Effects on Clinical Outcomes of a 5-Year Surgical Safety Checklist Implementation Experience: A Large-scale Population-Based Difference-in-Differences Study.

The adoption of a surgical checklist is strongly recommended worldwide as an effective practice to improve patient safety; however, several studies have reported mixed results and a number of issues are still unresolved. The main objective of this study was to explore the impact of the first 5-year period of a surgical checklist-based intervention in a large regional health care system in Italy (4 500 000 inhabitants). We conducted a retrospective longitudinal study on 1 166 424 patients who underwent surgery in 48 public hospitals between 2006 and 2014. The adherence to the checklist was measured between 2011 and 2013 through a computerized database. The effects of the intervention were explored through multivariable logistic regression and difference-in-differences (DID) approaches, based on current administrative data sources. In-hospital and 30-days mortality, 30-days readmissions and length-of-stay (LOS) ⩾8 days were the observed outcomes. Adherence to the checklist showed marked variations across hospitals (0%-93.3%). A pre/post analysis detected statistically significant differences between surgical interventions performed in hospitals with higher adherence to the checklist (⩾75% of the surgeries) and those performed in other hospitals, as for the 30-days readmissions rate (odds ratio [OR]: 0.96; 95% confidence interval [CI]: 0.94-0.98) and LOS ⩾ 8 days rate (OR: 0.88; 95% CI: 0.87-0.89). These findings were confirmed after risk adjustment and DID analysis. No association was observed with mortality outcomes. On the whole, our study attained mixed results. Although a protective effect of the surgical checklist use could not be proved over the first 5 years of this regional implementation experience, our research offers some methodological insights for practical use in the evaluation process of large-scale implementation projects.

International consensus conference on open abdomen in trauma.

BACKGROUND: A part of damage-control laparotomy is to leave the fascial edges and the skin open to avoid abdominal compartment syndrome and allow further explorations. This condition, known as open abdomen (OA), although effective, is associated with severe complications. Our aim was to develop evidence-based recommendations to define indications for OA, techniques for temporary abdominal closure, management of enteric fistulas, and methods of definitive wall closure. METHODS: The literature from 1990 to 2014 was systematically screened according to PRISMA [Preferred Reporting Items for Systematic Reviews and Meta-analyses] protocol. Seventy-six articles were reviewed by a panel of experts to assign grade of recommendations (GoR) and level of evidence (LoE) using the GRADE [Grading of Recommendations Assessment, Development, and Evaluation] system, and an international consensus conference was held. RESULTS: OA in trauma is indicated at the end of damage-control laparotomy, in the presence of visceral swelling, for a second look in vascular injuries or gross contamination, in the case of abdominal wall loss, and if medical treatment of abdominal compartment syndrome has failed (GoR B, LoE II). Negative-pressure wound therapy is the recommended temporary abdominal closure technique to drain peritoneal fluid, improve nursing, and prevent fascial retraction (GoR B, LoE I). Lack of OA closure within 8 days (GoR C, LoE II), bowel injuries, high-volume replacement, and use of polypropylene mesh over the bowel (GoR C, LoE I) are risk factors for frozen abdomen and fistula formation. Negative-pressure wound therapy allows to isolate the fistula and protect the surrounding tissues from spillage until granulation (GoR C, LoE II). Correction of fistula is performed after 6 months to 12 months. Definitive closure of OA has to be obtained early (GoR C, LoE I) with direct suture, traction devices, component separation with or without mesh. Biologic meshes are an option for wall reinforcement if bacterial contamination is present (GoR C, LoE II). CONCLUSION: OA and negative-pressure techniques improve the care of trauma patients, but closure must be achieved early to avoid complications.

Trauma-induced coagulopathy: impact of the early coagulation support protocol on blood product consumption, mortality and costs.

