The incidence and nature of in-hospital adverse events: a systematic review

INTRODUCTION: Adverse events in hospitals constitute a serious problem with grave consequences. Many studies have been conducted to gain an insight into this problem, but a general overview of the data is lacking. We performed a systematic review of the literature on in-hospital adverse events. METHODS: A formal search of Embase, Cochrane and Medline was performed. Studies were reviewed independently for methodology, inclusion and exclusion criteria and endpoints. Primary endpoints were incidence of in-hospital adverse events and percentage of preventability. Secondary endpoints were adverse event outcome and subdivision by provider of care, location and type of event. RESULTS: Eight studies including a total of 74 485 patient records were selected. The median overall incidence of in-hospital adverse events was 9.2%, with a median percentage of preventability of 43.5%. More than half (56.3%) of patients experienced no or minor disability, whereas 7.4% of events were lethal. Operation- (39.6%) and medication-related (15.1%) events constituted the majority. We present a summary of evidence-based interventions aimed at these categories of events. CONCLUSIONS: Adverse events during hospital admission affect nearly one out of 10 patients. A substantial part of these events are preventable. Since a large proportion of the in-hospital events are operation- or drug-related, interventions aimed at preventing these events have the potential to make a substantial differenc

The SURgical PAtient Safety System (SURPASS) checklist optimizes timing of antibiotic prophylaxis

Background: Surgical site infection (SSI) is an adverse event in which a close relation between process of care and outcome has been demonstrated: administration of antibiotic prophylaxis decreases the risk of SSI. In our tertiary referral centre, a SURgical PAtient Safety System (SURPASS) checklist was developed and implemented. This multidisciplinary checklist covers the entire surgical pathway and includes, among other items, administration of antibiotic prophylaxis before induction of anaesthesia. The aim of this study was to determine the effect of SURPASS implementation on timing of antibiotic prophylaxis. Methods: A retrospective analysis was performed on two cohorts of patients: one cohort of surgical patients that underwent surgery before implementation of the checklist and a comparable cohort after implementation. The interval between administration of antibiotic prophylaxis and incision was compared between the two cohorts. Results: A total of 772 surgical procedures were included. More than half of procedures were gastro-intestinal; others were vascular, trauma and hernia repair procedures. After implementation, the checklist was used in 81.4 % of procedures. The interval between administration of antibiotic prophylaxis and incision increased from 23.9 minutes before implementation of SURPASS to 29.9 minutes after implementation (p = 0.047). In procedures where the checklist was used, the interval increased to 32.9 minutes (p = 0.004). The proportion of patients that did not receive antibiotics until after the incision decreased significantly. Conclusion: The use of the SURPASS checklist leads to better compliance with regard to the timing of antibiotic prophylaxis administration

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Conservative Treatment in Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment

Background: Recently published studies advocate a conservative approach with observation and antibiotic treatment in diverticulitis patients with pericolic air on computed tomography (CT). The primary aim of this study was to assess the clinical course of initially conservatively treated diverticulitis patients with isolated pericolic air and to identify risk factors for conservative treatment failure. The secondary aim was to assess the outcome of non-antibiotic treatment. Methods: Patient data from a retrospective cohort study on risk factors for complicated diverticulitis were combined with data from the DIABOLO trial, a randomised controlled trial comparing non-antibiotic with antibiotic treatment in patients with uncomplicated diverticulitis. The present study identified all patients with Hinchey 1A diverticulitis with isolated pericolic air on CT. Pericolic air was defined as air located < 5 cm from the affected segment of colon. The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation. A multivariable logistic regression of clinical, radiological and laboratorial parameters with respect to treatment failure was performed. Results: A total of 109 patients were included in the study. Fifty-two (48%) patients were treated with antibiotics. Nine (8%) patients failed conservative management, seven (13%) in the antibiotic treatment group and two (4%) in the non-antibiotic group (p = 0.083). Only (increased) CRP level at presentation was an independent predictor for treatment failure. Conclusions: Conservative treatment in diverticulitis patients with isolated pericolic air is a suitable treatment strategy. Moreover, non-antibiotic treatment might be reasonable in selected patients

Sensor technologies for quality control in engineered tissue manufacturing

The use of engineered cells, tissues, and organs has the opportunity to change the way injuries and diseases are treated. Commercialization of these groundbreaking technologies has been limited in part by the complex and costly nature of their manufacture. Process-related variability and even small changes in the manufacturing process of a living product will impact its quality. Without real-time integrated detection, the magnitude and mechanism of that impact are largely unknown. Real-time and non-destructive sensor technologies are key for in-process insight and ensuring a consistent product throughout commercial scale-up and/or scale-out. The application of a measurement technology into a manufacturing process requires cell and tissue developers to understand the best way to apply a sensor to their process, and for sensor manufacturers to understand the design requirements and end-user needs. Furthermore, sensors to monitor component cells’ health and phenotype need to be compatible with novel integrated and automated manufacturing equipment. This review summarizes commercially relevant sensor technologies that can detect meaningful quality attributes during the manufacturing of regenerative medicine products, the gaps within each technology, and sensor considerations for manufacturing

