TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study.

BACKGROUND: Perioperative complications occur in 30-40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality. METHODS: TRACE is a prospective, multicenter, stepped-wedge cluster randomized interventional study in academic and peripheral hospitals in the Netherlands. All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase in which patients at risk are routinely followed up by an anesthesia professional at postoperative days 1 and 3, aiming to detect and prevent or treat postoperative complications. We aim to include 5600 adult patients who are at high risk of developing complications. The primary outcome variable is 30-day postoperative mortality. Secondary outcomes include incidence of postoperative complications and postoperative quality of life up to one year following surgery. Statistical analyses will be performed to compare the control and intervention cohorts with multilevel linear and logistic regression models, adjusted for temporal trends and for clusters (hospitals). The time horizon of the economic (cost-effectiveness) evaluation will be 30 days and one year following surgery. DISCUSSION: TRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals. TRIAL REGISTRATION: Nederlands Trial Register/Netherlands Trial Registration, NTR5506 . Registered on 02 December 2015.

Peri- and postoperative management of stage I-III Non Small Cell Lung Cancer: Which quality of care indicators are evidence-based?

Quality of care (QoC) has a central role in our health care system. The aim of this review is to present a set of evidence-based quality indicators for the surgical treatment and postoperative management of lung cancer. A search was performed through PubMed, Embase and the Cochrane library database, including English literature, published between 1980 and 2012. Search terms regarding 'lung neoplasms', 'surgical treatment' and 'quality of care' were used. Potential QoC indicators were divided into structure, process or outcome measures and a final selection was made based upon the level of evidence. High hospital volume and surgery performed by a thoracic surgeon, were identified as important structure indicators. Sleeve resection instead of pneumonectomy and the importance of treatment within a clinical care path setting were identified as evidence-based process indicators. A symptom-based follow-up regime was identified as a new QoC indicator. These indicators can be used for registration, benchmarking and ultimately quality improvement in lung cancer surgery.

Systematic review of the influence of enhanced recovery pathways in elective lung resection.

OBJECTIVE: Enhanced-recovery pathways aim to accelerate postoperative recovery and facilitate early hospital discharge. The aim of this systematic review was to summarize the evidence regarding the influence of this intervention in patients undergoing lung resection. METHODS: The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Eight bibliographic databases (Medline, Embase, BIOSIS, CINAHL, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials) were searched for studies comparing postoperative outcomes in adult patients treated within an enhanced-recovery pathway or traditional care. Risk of bias was assessed using the Cochrane Collaboration risk of bias tool. RESULTS: Six studies fulfilled our selection criteria (1 randomized and 5 nonrandomized studies). All the nonrandomized studies reported shorter length of stay in the intervention group (difference, 1.2-9.1 days), but the randomized study reported no differences. There were no differences between groups in readmissions, overall complications, and mortality rates. Two nonrandomized studies reported reduction in hospital costs in the intervention group. Risk of bias favoring enhanced recovery pathways was high. CONCLUSIONS: A small number of low-quality comparative studies have evaluated the influence of enhanced-recovery pathways in patients undergoing lung resection. Some studies suggest that this intervention may reduce length of stay and hospital costs, but they should be interpreted in light of several methodologic limitations. This review highlights the need for well-designed trials to provide conclusive evidence about the role of enhanced-recovery pathways in this patient population.

Postoperative transitional care needs in the elderly: an outcome of recovery associated with worse long-term survival.

OBJECTIVE: To characterize transitional care needs (TCNs) after colorectal cancer (CRC) surgery and examine their association with age and impact on overall survival (OS). BACKGROUND: TCNs after cancer surgery represent additional burden for patients and are associated with higher short-term mortality. They are not well-characterized in CRC patients, particularly in the context of a growing elderly population, and their effect on long-term survival is unknown. METHODS: A retrospective cohort study of CRC patients (N = 486) having curative surgery at a tertiary referral center (2002-2011) was conducted. Outcomes included TCNs (home health or nonhome destination at discharge) and OS. Patients were compared on the basis of age: young (<65 years), old (65-74 years), and oldest (≥75 years). Multivariate logistic regression models were used to examine the association of age with TCNs, and OS was compared on the basis of TCNs and stage, using the Kaplan-Meier method. RESULTS: TCNs were required by 130 patients (27%). The oldest patients had highest TCNs (49%) compared with the other age groups (P < 0.01), with rehabilitation services as their primary TCNs (80%). After multivariate analysis, patients 75 years or older had significantly increased TCN risk (odds ratio, 4.7; 95% confidence interval, 2.6-8.5). TCN was associated with worse OS for patients with early- and advanced stage CRC (P < 0.001). CONCLUSIONS: TCNs after CRC surgery are common and significantly increased in patients 75 years or older, represent an outcome of postoperative recovery, and are associated with worse long-term survival. Preoperative identification of higher risk populations should be used for patient counseling, advanced preoperative planning, and to implement strategies targeted at minimizing TCNs.

Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery: study protocol for a multicenter randomized controlled superiority trial.

BACKGROUND: Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients. Its application in high-risk abdominal surgery is, however, hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring. Arterial waveform analysis provides an easy, minimally invasive alternative to conventional monitoring techniques, and could be valuable in early goal-directed strategies. We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications, quality of life and healthcare costs after high-risk abdominal surgery. METHODS/DESIGN: In this multicenter, randomized, controlled superiority trial, 542 patients scheduled for elective, high-risk abdominal surgery will be included. Patients are allocated to standard care (control group) or early goal-directed therapy (intervention group) using a randomization procedure stratified by center and type of surgery. In the control group, standard perioperative hemodynamic monitoring is applied. In the intervention group, early goal-directed therapy is added to standard care, based on continuous monitoring of cardiac output with arterial waveform analysis. A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset, age-dependent target value. The primary outcome measure is a combined endpoint of major complications in the first 30 days after the operation, including mortality. Secondary endpoints are length of stay in the hospital, length of stay in the intensive care or post-anesthesia care unit, the number of minor complications, quality of life, cost-effectiveness and one-year mortality and morbidity. DISCUSSION: Before the start of the study, hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small, single-center studies, including minor complications as primary endpoint. Moreover, these studies did not include quality of life, healthcare costs, and long-term outcome in their analysis. As a result, the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown, which gave rise to the present trial. Patient inclusion started in May 2012 and is expected to end in 2016. TRIAL REGISTRATION: This trial was registered in the Dutch Trial Register (registration number NTR3380) on 3 April 2012.

Regional differences in recipient waitlist time and pre- and post-transplant mortality after the 2006 United Network for Organ Sharing policy changes in the donor heart allocation algorithm.

OBJECTIVES: This study examined the impact of the United Network for Organ Sharing (UNOS) policy changes for regional differences in waitlist time and mortality before and after heart transplantation. BACKGROUND: The 2006 UNOS thoracic organ allocation policy change was implemented to allow for greater regional sharing of organs for heart transplantation. METHODS: We analyzed 36,789 patients who were listed for heart transplantation from January 1999 through April 2012. These patients were separated into 2 eras centered on the July 12, 2006 UNOS policy change. Pre- and post-transplantation characteristics were compared by UNOS regions. RESULTS: Waitlist mortality decreased nationally (up to 180 days: 13.3% vs. 7.9% after the UNOS policy change, p < 0.001) and within each region. Similarly, 2-year post-transplant mortality decreased nationally (2-year mortality: 17.3% vs. 14.6%; p < 0.001) as well as regionally. Waitlist time for UNOS status 1A and 1B candidates increased nationally 17.8 days on average (p < 0.001) with variability between the regions. The greatest increases were in Region 9 (59.2-day increase, p < 0.001) and Region 4 (41.2-day increase, p < 0.001). Although the use of mechanical circulatory support increased nearly 2.3-fold nationally in Era 2, significant differences were present on a regional basis. In Regions 6, 7, and 10, nearly 40% of those transplanted required left ventricular assist device bridging, whereas only 19.6%, 22.3%, and 15.5% required a left ventricular assist device in regions 3, 4, and 5, respectively. CONCLUSIONS: The 2006 UNOS policy change has resulted in significant regional heterogeneity with respect to waitlist time and reliance on mechanical circulatory support as a bridge to transplantation, although overall both waitlist mortality and post-transplant survival are improved.

Despite overall improvement in surgical outcomes since 2000, income-related disparities persist.

Despite improvements in health care, disparities in care still exist and are widening for some health measures. This study examined postsurgical outcomes for patients from low-income areas as compared to outcomes for those from high-income areas in the United States from 2000 to 2009. We found that postsurgical outcomes improved in general, with significant decreases in nine of twelve mortality and patient safety measures and an increase in one measure. Patients from low-income areas had worse surgical outcomes than those from high-income areas for nine of twelve measures in both 2000 and 2009. The disparities in outcomes between low- and high-income groups did not change significantly for nine of the twelve measures. For the three measures that did change significantly, in only two of the cases was the change favorable for patients from low-income areas. These findings have implications for efforts to improve surgical outcomes and health policy and indicate the need for research on the cause of continued disparities in postsurgical outcomes.