INTRODUCTION: Hemorrhage is the principal cause of death in the first few hours following severe injury. Coagulopathy is a frequent complication of critical bleeding. A network of Italian trauma centers recently developed a protocol to prevent and treat trauma-induced coagulopathy. A pre-post cohort multicenter study was conducted to assess the impact of the early coagulation support (ECS) protocol on blood products consumption, mortality and treatment costs. METHODS: We prospectively collected data from all severely injured patients (Injury Severity Score (ISS) >15) admitted to two trauma centers in 2013 and compared these findings with the data for 2011. Patients transfused with at least 3 units of packed red blood cells (PRBCs) within 24 hours of an accident were included in the study. In 2011, patients with significant hemorrhaging were treated with early administration of plasma with the aim of achieving a high (≥1:2) plasma-to-PRBC ratio. In 2013, the ECS protocol was the treatment strategy. Outcome data, blood product consumption and treatment costs were compared between the two periods. RESULTS: The two groups were well matched for demographics, injury severity (ISS: 32.9 in 2011 versus 33.6 in 2013) and clinical and laboratory data on admission. In 2013, a 40% overall reduction in PRBCs was observed, together with a 65% reduction in plasma and a 52% reduction in platelets. Patients in the ECS group received fewer blood products: 6.51 units of PRBCs versus 8.14 units. Plasma transfusions decreased from 8.98 units to 4.21 units (P <0.05), and platelets fell from 4.14 units to 2.53 units (P <0.05). Mortality in 2013 was 13.5% versus 20% in 2011 (13 versus 26 hospital deaths, respectively) (nonsignificant). When costs for blood components, factors and point-of-care tests were compared, a €76,340 saving in 2013 versus 2011 (23%) was recorded. CONCLUSIONS: The introduction of the ECS protocol in two Italian trauma centers was associated with a marked reduction in blood product consumption, reaching statistical significance for plasma and platelets, and with a non-significant trend toward a reduction in early and 28-day mortality. The overall costs for transfusion and coagulation support (including point-of-care tests) decreased by 23% between 2011 and 2013.

Management of hemodynamically unstable pelvic trauma: results of the first Italian consensus conference (cooperative guidelines of the Italian Society of Surgery, the Italian Association of Hospital Surgeons, the Multi-specialist Italian Society of Young Surgeons, the Italian Society of Emergency Surgery and Trauma, the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care, the Italian Society of Orthopaedics and Traumatology, the Italian Society of Emergency Medicine, the Italian Society of Medical Radiology -Section of Vascular and Interventional Radiology- and the World Society of Emergency Surgery).

Hemodynamically Unstable Pelvic Trauma is a major problem in blunt traumatic injury. No cosensus has been reached in literature on the optimal treatment of this condition. We present the results of the First Italian Consensus Conference on Pelvic Trauma which took place in Bergamo on April 13 2013. An extensive review of the literature has been undertaken by the Organizing Committee (OC) and forwarded to the Scientific Committee (SC) and the Panel (JP). Members of them were appointed by surgery, critical care, radiology, emergency medicine and orthopedics Italian and International societies: the Italian Society of Surgery, the Italian Association of Hospital Surgeons, the Multi-specialist Italian Society of Young Surgeons, the Italian Society of Emergency Surgery and Trauma, the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care, the Italian Society of Orthopaedics and Traumatology, the Italian Society of Emergency Medicine, the Italian Society of Medical Radiology, Section of Vascular and Interventional Radiology and the World Society of Emergency Surgery. From November 2012 to January 2013 the SC undertook the critical revision and prepared the presentation to the audience and the Panel on the day of the Conference. Then 3 recommendations were presented according to the 3 submitted questions. The Panel voted the recommendations after discussion and amendments with the audience. Later on a email debate took place until December 2013 to reach a unanimous consent. We present results on the 3 following questions: which hemodynamically unstable patient needs an extraperitoneal pelvic packing? Which hemodynamically unstable patient needs an external fixation? Which hemodynamically unstable patient needs emergent angiography? No longer angiography is considered the first therapeutic maneuver in such a patient. Preperitoneal pelvic packing and external fixation, preceded by pelvic binder have a pivotal role in the management of these patients.Hemodynamically Unstable Pelvic Trauma is a frequent death cause among people who sustain blunt trauma. We present the results of the First Italian Consensus Conference.

