Marja A. Boermeester

Effect of a Comprehensive Surgical Safety System on Patient Outcomes

BACKGROUNDnAdverse events in patients who have undergone surgery constitute a large proportion of iatrogenic illnesses. Most surgical safety interventions have focused on the operating room. Since more than half of all surgical errors occur outside the operating room, it is likely that a more substantial improvement in outcomes can be achieved by targeting the entire surgical pathway.nnnMETHODSnWe examined the effects on patient outcomes of a comprehensive, multidisciplinary surgical safety checklist, including items such as medication, marking of the operative side, and use of postoperative instructions. The checklist was implemented in six hospitals with high standards of care. All complications occurring during admission were documented prospectively. We compared the rate of complications during a baseline period of 3 months with the rate during a 3-month period after implementation of the checklist, while accounting for potential confounders. Similar data were collected from a control group of five hospitals.nnnRESULTSnIn a comparison of 3760 patients observed before implementation of the checklist with 3820 patients observed after implementation, the total number of complications per 100 patients decreased from 27.3 (95% confidence interval [CI], 25.9 to 28.7) to 16.7 (95% CI, 15.6 to 17.9), for an absolute risk reduction of 10.6 (95% CI, 8.7 to 12.4). The proportion of patients with one or more complications decreased from 15.4% to 10.6% (P<0.001). In-hospital mortality decreased from 1.5% (95% CI, 1.2 to 2.0) to 0.8% (95% CI, 0.6 to 1.1), for an absolute risk reduction of 0.7 percentage points (95% CI, 0.2 to 1.2). Outcomes did not change in the control hospitals.nnnCONCLUSIONSnImplementation of this comprehensive checklist was associated with a reduction in surgical complications and mortality in hospitals with a high standard of care. (Netherlands Trial Register number, NTR1943.).

A Step-up Approach or Open Necrosectomy for Necrotizing Pancreatitis

BACKGROUNDnNecrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death. Standard treatment is open necrosectomy. The outcome may be improved by a minimally invasive step-up approach.nnnMETHODSnIn this multicenter study, we randomly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment. The step-up approach consisted of percutaneous drainage followed, if necessary, by minimally invasive retroperitoneal necrosectomy. The primary end point was a composite of major complications (new-onset multiple-organ failure or multiple systemic complications, perforation of a visceral organ or enterocutaneous fistula, or bleeding) or death.nnnRESULTSnThe primary end point occurred in 31 of 45 patients (69%) assigned to open necrosectomy and in 17 of 43 patients (40%) assigned to the step-up approach (risk ratio with the step-up approach, 0.57; 95% confidence interval, 0.38 to 0.87; P=0.006). Of the patients assigned to the step-up approach, 35% were treated with percutaneous drainage only. New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy (12% vs. 40%, P=0.002). The rate of death did not differ significantly between groups (19% vs. 16%, P=0.70). Patients assigned to the step-up approach had a lower rate of incisional hernias (7% vs. 24%, P=0.03) and new-onset diabetes (16% vs. 38%, P=0.02).nnnCONCLUSIONSnA minimally invasive step-up approach, as compared with open necrosectomy, reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue. (Current Controlled Trials number, ISRCTN13975868.)

Development and validation of the SURgical PAtient Safety System (SURPASS) checklist

Introduction: A large number of preventable adverse events are encountered during hospital admission and in particular around surgical procedures. Checklists may well be effective in surgery to prevent errors and adverse events. We developed, validated and evaluated a SURgical PAtient Safety System (SURPASS) checklist. Methods: A prototype checklist was constructed based on literature on surgical errors and adverse events, and on human-factors literature. The items on the theory-based checklist were validated by comparison with process deviations (safety risk events) during real-time observation of the surgical pathway. Subsequently, the usability of the checklist was evaluated in daily clinical practice. Results: The multidisciplinary SURPASS checklist accompanies the patient during each step of the surgical pathway and is completed by different members of the team. During 171 high-risk surgical procedures, 593 process deviations were observed. Of the deviations suitable for coverage by a checklist, 96% corresponded to an item on the checklist. Users were generally positive about the checklist, but a number of logistic improvements were suggested. Conclusion: The SURPASS checklist covers the vast majority of process deviations suitable for checklist assessment and can be applied in clinical practice relatively simply. SURPASS is the first validated patient safety checklist for the entire surgical pathway.

