58 patients were finally included. Amount of residual and voiding urine, operative factors (operation time, infused fluid, urine output, and blood loss), first voiding discomfort level, urinary discomfort score, and urine analysis were measured. Results: In the active group, the self-voiding volume and residual urine volume measured nearly equal (256 ml vs 244 ml) at 16 hours after transurethral catheter removal. The discomfort score of first self-voiding was lower in active group (P=0.041). Regarding urinary discomfort at postoperative day 2 and the urine analysis at postoperative day 5, there were no significant differences between the 2 groups. Conclusion: Immediate removal of the transurethral catheter could be feasible and safe in hemodynamically stable patients undergoing radical gastrectomy in aspects of ERAS programs. A prospective randomized controlled trial would be scheduled for acceptable evidence. (J Korean Surg Soc 2010;79:189-195)

Fast-track-Kinderchirurgie

Fast-track surgery is a comprehensive perioperative treatment concept that has been successfully performed and widely accepted in adult surgery since the 1990s. The crucial aim is to speed up convalescence and to avoid perioperative complications as pneumonia and thrombosis. Compared to conventional treatment strategies, hospital stays are substantially reduced. In the paediatric field fast-track surgery is not generally established. However, in recent studies a high efficiency of paediatric surgical fast-track procedures with respect to medical, psychological, economical and ethical parameters has been shown. It has been confirmed that early convalescence leads to an increase of satisfaction of the patients and their parents without higher complication rates. Shorter hospital stays lead to reduced expenses for the health insurances and parents. Fast-track concepts are not implemented in the German reimbursement system G-DRG. Thus, problems with intensified nursing and reimbursement remain to be solved.

TRADE AT A CROSSROADS

INDUSTRY LOBBYISTS and the White House have begun a campaign to persuade a skeptical Democratic-led Congress to extend a law that gives President George W. Bush authority to negotiate new international trade agreements. Chemical manufacturers and other U.S. businesses warn that failure to renew the Administration's trade promotion authority (TPA), which expires on June 30, could undermine global trade talks and weaken U.S. exports. Trade promotion authority is essential for the continued participation of the U.S. in trade negotiations around the world, says American Chemistry Council (ACC) President Jack N. Gerard. We cannot expect to see market-opening trade deals that support U.S. exporters without the extension of TPA. The law, which dates back to the Nixon Administration, enables the President to negotiate trade agreements with foreign governments that Congress must either approve or reject as a package, without making any changes. Under special fast track procedures, Congress also must vote ...

Anaesthesia and intensive care for cardiac surgery in France: results of the three days national survey realised in 2001 by the club of Anaesthesia, Intensive Care and Technics in Cardiac Surgery (ARTECC)

Ageing of the surgical population and the evolution in anaesthetic techniques have led the Club d'anesthésie-réanimation et techniques en chirurgie cardiaque (ARTECC) to conduct a survey among French cardiac surgery centers. The aim was to profile patient population undergoing cardiac surgery and perioperative techniques employed. National prospective study including all adult patients undergoing cardiac surgery on January 23rd, 24th and 25th, 2001. Data were collected during the first 48 postoperative hours. Seven referent centers drafted a record form. Sixty-one centers sent back 425 patient forms, 399 were analyzed. The following were statistically studied: type of surgery, patient characteristics, preoperative treatment, monitoring, anaesthesia, cardio-pulmonary bypass (CPB) characteristics, duration of mechanical ventilation, length of stay in intensive care unit, postoperative complications. Patient mean age was 64.3 +/- 13.3 years. Patients over 80-year-old represented 2.5% of the population. Beating heart coronary aortic bypass grafts (13% surgery) and preoperative transoesophagal echography were not frequent. Propofol and sufentanil were the main anaesthetic agents used. There was a marked trend for fast-track procedures. The ARTECC study pointed out some reserve in practices and that the impact of new techniques seems limited. Regular use of studies of that kind will provide an effective tool to compare national practices.

Senate voting patterns on the 1991 extension of the fast-track trade procedures: Prelude to NAFTA

In 1991 then-President George Bush requested an extension of fast-track procedures from Congress for the primary purpose of negotiating a North American Free Trade Agreement. This paper uses an econometric model to test the importance of three themes related to NAFTA that surfaced during Senate debates over whether to approve the request, that of employment effects, environmental effects and the impact on immigration from Mexico. The empirical results show that expected job gains and losses were significant in explaining Senate voting patterns on fast-track extension. Immigration was found to be somewhat important, but environmental issues were not found to statistically significant. In addition, the impact of organized labor and political ideology as proxied by political party were found to be important factors that shaped Senate voting patterns on fast-track.

International Trade Agreements: Fast Track Procedures

International Trade Agreements: Fast Track Procedures