Changes in the outcomes of severe trauma patients from 15-year experience in a Western European trauma ICU of Emilia Romagna region (1996-2010). A population cross-sectional survey study.

BACKGROUND: Our experience in trauma center management increased over time and improved with development of better logistics, optimization of structural and technical resources. In addition recent Government policy in safety regulations for road traffic accident (RTA) prevention, such compulsory helmet use (2000) and seatbelt restraint (2003) were issued with aim of decreasing mortality rate for trauma. INTRODUCTION: The evaluation of their influence on mortality during the last 15 years can lead to further improvements. METHODS: In our level I trauma center, 60,247 trauma admissions have been recorded between 1996 and 2010, with 2183 deaths (overall mortality 3.6 %). A total of 2,935 trauma patients with ISS >16 have been admitted to Trauma ICU and recorded in a prospectively collected database (1996-2010). Blunt trauma occurred in 97.1 % of the cases, whilst only 2.5 % were penetrating. A retrospective review of the outcomes was carried out, including mortality, cause of death, morbidity and length of stay (LOS) in the intensive care unit (ICU), with stratification of the outcome changes through the years. Age, sex, mechanism, glasgow coma scale (GCS), systolic blood pressure (SBP), respiratory rate (RR), revised trauma score (RTS), injury severity score (ISS), pH, base excess (BE), as well as therapeutic interventions (i.e., angioembolization and number of blood units transfused in the first 24 h), were included in univariate and multivariate analyses by logistic regression of mortality predictive value. RESULTS: Overall mortality through the whole period was 17.2 %, and major respiratory morbidity in the ICU was 23.3 %. A significant increase of trauma admissions has been observed (before and after 2001, p < 0.01). Mean GCS (10.2) increased during the period (test trend p < 0.05). Mean age, ISS (24.83) and mechanism did not change significantly, whereas mortality rate decreased showing two marked drops, from 25.8 % in 1996, to 18.3 % in 2000 and again down to 10.3 % in 2004 (test trend p < 0.01). Traumatic brain injury (TBI) accounted for 58.4 % of the causes of death; hemorrhagic shock was the death cause in 28.4 % and multiple organ failure (MOF)/sepsis in 13.2 % of the patients. However, the distribution of causes of death changed during the period showing a reduction of TBI-related and increase of MOF/sepsis (CTR test trend p < 0.05). Significant predictors of mortality in the whole group were year of admission (p < 0.05), age, hemorrhagic shock and SBP at admission, ISS and GCS, pH and BE (all p < 0.01). In the subgroup of patients that underwent emergency surgery, the same factors confirmed their prognostic value and remained significant as well as the adjunctive parameter of total amount of blood units transfused (p < 0.05). Surgical time (mean 71 min) showed a significant trend towards reduction but did not show significant association with mortality (p = 0.06). CONCLUSION: Mortality of severe trauma decreased significantly during the last 15 years as well as mean GCS improved whereas mean ISS remained stable. The new safety regulations positively influenced incidence and severity of TBI and seemed to improve the outcomes. ISS seems to be a better predictor of outcome than RTS.

Operating room data management: improving efficiency and safety in a surgical block.

BACKGROUND: European Healthcare Systems are facing a difficult period characterized by increasing costs and spending cuts due to economic problems. There is the urgent need for new tools which sustain Hospitals decision makers work. This project aimed to develop a data recording system of the surgical process of every patient within the operating theatre. The primary goal was to create a practical and easy data processing tool to give hospital managers, anesthesiologists and surgeons the information basis to increase operating theaters efficiency and patient safety. METHODS: The developed data analysis tool is embedded in an Oracle Business Intelligence Environment, which processes data to simple and understandable performance tachometers and tables. The underlying data analysis is based on scientific literature and the projects teams experience with tracked data. The system login is layered and different users have access to different data outputs depending on their professional needs. The system is divided in the tree profile types Manager, Anesthesiologist and Surgeon. Every profile includes subcategories where operators can access more detailed data analyses. The first data output screen shows general information and guides the user towards more detailed data analysis. The data recording system enabled the registration of 14.675 surgical operations performed from 2009 to 2011. RESULTS: Raw utilization increased from 44% in 2009 to 52% in 2011. The number of high complexity surgical procedures (≥120 minutes) has increased in certain units while decreased in others. The number of unscheduled procedures performed has been reduced (from 25% in 2009 to 14% in 2011) while maintaining the same percentage of surgical procedures. The number of overtime events decreased in 2010 (23%) and in 2011 (21%) compared to 2009 (28%) and the delays expressed in minutes are almost the same (mean 78 min). The direct link found between the complexity of surgical procedures, the number of unscheduled procedures and overtime show a positive impact of the project on OR management. Despite a consistency in the complexity of procedures (19% in 2009 and 21% in 2011), surgical groups have been successful in reducing the number of unscheduled procedures (from 25% in 2009 to 14% in 2011) and overtime (from 28% in 2009 to 21% in 2011). CONCLUSIONS: The developed project gives healthcare managers, anesthesiologists and surgeons useful information to increase surgical theaters efficiency and patient safety. In difficult economic times is possible to develop something that is of some value to the patient and healthcare system too.