Nature and timing of incidents intercepted by the SURPASS checklist in surgical patients

Introduction More than half of in-hospital adverse events can be attributed to a surgical discipline. Checklists can effectively decrease errors and adverse events. However, the mechanisms by which checklists lead to increased safety are unclear. This study aimed to assess the number, nature and timing of incidents intercepted by use of the Surgical Patient Safety System (SURPASS) checklist, a patient-specific multidisciplinary checklist that covers the entire surgical patient pathway. Methods The checklist was implemented in two academic hospitals and four teaching hospitals in the Netherlands. Users of the checklist had three options for each item that was checked: ‘not applicable’, ‘yes’ and ‘intercepted by checklist’. In each hospital, the first 1000 completed checklists were entered into an online central database. Results In six participating hospitals, 6313 checklists were collected. One or more incidents were intercepted in 2562 checklists (40.6%). In total, 6312 incidents were intercepted. After correction for the number of items and the extent of adherence in each part of the checklist, the number of intercepted incidents was highest in the preoperative and postoperative stages. Conclusions The checklist intercepts many potentially harmful incidents across all stages of the surgical patient pathway. The majority of incidents were intercepted in the preoperative and postoperative stages of the pathway. The degree to which these incidents would have been intercepted by a single checklist in the operating room only, compared with a checklist for the entire surgical pathway, remains a subject for future study.

Graded compression ultrasonography and computed tomography in acute colonic diverticulitis: Meta-analysis of test accuracy

The purpose was to investigate the diagnostic accuracy of graded compression ultrasonography (US) and computed tomography (CT) in diagnosing acute colonic diverticulitis (ACD) in suspected patients. We performed a systematic review and meta-analysis of the accuracy of CT and US in diagnosing ACD. Study quality was assessed with the QUADAS tool. Summary estimates of sensitivity and specificity were calculated using a bivariate random effects model. Six US studies evaluated 630 patients, and eight CT studies evaluated 684 patients. Overall, their quality was moderate. We did not identify meaningful sources of heterogeneity in the study results. Summary sensitivity estimates were 92% (95% CI: 80%-97%) for US versus 94% (95%CI: 87%-97%) for CT (pu2009=u20090.65). Summary specificity estimates were 90% (95%CI: 82%-95%) for US versus 99% (95%CI: 90%-100%) for CT (pu2009=u20090.07). For the identification of alternative diseases sensitivity ranged between 33% and 78% for US and between 50% and 100% for CT. The currently best available evidence shows no statistically significant difference in accuracy of US and CT in diagnosing ACD. Therefore, both US and CT can be used as initial diagnostic tool until new evidence is brought forward. However, CT is more likely to identify alternative diseases.

Intestinal barrier dysfunction in a randomized trial of a specific probiotic composition in acute pancreatitis

Objectives:To determine the relation between intestinal barrier dysfunction, bacterial translocation, and clinical outcome in patients with predicted severe acute pancreatitis and the influence of probiotics on these processes. Summary of Background data:Randomized, placebo-controlled, multicenter trial on probiotic prophylaxis (Ecologic 641) in patients with predicted severe acute pancreatitis (PROPATRIA). Methods:Excretion of intestinal fatty acid binding protein (IFABP, a parameter for enterocyte damage), recovery of polyethylene glycols (PEGs, a parameter for intestinal permeability), and excretion of nitric oxide (NOx, a parameter for bacterial translocation) were assessed in urine of 141 patients collected 24 to 48 h after start of probiotic or placebo treatment and 7 days thereafter. Results:IFABP concentrations in the first 72 hours were higher in patients who developed bacteremia (P = 0.03), infected necrosis (P = 0.01), and organ failure (P = 0.008). PEG recovery was higher in patients who developed bacteremia (PEG 4000, P = 0.001), organ failure (PEG 4000, P < 0.0001), or died (PEG 4000, P = 0.009). Probiotic prophylaxis was associated with an increase in IFABP (median 362 vs. 199 pg/mL; P = 0.02), most evidently in patients with organ failure (P = 0.001), and did not influence intestinal permeability. Overall, probiotics decreased NOx (P = 0.05) but, in patients with organ failure, increased NOx (P = 0.001). Conclusions:Bacteremia, infected necrosis, organ failure, and mortality were all associated with intestinal barrier dysfunction early in the course of acute pancreatitis. Overall, prophylaxis with this specific combination of probiotic strains reduced bacterial translocation, but was associated with increased bacterial translocation and enterocyte damage in patients with organ failure.

Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]

BackgroundInfected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.Methods/DesignThe TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4xa0year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6xa0months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.DiscussionThe TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.