Specialized vascular floors after open aortic surgery: cost containment while preserving quality outcomes.

BACKGROUND: Postoperative care of open abdominal aortic surgery (OAAS) traditionally involves the intensive care unit (ICU). We hypothesized that in patients without an indication for postoperative ICU admission, admission to a specialized vascular floor unit (hemodynamic monitoring, 2:1 nursing) offers cost savings to both payer and institution without compromising care. METHODS: The electronic medical record was used to collect perioperative data for patients who underwent OAAS between July 2007 and July 2011. The university's cost accounting system provided information on revenue, total margin, and professional billing. Patients with ICU indications (spinal drain, Swan-Ganz monitoring, vasopressors, intubation, or blood product resuscitation) were excluded. Comparative cost and outcome analysis was performed on vascular ward and ICU admissions using the Fisher's exact test for dichotomous categorical variables and the Student's t-test for continuous variables. Long-term survival comparison was calculated using Kaplan-Meier survival estimates. RESULTS: One hundred thirty of 215 patients were included for analysis (85 excluded, 51 floor, 79 ICU). Perioperative data amongst the floor and ICU cohorts were similar. Day of operation professional billing fees were comparable (ICU $13,365 vs. floor $12,626; P = 0.18); however, postoperative professional fees were significantly higher in the ICU cohort (ICU $3,258 vs. floor $2,101; P = 0.001) primarily because of intensivist billing. The hospital generated an average of 8.7% more revenue from the ICU cohort (ICU $37,770 vs. floor $34,756; P = 0.023). This was offset by greater expenses in the ICU cohort (ICU $30,756 vs. floor $25,144; P = 0.02), yielding a hospital profit margin of 107.5% favoring floor admission (ICU $2,858 vs. floor $5,931; P = 0.19). Duration of stay was similar (ICU 8.0 days vs. floor 7.8 days; P = 0.86). Kaplan-Meier survival analysis was not significantly different between cohorts (ICU 10.1%, median follow-up, 1,070 days vs. floor 0%, median follow-up, 405 days; P = 0.13). CONCLUSIONS: Postoperative admission to the ICU is not always necessary after OAAS. Specialized vascular floors offer a financial savings to both payer and institution, which allows for simultaneous cost containment while preserving quality outcomes.

Effect of postoperative epidural analgesia on morbidity and mortality after lung resection in Medicare patients.

STUDY OBJECTIVE: To perform an analysis of the Medicare claims database in patients undergoing lung resection to determine whether there is an association between postoperative epidural analgesia and mortality. DESIGN: Retrospective cohort (database) design. SETTING: University hospital. MEASUREMENTS: We examined a cohort of 3501 patients obtained from a 5% nationally random sample of 1997 to 2001 Medicare beneficiaries who underwent nonemergency segmental excision of the lung (International Classification of Diseases, 9th Revision, Clinical Modification codes 32.3 and 32.4). Patient data were divided into two groups depending on the presence or absence of billing for postoperative epidural analgesia (Current Procedural Terminology code 01996). The primary outcomes assessed were death at 7 and 30 days after the procedure. The rates of major morbidity (acute myocardial infarction, angina, cardiac dysrhythmias, heart failure, pneumonia, pulmonary edema, respiratory failure, deep venous thrombosis, pulmonary embolism, sepsis, acute renal failure, somnolence, acute cerebrovascular event, transient organic syndrome, and paralytic ileus) were also compared. Multivariate regression analysis incorporating race, gender, age, comorbidities, hospital size, hospital teaching status, and hospital technology status was performed to determine whether the presence of postoperative epidural analgesia had an independent effect on mortality or major morbidity. MAIN RESULTS: Multivariate regression analysis showed that the presence of epidural analgesia was associated with a significantly lower odds of death at 7 days (odds ratio, 0.39; 95% confidence interval, 0.19-0.80; P = 0.001) and 30 days (odds ratio, 0.53; 95% confidence interval, 0.35-0.78; P = 0.002) after surgery. There was no difference between the groups with regard to overall major morbidity. CONCLUSIONS: Postoperative epidural analgesia may contribute to lower odds of death after segmental excision of the lung, although the mechanism of such a benefit is not clear from our analysis.