Is the TMPM-ICD9 revolution in trauma risk-adjustment compatible with imperfect administrative coding?

BACKGROUND: TMPM-ICD9 is the latest injury-severity measure based on empirical estimation from ICD-9-CM codes. It is candidate to replace expert-based AIS measures worldwide because of easier accessibility and better predictive performances. In Italy and other countries administrative ICD coding is generally less complete than dedicated AIS coding. We attempted to ascertain how this affects TMPM performances. METHODS: Discrimination (c statistics) and calibration (calibration curves, Akaike's criterion) of hierarchical logistic regression models for hospital mortality comprising TMPM or ISS were compared using trauma-registry data on 3570 patients of years 2007-2009. The completeness of AIS vs. ICD-9-CM coding was also investigated through the ratio of the respective numbers of codes per patient. Model discrimination was further analyzed after stratification according to the above ratio (>1 and ≤ 1). RESULTS: The models with TMPM showed worse performances. The differences, concerned calibration (graphical evidence) in univariate models and discrimination (-1.2% of area under the ROC curve, p<0.05) in models completed with age, gender, mechanism of injury, motor GCS and systolic pressure. In parallel, ICD coding was less complete than AIS, as expected: 68% of patients had a ratio >1. The discrimination of TMPM vs. ISS models improved when the ratio changed from >1 to ≤ 1. CONCLUSIONS: The predictive performances of TMPM-ICD9 vs. ISS were lower than in the previous studies; the sub-optimal quality of ICD coding was a main cause. Imperfect administrative coding may hence hamper the TMPM-ICD9 revolution, although in our setting the negligible differences and the ready availability of administrative data may still give reason for adopting TMPM-ICD9.

Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study.

Understanding the sites of pharyngeal collapse is mandatory for surgical treatment decision-making in obstructive sleep-apnea-hypopnea syndrome patients. Drug-induced sleep endoscopy (DISE) allows for the direct observation of the upper airway during sedative-induced sleep. In order to re-create snoring and apnea patterns related to a spontaneous sleep situation, the authors used a target-controlled infusion (TCI) sleep endoscopy (DISE-TCI), comparing this technique to conventional DISE, in which sedation was reached by a manual bolus injection. The authors conducted a prospective, randomized, unicenter study. The apneic event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plans of DISE-TCI technique. From January 2009 to June 2009, 40 OSAHS patients were included in the study and randomized allocated in two groups: the bolus injection conventional DISE group and the DISE-TCI group. We recorded the complete apnea event at the oropharynx and hypopharynx levels in 4 patients of the conventional DISE group (20%) and in 17 patients of the DISE-TCI group (85%) (P < 0.0001). Two patients needed oxygen in the conventional DISE group because of severe desaturation that resulted from the first bolus of propofol (1 mg/kg) (P = 0.4872 ns). We recorded the instability of the sedation plan in 13 patients from the conventional DISE group (65%) and 1 patient from the DISE-TCI group (5%) (P = 0.0001). Our results suggest that the DISE-TCI technique should be the first choice in performing sleep endoscopy because of its increased accuracy, stability and safety.