Factors associated with posttraumatic stress symptoms in a prospective cohort of patients after abdominal sepsis: a nomogram

ObjectiveTo determine to what extent patients who have survived abdominal sepsis suffer from symptoms of posttraumatic stress disorder (PTSD) and depression, and to identify potential risk factors for PTSD symptoms.Design and settingPTSD and depression symptoms were measured using the Impact of Events Scale–Revised (IES-R), the Post-Traumatic Symptom Scale 10 (PTSS-10) and the Beck Depression Inventory II (BDI-II).Patients and participantsAxa0total of 135 peritonitis patients were eligible for this study, of whom 107 (80%) patients completed the questionnaire. The median APACHE-II score was 14 (range 12–16), and 89% were admitted to the ICU.Measurements and resultsThe proportion of patients with “moderate” PTSD symptom scores was 28% (95% CI 20–37), whilst 10% (95% CIxa06–17) of patients had “high” PTSD symptom scores. Only 5% (95% CIxa02–12) of the patients expressed severe depression symptoms. Factors associated with increased PTSD symptoms in axa0multivariate ordinal regression model were younger age (0.74 per 10 years older, pu202f=u202f0.082), length of ICU stay (ORu202f=u202f1.4 per doubling of duration, pu202f=u202f0.003) and having some (ORu202f=u202f4.9, pu202f=u202f0.06) or many (ORu202f=u202f55.5, pu202f<u202f0.001) traumatic memories of the ICU or hospital stay.ConclusionAs many as 38% of patients after abdominal sepsis report elevated levels of PTSD symptoms on at least one of the questionnaires. Our nomogram may assist in identifying patients at increased risk for developing symptoms of PTSD.

Clinical outcome in relation to timing of surgery in chronic pancreatitis: a nomogram to predict pain relief

OBJECTIVEnTo evaluate the effect of timing of surgery on the long-term clinical outcome of surgery in chronic pancreatitis (CP).nnnDESIGNnCohort study with long-term follow-up.nnnSETTINGnFive specialized academic centers.nnnPATIENTSnPatients with CP treated surgically for pain.nnnINTERVENTIONSnPancreatic resection and drainage procedures for pain relief.nnnMAIN OUTCOME MEASURESnPain relief (pain visual analogue score ≤4), pancreatic function, and quality of life.nnnRESULTSnWe included 266 patients with median follow-up of 62 months (interquartile range, 31-112). Results were presented as odds ratios (ORs)with 95% confidence intervals after correction for bias using bootstrap-corrected analysis. Pain relief was achieved in 149 patients (58%). Surgery within 3 years of symptoms was independently associated with more pain relief (OR, 1.8; 95% CI, 1.0-3.4; P = .03) and less endocrine pancreatic insufficiency (OR, 0.57; 95% CI, 0.33-0.96; P = .04). More pain relief was also observed in patients not taking opioids preoperatively (OR, 2.1; 95% CI, 1.2-4.0; P = .006) and who had 5 or fewer endoscopic treatments prior to surgery (OR, 2.5; 95% CI, 1.1-6.3; P = .04). The probability of achieving pain relief varied between 23% and 75%, depending on these risk factors.nnnCONCLUSIONSnThe timing of surgery is an important risk factor for clinical outcome in CP. Surgery may need to be considered at an earlier phase than it is now, preferably within 3 years of symptomatic CP. Likelihood of postoperative pain relief can be calculated on an individual basis using the presented nomogram.

Activation of factor VII-activating protease in human inflammation: a sensor for cell death

IntroductionCell death is a central event in the pathogenesis of sepsis and is reflected by circulating nucleosomes. Circulating nucleosomes were suggested to play an important role in inflammation and were demonstrated to correlate with severity and outcome in sepsis patients. We recently showed that plasma can release nucleosomes from late apoptotic cells. Factor VII-activating protease (FSAP) was identified to be the plasma serine protease responsible for nucleosome release. The aim of this study was to investigate FSAP activation in patients suffering from various inflammatory diseases of increasing severity.MethodsWe developed ELISAs to measure FSAP-C1-inhibitor and FSAP-α2-antiplasmin complexes in plasma. FSAP-inhibitor complexes were measured in the plasma of 20 adult patients undergoing transhiatal esophagectomy, 32 adult patients suffering from severe sepsis and 8 from septic shock and 38 children suffering from meningococcal sepsis.ResultsWe demonstrate plasma FSAP to be activated upon contact with apoptotic and necrotic cells by an assay detecting complexes between FSAP and its target serpins α2-antiplasmin and C1-inhibitor, respectively. By means of that assay we demonstrate FSAP activation in post-surgery patients, patients suffering from severe sepsis, septic shock and meningococcal sepsis. Levels of FSAP-inhibitor complexes correlate with nucleosome levels and correlate with severity and mortality in these patients.ConclusionsThese results suggest FSAP activation to be a sensor for cell death in the circulation and that FSAP activation in sepsis might be involved in nucleosome release, thereby contributing to lethality.