Assessment of available evidence in the management of gallbladder and bile duct stones:a systematic review of international guidelines

BACKGROUND: Gallstone disease is a frequent disorder in the Western world with a prevalence of 10-20%. Recommendations for the assessment and management of gallstones vary internationally. The aim of this systematic review was to assess quality of guideline recommendations for treatment of gallstones. METHODS: PubMed, EMBASE and websites of relevant associations were systematically searched. Guidelines without a critical appraisal of literature were excluded. Quality of guidelines was determined using the AGREE II instrument. Recommendations without consensus or with low level of evidence were considered to define problem areas and clinical research gaps. RESULTS: Fourteen guidelines were included. Overall quality of guidelines was low, with a mean score of 57/100 (standard deviation 19). Five of 14 guidelines were considered suitable for use in clinical practice without modifications. Ten recommendations from all included guidelines were based on low level of evidence and subject to controversy. These included major topics, such as definition of symptomatic gallstones, indications for cholecystectomy and intraoperative cholangiography. CONCLUSION: Only five guidelines on gallstones are evidence-based and of a high quality, but even in these controversy exists on important topics. High quality evidence is needed in specific areas before an international guideline can be developed and endorsed worldwide

Imaging strategies for detection of urgent conditions in patients with acute abdominal pain: diagnostic accuracy study

Objective To identify an optimal imaging strategy for the accurate detection of urgent conditions in patients with acute abdominal pain

A randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in patients with symptomatic gallstones (SECURE trial protocol)

BACKGROUND: Five to 22 % of the adult Western population has gallstones. Among them, 13 to 22 % become symptomatic during their lifetime. Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. Remarkably, cholecystectomy provides symptom relief in only 60-70 % of patients. The objective of this trial is to compare the effectiveness of usual (operative) care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. DESIGN AND METHODS: The SECURE-trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound proven gallstones or sludge. If patients meet the inclusion criteria they will be randomized to either usual care or the restrictive strategy. Patients in the usual care group will be treated according to the physician's knowledge and preference. Patients in the restrictive care group will be treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy. In this stepwise selection, patients strictly meeting the preselected criteria for symptomatic cholecystolithiasis will be offered a cholecystectomy. Patients not meeting these criteria will be assessed for other diagnoses and re-evaluated at 3-monthly intervals. Follow-up consists of web-based questionnaires at 3, 6, 9 and 12 months. The main end point of this trial is defined as the proportion of patients being pain-free at 12 months follow-up. Pain will be assessed with the Izbicki Pain Score and Gallstone Symptom Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, the association between the patients' symptoms and treatment and work performance, and ultimately, cost-effectiveness. DISCUSSION: The SECURE trial is the first randomized controlled trial examining the effectiveness of usual care versus restrictive care in patients with symptomatic gallstones. The outcome of this trial will inform clinicians whether a more restrictive strategy can minimize persistent pain in post-operative patients at least as good as usual care does, but at a lower cholecystectomy rate. (The Netherlands National Trial Register NTR4022, 17th December 2012) TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022 http://www.zonmw.nl/nl/projecten/project-detail/scrutinizing-inefficient-use-of-c holecystectomy-a-randomized-trial-concerning-variation-in-practi/samenvatting/

United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU)

There have been substantial improvements in the management of chronic pancreatitis, leading to the publication of several national guidelines during recent years. In collaboration with United European Gastroenterology, the working group on 'Harmonizing diagnosis and treatment of chronic pancreatitis across Europe' (HaPanEU) developed these European guidelines using an evidence-based approach.Twelve multidisciplinary review groups performed systematic literature reviews to answer 101 predefined clinical questions. Recommendations were graded using the Grading of Recommendations Assessment, Development and Evaluation system and the answers were assessed by the entire group in a Delphi process online. The review groups presented their recommendations during the 2015 annual meeting of United European Gastroenterology. At this one-day, interactive conference, relevant remarks were voiced and overall agreement on each recommendation was quantified using plenary voting (Test and Evaluation Directorate). After a final round of adjustments based on these comments, a draft version was sent out to external reviewers.The 101 recommendations covered 12 topics related to the clinical management of chronic pancreatitis: aetiology (working party (WP)1), diagnosis of chronic pancreatitis with imaging (WP2 and WP3), diagnosis of pancreatic exocrine insufficiency (WP4), surgery in chronic pancreatitis (WP5), medical therapy (WP6), endoscopic therapy (WP7), treatment of pancreatic pseudocysts (WP8), pancreatic pain (WP9), nutrition and malnutrition (WP10), diabetes mellitus (WP11) and the natural course of the disease and quality of life (WP12). Using the Grading of Recommendations Assessment, Development and Evaluation system, 70 of the 101 (70%) recommendations were rated as 'strong' and plenary voting revealed 'strong agreement' for 99 (98%) recommendations.The 2016 HaPanEU/United European Gastroenterology guidelines provide evidence-based recommendations concerning key aspects of the medical and surgical management of chronic pancreatitis based on current available evidence. These recommendations should serve as a reference standard for existing management of the disease and as a guide for future clinical research